VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1563892
Sex: F
Age: 22
State: MN

Vax Date: 02/09/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Site of injection is swelling; Swelling of lymph nodes in both arms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Site of injection is swelling) and LYMPHADENOPATHY (Swelling of lymph nodes in both arms) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Site of injection is swelling) and LYMPHADENOPATHY (Swelling of lymph nodes in both arms). At the time of the report, VACCINATION SITE SWELLING (Site of injection is swelling) and LYMPHADENOPATHY (Swelling of lymph nodes in both arms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1563893
Sex: M
Age: 68
State: OK

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Really really sick after receiving the vaccine; Got all the side effects except the rash; Felt horrible; Sweating; Difficulty breathing; Feeling weak; Felt freezing cold; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Really really sick after receiving the vaccine), VACCINATION COMPLICATION (Got all the side effects except the rash), DISCOMFORT (Felt horrible), HYPERHIDROSIS (Sweating) and DYSPNOEA (Difficulty breathing) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure management. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced MALAISE (Really really sick after receiving the vaccine), VACCINATION COMPLICATION (Got all the side effects except the rash), DISCOMFORT (Felt horrible), HYPERHIDROSIS (Sweating), DYSPNOEA (Difficulty breathing), ASTHENIA (Feeling weak), CHILLS (Felt freezing cold), PYREXIA (Fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 07-Mar-2021, MALAISE (Really really sick after receiving the vaccine), VACCINATION COMPLICATION (Got all the side effects except the rash), DISCOMFORT (Felt horrible), HYPERHIDROSIS (Sweating), DYSPNOEA (Difficulty breathing), CHILLS (Felt freezing cold), PYREXIA (Fever) and NAUSEA (Nausea) had resolved. On 08-Mar-2021, ASTHENIA (Feeling weak) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications include Blood pressure medications

Other Meds:

Current Illness: Blood pressure management

ID: 1563894
Sex: F
Age: 66
State: TX

Vax Date: 01/06/2021
Onset Date: 02/03/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: burning tongue, like she ate spice food; mouth dry, like she ate metal; peeling subsided is little better; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (burning tongue, like she ate spice food), DRY MOUTH (mouth dry, like she ate metal) and SKIN EXFOLIATION (peeling subsided is little better) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included AMLODIPINE for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced TONGUE DISCOMFORT (burning tongue, like she ate spice food), DRY MOUTH (mouth dry, like she ate metal) and SKIN EXFOLIATION (peeling subsided is little better). At the time of the report, TONGUE DISCOMFORT (burning tongue, like she ate spice food), DRY MOUTH (mouth dry, like she ate metal) and SKIN EXFOLIATION (peeling subsided is little better) outcome was unknown. No treatment information was provided.

Other Meds: AMLODIPINE

Current Illness:

ID: 1563895
Sex: M
Age: 63
State: CA

Vax Date: 01/31/2021
Onset Date: 01/31/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: More than 35 days after the first dose without receiving the second dose; Sore arm - left arm; Eyelids full of water; His vision is still getting worse; not be receiving the second dose; Headache/very intense waves of headache; Felt very hyped; a little bit of vertigo but not too bad, they weren't consistent/were intermittent; have no energy/ He still feels he doesn't have the energy he used to; Was super amped out - wide awake,could not sleep; Blurred vision/ vision was very much impaired; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose), PAIN IN EXTREMITY (Sore arm - left arm), VISION BLURRED (Blurred vision/ vision was very much impaired), LACRIMATION INCREASED (Eyelids full of water) and INSOMNIA (Was super amped out - wide awake,could not sleep) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VISION BLURRED (Blurred vision/ vision was very much impaired), INSOMNIA (Was super amped out - wide awake,could not sleep), FEELING ABNORMAL (Felt very hyped), VERTIGO (a little bit of vertigo but not too bad, they weren't consistent/were intermittent), ASTHENIA (have no energy/ He still feels he doesn't have the energy he used to) and HEADACHE (Headache/very intense waves of headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose), PAIN IN EXTREMITY (Sore arm - left arm), LACRIMATION INCREASED (Eyelids full of water), CONDITION AGGRAVATED (His vision is still getting worse) and TREATMENT NONCOMPLIANCE (not be receiving the second dose). The patient was treated with IBUPROFEN (ADVILMED) at a dose of 1 dosage form. On 14-Feb-2021, VERTIGO (a little bit of vertigo but not too bad, they weren't consistent/were intermittent) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved and PAIN IN EXTREMITY (Sore arm - left arm), VISION BLURRED (Blurred vision/ vision was very much impaired), LACRIMATION INCREASED (Eyelids full of water), INSOMNIA (Was super amped out - wide awake,could not sleep), CONDITION AGGRAVATED (His vision is still getting worse), FEELING ABNORMAL (Felt very hyped), ASTHENIA (have no energy/ He still feels he doesn't have the energy he used to), TREATMENT NONCOMPLIANCE (not be receiving the second dose) and HEADACHE (Headache/very intense waves of headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication details was provided. Per report, the patient will not be receiving the second dose of the vaccine following his adverse reactions. The patient also experienced mild intermittent vertigo, and very intense waves of headache. This case was linked to MOD-2021-035367 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up document received On 13-Jul-2021: Follow-up case received including treatment medications and new events.

Other Meds:

Current Illness:

ID: 1563896
Sex: F
Age: 73
State: CA

Vax Date: 02/01/2021
Onset Date: 02/02/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Chest tightest; She felt agitation; She felt spacey; Had anxiety; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Chest tightest), CONFUSIONAL STATE (She felt spacey), ANXIETY (Had anxiety) and AGITATION (She felt agitation) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced CONFUSIONAL STATE (She felt spacey) and ANXIETY (Had anxiety). On 04-Feb-2021, the patient experienced AGITATION (She felt agitation). On 14-Feb-2021, the patient experienced CHEST DISCOMFORT (Chest tightest). On 20-Feb-2021, CONFUSIONAL STATE (She felt spacey), ANXIETY (Had anxiety) and AGITATION (She felt agitation) had resolved. At the time of the report, CHEST DISCOMFORT (Chest tightest) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1563897
Sex: F
Age: 57
State: NV

Vax Date: 02/26/2021
Onset Date: 02/28/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: pain and pressure in the left ear; right arm swelling; chills; fever; hard area at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (right arm swelling), CHILLS (chills), PYREXIA (fever), VACCINATION SITE INDURATION (hard area at injection site) and EAR PAIN (pain and pressure in the left ear) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included VITAMINS NOS. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE SWELLING (right arm swelling), CHILLS (chills), PYREXIA (fever) and VACCINATION SITE INDURATION (hard area at injection site). On 08-Mar-2021, the patient experienced EAR PAIN (pain and pressure in the left ear). At the time of the report, VACCINATION SITE SWELLING (right arm swelling), CHILLS (chills), PYREXIA (fever), VACCINATION SITE INDURATION (hard area at injection site) and EAR PAIN (pain and pressure in the left ear) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication taken Nyquil.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1563898
Sex: M
Age:
State: NJ

Vax Date: 01/08/2021
Onset Date: 03/07/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: sore arm; Itchiness at the site injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PRURITUS (Itchiness at the site injection) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PRURITUS (Itchiness at the site injection). At the time of the report, PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PRURITUS (Itchiness at the site injection) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included Advil. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563899
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: weak; fatigued; unable to get out of bed; unable to care for themself; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FATIGUE (weak), FATIGUE (fatigued), ASTHENIA (unable to get out of bed) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to care for themself) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (weak), FATIGUE (fatigued), ASTHENIA (unable to get out of bed) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to care for themself). At the time of the report, FATIGUE (weak), FATIGUE (fatigued), ASTHENIA (unable to get out of bed) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to care for themself) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No Concomitant medications were provided. No Treatment history was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-037341 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-037341:

Other Meds:

Current Illness:

ID: 1563900
Sex: F
Age: 76
State: LA

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Chills; Fever; Swollen; red; Can't walk nor stand; No strength on the legs; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Can't walk nor stand), ASTHENIA (No strength on the legs), CHILLS (Chills), PYREXIA (Fever) and SWELLING (Swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Glaucoma. Concomitant products included SIMVASTATIN, METFORMIN, ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]), OMEPRAZOLE, LEVOTHYROXINE SODIUM (SYNTHYROID), BISOPROLOL, BUSPIRONE, DENOSUMAB (PROLIA), VITAMINS NOS and ZINC for an unknown indication, LIPO FLAVONOID PLUS. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced GAIT DISTURBANCE (Can't walk nor stand) and ASTHENIA (No strength on the legs). On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), SWELLING (Swollen) and ERYTHEMA (red). At the time of the report, GAIT DISTURBANCE (Can't walk nor stand), ASTHENIA (No strength on the legs), CHILLS (Chills), PYREXIA (Fever), SWELLING (Swollen) and ERYTHEMA (red) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not provided by reporter. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds: SIMVASTATIN; METFORMIN; PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]; OMEPRAZOLE; SYNTHYROID; BISOPROLOL; BUSPIRONE; PROLIA; VITAMINS NOS; ZINC; LIPO FLAVONOID PLUS

Current Illness: Glaucoma

ID: 1563901
Sex: F
Age:
State:

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: very little red spot at the site of the injection , smaller than a bite of an insect ?; received a lower dose than the recommended; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events received a lower dose than the recommended, very little red spot at the site of the injection , smaller than a bite of an insect ?, a friend knows people who works in another pharmacy next to the one she got the vaccine , was. The patient's medical history was not provided. No relevant concomitant medications were reported. On 3 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 3 Mar 2021, the patient experienced the event(s) received a lower dose than the recommended . On 8 Mar 2021, the patient experienced the event(s) very little red spot at the site of the injection . smaller than a bite of an insect ?. On an unknown date, the patient experienced the event(s) A friend knows people who works in another pharmacy next to the one she got the vaccine . was. Treatment details included No. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), received a lower dose than the recommended, very little red spot at the site of the injection ,smaller than a bite of an insect ?,a friend knows people who works in another pharmacy next to the one she got the vaccine ,was was unknown.

Other Meds:

Current Illness:

ID: 1563902
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: patient might have received saline instead of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient might have received saline instead of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (no reported medical history). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient might have received saline instead of vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (patient might have received saline instead of vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant information not provided. Treatment information not provided

Other Meds:

Current Illness:

ID: 1563903
Sex: M
Age: 66
State:

Vax Date: 02/14/2021
Onset Date: 02/14/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: oximetry reading 91 and now reads 96; congestion in the morning and evening; occasional night sweats; possible strep throat; Swallowing difficult; severe sore throat; coughed up flehm; headache; low grade fever 100.0; cough; some chills; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), COUGH (cough), OROPHARYNGEAL PAIN (severe sore throat), COUGH (coughed up flehm) and PHARYNGITIS STREPTOCOCCAL (possible strep throat) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 15-Feb-2021, the patient experienced CHILLS (some chills). On 23-Feb-2021, the patient experienced COUGH (cough). On 24-Feb-2021, the patient experienced HEADACHE (headache) and PYREXIA (low grade fever 100.0). On 25-Feb-2021, the patient experienced COUGH (coughed up flehm). On 26-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (severe sore throat), PHARYNGITIS STREPTOCOCCAL (possible strep throat) and DYSPHAGIA (Swallowing difficult). On 08-Mar-2021, the patient experienced NASAL CONGESTION (congestion in the morning and evening) and NIGHT SWEATS (occasional night sweats). On an unknown date, the patient experienced OXYGEN SATURATION (oximetry reading 91 and now reads 96). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Sore throat, at a dose of Unknown; AZITHROMYCIN ongoing since an unknown date for Streptococcal sore throat, at a dose of Unknown and DEXAMETHASONE ongoing since an unknown date for Streptococcal sore throat, at a dose of Unknown. On 15-Feb-2021, PAIN IN EXTREMITY (soreness in arm) and CHILLS (some chills) had resolved. On 25-Feb-2021, HEADACHE (headache) and PYREXIA (low grade fever 100.0) had resolved. On 27-Feb-2021, COUGH (cough) and OROPHARYNGEAL PAIN (severe sore throat) had resolved. On 28-Feb-2021, COUGH (coughed up flehm) had resolved. At the time of the report, PHARYNGITIS STREPTOCOCCAL (possible strep throat), NASAL CONGESTION (congestion in the morning and evening), NIGHT SWEATS (occasional night sweats), OXYGEN SATURATION (oximetry reading 91 and now reads 96) and DYSPHAGIA (Swallowing difficult) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Patient states that he indeed experience those symptoms which occurred about 6 days later (after his first shot) because he tested positive for COVID19. So in his opinion these symptoms had nothing to do with a reaction to the Moderna shot (he did experience a slightly sore arm on the first shot) all the other symptoms mentioned occurred after he got COVID19. Note: About 4 days after he got COVID19 he went to a hospital to get injected with antibodies. So he actually experienced three events within about 10 days: His first Moderna shot, testing positive with COVID19, and going to the hospital to get the antibody shot. Patient received his second Moderna shot 42 days later, and the only symptoms he felt was a very very sore arm and he felt really lethargic the second day. Because his symptoms were not from the Moderna shot, he said that he will not fill out the attachment. Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant Follow up: Added lab data and information about events.

Other Meds:

Current Illness:

ID: 1563904
Sex: F
Age: 74
State: OR

Vax Date: 02/26/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Itchy; Rash on the site of the vaccination and about 7 inches long and 4 or 5 inches wide, very irregular; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash on the site of the vaccination and about 7 inches long and 4 or 5 inches wide, very irregular) and VACCINATION SITE SWELLING (Swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE for Thyroid disorder, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash on the site of the vaccination and about 7 inches long and 4 or 5 inches wide, very irregular) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash on the site of the vaccination and about 7 inches long and 4 or 5 inches wide, very irregular) and VACCINATION SITE SWELLING (Swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment related information has been reported. This case was linked to US-MODERNATX, INC.-MOD-2021-101746 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Patient's contact details, action taken, Product-Event details tab with action taken, Dechallenge and rechallenge was updated. Extra Events with same PT was deleted and were merged together into single event (Vaccination Site Rash) and Patient's Date of birth was added.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-101746:2nd dose

Other Meds: VITAMIN D 2000; MULTIVITAMIN [VITAMINS NOS]; LEVOTHYROXINE

Current Illness: Penicillin allergy

ID: 1563905
Sex: F
Age:
State: TX

Vax Date: 02/27/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: There is blood underneath area above on the shoulder from the injection site; It is itchy in area above on the shoulder from the injection site; One week after receiving 1st dose, patient noticed swelling above on the shoulder from the injection site; Redness above on the shoulder from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (One week after receiving 1st dose, patient noticed swelling above on the shoulder from the injection site), ERYTHEMA (Redness above on the shoulder from the injection site), VACCINATION SITE HAEMORRHAGE (There is blood underneath area above on the shoulder from the injection site) and VACCINATION SITE PRURITUS (It is itchy in area above on the shoulder from the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. Concomitant products included GABAPENTIN, CALCIUM, CYANOCOBALAMIN (VITAMIN B-12), POTASSIUM, BISOPROLOL, Thyroid medication and SIMVASTATIN for an unknown indication. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced SWELLING (One week after receiving 1st dose, patient noticed swelling above on the shoulder from the injection site), ERYTHEMA (Redness above on the shoulder from the injection site) and VACCINATION SITE PRURITUS (It is itchy in area above on the shoulder from the injection site). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (There is blood underneath area above on the shoulder from the injection site). At the time of the report, SWELLING (One week after receiving 1st dose, patient noticed swelling above on the shoulder from the injection site), ERYTHEMA (Redness above on the shoulder from the injection site), VACCINATION SITE HAEMORRHAGE (There is blood underneath area above on the shoulder from the injection site) and VACCINATION SITE PRURITUS (It is itchy in area above on the shoulder from the injection site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: GABAPENTIN; CALCIUM; VITAMIN B-12; POTASSIUM; BISOPROLOL; Thyroid medication; SIMVASTATIN

Current Illness:

ID: 1563906
Sex: M
Age: 51
State: NY

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: tenderness in my lymph nodes in my arm/left groin I feel some tenderness; soreness in my arm; left groin I feel some pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness in my lymph nodes in my arm/left groin I feel some tenderness), PAIN IN EXTREMITY (soreness in my arm), GROIN PAIN (left groin I feel some pain) and HEADACHE (headache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. Concomitant products included EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) for an unknown indication. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced HEADACHE (headache). On 07-Mar-2021, the patient experienced TENDERNESS (tenderness in my lymph nodes in my arm/left groin I feel some tenderness), PAIN IN EXTREMITY (soreness in my arm) and GROIN PAIN (left groin I feel some pain). At the time of the report, TENDERNESS (tenderness in my lymph nodes in my arm/left groin I feel some tenderness), PAIN IN EXTREMITY (soreness in my arm), GROIN PAIN (left groin I feel some pain) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: TRUVADA

Current Illness:

ID: 1563907
Sex: U
Age:
State: NM

Vax Date: 01/08/2021
Onset Date: 01/07/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: mobilized and gave ALL 100 vaccines; excursion; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (excursion) and PRODUCT USE ISSUE (mobilized and gave ALL 100 vaccines) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PRODUCT STORAGE ERROR (excursion). On 08-Jan-2021, the patient experienced PRODUCT USE ISSUE (mobilized and gave ALL 100 vaccines). On 07-Jan-2021, PRODUCT STORAGE ERROR (excursion) outcome was unknown. On 08-Jan-2021, PRODUCT USE ISSUE (mobilized and gave ALL 100 vaccines) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant Medications were provided by Reporter

Other Meds:

Current Illness:

ID: 1563908
Sex: F
Age:
State: OH

Vax Date: 02/06/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: no energy at all; aches and pains; fever over 105 for like 5 days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy at all), PAIN (aches and pains) and PYREXIA (fever over 105 for like 5 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (no energy at all), PAIN (aches and pains) and PYREXIA (fever over 105 for like 5 days). At the time of the report, ASTHENIA (no energy at all), PAIN (aches and pains) and PYREXIA (fever over 105 for like 5 days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant Medications were provided by Reporter No treatment Medications were provided by Reporter Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563909
Sex: F
Age: 30
State: GA

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028L20A) for COVID-19 vaccination. The patient's past medical history included Stomach flu. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and POLYCARBOPHIL CALCIUM (FIBER) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Dec-2020 and the estimated date of delivery was 02-Oct-2021. On 19-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the third week of the pregnancy. On 18-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: unknown (Positive) Positive pregnancy.. Treatment information was not provided.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; FIBER

Current Illness:

ID: 1563910
Sex: F
Age:
State: RI

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Mild cough; Shortness of breath; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath) and COUGH (Mild cough) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 072M204) for COVID-19 vaccination. Concomitant products included OMEPRAZOLE and CARISOPRODOL (SOMA [CARISOPRODOL]) for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath). On 06-Feb-2021, the patient experienced COUGH (Mild cough). At the time of the report, DYSPNOEA (Shortness of breath) and COUGH (Mild cough) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment includes inhaler fovent

Other Meds: OMEPRAZOLE; SOMA [CARISOPRODOL]

Current Illness:

ID: 1563911
Sex: M
Age:
State: NJ

Vax Date: 03/04/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: swelling at injection site; pain at injection site; fatigue; Nauseous; dizzy; mental fog; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEELING ABNORMAL (mental fog), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (pain at injection site) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (Dizzy), FEELING ABNORMAL (mental fog) and NAUSEA (Nauseous). On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (pain at injection site) and FATIGUE (fatigue). At the time of the report, DIZZINESS (Dizzy), FEELING ABNORMAL (mental fog), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue) and NAUSEA (Nauseous) outcome was unknown. Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Reporter Contact information updated

Other Meds:

Current Illness:

ID: 1563912
Sex: F
Age:
State: MA

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Swelling; Hardness; Pink Dots; Moderna Vaccine Administered in right Thigh; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), INDURATION (Hardness), MACULE (Pink Dots) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Moderna Vaccine Administered in right Thigh) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (no reported medical history). On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 03-Feb-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Moderna Vaccine Administered in right Thigh). On 11-Feb-2021, the patient experienced SWELLING (Swelling), INDURATION (Hardness) and MACULE (Pink Dots). On 03-Feb-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Moderna Vaccine Administered in right Thigh) had resolved. On 15-Feb-2021, SWELLING (Swelling), INDURATION (Hardness) and MACULE (Pink Dots) had resolved. Not Provided Concomitant information not provided. Treatment included "Cortizone-10" - Self medicating to try to alleviate symptoms. "Cold Compress" - Self medicating to try to alleviate the symptoms This case was linked to MOD-2021-037401 (Patient Link).

Other Meds:

Current Illness:

ID: 1563913
Sex: F
Age: 46
State: LA

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Felt weak; Felt kind of funny; Lethargic; Dizzy where she almost had an incidence of falling while getting up; Chronic fatigue; Tenderness under her arm in the lymph node; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Felt weak), INAPPROPRIATE AFFECT (Felt kind of funny), LETHARGY (Lethargic) and DIZZINESS (Dizzy where she almost had an incidence of falling while getting up) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (Dizziness), FATIGUE (Chronic fatigue) and LYMPH NODE PAIN (Tenderness under her arm in the lymph node). On 06-Mar-2021, the patient experienced ASTHENIA (Felt weak), INAPPROPRIATE AFFECT (Felt kind of funny), LETHARGY (Lethargic) and DIZZINESS (Dizzy where she almost had an incidence of falling while getting up). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. On 06-Mar-2021, DIZZINESS (Dizzy where she almost had an incidence of falling while getting up) outcome was unknown. At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Felt weak), INAPPROPRIATE AFFECT (Felt kind of funny), LETHARGY (Lethargic), FATIGUE (Chronic fatigue) and LYMPH NODE PAIN (Tenderness under her arm in the lymph node) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1563914
Sex: F
Age: 28
State: OH

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: rash has ballooned to take up most of arm; kind of itchy; hot; hard; very red; rash; very tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (rash has ballooned to take up most of arm), PRURITUS (kind of itchy), FEELING HOT (hot), MASS (hard) and ERYTHEMA (very red) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FATIGUE (very tired). On 05-Mar-2021, the patient experienced SWELLING (rash has ballooned to take up most of arm), PRURITUS (kind of itchy), FEELING HOT (hot), MASS (hard), ERYTHEMA (very red) and RASH (rash). On 25-Feb-2021, FATIGUE (very tired) had resolved. At the time of the report, SWELLING (rash has ballooned to take up most of arm), PRURITUS (kind of itchy), FEELING HOT (hot), MASS (hard), ERYTHEMA (very red) and RASH (rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant Medications were provided by Reporter No Treatment Medications were provided by Reporter

Other Meds:

Current Illness:

ID: 1563915
Sex: M
Age: 67
State: VA

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: He had a temperature of 104.5F on Friday, Saturday, and Sunday; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (He had a temperature of 104.5F on Friday, Saturday, and Sunday) and MYALGIA (body aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (He had a temperature of 104.5F on Friday, Saturday, and Sunday) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, PYREXIA (He had a temperature of 104.5F on Friday, Saturday, and Sunday) had resolved. On 08-Mar-2021, MYALGIA (body aches) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication: Ibuprofen

Other Meds: ULORIC; PRAVASTATIN; LISINOPRIL

Current Illness:

ID: 1563916
Sex: F
Age: 81
State: NC

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: sick; couldn't eat; couldn't get out of bed; tremendous headache; joint pains; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), DECREASED APPETITE (couldn't eat), FATIGUE (couldn't get out of bed), HEADACHE (tremendous headache) and ARTHRALGIA (joint pains) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ILLNESS (sick), DECREASED APPETITE (couldn't eat), FATIGUE (couldn't get out of bed), HEADACHE (tremendous headache), ARTHRALGIA (joint pains), CHILLS (chills) and NAUSEA (nausea). On 06-Feb-2021, ILLNESS (sick), DECREASED APPETITE (couldn't eat), FATIGUE (couldn't get out of bed), HEADACHE (tremendous headache), ARTHRALGIA (joint pains), CHILLS (chills) and NAUSEA (nausea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient contracted the COVID-19 virus in September 2020, and was hospitalized from 26Sep2020 to 30Sep2020. No Concomitant Medications were provided by Reporter

Other Meds:

Current Illness:

ID: 1563917
Sex: F
Age: 53
State: TX

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: njection site is red; injection site is itchy; injection site is the size of a golf ball; injection site soreness/injection site tenderness; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site soreness/injection site tenderness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (njection site is red), INJECTION SITE PRURITUS (injection site is itchy) and INJECTION SITE HYPERTROPHY (injection site is the size of a golf ball) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site soreness/injection site tenderness) and INJECTION SITE SWELLING (injection site swelling). On 07-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (njection site is red), INJECTION SITE PRURITUS (injection site is itchy) and INJECTION SITE HYPERTROPHY (injection site is the size of a golf ball). At the time of the report, VACCINATION SITE PAIN (injection site soreness/injection site tenderness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (njection site is red), INJECTION SITE PRURITUS (injection site is itchy) and INJECTION SITE HYPERTROPHY (injection site is the size of a golf ball) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant Medications were provided by Reporter No Treatment Medications were provided by Reporter Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563918
Sex: M
Age:
State: NY

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: headache; shivering; HOT; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (shivering), FEELING HOT (HOT) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), CHILLS (shivering), FEELING HOT (HOT) and INFLUENZA LIKE ILLNESS (flu like symptoms). On 07-Mar-2021, HEADACHE (headache), CHILLS (shivering), FEELING HOT (HOT) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. treatment included Tylenol every 6 hrs. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: TCR attached

Other Meds: TYLENOL

Current Illness:

ID: 1563919
Sex: F
Age: 65
State: IL

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Hot then cold; She says she couldn't stand; Really fatigued day after 1st dose; maybe with fever after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE FLUCTUATION (Hot then cold), MUSCULAR WEAKNESS (She says she couldn't stand), FATIGUE (Really fatigued day after 1st dose) and PYREXIA (maybe with fever after 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination. The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL, CLONIDINE, LOSARTAN, MONTELUKAST, SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced BODY TEMPERATURE FLUCTUATION (Hot then cold), MUSCULAR WEAKNESS (She says she couldn't stand), FATIGUE (Really fatigued day after 1st dose) and PYREXIA (maybe with fever after 1st dose). At the time of the report, BODY TEMPERATURE FLUCTUATION (Hot then cold), MUSCULAR WEAKNESS (She says she couldn't stand), FATIGUE (Really fatigued day after 1st dose) and PYREXIA (maybe with fever after 1st dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Reporter did not allow further contact

Other Meds: METOPROLOL; CLONIDINE; LOSARTAN; MONTELUKAST; VENTOLIN ACCUHALER; SYMBICORT

Current Illness:

ID: 1563920
Sex: M
Age: 72
State:

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: sick; chest pain; tired; body aches all over; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), CHEST PAIN (chest pain), FATIGUE (tired) and MYALGIA (body aches all over) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ILLNESS (sick), CHEST PAIN (chest pain), FATIGUE (tired) and MYALGIA (body aches all over). On 18-Feb-2021, FATIGUE (tired) outcome was unknown. At the time of the report, ILLNESS (sick), CHEST PAIN (chest pain) and MYALGIA (body aches all over) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant Medications were provided by Reporter. No treatment Medications were provided by Reporter.

Other Meds:

Current Illness:

ID: 1563921
Sex: M
Age:
State: IA

Vax Date: 02/19/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: low energy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The patient's past medical history included Kidney transplant. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (low energy) and FATIGUE (Fatigue). The patient was treated with CYCLOSPORINE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ASTHENIA (low energy) and FATIGUE (Fatigue) had resolved. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up : Updated patient info and events outcome as resolved.

Other Meds:

Current Illness:

ID: 1563922
Sex: F
Age: 79
State: OH

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: they both felt like flu-like symptoms; achy; no appetite; her right arm extremely sore; loss of taste; tired/exhaustion; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), PAIN (achy), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (her right arm extremely sore) and AGEUSIA (loss of taste) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), PAIN (achy), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (her right arm extremely sore), AGEUSIA (loss of taste), FATIGUE (tired/exhaustion), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVEL) at an unspecified dose and frequency. On 06-Mar-2021, INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), PAIN (achy), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (her right arm extremely sore), AGEUSIA (loss of taste), FATIGUE (tired/exhaustion), CHILLS (chills) and HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1563923
Sex: M
Age: 69
State:

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: closing in on esophagus; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGEAL ACHALASIA (closing in on esophagus) and PAIN (Soreness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included BENAZEPRIL, AMLODIPINE, AMITRIPTYLINE and CLORAZEPATE DIPOTASSIUM (CLORAZEPATE) for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced OESOPHAGEAL ACHALASIA (closing in on esophagus) and PAIN (Soreness). At the time of the report, OESOPHAGEAL ACHALASIA (closing in on esophagus) and PAIN (Soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment includes Calming Exercises

Other Meds: BENAZEPRIL; AMLODIPINE; AMITRIPTYLINE; CLORAZEPATE

Current Illness:

ID: 1563924
Sex: F
Age:
State: TX

Vax Date: 01/17/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Missed second dose, more than 36 days difference from first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose, more than 36 days difference from first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose, more than 36 days difference from first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose, more than 36 days difference from first dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-Jun-2021 and does not contain any new information. Updated reporter E-mail; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot #: Not provided) with no associated AEs.

Other Meds:

Current Illness:

ID: 1563925
Sex: F
Age:
State: CA

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: felt very lethargic; started feeling tingling of tongue, face and neck immediately and it is still there; face has burning sensation; fatigue; she had abdominal discomfort; nausea; felt as if she was going to faint right away; diarrhea; patient became red,; Patient started with blurred vision in her left eye 2 days later; her tongue went numb; her heartrate accelerated (115 pulse); This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (patient became red,), ABDOMINAL DISCOMFORT (she had abdominal discomfort), VISION BLURRED (Patient started with blurred vision in her left eye 2 days later), HYPOAESTHESIA ORAL (her tongue went numb) and HEART RATE INCREASED (her heartrate accelerated (115 pulse)) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VISION BLURRED (Patient started with blurred vision in her left eye 2 days later), HYPOAESTHESIA ORAL (her tongue went numb) and HEART RATE INCREASED (her heartrate accelerated (115 pulse)). On 03-Mar-2021, the patient experienced ERYTHEMA (patient became red,), PRESYNCOPE (felt as if she was going to faint right away), DIARRHOEA (diarrhea) and NAUSEA (nausea). On 04-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (she had abdominal discomfort). On an unknown date, the patient experienced LETHARGY (felt very lethargic), PARAESTHESIA ORAL (started feeling tingling of tongue, face and neck immediately and it is still there), BURNING SENSATION (face has burning sensation) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) (intramuscular) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) (intramuscular) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (patient became red,), ABDOMINAL DISCOMFORT (she had abdominal discomfort), VISION BLURRED (Patient started with blurred vision in her left eye 2 days later), HYPOAESTHESIA ORAL (her tongue went numb), HEART RATE INCREASED (her heartrate accelerated (115 pulse)), PRESYNCOPE (felt as if she was going to faint right away), DIARRHOEA (diarrhea), LETHARGY (felt very lethargic), PARAESTHESIA ORAL (started feeling tingling of tongue, face and neck immediately and it is still there), BURNING SENSATION (face has burning sensation), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non significant follow up. Adverse event contact information was updated

Other Meds:

Current Illness:

ID: 1563926
Sex: F
Age:
State: MA

Vax Date: 02/03/2021
Onset Date: 02/11/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Pink-Red Dots; Swelling; Moderna Vaccine Administered in Thigh; Hardness; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Hardness), MACULE (Pink-Red Dots), SWELLING (Swelling) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Moderna Vaccine Administered in Thigh) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced INDURATION (Hardness) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Moderna Vaccine Administered in Thigh). On 06-Mar-2021, the patient experienced MACULE (Pink-Red Dots) and SWELLING (Swelling). On 15-Feb-2021, INDURATION (Hardness) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Moderna Vaccine Administered in Thigh) had resolved. At the time of the report, MACULE (Pink-Red Dots) and SWELLING (Swelling) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant information not provided. Treatment included "Cortizone-10" - Self medicating to try to alleviate symptoms "Cold Compress" - Self medicating to try to alleviate the symptoms

Other Meds:

Current Illness:

ID: 1563927
Sex: F
Age: 63
State: NY

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: Acid reflux; Burning in feet extending upwards; Burning in chest; Burning in lips and tongue; Elevated Blood pressure; Elevated pulse; Feeling Aweful; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning in feet extending upwards), BURNING SENSATION (Burning in chest), TONGUE DISCOMFORT (Burning in lips and tongue), BLOOD PRESSURE INCREASED (Elevated Blood pressure) and HEART RATE INCREASED (Elevated pulse) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced BURNING SENSATION (Burning in feet extending upwards), BURNING SENSATION (Burning in chest), TONGUE DISCOMFORT (Burning in lips and tongue), BLOOD PRESSURE INCREASED (Elevated Blood pressure), HEART RATE INCREASED (Elevated pulse) and FEELING ABNORMAL (Feeling Aweful). On 09-Jan-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ALUMINIUM HYDROXIDE GEL, MAGNESIUM HYDROXIDE, SIMETICONE (ANTACID [ALUMINIUM HYDROXIDE GEL;MAGNESIUM HYDROXIDE;SIMETICONE]) at an unspecified dose and frequency. On 11-Jan-2021, BURNING SENSATION (Burning in feet extending upwards), BURNING SENSATION (Burning in chest), TONGUE DISCOMFORT (Burning in lips and tongue), BLOOD PRESSURE INCREASED (Elevated Blood pressure) and HEART RATE INCREASED (Elevated pulse) had resolved. At the time of the report, FEELING ABNORMAL (Feeling Aweful) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products include Beta blockers for blood pressure

Other Meds:

Current Illness:

ID: 1563928
Sex: F
Age: 70
State:

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: itchy; soreness; swelling; rash all over; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), RASH (rash all over), PRURITUS (itchy) and ARTHRALGIA (soreness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced SWELLING (swelling), RASH (rash all over) and ARTHRALGIA (soreness). On 05-Mar-2021, the patient experienced PRURITUS (itchy). On 25-Feb-2021, SWELLING (swelling), RASH (rash all over) and ARTHRALGIA (soreness) had resolved. At the time of the report, PRURITUS (itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment information include Hydrocortisone cream.

Other Meds:

Current Illness:

ID: 1563929
Sex: F
Age: 51
State: TX

Vax Date: 01/12/2021
Onset Date: 02/11/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: inappropriate schedule; shingles; Pain in the chest area; Itching; Pain back; Fatigue useless; Pain arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), CHEST PAIN (Pain in the chest area), FATIGUE (Fatigue useless), PRURITUS (Itching) and VACCINATION SITE PAIN (Pain arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced RASH (Rash). On 12-Feb-2021, the patient experienced FATIGUE (Fatigue useless), PRURITUS (Itching), VACCINATION SITE PAIN (Pain arm) and BACK PAIN (Pain back). On 26-Feb-2021, the patient experienced HERPES ZOSTER (shingles) and CHEST PAIN (Pain in the chest area). On 08-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule ). On 13-Feb-2021, FATIGUE (Fatigue useless), PRURITUS (Itching), VACCINATION SITE PAIN (Pain arm) and BACK PAIN (Pain back) had resolved. At the time of the report, HERPES ZOSTER (shingles), CHEST PAIN (Pain in the chest area), RASH (Rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule ) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment information include Lyrica, Steroid pack,Valtrex

Other Meds:

Current Illness:

ID: 1563930
Sex: F
Age: 68
State: FL

Vax Date: 02/03/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Injection site turned green; Injection site turned black/Injection site turned blue purple; sore all day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore all day), VACCINATION SITE BRUISING (Injection site turned black/Injection site turned blue purple) and VACCINATION SITE DISCOLOURATION (Injection site turned green) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 038K20A) for COVID-19 vaccination. Concomitant products included LOVASTATIN, LEVOTHYROXINE and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore all day). On 04-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Injection site turned black/Injection site turned blue purple). On 08-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Injection site turned green). At the time of the report, PAIN IN EXTREMITY (sore all day), VACCINATION SITE BRUISING (Injection site turned black/Injection site turned blue purple) and VACCINATION SITE DISCOLOURATION (Injection site turned green) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact

Other Meds: LOVASTATIN; LEVOTHYROXINE; FOSAMAX

Current Illness:

ID: 1563931
Sex: M
Age: 75
State: CO

Vax Date: 03/06/2021
Onset Date: 03/07/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: irregular heartbeats; joints hurting real bad; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joints hurting real bad) and HEART RATE IRREGULAR (irregular heartbeats) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The patient's past medical history included Heart disorder (a 20 year history of irregular heartbeats), Open heart surgery (7 to 8 years ago) and Cardiac ablation (7 to 8 years ago). On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 07-Mar-2021, the patient experienced ARTHRALGIA (joints hurting real bad) and HEART RATE IRREGULAR (irregular heartbeats). The patient was treated with PARACETAMOL (TYLENOL) for Joint pain, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPRIN) for Joint pain, at an unspecified dose and frequency. On 08-Mar-2021, ARTHRALGIA (joints hurting real bad) and HEART RATE IRREGULAR (irregular heartbeats) had resolved. No Concomitant Medications were provided by Reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563932
Sex: F
Age: 77
State: GA

Vax Date: 02/15/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: rash in her mouth and throat; This spontaneous case was reported by a physician and describes the occurrence of ORAL MUCOSAL ERUPTION (rash in her mouth and throat) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL MUCOSAL ERUPTION (rash in her mouth and throat). At the time of the report, ORAL MUCOSAL ERUPTION (rash in her mouth and throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563933
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: severe headache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (severe headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced HEADACHE (severe headache). At the time of the report, HEADACHE (severe headache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Medications were provided by Reporter. No Treatment Medications were provided by Reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563934
Sex: F
Age:
State: FL

Vax Date: 03/02/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: "Moderna Arm"; Arm was incredibly hot; Arm red; Arm swollen; Barely sleep for 10 days; COVID ARM; Itchy; Uncomfortable rash on my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("Moderna Arm"), FEELING HOT (Arm was incredibly hot), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen) and INSOMNIA (Barely sleep for 10 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medication history was provided. Concurrent medical conditions included Rosacea. Concomitant products included SPIRONOLACTONE from 01-Jan-2018 to an unknown date for Rosacea. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY ("Moderna Arm"), FEELING HOT (Arm was incredibly hot), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), INSOMNIA (Barely sleep for 10 days), VACCINATION SITE REACTION (COVID ARM), PRURITUS (Itchy) and RASH (Uncomfortable rash on my arm). On 12-Mar-2021, INSOMNIA (Barely sleep for 10 days) had resolved. On 14-Mar-2021, PAIN IN EXTREMITY ("Moderna Arm"), FEELING HOT (Arm was incredibly hot), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), VACCINATION SITE REACTION (COVID ARM), PRURITUS (Itchy) and RASH (Uncomfortable rash on my arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No laboratory details were provided. No treatment medications were reported. This case was linked to MOD-2021-125639 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: ADR form attached on 10-may-2021, new events were added, updated outcome

Other Meds: SPIRONOLACTONE

Current Illness:

ID: 1563935
Sex: F
Age: 84
State: TX

Vax Date: 02/22/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Brain Fog; dizziness; unsteadiness; inability to think; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain Fog), DIZZINESS (dizziness), BALANCE DISORDER (unsteadiness) and THINKING ABNORMAL (inability to think) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced FEELING ABNORMAL (Brain Fog), DIZZINESS (dizziness), BALANCE DISORDER (unsteadiness) and THINKING ABNORMAL (inability to think). The patient was treated with DIHYDROERGOCRISTINE, LOMIFYLLINE (ANTIVERT [DIHYDROERGOCRISTINE;LOMIFYLLINE]) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Brain Fog), DIZZINESS (dizziness), BALANCE DISORDER (unsteadiness) and THINKING ABNORMAL (inability to think) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No laboratory details were provided. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Significant: Patient is feeling better nowfrom events

Other Meds:

Current Illness:

ID: 1563936
Sex: F
Age: 71
State: CA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Painful area from Injection Site to Elbow; Itching Injection Site Red Spot; Red Spot Spread From Injection Site to the elbow; Swollen area from Injection Site to Elbow; Red spot (Rash) under the Injection Site; Diarrhea; Fatigue; Pain in the Left Arm Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Painful area from Injection Site to Elbow), VACCINATION SITE PAIN (Pain in the Left Arm Injection Site), FATIGUE (Fatigue) and VACCINATION SITE PRURITUS (Itching Injection Site Red Spot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in the Left Arm Injection Site). On 18-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE RASH (Red spot (Rash) under the Injection Site). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Painful area from Injection Site to Elbow), VACCINATION SITE PRURITUS (Itching Injection Site Red Spot), RASH (Red Spot Spread From Injection Site to the elbow) and VACCINATION SITE SWELLING (Swollen area from Injection Site to Elbow). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 07-Mar-2021, PAIN IN EXTREMITY (Painful area from Injection Site to Elbow), VACCINATION SITE PAIN (Pain in the Left Arm Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site Red Spot), RASH (Red Spot Spread From Injection Site to the elbow) and VACCINATION SITE SWELLING (Swollen area from Injection Site to Elbow) had resolved. At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE RASH (Red spot (Rash) under the Injection Site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1563937
Sex: F
Age:
State: CT

Vax Date: 12/28/2020
Onset Date: 01/27/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: neck pain; weakness; mucous membranes are moist; goiter; skin is warm; Malaise; fatigue; chills; Sub-acute thryroiditis; fevers to 102; This spontaneous case was reported by a physician and describes the occurrence of THYROIDITIS SUBACUTE (Sub-acute thryroiditis), NECK PAIN (neck pain), ASTHENIA (weakness), MUCOSAL DISORDER (mucous membranes are moist) and GOITRE (goiter) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cervical spondylosis in 2018, Chest pain in November 2019, Shortness of breath in November 2019, Surgery (C-Section), Surgery (bunionectomy) and Paresthesia. Previously administered products included for an unreported indication: BCG. Family history included Breast cancer (The Patient's mother had breast cancer) and Ovarian cancer (The patients sister had ovarian cancer and she is deceased.). Concurrent medical conditions included Nephrolithiasis (The patient passed kidney stones twice approximately 10 years ago) since 2011, Migraine and Postmenopausal symptoms (For over a year). On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fevers to 102). On 28-Jan-2021, the patient experienced THYROIDITIS SUBACUTE (Sub-acute thryroiditis). On an unknown date, the patient experienced NECK PAIN (neck pain), ASTHENIA (weakness), MUCOSAL DISORDER (mucous membranes are moist), GOITRE (goiter), SKIN WARM (skin is warm), MALAISE (Malaise), FATIGUE (fatigue) and CHILLS (chills). The patient was treated with PREDNISONE for Thyroiditis, at a dose of 20 milligram once a day. On 20-May-2021, THYROIDITIS SUBACUTE (Sub-acute thryroiditis) and PYREXIA (fevers to 102) had resolved. At the time of the report, NECK PAIN (neck pain), ASTHENIA (weakness), MUCOSAL DISORDER (mucous membranes are moist), GOITRE (goiter), SKIN WARM (skin is warm), MALAISE (Malaise), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2018, Body temperature:. In May 2018, Magnetic resonance imaging: 1.1 centimeter soft tissue lesion (abnormal) 1.1 centimeter soft tissue lesion in the left posterior nasopharynx. In May 2018, Tuberculin test:. In 2018, Magnetic resonance imaging: cervical spondylosis (abnormal) Cervical Spondylosis most significant at C5-6 with sever right sided neural foraminal narrowing. On 20-Feb-2021, C-reactive protein: 2.1 (normal) CRP 2.1 normal. On 20-Feb-2021, Red blood cell sedimentation rate: 43 (High) ESR 43 high. On 03-Mar-2021, Anti-thyroid antibody: less than 28 (normal) Thyroid peroxidase antibody less than 28 normal. On 03-Mar-2021, Blood thyroid stimulating hormone: 0.011 (Low) TSH 0.011 low. On 04-Mar-2021, Ultrasound thyroid: thyroiditis (abnormal) thyroid ultrasound was consistent with thyroiditis. On an unknown date, Body temperature: 102 (High) 102. On an unknown date, Tuberculin test: negative (Inconclusive) Negative with a minimal erythematous.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient had two COVID-swab test after her second dose. In 2014 the patient underwent MRI examination of cervical spine and repeated the examination in 2018 which showed cervical spondylosis significant at C5-6. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Patient's ethnicity, race, historical condition, family history, lab data, drug dosage regimen, treatment information, event outcome and events were added

Other Meds:

Current Illness: Migraine; Nephrolithiasis (The patient passed kidney stones twice approximately 10 years ago); Postmenopausal symptoms (For over a year)

ID: 1563938
Sex: F
Age: 83
State: MI

Vax Date: 03/02/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: A spontaneous report was received from a 83-years-old female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event back ache. The patient's medical history was not provided. No relevant concomitant medications were reported. On 2 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 8 Mar 2021, the patient experienced the event back ache. Treatment details included Ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, back ache, was unknown.

Other Meds:

Current Illness:

ID: 1563939
Sex: F
Age: 77
State: CA

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Very hungry; Swelling at the injection site; Pain at the injection site; Muscle pain; Tiredness or fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (Very hungry), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain) and FATIGUE (Tiredness or fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain) and FATIGUE (Tiredness or fatigue). On 07-Mar-2021, the patient experienced HUNGER (Very hungry). On 06-Mar-2021, VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain) and FATIGUE (Tiredness or fatigue) had resolved. At the time of the report, HUNGER (Very hungry) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported No treatment medications were reported

Other Meds:

Current Illness:

ID: 1563940
Sex: M
Age:
State: FL

Vax Date: 02/04/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Extreme diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Extreme diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced DIARRHOEA (Extreme diarrhea). At the time of the report, DIARRHOEA (Extreme diarrhea) outcome was unknown. No concomitant medication nor treatment provided.

Other Meds:

Current Illness:

ID: 1563941
Sex: F
Age:
State: MD

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: NO ADVERSE EVENT; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (NO ADVERSE EVENT) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. Concurrent medical conditions included Sinus infection. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, NO ADVERSE EVENT (NO ADVERSE EVENT) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Patient was prescribed antibiotics for a sinus infection that started BEFORE the shot. Has not started taking it. Fluticasone (has been taking off an on), The dentist prescribed Augmentin and she wants to start it today 875mg 2/day for 10 days. Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2021: Additional (contact information updated)

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm