chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: Menactra mixed with a dose of varicella vaccine and administered in error as a diluent for the varicella instead of sterile diluent, no AE; Menactra mixed with a dose of varicella vaccine and administered in error as a diluent for the varicella instead of sterile diluent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse.  The physician mixed/ reconstituted a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] with VARICELLA ZOSTER VACCINE [VARICELLA VACCINE] (not produced by Sanofi Pasteur) in error as he/she thought that the MENACTRA was the diluent for the varicella instead of sterile diluent and vaccinated to an 18 year old male patient on an unknown date for prophylactic vaccination (product preparation error, labelled drug-drug interaction medication error,  batch number and other dosing details were not reported).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.  This was an actual medication error case due to wrong solution used in drug reconstitution and labelled drug-drug interaction medication error (latency same day).  The nurse had no more information on the vaccine and no adverse event reported to the patient at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was given expired dose of Tenivac/ no adverse event; Initial information was received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a male patient of unknown age who was vaccinated with expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (batch number not reported and expiry date 28-Jan-2021) via an unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  Caller wanted to know if they should re-vaccinate or it was okay with the expired dose.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Result of assessment was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.  Inquiry retrieved from proxy. Outbound call attempt made: No answer, Left voicemail message requesting a call back. Note: No direct contact with HCP. Product used : Used
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Discharge, Fatigue, Fluid intake reduced, Headache
Clinical narrative: The day after I had my vaccine I was very drained and had a headache.  This was to be expected.  On the second day after I slept 14 hours.   On the third day I woke up at noon and noticed that the right side of my lower cheek just above the jawline was markedly swollen, as well as half of my lower lip. There was no pain; the skin felt a bit numb, but it did itch at times, though not very intensely.  During the night of the third day, my full bottom lip swelled, and cracked open and oozed a clear liquid the thickness of water, though not a lot of it.  The whole lip looked as if it were a water balloon encased in a thin layer of skin.  Also this day I had a mild sore throat, but no other symptoms.   On the fourth day when I awoke, the swelling was all across the lower portion of my face, but was notably worse on the left side.  It looked like a golf ball was in my cheek.  Also the left side of my lips were so swollen I couldn't close my teeth.   In the afternoon, as I was eating biscuits my upper lip swelled enormously.   At this point it was hard to drink liquids as I couldn't make a seal as my lower lip was swollen unevenly. On the fifth day (today) I awoke with my upper lip extremely swollen.  My lower cheeks were still swollen, but not grotesquely so.  I had a tepid cup of coffee and when I finished my upper lip was no longer swollen!  My cheeks remain mildly swollen.  I didn't go into work today as the upper lip was so horrid, I couldn't be seen, but I will return to work tomorrow.   I should add that I tried EVERY conceivable home treatment for this: hot and cold compresses, ibuprofen, gargling salt, benadryl, hydrocortisone cream...nothing had ANY effect.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Impaired work ability, Lip swelling, Oropharyngeal pain, Swelling face
Clinical narrative: The day after I had my vaccine I was very drained and had a headache.  This was to be expected.  On the second day after I slept 14 hours.   On the third day I woke up at noon and noticed that the right side of my lower cheek just above the jawline was markedly swollen, as well as half of my lower lip. There was no pain; the skin felt a bit numb, but it did itch at times, though not very intensely.  During the night of the third day, my full bottom lip swelled, and cracked open and oozed a clear liquid the thickness of water, though not a lot of it.  The whole lip looked as if it were a water balloon encased in a thin layer of skin.  Also this day I had a mild sore throat, but no other symptoms.   On the fourth day when I awoke, the swelling was all across the lower portion of my face, but was notably worse on the left side.  It looked like a golf ball was in my cheek.  Also the left side of my lips were so swollen I couldn't close my teeth.   In the afternoon, as I was eating biscuits my upper lip swelled enormously.   At this point it was hard to drink liquids as I couldn't make a seal as my lower lip was swollen unevenly. On the fifth day (today) I awoke with my upper lip extremely swollen.  My lower cheeks were still swollen, but not grotesquely so.  I had a tepid cup of coffee and when I finished my upper lip was no longer swollen!  My cheeks remain mildly swollen.  I didn't go into work today as the upper lip was so horrid, I couldn't be seen, but I will return to work tomorrow.   I should add that I tried EVERY conceivable home treatment for this: hot and cold compresses, ibuprofen, gargling salt, benadryl, hydrocortisone cream...nothing had ANY effect.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Injection site erythema, Lymphadenopathy
Clinical narrative: Nausea, Fever 102, chills, body aches, vomiting, arm soreness, axillary lymph swelling in injected arm, sweating, redness at injection site, headache and fatigue.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Nausea, Fever 102, chills, body aches, vomiting, arm soreness, axillary lymph swelling in injected arm, sweating, redness at injection site, headache and fatigue.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy for two days so far
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: I had a bad outbreak of oral herpes (second only to my initial outbreak decades ago) the day after my Covid vaccine. People with herpes should be warned of the risk and take Vicyclovir or their prescribed preventative medication before getting the vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash
Clinical narrative: 4in dia. rash below injection site w pain appeared 12 days after injection.  Has not gone away yet.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient presented to clinic to get second dose of Moderna COVID 19 vaccine however was given Pfizer COVID 19 vaccine by RN
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Migraine, Nausea
Clinical narrative: felt achy and flu like 12 hours after 2nd dose that lasted approx 36 hours. Had a day of feeling ok, but fatigued and began to have migraine symptoms. Began with head tightness, developed facial tingling, nausea and tingling in extremities that developed into restless leg like symptoms. Constant "activity" in legs around the clock making sleep impossible.   Have been taking rizatriptan for migraine which provides short term relief of head pain. On 2/11/21 Had IV Toradol, Reglan and Magnesium to try and break cycle. Short term relief. Ongoing tylenol taking.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia, Restless legs syndrome, Sleep disorder, Tension headache
Clinical narrative: felt achy and flu like 12 hours after 2nd dose that lasted approx 36 hours. Had a day of feeling ok, but fatigued and began to have migraine symptoms. Began with head tightness, developed facial tingling, nausea and tingling in extremities that developed into restless leg like symptoms. Constant "activity" in legs around the clock making sleep impossible.   Have been taking rizatriptan for migraine which provides short term relief of head pain. On 2/11/21 Had IV Toradol, Reglan and Magnesium to try and break cycle. Short term relief. Ongoing tylenol taking.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: 2 days after second injection of Moderna, I developed hives and itching on Left am and left inner thigh. On the fourth day after, it spread to right arm and right inner thigh. Today is day 20 after the vaccine and still experiencing moderate generalized urticaria. Had taken Benadryl but doesn't help it just would make me sleepy.  Reported this to my workplace but had no response.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Cough, Pain, Pain in extremity
Clinical narrative: Arm pain, loss of taste, severe cough, body aches, chills
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: No further information is available; patient received an expired RECOMBIVAX.; This spontaneous report was received from an administrator in the office and refers to a female patient of unknown age. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On 18-JAN-2021, the patient was vaccinated with an expired hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) lot # R015160, expiration date 09-NOV-2020, dose of 0.5 ml once (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No further information was available.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion for PROQUAD/administered to patients; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. On 04-JAN-2021, the patient was administered improperly stored (PROQUAD) 1 dose, 0.5 ml, subcutaneously, lot number: T005404, expiration date: 12-AUG-2021. The vaccine experienced temperature excursion of 32.4 degrees Fahrenheit for 4 hours. Previous temperature excursion was not detected. The data logger was involved.
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: low MMR II titers; Caller believes the patient had received the vaccine per Prescribing Information/Patient received 1st dose of the most recent administration of the vaccine; Route of Administration: IM; This spontaneous report as received from a pharmacist refers to a female patient of unknown age.     Patient's current condition, medical history and concomitant therapy were not reported. On an unspecified date, when patient was a child, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, lot #, expiration date not reported) (reporter believed the patient had received the vaccine per Prescribing Information guidelines) for prophylaxis of measles, mumps, rubella. On unspecified date, patient had low MMR II titers and her nursing school requested revaccination. The nursing school requested 2 doses of the vaccine.  On 23-DEC-2020 the patient was revaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscular for prophylaxis of measles, mumps, rubella (dose, lot # and expiration date were not reported).        Pharmacist was going to re-draw MMR titers (date undecided yet) to confirm most recent dose of the vaccine was successful. The outcome of low MMR II titers was reported as recovering. Causality assessment was not provided.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 19-JAN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number: T022294 (lot number: T02294 was verified as non valid), expiration date: 26-MAR-2022 (exact dose and route of administration were not provided) for prophylaxis.  The vaccine experienced temperature excursion of 46.7 degrees Fahrenheit for 5 minutes. Previous temperature excursion was not detected. The data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T022294; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine administered; no adverse event; This spontaneous report was received from a licensed practical nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 20-JAN-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot: T014835, expiration date: 17-JUL-2021 (exact dose and route of administration were not provided) for prophylaxis.  The vaccine experienced temperature excursion of 50 degrees Fahrenheit for 1 hour. There was no previous temperature excursion detected. The digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T014835; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 5.0
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GARDASIL 9 was administered to 5 year old; no additional AE; This spontaneous report was received from a vaccine coordinator via vaccine representative (described also as field representative) and refers to a 5-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  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) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (inappropriate age at vaccine administration). No additional adverse event (AE) was reported.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE/PQC reported; a dose of expired VAQTA was inadvertently given to a patient; This spontaneous report as received from a medical assistant refers to a 17-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On 21-JAN-2021, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # T001419, expiration date: 06-JAN-2021(formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. The hepatitis a vaccine, inactivated (VAQTA) had not had any prior temperature excursions. No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored administered vaccine; This spontaneous report was received from a office manager and refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 14-JAN-2021, the patient received a dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # T010309 , expiry date 24-MAR-2022, for prophylaxis (concentration, dose, dose number, route of administration and frequency were not reported).  Digital data logger was involved. The vaccine underwent the temperature excursion at -8.5 degree of Celsius (C) to -10 C for 1 hour and 35 minutes. There was no previous temperature excursion. No product quality complaint (PQC) was involved.
Age: 12.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs; 12 year old recevied both Varivax with an expiration date of 10/23/2020 and MMR II with an expiration date of 10/14/2020; This spontaneous report was received from a medical assistant and refers to a 12-year-old patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 28-JAN-2021, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX), in dose 0.5 milliliter, expiration date: 23-OCT-2020. On the same day, the patient was also vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) in dose 0.5 milliliter, expiration date: 14-OCT-2020. Dose numbers, lot #, routes of administration and anatomical locations of aforementioned vaccines were not reported, both vaccines were used for prophylaxis. No temperature excursions of vaccines were reported. Both vaccines were supported by Post Expiry Memo Vaccines and Biologic's Administered information. The reporter declined to provide information on 12 year old at this time. No additional adverse events were reported.
Age: 61.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: he had a terrible reaction for a week, he had muscle aches, pain and joint pain and everything hurt.; he had a terrible reaction for a week, he had muscle aches, pain and joint pain and everything hurt.; he had a terrible reaction for a week, he had muscle aches, pain and joint pain and everything hurt.; This spontaneous report was received from a consumer via other company (Pfizer) concerning himself, a currently 65-year-old male patient. The patient's concurrent conditions included hypertension and stage 3 renal failure. Information regarding the patient's medical history, historical drug and concomitant therapies was not provided.  On approximatelly 2017, (reported as "about 4.5 years ago"), the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (dosage regimen, route of administration, lot number and expiration date were not provided) for prophylaxis.  On an unknown date, the patient had a terrible reaction for a week, he had muscle aches, pain and joint pain and everything hurt.  It was reported that the adverse events "eventually  went away". The causal relationship between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and the events was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administered after a temperature excursion; This spontaneous report was received from a nurse practitioner and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.  On 27-JAN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), dose 0.5 (unit not provided), once, lot # T024281 (valid lot #), expiration date was reported and also validated as 15-JUL-2022 (strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). It was reported, that the vaccine before administration was stored at the temperature of 7.1 Fahrenheit degree (F) for 59 hours and 45 minutes. There was no previous temperature excursion detected. The data logger was not involved. No product quality complaint (PQC) was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA000622: US-009507513-2102USA000364: US-009507513-2102USA000435:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored dose was administered; This spontaneous report was received from a nurse and refers to a 12-month-old patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 01-FEB-2021, the patient was vaccinated with a improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot# T013205, expiry date 03-DEC-2021 (route of administration was not reported) for prophylaxis.  The vaccine underwent temperature excursion of 48 (not further specified) for 24 hours and 45 minutes. There were no previous temperature excursions. The call was because of digital data logger. No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs.; PROQUAD was administered one time this morning before I called; This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 02-FEB-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA, 0.5 ml, lot number T025509 has been verified to be a valid lot number, expiration date 23-JAN-2022 (route of administration, vaccination site were not specified) for prophylaxis.   The temperature excursion was 13.1 degrees Fahrenheit for 20 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; PROQUAD, improperly stored vaccine administered.; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 29-DEC-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 ml orally, lot # S027467, expiration date 02-MAR-2021, for prophylaxis.  Temperature 6°F to 14°F (9.3F) for 15 minutes; 6°F to 14°F (9.lF) for 15 minutes Time frame see above Previous temperature excursion? NO Was call because of a "data logger"?
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose administered to a patient; This spontaneous report was received from a medical assistant and refers to a 67-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 03-FEB-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) vial, 1 ml, lot # S037821 was confirmed to be valid, expiration date 07-JAN-2021 (route of administration and anatomical location were not reported) for prophylaxis. No additional event details were available
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Electrocardiogram, Hypersensitivity, Respiratory therapy
Clinical narrative: she had allergic reaction to a Merck Hep B vaccine; This spontaneous report was received from a 59-year-old female patient who was reporting on herself. The patient concurrent condition included with celiac disease, fibromyalgia and Hashimoto's disease. She had allergy to penicillin, latex, bananas and bees. Medical history and concomitant medications were not reported.  On 08-AUG-2005, the patient was vaccinated with her first part of three hepatitis b vaccine (recombinant) (manufacturer unknown) injection, intramuscularly for prophylaxis (exact dose, dose #, strength, anatomical location, lot # and expiration date were not reported). On the same date, she experienced allergic reaction and seek medical attention. As the treatment, the patient received respiratory therapy and epinephrine (EPIPEN). She had performed electrocardiogram (EKG) but results were not provided. The event resolved on the same date. The patient wanted to get the coronavirus disease 2019 (COVID-19) vaccine and wanted to know the components of that vaccine hepatitis b vaccine (recombinant) (manufacturer unknown).   The relatedness between hepatitis b vaccine (recombinant) (manufacturer unknown) and the event was considered as related.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: she had swelling all up and down her arm as well as in her fingers; This spontaneous report was received from a currently 73-year-old female patient who was reporting on herself. The patient's concurrent condition included high blood pressure and overweight. She had allergy to dyes during magnetic resonance imaging (MRI). Her concomitant medications included unspecified heart medications and regular vitamins.  On an unknown date in 2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (strength, exact dose, dose #, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date in 2013, she had reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) which was described as swelling all up and down her arm as well as in her fingers. The event resolved within 24 hours after vaccination. She did not received any treatment.  The relatedness between the event and suspect vaccine was considered as related.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Vaccine had been administered since the excursion.; This spontaneous report was received from a medical assisstant and refers to a 6 month old patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 02-JAN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot # 1691307, expiration date 25-NOV-2021 (dose and frequency were not provided) for prophylaxis.       Temperature: 47.0lF Time frame: 1 minute 30 seconds Previous temperature excursion? No Was call because of a "data logger"? Y
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: No additional AE reported; Gardasil 9 was improperly stored and administered.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported.  On 06-JAN-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1637642, expiration date 28-MAY-22) at a dose of  0.5 milliliter for prophylaxis (strength, vaccination schedule, route and anatomical site of administration were not provided); which had a temperature excursion of 64.36 F for 3 hours on 14-OCT-2020, 35.7 F for 1 hour and 30 minutes on 27-OCT-2020 and 30.20 F for 1 hour and 30 minutes on 28-OCT-2020. The temperature excursion were detected by a data logger. No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Running fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2020, the patient received the 2nd dose of Shingrix. On 17th December 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had 2nd Shingrix vaccine on the day of reporting and experienced running fever.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever of 101.5; This case was reported by a consumer and described the occurrence of fever in a 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, unknown after receiving Shingrix, the patient experienced fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that his wife running a fever of 101.5 after taking the shingles vaccine.  She had taken two Tylenol for the fever. The reporter asked was there anything else she should do.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: diagnosed with shingles on her midsection; This case was reported by a pharmacist and described the occurrence of shingles in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number H4H34, expiry date 27th November 2021) for prophylaxis.   On 13th November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd December 2020, 39 days after receiving Shingrix, the patient experienced shingles. The patient was treated with famciclovir. Shingrix was interrupted. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the Shingrix in left arm. On 22nd December 2020, she was diagnosed with shingles on her midsection and started on antivirals (famciclovir 500 mg TID  for 7days).  She was advised by her physician to not receive the 2nd dose of Shingrix. This case had been linked with US2020220506 and US2020220495 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220506:same reporter US-GLAXOSMITHKLINE-US2020220495:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got first shot / Within 2 days I had Shingles; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix at local VA and within 2 days had shingles. When notified the Doctor was told it was a coincidence.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: Sicker than I have been in a long time; Having a sore was the least of my problems; Was tired; This case was reported by a consumer and described the occurrence of sickness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of no adverse event (received the original shingles vaccine several years ago from reporting day with no adverse reaction) and shingrix with an associated reaction of pain in extremity (1st dose received on unknown date and  experienced sore arm refer case US2021AMR000324).   On 28th December 2020, the patient received the 2nd dose of Shingrix. On 28th December 2020, less than a day after receiving Shingrix, the patient experienced sickness, pain and tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness and pain were unknown and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the sickness, pain and tiredness to be related to Shingrix.  Additional details were reported as follows: The patient was in reasonably good health. The patient got so sick within 8 hours of receiving her 2nd Shingrix vaccine. The patient had every side effect listed except fever. The patient was approximately 7-8 hours was sicker than she had  been in a long time. The patient was sore and was tired for 2 days after vaccination with no other side effects, fine at the time of reporting. The patient was extremely worried that she had Covid but she had none of the other Covid symptoms. The patient was received the original shingles vaccine several years ago with no adverse reaction. The patient was retired GSK employee. GSK was paying  pension and most of medical to patient hence she wanted to keep GSK up to date.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR000324:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain
Clinical narrative: Have a reddish where I got the shot; Achy body; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema and general body pain. On an unknown date, the outcome of the injection site erythema and general body pain were unknown.   It was unknown if the reporter considered the injection site erythema and general body pain to be related to Shingrix.  Additional details were provided as follows:    The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient self reported the case. The patient had achy body and reddish where the patient got the shot, had no fever. The oxygen was 98 and heart rate was 70.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea
Clinical narrative: shivering; stomach pains; diarrhea; This case was reported by a consumer and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th December 2020, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shivering, stomach pain and diarrhea. On an unknown date, the outcome of the shivering was recovered/resolved and the outcome of the stomach pain and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the shivering, stomach pain and diarrhea to be related to Shingrix.  Additional details were provided as follows:  The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The patient asked how long a reaction could last from taking the Shingrix shot.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea; This case was reported by a consumer and described the occurrence of diarrhea in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2021, the patient received Shingrix. On 4th January 2021, 1 days after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix in afternoon of a day before reporting. On the next day, at the time of reporting, the patient had severe diarrhea.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pain in extremity, Reaction to preservatives, Vaccine positive rechallenge
Clinical narrative: arm soreness; lethargy; achiness; This case was reported by a consumer and described the occurrence of pain in arm in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 16th September 2020 and experienced sore arm and crampning in arm. For the tolerance of 1st dose, refer linked case US2021000471).   On 16th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced lethargy and pain. On 16th December 2020, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, lethargy and pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, lethargy and pain to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose in left deltoid. After receiving Shingrix, the patient experienced arm soreness, lethargy, and achiness. Soreness began the same day as receiving the second dose and the lethargy and achiness began over the next 2 days.  The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021000471:1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: injection site pain; woke up with fever to 101; chills; nausea; headache; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2021, the patient received Shingrix. In January 2021, 14 hrs after receiving Shingrix, the patient experienced injection site pain, fever, chills, nausea and headache. On an unknown date, the outcome of the injection site pain, fever, chills, nausea and headache were unknown.   It was unknown if the reporter considered the injection site pain, fever, chills, nausea and headache to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had the Shingrix booster shot a day before reporting and did fine except injection site pain. During the night, the patient woke up with fever to 101 degree F, chills, nausea and headache. The patient asked if it was common for these reactions to be delayed, it was about 14 hours after the shot.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: spreading of soreness; itching; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced pain and pruritus. On an unknown date, the outcome of the pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the pain and pruritus to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. Almost 2 weeks after receiving Shingrix, the patient had a spreading of soreness and itching.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Injection site pain
Clinical narrative: CRP reactive protein level was over 10; Discomfort in her right arm around the injection site; This case was reported by a consumer and described the occurrence of injection site discomfort in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, 1 min after receiving Shingrix, the patient experienced injection site discomfort. On 14th December 2020, the patient experienced c-reactive protein increased. On an unknown date, the outcome of the injection site discomfort was recovered/resolved and the outcome of the c-reactive protein increased was unknown.   It was unknown if the reporter considered the injection site discomfort and c-reactive protein increased to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received vaccine on her right arm around 3 weeks ago from the reporting date. The patient was unsure of the exact date of vaccination if it was 20th or 21st  November 2020 and did not have lot number or expiration date of vaccine. The patient reported that from the minute she received the vaccine she had discomfort in her right arm around the injection site and this lasted for 3 days and resolved in November 2020. The patient went to have blood work drawn on monday 23rd November 2020 and found out on 14th December 2020, less than a month after vaccination that her C-reactive protein level was over 10 and her doctor told that a value for C-reactive protein over 10 was extremely high. The patient would have blood work done again in 3 weeks to recheck the C-reactive protein level. The patient gave consent to follow-up with her health care professional.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: itching at the injection site; redness; swelling; difficulty sleeping; fatigue; pain at the injection site/pain in the upper arm; This case was reported by a nurse and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site itching, erythema, swelling and difficulty sleeping. On an unknown date, the patient experienced fatigue. On an unknown date, the outcome of the injection site pain, injection site itching, erythema, swelling, difficulty sleeping and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site itching, erythema, swelling, difficulty sleeping and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was a retired nurse received Shingrix in left upper arm about a month ago from reporting day but she does not know the date. On the same day she had pain at the injection site with redness about 7-8 inches in diameter and swelling which lasted for about 3 days with pain in the upper arm area which was resolved at time of reporting. A week after vaccination patient had some itching at the injection site. Due to the pain at the injected site and upper arm, the patient had difficulty sleeping for about 2 nights. She also reports fatigue which lasted for a week. The patient did not want to provide information about the pharmacy and the MDO. The reporter did not consent to follow-up.