chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; The patient was supposed to return in October 2019 to receive his 3rd Gardasil 9, but it is now December; This spontaneous report was received from a pharmacist concerning a male patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies.  On 16-APR-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dosage schedule, anatomical location, route of administration, lot number and expiration date were not reported).  On 18-JUN-2019, the patient was administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dosage schedule, anatomical location, route of administration, lot number and expiration date were not reported).     In October 2019, the patient was supposed to return to receive his third hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose.  In December 2019, the patient was requesting his third dose (inappropriate schedule of product administration).     No additional adverse event reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information; a patient was inadvertently administered an expired dose of VAQTA; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On 20-DEC-2019, the patient was inadvertently administered an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (strength, dose, route of administration and anatomical site of vaccination were not reported; lot number R025518, expiration date 15-NOV-2019) (expired product administered). There was no temperature excursion. No additional adverse event information was provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered; This spontaneous report as received from medical assistant refers to a patient of unknown age.  The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent.    On 19-DEC-2019 the patient was inadvertently administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015742, expiry date: 02-DEC-2019) therapy type was reported as recombinant human albumin (rha) (expired product administered) for prophylaxis. No temperature excursion. No additional information was provided.  The outcome of expired product administered was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; upset stomach; Fatigue; Slight fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced headache, upset stomach, fatigue and fever. On an unknown date, the outcome of the headache and fatigue were unknown and the outcome of the upset stomach was recovering/resolving and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the headache, upset stomach, fatigue and fever to be related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported. The patient received the second shot of Shingrix yesterday.  The patient had some of the listed side effects as Headache, upset stomach, fatigue and slight fever and wanted to knowhow long should the patient allow for them  to pass. Fever seemed to have passed and stomach was getting better.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had two Shingrix vaccines in 2019 / Today I was diagnosed with Shingles/ suspected vaccination failure; Today I was diagnosed again with Shingles; This case was reported by a consumer and described the occurrence of vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles in November 2018, on right side and back).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and 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 unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 57 or 58 years. The patient had two Shingrix vaccines in 2019. Now the patient was diagnosed again with Shingles.  The patient was guessing if she was a part of the 3 percent. The patient received started antivirals. The patient asked if you were tracking shingles after Shingrix. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event, and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: chills; tiredness; This case was reported by a consumer via call center representative and described the occurrence of chills in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced chills and tiredness. On an unknown date, the outcome of the chills and tiredness were unknown.   It was unknown if the reporter considered the chills and tiredness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced chills and tiredness after vaccination. The patient asked how long will the event last. The patient scheduled to fight tomorrow.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash morbilliform
Clinical narrative: rash on her chest that looks more like a "measles" rash; This case was reported by a physician via call center representative and described the occurrence of measles-like rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included eczema. Previously administered products included Shingrix with an associated reaction of erythema (1st dose received on an unknown date (refer case US2019232438)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced measles-like rash. On an unknown date, the outcome of the measles-like rash was unknown.   It was unknown if the reporter considered the measles-like rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication.  The patient received 2nd dose of Shingrix and experienced more pronounced rash on her chest that looks more like a measles rash. The physician was not convinced that this was related to Shingrix as the patient has a history of eczema and did not wish to report this as an adverse event. The reporter submitted limited information as did not wish to report the event and disconnected the call. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Scar, Urticaria
Clinical narrative: scar; Welt; This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 63-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 3 months after receiving Shingrix, the patient experienced welts and scar. On an unknown date, the outcome of the welts was recovered/resolved and the outcome of the scar was unknown.   It was unknown if the reporter considered the welts and scar to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 62 or 63 years. The patient received a dose of Shingrix on an unknown arm. The patient was vaccinated about three months before the time of reporting and afterwards developed a welt near the injection site.  The welt resolved after a day, but the patient appeared to have a scar. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: aches/pain; little fever; This case was reported by a consumer via call center representative and described the occurrence of pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain and fever were unknown.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient's friends. The age at vaccination was not applicable for this report. Around 20 patients had aches, pain and little fever to Shingrix first or second dose of the vaccine. The patient's friends had stated it looked like if the 2nd dose was given further away from the 1st dose, might be closer to the sixth month the adverse reactions would have been relatively less.  No additional information was provided.  The reporter did not consent to follow-up. This case has been linked with case US2019230500 and US2019230503, reported by same reporter.
Age: 76.0
Sex: F
Vaccine: HEPA
Symptoms: Alopecia, Trichorrhexis, Urticaria
Clinical narrative: brittle hair; hives; hair loss; This case was reported by a consumer via call center representative and described the occurrence of hives in a 76-year-old female patient who received HAV (Havrix 1440) for prophylaxis.   Previously administered products included Havrix 1440 (Received 1st dose on an unknown date). Concurrent medical conditions included mosquito bite.   On 1st December 2019, the patient received the 2nd dose of Havrix 1440 (intramuscular). In December 2019, less than 3 weeks after receiving Havrix 1440, the patient experienced hives, hair loss and brittle hair. On an unknown date, the outcome of the hives was unknown and the outcome of the hair loss and brittle hair were not recovered/not resolved.   It was unknown if the reporter considered the hives, hair loss and brittle hair to be related to Havrix 1440.  Additional details were provided as follows: The patient received 2nd dose of Havrix 1440 and noticed hair was very brittle and falling out more than usual. The patient could hear her hair breaking when she runs her hand gently through it, and was constantly sweeping hair off the floor, some with the root. The patient had a few hives and there which might be mosquito bites. The follow up consent was not granted.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: vaccine leaked around the hub of the syringe; underdose; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves patient who was vaccinated with a leaked syringe (Syringe issue), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. The lot number: UJ213AA and expiry date not reported.  It was actual medication error due to vaccine underdoes. It was also a case of Syringe issue.  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was only given the DtaP/ IPV, however she did not receive the ActHIB powder portion of the Pentacel vaccine, no adverse event; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case from an other health care professional.  This case involves a two months old female patient who was vaccinated with a 0.5 ml first dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ134AA and expiration date 11-Oct-2020) via an intramuscular route in the left thigh on 07-Nov-2019. However she was only given the Dtap/ Ipv portion and did not receive the Act-Hib powder portion of the pentacel vaccine.  Medical history not reported and concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23) for Immunisation received on 07-Nov-2019.  It was an actual medication error case due to inappropriate reconstitution technique.  No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth, Urticaria, Vaccination site inflammation
Clinical narrative: injection site redness, with warmth to touch; injection site redness, with warmth to touch; injection site redness, with warmth to touch; hives spread down their arm; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (Office Staff).  This case is linked to cases 2019SA322706 and 2019SA327308.  This case involves a female (age not reported) patient of unknown age who had injection site redness, with warmth to touch (vaccination site inflammation) and hives spread down their arm (urticaria), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6719KA and expiry date: 30-Jun-2020) via unknown route in unknown administration site.  On an unknown date, the patient had injection site redness, with warmth to touch (vaccination site inflammation, vaccination site erythema, vaccination site warmth) and hives spread down their arm (urticaria), (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE..  No lab data was not reported.  Final diagnosis was vaccination site urticaria and vaccination site inflammation.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for all events.
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 year old patient received Flublok, no AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2019SA314663 (same reporter).  This case involves a 15 years old male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1952, expiry date: 30-Jun-2020) via intramuscular route in the right deltoid, on 07-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age of vaccine administration.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: an expired dose of Pentacel was administered; Initial information received on 02-Dec-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 months old female patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that an expired dose of Pentacel was administered (expired vaccine used).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 02-Dec-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5409AA and expiry date: 10-Oct-2019 via intramuscular route in the right thigh.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Rash pruritic
Clinical narrative: localized redness to the injection site.; puffiness to the injection site; itchy rash to the upper legs on the thighs; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 67 years old female patient who experienced localized redness and puffiness to the injection site (Erythema), (Swelling) and itchy rash to the upper legs on the thighs (Rash pruritic), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], lot UJ004AB  and expiration date: 30-MAR-2019 via an intramuscular route in the left arm.  On an unknown date, the patient developed a non-serious localized redness and puffiness to the injection site (Erythema), (Swelling) and itchy rash to the upper legs on the thighs (Rash pruritic) 3 days later following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  (Other relevant tests included no lab data.)  Final diagnosis was itchy rash to the upper legs on the thighs, localized redness and puffiness to the injection site.   It was not reported if the patient received a corrective treatment.  The outcome was reported as not recovered for localized redness and puffiness to the injection site and as resolving for itchy rash to the upper legs on the thighs on an unknown date.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: a patient received less than a full amount of a Pentacel dose due to a malfunction of a syringe and needle, no adverse event; a patient received less than a full amount of a Pentacel dose due to a malfunction of a syringe and needle, no adverse event; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four months old male patient who was vaccinated with a  0.5 ml second dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ016AA and expiration date 26-Oct-2020) via an unknown route in the left thigh on 03-Dec-2019. However the patient received less than a full amount of a pentacel dose due to a malfunction of a syringe and needle, there was 0.1 mL to 0.2 mL remaining in the syringe that was not given.  The past vaccination included first dose of pentacel and concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to vaccine underdose.  Also this was a case of syringe issue.  No adverse event 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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: received a partial dose of Pentacel with sterile water from a Merck MMR vaccine was mixed with the lyophilized hib powder while the DTaP-IPV diluent was not given, no AE; Initial information received on 04-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff).  This case involves a unknown demographic patient who received a partial dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with sterile water from a Merck MMR vaccine was mixed with the lyophilized HIB powder while the DTaP-IPV diluent was not given.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Dec-2019, while receiving a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) Sterile water from a Merck MMR vaccine was mixed with the Lyophilized Hib powder while the DTaP-IPV diluent was not given was mixed with the lyophilized hib powder while the DTaP-IPV diluent was not given via intramuscular route in unknown administration site.  It was actual medication error due to Inappropriate reconstitution technique.  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 holders 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.  Information on the batch number was requested.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: arm is still sore a month later; Initial information received on 04-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 64 years old female patient who experienced arm is still sore a month later (pain in extremity), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 31-Oct-2019, the patient received a standard dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ270AA expiry date 20-Jun-2020 via intramuscular route in the left arm.  On an unknown date, the patient experienced a non-serious arm is still sore a month later (pain in extremity) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Other relevant tests were reported.  Final diagnosis was arm sore.  It was not reported if the patient received a corrective treatment.  The outcome was reported as not recovered.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired vaccine Daptacel, no AE; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.   This case involves patient (unknown demographics) who received an expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date not reported) via unknown route in unknown administration site, On an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired Menactra vaccine / no AE; Initial information received on 06-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old male patient who was vaccinated with a 0.5 ml dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number U5986AA (expiration date 05-Aug-2019) via intramuscular route in the left deltoid On 05-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE RHA 3V (BACULOVIRUS) (FLUBLOK).  It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: Back pain, Headache, Nasopharyngitis, Pharyngeal swelling, Rhinorrhoea
Clinical narrative: cold; back pain; swollen throat; runny nose; pounding head; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 64 years old female patient who experienced cold (Nasopharyngitis), back pain (back pain), swollen throat (Pharyngeal swelling), runny nose (Rhinorrhoea) and pounding head (headache), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past vaccination(s) included imovax rabies with The patient receive the full pre-exposure series 30 years ago. The patient's past medical history, medical treatment(s) and family history were not provided.  On 06-Dec-2019, the patient received a single dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site. On 09-Dec-2019 she also received a second  dose of the same vaccine  with an unknown batch number via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious cold (nasopharyngitis), back pain, swollen throat (pharyngeal swelling), runny nose (rhinorrhoea) and pounding head (headache) (Unknown latency) following the administration of RABIES (HDC) VACCINE.  Other relevant tests were not reported.  Final diagnosis was pounding head, runny nose, swollen throat, back pain and cold.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for cold, as Unknown for back pain, as Unknown for pounding head, as Unknown for swollen throat and as Unknown for runny nose.
Sex: U
Vaccine: MEN
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: soreness all over; chills; fever; soreness around the injection site; Initial information received on 13-Dec-2019 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case involves a unknown demographic patient who experienced soreness all over (pain) ,chills (chills) ,fever (pyrexia) and soreness around the injection site (vaccination site pain), while he/she received vaccine MENINGOCOCCAL VACCINE.  Medical history, past medical treatment, past vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer (lot number and other dosing details were not reported).  On an unknown date, the patient developed  non-serious soreness all over (pain) ,chills (chills) ,fever (pyrexia) and soreness around the injection site (vaccination site pain) (Unknown latency) following the administration of MENINGOCOCCAL VACCINE.  Details of laboratory data not reported.  Final diagnosis was soreness around the injection site, fever, chills and soreness all over.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was not reported.  Information on the batch number was requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient stated that she developed a high temperature the evening following the administration of the vaccine. The temperature ranged from 103.4 the first night followed by 101.6 and 100.3 the following consecutive nights
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Loss of personal independence in daily activities, Muscle spasms, Pain in extremity
Clinical narrative: Received vaccine at urgent care.  There was no pain at injection site.  I recall that it was in the left arm, however, consent form states right arm.  Symptoms occurred about a week later.  At first I had neck spasms and thought it might be the way I was sleeping.  I took Ibuprofen at night for over a week.  I noted pain in upper arm and in forearm.  I am not on any meds and I continued taking Ibuprofen and alternating nights with acetaminophen.  Approximately 2 months later I still have some upper arm pain.  I contacted NP on 12/23/19 just to inquire as to whether other employees had symptoms.  She stated that the have 3-5/year out of 3000 employees who have indicated similar discomfort. I elected not to go to clinic as it appeared to be improving.  Treatment that might have been used would be steroids that would have affected my blood glucose as I am pre diabetic and maintain my fasting blood glucose at ~115 mg/dl for past 15 years.  I am going to consider other locations for receiving vaccine in future as this has been uncomfortable and I question doing physical activities that require lifting and/or upper body strength.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient had been given a Prevnar13 vaccination in April, 2019.  Pharmacist administering vaccination did not check the state registry prior to administering vaccination just went off of patient reporting vaccine naive.  Employee called the patient to explain the situation and set up an appointment for patient to receive pneumovax23 greater than 1 year from Prevnar13 dose given in December, 2019.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Left arm pain/weakness.  I was barely able to lift my arm due to the pain, aching and weakness.  My whole body ached for approximately 4 weeks.  Most of the ache went away after 4 weeks.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Multiple sclerosis relapse
Clinical narrative: Patient had dormant MS flare up after the immunization which required her to be hospitalized on 10/25/19
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Employee  developed approx. 2"X3" rash in sternum area which developed a couple of hours after administration of vaccine. Employee states he noticed the rash after working out because the area became red and itchy. Rash/redness "went away" by morning time. Did not take any medications.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Loss of consciousness, Wound
Clinical narrative: Patient reported feeling faint and then passing out approximately 12-18 hours after vaccination.  She went to local hospital emergency room to be treated for head wound.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Biopsy kidney abnormal, Blood creatinine increased, Complement factor C3 decreased, Complement factor C4 decreased, Genital swelling
Clinical narrative: 9/30/19: child had genital swelling  and ankle edema 10/18/19: worsening ankle edema and periorbital edema
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Glomerulonephritis membranoproliferative, Haematuria, Hypoalbuminaemia, Nephrotic syndrome, Oedema peripheral
Clinical narrative: 9/30/19: child had genital swelling  and ankle edema 10/18/19: worsening ankle edema and periorbital edema
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Periorbital oedema, Proteinuria, Urine analysis
Clinical narrative: 9/30/19: child had genital swelling  and ankle edema 10/18/19: worsening ankle edema and periorbital edema
Sex: M
Vaccine: FLUN3
Symptoms: Malaise
Clinical narrative: SICKEST I EVER GOT WAS AFTER THE NASAL FLU MIST IN THE ARMY.; A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza vaccine (live, attenuated)), via nasal route, on an unknown date.     On an unknown date, the patient experienced sickest i ever got was after the nasal flu mist in the army. (preferred term: Malaise).     The outcome of the event was unknown.    The event was considered non-serious.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Oedema, Pruritus, Rash papular, Scab
Clinical narrative: Very ill; Sores all over his body / especially head; Extremely itchy sores; Scratching himself; Hard bumps filled with liquid; Hard bumps filled with liquid; Bumps; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced malaise, skin ulcer, pruritus, scratch, edema, crust and papular rash. The patient was treated with prednisone. On an unknown date, the outcome of the malaise was recovered/resolved and the outcome of the skin ulcer, pruritus, scratch, edema, crust and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the malaise, skin ulcer, pruritus, scratch, edema, crust and papular rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix at the end of July. The reporter stated that, the patient should get the second shot by the end of January. After vaccination with dose of Shingrix, the patient had extremely itchy sores all over his body especially his head, they were hard bumps filled with liquid then they pop and crust over then the patient itching like crazy. The reporter stated that, it seems like chicken pox but the dermatologist said it was not chicken pox. The reporter adviced for follow up with doctor.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Scratch, Skin ulcer
Clinical narrative: Very ill; Sores all over his body / especially head; Extremely itchy sores; Scratching himself; Hard bumps filled with liquid; Hard bumps filled with liquid; Bumps; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced malaise, skin ulcer, pruritus, scratch, edema, crust and papular rash. The patient was treated with prednisone. On an unknown date, the outcome of the malaise was recovered/resolved and the outcome of the skin ulcer, pruritus, scratch, edema, crust and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the malaise, skin ulcer, pruritus, scratch, edema, crust and papular rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix at the end of July. The reporter stated that, the patient should get the second shot by the end of January. After vaccination with dose of Shingrix, the patient had extremely itchy sores all over his body especially his head, they were hard bumps filled with liquid then they pop and crust over then the patient itching like crazy. The reporter stated that, it seems like chicken pox but the dermatologist said it was not chicken pox. The reporter adviced for follow up with doctor.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After administration of Shingrix the patient experienced shingles outbreak.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: rapid heart rate; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2019, the patient received the 2nd dose of Shingrix. On 10th December 2019, 1 days after receiving Shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was unknown.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional details were provided as follows: The patient was received Shingrix vaccine and experienced rapid heart rate.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Reaction; This case was reported by a pharmacist and described the occurrence of adverse reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   The reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows The age at vaccination not provided. The patient was sustained a reaction to the shingrix vaccine resuiting ln medical treatment.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose, Malaise, Neuralgia
Clinical narrative: severe nerve pain; feeling under the weather; cause some spillage; This case was reported by a nurse via sales rep and described the occurrence of nerve pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nerve pain, malaise and accidental underdose. On an unknown date, the outcome of the nerve pain was recovered/resolved and the outcome of the malaise and accidental underdose were unknown.   It was unknown if the reporter considered the nerve pain and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose and a half of product this happened 8 weeks ago, and was patients first dose. The patient was receiving first dose of shingrix, when due to error, caused some spillage. The patient was immediately on same arm gave an additional dose of shingrix, full dose.  The patinet then suffered severe nerve pain for a couple of days following immunization, as well as feeling under the weather. The follow up consent was granted.
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: shoulder pain; This case was reported by a physician via call center representative and described the occurrence of shoulder pain in a adult female patient 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 at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a flu shot of unknown formulation years ago, that caused her shoulder pain and it resolved on unknown date. This case has been linked with US2019225256, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pain, Injection site urticaria, Pain, Urticaria
Clinical narrative: painful/burning; burning; broke out in hives; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (For tolerance of 1st dose of Shingrix, refer linked case US2019AMR226348).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site hives and hives. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site hives and hives were unknown.   The reporter considered the injection site pain, injection site hives and hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After Shingrix vaccination the patient experienced very burning painful,broke out in hives at the injection and around her neck.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site urticaria, Urticaria
Clinical narrative: painful/burning; broke out in hives; hives around my neck; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site hives and hives. On an unknown date, the outcome of the injection site pain, injection site hives and hives were recovered/resolved.   The reporter considered the injection site pain, injection site hives and hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After Shingrix vaccination the patient's injection site was very burning painful, broke out in hives at the injection and around her neck. This case has been linked with case US2019AMR226335, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: injection site is swollen; Injection site prettty sore; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix.   On 13th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, after vaccination with dose of Shingrix, the injection site was swollen and pretty sore. The patient asked for advice if could do heat , ice or just need to wait it out.