chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Fatigue, Headache, Mobility decreased, Peripheral swelling
Clinical narrative: couldn't lift my arm because it was extremly painful; couldn't lift my arm because it was extremly painful; bruising; arm started swelling really badly into my back; red rash from my elbow up my arm into my back; extreme fatigue; vomiting; pain in head; fever; This spontaneous report was received from a 67-year-old female patient, who was referring to herself. Her concurrent condition included allergy to sulfa and neosporin and adhesive allergy. On an unknown date in 2020 she was vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) administered perpendicular to the arm and did not experience any adverse reaction.  On 27-FEB-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered at an angle in arm (exact dose, frequency, lot #, expiration date and route of administration were not reported) as prevention of pneumonia.         On the same day, about an hour after vaccine administration, the patient experienced a very sever reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). Her arm started swelling really badly into back. She got a red rash from elbow up to arm and into back. Additionally, she experienced fever, extreme fatigue for day, could not lift her arm because it was extremely painful. The patient had vomiting one time of short duration, experienced pain in her head and bruising. The patient sought medical attention, she spoke with a physician. However, no treatment was given for the events. She did not expect this reaction because there was no reaction after pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) administration.  The patient recovered from the events on an unknown date in 2021, reported as a few days later. The events were considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash erythematous, Vomiting
Clinical narrative: couldn't lift my arm because it was extremly painful; couldn't lift my arm because it was extremly painful; bruising; arm started swelling really badly into my back; red rash from my elbow up my arm into my back; extreme fatigue; vomiting; pain in head; fever; This spontaneous report was received from a 67-year-old female patient, who was referring to herself. Her concurrent condition included allergy to sulfa and neosporin and adhesive allergy. On an unknown date in 2020 she was vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) administered perpendicular to the arm and did not experience any adverse reaction.  On 27-FEB-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered at an angle in arm (exact dose, frequency, lot #, expiration date and route of administration were not reported) as prevention of pneumonia.         On the same day, about an hour after vaccine administration, the patient experienced a very sever reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). Her arm started swelling really badly into back. She got a red rash from elbow up to arm and into back. Additionally, she experienced fever, extreme fatigue for day, could not lift her arm because it was extremely painful. The patient had vomiting one time of short duration, experienced pain in her head and bruising. The patient sought medical attention, she spoke with a physician. However, no treatment was given for the events. She did not expect this reaction because there was no reaction after pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) administration.  The patient recovered from the events on an unknown date in 2021, reported as a few days later. The events were considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: temperature excursion; Subcutaneous injection formulation administered by other route; No other AE; This spontaneous report was received from a nurse prescriber and refers to a 4 year old male patient.  No concomitant medications, concurrent conditions, medical history, drug allergies and reactions were reported.  On 10-MAR-2021, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) lot # T021640, upon internal review determined to be valid, expiration date 21-DEC-2021 (also reported as 12-DEC-2021 and 20-DEC-2021), intramuscularly (incorrect route of administration) in the right thigh for prophylaxis. The vaccine underwent temperature excursion of maximal 6.2F for 8 minutes (started at 1:41 pm and stopped at 1:49 pm) on 08-MAR-2021. Digital data logger was involved. Previous temperature excursion was reported. The patient experienced no adverse event. No product quality complaint was reported. After the administration, the nurse was placed on probation and completed mandatory training. Temperature/vaccine stability was determined and it was reported that the use of vaccine was ultimately supported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No other AE reported; "a pediatric patient was given a dose of 25U of adult VAQTA.; Inappropriate preparation of medication; This spontaneous report was received from a physician and refers to a pediatric patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 08-MAR-2021, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml (25 U) from the adult dose, lot # T014590 with expiration date on 15-APR-2021 (route of administration was unknown) for prophylaxis. The administering nurse drew up 1 ml of adult hepatitis a vaccine, inactivated (VAQTA) then wasted 0. 5 ml of the adult hepatitis a vaccine, inactivated (VAQTA). No adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: No symptoms reported.; Caller reports 6 mo old patient received three PEDV AX HIB vaccines. On 11/3/2020, 1/5/2021 and 3/9/2021.; This spontaneous report was received from a medical assistant and refers to a 6-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-NOV-2020 and 05-FEB-2021, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter, intramuscularly, lot # T026959 and expiration date 11-MAR-2023 (anatomical location not provided). On 09-MAR-2021, the patient received a third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), which was considered to be inappropriate schedule of vaccination. All doses were administered for prophylaxis. No adverse event was reported.
Age: 1.33
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event/No adverse reaction; Expired vaccine used; Age: 16 months old; This spontaneous report was received from a nurse, concerning a 16 month old patient of unknown gender. The patient's concurrent conditions included IgG deficiency. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 11-MAR-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), at a dose of 0.5 milliliter (ml) once in the right thigh (lot number S003872, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 22-DEC-2020) as prophylaxis (route of administration and vaccination scheme were not reported) (expired product administered and product administered to patient of inappropriate age). The vaccine did not have any prior temperature excursions. No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; VARlVAX had been administered to 3 patients after undergoing multiple temperature excursions; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-OCT-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S033952, expiration date: 24-OCT-2021, frequency reported as 3 (exact dose, injection site and route of administration were not provided) for prophylaxis.  The administered vaccine experienced multiple temperature excursions (exact temperature and time frame were unknown). No additional adverse events were reported.   This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA007465: US-009507513-2103USA007466:
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: An immunocompromised 44 year old patient received Zostavax intramuscularly; An immunocompromised 44 year old patient received Zostavax intramuscularly; An immunocompromised patient received Zostavax concomitantly with Moderna COVID-19 vaccine; The patient reported a rash on neck and arms; This spontaneous report was received from an immunocompromised 44 year old female nurse prescriber via company representative reporting on herself. Patient's drug reactions or allergies and pertinent medical history were not reported.  On 09-MAR-2021, the patient was vaccinated with a dose of  zoster vaccine live(ZOSTAVAX), 1 injection, intramuscularly (lot # and expiration date were not reported) for shingles prophylaxis.    Concomitant therapies included sars-cov-2 spike protein mrna vaccine(MRNA-1273) ( Moderna COVID-19 vaccine) administered in January and February 2021. On unknown date in March 2021, the patient experienced rash on neck and arms. No further adverse symptoms reported.   At the time of the report, the patient was recovering from rash.   The relationship between rash and zoster vaccine live(ZOSTAVAX) was not reported.
Sex: U
Vaccine: HEP, HEPA, HEPA, HIBV, HPV9, HPV9, RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: ROTATEQ, PEDV AX HIB, RECOMBIV AX HB, GARDASIL 9 and VAQTA that went out of range were potentially administered; No additional adverse effect reported; Information has been received from a nurse istant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On unknown dates, the patient was potentially vaccinated with doses of the following vaccines that were out of range: hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # R028529 and expiration date of 09-JUN-2021, lot # T004378 and expiration date of 01-NOV-2022 and lot # R021372 and expiration date of 25-MAY-2021, hepatitis a vaccine, inactivated(VAQTA) lot # T020442 and expiration date of 26-JAN-2022 and lot # T014835 and expiration date of 17-JUL-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T001208 and expiration date of 09-JUN-2022 and lot # T020615 and expiration date of 13-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1621926 and expiration date of 28-NOV-2021 and lot # 1602284 and expiration date of 26-SEP-2021 (route of administration and anatomical location were not reported) and with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1676322 and expiration date of 21-APR-2021, lot # 1688822 and expiration date of 20-NOV-2021 and lot # 1691301 and expiration date of 12-DEC-2021 per oral route, all for prophylaxis, which were stored in the following ranges: 9 Celsius degrees to 25 Celsius degrees (8.53 Celsius degrees) for 15 minutes and 9 Celsius degrees to 25 Celsius degrees (11.6 Celsius degrees) for 45 minutes.  No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2103USA003717: US-009507513-2103USA005236: US-009507513-2103USA005237: US-009507513-2103USA005238: US-009507513-2103USA005239: US-009507513-2103USA005240: US-009507513-2103USA005241: US-009507513-2103USA005234: US-009507513-2103USA005233:
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: I want to know what location is vaccinating with GARD ASIL 9. I saw my ob/ gyn last year and she doesn't do it. I am 51 years old and I don't think I have had it.; I want to know what location is vaccinating with GARD ASIL 9. I saw my ob/ gyn last year and she doesn't do it. I am 51 years old and I don't think I have had it.; This spontaneous report was received from a 51-year-old female patient who referred to herself. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  The patient was calling to inquire about locations where she could be vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). She saw her obstetrician/gynecologist (reported as ob/gyn) last year and the physician did not do it. The patient did not think she had had it (circumstance or information capable of leading to medication error and product administered to patient of inappropriate age). It was unknown if the patient missed a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No further AE; a 46 year old man received a dose of GARDASIL 9; This spontaneous report was received from a pharmacist and refers to a 46-year-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date in 2021, reported as 2 to 3 weeks ago, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, dose: 1 injection (dose number, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (Inappropriate age at vaccine administration).  No further adverse event was reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; product storage error; This spontaneous report was received from a healthcare professional referring to a 1 year old patient of unspecified gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-MAR-2021, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck) (VARIVAX) lot # T022315, expiring on 30-JUN-2022, 0.5 milliliter for prophylaxis (route and site of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S039319, expiring on 04-DEC-2021, for prophylaxis (dose, route and site of administration were not reported)      The administered doses of the vaccines experienced a temperature excursion of -1.6 degrees Celsius for 1 hours and 36 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: no additioanl AE reported; adverse event involving vaccines MMR II (stored in freezer) and VARIVAX; adverse event involving vaccines MMR II (stored in freezer) and VARIVAX; This spontaneous report was received from a medical assistant and refers to a 1-day-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-MAR-2020, the patient was vaccinated with improperly stored vaccines: measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) 0.5 mL, lot # S039319, expiration date 04-DEC-2021 (route of administration and anatomical location were not provided) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL, lot # T022315, expiration date 30-JUN-2022 (route of administration and anatomical location were not provided) for prophylaxis (inappropriate age at vaccine administration). The vaccines were stored in a temperature between - 50 degrees Celsius (C) to 8 C (- 1.6 C) for 1 hour 36 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event (AE) was reported.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: as an adult she has only had the pneumonia shot and the side effect she experienced was a sore arm; This spontaneous report was received from an adult female consumer of unknown age, via Pfizer, referring to herself. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (also reported as "pneumonia shot") as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). The reporter stated that as an adult she only had the pneumonia shot.   On an unknown date, the patient experienced the side effect of sore arm (pain in extremity).  The outcome of the event pain in extremity, and the causal relationship between the event pain in extremity and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) were not provided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster meningoencephalitis, Ill-defined disorder, Pain
Clinical narrative: shingles, included any and all of its sequelae/suffer pain as a result of Shingles; shingles, included any and all of its sequelae/ as well as other severe and personal injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a 65-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 05-APR-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On 08-NOV-2013, as a result of zoster vaccine live (ZOSTAVAX) administration, foregoing act and omissions, the patient was caused to suffered serious and dangerous side effects included: suffer pain as a result of shingles, included any and all of its sequelae, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, included diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of vaccine, the patient had been caused to suffered severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. Negligence was the proximate cause of injuries, harm and economic loss which the patient suffered and/or would continue to suffer. As a result of the foregoing acts and omissions the patient required and/or would require more health care and services and did incur medical, health, incidental and related expenses. The patient was informed and believed and further alleged that the patient would in the future be required to obtained further and/or hospital care, attention and services. The patient had incurred and would continue to incur medical and related expenses. The patient also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisted conditions, activated of latent conditions, and other losses and damages. The patient's direct medical losses and cost included physician care, monitoring and treatment. The patient had incurred and would continue to incur mental and physical pain and suffering. The outcome of herpes zoster and ill-defined disorder were not recovered. The reporter considered herpes zoster and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX).  Herpes zoster meningoencephalitis, shingles and ill-defined disorder were considered to be disable events.
Age: 14.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, Wrong product administered
Clinical narrative: No other AE reported; we inadvertently gave a 14-year-old patient an adult dose of VAQTA that was expired; we inadvertently gave a 14-year-old patient an adult dose of VAQTA that was expired; This spontaneous report was received from a medical assistant and refers to a 14-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-MAR-2021, the patient was inadvertently vaccinated with an expired, adult dose of hepatitis A vaccine, inactivated (VAQTA) 1 ml, lot # S037821, expiration date 07-JAN-2021 (route of administration and anatomical location were not provided) for prophylaxis (accidental overdose, expired vaccine used). There was no product to retrieve as it was disposed of at the office. No adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no other adverse events/effects reported; improperly stored ROT ATEQ was administered yesterday; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-MAR-2021, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, orally, lot # 1691303, expiration date 21-DEC-2021 (strength and dose were not reported) for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at 47.1 Fahrenheit degrees (F) for 10 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: No other adverse events/effects reported; that improperly stored ROT ATEQ and PEDV AX HIB was administered yesterday; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-MAR-2021, the patient was vaccinated with doses of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, orally, lot # 1691303, expiration date 21-DEC-2021 (strength and dose were not reported) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter, intramuscular, lot # T020616, expiration date 16-MAR-2023 (strength and dose were not reported), both for prophylaxis.  On an unknown date, the doses of the vaccines were exposed to temperature excursion at 47.1 Fahrenheit degrees (F) for 10 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Patient recived a dose of improperly stored PROQUAD; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 25-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114 with expiration date reported as 07-FEB-2022) 0.5 (units not reported) (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2103USA003425:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Product storage in error; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 27-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114 with expiration date reported as 07-FEB-2022) 0.5 (units not reported) (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2103USA003425:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a dose of improperly stored PROQUAD; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 05-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114 with expiration date reported as 07-FEB-2022) 0.5 (units not reported) (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2103USA003425:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Patient received a dose of improperly stored PROQUAD; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 09-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114 with expiration date reported as 07-FEB-2022) 0.5 (units not reported) (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2103USA003425:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported; underwent a temperature excursion was administered to a child; This spontaneous report was received from a medical assistant and refers to a patient (child: age unspecified) of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-MAR-2021, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T019420, expiration date 02-DEC-2021 (formulation, strength, route of administration and dose were not reported) for prophylaxis.  On an unknown date in February 2021, the dose of the vaccine was exposed to temperature excursion at 23.1 Celsius degrees (C) for 1 hour 36 minutes. There was reported previous temperature excursion at - 15.5 C for 2 hours 48 minutes. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: no other AE; administered a dose ofROTATEQ to a 7 month old patient that was expired on 3/19/2021; This spontaneous report was received from a nurse and refers to a 7-month-old patient of unknown gender. The patient concurrent condition, medical history and concomitant medication were not provided.   On 22-MAR-2021, the patient was vaccinated with expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660693, expiration date 19-MAR-2021, 1 dose, administered orally (strength was not provided) for prophylaxis. The vaccine did not experience any temperature excursions prior to administration. No other adverse event was reported. The nurse wanted to know if there was any recommendation on whether or not the patient should be revaccinated. The outcome was unknown.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: syncope; This spontaneous report as received from a nurse prescriber via a company representative, concerning a 14 year old female patient. There was no information about the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  In approximately 2016 (reported as "about 6 years ago"), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided). In approximately 2016 (reported as "about 6 years ago"), the patient experienced an episode of syncope after quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) vaccination. The patient was seated in chair after syncopal episode and recovered on the same day. Parents of patient opted out of subsequent doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). The outcome of syncope was reported as resolved. The reporter did not provide any causality assessment.     Upon internal review, the event syncope was determined to be a medically significant event.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AEs were reported; improperly stored, supported dose of VARlVAX was administered to a patient; This non-valid spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAR-2021, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S020464, expiration date 02-JUL-2021, 1 injection (strength, route of administration and exact dose were not reported) for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at -13.8 Celsius degrees (C) for 7 hours. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.  The report is non-valid due to lack of patient's identifiers.
Sex: M
Vaccine: PPV
Symptoms: Arthropathy, Muscle fatigue, Urticaria
Clinical narrative: he broke out in hives; had muscle fatigue; joint problems; This spontaneous report was received from a 72-year-old male patient, who was referring to himself. The patient's concurrent condition included drug reactions/allergies to generic medications (not further specified). He had no concomitant medications and pertinent medical history.  On an unknown date in 2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 1 time injection in the left arm (strength, exact dose, route of administration, lot number and expiry date were not reported) for pneumococcal disease prophylaxis.  On an unknown date in 2014, the patient broke out in hives, had muscle fatigue and joint problems over the next few days. The events were treated with diphenhydramine hydrochloride (BENADRYL). No lab diagnostics/studies were performed. The patient recovered from the events on an unspecified date a few months after initial events date.  The relatedness between the events and the suspect vaccine was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE's; VARlVAX had been administered to 3 patients after undergoing multiple temperature excursions; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-DEC-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S033952, expiration date: 24-OCT-2021, frequency reported as 3 (exact dose, injection site and route of administration were not provided) for prophylaxis.  The administered vaccine experienced multiple temperature excursions (exact temperature and time frame were unknown). No additional adverse events were reported.   This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA007466: US-009507513-2103USA003643:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE's; VARlVAX had been administered to 3 patients after undergoing multiple temperature excursions; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-FEB-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S033952, expiration date: 24-OCT-2021, frequency reported as 3 (exact dose, injection site and route of administration were not provided) for prophylaxis.  The administered vaccine experienced multiple temperature excursions (exact temperature and time frame were unknown). No additional adverse events were reported.   This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA003643: US-009507513-2103USA007465:
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Adverse Reaction or Side Effects Experienced: none; Pneumonia vaccine adminstered in October 2018 and October 2019; Information has been received from a lawyer via a Plaintiff Fact Sheet regarding a case in litigation concerning a patient of unknown age and gender. The patient's medical history included chicken pox. On an unspecified date in October 2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer inknown) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unspecified date in October 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer inknown) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. Pt did not experienced any adverse reaction or side effects.   This is one of two reports for this patient (MARRS # 2009USA001240).; Sender's Comments:  US-009507513-2009USA001240:
Sex: F
Vaccine: HEPA
Symptoms: Feeling abnormal, Heart rate irregular
Clinical narrative: heartbeat "went funny" / weird reaction" to the Havrix; Weird reaction; This case was reported by a pharmacist via other manufacturer and described the occurrence of heartbeats irregular in a female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced heartbeats irregular and weird feeling. On an unknown date, the outcome of the heartbeats irregular and weird feeling were unknown.   It was unknown if the reporter considered the heartbeats irregular and weird feeling to be related to Havrix and Havrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient had weird reaction and her heart beat went funny after administration of Havrix vaccine. The reporter wanted to know if patient should get Pfizer's COVID-19 vaccine or not It was unknown if the reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Throbbing in the left shoulder where the dose was received; Fever; Severe headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, fever and headache. On an unknown date, the outcome of the injection site pain, fever and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever and headache to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. The age at vaccination was not reported. The patient received Shingrix on left shoulder. Immediately after receiving Shingrix, the patient experienced throbbing in the left shoulder where the dose was received which lasted approximately 2 hours. Within 3 to 4 hours of receiving Shingrix, the patient experienced fever which lasted approximately 24 hours. The day after receiving Shingrix, the patient experienced severe headache which lasted approximately 48 hours and got progressively better as time passed. The reporter did not consent to follow-up.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: locally at the injection site of his arm: redness; locally at the injection site of his arm / hot; locally at the injection site of his arm / pain/hurt/ locally at the injection site of his arm: pounding; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Men B NVS (Bexsero) (batch number ABX657AA, expiry date 30th April 2019) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st November 2018, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site pain were recovered/resolved.   The reporter considered the injection site erythema, injection site warmth and injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter was the patient's mother. The patient received 1st dose of Bexsero in an unknown arm.  The patient experienced redness, hot, pounding, pain or hurt locally at the injection site of his arm and these events resolved after 2 days. The reporter consented to follow up and provided her email address but not a fax number. For tolerance to the 2nd dose of Bexsero, refer linked case US2021AMR070410, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR070410:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles; Unknown if patient received second dose/1st dose received on 13th February 2020; This case was reported by a other health professional and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter was a pharmacy technician. The age at vaccination was not reported. The patient had received his 1st dose of Shingrix and then developed shingles (unknown time lapse, but it was more than 2 months but less than 6 months.) It was unknown if the patient received the 2nd dose, hence incomplete course of vaccination was coded for 2nd dose conservatively. The reporter did not have details of adverse event at time of call but provided email of pharmacy for collection. The reporter consented to follow-up. Note: The reporter was not aware if second dose was administered or not but considering the time interval, incomplete course of vaccination was coded conservatively.The clarification has been raised for the same.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itch in the lower back / only the itch; This case was reported by a pharmacist and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced an itch in the lower back, after receiving 1st dose of Shingrix.  The reporter also  reported there was no rash associated with the itch, there was only the itch. The reporter felt uncertain that, issue experienced was related to vaccine and said she wanted to reach back out to the patient, before providing any additional information to GSK (GlaxoSmithKline). The reporter did not consent to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes simplex, Herpes simplex test positive
Clinical narrative: patient's HSV2 titer results 9 days after receiving 1st dose of Shingrix on 2/28/21 / Positive HSV2 titer 9 days after receiving 1st dose of shingrix; This case was reported by a physician and described the occurrence of herpes simplex test positive in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex test negative (received a HSV2 (Herpes Simplex virus type II) titer last year).   On 28th February 2021, the patient received the 1st dose of Shingrix. On 9th March 2021, 9 days after receiving Shingrix, the patient experienced herpes simplex test positive. On an unknown date, the outcome of the herpes simplex test positive was unknown.   It was unknown if the reporter considered the herpes simplex test positive to be related to Shingrix.  Additional details were provided as follows: The patient had a new consistent sexual partner since sometime after the first titer last year from the reporting date. The patient had positive HSV2 (Herpes Simplex virus type II) titer after receiving 1st dose of shingrix. The reporter wanted to know if Shingrix had any effect on HSV2 (Herpes Simplex virus type II) titer. The reporter consented to follow-up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Malaise, Nasopharyngitis, Nausea, Pain
Clinical narrative: FEVER; VOMITING; BODY ACHES; COLD; BOTH ARMS WERE "REAL SORE"; NAUSEA; FELT SICK FOR 11 TO 12 HOURS; This spontaneous report received from a consumer concerned a female (reporter's wife) of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of administration was not reported, batch number: unknown) dose was not reported, administered on 05-MAR-2021 at around 17:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 06-MAR-2021, at 2:00, the subject experienced fever with a body temperature between 103-105 F. The pharmacist advised the patient to take Tylenol / Advil for fever. On 06-MAR-2021, the subject experienced vomiting, body aches, nausea, cold and both her arms were sore. On an unspecified date in MAR-2021, the subject felt sick for 11 to 12 hours and then felt fine. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The patient recovered from vomiting on 06-MAR-2021, and felt sick for 11 to 12 hours on MAR-2021, had not recovered from fever, and the outcome of nausea, cold, body aches and both arms were "real sore" was not reported. The reporter considered the events (vomiting, fever, nausea, cold, body aches and both arms were 'real sore') as related to COVID-19 vaccine AD26.COV2.S. The reporter considered the causality of event 'felt sick for 11 to 12 hours' to COVID-19 vaccine AD26.COV2. as possible. This report was serious (Other Medically Important Condition).  Additional Information received on 17-Mar-2021: Start time for event fever updated from 3:00 to 2:00, pharmacist advised patient could take Tylenol / Advil for fever (added in treatment text and narrative), event verbatim updated from 'sore' to 'both her arms were real sore', event added (felt sick for 11 to 12 hours) and narrative updated with the additional information received.; Sender's Comments: V.2: The follow up information in this version updates event verbatim, event addition, other AE characteristics and treatment for fever. This updated information does not alter the causality of previously reported event fever.   20210312384-COVID-19 vaccine Ad26.COV2.S-Fever. This event is labeled and is therefore considered potentially related.