chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Muscular weakness, Pain in extremity
Clinical narrative: Arm pain; tiredness; legs weak knees felt like jello; weird feeling in leg; severe chills like shaking off the bed but no temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "legs weak knees felt like jello"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "weird feeling in leg"; CHILLS (non-serious), outcome "unknown", described as "severe chills like shaking off the bed but no temperature". Additional information: Event weird feeling in leg lasted about a day.  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: Pain in extremity
Clinical narrative: left arm is sore, can't lay on it or sleep on it, it's really sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 13:00 (Lot number: EN6205) at the age of 76 years as 1st dose, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: Verbatim: fibromyalgia. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Feb2021, outcome "recovering", described as "left arm is sore, can't lay on it or sleep on it, it's really sore".  Additional information: Patient had no prior vaccination within 4 weeks. There was no adverse event following prior vaccination. The reporter was calling about the Covid 19 vaccine, her second shot. She got the first vaccine ok. She had on a sweatshirt and the girl who gave her the injection had a hard time getting her shirt up on her arm. The girl hit the wrong place in her arm. She was wondering if she gets the other vaccine if she will have the same problem. Her second vaccine was scheduled for 19Mar2021 at the time of the report.  Her arm was sore, and she found herself having to use a heating pad. She was worried about her first arm getting sorer, she cannot sleep on it, and she cannot lay on it, it's really sore.  She had no idea that the sweatshirt was that tight that the girl giving the injection would have a hard time. she thought it would get better each day. She received the Covid 19 vaccine in her right arm and the pain is in her left arm. When the pain in her left arm began, she reported the vaccine was on 26Feb2021, so it would either be that day or that night. She thought if the pain did not start on 26Feb2021 it would have been the next day. Her arm might be a little bit better but the pain has not gone away.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: body aches; fatigue; chills; headache; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 52 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 16Mar2021 09:15 (Lot number: EN6203) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, lot number: EL3247), administration date: 23Feb2021, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 17Mar2021 04:00, outcome "recovered" (18Mar2021), described as "body aches"; FATIGUE (non-serious) with onset 17Mar2021 04:00, outcome "recovered" (18Mar2021), described as "fatigue"; CHILLS (non-serious) with onset 17Mar2021 04:00, outcome "recovered" (18Mar2021), described as "chills"; HEADACHE (non-serious) with onset 17Mar2021 04:00, outcome "recovered" (18Mar2021), described as "headache". Therapeutic measures were not taken as a result of pain, fatigue, chills, headache. Additional information: The patient had not received other vaccine in four weeks or other medications in two weeks. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Feb2021 (Lot number: EL9266) at the age of 68 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Allergies" (unspecified if ongoing); "Delayed emptying of stomach" (unspecified if ongoing); "Delayed emptying of bladder" (unspecified if ongoing); "Chronic pain" (unspecified if ongoing); "Irregular heartbeat" (unspecified if ongoing); "Inflammation" (unspecified if ongoing); "Constipation" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Chronic headaches" (unspecified if ongoing). Concomitant medication(s) included: BUDESONIDE taken for hypersensitivity, start date: 2001 (ongoing); DICLOFENAC SODIUM taken for inflammation, start date: 2009 (ongoing); ESOMEPRAZOLE taken for impaired gastric emptying, start date: 2002 (ongoing); FEXOFENADINE taken for hypersensitivity, start date: 2001 (ongoing); MEGARED OMEGA 3 KRILL OIL taken for supplementation therapy (ongoing); MELATONIN taken for insomnia, start date: 2019 (ongoing); METOPROLOL taken for heart rate irregular (ongoing); MIRALAX taken for constipation, start date: 2020 (ongoing); MULTIVITAMINS [VITAMINS NOS], start date: 2001 (ongoing); NORCO taken for pain, headache (ongoing); TERAZOSIN taken for urinary retention, start date: 1996 (ongoing); VITAMIN D3 taken for vitamin d deficiency, start date: 2014 (ongoing). The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Swollen arm".  Additional information: The patient received the 2nd dose of the COVID-19 vaccine on 14Mar2021. Her arm was slightly swollen like the first time.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness
Clinical narrative: Flu like symptoms; Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "lung problem" (unspecified if ongoing); "multiple sclerosis" (unspecified if ongoing); "asthma" (unspecified if ongoing); "frequent respiratory infections" (unspecified if ongoing); "pulmonology issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy".  Additional information; The patient is calling about the Pfizer covid 19 vaccine. The patient and her husband, (name), both got the covid-19 vaccine. The patient had her first dose of the vaccine on 11Mar2021 and her husband had his on 12Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: recurrent wart/disappearance of an otherwise persistent palmar wart following the Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter (physician). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "recurrent wart in the palmar aspect of the 2nd phalange, middle finger of left hand" (ongoing), notes: for the last 2 years and it kept recurring despite treatment with salicylic acid application, Duragel Clear Away Wart Remover, etc. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "recurrent wart/disappearance of an otherwise persistent palmar wart following the Pfizer COVID-19 vaccine".  Additional information: Following 1-2 weeks of the COVID-19 vaccine the wart disappeared completely. The patient was unable to find a site in CDC to report the beneficial effect of COVID-19 vaccine.   No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Pain
Clinical narrative: Chills; Hot flashes; Body aches; Slight headache; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes"; PAIN (non-serious), outcome "unknown", described as "Body aches"; HEADACHE (non-serious), outcome "unknown", described as "Slight headache".  Additional Information: Event took place after use of product. Second dose was given at 09:05 AM. At 11:00 PM, there were chills and then hot flashes. Throughout the night body aches and slight headache. On the day after the second dose, the patient had slight headache and chills.  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: Fatigue, Headache, Lymphadenopathy, Malaise, Vomiting
Clinical narrative: she wants to throw up; she is tired; she has a headache; she is not feeling well; The lymph node is swollen under her arm pit.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 13Mar2021 11:45 (Lot number: NFB199) at the age of 43 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot: EM9809), administration date: 20Feb2021, for COVID-19 immunisation.  The following information was reported: VOMITING (non-serious), outcome "unknown", described as "she wants to throw up"; FATIGUE (non-serious), outcome "unknown", described as "she is tired"; HEADACHE (non-serious), outcome "unknown", described as "she has a headache"; MALAISE (non-serious), outcome "unknown", described as "she is not feeling well"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "The lymph node is swollen under her arm pit.".  Additional information: The events did not require a visit to emergency room and physician office.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Sore arm; body aches; pain in legs; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 14:00 (Lot number: EL3247) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Unknown Manufacturer), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Mar2021 05:00, outcome "recovering", described as "Sore arm"; PAIN (non-serious) with onset 19Mar2021 05:00, outcome "recovering", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 19Mar2021 05:00, outcome "recovering", described as "pain in legs"; HEADACHE (non-serious) with onset 19Mar2021 05:00, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of pain in extremity, pain, pain in extremity, headache.  Additional Information: It was reported that, the patient became aware of the adverse events on 19Mar2021, 24hrs after receiving the 2nd vaccine dose. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was diagnosed with COVID-19 and not tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; Chills; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 10:00 (Lot number: en6204) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: en6205, Location of vaccination: Left arm, Administration time: 16:00, Administration site: Left arm), administration date: 26Feb2021, when the patient was 56 years old, for COVID-19 immunisation, reaction(s): "Sore arm". The following information was reported: HEADACHE (non-serious) with onset 19Mar2021, outcome "recovering", described as "Headache"; CHILLS (non-serious) with onset 19Mar2021, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 19Mar2021, outcome "recovering", described as "Fatigue". Therapeutic measures were not taken as a result of headache, chills, fatigue.  Additional information: The patient did not have any allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other medications or vaccines within two weeks prior to the vaccination. The patient did not receive any treatment for events. The clinical outcome of events headache, chills, fatigue was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Laziness, Pain in extremity
Clinical narrative: tired; had no energy; the opposite arm hurt from injection; lazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Feb2021 08:35 (Lot number: EN6201) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "heart palpitation" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired"; LAZINESS (non-serious) with onset 10Feb2021 12:00, outcome "unknown", described as "lazy"; ASTHENIA (non-serious), outcome "unknown", described as "had no energy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "the opposite arm hurt from injection".  Additional Information: The date of first injection was on 10Feb2021, at 08:35 am. She felt tired and lazy. They got home and had lunch and she was feeling lazy, so she laid on floor and fell asleep for a few hours. It continued for a couple of days and then she was total 4-5 days, was still feeling lazy and had no energy. Nothing hurt. She then stated that the opposite arm hurt from injection. She got injection in left arm and her right arm was sore. She got shot on left arm both times. Both have improved. Her arm was fine after that.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore Arm; Fatigue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 16Mar2021 12:00 (Lot number: EL3247) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid Disease (Underactive)" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing). Concomitant medication included: SYNTHYROID. Vaccination history included: Bnt162b2 (brand=Pfizer / BioNTech, lot_number: EL3247, administration_time=09:30 AM), administration date: 23Feb2021, when the patient was 42 years old, for Covid-19 immunisation. The vaccine was administered in other facility. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with Covid prior vaccination and was not tested for Covid after vaccination. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Mar2021 13:00, outcome "recovering", described as "Sore Arm"; FATIGUE (non-serious) with onset 17Mar2021 13:00, outcome "recovering", described as "Fatigue". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: After 3/18/21 second covid vaccine I developed body aches 12 hours later; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 09:30 (Lot number: EN6203) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic migraines" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: SHINGRIX, start date: 09Feb2021; ADVIL; RELPAX. Vaccination history included: Bnt162b2 (Dose number: 1, lot number: EL3247, administration date:25Feb2021, administration time:09:30 AM, vaccine location:Left arm), administration date: 25Feb2021, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 18Mar2021 21:30, outcome "recovering", described as "After 3/18/21 second covid vaccine I developed body aches 12 hours later"; CHILLS (non-serious) with onset 18Mar2021 21:30, outcome "recovering", described as "Chills". Therapeutic measures were not taken as a result of pain, chills.  Additional information: The patient reported that 24 hours post vaccine, still have body aches, but not as strong as during the night. The facility where the most recent COVID-19 vaccine was administered is Workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well, and he needed to go lay down; This is a spontaneous report received from a non-contactable reporter (consumer).  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, lot number unknown), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well, and he needed to go lay down".  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 16:00 (Lot number: EN6205) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "heart condition" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Feb2021, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity. Additional information: the patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The event was reported as non-serious.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 11:00 (Lot number: EN6205) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Muscle ache" (unspecified if ongoing); "Prostate" (unspecified if ongoing); "heart protection" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal (ongoing); SIMVASTATIN taken for blood cholesterol abnormal (ongoing); TAMSULOSIN taken for prostatitis (ongoing); FISH OIL taken for cardiac disorder (ongoing); GLUCOSAMINE HYDROCHLORIDE taken for myalgia (ongoing); AMLODIPINE. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of headache. No follow-up attempts are possible. No further information is expected.  Additional information: Patient wanted to know if headache was normal. He was due to have the second shot on Tuesday which was in 4 days and he needed to find out if he needs to get it or not. He has taken 2 Aspirin every other night before he goes to sleep. He tries to take as little medication as possible. He has not had any testing as he has only had a headache for a week. The event did not require a visit to Emergency Roomor Physician Office. Patient had no prior vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. He had no Family medical history relevant to the event.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little bit of pain at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2021 10:00 (Lot number: EN6198) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "fibromyalgia" (unspecified if ongoing), notes: for 30 years; "feeling feverish without a fever in the past" (unspecified if ongoing); "blood pressure" (ongoing); "Tachycardia" (ongoing). Concomitant medication(s) included: VERAPAMIL taken for blood pressure abnormal (ongoing); METOPROLOL XL SANDOZ taken for tachycardia (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Feb2021, outcome "recovered" (25Feb2021), described as "little bit of pain at the injection site".  Additional information: There were no additional vaccines administered on the day of Pfizer suspect vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was also reported to be taking VERAPAMIL for 30 years and METOPROLOL XL for 15 years.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastric disorder, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 15:30 (Lot number: EL3247) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADVIL [IBUPROFEN]; EXCEDRIN [CAFFEINE; PARACETAMOL]; ALPRAZOLAM. Past drug history included: Xanax. Vaccination history included: Bnt162b2 (1st dose, Lot number=EL3247, time: 03:30 PM, Vaccine location: Right arm), administration date: 23Feb2021, when the patient was 52 years old, for Covid-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Mar2021 15:30, outcome "recovered", described as "site injection pain"; GASTRIC DISORDER (non-serious) with onset 16Mar2021 15:30, outcome "recovered", described as "stomach issues"; FATIGUE (non-serious) with onset 17Mar2021, outcome "recovered", described as "extreme tiredness". Therapeutic measures were not taken as a result of vaccination site pain, gastric disorder, and fatigue. Additional information: The patient was also taking the following medication in two weeks: juice plus vitamin and allergy medication. The patient had no other vaccine in four weeks. The patient had no Covid-19 prior vaccination and was not Covid-19 tested post vaccination. The patient had no known allergies. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: SINUSITIS (non-serious) with onset Mar2021, outcome "unknown", described as "sinus infection".  Additional information:  The patient had the first dose of the Pfizer Covid-19 Vaccine on 24Feb2021. She is scheduled to have the second dose today (at the time of the reporting), but she had a sinus infection since the day before yesterday, 14Mar2021. She would like to know how long it would take before she feels better and how long to wait before taking the second dose of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: extremely tired; he was light-headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Elevated blood pressure" (unspecified if ongoing), notes: He takes a blood pressure medication (unknown what medication) for elevated blood pressure.; "Prostate CA" (unspecified if ongoing), notes: two years for which he received radiation therapy, but no adjuvant chemotherapy.; "radiation therapy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 16Mar2021, outcome "recovered" (17Mar2021), described as "extremely tired"; DIZZINESS (non-serious) with onset 16Mar2021, outcome "recovered" (17Mar2021), described as "he was light-headed".  Additional Information: It was reported that patient was light-headed and extremely tired. He has been working extremely long hours in tax preparation activities, which does involve face-to-face (with mask) interactions with clients. The lightheadedness and tiredness resolved completely within 24 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Pain
Clinical narrative: body pain; Discomfort; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Temperature: 107" (unspecified if ongoing), notes: reaction to typhoid medication, so bad she had to go to for treatment; was put in buckets of ice. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "body pain"; DISCOMFORT (non-serious) with onset Mar2021, outcome "not recovered", described as "Discomfort"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Fatigue". Additional information: The patient expected to have some discomfort for a couple of days like any shot would give her. She was just confused because she had body pain, discomfort, and fatigue. She has never had a reaction to any product except one. The only reaction she has ever had in her 59 years was from a drug that came from Canada. She had a reaction to a typhoid medication. It was so bad she had to go for treatment. Her temperature was 107, and they put her in buckets of ice. Other than that, she has never had an adverse reaction. She did not really feel like this was shot related because it was lasting so long, the discomfort and fatigue. She just didn't think any of the side effects could be related to this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: Felt pressure in his head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 14:30 (Lot number: EP7534) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: high blood pressure; "High cholesterol" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing). Concomitant medication(s) included: FOLIC ACID; HYDROCHLOROTHIAZIDE; LEVOCETIRIZINE; FENOFIBRATE; VITAMIN D3; VITAMIN-C; ZINC; ASPIRIN. Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer,, lot number= ENG198,, lot unknown= False,, administration date= 28Feb2021,, administration time= 02:00 pm,, vaccine location= Left arm,, dose number=1), administration date: 28Feb2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: HEAD DISCOMFORT (non-serious) with onset 21Mar2021 15:30, outcome "recovered", described as "Felt pressure in his head". Therapeutic measures were taken as a result of head discomfort.  Additional Information: Facility type vaccine: School or Student Health Clinic. If other vaccine in four weeks: No. Patient recovered: Recovered. If treatment ae: Yes. Treatment ae: took advil. Covid prior vaccination: No. Covid tested post vaccination: No.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness on her arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "soreness on her arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Jaw pain; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unknown dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN JAW (non-serious), outcome "unknown", described as "Jaw pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Malaise, Muscular weakness
Clinical narrative: real dizzy/ woozy; Real weak/ no energy to speak up/ don't have any energy to work; Diarrhea; my legs gave up on bathroom floor for 28 to may be 30 minutes and no energy to get up; I don't feel great; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ALEVE. Vaccination history included: Bnt162b2 (dose 1, single), administration date: 10Feb2021, when the patient was 69 years old, for COVID-19 IMMUNISATION, reaction(s): "dizziness". The following information was reported: DIZZINESS (non-serious) with onset 18Mar2021, outcome "not recovered", described as "real dizzy/ woozy"; ASTHENIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "Real weak/ no energy to speak up/ don't have any energy to work"; DIARRHOEA (non-serious) with onset 18Mar2021, outcome "recovered", described as "Diarrhea"; MUSCULAR WEAKNESS (non-serious) with onset 18Mar2021, outcome "unknown", described as "my legs gave up on bathroom floor for 28 to may be 30 minutes and no energy to get up"; MALAISE (non-serious) with onset 18Mar2021, outcome "unknown", described as "I don't feel great". Therapeutic measures were not taken as a result of dizziness, asthenia, diarrhoea, muscular weakness, malaise.  Additional Information: The patient's concomitant therapy included vitamins. The reporter (patient) did not know if the events were from a different problem or if it's common with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness, not very bad; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 69 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administration date 10Feb2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: ALEVE. The following information was reported: DIZZINESS (non-serious) with onset Feb2021, outcome "not recovered", described as "dizziness, not very bad". Therapeutic measures were not taken as a result of dizziness.  Additional information: The patient was also taking a vitamin. The patient reported, "After the first shot, I had little diarrhea, not diarrhea but dizziness, not very bad." Consumer stated there was no treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021318611 same reporter/patient/vaccine, different dose/event
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I noticed my low-grade, chronic arthritis pain had started to fade last week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis. The patient's concomitant medications were not reported. Past drug history included: Tylenol for acute arthritis pain. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Mar2021, outcome "unknown", described as "I noticed my low-grade, chronic arthritis pain had started to fade last week".  Additional information: It was reported that Pfizer covid vaccine seems to have made patient's year-long arthritis symptoms finally disappear. Since last winter, when she believed she got covid (unable to be tested), she had suffered episodes of acute arthritis pain necessitating arthritis Tylenol (she did minimal medicine). She got her first Pfizer covid vaccine on 02Mar2021 and she was due for the second shot on 22Mar2021. But she noticed her low-grade, chronic arthritis pain had started to fade last week.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Oropharyngeal pain
Clinical narrative: Dizzy spell, feeling dizzy; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizzy spell, feeling dizzy"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat". Additional information: The patient wanted to contact the facility where he/she took his/her vaccination because he/she needed to know if these are side effects, if he/she should go to the doctors or get tested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: PSA went up; This is a spontaneous report received from a contactable reporter(s) (Consumer).  A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, administration date 02Mar2021 (Lot number: EN6205) at the age of 71 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious) with onset 08Mar2021, outcome "unknown", described as "PSA went up". Relevant laboratory tests and procedures are available in the appropriate section. The patient had a PSA test done 6 days after receiving the first shot and the PSA went up. The reporter would like to know if that was possibly due to the inflammatory process caused by the vaccine that caused that rise.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: poison Ivy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), administration date 28Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS CONTACT (non-serious), outcome "unknown", described as "poison Ivy". Therapeutic measures were taken as a result of dermatitis contact. Additional information: Patient was taking prednisone for poison Ivy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: had bladder infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CYSTITIS (non-serious), outcome "unknown", described as "had bladder infection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: had a severe flu-like reaction to it; Experienced the reaction flu, the reaction was similar to what someone would experience having got on the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Mar2021 10:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 15Mar2021 22:00, outcome "recovered" (17Mar2021), described as "had a severe flu-like reaction to it; Experienced the reaction flu, the reaction was similar to what someone would experience having got on the flu". Additional information: The patient received the Pfizer vaccine on 15Mar2021 (Monday) and experienced a severe flu-like reaction to it on 15Mar2021 22:00 (12 hours after the vaccination). This lasted for 24 hours until 17Mar2021 (Wednesday). So mid-way Wednesday, the patient felt better. The patient reported that the reaction was similar to what someone would experience having got the flu. The patient asked since "I had received such a severe reaction with, you know, I was surprised with that. Can I expect the same kind of severe reaction from second dosage?".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing), notes: I have allergies that require me to carry an epi pen and I had no allergic reaction at all. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021319544 same reporter, different patient
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from a sponsored program Corporate Social Media Platforms for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  Additional information: (As reported) Thank you Pfizer! My husband and I had our first snots already and we only had arm soreness for a day or so. Second shots on 4/31 1 nave allergies that require me to carry an epi pen and I had no allergic reaction at all.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021319541 Same reporter, different patient
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: twitching under left eye and cheek; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021320430 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitching under left eye and cheek". Additional information: Caller had her first dose of the covid-19 vaccine on 12Mar2021. Caller states that for the last 3 days she has twitching under left eye and cheek, inquiring if this was a side effect. No unaddressed medical questions were referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.