chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Fatigue, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; experienced headache, lasting 24hrs; experienced fever, lasting 24hrs; experienced tired, lasting 24hrs; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID-19), HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no known allergies. Patient had no history of Myocarditis/pericarditis.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs). The patient was treated with ACETAMINOPHEN at a dose of 500 milligram. At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. The patient had not taken any other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient was not hospitalized due to COVID-19.  Company comment: This is a Spontaneous case concerning a 25-year-old female patient with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (reported as Tested positive for COVID-19). The event occurred 8 months and 17 days after the second dose of mRNA-1273. Exact period of time between doses 1 and 2 of mRNA-1273 was not reported. The patient was not hospitalized due to COVID-19. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.   This case was linked to MOD-2022-593007, MOD-2022-593014, MOD-2022-592989 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 25-year-old female patient with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (reported as Tested positive for COVID-19). The event occurred 8 months and 17 days after the second dose of mRNA-1273. Exact period of time between doses 1 and 2 of mRNA-1273 was not reported. The patient was not hospitalized due to COVID-19. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood glucose, Blood test, Computerised tomogram, Electrocardiogram
Clinical narrative: Transient Global Amnesia episode; Vomiting; Vertigo; Hives; Crushing pain in lung and back area during 36 hours after the 2nd booster; Crushing pain in lung and back area during 36 hours after the 2nd booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2022 at 15:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CALCIUM and VIT D; D3. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin", notes: Known allergies: Neomycin. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 Immunization. The following information was reported: PULMONARY PAIN (non-serious), BACK PAIN (non-serious) all with onset 28May2022, outcome "recovered with sequelae" and all described as "Crushing pain in lung and back area during 36 hours after the 2nd booster"; URTICARIA (non-serious) with onset 28May2022, outcome "recovered with sequelae", described as "Hives"; VERTIGO (non-serious) with onset 28May2022, outcome "recovered with sequelae"; VOMITING (non-serious) with onset 28May2022, outcome "recovered with sequelae"; TRANSIENT GLOBAL AMNESIA (hospitalization) with onset 20Jun2022, outcome "recovered with sequelae", described as "Transient Global Amnesia episode". The event "transient global amnesia episode" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (2022) Unknown results, notes: Multiple Blood Work; SARS-CoV-2 test: (19Jun2022) Negative; Urine analysis: (2022) Unknown results. Therapeutic measures were taken as a result of transient global amnesia, vomiting, vertigo, urticaria, pulmonary pain, back pain. Clinical course: Went to the ER at (Hospital) at approximately 7:15 pm. Admitted at approximately 1:30 am on 21Jun2022. Adverse event treatment were Multiple Blood Work, urinalysis, heart and blood p No COVID prior vaccination. COVID was tested post vaccination. Adverse events were during 36 hours after the 2nd booster.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Pulmonary pain, Transient global amnesia, Urine analysis, Urticaria
Clinical narrative: Transient Global Amnesia episode; Vomiting; Vertigo; Hives; Crushing pain in lung and back area during 36 hours after the 2nd booster; Crushing pain in lung and back area during 36 hours after the 2nd booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2022 at 15:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CALCIUM and VIT D; D3. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin", notes: Known allergies: Neomycin. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 Immunization. The following information was reported: PULMONARY PAIN (non-serious), BACK PAIN (non-serious) all with onset 28May2022, outcome "recovered with sequelae" and all described as "Crushing pain in lung and back area during 36 hours after the 2nd booster"; URTICARIA (non-serious) with onset 28May2022, outcome "recovered with sequelae", described as "Hives"; VERTIGO (non-serious) with onset 28May2022, outcome "recovered with sequelae"; VOMITING (non-serious) with onset 28May2022, outcome "recovered with sequelae"; TRANSIENT GLOBAL AMNESIA (hospitalization) with onset 20Jun2022, outcome "recovered with sequelae", described as "Transient Global Amnesia episode". The event "transient global amnesia episode" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (2022) Unknown results, notes: Multiple Blood Work; SARS-CoV-2 test: (19Jun2022) Negative; Urine analysis: (2022) Unknown results. Therapeutic measures were taken as a result of transient global amnesia, vomiting, vertigo, urticaria, pulmonary pain, back pain. Clinical course: Went to the ER at (Hospital) at approximately 7:15 pm. Admitted at approximately 1:30 am on 21Jun2022. Adverse event treatment were Multiple Blood Work, urinalysis, heart and blood p No COVID prior vaccination. COVID was tested post vaccination. Adverse events were during 36 hours after the 2nd booster.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Transient Global Amnesia episode; Vomiting; Vertigo; Hives; Crushing pain in lung and back area during 36 hours after the 2nd booster; Crushing pain in lung and back area during 36 hours after the 2nd booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2022 at 15:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CALCIUM and VIT D; D3. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin", notes: Known allergies: Neomycin. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 Immunization. The following information was reported: PULMONARY PAIN (non-serious), BACK PAIN (non-serious) all with onset 28May2022, outcome "recovered with sequelae" and all described as "Crushing pain in lung and back area during 36 hours after the 2nd booster"; URTICARIA (non-serious) with onset 28May2022, outcome "recovered with sequelae", described as "Hives"; VERTIGO (non-serious) with onset 28May2022, outcome "recovered with sequelae"; VOMITING (non-serious) with onset 28May2022, outcome "recovered with sequelae"; TRANSIENT GLOBAL AMNESIA (hospitalization) with onset 20Jun2022, outcome "recovered with sequelae", described as "Transient Global Amnesia episode". The event "transient global amnesia episode" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (2022) Unknown results, notes: Multiple Blood Work; SARS-CoV-2 test: (19Jun2022) Negative; Urine analysis: (2022) Unknown results. Therapeutic measures were taken as a result of transient global amnesia, vomiting, vertigo, urticaria, pulmonary pain, back pain. Clinical course: Went to the ER at (Hospital) at approximately 7:15 pm. Admitted at approximately 1:30 am on 21Jun2022. Adverse event treatment were Multiple Blood Work, urinalysis, heart and blood p No COVID prior vaccination. COVID was tested post vaccination. Adverse events were during 36 hours after the 2nd booster.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Pulmonary pain, SARS-CoV-2 test, Transient global amnesia
Clinical narrative: Transient Global Amnesia episode; Vomiting; Vertigo; Hives; Crushing pain in lung and back area during 36 hours after the 2nd booster; Crushing pain in lung and back area during 36 hours after the 2nd booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2022 at 15:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CALCIUM and VIT D; D3. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin", notes: Known allergies: Neomycin. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 Immunization. The following information was reported: PULMONARY PAIN (non-serious), BACK PAIN (non-serious) all with onset 28May2022, outcome "recovered with sequelae" and all described as "Crushing pain in lung and back area during 36 hours after the 2nd booster"; URTICARIA (non-serious) with onset 28May2022, outcome "recovered with sequelae", described as "Hives"; VERTIGO (non-serious) with onset 28May2022, outcome "recovered with sequelae"; VOMITING (non-serious) with onset 28May2022, outcome "recovered with sequelae"; TRANSIENT GLOBAL AMNESIA (hospitalization) with onset 20Jun2022, outcome "recovered with sequelae", described as "Transient Global Amnesia episode". The event "transient global amnesia episode" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (2022) Unknown results, notes: Multiple Blood Work; SARS-CoV-2 test: (19Jun2022) Negative; Urine analysis: (2022) Unknown results. Therapeutic measures were taken as a result of transient global amnesia, vomiting, vertigo, urticaria, pulmonary pain, back pain. Clinical course: Went to the ER at (Hospital) at approximately 7:15 pm. Admitted at approximately 1:30 am on 21Jun2022. Adverse event treatment were Multiple Blood Work, urinalysis, heart and blood p No COVID prior vaccination. COVID was tested post vaccination. Adverse events were during 36 hours after the 2nd booster.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis, Urticaria, Vertigo, Vomiting
Clinical narrative: Transient Global Amnesia episode; Vomiting; Vertigo; Hives; Crushing pain in lung and back area during 36 hours after the 2nd booster; Crushing pain in lung and back area during 36 hours after the 2nd booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2022 at 15:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CALCIUM and VIT D; D3. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin", notes: Known allergies: Neomycin. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 Immunization. The following information was reported: PULMONARY PAIN (non-serious), BACK PAIN (non-serious) all with onset 28May2022, outcome "recovered with sequelae" and all described as "Crushing pain in lung and back area during 36 hours after the 2nd booster"; URTICARIA (non-serious) with onset 28May2022, outcome "recovered with sequelae", described as "Hives"; VERTIGO (non-serious) with onset 28May2022, outcome "recovered with sequelae"; VOMITING (non-serious) with onset 28May2022, outcome "recovered with sequelae"; TRANSIENT GLOBAL AMNESIA (hospitalization) with onset 20Jun2022, outcome "recovered with sequelae", described as "Transient Global Amnesia episode". The event "transient global amnesia episode" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (2022) Unknown results, notes: Multiple Blood Work; SARS-CoV-2 test: (19Jun2022) Negative; Urine analysis: (2022) Unknown results. Therapeutic measures were taken as a result of transient global amnesia, vomiting, vertigo, urticaria, pulmonary pain, back pain. Clinical course: Went to the ER at (Hospital) at approximately 7:15 pm. Admitted at approximately 1:30 am on 21Jun2022. Adverse event treatment were Multiple Blood Work, urinalysis, heart and blood p No COVID prior vaccination. COVID was tested post vaccination. Adverse events were during 36 hours after the 2nd booster.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech/ Treatment of COVID-19; Pfizer / BioNTech/ Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 03Jan2021 as dose 2, single (Lot number: EK3730), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech/ Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: No other medication in 2weeks. No known allergies.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Pfizer / BioNTech/ Treatment of COVID-19; Pfizer / BioNTech/ Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 03Jan2021 as dose 2, single (Lot number: EK3730), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech/ Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: No other medication in 2weeks. No known allergies.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out
Age: 1.33
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Diarrhoea, Insomnia, Rash
Clinical narrative: Horrible rash on bottom (48 hours after vaccination), diarrhea (24 hours after vaccination), sleeplessness ( 12 hours after vaccination)  low grade temp (12 hours after vaccination)
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angioedema, Blister, Dysstasia, Gait inability, Hypersensitivity
Clinical narrative: Woke up with itchy hives, these hives then turned to fluid looking like sacs of welts. They were never the same size in circumference or depth. They would pop up on say for example my hands and my stomach. Then 10 minutes later, it would appear on my chest and face. It alternated like that on my entire body for a week until I could no longer walk, use my hands or move my neck. Itchiness isn't the word to describe the painstaking deep deep itch that I couldn't alleviate. I finally went to the ER, without insurance because I believed, truly, I would die soon had I not. I was given famotidine at 6:47am, methylprednisolone SOD SUCC (PF) (SOLU - MEDROL) at 6:47am and benadryl at 6:45 am . I was sent home with diagnosis of allergic reaction and severe angiodema from the ER doctor. I was to continue icing and taking benadryl for a full week every 3-4 hours in addition to a week steroid pack.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Movement disorder, Odynophagia, Rash pruritic, Speech disorder
Clinical narrative: Woke up with itchy hives, these hives then turned to fluid looking like sacs of welts. They were never the same size in circumference or depth. They would pop up on say for example my hands and my stomach. Then 10 minutes later, it would appear on my chest and face. It alternated like that on my entire body for a week until I could no longer walk, use my hands or move my neck. Itchiness isn't the word to describe the painstaking deep deep itch that I couldn't alleviate. I finally went to the ER, without insurance because I believed, truly, I would die soon had I not. I was given famotidine at 6:47am, methylprednisolone SOD SUCC (PF) (SOLU - MEDROL) at 6:47am and benadryl at 6:45 am . I was sent home with diagnosis of allergic reaction and severe angiodema from the ER doctor. I was to continue icing and taking benadryl for a full week every 3-4 hours in addition to a week steroid pack.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Woke up with itchy hives, these hives then turned to fluid looking like sacs of welts. They were never the same size in circumference or depth. They would pop up on say for example my hands and my stomach. Then 10 minutes later, it would appear on my chest and face. It alternated like that on my entire body for a week until I could no longer walk, use my hands or move my neck. Itchiness isn't the word to describe the painstaking deep deep itch that I couldn't alleviate. I finally went to the ER, without insurance because I believed, truly, I would die soon had I not. I was given famotidine at 6:47am, methylprednisolone SOD SUCC (PF) (SOLU - MEDROL) at 6:47am and benadryl at 6:45 am . I was sent home with diagnosis of allergic reaction and severe angiodema from the ER doctor. I was to continue icing and taking benadryl for a full week every 3-4 hours in addition to a week steroid pack.
Sex: F
Vaccine: PPV, PPV
Symptoms: Product storage error
Clinical narrative: No additional AE information provided; PNEUMOVAX 23 syringes experienced a temperature excursion on March 21, 2022; This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringes (lot #T033369, expiration date: 26-MAY-2022; lot #T039322, expiration date: 09-SEP-2022) that experienced a temperature excursion on 21-MAR-2022 may have been administered (strength, dose and route were not provided) to patients for prophylaxis after that date (product storage error).  The aforementioned doses of vaccine experienced a temperature excursion in 30.2 degrees Fahrenheit (F) for 7 hours 45 minutes. There was no previous temperature excursion. The reporter was not able to provide any additional details at this time. No additional adverse event (AE) information provided.   Follow up information has been received from the medical assistant on 23-JUN-2022. The patient was 60-year-old female. The vaccine was administered by medical assistant in the left deltoid. The patient was vaccinated at private doctor's office/ hospital and the vaccine was purchased with private funds. Temperature excursion occurred as a result of a reading from a Digital Data Logger. On 21-MAR-2022, current temperature was 30.2 degrees (min 37.9-max 41.8) at 4:30 pm and 41.5 degrees (min 37.7-max 42.4) at 7:45 am. The pm read appeared to be written wrong, possible 38.2 degrees vs 30.2, but to be safe it was removed from inverting. It was not available for return as it was destroyed. ; Sender's Comments:  US-009507513-2206USA007739:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events; MMR II was administered after the labeled expiration date.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 31-MAY-2022, the patient was vaccinated with one dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (Lot # T018669 has been verified to be valid, expiration date 29-MAY-2022) as prophylaxis (Dose, and administration route were not provided).   The reporter informed the patient was vaccinated after the labeled expiration date (Expired product administered), additionally, confirmed that the vaccine did not undergo any temperature excursion. It was noted that the supported disclaimer based on the post expiry memo was provided to the reporter. Furthermore, no additional adverse events were reported.
Age: 21.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse reporting that a 21 year old patient was administered PROQUAD on 27-MAY-2022; No additional AE reported.; his spontaneous report was received from a nurse, regarding a 21-year-old patient of unknown race and gender. The patient's medical history, historical medications, known allergies, concurrent conditions, and concomitant therapies were not provided.   On 27-MAY-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (dose, frequency, strength, lot #, expiry date, and route of administration were not provided) (inappropriate age at vaccine administration). Further information, pertaining to the administration or additional adverse events (AE) was provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported that M-M-R II, ROTATEQ and VAQTA that underwent temperature excursions were administered. No further information was provided. No additional AE. No PQC.   ?    Names of vaccines involved (including lot/exp): M-M-R II LOT: T029550 EX; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 27-MAY-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #T029550, expiration date: 01-SEP-2022, administered for prophylaxis (strength, dose, anatomical location and route of administration were not provided).  The vaccine was stored at the temperature that was reported as above 46 degrees of Fahrenheit (46.9 F) for 25 minutes. There was a previous temperature excursion reported: above 46 degrees of Fahrenheit (47.2 F) for 25 minutes.  No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005639: US-009507513-2206USA005640: US-009507513-2206USA006600: US-009507513-2206USA006599: US-009507513-2206USA006597: US-009507513-2206USA006596: US-009507513-2206USA006598:
Age: 1.42
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Medical assistant reports an expired dose of MMR II was administered to a patient on 02JUNE2022. Caller confirmed the dose was not involved in a temperature excursion.; This spontaneous report was received from a medical assistant referring to a 17-month-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 02-JUN-2022, the patient was vaccinated 3 days after expiring vaccine measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live rHA (recombinant Human albumin) (M-M-R II) first dose, lot #T018635, expiration date: 29-MAY-2022, administered subcutaneously (SQ) at right lower forearm (RL) as prophylaxis (dose, strength was not provided) (expired product administered). It was spoke to manufacturer (conflicting information: also reported as no previously report this adverse event) and notified to the patient. The patient had no side effects. Per the patient, there should be no issue with the timing of vaccine. The dose was not involved in a temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; VARIVAX was administered following temperature excursion; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 15-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # U020244, expiration date 28-JUN-2023, 0.5 ml (route of administration and exact anatomical location were not reported) for prophylaxis (Product storage error). Administered dose of vaccine experienced a temperature excursion of 6 degrees Fahrenheit for 7 minutes. There were no previous excursions or additional adverse events reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; VARIVAX was administered following temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. Concomitant medications included sterile diluent (STERILE DILUENT).   On 01-JUN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U020244, expiration date: 28-JUN-2023, (strength and route of administration were not provided) for prophylaxis (Product storage error).  On 15-MAY-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) underwent temperature excursion at 6 degrees Fahrenheit (F) for 7 minutes. No previous temperature excursions were reported. No adverse events were reported (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs were reported.; The pharmacist stated that the patient received VARIVAX shorter than recommended interval. The patient received first dose of VARIVAX on 5/1/2022 and second dose on 5/27/2022.; This spontaneous report was received from pharmacist and referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, drugs reactions or allergies and concomitant medication were not provided.  On 01-MAY-2022, the patient was vaccinated with a first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (ml) /dose, lot number u016065, expiration date: 20-MAY-2023 administered subcutaneously for prophylaxis (anatomical location was not provided).  On 27-MAY-2022, the patient was vaccinated with a second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5ml/dose, lot number u016065, expiration date: 20-MAY-2023, administered subcutaneously for prophylaxis (anatomical location was not provided) (inappropriate schedule of product administration).  No adverse event (AE) was reported.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pneumonia vaccines administered in 2014 and 2018; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (2112USA008003), concerning a 70-year-old male patient. His concurrent conditions included Parkinson's disease, tic douloureux/nerve pain, high cholesterol and high blood pressure. He smoked cigarettes (approx. 4 cigarettes a day) from 1967 to 1972. On 01-JUN-2009 (also reported as on 01-OCT-2014, conflicting information), the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) with an adverse reaction of shingles. Concomitant therapies included atorvastatin, lisinopril (manufacturer unknown), carbidopa (+) levodopa and topiramate.  On an unspecified date in 2014, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia vaccine) (dose, route of vaccination, vaccination site, lot # and expiration date were not reported) for prophylaxis. On an unspecified date in 2018, the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia vaccine) (dose, route of administration, vaccination site, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). The patient had no adverse reactions or side effects after the vaccines.  This is one of the two reports received from the same reporter, concerning the same patient.; Sender's Comments:  US-009507513-2112USA008003:
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; a dose of MMR II was inadvertently administered after it's expiration date; This spontaneous report has been received from a nurse concerning a 16-year-old male patient.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 07-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 milliliter (ml), once (lot# T018635, has been verified to be a valid lot number for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live [rHA] [M-M-R II], expiration date reported as 29-MAY-2022) dissolved in a sterile diluent (manufacturer unknown) for prophylaxis (Expired product administered).  The reporter stated that no adverse events were noted.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, Product preparation issue
Clinical narrative: No additional AEs; vaccine administered after reconstitution with expired sterile diluent; vaccine administered after reconstitution with expired sterile diluent; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 07-JUN-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD), 0.5 milliliter (ml), administered subcutaneous (lot# U010742, has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [rHA] [PROQUAD], expiration date reported as 03-OCT-2022, but upon internal validation established as 02-OCT-2022) as prophylaxis, The vaccine was reconstituted with an expired sterile diluent (manufacturer unknown), 0.5 ml, subcutaneous (lot# S030249, has been verified to be a valid lot number for sterile diluent, expiration date reported as 02-JUN-2022) (Product preparation issue) (Expired product administered).  No additional adverse events reported.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: HCP states they are unable to clarify if the patient received the full dose schedule or not, as they are not clear what product the patient received.; No additional AE information provided.; This spontaneous report was received from Licensed Practical Nurse and refers to a currently 38-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-APR-2011, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (lot number 0732z expiration date 11-DEC-2012, strength and route of administration were not provided). On 27-MAY-2011, the patient was vaccinated with second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (lot number 0732z expiration date 11-DEC-2012, strength and route of administration were not provided). It was unable to clarify if the patient received the full dose schedule or not, as they are not clear what product the patient received (product dose omission issue). No additional adverse event information provided.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; administration of PEDVAXHIB after expiration date.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 08-JUN-2022, the patient was vaccinated with 1 dose of an expired haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot number: T001206 was found to be valid, expiration date: 03-JUN-2022 (exact dose, strength, route of administration and vaccination site were not provided) for prophylaxis (expired product administered). No additional adverse events were reported.
Age: 16.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additoinal adverse event; Pharmacist reports administration of MMR II via the intramuscular route instead of subcutaneously to a 16 year old patient on 07JUNE2022.; This spontaneous report was received from a pharmacist concerning a 16-year-old male patient. Information regarding the patient's current conditions, medical history and historical drug was not provided. His concomitant therapies included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), polio vaccine (POLIOVIRUS), hepatitis b vaccine (HEPATITIS-B), and varicella zoster vaccine rge (cho) (SHINGRIX).  On 07-JUN-2022, the patient was vaccinated with one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, lot, expiration date, and anatomical location were not provided) intramuscular route instead of subcutaneously (Incorrect route of product administration) for prophylaxis. The outcome of the event was reported as resolved.   The operator of vaccine was a trained healthcare professional (registered nurse). No additional information or adverse event were reported.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had not experienced any 'reactions'/No additional AE reported; Patient's 1st PNEUMOVAX 23 dose on 02/17/2022 was administered a 2nd PNEUMOVAX 23 dose on 04/22/2022; This spontaneous report was received from a healthcare business professional and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 17-FEB-2022, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, strength, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 22-APR-2022, the patient was vaccinated with a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, strength, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (extra dose administered). The patient had not experienced any 'reactions' as it was confirmed by the reporter at the time of the report (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no further adverse event; Caller is Medical Assistant reporting administered dose of expired MMR II; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 09-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dose, lot #T016198, expiration date: 11-MAY-2022, administered as prophylaxis (strength, and route of administration were not provided). There was no history of temperature excursions and no further adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details or PQC.; Inbound all from HCP stating VARIVAX experienced a supported temp excursion and then was administered to patients. No additional AE details or PQC.          ?    Names of vaccines involved (including lot/exp) VARIVAX T031383 09/15/2022        ?; This spontaneous report has been received from a medical  assistant referring a patient of an unknown age and gender. The patient's concomitant medications included sterile diluent. The patient's medical history, concurrent conditions and drug reactions or allergies were not provided.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number T031383 expiration date on 15-SEP-2022 for prophylaxis (strength, dose, frequency, and route of administration were not reported) that underwent a temperature excursion of 9 fahrenheit for 3 hours 50 minutes (product storage error). No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details; patient was inadvertently administered an expired MMR-II vaccine; This spontaneous report was received from a medical student referring to an unknown age and gender patient. The patient's medical history and concurrent conditions were not provided. The patient's concomitant medication included sterile diluent (STERILE DILUENT).  On 10-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, for prophylaxis (strength, dose, route of administration, anatomical location, and vaccine scheme were not reported; lot number T016198 was determined to be a valid lot number, the expiration date was reported and established as 11-MAY-2022). No additional adverse events (AE) were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Customer called and reported that a dose of PNEUMOVAX 23 expired on 2/28/2022 and was administered on 5/10/2022. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 10-MAY-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot #T016159, expiration date: 28-FEB-2022, administered for prophylaxis (strength, and route of administration were not provided)(expired dose administered). No additional adverse event reported. No additional information provided.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: MMR # of previous doses: 3; indicate at which point in the process the medication error occured: dispensing; No additional AE details provided.; Varivax # of previous doses: 2/ MMR # of previous doses: 3; MOA calling to report expired MMR II had been administered to a patient. Product and sterile diluent used to reconstitute product had not experienced any temperature excursions.; This spontaneous report was received from the Medical Office Assistant (MOA) and refers to a 24-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included hepatitis b vaccine rhbsag (yeast) (ENGERIX B) and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP).   On an unknown date, the patient was vaccinated with the 3 dose of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (extra dose administered) (dose, route of administration, anatomical location, strength, expiry date and lot number were not provided). On an unknown date, the dispensing medication error occurred and the expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA type: recombinant human albumin) was dispensed. On 14-JUN-2022, it was administered to the patient, already as a 4th dose of this product (3 previous doses reported) (extra dose administered), subcutaneous injection, lot #T018669, expiry date: 29-MAY-2022, for prophylaxis (strength and dose not provided), with the sterile diluent, used to reconstitute the product (lot number: U005973, expiry date reported as 08-APR-2023, but validated as 09-APR-2023). On the same day, additionally the varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection was given to the patient, as a third dose already (two previous doses reported) (extra dose administered), lot #U010400, expiration date: 01-APR-2023, for prophylaxis (strength and dose was not provided). On 14-JUN-2022, the 4th dose of hepatitis b vaccine rhbsag (yeast) (ENGERIX B) (3 previous doses) and 2nd dose of diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (1 previous dose) were also administered. No additional adverse event details were provided.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report administered vaccine temperature excursion on multiple patients. Per caller vaccines went out of range yesterday and it was not discovered until this morning when checking the data logger. Multiple AE's filed. See; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-JUN-2022, the patient was vaccinated with improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 injection lot # 1879860 had been verified to be valid, expiration date: 13-OCT-2023, (dose, strength, route of administration and anatomical location were not provided) administered for prophylaxis.   Administered dose of vaccine experienced the temperature excursion. It was reported that the vaccine went out of range on 13-JUN-2022 (reported as "yesterday") (Product storage error) and it was not discovered until the morning on 14-JUN-2022 when checking the data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA004511: US-009507513-2206USA004154: US-009507513-2206USA004187: US-009507513-2206USA004506: US-009507513-2206USA004557:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Pharmacist calling reports expired dose of PNEUMOVAX 23 was administered to a patient. The vaccine did not experience any temperature excursions.; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The subject's medical history, historical drugs, concurrent conditions, known allergies, and concomitant medications were not provided  On 15-MAR-2022, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) administered as prophylaxis (dose, strength, frequency, route of administration and anatomical site of application were not reported); lot # T020639 had been verified to be valid with an expiration date reported and established as 13-MAR-2022 (Expired product administered).  The vaccine did not experience any temperature excursions. No additional adverse event (AE) details were available.