chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: The 1st shot only had the red mark on arm with injection that lasted 4 days; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 74-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6203) intramuscularly in left arm on 24Feb2021 09:15 dose 1, single (at the age of 74-years-old) for COVID-19 immunization. Vaccination facility type was reported as workplace clinic. Patient was not pregnant at the time of vaccination. Medical history included blood potassium low, low thyroid, chronic obstructive pulmonary disease (COPD), bladder cancer stage IV (Stage 4 Invasive bladder cancer with metastasis to liver survivor), contrast media allergy (Contrast Dye), allergic transfusion (AB+ platelets), and allergy (rash) to Zoster vaccine. The patient had received other medications within 2 weeks prior to the vaccination. The patient had previously received VARICELLA ZOSTER VACCINE on 19Jul2014 for immunization and experienced allergy (rash). Patient had a similar reaction to Zoster Shingle shot on 19Jul2014 that lasted over 44 days. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19, since the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On unspecified date in Feb2021, the patient reported the first shot only had the red mark on arm with injection that lasted 4 days. The reported seriousness of the report was non-serious. Patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6207) intramuscularly in left arm on 20Mar2021 09:00 as dose 2, single for COVID-19 immunization. Measle like rash primarily on arms and legs from second injection. The outcome of the event was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Neck pain, Pain in extremity
Clinical narrative: very bad headache as if someone was compressing her head; Her joints hurt a lot as well, especially her elbows and knees; chills; her neck hurt a lot; Heart palpitations; The area of the arm is still sore 2 days later; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 51-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: ER8734) via an unspecified route of administration in left arm on 06Apr2021 (age at the time of the vaccination 51 year) as dose 2, single for COVID-19 immunization at pharmacy or drug store. The patient's medical history and concomitant medications were none. It was unknown if she had known allergies. The patient was not pregnant at the time of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No, other medications the patient received within 2 weeks of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EN6204) via an unspecified route of administration in left arm on 16Mar2021 at 18:30 (age at the time of the vaccination 51 year) as historical vaccine as dose 1, single for COVID-19 immunization and experienced headaches for about 3 days and Joint aches (not able to wear wedding ring for about 5 days). On 07Apr2021 at noon, the patient experienced chills, very bad headache as if someone was compressing her head, her neck hurt a lot, heart palpitations. Her joints hurt a lot as well, especially her elbows and knees. Two days after she still could not wear her wedding ring and the area of the arm was still sore 2 days later. No treatment received for adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of all events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: very bad headache as if someone was compressing her head; Her joints hurt a lot as well, especially her elbows and knees; chills; her neck hurt a lot; Heart palpitations; The area of the arm is still sore 2 days later; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 51-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: ER8734) via an unspecified route of administration in left arm on 06Apr2021 (age at the time of the vaccination 51 year) as dose 2, single for COVID-19 immunization at pharmacy or drug store. The patient's medical history and concomitant medications were none. It was unknown if she had known allergies. The patient was not pregnant at the time of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No, other medications the patient received within 2 weeks of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EN6204) via an unspecified route of administration in left arm on 16Mar2021 at 18:30 (age at the time of the vaccination 51 year) as historical vaccine as dose 1, single for COVID-19 immunization and experienced headaches for about 3 days and Joint aches (not able to wear wedding ring for about 5 days). On 07Apr2021 at noon, the patient experienced chills, very bad headache as if someone was compressing her head, her neck hurt a lot, heart palpitations. Her joints hurt a lot as well, especially her elbows and knees. Two days after she still could not wear her wedding ring and the area of the arm was still sore 2 days later. No treatment received for adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of all events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site swelling
Clinical narrative: swelling she is experiencing around the injection site and in her fingers; swelling she is experiencing around the injection site and in her fingers; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (friend) of an unspecified age who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling around the injection site and in her fingers after receiving her second vaccine dosage. The outcome of both the events 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: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: First shot I got a large red circle around the injection sight. It got hard. It hurt. But it went away in a week. It also got itchy.; First shot I got a large red circle around the injection sight. It got hard. It hurt. But it went away in a week. It also got itchy.; First shot I got a large red circle around the injection sight. It got hard. It hurt. But it went away in a week. It also got itchy.; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8727) via an unspecified route of administration, administered in arm left on 20Mar2021 at 14:30 (at the age of 42-year-old) as dose 1, single for COVID-19 immunisation. Medical history included irritable bowel syndrome, endometriosis, hypothyroid all from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient had no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Concomitant medications received within 2 weeks of vaccination included as prescribed and OTC. On unknown date in 2021 the patient experienced a large red circle around the injection sight, it got hard, it hurt but it went away in a week. it also got itchy. The events were reported as non-serious. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number=EP7533) via an unspecified route of administration, administered in arm right on 10Apr2021 at 14:45 as dose 2, single for COVID-19 immunisation. Outcome of the event vaccination site pruritus was unknown and for other events was resolved on unknown date in 2021.  No follow up attempts are needed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chills, Feeling cold, Migraine
Clinical narrative: Feeling cold and chills; Bones hurting; Migraine; Rash on my arm where it swelled up, its red; starting to move from out of my arm to the underneath where my armpit is and to my breast area; Rash on my arm where it swelled up, its red; starting to move from out of my arm to the underneath where my armpit is and to my breast area; Feeling cold and chills; Fever on and off all of day; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number was not reported, NDC number, UPC number, expiry date: unknown) via an unspecified route of administration on an unspecified date (at the age of 43 years old) as dose 2, single for covid-19 immunisation. Medical history included that the patient was allergic to lot of things from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number- not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that the patient got her second shot on Tuesday, and she had bad reaction to it. She got it at 1 pm and her first side effect started at 9 pm that night with feeling cold and chills, her bones were hurting and then the following day she had 100.6 highest, the fever on and off all of day, with migraine that was bothering her. She also had rash on arm where it swelled up, it was red and started to move from out of her arm to the underneath where her armpit was and to her breast area as well. The patient underwent lab tests and procedures which included body temperature: 100.6 on an unknown date. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash erythematous
Clinical narrative: Feeling cold and chills; Bones hurting; Migraine; Rash on my arm where it swelled up, its red; starting to move from out of my arm to the underneath where my armpit is and to my breast area; Rash on my arm where it swelled up, its red; starting to move from out of my arm to the underneath where my armpit is and to my breast area; Feeling cold and chills; Fever on and off all of day; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number was not reported, NDC number, UPC number, expiry date: unknown) via an unspecified route of administration on an unspecified date (at the age of 43 years old) as dose 2, single for covid-19 immunisation. Medical history included that the patient was allergic to lot of things from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number- not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that the patient got her second shot on Tuesday, and she had bad reaction to it. She got it at 1 pm and her first side effect started at 9 pm that night with feeling cold and chills, her bones were hurting and then the following day she had 100.6 highest, the fever on and off all of day, with migraine that was bothering her. She also had rash on arm where it swelled up, it was red and started to move from out of her arm to the underneath where her armpit was and to her breast area as well. The patient underwent lab tests and procedures which included body temperature: 100.6 on an unknown date. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Swollen tongue, Tonsillar hypertrophy
Clinical narrative: Swelling of right tonsil after about 13 minutes. Increased in intensity for both tonsils until about 25 minutes after shot.; Tongue swelling; currently breastfeeding; currently breastfeeding; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8737 (721)), via an unspecified route of administration, administered in right arm on 01Apr2021 at 14:45 (at the age 32-year-old) as a single dose for COVID-19 immunization. Medical history included gastrointestinal disorder and Bee sting hypersensitivity. Concomitant medications included multivitamins and vitamin D. The patient previously received MMR vaccine and hospitalization after MMR vaccine in 1989, unknown cause. 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 receive any other vaccines within four weeks prior to the vaccination. The patient was breastfeeding at the time of this report. On 01Apr2021 at 15:00, the patient experienced swelling of right tonsil after about 13 minutes. Increased in intensity for both tonsils until about 25 minutes after shot. Possible tongue swelling (unsure). Never lost ability to swallow, breathe, or speak. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of swelling of right tonsil, tongue swelling was recovered on an unspecified date in Apr2021 and for other events outcome was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101084322 maternal/child case
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Dysstasia
Clinical narrative: uncontrollable shivering; 101.1 fever; severe headaches; could not stand; weak; dizzy; nausea; vomited; This is a spontaneous report from a contactable consumer (patient herself). A 68-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported, expiration date: not reported), via an unspecified route of administration, administered in Arm Right on 12Mar2021 14:30 (at the age of 68 years) as dose 1, single in right arm for covid-19 immunization in hospital. Medical history included High blood pressure from an unknown date and unknown if ongoing, Chronic hives from an unknown date and unknown if ongoing, high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Patient had no covid prior vaccination. Patient was not tested covid post vaccination. Patient had no other vaccine in four weeks. On an unspecified date in 2021, the patient experienced uncontrollable shivering, 101.1 fever, severe headaches, could not stand, weak, dizzy, nausea, vomited. Patient did not received any treatment. The patient underwent lab tests and procedures which included body temperature: 101.1 on an unspecified date in 2021. Clinical outcome of the events was reported as recovered on an unspecified date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: uncontrollable shivering; 101.1 fever; severe headaches; could not stand; weak; dizzy; nausea; vomited; This is a spontaneous report from a contactable consumer (patient herself). A 68-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported, expiration date: not reported), via an unspecified route of administration, administered in Arm Right on 12Mar2021 14:30 (at the age of 68 years) as dose 1, single in right arm for covid-19 immunization in hospital. Medical history included High blood pressure from an unknown date and unknown if ongoing, Chronic hives from an unknown date and unknown if ongoing, high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Patient had no covid prior vaccination. Patient was not tested covid post vaccination. Patient had no other vaccine in four weeks. On an unspecified date in 2021, the patient experienced uncontrollable shivering, 101.1 fever, severe headaches, could not stand, weak, dizzy, nausea, vomited. Patient did not received any treatment. The patient underwent lab tests and procedures which included body temperature: 101.1 on an unspecified date in 2021. Clinical outcome of the events was reported as recovered on an unspecified date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: Fever/ had 101 temperature; Sick all night; He did not feel good; This is a spontaneous report from a contactable consumer (patient wife) reported for her husband. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date, NDC number, UPC number were unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number and Expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unknown date, the reported stated that she just had a question her husband got second shot yesterday and he had fever, sick all night, moving around and he did not feel good, he had 101 temperature on an unspecified date. The clinical outcome of events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Severe headache; Body pain; Dizziness; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and Expiry date: unknown) via an unspecified route of administration in the right arm on 14Apr2021 (at the age of 61-year-old) as Dose 2, Single for COVID-19 immunisation. Medical history included osteoporosis, raised cholesterol, anxiety, depression, and migraine. The patient had known allergies to many plant pollens, dust, mold, mildew and sulfa. Concomitant medications included atorvastatin, venlafaxine hydrochloride (EFFEXOR), lisdexamfetamine mesilate (VYVANSE), topiramate (TOPAMAX) and unspecified vitamins. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and Expiry date: unknown), via an unspecified route of administration in the left arm on 24Mar2021 at 13:15 as dose 1, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 01:30, the patient had severe headache, body pain and dizziness which started 12 hours after vaccination. Body aches and dizziness stopped by second day, but low-grade fever and headache continued for an additional 48 hours. The headache persisted for more than four days as a nagging ache. Tylenol and Motrin were not able to stop the pain. At day four, the patient was still having the headache, it was not going away. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event headache, low-grade fever and body pain and included treatment with paracetamol (TYLENOL) and ibuprofen (MOTRIN). It was unknown whether any therapeutic measures were taken as a result of the event dizziness. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe body pain and dizziness were recovered on 16Apr2021, while the outcome of the events low grade fever and severe headache was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Sore arm at injection site; Fatigue; aches; fever; chills; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old male patient received BNT162B2 (BIONTECH COVID 19 vaccine, Formulation: Solution for injection, Batch/Lot Number: EP6955) via an unspecified route, administered in Arm Left on 13Apr2021 at 17:30 (age at vaccination 49-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included escitalopram oxalate (LEXAPRO); atorvastatin calcium (LIPITOR); psyllium hydrophilic mucilloid (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]), omeprazole (PRILOSEC [OMEPRAZOLE]) and eszopiclone (LUNESTA). Historical vaccination included first dose of BNT162B2 (BIONTECH COVID 19 vaccine, solution for injection, Batch/Lot Number: EP6955) via intramuscular route, administered in Left arm on an 23Mar2021 at 17:45 as dose 1, single for COVID-19 immunization. Facility type Vaccine was workplace Clinic. The patient did not receive any other medications within 4 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to and Post vaccination. On 14Apr2021 at 10:00 the patient experienced sore arm at injection site, fatigue, aches, fever and chills. No treatment was received. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: tiredness this morning; He also has a 99.9 degrees fever and is slowly going away now; he has a very congested runny nose; general fatigue; This is a spontaneous report from a Pfizer Sponsored Program. A spontaneous report from a contactable consumer or other non hcp (Patient). A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was not reported), via an unspecified route of administration on 11Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Apr2021, the patient experienced a very congested runny nose, general fatigue, he also had a 99.9 degrees fever and is slowly going away now. The patient experienced tiredness on 14Apr2021. The patient underwent lab tests and procedures which included body temperature was 99.9 degrees on 13Apr2021. The outcome of the events was unknown except in the event he also had a 99.9 degrees fever and is slowly going away now was recovered on 14Apr2021.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperhidrosis, Pain, Vomiting
Clinical narrative: Vomiting; Diarrhea; Sweating; Aches; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EN6204) via an unspecified route of administration in the left arm on 23Mar2021 at 11:30 (at the age of 38-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 13Apr2021 at 11:30 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and the gallbladder was removed last summer. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included loratadine (CLARITIN) from an unknown date for an unspecified indication and unknown if ongoing. On 15Apr2021 at 07:30, 48 hours after, the patient experienced vomiting and diarrhea, sweating, and aches. The patient experienced the same side effects on 26Mar2021, 3 days after the first vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, diarrhea, sweating and aches that occurred after first dose was resolved on an unknown date in 2021 and the outcome of the same events vomiting, diarrhea, sweating and aches that occurred after second dose was resolved on 15Apr2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated medical history data and vaccine facility data.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Pain in extremity
Clinical narrative: 1st Dose=sore arm 2 days, pain in left hip joint; 1st Dose=sore arm 2 days, pain in left hip joint; Blisters on 3 toes of left foot started to form weekend prior to 2nd dose; This is a spontaneous report from a contactable Consumer (Patient). An 83-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: er263), via an unspecified route of administration, administered left arm on 18Mar2021 at 15:15 and second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: ew0158), via an unspecified route of administration, administered left arm on 08Apr2021 at 14:30, both as a single dose for COVID-19 immunization. Medical history included High Blood Pressure, Type 2 Diabetes, Degenerative Disc Disease, Spinal Stenosis and Arthritis. The patient had no allergies. Concomitant medications included Metformin, Amlodipine Besylate, Lisinopril. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 16:00, patient experienced with 1st Dose: sore arm 2 days, pain in left hip joint and with 2nd Dose: very tired-2days, sore arm 2 days and pain in left hip joint that radiated all the way down left leg and leg felt like it would give out. Blisters on 3 toes of left foot started to form weekend prior to 2nd dose. Painful to touch and felt like they were burning. The patient did not receive any treatment for the events. The outcome of events was recovering.  No follow-up attempts are needed; No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Emotional distress, Fatigue, Headache
Clinical narrative: She shampooed her head and as she was washing her hair it was falling out/she now has a bald spot; She told her boss she didn't feel well and went home; She said that this event is very painful to her; Sore arm; he states that she got the second vaccine on Wednesday and that day she had a little sore shoulder; fatigue, so tired; light headache/Pounding in the head; This is a spontaneous report from a contactable 47-year-old female consumer or other non HCP (patient) reported for herself. A 47-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0150, Expiry date: unknown) via an unspecified route of administration, administered in Arm Right on 14Apr2021 around 08:00 or 09:00 (age at vaccination: 47-year-old) as a single dose for covid-19 immunization. No medical history reported. There were no concomitant medications reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in Arm Right on 24Mar2021 at 10:00 (age at vaccination: 47-year-old) as a single dose for covid-19 immunization and experienced a lot of hair fall out of her head reported as worsened on 13Apr2021. The patient had not received prior Vaccinations (within 4 weeks). On 14Apr2021, patient had a little sore shoulder, also confirmed as sore arm, headache and fatigue like 3-4 hours later. She told her boss she did not feel well and went home. She states she decided to take a shower because her head was like someone was pounding inside her head. She shampooed her head and as she was washing her hair it was falling out. She states that she now has a bald spot and people are looking at her like she has gone through chemo. She states that her daughters asked her if she had cancer and she is not telling them about it. She said that this event is very painful to her. She also stated that she has pictures from the salon. She has a light headache, and she took Tylenol this morning, but it is still persisting. However, she confirmed it is not like yesterday. She confirmed the pounding in her head has resolved. adverse events did not result in emergency room or physician office visit. The clinical outcome of sore arm, fatigue, so tired was recovering, pounding in her head has resolved on an unspecified date in 2021 and for other events outcome was unknown.  No follow-up attempts are possible; no further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: She shampooed her head and as she was washing her hair it was falling out/she now has a bald spot; She told her boss she didn't feel well and went home; She said that this event is very painful to her; Sore arm; he states that she got the second vaccine on Wednesday and that day she had a little sore shoulder; fatigue, so tired; light headache/Pounding in the head; This is a spontaneous report from a contactable 47-year-old female consumer or other non HCP (patient) reported for herself. A 47-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0150, Expiry date: unknown) via an unspecified route of administration, administered in Arm Right on 14Apr2021 around 08:00 or 09:00 (age at vaccination: 47-year-old) as a single dose for covid-19 immunization. No medical history reported. There were no concomitant medications reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in Arm Right on 24Mar2021 at 10:00 (age at vaccination: 47-year-old) as a single dose for covid-19 immunization and experienced a lot of hair fall out of her head reported as worsened on 13Apr2021. The patient had not received prior Vaccinations (within 4 weeks). On 14Apr2021, patient had a little sore shoulder, also confirmed as sore arm, headache and fatigue like 3-4 hours later. She told her boss she did not feel well and went home. She states she decided to take a shower because her head was like someone was pounding inside her head. She shampooed her head and as she was washing her hair it was falling out. She states that she now has a bald spot and people are looking at her like she has gone through chemo. She states that her daughters asked her if she had cancer and she is not telling them about it. She said that this event is very painful to her. She also stated that she has pictures from the salon. She has a light headache, and she took Tylenol this morning, but it is still persisting. However, she confirmed it is not like yesterday. She confirmed the pounding in her head has resolved. adverse events did not result in emergency room or physician office visit. The clinical outcome of sore arm, fatigue, so tired was recovering, pounding in her head has resolved on an unspecified date in 2021 and for other events outcome was unknown.  No follow-up attempts are possible; no further information expected.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Chills, Mouth haemorrhage, SARS-CoV-2 test, Tongue haemorrhage
Clinical narrative: Chills; I was bleeding through mouth, bleeding of my tongue, blood was coming out of my mouth.; I was bleeding through mouth, bleeding of my tongue, blood was coming out of my mouth.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 15Apr2021 (at the age of 56-years-old) as dose 2, single for COVID-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included clopidogrel bisulfate (PLAVIX) taken for high blood pressure, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 25Mar2021 (at the age of 56-years-old) as dose 1, single for COVID-19 immunisation. On 15Apr2021, the patient had a side effect like bleeding through her mouth, bleeding of tongue, blood was coming out of mouth, that was about 6 0' clock yesterday. About 05:30 to 6 0' clock yesterday when the blood was coming out. She took the test at 1 0' clock yesterday she started bleeding out the mouth at 18:00 last night. On 16Apr2021 (today), she had the chills but her most concern was about bleeding through the mouth. The patient underwent lab tests and procedures which included blood test with unknown results on 25Mar2021 and sars-cov-2 test with unknown results on 25Mar2021 and 15Apr2021. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Pyrexia
Clinical narrative: headache; cough; fever; This is Spontaneous report from a contactable consumer or other non hcp reporting for himself (patient) via Pfizer sponsored program. A contactable male consumer reported that:  A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on 16Apr2021 as dose 1, single for covid-19 immunization. The patient medical history included he was exposed to a person who was positive for the Covid-19. The patient concomitant medications were not reported. The patient experienced headache, cough, fever on an unspecified date. The patient experienced a headache, cough that stopped a little bit and cough a lot of liquid, and fever. He took a cough drop. Prior taking the 1st dose, he was exposed to a person who was positive for the Covid-19 virus. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pruritus, Rash
Clinical narrative: following second shot came back worse- Almost 4 weeks after 2nd shot it appears to cover much more of my body and itches worse than any other time; following second shot came back worse- Almost 4 weeks after 2nd shot it appears to cover much more of my body and itches worse than any other time; following second shot came back worse- Almost 4 weeks after 2nd shot it appears to cover much more of my body and itches worse than any other time; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8732, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 25Mar2021 (age at vaccination: 58years-old) as dose 2, single for COVID-19 immunization. Faciltiy type of vaccine was reported as  pharmacy or drug store. Medical history included anaemia neuropathy peripheral, hypertension, diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included gabapentin; lisinopril; atorvastatin and allopurinol taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior and received other medications 2 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Historical vaccine include dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 11:00 AM as dose 1, single for COVID-19 immunization and 6 Days after first dose experienced rash on extremities. On an unspecified date, it was reported that following second shot came back worse, almost 4 weeks after 2nd shot it appears to cover much more of my body and itches worse than any other time. AE resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. The outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Dyspnoea, Headache
Clinical narrative: could not take a deep breath; fever 103.2; chills; aches; diarrhea; nausea; tinnitus; mild headache; Her arm started hurting; This is a spontaneous report from a contactable consumer (patient) reported herself. An adult non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161), via an unspecified route of administration in right arm on 19Apr2021 at 14:00 (at the age of 49-years-old) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient's medical history included hypothyroidism from an unknown date and unknown if ongoing. Known allergies was none. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration in left arm on 28Mar2021 at 14:00 (at the age of 490years-old) as dose 1, single for COVID-19 immunisation at pharmacy or drug store and experienced mild headache and pain in the arm for three days. On 19Apr2021, the second shot she got the shot at 14:00 on Monday, no bad effects until the evening, the patient experienced mild headache and her arm started hurting. On 20Apr2021 at 10:00, she had could not take a deep breath, fever 103.2, chills, aches, diarrhea, nausea, a severe headache and tinnitus. These symptoms were the worst about 24 hours after the shot and decreased after that. The patient assessed the events as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 103.2 on an unspecified date. No treatment was received in response to the adverse events. The outcome of all events was recovering at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Tinnitus
Clinical narrative: could not take a deep breath; fever 103.2; chills; aches; diarrhea; nausea; tinnitus; mild headache; Her arm started hurting; This is a spontaneous report from a contactable consumer (patient) reported herself. An adult non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161), via an unspecified route of administration in right arm on 19Apr2021 at 14:00 (at the age of 49-years-old) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient's medical history included hypothyroidism from an unknown date and unknown if ongoing. Known allergies was none. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration in left arm on 28Mar2021 at 14:00 (at the age of 490years-old) as dose 1, single for COVID-19 immunisation at pharmacy or drug store and experienced mild headache and pain in the arm for three days. On 19Apr2021, the second shot she got the shot at 14:00 on Monday, no bad effects until the evening, the patient experienced mild headache and her arm started hurting. On 20Apr2021 at 10:00, she had could not take a deep breath, fever 103.2, chills, aches, diarrhea, nausea, a severe headache and tinnitus. These symptoms were the worst about 24 hours after the shot and decreased after that. The patient assessed the events as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 103.2 on an unspecified date. No treatment was received in response to the adverse events. The outcome of all events was recovering at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: Sore arm immediately after injection; 12 hours later experienced fever; chills; severe body aches; fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE; formulation: solution for injection, Lot Number: EN5318), dose 2 via an unspecified route of administration, administered in left arm on 20Apr2021 as DOSE 2, SINGLE (at the age of 40-years-old) for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE; formulation: solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 as DOSE 1, SINGLE (at the age of 40-years-old) for COVID-19 immunization. The patient had no known allergies. The patient received no other vaccine in four weeks and no other medications in two weeks. The patient did not have COVID prior to vaccination and has not been COVID tested post vaccination. On 20Apr2021 at 12:00 hours, the patient experienced sore arm immediately after injection. 12 hours later, experienced fever, chills, and severe body aches. For the next 16 hours, the patient had a fever of 101F, fatigue, body aches, and chills. Then the fever broke, and the patient started to feel better. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 20Apr2021. Therapeutic measures were taken as a result of the events and treatment with 500 mg of Tylenol was provided. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore arm immediately after injection; 12 hours later experienced fever; chills; severe body aches; fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE; formulation: solution for injection, Lot Number: EN5318), dose 2 via an unspecified route of administration, administered in left arm on 20Apr2021 as DOSE 2, SINGLE (at the age of 40-years-old) for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE; formulation: solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 as DOSE 1, SINGLE (at the age of 40-years-old) for COVID-19 immunization. The patient had no known allergies. The patient received no other vaccine in four weeks and no other medications in two weeks. The patient did not have COVID prior to vaccination and has not been COVID tested post vaccination. On 20Apr2021 at 12:00 hours, the patient experienced sore arm immediately after injection. 12 hours later, experienced fever, chills, and severe body aches. For the next 16 hours, the patient had a fever of 101F, fatigue, body aches, and chills. Then the fever broke, and the patient started to feel better. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 20Apr2021. Therapeutic measures were taken as a result of the events and treatment with 500 mg of Tylenol was provided. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.