chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: pediatric patient received an adult dose; no adverse event; Information has been received from a registered nurse, regarding a 15-year-old patient (gender not provided). The patient's pertinent medical history, concurrent conditions, and concomitant therapies were not provided.  On 24-JUL-2020, the pediatric patient was vaccinated with an adult dose of Hepatitis A Vaccine, inactivated (VAQTA), 1 milliliter, lot # S030588 and expiration date 20-OCT-2020, (route not provided) for prophylaxis (product administered to patient of inappropriate age). The reporter stated that she had followed up with the patient's pediatrician who was not concerned with the dose. The patient was not experiencing any side effects.  This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2007USA009968:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported; the patient received improperly stored VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gander. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 23-JUL-2020, the patient was vaccinated with a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot# T008698, was established as valid, with expiration date: 04-JUN-2021) 25/0.5 (units not provided) vial (upon internal validation process, the formulation was established as prefilled syringe) (dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperature to which the vaccines was exposed was 62.2 degrees of Fahrenheit and the time frame was reported as 3 hours 50 minutes. No previous temperature excursion was reported. A digital data logger was involved. No additional adverse effects were reported..  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: T008698; expirationdate: 04-JUN-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; Sender's Comments:  US-009507513-2007USA009779: US-009507513-2007USA010267: US-009507513-2007USA010269:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported; the patient received improperly stored VAQTA; This spontaneous report was received from a medical assistant 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 23-JUL-2020, the patient was vaccinated with a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided) vial (upon internal validation process, the formulation was established as prefilled syringe) (lot# T008698, was established as valid, with expiration date: 04-JUN-2021) (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis.  The temperature to which the vaccines was exposed was 62.2 degrees of Fahrenheit and the time frame was reported as 3 hours 50 minutes. No previous temperature excursion was reported. A digital data logger was involved. No additional adverse effects were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-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; Sender's Comments:  US-009507513-2007USA010267: US-009507513-2007USA010268: US-009507513-2007USA009779:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or additional adverse effects reported.; Nurse reporting patient received unspecified dose of PROQUAD that was improperly stored.; This spontaneous report was received from a registered 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 24-JUL-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection (lot number T003714 which has been verified to be valid, expiration date reported and validated as 29-JUL-2021) (dosage, vaccination scheme, frequency, route of administration and anatomical site of injection were not reported) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). The administered dose of the vaccine was stored at a temperature of -9.2 degrees Celsius, during a time frame of 3 hours and 20 minutes, as recorded by a digital data logger. There was no previous temperature excursion. No symptoms or additional adverse effects were reported in the patient.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Laboratory test abnormal, Lethargy, Systemic lupus erythematosus
Clinical narrative: patient received the "HPV vaccine" and experienced "lethargy, irregular lab results, and a potential diagnosis of Lupus"; patient received the "HPV vaccine" and experienced "lethargy, irregular lab results, and a potential diagnosis of Lupus"; patient received the "HPV vaccine" and experienced "lethargy, irregular lab results, and a potential diagnosis of Lupus"; This spontaneous report was received from a consumer via a company representative, referring to a female patient of unknown age. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On an unknown date in October 2019, the patient was vaccinated with an HPV vaccine (manufacturer unknown) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date, the patient experienced lethargy (lethargy), irregular lab results (unspecified) (laboratory test abnormal) and a potential diagnosis of lupus (systemic lupus erythematosus). It was not reported, if the patient sought medical attention, if any treatment was given for the events, or if any laboratory diagnostics or studies were performed. At the reporting time the outcome of the adverse events was unknown.  The causal relationship between and the aforementioned adverse events and HPV vaccine (manufacturer unknown) was reported by the patient's mother as might be a cause but was not confirmed by the treating physician.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA010586:
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster, Rash
Clinical narrative: herpes zoster/painful skin rashes; herpes zoster/painful skin rashes; herpes zoster/painful skin rashes; painful skin rashes and was diagnosed with cellulitis; herpes zoster/painful skin rashes; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On or around 18-AUG-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date in 2015, several days after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered painful skin rashes and was diagnosed with cellulitis. These skin rashes persisted into an unknown date in 2016 and an unknown date 2017. On an unknown date in 2017, she was formally diagnosed with herpes zoster. The patient subsequently had at least four additional bouts of severe shingles on an unknown date in 2018 and an unknown date in 2019. These shingles episodes often lasted several weeks. All of these injuries were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of shingles (onset date 2015 and 2018) was recovered on an unknown date; the outcome of shingles (onset date 2019) and cellulitis was unknown. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was related.  Upon internal review, the event of cellulitis was considered to be medical significant and disabling. The events of herpes zoster were considered to be disabling.
Sex: U
Vaccine: SMALL
Symptoms: Injection site rash, Local reaction, Rash
Clinical narrative: Developed a local and minor rash on the arm; Spontaneous report received on 13JUL2020.  A healthcare professional reported that a patient "developed a local and minor rash on the arm" (PT: Injection site rash) following immunization with ACAM2000. On an unknown date, the patient was administered Emergent's smallpox vaccine. The consumer developed a rash on their arm. It was reported that the reaction was small, local, and minor thus, the patient was prescribed Z-pak (azithromycin) on 13JUL2020. Additionally, the prescriber cleared the consumer to go back to work stating that no medical leave was required and they can perform at their regular full duty. At the time of report, the outcome was unknown.  Company Comment: A consumer developed a local and minor rash on the arm (injection site rash) after receiving ACAM2000. In response to the event, the consumer was prescribed with Z-pack, and further details of the event is limited. Local injection site reactions like erythema and rash are known effects of ACAM2000, and the causality of injection site rash is assessed as possible.; Sender's Comments: A consumer developed a local and minor rash on the arm (injection site rash) after receiving ACAM2000. In response to the event, the consumer was prescribed with Z-pack, and further details of the event is limited. Local injection site reactions like erythema and rash are known effects of ACAM2000, and the causality of injection site rash is assessed as possible.
Sex: M
Vaccine: VARZOS
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 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. In March 2020, 12 hrs after receiving Shingrix, 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 Shingrix.  Additional case details were reported as follows: The patient had his 1st dose either the 10th or the 15th of March 2020 in his left arm. The patient experienced a sore arm for a couple of days. No other symptoms were reported. The reporter consent to follow up. For tolerance after 2nd dose of Shingrix, refer case US2020139466.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020139466:2nd dose
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Tenderness
Clinical narrative: tenderness; redness; This case was reported by a physician via call center representative and described the occurrence of tenderness in a 65-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, less than 2 months after receiving Shingrix, the patient experienced tenderness and erythema. On an unknown date, the outcome of the tenderness and erythema were unknown.   It was unknown if the reporter considered the tenderness and erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and developed tenderness and redness following that resolved after a few days. For tolerances of 2nd dose, refer case US2020140210, reported by same reporter for the same patient. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020140210:same reporter
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; This case was reported by a nurse via sales rep and described the occurrence of fever in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On 22nd July 2020, the patient received Menveo and Bexsero. On 22nd July 2020, 3 hrs 15 min after receiving Menveo and Bexsero, the patient experienced fever, chills and general body pain. On an unknown date, the outcome of the fever, chills and general body pain were unknown.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Menveo and Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. At9:45 p.m, the patient received Menveo and Bexsero. At 1:00 p.m, the patient experienced the symptoms were fever, chills, body aches.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction / Bad rash; Injection site / red; Injection site / raised; Injection site / warm to the touch; Injection site / very tender; This case was reported by a physician via sales rep and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced injection site rash, injection site erythema, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site rash, injection site erythema, injection site swelling, injection site warmth and injection site tenderness were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, injection site erythema, injection site swelling, injection site warmth and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient was given Shingrix dose and experienced injection site reaction.  The physician stated there was a really bad rash that was abnormally large, red, raised and warm to the touch and very tender. The physician stated she has never seen this bad of a reaction like this to a vaccine.  It was reported that It had been 2 days since she was administered the vaccine. The patient has not had an injection site reaction like this before with other vaccines.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: On 29Jul2019, the patient received second dose / On 17Jul2020, the patient was diagnosed with a case of the shingles; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 4th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 17th July 2020, 470 days after receiving Shingrix and 354 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix in the left deltoid and second dose of Shingrix in the right deltoid. On17th July 2020, the patient was diagnosed with a shingles, unknown severity and unknown location of the shingles lesions.  The patient was prescribed anti viral for treatment and started treatment on 18th July 2020. The shingles was ongoing at the time of reporting. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020087418:same reporter US-GLAXOSMITHKLINE-US2018126864:same reporter
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Joint swelling, Malaise, Musculoskeletal pain
Clinical narrative: persistent lower back pain; Bad shape and felt "just rotten"; Sore shoulder; Site of injection was painful; right shoulder swollen; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included spinal fusion (had lower back spinal fusion 30 years ago). Concomitant products included celecoxib (Celebrex).   On 16th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 16th July 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, swollen joints and shoulder soreness. On 17th July 2020, the patient experienced feeling unwell. On 21st July 2020, the patient experienced low back pain. On an unknown date, the outcome of the injection site pain and swollen joints were recovered/resolved and the outcome of the low back pain was not recovered/not resolved and the outcome of the shoulder soreness and feeling unwell were unknown.   It was unknown if the reporter considered the injection site pain, swollen joints, low back pain, shoulder soreness and feeling unwell to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the afternoon and had a sore shoulder and site of injection was painful both have resolved.   The patient was in bad shape and felt just rotten and persistent lower back pain and the only time was did not hurt was when the patient lying down with his knees pulled into his chest This where the persistent lower back pain was coming from. The reporter did not consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pyrexia
Clinical narrative: fever; trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (did not had any adverse reaction).   On 16th July 2020 04:00, the patient received the 2nd dose of Shingrix. In July 2020, 17 hrs after receiving Shingrix, the patient experienced fever and difficulty sleeping. The patient was treated with melatonin and paracetamol (Tylenol). On 18th July 2020, the outcome of the fever and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the fever and difficulty sleeping to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix about 4 PM and had trouble sleeping so she took Melatonin at 2 AM, but it did not work so they took Tylenol. The patient temperature at 9 AM was 100.5 degrees F and it increased to 101.6 so she contacted her doctor. She was instructed to take Tylenol every 6 to 8 hours instead of every 12 hours. She went to the Urgent Care at 5 PM and her temperature had decreased to 99.7 degrees F. The reporter consented to follow up. Emergency room visit was required.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: redness in arm; hot itching area; hot itching area; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced erythema of extremities, feeling hot and pruritus. On an unknown date, the outcome of the erythema of extremities, feeling hot and pruritus were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, feeling hot and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had redness, hot, itching area covering an 3 X 6 long, it lasted 5 days. The reporter asked was this normal.  The patient felt fine the first day of the shot but then her whole arm was red, hot and itching. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Demyelination, Myelitis transverse, Neurological symptom
Clinical narrative: Tranverse myelitis (suspected); Demyelinating neuritis (suspected); Neurological symptoms that have progressed / Band like effect around her abdomen; This case was reported by a physician via call center representative and described the occurrence of myelitis transverse in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2020, the patient received the 2nd dose of Shingrix. On 17th July 2020, 2 days after receiving Shingrix, the patient experienced myelitis transverse (serious criteria GSK medically significant), demyelination (serious criteria GSK medically significant) and neurological symptom. On an unknown date, the outcome of the myelitis transverse, demyelination and neurological symptom were not recovered/not resolved.   It was unknown if the reporter considered the myelitis transverse, demyelination and neurological symptom to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported but could be 59 or 60 years. The patient developed neurological symptoms that have progressed over the days. It was started as a band like effect around her abdomen, now all the sensation was going all the way down to her feet. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Hepatic steatosis, Herpes zoster, Liver function test abnormal, Pneumonia, Pyrexia
Clinical narrative: pneumonia; fever; fatty liver; shingles in chest; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cellulitis of leg and fever.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, 10 days after receiving Shingrix, the patient experienced fever (serious criteria hospitalization) and shingles. In July 2020, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant) and fatty liver. On an unknown date, the outcome of the pneumonia, fever, fatty liver and shingles were not recovered/not resolved.   It was unknown if the reporter considered the pneumonia, fever, fatty liver and shingles to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient received Shingrix 1st dose on September 2019 and at that time had fever and cellulitis in leg. 10 days aafter vaccination with Shingrix, the patient developed a fever and shingles across chest and back. Less than a year after vaccination, the patient had fatty liver and pneumonia. The reporter stated that, the patient went to emergency room and was told that, the patient had shingles and gave couple of shots and sent home. At the time of reporting, the reporter stated that, recently the patient was diagnosed with a fatty liver. On Monday 20th July 2020, the patent was admitted to the hospital for fever and pneumonia. The reporter stated that, the patient was negative for Covid-19. The reporter stated that, was not sure if it was Shingrix that the patient received. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative
Clinical narrative: pneumonia; fever; fatty liver; shingles in chest; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cellulitis of leg and fever.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, 10 days after receiving Shingrix, the patient experienced fever (serious criteria hospitalization) and shingles. In July 2020, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant) and fatty liver. On an unknown date, the outcome of the pneumonia, fever, fatty liver and shingles were not recovered/not resolved.   It was unknown if the reporter considered the pneumonia, fever, fatty liver and shingles to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient received Shingrix 1st dose on September 2019 and at that time had fever and cellulitis in leg. 10 days aafter vaccination with Shingrix, the patient developed a fever and shingles across chest and back. Less than a year after vaccination, the patient had fatty liver and pneumonia. The reporter stated that, the patient went to emergency room and was told that, the patient had shingles and gave couple of shots and sent home. At the time of reporting, the reporter stated that, recently the patient was diagnosed with a fatty liver. On Monday 20th July 2020, the patent was admitted to the hospital for fever and pneumonia. The reporter stated that, the patient was negative for Covid-19. The reporter stated that, was not sure if it was Shingrix that the patient received. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Light headed; Fever; feeling nauseated; arm very sore/injection site" hurts like a devil; This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 22nd July 2020, the patient experienced light headedness, fever and nausea. On an unknown date, the outcome of the light headedness, fever and nausea were not recovered/not resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the light headedness, fever, nausea and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient reporter that the arm was very sore from the beginning and injection site hurts like a devil. The patient reporter having a fever of 100.4, feeling nauseated and lightheaded.  The patient stated that symptoms have not resolved. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Feeling abnormal, Injection site pain
Clinical narrative: chills; achiness; felt wet; nausea; dry heaving; weakness; felt like they were going to pass out; tenderness around injection site; fever; night sweats; This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received the 2nd dose of Shingrix. On 22nd July 2020, less than a day after receiving Shingrix, the patient experienced injection site tenderness, fever and night sweat. On 23rd July 2020, the patient experienced chills, pain, feeling abnormal, nausea, dry heaves, weakness and felt faint. On an unknown date, the outcome of the injection site tenderness, fever, night sweat, chills, pain, feeling abnormal, nausea, dry heaves, weakness and felt faint were unknown.   It was unknown if the reporter considered the injection site tenderness, fever, night sweat, chills, pain, feeling abnormal, nausea, dry heaves, weakness and felt faint to be related to Shingrix.  Additional case details were reported as follows: The patient had No underlying medical conditions.  On 22nd July 2020, the patient received late afternoon and in less than 24 hours, tenderness around, injection site, experienced fever, night sweats.0 On 23rd July 2020 morning, 1day after vaccination, the patient felt  like fever, chills, felt wet, achiness, significant nausea, dry heaving not productive.  The patient was asymptomatic before vaccine and they took her temperature before vaccination and it was 99.5. She also has weakness and felt like she was going to pass out. The patient was very physically fit. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR141020:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Night sweats, Pain, Pyrexia, Retching
Clinical narrative: chills; achiness; felt wet; nausea; dry heaving; weakness; felt like they were going to pass out; tenderness around injection site; fever; night sweats; This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received the 2nd dose of Shingrix. On 22nd July 2020, less than a day after receiving Shingrix, the patient experienced injection site tenderness, fever and night sweat. On 23rd July 2020, the patient experienced chills, pain, feeling abnormal, nausea, dry heaves, weakness and felt faint. On an unknown date, the outcome of the injection site tenderness, fever, night sweat, chills, pain, feeling abnormal, nausea, dry heaves, weakness and felt faint were unknown.   It was unknown if the reporter considered the injection site tenderness, fever, night sweat, chills, pain, feeling abnormal, nausea, dry heaves, weakness and felt faint to be related to Shingrix.  Additional case details were reported as follows: The patient had No underlying medical conditions.  On 22nd July 2020, the patient received late afternoon and in less than 24 hours, tenderness around, injection site, experienced fever, night sweats.0 On 23rd July 2020 morning, 1day after vaccination, the patient felt  like fever, chills, felt wet, achiness, significant nausea, dry heaving not productive.  The patient was asymptomatic before vaccine and they took her temperature before vaccination and it was 99.5. She also has weakness and felt like she was going to pass out. The patient was very physically fit. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR141020:same reporter
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: shingles in neck forehead and arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th June 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced shingles on her neck which has expanded to her forehead and eyes.  The patient was taking an antiviral and was getting better. The reporter consented to follow up and allows contact with HCP.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Lymphadenopathy, Pain, Peripheral swelling
Clinical narrative: swelling under his left arm; swollen lymph node; very tired; achy; foggy; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in March 2020, refer case US2020AMR141197).   On 22nd July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd July 2020, less than a day after receiving Shingrix, the patient experienced tiredness, pain and foggy feeling in head. On 23rd July 2020, the patient experienced swelling arm and enlargement of lymph nodes. On an unknown date, the outcome of the tiredness, swelling arm, pain and foggy feeling in head were not recovered/not resolved and the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the tiredness, swelling arm, pain, foggy feeling in head and enlargement of lymph nodes to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and was very tired, achy and foggy.   These side effects seem to be getting better but when he awoke this morning, he noticed a large swelling under his left arm and doctor thinks it may be a swollen lymph node. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR141197:same reporter
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a 61-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Tdap Vaccine.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Tdap vaccine, the patient experienced an anaphylactic reaction. The reporter would like to know if this patient was able to receive 1st dose of Shingrix.  The reporter was consented to follow up. No further details were provided.
Age: 11.0
Sex: M
Vaccine: MENB, UNK
Symptoms: Syncope
Clinical narrative: Fainted; This is a spontaneous report from contactable nurse via Pfizer Sales Representative.   An 11-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, Lot # number CN8295. Exp 31Aug2022) at single dose in the right deltoid, hpv vaccine (HPV VACCINE) via an unspecified route of administration in the left deltoid, both on 17Jun2020 for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced fainted after the doses were given in the doctors' office on 17Jun2020. Patient said that he had not had breakfast that morning. The outcome of unknown.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, Increased upper airway secretion
Clinical narrative: developing excess mucus dripping down the back of her throat "like motor oil" every time she eats and drinks; This is a spontaneous report from a contactable Consumer (patient).   A female patient of an unspecified age received one dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose on 02Jun2015 and on 08Oct2015 for immunization, one at a drugstore and the other at a doctor's office.  The patient medical history and concomitant medications were not reported.  On an unspecified date she started developing excess mucus dripping down the back of her throat "like motor oil" every time she eats and drinks. She received lots of medical advice, regarding the mistake with the administration. Could the excess mucus be a side effect? Her phamacist looked up the side effects, and it is not listed as one. The outcome of event unknown. The patient queried whether there was a difference between Prevnar and Prevnar 13.  No follow up attempts are needed, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: MENB
Symptoms: Chills, Pain
Clinical narrative: Chills; Soreness; This is a spontaneous report from a contactable other health professional via a Pfizer Sales representative. A male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills and soreness both on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 12.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: a 12 year old patient received fourth dose of IPOL vaccine, No AE; IPOL vaccine was exposed to a temperature excursion, had stability issue for open Ipol but given the product already by the time they found out they should not have given it to patient, No AE; Initial information was received on 23-Jul-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional (office staff).  This case involves a 12-year-old female patient who was vaccinated with the fourth dose of vaccine IPV (VERO) [IPOL] (lot number R1B252M and expiration date 13-Mar-2021) via an intramuscular route in the left arm for prophylactic vaccination on an unknown date. However, this vaccine was exposed to a temperature excursion.   The patient's medical history, medical treatment, vaccination and family history were not provided.  The patient received concomitant VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and incorrect product storage as fourth dose of Ipol should be administer in 4 to 6 year of age  and it was reported that, There was stability issue for open Ipol but had given the product already by the time they found out they should not have given it.  The patient had no adverse event at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.
Age: 23.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given an expired dose of Ipol / No AE; Initial information was received on 24-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 23 year old female patient who received an expired dose of POLIOMYELITIS VACCINE (INACTIVATED) [IPOL].  The patient's past vaccination(s) included POLIO VACCINE INACT 3V (VERO) (IPOL) which was recieved 20 years ago. The patient's medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On an unknown date, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot P1A461M, expiry date-03-May-2020) (Interval Dosage : 24-Jul-2020) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  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.
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Axillary pain, Injection site pain, Neck pain
Clinical narrative: pain in hip, neck, pain in her arm where the shot is and in the neck,; pain in armpit that is persistent; pain in hip, neck, pain in her arm where the shot is and in the neck,; pain in her arm where the shot is; Initial information was received on 25-Jul-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 36 year old female patient who experienced pain in her arm where the shot is and in the neck, pain in hip, neck and pain in armpit that is persistent (vaccination site pain, neck pain, axillary pain and arthralgia), while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. At the time of the event, the patient had ongoing Food allergy (alpha-gal allergy).  On 26-Jul-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported (expiry date- 28-Jul-2020; Injection) via unknown route in the right arm for prophylactic vaccination.  On 26-Jul-2020, the patient developed a non-serious pain in her arm where the shot is and in the neck, pain in hip, neck and pain in armpit that is persistent (vaccination site pain, neck pain, axillary pain and arthralgia) on same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Laboratory data was not provided.  Final diagnosis was vaccination site pain, neck pain, axillary pain and arthralgia.   Has not taken any medication for pain at this time.  The patient was not recovered from vaccination site pain, neck pain, axillary pain and arthralgia.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received vaccine which had temperature excursion of negative 3 degrees Celsius for 22 minutes, No AE; Initial information regarding an unsolicited valid non-serious case received from a health care professional on 28-Jul-2020.  This case involves a 2-month-old female patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine (Batch number UJ261AAA, expiry date:14-May-2021) via an intramuscular route in left thigh for prophylactic vaccination, which had temperature excursion of negative 3 degrees Celsius for 22 minutes (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included a dose of pneumococcal vaccine conj 13v (crm197) (Prevnar 13); a dose of rotavirus vaccine live reassort oral 5v (Rotateq); and hepatitis B vaccine (Hepatitis B Vaccine) for prophylactic vaccination.  This was a case of actual medication error due to product storage error temperature too low.  Reported stated that they had a temperature excursion yesterday with Pentacel and had questions about revaccination. It was reported that Pentacel was administered to a patient after the excursion. Caller wanted to know if the patient needed to be revaccinated. It was reported that the data logger had a momentary glitch and was out of range for 22 minutes and the temperature was negative 3 degrees Celsius.  At the time of report no adverse event was reported.  Outcome: not applicable.  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
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administered a dose of improperly stored VARN AX; No adverse symptoms were reported; This non-valid spontaneous report was received from a medical assistant and refers to a multiple patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant medication and medical history provided.  On an unknown dates, the patients were vaccinated with a doses of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot number: S038177, expiration date: 26-NOV-2021, for prophylaxis (exact dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent.  The vaccines experienced temperature excursion of -14 degrees Celsius to -10 degrees Celsius (-13 degrees Celsius) for 24 minutes. Previous temperature excursion was detected and it was from -14 degrees Celsius to -10 degrees Celsius (-10.4 degrees Celsius) for 29 minutes. The digital data logger was involved.  The report is non-valid due to lack of the patients' identifiers.