chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache
Clinical narrative: Intense Back pain; headaches; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0172), via an unspecified route of administration, in left arm on 06May2021 17:30 (at the age of 36-years-old) at first dose, single for COVID-19 immunization. Medical history included COVID-19. The patient had no known allergies. Prior to vaccination, the patient was not pregnant, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced intense back pain and headaches on 06May2021 20:00. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the events. Outcome of the events was not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: On the same arm as vaccine he developed a muscle twitch; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the arm on 01May2021, 2nd dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0158, expiration date: 31Jul2021) administered via an unspecified route of administration on 10Apr2021, 1st dose, single, for COVID-19 immunization. About 2 to 3 days after the second dose, the patient developed a muscle twitch on the same arm where the vaccine received. It was not constant but periodic throughout the day. The patient wanted to know if there had been any notes on it about the vaccine and should he expect it to go away. The outcome of the event was unknown.  No follow-up attempts are possible; No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Poor quality product administered, Product temperature excursion issue
Clinical narrative: His arm was sore; Felt fatigued; Him and his wife both got their 1st shot of the Pfizer covid vaccine last week at pharmacy/they got a call from pharmacy that it was not stored at the right temperature; Him and his wife both got their 1st shot of the Pfizer covid vaccine last week at pharmacy/they got a call from pharmacy that it was not stored at the right temperature; This is a spontaneous report from a contactable consumer. Patient reported about him and his wife. This is report 1 of 2. A 32-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and expiration date: Unknown), via an unspecified route of administration on 07Mar2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received vaccine which was not stored at the right temperature and patient stated he was given a bad vaccine and offered a new appointment for a good vaccine. Patient reported his arm was sore, felt fatigued for 2 days, but now although him and his wife feel okay. The outcome of arm was sore, felt fatigued was recovered and other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache
Clinical narrative: She had a slight headache; This is spontaneous report received from a contactable consumer (husband). This is the second case out of two cases in which reporter is reporting for his wife. A 31-years-old female non pregnant patient received unknown dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration as an unspecified dose for covid-19 immunization. The patient medical history included her husband few months back had Covid and he experienced fever, weakness and soreness for a period of 3 days but it was gone after 3 days and then when he got tested, it came back positive and when he checked his blood pressure it went to 130/91 mmHg. He said that he followed instructions from the department and he noticed that his fever and weakness were gone after 3 days and after a week of isolation, he got himself tested and the results came back negative however, his soreness lasted for 3 to 4 weeks till he got tested for second time and it came back negative again. He also mentioned that his wife had the same symptoms she had when he had Covid but his wife did not get tested and then when he went back to get tested again after isolating they both tested negative. So, his wife took the vaccine 10 days ago and he noticed that she did not have any symptoms and also said that after his symptoms were all gone he decided to take the vaccine, (as patient had Covid before taking the vaccine, hence Covid not captured as event). The concomitant medications were not reported.  The Patient experienced headache on an unspecified date after the vaccination. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Hypersensitivity, Pruritus, Swelling face, Urticaria
Clinical narrative: He had an allergic reaction after he got his first dose; His head feels warm and itchy; His head feels warm and itchy; Swelling on face and hives at his back.; Swelling on face and hives at his back.; This is a spontaneous report from a non-contactable consumer or other non hcp via Pfizer sponsored program .    A male patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and expiration date were unknown), dose 1 via an unspecified route of administration on 14Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient also received second dose of BNT162b2 via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced an allergic reaction after he got his first dose, his head feels warm and itchy, swelling on face and hives at his back. The patient (consumer) reported that he is already done with the first dose on the 14th April, he got the second dose on 11th May. Reporter was asked if there are any, based on what he read and from what he was advised, the side effect of the vaccine could occur an hour or several hours after vaccine or after taking the vaccine. Reporter asked, if there are any cases reported that this allergic reaction was experienced several days later after taking vaccine. Reporter also stated that he had an allergic reaction after he got his first dose, so he said that he experienced head feels warm and itchy and then he also had a little swelling on his face and hives at his back. He denied providing personal information. He informed that he was just called to see if there is other cases or instances because he has been reading here at the fax sheets that once you get the Pfizer dose whatever, if you get an allergic reaction and tell that within a minute to an hour but the patient had an allergic reaction. The patient asked if patient tends to have an allergic reaction within minutes to an hour and if that's the reason, they make patients way around to get a shot. He wanted to know if there have been other cases of people having allergic reactions several days afterwards, referred for medical information department for further guidance. NDC and UPC number was not provided. The Outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Bad cold; This is a spontaneous report from a contactable consumer (patient's mother) via a Pfizer sponsored program. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FN6201, expiration date: 30Jun2021), intramuscularly in left arm on 20Apr2021, (at the age of 18-years-old), 1st dose, 0.3 mL single, for COVID-19 immunization. The patient had no medical history and there were no concomitant medications. On 11May2021, the patient developed a bad cold with stuffy nose and cough. As per the reporter, it had gone through the stages as; on 11May2021, the patient had a sore throat, then on 12May2021, it was progressed to stuffy nose and on 13May2021, the patient was congested and had a cough a little bit. The patient had no fever. As of this report, the bad cold and its symptoms were ongoing. The second dose was scheduled for 13May2021. The reporter was calling to see if the patient could take the second dose on the reporting day or if they need to reschedule it. The patient did not undergo any lab tests and procedures. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itched a little; This is a spontaneous report from a contactable consumer (patient's aunt). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), 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 experienced itched a little on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021544038 Same patient/drug, different dose/events
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Caller said that her arm was swollen after the first dose too.; This is a spontaneous report received from a contactable consumer (patient). A 73-year-old female patient received first dose of bnt162b2 (Batch/Lot Number: EN9581, Pfizer BioNTech), via an unspecified route of administration, administered in left arm on 18Jan2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm was swollen after the first dose on an unspecified date. Caller said that her arm was swollen after the first dose too, but she did not run a fever. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Paraesthesia
Clinical narrative: Tingling in his right hand and then subsequently developed tingling in his right leg and down to his foot; Chest pain; This is a spontaneous report from a contactable physician (patient's father) via Medical Information Team. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 30Apr2021 (at the age of 18-years-old), 1st dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The vaccine was administered at a pharmacy. On 30Apr2021, the patient developed tingling in his right hand and then subsequently developed tingling in his right leg and down to his foot, and then developed chest pain. The reporter stated that the patient went to the emergency room and an electrocardiogram was done on 30Apr2021 that came back normal, so he was sent home. The reporter would like to know if there was any guidance that could be provided on the safety of the patient getting the second dose of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Small patches of breakthrough (pso) spots; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced small patches of breakthrough (pso) spots, coincidently about the time she had got her COVID-19 vaccine. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected. Batch/lot number not obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she was "sick " for 16 days following covid vaccine; This is a spontaneous report from a contactable other HCP and a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date. It was reported that the patient was "sick " for 16 days following covid vaccine in Apr2021. Exact symptoms unknown, md aware. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: chills; body aches; This is a spontaneous report from a contactable other HCP. This Other HCP reported that a 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, Expiration date not reported), via an unspecified route of administration on 11May2021 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history included pre-existing condition of mouth ulceration from an unknown date. The patient's concomitant medication included palbociclib (IBRANCE, 125mg,) taken orally from 31Mar2021 as daily dose (day 1-21 of 28 day cycle) for breast cancer and is ongoing.  The patient experienced chills and body aches on an unspecified date. The outcome of both the events was reported as unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Cough, Dry throat, Inflammation, Lacrimation increased
Clinical narrative: Dry nose and throat; Dry nose and throat; Weepy eyes, a lot of tears, water coming from her eyes; Fever; Cough; Cold-like symptoms; Body pain; inflammation under her armpit; Pain under her armpit; This is a spontaneous report from a contactable consumer (patient) via Medical information team.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on 12May2021 (at the age of 42-years-old ) at 1ST DOSE, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had dry nose and throat; weepy eyes, a lot of tears, water coming from her eyes and had fever; a lot of coughing; cold-like symptoms; body pain; felt inflammation and pain under her armpit in May2021 after the first dose. She mentioned that because of symptoms she could not go to work for 2 days i.e. 13May2021 and 14May2021. The events were reported as non serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal dryness, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: Dry nose and throat; Dry nose and throat; Weepy eyes, a lot of tears, water coming from her eyes; Fever; Cough; Cold-like symptoms; Body pain; inflammation under her armpit; Pain under her armpit; This is a spontaneous report from a contactable consumer (patient) via Medical information team.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on 12May2021 (at the age of 42-years-old ) at 1ST DOSE, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had dry nose and throat; weepy eyes, a lot of tears, water coming from her eyes and had fever; a lot of coughing; cold-like symptoms; body pain; felt inflammation and pain under her armpit in May2021 after the first dose. She mentioned that because of symptoms she could not go to work for 2 days i.e. 13May2021 and 14May2021. The events were reported as non serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: started feeling COVID symptoms on 04May 2021, and received a COVID positive diagnosis on 07May 2021; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 08:15 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Patients Medical History (including any illness at time of vaccination) was none. No Family Medical History Relevant to AE(s). There were no concomitant medications. No history of previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No prior vaccinations (within 4 weeks). No AE(s) following prior vaccinations. It was reported that the patient had the first vaccine on 30Apr2021, and started feeling COVID symptoms on 04May 2021, and received a COVID positive diagnosis on 07May 2021. The patient is scheduled on 21May2021 for her second shot, and was trying to decide if should delay her vaccine based on fact that she had COVID after the first shot. States she thinks she is mostly recovered, so she is improving. The patient did a virtual visit to physician office to get scheduled for COVID test, did drive through test. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Headache, Malaise, Pain
Clinical narrative: fever keeps going up; 1st it was 99, then 100 and then 101; headache; body aches; Not feeling well; weak; This is a spontaneous report from a contactable consumer (patient) via Medical information team.  A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on 13May2021 at 15:00, (at the age of 47-years-old) at 1ST DOSE single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever and it  kept going up, 99 at first, then 100 and then 101, had headache, body aches, not feeling well and weak in May2021 after the first dose. He stated he just took two pills of Tylenol Extra Strength. Treatment was given for the events. Patient wanted to know if it was normal to have a fever and other symptoms and how long it would lasts. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever keeps going up; 1st it was 99, then 100 and then 101; headache; body aches; Not feeling well; weak; This is a spontaneous report from a contactable consumer (patient) via Medical information team.  A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on 13May2021 at 15:00, (at the age of 47-years-old) at 1ST DOSE single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever and it  kept going up, 99 at first, then 100 and then 101, had headache, body aches, not feeling well and weak in May2021 after the first dose. He stated he just took two pills of Tylenol Extra Strength. Treatment was given for the events. Patient wanted to know if it was normal to have a fever and other symptoms and how long it would lasts. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: He got covid the next day after taking the vaccine; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable male consumer of an unspecified age reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/ Lot number: unknown), via an unspecified route of administration on 22Apr2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller was scheduled to take his second dose tomorrow. He got his first dose 3 weeks ago on 22Apr2021. However, he got covid the next day after taking the vaccine. He wanted to know if he can still take the second dose tomorrow or not. The patient underwent lab tests and procedures which included sars-cov-2 test results positive on 23Apr2021. The outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Illness, Nausea
Clinical narrative: Nausea; Chills; Diarrhea; sick; This is a spontaneous report from a contactable consumer (patient's friend). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at an unknown single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was sick for about four and a half days. The patient had nausea, chills, and diarrhea. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea
Clinical narrative: Strong joint pain; Strong nausea; This is a spontaneous report from a Pfizer sponsored program  received from a contactable consumer (patient's daughter). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route at the age of 55 years on 22Apr2021 (Lot number: not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of 2021, the patient experienced strong joint pain and strong nausea, which the patient never had before. The outcome was unknown for the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Malaise
Clinical narrative: he is not feeling  "100% fine"; her husband is experiencing sometimes dizziness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (herself and husband). This is the second of reports. A 42-year-old male patient received BNT162B2 (COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her husband received the same COVID-19 vaccine as her and he is not feeling "100% fine", he feels dizzy as well. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : Same reporter/drug/events, different Patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Paraesthesia, Ultrasound scan, Vaccination site pain
Clinical narrative: sharp pain where the vaccine was provided a couple of times; numbness and tingling on my arm; numbness and tingling on my arm; can not do certain movements; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (no pregnant) received the second dose of BNT162B2 via an unspecified route of administration on left arm on 16Apr2021 at 15:30 (Lot Number: ER8733) as single dose for COVID-19 immunization. Medical history was none. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient was not received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 on left arm on 18Mar2021 at 16:00 (Lot Number: ER2613) as single dose for COVID-19 immunization. The patient experienced sharp pain where the vaccine was provided a couple of times and numbness and tingling on arm and cannot do certain movements on 16Apr2021. The adverse event results in doctor or other healthcare professional office/clinic visit. The patient received ultrasound of left arm. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over the body; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), in left arm on 13May2021 10:00 at single dose for covid-19 immunisation. Medical history included known sulfa and shellfish allergies. The patient was not pregnant at time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: unknown), on an unspecified date at single dose for covid-19 immunisation. The patient experienced hives all over the body on 14May2021 16:00. The patient had not been tested for covid-19 since the vaccination. Therapeutic measures were taken as a result of hives all over the body and included treatment with oral steroids. The outcome of the event hives all over the body was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Headache; fever of 102.6; This is a spontaneous report from a contactable consumer (patient). A 13-year-old female (no pregnant) patient received the first dose of BNT162B2 via an unspecified route of administration on left arm on 14May2021 at 17:30 as single dose for COVID-19 immunization. Medical history was not reported. The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received the list of other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and hadn't been tested for COVID-19 since the vaccination. Concomitant medication was not reported. The patient experienced headache and fever of 102.6 on 15May2021. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Pain, Pyrexia
Clinical narrative: Heavy fever - 102.8 degrees; Body aches; loss of taste; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on left arm on 13May2021 at 13:30 as single dose for COVID-19 immunization. Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, unknown whether the patient had been tested for COVID-19. No known allergies. Concomitant medication were not reported. The patient previously took the first dose of BNT162B2 as single dose for covid-19 immunization. The patient experienced heavy fever-102.8 degrees, body aches and loss of taste on 14May2021 at 12:00. The treatment was not taken. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, Off label use
Clinical narrative: current_age: 15; Headache; chest pain; fatigue; This is a spontaneous report received from a non-contactable consumer. A 15-year-old male patient reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Left Arm on 13May2021 16:00 (at the age of 15-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14May2021 at 16:30 the patient experienced Headache, chest pain, and fatigue. The patient received Tylenol as treatment for the events. The reporter stated that events as non-serious. The outcome of the events was reported as recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Somnolence
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0183), via an unspecified route of administration in right arm, on 14May2021 at 10:00 (at the age of 55-years-old) as first dose, single for COVID-19 immunization in a hospital. Medical history included rheumatoid arthritis, asthma, hypertension and medullary sponge kidneys. The patient had known allergies. The patient had concomitant medications but not reported. The patient was not pregnant and 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 and since the vaccination, the patient was never tested for COVID-19. The patient's both feet feel like having pins and needles and feel asleep on 14May2021 at 10:45. No treatment was received by the patient for these events. The outcome of these events was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: Pain in arm of injection; all over body soreness; headache; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, in the right arm on 14May2021 (at the age of 25-years-old) as 2nd dose, single for COVID-19 immunization. Medical history included irritable bowel syndrome, migraines and allergy to penicillin. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), loperamide, probiotics and multivitamins. The vaccine was administered at Pharmacy/Drug Store. The patient did not receive any other vaccine within 4 weeks of vaccination. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, in the left arm on an unspecified date (at the age of 25-years-old) as first dose, single for COVID-19 immunization. The patient experienced pain in arm of injection, all over body soreness and headache on 15May2021. The events were reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patients' wife). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 26Apr2021, as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.On 28Apr2021,the patient experienced cough and fever. On 29Apr2021 next morning (2 days later),patient was diagnosed with COVID-19. The patient still had cough and stuff. His rapid test was negative but his PCR was positive still, so he had been positive for a while. He tested negative with the rapid test but the PCR test still come back positive.The patient was supposed to get his second vaccine on Monday. The reporter inquired about the recommendations, like patient still have lingering symptoms, does he wait, does he have to start over.The patient underwent lab tests and procedures which included COVID rapid test : negative on Apr2021 and PCR test : positive on 29Apr2021. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Headache, Pain
Clinical narrative: he had the second dose of Pfizer's covid vaccine and it gave him a headache, body aches and bone pain that all went away within two days.; he had the second dose of Pfizer's covid vaccine and it gave him a headache, body aches and bone pain that all went away within two days.; covid vaccine and it gave him a headache, body aches and bone pain that all went away within two days.; On 16May, he began to feel very dizzy and in the early morning he rose from dizziness; This is a spontaneous report from a contactable consumer. A 43-year-old male consumer (patient) reported for himself that, received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. The patient's medical and concomitant medication history were not reported. Historical vaccination included 1st dose BNT162B2 (COMIRANTY) for COVID-19 immunization. It was reported that, on an unknown date, the patient had the second dose of Pfizer's covid vaccine and it gave him a headache, body aches and bone pain that all went away within two days. On 16May2021, patient began to feel very dizzy and in the early morning rose from dizziness. The patient wanted to know what he can do to treat the dizziness or if he should wait for it to go away.   Follow-up attempts not completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Diarrhoea, Fatigue, Headache
Clinical narrative: crazy fatigue; she couldn't move any of the muscles in her arms, nothing; diarrhea; extreme head pounding; She says she finally got her sense of taste back a month ago and now she is losing it again; nausea; weakness; it was April 24th that she got her first dose/ got her second dose of the Pfizer COVID-19 vaccine on 11 May 2021; it was April 24th that she got her first dose/ got her second dose of the Pfizer COVID-19 vaccine on 11 May 2021; This is a spontaneous report from a contactable physician. A 70-years-old elderly female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 11May2021 at 15:00 as 2nd dose, single for COVID-19 immunization. The patient medical history included multiple sclerosis from 1994 to an unknown date. She reported that she has only had the tetanus vaccine 10 years ago, not even the flu shot, since she was diagnosed she never got any vaccines because she is immunocompromised. She reported that   and barometric pressure, it was a beautiful sky blue day and she was miserable, She says that the way she feels waxes and wanes, sometimes she gets a little better, but the fatigue is ongoing, it never changes. She suffered from COVID-19 in Nov2020, she was wiped out for days and days and lost sense of taste and smell for months, which she had fully recovered from. She clarified she got her sense of smell back two months ago. On Saturday 24Apr2021 at 1:30 pm, the patient received first dose of COVID-19 Vaccination and 3 weeks and two days later was her 2nd dose. She had no other vaccinations the same day as her Pfizer COVID-19 vaccine doses or in the four weeks prior and has started no new meds before vaccine doses. She has only been taking her regular MS meds and she never changes those and did not report any medications. On 12May2021, the patient experienced extreme head pounding, diarrhoea on 14May2021, Friday and has persisted. On an unspecified date the patient experienced nausea every single day, crazy fatigue. She was fine until Wednesday night when she crashed and she could not move any of the muscles in her arms (muscle disorder), weakness (asthenia). It was April 24th that she got her first dose/ got her second dose of the Pfizer COVID-19 vaccine on 11May2021 as off label use and inappropriate schedule of product administration), She says she finally got her sense of taste back a month ago and now she is losing it again(Ageusia). No treatment has been done for the extreme head pounding or diarrhoea, Her MS medication did not help the head pounding or diarrhoea. She stated she guesses if it does not kill you, it is not serious. She says that the best word she thinks to describe it is troublesome, though maybe something more than troublesome. She says she thinks that the exhaustion is the worst part. The outcome for the events was unknown.  Information about Lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Muscle disorder, Nausea, Off label use
Clinical narrative: crazy fatigue; she couldn't move any of the muscles in her arms, nothing; diarrhea; extreme head pounding; She says she finally got her sense of taste back a month ago and now she is losing it again; nausea; weakness; it was April 24th that she got her first dose/ got her second dose of the Pfizer COVID-19 vaccine on 11 May 2021; it was April 24th that she got her first dose/ got her second dose of the Pfizer COVID-19 vaccine on 11 May 2021; This is a spontaneous report from a contactable physician. A 70-years-old elderly female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 11May2021 at 15:00 as 2nd dose, single for COVID-19 immunization. The patient medical history included multiple sclerosis from 1994 to an unknown date. She reported that she has only had the tetanus vaccine 10 years ago, not even the flu shot, since she was diagnosed she never got any vaccines because she is immunocompromised. She reported that   and barometric pressure, it was a beautiful sky blue day and she was miserable, She says that the way she feels waxes and wanes, sometimes she gets a little better, but the fatigue is ongoing, it never changes. She suffered from COVID-19 in Nov2020, she was wiped out for days and days and lost sense of taste and smell for months, which she had fully recovered from. She clarified she got her sense of smell back two months ago. On Saturday 24Apr2021 at 1:30 pm, the patient received first dose of COVID-19 Vaccination and 3 weeks and two days later was her 2nd dose. She had no other vaccinations the same day as her Pfizer COVID-19 vaccine doses or in the four weeks prior and has started no new meds before vaccine doses. She has only been taking her regular MS meds and she never changes those and did not report any medications. On 12May2021, the patient experienced extreme head pounding, diarrhoea on 14May2021, Friday and has persisted. On an unspecified date the patient experienced nausea every single day, crazy fatigue. She was fine until Wednesday night when she crashed and she could not move any of the muscles in her arms (muscle disorder), weakness (asthenia). It was April 24th that she got her first dose/ got her second dose of the Pfizer COVID-19 vaccine on 11May2021 as off label use and inappropriate schedule of product administration), She says she finally got her sense of taste back a month ago and now she is losing it again(Ageusia). No treatment has been done for the extreme head pounding or diarrhoea, Her MS medication did not help the head pounding or diarrhoea. She stated she guesses if it does not kill you, it is not serious. She says that the best word she thinks to describe it is troublesome, though maybe something more than troublesome. She says she thinks that the exhaustion is the worst part. The outcome for the events was unknown.  Information about Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Pyrexia
Clinical narrative: cold; fever; headache; This is a spontaneous report from a contactable Consumer. This consumer reported for her son (patient).  A male patient of an unspecified age received first dose of BNT162B2(solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration on 03May2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cold, fever and headache. Reporter stated that her son got the first dose of the COVID vaccine on 03May and is scheduled for the second dose of the covid vaccine on 24May but at this time the patient had cold, fever and headache. Reporter wanted to know can already do the covid test before the second dose or it may be after. Reporter wanted to know if those side effects are normal since she had seen those in the papers they were given after vaccination. Referred CDC to check about recommendations on covid tests. Information about lot/batch number has been requested.  Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID PCR: Positive (Date: 12-FEB-2021); This is a spontaneous report from a contactable other hcp. A 34-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: EM9810, Pfizer NTEC), via an unspecified route of administration in arm left on 03Feb2021 09:00 as 1st dose, single for covid-19 immunisation. Medical history included post-traumatic stress disorder, anxiety, attention deficit hyperactivity disorder, depression from an unknown date and unknown if ongoing. Concomitant medications included sertraline, birth control, alprazolam and trazodone taken for an unspecified indication, start and stop date were not reported. The patient experienced covid pcr: positive (date: 12-feb-2021) on 12Feb2021. The events assessed as non-serious. Treatment was received for the adverse events, diagnostic and lab testing work up on going. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Feb2021 Nasal Swab. In Hospital where the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Patient went to doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as not recovered.  Follow-up attempts needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pre-existing condition improved
Clinical narrative: had skin cancer on her left cheek. It had been slowly growing for years and after the Covid vaccine it has resolved!; This is a spontaneous report from a contactable other healthcare professional. A 101-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection ;Lot Number: UNKNOWN), via an unspecified route of administration on Mar2021 as a single dose for covid-19 immunization at Nursing Home/Senior Living Facility. Medical history included Asthma, heart disease, skin cancer. It was unknown, whether the patient had allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient had not received any other vaccine within four weeks prior to the COVID vaccine. The patient received unspecified chronic prescribed medications within 2 weeks of vaccination. It was unknown, the patient had any allergies. On an unspecified date in May2021, the patient experienced skin cancer on her left cheek. it had been slowly growing for years and after the covid vaccine it has resolved. The patient did not receive any treatment for the events. The Device Date was reported as 17May2021. The outcome of the event was recovered.  No follow-up attempts are needed; Information about Lot/Batch number cannot be requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity
Clinical narrative: current_age: 12; Sore arm; This is a spontaneous report from a contactable 12-year-old male consumer reported for himself that he received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EWO0182), via an unspecified route of administration in the right arm on 17-MAY-2021 15:45 as 1 ST DOSE SINGLE for covid-19 immunization. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested positive for covid-19. The patient's medical history and concomitant medications were not reported. On 17May2021 at 04:00pm, the patient experienced sore arm. Since the patient was 12-Year-old Off label use in unapproved age group was added as an additional event. The outcome of the event was recovered.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he experienced fever and tested positive to COVID-19.; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiry date: unknown) dose 1 via an unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 09Apr2021, (on travel to other country) he experienced fever and tested positive to Covid-19. The patient received unspecified treatment until 21Apr2021.On 08May2021 the patient tested negative to Covid-19. The patient wants to know if he can take the second dose tomorrow or the day after as he came back to his own country. Outcome of the event was resolved on 08May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.