chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: myalgias; fever; headache; nausea; This is a spontaneous report from a contactable consumer. A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 08Jan2021 (12:00 PM) at single dose for Covid-19 immunization. The patient's medical history reported as none; no known allergies. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration (left arm) on 18Dec2020. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the day after the 2nd injection 09Jan2021, the patient had myalgias, fever, headache and nausea. It had mostly resolved on the following day 10Jan2021 and completely resolved on 11Jan2021. The patient took Tylenol and Advil as treatment. The outcome of events was recovered on 11Jan2021. The patient has not been tested for COVID-19 since the vaccination.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Hypersensitivity, Pyrexia
Clinical narrative: At 10am feel hot, took temp was 102.7; At 10am feel hot, took temp was 102.7/ Temp at 12am was 101; Red all over; Face swelling; Shot site was red; Allergic reaction; Hives; Around 8pm start to feel chill; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: el1284), via an unspecified route of administration on 09Jan2021 09:30 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included HTN, GERD, IBS, known allergies: PCN, IV contrast. Concomitant medications included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN), linaclotide (LINZESS).  The patient previously took morphine and percocet [oxycodone hydrochloride;paracetamol]; and experienced known allergies. The patient received first dose of bnt162b2 on 19Dec2020 09:30 at right arm. Lot number: el1284. The patient got the 2nd shot at 09:30, went back to work was fine, got home at 07:15pm, around 8pm on 09Jan2021 start to feel chill. On 09Jan2021 20:45, the patient was reported to be red all over, took 650 of Tylenol. Face swelling, the shot site was red. Went to bed at 9pm. Temp at 12am was 101. Went to the ER 12:50am. They stated the patient was having allergic reaction and hives (reported as 09Jan2021 20:45). The ER gave the patient Benadryl IV, Prednisone IV, Pepcid. They discharge the patient with Prednisone and Pepcid. On 10Jan2021 at 10am feel hot, on the same day took temp was 102.7. The patient had to miss work 1 day of work sunday 10Jan2021. The patient received treatment for the events. The patient visited the ER for the events. The outcome of the events was recovering.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: At 10am feel hot, took temp was 102.7; At 10am feel hot, took temp was 102.7/ Temp at 12am was 101; Red all over; Face swelling; Shot site was red; Allergic reaction; Hives; Around 8pm start to feel chill; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: el1284), via an unspecified route of administration on 09Jan2021 09:30 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included HTN, GERD, IBS, known allergies: PCN, IV contrast. Concomitant medications included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN), linaclotide (LINZESS).  The patient previously took morphine and percocet [oxycodone hydrochloride;paracetamol]; and experienced known allergies. The patient received first dose of bnt162b2 on 19Dec2020 09:30 at right arm. Lot number: el1284. The patient got the 2nd shot at 09:30, went back to work was fine, got home at 07:15pm, around 8pm on 09Jan2021 start to feel chill. On 09Jan2021 20:45, the patient was reported to be red all over, took 650 of Tylenol. Face swelling, the shot site was red. Went to bed at 9pm. Temp at 12am was 101. Went to the ER 12:50am. They stated the patient was having allergic reaction and hives (reported as 09Jan2021 20:45). The ER gave the patient Benadryl IV, Prednisone IV, Pepcid. They discharge the patient with Prednisone and Pepcid. On 10Jan2021 at 10am feel hot, on the same day took temp was 102.7. The patient had to miss work 1 day of work sunday 10Jan2021. The patient received treatment for the events. The patient visited the ER for the events. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: I became aware that my sister was exposed to and tested positive for COVID (I assume at work as she is a nurse) after she had received the initial dose of the COVID-19 Pfizer vaccine; I became aware that my sister was exposed to and tested positive for COVID (I assume at work as she is a nurse) after she had received the initial dose of the COVID-19 Pfizer vaccine; This is a spontaneous report from a contactable consumer. A 32-year-old female patient received first single dose of BNT162B2 (Manufacturer: Pfizer, solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID -19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant. Patient had no prior COVID vaccination. The reporter became aware that her sister was exposed to and tested positive for COVID (she assumed at work as she was a nurse) on Jan2021 after she had received the initial dose of the COVID-19 Pfizer vaccine. She was not sure when the exposure took place, but it had been about 3 weeks since she received the first dose. Patient was tested post vaccination. The outcome of events was recovering.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Visual field defect
Clinical narrative: right eye right peripheral vision became starburst; This is a spontaneous report from non-contactable healthcare professional (patient). A 56-year-old female patient received the first dose of bnt162b2 (BNT162B2; lot number EL3248), intramuscular on the right arm on 07Jan2021 at 15:45 at a single dose in the hospital for covid-19 immunisation. Medical history included myasthenia gravis. The patient did not have COVID prior vaccination. The patient was not pregnant at the time of report. The patient received unspecified concomitant medications (other medications received in two weeks). On 08Jan2021 at 08:15 (also reported as approximately 18 hours post injection), the patient's right eye right peripheral vision became starburst. It was odd enough that patient thought it should be reported even if it might be coincidence. The patient did not receive treatment for the event. Vision resolved in about 45 minutes, on 08Jan2021 at 09:00.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Laryngospasm
Clinical narrative: approx 34 hours after vaccine awoke unable to breath. symptoms consistent with laryngospasm. symptoms lasted approx 2 minutes; approx 34 hours after vaccine awoke unable to breath. symptoms consistent with laryngospasm. symptoms lasted approx 2 minutes; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot ek9231) on 08Jan2021 03.00 pm intramuscular in the left arm for COVID-19 immunization. Medical history included RA, spondylitis, GERD, known allergies to sulfa, penicillin, cefalexin monohydrate (KEFLEX), sulfamethoxazole, trimethoprim (BACTRIM), adalimumab (HUMIRA), ankylosis. Concomitant medications included acetylsalicylic acid (ASPIRIN), omeprazole, loratadine (CLARITIN) and infliximab (RENFLEXIS). First dose of BNT162B2 was administered on 21Dec2020 11:00 am (lot ek5730) intramuscular in the left arm for COVID-19 immunization. Approx 34 hours after vaccine (also reported as 03Jan2021) awoke unable to breath. Symptoms consistent with laryngospasm, symptoms lasted approx 2 minutes. No treatment provided. No COVID test performed prior or after vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of unable to breath/ Laryngospasm cannot be excluded, considering the plausible temporal relationship.  Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of allergic reaction to vaccine.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive on 06Jan2021/Came positive for COVID; I am concerned because I am positive; tested positive on 06Jan2021/Came positive for COVID; I am concerned because I am positive; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date Mar2021), via an unspecified route of administration on 28Dec2020 at a single dose for covid-19 immunization. Medical history included diabetes. There were no concomitant medications. The patient got the vaccination on 28Dec2020. He have been testing every day. The patient got a tested on Sunday, 03Jan2021 and was negative. He was negative on Monday, 04Jan2021  different Company. He went back on Tuesday, 05Jan2021, different Company and was negative. On Wednesday, 06Jan2021, he was tested positive, then on Thursday, 07Jan2021, he was tested negative. He wanted to know if he can continue to get the second vaccination shot 18Jan2021 or not?. The patient did not received any treatment for the event and he just stayed at home. The patient had a lab work last Sep2020. The outcome of the events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: contracted COVID after the first dose; contracted COVID after the first dose; This is a spontaneous report from a contactable nurse (patient).  A 36-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 vaccine. Medical history and concomitant medications were not reported. It was reported that the patient contracted COVID after the first dose on an unspecified date. He has question about the second dose. He had his first dose on 22Dec2020. He contracted COVID in-between doses. His second dose was due today. He wanted to know if he should receive it today or what was the safety issue. He asked if was it safe to get the second dose of his COVID vaccine if he had COVID? Lab data included COVID-19 positive on an unspecified date. The outcome of 'contracted COVID after the first dose' was unknown.   Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Acarodermatitis, Pruritus, Rash
Clinical narrative: scabies; itching; rash neck to waist down/she developed a rash on her back; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. Medical history included pacemaker. The patient's concomitant medications were not reported. She received the COVID vaccine on 29Dec2020 and 10 days later she developed a rash neck to waist down, she is in the nursing home and they are not sure if its scabies, she said the itching has lessened. She is in the nursing home for follow up for her pacemaker. caller wanted to know if there are reports of rash. Patient wanted to know about partial immunity (immunity after the first dose) and how long it takes to build it. Reporter wanted to find out if anyone reported a skin rash after having the Covid shot. Stated that her rash started 10 days later on her back and it looked like scabies. Stated that it will be treated as scabies. Stated the she did a report about the above mentioned previously. Stated that she is going to see her doctor later on today. It was also reported that she had the COVID vaccine 29Dec2020 and 10 days later on 07Jan2021, she developed a rash on her back and she was wondering if this was normal. It was confirmed that the patient was given the Pfizer BioNtech COVID-19 vaccine on 29Dec2020 and then developed a rash on her back 07Jan2021. She was asking if this was from the shot? Is the rash something that has been reported before? How long until she has some sort of immunity after getting first vaccine? She was not sure it is a side effect for sure. The aid at the nursing home thought it was scabies. But the patient has not been in contact with anyone with scabies, and has a clean bed and everything. The outcome of the event 'itching' was recovering while unknown for the other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Diarrhoea, Fatigue
Clinical narrative: severe muscle pain; joint pain; temperature 102.3; headache; nausea; fatigue; generalized body aches; diarrhea; This is a spontaneous report from a contactable physician (patient). A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (left arm) on 07Jan2021 (17:45) at single dose for Covid-19 immunization. The patient previously received the first dose of BNT162B2 (lot number: EL1283) on 19Dec2020 (01:15 PM) via an unspecified route (left arm). Medical history included asthma and "known allergies: yes". Concomitant medications included fish oil (OMEGA 3), colecalciferol (VITAMIN D), ascorbic acid (VITAMIN C), and meloxicam. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe muscle pain, joint pain (fingers, skin!-pending clarification), temperature 102.3, headache, nausea lasting 24hours, followed by persistent fatigue and generalized body aches and diarrhea for the next 24hours. The patient was treated with acetaminophen. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain
Clinical narrative: severe muscle pain; joint pain; temperature 102.3; headache; nausea; fatigue; generalized body aches; diarrhea; This is a spontaneous report from a contactable physician (patient). A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (left arm) on 07Jan2021 (17:45) at single dose for Covid-19 immunization. The patient previously received the first dose of BNT162B2 (lot number: EL1283) on 19Dec2020 (01:15 PM) via an unspecified route (left arm). Medical history included asthma and "known allergies: yes". Concomitant medications included fish oil (OMEGA 3), colecalciferol (VITAMIN D), ascorbic acid (VITAMIN C), and meloxicam. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe muscle pain, joint pain (fingers, skin!-pending clarification), temperature 102.3, headache, nausea lasting 24hours, followed by persistent fatigue and generalized body aches and diarrhea for the next 24hours. The patient was treated with acetaminophen. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Vaccination site pain
Clinical narrative: Pain at the injection site; Swelling in his lymph nodes; Fatigue; This is a spontaneous report from a contactable consumer. A male patient (reporter's father) of an unspecified age (Age: 65; Unit: unknown) received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 05Jan2021 for COVID -19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Covid-19 vaccine last Tuesday. On 06Jan2021, the day after the injection, he developed pain at the injection site that quickly resolved, and he felt great. He recently developed swelling in his lymph nodes and fatigue and the caller would like to know if that is normal to have this delayed reaction 5-6 days later. The patient recovered from the pain at the injection site on an unspecified date in Jan2021. Outcome of other events was unknown.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Event: Fever (100.4), chills, nausea, headache Treatment: Rest, Tylenol & Advil Outcomes: Better within 24 hours
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: did not feel like herself; fever; shaking; chills; tiredness; arm swelling; headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 17 patients. This is the first of seventeen reports. A female patient of an unspecified age started to receive bnt162b2 (BNT162B2), via an unspecified route of administration on 07Jan2021, single for COVID-19 immunization. Medical history included covid-19. The patient's concomitant medications were not reported. The patient reported that after getting the vaccine she experienced a fever up to 102, chills and shaking on Jan2021. She also reported that multiple friends had the "regular side effects" of soreness in the arm. Patient stated that she got her COVID vaccine shot on along with 15 of her friends. They all had the typical arm swelling, headache, and tiredness if anything. Some did not have any side effects at all. She herself woke up with a 101 fever, then at 11 AM had a 102 fever and was shaking like crazy she could not even hold the thermometer in her mouth on 07Jan2021. On 08Jan2021, (Friday), she began to feel a little better. She just did not feel like herself on 09Jan2021. She got a COVID swab and was negative. After she got the fever she decided to have her blood drawn, and it showed antibodies. Patient was inquiring, because she previously had COVID, is that why she had this reaction. Outcome of the event swas unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021021735 same reporter/ drug/ events, different patient;PFIZER INC-2021026894 same reporter/drug/event, different patient;PFIZER INC-2021026885 same reporter/drug/event, different patient PFIZER INC-2021026883 same reporter/drug/AE, different patient PFIZER INC-2021026893 same reporter/drug/similar event, different patient;PFIZER INC-2021026888 Same reporter/drug/event, different patient;PFIZER INC-2021026890 same reporter/drug/event, different patient;PFIZER INC-2021026886 same reporter/product, diff AE/patients;PFIZER INC-2021026413 same reporter/drug/event, different patient;PFIZER INC-2021026881 same reporter/drug/event, different patient;PFIZER INC-2021026882 same reporter/drug/event, different patient;PFIZER INC-2021026884 same reporter/drug/event, different patient;PFIZER INC-2021026889 same reporter/drug/event, different patient;PFIZER INC-2021026891 same reporter/drug/event, different patient;-PFIZER INC-2021026892 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, SARS-CoV-2 test, Tremor
Clinical narrative: did not feel like herself; fever; shaking; chills; tiredness; arm swelling; headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 17 patients. This is the first of seventeen reports. A female patient of an unspecified age started to receive bnt162b2 (BNT162B2), via an unspecified route of administration on 07Jan2021, single for COVID-19 immunization. Medical history included covid-19. The patient's concomitant medications were not reported. The patient reported that after getting the vaccine she experienced a fever up to 102, chills and shaking on Jan2021. She also reported that multiple friends had the "regular side effects" of soreness in the arm. Patient stated that she got her COVID vaccine shot on along with 15 of her friends. They all had the typical arm swelling, headache, and tiredness if anything. Some did not have any side effects at all. She herself woke up with a 101 fever, then at 11 AM had a 102 fever and was shaking like crazy she could not even hold the thermometer in her mouth on 07Jan2021. On 08Jan2021, (Friday), she began to feel a little better. She just did not feel like herself on 09Jan2021. She got a COVID swab and was negative. After she got the fever she decided to have her blood drawn, and it showed antibodies. Patient was inquiring, because she previously had COVID, is that why she had this reaction. Outcome of the event swas unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021021735 same reporter/ drug/ events, different patient;PFIZER INC-2021026894 same reporter/drug/event, different patient;PFIZER INC-2021026885 same reporter/drug/event, different patient PFIZER INC-2021026883 same reporter/drug/AE, different patient PFIZER INC-2021026893 same reporter/drug/similar event, different patient;PFIZER INC-2021026888 Same reporter/drug/event, different patient;PFIZER INC-2021026890 same reporter/drug/event, different patient;PFIZER INC-2021026886 same reporter/product, diff AE/patients;PFIZER INC-2021026413 same reporter/drug/event, different patient;PFIZER INC-2021026881 same reporter/drug/event, different patient;PFIZER INC-2021026882 same reporter/drug/event, different patient;PFIZER INC-2021026884 same reporter/drug/event, different patient;PFIZER INC-2021026889 same reporter/drug/event, different patient;PFIZER INC-2021026891 same reporter/drug/event, different patient;-PFIZER INC-2021026892 same reporter/drug/event, different patient
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: Injection into left arm hurt upon injection; The arm got very sore and felt like lead-I could barely raise my arm up without assistance of the other arm; The arm got very sore and felt like lead-I could barely raise my arm up without assistance of the other arm; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the left arm on 07Jan2021 at 14:00 at a single dose for COVID-19 immunisation. Medical history included HBP (hypertension). The patient was not pregnant at the time of vaccination, has not received any other vaccine within four weeks, and did not have COVID prior to the vaccination. Concomitant medication included losartan (also reported as other medication in two weeks). The patient previously took Aleve and experienced allergies. On 07Jan2021 at 02:00 PM, the patient experienced injection into left arm hurt upon injection and as the hours wore on, the arm got very sore and felt like lead-she could barely raise her arm up without assistance of the other arm. However, it dissipated within 24 hours and felt fine thereafter. The patient did not test positive for COVID post-vaccination. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: She was observed scratching and when questioned stated she was itchy on her chest and forearms; This is a spontaneous report from a contactable pharmacist. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) intramuscularly at right arm on 11Jan2021 08:45 at single dose for COVID-19 immunization. Medical history included seasonal allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EK5730) intramuscularly on 21Dec2020 at single dose for COVID-19 immunization. Patient received vaccine at 08:45, she was observed for 30 minutes - during which time she took 50mg diphenhydramine hydrochloride (Benadryl) (patient's own med) - she was observed scratching and when questioned stated she was itchy on her chest and forearms. She denied any difficulty breathing, swelling around face, lips, tongue or itchiness anywhere other than her chest and forearms. She was observed for minutes after diphenhydramine hydrochloride and all symptoms had resolved. Patient was instructed to read Fact sheet and report additional allergic symptoms and to follow up if any symptoms worsen. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the event was recovered on 11Jan2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Pain, Polyuria
Clinical narrative: body pain; rapid onset of fever (within 30 min 101.7); skin sensitivity; cough; itchy throat; violent episodes of shaking and chills for 36 hours; violent episodes of shaking and chills for 36 hours; increased urination/diuresis; This is a spontaneous report received from a contactable nurse (who is also the patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in left arm, on 09Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. The patient medical history was not reported. The patient is not pregnant. The patient had no other medications in two weeks. The patient did not have COVID-19 prior to vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in right arm, on 22Dec2020 12:00, at single dose, for COVID-19 immunization. The patient experienced body pain, rapid onset of fever (within 30 min. 101.7, as reported), skin sensitivity, cough, itchy throat, violent episodes of shaking and chills for 36 hours and increased urination/diuresis all on 09Jan2021 at 22:15. No treatment was received for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events body pain, rapid onset of fever (within 30 min 101.7), skin sensitivity, cough, itchy throat and increased urination/diuresis was recovered on unspecified dates; and the outcome of violent episodes of shaking and chills for 36 hours was recovered on 11Jan2021 at 08:15.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensitive skin, Throat irritation, Tremor
Clinical narrative: body pain; rapid onset of fever (within 30 min 101.7); skin sensitivity; cough; itchy throat; violent episodes of shaking and chills for 36 hours; violent episodes of shaking and chills for 36 hours; increased urination/diuresis; This is a spontaneous report received from a contactable nurse (who is also the patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in left arm, on 09Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. The patient medical history was not reported. The patient is not pregnant. The patient had no other medications in two weeks. The patient did not have COVID-19 prior to vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in right arm, on 22Dec2020 12:00, at single dose, for COVID-19 immunization. The patient experienced body pain, rapid onset of fever (within 30 min. 101.7, as reported), skin sensitivity, cough, itchy throat, violent episodes of shaking and chills for 36 hours and increased urination/diuresis all on 09Jan2021 at 22:15. No treatment was received for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events body pain, rapid onset of fever (within 30 min 101.7), skin sensitivity, cough, itchy throat and increased urination/diuresis was recovered on unspecified dates; and the outcome of violent episodes of shaking and chills for 36 hours was recovered on 11Jan2021 at 08:15.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: swollen lymph nodes on left side of neck; first dose on 27Dec2020 and second dose on 07Jan2021; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 07Jan2021 at a single dose for COVID-19 immunization. The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 at 16:45. Both doses were administered at the hospital. Relevant medical history included non-insulin-dependent diabetes mellitus (NIDDM), hypertension (HTN), hypersensitivity lung disease (HLD), hyperthyroid, and Graves. The patient had no known allergies. Concomitant medications included empagliflozin (JARDIANCE), metformin, methimazole, cetirizine hydrochloride (ZYRTEC), and montelukast sodium (SINGULA). The patient was not pregnant. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. The patient received her first dose on 27Dec2020 and second dose on 07Jan2021. The patient had an adverse event on the next eve of the second (2nd) vaccine. On 08Jan2021 at 22:00, she experienced swollen lymph nodes on left side of neck. The swelling was going down incrementally as she took paracetamol (TYLENOL) 1000 mg per oral (p.o.) daily. The patient underwent Covid test via nasal swab post vaccination on 29Dec2020, which resulted negative. The patient was recovering from the event.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pain assessment
Clinical narrative: headache; fatigue; muscle aches; joint pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as Age: 59; Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, fatigue, muscle aches, and joint pain on an unspecified date in Jan2021. The patient was still experiencing muscle aches and joint pains 5-7 out of 10 currently. She reached out to healthcare professional and vaccination clinic which referred her to Pfizer. She was wondering if it was okay to be experiencing side effects that long. The outcome of the events muscle aches and joint pain was not recovered while the outcome of the events headache and fatigue was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal, Fatigue, Headache, Malaise
Clinical narrative: headache; nausea; feeling unwell; fatigue; fell in asleep; glucose levels or just doing something else that's causing me to have headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL324U), 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 patient received first dose of vaccine, and since yesterday the patient have had headache that does not go away with like Ibuprofen and Tylenol. When the patient first got it she was reading on the factsheet that headache, nausea and feeling unwell are some of the symptoms so the patient was getting those and have had some fatigue as well but then she fell in asleep. And this morning, the patient have a headache that goes and come, it's not really, really bad but it's just like it is there and it just bothers her. It was reported that "I was taking Tylenol and Ibuprofen and it really doesn't seem to do anything. I noticed that if I eat something then I will start feeling a little bit better so, I do not know if the vaccine is doing something as far as my glucose levels or just doing something else that's causing me to have headache." The patient received treatment for the events. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Somnolence
Clinical narrative: headache; nausea; feeling unwell; fatigue; fell in asleep; glucose levels or just doing something else that's causing me to have headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL324U), 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 patient received first dose of vaccine, and since yesterday the patient have had headache that does not go away with like Ibuprofen and Tylenol. When the patient first got it she was reading on the factsheet that headache, nausea and feeling unwell are some of the symptoms so the patient was getting those and have had some fatigue as well but then she fell in asleep. And this morning, the patient have a headache that goes and come, it's not really, really bad but it's just like it is there and it just bothers her. It was reported that "I was taking Tylenol and Ibuprofen and it really doesn't seem to do anything. I noticed that if I eat something then I will start feeling a little bit better so, I do not know if the vaccine is doing something as far as my glucose levels or just doing something else that's causing me to have headache." The patient received treatment for the events. The outcome of the events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: I had severe nerve pain in the arm I received the injection in/the pain is intermittent and severe and starts from upper arm to my fingers; This is a spontaneous report from a contactable nurse.  A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), via an unspecified route of administration on 07Jan2021 10:30 at single dose at left arm for COVID-19 immunization. Medical history included seizure, meningioma, and asthma. Known allergies: Latex, reglan, and Bactrim. Concomitant medications included lamotrigine (LAMICTAL), mirabegron (MYRBETRIQ).  The patient previously took reglan [metoclopramide], and bactrim and experienced allergies. On day 2, 09Jan2021 21:00 post vaccine the patient reported "I had severe nerve pain in the arm I received the injection in. the pain is intermittent and severe and starts from upper arm to my fingers." It was unknown if the patient received treatment for the event. The patient underwent lab tests and procedures which included Nasal Swab: negative, and PCR: negative covid test name post vaccination PCR; both on 04Jan2021. The outcome of the event was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Headache, Hypoaesthesia, Nausea
Clinical narrative: Strong chills; Bad headache; Very painful abdominal cramping; Heavy salivating; Nausea/going to vomit; Both hands went numb with pins and needles; Both hands went numb with pins and needles; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284), via an unspecified route of administration from 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization.  Medical history included known allergies: latex, high blood pressure, hypothyroidism, and mitral valve prolapse. There were no concomitant medications. At 11am, 2 hours after receiving the first COVID19 vaccine, my reactions occurred simultaneously. The patient experienced Strong chills, Bad headache, Abdominal Very painful abdominal cramping, Heavy salivating, Nausea, Both hands went numb with pins and needles, the patient felt like she was either going to vomit or have a bowel movement, ultimately it was the latter. This is when both her hands went numb. These reactions lasted 15-20 minutes and then dissipated with the exception of a lingering less painful headache through Friday and Saturday. The patient did not receive treatment for the events. The outcome of the events was recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Salivary hypersecretion
Clinical narrative: Strong chills; Bad headache; Very painful abdominal cramping; Heavy salivating; Nausea/going to vomit; Both hands went numb with pins and needles; Both hands went numb with pins and needles; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284), via an unspecified route of administration from 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization.  Medical history included known allergies: latex, high blood pressure, hypothyroidism, and mitral valve prolapse. There were no concomitant medications. At 11am, 2 hours after receiving the first COVID19 vaccine, my reactions occurred simultaneously. The patient experienced Strong chills, Bad headache, Abdominal Very painful abdominal cramping, Heavy salivating, Nausea, Both hands went numb with pins and needles, the patient felt like she was either going to vomit or have a bowel movement, ultimately it was the latter. This is when both her hands went numb. These reactions lasted 15-20 minutes and then dissipated with the exception of a lingering less painful headache through Friday and Saturday. The patient did not receive treatment for the events. The outcome of the events was recovered.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: Inability to taste or smell; Inability to taste or smell; This is a spontaneous report from a contactable nurse. A 25-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date) dose number 1, intramuscularly on 06Jan2021 12:00 at a single dose on the left arm for COVID-19 immunization. There was no relevant medical history. Concomitant medications were not reported. No other vaccine was received within 4 weeks and no other medications were taken within 2 weeks. The patient experienced inability to taste or smell on 10Jan2021. The patient underwent Nasal Swab/PCR on 11Jan2021 with unknown results (pending). The outcome of the events was not recovered.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Chills; fever; body and muscle aches; body and muscle aches; fatigue; This is a spontaneous report from a contactable nurse (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Jan2021 16:45 (04:45 PM) at a single dose for COVID vaccine. There was no medical history. The patient had no known allergies. Concomitant medications were not reported. The patient previously had his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at a single dose for COVID vaccine. He had no other vaccine in four weeks. The patient experienced chills, fever, body and muscle aches, fatigue, all on 09Jan2021 08: 00 AM. Treatment was not received for the events. The patient had no COVID prior to vaccination and did not have COVID tested post vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia
Clinical narrative: She referred to herself as a "long-hauler" still experiencing symptoms of muscle pain, tightness; She referred to herself as a "long-hauler" still experiencing symptoms of muscle pain, tightness; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included asthma and history of SARS-COV-2 from 2020, reported as 6 months ago. The patient is taking breathing treatments (unspecified). The patient referred to herself as a "long-hauler" still experiencing symptoms of muscle pain, tightness on an unspecified date. The patient has not recovered from the events.   Information on the lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Aphthous ulcer
Clinical narrative: Developed apthous ulcers in throat 6 days after vaccine; This is a spontaneous report from a contactable physician (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK7350), via an unspecified route of administration in left arm on 30Dec2020 18:00 at a single dose for COVID-19 immunization in a hospital. The patient's medical history was not reported. Concomitant medication included multivitamin. The patient previously took LEVAQUIN and experienced allergies. The patient developed aphthous ulcers in throat on 05Jan2021 14:00 6 days after vaccine. Patient does not have COVID prior vaccination. The patient has not been tested for COVID post vaccination. Treatment for the event included magic mouthwash, Vitamin C, and one dose of oral Medrol. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Viral test positive
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable pharmacist (reporting for herself).  A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration in the left arm on 22Dec2020 at a single dose for COVID-19 immunization.  There was no medical history and no concomitant medications.  The patient experienced COVID-19 on 28Dec2020, which was reported as being medically significant.  The patient underwent lab tests and procedures which included nasal swab test: positive on 29Dec2020.  Therapeutic measures were taken as a result of the event and included treatment with bamlanivimab on 30Dec2020.  The outcome of COVID-19 was recovered on 07Jan2021.  The causality was reported as no (unrelated); Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Pain in the arm; Swelling in her lymph nodes; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician (patient's colleague) reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in arm, 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 previously took the first dose of BNT162B2 for COVID-19 immunization (in arm). On an unspecified date, the patient received the second dose of the COVID-19 vaccine in the same arm as the first dose and was experiencing pain in the arm and swelling in her lymph nodes (after the second dose administration). The physician would like to know if there is any information on whether or not the second dose should be given in the opposite arm of the first dose. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: facial numbness that started on her cheek, nose, and neck; This is a spontaneous report from a contactable pharmacist. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (pending clarification) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that within 10 minutes of administration, the patient experienced facial numbness that started on her cheek, nose, and neck. Three weeks later, she still has the numbness. The patient has reported improvement, but it has not been totally resolved. The patient described it as receiving a shot of Novocaine from the dentist but does not describe the sensation of paralysis or bell's palsy. The reporter asked whether or not the patient should receive the second dose of the vaccine after experiencing this side effect. Her 3-week mark was on Friday, in which she has missed her second dose (pending clarification). The patient received an unspecified treatment for the event. The outcome of event was recovering.  Information on the lot/batch number has been requested.