chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Underdose
Clinical narrative: Right after the needle came out a lot of blood came out; Possible that some of the vaccine came out with the blood; Maybe he hit an artery, a blood vessel; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   On 8th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 8th October 2020, immediately after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced injection site hemorrhage, accidental underdose and wrong injection technique. On an unknown date, the outcome of the injection site hemorrhage, accidental underdose and wrong injection technique were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix vaccination and right after the needle came out a lot of blood came out. The reporter stated that maybe he hit an artery, a blood vessel. The reporter consented to follow up. No data regarding the patient or vaccine administered were provided as reporter stated not being at the facility at the time of reporting. Upon escalation to second line specialist, the reporter asked about validity of dose of Fluarix since he was not sure but it was possible that some of the vaccine came out with the blood, which led to accidental underdose.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Mass, Myalgia, Nodule
Clinical narrative: Developed some sores; Developed some bumps; painful knot; Painful knot; Painful knot that feels like a sore muscle; Redness / at left arm injection site; Itching at left arm injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd August 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On 21st September 2020, the patient experienced skin ulcer, papular rash, pain, mass and muscle soreness. On 1st September 2020, the outcome of the injection site erythema and injection site itching were recovered/resolved. On 12th October 2020, the outcome of the skin ulcer and papular rash were not recovered/not resolved. On an unknown date, the outcome of the pain, mass and muscle soreness were not recovered/not resolved.   The reporter considered the injection site erythema and injection site itching to be related to Shingrix. It was unknown if the reporter considered the skin ulcer, papular rash, pain, mass and muscle soreness to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Consumer reported that she received her 2nd shingrix dose on 21st August, 2020 and About a day later, she experienced Redness and itching at left arm injection site which lasted for 10 days. She also reported that around 3 weeks ago, on the same arm, she developed some bumps/sores and that on the back of her arm she had a very painful knot that felt like a sore muscle. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash papular, Skin ulcer
Clinical narrative: Developed some sores; Developed some bumps; painful knot; Painful knot; Painful knot that feels like a sore muscle; Redness / at left arm injection site; Itching at left arm injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd August 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On 21st September 2020, the patient experienced skin ulcer, papular rash, pain, mass and muscle soreness. On 1st September 2020, the outcome of the injection site erythema and injection site itching were recovered/resolved. On 12th October 2020, the outcome of the skin ulcer and papular rash were not recovered/not resolved. On an unknown date, the outcome of the pain, mass and muscle soreness were not recovered/not resolved.   The reporter considered the injection site erythema and injection site itching to be related to Shingrix. It was unknown if the reporter considered the skin ulcer, papular rash, pain, mass and muscle soreness to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Consumer reported that she received her 2nd shingrix dose on 21st August, 2020 and About a day later, she experienced Redness and itching at left arm injection site which lasted for 10 days. She also reported that around 3 weeks ago, on the same arm, she developed some bumps/sores and that on the back of her arm she had a very painful knot that felt like a sore muscle. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: did not return within the recommended time frame to receive the second dose; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In April 2020, between 3 and 5 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 76 or 77 years. The patient received the first dose on Shingrix, however did not return within the recommended time frame to receive the second dose. On an unknown date in April 2020 the patient developed a case of shingles that was reported as resolved. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Angioedema, Urticaria
Clinical narrative: anaphylaxis; angioedema; hives; This case was reported by a physician via call center representative and described the occurrence of anaphylaxis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant), angioedema (serious criteria GSK medically significant) and hives. On an unknown date, the outcome of the anaphylaxis, angioedema and hives were unknown.   It was unknown if the reporter considered the anaphylaxis, angioedema and hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The doctor reported that she had a patient that received the second injection of the Shingrix series and the patient experienced anaphylaxis, hives and angioedema. The symptoms continued over the next several days. The case came through as a CRM, this is all that was reported. The reporter consent to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: joint pain in the hips, back, shoulders and wrists.; This case was reported by a consumer via call center representative and described the occurrence of generalized joint pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 week after receiving Shingrix, the patient experienced generalized joint pain. On an unknown date, the outcome of the generalized joint pain was not recovered/not resolved.   It was unknown if the reporter considered the generalized joint pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that one week after vaccination, he experienced joint pain in the hips, back, shoulders and wrists. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Extra dose administered, Sarcoidosis
Clinical narrative: Sarcoidosis; experience breathing difficulties; received a third dose; This case was reported by a pharmacist via call center representative and described the occurrence of sarcoidosis in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2019.) and Shingrix (2nd dose received in September 2019.).   On 12th October 2020, the patient received the 3rd dose of Shingrix. On 12th October 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On 13th October 2020, the patient experienced difficulty breathing. On an unknown date, the patient experienced sarcoidosis (serious criteria GSK medically significant). On an unknown date, the outcome of the sarcoidosis and difficulty breathing were not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the sarcoidosis and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 3rd dose of Shingrix, the patient experienced breathing difficulties and sarcoidosis. The patient inadvertently received a third dose of Shingrix, which led to extra dose administered. The pharmacist reported that, breathing difficulties which potentially could be related to a recent diagnosis on an unknown date within a month of this report of sarcoidosis. The reporter consent to follow up. The case was considered as medication error with harm.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: sore in the injection site; This case was reported by a physician and described the occurrence of injection site pain in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the 1st dose and experienced sore in the injection site.  The reporter did not consent to followup.  This case has been linked with US2020204756 and US2020AMR206625 reported by same reporter. For tolerance of 2nd dose refer case US2020AMR206445.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020204756:same reporter (wife´s case 1st dose) US-GLAXOSMITHKLINE-US2020AMR206625:same reporter (wife´s case 2nd dose) US-GLAXOSMITHKLINE-US2020AMR206445:same patient, 1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: sore in the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the 1st dose and experienced sore in the injection site.  The reporter did not consent to followup.  This case has been linked with US2020204752 and US2020AMR206445 reported by same reporter. For tolerance of 2nd dose refer case US2020AMR206625.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020204752:same reporter (reporter´s case)
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: fatigue; myalgia; pain all over body; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number AD9A5, expiry date 9th May 2022) for prophylaxis.   On 28th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced fatigue, myalgia and general body pain. On an unknown date, the outcome of the fatigue, myalgia and general body pain were unknown.   It was unknown if the reporter considered the fatigue, myalgia and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with dose of Shingrix and experienced fatigue, myalgia, and pain all over her body. The event onset time was not known. If events resolved or not was unknown. The reporter consent to follow up.
Sex: M
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Pain; This is a spontaneous report from contactable nurse through a Pfizer sales representative.   A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, on an unspecified date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced pain. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 55 year-old patient received 1 mL of Fluzone QIV instead of 0.5 mL/No adverse event; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA263223, 2020SA263253 and 2020SA263271 (same reporter)  This case involves a 55 year-old male patient who was vaccinated with 1 mL dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] instead of 0.5 mL(overdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given.  On 22-Sep-2020, the patient received 1 mL (once) of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (injection) (lot UJ475AA and expiry date 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of overdose (latency was same day).  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 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: M
Vaccine: FLUR4
Symptoms: Feeling abnormal, Malaise, Viral infection, Weight decreased
Clinical narrative: became really sick; bad virus; lost about 20 pounds; feeling bad; Initial information was received on 06-Oct-2020 regarding an unsolicited valid non-serious case from the physician via email..  This case involves a male patient (age in mid of 50's) who became really sick (malaise), feeling bad (feeling abnormal), viral infection (not corona) and lost about 20 pounds (weight decreased), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2017 and expiration date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient became really sick (malaise) and feeling bad (feeling abnormal), 24 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  On an unknown date, the patient developed non-serious viral infection (not corona) and lost about 20 pounds (weight decreased), (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Details of laboratory data were not reported.  The patient treated with IMMUNOGLOBULINS.  At the time of reporting, the event outcome was not reported however, the patient returned to work after 1 week.
Sex: U
Vaccine: IPV
Symptoms: Dyspnoea, Paralysis, Paraplegia, Poliomyelitis, Respiratory arrest
Clinical narrative: Polio; stopped breathing; paralyzed from the waist down; Initial information received on 08-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional.   This case involves a patient (unknown demographics) who experienced polio (poliomyelitis), paralyzed from  the waist down (paraplegia) and stopped breathing (dyspnoea), when received POLIOMYELITIS VACCINE (INACTIVATED).  Concomitant medications included BENZYLPENICILLIN from which the patient almost died.  The patient's medical history, past medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect POLIOMYELITIS VACCINE (INACTIVATED) produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed polio (poliomyelitis), paralyzed from  the waist down (paraplegia) and stopped breathing (dyspnoea) unknown latency following the administration of POLIOMYELITIS VACCINE (INACTIVATED).   Event poliomyelitis and paraplegia was assessed as medically significant.  Intensity of polio event was mild.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from paraplegia (paralyzed from the waist down for a week).  The event outcome was unknown for poliomyelitis and dyspnoea.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case reported from Facebook involved patient (unknown demographics) who presented with poliomyelitis and dyspnoea following the vaccination with POLIOMYELITIS VACCINE. The time to onset is unknown. Medical history, concomitant medication include PENICILLIN shot, and precise final diagnosis and lab data ruling out alternative etiologies were not reported. Based upon the reported information, role the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: had Pneumonia; Initial information received on 09-Oct-2020 regarding an unsolicited valid serious case received from a consumer (patient). This case involves patient (unknown demographics) who experienced pneumonia, while received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event pneumonia was unknown.  Information on lot number was requested; Sender's Comments: This case concerns a patient (unknown demographics) who presented with pneumonia after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information on patient's medical condition at time of vaccination, concomitant medication and investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Malaise, Sudden death
Clinical narrative: Patient had never felt better and then suddenly died; Initial information was received on 12-Oct-2020 regarding an unsolicited valid serious case received from a consumer/ non-healthcare professional (patient's spouse) via public post on the Sanofi flu shot campaign via Social Media.  This case involves male patient (age not reported) who had never felt better and then suddenly died (malaise), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious adverse event as the patient had never felt better and then suddenly died (malaise) on an unknown latency following the administration of INFLUENZA VACCINE. This event was was leading to death.  Case details: Product name was not provided, since this is a public post on the Sanofi flu shot campaign, the Race for 200M it was assuming that the consumer was referring to the Sanofi flu vaccine. The reporter commented on social media that 'my husband had never felt better then suddenly died'  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as fatal as the patient suddenly died due to suspect vaccine on an unknown date  It is unknown if an autopsy was done and the cause of death was captured as malaise.  Information on the batch number was requested.; Sender's Comments: A case was reported from Social Media, which involves male patient of unknown age who had felt unwell and then suddenly died following the administration of INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Additional information of past medical treatments, concomitant therapies, past vaccination and tolerance, allergic history, concurrent conditions, laboratory data and autopsy results is needed for complete assessment of the case. Based upon the reported information the role of the suspect product cannot be assessed. Missing data needed for further assessment of the case.; Reported Cause(s) of Death: Patient had never felt better and then suddenly died
Sex: U
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: pneumonia; Initial information was received on 09-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media. This case involves a patient (unknown demographics) who had pneumonia, when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This was supposed to be the last flu shot according to the patient.  This event was assessed as medically significant.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a patient (unknown demographics) who had pneumonia after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Seizure
Clinical narrative: seizures because of a shot that had eggs in it; Initial information was received on 08-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional.  This case involves patient who had seizures because of a shot that had eggs in it (seizure) when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious seizures because of a shot that had eggs in it (seizure) (unknown latency) following the administration of INFLUENZA VACCINE.   This event was assessed as medically significant.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  Information on lot number was requested.; Sender's Comments: This case concerns a patient of unknown demographics who had seizures after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Death
Clinical narrative: died from the flu shot; Initial information was received on 12-Oct-2020 regarding an unsolicited valid serious case from a non-health care professional via social media.  This case is linked to case 2020SA289370 (same reporter).  This case involves a female patient of unknown age who died (death), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment before death.  It was unknown if an autopsy was done and the cause of death was not reported.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns a female patient of unknown age who died, after vaccination with INFLUENZA VACCINE (produced by unknown manufacture). The time to onset is unknown. Also, further information regarding patient's concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations and autopsy result are needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: death nos
Age: 13.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 13 years-old was administered a dose of FLUBLOK QUADRIVALENT/ No AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 13 years old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2028, expiry date: 30-Jun-2021) via intramuscular route on left arm on an unknown date (also reported as 24-Sep-2020 or 26-Sep-2020) for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No concomitant vaccines received by the patient.  It was an actual medication error due to inappropriate age at vaccine administration.  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 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: 66.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient recieved Fluzone Quadrivalent High Dose that was too-long in transit and was not suitable for use, no AE; Initial information was received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a Nurse Practitioner.  This case is linked to cases 2020SA268090, 2020SA268092, 2020SA268094, 2020SA268091 and 2020SA268093 (same reporter).  This case involves a 66 year old male patient who was vaccinated with 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (form: prefilled syringe, lot number: UJ498AA and expiration date: 30-Jun-2021) once via unknown route in the left deltoid for prophylactic vaccination on 28-Sep-2020. The vaccine was too-long in transit and was not suitable for use (PT: product storage error).  Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to incorrect product storage.  The NP stated that they gave Fluzone high dose to the patients before they got call that vaccines were too long in transit and were not suitable for use. It was reported that the boxes were cold, but the ice packs were not hard frozen. Reporter asked if the vaccines were still good to be used or if they need to revaccinate. This was the only vaccine received by the patients.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: rash but not near the injection site; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from the pharmacist via phone.  This case involves an unknown demographic patient who experienced rash but not near the injection site (rash), while the patient received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   On 30-Sep-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (batch number and other dosing details were not reported) for prophylactic vaccination.  On 01-Oct-2020, the patient developed non-serious rash but not near the injection site (rash), 1 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLU4
Symptoms: Lymph node pain
Clinical narrative: patient had left, sub-mandular lymph node, severe pain; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 71 years old male patient who experienced patient had left, sub-mandular lymph node, severe pain (lymph node pain) , while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 01-Oct-2020, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 02-Oct-2020, the patient developed a non-serious patient had left, sub-mandular lymph node, severe pain  (lymph node pain), 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event lymph node pain at the time of reporting.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Vaccination site bruising
Clinical narrative: bad bruise from a intramuscular injection in the past; Initial information regarding this valid unsolicited non-serious case from nurse and transmitted to on 08-Oct-2020.  This case involved an elderly patient who experienced bad bruise from intermuscular injection in the past (Vaccination site bruising), while the patient received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant drug was not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Lot number and expiration date unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bad bruise from a intramuscular injection in the past (Vaccination site bruising), (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of the event was unknown.
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Erythema, Peripheral swelling, Tenderness
Clinical narrative: red, tender, swollen area, 2 inch in diameter lower on her upper arm but not in the deltoid; anxious; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from the patient via phone.  This case involves a female patient of unknown age who experienced red, tender, swollen area, 2 inch in diameter lower on her upper arm but not in the deltoid (inflammation) and she was anxious (anxiety), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On 08-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE in the deltoid (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious red, tender, swollen area, 2 inch in diameter lower on her upper arm but not in the deltoid (inflammation) and she was anxious (anxiety), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: MNQ
Symptoms: Limb injury, Syringe issue
Clinical narrative: neck of vial was broken from where it was weak and someone in the office cut her finger on it; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a physician.   This case involves patient of unknown demographics who while opening the new box after delivery on 29th, had a finger cut as the neck of vial was broken from where it was weak and also as the delivery contained shattered vial in center, while he/she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6827BA and expiration date 18-Feb-2022) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious finger cut as the neck of vial was broken from where it was weak  (limb injury) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Other case details reported regarding product details: Number of units affected- one vial , but was requesting the entire box of five to be replaced as the reporter doesn't feel comfortable using them and the broken vial was kept in the box ; Is dose not used or not available- not used and available ; Whether product is available for return- yes ; Broke or cracked during preparation or use- no; Received broken or cracked in the carton- yes; Was there any damage to the carton upon receipt- no ; Was there any product residue in the carton- no ; Were there any signs of damage to any other vial in the carton- not that he can tell.  No laboratory date reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event limb injury.  there will be no information on the batch number for this case.
Age: 36.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient stated his right arm was bruised below the injection site and sore.  Patient states that it is less sore now.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Hyperhidrosis, Impaired work ability, Vomiting
Clinical narrative: Sweating and vomiting. Left work early
Age: 89.0
Sex: F
Vaccine: FLUA4
Symptoms: Facial pain, Gingival pain, Joint stiffness, Pain in jaw, Paraesthesia oral
Clinical narrative: pain on left side of face; prickling sensation in nerves tingling and throbbing in upper and lower rear gums at the base of the teeth jaws aching and stiff at sides where they met left sinus cavity irritated sensitivity and soreness intermittent , lasted six weeks
Age: 89.0
Sex: F
Vaccine: FLUA4
Symptoms: Sinus pain
Clinical narrative: pain on left side of face; prickling sensation in nerves tingling and throbbing in upper and lower rear gums at the base of the teeth jaws aching and stiff at sides where they met left sinus cavity irritated sensitivity and soreness intermittent , lasted six weeks
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Atrial fibrillation, Condition aggravated, Erythema, Hypersensitivity, Influenza like illness
Clinical narrative: Atrial fibrillation; allergic reaction; flu like symptoms; This spontaneous report was received from a 79 years old male patient referring to himself. The patient had none concomitant medication. Pertinent medical history was reported as atrial fibrillation.   On an unknown date in 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (Single dose 0.5 ml; route, lot# and expiration date were not reported) given in the arm for preventative measures.     The patient went to his local pharmacy and was given the flu shot and the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine. On 04-OCT-2020 (reported as 10 days ago), later that day the patient experienced an allergic reaction were his elbow swelled and it was red (also reported allergic reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)). The reaction lasted about 3 days. He also had flu like symptoms which included a fever, aches and pains. The patient explained that he had atrial fibrillation issues as well but he believed that was due to not drinking enough water and staying hydrated and explained that if he did not stay hydrated he had issues with his atrial fibrillation. No treatment was given for AE. The patient had lab diagnostics/studies performed, he had them done annually. Outcome of the events was recovered on an unknown date in October 2020 (reported as 3 days). The patient had not sought medical attention.   The causal relationship between the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.  Upon internal review, atrial fibrillation was determined to be medically significant.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Joint swelling, Pain, Pyrexia
Clinical narrative: Atrial fibrillation; allergic reaction; flu like symptoms; This spontaneous report was received from a 79 years old male patient referring to himself. The patient had none concomitant medication. Pertinent medical history was reported as atrial fibrillation.   On an unknown date in 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (Single dose 0.5 ml; route, lot# and expiration date were not reported) given in the arm for preventative measures.     The patient went to his local pharmacy and was given the flu shot and the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine. On 04-OCT-2020 (reported as 10 days ago), later that day the patient experienced an allergic reaction were his elbow swelled and it was red (also reported allergic reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)). The reaction lasted about 3 days. He also had flu like symptoms which included a fever, aches and pains. The patient explained that he had atrial fibrillation issues as well but he believed that was due to not drinking enough water and staying hydrated and explained that if he did not stay hydrated he had issues with his atrial fibrillation. No treatment was given for AE. The patient had lab diagnostics/studies performed, he had them done annually. Outcome of the events was recovered on an unknown date in October 2020 (reported as 3 days). The patient had not sought medical attention.   The causal relationship between the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.  Upon internal review, atrial fibrillation was determined to be medically significant.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: More sore than getting a flu shot; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of patients who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that arm soreness felt after Shingrix vaccine was more sore than getting a flu shot. The reporter consented to followup. This case has been linked with US2020203882 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020203882:same reporter
Sex: F
Vaccine: MEN
Symptoms: Arthralgia, Rheumatoid arthritis, Swelling
Clinical narrative: rheumatoid arthristris developed; severe pain in her joints; swelling; This case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant), joint pain and swelling. On an unknown date, the outcome of the rheumatoid arthritis, joint pain and swelling were unknown.   The reporter considered the rheumatoid arthritis, joint pain and swelling to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. Age at vaccination was not reported. The patient was always a completely healthy girl. The reporter stated that the patient had severe pain in her joints, swelling and appears to see rheumatoid arthristris developed.  The physician pressured to administer the vaccine because they were in favor of vaccines. These companies should compensate these children for the damages caused by the vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR205371:same reporter
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea haemorrhagic, Laboratory test abnormal
Clinical narrative: diarrhea; This case was reported by a physician via other manufacturer and described the occurrence of bloody diarrhea in a 2-month-old female patient who received Rota (Rotarix) for prophylaxis.   On an unknown date, the patient received Rotarix (oral). On an unknown date, less than a month after receiving Rotarix, the patient experienced bloody diarrhea (serious criteria GSK medically significant). On an unknown date, the outcome of the bloody diarrhea was unknown.   It was unknown if the reporter considered the bloody diarrhea to be related to Rotarix.  Additional details were provided as follows: The patient received Rotarix at 2 months of age and experienced bloody diarrhea. The reporter called to find out if that was a typical adverse event for that vaccine or he could rule out if that was cause or if something else was going with the patient.