chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative:  76yo male Pt died on 11/20/2021 where he lived . No information given about pt's death. Hospital problem list: 13 Active Problems PROBLEM LAST MOD PROVIDER - Coronary artery disease  09/27/2018 (ICD-10-CM I25.10) Polyp colon (ICD-10-CM K63.5) 09/27/2018 HTN- Hypertension (ICD-10-CM 09/27/2018 I10.) Hyperlipidemia (ICD-10-CM E78.5) 09/27/2018 Obesity (ICD-10-CM E66.9) 09/27/2018 Sleep apnea (ICD-10-CM G47.30) 09/27/2018 GERD - Gastro-esophageal reflux disease  09/27/2018 (ICD-10-CM K21.9) Closed fracture of base of thumb 09/23/2015 (ICD-9-CM 815.01) Gout (ICD-10-CM M1A.00X0) 08/25/2020 (ICD-9-CM 788.41); Frequency of Urination 05/12/2009 (ICD-9-CM 788.41) (ICD-9-CM 715.90); Osteoarthritis * (ICD-9-CM 05/12/2009 715.90) Alcohol Dependence (ICD- 9-CM 303.90) 05/20/1997 Other specified diseases of the salivary glands 05/27/1997 (ICD-9-CM 527.8) Pt had received  only one covid vaccine at hospital on 4/5/2021. Unable to assess if this death is related to the covid vaccine, likely is not given pt's age and long time frame between date of covid vaccine administration and date of death.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative: 70yo male patient died while on vacation on 1/12/2022. No  information given about cause of pt's death. Pt had received covid vaccines from  pharmacy on 1/23/21, 2/13/21, & 8/19/21. Likely pt's death is not related  to covid vaccines given pt's advanced age, comorbidies, and long length of time  between death & date of vaccine administrations. Past Medical History:  Hyperkalemia RA - Rheumatoid Arthritis   Allergic rhinitis Chronic kidney disease stage 2 Complaining of erectile dysfunction Benign hypertension  Hyperlipidemia Overactive bladder Benign prostatic hypertrophy without outGastroesophageal reflux  disease Anemia  Bilateral carotid artery  stenosis  Thoracic aortic aneurysm without  ruptureChronic low back pain
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiac arrest, Death, Inappropriate schedule of product administration, Pneumonia
Clinical narrative: Narrative:  85 yo mail patient died on 1/12/2022 during inpatient admission. Death was caused by: Cardiac arrest secondary to acute hypoxic respiratory failure secondary to pneumonia (covid negative). Pt had received covid vaccines on 2/23/2021 & 12/23/2021. This death is not related to covid vaccines. Pt's Medical Hx: HTN, T2DM, CAD s/p PCI, obesity, TIA.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Narrative:  85 yo mail patient died on 1/12/2022 during inpatient admission. Death was caused by: Cardiac arrest secondary to acute hypoxic respiratory failure secondary to pneumonia (covid negative). Pt had received covid vaccines on 2/23/2021 & 12/23/2021. This death is not related to covid vaccines. Pt's Medical Hx: HTN, T2DM, CAD s/p PCI, obesity, TIA.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Neoplasm malignant
Clinical narrative: Narrative:  79yo male patient died on 1/8/2021 from stage 4 cancer in hospice care. Pt received covid vaccines on 1/29/2021 & 2/26/2021. This death is not related to covid vaccines.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Neoplasm malignant, Oesophageal adenocarcinoma
Clinical narrative: Narrative:  82yo male patient died on 01/10/22 from distal esophageal adenocarcinoma (cancer). Pt had received covid vaccines on 1/22/21, 2/24/21, & 9/7/21. This death is not related to the covid vaccines.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Death, End stage renal disease, Haemodialysis, Inappropriate schedule of product administration
Clinical narrative: Narrative:  91yo male Pt died on 11/30/2021. Death caused from End- Stage Renal Disease (Hemodialysis). Pt received covid vaccines on  6/15/2021 & 5/13/2021. This death is not related to covid vaccines.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Patient completed Pfizer COVID-19 vaccination series in Feb 2021. Had a persistent cough for 6 weeks before presenting to hospital and tested positive for COVID-19. Admitted and treated with oxygen, dexamethasone, and remdesivir. Discharged home 8/21/21. History significant for multiple myeloma and taking lenalidomide 21 days on, 7 days off May 2020 to present previously with dexamethasone which was stopped April 2021.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Patient tested positive for COVID-19 while hospitalized despite full vaccination. Pt received 2 doses of Moderna, along with a booster on 12/13/2021. Pt was hospitalized on 1/6/2022 but was positive for COVID-19 on 1/15/2022 during hospitalization.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative:  88 year-old patient with multiple comorbidities expired under care of hospice service after receiving COVID vaccine
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: Narrative: COVID infection following COVID vaccine series 03/09, Pfizer, dose#1 04/01, Pfizer, dose#2 11/23, Pfizer, dose#3 12/27 COVID swab, result: detected 12/25 pt cc: chills, cough, fatigue, fever, myalgias, nausea, rhinorrhea, dyspnea sore throat exposure: unknown 1/1 clinically resolved
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Narrative: COVID infection following COVID vaccine series 03/09, Pfizer, dose#1 04/01, Pfizer, dose#2 11/23, Pfizer, dose#3 12/27 COVID swab, result: detected 12/25 pt cc: chills, cough, fatigue, fever, myalgias, nausea, rhinorrhea, dyspnea sore throat exposure: unknown 1/1 clinically resolved
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Narrative: COVID infection following COVID vaccine series 03/09, Pfizer, dose#1 04/01, Pfizer, dose#2 11/23, Pfizer, dose#3 12/27 COVID swab, result: detected 12/25 pt cc: chills, cough, fatigue, fever, myalgias, nausea, rhinorrhea, dyspnea sore throat exposure: unknown 1/1 clinically resolved
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: NO SIDE EFFECTS OR ADVERSE REACTION AFTER EACH DOSE OF COVID VACCINE
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Musculoskeletal pain, Pain
Clinical narrative: Within a week after receiving the J&J vaccine, my rt thigh, rt buttock began to burn and ache (with no physical injury or other trauma sustained). A few days later my lower back started aching making it painful to rise from a seated position. These symptoms have not subsided after 6 months and are debillating Help.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: NO SIDE EFFECTS OR ADVERSE REACTION AFTER EACH DOSE OF COVID VACCINE
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: NO NEGATIVE OUTCOME OBSERVED AFTER RECEIVING COVID VACCINE
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Cardiac monitoring normal, Chills, Echocardiogram normal, Fatigue
Clinical narrative: Extreme Fatique 20 minutes after injection of Pfizer 3rd Covid booser vaccine  Very ill for 3 days after booster shot consisting of fatique and chills After being sick for 3 days, I developed a rapid heart rate. Saw a Cardiologist on 1/12/22. EKG was Normal Started wearable heart monitor for 7 days: 1/14/22-1/20/22 Echocardiogram on 1/25/22. Results were normal.   Please Note: I was also sick for 2 days after I received the 2nd Pfizer booster shot on 4/5/21 in my right arm (Pfizer 7/21 ER8735). I believe I developed ongoing arthritis in my hands after the 1st Pfizer shot in  my right arm on 3/15/21 (Pfizer 7/21 EP7534).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise
Clinical narrative: Extreme Fatique 20 minutes after injection of Pfizer 3rd Covid booser vaccine  Very ill for 3 days after booster shot consisting of fatique and chills After being sick for 3 days, I developed a rapid heart rate. Saw a Cardiologist on 1/12/22. EKG was Normal Started wearable heart monitor for 7 days: 1/14/22-1/20/22 Echocardiogram on 1/25/22. Results were normal.   Please Note: I was also sick for 2 days after I received the 2nd Pfizer booster shot on 4/5/21 in my right arm (Pfizer 7/21 ER8735). I believe I developed ongoing arthritis in my hands after the 1st Pfizer shot in  my right arm on 3/15/21 (Pfizer 7/21 EP7534).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: NO NEGATIVE OUTCOME AFTER RECEIVING COVID VACCINE. RESIDENT DIED IN HOUSE AS COMFORT MEASURES PRIOR TO COVID POSITIVE TEST RESULT
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: NO NEGATIVE OUTCOME AFTER RECEIVING VACCINE RESIDENT DIED IN HOUSE UNDER HOSPICE CARE SERVICES
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: NO NEGATIVE OUTCOME AFTER RESIDENT RECEIVED 2 DOSES OF COVID VACCINE
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hepatitis B vaccine administered on 26-AUG-2000 and 21-SEP-2000; This spontaneous report has been received from a lawyer via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS #2105USA001456), concerning a 47-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications was reported.  The patient was vaccinated with 3 doses of Hepatitis B Vaccine (Recombinant)(manufacturer unknown) on 26-AUG-2000, 21-SEP-2000, and 26-FEB-2001)(doses, anatomical locations, routes of administration, lot numbers and expiration dates were not provided) at a clinic for prophylaxis (inappropriate schedule of product administration).  This is one of three reports concerning the same patient.; Sender's Comments:  US-009507513-2105USA001456: US-009507513-2201USA002908:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fear, Hypoaesthesia oral, Skin abrasion
Clinical narrative: Her face and left side cheek from cheek bone down to her jaw bone turned blotchy red; in the left corner of her lip, she had a little bit of numbness; Very fearful; chaffing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2021 08:30 (Lot number: EL3247) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2011 (not ongoing), notes: she has been cleared from this condition going on 10 years.; "memory" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; DONEPEZIL taken for memory impairment. The following information was reported: ERYTHEMA (non-serious) with onset 20Jan2021 16:00, outcome "recovered" (Jan2021), described as "Her face and left side cheek from cheek bone down to her jaw bone turned blotchy red"; SKIN ABRASION (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "chaffing"; HYPOAESTHESIA ORAL (non-serious) with onset 20Jan2021 16:00, outcome "recovered" (Jan2021), described as "in the left corner of her lip, she had a little bit of numbness"; FEAR (non-serious) with onset Jan2021, outcome "unknown", described as "Very fearful".  Additional information: Reporter is a consumer calling on behalf of his wife inquiring about receiving the booster for the Pfizer Covid-19 vaccine after she had a reaction to the first dose. They couldn't get the second shot because at that time with the vaccine being new the CDC said don't take it. He went back about a month later beyond the date of a month spoke to hospital, they said they couldn't give her the vaccine because it was beyond the month at that time and also they advised not to take the shots over again. He read about the booster shot, he trying to increase my wife's motility against this virus since she didn't take the second shot, he asked if there was any record about bypassing the second shot and getting the booster shot. They bypassed the second shot because of the reaction he described and the setback she had it took about 7 days to reduce itself to where she felt normal. Patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine prior Vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Headache, Investigation, Magnetic resonance imaging, Migraine
Clinical narrative: Headaches and migraines; tension pressure headache; Headaches and migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 04Feb2021 (Lot number: EM9809) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "occasional headache" (unspecified if ongoing). Concomitant medication(s) included: MIRENA. The following information was reported: TENSION HEADACHE (non-serious) with onset Feb2021, described as "tension pressure headache"; MIGRAINE (non-serious) with onset Feb2021, HEADACHE (non-serious) with onset 04Feb2021 and all described as "Headaches and migraines". The event "headaches and migraines" and "headaches and migraines" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, headache.  Additional information: The patient reported she got the vaccine on 04Feb2021 and about an hour after that she had a dull headache and then that progressed for the next several days and then and till now 6 weeks later she was experiencing these headaches with migraine. So, she got tension pressure headache that flares up into migraine. The patient reports that she has been experiencing headaches and migraines almost daily since receiving the vaccine. She did not have a history of headache prior to receiving the vaccine, nothing just the occasional headache. She wants to report her symptoms and know if anyone else has experienced headaches lasting approximately 7 weeks since vaccination. Concomitant Products Mirena IUD (intrauterine device). The patient received Advil, Tylenol, Methylprednisolone, Ephedrine as treatment for the events.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Tension headache
Clinical narrative: Headaches and migraines; tension pressure headache; Headaches and migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 04Feb2021 (Lot number: EM9809) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "occasional headache" (unspecified if ongoing). Concomitant medication(s) included: MIRENA. The following information was reported: TENSION HEADACHE (non-serious) with onset Feb2021, described as "tension pressure headache"; MIGRAINE (non-serious) with onset Feb2021, HEADACHE (non-serious) with onset 04Feb2021 and all described as "Headaches and migraines". The event "headaches and migraines" and "headaches and migraines" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, headache.  Additional information: The patient reported she got the vaccine on 04Feb2021 and about an hour after that she had a dull headache and then that progressed for the next several days and then and till now 6 weeks later she was experiencing these headaches with migraine. So, she got tension pressure headache that flares up into migraine. The patient reports that she has been experiencing headaches and migraines almost daily since receiving the vaccine. She did not have a history of headache prior to receiving the vaccine, nothing just the occasional headache. She wants to report her symptoms and know if anyone else has experienced headaches lasting approximately 7 weeks since vaccination. Concomitant Products Mirena IUD (intrauterine device). The patient received Advil, Tylenol, Methylprednisolone, Ephedrine as treatment for the events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Adenosine deaminase, Adenosine deaminase increased, Dizziness, Feeling abnormal, Myalgia
Clinical narrative: woke up with excruciating muscle pain; woke up with dizziness/ so dizzy, couldn't even get out of bed/ couldn't move, still felt like walking on rocks; brain fog; SED and ADA levels were elevated; SED and ADA levels were elevated; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 13Feb2021 (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, SINGLE), administration date: Jan2021, for COVID-19 immunisation, reaction(s): "no adverse reaction". The following information was reported: MYALGIA (non-serious) with onset Feb2021, outcome "not recovered", described as "woke up with excruciating muscle pain"; DIZZINESS (non-serious) with onset Feb2021, outcome "not recovered", described as "woke up with dizziness/ so dizzy, couldn't even get out of bed/ couldn't move, still felt like walking on rocks"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "brain fog"; RED BLOOD CELL SEDIMENTATION RATE INCREASED (non-serious), ADENOSINE DEAMINASE INCREASED (non-serious) all with onset 2021, outcome "unknown" and all described as "SED and ADA levels were elevated". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, dizziness, feeling abnormal. Additional information: The patient took diphenhydramine (BENADRYL) prior to receiving the second dose per physician's recommendation. Onset latency of events myalgia and dizziness was 6 hours, and still has the events for 4 and a half week already (as reported). The patient received prednisone (7-day period) and had bedrest for 6 days as treatment for the events myalgia, dizziness, and feeling abnormal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Red blood cell sedimentation rate increased
Clinical narrative: woke up with excruciating muscle pain; woke up with dizziness/ so dizzy, couldn't even get out of bed/ couldn't move, still felt like walking on rocks; brain fog; SED and ADA levels were elevated; SED and ADA levels were elevated; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 13Feb2021 (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, SINGLE), administration date: Jan2021, for COVID-19 immunisation, reaction(s): "no adverse reaction". The following information was reported: MYALGIA (non-serious) with onset Feb2021, outcome "not recovered", described as "woke up with excruciating muscle pain"; DIZZINESS (non-serious) with onset Feb2021, outcome "not recovered", described as "woke up with dizziness/ so dizzy, couldn't even get out of bed/ couldn't move, still felt like walking on rocks"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "brain fog"; RED BLOOD CELL SEDIMENTATION RATE INCREASED (non-serious), ADENOSINE DEAMINASE INCREASED (non-serious) all with onset 2021, outcome "unknown" and all described as "SED and ADA levels were elevated". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, dizziness, feeling abnormal. Additional information: The patient took diphenhydramine (BENADRYL) prior to receiving the second dose per physician's recommendation. Onset latency of events myalgia and dizziness was 6 hours, and still has the events for 4 and a half week already (as reported). The patient received prednisone (7-day period) and had bedrest for 6 days as treatment for the events myalgia, dizziness, and feeling abnormal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Caller is consumer who reports having had seizures after her second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 04Mar2021 (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: Comirnaty (Dose: 1), for COVID-19 immunization. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Caller is consumer who reports having had seizures after her second dose". Caller was asking about the ingredients in the vaccine, as she was trying to figure out what she reacted to.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Fatigue, Pain
Clinical narrative: Dizziness; Fatigue; Stomach cramps; Diarrhea; Body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 12:45 (Batch/Lot number: unknown) at the age of 61 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Hashimotos disease" (unspecified if ongoing); "Graves disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DIZZINESS (non-serious) with onset 16Mar2021 23:45, outcome "not recovered", described as "Dizziness"; FATIGUE (non-serious) with onset 16Mar2021 23:45, outcome "not recovered", described as "Fatigue"; ABDOMINAL PAIN UPPER (non-serious) with onset 16Mar2021 23:45, outcome "not recovered", described as "Stomach cramps"; DIARRHOEA (non-serious) with onset 16Mar2021 23:45, outcome "not recovered", described as "Diarrhea"; PAIN (non-serious) with onset 16Mar2021 23:45, outcome "not recovered", described as "Body aches". The events "dizziness", "fatigue", "stomach cramps", "diarrhea" and "body aches" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of dizziness, fatigue, abdominal pain upper, diarrhoea, pain. Additional information: The patient did not have any allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the 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 is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: severe case of tinnitus; partial hearing loss; 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 67 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, single), for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "severe case of tinnitus"; HYPOACUSIS (non-serious), outcome "unknown", described as "partial hearing loss".  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, Feeling abnormal, Hot flush, Influenza like illness, Malaise
Clinical narrative: feeling like she has the flu without fever; she is wrecked; fatigued; not doing well / feels unwell; hot flashing; 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), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "feeling like she has the flu without fever"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she is wrecked"; FATIGUE (non-serious), outcome "unknown", described as "fatigued"; MALAISE (non-serious), outcome "unknown", described as "not doing well / feels unwell"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flashing".  The patient's age was reported as 49, no unit provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: dizziness and real lightheaded / doctor told him he developed vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021344907 (Pfizer).  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 12:00 (Lot number: EN6199, Expiration Date: 30Jun2021) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: HYDROXYCHLOROQUINE. The following information was reported: VERTIGO (non-serious) with onset 09Mar2021 13:30, outcome "not recovered", described as "dizziness and real lightheaded / doctor told him he developed vertigo". The event "dizziness and real lightheaded / doctor told him he developed vertigo" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. An hour and a half after the vaccination, he developed severe dizziness and real lightheaded. Everything started to spin, it has been going on almost a month (has not stopped since then). He went to his primary care doctor and the doctor told him he developed vertigo. He was prescribed meclizine 25mg- take 1 tablet by mouth daily for 30 days, and FLONASE. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Increased volume with his tinnitus; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 69 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 27Jan2021 18:55 (Lot number: EL9261) at the age of 69 years as dose 1, single for covid-19 immunisation. Patient medical history was not provided. Concomitant medications included chondroitin sulfate sodium, glucosamine sulfate potassium chloride, methylsulfonylmethane (GLUCOSAMINE & CHONDROITIN & MSM) and acetylcysteine (NAC). On 28Jan2021 08:00 patient reported with Increased volume with his tinnitus. The patient did not receive any treatment for the event. Outcome of event was not recovered. The patient received the second dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot no: EL9267) via intramuscular in the left arm on 17Feb2021  Follow-up (07May2021): Follow-up attempts completed. No further information expected.  Follow-up (30Mar2021): This is a follow-up spontaneous report from a contactable consumer (patient) reported in response to consumer letter sent. Updated information: age at the time of vaccination, vaccination details (date, route of administration, dose, lot number and anatomical location) and clinical course.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Inappropriate schedule of product administration, Vertigo, Vomiting
Clinical narrative: head spinning/extreme vertigo; Any attempt to sit or stand resulted in extreme dizziness, head spinning and vomiting; Any attempt to sit or stand resulted in extreme dizziness, head spinning and vomiting; product COVID 19, administration dated 17Mar2021, dose number 2; product COVID 19, administration dated 03Mar2021,  dose number 1.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 16:00 (Lot number: EP7534) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE 10; DOXAZOSIN. Vaccination history included: Bnt162b2 (Lot number=EN6205, Administration date=03Mar2021, Administration time=16:00, Vaccine location=Left arm, Dose number=1), administration date: 03Mar2021, when the patient was 64 years old, for COVID-19 immunisation. The following information was reported: VERTIGO (non-serious) with onset 18Mar2021 08:00, outcome "not recovered", described as "head spinning/extreme vertigo"; DIZZINESS (non-serious), VOMITING (non-serious) all with onset 18Mar2021 08:00, outcome "not recovered" and all described as "Any attempt to sit or stand resulted in extreme dizziness, head spinning and vomiting"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Mar2021 16:00, outcome "unknown", described as "product COVID 19, administration dated 17Mar2021, dose number 2; product COVID 19, administration dated 03Mar2021, dose number 1.". Therapeutic measures were not taken as a result of vertigo, dizziness, vomiting.  Additional information: approx 16 hours after 2nd dose, patient experienced extreme vertigo. Any attempt to sit or stand resulted in extreme dizziness, head spinning and vomiting. 3 weeks later, still experiencing pretty extreme vertigo multiple times daily. Patient had no other vaccine in four weeks. Patient had no covid or tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Hypopnoea, Nausea, Panic attack
Clinical narrative: Very tearful and anxious; Very tearful and anxious; Nauseous; Lightheadedness; panic attack; Shallow breathing; 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 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: ER2613) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Panic attacks" (unspecified if ongoing), notes: She had panic attacks before, maybe 5 in her whole life. The patient's concomitant medications were not reported. The following information was reported: PANIC ATTACK (non-serious) with onset 24Mar2021, outcome "not recovered", described as "panic attack"; TEARFULNESS (non-serious), ANXIETY (non-serious), outcome "unknown" and all described as "Very tearful and anxious"; NAUSEA (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Nauseous"; DIZZINESS (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Lightheadedness"; HYPOPNOEA (non-serious) with onset 23Mar2021, outcome "not recovered", described as "Shallow breathing".  Additional information: Caller asking that I have been experiencing panic attack since getting my first dose and I am having one since 11 today and it is still happening. What should I do about second vaccine? Caller states had first dose of Pfizer vaccine at 9:30 this morning, has had two panic attacks and then a third one that has not gone away. States she has had panic attacks before, maybe 5 in her whole life, states last one was about 8 months ago, states they usually last for a few minutes and then petered out. Caller states she was not anxious about the vaccine at all before she got it. The facility where the most recent COVID-19 vaccine was administered is Health Department. The patient did not receive any additional Vaccines on same Date of the Pfizer Suspect vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tearfulness
Clinical narrative: Very tearful and anxious; Very tearful and anxious; Nauseous; Lightheadedness; panic attack; Shallow breathing; 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 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: ER2613) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Panic attacks" (unspecified if ongoing), notes: She had panic attacks before, maybe 5 in her whole life. The patient's concomitant medications were not reported. The following information was reported: PANIC ATTACK (non-serious) with onset 24Mar2021, outcome "not recovered", described as "panic attack"; TEARFULNESS (non-serious), ANXIETY (non-serious), outcome "unknown" and all described as "Very tearful and anxious"; NAUSEA (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Nauseous"; DIZZINESS (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Lightheadedness"; HYPOPNOEA (non-serious) with onset 23Mar2021, outcome "not recovered", described as "Shallow breathing".  Additional information: Caller asking that I have been experiencing panic attack since getting my first dose and I am having one since 11 today and it is still happening. What should I do about second vaccine? Caller states had first dose of Pfizer vaccine at 9:30 this morning, has had two panic attacks and then a third one that has not gone away. States she has had panic attacks before, maybe 5 in her whole life, states last one was about 8 months ago, states they usually last for a few minutes and then petered out. Caller states she was not anxious about the vaccine at all before she got it. The facility where the most recent COVID-19 vaccine was administered is Health Department. The patient did not receive any additional Vaccines on same Date of the Pfizer Suspect vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: Knot on top of my head/brain, like a little ball; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 08Mar2021 (Lot number: EN6205, Expiration Date: Jun2021) at the age of 72 years as 1st dose, 0.3 ml single dose for covid-19 immunisation. Relevant medical history included: "Parkinson's disease" (unspecified if ongoing), notes: Diagnosed in 2012-2013.; "Prostate Cancer" (not ongoing), notes: Cancer, at the bottom, where you pee. Diagnosed in 2012-2013; "Prostate Cancer. Caller stated he has had surgery to remove" (unspecified if ongoing), notes: Prostate Cancer. Caller stated he has had surgery to remove. There were no concomitant medications. The following information was reported: SKIN MASS (non-serious) with onset Mar2021, outcome "recovered", described as "Knot on top of my head/brain, like a little ball". Therapeutic measures were not taken as a result of skin mass. Additional Information: The patient has not taken any other products. The patient received his first Pfizer COVID Vaccine on 08Mar2021. He said it went fine. A week later he developed a knot on the top of his head/brain like a little ball. The knot developed then went away. The knot came back and went away again. Two times he developed the knot. The patient wanted to know if he should get a CT scan of his brain. He was worried because he is scheduled to have his second vaccine on Monday 29Mar2021 and didn't know if he should postpone it. The patient was not sure if he will get the second vaccine on Monday. He was going to call the hospital Monday morning. The patient was retired. The vaccination time was between 10:00AM - 11:00AM. There were no additional vaccines administered on same date of the COVID-19 Vaccine. The adverse events did not require emergency room nor physician office visit. The patient did not receive any other vaccinations within four weeks prior to the COVID-19 Vaccine. The patient has no family medical history relevant to the adverse events and has no relevant tests done.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Head titubation, Palpitations, Paraesthesia, Tremor
Clinical narrative: Tingling of extremities; Internal tremors; Brain tremors; Heart palpitation; Feeling of constriction in the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 14:30 (Lot number: EA7534) at the age of 57 years as dose, 1 single for covid-19 immunisation. Relevant medical history included: "Thyroid condition," (unspecified if ongoing), notes: other medical history: Thyroid condition, HSV2; "HSV2" (unspecified if ongoing), notes: other medical history: Thyroid condition, HSV2. Concomitant medication(s) included: LEVOTHYROXINE; VALTREX.  The following information was reported: PARAESTHESIA (non-serious) with onset 04Apr2021 07:00, outcome "not recovered", described as "Tingling of extremities"; TREMOR (non-serious) with onset 04Apr2021 07:00, outcome "not recovered", described as "Internal tremors"; HEAD TITUBATION (non-serious) with onset 04Apr2021 07:00, outcome "not recovered", described as "Brain tremors"; PALPITATIONS (non-serious) with onset 04Apr2021 07:00, outcome "not recovered", described as "Heart palpitation"; CHEST DISCOMFORT (non-serious) with onset 04Apr2021 07:00, outcome "not recovered", described as "Feeling of constriction in the body". The events "tingling of extremities", "internal tremors", "brain tremors", "heart palpitation" and "feeling of constriction in the body" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of paraesthesia, tremor, head titubation, palpitations, chest discomfort.  Additional Information: No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. No known allergies. Facility where the most recent COVID-19 vaccine was administered: Hospital.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test abnormal, C-reactive protein increased, Fibrin D dimer increased, Injection site swelling
Clinical narrative: 8/8/21 - received covid shot in left arm 8/9/21 - woke up that morning w/ left neck pain, left shoulder pain, and left arm pain; left upper arm swelling present 8/10/21 - symptoms remain the same as previous day; felt a small to medium size knot in the left side of neck and clavicle 8/11/21 - symptoms continued; office visit w/ pcp - ordered a stat left upper extremity ultrasound and blood work; diagnosed w/ acute SVT, positive D-dimer, and positive CRP 8/12/21 - symptoms continued. taking aspirin 325 mg TID and applying warm compress to blood clot throughout the day, appointment scheduled w/ vascular surgeon on 8/24/21
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Neck mass, Neck pain, Pain in extremity, Superficial vein thrombosis, Thrombosis
Clinical narrative: 8/8/21 - received covid shot in left arm 8/9/21 - woke up that morning w/ left neck pain, left shoulder pain, and left arm pain; left upper arm swelling present 8/10/21 - symptoms remain the same as previous day; felt a small to medium size knot in the left side of neck and clavicle 8/11/21 - symptoms continued; office visit w/ pcp - ordered a stat left upper extremity ultrasound and blood work; diagnosed w/ acute SVT, positive D-dimer, and positive CRP 8/12/21 - symptoms continued. taking aspirin 325 mg TID and applying warm compress to blood clot throughout the day, appointment scheduled w/ vascular surgeon on 8/24/21
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal, Vascular operation
Clinical narrative: 8/8/21 - received covid shot in left arm 8/9/21 - woke up that morning w/ left neck pain, left shoulder pain, and left arm pain; left upper arm swelling present 8/10/21 - symptoms remain the same as previous day; felt a small to medium size knot in the left side of neck and clavicle 8/11/21 - symptoms continued; office visit w/ pcp - ordered a stat left upper extremity ultrasound and blood work; diagnosed w/ acute SVT, positive D-dimer, and positive CRP 8/12/21 - symptoms continued. taking aspirin 325 mg TID and applying warm compress to blood clot throughout the day, appointment scheduled w/ vascular surgeon on 8/24/21
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dysphagia, Dyspnoea, Loss of consciousness, Oropharyngeal discomfort
Clinical narrative: started convulsing; passed out; throat felt funny; condition was worsening; hard to swallow; breathing was becoming more difficult; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 16:45 (Lot number: FD8448) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. There were no concomitant medications. No other Vaccine in four weeks. No Other medications in two weeks. The following information was reported: SEIZURE (medically significant, life threatening) with onset 23Aug2021 16:45, outcome "recovered", described as "started convulsing"; LOSS OF CONSCIOUSNESS (medically significant, life threatening) with onset 23Aug2021 16:45, outcome "recovered", described as "passed out"; OROPHARYNGEAL DISCOMFORT (life threatening) with onset 23Aug2021 16:45, outcome "recovered", described as "throat felt funny"; CONDITION AGGRAVATED (life threatening) with onset 23Aug2021 16:45, outcome "recovered", described as "condition was worsening"; DYSPHAGIA (life threatening) with onset 23Aug2021 16:45, outcome "recovered", described as "hard to swallow"; DYSPNOEA (life threatening) with onset 23Aug2021 16:45, outcome "recovered", described as "breathing was becoming more difficult". The events "started convulsing", "passed out", "throat felt funny", "condition was worsening", "hard to swallow" and "breathing was becoming more difficult" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of seizure, loss of consciousness, oropharyngeal discomfort, condition aggravated, dysphagia, dyspnea. Clinical course: Immediately after receiving the shot the patient started convulsing and then passed out. The patient CMA to and waited until the color was back in his face and was able to stand. After 15 minutes we were told we could leave. The patient returned to his home, which is 2 miles from the pharmacy. The patient then alerted his mother that his throat felt funny. His mother called the pharmacy and they instructed him to watch for increased heartrate and labored breathing and go to the ER if this happens. The patient stated the condition was worsening and it was hard to swallow and breathing was becoming more difficult. # was called and the the patient then went to a neighbor's house who is a nurse and has epinephrine. He was administered an injection and immediately able to breathe. The ambulance arrived, took his vitals and then transported him to Hospital in (City and state name). AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event. Treatment included Patient was taken to ER at Hospital. No covid prior vaccination. No covid tested post vaccination.