chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nervousness
Clinical narrative: Slight headache; Little nervousness; Tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 10:45 (Lot number: EN8207, Expiration Date: 03Jul2021) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Depression" (unspecified if ongoing), notes: Verbatim: Chronic depression, Caller says this was diagnosed about 5 years ago. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 11Mar2021 12:00, outcome "unknown", described as "Slight headache"; NERVOUSNESS (non-serious) with onset 11Mar2021 12:00, outcome "unknown", described as "Little nervousness"; FATIGUE (non-serious) with onset 11Mar2021 12:00, outcome "unknown", described as "Tiredness".  Additional Information: Patient had his first dose yesterday on 11Mar, and his vaccine card has a sticker on it and other than his name and L for left arm and date given, nothing is provided on there. He says "my eyeballs" while looking at handwritten vaccine card with a sticker and does not clarify this statement. He says that the NDC is not provided on vaccine card, but EXP is. He says his first dose was injected at 10:45AM, and his side effects began at approximately at 12:00PM 11Mar. He says he started to feel something, a slight headache and a little nervousness around the edges and an all over feeling tired like he had gone to the gym and worked out his entire body. He says everywhere feels blah. Documented as provided. He says he got home yesterday and went straight to bed. He says if it was a 10 yesterday, then today is a 6, it is a little bit better, just kind of, not bad at all really, it is just annoying. He says he would do it again and will do it again. He says he didn't treat the slight headache. He says he got his first dose, which was a monster event, and it was provided. He said they have not had any other recent vaccinations or started any new medications.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 71 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold symptoms".  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, Vaccination site erythema
Clinical narrative: Soreness in her arm; Redness popped up around the site; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 75 year-old female patient received BNT162B2 (BNT162B2), administered in arm, administration date Feb2021 (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 2021, outcome "not recovered", described as "Soreness in her arm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 2021, outcome "recovering", described as "Redness popped up around the site".  Additional Information: The patient received the Pfizer COVID-19 vaccine three weeks ago. The patient still has soreness in her arm. Redness popped up around the site a week after the vaccine. Redness is almost gone and looks better today but her arm is still sore. The patient wanted to know if she should get the second dose and should she get it in the other arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: general muscle soreness; tiredness; day of injection minor injection arm soreness; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  A 61-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Mar2021 11:30 (Lot number: EL 3247) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "gout" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; OLMESARTAN; AMLODIPINE. Vaccination history included: Bnt162b2 (Product: COVID 19, brand=COVID- 19 mRNA VACCINE BNT162b2, Lot number: EL 3247, Lot unknown: False, Administration date: 22Feb2021, Administration time: 09:30, Vaccine location: Right arm, Dose number: 1), administration date: 22Feb2021, when the patient was 61 years old, for Covid-19 Immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Mar2021 17:00, outcome "not recovered", described as "day of injection minor injection arm soreness"; MYALGIA (non-serious) with onset 16Mar2021, outcome "unknown", described as "general muscle soreness"; FATIGUE (non-serious) with onset 16Mar2021, outcome "unknown", described as "tiredness". Therapeutic measures were not taken as a result of vaccination site pain, myalgia, fatigue.  No follow-up attempts are possible. No further information is expected.  Additional information: The patient did not receive other vaccine in four weeks, had no known allergies, no COVID prior to vaccination, and was not COVID tested post-vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: patient got very sleepy and must have slept on and off for about patient would say 30 hours; patient just could not wake up; 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 2021 (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: SOMNOLENCE (non-serious) with onset 2021, outcome "recovered" (2021), described as "patient got very sleepy and must have slept on and off for about patient would say 30 hours; patient just could not wake up".  Additional information included: Patient would receive the second dose of vaccine on 18Mar2021. The patient came out of it but wanted to get the second shot but was afraid that it might be worse and the patient did not want it to be worse.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; 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 (159558). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Allegra for allergy. Vaccination history included: Bnt162b2 (1st dose and experienced "a little bit of a swollen arm but it was no big deal"), administration date: 18Feb2021, for Covid-19 immunization, reaction(s): "swollen arm". The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headaches".  Additional information: It was stated that the patient received her first dose of the Pfizer COVID-19 vaccine on 18Feb2021 and experienced "a little bit of a swollen arm but it was no big deal" and she received her second dose of the Pfizer COVID-19 vaccine on 11Mar2021. She had been experiencing headaches and she was not sure if they were side effects from the vaccine or if they were due to her not taking her allergy medication (Allegra). She stopped taking her Allegra a few days before receiving the second dose of the vaccine because she did not want anything to interfere with the efficacy of the vaccine. The caller wants to know if we have any information on whether or not she can take her headache medication, butalbital-acetaminophen-caffeine or ibuprofen to help with her headache and whether it would interfere with the Pfizer COVID-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 89 year-old female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Lot number: EN6202) at the age of 89 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing). Concomitant medication(s) included: GLIPIZIDE taken for diabetes mellitus; METFORMIN taken for diabetes mellitus; INSULIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (First dose), administration date: 15Feb2021, when the patient was 88 years old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 11Mar2021, outcome "recovering", described as "Dizzy". Therapeutic measures were not taken as a result of dizziness.  Additional information: Clinical course: It was reported that patient had her second shot on last Saturday (06Mar2021) and yesterday she was quite dizzy during the day and she was also a diabetic (medical history) so that's not unusual for her because some times when her sugar was low then she have a dizzy spell but it persistence to go on for rest of the day and then in the evening it was subsided but this morning when she got up she still dizzy. Patient stated that she had full of problems. When probed for any laboratory test, patient stated, she was scheduled for an appointment, but she hasn't had any blood work recently. Consumer stated, yesterday she slept better in the evening she hoped it would go away, she feels better already.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness was in the injection site arm; 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.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single and administration date 03Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Eosinophilia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness was in the injection site arm". Additional information: Caller stated that he had a situation, that his wife who had to have a diagnostic test next week Monday. The Doctors office said that they need to get their covid test to see if they test positive for covid. The consumer wife already had the 2nd dose of the Pfizer vaccine on 03Mar. The patient had two shots, did she still need to get test. She was being treated for eosinophilia, which complicates COPD, test that was set up before the vaccines were provided. The consumer and his wife (patient) got a sore arm after the vaccine, everyone we had talked to have always said that we had a sore arm. They did not think this was reportable, the soreness was in the injection site arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: feeling pain on the left side of [their] arm where [they] got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (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: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "feeling pain on the left side of [their] arm where [they] got the shot".  Additional information: This 52-year-old caller stated he and his 51-year-old wife received the first dose of the Pfizer-BioNTech COVID-19 yesterday (unspecified date in 2021). He added they "are feeling pain on the left side of [their] arm where [they] got the shot". He asked if they could take Ibuprofen or Tylenol for the pain after vaccination. He said he is concern that if he takes "those medications, they could create some problem with the vaccine".   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-2021292288 same reporter/product/event, different patient.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Scan
Clinical narrative: after the second shot in the middle of the night I had severe pains in my left arm in the area near a Lipoma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 82 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HTZ; LEVOTHYROXINE. Past drug history included: Cipro, reaction(s): "known allergies Cipro"; Prolia, reaction(s): "known allergies: Prolia"; Risedronate, reaction(s): "known allergies Risedronate". Vaccination history included: Bnt162b2 (administration time=06:30 AM,, vaccine location=Right arm,, dose number=1), administration date: 17Feb2021, when the patient was 82 years old, for COVID-19 immunisation, reaction(s): "vertigo", "dizziness".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "after the second shot in the middle of the night I had severe pains in my left arm in the area near a Lipoma". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Tinder upon my armpit and it is kind of like puffy, like it is swollen; Hurts a little bit; 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) (Lot number: Unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Tinder upon my armpit and it is kind of like puffy, like it is swollen"; PAIN (non-serious), outcome "unknown", described as "Hurts a little bit".  Additional information: The patient had vaccine shot (Pfizer Covid-19 Vaccine) on Thursday and this morning "it is like a kind of a tinder upon my armpit and it is kind of like puffy, like it is swollen. But it is puffy. But it hurts a little bit if I push on it".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: it feels like a rock in there; muscle where the shot went in it is not hard but its painful; cannot lift it up; it feels like a rock in there; muscle where the shot went in it is not hard but its painful; cannot lift it up; Sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 73 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown" and all described as "it feels like a rock in there; muscle where the shot went in it is not hard but its painful; cannot lift it up"; PAIN (non-serious), outcome "unknown", described as "Sore". Therapeutic measures were not taken as a result of pain in extremity, loss of personal independence in daily activities, pain.  Additional Information : The patient reported that patient got the vaccine yesterday and the only thing is patient's arm with shot in the arm, patient had a rock in it and could not lift it up. So, how long would that last. Would they get better. When patient got the shot it was really no problem patient did not even feel it going in and yesterday afternoon patient was fine it was only like during the night when patient slept patient woke up and patient's arm was, it feels like a rock in there you know the muscle where the shot went in it was not hard but it was painful that was what patient meant. Patient could not explain so good. patient reported Well, patient did not think it would not last, patient was fine it was just today it was sore. Patient's second dose would be in 02Apr that is why patient took it, the second one. The patient did not receive any treatment for the events.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes in neck by jaw. left side (same side as shot); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 15:00 (Lot number: EN6206) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TERBINAFINE; OMEPRAZOLE. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 08Mar2021 14:00, outcome "not recovered", described as "swollen lymph nodes in neck by jaw. left side (same side as shot)". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient had no known allergies. The patient did not received other vaccine in four weeks. Patient received no treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID. Post vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Nausea
Clinical narrative: feeling like rolling tiger; Nauseated; Chills; Diarrhea; Tired; I feel like sleeping all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6204) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol; "Cyst in my brain" (unspecified if ongoing). Concomitant medication(s) included: OXCARBAZEPINE taken for cerebral cyst; PRAVASTATIN taken for blood cholesterol. The following information was reported: FEELING ABNORMAL (non-serious) with onset 09Mar2021, outcome "not recovered", described as "feeling like rolling tiger"; NAUSEA (non-serious) with onset 09Mar2021, outcome "not recovered", described as "Nauseated"; CHILLS (non-serious) with onset 09Mar2021, outcome "not recovered", described as "Chills"; DIARRHOEA (non-serious) with onset 09Mar2021, outcome "not recovered", described as "Diarrhea"; FATIGUE (non-serious) with onset 09Mar2021, outcome "not recovered", described as "Tired"; SOMNOLENCE (non-serious) with onset 09Mar2021, outcome "not recovered", described as "I feel like sleeping all the time". Therapeutic measures were not taken as a result of feeling abnormal, nausea, chills, diarrhoea, fatigue, somnolence.  Additional information: Consumer stated I am getting some side effects, I guess from the shot, which I had on Monday and I have been feeling the last couple of days I have been feeling like rolling tiger, nauseated, chills and I have been having the diarrhea, I have been rolling rolling, I feel like sleeping all the time its so terrible. Consumer asked, what should I do, is this like a reaction from the shot, should I stay in the house should I go out, what should I do.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: feeling like rolling tiger; Nauseated; Chills; Diarrhea; Tired; I feel like sleeping all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6204) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol; "Cyst in my brain" (unspecified if ongoing). Concomitant medication(s) included: OXCARBAZEPINE taken for cerebral cyst; PRAVASTATIN taken for blood cholesterol. The following information was reported: FEELING ABNORMAL (non-serious) with onset 09Mar2021, outcome "not recovered", described as "feeling like rolling tiger"; NAUSEA (non-serious) with onset 09Mar2021, outcome "not recovered", described as "Nauseated"; CHILLS (non-serious) with onset 09Mar2021, outcome "not recovered", described as "Chills"; DIARRHOEA (non-serious) with onset 09Mar2021, outcome "not recovered", described as "Diarrhea"; FATIGUE (non-serious) with onset 09Mar2021, outcome "not recovered", described as "Tired"; SOMNOLENCE (non-serious) with onset 09Mar2021, outcome "not recovered", described as "I feel like sleeping all the time". Therapeutic measures were not taken as a result of feeling abnormal, nausea, chills, diarrhoea, fatigue, somnolence.  Additional information: Consumer stated I am getting some side effects, I guess from the shot, which I had on Monday and I have been feeling the last couple of days I have been feeling like rolling tiger, nauseated, chills and I have been having the diarrhea, I have been rolling rolling, I feel like sleeping all the time its so terrible. Consumer asked, what should I do, is this like a reaction from the shot, should I stay in the house should I go out, what should I do.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Got a 2-3 inch red raised rash at injection site; Hot to the touch; It's been over two weeks & it's still red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 16:00 (Batch/Lot number: unknown) at the age of 51 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: VACCINATION SITE RASH (non-serious) with onset 04Mar2021, outcome "not recovered", described as "Got a 2-3 inch red raised rash at injection site"; VACCINATION SITE WARMTH (non-serious) with onset 04Mar2021, outcome "not recovered", described as "Hot to the touch"; VACCINATION SITE ERYTHEMA (non-serious) with onset 04Mar2021, outcome "not recovered", described as "It's been over two weeks & it's still red". The events "got a 2-3 inch red raised rash at injection site", "hot to the touch" and "it's been over two weeks & it's still red" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of vaccination site rash, vaccination site warmth, vaccination site erythema. Additional information: Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for covid post vaccination.  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: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Moderate left arm pain; Mild left arm swelling; Moderate muscle aches; Chills; Mild headache; Moderate Fatigue; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 12Mar2021 11:30 (Lot number: EN6203) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR [ATORVASTATIN]; LANSOPRAZOLE. Vaccination history included: Bnt162b2 (Lot number=EL3247, administration date=17Feb2021, administration time=11:30 AM, vaccine location=Left arm, dose number=1), administration date: 17Feb2021, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Mar2021, outcome "recovering", described as "Moderate left arm pain"; PERIPHERAL SWELLING (non-serious) with onset 13Mar2021, outcome "recovering", described as "Mild left arm swelling"; MYALGIA (non-serious) with onset 13Mar2021, outcome "recovering", described as "Moderate muscle aches"; CHILLS (non-serious) with onset 13Mar2021, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 13Mar2021, outcome "recovering", described as "Mild headache"; FATIGUE (non-serious) with onset 13Mar2021, outcome "recovering", described as "Moderate Fatigue". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling, myalgia, chills, headache, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Moderate left arm pain; Mild left arm swelling; Moderate muscle aches; Chills; Mild headache; Moderate Fatigue; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 12Mar2021 11:30 (Lot number: EN6203) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR [ATORVASTATIN]; LANSOPRAZOLE. Vaccination history included: Bnt162b2 (Lot number=EL3247, administration date=17Feb2021, administration time=11:30 AM, vaccine location=Left arm, dose number=1), administration date: 17Feb2021, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Mar2021, outcome "recovering", described as "Moderate left arm pain"; PERIPHERAL SWELLING (non-serious) with onset 13Mar2021, outcome "recovering", described as "Mild left arm swelling"; MYALGIA (non-serious) with onset 13Mar2021, outcome "recovering", described as "Moderate muscle aches"; CHILLS (non-serious) with onset 13Mar2021, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 13Mar2021, outcome "recovering", described as "Mild headache"; FATIGUE (non-serious) with onset 13Mar2021, outcome "recovering", described as "Moderate Fatigue". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling, myalgia, chills, headache, fatigue.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Dizziness; Tingling sense like needles in hands and feet; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 (Lot number: EN6205) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling sense like needles in hands and feet". Therapeutic measures were taken as a result of dizziness, paraesthesia.  Additional information: Treatment: Benadryl.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm soreness lasted 24hrs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EL3247) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JUNEL FE. Past drug history included: Augmentin for Allergy to Augmentin. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Left arm soreness lasted 24hrs". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient had no other vaccine in four weeks. Patient had received Junel Fe (birth control pill) other medications in two weeks. Patient had not covid prior vaccination. Patient had not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: equilibrium is all off; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 14:00 (Lot number: EN6205) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "vascular disease" (unspecified if ongoing), notes: Verbatim: vascular disease. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, Lot/batch number: EN9581), administration date: 19Feb2021, for COVID-19 Immunisation. The following information was reported: BALANCE DISORDER (non-serious) with onset 12Mar2021 01:00, outcome "unknown", described as "equilibrium is all off". Therapeutic measures were not taken as a result of balance disorder.  Additional Information: for Other Conditions, Reporter said this was diagnosed years ago, his blood veins had a lot of calcium in them, and he was losing blood flow to his legs, so they did an extra bypass inside him to get more blood to his legs. Reporter said he got his second Pfizer COVID-19 vaccination shot Tuesday afternoon and woke up this morning and his equilibrium is all off, to where if he stands up fast, he has got to stop. He says actually at a normal pace, not real fast, or if he turns. He says he would like to know if this is normal, since he got his shot last Tuesday. he got his vaccine doses at hospital. Reporter said he got his second shot on 09Mar2021 at 02:00PM, and his equilibrium was off this morning first when he got up at 01:00AM. He says he flipped the covers off and it was totally weird, and he laid there then rolled over and got up and almost fell over. He says he has a urinal by the bed, he had to stand with his hand on the wall. He said that the first dose he got of the Pfizer COVID-19 vaccine was LOT EN9581 and was given 19Feb2021, which he had absolutely no side effects from it at all. He said his second dose on 09Mar2021 was LOT EN6205. For concomitant Medications, Reporter said they have not had any other recent vaccinations or started any new medications. Reporter said something about not having any for two weeks when asked about new medications or recent vaccinations, caller does not clarify this statement. Reporter said that he has done no treatment for his equilibrium being off. He said he just woke up with that this morning. He said it seems it has gotten better after he got out of bed at 06:00AM he has been lounging in his chair and can get up and move better, he just has to move slowly.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Illness, Movement disorder
Clinical narrative: Sick; Could not move; Diarrhea; Chills; 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 10Mar2021 (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: ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "Sick"; MOVEMENT DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "Could not move"; DIARRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "Diarrhea"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "Chills".  Additional information: Patient had the covid shot Wednesday, Thursday night, until Friday morning, was so sick, could not move, had diarrhea and body weighed like 400 Pounds and had chills, the whole night. This was first shot. Patient was skeptical of taking a second shot and questioned do have the second shot if get this sick on the first shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Palpitations
Clinical narrative: Chills; I was very weak; Headache; Palpitations; 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 female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 (Lot number: EN6202) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "have a pace maker" (unspecified if ongoing), notes: "I have a pace maker and I also have a clip. I have a micro valve leakage and they put a clip in.". The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; ASTHENIA (non-serious), outcome "unknown", described as "I was very weak"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PALPITATIONS (non-serious), outcome "unknown", described as "Palpitations". Therapeutic measures were taken as a result of chills, asthenia, headache, palpitations.  Additional information- It was reported that the patient received treatment with Tylenol.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient. A 19 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 19 years 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), when the patient was 19 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; HEADACHE (non-serious), outcome "unknown", described as "headache"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at the injection site". Additional information: Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: sinus infection has accelerated after receiving vaccine. 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 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sinus infection" (unspecified if ongoing), notes: Caller has been fighting sinus infection prior to recieving her first Vaccine. The patient's concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "sinus infection has accelerated after receiving vaccine.  Additional information: Patient has been fighting sinus infection prior to recieving her first Vaccine dose on 10Mar. She was wondering if ok to have an anti-biotic like a Z-pack since she's now had her 1st dose. Relayed number and transferred to PMI. (name) took call. Faxing to Pfizer DSU for concerns sinus infection has accelerated after receiving vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fluid retention
Clinical narrative: fluid retention; 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 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: FLUID RETENTION (non-serious), outcome "unknown", described as "fluid retention".  Additional information:He had fluid retention and just came out from the hospital. According to him, he has a hard time driving because of his condition. He is asking if he can postpone his 2nd dose today and get his 2nd dose next week.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Thirst
Clinical narrative: face felt very warm; also - I've had 2 liters of water today so far; minor headache (very minor); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 12:00 (Batch/Lot number: unknown) at the age of 40 years 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: HEADACHE (non-serious) with onset 12Mar2021, outcome "recovered" (12Mar2021), described as "minor headache (very minor)"; FEELING HOT (non-serious) with onset 12Mar2021 12:30, outcome "recovered" (12Mar2021 13:30), described as "face felt very warm"; THIRST (non-serious) with onset 12Mar2021, outcome "unknown", described as "also - I've had 2 liters of water today so far". Therapeutic measures were taken as a result of headache.  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: Mild Flu like symptoms after administration of the first dose of the COVID-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) 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: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Mild Flu like symptoms after administration of the first dose of the COVID-19 vaccine". Event took place after use of product.  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: Experiencing lot of pain in her left arm; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient received 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) with onset 14Mar2021, outcome "unknown", described as "Experiencing lot of pain in her left arm". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient reported that she was experiencing a lot of pain in her left arm so she took two Extra Strength Tylenol at 11 pm the night before. At the time of report, she was scheduled to have her second vaccine at 11:40 am and remembered that she was not supposed to take any Tylenol 24 hours before the vaccine. So it would be 12 hours later that she would be due to have the shot and asked if that was okay.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: felt dizzy; a light headache; 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) (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 "felt dizzy"; HEADACHE (non-serious), outcome "unknown", described as "a light headache".  Additional Information: The reporter had an appointment for her 2nd dose today. She was asking for the time. According to her she felt dizzy and had a light headache. She was asking if this is the cause of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional information: Patient was claiming that the symptom that he was experiencing is not related with the vaccine. Patient only wants to know what pain medication can he took for headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 antibody test
Clinical narrative: got extremely sick; 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 12Feb2021 (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: ILLNESS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "got extremely sick". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that, caller got her 1st dose on 12Feb2021 and within 24 hours she got extremely sick and was sick for 3 weeks. They told her to not get the 2nd dose and instead do a anit-body test. She did an antibody test and it came back negative. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: she started to feel weird things; 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) (Batch/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), for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset 11Mar2021, outcome "unknown", described as "she started to feel weird things".  Additional information: There is no unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible. No further information is expected.