chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired vaccine used/ patient recieved expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ patient recieved expired vaccine) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ patient recieved expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ patient recieved expired vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ patient recieved expired vaccine).    No concomitant medications were reported.  Reporter started that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine reported as Unknown and did not had information about previous COVID-19 vaccination doses.  The vial was exposed to room temperature for about 15-20 minutes.  Reporter stated that there were two patients 35-40 years old. One was male and one was female, and They dispensed 2 expired vaccines. It was first thawed yesterday 6-Dec-2022.  No treatment medications were reported.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; No Adverse event; 14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.), PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.), PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.).    No concomitant drug information was provided.  It was reported that 14 patient had received the vaccine which was in refrigerator past 30 days.  the vaccine used by date was 26-Nov-2022 however vaccine was administered on 01-Dec-2022.  No treatment drug details were provided.  The case contains the details of one of the 14 adult patients who had received an expired vaccine as reported by the reporter.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No Adverse event; 14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) in an adult 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. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      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 (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.).    No relevant concomitant medications were reported.  Dose was administered on 01-Dec-2022 from lot number 021H22A, best use by date of 26-Nov-2022. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-685141 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-685141:Samer Reporter
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) in an adult 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. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      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 (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.).    No relevant concomitant medications were reported.  Dose was administered on 01-Dec-2022 from lot number 021H22A, best use by date of 26-Nov-2022. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-685141 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-685141:Samer Reporter
Age: 46.0
Sex: F
Vaccine: FLUC4, PNC20, FLUC4, PNC20
Symptoms: Cough, Paraesthesia oral, Swollen tongue
Clinical narrative: Per PCP: Patient given flu shot left arm, then given prevnar 20 right arm. After prevnar - complained of tingling tongue. No swelling.  50mg Benedryl given.  Then developed itching and cough. Epi given and EMS called.  Albuterol neb given - she does develop tremors with this. Abodominal pain/nausea - no vomit.  Vitals noted in system and on Emergency response report. Lowest pulse ox 95% ER called - report given.  Transport to ER by Ambulance.   per ED: Patient arrives via EMS with c/o allergic reaction after receiving pneumonia and flu vaccines. Reports having mouth tingling, progressed to tongue swelling. Benadryl 50 mg given, symptoms progressed, to throat tightness and cough. Albuterol administered, pt has allergy to medication. Epi then given in route. A/O, dry cough, abdominal pain, mild tongue swelling on arrival. 98% RA  Tongue itching and swelling after IM Prevnar and Flu vaccine. Given oral Benadryl 50 mg. Then had coughing so gave IM Epi. No swelling on physical exam.  ED COURSE/MEDICAL DECISION MAKING  15:00 Pt presenting with complaints of tongue swelling/tingling. Patient well-appearing on exam, no obvious facial swelling was noted. Will give patient prednisone 17:30 patient remained asymptomatic, feels comfortable being discharged home. Pt is 4 hours post treatment. Was given prescription for prednisone and Benadryl. Patient does have an EpiPen home if needed  Impression: The encounter diagnosis was Allergic reaction to drug, initial encounter.
Age: 46.0
Sex: F
Vaccine: FLUC4, PNC20, FLUC4, PNC20
Symptoms: Abdominal pain, Cough, Electrocardiogram normal, Hypersensitivity, Nausea
Clinical narrative: Per PCP: Patient given flu shot left arm, then given prevnar 20 right arm. After prevnar - complained of tingling tongue. No swelling.  50mg Benedryl given.  Then developed itching and cough. Epi given and EMS called.  Albuterol neb given - she does develop tremors with this. Abodominal pain/nausea - no vomit.  Vitals noted in system and on Emergency response report. Lowest pulse ox 95% ER called - report given.  Transport to ER by Ambulance.   per ED: Patient arrives via EMS with c/o allergic reaction after receiving pneumonia and flu vaccines. Reports having mouth tingling, progressed to tongue swelling. Benadryl 50 mg given, symptoms progressed, to throat tightness and cough. Albuterol administered, pt has allergy to medication. Epi then given in route. A/O, dry cough, abdominal pain, mild tongue swelling on arrival. 98% RA  Tongue itching and swelling after IM Prevnar and Flu vaccine. Given oral Benadryl 50 mg. Then had coughing so gave IM Epi. No swelling on physical exam.  ED COURSE/MEDICAL DECISION MAKING  15:00 Pt presenting with complaints of tongue swelling/tingling. Patient well-appearing on exam, no obvious facial swelling was noted. Will give patient prednisone 17:30 patient remained asymptomatic, feels comfortable being discharged home. Pt is 4 hours post treatment. Was given prescription for prednisone and Benadryl. Patient does have an EpiPen home if needed  Impression: The encounter diagnosis was Allergic reaction to drug, initial encounter.
Age: 46.0
Sex: F
Vaccine: FLUC4, PNC20, FLUC4, PNC20
Symptoms: Paraesthesia oral, Pruritus, Swollen tongue, Throat tightness, Tongue pruritus
Clinical narrative: Per PCP: Patient given flu shot left arm, then given prevnar 20 right arm. After prevnar - complained of tingling tongue. No swelling.  50mg Benedryl given.  Then developed itching and cough. Epi given and EMS called.  Albuterol neb given - she does develop tremors with this. Abodominal pain/nausea - no vomit.  Vitals noted in system and on Emergency response report. Lowest pulse ox 95% ER called - report given.  Transport to ER by Ambulance.   per ED: Patient arrives via EMS with c/o allergic reaction after receiving pneumonia and flu vaccines. Reports having mouth tingling, progressed to tongue swelling. Benadryl 50 mg given, symptoms progressed, to throat tightness and cough. Albuterol administered, pt has allergy to medication. Epi then given in route. A/O, dry cough, abdominal pain, mild tongue swelling on arrival. 98% RA  Tongue itching and swelling after IM Prevnar and Flu vaccine. Given oral Benadryl 50 mg. Then had coughing so gave IM Epi. No swelling on physical exam.  ED COURSE/MEDICAL DECISION MAKING  15:00 Pt presenting with complaints of tongue swelling/tingling. Patient well-appearing on exam, no obvious facial swelling was noted. Will give patient prednisone 17:30 patient remained asymptomatic, feels comfortable being discharged home. Pt is 4 hours post treatment. Was given prescription for prednisone and Benadryl. Patient does have an EpiPen home if needed  Impression: The encounter diagnosis was Allergic reaction to drug, initial encounter.
Age: 46.0
Sex: F
Vaccine: FLUC4, PNC20, FLUC4, PNC20
Symptoms: Tremor
Clinical narrative: Per PCP: Patient given flu shot left arm, then given prevnar 20 right arm. After prevnar - complained of tingling tongue. No swelling.  50mg Benedryl given.  Then developed itching and cough. Epi given and EMS called.  Albuterol neb given - she does develop tremors with this. Abodominal pain/nausea - no vomit.  Vitals noted in system and on Emergency response report. Lowest pulse ox 95% ER called - report given.  Transport to ER by Ambulance.   per ED: Patient arrives via EMS with c/o allergic reaction after receiving pneumonia and flu vaccines. Reports having mouth tingling, progressed to tongue swelling. Benadryl 50 mg given, symptoms progressed, to throat tightness and cough. Albuterol administered, pt has allergy to medication. Epi then given in route. A/O, dry cough, abdominal pain, mild tongue swelling on arrival. 98% RA  Tongue itching and swelling after IM Prevnar and Flu vaccine. Given oral Benadryl 50 mg. Then had coughing so gave IM Epi. No swelling on physical exam.  ED COURSE/MEDICAL DECISION MAKING  15:00 Pt presenting with complaints of tongue swelling/tingling. Patient well-appearing on exam, no obvious facial swelling was noted. Will give patient prednisone 17:30 patient remained asymptomatic, feels comfortable being discharged home. Pt is 4 hours post treatment. Was given prescription for prednisone and Benadryl. Patient does have an EpiPen home if needed  Impression: The encounter diagnosis was Allergic reaction to drug, initial encounter.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Vaccine was administered in error, as it was not bivalent and had expired on 10/5/2022. No adverse outcomes resulted from the event.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered in error, as it was not bivalent and had expired on 10/5/2022. No adverse outcomes resulted from the event.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Vaccine was administered in error, as it was not the bivalent vaccine and had expired on 10/5/2022. No reported adverse outcomes as a result of the event.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Incorrect product formulation administered
Clinical narrative: Vaccine was administered in error, as it was not the bivalent vaccine and had expired on 10/5/2022. No reported adverse outcomes as a result of the event.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Vaccine administered in error, as it was not the bivalent vaccine and had expired on 10/5/2022.  No reported adverse outcomes as a result of the event.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Incorrect product formulation administered
Clinical narrative: Vaccine administered in error, as it was not the bivalent vaccine and had expired on 10/5/2022.  No reported adverse outcomes as a result of the event.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Vaccine was administered in error, as it was not the bivalent vaccine and had expired on 10/5/2022. No reported adverse outcomes as a result of the event.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Incorrect product formulation administered
Clinical narrative: Vaccine was administered in error, as it was not the bivalent vaccine and had expired on 10/5/2022. No reported adverse outcomes as a result of the event.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Vaccine was administered in error, as it was not the bivalent vaccine and had expired on 10/5/2022. No reported adverse outcomes as a result of the event.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Incorrect product formulation administered, No adverse event, Product administration error
Clinical narrative: Vaccine was administered in error, as it was not the bivalent vaccine and had expired on 10/5/2022. No reported adverse outcomes as a result of the event.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Vaccine was administered in error, as it was not the bivalent vaccine and had expired on 10/05/2022. No reported adverse outcomes as a result of the event.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Incorrect product formulation administered
Clinical narrative: Vaccine was administered in error, as it was not the bivalent vaccine and had expired on 10/05/2022. No reported adverse outcomes as a result of the event.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Vaccine was administered in error, as it was not the bivalent vaccine and had expired on 10/05/2022. No reported adverse outcomes resulting from event.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Incorrect product formulation administered
Clinical narrative: Vaccine was administered in error, as it was not the bivalent vaccine and had expired on 10/05/2022. No reported adverse outcomes resulting from event.
Age: 79.0
Sex: M
Vaccine: FLUA4, FLU4
Symptoms: Adverse reaction, Gait disturbance, Hemiparesis, Muscular weakness, Nervous system disorder
Clinical narrative: Muscle weakness in lower extremeties
Age: 79.0
Sex: M
Vaccine: FLUA4, FLU4
Symptoms: Posture abnormal
Clinical narrative: Muscle weakness in lower extremeties
Age: 79.0
Sex: M
Vaccine: FLUA4, FLU4
Symptoms: Computerised tomogram, Magnetic resonance imaging, Muscular weakness, Ultrasound Doppler
Clinical narrative: Muscle weakness in lower extremeties
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hip replacement" (unspecified if ongoing), notes had to take amoxicillin due to history of a hip replacement. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, notes had to take amoxicillin due to history of a hip replacement. The following information was reported: INJECTION SITE PAIN (non-serious), outcome "unknown", described as "I always get a sore arm where I get the shot". Additional information: Patient had received the newest booster. She mentioned, at the time, she always gets a sore arm where she gets the shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hip replacement" (unspecified if ongoing), notes had to take amoxicillin due to history of a hip replacement. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, notes had to take amoxicillin due to history of a hip replacement. The following information was reported: INJECTION SITE PAIN (non-serious), outcome "unknown", described as "I always get a sore arm where I get the shot". Additional information: Patient had received the newest booster. She mentioned, at the time, she always gets a sore arm where she gets the shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hip replacement" (unspecified if ongoing), notes: had to take amoxicillin due to history of a hip replacement. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, sngle), for Covid-19 Immunization, reaction(s): "I always get a sore arm where I get the shot". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I always get a sore arm where I get the shot". Additional information: Caller states she called a few weeks ago and informed that she had received the newest booster. She had to go to her dentist and had to take amoxicillin due to history of a hip replacement. She mentioned, at the time, she always gets a sore arm where she get the shot. She did share information about friends that came down with Covid a few weeks (approximately 2 weeks) after receiving their Pfizer newest booster dose.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body height, Vaccination site pain, Weight
Clinical narrative: I always get a sore arm where I get the shot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hip Replacement" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILLIN taken for hip arthroplasty. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: Unknown), for COVID-19 immunization, reaction(s): "I always get a sore arm where I get the shot"; Bnt162b2 (Dose 2, Single, Lot number: Unknown), for COVID-19 immunization, reaction(s): "I always get a sore arm where I get the shot"; Bnt162b2 (Dose 3 (Booster), Single, Lot number: Unknown), for COVID-19 immunization, reaction(s): "I always get a sore arm where I get the shot". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I always get a sore arm where I get the shot".  Additional information: The patient received the newest booster dose. She consulted her dentist and recommended her to take amoxicillin due to the history of a hip replacement. At the vaccination time, she always got a sore arm where she got the shot. The patient stated that she did share information about her friends that came down with Covid-19 a few weeks (approximately 2 weeks) after receiving their Pfizer newest booster dose. She reported that she's being bombarded with multiple (8 packs) of mailed packages. She doesn't want to get any more questionnaires regarding the provided information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: I always get a sore arm where I get the shot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hip Replacement" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILLIN taken for hip arthroplasty. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: Unknown), for COVID-19 immunization, reaction(s): "I always get a sore arm where I get the shot"; Bnt162b2 (Dose 2, Single, Lot number: Unknown), for COVID-19 immunization, reaction(s): "I always get a sore arm where I get the shot"; Bnt162b2 (Dose 3 (Booster), Single, Lot number: Unknown), for COVID-19 immunization, reaction(s): "I always get a sore arm where I get the shot". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I always get a sore arm where I get the shot".  Additional information: The patient received the newest booster dose. She consulted her dentist and recommended her to take amoxicillin due to the history of a hip replacement. At the vaccination time, she always got a sore arm where she got the shot. The patient stated that she did share information about her friends that came down with Covid-19 a few weeks (approximately 2 weeks) after receiving their Pfizer newest booster dose. She reported that she's being bombarded with multiple (8 packs) of mailed packages. She doesn't want to get any more questionnaires regarding the provided information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 17.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok vaccine intended for 18 yo and older administered to pt, no side effects, treatment required
Age: 17.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok vaccine intended for 18 yo and older administered to pt, no side effects, treatment required
Age: 14.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok vaccine intended for 18 yo and older administered to pt, no side effects, treament required
Age: 14.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok vaccine intended for 18 yo and older administered to pt, no side effects, treament required
Age: 0.5
Sex: U
Vaccine: HEPA, MMRV
Symptoms: Incorrect route of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs or PQC reported; Caller reported PROQUAD administered to a 6 month old and is also documented as being administered IM.; Caller reported PROQUAD administered to a 6 month old and is also documented as being administered IM.; This spontaneous report was received from  a nurse prescriber and refers to a 6-month-old patient of unknown gender.The patient's medical history and concurrent conditions were not reported.   On 07-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter, lot #W024968, expiration date: 05-FEB-2024, administered intramuscularly(IM) for prophylaxis (strength was not provided) (product administered to patient of inappropriate age, incorrect route of product administration; the reporter was unsure if injection was truly given IM or if the documentation was incorrect). On the same date and visit, the patient also received the first doses of diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided; no information was provided but since patient received first dose at 6 months of age,  the use was outside of prescribing information (PI)); and  hepatitis a vaccine inact (HAVRIX), administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided). No additional adverse events were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored vaccine involved in a temperature excursion was administered to a patient.; No additional AE; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # W006595 has been verified to be a valid lot number haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and establish 10-OCT-2024) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 57.49° Fahrenheit (F) for 1 hour and 45 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.
Sex: U
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia) in an adult 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. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (tachycardia). At the time of the report, TACHYCARDIA (tachycardia) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient had a lot of Tachycardia after taking the Moderna COVID-19 vaccines. No treatment information was reported.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: lot of hair loss to the point where her hair is now only half an inch in thickness; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (lot of hair loss to the point where her hair is now only half an inch in thickness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 025L20A, 007M20A and 026D21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism, Blood pressure high and Cholesterol. Concomitant products included LOSARTAN and AMLODIPINE for Blood pressure high, PRAVASTATIN for Cholesterol, LEVOTHYROXINE for Hypothyroidism.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ALOPECIA (lot of hair loss to the point where her hair is now only half an inch in thickness). At the time of the report, ALOPECIA (lot of hair loss to the point where her hair is now only half an inch in thickness) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had 4 Moderna COVID-19 vaccines previously, including 2 primary doses and 2 boosters. Patient received her most recent booster dose on 10APR2022 and about a month later the patient started experiencing hair loss. The hair was almost down to the knees and had a thickness of at least 2 inches. Ever since the 2nd booster dose, having a lot of hair loss to the point where the hair was only half an inch in thickness. The patient had gone on a cruise and by the time,  got off the cruise  had lost so much hair and had to cut the hair off. The patient had finally the little hairs are coming back but it was still very thin. Some hair was still falling out as well. The diagnosis was called alopecia areata. The patient was concerned that she will continue to lose more hair if the patient goes for the updated Moderna COVID-19 bivalent booster. The patient had looked everywhere online and has not found any information on whether the bivalent booster was causing hair loss in people. No treatment medication was reported.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; expired dose of Moderna Covid-19 vaccine (Monovalent) was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose of Moderna Covid-19 vaccine (Monovalent) was administered) and NO ADVERSE EVENT (No Adverse event) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose of Moderna Covid-19 vaccine (Monovalent) was administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose of Moderna Covid-19 vaccine (Monovalent) was administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired dose of Moderna Covid-19 vaccine (Monovalent) was administered).    Concomitant medications were not reported.  The vial size was 5.5 ml. The vial did not undergo any temperature excursions. Treatment medications were not reported.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: COVID-19 Vaccine monovalent and bivalent that experienced a temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 Vaccine monovalent and bivalent that experienced a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 Vaccine monovalent and bivalent that experienced a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 Vaccine monovalent and bivalent that experienced a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 Vaccine monovalent and bivalent that experienced a temperature excursion).  For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Moderna Covid-19 Batch number reported as AS1416B, 018C22A, 024H22A, 044C22A. HCP stated hundreds of patients were administered with vials of Moderna COVID-19 Vaccine monovalent and bivalent that experienced a temperature excursion with cumulative time (between 2Dec2022 and 8Dec2022) of 50 minutes with minimum temperature of 1.3°C in the fridge.  No Concomitant medications were reported by reporter. No Treatment medication was provided by reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: patient received a 0.25ml bivalent booster dose instead of a 0.5ml Moderna bivalent booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received a 0.25ml bivalent booster dose instead of a 0.5ml Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 08-Dec-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received a 0.25ml bivalent booster dose instead of a 0.5ml Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received a 0.25ml bivalent booster dose instead of a 0.5ml Moderna bivalent booster) 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 ACCIDENTAL UNDERDOSE (patient received a 0.25ml bivalent booster dose instead of a 0.5ml Moderna bivalent booster).    No concomitant medication information was provided.  The patient received her first Moderna additional booster dose on 08-Dec-2022  The patient received the vaccine in her right arm deltoid muscle, the patient reports no other adverse reactions.  The patient received her first dose of the Moderna Covid-19 vaccine on 27-Apr-202, lot number 045B21A expiration date is not known. It is not known which arm the patient received the vaccine in. There are no known adverse reactions.   The patient received her second Moderna Primary Series vaccine on 25-May-2021, lot number 033B21A expiration date is not known. Injection site arm is not known. There are no known adverse reactions.  No treatment medication were provided.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Chills, Headache, Impaired quality of life, Insomnia
Clinical narrative: tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch; She can't sleep; Her quality of life is not good since then; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), INSOMNIA (She can't sleep), IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then), HEADACHE (headache) and CHILLS (chills) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), INSOMNIA (She can't sleep), IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had not resolved and INSOMNIA (She can't sleep) and IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: Negative. On an unknown date, Magnetic resonance imaging: Negative.         No concomitant product reported by the reporter. It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the doctors kept saying they don't know enough about the COVID vaccines. They had other patients who had tinnitus. They say to wait it out and let it go away. She did wait it out and do what they were saying. Her quality of life was not good since then. that the ringing turned into a piercing sound and it's pulsating in her left ear only. It was a high pitch. It  was repetitive like a ceiling fan. It was all day. It was a high-pitched pierce. It was hard to turn it off and not think about it. No treatment medication reported by the reporter.   This case was linked to MOD-2022-685668 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Pyrexia, Tinnitus
Clinical narrative: tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch; She can't sleep; Her quality of life is not good since then; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), INSOMNIA (She can't sleep), IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then), HEADACHE (headache) and CHILLS (chills) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), INSOMNIA (She can't sleep), IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had not resolved and INSOMNIA (She can't sleep) and IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: Negative. On an unknown date, Magnetic resonance imaging: Negative.         No concomitant product reported by the reporter. It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the doctors kept saying they don't know enough about the COVID vaccines. They had other patients who had tinnitus. They say to wait it out and let it go away. She did wait it out and do what they were saying. Her quality of life was not good since then. that the ringing turned into a piercing sound and it's pulsating in her left ear only. It was a high pitch. It  was repetitive like a ceiling fan. It was all day. It was a high-pitched pierce. It was hard to turn it off and not think about it. No treatment medication reported by the reporter.   This case was linked to MOD-2022-685668 (Patient Link).