chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash, Spinal stenosis, Vaccination site pain
Clinical narrative: Spinal stenosis; More anxious; Fever of 101; Rash; Pain in the arm where she got the shot; Feeling clammy and nervous; Feeling clammy and nervous; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration on arm from 15Jan2021 to 15Jan2021 at SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient previously took trazodone and antibiotics and had problems with them. Caller also stated she might be having withdrawals from a sugar high, has been coming off gabapentin for 2 years. Caller stated she got the first dose of the COVID-19 vaccine on Friday 15Jan2021. Caller reports pain in the arm where she got the shot on Saturday, a rash started Sunday night and fever of 101 started Monday morning, had a fever Tuesday morning and it went away and took more Benadryl for the rash. Caller stated she took Benadryl. Caller states she has been more anxious since Tuesday. Caller states she is feeling clammy and nervous and wants to know if this is normal. Caller had a root canal on Thursday and has spinal stenosis. Could be too much Benadryl or mind over matter issue as she has been reading information online about the vaccine. The outcome of the event fever was recovered; while the other events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: got sick; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Customer called and said that he got the first dose of covid-19 vaccine on 29Dec2020 and he got sick on an unspecified date, he tested negative twice on an unspecified date and wanted to know if he can get the second dose. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Pain, Vaccination site pain
Clinical narrative: Pain in her body; Pain at the injection site; Back pain; Headaches; This is a spontaneous report from a contactable consumer reporting for consumer's wife. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, 30Jan2021 19:40 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included the patient was diabetic. The patient previously received the first dose of BNT162B2 on an unspecified date. Concomitant medication was not provided. On an unknown date, the patient experienced pain in her body, pain at the injection site, back pain and headaches. The outcome of the events pain in her body, pain at the injection site, back pain and headaches was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Test positive for covid; Test positive for covid; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (lot number unknown), via an unspecified route of administration, on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer covid vaccine first dose on 07Jan2021, then she tested positive for covid on 18Jan2021. The patient was scheduled for second vaccine on 28Jan2021. The patient asked if still get 2nd dose on 28Jan or start series again at later date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; 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: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: terrible chills; fever; This is a spontaneous report from a non-contactable consumer (patient himself). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown), via an unspecified route of administration, on 14Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he got his Covid shot last Thursday 14Jan2021 and everything was good. Then on Jan2021 he started having terrible chills, all kinds of bad things going on, fever, everything, he just suffered it all. The patient called down this morning to ask what to do later on. He added that he has a second shot scheduled for 04Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: he  felt "fluttering in his leg, behind the knee cap and the calf; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left arm Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021, a little over a day after vaccination, the patient reported he felt "fluttering in his leg, behind the knee cap and the calf". He specified that it was not painful but almost like a twitching feeling. The patient mentioned that he was scheduled for their second dose in two weeks. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Body temperature, Dizziness, Headache, Influenza like illness
Clinical narrative: dizziness/dizzy; little headache; felt like she had the flu/flu-like symptoms; body aches; low grade fever that never went over 101.4/low grade fever between 99.6 and 100; red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised/rash was across her chest, breasts, and above her belly button, but not on her back; pain in her right arm which got stronger at the injection site overnight/sore arm; This is a spontaneous report from a contactable nurse (patient).  A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date: Apr2021), via an unspecified route of administration on 15Jan2021 at 12:30 at a single dose on the right arm for COVID-19 immunization.  The patient has a medical history of having covid infection in Aug2020 where her symptoms were low grade fever and headaches only. The patient also stated that when she gets a virus, she always gets this kind of rash. The patient is in an ongoing year -long antibody study where they check for antibodies every 3 months. The results of the 1st titre was 270 after her 10-day quarantine period, and in Dec2020, it was still 270. There were no concomitant medications. The patient reported that she had a sore arm on Friday, the day of the vaccination, 15Jan2021. She experienced pain in her right arm which got stronger at the injection site overnight. Then on Saturday 16Jan2021 at 11:00 AM all her symptoms started. She developed a low grade fever that never went over 101.4, a little headache, dizziness, and body aches. She stated that it was weird because she rarely gets sick, but she felt like she had the flu. She is getting a low grade fever between 99.6 and 100, flu-like symptoms and was dizzy. Then on the night of Saturday 16Jan2021, when she went to bed she had a red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised. The rash was across her chest, breasts, and above her belly button, but not on her back. The patient reported that she still has the rash, and that it has actually gotten worse; it's spread more across her whole chest which is typical. Since when she gets a virus, she always gets this kind of rash; it doesn't itch; it's just kind of there and it's always in the same place whenever she gets it. The outcome of the event 'red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised/rash was across her chest, breasts, and above her belly button, but not on her back' was not recovered while the outcome of the other events was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash erythematous, Vaccination site pain
Clinical narrative: dizziness/dizzy; little headache; felt like she had the flu/flu-like symptoms; body aches; low grade fever that never went over 101.4/low grade fever between 99.6 and 100; red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised/rash was across her chest, breasts, and above her belly button, but not on her back; pain in her right arm which got stronger at the injection site overnight/sore arm; This is a spontaneous report from a contactable nurse (patient).  A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date: Apr2021), via an unspecified route of administration on 15Jan2021 at 12:30 at a single dose on the right arm for COVID-19 immunization.  The patient has a medical history of having covid infection in Aug2020 where her symptoms were low grade fever and headaches only. The patient also stated that when she gets a virus, she always gets this kind of rash. The patient is in an ongoing year -long antibody study where they check for antibodies every 3 months. The results of the 1st titre was 270 after her 10-day quarantine period, and in Dec2020, it was still 270. There were no concomitant medications. The patient reported that she had a sore arm on Friday, the day of the vaccination, 15Jan2021. She experienced pain in her right arm which got stronger at the injection site overnight. Then on Saturday 16Jan2021 at 11:00 AM all her symptoms started. She developed a low grade fever that never went over 101.4, a little headache, dizziness, and body aches. She stated that it was weird because she rarely gets sick, but she felt like she had the flu. She is getting a low grade fever between 99.6 and 100, flu-like symptoms and was dizzy. Then on the night of Saturday 16Jan2021, when she went to bed she had a red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised. The rash was across her chest, breasts, and above her belly button, but not on her back. The patient reported that she still has the rash, and that it has actually gotten worse; it's spread more across her whole chest which is typical. Since when she gets a virus, she always gets this kind of rash; it doesn't itch; it's just kind of there and it's always in the same place whenever she gets it. The outcome of the event 'red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised/rash was across her chest, breasts, and above her belly button, but not on her back' was not recovered while the outcome of the other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, SARS-CoV-2 antibody test
Clinical narrative: gotten the 2 doses of the COVID-19 vaccine/He tested his IgM and IgG /and they were negative; This is a spontaneous report from a contactable physician reporting for himself. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation on an unspecified date. Patient reported he has gotten the 2 doses of the COVID-19 vaccine 2 weeks before. He got his second dose on 06Jan2021. He tested his IgM and IgG yesterday (19Jan2021) and they were negative. He wanted to know information from the clinical trials if Pfizer has tested the patients' IgG and IgM and what was done for them to have immunity. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nystagmus, Vertigo, Vomiting
Clinical narrative: Acute vertigo; Vertigo with nystagmus; vomiting; general myalgias; This is a spontaneous report from a contactable physician, the patient. A 75 years old male patient (physician) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), intramuscular in the left arm on 17JAN2021 at 10:30 as a single dose for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital.  Medical history included Prostate hypertrophy, reflux, osteoarthritis. Known food allergy (details not provided) and  drug hypersensitivity to inhalant allergens. Concomitant medication included tamsulosin (TAMSULOSIN), famotidine (FAMOTIDINE), acetaminophen (ACETAMINOPHEN). The patent received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot Number EH 9899), intramuscular in the left arm on 28Dec2020 at 14:00. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Jan2021 at 18:30 (8 hours post booster) the patient experienced general myalgias and vomiting. Myalgias were decreasing as vertigo began. On 19Jan2021 at 10:30 the patient experienced Acute vertigo and Vertigo with nystagmus. The  Vertigo with nystagmus peaked 56 hrs. post booster, with vomiting. At 72 hours, vertigo decreasing but still prevents normal activities.  The events did result in a Physician Office Visit. Treatment was given for the events that  included Meclizine. The clinical outcome of vertigo myalgias, vertigo with nystagmus and vomiting was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administered at inappropriate site, Vaccination site erythema
Clinical narrative: They suspect that the vaccine was not administered in deltoid; administered subcutaneously; red spot on arm/red area where injection was; This is a spontaneous report from a contactable other healthcare professional (pharmacy student) and pharmacist via a Pfizer-sponsored program  inbound call center. A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), subcutaneously on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The pharmacy student called to ask if 3rd dose is needed if the COVID 19 vaccine was administered subcutaneously. He also wanted to know the efficacy and absorption of the vaccine if it was administered subcutaneously. The patient came back to the clinic with red spot on arm. They suspect that the vaccine was not administered in deltoid. They reported that the patient got her first and second dose of Covid vaccine. She came back in after second dose with red area where injection was. It was stated that they suspect that they gave the injection too low. They were wondering if the patient needed a third dose and if so when. It was stated that it may not be fully be in the deltoid muscle. They wondered if this affected absorption and efficacy of the vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: exposed to COVID19-positive daughter; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) reported that a male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration in 31Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled to receive the second dose on 22Jan2021 but on 17Jan2021 his daughter had symptoms and tested positive for COVID-19. The patient was asking if he can take the second dose of vaccine after exposure to a positive person. The outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Menstruation delayed, Premenstrual syndrome
Clinical narrative: 5 days late for her menstruation; breaking out; PMS syndromes; This is a spontaneous report from a contactable consumer. A 31-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular (left arm) on 12Jan2021 14:00 at a single dose for covid-19 immunization. Medical history included celibate and on birth control. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in 17Dec2020 (first dose). It was reported by the patient that she is 5 days late for her menstruation. She is also experiencing PMS syndromes and have been breaking out after having the second dose of COVID-19 vaccine; all on 14Jan2021. The outcome of the event breaking out was recovering while not recovered for the other events.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: muscle twitches; This is a spontaneous report from a contactable other HCP. A 22-year-old female patient  received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:  EK9231), via an unspecified route of administration in right arm on 03Jan2021 at a single dose for COVID-19 immunization. There was no relevant medical history. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) as oral contraception. She has developed muscle twitches after the first dose. Especially in the arm the vaccine was administered in. She has noticed it in other parts of her body as well. She has experienced twitching of the muscle. She noticed it a couple of days after the vaccine, Jan2021. Then she started to notice them more. She knows muscle twitches can be normal, but this was more than usual. It was especially in arm the vaccine was received in. She feels it most in her right bicep. She started taking magnesium supplements to help. Today she didn't take the magnesium, and she noticed she had muscle twitches still. The outcome of the event was not recovered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: swollen lymph node; lymph node was swollen and she described it as "not terrible just a constant pain."; pain and swelling at injection site; pain and swelling at injection site; This is a spontaneous report from a contactable consumer who reported for herself, a 23-year-old female patient (home health aid) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1283, Expiration date: 30Apr2021), intramuscular at the left arm, on 11Jan2021 at around 09:00 at the age of 23 years, at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. There were no prior vaccinations within 4 weeks. Patient reported that she experienced swelling and pain at the injection site on 11Jan2021, she didn't feel any pain until that night around 4 or 5pm. By Thursday, 14Jan2021, she woke up and felt better, she didn't have any pain or swelling. Patient reported that on 18Jan2021, on the right side of her face under her jaw she noticed her lymph node was swollen and she described it as "not terrible just a constant pain." She would like to know if this was a common side effect, and if how long should she wait before she could contact her doctor about this side effect. These were the only symptoms she experienced. The swelling has stayed the same. She did not know if the swollen lymph node could be from the COVID vaccine or not. Patient stated if the swollen lymph node was not a part of the symptoms for the COVID vaccine, she definitely needs to go see a doctor. The events were considered as non-serious by the reporter. The events did not require a visit to emergency room nor the physician office. The outcome of swollen lymph node and lymph node pain was not recovered; while pain and swelling at injection site recovered on 14Jan2021.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Malaise, Pain in extremity, Pyrexia
Clinical narrative: began to run a fever, so she had a COVID test which came back positive; began to run a fever, so she had a COVID test which came back positive; her arm began to be sore; feels pretty crummy; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 likely around 2pm-ish at a single dose for COVID-19 immunization. Medical history included diabetic from 1993 to an unknown date. There were no concomitant medications. The patient called about the Pfizer BioNTech COVID19 vaccine and says she took the first shot on 07Jan2021, then one week later, 14Jan2021, she began to run a fever, so she had a COVID test on Monday 18Jan2021, which came back positive. She says she has had a fever at the time of report for the 7th day. The patient received the vaccine and doesn't know if she is willing to get the second shot after this. The patient was asking if it could be a false positive, can she take ibuprofen, can she take the second dose and could the vaccine cause coronavirus. She says that she got the first dose of the vaccine, it was injected into her left arm, and it wasn't painful, she felt so good, then night of 07Jan2021 her arm began to be sore, her vaccine arm was now ok, she started feeling sick a week later. She has been taking Tylenol only, since she heard that it is not good to take Ibuprofen. Tylenol EXP: Mar2024, LOT: SEA054, she says that the Tylenol is 325mg, and she has been taking two at a time, she takes it when she needs it for the fever, she tries to space out doses 5-6 hours. Her temperature on morning of 20Jan2021 was the highest it has been, 102.1 degrees Fahrenheit. She says she has kept a log, it has also been 101.4, 100.5, after it started out a week ago at 99.7, 99.1, 99.5, and then on Saturday, unknown date in Jan2021, it started climbing up, it has been 100.4 degrees Fahrenheit last two to three days and higher, she feels pretty crummy. She has had a positive COVID test which she took Monday 18Jan2021 and the results came back morning of 20Jan2021 on the phone, it is unknown which test exactly they used. She says it was the 2-3 day one with a swab, she did her own swabbing and swabbed each nostril with the same swab really well. The events were reported as non-serious. Outcome of the event her arm began to be sore was recovered in Jan2021, for the other events was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: began to run a fever, so she had a COVID test which came back positive; began to run a fever, so she had a COVID test which came back positive; her arm began to be sore; feels pretty crummy; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 likely around 2pm-ish at a single dose for COVID-19 immunization. Medical history included diabetic from 1993 to an unknown date. There were no concomitant medications. The patient called about the Pfizer BioNTech COVID19 vaccine and says she took the first shot on 07Jan2021, then one week later, 14Jan2021, she began to run a fever, so she had a COVID test on Monday 18Jan2021, which came back positive. She says she has had a fever at the time of report for the 7th day. The patient received the vaccine and doesn't know if she is willing to get the second shot after this. The patient was asking if it could be a false positive, can she take ibuprofen, can she take the second dose and could the vaccine cause coronavirus. She says that she got the first dose of the vaccine, it was injected into her left arm, and it wasn't painful, she felt so good, then night of 07Jan2021 her arm began to be sore, her vaccine arm was now ok, she started feeling sick a week later. She has been taking Tylenol only, since she heard that it is not good to take Ibuprofen. Tylenol EXP: Mar2024, LOT: SEA054, she says that the Tylenol is 325mg, and she has been taking two at a time, she takes it when she needs it for the fever, she tries to space out doses 5-6 hours. Her temperature on morning of 20Jan2021 was the highest it has been, 102.1 degrees Fahrenheit. She says she has kept a log, it has also been 101.4, 100.5, after it started out a week ago at 99.7, 99.1, 99.5, and then on Saturday, unknown date in Jan2021, it started climbing up, it has been 100.4 degrees Fahrenheit last two to three days and higher, she feels pretty crummy. She has had a positive COVID test which she took Monday 18Jan2021 and the results came back morning of 20Jan2021 on the phone, it is unknown which test exactly they used. She says it was the 2-3 day one with a swab, she did her own swabbing and swabbed each nostril with the same swab really well. The events were reported as non-serious. Outcome of the event her arm began to be sore was recovered in Jan2021, for the other events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Myalgia, Nausea, SARS-CoV-2 test
Clinical narrative: first dose was administered on 03Jan2021 and second dose was administered on 15Jan2021; pain at injection site; Muscle pain; joint pain; nausea; This is a spontaneous report from a non-contactable other health professional. A 45-year-old female patient received second dose oBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number and expiry not available), via an unspecified route of administration, in the left arm, on 15Jan2021 13:00 at a SINGLE DOSE for COVID-19 immunization.  The patient's medical history was not reported.  Patient was not pregnant during vaccination. Historical vaccine included BNT162B2 on 03Jan2021 at 02:00 PM, in the Left arm (1st dose) for COVID-19 immunization. Concomitant medications included Birth control (unspecified) and sertraline hydrochloride (ZOLOFT). The first dose was administered on 03Jan2021 and second dose was administered on 15Jan2021. On 15Jan2021, the patient experienced muscle pain, joint pain, nausea and pain at injection site. The patient underwent lab tests and procedures which included covid test via nasal swab post vaccination (on 15Jan2021) with unknown result. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: first dose was administered on 03Jan2021 and second dose was administered on 15Jan2021; pain at injection site; Muscle pain; joint pain; nausea; This is a spontaneous report from a non-contactable other health professional. A 45-year-old female patient received second dose oBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number and expiry not available), via an unspecified route of administration, in the left arm, on 15Jan2021 13:00 at a SINGLE DOSE for COVID-19 immunization.  The patient's medical history was not reported.  Patient was not pregnant during vaccination. Historical vaccine included BNT162B2 on 03Jan2021 at 02:00 PM, in the Left arm (1st dose) for COVID-19 immunization. Concomitant medications included Birth control (unspecified) and sertraline hydrochloride (ZOLOFT). The first dose was administered on 03Jan2021 and second dose was administered on 15Jan2021. On 15Jan2021, the patient experienced muscle pain, joint pain, nausea and pain at injection site. The patient underwent lab tests and procedures which included covid test via nasal swab post vaccination (on 15Jan2021) with unknown result. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; body aches; This is a spontaneous report from a contactable consumer.  An adult female patient received second BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 13Jan2021, after receiving 2nd injection of COVID vaccine, the patient had a fever for 24 hours and body aches. The outcome of the event fever was recovered on 14Jan2021; while body aches was unknown. The patient is not pregnant at the time of vaccination. No treatment was received for the events.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: first dose of BNT162B2 on 20Dec2020 and second dose of BNT162B2 on 15Jan2021; left axillary swelling, tenderness; headache; left axillary swelling; fatigue; chills; fever; This is a spontaneous report from a contactable healthcare professional. A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), intramuscular in left arm on 15Jan2021 13:00 at single dose for COVID-19 immunization.  Medical history included hypertension (HTN) and tomatoes, egg whites and milk-related products allergy; all from an unknown date and unknown if ongoing. Concomitant medication included hctz, metoprolol and ibuprofen. The patient previously had first dose of BNT162B2 lot number: EJ1685, on 20Dec2020 01:00 PM at single dose for COVID-19 immunization. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 16Jan2021, the patient experienced fatigue, fever and chills. On 17Jan2021, the patient experienced headache and left axillary swelling. On 20Jan2021,on follow up in the office, the patient experienced left axillary swelling, tenderness without lymphadenopathy or erythema. The injection site without redness or localized swelling. The events resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient received first dose of BNT162B2 on 20Dec2020 and second dose of BNT162B2 on 15Jan2021. The outcome of the events was unknown. No treatment was given to the patient for the events.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: first dose of BNT162B2 on 20Dec2020 and second dose of BNT162B2 on 15Jan2021; left axillary swelling, tenderness; headache; left axillary swelling; fatigue; chills; fever; This is a spontaneous report from a contactable healthcare professional. A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), intramuscular in left arm on 15Jan2021 13:00 at single dose for COVID-19 immunization.  Medical history included hypertension (HTN) and tomatoes, egg whites and milk-related products allergy; all from an unknown date and unknown if ongoing. Concomitant medication included hctz, metoprolol and ibuprofen. The patient previously had first dose of BNT162B2 lot number: EJ1685, on 20Dec2020 01:00 PM at single dose for COVID-19 immunization. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 16Jan2021, the patient experienced fatigue, fever and chills. On 17Jan2021, the patient experienced headache and left axillary swelling. On 20Jan2021,on follow up in the office, the patient experienced left axillary swelling, tenderness without lymphadenopathy or erythema. The injection site without redness or localized swelling. The events resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient received first dose of BNT162B2 on 20Dec2020 and second dose of BNT162B2 on 15Jan2021. The outcome of the events was unknown. No treatment was given to the patient for the events.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Eye irritation, Nausea, Pain
Clinical narrative: fever of 101.5; chills; nausea; body aches; burning behind the eyes; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 12Jan2021 17:15 (05:15 PM) at a single dose for Covid vaccine. Medical history included known allergies to penicillin and Covid prior to vaccination. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). It was reported that within 16 hours the patient had fever of 101.5, chills, nausea, body aches, and burning behind the eyes, all on 13Jan2021 08:00 AM. Treatment was not received for the events. She did not have Covid tested post vaccination. The outcome of the events was recovered on Jan2021.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 101.5; chills; nausea; body aches; burning behind the eyes; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 12Jan2021 17:15 (05:15 PM) at a single dose for Covid vaccine. Medical history included known allergies to penicillin and Covid prior to vaccination. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). It was reported that within 16 hours the patient had fever of 101.5, chills, nausea, body aches, and burning behind the eyes, all on 13Jan2021 08:00 AM. Treatment was not received for the events. She did not have Covid tested post vaccination. The outcome of the events was recovered on Jan2021.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for the COVID-19 Virus; tested positive for the COVID-19 Virus; This is a spontaneous report from a contactable nurse (patient's wife). This nurse reported similar events for her and her husband. This case refers to the husband.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), 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. It was reported that the patient tested positive for the COVID-19 virus on an unspecified date. The outcome of the event was recovered on an unspecified date. The wife asked on how the patient should proceed for the second dose (if they will wait for 90 days).  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021034841 Same reporter/drug/event, different patient
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Culture throat, Odynophagia, Oropharyngeal pain, Pharyngeal erythema, Smear test
Clinical narrative: severe sore throat; very painful to swallow; flaming red posterior pharynx; flaming red posterior pharynx; This is a spontaneous report from a contactable physician (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via an unspecified route of administration on 14Jan2021 at 14:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included hypertension, breast cancer, seasonal allergies, and depression. Concomitant medications included unspecified medicines. The patient previously took doxycycline and had allergies; and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283) on 24Dec2020 at 07:30 am in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 17Jan2021 at 06:00, the patient started getting a severe sore throat, very painful to swallow. The patient had no fever, no lymphadenopathy, no tonsillar excavate, just flaming red posterior pharynx on 17Jan2021 at 06:00. The reported events led to doctor office/clinic visit and emergency room visit. The doctor thinks these may be a reaction to the vaccine, however, the patient did not receive any treatment for the reported events. On 18Jan2021, the patient underwent throat swab and nasal swab tests and both were negative. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: severe sore throat; very painful to swallow; flaming red posterior pharynx; flaming red posterior pharynx; This is a spontaneous report from a contactable physician (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via an unspecified route of administration on 14Jan2021 at 14:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included hypertension, breast cancer, seasonal allergies, and depression. Concomitant medications included unspecified medicines. The patient previously took doxycycline and had allergies; and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283) on 24Dec2020 at 07:30 am in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 17Jan2021 at 06:00, the patient started getting a severe sore throat, very painful to swallow. The patient had no fever, no lymphadenopathy, no tonsillar excavate, just flaming red posterior pharynx on 17Jan2021 at 06:00. The reported events led to doctor office/clinic visit and emergency room visit. The doctor thinks these may be a reaction to the vaccine, however, the patient did not receive any treatment for the reported events. On 18Jan2021, the patient underwent throat swab and nasal swab tests and both were negative. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia, Pruritus
Clinical narrative: feels itchy; burning; tingling and paresthesia all over her body; This is a spontaneous report from a contactable physician. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 12Jan2021, and she has had a serious reaction since; she felt itchy, burning, tingling and paresthesia all over her body. She has been on Benadryl for it. The outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events itchy, burning sensation, paresthesia. 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dry skin, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Her skin is a little more rough and more leathery than normal; developed rash at injection site, 'very, very' itching and red, puffy and raised at the injection site; developed rash at injection site, 'very, very' itching and red, puffy and raised at the injection site; developed rash at injection site, 'very, very' itching and red, puffy and raised at the injection site; developed rash at injection site, 'very, very' itching and red, puffy and raised at the injection site; bruise; This is a spontaneous report from a contactable consumer. A 79-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 11Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included ongoing allergic to penicillin. There were no concomitant medications. On 12Jan2021, the patient experienced bruise/ She had a little bit of a bruise from the shot initially. On 18Jan2021, two nights ago, it was reported that the patient developed rash at injection site/rash by the site, 'very, very' itching, it itches a lot and red, puffy and raised at the injection site. On an unspecified date, it was reported that the patient's skin is a little more rough and more leathery than normal. Therapeutic measures were taken as a result of vaccination site pruritus. The outcome of the event Her skin is a little more rough and more leathery than normal was unknown while not recovered for the other events.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Her skin is a little more rough and more leathery than normal; developed rash at injection site, 'very, very' itching and red, puffy and raised at the injection site; developed rash at injection site, 'very, very' itching and red, puffy and raised at the injection site; developed rash at injection site, 'very, very' itching and red, puffy and raised at the injection site; developed rash at injection site, 'very, very' itching and red, puffy and raised at the injection site; bruise; This is a spontaneous report from a contactable consumer. A 79-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 11Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included ongoing allergic to penicillin. There were no concomitant medications. On 12Jan2021, the patient experienced bruise/ She had a little bit of a bruise from the shot initially. On 18Jan2021, two nights ago, it was reported that the patient developed rash at injection site/rash by the site, 'very, very' itching, it itches a lot and red, puffy and raised at the injection site. On an unspecified date, it was reported that the patient's skin is a little more rough and more leathery than normal. Therapeutic measures were taken as a result of vaccination site pruritus. The outcome of the event Her skin is a little more rough and more leathery than normal was unknown while not recovered for the other events.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache/Headache was reported as worsened; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A 27-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) on her right arm, via an unspecified route of administration on 19Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included migraine in 2016 and on Birth control.  Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) for Birth control and paracetamol (TYLENOL). It was reported that the patient received the Pfizer COVID 19 vaccine yesterday and started to have a headache last night (19Jan2021). She noticed the headache last night and now it is worse than last night. The outcome of the event was not recovered.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Threw up close to 30 times; extreme body aches; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 25-year-old female patient received second single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported) , via an unspecified route of administration (Vaccine location: left arm) on 14Jan2021 17:45 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included factor 5. The patient was not pregnant and was not pregnant at the time of vaccination. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications the patient received within 2 weeks of vaccination. The patient previously took first single dose of BNT162B2 (Pfizer) on 24Dec2020 10:15, Vaccine location: left arm for COVID-19 immunization. On 15Jan2021 07:45, the patient threw up close to 30 times with extreme body aches. The events were considered as non-serious by the reporter. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021 with lasting effects.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.