chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Visual impairment
Clinical narrative: This currently 35 year old male patient started Gardasil 9 on 26Nov2020; On 02Mar2020 the caller woke up and had difficulty seeing out of his right eye/They suspected that he had multiple sclerosis at one time during his visit, but he was eventually given the diagnosis of optic neuritis/his vision is getting worse; the patient also developed hearing loss in his right ear/He explains that it feels as if he bas water in his right ear; This spontaneous report was received from a 35 years old male patient referring to himself. The patient's medical history, concurrent condition, concomitant therapies and drug allergies were not provided.  On an unknown date (reported as 26-NOV-2020), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose detail, route, lot# and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). On 28-JAN-2020, the patient received his second injection of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose detail, route, lot# and expiration date were not provided).   On 02-MAR-2020, the patient woke up and had difficulty seeing out of his right eye. The patient went to the emergency department on the same day. He had a brain magnatic resonance imaging (MRI) and a lumber spinal tap, which suspected that he had multiple sclerosis at one time during his visit, but he was eventually given the diagnosis of optic neuritis. From 02-MAR-2020 to 06-MAR-2020, the patient had been to the emergency department every day. The patient received methylprednisolone sodium succinate (SOLU-MEDROL) injections from 04-MAR-2020 to 06-MAR-2020 for treatment, but these did not improve his vision in fact his vision seemed to be getting worse. He stated that he only had peripheral vision in his right eye and be only had 10 percent of his vision in that eye as well. On an unknown date of March 2020 (also reported as some point of time this last week), the patient also developed hearing loss in his right ear. He explained that he did not notice at first, because of his vision issue, but this was an issue when listening to music. He explained that it felt as if he had water in his right ear. He explained that his vision was getting worse and he would be visiting a neurologist in the future. Medical attention had been sought.  The outcome of optic neuritis and hearing loss was reported as not recovered. The causality between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) and optic neuritis, hearing loss was not provided.  Upon internal review, optic neuritis and hearing loss in right ear were determined to be medically significant.; Sender's Comments:  US-009507513-2003USA004150: US-009507513-2003USA003782:
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Blindness unilateral, Multiple sclerosis, Optic neuritis, Plasmapheresis, Substance-induced psychotic disorder
Clinical narrative: This currently 35 year old male patient started Gardasil 9 on 26Nov2020; On 02Mar2020 the caller woke up and had difficulty seeing out of his right eye/They suspected that he had multiple sclerosis at one time during his visit, but he was eventually given the diagnosis of optic neuritis/his vision is getting worse; the patient also developed hearing loss in his right ear/He explains that it feels as if he bas water in his right ear; This spontaneous report was received from a 35 years old male patient referring to himself. The patient's medical history, concurrent condition, concomitant therapies and drug allergies were not provided.  On an unknown date (reported as 26-NOV-2020), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose detail, route, lot# and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). On 28-JAN-2020, the patient received his second injection of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose detail, route, lot# and expiration date were not provided).   On 02-MAR-2020, the patient woke up and had difficulty seeing out of his right eye. The patient went to the emergency department on the same day. He had a brain magnatic resonance imaging (MRI) and a lumber spinal tap, which suspected that he had multiple sclerosis at one time during his visit, but he was eventually given the diagnosis of optic neuritis. From 02-MAR-2020 to 06-MAR-2020, the patient had been to the emergency department every day. The patient received methylprednisolone sodium succinate (SOLU-MEDROL) injections from 04-MAR-2020 to 06-MAR-2020 for treatment, but these did not improve his vision in fact his vision seemed to be getting worse. He stated that he only had peripheral vision in his right eye and be only had 10 percent of his vision in that eye as well. On an unknown date of March 2020 (also reported as some point of time this last week), the patient also developed hearing loss in his right ear. He explained that he did not notice at first, because of his vision issue, but this was an issue when listening to music. He explained that it felt as if he had water in his right ear. He explained that his vision was getting worse and he would be visiting a neurologist in the future. Medical attention had been sought.  The outcome of optic neuritis and hearing loss was reported as not recovered. The causality between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) and optic neuritis, hearing loss was not provided.  Upon internal review, optic neuritis and hearing loss in right ear were determined to be medically significant.; Sender's Comments:  US-009507513-2003USA004150: US-009507513-2003USA003782:
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Vision blurred
Clinical narrative: This currently 35 year old male patient started Gardasil 9 on 26Nov2020; On 02Mar2020 the caller woke up and had difficulty seeing out of his right eye/They suspected that he had multiple sclerosis at one time during his visit, but he was eventually given the diagnosis of optic neuritis/his vision is getting worse; the patient also developed hearing loss in his right ear/He explains that it feels as if he bas water in his right ear; This spontaneous report was received from a 35 years old male patient referring to himself. The patient's medical history, concurrent condition, concomitant therapies and drug allergies were not provided.  On an unknown date (reported as 26-NOV-2020), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose detail, route, lot# and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). On 28-JAN-2020, the patient received his second injection of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose detail, route, lot# and expiration date were not provided).   On 02-MAR-2020, the patient woke up and had difficulty seeing out of his right eye. The patient went to the emergency department on the same day. He had a brain magnatic resonance imaging (MRI) and a lumber spinal tap, which suspected that he had multiple sclerosis at one time during his visit, but he was eventually given the diagnosis of optic neuritis. From 02-MAR-2020 to 06-MAR-2020, the patient had been to the emergency department every day. The patient received methylprednisolone sodium succinate (SOLU-MEDROL) injections from 04-MAR-2020 to 06-MAR-2020 for treatment, but these did not improve his vision in fact his vision seemed to be getting worse. He stated that he only had peripheral vision in his right eye and be only had 10 percent of his vision in that eye as well. On an unknown date of March 2020 (also reported as some point of time this last week), the patient also developed hearing loss in his right ear. He explained that he did not notice at first, because of his vision issue, but this was an issue when listening to music. He explained that it felt as if he had water in his right ear. He explained that his vision was getting worse and he would be visiting a neurologist in the future. Medical attention had been sought.  The outcome of optic neuritis and hearing loss was reported as not recovered. The causality between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) and optic neuritis, hearing loss was not provided.  Upon internal review, optic neuritis and hearing loss in right ear were determined to be medically significant.; Sender's Comments:  US-009507513-2003USA004150: US-009507513-2003USA003782:
Sex: M
Vaccine: HPV9
Symptoms: Blindness, Visual impairment
Clinical narrative: blindness; vision problems/vision changes; This spontaneous report was received from a patient's mother via a consumer and refers to a 10 or 11-year-old male patient. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, site of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced vision problems and blindness. It was unclear if the patient was diagnosed with optic neuritis, but at the reporting time, the patient was experiencing vision changes and blindness. The outcome of the event was not recovered/not resolved.   The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event of blindness was considered to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA003867:
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Oropharyngeal discomfort, Urticaria
Clinical narrative: broke out in hives; Need to clear throat; This case was reported by a physician via call center representative and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date unknown) for prophylaxis.   Previously administered products included pennicillin with an associated reaction of anaphylactic reaction (anaphylaxis after receiving pennicillin, cephalosporins, propofol and also a severe case of  angioedema after lisinopril), lisinopril with an associated reaction of angioedema, propofol with an associated reaction of anaphylactic reaction and cephalosporins with an associated reaction of anaphylactic reaction. Concurrent medical conditions included anaphylaxis.   On 4th September 2019, the patient received the 1st dose of Shingrix. On 4th September 2019, immediately after receiving Shingrix, the patient experienced hives and throat discomfort. On an unknown date, the outcome of the hives and throat discomfort were recovered/resolved.   It was unknown if the reporter considered the hives and throat discomfort to be related to Shingrix.   Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient with a history of history of anaphylaxis after receiving penicillin, Cephalosporins, Propofol and also a severe case of angioedema after lisinopril. Immediately after receiving the 1st dose of Shingrix the patient broke out in hives and had to clear throat.  The symptoms passed with no treatment after a few hours.  The reporter did not consent to follow up.
Sex: M
Vaccine: TDAP
Symptoms: 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 35-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In February 2020, the patient received Boostrix. In February 2020, couple of weeks after receiving Boostrix, the patient experienced pain in arm. On an unknown date, 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 Boostrix.  Additional information was provided as follows: The reporter was mother of the patient. The age at vaccination was not reported. The patient received the Boostrix shot a couple weeks before the time of reporting and had a sore arm. This case is linked with US2020AMR037541, reported by same reporter for same patient.
Age: 59.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High-Dose to 59 year old patient / noAE; Fluzone High-Dose to 59 year old patient / noAE; Initial information received on 05-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with case 2020SA065020 and 2020SA065018 (same reporter)  This case involves 59 year old patient (gender not reported) who was vaccinated with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Inappropriate age at vaccine administration, PT: Product administered to patient of inappropriate age)  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  This is a case of actual medication error due to product administered to patient of inappropriate age and overdose.  At the time of this 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 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.
Sex: F
Vaccine: DT
Symptoms: Myalgia, Neuralgia, Pyrexia
Clinical narrative: experiencing incredible muscle pain and nerve pain; experiencing incredible muscle pain and nerve pain; cannot control her body temperature, sometimes it is high; Initial information received on 05-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-health care professional.  This case involves a female patient of unknown age who was experiencing incredible muscle pain and nerve pain (neuralgia), (myalgia) and cannot control her body temperature, sometimes it is high (pyrexia), while she received vaccine DIPHTHERIA AND TETANUS TOXOIDS.  Medical history included Guillain-Barre syndrome (Gulliane Barre syndrome which was undiagnosed when she was 14 years old), Epstein Barr virus infection and difficult walking (Gait disturbance).   Past medical treatment(s), vaccination(s) and family history were not provided.  On 02-Mar-2020 on Monday, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was experiencing incredible muscle pain and nerve pain (neuralgia), (myalgia) and cannot control her body temperature, sometimes it is high (pyrexia) (unknown latency) following the administration of DIPHTHERIA AND TETANUS TOXOIDS.  Laboratory data was not reported.  Final diagnosis was nerve pain, muscle pain and high temperature.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient had not recovered from nerve pain and muscle pain and outcome for cannot control her body temperature, sometimes it is high was unknown.  Information on the batch number was requested.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthma, Bronchial hyperreactivity, Dyspnoea
Clinical narrative: reactive airway issue; asthma attack feeling; Initial information received on 05-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient who experienced reactive airway issue (bronchial hyperreactivity) and asthma attack feeling (dyspnoea), while she received vaccines INFLUENZA VACCINE [INFLUENZA VACCINE] and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23).  Medical history, medical treatment, vaccination and family history were not provided.  On 11-Oct-2019, the patient received a dose of suspect INFLUENZA VACCINE and on 02-Mar-2020, the patient also received a dose of suspect PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23) not produced by Sanofi Pasteur (lot number and expiration date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious reactive airway issue (bronchial hyperreactivity) and asthma attack feeling (dyspnoea) a day or two day later following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23).  Details of laboratory data was not provided.  Final diagnosis was bronchial hyperreactivity and dyspnoea.   On an unknown date, the patient was treated with inhalers for dyspnoea and bronchial hyperreactivity.  The patient had recovered from bronchial hyper reactivity and dyspnoea.  Information on batch number was requested.
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: an expired dose of Tenivac was accidentally administered/no AE; Initial information received on 06-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a male patient of unknown age who received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and reported that an expired dose of Tenivac was accidentally administered/ no AE (expired product administered).  Medical history included Skin laceration. Past medical treatment(s), vaccination(s) and family history were not provided.  On 05-Mar-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5856AA and expiry date: 26-Jan-2020 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, it was unknown if the patient had any adverse event.  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: 0.75
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse symptoms reported; who was 9 months old, received a dose of MMR II and VARIVAX; Information has been received from a physician referring to a 9 months old patient. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant Medication included sterile diluent (STERILE DILUENT).     On 26-DEC-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA(strength, dose detail and route were not reported) (lot # S013719, expiration date 05-MAY-2021) and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose detail and route were not reported) (lot # S012036, expiration date 17-APR-2021) for prophylaxis (product administered to patient of inappropriate age). No adverse symptoms were reported.
Age: 0.5
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse effects reported; a 6 month old patient was administered PNEUMOVAX 23 instead of PREVNAR 13; This initial spontaneous report as received from a medical assistant referring to a 6 months old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 11-MAR-2020, the patient was administered with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# S029265 with expiration date 31-MAR-2021, dose detail and route were not reported) instead of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13), for prophylaxis (wrong product administered). The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23 SYRINGE (DEVICE)). No additional adverse effects reported.   For pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23 SYRINGE (DEVICE)), the lot number was not available and the serial number was not available.   combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029265; expirationdate: 31-MAR-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: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Myalgia, Nausea
Clinical narrative: Muscle ache; diarrhea; nausea; This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a 68-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 myalgia, diarrhea and nausea. On an unknown date, the outcome of the myalgia, diarrhea and nausea were unknown.   It was unknown if the reporter considered the myalgia, diarrhea and nausea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experinced muscle ache, diarrhea and nausea. This case has been linked with case US2020028071, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: side effects of shingrix; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event 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 an adult as per the vaccine indication. The patient received Shingrix and had side effects.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: soreness at the injection site; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and tiredness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingrix vaccine at 7 PM and experienced mild side effects like injection site pain and tiredness. The patient wanted to know how long these side effects might last.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Iritis
Clinical narrative: Iritis; This case was reported by a other health professional via sales rep and described the occurrence of iritis in a 66-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, immediately after receiving Shingrix, the patient experienced iritis. On an unknown date, the outcome of the iritis was unknown.   The reporter considered the iritis to be possibly related to Shingrix.  Additional details were provided as follows: The patient received  a dose of shingrix at a pharmacy and followed up with 2-3 weeks later with Iritis that had been happening since shortly after he received the dose of Shingrix.  The reporter was concerned that it could be vaccine related.
Sex: U
Vaccine: VARZOS
Symptoms: Administration site pain, Incorrect dose administered, Product preparation issue
Clinical narrative: Soreness at the administration site; received the liquid diluent portion of Shingrix; received the liquid diluent portion of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. The action taken with Shingrix was unknown. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient might had just received the liquid diluent portion of Shingrix which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter was consented to follow up. This is 1 of 4 cases reported by the same reporter.   Follow up information received from pharmacist on 25th February 2020: Four patients were identified as having received the Shingrix vaccine during the timeframe of the discovery of the single Shingrix vaccine in the box with no adjuvant. The patient's age was ranged between 50 years to 63 years. The patient received 1st dose of Shingrix. The patient might had just received the liquid diluent portion of Shingrix and the timeframe of the incident happened between 10th December 2019 through 06th January 2020. After receiving Shingrix, the patient had soreness at the administration site. No further symptoms or adverse reactions were reported. The vaccinator was questioned and said they reconstituted both components of the Shingrix vaccine. It was undetermined which patient out of 4 might have only received the adjuvant component of the Shingrix vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Rash
Clinical narrative: Rash; Difficulty breathing; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (allergic to neomycin).   On 14th February 2020, the patient received the 1st dose of Shingrix. In February 2020, 3 days after receiving Shingrix, the patient experienced rash and difficulty breathing. On an unknown date, the outcome of the rash and difficulty breathing were unknown.   It was unknown if the reporter considered the rash and difficulty breathing to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist checked the patient's allergies and he did not find anything related. The patient was allergic to neomycin but the package insert didn't say anything about Neomycin. The reporter was asking if there were any allergic reports about Shingrix. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles on the inside of his legs; pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-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 shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced shingles during the time period he was waiting to get his second Shingrix, on the inside of his legs, and it was so painful that he had to go to the emergency room twice.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: low grade fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th February 2020, 3 hrs after receiving Shingrix, the patient experienced fever. 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 provided as follows: Patient stated he experienced low grade fever 3 hours after getting the dose of Shingrix vaccine. The reporter did not consent to follow up. No further details were provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Chills, Dizziness, Headache
Clinical narrative: weak; poor balance; was up off; felt "sudden" dizziness; chills; fingers and hands "prickling"; headache; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in November 2019, for tolerance refer US2020036849).   On 27th February 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th February 2020, less than a day after receiving Shingrix, the patient experienced dizziness, chills, tingling of extremity, headache and sleeplessness. On 28th February 2020, the patient experienced weakness and balance difficulty. On 28th February 2020, the outcome of the dizziness, chills, tingling of extremity and headache were recovered/resolved. On an unknown date, the outcome of the weakness and balance difficulty were not recovered/not resolved and the outcome of the sleeplessness was recovered/resolved.   It was unknown if the reporter considered the dizziness, chills, tingling of extremity, headache, weakness, balance difficulty and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient received Shingrix and within 6 or 7 hours, she felt sudden dizziness, chills, finger and hand prickling and headache. She was up off and on most of the night with these symptoms and they had resolved in the morning of 28th February 2020. She felt weak and had poor balance that continues at this time. The reporter consented for follow up. For tolerance after 2nd dose refer case US2020036850.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Paraesthesia
Clinical narrative: weak; poor balance; was up off; felt "sudden" dizziness; chills; fingers and hands "prickling"; headache; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in November 2019, for tolerance refer US2020036849).   On 27th February 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th February 2020, less than a day after receiving Shingrix, the patient experienced dizziness, chills, tingling of extremity, headache and sleeplessness. On 28th February 2020, the patient experienced weakness and balance difficulty. On 28th February 2020, the outcome of the dizziness, chills, tingling of extremity and headache were recovered/resolved. On an unknown date, the outcome of the weakness and balance difficulty were not recovered/not resolved and the outcome of the sleeplessness was recovered/resolved.   It was unknown if the reporter considered the dizziness, chills, tingling of extremity, headache, weakness, balance difficulty and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient received Shingrix and within 6 or 7 hours, she felt sudden dizziness, chills, finger and hand prickling and headache. She was up off and on most of the night with these symptoms and they had resolved in the morning of 28th February 2020. She felt weak and had poor balance that continues at this time. The reporter consented for follow up. For tolerance after 2nd dose refer case US2020036850.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Got a shingles shot in 2018.  Last year he got the new shingles shot; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and drug dose administration interval too long. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine in 2018 and he did not had any shingles for a year. As soon as he got the new shot in 2019, he had shingles. This also led to lengthening of vaccination schedule. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The reporter did not consent to follow-up.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: BLISTER LIKE RAS ON RIGHT THIGH. PAPULE RASH ON CHEST & TORSO
Age: 58.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Chills, Computerised tomogram head, Confusional state, Differential white blood cell count, Disorientation
Clinical narrative: I began feeling extremely tired about 4-5 hours after receiving the injections. I have had the flu shot in the past and not had any reaction other than mild soreness in my arm. During the night of 11/15/19, I woke up with chills, skin very warm to the touch and generally feeling terrible. The next morning, I had blurred vision, dizziness and still felt terrible. I was sitting in a chair and apparently fainted, fell and hit my head. My husband said I was out for about one minute. When I regained consciousness, I was disoriented and confused. I went to Hospital Emergency Department.
Age: 58.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Dizziness, Electrocardiogram, Fall, Fatigue, Feeling abnormal
Clinical narrative: I began feeling extremely tired about 4-5 hours after receiving the injections. I have had the flu shot in the past and not had any reaction other than mild soreness in my arm. During the night of 11/15/19, I woke up with chills, skin very warm to the touch and generally feeling terrible. The next morning, I had blurred vision, dizziness and still felt terrible. I was sitting in a chair and apparently fainted, fell and hit my head. My husband said I was out for about one minute. When I regained consciousness, I was disoriented and confused. I went to Hospital Emergency Department.
Age: 58.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Full blood count, Head injury, Metabolic function test, Platelet count, Skin warm
Clinical narrative: I began feeling extremely tired about 4-5 hours after receiving the injections. I have had the flu shot in the past and not had any reaction other than mild soreness in my arm. During the night of 11/15/19, I woke up with chills, skin very warm to the touch and generally feeling terrible. The next morning, I had blurred vision, dizziness and still felt terrible. I was sitting in a chair and apparently fainted, fell and hit my head. My husband said I was out for about one minute. When I regained consciousness, I was disoriented and confused. I went to Hospital Emergency Department.
Age: 58.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Syncope, Troponin I, Vision blurred
Clinical narrative: I began feeling extremely tired about 4-5 hours after receiving the injections. I have had the flu shot in the past and not had any reaction other than mild soreness in my arm. During the night of 11/15/19, I woke up with chills, skin very warm to the touch and generally feeling terrible. The next morning, I had blurred vision, dizziness and still felt terrible. I was sitting in a chair and apparently fainted, fell and hit my head. My husband said I was out for about one minute. When I regained consciousness, I was disoriented and confused. I went to Hospital Emergency Department.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: pt received pediatric dose (0.5 ml) of Hepatitis A vaccine instead of adult dose (1 ml) during program no negative outcomes
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, redness around the injection site, I felt tired, had muscle pain, and felt slightly feverish.  I took 4, or 5 doses of 200 mg of Ibuprofen, over the 48 hour period following the vaccination to successfully reduce the impact of the side effects.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: AROUND 12:00 AM PT STARTED TO EXPERIENCE PAIN AND SWELLING OF WHOLE UPPER LEFT ARM - THE ARM IS WARM TO TOUCH AS WELL. PATIENT IS UNABLE TO MOVE ARM COMFORTABLY
Age: 41.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Pt received pediatric dose (0.5 ml) of Hepatitis A vaccine instead of adult dose (1 ml) during program  no negative outcomes
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: on 2/28/2020 a patient was administered a dose of GARDASIL 9  while 13 weeks and 3 days pregnant; experienced no symptoms; This spontaneous prospective pregnancy report as received from a healthcare business professional referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.     On 28-FEB-2020 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1637642, expiration date 28-MAY-2022; dose and route were not reported) for prophylaxis while she was 13 weeks and 3 days pregnant (exposure during pregnancy). The patient experienced no symptoms. Last menstrual period (LMP) was assumed as 26-NOV-2019, date of conception was assumed as 10-DEC-2019 and the estimated due date (EDD) was 01-SEP-2020. Pregnancy outcome was pending. 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: 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: PPV, UNK
Symptoms: No adverse event, Product distribution issue
Clinical narrative: the patient experienced no symptoms; shipment of PNEUMOVAX 23 was dueto be delivered on 2/26/2020 but was not delivered until 2/27/2020; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. This case concerns 1 patient and 1 combination product. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-MAR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029542, expiration date 10-JUN-2021 (dose and route of administration were not reported) for prophylaxis that was due to be delivered on 26-FEB-2020, but the vaccine was not delivered until 27-FEB-2020. The patient experienced no symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash macular, Rash pruritic, Skin exfoliation
Clinical narrative: A few spots were slightly itchy; red scaly spots / I noticed he had some of the same kind of spots; red scaly spots / I noticed he had some of the same kind of spots; This case was reported by a consumer and described the occurrence of exfoliation in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced exfoliation, erythromacular rash and itchy rash. The patient was treated with cortisone (non-proprietary) (Cortisone Cream), antibiotics nos (Antibiotic Ointment (Unknown Ingredients)), ketoconazole (Ketoconazole Cream) and emollients and protectives (Moisturizer). On an unknown date, the outcome of the exfoliation and erythromacular rash were recovered/resolved and the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the exfoliation, erythromacular rash and itchy rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccione about a month ago from reporting date and got few random red scaly spots on body. A few spots were slightly itchy. The patient tried cortisone cream, antibiotic ointment, Ketoconazole cream and moisturizer on the spots but nothing seems to affect them. They eventually fade after about 3 weeks. The patient wanted to know whether it was common after receiving shingrix vaccine. This case has been linked with US2020AMR032951, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: soreness in my left arm; pain in my left hip joint; difficulty walking; difficulty walking and sleeping; Activities like bowling became bad enough I had to quit bowling; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th February 2020, the patient received the 1st dose of Shingrix. On 12th February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and pain in hip. In February 2020, the patient experienced walking difficulty, difficulty sleeping and activities of daily living impaired. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the pain in hip was not recovered/not resolved and the outcome of the walking difficulty, difficulty sleeping and activities of daily living impaired were unknown.   It was unknown if the reporter considered the pain in arm, pain in hip, walking difficulty, difficulty sleeping and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient shingrix vaccine and experienced soreness in left arm and on same day also experienced increased pain in left hip joint. This pain continued and increased for the next several days, which caused patient to have difficulty walking and sleeping. Activities like bowling became bad enough that the patient had to quit bowling temporarily. The patient made an appointment with physician. At the time of reporting pain was somewhat decreased, but patient still feel pain in that joint. The patient wanted to know whether events were reaction to the vaccine.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: feel awful; body aches; Fever; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 20th February 2020, the patient received the 2nd dose of Shingrix. On 21st February 2020, 1 days after receiving Shingrix, the patient experienced feeling bad, general body pain and fever. On an unknown date, the outcome of the feeling bad, general body pain and fever were unknown.   It was unknown if the reporter considered the feeling bad, general body pain and fever to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix vaccine and felt awful and also experienced fever and body aches. The patient wanted to know if there was something that he or she could do to alleviate the side effects like use of pain killers, food or water. No other information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Tiredness; headache; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingles vaccine. In February 2020, less than a week after receiving Shingles vaccine, the patient experienced tiredness and headache. On an unknown date, the outcome of the tiredness and headache were unknown.   It was unknown if the reporter considered the tiredness and headache to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced tiredness and headache. The reporter wanted to know how long might tiredness and headache last. No other information was reported.