chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Nasopharyngitis, Pain
Clinical narrative: Vaccination failure; COVID_test_result=Positive; Cold-like symptoms; clogged sinuses; fever (99.9 F); cough; chest congestion; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 26Mar2021 as dose 2, single (Lot number: ER8730), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 24 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: PULMICORT; CLINDAMYCIN. Past drug history included: Amoxycillin, reaction(s): "Known allergies: amoxycillin", notes: Known allergies: amoxycillin. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 18Apr2022, outcome "recovering", described as "Cold-like symptoms"; PAIN (non-serious) with onset 18Apr2022, outcome "recovering", described as "body aches"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 18Apr2022, outcome "recovering", described as "chest congestion"; SINUS CONGESTION (non-serious) with onset 18Apr2022, outcome "recovering", described as "clogged sinuses"; COUGH (non-serious) with onset 18Apr2022, outcome "recovering"; PYREXIA (non-serious) with onset 18Apr2022, outcome "recovering", described as "fever (99.9 F)"; COVID-19 (medically significant) with onset 19Apr2022, outcome "recovering", described as "COVID_test_result=Positive"; VACCINATION FAILURE (medically significant) with onset 19Apr2022, outcome "unknown". The events "covid_test_result=positive", "cold-like symptoms", "clogged sinuses", "fever (99.9 f)", "cough", "chest congestion" and "body aches" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (18Apr2022) 99.9 Fahrenheit; SARS-CoV-2 test: (18Apr2022) Negative, notes: COVID test post vaccination: Nasal swab; (19Apr2022) Positive, notes: COVID test post vaccination: Nasal swab. Therapeutic measures were taken as a result of covid-19, nasopharyngitis, sinus congestion, pyrexia, cough, respiratory tract congestion, pain.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Pulmicort inhaler, Clindamycin, daily multi-vitamin, Fiber gummy within 2 weeks of the vaccination. Hospitalization was not prolonged. Treatment received for the adverse event were Zpak and OTC Muscinex, Advil, Robutussin cough gels. Prior to vaccination, patient was not diagnosed with covid-19. Since the vaccination, patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test, Sinus congestion, Vaccination failure
Clinical narrative: Vaccination failure; COVID_test_result=Positive; Cold-like symptoms; clogged sinuses; fever (99.9 F); cough; chest congestion; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 26Mar2021 as dose 2, single (Lot number: ER8730), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 24 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: PULMICORT; CLINDAMYCIN. Past drug history included: Amoxycillin, reaction(s): "Known allergies: amoxycillin", notes: Known allergies: amoxycillin. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 18Apr2022, outcome "recovering", described as "Cold-like symptoms"; PAIN (non-serious) with onset 18Apr2022, outcome "recovering", described as "body aches"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 18Apr2022, outcome "recovering", described as "chest congestion"; SINUS CONGESTION (non-serious) with onset 18Apr2022, outcome "recovering", described as "clogged sinuses"; COUGH (non-serious) with onset 18Apr2022, outcome "recovering"; PYREXIA (non-serious) with onset 18Apr2022, outcome "recovering", described as "fever (99.9 F)"; COVID-19 (medically significant) with onset 19Apr2022, outcome "recovering", described as "COVID_test_result=Positive"; VACCINATION FAILURE (medically significant) with onset 19Apr2022, outcome "unknown". The events "covid_test_result=positive", "cold-like symptoms", "clogged sinuses", "fever (99.9 f)", "cough", "chest congestion" and "body aches" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (18Apr2022) 99.9 Fahrenheit; SARS-CoV-2 test: (18Apr2022) Negative, notes: COVID test post vaccination: Nasal swab; (19Apr2022) Positive, notes: COVID test post vaccination: Nasal swab. Therapeutic measures were taken as a result of covid-19, nasopharyngitis, sinus congestion, pyrexia, cough, respiratory tract congestion, pain.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Pulmicort inhaler, Clindamycin, daily multi-vitamin, Fiber gummy within 2 weeks of the vaccination. Hospitalization was not prolonged. Treatment received for the adverse event were Zpak and OTC Muscinex, Advil, Robutussin cough gels. Prior to vaccination, patient was not diagnosed with covid-19. Since the vaccination, patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: your covid vaccine can cause permanent headaches.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "your covid vaccine can cause permanent headaches.".  Additional information: Reported as, Patient took the shot over 9 months now and the headaches never went away. Patient lived in misery everyday since then.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dyspnoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: exhaustion; headache; difficulty breathing; sweating; tired; could not concentrate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 17Apr2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1,single , MANUFACTURER UNKNOWN.), for Covid-19 immunization. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset 18Apr2022, outcome "unknown", described as "could not concentrate"; DYSPNOEA (non-serious) with onset 18Apr2022, outcome "unknown", described as "difficulty breathing"; HYPERHIDROSIS (non-serious) with onset 18Apr2022, outcome "unknown", described as "sweating"; FATIGUE (non-serious) with onset 18Apr2022, outcome "unknown", described as "tired"; FATIGUE (non-serious) with onset 19Apr2022, outcome "unknown", described as "exhaustion"; HEADACHE (non-serious) with onset 19Apr2022, outcome "unknown".  Additional Information: On 20Apr22, at 7:04 reported receiving 2nd dose of COVID vaccination on 17Apr22. She said on 18Apr22, she was experiencing difficulty breathing throughout the day and night, Sweating, tired, and could not concentrate. On 19Apr22, she said that she was experiencing sweating, exhaustion, headache, and difficulty breathing in the morning. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: Thrown her immune system off; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). A 36-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Thrown her immune system off".  Additional information: patient reports being evaluated for rheumatoid arthritis but has not been diagnosed with it; unknown if joint symptoms or other reason for work up. reports pre-existing history of elevated cholesterol improved with diet, now under control, not on any meds. educated on importance of blood work to monitor. pt. states she had a "reaction" to her covid-19 vaccination in January, that has thrown her immune system off. reports getting "sick" after starting xeljanz (exact date unknown) with nasal congestion, phlegm, post nasal drip, mild symptoms persisting. states md aware. no more information or dates provided.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for Covid-19 immunisation; Covid-19 vaccine (COVID-19 VACCINE), on 25Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation; Covid-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Interchange of vaccine" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; DIVIGEL; PROMETRIUM [PROGESTERONE]; LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", Suspected COVID-19 (medically significant) with onset Apr2022, outcome "recovered" (Apr2022) and all described as "tested negative 7 days after I initiated Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Negative. Therapeutic measures were taken as a result of Covid-19. Clinical Information: The patient was taking other medications within 2 weeks of starting COVID-19 treatment. She received COVID-19 vaccine. She received treatment with Paxlovid for COVID from 11-Apr-2022 to 15-Apr-2022. She tested negative for COVID-19, 7 days after she initiated Paxlovid. She completed all five days and was adherent to the package insert instructions. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Acute hepatic failure, Biopsy liver, Blood test, Diarrhoea
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Helicobacter pylori" (unspecified if ongoing), notes: history of Helicobacter pylori treated with amoxicillin and pantoprazole three months ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: ACUTE HEPATIC FAILURE (medically significant), outcome "unknown", described as "acute liver failure"; MENTAL STATUS CHANGES (non-serious), outcome "unknown", described as "altered mental status"; YELLOW SKIN (non-serious), outcome "unknown", described as "yellowing of her skin"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "right upper quadrant pain"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; RASH PRURITIC (non-serious), outcome "unknown", described as "Pruritic rash"; VOMITING (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Biopsy liver: portal inflammation with interface activity; diffuse lobular inflammation; perivenulitis with abundant lymphocyte; plasma cells consistent with seronegative AIH, notes: drug induced AH; Blood test: 2.4, notes: showed international normalized ratio; 212 U/L, notes: alkaline phosphate; 3769, notes: ALT; 1572 U/L, notes: AST; 23.8 mg/dL, notes: total bilirubin; Hepatitis viral test: normal; chronic liver disease workup: normal; Physical examination: normal, notes: mentation, scleral icterus, jaundice, and a maculopapular rash; Scan: no intra-or extra-hepatic biliary duct dilation; Serology test: normal. Therapeutic measures were taken as a result of acute hepatic failure, mental status changes. Additional information: Several etiologies of drug-induced AIH are well-established, cases secondary to COVID-19 vaccination have been minimally reported. Common adverse events for COVID-19 vaccination have been noted such as fever, chills, fatigue, headache, and muscle pain. Several rare side effects have occurred including immune thrombocytopenia and one other suspected case Of Pfizer- BioNTech COVID-19 vaccination-induced AIH reported in the literature. In that case the patient developed symptoms within one week of the first dose. This case serves to report a potential association and not necessarily causation between the Pfizer BioNTech COVID 19 vaccination and AIH. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis viral test, Investigation, Mental status changes, Physical examination, Rash pruritic
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Helicobacter pylori" (unspecified if ongoing), notes: history of Helicobacter pylori treated with amoxicillin and pantoprazole three months ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: ACUTE HEPATIC FAILURE (medically significant), outcome "unknown", described as "acute liver failure"; MENTAL STATUS CHANGES (non-serious), outcome "unknown", described as "altered mental status"; YELLOW SKIN (non-serious), outcome "unknown", described as "yellowing of her skin"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "right upper quadrant pain"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; RASH PRURITIC (non-serious), outcome "unknown", described as "Pruritic rash"; VOMITING (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Biopsy liver: portal inflammation with interface activity; diffuse lobular inflammation; perivenulitis with abundant lymphocyte; plasma cells consistent with seronegative AIH, notes: drug induced AH; Blood test: 2.4, notes: showed international normalized ratio; 212 U/L, notes: alkaline phosphate; 3769, notes: ALT; 1572 U/L, notes: AST; 23.8 mg/dL, notes: total bilirubin; Hepatitis viral test: normal; chronic liver disease workup: normal; Physical examination: normal, notes: mentation, scleral icterus, jaundice, and a maculopapular rash; Scan: no intra-or extra-hepatic biliary duct dilation; Serology test: normal. Therapeutic measures were taken as a result of acute hepatic failure, mental status changes. Additional information: Several etiologies of drug-induced AIH are well-established, cases secondary to COVID-19 vaccination have been minimally reported. Common adverse events for COVID-19 vaccination have been noted such as fever, chills, fatigue, headache, and muscle pain. Several rare side effects have occurred including immune thrombocytopenia and one other suspected case Of Pfizer- BioNTech COVID-19 vaccination-induced AIH reported in the literature. In that case the patient developed symptoms within one week of the first dose. This case serves to report a potential association and not necessarily causation between the Pfizer BioNTech COVID 19 vaccination and AIH. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Scan, Serology test, Vomiting, Yellow skin
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Helicobacter pylori" (unspecified if ongoing), notes: history of Helicobacter pylori treated with amoxicillin and pantoprazole three months ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: ACUTE HEPATIC FAILURE (medically significant), outcome "unknown", described as "acute liver failure"; MENTAL STATUS CHANGES (non-serious), outcome "unknown", described as "altered mental status"; YELLOW SKIN (non-serious), outcome "unknown", described as "yellowing of her skin"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "right upper quadrant pain"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; RASH PRURITIC (non-serious), outcome "unknown", described as "Pruritic rash"; VOMITING (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Biopsy liver: portal inflammation with interface activity; diffuse lobular inflammation; perivenulitis with abundant lymphocyte; plasma cells consistent with seronegative AIH, notes: drug induced AH; Blood test: 2.4, notes: showed international normalized ratio; 212 U/L, notes: alkaline phosphate; 3769, notes: ALT; 1572 U/L, notes: AST; 23.8 mg/dL, notes: total bilirubin; Hepatitis viral test: normal; chronic liver disease workup: normal; Physical examination: normal, notes: mentation, scleral icterus, jaundice, and a maculopapular rash; Scan: no intra-or extra-hepatic biliary duct dilation; Serology test: normal. Therapeutic measures were taken as a result of acute hepatic failure, mental status changes. Additional information: Several etiologies of drug-induced AIH are well-established, cases secondary to COVID-19 vaccination have been minimally reported. Common adverse events for COVID-19 vaccination have been noted such as fever, chills, fatigue, headache, and muscle pain. Several rare side effects have occurred including immune thrombocytopenia and one other suspected case Of Pfizer- BioNTech COVID-19 vaccination-induced AIH reported in the literature. In that case the patient developed symptoms within one week of the first dose. This case serves to report a potential association and not necessarily causation between the Pfizer BioNTech COVID 19 vaccination and AIH. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Mass
Clinical narrative: The patient has a weird lump and bruise but not the arm where she had the injection; The patient has a weird lump and bruise but not the arm where she had the injection; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  An 86-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 86 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; HYDROXYUREA. Vaccination history included: Moderna covid-19 vaccine (DOSE 1), for Covid-19 immunization, reaction(s): "None"; Moderna covid-19 vaccine (DOSE 2), for Covid-19 immunization, reaction(s): "None"; Moderna covid-19 vaccine (DOSE 3), for COVID-19 immunization, reaction(s): "None". The following information was reported: MASS (non-serious), CONTUSION (non-serious) all with onset 19Apr2022, outcome "unknown" and all described as "The patient has a weird lump and bruise but not the arm where she had the injection".  Additional information: Patient who is 86 years old and after receiving the Pfizer-BioNTech Covid 19 Vaccine, the patient had a "lump in bruise" in the opposite arm where the patient received the vaccine. Wants to know if this is a reported adverse event due to the vaccine. Patient had weird thing happen. She is some one who had 3 shots of Moderna and then had the Pfizer Booster. The patient has a weird lump and bruise but not the arm where she had the injection. The lump and bruise are high up on her arm but not on the same arm of injection. Concomitant medications includes Vitamins. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect. Did any AE(s) require a visit to: Emergency Room? No; Physician Office? No.  Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none. AE(s) following prior vaccinations: None. Family Medical History Relevant to AE(s): none  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Pyrexia
Clinical narrative: experiencing trouble breathing; chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary immunization complete, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Primary immunization complete, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, Manufacturer unknown), for Covid-19 immunization.  The following information was reported: CHILLS (non-serious) with onset 20Apr2022, outcome "unknown"; DYSPNOEA (non-serious) with onset 20Apr2022, outcome "unknown", described as "experiencing trouble breathing"; PYREXIA (non-serious) with onset 20Apr2022, outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Agent stated that caller was calling on behalf of his wife. Agent stated that caller stated yesterday his wife received her second booster dose of the Pfizer Covid Vaccine and today she was experiencing trouble breathing, chills and a fever. Agent stated caller wants to know have these symptoms been reported with use of the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Deafness unilateral
Clinical narrative: Unilateral hearing loss; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 32-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2022 as dose 3 (booster), single (Lot number: FH8027) at the age of 32 years for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 07Jan2022 as dose 1, single (Lot number: NK45F), in arm for immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: TRIUMEQ; BIKTARVY; HCTZ. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6200), administration date: 09Apr2021, when the patient was 32-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6204), administration date: 19Mar2021, when the patient was 31-year-old, for COVID-19 immunization. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 23Mar2022, outcome "not recovered", described as "Unilateral hearing loss". The event "unilateral hearing loss" required physician office visit. Therapeutic measures were taken as a result of deafness unilateral.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.What treatment received for the adverse event was Steroids, no improvementPrior to vaccination, was the patient not  diagnosed with COVID-19.Since the vaccination, has the patient not had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Deafness unilateral" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Near death experience, Pulmonary embolism
Clinical narrative: I had pulmonary embolism; I had chest pain; Almost died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 20May2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 10Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: CHEST PAIN (hospitalization) with onset 10Dec2021, outcome "unknown", described as "I had chest pain"; PULMONARY EMBOLISM (hospitalization, medically significant) with onset 10Dec2021, outcome "unknown", described as "I had pulmonary embolism"; NEAR DEATH EXPERIENCE (hospitalization, medically significant) with onset Dec2021, outcome "unknown", described as "Almost died". The patient was hospitalized for near death experience, pulmonary embolism, chest pain (start date: 13Dec2021, discharge date: 18Dec2021, hospitalization duration: 5 day(s)). Therapeutic measures were taken as a result of near death experience, pulmonary embolism, chest pain (treated in the hospital).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product preparation error
Clinical narrative: sore arm; The patient was inadvertently administered with an undiluted Pfizer-BioNTech COVID-19 Vaccine (orange cap).; The patient was inadvertently administered with an undiluted Pfizer-BioNTech COVID-19 Vaccine (orange cap).; This is a spontaneous report received from a contactable pharmacist and a contactable consumer. This pharmacist and consumer also received report in response to HCP letter sent in a cross-referenced case. A 6-year-old patient received BNT162b2 (BNT162B2), on 09Mar2022 at 16:00 as dose 1, single (Lot number: FL0007), in right deltoid and on 30Mar2022 at 14:00 as dose 2, single (Lot number: FL0007) at the age of 6 years, in left deltoid, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset Mar2022, outcome "unknown" and all described as "The patient was inadvertently administered with an undiluted Pfizer-BioNTech COVID-19 Vaccine (orange cap)."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The patient did not provided information to you regarding the adverse event(s) with the use of the product. Patient age at time of vaccination: 6 (years). Pfizer/BioNtech COVID-19 Vaccine Details: Dose: 1st, Date: 09Mar2022, Time (24hr): Approx. 16:00. Dose: 2nd, Date: 30Mar2022, Time (24hr): Approx. 14:00. Vaccination Facility Type: Doctors office/ Urgent care. Vaccine Administered at Military Facility: No. Prior vaccination (within 4 weeks): None. Patient Medical History (including any illness at time of vaccination): None. Relevant Tests: None. Relevant Test for thromboembolic events with thrombocytopenia: None. Comments/Narrative: Vaccine was received from pharmacy repackaged in plastic bag with 'Do Not Dilute' sticker affixed. Dose was administered to patient undiluted. With the exception of a sore arm, parent reported no adverse effects.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, SARS-CoV-2 test
Clinical narrative: back ache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): 20220407295(0.0) (Janssen).  A 41-year-old female patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "back ache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient height and weight were not reported. Patient was health care professional. No past medical history or concurrent condition were reported. The patient received Covid-19 vaccine av26.cov2.s (dose number in series 1) (Suspension for injection, route of administration not reported, Batch number: 1805018, expiry: Unknown) Dose was not reported, 1 total administered on left arm on 05Mar2021 for prophylactic vaccination , No concomitant medication were reported. It was unknown weather patient had any adverse events following vaccination with covid-19 vaccine ad26.Cov2.s (Dose number is in series 1). The patient additionally received non-company suspect vaccine Pfizer biontech covid-19 vaccine (Dose number in series 2) (Form of admin not reported, rote of admin, batch number: Unknown, dose was not reported, 1 total administered on 28Oct2021 for prophylactic vaccination. On an unspecified date, the patient experienced back ache (dose number in series 2). On 03Apr2022, Laboratory data included: SARS-COV-2 rapid diagnostic test (NR: Not provided) negative. This report was non-serious. Causality as per reporter and Causality as per Mfr. for the event back pain with Janssen Covid-19 Vaccine (Covid-19 Vaccine Ad26.Cov2.S) was possible. Causality as per reporter and Causality as per Mfr. for the event back pain with Pfizer Biontech Covid-19 Vaccine (Tozinameran) was not applicable  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: Throwing up; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Disabled" (unspecified if ongoing), notes: Disabled. The patient's concomitant medications were not reported. Vaccination history included: comirnaty (dose 1 single, Lot: FL3209, after her first dose she was also sick like that, 3 weeks later, the same thing happened.), administration date: 24Feb2022, for COVID-19 Immunization, reaction(s): "Sick", "Throwing up", "Chills".  The following information was reported: CHILLS (non-serious) with onset 19Apr2022, outcome "unknown"; VOMITING (non-serious) with onset 19Apr2022, outcome "unknown", described as "Throwing up".  Additional information: Question: Caller on behalf of her 44-year-old daughter who she describes as disabled. Patient received her Pfizer BioNtech covid 19 vaccine second dose on 7th of this month and reports side effects of throwing up and chills beginning yesterday. Caller seeking information as it has been longer than a week since she received the vaccine. Caller states no one is giving me an answer; been having for 6 days that's too long. Caller also reports that after her first dose she was also sick like that, 3 weeks later, the same thing happened.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: 101 degree F fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information tea. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, All of my vaccinations have been Pfizer), for COVID-19 Immunization, reaction(s): "Elevated temperature"; Bnt162b2 (DOSE 2, All of my vaccinations have been Pfizer), for COVID-19 Immunization, reaction(s): "Elevated temperature"; Bnt162b2 (DOSE 3, All of my vaccinations have been Pfizer), for COVID-19 Immunization, reaction(s): "Elevated temperature". The following information was reported: PYREXIA (non-serious) with onset Apr2022, outcome "unknown", described as "101 degree F fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient got his second booster dose of the Pfizer-BioNTech COVID-19 vaccine yesterday evening [19Apr2022]. This is my is second booster. All of my vaccinations have been Pfizer. I forget what my experience was in the past, but I remember getting an elevated temperature as a side effect from it [vaccination] and now, but I'm experiencing a 101 degree F fever. The patient has an elevated temperature. The patient is wondering if the elevated temperature is normal. Patient ask "How should I manage my fever of 101 degree F after my second booster dose of the Pfizer-BioNTech COVID-19 vaccine". Running a fever of 101: The patient forgets how much fever to expect but knows fever is a side effect. The patient is running a fever of 101. The patient took Tylenol. Is fever of 101 after receiving second booster dose Pfizer Covid 19 Vaccine normal. Patient clarifies he would like to know what database puts the Pfizer Covid 19 Vaccine information in, the fact the caller received the Pfizer Covid 19 Vaccine, the lot number, etcetera, so health care provider can look up the information. Investigations, Expiry Date of Pfizer Covid 19 Vaccine and other products was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Drug ineffective, Pain, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Felt pain of aching; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1155991), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19"; PAIN (non-serious), outcome "not recovered", described as "Felt pain of aching". The action taken for adalimumab was unknown.  Clinical Course: The reporter's causality for the event (s) of Felt pain of aching with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event (s) of Covid-19 with Humira (Adalimumab) was not provided.The reporter's causality for the event (s) of Felt pain of aching and Covid-19 with Moderna covid-19 vaccine was possible. The reporter's causality for the event (s) of Felt pain of aching and Covid-19 with Pfizer-BioNTech Covid-19 Vaccine was possible.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac monitoring, Cardiomegaly, Carditis, Computerised tomogram
Clinical narrative: heart inflamed; enlarged heart; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220409107 (Janssen).  A 53-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Ad26.cov2.s (Dose 1, Route of administration: Unknown, Indication for use: Prophylactic vaccination, Therapy duration: Unknown), administration date: Sep2021, for Prophylactic vaccination. The following information was reported: CARDITIS (medically significant), outcome "unknown", described as "heart inflamed"; CARDIOMEGALY (medically significant), outcome "unknown", described as "enlarged heart". The patient underwent the following laboratory tests and procedures: Blood test: Unspecified Results, notes: Classification: Unk; Cardiac monitoring: Unspecified Results, notes: Classification: Unk; Computerised tomogram: Unspecified Results, notes: Classification: Unk; Electrocardiogram: Unspecified Results, notes: Classification: Unk; Ton of tests: Unspecified Results.  Sender's comments:  covid19 vaccine ad26.cov2.s Heart- inflamed. The event (s) has unknown/ unclear temporal relationship is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event (s). Therefore this event (s) is considered unassessable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Investigation
Clinical narrative: heart inflamed; enlarged heart; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220409107 (Janssen).  A 53-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Ad26.cov2.s (Dose 1, Route of administration: Unknown, Indication for use: Prophylactic vaccination, Therapy duration: Unknown), administration date: Sep2021, for Prophylactic vaccination. The following information was reported: CARDITIS (medically significant), outcome "unknown", described as "heart inflamed"; CARDIOMEGALY (medically significant), outcome "unknown", described as "enlarged heart". The patient underwent the following laboratory tests and procedures: Blood test: Unspecified Results, notes: Classification: Unk; Cardiac monitoring: Unspecified Results, notes: Classification: Unk; Computerised tomogram: Unspecified Results, notes: Classification: Unk; Electrocardiogram: Unspecified Results, notes: Classification: Unk; Ton of tests: Unspecified Results.  Sender's comments:  covid19 vaccine ad26.cov2.s Heart- inflamed. The event (s) has unknown/ unclear temporal relationship is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event (s). Therefore this event (s) is considered unassessable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested Covid positive/Caller states she is vaccinated and boosted and can't believe she got Covid; tested Covid positive/Caller states she is vaccinated and boosted and can't believe she got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: ER8733), in left arm, on 07May2021 as dose 2, single (Lot number: EW0158), in left arm and on 06Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 59 years, in arm 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 16Apr2022, outcome "unknown" and all described as "tested Covid positive/Caller states she is vaccinated and boosted and can't believe she got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) positive, notes: Unit: Not Provided.  Clinical Course: Vaccination Facility Type: Pharmacy/Drug Store. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations: None, doesn't even get the flu shot. States as a matter of fact she had the least symptoms with Pfizer vaccine and wondered if it was effective, she barely had a sore arm.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID after vaccines; tested positive for COVID after vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 1, single (Batch/Lot number: unknown) and (Batch/Lot number: unknown) 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 16Apr2022, outcome "unknown", described as "Tested positive for COVID after vaccines"; COVID-19 (medically significant) with onset 16Apr2022, outcome "unknown", described as "tested positive for COVID after vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased
Clinical narrative: Getting an elevated temperature as a side effect from it [vaccination]; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) via medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Getting an elevated temperature as a side effect from it [vaccination]". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Call was transferred from DSU: (withheld) ID: withheld, Reportum number: withheld). Caller stated he got his second booster dose of the Pfizer-BioNTech Covid-19 vaccine yesterday evening [19Apr2022] at a (facility name, city, state withheld). This was his second booster. All of his vaccinations have been Pfizer. He forget what his experience was in the past, but he remembered getting an elevated temperature as a side effect from it [vaccination] and now, but he was experiencing a 101 degree F fever." Caller asked: was this normal or not. According to agent, caller declined to provide last name and address. Question: Caller asked: What database does (facility name withheld) puts the Pfizer-BioNTech Covid-19 vaccine in (withheld).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200604609 Same reporter/ patient, different dose number/ event