chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Dyspnoea, Electrocardiogram, Myocardial infarction, Pain in extremity
Clinical narrative: Shortness of breath Chest pains Leg pains Heart Attack Timeline of Adverse Events: March 5, 2023: Went to the Emergency Room due to chest pain, discovered my right artery blockage and was having a heart attack. Had an emergency procedure to add stents to open passage way.  March 6, 2023: Had a second procedure to add another stent to the right artery.  (Hospitalized for one week) April 20, 2023: Had third procedure to add stent in the cx left artery done by Dr.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to chemicals, Amenorrhoea, Arthritis, Autoimmune disorder, Cardiac disorder
Clinical narrative: Heart palpitations, severe tremors, dysesthesia, dizziness, shortness of breath, squeezing and pounding chest pain, restless arms and legs, numbness, loss of coordination, swollen lymph nodes (softball sized starting in the under arm on the side of the shot, moved elsewhere in time)...diagnosed shortly after with heart damage from cardiac inflamation, PVC, PAC, mitral valve regurgitation, irregular T-waves. Amenorrhea (nearly no period) for ten months, followed by irregular periods with severe dysmenorrhea - not in peri or menopause, family history of children born late in life and menopause not until 50s. Onset of several autoimmune disorders in later months - MCAS skin rashes, severe arthritis, new food/chemical sensitivities.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Carditis, Chest discomfort, Chest pain, Coordination abnormal, Dizziness
Clinical narrative: Heart palpitations, severe tremors, dysesthesia, dizziness, shortness of breath, squeezing and pounding chest pain, restless arms and legs, numbness, loss of coordination, swollen lymph nodes (softball sized starting in the under arm on the side of the shot, moved elsewhere in time)...diagnosed shortly after with heart damage from cardiac inflamation, PVC, PAC, mitral valve regurgitation, irregular T-waves. Amenorrhea (nearly no period) for ten months, followed by irregular periods with severe dysmenorrhea - not in peri or menopause, family history of children born late in life and menopause not until 50s. Onset of several autoimmune disorders in later months - MCAS skin rashes, severe arthritis, new food/chemical sensitivities.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysaesthesia, Dyspnoea, Electrocardiogram T wave abnormal, Food allergy, Hypoaesthesia
Clinical narrative: Heart palpitations, severe tremors, dysesthesia, dizziness, shortness of breath, squeezing and pounding chest pain, restless arms and legs, numbness, loss of coordination, swollen lymph nodes (softball sized starting in the under arm on the side of the shot, moved elsewhere in time)...diagnosed shortly after with heart damage from cardiac inflamation, PVC, PAC, mitral valve regurgitation, irregular T-waves. Amenorrhea (nearly no period) for ten months, followed by irregular periods with severe dysmenorrhea - not in peri or menopause, family history of children born late in life and menopause not until 50s. Onset of several autoimmune disorders in later months - MCAS skin rashes, severe arthritis, new food/chemical sensitivities.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mast cell activation syndrome, Menstruation irregular, Mitral valve incompetence, Palpitations
Clinical narrative: Heart palpitations, severe tremors, dysesthesia, dizziness, shortness of breath, squeezing and pounding chest pain, restless arms and legs, numbness, loss of coordination, swollen lymph nodes (softball sized starting in the under arm on the side of the shot, moved elsewhere in time)...diagnosed shortly after with heart damage from cardiac inflamation, PVC, PAC, mitral valve regurgitation, irregular T-waves. Amenorrhea (nearly no period) for ten months, followed by irregular periods with severe dysmenorrhea - not in peri or menopause, family history of children born late in life and menopause not until 50s. Onset of several autoimmune disorders in later months - MCAS skin rashes, severe arthritis, new food/chemical sensitivities.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Restless arm syndrome, Restless legs syndrome, Supraventricular extrasystoles, Tremor
Clinical narrative: Heart palpitations, severe tremors, dysesthesia, dizziness, shortness of breath, squeezing and pounding chest pain, restless arms and legs, numbness, loss of coordination, swollen lymph nodes (softball sized starting in the under arm on the side of the shot, moved elsewhere in time)...diagnosed shortly after with heart damage from cardiac inflamation, PVC, PAC, mitral valve regurgitation, irregular T-waves. Amenorrhea (nearly no period) for ten months, followed by irregular periods with severe dysmenorrhea - not in peri or menopause, family history of children born late in life and menopause not until 50s. Onset of several autoimmune disorders in later months - MCAS skin rashes, severe arthritis, new food/chemical sensitivities.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Heart palpitations, severe tremors, dysesthesia, dizziness, shortness of breath, squeezing and pounding chest pain, restless arms and legs, numbness, loss of coordination, swollen lymph nodes (softball sized starting in the under arm on the side of the shot, moved elsewhere in time)...diagnosed shortly after with heart damage from cardiac inflamation, PVC, PAC, mitral valve regurgitation, irregular T-waves. Amenorrhea (nearly no period) for ten months, followed by irregular periods with severe dysmenorrhea - not in peri or menopause, family history of children born late in life and menopause not until 50s. Onset of several autoimmune disorders in later months - MCAS skin rashes, severe arthritis, new food/chemical sensitivities.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Anxiety, Crying, Discomfort, Flushing, Hypophagia
Clinical narrative: Patient received the DTaP-IPV on R thigh and VAR on L thigh approximately noon on 5/24/23.  Parents state overnight (Wednesday  evening 5/24/23 to Thursday morning 5/25/23), he was more uncomfortable, fussy and itchy.  They checked his temperature frequently, never higher than 99 oF.  He was eating less than normal on Thursday 5/25/23.  On Friday 5/26/23 when he woke up in the morning, the parents noted his R thigh was erythematous, swollen and with a blotchy rash.  He was itching this leg more frequently.  He was seen in the clinic. on 5/26/23 at 11 am.  At the visit on 5/24/23 he had stranger anxiety and was frequently crying; at the follow up visit on 5/26/23 he was crying again - not clear if due to pain or anxiety.  His R cheek was slightly flushed.  His R thigh was noticeably swollen compared to the L thigh (circumferentially) with an amorphous erythematous blanching rash and warm to touch compared to other skin sites.  There were no urticaria, bruises, petechiae.  No evidence of purulence or drainage.  The R and L legs had full range of motion at hips, knees, ankles, without effusions.  The patient was able to walk normally.  The patient was prescribed oral diphenhydramine, topical triamcinolone 0.1% ointment for the reaction site.  I also advised cool compresses to the area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Patient received the DTaP-IPV on R thigh and VAR on L thigh approximately noon on 5/24/23.  Parents state overnight (Wednesday  evening 5/24/23 to Thursday morning 5/25/23), he was more uncomfortable, fussy and itchy.  They checked his temperature frequently, never higher than 99 oF.  He was eating less than normal on Thursday 5/25/23.  On Friday 5/26/23 when he woke up in the morning, the parents noted his R thigh was erythematous, swollen and with a blotchy rash.  He was itching this leg more frequently.  He was seen in the clinic. on 5/26/23 at 11 am.  At the visit on 5/24/23 he had stranger anxiety and was frequently crying; at the follow up visit on 5/26/23 he was crying again - not clear if due to pain or anxiety.  His R cheek was slightly flushed.  His R thigh was noticeably swollen compared to the L thigh (circumferentially) with an amorphous erythematous blanching rash and warm to touch compared to other skin sites.  There were no urticaria, bruises, petechiae.  No evidence of purulence or drainage.  The R and L legs had full range of motion at hips, knees, ankles, without effusions.  The patient was able to walk normally.  The patient was prescribed oral diphenhydramine, topical triamcinolone 0.1% ointment for the reaction site.  I also advised cool compresses to the area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site warmth, Irritability, Pallor, Pruritus, Rash macular
Clinical narrative: Patient received the DTaP-IPV on R thigh and VAR on L thigh approximately noon on 5/24/23.  Parents state overnight (Wednesday  evening 5/24/23 to Thursday morning 5/25/23), he was more uncomfortable, fussy and itchy.  They checked his temperature frequently, never higher than 99 oF.  He was eating less than normal on Thursday 5/25/23.  On Friday 5/26/23 when he woke up in the morning, the parents noted his R thigh was erythematous, swollen and with a blotchy rash.  He was itching this leg more frequently.  He was seen in the clinic. on 5/26/23 at 11 am.  At the visit on 5/24/23 he had stranger anxiety and was frequently crying; at the follow up visit on 5/26/23 he was crying again - not clear if due to pain or anxiety.  His R cheek was slightly flushed.  His R thigh was noticeably swollen compared to the L thigh (circumferentially) with an amorphous erythematous blanching rash and warm to touch compared to other skin sites.  There were no urticaria, bruises, petechiae.  No evidence of purulence or drainage.  The R and L legs had full range of motion at hips, knees, ankles, without effusions.  The patient was able to walk normally.  The patient was prescribed oral diphenhydramine, topical triamcinolone 0.1% ointment for the reaction site.  I also advised cool compresses to the area.
Age: 76.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Immediate post-injection reaction, Injection site cellulitis
Clinical narrative: Patient came back about 1 week later reported that she developed cellulitis at the injection site immediately after immunization
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina pectoris
Clinical narrative: Angina within 2 weeks that still persists.
Age: 56.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Blood test, Colonoscopy, Computerised tomogram, Contusion, Oesophagogastroduodenoscopy
Clinical narrative: bruise on left leg, then swelling and pain in both legs, lasting 8+ weeks until completely resolved
Age: 56.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Pain in extremity, Peripheral swelling, Ultrasound Doppler
Clinical narrative: bruise on left leg, then swelling and pain in both legs, lasting 8+ weeks until completely resolved
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthritis, Injection site pain, Neuralgia, Pain, X-ray limb abnormal
Clinical narrative: patient came to the pharmacy on Monday 05/29/23 around 4:50 pm stating that she had received a vaccine  where she experienced pain at the injection site (left arm).She states the pain has not gone away and describes it as sharp shooting nerve pain. She has tried OTC pain meds and her pain still persists and is really bothering her. Pharmacist informed that temporary pain and soreness was normal, but it should not have lasted this long. Pharmacist asked why she did not notify pharmacy right away, but patient states because she did not want to get the person who gave the vaccine in trouble. Patient informed she visited her doctor about the issue, but does not recall when.  Patient informed she visited her doctor about the issue, but does not recall when. Her provider ordered x-ray of her left arm and it showed that she had arthritis. But she states that she does not agree that her pain is due to arthritis, she believes that the pain was caused by the vaccine. Her provider gave her medication for the pain but did not help, she stated that the medication was a tablet, but she does not know the name and she denies it being gabapentin or naproxen.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Nurse reported that GARDASIL 9 was administered to 1 patient following temperature excursion; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-MAY-2023, the patient was vaccinated with 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection that suffered a temperature excursion; lot # U031056, expiration date on 16-JUN-2024, for prophylaxis (route of administration and anatomical location were not provided).  The temperature excursion ranged from a temperature of 33.5°C for 7 hours and 31 minutes to a temperature of 16.3°C for 7 hours and 53 minutes. No previous temperature excursion occurred and no additional adverse events were reported.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; Caller reported VARIVAX administered after temperature excursion.  Caller states the Lot number and expiration date was incorrectly documented as W031810 10/5/2023 but the administered VARIVAX was actually W034708  11/1/2024.  No other information pr; This spontaneous report was received from a nurse referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 19-MAY-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, by intramuscular route, lot # W034708, expiation date: 01-NOV-2024 (validated internally), for prophylaxis (Strength and anatomical location were not reported) which was administered after temperature excursion (product storage error). The temperature was 6.4°F during a time frame of 42 minutes. No previous temperature excursions neither additional adverse events (no adverse event) were reported.     This is one of several report received from the same reporter.; Sender's Comments:  US-009507513-2305USA007991: US-009507513-2305USA007944:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient was vaccinated on 2003, then on 2011; This spontaneous report has been received from a health care professional via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (MARRS# 2207USA008600) concerning female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2003 (at approximately 1 year old) and on an unknown date in 2011 (at approximately 9 years old), the patient was vaccinated with first and second dose of varicella virus vaccine live (oka/merck) (VARIVAX) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration).  This is one from 2 cases from the same patient.; Sender's Comments:  US-009507513-2207USA008600:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient was administered her first dose of GARDASIL 9 before the age of 14 and then received her second dose at the age of 22.; no additional AE's were reported; This spontaneous report has been received from a nurse, regarding a 22-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies and drugs reactions or allergies were not reported.  On an unknown date (reported as before the age of 14 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, vaccination scheme, frequency, lot number, expiration date, and route of administration were not provided) administered for prophylaxis and on an unknown date (reported at age of 22 years old), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, vaccination scheme, frequency, lot number, expiration date, and route of administration were not provided) administered for prophylaxis (inappropriate schedule of product administration).  No additional adverse events (AE's) were reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details; HCP called to report a post TE Administration of VARIVAX Lot #W021741 EXP: 7/10/2024.; This spontaneous report has been received from an office manager and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 25-MAY-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (ml) once (valid lot number W021741 [expiration date 10-JUL-2024]) (dose number, frequency, route of administration vaccination scheme, and anatomical location were not provided), administered for prophylaxis, after a temperature excursion out of range for 0 hours 12 minutes and 0 seconds at -14.09 degrees Celsius, with a prior excursion of -2.2 degrees Celsius for 12 hours 30 minutes 0 seconds (product storage error).   No further adverse events (AEs) details.
Sex: U
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, Body temperature, Pyrexia, Rhinorrhoea
Clinical narrative: scratchy throat; runny nose; loss of taste; loss of taste and smell; elevated temp; This spontaneous case was reported by a patient and describes the occurrence of THROAT IRRITATION (scratchy throat), RHINORRHOEA (runny nose), AGEUSIA (loss of taste), ANOSMIA (loss of taste and smell) and PYREXIA (elevated temp) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient did not report any relevant medical history, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).     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 THROAT IRRITATION (scratchy throat), RHINORRHOEA (runny nose), AGEUSIA (loss of taste), ANOSMIA (loss of taste and smell) and PYREXIA (elevated temp). At the time of the report, THROAT IRRITATION (scratchy throat), RHINORRHOEA (runny nose), AGEUSIA (loss of taste), ANOSMIA (loss of taste and smell) and PYREXIA (elevated temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: elevated.     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.  The patient received all 3 shots. And within 8 hours, the patient had covid symptoms.  No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a patient (unknown age and gender) with no reported medical history, who experienced the non-serious unexpected, AESIs of ageusia and anosmia, which occurred within 8 hours after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as a dose of COVID-19 vaccination schedule, dose number not provided. The outcome of both events was reported as unknown. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: Throat irritation
Clinical narrative: scratchy throat; runny nose; loss of taste; loss of taste and smell; elevated temp; This spontaneous case was reported by a patient and describes the occurrence of THROAT IRRITATION (scratchy throat), RHINORRHOEA (runny nose), AGEUSIA (loss of taste), ANOSMIA (loss of taste and smell) and PYREXIA (elevated temp) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient did not report any relevant medical history, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).     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 THROAT IRRITATION (scratchy throat), RHINORRHOEA (runny nose), AGEUSIA (loss of taste), ANOSMIA (loss of taste and smell) and PYREXIA (elevated temp). At the time of the report, THROAT IRRITATION (scratchy throat), RHINORRHOEA (runny nose), AGEUSIA (loss of taste), ANOSMIA (loss of taste and smell) and PYREXIA (elevated temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: elevated.     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.  The patient received all 3 shots. And within 8 hours, the patient had covid symptoms.  No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a patient (unknown age and gender) with no reported medical history, who experienced the non-serious unexpected, AESIs of ageusia and anosmia, which occurred within 8 hours after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as a dose of COVID-19 vaccination schedule, dose number not provided. The outcome of both events was reported as unknown. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; a dose was administered after 30-day Use By Date; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose was administered after 30-day Use By Date) and NO ADVERSE EVENT (no adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-May-2023, 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 12-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 (a dose was administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a dose was administered after 30-day Use By Date) 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 (a dose was administered after 30-day Use By Date).    Concomitant medication details not reported by the reporter. The vial was stored in the fridge on 03-Apr-2023. This was the 1st Bivalent dose for the patient. Treatment details was not reported by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 03-Apr-2023 and was administered to patient on 09-May-2023; No adverse event; HCP is reporting that a dose was administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP is reporting that a dose was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 03-Apr-2023 and was administered to patient on 09-May-2023) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-May-2023, 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 09-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 (HCP is reporting that a dose was administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 03-Apr-2023 and was administered to patient on 09-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP is reporting that a dose was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 03-Apr-2023 and was administered to patient on 09-May-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP is reporting that a dose was administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 03-Apr-2023 and was administered to patient on 09-May-2023).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. It was reported that it was the 2nd Bivalent dose for the patient. Treatment medications were not provided.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: HCP is reporting that a dose was administered after 30-day Use By Date.; no adverse event; HCP is reporting that a dose was administered after 30-day Use By Date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP is reporting that a dose was administered after 30-day Use By Date.), PRODUCT STORAGE ERROR (HCP is reporting that a dose was administered after 30-day Use By Date.) and NO ADVERSE EVENT (no adverse event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-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 (HCP is reporting that a dose was administered after 30-day Use By Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (HCP is reporting that a dose was administered after 30-day Use By Date.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP is reporting that a dose was administered after 30-day Use By Date.), PRODUCT STORAGE ERROR (HCP is reporting that a dose was administered after 30-day Use By Date.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP is reporting that a dose was administered after 30-day Use By Date.) and PRODUCT STORAGE ERROR (HCP is reporting that a dose was administered after 30-day Use By Date.).    No concomitant medication was reported. It was reported that the vial was stored in the fridge on 03-Apr-2023. This was the 2nd Bivalent dose for the patient. The dosage text of the suspect product was reported as unknown. No treatment medication was reported.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the fridge on 03-Apr-2023 and was administered on 10-May-2023; No adverse event; dose was administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was stored in the fridge on 03-Apr-2023 and was administered on 10-May-2023) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-May-2023, 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 10-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 (dose was administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the fridge on 03-Apr-2023 and was administered on 10-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was stored in the fridge on 03-Apr-2023 and was administered on 10-May-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose was administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was stored in the fridge on 03-Apr-2023 and was administered on 10-May-2023).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that was the 2nd Bivalent dose for the patient. No treatment information was provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was reported that patient had no known conditions and received no other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 18-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023).    Concomitant drugs were not reported. No other adverse events were reported. Treatment medications were not provided.   This case was linked to MOD-2023-726266 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Circumstance or information capable of leading to a medication error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error).    No concomitant information was reported. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeding disorder, Illness, Impaired work ability, Nausea
Clinical narrative: loss of weight/ got down to 52 pounds; very ill/sickness/sick; can't even work anymore; constant nausea; constant vomiting; constant diarrhea; can't eat; can't gain weight; 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 53-year-old female patient received BNT162b2 (BNT162B2), on 08Jul2021 as dose 2, single (Lot number: FA6780) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: WEIGHT DECREASED (medically significant), outcome "unknown", described as "loss of weight/ got down to 52 pounds"; ILLNESS (non-serious), outcome "unknown", described as "very ill/sickness/sick"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "can't even work anymore"; NAUSEA (non-serious), outcome "unknown", described as "constant nausea"; VOMITING (non-serious), outcome "unknown", described as "constant vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "constant diarrhea"; FEEDING DISORDER (non-serious), outcome "unknown", described as "can't eat"; WEIGHT GAIN POOR (non-serious), outcome "unknown", described as "can't gain weight". The patient underwent the following laboratory tests and procedures: Weight: can't gain weight; Weight: 52 pounds, notes: got down to 52 pounds.  Additional information: Caller was a patient. Caller mentioned that she got Pfizer covid-19 vaccine Lot number FA6780 on 08Jul2021 (unverified) and she completed the 2 doses required on her job. She said that she was very ill since then, she never had covid, she consulted HCPs but they cannot point out the reason of her sickness, she was still sick and can't even work anymore. She experienced loss of weight, constant nausea, constant vomiting and constant diarrhea for almost 2 years now, got down to 52 pounds, can't eat and can't gain weight. Caller wanted to know the contents of the Pfizer covid-19 vaccine. She also mentioned that her mom had experienced the same symptoms who also received Pfizer covid-19 vaccine (she was not sure which formulation). She also added that she felt like 80 years old even though she was only 53 years old.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Weight, Weight decreased, Weight gain poor
Clinical narrative: loss of weight/ got down to 52 pounds; very ill/sickness/sick; can't even work anymore; constant nausea; constant vomiting; constant diarrhea; can't eat; can't gain weight; 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 53-year-old female patient received BNT162b2 (BNT162B2), on 08Jul2021 as dose 2, single (Lot number: FA6780) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: WEIGHT DECREASED (medically significant), outcome "unknown", described as "loss of weight/ got down to 52 pounds"; ILLNESS (non-serious), outcome "unknown", described as "very ill/sickness/sick"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "can't even work anymore"; NAUSEA (non-serious), outcome "unknown", described as "constant nausea"; VOMITING (non-serious), outcome "unknown", described as "constant vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "constant diarrhea"; FEEDING DISORDER (non-serious), outcome "unknown", described as "can't eat"; WEIGHT GAIN POOR (non-serious), outcome "unknown", described as "can't gain weight". The patient underwent the following laboratory tests and procedures: Weight: can't gain weight; Weight: 52 pounds, notes: got down to 52 pounds.  Additional information: Caller was a patient. Caller mentioned that she got Pfizer covid-19 vaccine Lot number FA6780 on 08Jul2021 (unverified) and she completed the 2 doses required on her job. She said that she was very ill since then, she never had covid, she consulted HCPs but they cannot point out the reason of her sickness, she was still sick and can't even work anymore. She experienced loss of weight, constant nausea, constant vomiting and constant diarrhea for almost 2 years now, got down to 52 pounds, can't eat and can't gain weight. Caller wanted to know the contents of the Pfizer covid-19 vaccine. She also mentioned that her mom had experienced the same symptoms who also received Pfizer covid-19 vaccine (she was not sure which formulation). She also added that she felt like 80 years old even though she was only 53 years old.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Wrong product administered
Clinical narrative: both doses of Pfizer BioNTech COVID 19 Vaccine the Bivalent Gray Cap; Arm swelled up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2, 30 ug single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (COMIRNATY). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2;bnt162b2 omi ba.4-5 (Dose: 01, Lot/exp/NDC Unknown), when the patient was 65 years old, for COVID-19 Immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "both doses of Pfizer BioNTech COVID 19 Vaccine the Bivalent Gray Cap"; PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "Arm swelled up". It was unknown if therapeutic measures were taken as a result of peripheral swelling.  Additional information: Patient received the Pfizer BioNTech COVID 19 Vaccine the Bivalent Gray Cap. Her arm swelled up and was swollen for 4 weeks or more. She had complications in that regard. She was okay then. This was just mentioned in passing. She appeared to have recovered completely and has normal function now. The event occurred after the second dose.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeding disorder, Illness, Nausea, Vomiting
Clinical narrative: loss of weight; very ill/sickness/sick; constant nausea; constant vomiting; constant diarrhea; can't eat; can't gain weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 88-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WEIGHT DECREASED (medically significant), outcome "recovered", described as "loss of weight"; ILLNESS (non-serious), outcome "recovered", described as "very ill/sickness/sick"; NAUSEA (non-serious), outcome "recovered", described as "constant nausea"; VOMITING (non-serious), outcome "recovered", described as "constant vomiting"; DIARRHOEA (non-serious), outcome "recovered", described as "constant diarrhea"; FEEDING DISORDER (non-serious), outcome "recovered", described as "can't eat"; WEIGHT GAIN POOR (non-serious), outcome "recovered", described as "can't gain weight". The patient underwent the following laboratory tests and procedures: Weight: loss. Clinical course: she was still sick and can not even work anymore. She experienced loss of weight, constant nausea, constant vomiting and constant diarrhea for almost 2 years now, got down to 52 pounds, can not eat, can not gain weight. Caller wanted to know the contents of the Pfizer covid-19 vaccine. She also mentioned that her mom (patient) is experienced the same symptoms who also received Pfizer covid-19 vaccine (she was not sure which formulation). Her mom was not going through that and she was 88. Her symptoms were by her daughter checked in the last 3 months.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300202423 Same reporter/vaccine/event, different patient;US-PFIZER INC-202300203422 Same reporter, different patient/drug/event;
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased, Weight gain poor
Clinical narrative: loss of weight; very ill/sickness/sick; constant nausea; constant vomiting; constant diarrhea; can't eat; can't gain weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 88-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WEIGHT DECREASED (medically significant), outcome "recovered", described as "loss of weight"; ILLNESS (non-serious), outcome "recovered", described as "very ill/sickness/sick"; NAUSEA (non-serious), outcome "recovered", described as "constant nausea"; VOMITING (non-serious), outcome "recovered", described as "constant vomiting"; DIARRHOEA (non-serious), outcome "recovered", described as "constant diarrhea"; FEEDING DISORDER (non-serious), outcome "recovered", described as "can't eat"; WEIGHT GAIN POOR (non-serious), outcome "recovered", described as "can't gain weight". The patient underwent the following laboratory tests and procedures: Weight: loss. Clinical course: she was still sick and can not even work anymore. She experienced loss of weight, constant nausea, constant vomiting and constant diarrhea for almost 2 years now, got down to 52 pounds, can not eat, can not gain weight. Caller wanted to know the contents of the Pfizer covid-19 vaccine. She also mentioned that her mom (patient) is experienced the same symptoms who also received Pfizer covid-19 vaccine (she was not sure which formulation). Her mom was not going through that and she was 88. Her symptoms were by her daughter checked in the last 3 months.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300202423 Same reporter/vaccine/event, different patient;US-PFIZER INC-202300203422 Same reporter, different patient/drug/event;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: Gh9694) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 20Jan2021 as dose 2, single (Lot number: EL1283), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: Fe3592), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: Fj9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ASPIRINE; TYLENOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had no known allergy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300202467 same patient, different drug/event;
Sex: U
Vaccine: PNC13
Symptoms: Illness, Malaise
Clinical narrative: not getting high enough IG and requiring boosting as they get sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "not getting high enough IG and requiring boosting as they get sick".  Additional information: Some kids [5 over the last few years] not getting high enough IG and requiring boosting as they get sick.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300092588 same drug and event with different patient.;