chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date Jan2021 (Lot number: 8982) at the age of 42 years as dose 2, single and administration date Dec2020 (Lot number: el1284) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive, notes: Nasal Swab.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events drug ineffective/COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Thrombosis
Clinical narrative: Blood clot behind his eye; He started not being able to see and went blind the other day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 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: THROMBOSIS (hospitalization, disability, medically significant), outcome "unknown", described as "Blood clot behind his eye"; BLINDNESS (hospitalization, disability, medically significant), outcome "unknown", described as "He started not being able to see and went blind the other day". Therapeutic measures were taken as a result of thrombosis, blindness.   Clinical course: The patient got the vaccine and by the time he got home he started not being able to see and went blind the other day. His wife is a nurse and started filling him full of Aspirin and got him to the hospital. When she got him to the hospital, they found he had a blood clot behind his eye. He had to have surgery and remove the blood clot. He can see now, but not like before. He can't work. They said he will have to placed on disability because he has to be able to see to drive.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Drug ineffective, Herpes zoster
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. An adult female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 18Aug2021 12:00 (Lot number: ew0196) as dose 2, single and administered in arm left, administration date 28Jul2021 12:00 (Lot number: ew0191) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "recovered with sequelae", COVID-19 (medically significant) with onset 25Aug2021 14:00, outcome "recovered with sequelae" and all described as "I also contracted Covid"; HERPES ZOSTER (non-serious) with onset 25Aug2021 14:00, outcome "recovered with sequelae", described as "shingles"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 25Aug2021 14:00, outcome "recovered with sequelae" and all described as "Lost of taste and smell". The events "i also contracted covid", "i also contracted covid", "shingles", "lost of taste and smell" and "lost of taste and smell" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, herpes zoster, ageusia, anosmia. Clinical Information: Patient developed shingles exactly 10 days after the second vaccine. She also contracted Covid and had well pronounced symptoms that lasted longer than 5 days. Lost of taste and smell. AE treatment was Valtrex. Device date was 13Jan2022. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. An adult female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 18Aug2021 12:00 (Lot number: ew0196) as dose 2, single and administered in arm left, administration date 28Jul2021 12:00 (Lot number: ew0191) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "recovered with sequelae", COVID-19 (medically significant) with onset 25Aug2021 14:00, outcome "recovered with sequelae" and all described as "I also contracted Covid"; HERPES ZOSTER (non-serious) with onset 25Aug2021 14:00, outcome "recovered with sequelae", described as "shingles"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 25Aug2021 14:00, outcome "recovered with sequelae" and all described as "Lost of taste and smell". The events "i also contracted covid", "i also contracted covid", "shingles", "lost of taste and smell" and "lost of taste and smell" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, herpes zoster, ageusia, anosmia. Clinical Information: Patient developed shingles exactly 10 days after the second vaccine. She also contracted Covid and had well pronounced symptoms that lasted longer than 5 days. Lost of taste and smell. AE treatment was Valtrex. Device date was 13Jan2022. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Organ failure
Clinical narrative: The patient had a severe reaction to the vaccine, all his/her organs failed; 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.  A patient (no qualifiers provided) 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: ORGAN FAILURE (medically significant), outcome "unknown", described as "The patient had a severe reaction to the vaccine, all his/her organs failed". The patient had a severe reaction to the vaccine, all his/her organs failed and he/she was now a permanent dialysis patient. Commercials are telling us to get vaccinated; however, they are not informing the people of the adverse reactions nor its ingredients.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive had mild symptoms; tested positive had mild symptoms; received the booster; 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. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (about 8 weeks ago) (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (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: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "received the booster"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jan2022 (last week), outcome "unknown" and all described as "tested positive had mild symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. The consumer wanted to know "what level of protection am I going to need next. Another vaccine or booster? "  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Disorder of orbit
Clinical narrative: mass on my eye orbit; 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.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13Apr2021 (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: 1st), administration date: 22Mar2021, for COVID-19 immunization. The following information was reported: DISORDER OF ORBIT (non-serious), outcome "unknown", described as "mass on my eye orbit".  Additional Information: The patient had COVID vaccines on 22Mar2021 and 13Apr2021 and developed a mass on eye orbit that was removed May2021 and another subsequent lump in Sep2021. Both doctors suggested this might be an adverse reaction to the vaccine, potentially as a result of lingering facial fillers. Patient had any lingering filler dissolved in Nov2021 and asked if it was safe for to have the COVID booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: Booster; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. After 3 vaccines the patient got a COVID-19. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hepatic cirrhosis, Hepatic failure, Illness
Clinical narrative: liver failure; now have non-alcoholic cirrhosis of the liver; sick; 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 26 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (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: HEPATIC FAILURE (hospitalization, medically significant) with onset Sep2021, outcome "unknown", described as "liver failure"; HEPATIC CIRRHOSIS (hospitalization, medically significant) with onset Sep2021, outcome "unknown", described as "now have non-alcoholic cirrhosis of the liver"; ILLNESS (non-serious) with onset Sep2021, outcome "unknown", described as "sick".Event details reported as follow: A healthy patient received the first dose of the vaccine in Sep2021, two weeks after receiving the vaccine and with no change in her day to day lifestyle she was hospitalized due to liver failure. She now had non-alcoholic cirrhosis of the liver. She had been sick ever since. She was also not the only person to have this problem after taking the vaccine. She had been to many specialists that believe it was the vaccine that did this to her. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Menstruation irregular
Clinical narrative: Onset of continual menses for 4+ weeks after none for previous 6 months; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Dec2021 (Lot number: FH8027) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Gluten" (unspecified if ongoing), notes: known allergies: Gluten. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 08Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8731, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 29Apr2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021, outcome "unknown", described as "Booster"; MENSTRUATION IRREGULAR (non-serious) with onset 11Dec2021, outcome "recovering", described as "Onset of continual menses for 4+ weeks after none for previous 6 months". Therapeutic measures were not taken as a result of menstruation irregular.  Additional Information: The patient had no other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other medications within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Pain, Pyrexia
Clinical narrative: patients had symptoms of body aches, low grade fever and cough which resolved within 2 days; patients had symptoms of body aches, low grade fever and cough which resolved within 2 days; patients had symptoms of body aches, low grade fever and cough which resolved within 2 days; Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 64 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZINC; VITAMIN C [ASCORBIC ACID]; SEROPHENE; TRULICITY; METFORMIN; ROSUVASTATIN; JARDIANCE; OMEPRAZOLE; VITAMIN D NOS; ECONAZOLE; LISINOPRIL; ASPIRIN (E.C.). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "recovered" (2022) and all described as "Covid-19"; PAIN (medically significant), PYREXIA (medically significant), COUGH (medically significant), outcome "recovered" (2022) and all described as "patients had symptoms of body aches, low grade fever and cough which resolved within 2 days". The detail information was reported as due to being diagnosed with covid 19 on 02Jan2022. Patients had symptoms of body aches, Low grade fever and cough which resolved within 2 days. Reporter seriousness for COVID -19: Medically significant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID test; Positive COVID test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202200071639 (Pfizer).  An adolescent patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 3 people died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter reported for three patients.  A patient (no qualifiers provided) 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: DEATH (death, medically significant), outcome "fatal", described as "3 people died". The patient date of death was unknown. The reported cause of death was "Unknown cause of death". It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200073487 Same reporter/drug/AE, different patient;US-PFIZER INC-202200073488 Same reporter/drug/AE, different patient; Reported Cause(s) of Death: Unknown cause of death
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Immunisation
Clinical narrative: Sudden hearing loss left ear 2 days after receiving Pfizer covid booster; Sudden hearing loss left ear 2 days after receiving Pfizer covid booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Dec2021 10:15 (Lot number: 3303080) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: OXYBUTYNIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205), administration date: 02Mar2021, when the patient was 77 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9262), administration date: 09Feb2021, when the patient was 77 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 16Dec2021 10:15, outcome "unknown", DEAFNESS (medically significant) with onset 18Dec2021 03:00, outcome "not recovered" and all described as "Sudden hearing loss left ear 2 days after receiving Pfizer covid booster". The event "sudden hearing loss left ear 2 days after receiving pfizer covid booster" was evaluated at the physician office visit. Therapeutic measures were taken as a result of deafness including oral steroids.  Follow up information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Chest X-ray, Chest pain, Dyspnoea, Pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "prolapsed hemorrhoids" (unspecified if ongoing); "abnormal weight loss" (unspecified if ongoing); "Latex" (unspecified if ongoing), notes: know allergies: Latex; "adhesive" (unspecified if ongoing), notes: know allergies: adhesive; "tape" (unspecified if ongoing), notes: know allergies: tape; "landed flat in my back" (unspecified if ongoing), notes: Previous fall 4 months prior to injections and landed flat in my back. Concomitant medication(s) included: ESTRADIOL; SYNTHROID; PRAMIPEXOLE; DULOXETINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), for COVID-19 Immunization.The following information was reported: ANOSMIA (non-serious) with onset 14Aug2020, outcome "recovered with sequelae", described as "No sense of smell"; CHEST PAIN (non-serious) with onset 10Dec2021 12:00, outcome "recovered with sequelae", described as "Left side chest pain between the sternum and left nipple"; DYSPNOEA (non-serious) with onset 10Dec2021 12:00, outcome "recovered with sequelae", described as "Sharp, hard to breathe"; PAIN (non-serious) with onset 10Dec2021 12:00, outcome "recovered with sequelae", described as "dull non stop irritating pain, left side exact same spot". The events "no sense of smell", "left side chest pain between the sternum and left nipple", "sharp, hard to breathe" and "dull non stop irritating pain, left side exact same spot" were 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 anosmia, chest pain, dyspnoea, pain.The lot number for bnt162b2 was not provided and will be requested during follow up.Additional information: Ae treatment: Chest X-ray, physician eval, Take Ibuprofen.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: a school exposure and her pod was tested/she tested positive; a school exposure and her pod was tested/she tested positive; stomach ache; This is a spontaneous report received from a contactable consumer or other non hcp.  A 11 year-old female patient received BNT162B2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 11 years 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jan2022, outcome "unknown" and all described as "a school exposure and her pod was tested/she tested positive"; ABDOMINAL PAIN UPPER (non-serious) with onset 13Jan2022, outcome "unknown", described as "stomach ache". It was reported that patient had a school exposure and her pod was tested. She tested positive on 13Jan2022 and reported sore throat and stomach ache. On 14Jan2022 developed fever to 103, lethargic. The patient underwent the following laboratory tests and procedures: body temperature: (14Jan2022) 103, notes: fever to 103; COVID-19 test: (13Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR on 05Jan2022 covid test result=Positive; PCR on 05Jan2022 covid test result=Positive; dose received 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 47 year-old male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Lot number: FF2589) at the age of 47 years as dose 3 (booster), single, administration date 22Mar2021 (Lot number: EL3247) as dose 2, single and administration date 01Mar2021 (Lot number: EL3247) 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: IMMUNISATION (medically significant) with onset 14Dec2021, outcome "unknown", described as "dose received 3"; VACCINATION FAILURE (medically significant) with onset 05Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 05Jan2022, outcome "recovered" (Jan2022) and all described as "PCR on 05Jan2022 covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19. Clinical course: The patient experienced nasal congestion and was in contact with covid positive family members, and then the patient got positive result for Covid PCR test on 05Jan2022. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Immunization, drug ineffective and covid-19 and BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, Respiratory tract infection, SARS-CoV-2 test
Clinical narrative: a secondary respiratory infection; Seasonal Allergies; tested positive for covid 14Jan2022; tested positive for covid 14Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 28 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Allergies: Mountain Cedar is the current allergen" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jan2022, outcome "unknown" and all described as "tested positive for covid 14Jan2022"; RESPIRATORY TRACT INFECTION (medically significant), outcome "unknown", described as "a secondary respiratory infection"; SEASONAL ALLERGY (medically significant), outcome "unknown", described as "Seasonal Allergies". The patient underwent the following laboratory tests and procedures: investigation: (26Dec2021) negative; sars-cov-2 test: (26Dec2021) negative; (14Jan2022) positive. Therapeutic measures were taken as a result of respiratory tract infection, seasonal allergy. Clinical course: Seasonal Allergies. Was being treated for a secondary respiratory infection with Cefdinir after having tested negative for COVID-19, flu and strep around 26Dec. At that point he was given a steroid shot and antihistamine and decongestants. Mountain Cedar is the current allergen in the (withheld) still very high pollen counts reported daily.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Seasonal allergy
Clinical narrative: a secondary respiratory infection; Seasonal Allergies; tested positive for covid 14Jan2022; tested positive for covid 14Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 28 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Allergies: Mountain Cedar is the current allergen" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jan2022, outcome "unknown" and all described as "tested positive for covid 14Jan2022"; RESPIRATORY TRACT INFECTION (medically significant), outcome "unknown", described as "a secondary respiratory infection"; SEASONAL ALLERGY (medically significant), outcome "unknown", described as "Seasonal Allergies". The patient underwent the following laboratory tests and procedures: investigation: (26Dec2021) negative; sars-cov-2 test: (26Dec2021) negative; (14Jan2022) positive. Therapeutic measures were taken as a result of respiratory tract infection, seasonal allergy. Clinical course: Seasonal Allergies. Was being treated for a secondary respiratory infection with Cefdinir after having tested negative for COVID-19, flu and strep around 26Dec. At that point he was given a steroid shot and antihistamine and decongestants. Mountain Cedar is the current allergen in the (withheld) still very high pollen counts reported daily.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: tested positive for covid-19; tested positive for covid-19; mild, cold-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid-19"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "mild, cold-like symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical information: My cousin, a 27-year-old male, tested positive for covid-19 after having previously received a full course of PFEs covid-19 vaccine, learned of this yesterday, 13Jan. He has mild, cold-like symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Booster dose: Currently Covid positive; Booster dose: Currently Covid positive; Booster dose: About 15 minutes after receiving booster dose lost sensation in nose; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 28 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 16:00 (Lot number: FF2593) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia", start date: 2020 (ongoing), notes: Verbatim: Fibromyalgia, Additional Information for Other Conditions: Diagnosed with mid year of 2020. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: 27Feb2021, lot: EN6200, NDC: Unknown , Expiration: Unknown , Route of administration: left arm), administration date: 27Feb2021, when the patient was 27 years old, for COVID-19 immunization, reaction(s): "pain on the side of injection"; Bnt162b2 (Second dose: 20Mar2021, lot: ER2613, NDC: Unknown , Expiration: unknown , route of administration: left arm), administration date: 20Mar2021, when the patient was 27 years old, for COVID-19 Immunization, reaction(s): "pain on the side of injection", "Fever", "Malaise". The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "Booster dose: Currently Covid positive"; ANOSMIA (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster dose: About 15 minutes after receiving booster dose lost sensation in nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive.  Clinical information: It was reported that, unusual side effects after receiving the booster dose Adult Pfizer Covid 19 Vaccine. The caller had no side effects with the first and second dose Adult Pfizer Covid 19 Vaccine except for typical side effects. Currently Covid positive: The reason the caller is calling Pfizer now is when the caller got sick with Covid, the caller didn't realize had Covid. The caller did not test positive for Covid until 12Jan2022. The caller got sick with Covid one week before.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Immunisation, Loss of personal independence in daily activities
Clinical narrative: Booster; chronic spontaneous urticaria; severely impacted my life; 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.  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: Covid-19 vaccine (Unknown Manufacturer, DOSE 01), for Covid-19 immunization; Covid-19 vaccine (Unknown Manufacturer, DOSE 02), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; CHRONIC SPONTANEOUS URTICARIA (non-serious), outcome "unknown", described as "chronic spontaneous urticaria"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "severely impacted my life".  Additional information: It was stated that after receiving booster shot patient have developed chronic spontaneous urticaria and it was very very disruptive and has severely impacted life now.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Immunisation, Malaise
Clinical narrative: booster; died of multiple cardiac arrest in the hospital.; felt really sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: IMMUNISATION (death, hospitalization, medically significant), outcome "fatal", described as "booster"; CARDIAC ARREST (death, hospitalization, medically significant), outcome "fatal", described as "died of multiple cardiac arrest in the hospital."; MALAISE (death, hospitalization, medically significant), outcome "fatal", described as "felt really sick". The patient date of death was unknown. The reported cause of death was cardiac arrest. It was not reported if an autopsy was performed.  Clinical course: It was reported that 2 weeks after getting the booster shot, the patient suffered for 2 weeks, felt really sick and then died of multiple cardiac arrest in the hospital.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died of multiple cardiac arrest in the hospital
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Immunisation, Immunodeficiency
Clinical narrative: He is immunocompromised; has hypertension.; Booster; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program. The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administration date 10Sep2021 (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), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: immunisation (medically significant) with onset 10Sep2021, outcome "unknown", described as "Booster"; immunodeficiency (medically significant), outcome "unknown", described as "He is immunocompromised"; hypertension (non-serious), outcome "unknown", described as "has hypertension.". Event details reported as follow: The patient is seeking guidance if it is possible for him to get vaccination number 4 because it is now available and would like to know if there will be any harm to him because He is immunocompromised and has hypertension. Someone also said that the 5th vaccination will soon be available and if once released he also would like to get it. He already got the first and second doses of the Pfizer vaccine and also the Booster shot dated 10Sep2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test after Vaccine and booster; Positive COVID test after Vaccine and booster; Positive COVID test after Vaccine and booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 14Oct2021 (Lot number: EW0217) at the age of 32 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 15Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm right, administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 14Oct2021, outcome "unknown", VACCINATION FAILURE (medically significant) with onset 16Jan2022, outcome "unknown" and all described as "Positive COVID test after Vaccine and booster"; COVID-19 (medically significant) with onset 16Jan2022, outcome "recovering", described as "Positive COVID test after Vaccine and booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical Course: Patient had been tested for COVID-19, Since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19.The patient had no known allergies.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: had your vaccine on 04Jan, tested positive for Omnicron on the 5th; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (005570). A male patient received bnt162b2 (BNT162B2), administration date 04Jan2022 (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 reporter had a patient that received the vaccine on 04Jan2022 and tested positive for Omnicron on the 5th  (05Jan2022) who was trying to leave on a cruise on the 29Jan2022. The He must be vaccinated by today or tomorrow to meet the requirements of the cruise ship of being vaccinated two weeks before boarding. The reporter inquired how early can he be administered the second vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4230743-00 (Agency).  A 71 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 71 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk, cf for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up". The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of rheumatoid arthritis flare and covid vaccine caused rheumatoid arthritis flare with humira(adalimumab) was no reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of event rheumatoid arthritis cannot be excluded.   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.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Pyrexia
Clinical narrative: Vaccinated but recently contracted COVID; Vaccinated but recently contracted COVID; High fever of 103°F; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A patient (no qualifiers provided) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Vaccinated but recently contracted COVID"; PYREXIA (non-serious), outcome "unknown", described as "High fever of 103°F". Reporter's friend who was vaccinated but recently contracted COVID with a really high fever of 103 degree F. The patient underwent the following laboratory tests and procedures: body temperature: 103 Fahrenheit, notes: High; fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and covid19 cannot be totally excluded
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Rhinorrhoea, SARS-CoV-2 test, Sneezing
Clinical narrative: + covid positive test; + covid positive test; rhonorrhea; sneezing; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 65 year-old male patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF2589) at the age of 65 years as dose 3, (booster) single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) 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: IMMUNISATION (medically significant) with onset 08Oct2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "+ covid positive test"; RHINORRHOEA (non-serious) with onset 10Jan2022, outcome "unknown", described as "rhonorrhea"; SNEEZING (non-serious) with onset 10Jan2022, outcome "unknown", described as "sneezing". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, rhinorrhoea, sneezing.  Clinical course: product: COVID 19, brand: Pfizer, brand unknown: False, lot unknown: False, dose number: 3 previous dose details: prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot unknown: False, prev dose, dose number: 2, prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot unknown: False, prev dose, dose number: 1. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Reported Event: + Covid positive test on 1/10 mild sx rhinorrhoea sneezing prior to vaccination, was the patient diagnosed with COVID-19?: Unknown, Covid test post vaccination: Covid test type post vaccination: Unknown, Covid test name post vaccination: unknown. Device Date : 18Jan2022.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: + covid positive test; + covid positive test; rhonorrhea; sneezing; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 65 year-old male patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF2589) at the age of 65 years as dose 3, (booster) single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) 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: IMMUNISATION (medically significant) with onset 08Oct2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "+ covid positive test"; RHINORRHOEA (non-serious) with onset 10Jan2022, outcome "unknown", described as "rhonorrhea"; SNEEZING (non-serious) with onset 10Jan2022, outcome "unknown", described as "sneezing". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, rhinorrhoea, sneezing.  Clinical course: product: COVID 19, brand: Pfizer, brand unknown: False, lot unknown: False, dose number: 3 previous dose details: prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot unknown: False, prev dose, dose number: 2, prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot unknown: False, prev dose, dose number: 1. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Reported Event: + Covid positive test on 1/10 mild sx rhinorrhoea sneezing prior to vaccination, was the patient diagnosed with COVID-19?: Unknown, Covid test post vaccination: Covid test type post vaccination: Unknown, Covid test name post vaccination: unknown. Device Date : 18Jan2022.  No follow-up attempts are possible. No further information is expected.