chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Movement disorder, Pain in extremity, Peripheral swelling
Clinical narrative: Limited range of movement; Right wrist is swollen; pain in her hand and wrist/ Right hand hurting; pain in her hand and wrist/ Right wrist hurting; Right hand is quite swollen; This is a spontaneous report from a contactable consumer or other non hcp.  A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number ER8737) dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 11:30 (age at vaccination 31) as dose 1, Single for covid-19 immunisation. Medical history was not reported and concomitant drug was Antibiotic eye cream. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Caller got the first dose of the Covid Vaccine on 02Apr2021, this past Friday. She got it in her left arm. On 3Apr2021, the next day her right hand and wrist started hurting. She thought it was unrelated, but it got worse. Her hand is quite swollen. She has no other symptoms. She has never had any issues with arthritis or anything like that. She went to Urgent Care. X-rays didn't show anything. They suggested it was a potential vaccine reaction. It hasn't gotten worse or better. Another doctor said it could be a vaccine thing and to reach out to Pfizer and see if we have heard about anything like this happening before or have any tips on what to do about it. Antibiotic eye cream took it for a few days a week or 2 weeks before she got the vaccine. She was not currently taking it, she finished it. The patient had Right hand and wrist felt like a sprain at first. It was not severe the first day, but towards the evening it got worse. The pain has decreased a bit. She has been taking Tylenol. On 4Apr2021, Her hand and wrist are swollen, and she has a limited range of movement. She can't bend it. The pain started out not too bad. On 5Apr2021, that Sunday it was bad enough to go to Urgent Care. She has been in a brace and since then it has gotten better. If she moves it, it is worse. The swelling started Saturday, but she didn't notice it until Sunday. She can move it a little bit, it was pretty swollen. She thinks the 4th character in the lot number is a 7 or a 1, but she is pretty sure it is a 7. She hates needles, and having a reaction was something she was scared of. This is the worst thing that could have happened. She will still get the second dose. She is not 100 percent sure, she is not a doctor, but it is suspicious that it happened right after getting the vaccine and she had never had any problems.  The patient underwent lab tests and procedures which included x-ray: unknown result as Nothing found in report on an unknown date. The outcome of event right wrist is swollen was not recovered, pain in her hand and wrist/ right hand hurting was unknown, pain in her hand and wrist/ right wrist hurting was unknown , right hand is quite swollen was not recovered , limited range of was not recovered.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Limited range of movement; Right wrist is swollen; pain in her hand and wrist/ Right hand hurting; pain in her hand and wrist/ Right wrist hurting; Right hand is quite swollen; This is a spontaneous report from a contactable consumer or other non hcp.  A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number ER8737) dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 11:30 (age at vaccination 31) as dose 1, Single for covid-19 immunisation. Medical history was not reported and concomitant drug was Antibiotic eye cream. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Caller got the first dose of the Covid Vaccine on 02Apr2021, this past Friday. She got it in her left arm. On 3Apr2021, the next day her right hand and wrist started hurting. She thought it was unrelated, but it got worse. Her hand is quite swollen. She has no other symptoms. She has never had any issues with arthritis or anything like that. She went to Urgent Care. X-rays didn't show anything. They suggested it was a potential vaccine reaction. It hasn't gotten worse or better. Another doctor said it could be a vaccine thing and to reach out to Pfizer and see if we have heard about anything like this happening before or have any tips on what to do about it. Antibiotic eye cream took it for a few days a week or 2 weeks before she got the vaccine. She was not currently taking it, she finished it. The patient had Right hand and wrist felt like a sprain at first. It was not severe the first day, but towards the evening it got worse. The pain has decreased a bit. She has been taking Tylenol. On 4Apr2021, Her hand and wrist are swollen, and she has a limited range of movement. She can't bend it. The pain started out not too bad. On 5Apr2021, that Sunday it was bad enough to go to Urgent Care. She has been in a brace and since then it has gotten better. If she moves it, it is worse. The swelling started Saturday, but she didn't notice it until Sunday. She can move it a little bit, it was pretty swollen. She thinks the 4th character in the lot number is a 7 or a 1, but she is pretty sure it is a 7. She hates needles, and having a reaction was something she was scared of. This is the worst thing that could have happened. She will still get the second dose. She is not 100 percent sure, she is not a doctor, but it is suspicious that it happened right after getting the vaccine and she had never had any problems.  The patient underwent lab tests and procedures which included x-ray: unknown result as Nothing found in report on an unknown date. The outcome of event right wrist is swollen was not recovered, pain in her hand and wrist/ right hand hurting was unknown, pain in her hand and wrist/ right wrist hurting was unknown , right hand is quite swollen was not recovered , limited range of was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: I lost my taste 5 days after receiving my 2d covid 19 vaccination; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 2, single 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 unspecified date as single dose for COVID-19 immunization. The patient lost his/her taste 5 days after receiving the 2nd dose of COVID-19 vaccination on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible; information on batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever between 99 and 102; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reporting for self. A patient of unspecified age and gender received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had a fever between 99 and 102 for the whole three weeks since first vaccine on an unknown date. The patient underwent lab tests and procedures which included body temperature: between 99 and 102 (units unspecified) on an unknown date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: hives; fever; chills; headache; muscles and joint pain; muscles and joint pain; fatigue for several days; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 70 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 31Mar2021 08:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing, lung neoplasm malignant from an unknown date and unknown if ongoing and surgery, the oncologist said that's body's reaction to gaining antibodies. they weren't itchy, no other effect on her. Concomitant medication(s) included phenazepam (PHENAZEPAM) taken for an unspecified indication, start and stop date were not reported; nitrazepam (NITRAZEPAM) taken for an unspecified indication, start and stop date were not reported. The patient experienced fever on 01Apr2021 02:00 with outcome of recovered, chills on 01Apr2021 02:00 with outcome of recovered, headache on 01Apr2021 02:00 with outcome of recovered , muscles and joint pain causing myalgia on 01Apr2021 02:00 with outcome of recovered, muscles and joint pain causing arthralgia on 01Apr2021 02:00 with outcome of recovered, fatigue for several days on 01Apr2021 02:00 with outcome of unknown and hives causing urticaria on 01Apr2021 08:30 with outcome of unknown. Therapeutic measures were taken as a result of this with Tylenol.  Follow-up(05Apr2021) : This is a follow-up spontaneous report from the same contactable consumer, new information received which includes that : relevant medical history added and concomitant drugs added.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: hives; fever; chills; headache; muscles and joint pain; muscles and joint pain; fatigue for several days; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 70 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 31Mar2021 08:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing, lung neoplasm malignant from an unknown date and unknown if ongoing and surgery, the oncologist said that's body's reaction to gaining antibodies. they weren't itchy, no other effect on her. Concomitant medication(s) included phenazepam (PHENAZEPAM) taken for an unspecified indication, start and stop date were not reported; nitrazepam (NITRAZEPAM) taken for an unspecified indication, start and stop date were not reported. The patient experienced fever on 01Apr2021 02:00 with outcome of recovered, chills on 01Apr2021 02:00 with outcome of recovered, headache on 01Apr2021 02:00 with outcome of recovered , muscles and joint pain causing myalgia on 01Apr2021 02:00 with outcome of recovered, muscles and joint pain causing arthralgia on 01Apr2021 02:00 with outcome of recovered, fatigue for several days on 01Apr2021 02:00 with outcome of unknown and hives causing urticaria on 01Apr2021 08:30 with outcome of unknown. Therapeutic measures were taken as a result of this with Tylenol.  Follow-up(05Apr2021) : This is a follow-up spontaneous report from the same contactable consumer, new information received which includes that : relevant medical history added and concomitant drugs added.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: I am a Pfizer employee. My mother received the second vaccine shot and told me her face got swollen afterwards.; This is a spontaneous report from a contactable reporter reported for a 64-year-old female consumer. A 64-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 05Apr2021 (at the age of 64-years) as dose 2, single for covid-19 immunisation. The patient medical history included known allergies to penicillin. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 05Mar2021 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021, the patient experienced her face got swollen. Reporter stated that mother received the second vaccine shot and told me her face got swollen afterwards. Patient did not received treatment for events. The outcome of the events was recovered on unspecified date of 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Aura, Dizziness, Dysphagia, Emotional disorder
Clinical narrative: She experienced ear sensitivity to high pitch noises; severe headache; not feeling well after that night; tightness around neck, chest, arm again; could not eat or drink water for 43 h; could not tolerate anything; could not eat or drink water for 43 h; felt week; felt extremely dizzy and nauseated; felt extremely dizzy and nauseated; auras; arm hurt a lot; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization. Medical history included migraine neurologic condition not diagnosed yet, but she gets migraines often. The patient's concomitant medications were not reported. It was reported that She experienced ear sensitivity to high pitch noises. She felt ok during the first night, not feeling well after that night. She had on the second day after the second dose severe headache that she catalogued as extreme. She felt tightness around neck, chest, arm again, could not eat or drink water for 43 h, could not tolerate anything. On Saturday 54 h later from the vaccinate in bed for 24h straight, she felt week when she raised up and that afternoon, she got a lot of auras when she went to do the grocery and also felt extremely dizzy and nauseated. On Sunday Morning her body did not want to drink water and she did not eat until 3 pm; her arm hurt a lot and at 6 pm auras started again. She experienced for both doses water retention. She said that if she would know what the vaccine would do to her, she would have not been vaccinated with the Pfizer vaccine. She wanted to know how the vaccine works so to know if it overrides your system to product antibodies. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Headache, Malaise, Muscle tightness, Nausea
Clinical narrative: She experienced ear sensitivity to high pitch noises; severe headache; not feeling well after that night; tightness around neck, chest, arm again; could not eat or drink water for 43 h; could not tolerate anything; could not eat or drink water for 43 h; felt week; felt extremely dizzy and nauseated; felt extremely dizzy and nauseated; auras; arm hurt a lot; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization. Medical history included migraine neurologic condition not diagnosed yet, but she gets migraines often. The patient's concomitant medications were not reported. It was reported that She experienced ear sensitivity to high pitch noises. She felt ok during the first night, not feeling well after that night. She had on the second day after the second dose severe headache that she catalogued as extreme. She felt tightness around neck, chest, arm again, could not eat or drink water for 43 h, could not tolerate anything. On Saturday 54 h later from the vaccinate in bed for 24h straight, she felt week when she raised up and that afternoon, she got a lot of auras when she went to do the grocery and also felt extremely dizzy and nauseated. On Sunday Morning her body did not want to drink water and she did not eat until 3 pm; her arm hurt a lot and at 6 pm auras started again. She experienced for both doses water retention. She said that if she would know what the vaccine would do to her, she would have not been vaccinated with the Pfizer vaccine. She wanted to know how the vaccine works so to know if it overrides your system to product antibodies. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: She experienced ear sensitivity to high pitch noises; severe headache; not feeling well after that night; tightness around neck, chest, arm again; could not eat or drink water for 43 h; could not tolerate anything; could not eat or drink water for 43 h; felt week; felt extremely dizzy and nauseated; felt extremely dizzy and nauseated; auras; arm hurt a lot; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization. Medical history included migraine neurologic condition not diagnosed yet, but she gets migraines often. The patient's concomitant medications were not reported. It was reported that She experienced ear sensitivity to high pitch noises. She felt ok during the first night, not feeling well after that night. She had on the second day after the second dose severe headache that she catalogued as extreme. She felt tightness around neck, chest, arm again, could not eat or drink water for 43 h, could not tolerate anything. On Saturday 54 h later from the vaccinate in bed for 24h straight, she felt week when she raised up and that afternoon, she got a lot of auras when she went to do the grocery and also felt extremely dizzy and nauseated. On Sunday Morning her body did not want to drink water and she did not eat until 3 pm; her arm hurt a lot and at 6 pm auras started again. She experienced for both doses water retention. She said that if she would know what the vaccine would do to her, she would have not been vaccinated with the Pfizer vaccine. She wanted to know how the vaccine works so to know if it overrides your system to product antibodies. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: for her first dose the only thing was a sore arm, it was very sore; slight bit of fatigue; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 54-year-old female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration, administered in Arm Right on 14Jan2021 (at the age of 54-year-old) as single dose for COVID-19 immunization. The patient's medical history included history of three spinal surgeries (takes no pain meds, she is not on pain meds, she has never been on or kept taking them); and had "neuropathy and nerve related issues" that were not this bad since ten years ago, clarified that what she has is not actually neuropathy, something with the peripheral nerve, she says she doesn't remember actual verbiage). She doesn't react well to pharmaceuticals anyway (unspecified). Her medications are that she takes the minimum amount of medications, very minimal (unspecified). There were no concomitant medications. There was no other products. Also, she has not had any other recent vaccinations or started any new medications. For past drug, she didn't take anything other than 5mg of zolpidem tartrate (AMBIEN) to sleep at night because of her spine. Patient previously also took pregabalin (LYRICA) and was off it, was also on gabapentin or neurontin (patient did not have those medications to provide NDC/LOT/EXP for either of them because she took them back to the pharmacy or turned them in to the police station because she doesn't keep medications in her house if she isn't taking them, and she couldn't take that medication). It was reported that for her first dose the only thing was a sore arm, it was very sore, and the patient only experienced a slight bit of fatigue after her first dose. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: fever, temperature of 102 degrees; cold spells; general fatigue; patient was not felt good,general malaise; felt weak; patient felt hot and then cold; headache; This is a spontaneous report from a contactable consumer (patient) or other non hcp reporting for self. A 60-year-old male patient received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EV0150, Expiry date: Unknown) via an unspecified route of administration, administered in Deltoid Right on 31Mar2021 at 10:10 as dose 1, single (at the age of 60-year-old) for COVID-19 immunisation. Medical history included hang nail from an unknown date and ongoing (hang nail that got infected). Concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM F) taken for Infected hangnail 2x/day. Prior Vaccinations (within 4 weeks) was reported as None. Patient stated that, he feels cold. It is really warm there. Last night, he had a temperature of 102 degrees. This morning he took his temperature and it was 100 degrees. He has general fatigue. He just does not feel good. He feels weak. He was hot and then he was cold. slightly better. He was drinking a lot of water to stay hydrated. He just does not feel good. He thinks its called general malaise: The day was still early so he was not for sure, but he thinks it was improving. He has a headache that has not gone away: He took Tylenol for his headache. He does not like taking medications. But the Tylenol really helped his headache. He had a hang nail that got infected. His doctor put him on an antibiotic called Bactrim. He takes two doses a day. On 03Apr2021, the patient experienced headache, patient was not felt good, general malaise, general fatigue, felt weak, patient felt hot and then cold; cold spells on 04Apr2021; fever, temperature of 102 degrees on 06Apr2021. Seriousness of the event was not specified. Events were not resulted in visit of emergency room or physician office. The patient underwent lab tests and procedures which included temperature: 102 on 06Apr2021 and 100 on 07Apr2021. Therapeutic measures were taken as a result of all events and Tylenol for headache. The outcome of the events headache, cold spells, patient was not felt good, general malaise, patient felt hot and then cold was recovering, fatigue was unknown, fever, temperature of 102 degrees, felt weak was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Pyrexia
Clinical narrative: fever, temperature of 102 degrees; cold spells; general fatigue; patient was not felt good,general malaise; felt weak; patient felt hot and then cold; headache; This is a spontaneous report from a contactable consumer (patient) or other non hcp reporting for self. A 60-year-old male patient received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EV0150, Expiry date: Unknown) via an unspecified route of administration, administered in Deltoid Right on 31Mar2021 at 10:10 as dose 1, single (at the age of 60-year-old) for COVID-19 immunisation. Medical history included hang nail from an unknown date and ongoing (hang nail that got infected). Concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM F) taken for Infected hangnail 2x/day. Prior Vaccinations (within 4 weeks) was reported as None. Patient stated that, he feels cold. It is really warm there. Last night, he had a temperature of 102 degrees. This morning he took his temperature and it was 100 degrees. He has general fatigue. He just does not feel good. He feels weak. He was hot and then he was cold. slightly better. He was drinking a lot of water to stay hydrated. He just does not feel good. He thinks its called general malaise: The day was still early so he was not for sure, but he thinks it was improving. He has a headache that has not gone away: He took Tylenol for his headache. He does not like taking medications. But the Tylenol really helped his headache. He had a hang nail that got infected. His doctor put him on an antibiotic called Bactrim. He takes two doses a day. On 03Apr2021, the patient experienced headache, patient was not felt good, general malaise, general fatigue, felt weak, patient felt hot and then cold; cold spells on 04Apr2021; fever, temperature of 102 degrees on 06Apr2021. Seriousness of the event was not specified. Events were not resulted in visit of emergency room or physician office. The patient underwent lab tests and procedures which included temperature: 102 on 06Apr2021 and 100 on 07Apr2021. Therapeutic measures were taken as a result of all events and Tylenol for headache. The outcome of the events headache, cold spells, patient was not felt good, general malaise, patient felt hot and then cold was recovering, fatigue was unknown, fever, temperature of 102 degrees, felt weak was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Feeling hot, Rash
Clinical narrative: Her face and ears were rashy and red; Her face and ears were rashy and red; eyes swollen 3 day after taking; it feels like her body is heating up like she has menopause; This is a spontaneous report from a non-contactable consumer via Pfizer sponsored program. An unspecified age of female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Feb2021 as a single dose for COVID-19 immunisation. The patient had 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 on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history included menopause. The concomitant medications were not reported. On an unspecified date, her face and ears were rashy and red and on 22Feb2021, eyes swollen 3 day after taking. States that her neck looks like it is burnt and it feels like her body is heating up like she has menopause. She states that it has been this way since 19Feb2021.The outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Hypersomnia, Malaise
Clinical narrative: lot of fever; lot of pain on my arm; body chills; felt very tired; was not feeling very well, I felt bad the whole day; was not feeling very well, I felt bad the whole day; slept the whole day and night; This is a spontaneous report from a contactable consumer. This 36-year-old consumer (patient) reported.  A 36-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: ER8733), via an unspecified route of administration, administered in Left arm on 30Mar2021 (at the age of 36-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history was reported as none. The patient's concomitant medications were none. On 31Mar2021, the patient experienced lot of fever, lot of pain on my arm, body chills, felt very tired, was not feeling very well, I felt bad the whole day and slept the whole day and night. The reporter stated that reporter had the COVID vaccine on 30Mar2021, around 5 pm, 5:30 more or less and patient had a lot of fever 31Mar2021 and had a lot of pain in arm, fever and body chills and felt very tired and when it was around 9pm, 8:30, I 8 O'clock, 8, the patient took ibuprofen, 2 tablets of Ibuprofen(treatment) of 20 Millimeter (further clarification unknown). The reporter stated, "Today I feel better but yesterday I was not feeling very well, I felt bad the whole day, I slept the whole day and night I needed to do some work for my university so, after I ate, I decided to take the 2 Ibuprofen of 200 Millimeter, more or less it was already 24 hours after I took the vaccine. The patient took 2 Ibuprofen tablets of 200 millimeter as therapeutic measures for events. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: lot of fever; lot of pain on my arm; body chills; felt very tired; was not feeling very well, I felt bad the whole day; was not feeling very well, I felt bad the whole day; slept the whole day and night; This is a spontaneous report from a contactable consumer. This 36-year-old consumer (patient) reported.  A 36-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: ER8733), via an unspecified route of administration, administered in Left arm on 30Mar2021 (at the age of 36-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history was reported as none. The patient's concomitant medications were none. On 31Mar2021, the patient experienced lot of fever, lot of pain on my arm, body chills, felt very tired, was not feeling very well, I felt bad the whole day and slept the whole day and night. The reporter stated that reporter had the COVID vaccine on 30Mar2021, around 5 pm, 5:30 more or less and patient had a lot of fever 31Mar2021 and had a lot of pain in arm, fever and body chills and felt very tired and when it was around 9pm, 8:30, I 8 O'clock, 8, the patient took ibuprofen, 2 tablets of Ibuprofen(treatment) of 20 Millimeter (further clarification unknown). The reporter stated, "Today I feel better but yesterday I was not feeling very well, I felt bad the whole day, I slept the whole day and night I needed to do some work for my university so, after I ate, I decided to take the 2 Ibuprofen of 200 Millimeter, more or less it was already 24 hours after I took the vaccine. The patient took 2 Ibuprofen tablets of 200 millimeter as therapeutic measures for events. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Erythema, Heart rate, Heart rate increased
Clinical narrative: blood pressure and it was high; tingly/tingling in left hand; Rash, hot red tone to skin; Rash, hot red tone to skin; Difficulty Breathing; Fast Heartbeat/rapid HR; sore arm; nausea a little bit; SOB; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 41-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration, administered in left arm on 02Apr2021 (at the age of 42-years-old) as dose 1, single for covid-19 immunization. Medical history included prone to get pneumonia, bronchitis and airway issues when sick, attack and flares his anxiety. The patient's concomitant medications were not reported. Patient had not received Prior Vaccinations (within 4 weeks), states this was his first vaccine in years. No AE(s) prior to vaccination. History of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None Additional Vaccines Administered on Same Date of the Pfizer Suspect not received. On 03Apr2021, patient undergo lab test which included rapid HR/ fast heartbeat resulted Fast and on an unspecified date blood pressure resulted high. On 03Apr2021, patient started with a sore arm, nausea a little bit, difficulty breathing, "rapid HR/ fast heartbeat", SOB and tingling in left hand. That "would come and go". on 06Apr2021 patient experienced rash, hot red tone to skin. On 07Apr2021, tingly/tingling in left hand and blood pressure and it was high experienced on and unspecified date. Patient is a "war veteran and the symptoms kicks my anxiety into gear." He went to his doctor, who "told me I needed to see a psychiatrist" and the psychiatrist said he felt these were symptoms/ side effects of the Pfizer vaccine. Caller denies hospital visit and is able to walk around today and do the treadmill today and SOB is not bad, "BP is a little high for me." Caller states he "felt better today and than it started again. States he was feeling a little better this morning. When he sat down on the couch he had an attack. States it doesn't help that when it happens it flares his anxiety. Says he was feeling tingly and was red. Checked his blood pressure and it was high so he knows his heart rate was high. he is not a HCP but that he is a military veteran. States maybe veterans have been having different reactions because of all the drugs they are given in the military. The outcome of events difficulty breathing, "rapid HR/ fast heartbeat was not recovered rest all events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Nausea, Pain in extremity, Paraesthesia, Rash
Clinical narrative: blood pressure and it was high; tingly/tingling in left hand; Rash, hot red tone to skin; Rash, hot red tone to skin; Difficulty Breathing; Fast Heartbeat/rapid HR; sore arm; nausea a little bit; SOB; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 41-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration, administered in left arm on 02Apr2021 (at the age of 42-years-old) as dose 1, single for covid-19 immunization. Medical history included prone to get pneumonia, bronchitis and airway issues when sick, attack and flares his anxiety. The patient's concomitant medications were not reported. Patient had not received Prior Vaccinations (within 4 weeks), states this was his first vaccine in years. No AE(s) prior to vaccination. History of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None Additional Vaccines Administered on Same Date of the Pfizer Suspect not received. On 03Apr2021, patient undergo lab test which included rapid HR/ fast heartbeat resulted Fast and on an unspecified date blood pressure resulted high. On 03Apr2021, patient started with a sore arm, nausea a little bit, difficulty breathing, "rapid HR/ fast heartbeat", SOB and tingling in left hand. That "would come and go". on 06Apr2021 patient experienced rash, hot red tone to skin. On 07Apr2021, tingly/tingling in left hand and blood pressure and it was high experienced on and unspecified date. Patient is a "war veteran and the symptoms kicks my anxiety into gear." He went to his doctor, who "told me I needed to see a psychiatrist" and the psychiatrist said he felt these were symptoms/ side effects of the Pfizer vaccine. Caller denies hospital visit and is able to walk around today and do the treadmill today and SOB is not bad, "BP is a little high for me." Caller states he "felt better today and than it started again. States he was feeling a little better this morning. When he sat down on the couch he had an attack. States it doesn't help that when it happens it flares his anxiety. Says he was feeling tingly and was red. Checked his blood pressure and it was high so he knows his heart rate was high. he is not a HCP but that he is a military veteran. States maybe veterans have been having different reactions because of all the drugs they are given in the military. The outcome of events difficulty breathing, "rapid HR/ fast heartbeat was not recovered rest all events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Lethargy, Pain, Pyrexia
Clinical narrative: lethargy; aches/some lingering aches; fevers; severe stabbing pains in the center of her chest/stabbing chest pain; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in Arm Right on Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient Concomitant medications included levothyroxine sodium (SYNTHROID). The patient reported was received the first dose of the Pfizer COVID Vaccine last January and had a pretty significant response to it. She mentioned that she had all the expected side effects such as lethargy, aches/ some lingering aches, and fevers but by the second day she had severe stabbing pains in the center of her chest/ stabbing chest pain. Because of this she opted not to get the second dose. She mentioned that because of the changing times and states requiring full vaccination, she is considering of getting vaccinated. She is asking when she can receive her second dose and for what to do if her side effects arise again after the second dose. She states she made it through it by taking Tylenol. She is a little concerned about taking the second one. She says that with everything going on it looks like she made need to do that. She wants to know are here things she can do to ward off the side effects. She doesn't have an anaphylactic reaction but since its been such a long time should she get the vaccine if she wants to do. she says that with everything going on it looks like she made need to do that all from an unspecified date. The clinical outcome of the events was recovered on unspecified date.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Pyrexia
Clinical narrative: low grade fever; felt tired; the skin on her back and face was warm; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced low grade fever, felt tired and the skin on her back and face was warm. Patient called in to ask if weight was a factor in the dosage for bnt162b2 vaccine. She explained that after the first dose she had a low grade fever, felt tired, and the skin on her back and face was warm. Patient mentioned that she is 99 to 100 pounds and felt like the dosage was too high. The patient underwent lab tests and procedures which included body temperature: the skin on her back and face was warm on an unspecified date. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue discolouration
Clinical narrative: swelling of tongue and turned purple/tongue started to swell and turn purple; swelling of tongue and turned purple/tongue started to swell and turn purple; This is a spontaneous case received from a contactable consumer (patient) reported for herself that: A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot Number: ER8730) as DOSE 1 SINGLE for covid-19 immunization. The patient past medical history included hypertension from an unknown date and unknown if ongoing. Caller states she has recent HX of reaction to medications. Concomitant medication(s) included atenolol (TENORMIN) taken for hypertension, start and stop date were not reported. On 23Mar2021 after the first vaccination between 2-3 hours later her tongue started to swell and turn purple. Patient states over the past few years at different times her tongue has swelled and turned purple.  States she went to the doctor on Tuesday about it doing it again but by the time she saw the doctor the swelling was gone. Patient says today at 0500 her tongue was pink and normal also but by 0700 it was purple, says this has happened over the years to her. The patient Sick for a few months after flu vaccines, lost 7 pounds one time and 13 pounds another; states she doesn't know if it was from the vaccine or not. If patient receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, he should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series.1Side effects that have been reported with the Pfizer BioNTech COVID-19 Vaccine include: These may not be all the possible side effects of the Pfizer BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer BioNTech COVID-19 Vaccine is still being studied in clinical trials.1. Patient states she is trying to get more information to decide if she should take the second vaccine she is scheduled for on 13 Apr 2021. Patient mentions at the end of the call that she was outside to help read the Lot number.  States she hasn't gotten new glasses since Covid shut everything down.  Mentions she is going tomorrow to get her eyes checked.  States hopefully soon life can start again in 2021.The event outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: His son had a sore arm too; This is a spontaneous report received from a contactable consumer (parent/father). A male patient of unspecified age received unknown number dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, after receiving vaccination patient experienced sore arm. Outcome of the event was unknown.  No Follow-up attempts are needed. No further information expected. Information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash, Swelling face
Clinical narrative: I was also short of breath, feeling breathless; my face was swollen; about a week and a half later the same type of rash showed up on my face and neck area. This time it was worse than the first time to the point that my ear lobe was weeping; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EP7534), via an unspecified route of administration on 17Mar2021 (at the age of 74-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6205), via an unspecified route of administration on 24Feb2021 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization and experienced rash basically on her face and neck. The patient stated that she received her second dose on 17Mar2021 and reported that about a week and a half later the same type of rash (as after first dose) showed up on her face and neck area. This time it was worse than the first time to the point that her ear lobe was weeping. She was also short of breath, feeling breathless and her face was swollen. When the rash was the worst the breathing was also worse. It does seem to be going away and it was getting better then. The clinical outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.