chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration) and NO ADVERSE EVENT (no adverse event) in a 2-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-May-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration).    No concomitant medication was reported. No treatment medication was reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-734254 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734254:Patient 02
Age: 33.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient given expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) in a 33-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose).    Concomitant medication was not reported. Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Age: 63.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient given expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) in a 63-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose).    It was unknown if the patient had experienced any additional symptoms/events.  Concomitant medications were not reported.  No treatment information was provided by the reporter.
Age: 84.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Patient given expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (no adverse event) in an 84-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose).    It was unknown if the patient had experienced any additional symptoms/events.  Concomitant medications were not reported.  No treatment information was provided by the reporter.
Age: 63.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient given expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) in a 63-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose).    No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: neurological symptoms with the Pfizer COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GL0087) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Flu shot (I've never experienced these symptoms with the flu shot), for Immunization. The following information was reported: NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "neurological symptoms with the Pfizer COVID vaccine".  Additional information: Caller asking how long does the Pfizer COVID booster 12 years of age and older vaccine stay in the body. The patient did not asked for this shot but wanted the flu shot. Patient had neurological symptoms with the Pfizer COVID vaccine. It started a month after the vaccine and got worse after 6 months. Patient never experienced these symptoms with the flu shot. The doctor's did not had a test to find out if it's still in the blood. There's no way to prove that it's from the vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chest pain, Chills, Cough, Ear discomfort, Fatigue
Clinical narrative: new cough; muscle soreness in chest and bilateral arms; severe arm pain; fever; chills; fatigue; severely swollen lymph nodes in neck; sore scratchy throat; headache; neck ache; ear pressure; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 18-year-old female patient (not pregnant) received meningococcal group b Rlp2086 (TRUMENBA), on 19Jul2023 as dose 2, single (batch/lot number: unknown) at the age of 18 years, in left deltoid for immunization. The patient's relevant medical history included: "depression" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medications included: SERTRALINE, start date: 01Mar2021; ABILIFY, start date: 03May2021; NEXPLANON, start date: 14Jun2023. The following information was reported: CHILLS (non-serious) with onset 19Jul2023, outcome "not recovered"; EAR DISCOMFORT (non-serious) with onset 19Jul2023, outcome "not recovered", described as "ear pressure"; FATIGUE (non-serious) with onset 19Jul2023, outcome "not recovered"; PYREXIA (non-serious) with onset 19Jul2023, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 19Jul2023, outcome "not recovered"; NECK PAIN (non-serious) with onset 19Jul2023, outcome "not recovered", described as "neck ache"; PAIN IN EXTREMITY (non-serious) with onset 19Jul2023, outcome "not recovered", described as "severe arm pain"; LYMPHADENOPATHY (non-serious) with onset 19Jul2023, outcome "not recovered", described as "severely swollen lymph nodes in neck"; THROAT IRRITATION (non-serious) with onset 19Jul2023, outcome "not recovered", described as "sore scratchy throat"; MYALGIA (non-serious) with onset 21Jul2023, outcome "not recovered", described as "muscle soreness in chest and bilateral arms"; COUGH (non-serious) with onset 21Jul2023, outcome "not recovered", described as "new cough". The events "severe arm pain", "fever", "chills", "fatigue", "severely swollen lymph nodes in neck", "sore scratchy throat", "headache", "neck ache", "ear pressure", "new cough" and "muscle soreness in chest and bilateral arms" required emergency room visit. Therapeutic measures were taken as a result of pain in extremity, pyrexia, chills, fatigue, lymphadenopathy, throat irritation, headache, neck pain, ear discomfort, cough, myalgia.  Additional information: The patient informed that the facility type was doctor's office/urgent care. On 19Jul2023, the patient experienced severe arm pain within 1 hour followed by fever, chills, fatigue, severely swollen lymph nodes in neck, sore scratchy throat, headache, neck ache and ear pressure. These worsened over 24 hours, only slightly responsive to Advil, Benadryl, sinus medicine and Tylenol. These persisted on day 3 post vaccine and now with new cough, muscle soreness in chest and bilateral arms. The patient went to urgent care and was treating symptoms with OTC.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Lymphadenopathy, Myalgia, Neck pain, Pain in extremity
Clinical narrative: new cough; muscle soreness in chest and bilateral arms; severe arm pain; fever; chills; fatigue; severely swollen lymph nodes in neck; sore scratchy throat; headache; neck ache; ear pressure; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 18-year-old female patient (not pregnant) received meningococcal group b Rlp2086 (TRUMENBA), on 19Jul2023 as dose 2, single (batch/lot number: unknown) at the age of 18 years, in left deltoid for immunization. The patient's relevant medical history included: "depression" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medications included: SERTRALINE, start date: 01Mar2021; ABILIFY, start date: 03May2021; NEXPLANON, start date: 14Jun2023. The following information was reported: CHILLS (non-serious) with onset 19Jul2023, outcome "not recovered"; EAR DISCOMFORT (non-serious) with onset 19Jul2023, outcome "not recovered", described as "ear pressure"; FATIGUE (non-serious) with onset 19Jul2023, outcome "not recovered"; PYREXIA (non-serious) with onset 19Jul2023, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 19Jul2023, outcome "not recovered"; NECK PAIN (non-serious) with onset 19Jul2023, outcome "not recovered", described as "neck ache"; PAIN IN EXTREMITY (non-serious) with onset 19Jul2023, outcome "not recovered", described as "severe arm pain"; LYMPHADENOPATHY (non-serious) with onset 19Jul2023, outcome "not recovered", described as "severely swollen lymph nodes in neck"; THROAT IRRITATION (non-serious) with onset 19Jul2023, outcome "not recovered", described as "sore scratchy throat"; MYALGIA (non-serious) with onset 21Jul2023, outcome "not recovered", described as "muscle soreness in chest and bilateral arms"; COUGH (non-serious) with onset 21Jul2023, outcome "not recovered", described as "new cough". The events "severe arm pain", "fever", "chills", "fatigue", "severely swollen lymph nodes in neck", "sore scratchy throat", "headache", "neck ache", "ear pressure", "new cough" and "muscle soreness in chest and bilateral arms" required emergency room visit. Therapeutic measures were taken as a result of pain in extremity, pyrexia, chills, fatigue, lymphadenopathy, throat irritation, headache, neck pain, ear discomfort, cough, myalgia.  Additional information: The patient informed that the facility type was doctor's office/urgent care. On 19Jul2023, the patient experienced severe arm pain within 1 hour followed by fever, chills, fatigue, severely swollen lymph nodes in neck, sore scratchy throat, headache, neck ache and ear pressure. These worsened over 24 hours, only slightly responsive to Advil, Benadryl, sinus medicine and Tylenol. These persisted on day 3 post vaccine and now with new cough, muscle soreness in chest and bilateral arms. The patient went to urgent care and was treating symptoms with OTC.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Throat irritation
Clinical narrative: new cough; muscle soreness in chest and bilateral arms; severe arm pain; fever; chills; fatigue; severely swollen lymph nodes in neck; sore scratchy throat; headache; neck ache; ear pressure; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 18-year-old female patient (not pregnant) received meningococcal group b Rlp2086 (TRUMENBA), on 19Jul2023 as dose 2, single (batch/lot number: unknown) at the age of 18 years, in left deltoid for immunization. The patient's relevant medical history included: "depression" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medications included: SERTRALINE, start date: 01Mar2021; ABILIFY, start date: 03May2021; NEXPLANON, start date: 14Jun2023. The following information was reported: CHILLS (non-serious) with onset 19Jul2023, outcome "not recovered"; EAR DISCOMFORT (non-serious) with onset 19Jul2023, outcome "not recovered", described as "ear pressure"; FATIGUE (non-serious) with onset 19Jul2023, outcome "not recovered"; PYREXIA (non-serious) with onset 19Jul2023, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 19Jul2023, outcome "not recovered"; NECK PAIN (non-serious) with onset 19Jul2023, outcome "not recovered", described as "neck ache"; PAIN IN EXTREMITY (non-serious) with onset 19Jul2023, outcome "not recovered", described as "severe arm pain"; LYMPHADENOPATHY (non-serious) with onset 19Jul2023, outcome "not recovered", described as "severely swollen lymph nodes in neck"; THROAT IRRITATION (non-serious) with onset 19Jul2023, outcome "not recovered", described as "sore scratchy throat"; MYALGIA (non-serious) with onset 21Jul2023, outcome "not recovered", described as "muscle soreness in chest and bilateral arms"; COUGH (non-serious) with onset 21Jul2023, outcome "not recovered", described as "new cough". The events "severe arm pain", "fever", "chills", "fatigue", "severely swollen lymph nodes in neck", "sore scratchy throat", "headache", "neck ache", "ear pressure", "new cough" and "muscle soreness in chest and bilateral arms" required emergency room visit. Therapeutic measures were taken as a result of pain in extremity, pyrexia, chills, fatigue, lymphadenopathy, throat irritation, headache, neck pain, ear discomfort, cough, myalgia.  Additional information: The patient informed that the facility type was doctor's office/urgent care. On 19Jul2023, the patient experienced severe arm pain within 1 hour followed by fever, chills, fatigue, severely swollen lymph nodes in neck, sore scratchy throat, headache, neck ache and ear pressure. These worsened over 24 hours, only slightly responsive to Advil, Benadryl, sinus medicine and Tylenol. These persisted on day 3 post vaccine and now with new cough, muscle soreness in chest and bilateral arms. The patient went to urgent care and was treating symptoms with OTC.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Limb discomfort, Lung disorder
Clinical narrative: Guillain Barre; It affected his lungs and he had to be intubated; has limited use of his hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "HIV" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: LUNG DISORDER (hospitalization) with onset 2023, outcome "unknown", described as "It affected his lungs and he had to be intubated"; LIMB DISCOMFORT (hospitalization) with onset 2023, outcome "unknown", described as "has limited use of his hands"; GUILLAIN-BARRE SYNDROME (hospitalization) with onset 21Jun2023, outcome "not recovered", described as "Guillain Barre". The patient was hospitalized for guillain-barre syndrome, lung disorder, limb discomfort (start date: 04Jul2023). Therapeutic measures were taken as a result of guillain-barre syndrome, lung disorder, limb discomfort. Clinical course: He was in the hospital for over two weeks. They were doing every treatment under the sun. The PRIVACY didn't had the specialties to address his medical needs so he was transferred to (PRIVACY) in (PRIVACY). He was getting just a smidge better based on the parameters, but he still did not had any use of his legs, and had limited use of his hands. It affected his lungs and he had to be intubated. They were doing the plasmapheresis. They did 5 treatments and the last one would be the next day. Vaccine was received at the (PRIVACY). He was in (PRIVACY) at the time and he went to an Emergency Care clinic. Was told it wasn't COVID or Strep. He had that report information at home. Specific Relevant Test for Thromboembolic events with Thrombocytopenia were not applicable. He began hospital admission in the regular care, then was moved to the step down unit. He had to be intubated and was moved to the ICU. Right now, he was in the step down unit again. He was currently still admitted. Autopsy Information was not applicable.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Severe diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Jul2023 at 19:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: moderna (DOSE 1, SINGLE, Batch/Lot number: 026A21A), administration date: 05Mar2021, for COVID-19 immunisation; moderna (DOSE 2, SINGLE, Batch/Lot number: 044A214), administration date: 02Apr2021, for COVID-19 immunisation; moderna (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: 065F21A), administration date: 10Nov2021, for COVID-19 immunization; moderna (DOSE 4(BOOSTER), SINGLE, Batch/Lot number: 056A22A), administration date: 21Apr2022, for COVID-19 immunisation; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot number: 6H9697), administration date: 23Nov2022, for COVID-19 immunisation, reaction(s): "Interchange of vaccine products". The following information was reported: DIARRHOEA (non-serious) with onset 19Jul2023, outcome "recovering", described as "Severe diarrhea"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "recovering". The event "severe diarrhea" required physician office visit. Therapeutic measures were taken as a result of diarrhoea.  Additional Information: The patient Initially stated the diarrhea was resolved and clarified it started to resolve after four Imodium and Pepto Bismol and the diarrhea started to resolve yesterday and it was not completely resolved but was improved. For other medical conditions the patient stated there are not really any; no further details were provided. Regarding the diarrhea, she called her doctor and he said he trusted her to know if needed to go to the hospital and she considered it but she figured she was better off at home. Patient had no investigations. Expiry Date of Pfizer bivalent booster Covid vaccine was unknown.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Batch/Lot number: unknown), on 12Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Jul2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Treatment of COVID-19; (15Jul2023) Negative, notes: tested negative 7 days after starting paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid and recovered from COVID quickly and tested negative 7 days after starting paxlovid.   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 available information, a possible contributory role of the subject product cannot be excluded for suspected LOE.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.,Linked Report(s) : US-PFIZER INC-202300257232 Same patient different drug/events;
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201), on 04Mar2021 as dose 2, single (Lot number: EN6203), in right arm, on 29Sep2021 as dose 3 (booster), single (Lot number: FF2587), in right arm and on 20May2022 as dose 4 (booster), single (Lot number: FJ4989), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: other medical history: Arthritis. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19; patient was treated with PAXLOVID.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Known allergies: clindamycin"; Sentra, reaction(s): "Known allergies: Sentra". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was treated with Paxlovid from 12Jul2023 to 17Jul2023.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), on 20Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 20Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "mildly elevated LFTs (ALT 59, AST 44)" (unspecified if ongoing); "ALT 59" (unspecified if ongoing); "AST 44" (unspecified if ongoing); "self reported hx fatty liver" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with oral Paxlovid from 20Jul2023 to 22Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy (vaccination failure and COVID-19) with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Paxlovid treatment start date: 13Jul2023, stop date=17Jul2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 03: Pfizer/ Dose 04: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 at 09:00 as dose 1, single (Lot number: EP7534), in left arm, on 08Apr2021 at 09:00 as dose 2, single (Lot number: EW0151), in left arm and on 20Oct2021 at 09:00 as dose 3 (booster), single (Lot number: FE3509) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Apr2022 at 09:00 as dose 4 (booster), single (Lot number: 056A22A), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 17Sep2022 at 09:00 as dose 5 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "slightly elevated blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: XIGDUO XR, start date: 01Jul2023, stop date: 12Jul2023; ATORVASTATIN, start date: 01Jul2023, stop date: 12Jul2023; LISINOPRIL, start date: 01Jul2023, stop date: 12Jul2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Apr2022 at 09:00, outcome "unknown", described as "Dose 03: Pfizer/ Dose 04: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (20Jul2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2023) Negative, notes: Negative test 20Jul2023. Therapeutic measures, Paxlovid from 12Jul2023 to 17Jul2023 (Lot number: GF7308), were taken as a result of drug ineffective, covid-19. The patient has no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Jul2023 to unknown date in Jul2023. Clinical Course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300257454 same reporter/patent, different dug/AE;
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (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), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date: 07Jul2023 and stop date: 11Jul2023).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300257760 Same patient, different drug and event;
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Lot number: CtHg6g4) at the age of 52 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6204), on 01Apr2021 as dose 2, single (Lot number: ER8727), on 04Nov2021 as dose 3 (booster), single (Lot number: FG3527) and on 15Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid from 05Jul2023 to 10Jul2023, for the treatment of COVID-19. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ace inhibitors allergies" (unspecified if ongoing); "High blood pressure" (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 Jul2023, outcome "recovered" (Jul2023) and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 10Jul2023 to 15Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 14:30 as dose 4 (booster), single (Lot number: GH9694) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Obstructive Sleep Apnea" (unspecified if ongoing); "non-24 Sleep-Wake Circadian Rhythm Disorder" (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 Jul2023, outcome "recovered" (18Jul2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) Positive, notes: Treatment of COVID-19; (18Jul2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 11Jul2023 to 16Jul2023. Clinical course: The patient had no known allergies. Patient finished Paxlovid course on 16Jul2023. Felt better over 5-days while taking it. Throat and cough cleared up, sinuses were getting better. Symptoms mostly subsided Monday, 17Jul2023. Tested negative via at-home rapid test on Thurs 18Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300257791 same patient, different drug/events;
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Peripheral swelling
Clinical narrative: As I have taken boosters the legs have become more bigger; As I have taken boosters the legs have become more bigger; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in arm, on 23Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in arm and as dose 5 (booster), single (Lot number: GH9497) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1st, Date: 26Jan2021, Time (24hrs): Am, Site and route of injection:, Anatomical site of injection: Arm, Batch/Lot number: Pfizer EN5318, (name-withheld) came to facility), administration date: 26Jan2021, for COVID-19 immunization, reaction(s): "legs began to get bigger at a greater rate and itch and hot to the touch", "legs began to get bigger at a greater rate and itch and hot to the touch", "legs began to get bigger at a greater rate and itch and hot to the touch"; BNT162b2 (Dose: 2nd , Date: 16Feb2021, Time (24hrs): Am, Site and route of injection:, Anatomical site of injection: Arm, Batch/Lot number: Pfizer EN5318, (name-withheld) came to facility), administration date: 16Feb2021, for COVID-19 immunization, reaction(s): "the right began to swell, itching, hot to touch happened noticeable about 3 months  after second shot", "the right began to swell, itching, hot to touch happened noticeable about 3 months  after second shot", "the right began to swell, itching, hot to touch happened noticeable about 3 months  after second shot". The following information was reported: PERIPHERAL SWELLING (non-serious), CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "As I have taken boosters the legs have become more bigger".  Additional information: As I have taken boosters the legs have become more bigger. It caused by rebound to become worse. Prior vaccinations (within 4 weeks): None.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 at 13:00 as dose number unknown (booster), single (Lot number: GL0447), in right arm and on 14Jun2023 at 13:00 as dose number unknown (booster), single (Lot number: GJ6743) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (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), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event: Rebound Covid19; initial symptoms gone by 15Jul2023, returned 18Jul2023. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: terrible joint pain; muscle aches; headaches; naseaua; terrible fatigus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6201) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "headaches"; MYALGIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "muscle aches"; NAUSEA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "naseaua"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "terrible fatigus"; ARTHRALGIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "terrible joint pain".  Additional information: Within hours, Patient had terrible joint pain and muscle aches in all parts of my body at various times. She also had headaches, nausea and terrible fatigue. The reaction after the first lasted about 2 weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300258808 same reporter/patient/product, different dose/event;US-PFIZER INC-202300258807 same reporter/patient/product, different dose/event;US-PFIZER INC-202300258809 same reporter/patient/product, different dose/event;