chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Gastric disorder, Insomnia, Malaise
Clinical narrative: stomach did not feel good; no appetite; not sleeping well; nauseous; did not feel well; felt tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID- 19 VACCINE, solution for injection), administration date 18Jan2021 (Lot number: EL3247, Expiration Date: 20May2021) at the age of 83 years as dose 1, single and administration date 08Feb2021 (Lot number: EN9581, Expiration Date: 31May2021) as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: NAUSEA (non-serious) with onset 15Mar2021, outcome "not recovered", described as "nauseous"; MALAISE (non-serious) with onset 15Mar2021, outcome "not recovered", described as "did not feel well"; FATIGUE (non-serious) with onset 15Mar2021, outcome "not recovered", described as "felt tired"; GASTRIC DISORDER (non-serious), outcome "unknown", described as "stomach did not feel good"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; INSOMNIA (non-serious), outcome "unknown", described as "not sleeping well". Therapeutic measures were taken as a result of gastric disorder.  Additional information: The events did not require a visit to emergency room and physician office. The patient had no prior vaccinations within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: stomach did not feel good; no appetite; not sleeping well; nauseous; did not feel well; felt tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID- 19 VACCINE, solution for injection), administration date 18Jan2021 (Lot number: EL3247, Expiration Date: 20May2021) at the age of 83 years as dose 1, single and administration date 08Feb2021 (Lot number: EN9581, Expiration Date: 31May2021) as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: NAUSEA (non-serious) with onset 15Mar2021, outcome "not recovered", described as "nauseous"; MALAISE (non-serious) with onset 15Mar2021, outcome "not recovered", described as "did not feel well"; FATIGUE (non-serious) with onset 15Mar2021, outcome "not recovered", described as "felt tired"; GASTRIC DISORDER (non-serious), outcome "unknown", described as "stomach did not feel good"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; INSOMNIA (non-serious), outcome "unknown", described as "not sleeping well". Therapeutic measures were taken as a result of gastric disorder.  Additional information: The events did not require a visit to emergency room and physician office. The patient had no prior vaccinations within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue
Clinical narrative: felt totally wiped out/tired; weak; having chills; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 14Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 14Mar2021, outcome "recovering", described as "felt totally wiped out/tired"; ASTHENIA (non-serious) with onset 14Mar2021, outcome "recovering", described as "weak"; CHILLS (non-serious) with onset 14Mar2021, outcome "recovering", described as "having chills".  Additional information: Patient reported receiving the first Pfizer covid vaccine dose on Sunday afternoon and afterwards felt "totally wiped out, tired, weak and having chills". Patient also reported that the next day the tiredness and weakness continued and started to feel better. Patient was querying if it was normal and how long it was expected to last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: Low platelet count (59 TH/uL) discovered with routine blood test 3 weeks after second dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 09:15 (Lot number: EL3247) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies to kiwi fruit" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Administration time: 10:30, Vaccine location: Left arm, Lot number: EL3247), administration date: 04Feb2021, when the patient was 30 years old, for COVID-19 immunisation. The following information was reported: PLATELET COUNT DECREASED (non-serious) with onset 16Mar2021, outcome "unknown", described as "Low platelet count (59 TH/uL) discovered with routine blood test 3 weeks after second dose". The event "low platelet count (59 th/ul) discovered with routine blood test 3 weeks after second dose" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of platelet count decreased.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: lots of nausea; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "lots of nausea".  Additional Information: The patient was due for second dose on 26Mar2021 and she pretty much have decided not to get the second shot. The patient was 72 (unit: unknown) and anyone she have talked to have had significant side effects and that scared her. It's her fear. The patient was asking if she will have the same event after the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Injection site pain, Lymph node pain
Clinical narrative: injection site was sore; body aches for 3-4 days; Lymph nodes under both arms were big / He specified the lymph node under the left arm was bigger; Lymph node under the left arm was sore; chills; slight headaches; really bad diarrhea; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 57-year-old male patient received BNT162B2 (BNT162B2), administration date 05Mar2021 (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: INJECTION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "injection site was sore"; PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "body aches for 3-4 days"; LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Lymph nodes under both arms were big / He specified the lymph node under the left arm was bigger"; LYMPH NODE PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Lymph node under the left arm was sore"; CHILLS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "chills"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "slight headaches"; DIARRHOEA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "really bad diarrhea".  Additional Information: The patient had side effects for a week after vaccination. He said that he was fine that day and the injection site was sore. He said that he had body aches for 3-4 days and the lymph nodes under both arms were big. He specified that the lymph node under the left arm was bigger and sore when he would touch it and when he was putting his arm down. He added that he had: no fever, chills, slight headaches, and a really bad diarrhea until Saturday. He explained that his second dose was due on 26Mar2021 and asked if he should get it.  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, Pain
Clinical narrative: injection site was sore; body aches for 3-4 days; Lymph nodes under both arms were big / He specified the lymph node under the left arm was bigger; Lymph node under the left arm was sore; chills; slight headaches; really bad diarrhea; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 57-year-old male patient received BNT162B2 (BNT162B2), administration date 05Mar2021 (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: INJECTION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "injection site was sore"; PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "body aches for 3-4 days"; LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Lymph nodes under both arms were big / He specified the lymph node under the left arm was bigger"; LYMPH NODE PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Lymph node under the left arm was sore"; CHILLS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "chills"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "slight headaches"; DIARRHOEA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "really bad diarrhea".  Additional Information: The patient had side effects for a week after vaccination. He said that he was fine that day and the injection site was sore. He said that he had body aches for 3-4 days and the lymph nodes under both arms were big. He specified that the lymph node under the left arm was bigger and sore when he would touch it and when he was putting his arm down. He added that he had: no fever, chills, slight headaches, and a really bad diarrhea until Saturday. He explained that his second dose was due on 26Mar2021 and asked if he should get it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspepsia, Fatigue, Headache, Pain in extremity
Clinical narrative: Constant headache; Massive fatigue; No appetite; Sluggish digestion/decreased digestion; Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021295447.  A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 09:15 (Lot number: EN6204) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Lot number: EM9809, Administration time: 08:30 AM, Vaccine location: Left arm, dose 1), administration date: 10Feb2021, when the patient was 68 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 10Mar2021 18:00, outcome "recovered", described as "Constant headache"; FATIGUE (non-serious) with onset 10Mar2021 18:00, outcome "recovered", described as "Massive fatigue"; DECREASED APPETITE (non-serious) with onset 10Mar2021 18:00, outcome "recovered", described as "No appetite"; DYSPEPSIA (non-serious) with onset 10Mar2021 18:00, outcome "recovered", described as "Sluggish digestion/decreased digestion"; PAIN IN EXTREMITY (non-serious) with onset 10Mar2021 18:00, outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of headache, fatigue, decreased appetite, dyspepsia, pain in extremity. Additional information: Patient had no other vaccine in four weeks. Patient received any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from contactable reporter(s) (Other HCP).  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: HEADACHE (non-serious), outcome "recovered" (2021), described as "Headache".  Additional information: The patient had headache for no less than 10 days. No history of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Administered Vaccines. No Prior Vaccinations (within 4 weeks). No relevant tests performed.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Nausea, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Localized muscle pain and tenderness at the injection site; Fatigue; Loss of appetite; Nausea; Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Mar2021 11:30 (Lot number: EN6205) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Neurological functioning disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Pineapple allergy" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE; VYVANSE; PREGABALIN; MONTELUKAST. Vaccination history included: Bnt162b2 (1st dose, Lot number: EM9809, Administration time: 09:00 AM, Vaccine location: Left arm), administration date: 12Feb2021, when the patient was 25 years old, for COVID-19 immunisation, reaction(s): "Tired/Fatigue", "Slurred Speech", "Red skin on hands, face, neck", "Balance problems", "Dizziness", "Swollen hands", "Severe flu like symptoms", "Vertigo", "Full body muscle aches", "No appetite", "Temperature was slightly elevated (98.7) from my "baseline,"  which is around 96.7". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Mar2021, outcome "recovering", described as "Localized muscle pain and tenderness at the injection site"; FATIGUE (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Fatigue"; DECREASED APPETITE (non-serious) with onset 06Mar2021, outcome "recovering", described as "Loss of appetite"; NAUSEA (non-serious) with onset 06Mar2021, outcome "recovering", described as "Nausea"; VERTIGO (non-serious) with onset 06Mar2021, outcome "recovering", described as "Vertigo". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, fatigue, decreased appetite, nausea, vertigo.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Localized muscle pain and tenderness at the injection site; Fatigue; Loss of appetite; Nausea; Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Mar2021 11:30 (Lot number: EN6205) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Neurological functioning disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Pineapple allergy" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE; VYVANSE; PREGABALIN; MONTELUKAST. Vaccination history included: Bnt162b2 (1st dose, Lot number: EM9809, Administration time: 09:00 AM, Vaccine location: Left arm), administration date: 12Feb2021, when the patient was 25 years old, for COVID-19 immunisation, reaction(s): "Tired/Fatigue", "Slurred Speech", "Red skin on hands, face, neck", "Balance problems", "Dizziness", "Swollen hands", "Severe flu like symptoms", "Vertigo", "Full body muscle aches", "No appetite", "Temperature was slightly elevated (98.7) from my "baseline,"  which is around 96.7". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Mar2021, outcome "recovering", described as "Localized muscle pain and tenderness at the injection site"; FATIGUE (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Fatigue"; DECREASED APPETITE (non-serious) with onset 06Mar2021, outcome "recovering", described as "Loss of appetite"; NAUSEA (non-serious) with onset 06Mar2021, outcome "recovering", described as "Nausea"; VERTIGO (non-serious) with onset 06Mar2021, outcome "recovering", described as "Vertigo". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, fatigue, decreased appetite, nausea, vertigo.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swelling of the lymphnode in the left armpit; pain can be felt there; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 09:00 (Lot number: EN6206) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Lot: EC9266, Administration time: 03:00 PM, Vaccine location-Left arm), administration date: 23Feb2021, when the patient was 44 years old, for Covid-19 immunization.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 14Mar2021 22:00, outcome "not recovered", described as "Swelling of the lymph node in the left armpit"; AXILLARY PAIN (non-serious) with onset 14Mar2021 22:00, outcome "not recovered", described as "pain can be felt there". Therapeutic measures were not taken as a result of lymphadenopathy, axillary pain.  Additional information:Swelling of the lymph node in the left armpit within 24hrs of receiving the 2nd shot in the left arm. it's been 48hrs at time of writing this and the armpit is still swollen and pain can be felt there. Patient not diagnosed with COVID 19 prior to vaccination and no other medications the patient received within 2 weeks of vaccination and Since the vaccination. The patient has not tested for COVID-19, since vaccine. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Dizziness, Fall, Fatigue, Hypoglycaemia
Clinical narrative: bent down and fell and hit the floor; dizzy/ light headedness; nauseous; slept all day; he tests his sugar every morning/ it was 54; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 15Mar2021 11:45 (Lot number: EN6208) at the age of 61 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "hypoglycemic", start date: 2013 (unspecified if ongoing), notes: for the past eight years and tries to control that with diet; "acid reflux" (unspecified if ongoing); "heartburn" (unspecified if ongoing); "allergy" (unspecified if ongoing); "sneezes" (unspecified if ongoing). Concomitant medications included: PANTOPRAZOLE taken for dyspepsia, gastrooesophageal reflux disease, start date: 2011; CETIRIZINE taken for hypersensitivity, sneezing. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Lot number: EN6200), administration date: 22Feb2021 14:00, when the patient was 61 years old, for COVID-19 immunisation; Flu shot, administration date: Nov2020, for immunisation. The following information was reported: DIZZINESS (non-serious) with onset 16Mar2021, outcome "not recovered", described as "dizzy/ light headedness"; NAUSEA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "nauseous"; FATIGUE (non-serious) with onset 16Mar2021, outcome "unknown", described as "slept all day"; HYPOGLYCAEMIA (non-serious) with onset 16Mar2021, outcome "unknown", described as "he tests his sugar every morning/ it was 54"; FALL (non-serious) with onset 17Mar2021, outcome "unknown", described as "bent down and fell and hit the floor". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient has no family history. He has no history of all previous immunisation with the Pfizer vaccine considered as suspect and additional vaccines administered on the same date of the Pfizer suspect. The events did not require a visit to physician or ER. On 17Mar2021, The patient went back to work but he felt nauseous and dropped something from the tool box and bent over to pick it up and the next thing he knew he was on the ground. He didn't think he passed out but he was just that light headed.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: bent down and fell and hit the floor; dizzy/ light headedness; nauseous; slept all day; he tests his sugar every morning/ it was 54; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 15Mar2021 11:45 (Lot number: EN6208) at the age of 61 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "hypoglycemic", start date: 2013 (unspecified if ongoing), notes: for the past eight years and tries to control that with diet; "acid reflux" (unspecified if ongoing); "heartburn" (unspecified if ongoing); "allergy" (unspecified if ongoing); "sneezes" (unspecified if ongoing). Concomitant medications included: PANTOPRAZOLE taken for dyspepsia, gastrooesophageal reflux disease, start date: 2011; CETIRIZINE taken for hypersensitivity, sneezing. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Lot number: EN6200), administration date: 22Feb2021 14:00, when the patient was 61 years old, for COVID-19 immunisation; Flu shot, administration date: Nov2020, for immunisation. The following information was reported: DIZZINESS (non-serious) with onset 16Mar2021, outcome "not recovered", described as "dizzy/ light headedness"; NAUSEA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "nauseous"; FATIGUE (non-serious) with onset 16Mar2021, outcome "unknown", described as "slept all day"; HYPOGLYCAEMIA (non-serious) with onset 16Mar2021, outcome "unknown", described as "he tests his sugar every morning/ it was 54"; FALL (non-serious) with onset 17Mar2021, outcome "unknown", described as "bent down and fell and hit the floor". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient has no family history. He has no history of all previous immunisation with the Pfizer vaccine considered as suspect and additional vaccines administered on the same date of the Pfizer suspect. The events did not require a visit to physician or ER. On 17Mar2021, The patient went back to work but he felt nauseous and dropped something from the tool box and bent over to pick it up and the next thing he knew he was on the ground. He didn't think he passed out but he was just that light headed.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 44 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain".  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-2021294101 Same reporter, drug, and event; different patient;US-PFIZER INC-2021297074 Same reporter, drug, and event; different patient
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt lousy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 37 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: MALAISE (non-serious), outcome "unknown", described as "felt lousy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Nasopharyngitis, Pain
Clinical narrative: cold like symptoms; chills; aches and pain; feeling sick; 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 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 "recovered", described as "cold like symptoms"; CHILLS (non-serious), outcome "recovered", described as "chills"; PAIN (non-serious), outcome "recovered", described as "aches and pain"; MALAISE (non-serious), outcome "recovered", described as "feeling sick".  Additional information: Events lasted one day and was gone the next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Sinus disorder, Somnolence
Clinical narrative: headache; feeling very sleepy; tired; sinus problems; 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 58 year-old female patient received bnt162b2 (BNT162B2), administration date 13Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: since she was a child. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "feeling very sleepy"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired"; SINUS DISORDER (non-serious) with onset 2021, outcome "unknown", described as "sinus problems".  Additional information: The patient received her first dose of the Pfizer vaccine this past Saturday, 13Mar2021 along with her husband. She mentioned that she has been feeling very sleepy, really tired, and sinus problems where she would tend to get a headache. She mentioned that she's had allergies since she was a child and it was no issue for her. She is asking if these side effects may last 5-6 days after receiving the 1st dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: fatigue; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 10:00 (Lot number: EL3247) at the age of 45 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 17Mar2021 12:00, outcome "recovered" (17Mar2021 15:00), described as "nausea"; FATIGUE (non-serious) with onset 17Mar2021 14:00, outcome "recovered" (18Mar2021 02:00), described as "fatigue". Therapeutic measures were not taken as a result of nausea, fatigue.  Additional information: The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Nausea was experienced for 3 hours (reported onset as 1 hour post injection; discrepant information) and 4 hours post injection, patient experienced fatigue that lasted for 12 hours.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmological examination, Vision blurred, Visual impairment
Clinical narrative: he noticed that his vision has deteriorated; vision/getting fuzzy; 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 male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), administration date 11Mar2021, around noon (Lot number: EN6206) as dose 1, single for covid-19 immunisation. Relevant medical history included: does wear glasses, but they were only for occasional use, until now. The patient's concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 13Mar2021, outcome "unknown", described as "he noticed that his vision has deteriorated"; VISION BLURRED (non-serious) with onset 13Mar2021, outcome "unknown", described as "vision/getting fuzzy". The patient underwent the following laboratory tests and procedures: ophthalmological examination: (Nov2020) did not need any upgrade to his prescription. Additional information: on 13Mar2021, 2 days later from vaccination, while he was driving, he noticed that his vision has deteriorated and was getting fuzzy. He wants to know if anyone has experienced this reaction before. He said that it was his near and far-sightedness that was affected.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Pfizer covid vaccine (She received both doses. She did not know which arm and she does not have a lot or expiration.  It was the Pfizer COVID vaccine.), for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information: Patient did not know her height, weight and her age. Reporter said patient is overweight but healthy. Complainant does not have the product with them at the time of call.  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: Chills, Fatigue, Feeling cold, Hyperhidrosis, Muscle spasms
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Lot number: EN6207) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (ongoing), notes: Onset probably 10 years ago; "Kidney disease" (ongoing), notes: Onset date was probably a long time ago but she was just diagnosed like a year ago. The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Tetracycline allergy". The following information was reported: FATIGUE (non-serious) with onset 15Mar2021, outcome "recovering", described as "she was kind of tired so she went to bed"; FEELING COLD (non-serious) with onset 15Mar2021, outcome "recovering", described as "proceeded to get colder/she got cold"; CHILLS (non-serious) with onset 15Mar2021, outcome "recovering", described as "shiver"; HYPERHIDROSIS (non-serious) with onset 15Mar2021, outcome "recovering", described as "sweat"; MUSCLE SPASMS (non-serious) with onset 15Mar2021, outcome "recovering", described as "charley horses in her legs"; OROPHARYNGEAL PAIN (non-serious) with onset 16Mar2021, outcome "not recovered", described as "sore throat". Additional information: It was reported that patient received the first dose on 15Mar2021, around 14:00, at upper left shoulder. Patient did not received any other Pfizer vaccine on the same date of BNt162b2 administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that starting last night on 15Mar2021 at unknown time, patient was kind of tired so she went to bed. Sometime in the middle of the night at unknown time she got cold. She put on and extra blanket and proceeded to get colder and started to shiver and sweat which went on most of the night. She also had charley horses in her legs, all up and down her legs that went on all night long. Outcome: She was feeling better at this time, although a little shaky and she woke up with a terrible sore throat this morning (16Mar2021) which remains persistent at this time. Events did not result to emergency room and physician office visit. No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Lot number: EN6207) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (ongoing), notes: Onset probably 10 years ago; "Kidney disease" (ongoing), notes: Onset date was probably a long time ago but she was just diagnosed like a year ago. The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Tetracycline allergy". The following information was reported: FATIGUE (non-serious) with onset 15Mar2021, outcome "recovering", described as "she was kind of tired so she went to bed"; FEELING COLD (non-serious) with onset 15Mar2021, outcome "recovering", described as "proceeded to get colder/she got cold"; CHILLS (non-serious) with onset 15Mar2021, outcome "recovering", described as "shiver"; HYPERHIDROSIS (non-serious) with onset 15Mar2021, outcome "recovering", described as "sweat"; MUSCLE SPASMS (non-serious) with onset 15Mar2021, outcome "recovering", described as "charley horses in her legs"; OROPHARYNGEAL PAIN (non-serious) with onset 16Mar2021, outcome "not recovered", described as "sore throat". Additional information: It was reported that patient received the first dose on 15Mar2021, around 14:00, at upper left shoulder. Patient did not received any other Pfizer vaccine on the same date of BNt162b2 administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that starting last night on 15Mar2021 at unknown time, patient was kind of tired so she went to bed. Sometime in the middle of the night at unknown time she got cold. She put on and extra blanket and proceeded to get colder and started to shiver and sweat which went on most of the night. She also had charley horses in her legs, all up and down her legs that went on all night long. Outcome: She was feeling better at this time, although a little shaky and she woke up with a terrible sore throat this morning (16Mar2021) which remains persistent at this time. Events did not result to emergency room and physician office visit. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: felt mushy; feeling tired; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt mushy"; FATIGUE (non-serious), outcome "unknown", described as "feeling tired"; HEADACHE (non-serious), outcome "unknown", described as "headache".  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-2021294001 Same reporter and drug; similar events and different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Nausea, Throat clearing
Clinical narrative: dizziness; nausea; tingling down left arm where she gother shot.; frequent throat clearing; vomiting (nausea); muscle aches (left arm); headaches; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: EN6205) at the age of 51 years as 2nd dose, single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose : 1ST DOSE, SINGLE DOSE), when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "dizziness"; NAUSEA (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "nausea"; VACCINATION SITE PARAESTHESIA (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "tingling down left arm where she gother shot."; THROAT CLEARING (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "frequent throat clearing"; VOMITING (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "vomiting (nausea)"; MYALGIA (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "muscle aches (left arm)"; HEADACHE (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "headaches". Therapeutic measures were taken as a result of dizziness, nausea, vaccination site paraesthesia, throat clearing, vomiting, myalgia, headache. Additional information: The patient was stable and responded good to the treatment provided and was discharged asking for follow up with general physician.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Age for Historical Vaccine added. Vaccination Facility Country added  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site paraesthesia, Vomiting
Clinical narrative: dizziness; nausea; tingling down left arm where she gother shot.; frequent throat clearing; vomiting (nausea); muscle aches (left arm); headaches; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: EN6205) at the age of 51 years as 2nd dose, single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose : 1ST DOSE, SINGLE DOSE), when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "dizziness"; NAUSEA (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "nausea"; VACCINATION SITE PARAESTHESIA (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "tingling down left arm where she gother shot."; THROAT CLEARING (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "frequent throat clearing"; VOMITING (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "vomiting (nausea)"; MYALGIA (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "muscle aches (left arm)"; HEADACHE (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "headaches". Therapeutic measures were taken as a result of dizziness, nausea, vaccination site paraesthesia, throat clearing, vomiting, myalgia, headache. Additional information: The patient was stable and responded good to the treatment provided and was discharged asking for follow up with general physician.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Age for Historical Vaccine added. Vaccination Facility Country added  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) "on an Tuesday" 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: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "had a sore arm". Therapeutic measures were taken as a result of pain in extremity. Additional information: Patient wanted to know if it was okay for to take a Tylenol after getting the vaccine. She has stopped her other pain medications but wanted to make sure of Tylenol. She mentioned that her arm was fine as of calling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ligament sprain, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: sprained ankle; Got really sick/ kind of a bad cold; 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 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 12Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Were outside playing also has asthma; "sprain ankle", start date: 2020 (not ongoing). The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 05Mar2021, outcome "recovered" (12Mar2021), described as "Got really sick/ kind of a bad cold"; LIGAMENT SPRAIN (non-serious) with onset 12Mar2021, outcome "unknown", described as "sprained ankle". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was had a family of around 4 children, wearing masks and social distancing - no other ones got sick. The patient was supposed to receive the 2nd dose of BNT162B2 on 05Mar2021 but could not go to the vaccine location as she was unable to drive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.