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

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1068364
Sex: F
Age: 72
State: WV

Vax Date: 02/12/2021
Onset Date: 01/13/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: All hair has fallen out; Heartburn; Nausea feeling; Passed out; Wasn't feeling right after dose; Face was tingling; Burning feeling in head; A spontaneous report was received from a Consumer regarding a ? 63Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like passed out, Wasn't feeling right after dose, face was tingling,bBurning feeling in head, devastated about hair loss after 1st dose, Heartburn and Nausea. The patient's medical history was not reported. Relevant concomitant medications were reported like amitriptyline, duloxetine, gabapentin, metformin, Nexium, hydrocodone, potassium, Proair, ropinrole, simvastatin, spironolactone, Topamax, vitamin d, vitamin b12. On 12- Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:030m20a) intramuscularly for prophylaxis of COVID-19 infection. On 12- Feb-2021, the patient experienced the event like Passed out. On an unknown, date the patient experienced events like Wasn't feeling right after dose, Face was tingling, Burning feeling in head, Devastated about hair loss after 1st dose, Heartburn nausea feeling and Nausea. Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events Passed out, Face was tingling is resolved. The outcome of the events Devastated about hair loss after 1st dose is Recovering/Resolving. The outcome of the events like Wasn't feeling right after dose, Burning feeling in head, Heartburn nausea feeling and Nausea are unkown; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 cannot be excluded. Nausea is consistent with the known safety profile of the vaccine.

Other Meds: AMITRIPTYLINE; DULOXETINE; GABAPENTIN; METFORMIN; NEXIUM 1-2-3; HYDROCODONE; POTASSIUM; PROAIR BRONQUIAL; ROPINIROLE; SIMVASTATIN; SPIRONOLACTONE; TOPAMAX; VITAMIN D 2000; VITAMIN B12 & FOLIC ACID

Current Illness:

ID: 1068365
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/03/2021
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Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: when the patient can receive the next dose given that the dose they received is expired; A spontaneous report was received from an Other Health Professional concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that the patient can receive the next dose given that the dose they received is expired. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, it was reported, when the patient can receive the next dose given that the dose they received is expired. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event was not reported.; Reporter's Comments: This report refers to a case of a patient who received Moderna's COVID-19 vaccine (mRNA-1273) (Lot # not provided) and reported that the patient can receive the next dose given that the dose they received is expired. No associated AEs were reported.

Other Meds:

Current Illness:

ID: 1068366
Sex: M
Age: 68
State: CA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 03/03/2021
Hospital:

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

Symptoms: Received the Moderna COVID vaccine past the 6 hours mark; A spontaneous report) was received from a nurse concerning a 68-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received the Moderna COVID vaccine past the 6 hours mark/expired product administered. The patient's medical history was not provided. No concomitant product use was reported. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, a nurse reported a patient received their first dose of the Moderna COVID-19 vaccine after the 6 hour mark. Per the reporter, the patient did not report any side effects. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, received the Moderna COVID vaccine past the 6 hours mark/expired product administered, was considered resolved on 26 Jan 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 042L20A) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1068367
Sex: U
Age:
State: NM

Vax Date: 01/05/2021
Onset Date: 01/27/2021
Rec V Date: 03/03/2021
Hospital:

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Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Second dose of Moderna vaccine administered on day 22; A spontaneous reportwas received from a healthcare professional (medical director) concerning two patients, age and gender not provided, who received Moderna's COVID-19 Vaccine, and who experienced receiving the second dose vaccine on day 22 (Inappropriate schedule of product administration). The patients' medical histories were not provided. Concomitant product use was not provided by the reporter. The patients received their first of two planned doses of mRNA-1273 (Batch number not provided) on 05-JAN-2021 (route of administration unknown). On 27-JAN-2021, the patients received their second of two planned doses of mRNA-1273 (Batch number not provided), route of administration unknown for prophylaxis of COVID-19 infection. A medical directer reported that at one of his facilities, two employees received their first dose of the mRNA-1273 vaccine on 05-JAN-2021. They were supposed to receive their second dose of mRNA-1273 the week of 01-FEB-2021 but got it instead on 27-JAN-2021 (day 22). The reporter questioned if the dose would be effective or would the patients need to be revaccinated. Treatment information was not provided. The patients received both doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The event, second dose of Moderna vaccine administered on day 22, was considered recovered/resolved; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated adverse events. The event occurred when the second dose was administered 23 days after the first dose of mRNA-1273. Event resolved.

Other Meds:

Current Illness:

ID: 1068368
Sex: F
Age:
State:

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 03/03/2021
Hospital:

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

Symptoms: She thinks she had Afib; Heart rate went up; Symptoms were similar to when she had COVID; Temperature of 99 degrees; Severe Headache; Very fatigued, which is unlike her; A spontaneous report was received from a Consumer concerning a unknown Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- severe headache, had a temperature of 99 degrees, was very fatigued, atrial fibrillation, increased heart rate and recurrence of Covid-19 symptoms. The patient's medical history includes Covid-19, she was on a pacemaker. Relevant concomitant medications reported include patient was taking Diltiazem 120 ER. On 26 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced severe headache, had a temperature of 99 degrees, was very fatigued, which was unlike her, she thinks she had atrial fibrillation (seriousness criteria- medically significant) and increased heart rate. She said her symptoms was similar to when she had Covid-19. Patient is on a pacemaker Laboratory details include she had a body temperature of 99 degrees. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events- severe headache, had a temperature of 99 degrees, was very fatigued, atrial fibrillation, increased heart rate and recurrence of Covid-19 symptoms was considered unknown.; Reporter's Comments: This case concerns a 72 year old, female patient, COVID (March 2020) and has a pacemaker, who experienced a serious unexpected event of Atrial fibrillation among others, 1 day after receiving 1st dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds: DILTIAZEM

Current Illness: Pacemaker insertion (cardiac) (Patient is on a pacemaker.)

ID: 1068369
Sex: U
Age:
State:

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Rec V Date: 03/03/2021
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Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: 16 year old patient accidentally received the moderna covid-19 vaccine; A spontaneous report was received from a HCP concerning a 16-years-old patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a 16-year-old patient accidentally received the Moderna Covid-19 vaccine (Product administered to patient of inappropriate age). The patient's medical history was not reported. No relevant concomitant medications were reported. On unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient experienced product administered to patient of inappropriate age. Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event is unknown.; Reporter's Comments: This case concerns a 16-year-old patient of unknown gender who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.

Other Meds:

Current Illness:

ID: 1068370
Sex: F
Age: 19
State: AZ

Vax Date: 12/30/2020
Onset Date: 01/27/2021
Rec V Date: 03/03/2021
Hospital:

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Symptom List: Pyrexia, White blood cell count decreased

Symptoms: not all the solution was injected; A spontaneous report ) was received from a healthcare provider concerning a 19-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the administration of less than 0.5mL of vaccine. The event was reported as: not all the solution was injected. The patient's medical history was not reported. No relevant concomitant medications were reported. On 20-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27-Jan-2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch:041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. While receiving the vaccine, the patient stated that all the solution was not injected. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event vaccine underdose is resolved/recovered.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273, lot # 041L20A with no associated AEs.

Other Meds:

Current Illness:

ID: 1068371
Sex: U
Age: 50
State: MD

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 03/03/2021
Hospital:

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Symptom List: Pharyngeal swelling

Symptoms: Second Moderna vaccine was injected in wrong location; swollen arm; A spontaneous report was received from a nurse concerning a 50- year-old patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273) and was injected in wrong location (inappropriate route of vaccination) and developed swollen arm(peripheral swelling). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknow date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 JAN 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route not in the deltoid muscle for prophylaxis of COVID-19 infection. On 26 JAN 2021, it was reported that the patient received second Moderna vaccine in an area that may not have been injected in deltoid muscle (injected in wrong location) and developed swollen arm (far back of arm) on the same day. On 28 JAN 2021, the patient consulted an HCP who advised patient to monitor the affected area and prescribed Benadryl, which was not applied. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The event, injected in wrong location (inappropriate route of vaccination) was considered recovered/resolved and the outcome of swollen arm(peripheral swelling) was unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event of peripheral swelling, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1068372
Sex: F
Age:
State:

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 03/03/2021
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Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: the vaccine dripped out in my arm and it was on my hand. Then they give me a very small dose about a quarter of a dose in my other arm; the vaccine dripped out in my arm and it was on my hand. Then they give me a very small dose about a quarter of a dose in my other arm; A spontaneous report received from a health care professional concerning, 39-year-old age female patient who received second dose of the Moderna COVID-19 vaccine and vaccine dripped out in my arm and it was on my hand. Then they give me a very small dose about a quarter of dose in my other are. The patient's medical history was not included. Patient's concomitant was not included. On 22 Jan 2021 date, the patient received their second dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. Patient stated that she was vaccinated with her second dose of the Moderna COVID-19 vaccine on 22 Jan 2021. Patient stated that the vaccine dripped out of her arm and it was on her hand. Patient stated they then gave her a very small dose about a quarter of a dose in her other arm. Patient wants to know if the dose was enough. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of 39-year-old female who experienced nonserious unexpected events of Exposure via skin contact and Incomplete dose administered for mRNA-1273, lot # 012L20A with no associated adverse events.

Other Meds:

Current Illness:

ID: 1068373
Sex: F
Age: 60
State: NJ

Vax Date: 01/05/2021
Onset Date: 02/02/2021
Rec V Date: 03/03/2021
Hospital:

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Symptom List: Diarrhoea, Nasal congestion

Symptoms: Lymph node enlarged at the base of neck near the shoulder; Chills; Nausea; Sore arm; patient received vaccine right below shoulder bone; A spontaneous report was received from a nurse, a 60 year old female patient who received Moderna's COVID-19 mRNA-1273 vaccine at inappropriate site of vaccination and who experienced chills (Chills), nausea (Nausea), sore arm (pain in extremity) and enlarged lymph nodes at base of neck and shoulder (Lymphadenopathy). The patient's medical history included prior dose of Covid-19 vaccination. No adverse event was reported in the medical history of the patient. Concomitant medications were not reported. On 05 Jan 2021, the patient received first of the two planned doses of mRNA-1273 (Batch number:011L20A) for the prophylaxis of Covid-19 infection. No adverse event was reported related to the first dose. On 02 Feb 2021, the prior to the onset of the events, the patient received second of their two planned doses of mRNA-1273 (Lot number:007M20A) at inappropriate site of vaccination (right below the shoulder bone). On 03 Feb 2021,the patient reported to experience chills(Chills), nausea(Nausea), sore arm(pain in extremity) and enlarged lymph nodes at base of neck and shoulder (Lymphadenopathy). Treatment for the events were not reported. The outcome of the event inappropriate site of vaccination was considered to be resolved on 08 Feb 2021. The outcome of the events chills (Chills), nausea (Nausea), sore arm (pain in extremity) and enlarged lymph nodes at base of neck and shoulder (Lymphadenopathy) was considered not resolved.; Reporter's Comments: This case concerns a 60-year-old female who had a nonserious unexpected Product administered at inappropriate site along with nonserious expected pain in extremity, lymphadenopathy, nausea, and chills. Event onset was 1 day after second dose and 29 days after first dose of mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1068374
Sex: M
Age:
State: TX

Vax Date: 01/11/2021
Onset Date: 01/29/2021
Rec V Date: 03/03/2021
Hospital:

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

Symptoms: Received 2nd dose 18 days after 1st dose; A spontaneous report report was received from pharmacists concerning a male patient (age unknown) who received the 2nd dose of the vaccine 18 days after 1st dose/inappropriate schedule of product. The patient's medical history was not provided. No current illness was reported. Concomitant product use was not provided by the reporter. On 11 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch# 007M20A) intramuscularly for prophylaxis of covid-19 infection. On 29 Jan 2021, 18 days following the first dose, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of covid-19 infection. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event is not applicable. The outcome of the event, 2nd dose of the vaccine 18 days after 1st dose, was considered resolved on 29 Jan 2021; Reporter's Comments: This report refers to a case of inappropriate schedule of product for mRNA-1273, Batch # 007M20A with no associated AEs. Causality for the medication error is not applicable.

Other Meds:

Current Illness:

ID: 1068375
Sex: F
Age:
State: DE

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 03/03/2021
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Symptom List: Rash, Urticaria

Symptoms: Fever 102.1; Chills; achy; This is a spontaneous report from two contactable healthcare professionals. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) at the age of 61 years, intramuscular on the left arm on 27Jan2021 16:15 at a single dose for COVID-19 immunization. Medical history included high blood pressure, COVID-19 and allergies to quinolones. The patient's concomitant medications were not reported. The patient is not pregnant. The patient previously took celecoxib (CELEBREX) and experienced allergies. The patient experienced fever 102.1, chills and achy on 28Jan2021 08:00. The patient did not received any treatment for the events. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1068376
Sex: M
Age:
State: NY

Vax Date: 01/25/2021
Onset Date: 01/28/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
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Allergies:

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

Symptoms: Chills; fever; nausea; vomiting; body aches/pains; fatigue; This is a spontaneous report from a contactable healthcare professional (patient himself). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), (at the age of 37-years-old) intramuscular in the left arm on 25Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history and allergies to medications, food, or other products/known allergies: were reported none. The patient's concomitant medications were not reported. The vaccine was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has not received any other medications within 2 weeks of vaccination. On 28Jan2021 at 10:30 AM, the patient experienced chills, fever, nausea, vomiting, body aches/pains, fatigue. The events were considered non-serious. The events resulted in emergency room/ department or urgent care. There was no treatment received for the adverse events. The patient has not been tested for COVID since the vaccination. The outcome of the events was not recovered at the time of report. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1068377
Sex: F
Age:
State:

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

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Allergies:

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

Symptoms: diarrhea; This is a spontaneous report from a contactable consumer (mother of the patient). A female patient of an unspecified age (age: 66, units: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported that her daughter (age 66) got a little sick after she got her vaccine. She was sick in stomach, diarrhea really bad. She didn't eat breakfast just had coffee. She had a hamburger after the vaccine and made a mess at the consumer's house. So the consumer was worried. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1068378
Sex: M
Age:
State: SC

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
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Allergies:

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

Symptoms: On Saturday morning I woke up with a large rash on my left shoulder and my upper left chest. It itches.; On Saturday morning I woke up with a large rash on my left shoulder and my upper left chest. It itches.; First dose on 11Jan2021 and second dose on 28Jan2021; First dose on 11Jan2021 and second dose on 28Jan2021; ached all over my body; I felt very weak; I had a temperature of 100.7.; This is a spontaneous report from a contactable consumer. A 30-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on his left arm, via an unspecified route of administration on 28Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included allergies to sulfa medicine. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 07:00AM for COVID-19 immunization (first dose). It was reported that approximately 12 hours after the 2nd shot, the patient felt very weak and ached all over her body. She had a temperature of 100.7. This lasted from late Thursday night until late Friday Morning. On Saturday morning, she woke up with a large rash on her left shoulder and her upper left chest. No treatment was received for the events. The outcome of all event fever was recovered on an unspecified date while recovering for the remaining events.

Other Meds:

Current Illness:

ID: 1068379
Sex: M
Age:
State: CT

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
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Allergies:

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

Symptoms: Fever; Body aches; Fatigue; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for self). A 57-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL 3247, expiry date not reported), via an unspecified route of administration on 27Jan2021 14:45 at a single dose in the right arm for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. The patient had no known allergies. Patient had no covid prior to vaccination. Concomitant medications included atorvastatin calcium (LIPITOR); ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER); and fish oil. The patient had no other vaccine in four weeks. On 28Jan2021 22:30, patient had fever, body aches, and fatigue. No treatments received in response to the events reported. The patient was not tested for covid post vaccination. The patient recovered from the events fever, body aches, and fatigue in Jan2021.

Other Meds: LIPITOR [ATORVASTATIN CALCIUM]; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;; FISH OIL

Current Illness:

ID: 1068380
Sex: F
Age:
State:

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Rec V Date: 03/03/2021
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Lab Data:

Allergies:

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

Symptoms: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had diarrhea since an unspecified date for two weeks after getting the first dose of Pfizer COVID vaccine. She took a whole bottle of Pepto Bismol. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1068381
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Mother has an internal itch; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 99, unit unknown) received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller wanted to know if there will be an interaction between the Pfizer COVID-19 vaccine and betamethasone injection. Reporter is calling for her mother who has received the first dose of the COVID-19 vaccine and is scheduled for the second dose a week from today. Because her mother has an internal itch, her mother's doctor gives her betamethasone. She had conflicting recommendations from her mother's doctors and wanted to know Pfizer's recommendations. The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1068382
Sex: F
Age:
State: CT

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Joint aches (hips); tiredness; fever 102; patient is taking anastrazole for breast cancer; patient is taking anastrazole for breast cancer; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient, who was also 53-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number: EL3247, via an unspecified route of administration on left leg on 29Jan2021 14:45 as SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer, stroke, migraines is situ melanoma, penicillin allergy, and COVID-19 prior vaccination. Concomitant medication included atorvastatin (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), anastrozole, and colecalciferol (VITAMIN D). On 30Jan2021 04:30, the patient experienced Joint aches (hips), tiredness, and fever 102 (unknown unit). The outcome of the events was recovering. No treatment given for the events. The patient has COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination.

Other Meds: LIPITOR [ATORVASTATIN]; BABY ASPIRIN; ANASTROZOLE; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1068383
Sex: F
Age:
State: IL

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Dizziness; tiredness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration (vaccine location=left arm) on 29Jan2021 12:45 at a single dose for COVID-19 immunization at a hospital. Medical history was not reported. Concomitant medications included prenatal vitamins. No other vaccine in four weeks. No covid prior vaccination. On 29Jan2021 06:30 PM (as reported), the patient experienced dizziness and tiredness, onset less than one hour post injection. Symptoms worsened into following day. No treatment received for the events. No covid test post vaccination. The outcome of the events was not recovered. Information on batch/lot number was requested.

Other Meds:

Current Illness:

ID: 1068384
Sex: F
Age:
State:

Vax Date: 01/17/2021
Onset Date:
Rec V Date: 03/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Very mild sore arm; This is a spontaneous report from a contactable consumer or (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from 17Jan2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced very mild sore arm on an unspecified date with outcome of unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1068385
Sex: F
Age:
State: TX

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Heart palpitations to the point where I could not sleep; Heart palpitations to the point where I could not sleep; Extreme fatigue; Slight headache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (brand=PFIZER), via an unspecified route of administration (vaccine location=right arm) on 28Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included breast cancer and mitral valve prolapse. She had no known allergies. Concomitant medications included celecoxib (CELEBREX). No other vaccine in four weeks. No covid prior vaccination. The patient experienced heart palpitations on 28Jan2021 10:00 PM to the point where she could not sleep - started 6-8 hours after receiving vaccine. Some better the next day but still having palpitations. Day 2 after vaccine about the same. Extreme fatigue, slight headache & sore arm but not too bad on an unspecified date in 2021. No treatment received for the events. No covid test post vaccination. The patient was recovering from heart palpitations to the point where I could not sleep while outcome of other events was unknown. Information on the lot/batch number has been requested.

Other Meds: CELEBREX

Current Illness:

ID: 1068386
Sex: F
Age:
State: MO

Vax Date:
Onset Date: 01/30/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: patient had pain in the arm that she received the vaccine; patient had pain in the arm that she received the vaccine. It was also a little swollen; the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it; the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9262, via an unspecified route of administration in the left arm, on an unspecified date at SINGLE DOSE for covid-19 immunization. Medical history included covid-19 diagnosed prior vaccination. Concomitant medication included spironolactone, linaclotide (LINZESS), paracetamol (TYLENOL) and caffeine, paracetamol (EXCEDRIN). On 30Jan2021, 20:45, the patient had pain in the arm that she received the vaccine. It was also a little swollen. As well as the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it. Outcome of events was not recovered. Patient did not receive treatment due to the events. Follow-up attempts are completed. The following information on the batch number has been obtained.

Other Meds: SPIRONOLACTONE; LINZESS; TYLENOL; EXCEDRIN

Current Illness:

ID: 1068387
Sex: F
Age:
State: FL

Vax Date: 01/22/2021
Onset Date: 01/30/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: smoked cigarettes for nearly 30 years and the day after the vaccine she lost the mental aspect of craving them; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN5318), via an unspecified route of administration into right arm on 22Jan2021 19:45 (at the age of 49-year-old) at a single dose for COVID-19 immunisation. Medical history included ongoing cigarette smoker and smoked cigarettes for nearly 30 years. Patient was not pregnant. Concomitant medication included calcium (VIACTIV), evening primrose oil [oenothera biennis oil] (EVENING PRIMROSE OIL [OENOTHERA BIENNIS OIL]), linum usitatissimum seed (FLAXSEED) and multivitamin. The patient previously took demerol and codeine and experienced drug allergy to both drugs. It was reported that the patient has smoked cigarettes for nearly 30 years and the day after the vaccine (also reported as 30Jan2021 07:00), she lost the mental aspect of craving them. She have gone from a pack a day to four or five because her body still craves them. The event was reported as non-serious. The patient has not received treatment from the event reported. Outcome of event was not recovered.

Other Meds: VIACTIV [CALCIUM]; EVENING PRIMROSE OIL [OENOTHERA BIENNIS OIL]; FLAXSEED

Current Illness: Cigarette smoker (smoked cigarettes for nearly 30 years.)

ID: 1068388
Sex: F
Age:
State: IN

Vax Date: 01/26/2021
Onset Date: 01/31/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: became totally nauseous; light headed; very chilled; extremely tired; very cold; Fell asleep under warm down quilt until 2:00pm (total 13 hours sleep); This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number en5318, Expiry date not reported) via an unspecified route of administration to left arm on 26Jan2021 08:15 at single dose for covid-19 immunization. Medical history included UTI (urinary tract infection), rosacea, severe breathing problems, no sense of taste or smell, severe bronchitis, pneumonia, productive cough (productive cough that lasted for 2 months) and known allergies: some eye drops; some pain killers (nausea). The patient became totally nauseous, light headed, very chilled, extremely tired, very cold, fell asleep under warm down quilt until 2:00pm (total 13 hours sleep) all on 31Jan2021. The events were reported as non-serious. Reporter states she Woke up 8:00 am and dressed. Felt fine until 9:00. Had some milk tea and 2 morning pills and became totally nauseous and light headed. Went back to bed immediately. Became very chilled, and extremely tired. Checked temperature at 97.5 and was very cold. Fell asleep under warm down quilt until 2:00pm (total 13 hours sleep). Felt better, but ate little and wore a coat inside. After a light dinner, nausea mostly gone, but still tired. Reporter added that she almost certainly had a serious case of Covid in early February, 2020. Nobody knew the symptoms, so both urgent care and the ER sent her home with minimal treatment. She had severe breathing problems, no sense of taste or smell, severe bronchitis with some pneumonia (X-ray), and a productive cough that lasted for 2 months. The patient underwent lab tests and procedures which included body temperature: 97.5 (Unit unspecified) on 31Jan2021 and x-ray: some pneumonia on an unspecified date. No treatment was received for the adverse event. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1068389
Sex: F
Age:
State: AL

Vax Date: 01/29/2021
Onset Date: 01/01/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: 5 minutes after receiving the COVID-19 Vaccine shot, she had generalized itching allover her body; Her heart rate was in the 140s/tachycardia; She noticed the COVID-19 Vaccine injection site had a red welt; She developed a rash on her torso first, and then she developed a rash on her neck and face; Shortness of breath; Allergic reaction; Injection site rash; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL8982, expiry: unknown), via an unspecified route of administration in the left arm on 29Jan2021 14:25 at a single dose for COVID-19 immunization at a hospital. Medical history included asthma from 2001. The patient also had history of anaphylactic reactions to bee stings and strawberries. She said her allergist tested her further and told her she has severe allergies to tomatoes and to not eat tomatoes anymore. She said she has allergies to sulfa antibiotics. She said about 10 years ago was the last time she took a sulfa antibiotic and she had hives. She said her allergist recommended she avoid sulfa antibiotics. Concomitant medication included salbutamol sulfate (PROAIR HFA; lot: DAE36A, expiry: May2021; NDC Number: 59310-5779-22) from 2001 and ongoing for asthma. The patient has no prior vaccinations within 4 weeks. The patient received her first COVID-19 vaccine shot on Friday, 29Jan2021, and had an allergic reaction (Jan2021). 5 minutes after receiving the COVID-19 vaccine shot (29Jan2021 14:30), she had generalized itching all over her body, she then had tachycardia. She was administered some medication by the staff at the site where the COVID-19 vaccine was being administered, but her allergic reaction kept progressing. She developed a rash on her torso first, and then she developed a rash on her neck and face. She then developed shortness of breath. She was brought to the hospital's Emergency Room for further treatment. She was given the oral medications Pepcid 40mg, Claritin (dose unknown), and Benadryl 25mg at the location where the COVID-19 vaccines were being administered. When she started to experience shortness of breath, she used her own personal Albuterol inhaler. When she was in the Emergency Room, she was given a shot of Epinephrine .4ml at 15:16, and a dose of Benadryl 25mg IV at 15:10. She was observed in the Emergency Room for a couple of hours and then discharged. The patient was also given a steroid dose pack for her itching, clarified as Medrol 4mg tablets. She said she is titrating down the amount of Medrol 4mg tablets (NDC Number: 59762-4440-2, Lot Number: DM4008, Expiration Date: Oct2022). The patient reported that her itching has improved, but she still has a rash on her torso. She noticed the COVID-19 vaccine injection site had a red welt first on 29Jan2021, clarifying the vaccine injection site has a rash now (2021). She said she was put on a heart monitor when her allergic reaction began to progress, and her heart rate was in the 140s, clarifying she has a heart rate of 145. She said at the time she was discharged from the Emergency Room; her heart rate was 115. She stated she has had to use her Albuterol inhaler throughout the weekend, which is more so than usual, but it is currently allergy season where she lives in. She had no blood work performed while she was being treated in the Emergency Room but did have an EKG to be on the safe side, along with monitoring of her vital signs. The outcome of the events generalized itching, rash, and shortness of breath was recovering; event tachycardia was recovered on 29Jan2021; event vaccination site rash was not recovered while the other events was unknown.

Other Meds: PROAIR HFA

Current Illness:

ID: 1068390
Sex: F
Age:
State: MO

Vax Date: 01/27/2021
Onset Date: 01/01/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Severe difficulty breathing; difficulty breathing frightened her; This is a spontaneous report from a contactable consumer (patient). A 64 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9262), intramuscular (on the upper left shoulder) on 27Jan2021 09:20 (at the age of 64-year-old), single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism diagnosed about 14 years ago, breast cancer from Dec2017 and ongoing diagnosed in Dec2017, ongoing asthma she was diagnosed with asthma when she was 39 years old, surgery from an unknown date, she had surgery to correct a deviated septum and her asthma got better, she has high blood pressure after all the treatment. Concomitant medication included salbutamol (ALBUTEROL). On 27Jan2021 she had the first injection. It was about 14 to 16 hours after the injection that she had severe difficulty breathing. Reported she has asthma. She was a cancer survivor, and she has high blood pressure after all the treatment. The difficulty breathing woke her out of her sleep. She had to call the doctor since she is concerned about her second dose which is scheduled for 17Feb2021. The difficulty breathing frightened her, and it was not an immediate reaction, she had the shot at 9:30 am (clarifies she received the injection at 09:20 am) and between 1 to 2 am in the night, she woke up not able to breathe. She could not use her inhaler since she could not really breathe in. She was obviously able to get some air in since she did not pass out. She contacted her doctor and he will send her a prescription to get an Epipen, so she has it on hand when she gets her second dose. Her doctor does not want her to not get the second dose. States she is concerned about other asthmatics receiving the vaccine and wanted to call and report this. She expected it to happen onsite where she received the injection but it did not. Her doctor asked her if she thought it was an asthma attack and she told her doctor that she has not felt like this in 24 years. Treatment/Outcome: She stepped out into the cold to shrink her airways and then was able to use her inhaler. Reports it was not a 2 hour episode thank god, and within 15 minutes she was able to force an inhaler dose in. Everything is fine. She is a breast cancer survivor and cannot use her right side so she had the injection on her left side in her upper shoulder, she has to wait 5 years to be considered cancer free. Her doctor suggested to use her albuterol inhaler for 4 days in advance of getting the second dose of the vaccine. She would think that would be abusing her albuterol but she will do that since she was instructed to do so by her doctor. She was terrified. She will have an Epipen on hand when she goes to get her second dose. She understands the symptoms can be worse with the second dose, she is anticipating everything should be fine. The outcome of the event difficulty of breathing was recovered on Jan2021, for the other event was unknown. No additional vaccines administered on same date of the Pfizer Suspect. No AE(s) following prior vaccinations, states she has had everything. No Prior Vaccinations within 4 weeks.

Other Meds: ALBUTEROL [SALBUTAMOL]

Current Illness: Asthma (she was diagnosed with asthma when she was 39 years old); Breast cancer (diagnosed in Dec2017); Hypothyroidism (diagnosed about 14 years ago)

ID: 1068391
Sex: F
Age:
State: CA

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Took advil due to her sore arm after shot.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unspecified), via an unspecified route of administration in the arm on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm. It was reported that patient took Advil due to her sore arm after shot and inquired if that would have an effect on the vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1068392
Sex: M
Age:
State:

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: feels dizzy and woosey; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer, reporting for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine this morning, on an unspecified date in Jan2021, and felt dizzy and woosey - wondering if that was normal. The outcome of the event was unknown. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1068393
Sex: M
Age:
State: TX

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Body ache; Fever about 100; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with therapy date and route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had body ache and fever at about 100 (unit was not reported). The outcome of the events, 'body ache' and 'fever', was unknown. The patient wanted to know if he could get his second dose, or if he has to start over. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1068394
Sex: F
Age:
State: NJ

Vax Date: 01/31/2021
Onset Date: 01/31/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: almost faded on the floor a while ago; This is a spontaneous report from a Pfizer Sponsored program Pfizer First Connect from a contactable consumer. A female patient (wife) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose,via an unspecified route of administration on 31Jan2021 14:45 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer's wife received Covid-19 vaccine first shot earlier today at 2:45pm and almost faded on the floor a while ago. Outcome of event was unknown. Information about Lot/Batch Number has been requested.

Other Meds:

Current Illness:

ID: 1068395
Sex: F
Age:
State: IL

Vax Date: 01/20/2021
Onset Date: 01/30/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle cramps; Swollen lymph nodes; Dizzy; Body weakness; Fatigue; Pain moving across my neck/chest/back; Pain moving across my neck/chest/back; pain moving across my neck/chest/back; Trouble sleeping; Pressure in my chest; Splotchy skin; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration, on the left arm, on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included sinusitis, placenta accreta, infertility, caesarean section, seasonal allergy, sulfa allergy, and coriander allergy all from an unknown date. The patient did not have COVID-19 prior to vaccination. The patient is not pregnant. Concomitant medication included prednisone from an unspecified date. The patient previously took hydrocodone and experienced drug allergy. The patient previously received the first dose of BNT162B2 (lot number: EL1284) on 30Dec2020 for COVID-19 immunisation and experienced left arm completely numb and tingling for 4 weeks. No other vaccines were given in four weeks. On an unspecified date after the second shot, it was reported that the patient experienced elevated BP of 166/99, nausea, heart palpitations HR 111, sweating, muscle cramps, swollen lymph nodes, dizzy, body weakness, fatigue, pain moving across the neck/chest/back, trouble sleeping, and pressure in chest. On 30Jan2021, 10 days after the second vaccination, the patient experienced splotchy skin. The events resulted in doctor clinic visit and emergency room care. The patient was given an unspecified treatment for the events. The patient was tested for COVID-19 post vaccination via nasal swab on 26Jan2021 with a negative result. The vaccine was administered in the workplace clinic. The outcome of the events were reported as recovering.; Sender's Comments: A causal association between BNT162B2 and the reported elevated blood pressure cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: PREDNISONE

Current Illness:

ID: 1068396
Sex: F
Age:
State: MN

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Hives; This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN9581, expiry date: May2021), via an unspecified route of administration on 30Jan2021 (at the age of 74-years-old) at a single dose for COVID-19 immunization. Medical history included diabetes from an unknown date and unknown if ongoing. Concomitant medication included glipizide, metformin, apixaban (ELIQUIS), flecainide, omeprazole, simvastatin, losartan, lorazepam, hydralazine. The patient received the Pfizer COVID vaccine on 30Jan2021 and ended up getting hives from it on 30Jan2021. The event started three hours after the injection. The patient received CLARITIN at 10 mg one pill as treatment. The patient underwent lab tests and procedures which included basic metabolic panel (where they check your creatinine, check your A1C, they check your kidneys and they check your back and stuff) with unknown results. The outcome of the event was recovered on 30Jan2021.

Other Meds: GLIPIZIDE; METFORMIN; ELIQUIS; FLECAINIDE; OMEPRAZOLE; SIMVASTATIN; LOSARTAN; LORAZEPAM; HYDRALAZINE

Current Illness:

ID: 1068397
Sex: M
Age:
State: TX

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Coughing blood; I went last Thursday to a COVID testing station and I tested positive; Iron was little bit low; My sugar was a little high that is because I was taking taking a steroid (Unspecified Medication); This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3248), via an unspecified route of administration (on right arm) on Jan2021 (at the age of 75-years-old), single dose for COVID-19 immunization. Medical history included diabetes from an unknown date, bypass (20 years ago). Concomitant medication included apixaban (ELIQUIS), insulin glargine (BASAGLAR). Patient went in for his COVID 'vaccine' (not clear) Shot a week ago and he has a follow up in two more weeks. He went last Thursday to a COVID testing station his wife and him and came back, tested positive. So, he went to my healthcare provider and they gave him some meds (Unspecified Medications) and he was worse than that today. So, he went to the hospital this morning (not clarified further if hospitalized or not), he was coughing up blood and they gave him some medication for that and did some chest x-rays, everything was good. He told his doctor about the COVID Shot another one scheduled in two weeks, the 14th two weeks from today and they recommended that he postpones it for three months. The patient had unspecified lab work done, and showing Iron was little bit low but nothing to be concerned about and his sugar was a little high that is because he was taking taking a steroid (Unspecified Medication). The outcome of the events was unknown.; Sender's Comments: The reported sugar high was due to unspecified concomitant steroid, and was unrelated to the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE).

Other Meds: ELIQUIS; BASAGLAR

Current Illness:

ID: 1068398
Sex: F
Age:
State:

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318; Expiration date was not reported) on 28Jan2021 (16:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient did not have relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on the left arm on 08Jan2021 (when the patient was 25 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 29Jan2021, the patient had nausea and vomiting. The patient did not receive any treatment for the reported events. The outcome of the events, nausea and vomiting, was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not tested positive post-vaccination.

Other Meds:

Current Illness:

ID: 1068399
Sex: F
Age:
State: GA

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 03/03/2021
Hospital:

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Allergies:

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

Symptoms: Chills; Injection site pain; flu; cold; Joint pain; Muscle stagnant; Where they gave me the shot the muscle goes jumping up and down; Not feeling well; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL9262 expiry date not reported, via an unspecified route of administration from 28Jan2021 at single dose for COVID-19 Immunization. Medical history included High blood pressure and Pre-diabetic. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) 12.5 mg, metformin (METFORMIN) 1000 mg, twice a day, lisinopril (LISINOPRIL) 20 mg at night, pravastatin (PRAVASTATIN) 20 mg, acetylsalicylic acid (BABY ASPIRIN) and atorvastatin calcium (ATROSTAT). The patient experienced joint pain, not feeling well and muscle stagnant; where they gave me the shot the muscle goes jumping up and down all on 29Jan2021 and chills, injection site pain, flu and cold all on unspecified date. Consumer stated, "I am having a joint pain and chills and not feeling well, I had it Thursday evening, I took it Thursday evening. I am not feeling well from that Friday night and last night I mean the joint pain, the muscle pain you know, it's just you have to deal with." Consumer added, "I have been taking pain medicines, Ibuprofen and Tramadol for pain and Mucinex for cold and flu." Therapeutic measures were taken as a result of joint pain, injection site pain, flu and cold. Outcome of the events was unknown.

Other Meds: LISINOPRIL HCTZ; METFORMIN; LISINOPRIL; PRAVASTATIN; BABY ASPIRIN; ATROSTAT

Current Illness:

ID: 1068400
Sex: F
Age:
State: CA

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

Vax Type:
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Allergies:

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

Symptoms: Injection site pain; This is a spontaneous report from a contactable nurse (patient). A 35-year-old non-pregnant female patient received first dose of BNT162B2 (brand=Pfizer), lot no. EK5730, intramuscular (right arm) on 07Jan2021 11:30 at a single dose for COVID-19 immunization at a hospital. The patient had no relevant medical history. She had no known allergies. Concomitant medication included colecalciferol (VITA D). No other vaccine in four weeks. No COVID prior vaccination. The patient experienced injection site pain on 07Jan2021 12:00 PM. No treatment received. No COVID test post vaccination. The patient recovered from injection site pain on an unspecified date.

Other Meds: VITA D [COLECALCIFEROL]

Current Illness:

ID: 1068401
Sex: F
Age:
State: TN

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
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Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: The morning after the vaccine, I woke up with a generalized rash across my abdomen, evenly dispersed across my torso. Nonpruritic.; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL9261), intramuscular in the left arm on 25Jan2021 14:00 (at the age of 35-years-old) at single dose for COVID-19 immunization in a hospital. The patient had no medical history. The patient was not pregnant. The patient had no known allergies. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) and birth control pills. The patient did not receive other vaccine in four weeks. The patient had no COVID prior to vaccination. On 26Jan2021 at 06:00 AM, the morning after the vaccine, the patient woke up with a generalized rash across her abdomen, evenly dispersed across her torso. It was nonpruritic. The patient received BENADRYL and CLARITIN as treatment for the event. The patient was not tested for COVID post vaccination. The outcome of the event was recovering.

Other Meds: VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN]

Current Illness:

ID: 1068402
Sex: F
Age:
State: CA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 03/03/2021
Hospital:

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Allergies:

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

Symptoms: Low fever; Headache; Nausea; Diarrhea; Severe muscle and bone pain; Severe muscle and bone pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunization. Vaccination was done in a health clinic. Medical history included thrombocytosis Thrombocythemia, Polycythemia Vera, Neuropathy. The patient had non known allergies. Concomitant medication included apixaban (ELIQUIS), colecalciferol (D3), hydroxycarbamide (HYDREA), pregabalin (PREGABALIN) and venlafaxine hydrochloride (EFFEXOR). On 28Jan2021, the patient experienced headache, nausea, diarrhea, severe muscle and bone pain and low fever. The outcome of the events was recovering. The patient did not have COVID-19 prior to vaccination and was not tested for VOCID-19 after the vaccination. There was no treatment for the events. Information on the lot/batch number has been requested.

Other Meds: ELIQUIS; D3; HYDREA; PREGABALIN; EFFEXOR

Current Illness:

ID: 1068403
Sex: F
Age:
State:

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
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Allergies:

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

Symptoms: Dry mouth; excessive thirst; This is a spontaneous report from a non-contactable healthcare professional (patient). A 30-year-old non-pregnant female patient received first dose of BNT162B2, via an unspecified route of administration (Vaccine location: right arm) on 29Jan2021 20:00 at a single dose for COVID-19 immunization at a hospital. Medical history included insomnia, anxiety, sebbhoreic dermatitis, and Covid prior vaccination. Concomitant medications included retinol, dandelion, melatonin, and unspecified multivitamin. No other vaccine in four weeks. On 29Jan2021 11:00 PM, the patient experienced dry mouth/excessive thirst (this is a side effect she has not yet seen listed). Every other symptom was pretty par for the course. No treatment received for the events. No Covid test post vaccination. The patient recovered from both events on an unspecified date. No follow up attempts are possible. No further information is expected.

Other Meds: RETINOL; DANDELION; MELATONIN

Current Illness:

ID: 1068404
Sex: F
Age:
State: FL

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 03/03/2021
Hospital:

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Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Dizzy; Blurred vision; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246; Expiration date was not reported) on 29Jan2021 (10:45) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the Public Health Department. Medical history included hypertension (HTN), atrial fibrillation (Afib), diabetes mellitus (DM), migraine and sulfa drug allergy. Concomitant medications included dabigatran etexilate mesilate (PRADAXA), metoprolol, montelukast sodium (SINGULAIR) and other unspecified medications. The patient previously took clarithromycin (MACROBID), and had allergies; and had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246; Expiration date was not reported) on 08Jan2021 (when the patient was 74 years old) on the right arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 29Jan2021 (21:00), the patient was dizzy; and had blurred vision. The patient did not receive any treatment for the reported events. The outcome of the events, 'dizzy' and 'blurred vision', was recovering. The patient was diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.

Other Meds: PRADAXA; METOPROLOL; SINGULAIR

Current Illness:

ID: 1068405
Sex: F
Age:
State: GA

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

Vax Type:
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Allergies:

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

Symptoms: Increased heart rate/heart rate increased to 200 beats per minute; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose in the left arm for covid-19 immunization. Medical history included high blood pressure from 2017 and ongoing, open heart surgery in Aug2017 (for two holes in her heart), complete heart valve replacement in Sep2017 (replaced with pig valve), pacemaker in Oct2017 and ongoing, thyroid condition and allergies. Concomitant medications included metoprolol from unspecified date in 2017 and ongoing for thyroid condition, amlodipine from unspecified date in 2017 and ongoing for high blood pressure and clarithromycin (CLARITIN [CLARITHROMYCIN]) from unspecified date in 2017 and ongoing for allergies. No vaccines administered on the same date or within four weeks prior to administration of bnt162b2. The patient experienced increased heart rate, four to five days following first dose on unspecified date. She was asleep when her heart rate increased to 200 beats per minute around 20:00 which woke her. She did not see it coming. She was seen in the emergency room, but not admitted to the hospital in response to this event. They did not know at that time what caused this event. While in the emergency room, the patient was given intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. She does not know the name of the intravenous medication for cardioversion that she was administered. She recovered completely from this event on unknown date. The patient underwent lab tests and procedures which included: in the emergency room visit, kidneys and heart were tested, x-ray was performed, electrocardiogram (EKG), liver and thyroid tested, all of which came back good; and her heart rhythm was fast, and irregular. Therapeutic measure was taken as a result of the event. Outcome of the event was recovered on unspecified date.

Other Meds: METOPROLOL; AMLODIPINE; CLARITIN [CLARITHROMYCIN]

Current Illness: Artificial cardiac pacemaker user; Blood pressure abnormal; Open heart surgery (for two holes in her heart)

ID: 1068406
Sex: F
Age:
State: GA

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
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Allergies:

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

Symptoms: Increased heart rate following second dose; they took her blood pressure which was 193; she feels a little lightheaded still; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm shoulder (as reported) on 29Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure from 2017 and ongoing, open heart surgery in Aug2017 (for 2 holes in the heart), complete heart valve replacement in Oct2017 and ongoing, "pacemaker" from Oct2017 and ongoing. Concomitant medication included metoprolol for thyroid condition, amlodipine for high blood pressure, clarithromycin (CLARITIN [CLARITHROMYCIN]) for allergies; all from 2017 and ongoing. Patient previously took first dose of BNT16B2 on an unspecified date for COVID-19 immunization and experienced heart rate increased. She was brought to the emergency room and they gave her an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. Family medical history included mother and sister died from lung cancer; father died of pancreatic cancer. Heart rate increased following second dose of Pfizer-BioNTech COVID-19 vaccine administered on 29Jan2021; onset of event was in the afternoon on 30Jan2021 while at work. Her heart kind of jumped, skipped a beat and then just took off; she could feel her body twerking. Her heart rate went up to 193 beats per minute. She went to the nurses station at work, they took her blood pressure which was 193-verified this as same number of bpm of heart rate-documented as provided. That nurse told her she should go to the hospital, so patient just left work and walked to the hospital which was a block away from work. She did not feel lightheaded, sick, or pain, just heart racing. She was again seen in the emergency room in response to this event, but was not admitted to the hospital. She was again given an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. She does not know the name of the intravenous medication for cardioversion that she was administered. The only thing still ongoing related to this event was that she feels a little lightheaded still. Relevant Tests: All were good. They tested her kidneys, heart did an X-ray, EKG; tested her liver and thyroid and they said everything came back good; They said her heart rhythm was fast, and irregular, but something else was normal-she does not remember what that was. She had no further details or results for testing/investigations to provide at this time. Outcome of increased heart rate was recovered while outcome of the remaining events was unknown. Information on the batch number has been requested.

Other Meds: METOPROLOL; AMLODIPINE; CLARITIN [CLARITHROMYCIN]

Current Illness: Artificial cardiac pacemaker user; Blood pressure high; Cardiac operation (Replaced with pig valve)

ID: 1068407
Sex: F
Age:
State: CA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 03/03/2021
Hospital:

Vax Type:
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Allergies:

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

Symptoms: blood pressure went up/blood pressure was 156/81/her blood pressure was 180 over 80 something; This is a spontaneous report from a contactable consumer who reported for herself, a 67-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9263), intramuscular in left arm, on 26Jan2021 at 11:00, at the age of 67 years, at a single dose for COVID-19 immunization. Medical history included ongoing high cholesterol, ongoing high blood pressure, and eyeglasses wearer. Ongoing concomitant medications included nebivolol hydrochloride (BYSTOLIC Tablet) for high blood pressure, bumetanide tablet taken as diuretic, rosuvastatin calcium (ROSUVASTIN Tablet) for high cholesterol, and acetylsalicylic acid (BABY ASPIRIN Tablet) to keep healthy. The patient reported that her blood pressure went up and is still up since last Tuesday (as reported). She received the first dose of the COVID vaccine at 11 am. She was okay until that evening around 5 pm, her blood pressure started going up, her blood pressure shot up. She called her doctor. Her doctor and her did not know if her blood pressure going up could be from the vaccine. Her doctor told her to take more of her already prescribed blood pressure medication. The next day, she went to see her doctor due to blood pressure still being high and he gave her more blood pressure medications. Her doctor prescribed a different kind of blood pressure medication to take along with her existing blood pressure medication (BYSTOLIC). She is concerned and asked if her elevated blood pressure will go back to normal, her blood pressure is still high. Her doctor told her when someone has a reaction to a vaccine, it usually takes days or up to two weeks to recover from the reaction. Her blood pressure is still high and her doctor is puzzled and prescribed her more medications to control her blood pressure. Today, 01Feb2021, at the doctors office her blood pressure was 156/81. Yesterday, 31Jan2021, her blood pressure was 180 over 80 something. She puts her glasses on to read the card. Patient would like to know how long will her symptoms last and if she is going to die from this. She is getting nervous and requests to be transferred to address her question. She thought she was the first person this has happened to but she read online that one person has had the same symptoms with high blood pressure after receiving the vaccine. She had been advising everyone to get the vaccine but now she will advise her family to hold off. The outcome of the event was not recovered.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9263) to reported event Blood pressure increased cannot totally be excluded.

Other Meds: BYSTOLIC; BUMETANIDE; ROSUVASTIN; BABY ASPIRIN

Current Illness: Blood pressure high; High cholesterol

ID: 1068408
Sex: M
Age:
State: TN

Vax Date: 02/09/2021
Onset Date: 02/01/2021
Rec V Date: 03/03/2021
Hospital: Y

Vax Type:
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Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Bell's Palsy/drooping of his face and mouth; Bloody nose; vertigo (dizzy / lightheaded); vertigo (dizzy / lightheaded); swallowing issues; Chewing issues; weak; tired / does not have stamina; This is a spontaneous report from a contactable consumer (the patient's wife). A 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9264), via an unspecified route of administration in the right arm on 09Feb2021 at 12:30 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included vertigo (before the 2nd dose all the time), diabetic type 2 due to exposure to Agent Orange, stent in Dec2019, sulfa allergies, blood pressure abnormal. Concomitant medications included metformin, buspirone, sitagliptin phosphate (JANUVIA), hyoscyamine sulfate (OSCIMIN), doxepin, lisinopril for blood pressure, silodosin, simvastatin (ZOCOR), exenatide (BYDUREON) for diabetes, fish oil, zinc tablet in the morning, ubidecarenone (COQ-10), vitamin D3, cyanocobalamin (VIT B12), allium sativum bulb (GARLIC EXTRACT), ascorbic acid/ betacarotene/ biotin/ calcium/ chloride/ chromium/ copper/ folic acid/ iodine/ lycopene/ magnesium/ manganese/ molybdenum/ nickel/ nicotinic acid/ pantothenic acid/ phosphorus/ potassium/ pyridoxine hydrochloride/ riboflavin/ selenium/ silicon/ thiamine/ vanadium/ vitamin b12 nos/ vitamin d nos/ vitamin e nos/ vitamin k nos/ xantofyl/ zinc (CENTRUM SILVER FOR MEN 50+). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 23Jan2021 at 10:30 (at the age of 76-years-old) in the right arm and experienced pain in arm and fatigue. On 09Feb2021, the patient developed a bloody nose that was unstoppable at home. The reporter took the patient to the emergency room (ER), where his nose was packed, and he was kept overnight. The following day, while his nose was being unpacked, drooping of his face and mouth was observed. Tests for a stroke were negative on Feb2021. The patient was kept in the hospital for three days and was diagnosed with Bell's Palsy on 11Feb2021. The events "Bell's Palsy/drooping of his face and mouth" and bloody nose resulted in hospitalization/prolonged hospitalization in Feb2021 for 3 days. The patient's wife reported that as of 09Feb2021, he had swallowing issues when it came to solid foods and was looking for suggestions on what he can eat. The tongue was not swollen, and he was breathing better since the packing had been removed. As of Feb2021, the patient had chewing issues and cannot take solid food. The patient had vertigo before the second vaccination dose all the time, and experienced it again last night on 16Feb2021, he was dizzy and lightheaded. As of an unspecified date in Feb2021, the patient was weak and tired (did not have stamina). The patient was treated for "Bell's Palsy/drooping of his face and mouth" with prednisone 20 mg 2 tablets once a day and valacyclovir 500 mg 2 tablets twice a day. The patient was not treated for bloody nose and swallowing issues. The clinical outcome of " Bell's Palsy/drooping of his face and mouth", swallowing issues, chewing issues, weak, "tired / does not have stamina" was not resolved; bloody nose was resolved on Feb2021; "vertigo (dizzy / lightheaded)" was resolved on 17Feb2021.

Other Meds: METFORMIN; BUSPIRONE; JANUVIA [SITAGLIPTIN PHOSPHATE]; OSCIMIN; DOXEPIN; LISINOPRIL; SILODOSIN; ZOCOR; BYDUREON; FISH OIL; ZINC; COQ-10; VITAMIN D3; VIT B12; GARLIC EXTRACT [ALLIUM SATIVUM BULB]; CENTRUM SILVER MEN 50+

Current Illness:

ID: 1068409
Sex: F
Age:
State: CA

Vax Date: 01/24/2021
Onset Date:
Rec V Date: 03/03/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Lungs were filled with fluid; couldn't breathe; fatigue; woke up in the middle of the night; couldn't lean back; felt like her lung was on fire; This is a spontaneous report from a Pfizer-sponsored program from a contactable female consumer, the patient. This 62 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 24Jan2021 for COVID-19 vaccination. Medical history was unknown. Concomitant medication sere unknown. On an unknown date, the patient experienced severe adverse reactions after the 1st dose reported as she woke up in the middle of the night and couldn't breathe/difficulty in breathing and lasted for 4 hours, her lungs were filled with fluid and felt like her lung was on fire, couldn't lean back and had fatigue the next day. The clinical outcome of woke up in the middle of the night couldn't breathe/difficulty in breathing, lungs were filled with fluid, felt like her lung was on fire, couldn't lean back and fatigue was unknown.

Other Meds:

Current Illness:

ID: 1068410
Sex: U
Age:
State:

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

Vax Type:
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Allergies:

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

Symptoms: deathly ill; Initial information received on 04-Feb-2021 regarding an unsolicited valid non-serious case received from a social media via consumer. This case involves patient (unknown demographics) who experienced deathly ill (illness), while he/she received INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. Medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious deathly ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was also reported that Got deathly ill with the regular flu shot ended up in the hospital, not asking a chance on this one. Medication details and reason for taking the medicine: route of administration: unknown Indication: unknown dose- unknown product name: product name was not provided. Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. It is unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was reported as unknown. There will be no information on the batch number to be requested for this case.

Other Meds:

Current Illness:

ID: 1068411
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: fluzone QIV multi-dose vials, split the .5ml dose into 2 or 3 doses with no AE; Initial information received on 04-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult patient who administered fluzone QIV multi-dose vials, split the 0.5ml dose into 2 or 3 doses (off label use), while he/she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE]. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious fluzone QIV multi-dose vials, split the .5ml dose into 2 or 3 doses (off label use) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. No laboratory data was provided. It was also a case of off label dosing frequency (latency on same day). It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was unknown. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1068412
Sex: U
Age:
State:

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 03/03/2021
Hospital:

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Lab Data:

Allergies:

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

Symptoms: patient received expired YF-VAX vaccine/ NO AE; Initial information received on 12-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient (unknown demographics) who received 0.5 mL YELLOW FEVER VACCINE - US [YF-VAX] (batch number: UJ090AA and expiry date: 08-Jan-2021 via an unknown at an unknown administration site) (expired product administered) on 10-Feb-2021 for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. It was an actual medication error case due to expired vaccine used (latency: same day). Caller would like to know if patient needs to revaccinate. The caller stated that he did not have time to provide additional adverse event details at the time of the call, as he was involved in patient care. He stated he would call back with the details. No Still using product. At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1068413
Sex: M
Age: 1
State: FL

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 03/03/2021
Hospital:

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Lab Data:

Allergies:

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

Symptoms: ActHIB was administered to a patient 1 day after the expiration date/ NO AE; Initial information received on 18-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional via call-center. This case involves a 16-months-old male patient who administered a vaccine HIB (PRP/T) VACCINE [ACT-HIB] 1 day after the expiration date (batch number: UJ147AAC and expiry date: 17-Feb-2021 via an unknown route in right vastus lateralis) (expired product administered) on 18-Feb-2021 for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and booster INFLUENZA VACCINE (FLU) for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency: same day). The reporter would like to know if the patient must be revaccinated. vaccine was accidently used the expiration date on the diluent initially which was 22-Apr-2021. At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am