chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: had a sore injection site reaction the day after getting vaccinated; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (had a sore injection site reaction the day after getting vaccinated) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 prophylaxis.     The patient had no allergies to medications, food and other product. The patient did not have COVID-19 positive test or diagnosis. The patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Blood pressure high.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (had a sore injection site reaction the day after getting vaccinated). At the time of the report, VACCINATION SITE PAIN (had a sore injection site reaction the day after getting vaccinated) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient's concomitant medications included unspecified medications for high blood pressure.   It was reported that, the patient had a sore injection site reaction the day after getting vaccinated, nothing out of the ordinary after both vaccines.  The patient did not experience a similar event in the past. It was reported as symptoms were improved, but not over yet.  No treatment details were reported.   This case was linked to MOD-2022-611787 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy, Dermatitis atopic, Ear discomfort, Hypersensitivity, Skin cancer
Clinical narrative: had a sore injection site reaction the day after getting vaccinated; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (had a sore injection site reaction the day after getting vaccinated) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 prophylaxis.     The patient had no allergies to medications, food and other product. The patient did not have COVID-19 positive test or diagnosis. The patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Blood pressure high.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (had a sore injection site reaction the day after getting vaccinated). At the time of the report, VACCINATION SITE PAIN (had a sore injection site reaction the day after getting vaccinated) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient's concomitant medications included unspecified medications for high blood pressure.   It was reported that, the patient had a sore injection site reaction the day after getting vaccinated, nothing out of the ordinary after both vaccines.  The patient did not experience a similar event in the past. It was reported as symptoms were improved, but not over yet.  No treatment details were reported.   This case was linked to MOD-2022-611787 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site reaction
Clinical narrative: had a sore injection site reaction the day after getting vaccinated; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (had a sore injection site reaction the day after getting vaccinated) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 prophylaxis.     The patient had no allergies to medications, food and other product. The patient did not have COVID-19 positive test or diagnosis. The patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Blood pressure high.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (had a sore injection site reaction the day after getting vaccinated). At the time of the report, VACCINATION SITE PAIN (had a sore injection site reaction the day after getting vaccinated) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient's concomitant medications included unspecified medications for high blood pressure.   It was reported that, the patient had a sore injection site reaction the day after getting vaccinated, nothing out of the ordinary after both vaccines.  The patient did not experience a similar event in the past. It was reported as symptoms were improved, but not over yet.  No treatment details were reported.   This case was linked to MOD-2022-611787 (Patient Link).
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Hypotonia, Pallor
Clinical narrative: First rotavirus was given, Pediarix then Prevnar 13 in that order. Baby became pale and limp, then dusky, No loss of concisouness, normal vitals signs, normal o2 sat. No treatment gradually returned to baseline at 11:30am
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Musculoskeletal disorder, Pallor, Skin discolouration
Clinical narrative: First rotavirus was given, Pediarix then Prevnar 13 in that order. Baby became pale and limp, then dusky, No loss of concisouness, normal vitals signs, normal o2 sat. No treatment gradually returned to baseline at 11:30am
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Sore throat Headache Runny nose Upset stomach General fatigue lasting for over 3 weeks
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Sore throat Headache Runny nose Upset stomach General fatigue lasting for over 3 weeks
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Covid/ BA.5 started with sore throat and really tired, to worse the second day and called the dr on call who ordered a PCR test. Next day checked my medical portal and saw it was positive .  I called back and an order for Paxlovid was called into the Pharmacy.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Customer reported outbreak of hives and feeling shortness of breath next day
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Coordination abnormal, Dry eye, Dry mouth, Fatigue, Gait disturbance
Clinical narrative: August through January I became severely ill. Extreme fatigue, nausea and vomiting. My coordination was off.. difficulties walking and vision problems. Extreme dry mouth and eyes. Pins and needles along with numbness that started with my feet and progressed up my legs, thighs and stomach. Finally my entire face went numb. I was hospitalized for 3 months. Diagnosed with Critical Illness Polyneuropathy and Guillain Barre Syndrome.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Malaise, Nausea, Paraesthesia
Clinical narrative: August through January I became severely ill. Extreme fatigue, nausea and vomiting. My coordination was off.. difficulties walking and vision problems. Extreme dry mouth and eyes. Pins and needles along with numbness that started with my feet and progressed up my legs, thighs and stomach. Finally my entire face went numb. I was hospitalized for 3 months. Diagnosed with Critical Illness Polyneuropathy and Guillain Barre Syndrome.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Polyneuropathy, Visual impairment, Vomiting
Clinical narrative: August through January I became severely ill. Extreme fatigue, nausea and vomiting. My coordination was off.. difficulties walking and vision problems. Extreme dry mouth and eyes. Pins and needles along with numbness that started with my feet and progressed up my legs, thighs and stomach. Finally my entire face went numb. I was hospitalized for 3 months. Diagnosed with Critical Illness Polyneuropathy and Guillain Barre Syndrome.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Chills, Computerised tomogram head, Computerised tomogram spine
Clinical narrative: After 2nd injection low grade fever, severe chills, muscle pain, headache, weakness, tiredness, nausea, hands tremor, body shaking  started, and repeated every week / every 10 days for 7 months. All COVID tests ordered by physicians returned negative.  After 7 months symptoms improved except left hand tremor.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Laboratory test, Magnetic resonance imaging head, Myalgia
Clinical narrative: After 2nd injection low grade fever, severe chills, muscle pain, headache, weakness, tiredness, nausea, hands tremor, body shaking  started, and repeated every week / every 10 days for 7 months. All COVID tests ordered by physicians returned negative.  After 7 months symptoms improved except left hand tremor.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test negative, Symptom recurrence, Tremor
Clinical narrative: After 2nd injection low grade fever, severe chills, muscle pain, headache, weakness, tiredness, nausea, hands tremor, body shaking  started, and repeated every week / every 10 days for 7 months. All COVID tests ordered by physicians returned negative.  After 7 months symptoms improved except left hand tremor.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: I had hives for 2 weeks straight. I had a lot of swelling in my face and injection sight area for 2 weeks.  was very tired and very itchy. I had to take benadryl twice a day for 2 weeks. before I saw any changes.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute psychosis, Acute sinusitis, Anxiety, Depression, Dyspnoea
Clinical narrative: I had breathing problems after vaccination and had seizure. I was taken to the hospital by the ambulance on 12/21/2021. I was taken to Medical center on 12/21/2021. Then was taken to behavioral health center and then was diagnosed with sinusitis acute, Psychosis acute, bipolar type acute and Schizoaffective disorder. Also depression and anxiety as diagnosed by the psychologists.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Schizoaffective disorder bipolar type, Seizure
Clinical narrative: I had breathing problems after vaccination and had seizure. I was taken to the hospital by the ambulance on 12/21/2021. I was taken to Medical center on 12/21/2021. Then was taken to behavioral health center and then was diagnosed with sinusitis acute, Psychosis acute, bipolar type acute and Schizoaffective disorder. Also depression and anxiety as diagnosed by the psychologists.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered an expired vaccine. There was a different BUD and and expiration date which was that of 9/10/22. Instructions were not clear on what date to use therefore , instructed  to go by the expiration date  9/10 instead of BUD of 7/13.
Age: 1.75
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Despite them checking and double checking with the provider to give him Moderna, they gave him Pfizer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Despite them checking and double checking with the provider to give him Moderna, they gave him Pfizer) in a 21-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Despite them checking and double checking with the provider to give him Moderna, they gave him Pfizer). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Despite them checking and double checking with the provider to give him Moderna, they gave him Pfizer) outcome was unknown.            No concomitant medication were provided.  It was reported that 4 weeks ago 20 month old got the Moderna vaccine. Further it was reported that patient got second vaccine. Despite them checking and double checking with the provider to give patient Moderna, they gave Pfizer.   No treatment details were provided
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Pain in extremity
Clinical narrative: Severe leg pain, losing ability to walk
Sex: U
Vaccine: HEP, HEPAB
Symptoms: Interchange of vaccine products, Product prescribing error
Clinical narrative: No other AE/no PQC.; before receiving the dose, the doctor changed the order from RECOMBIVAX HB to TWINRIX; The first dose of hepatitis B vaccine was TWINRIX, the second dose of hepatitis B vaccine was RECOMBIVAX HB. The patient was initially scheduled to get RECOMBIVAX HB today, but will now be receiving TWINRIX.; This spontaneous report has been received from a registered nurse concerning a patient of unknown gender and age. The concomitant medications, medical history, drug reactions or allergies, and concurrent conditions were not reported.  On 04-NOV-2021, the patient was vaccinated with the first dose of hepatitis A vaccine inact, hepatitis B vaccine rhbsag (yeast)(TWINRIX) (lot # 75C72, expiration date 01-JUN-2022, 1 ml, strength, route of administration and anatomical location were not provided). On 15-DEC-2021, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (1 milliliter, lot # 74EM4 is not valid, expiration date 01-JUN-2022, strength, route of administration and anatomical location were not provided) (interchange of vaccine products). Both vaccines were administered for prophylaxis. On 27-JUN-2022, the patient was scheduled to receive the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), which would had been the third dose of hepatitis B series, but would now be receiving hepatitis A vaccine inact, hepatitis B vaccine rhbsag (yeast)(TWINRIX). The vaccine had not yet been given.. Before receiving the dose, the doctor changed the order from hepatitis b vaccine (recombinant) (RECOMBIVAX HB) to hepatitis A vaccine inact, hepatitis B vaccine rhbsag (yeast)(TWINRIX) (product prescribing error). The patient had not had any adverse effects or symptoms from this dosing.
Sex: U
Vaccine: HEPA, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored vaccines; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies was provided.  On 27-JUN-2022, the patient was vaccinated with improperly stored vaccines of hepatitis A vaccine, inactivated (VAQTA) (lot #U033212; expiration date: 07-NOV-2022; strength, dose and route of administration were not provided), and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # W00774 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported as 04-SEP-2023; strength, dose and route of administration were not provided), both administered for prophylaxis (product storage error). No additional adverse event was reported (no adverse event).
Age: 11.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE, no PQC reported; MMR II being administered to an 11 year old patient instead of a Meningococcal vaccine; This spontaneous report was received from an office manager, referring to a 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On 29-JUN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route, lot# and expiration date were not provided) for prophylaxis instead of a meningococcal vaccine (wrong product administered). No additional adverse events (AEs) or product quality complaint (PQC) reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE details available; PROQUAD (4 doses) that have been stored outside of recommended range have been administered to patients; This spontaneous report was received from an office manager and refers to a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. The concomitant therapies included sterile diluent used for vaccine reconstitution.  On an unknown date in 2022, also reported as between 28-JUN-2022 and 1-JUL-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot #W006585, expiration date: 23-AUG-2023 (dose, vaccination schedule, site and route of administration were not provided) for prophylaxis (product storage error). Temperature excursion occurred on 28-JUN-2022 in temperature ranges: 6 Fahrenheit degrees (F) up to 14F for 50 minutes; 14F up to 46F (15F) for 30 minutes. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000680: US-009507513-2207USA000563: US-009507513-2207USA000544: US-009507513-2207USA000470: US-009507513-2207USA000552: US-009507513-2207USA000561: US-009507513-2207USA000765: US-009507513-2207USA000771: US-009507513-2207USA000775:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Caller reported that VARIVAX that underwent temperature excursions was administere; This spontaneous report was received from a licensed practical nurse referring to an unknown age and gender patient. No information regarding the patient's medical history, concurrent condition or concomitant therapy was provided.  On 15-JUN-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U022320, expiration date 15-JUL-2023) for prophylaxis (dose, administered route, strength and frequency were not reported) that after temperature excursion of 14 Fahrenheit (F) up to 46F for 13 hours 50 minutes and minus 58 F to 5F (0.0F) for 6 hours 56 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported (no adverse event).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA002170:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Caller reported that VARIVAX that underwent temperature excursions was administere; This spontaneous report was received from a licensed practical nurse referring to an unknown age and gender patient. No information regarding the patient's medical history, concurrent condition or concomitant therapy was provided.  On 16-JUN-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U022320, expiration date 15-JUL-2023) for prophylaxis (dose, administered route, strength and frequency were not reported) that after temperature excursion of 14 Fahrenheit (F) up to 46F for 13 hours 50 minutes and minus 58F to 5F (0.0F) for 6 hours 56 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002160:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further adverse events; Caller is nurse reporting administered dose of expired VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #T017682, expiration date: 21-MAY-2022, administered for prophylaxis (strength, exact dose and route of administration were not provided) (expired product administered).  No further adverse events provided.
Sex: U
Vaccine: MMR
Symptoms: Accidental underdose, No adverse event
Clinical narrative: no adverse event; AE filed due to the medical assistant pulling out the needle since the patient moved.  They are not sure if the patient received any of the medication.; This spontaneous report was received from a healthcare business professional/ administrator and referred to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On 07-JUL-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, lot #, expiry date and route of administration were not provided) but the needle was pulled out by a medical assistant since the patient moved. It was not sure if the patient received any of the vaccine (accidental underdose). No other issues or concerns were noted (no adverse event).   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002271:
Age: 71.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; administration of MMR II outside the recommendation in the prescribing information. the 2nd and 3rd doses were administered 1 week apart on 07JUN2022 and on 14JUN2022; This spontaneous report was received from a pharmacist, concerning a 71-year-old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies was not provided.  On 07-JUN-2022, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, lot #, expiry date, route of administration, and anatomical location were not provided); on 14-JUN-2022, the patient received the third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, lot #, expiry date, route of administration, and anatomical location were not provided). Both vaccines were administered 1 week apart, for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported.
Sex: M
Vaccine: HPV9
Symptoms: Rash, Rosacea
Clinical narrative: The physician also mentioned Rosacia as a side effect.; AE: patient reported to the physician that they experienced a body rash weeks after receiving vaccine.; This spontaneous report was received from a physician via company representative regarding a male patient of an unspecified age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose regimen, lot #, expiry date, and route of administration were not provided) as prophylaxis.  On an unknown date (reported as "weeks after receiving vaccine"), the patient experienced a body rash (Rash). On an unknown date, he experienced rosacea (reported as "rosacia as a side efect"). It was unknown if any laboratory was performed or if any treatment was given for the events. The outcome of the events was unknown.   The causal relationship between rash and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. The causal relationship between rosacea and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was related.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Vaccine induced antibody absent
Clinical narrative: No antibodies secondary to the vaccine; This spontaneous report was received from the patient, a currently 52-year-old female, reporting on herself.  The patient's medical history included sinusitis, deviated septum, partial hysterectomy, and vision problem. The patient's concurrent conditions included multiple sclerosis, headache, cholesterol high, blood pressure high, The patient's drug allergies included lortab, Levaquin, and afrin nasal spray. It was also reported that she had banana allergy. Historical drugs included lortab, levaquin, and afrin nasal spray. Concomitant medications included ocrelizumab (OCREVUS), gabapentin, fluoxetine hydrochloride (PROZAC), nebivolol hydrochloride (BYSTOLIC), hydrochlorothiazide (HCTZ), fluticasone propionate (FLONASE) and colecalciferol (VITAMIN D3).  On an unspecified date in January or February 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (strength, dose, lot #, expiry date, route of administration, and anatomical location were not provided) administered for prophylaxis.  On unknown date, the patient had no antibodies secondary to the vaccine (vaccine induced antibody absent).   The outcome of the event of vaccine induced antibody absent was unknown.  The causal relationship between vaccine induced antibody absent and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported.; VARIVAX was administered to a patient after a prior temperature excursion occured, but before the most recent temperature excursion.; This spontaneous report has been received from a nurse and refers to patient of unknown age and gender.  The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 08-JUL-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, at dose 0.5 ml, lot number U025205 has been verified to be valid, expiration date 13-AUG-2023 for prophylaxis (strength, route of administration and anatomical location of vaccination were not provided) that underwent a temperature excursion of 9.4 Fahrenheit degrees (reported as the highest temperature) for 48 hours (product storage error). No additional adverse events were reported. There was a previous temperature excursion of 32.2 Fahrenheit degrees for 5 hours.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; Patient received recommended pediatric dose of RECOMBIVAX HB instead of the adult dose on 9 JUN 2022.; This spontaneous report was received from a certified medical assistant concerning a 62-year-old female patient. The patient's medical history, concurrent conditions, and concomitant medication were not provided.   On 09-JUN-2022, the patient received a pediatric dose instead of the adult dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 0.5 ml, lot # T018888, expiration date 03-NOV-2022, for prophylaxis (route of administration and anatomical vaccination location were not reported) (Product administered to patient of inappropriate age). No additional adverse events were reported (No adverse event).
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: No additional AE; Nurse reporting an AE for a five year old that was given 2 doses of PROQUAD instead of PROQUAD and KINRIX.; Nurse reporting an AE for a five year old that was given 2 doses of PROQUAD instead of PROQUAD and KINRIX.; This spontaneous report was received from nurse,referring to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-JUL-2022, the patient was vaccinated with two doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 05 milliliter, (lot # W012729 has been verified to be a valid lot for PROQUAD, expiration date: 16-OCT-2023),  for prophylaxis (strength, and route of administration were not provided) instead  diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) (Overdose) (Wrong product administered). No additional adverse event was reported.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE's.; A medical assistant reported that a patient received a dose of MMR II on 1/16/2018 and on 5/9/2022.  The same patient received a dose of PROQUAD on 7/12/2022.; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-JAN-2018 and on 09-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dosage regimen, lot #, expiry date, anatomical location and route of administration were not provided), administered as prophylaxis.   On 12-JUL-2022, the patient received a dose of mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human Albumin (rHA) used as directed to prevent measles, mumps, rubella and varicella infection, lot # W007748, expiration date: 04-SEP-2023, (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (extra dose administered). Lot # W007748 has been verified to be a valid lot number for mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).  No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details or PQC; a patient was inadvertently administered a GARDASIL 9 that experienced a supported temp excursion; This spontaneous report was received from an office manager/healthcare business professional (HBP) referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.   On 08-JUL-2022, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1775808, expiration date: 20-AUG-2023, strength, dose, and route of administration were unknown) for prophylaxis. The vaccine had a supported temperature excursion (Incorrect product storage). The vaccine involved was stored at 0.17 Celsius (C) for 192 hours. There was no previous temperature excursion reported. No additional adverse event (AE) details was reported.
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Vaccination site discomfort
Clinical narrative: discomfort in the area of vaccination; limited range of motion as well; This spontaneous report has been received from a nurse concerning a 43-year-old female patient. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route of administration and anatomical location were not provided) as prophylaxis.  On 28-MAR-2022, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route of administration and anatomical location were not provided). On the same date, she experienced discomfort in the area of vaccination and limited range of motion as well (vaccination site discomfort) (vaccination site movement impairment).  It was reported that the patient went to the healthcare providers office again on 11-APR-2022, 10-MAY-2022 and 11-JUL-2022. It was at the last date that the vents were documented. The outcome for vaccination site discomfort and vaccination site movement impairment was reported as not recovered.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; a dose of PROQUAD was administered to the patient last year on 6JUL2021 after experiencing a temperature excursion; This spontaneous report has been received from a medical assistant concerning a female patient of unknown age. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with an unknown maximum temperature and a timeframe longer than 30 minutes. it was unknown if previous temperature excursions occurred.  On 06-JUL-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 milliliter, lot # T029104, expiration date 23-FEB-2022 (route of administration and anatomical location were not provided) as prophylaxis (product storage error). No additional events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Accidental underdose
Clinical narrative: patient received less than the full dose of GARDASIL 9.  Some of the solution "ran down" the patient's arm during the administration.; No adverse event; This spontaneous report has been received from a nurse concerning a patient of an unknown gender who would be 12-year-old at the time of the report.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient received less than the full dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #U034200, expiration date: 21-OCT-2023, (anatomical location and route of administration were not provided) administered for prophylaxis. It was reported that some of the solution "ran down" the patient's arm during the administration (Accidental underdose).
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Caller is a medical assistant calling to report an adverse event for M-M-R II, VAQTA, and VARIVAX. Caller reports that the patient was administered all three vaccines on 13JUL2022, after they were exposed to a temperautre excursion.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown gender and age.  The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 13-JUL-2022, the patient was vaccinated with improperly storage dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) injection (lot number U022983 which has been verified to be valid, expiration date reported and validated as 22-JUL-2023), hepatitis A vaccine, inactivated (VAQTA) injection (lot number U038841 which has been verified to be valid, expiration date reported and validated as 06-MAR-2023), and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W002599 which has been verified to be valid, expiration date reported and validated as 24-JAN-2024). All of the vaccines were administered at a dose of 0.5 milliliters (ml) as prophylaxis (strengths, routes of administration, and anatomical sites of injection were not reported). The administered dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) and hepatitis A vaccine, inactivated (VAQTA) were stored at a temperature of 65 degrees Fahrenheit (F), during a time frame of 17 hours; the dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at a temperature of 67 degrees F, during a time frame of 17 hours (product storage error). There was no previous temperature excursion No additional adverse events were reported in the patient.
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; a patient was administered PROQUAD that was reconstituted with an expired STERILE DILUENT; This spontaneous report was received from a nurse, regarding a patient of unknown age and gender.   Their medical history, concurrent condition, and concomitant therapies were not reported.  On 07-JUL-2022, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, recombinant human albumin (PROQUAD) 0.5, subcutaneously, valid lot# U002530, expiration date 24-JUL-2022 (dosage regimen and anatomical location were not provided) that was reconstituted with an expired sterile diluent 0.7 ml, Lot# S037038, expiration date 05-JUL-2022 (Expired product administered). Lot Number S037038 is not valid for sterile diluent and does not match any company product. No adverse event was reported.
Age: 1.17
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: HCP calling to report administration of VAQTA during temperature excursion on 7/14/22 (02205580). Additional AEs filed for other vaccine products and patients. No PQCs reported.; This spontaneous report has been received from a nurse, regarding a 14-months-old female patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 14-JUL-2022, the patient was vaccinated with an improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 ml as prophylaxis (strength, route of administration, lot number, and expiration date were not provided) (product storage error). Temperature and period of time of the temperature excursion were not provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA005196:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: multiple outbreaks of herpes zoster; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a patient (pt) of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot #, and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care at the time of reporting. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not resolved. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX).  The event of multiple outbreaks of herpes zoster was considered to be disabling by the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient is not reported to have any symptomatic side effects; A patient was inadvertently administered a GARDASIL 9 after it's expiration date.; This spontaneous report was received from a pharmacy technician referring to a patient of unspecified age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 05-JUL-2022, the patient was inadvertently administered an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, route of administration and anatomical site of vaccination were not reported; lot number T008151 has been verified to be valid, expiration date reported as 22-JUN-2022 but upon internal verification was established as 21-JUN-2022) (expired product administered).   No symptomatic side effects were reported (no adverse event).
Sex: U
Vaccine: HPV9, PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE reported; patient was scheduled to receive GARDASIL 9 but was accidentally administered a dose of PNEUMOVAX 23 instead; This spontaneous report was received from a registered nurse concerning a patient of unknown age (reported as "under the age of 50 years") and gender. The patient's medical history, concurrent conditions, and concomitant medication were not provided.    On 17-FEB-2022, the patient was inadvertently administered a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot #U003306, expiration date 15-OCT-2022, for prophylaxis instead of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Wrong product administered) (Route of administration, and injection anatomical location were not provided). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE's and no PQC's were reported.; patient received 2 doses of GARDASIL 9 five days apart on 7/13/2022 and 7/18//2022; 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 provided.   On 13-JUL-2022, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), lot # 1780876, expiration date 09-NOV-2023, to prevent Human Papillomavirus infection (dose, route of administration, injection anatomical location, lot # and expiration date were not provided).   On 18-JUL-2022, five days apart, the patient received another dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), lot # 1780876, expiration date 09-NOV-2023, to prevent Human Papillomavirus infection (dose, route of administration, injection anatomical location, lot # and expiration date were not provided) (Inappropriate schedule of product administration). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Patient was administered improperly stored, separate GARDASIL 9 on 07/15/2022; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On an unspecified date (reported as "within this past year") there was a temperature excursion registered for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) of 46.8 Fahrenheit degrees for 40 minutes; and on 24-JUN-2022, there was another temperature excursion registered below 36 Fahrenheit degrees (34.7 Fahrenheit degrees) for 20 minutes.  On an unknown date, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot #U019412, expiration date: 30-OCT-2023 (dose, route of administration, and anatomical location were not provided) administered for prophylaxis (product storage error). No additional adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Drug ineffective
Clinical narrative: pharmacy told the caller that the ZOSTAVAX vaccine she received "was not effective." and she would need another shingles vaccine.; This spontaneous report was received from a currently 58-year-old female patient referring to herself.  The patient's concurrent conditions included eczema. The patient's medical history included chickenpox as child. The patient's concomitant therapies included low dose of unspecified blood pressure medicine and risankizumab (SKYRIZI) (reported as "Shyrizi").  On 16-JUL-2014, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for the prevention of shingles. After eight years the caller was told "by a friend that vaccine live(ZOSTAVAX) was not effective." According to the patient, she decided to do some research and found information on internet suggesting that her vaccine live(ZOSTAVAX) vaccine was "no good," The caller stated, she received vaccine live(ZOSTAVAX) at her local pharmacy, so she contacted them  18-JUL-2022 to ask about the efficacy of the vaccine; the pharmacy told the caller that the vaccine live(ZOSTAVAX) vaccine she received "was not effective" and she would need another shingles vaccine. The caller was unable to provide any additional information pertaining to the vaccine live(ZOSTAVAX) vaccine she received, however, she was going to call her local pharmacy back to retrieve that information. She would like to get more information about a reimbursement. No further information was provided. No additional adverse event was reported. No product quality complaint was reported.  The outcome of drug ineffective was reported as not recovered.  The causal relationship between the event and the suspect therapy was not reported.
Sex: M
Vaccine: DTAP, HPV9, MNQ
Symptoms: Head injury, Syncope
Clinical narrative: patient fainted; hit his head; This spontaneous report was received from a physician referring to an adolescent male patient. Pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  In approximately 2017 to 2018 (4-5 years ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered for prophylaxis (strength, dose, lot #, expiry date and route of administration were not provided); meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA)  (strength, formulation, dose, lot #, expiry date, route of administration and indication were not provided); and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) (strength, formulation, dose, lot #, expiry date, route of administration, and indication were not provided). After vaccination, the patient experienced fainted when he was getting up from the exam table and hit his head. The patient was followed concussion protocol (details of protocol were unknown) and received treatment by the physician. The outcome of the events was reported as recovered.   The causality between the events and suspect vaccines was not reported.  Upon internal review, the event of syncope was determined to be medically significant.