chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The nurse verified a total of 9 administrations of improperly stored vaccines; This spontaneous report was received from a nurse regarding to a patient of unknown age and gender.    The medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  This is one of multiple reports from the same reporter. On 22-JUL-2020 the reporter noticed that an improperly stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T006792 exp date: 24-AUG-2021 , 0.5 milliliter for prophylaxis (route and application site were not reported); had been administered to the patient.  The reported temperatures were: -13.5 C, -11.4 C and -1.8 C and the time frames were: 24 minutes, 27 minutes, 2 hours and 8 minutes. There was a previous temperature excursion and the issue was noticed due to a data logger.  The outcome of the patient was unknown.    The reporter also mentioned a case of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) and additional cases reporting the administration of improperly stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD).; Sender's Comments:  US-009507513-2007USA010419: US-009507513-2007USA010374:Varivax case US-009507513-2007USA010361: US-009507513-2007USA010893: US-009507513-2007USA010434: US-009507513-2007USA010252:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported.; Nurse reported administered ROTATEQ after temperature excursion.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 23-JUL-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter (ml) orally administered (lot number 1676324 which has been verified to be valid, expiration date reported and validated as 21-APR-2021) (vaccination scheme and frequency were not reported) as prophylaxis. The administered dose of the vaccine was stored at a temperature of 8.83 degrees Celsius, during a time frame of 20 hours, as recorded by a digital data logger. There was no previous temperature excursion. No additional adverse events were reported in the patient.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse effects; An 18 year old patient inadvertently received unspecified dose of PROQUAD instead of MMR II and VARIVAX due to human error in selection; An 18 year old patient inadvertently received unspecified dose of PROQUAD instead of MMR II and VARIVAX due to human error in selection; An 18 year old patient inadvertently received unspecified dose of PROQUAD instead of MMR II and VARIVAX due to human error in selection; This spontaneous report was received from a nurse referring to an 18 year old patient.  No information was provided regarding the patient's medical history, concurrent conditions or past drug history.  Concomitant therapies included sterile diluent.  On 08-JUN-2020, the patient inadvertently received an unspecified dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S021325, expiring on 05-JAN-2021, for prophylaxis (dose, route and site of administration were not reported), outside recommended age range.  The nurse stated it was human error in selection as patient needed  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) immunizations. There were no symptoms or additional adverse effects reported.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Neurological symptom, Rash, Rash vesicular
Clinical narrative: serious neurological problems; painful blistering rash; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JUL-2015, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage, and route of administration not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently (date not reported), the patient was treated by a provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: painful blistering rash and serious neurological problems. The outcome of the events was not reported. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: No adverse effect reported; The third dose was GARDASIL 9 and not GARDASIL quadrivalent; The third dose was GARDASIL 9 and not GARDASIL quadrivalent; on 12/16/2015 patient received a first dose of GARDASIL quadrivalent. Then on 1/13/2016, patient received a second dose of GARDASIL quadrivalent which was earlier than the indicated dosing regimen per PI; This spontaneous report was received from a Registered Nurse referring to a 16 year old male patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On 16-DEC-2015, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) by intramuscular route (dose, anatomical location, lot number and expiration date were not reported); then, on 13-JAN-2016, he received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vial lot # K010215 the expiration date was not reported, but upon internal verification has been confirmed as 17-JAN-2016, intramuscularly, both for prophylaxis. It was specified that this dose was earlier than the indicated dosing regimen (inappropriate schedule of product administration).    Furthermore, the nurse reported that on 17-JUL-2020, the patient received a third dose of vaccination, but it was with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection in prefilled-syringe intramuscularly, for prophylaxis, lot # 1602284, the expiration date was not reported, but upon internal verification has been confirmed as  26-SEP-2021 (dose and anatomical location were not reported), instead of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (interchange of vaccine products and wrong product administered). 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: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; 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, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE/PQC reported; patient was administered VAQTA after expiration date; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 28-JUL-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (1 milliliter, lot # S007265, expiration date 07-JUL-2020; route was not reported) for prophylaxis after expiration date (expired product administered). The reported was also inquiring if the dose was valid. No other adverse event (AE) or product quality complaints (PQC ) were reported. The product was not available for investigation (Obtain was false). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007265; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; 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, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired drug administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 29-JUL-2020, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) lot # S007769, 0.5 milliliter for prophylaxis (route and site of administration were not reported), which had expired on 24-JUL-2020 (expired product administered).   The product had never had a temperature excursion.  There were no adverse events reported.  There was not any PQC reported.  The product was supported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007769; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Myalgia, Social problem
Clinical narrative: sore arm muscle; sore arm muscle; Social problem; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of bursitis (received 1st dose on September 2019 (refer case ID:US2020118935)).   On 10th July 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, myalgia and social problem. On an unknown date, the outcome of the injection site pain and myalgia were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the injection site pain and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient received her first Shingrix dose in September 2019 and had not received the second shingrix dose because her pharmacy was not administering it because of COVID-19. The pharmacy was not planning to get 2nd Shingrix vaccine. The patient received the 2nd Shingrix vaccine on 10th July 2020. There were no adverse reactions except for a slightly sore arm muscle where the shot received. The adverse event lasted for less than 3 days. At the time of reporting patient did not experienced adverse event. The would be contacting to make an appointment and patient like to know how long to wait.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020118935:same reporter
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Pallor, Vision blurred
Clinical narrative: dizziness; felt she couldn't focus her eyes; super pale; This case was reported by a other health professional via sales rep and described the occurrence of dizziness in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced dizziness, difficulty focusing eyes and pallor. On an unknown date, the outcome of the dizziness, difficulty focusing eyes and pallor were recovered/resolved.   It was unknown if the reporter considered the dizziness, difficulty focusing eyes and pallor to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported dizziness after the first dose and felt she couldn't focus her eyes. The patient was super pale.  The patient felt ok after 24 hours. The reporter consent to follow up.
Age: 79.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Paraesthesia
Clinical narrative: prickly sensation in both arms; This case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a 79-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced tingling sensation. On an unknown date, the outcome of the tingling sensation was not reported.   It was unknown if the reporter considered the tingling sensation to be related to Shingrix.  Additional details were reported as follows: The patient received the 1st dose of Shingrix. The patient experienced a prickly sensation in both arms. The patient did not experience redness or itching at the injection site until the time of reporting. The patient asked was it common. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: How long do the side effects last?; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2020, the patient received Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not reported.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient asked how long do the side effects last. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia, Social problem
Clinical narrative: slight fever; body aches; similar to a mild flu; planning to have the remaining dose/Because the virus hit, I have yet to have this done; This case was reported by a consumer via call center representative and described the occurrence of fever in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, general body pain, influenza-like symptoms and social problem. On an unknown date, the outcome of the fever, general body pain and influenza-like symptoms were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the fever, general body pain and influenza-like symptoms to be related to Shingrix.  The age at vaccination was not reported. On 13th July 2020, the patient received the 1st dose Shingrix. The patient had a slight fever, body aches last time, similar to a mild flu and wonder if the patient would get these again, or even worse. The patient was planning to have the remaining dose within 6 months. Because the virus hit, the patient has yet to have this done. The patient physician said the patient should go ahead despite the time lapse. The patient asked to advise would be getting the 2nd dose at my local if or when he decide. The reporter did not consent to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2020, the patient received the 1st dose of Shingrix. On 9th January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 13th January 2020, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced pain in arm, body temperature increased and chills. The reporter consented to follow up. For tolerance to 2nd dose refer linked case US2020AMR146116, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR146116:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: outbreak of Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. In July 2020, between 6 and 8 months 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 reported as follows: The age at vaccination was not reported. All patient identifiers were reported. No details on Batch Number or Expiration date since it was administered on a different facility and they do not have those details. The patient received Shingrix. The patient experienced an outbreak of Shingles. The patient was wondering on how to proceed with 2nd dose. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020123388:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 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. It was reported that the patient experienced shingles 1 week after receiving the first dose of Shingrix. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Herpes zoster, Rash, Skin discolouration
Clinical narrative: Diagnosed as shingles; Was in so much pain / Right flank pain; Rash; Discoloration; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2020, the patient received the 1st dose of Shingrix (intramuscular). In July 2020, less than 2 weeks after receiving Shingrix, the patient experienced skin discoloration. On 22nd July 2020, the patient experienced shingles, flank pain and rash. The patient was treated with prednisone, gabapentin and antivirals nos. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the flank pain was recovering/resolving and the outcome of the rash was recovered/resolved and the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the shingles, flank pain, rash and skin discoloration to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was in so much pain she was taken to an emergency room facility to treat her for right flank pain and rash which was diagnosed as Shingles. The rash was gone but there was something was there described as discoloration and that her pain was a lot better but not gone in the right flank area of her back.  The patient was prescribed Gabapentin, Antiviral, and prednisone as treatment for the diagnosis of Shingles. The reporter consent to follow up.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site extravasation, No adverse event, Product leakage, Underdose, Wrong technique in product usage process
Clinical narrative: while administrating Menactra some of the vaccine leak from the injection site of the left arm after the syringe was removed from the arm, No AE; syringe was removed too quickly after injection and some of the vaccine leak from the injection site of the left arm, No AE; while administrating Menactra some of the vaccine leak from the injection site of the left arm after the syringe was removed from the arm, No AE; Initial information received on 24-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 18-year-old male patient who received 0.5 mL second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6586A, expiry date 14-Apr-2021, via an intramuscular route in the left arm) for prophylactic vaccination on 24-Jul-2020, which leak from the injection site after removing syringe too quickly from the arm.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for prophylactic vaccination on 24-Jul-2020.  It was a case of vaccine underdose, wrong injection technique and product leakage.  The nurse reported that the patient was very muscular and one inch needle was used, the syringe was removed too quickly after injection and vaccine leaked and with another vaccine given on the other arm the syringe was not removed as quickly and no vaccine leaked arm.  At the time of reporting, no adverse event was 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.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: The patient received Menactra and Adacel subcutaneously instead of intramuscularly, No AE; Initial information was received on 29-Jul-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional. This case involves a 12 year old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] subcutaneously instead of intramuscularly.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 27-Jul-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE once and a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number not reported) via subcutaneous route in unknown administration site for prophylactic vaccination respectively.  It was a case of an actual medication error due to inappropriate route of vaccination.  At the time of report, no adverse event was 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 and Module VI of the 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 lot number.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria chronic
Clinical narrative: Chronic Urticaria
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Alopecia areata
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Hot flush, Insomnia
Clinical narrative: Injection made approximately 8:50 am Friday 7/31.  Redness, pain and swelling began several hours later.  Had trouble sleeping Friday night.  Woke up with headache on Saturday morning.  Headache lasted 2 days.  Extreme fatigue all day Saturday and most of the day Sunday.  Hot flashes made me feel like I had a fever, but temperature was taken twice on Saturday and it was normal.  Unable to do normal daily activities Saturday and Sunday.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain, Swelling
Clinical narrative: Injection made approximately 8:50 am Friday 7/31.  Redness, pain and swelling began several hours later.  Had trouble sleeping Friday night.  Woke up with headache on Saturday morning.  Headache lasted 2 days.  Extreme fatigue all day Saturday and most of the day Sunday.  Hot flashes made me feel like I had a fever, but temperature was taken twice on Saturday and it was normal.  Unable to do normal daily activities Saturday and Sunday.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had soreness at the injection site. For tolerance of 2nd dose refer case US2020141485. On 22nd July 2020 the patient received a hepatitis A booster vaccine in her right arm. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020141485:
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had soreness at the injection site.  The reporter consented to follow up. For tolerance of 2nd dose refer case US2020141489.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020141485:same reporter US-GLAXOSMITHKLINE-US2020141489:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: where shot was administered / is red; where shot was administered / is itches.; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  Additional details were reported 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 received Shingrix 3 days prior to the reporting and the area affected upper arm where shot was administered and was red and itches.
Age: 83.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: left arm site of shot / upper arm is red and it itches / problem with Shingles shot site; left arm site of shot / upper arm is red and it itches / problem with Shingles shot site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left arm and experienced upper arm redness and itches.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Axillary pain, Feeling hot, Headache, Injection site pain
Clinical narrative: the pain in injection site radiated to the lateral border of her axilla, she describes this pain as a shooting and nagging pain on her axilla border.; Slight headache; being weak and having no energy; warmth around the axilla border and armpit; All pain are on the left side; is 42 years old and states that her doctor recommended she get the Shingrix vaccine; is 42 years old and states that her doctor recommended she get the Shingrix vaccine; pain around injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 42-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd July 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, off label use and inappropriate age at vaccine administration. On 24th July 2020, the patient experienced axillary pain, headache, weakness, feeling of warmth and pain localized. On an unknown date, the outcome of the injection site pain, axillary pain, headache, weakness and feeling of warmth were not recovered/not resolved and the outcome of the pain localized, off label use and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the injection site pain, axillary pain, headache, weakness, feeling of warmth and pain localized to be related to Shingrix.  Additional details were reported as follows: The patient received her first Shingrix dose in her left upper arm and she experienced pain around injection site on same day after receiving vaccine. On 24th July 2020 she woke up with the pain in injection site radiated to the lateral border of her axilla, she describes that pain as a shooting and nagging pain on her axilla border. She also reports some warmth around the axilla border and armpit. All pain was on the left side. She also reports a slight headache, being weak and having no energy.  The reporter consented to follow up. The patient was 42 years old and her doctor recommended she get the Shingrix vaccine because of concerns for her immune system because she takes biologics drugs and her roommate had shingles a week ago which led to drug use for unapproved indication and inappropriate age at vaccine administration.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Off label use, Pain, Product administered to patient of inappropriate age
Clinical narrative: the pain in injection site radiated to the lateral border of her axilla, she describes this pain as a shooting and nagging pain on her axilla border.; Slight headache; being weak and having no energy; warmth around the axilla border and armpit; All pain are on the left side; is 42 years old and states that her doctor recommended she get the Shingrix vaccine; is 42 years old and states that her doctor recommended she get the Shingrix vaccine; pain around injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 42-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd July 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, off label use and inappropriate age at vaccine administration. On 24th July 2020, the patient experienced axillary pain, headache, weakness, feeling of warmth and pain localized. On an unknown date, the outcome of the injection site pain, axillary pain, headache, weakness and feeling of warmth were not recovered/not resolved and the outcome of the pain localized, off label use and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the injection site pain, axillary pain, headache, weakness, feeling of warmth and pain localized to be related to Shingrix.  Additional details were reported as follows: The patient received her first Shingrix dose in her left upper arm and she experienced pain around injection site on same day after receiving vaccine. On 24th July 2020 she woke up with the pain in injection site radiated to the lateral border of her axilla, she describes that pain as a shooting and nagging pain on her axilla border. She also reports some warmth around the axilla border and armpit. All pain was on the left side. She also reports a slight headache, being weak and having no energy.  The reporter consented to follow up. The patient was 42 years old and her doctor recommended she get the Shingrix vaccine because of concerns for her immune system because she takes biologics drugs and her roommate had shingles a week ago which led to drug use for unapproved indication and inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Eczema, Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in August 2019 / not received a second dose; eczema that involved both arms; This case was reported by a pharmacist via call center representative and described the occurrence of eczema in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In May 2020, between 8 and 10 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced eczema. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with topical steroid nos (Topical Steroids). On an unknown date, the outcome of the eczema was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the eczema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose and was not applicable for 2nd dose. The reporter stated that, the patient received 1st dose in August 2019 and 2 months before reporting, the patient experienced eczema in both arms. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient received topical steroids which was ongoing. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: - Sore arm lasting about five days - Fatigue day after vaccination, lasting one day - Body aches day after vaccination, lasting one day - Shivering day after vaccination, lasting only 10 minutes - Slightly swollen/tender lymph node in left armpit, lasting about five days
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: - Sore arm lasting about five days - Fatigue day after vaccination, lasting one day - Body aches day after vaccination, lasting one day - Shivering day after vaccination, lasting only 10 minutes - Slightly swollen/tender lymph node in left armpit, lasting about five days
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: PATIENT CALL PHARMACY AND SAID SOAR AND REDNESS AROUND THE INJECTION SITE.  NO FEVER OR OTHER REACTION. TOLD PATIENT TO USE ICE PACK FOR WHILE , NEXT DAY FOLLOW UP WITH PATIENT AND SAID PAIN REDUCED AND BUT STILL REDDISH AROUND THE INJECTION SITE. OFFER TO CONTACT PCP BUT DENIED SAID WILL WAIT AND HAVE APPOINTMENT WITH DR AND WILL ASK HIM TO SEE.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia
Clinical narrative: Patient has stated that he's been experiencing muscle pain and insomnia after getting the Shingrix vaccine which starting the same night. He also said that the muscle pains radiating to the whole body and it's really bother him. The events have been going on since he got the vaccine (on 07/03/2020) and still going on until now (08/01/2020). He had been seen by  his PCP and also to ER room, however,  according to him, no other treatment has been rendered for this on going issues. He has been taking Advil/Ibuprofen in which he thinks it's helping.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Soreness and redness at injection site. Headache began around 7 pm.  Awakened by chills about 1 a.m., put on warmer pjs.  Awoke about 7 a.m. , still with headache. Took one ibuprofen about 9 a.m.   Headache subsided within about an hour, didn't recur. As of 2nd day following injection (Monday, following Saturday injection), felt fine except for soreness and a red patch at injection site.  This was a far less troublesome reaction than I had with the first  Shingrix injection in February.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Cough, Decreased appetite, Dysphagia, Fatigue
Clinical narrative: Swollen lymph gland in neck(huge), headache, stiff neck, fever, chills, sore throat/difficulty swallowing, cough, fatigue, nausea, loss of appetite, very difficult to sleep.  All symptoms have been present since evening of 7/31 or morning of 8/1.  Lymph gland on right side of necks is about the size of a golf ball.  Throat have become progressively worse and inflamed each day.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Inflammation, Insomnia, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Swollen lymph gland in neck(huge), headache, stiff neck, fever, chills, sore throat/difficulty swallowing, cough, fatigue, nausea, loss of appetite, very difficult to sleep.  All symptoms have been present since evening of 7/31 or morning of 8/1.  Lymph gland on right side of necks is about the size of a golf ball.  Throat have become progressively worse and inflamed each day.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Swollen lymph gland in neck(huge), headache, stiff neck, fever, chills, sore throat/difficulty swallowing, cough, fatigue, nausea, loss of appetite, very difficult to sleep.  All symptoms have been present since evening of 7/31 or morning of 8/1.  Lymph gland on right side of necks is about the size of a golf ball.  Throat have become progressively worse and inflamed each day.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Gait disturbance, Nausea, Pain in extremity
Clinical narrative: woke at 3AM very dizzy, light headed and nauseous, leg very painful and hard to walk
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptoms or additional adverse effects reported; incorrect product storage; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies provided.  On 26-JUN-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally second dose, lot # S005874, was a valid lot #, expiration date was reported as 03-OCT-2020, however after validation, expiration date was confirmed to be 31-OCT-2020. The vaccine was stored in 47.1 degrees Fahrenheit for 7 minutes. There was no previous temperature excursions. The storage was recorded by Digital Data Logger. There were no symptoms or additional adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The nurse verified a total of 9 administrations of improperly stored vaccines:; This 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, allergies, drug reactions, concomitant therapies or medical history provided. On 18-JUL-2020, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot #T006792, expiration date: 24-AUG-2021) 0.5 milliliter (dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperatures to which the vaccine was exposed were: -13.5 degrees of Celsius (C), -11.4 C, -1.8 C and the time frame was reported as 24 minutes, 27 minutes, 2 hours and 8 minutes. There was previous temperature excursion reported. A digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: problem with shot site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had Shingle's Shot problem with shot site.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Became sick; This case was reported by a consumer via other manufacturer and described the occurrence of sickness 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, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter who reported for an unspecified patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and became sick. No clarifying details were provided.  No additional information was provided. This case linked with US2020AMR145811 and US2020AMR145831, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR145811:same reporter US-GLAXOSMITHKLINE-US2020AMR145831:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Became sick; This case was reported by a consumer via other manufacturer and described the occurrence of sickness 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, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter who reported for an unspecified patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and became sick. No clarifying details were provided.  No additional information was provided. This case linked with US2020AMR145802 and US2020AMR145831, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR145802:same reporter US-GLAXOSMITHKLINE-US2020AMR145831:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: I am having an allergic reaction; My face and body are covered in welts; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction and welts. On an unknown date, the outcome of the allergic reaction and welts were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction and welts 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 and had allergic reaction and face and body were covered in welts. The reporter had to go to the hospital.