chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Fatigue, Headache, Product use issue, Pyrexia
Clinical narrative: Fever - 100.5; Headache; Tiredness; Other vaccine same date, vaccine date 14Mar2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Mar2022 16:00 (Lot number: fl8095) at the age of 5 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 14Mar2022 (Batch/Lot number: unknown) as dose number unkown, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 14Mar2022, outcome "unknown", described as "Other vaccine same date, vaccine date 14Mar2022"; PYREXIA (non-serious) with onset 15Mar2022 12:00, outcome "recovering", described as "Fever - 100.5"; HEADACHE (non-serious) with onset 15Mar2022 12:00, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 15Mar2022 12:00, outcome "recovering", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, fatigue.  Additional Information: Covid test post vaccination was done nasal swab and results were negative. No known allergies and other medical history reported.  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: Fever - 100.5; Headache; Tiredness; Other vaccine same date, vaccine date 14Mar2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Mar2022 16:00 (Lot number: fl8095) at the age of 5 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 14Mar2022 (Batch/Lot number: unknown) as dose number unkown, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 14Mar2022, outcome "unknown", described as "Other vaccine same date, vaccine date 14Mar2022"; PYREXIA (non-serious) with onset 15Mar2022 12:00, outcome "recovering", described as "Fever - 100.5"; HEADACHE (non-serious) with onset 15Mar2022 12:00, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 15Mar2022 12:00, outcome "recovering", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, fatigue.  Additional Information: Covid test post vaccination was done nasal swab and results were negative. No known allergies and other medical history reported.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: still experiencing daily swelling in my fingers (no pain) with diminished swelling from last year; 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 male patient received bnt162b2 (BNT162B2), administration date 02Nov2021 (Lot number: FF2593) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "Fluid retention"; Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "High blood pressure". The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "still experiencing daily swelling in my fingers (no pain) with diminished swelling from last year".  Additional information: It was reported that the cause of the fluid retention in the patient's fingers (both hands) was not caused by the Pfizer Covid Vaccine (BNT162B2). The patient received the Pfizer Covid vaccine booster shot (FF2593) on 02Nov2021 without incident. It was reported that the cause of the fluid retention in fingers (both hands) appeared to be due to a paint remover. The patient was able to determine that the finger/hand issues began prior to receiving the first dose of the Pfizer Covid vaccine and while he was using the paint remover. Over time, the fluid retention (edema) spread to the hands/arms/shoulders and eventually resulted in an emergency room visit due to high blood pressure on 01Aug2021. The patient never had issue with blood pressure, and it had returned to normal levels without medication. The patient was still experiencing daily swelling in his fingers (no pain) with diminished swelling from last year. The patient was unsure if Pfizer Covid vaccine had any interaction effects with the paint remover's ingredients or known exposure symptoms to aggravate the situation.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Myalgias; Sore arm; This is a spontaneous report received from contactable reporter(s) (Physician).  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Lot number: EL3247) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "HTN" (ongoing); "DMZ" (ongoing); "BPH" (ongoing); "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: ALFUZOSIN [ALFUZOSIN HYDROCHLORIDE] taken for benign prostatic hyperplasia (ongoing); LISINOPRIL taken for blood pressure abnormal (ongoing); METFORMIN XR taken for diabetes mellitus (ongoing). The following information was reported: MYALGIA (non-serious), outcome "recovered", described as "Myalgias"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of myalgia, pain in extremity.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received the 2nd dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunization. The patient had pain in extremity (sore arm), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Eye inflammation, Retinal artery occlusion, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient. A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Nov2021 13:15 (Lot number: FJ1620) at the age of 48 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "PCOS" (Polycystic ovary - unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Covid-19 prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: RETINAL ARTERY OCCLUSION (disability, medically significant) with onset 10Dec2021 13:15, outcome "not recovered", described as "I had a retinal arterial partial occlusion"; EYE INFLAMMATION (disability, medically significant) with onset 10Dec2021 13:15, outcome "not recovered", described as "I have alot of inflammation in my right eye". The events "I had a retinal arterial partial occlusion" and "I have alot of inflammation in my right eye" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Nasal swab. Therapeutic measures were not taken as a result of retinal artery occlusion, eye inflammation. Follow up information has been requested. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the evens Retinal artery occlusion Eye inflammation and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP. A 44-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FL3209), at the age of 44, on Feb 24, 2022, single dose, for COVID-19 immunization. Concomitant medication included simvastatin 20 mg 1x/day for high cholesterol. Medical history included high cholesterol (ongoing). The patient had diarrhea (she has had diarrhea lately), onset Mar 16, 2022, with outcome of unknown. Additional information: Reporter stated her mother got the first dose of the Pfizer-BioNTech COVID-19 vaccine on Feb 24, 2022. She's scheduled to get the second dose on Mar 17, 2022. Her mother is currently using simvastatin and has had diarrhea lately. Reporter would like to know if her mother can get the second dose tomorrow. She was not sure if it was from the vaccine or from the new medication (simvastatin 20mg) the doctor gave her for high cholesterol, which she started a few days ago. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Fatigue, Feeling abnormal, Lymphadenopathy
Clinical narrative: extremely allergic to your drugs; Brain Fog; I have swollen lymph nodes still after 10 days; extreme exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), 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 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "extremely allergic to your drugs"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain Fog"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "I have swollen lymph nodes still after 10 days"; FATIGUE (non-serious), outcome "unknown", described as "extreme exhaustion".  Additional information: The patient stated that received booster shot and had swollen lymph nodes still after 10 days, brain Fog, extreme exhaustion. My doctor informed me I am extremely allergic to your drugs which literally poisoned me. So No More shots.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: Raynaud's Phenomenon; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Oct2021 (Lot number: FF2590) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation.   The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, start date: 21Oct2021, stop date: 21Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0158), administration date: 07Apr2021, when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172), administration date: 28Apr2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: RAYNAUD'S PHENOMENON (non-serious) with onset Jan2022, outcome "not recovered", described as "Raynaud's Phenomenon". Therapeutic measures were not taken as a result of raynaud's phenomenon.  Additional information: Other vaccine 4 weeks product was Influenza Vaccine, injection, quadrivalent. No covid prior vaccination. No covid tested post vaccination and no Known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Musculoskeletal stiffness, Pain
Clinical narrative: 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 77 year-old male patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 07Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 17Feb2021 (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: MUSCULOSKELETAL STIFFNESS (non-serious), PAIN (non-serious), MUSCLE TWITCHING (non-serious), outcome "unknown" and all described as "I received my 3 covid vaccine shots 1st 17Feb2021 2nd 07Mar2021 3rd 06Oct2021 and just this month started experiencing ALS symptoms(aching & stiffness in my legs - random body twitching at night)".  Additional information:I received my 3 covid vaccine shots 1st 17Feb2021 2nd 07Mar2021 3rd 06Oct2021 and just this month started experiencing ALS symptoms (aching & stiffness in my legs - random body twitching at night)   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia totalis, Stress
Clinical narrative: Alopecia totalis; Stress; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 51 year-old 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: ALOPECIA TOTALIS (non-serious), outcome "unknown", described as "My Pfizer Covid vaccination induced a case of Alopecia Totalis"; STRESS (non-serious), outcome "unknown", described as "This situation has already created 10 months of stress".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization; Bnt162b2 (Dose Number: 2), for COVID-19 immunization, reaction(s): "I had some of the side effects after the second shot that lasted 1-2 days". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information included: Patient was 65+ category and was reading about the possibility of a fourth covid shot. Patient had some of the side effects after the second shot that lasted 1-2 days. When patient got the booster shot, patient had almost all of the side effects and was sick for over a week. Her husband was so concerned he almost took her to the hospital. She would be interested in the fourth shot, but what was the chance the side effects would be worse than those she experienced with the third shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A female patient received unknown dose number of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced pain (body pain), with outcome of unknown. Additional information: Reporter mentioned she experienced light side effects of the Pfizer COVID-19 vaccine. She asked if it's okay to take Tylenol for her body pain. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Somnolence
Clinical narrative: sore arm; fever; wanted to sleep all the time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4557823.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) at the age of 63 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization.The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Dec2021, outcome "unknown", described as "sore arm"; PYREXIA (non-serious) with onset 14Dec2021, outcome "unknown", described as "fever"; SOMNOLENCE (non-serious) with onset 14Dec2021, outcome "unknown", described as "wanted to sleep all the time".  We have no further information regarding the reported event(s) described above. Any additional material information received will be forwarded to you in accordance. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: my smell and taste senses were completely altered and everything has the exact same chemical taste.; my smell and taste senses were completely altered and everything has the exact same chemical taste.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jan2022 13:00 (Lot number: FE3594) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FE3594, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 05Jan2022, for covid-19 immunisation.  The following information was reported: PAROSMIA (non-serious), TASTE DISORDER (non-serious) all with onset 02Feb2022 06:00, outcome "not recovered" and all described as "my smell and taste senses were completely altered, and everything has the exact same chemical taste.". Therapeutic measures were not taken as a result of parosmia, taste disorder.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient had not been tested for covid tested post vaccination. The patient had no known allergies. The patient had no other medical history. Adverse events start time: 06:00 AM. A few days after receiving my second dose of the Pfizer vaccine my smell and taste senses were completely altered and everything has the exact same chemical taste. It has now been about 50 days and I still do not have my smell or taste back; everything is still altered. Only thing that has changed is sweet stuff now has a artificial vanilla extract smell and taste, this change came about two weeks ago.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, C-reactive protein abnormal, Echocardiogram, Heart rate, Heart rate increased
Clinical narrative: Increased heart rate after booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 16:30 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing), notes: Diagnosed allergies; "Compromised immune status" (unspecified if ongoing), notes: Compromised immune status; "Respiratory illness" (unspecified if ongoing), notes: Respiratory illness; "Genetic/chromosomal abnormalities" (unspecified if ongoing), notes: Genetic/chromosomal abnormalities; "Endocrine abnormalities" (unspecified if ongoing), notes: Endocrine abnormalities; "Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Lot: EP6955, Expiration: Jun2021, Anatomical location: left arm), administration date: 27Mar2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "AFib"; Bnt162b2 (Dose: 02, Lot: ER8731, Expiration: Jul2021, Anatomical location: left arm, Time: 1615 about), administration date: 19Apr2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "AFib"; Flu shot, administration date: 01Nov2021, when the patient was 56 years old, for Immunization; Shingrix (Dose: 01, Manufacturer: Glaxo Smith Kline, Lot: t29Y2), administration date: 01Nov2021, when the patient was 56 years old, for Immunization; Shingrix (Dose:02, Lot: 54tf4, Manufacturer: Glaxo Smith Kline), administration date: 24Feb2022, for Immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "not recovered", described as "Increased heart rate after booster shot". The event "increased heart rate after booster shot" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course: She received booster shot and then that day or the next day, anything she drinks caused her heartrate to go up. When laying down her heartrate went up. She was put on medication and when medication did not work they doubled the medication.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker test
Clinical narrative: Increased heart rate after booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 16:30 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing), notes: Diagnosed allergies; "Compromised immune status" (unspecified if ongoing), notes: Compromised immune status; "Respiratory illness" (unspecified if ongoing), notes: Respiratory illness; "Genetic/chromosomal abnormalities" (unspecified if ongoing), notes: Genetic/chromosomal abnormalities; "Endocrine abnormalities" (unspecified if ongoing), notes: Endocrine abnormalities; "Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Lot: EP6955, Expiration: Jun2021, Anatomical location: left arm), administration date: 27Mar2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "AFib"; Bnt162b2 (Dose: 02, Lot: ER8731, Expiration: Jul2021, Anatomical location: left arm, Time: 1615 about), administration date: 19Apr2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "AFib"; Flu shot, administration date: 01Nov2021, when the patient was 56 years old, for Immunization; Shingrix (Dose: 01, Manufacturer: Glaxo Smith Kline, Lot: t29Y2), administration date: 01Nov2021, when the patient was 56 years old, for Immunization; Shingrix (Dose:02, Lot: 54tf4, Manufacturer: Glaxo Smith Kline), administration date: 24Feb2022, for Immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "not recovered", described as "Increased heart rate after booster shot". The event "increased heart rate after booster shot" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course: She received booster shot and then that day or the next day, anything she drinks caused her heartrate to go up. When laying down her heartrate went up. She was put on medication and when medication did not work they doubled the medication.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 78-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed alopecia (hair loss), with outcome of unknown. Additional information: Reportedly, patient thinks it started in October or the first of October. Patient continued to explain she is losing her hair and she can't figure it out. She takes Biotin which helps for hair. She and her daughter both received the COVID-19 vaccine and both are experiencing hair loss. The lot number for batch/lot number not provided and will be requested during follow up. Sender's comments: Linked report: US-PFIZER INC-202200427816 (same reporter/drug/event, different patient).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Hypoaesthesia, Inappropriate schedule of product administration, Limb discomfort
Clinical narrative: Dose Number 1/Date of start of drug: 16-MAR-2021/ Dose Number 2/Date of start of drug: 29-DEC-2021; symptoms of sharp pains and numbness in my head; symptoms of sharp pains and numbness in my head; right arm felt dead, listless; left hand tingling and legs are worse; left hand tingling and legs are worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 17:30 (Lot number: FD7218) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Arthritis" (unspecified if ongoing), notes: knees; "high cholesterol" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: From the mass behind my left optic nerve.; "Morbidly Obese" (unspecified if ongoing); "bulging discs in neck and back" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "allergy"; Ampicillin, reaction(s): "Allergy"; Chemicals, reaction(s): "Allergy", notes: Some perfumes,peanuts. Vaccination history included: Bnt162b2 (Dose Number: 1,(11:45 am), Batch/Lot No: EN6205, Location of injection: Arm left), administration date: 16Mar2021, when the patient was 58 years old, for COVID-19 immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Dec2021 17:30, outcome "unknown", described as "Dose Number 1/Date of start of drug: 16-MAR-2021/ Dose Number 2/Date of start of drug: 29-DEC-2021"; HEADACHE (non-serious), HYPOAESTHESIA (non-serious) all with onset 29Dec2021, outcome "unknown" and all described as "symptoms of sharp pains and numbness in my head"; LIMB DISCOMFORT (non-serious) with onset 29Dec2021, outcome "unknown", described as "right arm felt dead, listless"; PARAESTHESIA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 29Dec2021, outcome "unknown" and all described as "left hand tingling and legs are worse". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional Information:No other vaccines were received within 4 weeks prior to the COVID vaccine. Patient received some medications in two weeks. Prior to vaccination,patient was not diagnosed with COVID-19.After the vaccination, patient tested negative for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: Dose Number 1/Date of start of drug: 16-MAR-2021/ Dose Number 2/Date of start of drug: 29-DEC-2021; symptoms of sharp pains and numbness in my head; symptoms of sharp pains and numbness in my head; right arm felt dead, listless; left hand tingling and legs are worse; left hand tingling and legs are worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 17:30 (Lot number: FD7218) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Arthritis" (unspecified if ongoing), notes: knees; "high cholesterol" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: From the mass behind my left optic nerve.; "Morbidly Obese" (unspecified if ongoing); "bulging discs in neck and back" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "allergy"; Ampicillin, reaction(s): "Allergy"; Chemicals, reaction(s): "Allergy", notes: Some perfumes,peanuts. Vaccination history included: Bnt162b2 (Dose Number: 1,(11:45 am), Batch/Lot No: EN6205, Location of injection: Arm left), administration date: 16Mar2021, when the patient was 58 years old, for COVID-19 immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Dec2021 17:30, outcome "unknown", described as "Dose Number 1/Date of start of drug: 16-MAR-2021/ Dose Number 2/Date of start of drug: 29-DEC-2021"; HEADACHE (non-serious), HYPOAESTHESIA (non-serious) all with onset 29Dec2021, outcome "unknown" and all described as "symptoms of sharp pains and numbness in my head"; LIMB DISCOMFORT (non-serious) with onset 29Dec2021, outcome "unknown", described as "right arm felt dead, listless"; PARAESTHESIA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 29Dec2021, outcome "unknown" and all described as "left hand tingling and legs are worse". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional Information:No other vaccines were received within 4 weeks prior to the COVID vaccine. Patient received some medications in two weeks. Prior to vaccination,patient was not diagnosed with COVID-19.After the vaccination, patient tested negative for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: This is a spontaneous report received from a contactable pharmacist. A 50-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FK9895), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced joint swelling (ankle swelling), with outcome of unknown. Additional information: A 50-year-old male patient, received a dose of the Pfizer COVID-19 vaccine, gray cap vial (confirmed). 5 days after receiving the vaccine, patient had swelling in his ankles. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Herpes zoster, Pruritus
Clinical narrative: I received a diagnosis of very unpleasant SHINGLES; itching and moderate pain, in particular in my right breast; itching and moderate pain, in particular in my right breast; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 (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: HERPES ZOSTER (non-serious) with onset 16Feb2022, outcome "not recovered", described as "I received a diagnosis of very unpleasant SHINGLES "; PRURITUS (non-serious), BREAST PAIN (non-serious) all with onset 16Feb2022, outcome "not recovered" and all described as "itching and moderate pain, in particular in my right breast". The events "i received a diagnosis of very unpleasant shingles ", "itching and moderate pain, in particular in my right breast" and "itching and moderate pain, in particular in my right breast" were evaluated at the physician office visit. Therapeutic measures were taken as a result of herpes zoster, pruritus, breast pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient don't have known allergies. Ae treatment: 2 weeks Rx of 2 grams Valacyclovir and 2 weeks 3.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Lymphoedema
Clinical narrative: pain in left armpit down to the breast; pain in left armpit down to the breast; lymphedema; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Jan2022 14:30 (Lot number: GL3198) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: Latex allergy" (unspecified if ongoing), notes: Known allergy: Latex; "Known allergies: Adhesive tape allergy" (unspecified if ongoing), notes: Known allergy: Adhesive tape; "Known allergies: Diary" (unspecified if ongoing), notes: Known allergy: Diary; "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Imitrex, reaction(s): "Known allergies: Imitrex". The following information was reported: AXILLARY PAIN (non-serious), BREAST PAIN (non-serious) all with onset 03Jan2022, outcome "unknown" and all described as "pain in left armpit down to the breast"; LYMPHOEDEMA (non-serious) with onset 03Jan2022, outcome "unknown", described as "lymphedema". The events "pain in left armpit down to the breast", "pain in left armpit down to the breast" and "lymphedema" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of axillary pain, breast pain, lymphoedema.  Additional information included: It was reported that the next morning c/o pain in left armpit down to the breast. Saw provider at virtual urgent care 2 days later due to worsening painful mass in Left armpit. Dx with lymphedema recommended symptom management. As per patient she was informed to c/w vaccination series. Patient also received other vaccine in four weeks. Adverse events resulted in emergency department or physician office. Patient had COVID prior vaccination. Patient did not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: This is a spontaneous report received from noncontactable consumer or other non-HCP. Other case identifier: US-2022-0152142. A 70-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), in 2021, for immunization. The patient developed a skin disorder (skin condition started), with outcome of unknown. Additional information: The reporter stated patient had the Pfizer COVID vaccine in Feb and March of last year. Shortly after the second vaccine, patient started having a skin condition. The patient did not want to take anything else if her skin condition is improving. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8734), on Apr 6, 2021, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient experienced fatigue (he thought he was tired due to the vaccine), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 71-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in right arm, single dose, for COVID-19 immunization. The patient had no medical history. Concomitant medication included Vitamin C (ascorbic acid). The patient developed fatigue (tired) and pain (a lot aching), with outcome of unknown. No therapeutic measures taken as a result of fatigue and pain. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Hair injury
Clinical narrative: losing hair in large amounts; Hair was literally falling out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 16:45 (Lot number: FE3592) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]; RED YEAST RICE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9267, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 16Feb2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 26Jan2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: HAIR INJURY (non-serious) with onset 18Oct2021 05:00, outcome "recovering", described as "losing hair in large amounts"; ALOPECIA (non-serious) with onset 18Oct2021 05:00, outcome "recovering", described as "Hair was literally falling out". The events "losing hair in large amounts" and "hair was literally falling out" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hair injury, alopecia.  Additional information:   prior vaccination there is no covid, post vaccination there is no Covid test  A few weeks after 3rd dose I started losing hair in large amounts. Hair was literally falling out. At my physical in Nov. I voiced the concern to my doctor. He checked my thyroid & all test results were fine. Went to dermatologist in early December. She had me start Viviscal daily hair supplements and Viviscal shampoo/conditioner. I started drinking protein drinks and was using the above even till now. My hair seems to be slowing down on falling out and I have seen new growth on the top of my head. I never had covid and can't see any other reason why this happened.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: his legs still bother him every once in a while; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 6 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: LIMB DISCOMFORT (non-serious), outcome "not recovered", described as "his legs still bother him every once in a while".  Additional information: The only thing the reporter would like to add to the previously filed safety report is that the patient is much better and his legs still bother him every once in a while.   The lot number for bnt162b2 was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Confusional state, Diplopia, Eye disorder, Impaired driving ability
Clinical narrative: This is a spontaneous report received from a contactable  consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the (3rd booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# 30155BA), on Sep 27, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), single dose, for COVID-19 immunization. The  patient experienced diplopia, visual impairment, reduced visual acuity, all with onset Sep 2021, with outcome of unknown. In summary: After receiving the booster vaccine, patient experienced an adverse event or adverse reaction of having double vision, vision problem/eye problem ("deteriorated terribly"); eye disorder (20/20 vision in each eye but together have a problem), onset Sep 2021, with outcome of unknown. Patient also experienced a confusional state ("my head isn't right"), loss of personal independence in daily activities (haven't been able to go out) and impaired driving ability (haven't been able to drive), onset Sep 2021, with outcome of unknown. All events evaluated at a physician office visit. Relevant laboratory tests and procedures available in the appropriate section. Additional information: Patient mentioned after receiving the booster vaccine, she had an adverse event or adverse reaction. She is having double vision/vision problem. She went to the doctor to remedy the symptoms. She had the vaccination equally apart like she was supposed to - all three Pfizer shots. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Scan brain, Visual acuity reduced, Visual impairment
Clinical narrative: This is a spontaneous report received from a contactable  consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the (3rd booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# 30155BA), on Sep 27, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), single dose, for COVID-19 immunization. The  patient experienced diplopia, visual impairment, reduced visual acuity, all with onset Sep 2021, with outcome of unknown. In summary: After receiving the booster vaccine, patient experienced an adverse event or adverse reaction of having double vision, vision problem/eye problem ("deteriorated terribly"); eye disorder (20/20 vision in each eye but together have a problem), onset Sep 2021, with outcome of unknown. Patient also experienced a confusional state ("my head isn't right"), loss of personal independence in daily activities (haven't been able to go out) and impaired driving ability (haven't been able to drive), onset Sep 2021, with outcome of unknown. All events evaluated at a physician office visit. Relevant laboratory tests and procedures available in the appropriate section. Additional information: Patient mentioned after receiving the booster vaccine, she had an adverse event or adverse reaction. She is having double vision/vision problem. She went to the doctor to remedy the symptoms. She had the vaccination equally apart like she was supposed to - all three Pfizer shots. No follow-up attempts possible. No further information expected.