chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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 immunization, reaction(s): "no adverse event". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu-like symptoms".".  Additional information: Caller says he got the Pfizer shot. After the 1st shot, he nor his wife had any adverse effects. After their 2nd shot, his wife had flu-like 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: Limb discomfort
Clinical narrative: a dead arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "a dead arm".  Additional information: Event verbatim : His wife received her second dose today, 05May2021. However, when the shot was administered, it was administered in the rear part of her arm near her triceps and he is suspecting it was injected subcutaneously instead of in the muscle. It has been 6 hours now since she had received the vaccine but she has not had any side effects or dead arm or anything. Caller stated his wife had experienced immediate side effects from the first dose and a dead arm. Caller had reached out to PCP and DPH and had no response yet. Caller is asking are there any safety concerns with having to inject subcutaneously and is the shot still effective?  Caller declined warm-transfer and did not want to provide further demographic details as his wife wanted to consult with the doctor first before providing further details to report AE. Thus, AE e-transmitted. Age and HCP information not gathered. Response: Responded per CONS document and spoke from EUA fact sheet under "2 DOSAGE AND ADMINISTRATION". Told caller we are unable to speak for the efficacy of the vaccine outside of intramuscular injection as Pfizer did not specifically study the vaccine as subcutaneous use. Told caller it is the HCP's discretion whether the dose was administered as an invalid dose and the HCP does have available to them information from CDC regarding inadvertent administration of a subcutaneous injection.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient in his 30's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 4 decade 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: CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional Information: Patient said that he had checked in on a friend of mine who got it and he said he had chills.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Slight chill and fatigue; Slight chill and fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 02May2021 (Batch/Lot number: unknown) at the age of 33 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), administration date: 11Apr2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious), FATIGUE (non-serious) all with onset 03May2021, outcome "unknown" and all described as "Slight chill and fatigue".  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was unknown. Device Date : 04May2021.  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: Blood test, Dizziness, Fatigue, Myalgia, Nausea
Clinical narrative: tiredness; nausea; woozy; pains; muscle pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Apr2021 (Lot number: EW0170) at the age of 69 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "Cholesterol" (unspecified if ongoing), notes: Cholesterol; "Sugar" (unspecified if ongoing), notes: Sugar coded as diabetes. Concomitant medication(s) included: DAPAGLIFLOZIN taken for diabetes mellitus; METFORMIN taken for diabetes mellitus; METOPROLOL taken for blood pressure measurement; ATORVASTATIN taken for blood cholesterol; TAMSULOSIN; TELMISARTAN. Vaccination history included: Bnt162b2 (First dose), administration date: 07Apr2021, when the patient was 69 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Apr2021, outcome "not recovered", described as "tiredness"; NAUSEA (non-serious) with onset Apr2021, outcome "not recovered", described as "nausea"; DIZZINESS (non-serious) with onset Apr2021, outcome "not recovered", described as "woozy"; PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "pains"; MYALGIA (non-serious) with onset Apr2021, outcome "not recovered", described as "muscle pains". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient stated that after 2nd dose he felt nausea and tiredness. And he was stated that I do not know what to take it but I took Tylenol in the beginning.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: tiredness; nausea; woozy; pains; muscle pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Apr2021 (Lot number: EW0170) at the age of 69 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "Cholesterol" (unspecified if ongoing), notes: Cholesterol; "Sugar" (unspecified if ongoing), notes: Sugar coded as diabetes. Concomitant medication(s) included: DAPAGLIFLOZIN taken for diabetes mellitus; METFORMIN taken for diabetes mellitus; METOPROLOL taken for blood pressure measurement; ATORVASTATIN taken for blood cholesterol; TAMSULOSIN; TELMISARTAN. Vaccination history included: Bnt162b2 (First dose), administration date: 07Apr2021, when the patient was 69 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Apr2021, outcome "not recovered", described as "tiredness"; NAUSEA (non-serious) with onset Apr2021, outcome "not recovered", described as "nausea"; DIZZINESS (non-serious) with onset Apr2021, outcome "not recovered", described as "woozy"; PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "pains"; MYALGIA (non-serious) with onset Apr2021, outcome "not recovered", described as "muscle pains". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient stated that after 2nd dose he felt nausea and tiredness. And he was stated that I do not know what to take it but I took Tylenol in the beginning.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Nerve injury, Pain, Pain in extremity
Clinical narrative: his arm has been very sore and almost dead; throbbing and in pain; he thinks he got nerve damage; 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 47 year-old male patient received bnt162b2 (BNT162B2), administration date 01May2021 (Lot number: PBl211) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma; "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure. Concomitant medication(s) included: LOSARTAN taken for hypertension; HYDROCHLOROTHIAZIDE taken for hypertension. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "his arm has been very sore and almost dead"; PAIN (non-serious), outcome "not recovered", described as "throbbing and in pain"; NERVE INJURY (non-serious), outcome "unknown", described as "he thinks he got nerve damage". Therapeutic measures were taken as a result of pain in extremity, pain, nerve injury.  Additional information: Therapeutic measures were taken. Patient had iced the arm, taken warm showers and taken Advil and Tylenol around the clock and it still hurts. He started Aleve, he thinks it was a bad shot. Patient was taking medicines for high blood pressure. He had vaccine last Saturday and his arm was still hurted. He had been taking Tylenol everything round the clock and he was in pain and his arm was almost dead. He had done laboratory tests about a month ago and that were fine.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of the lymph nodes near the clavicle, right side where the vaccine was administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05May2021 (Lot number: EW0158) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing); "Lactose" (unspecified if ongoing), notes: known allergy: Lactose. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (lot number: EW0161, dose: 1, vaccine location:Right arm), administration date: 14Apr2021, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 07May2021, outcome "not recovered", described as "Swelling of the lymph nodes near the clavicle, right side where the vaccine was administered". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Fatigue, Headache, Incoherent
Clinical narrative: lightheaded and mildly incoherent; lightheaded and mildly incoherent; unable to walk in a straight line; nearly falling over; nauseous; headache; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 14:00 (Lot number: EP7533) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin for Known allergies: amoxicillin. The following information was reported: DIZZINESS (non-serious) with onset 16Apr2021 14:30, outcome "recovered" (2021), described as "dizzy"; DIZZINESS (non-serious) with onset 16Apr2021 16:30, outcome "recovered" (2021), INCOHERENT (non-serious) with onset 16Apr2021 14:30, outcome "recovered" (2021) and all described as "lightheaded and mildly incoherent"; WALKING DISABILITY (non-serious) with onset 16Apr2021 14:30, outcome "recovered" (2021), described as "unable to walk in a straight line"; FALL (non-serious) with onset 16Apr2021 14:30, outcome "recovered" (2021), described as "nearly falling over"; NAUSEA (non-serious) with onset 16Apr2021 14:30, outcome "recovered" (2021), described as "nauseous"; HEADACHE (non-serious) with onset 16Apr2021 14:30, outcome "recovered" (2021), described as "headache"; FATIGUE (non-serious) with onset 16Apr2021 14:30, outcome "recovered" (2021), described as "tired". Therapeutic measures were not taken as a result of dizziness, dizziness, incoherent, walking disability, fall, nausea, headache, fatigue.   Clinical course: Within 45 minutes the patient became dizzy, lightheaded and mildly incoherent (as if was under the influence of alcohol). The patient was unable to walk in a straight line without leaning or nearly falling over. The patient had to ask her spouse to pick her up and drive her home. After 2 hours the patient became nauseous with a headache. The dizziness and nausea subsided after 4-5 hours. The patient felt tired but was back to normal by 22:00 (8 hours after receiving the shot). The patient had no side effects the following day. Recurring nausea and mild headache started a week later but resolved within the day.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Walking disability
Clinical narrative: lightheaded and mildly incoherent; lightheaded and mildly incoherent; unable to walk in a straight line; nearly falling over; nauseous; headache; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 14:00 (Lot number: EP7533) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin for Known allergies: amoxicillin. The following information was reported: DIZZINESS (non-serious) with onset 16Apr2021 14:30, outcome "recovered" (2021), described as "dizzy"; DIZZINESS (non-serious) with onset 16Apr2021 16:30, outcome "recovered" (2021), INCOHERENT (non-serious) with onset 16Apr2021 14:30, outcome "recovered" (2021) and all described as "lightheaded and mildly incoherent"; WALKING DISABILITY (non-serious) with onset 16Apr2021 14:30, outcome "recovered" (2021), described as "unable to walk in a straight line"; FALL (non-serious) with onset 16Apr2021 14:30, outcome "recovered" (2021), described as "nearly falling over"; NAUSEA (non-serious) with onset 16Apr2021 14:30, outcome "recovered" (2021), described as "nauseous"; HEADACHE (non-serious) with onset 16Apr2021 14:30, outcome "recovered" (2021), described as "headache"; FATIGUE (non-serious) with onset 16Apr2021 14:30, outcome "recovered" (2021), described as "tired". Therapeutic measures were not taken as a result of dizziness, dizziness, incoherent, walking disability, fall, nausea, headache, fatigue.   Clinical course: Within 45 minutes the patient became dizzy, lightheaded and mildly incoherent (as if was under the influence of alcohol). The patient was unable to walk in a straight line without leaning or nearly falling over. The patient had to ask her spouse to pick her up and drive her home. After 2 hours the patient became nauseous with a headache. The dizziness and nausea subsided after 4-5 hours. The patient felt tired but was back to normal by 22:00 (8 hours after receiving the shot). The patient had no side effects the following day. Recurring nausea and mild headache started a week later but resolved within the day.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Dry eye
Clinical narrative: right eye was extremely dry behind eye and behind upper lid; twitching happens to right eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19Apr2021 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "Autoimmune reactions affect my eyes" (ongoing), notes: I have had autoimmune reactions affect my eyes for the past few years. Concomitant medication(s) included: SYNTHROID. Past drug history included: Augmenting, reaction(s): "Allergies", notes: Known allergies: Augmenting, Percaset, Zyrtec; Percaset, reaction(s): "Allergies", notes: Known allergies: Augmenting, Percaset, Zyrtec; Zyrtec, reaction(s): "Allergies", notes: Known allergies: Augmenting, Percaset, Zyrtec. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: EN6208, Administration time: 09:00 AM, dose number: 1, Vaccine location: Left arm), administration date: 29Mar2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: DRY EYE (non-serious) with onset 2021, outcome "recovering", described as "right eye was extremely dry behind eye and behind upper lid"; BLEPHAROSPASM (non-serious) with onset 2021, outcome "not recovered", described as "twitching happens to right eye". Therapeutic measures were not taken as a result of dry eye, blepharospasm.  Additional Information: After 2nd dose right eye was extremely dry behind eye and behind upper lid. Where I have to add rewettimg gel drops 4 times a day. More symptoms happened to left eye, but twitching happens to right eye. The dryness is improving now (2nd dose was 19Apr2021. Twitching is not as often but still comes and goes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Tired; Mildly nauseated; Mild headache that migrated around my head and face; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 11:00 (Lot number: EW0162) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "adhesives" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; CLARITIN-D. Past drug history included: Vicodin for known allergy: Vicodin, notes: Vicodin and adhesives. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer-BioNTech, lot number=ER8737,, lot unknown=False,, administration date=08Apr2021,, dose number=1,, vaccine location=Left arm), administration date: 08Apr2021, when the patient was 45 years old, for covid-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset 30Apr2021 05:00, outcome "recovered", described as "mild headache that migrated around my head and face"; FATIGUE (non-serious), outcome "recovered", described as "tired"; NAUSEA (non-serious), outcome "recovered", described as "mildly nauseated". Therapeutic measures were taken as a result of headache, fatigue, nausea.  Additional information: It was reported that, the patient did not receive other vaccine in four weeks. The patient not tested for covid post vaccination. It was reported that the patient had mild headache that migrated around my head and face and came and went. It was reported that it lasted a couple days. The patient was also very tired and mildly nauseated  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: strong odor in my nose; metallic taste; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Lot number: ER8737) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; HYDROCHLOROTHIAZIDE; VITAMIN D3. The following information was reported: PAROSMIA (non-serious), outcome "recovering", described as "strong odor in my nose"; DYSGEUSIA (non-serious), outcome "recovering", described as "metallic taste". Therapeutic measures were not taken as a result of parosmia, dysgeusia.  Additional information: Patient had no covid prior vaccination.The patient had not been tested post vaccination. Device timestamp: 04May2021.The patient did not receive any other vaccines in 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Just a sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administration date 12Apr2021 10:00 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "Just a sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No covid prior vaccination. No covid tested post vaccination. No known allergies. Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain on her leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) Pfizer Sponsored Program COVAX Support. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (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 "pain on her leg". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient received the 1st dose on 15Apr2021 and she is scheduled to get the 2nd dose tomorrow. She was asking us to send someone to her house to administer the vaccine because of the pain on her leg. She mentioned that it is sore because she has not taken her pain medication.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature abnormal, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Swollen lymph  nodes; pain in armpit; headache; temperature 38.7; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 09:00 (Lot number: EWO175) at the age of 35 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "Swollen lymph  nodes"; AXILLARY PAIN (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "pain in armpit"; HEADACHE (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "headache"; PYREXIA (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "temperature 38.7"; MYALGIA (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, axillary pain, headache, pyrexia, myalgia.  Additional information: No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Swollen lymph  nodes; pain in armpit; headache; temperature 38.7; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 09:00 (Lot number: EWO175) at the age of 35 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "Swollen lymph  nodes"; AXILLARY PAIN (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "pain in armpit"; HEADACHE (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "headache"; PYREXIA (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "temperature 38.7"; MYALGIA (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, axillary pain, headache, pyrexia, myalgia.  Additional information: No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
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 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 19:00 (Lot number: EW0151) at the age of 43 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypomania, Pain in extremity, Therapeutic response unexpected
Clinical narrative: Sore arm; exhaustion; I have uncontrolled rheumatoid arthritis and thought I was cured. All RA symptoms gone; 2nd shot: Hypomanic for 4 glorious hours; 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 received bnt162b2 (BNT162B2), administered in arm left (Lot number: er 8729) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Rheumatoid Arthritis; "Known allergies: Beta Blocker Medication" (unspecified if ongoing), notes: Known allergies: Beta Blocker Medication; "COVID-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st shot: Hypomanic for 2 hours, Other vaccine same date details:, Other vaccine same date Product=Pfizer, Other vaccine same date Lot number= er 8737, Other vaccine same date Dose number= 1, Other vaccine same date Vaccine location= Left arm.), for Covid-19 immunisation, reaction(s): "Hypomanic for 2 hours". The following information was reported: HYPOMANIA (non-serious), outcome "recovered", described as "2nd shot: Hypomanic for 4 glorious hours"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm"; FATIGUE (non-serious), outcome "recovered", described as "exhaustion"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "recovered", described as "I have uncontrolled rheumatoid arthritis and thought I was cured. All RA symptoms gone". Therapeutic measures were not taken as a result of hypomania, pain in extremity, fatigue, therapeutic response unexpected.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight soreness at the injection sight for both shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Lot number: ER8734) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "allergy to Sunflower seed" (unspecified if ongoing), notes: allergy to Sunflower seed; "Allergy: Menthol" (unspecified if ongoing), notes: Allergy: Menthol. Concomitant medication(s) included: SERTRALINE; NUVARING. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03May2021, outcome "recovering", described as "slight soreness at the injection sight for both shots". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Patient received other medications (Sertraline 100mg daily and Nuvaring) within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Tinnitus
Clinical narrative: headache, dizzy, ringing in ears, and nausea; headache, dizzy, ringing in ears, and nausea; headache, dizzy, ringing in ears, and nausea; headache, dizzy, ringing in ears, and nausea; 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 16Apr2021 (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: HEADACHE (non-serious), DIZZINESS (non-serious), NAUSEA (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "headache, dizzy, ringing in ears, and nausea".  Additional information: Patient stated she may not get the second COVID-19 vaccine.  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: Abdominal pain lower, Muscular weakness, Pain in extremity, Paraesthesia, Sciatica
Clinical narrative: Left hand started to feel weak; slight pins-and-needles feeling; Left hand continues to hurt; Sciatica pain in my left leg; a sharp pain at the bottom of my tummy; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient..  A 40 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 02Apr2021 11:30 (Lot number: F-EP7533) at the age of 40 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hand weakness" (unspecified if ongoing); "Pinched nerves in her spine" (unspecified if ongoing). Concomitant medications included: SPIRONOLACTONE; OCELLA; DEXEDRINE; YAZ. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Left hand started to feel weak"; PARAESTHESIA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "slight pins-and-needles feeling"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Left hand continues to hurt"; SCIATICA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Sciatica pain in my left leg"; ABDOMINAL PAIN LOWER (non-serious) with onset Apr2021, outcome "not recovered", described as "a sharp pain at the bottom of my tummy". Therapeutic measures were not taken as a result of muscular weakness, paraesthesia, pain in extremity, sciatica, abdominal pain lower. Additional information: Patient also experienced the events after the second much the same way but with higher intensity than after the first shot. Patient has not taken other vaccine within four weeks. Patient did not have COVID prior to the vaccination and had not tested for COVID since the vaccination. Patient has no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021494829 Same patient/product; different events/dose
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Nightmare, SARS-CoV-2 test, Tinnitus
Clinical narrative: nightmare; woke up sweating that night; Tinnitus temp disappeared.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021785350 (Pfizer).  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 10:00 (Lot number: EP69SS) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "bipolar" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing);" (unspecified if ongoing); "smoke cigarettes" (unspecified if ongoing). Concomitant medication(s) included: ABILIFY; HYDROXIZINE; QUININE; FLONASE ALLERGY RELIEF; VITAMINS A & D. The following information was reported: NIGHTMARE (non-serious) with onset 06May2021 12:00, outcome "unknown", described as "nightmare"; NIGHT SWEATS (non-serious) with onset 06May2021 12:00, outcome "unknown", described as "woke up sweating that night"; TINNITUS (non-serious) with onset 06May2021 12:00, outcome "unknown", described as "Tinnitus temp disappeared.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nightmare, night sweats, tinnitus.  Additional information: The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Lymph node pain, Lymphadenopathy
Clinical narrative: My lymph nodes under left arm (that i received vaccine at) is swollen and very painful. The pain is about 7 on a scale of 1-10. It spreads into my inside side of my left arm. Almost burning sensation.; My lymph nodes under left arm (that i received vaccine at) is swollen and very painful. The pain is about 7 on a scale of 1-10. It spreads into my inside side of my left arm; Almost burning sensation; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 (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 (1st dose), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset May2021, outcome "unknown", described as "My lymph nodes under left arm (that i received vaccine at) is swollen and very painful. The pain is about 7 on a scale of 1-10. It spreads into my inside side of my left arm. Almost burning sensation."; LYMPH NODE PAIN (non-serious) with onset May2021, outcome "unknown", described as "My lymph nodes under left arm (that i received vaccine at) is swollen and very painful. The pain is about 7 on a scale of 1-10. It spreads into my inside side of my left arm"; BURNING SENSATION (non-serious) with onset May2021, outcome "unknown", described as "Almost burning sensation".  Additional Information: Customer Verbatim reported as, Patient received two dozes of Pfezer Covid vaccine. Patient have severe reaction after the second doze. Patient mentioned that, My lymph nodes under left arm (that patient received vaccine at) is swollen and very painful. The pain is about 7 on a scale of 1-10. It spreads into my inside side of my left arm. Almost burning sensation. Today is my second day after i got the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Illness, Nausea
Clinical narrative: horrible like disgusting like metal taste in my mouth; Dizzy; its like making me sick; Nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 15:15 (Lot number: ER8735, Expiration Date: 30Jul2021) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "bladder disease" (unspecified if ongoing), notes: Verbatim:  I have a bladder disease. The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 05May2021, outcome "unknown", described as "horrible like disgusting like metal taste in my mouth"; DIZZINESS (non-serious) with onset 05May2021, outcome "unknown", described as "Dizzy"; ILLNESS (non-serious) with onset 05May2021, outcome "unknown", described as "its like making me sick"; NAUSEA (non-serious) with onset 05May2021, outcome "unknown", described as "Nauseous". Therapeutic measures were not taken as a result of dysgeusia, dizziness, illness, nausea.  Additional information: Patient had Pfizer vaccine just a coupe of hours ago and since been home I have those horrible like disgusting like metal taste in my mouth its like making me sick and I am really dizzy and it said it wasnt a common side effect so to call this number if having abnormal side effects. Can taste medicine like metal in my mouth and  know that was like not a common side effect Product details (LOT#, NDC#, UPC# and Expiration Date) and pharmacy details could not be probed over the call as the consumer was unwilling to compete the report.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her arm was a little sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 14:00 (Lot number: EW0158) at the age of 70 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: PAIN IN EXTREMITY (non-serious) with onset 08Apr2021, outcome "recovered" (09Apr2021), described as "Her arm was a little sore".  Additional Information: Reporter states after the first one, her arm was a little sore.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: throat condition improved; throat condition improved; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "Anxiety" (ongoing); "High Blood Pressure" (ongoing). Concomitant medication(s) included: ATENOLOL taken for hypertension (ongoing); LISINOPRIL (ongoing); BUSPIRONE taken for anxiety (ongoing); CLONIDINE; CITALOPRAM; CLONAZEPAM taken for anxiety; ADVAIR taken for asthma. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 05May2021, outcome "recovered" (May2021), PRE-EXISTING CONDITION IMPROVED (non-serious) with onset 04May2021, outcome "recovered" (May2021) and all described as "throat condition improved".  Additional information: Patient has had a build up of phlegm in his throat for about 3 months.  He received his first dose of the Covid-19 vaccine on 04May2021 and the phlegm in his throat is now gone he was so amazed and doesnt know whats in the Covid-19 vaccine but whatever it is its good. He feels so much better. He did not go to see his doctor about the phlegm in his throat because he thought the phlegm would clear up by itself. He cant wait until his next dose of the Pfizer Covid-19 vaccine. about 2.5 hours after he received the first dose of the Covid-19 vaccine, the phlegm in his throat cleared up. He has been taking all his medications for years. He looked up phlegm in the throat on the internet and has been gargling with warm salt water per the recommendation he found. The phlegm has been gone since he had the Covid-19 vaccine yesterday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Is not feeling well/feeling sick right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558) from a regulatory authority  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (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: MALAISE (non-serious), outcome "unknown", described as "Is not feeling well/feeling sick right now".  Additional Information: Caller (Withheld) and his wife (Withheld) had their first dose about two weeks ago and scheduled today 05May2021 for their second dose. (Withheld) mentioned that he just got back from town and his wife was not feeling well that's why they cannot get their dose today. He and his wife are scheduled for their second dose of the vaccine today, but they won't be able to go. His wife is feeling sick right now  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Paraesthesia
Clinical narrative: Small lump on my collar bone, on the left side; Small tingling sensation like alongside my body; 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 36 year-old male 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 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Small lump on my collar bone, on the left side"; PARAESTHESIA (non-serious), outcome "unknown", described as "Small tingling sensation like alongside my body".  Additional information: Patient got a lump on his collar bone like on the same side where he got his vaccination on the left and it was kind of like rubbery and it seems like it a got a little bit bigger like he saw it was come up maybe one hour ago. Patient mentioned it felt a little bit a like small piece of rubber but it was soft and it did not hurt but when he touched on it, it gave small tingling sensation like alongside his body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.