chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Limb discomfort, Migraine
Clinical narrative: numbness that progressively went away from my knees to my toes over the course of a week; lower legs felt heavy, like I had weights around them for the week; Initial information was received on 03-Nov-2021 regarding an unsolicited valid non-serious case received from consumer/non-health care professional via Agency (under reference number - US-SA-SAC20211110000225).  This case involves adult patient of unknown age and gender who experienced numbness that progressively went away from knees to toes over the course of a week (hypoaesthesia) and lower legs felt heavy, for the week (limb discomfort), after receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (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 non-serious numbness that progressively went away from knees to toes over the course of a week (hypoaesthesia) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  On an unknown date, the patient developed a non-serious lower legs felt heavy, for the week (limb discomfort) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "Upon sharing this with my colleague, I learned that she had a migraine for 4 days after receiving Flublok. I do not know when she received the shot, her age, etc., but she is internal, so you can find her in the system and contact her."  It is unknown if the patient experienced any additional symptoms/events.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Arthralgia, Injection site pain
Clinical narrative: This case involves adult patient (unknown age and gender) who had shoulder is a little sore (arthralgia) and a little soreness at the injection site (vaccination site pain), after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient's medical treatment, vaccination, concomitant medication, 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 non-serious shoulder is a little sore (arthralgia) and a little soreness at the injection site (vaccination site pain), (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Just got mine yesterday. Didn't even feel it go in. A little soreness at the injection site an hour later and my shoulder is a little sore today but no fever or any other symptoms at all. Plan on getting my coronavirus disease (covid) booster the last week of November. I've been fully vaccinated since March 25th". It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported events. There will be no information available on the batch number for this case.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Wrong product administered
Clinical narrative: patient receive a dose of Flulaval instead of FLUZONE HIGH-DOSE QUADRIVALENT with no adverse event; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from pharmacist and non-healthcare professional via phone the Regulatory Authority (Reference number- 00832892).  This case involves a 72 year old female patient who received a dose of INFLUENZA VACCINE INACT SPLIT 3V [FLULAVAL] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect FLULAVAL not produced by Sanofi Pasteur (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination instead of  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  It was of actual medication error due to wrong vaccine administered (latency: same day).  It was reported "The Department of Health representative confirmed that we should re-dose the individual but asked that I contact you for guidance on when to re-dose. I would appreciate any information you can provide regarding how soon after administration of a sub-therapeutic dose of influenza vaccine, we should administer a therapeutic dose to this patient?"  At time of reporting, it was unknown whether the patient had any adverse event or not.  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 the 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.  There will be no information on batch number for this case.
Age: 69.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Wrong product administered
Clinical narrative: Patient was administered with flublok instead of fluzone high dose, no reported adverse event; Initial information received on 01-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professionals via Medical Information (under reference number 00837197).  This case involves a 69 years old female patient who was administered with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, sometime in the last month as per report, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered (same day latency).  It was reported "Caller was administered FLUBLOK "sometime last month" although she asked for FLUZONE HIGH DOSE; caller has been advised by her allergist to reach out to medical information on counseling regarding having another FLUBLOK shot administered in order to be protected for her age range; caller states she needs to start diabetic medicine and is refusing to do so until has information regarding another dose of a flu vaccine. Upon transfer, caller asked how Flublok Quadrivalent, Fluzone High-Dose Quadrivalent, and Fluzone Quadrivalent compare in terms of the dose of the 4 strains in the vaccine. Caller asked if she could get another dose of a flu vaccine to "make up" for not having gotten the Fluzone Quadrivalent High-Dose. Caller asked what is a situation where someone would get the Flublok rather than the Fluzone High-Dose. Caller asked if the 4 strains are the same in the Flublok and the Fluzone."  At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.  There will be no information available on the batch number for this case.
Age: 14.0
Sex: U
Vaccine: FLUR4
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: may have administered FLUBLOK to a 14 year old patient; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via consumer/non-health care professional via Medical Information (Reference number- 00837243) and transmitted to Sanofi on 01-Nov-2021.  This case involves a 14-year-old patient (unknown gender) who reportedly may have received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age)  The patient's medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.  On 31-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to Inappropriate age at vaccine administration (latency same day)  It was reported "Pharmacist reports that her intern told her they may have administered FLUBLOK to a 14 year old patient yesterday, 31OCT2021; states she still has to verify that this event occurred. Pharmacist asks if there are any recommendations when FLUBLOK is administered to a patient younger than 18 years; asks if there are any side effects when FLUBLOK is administered to a patient younger than 18 years. Pharmacist states she will call back to complete adverse event (AE) report when she verifies that the event occurred and collects the information about the event; agent gave pharmacist case reference number. Pharmacist confirms that it would have been the standard 0.5 mL dose of FLUBLOK that was administered"  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 the 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.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: child receives vaccines on delayed schedule; Initial information received on 01-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer or non-healthcare professional.  This case involves child male patient who receives vaccines on delayed schedule while receiving vaccines HIB (PRP/T) VACCINE [ACT-HIB], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and IPV (VERO) [IPOL] (inappropriate schedule of vaccine administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO), DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and HIB (PRP/T) VACCINE lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to inappropriate schedule of product administration.  It was reported ''asks if there is a maximum length of time between vaccine schedule for Daptacel, ActHIB, Ipol. She asks why is it not necessary to get ActHIB vaccine if not completed series at age 5. She reports child receives vaccines on delayed schedule, individually, not as combined products like Pentacel.''  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient was given the DTap/IPV portion of PENTACEL, but not the ActHIB portion with no reported adverse event; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case from a other health professional via Agency (under reference number 0083849).  This case involves a 6 months old male patient who was given the dtap/ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], but not the acthib portion (product preparation issue).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS B VACCINE (lot numbers and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date.  On 27-Oct-2021, the patient received a 0.5 ml third standard dose in total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (once , lot UJ527AA and expiration date not reported) via intramuscular route in the left thigh for prophylactic vaccination (the caller stated that she had the same lot and expiration date for both components of the PENTACEL vaccine).  It was an actual medication error case due to inappropriate reconstitution technique (same day latency).  It was reported "Nurse reported that a patient was given the DTap/IPV portion of PENTACEL, but not the ActHIB portion. The caller would like to speak with someone about obtaining the diluent portion of ActHIB. Caller declined to provide her email address. I referred the caller to the PENTACEL reconstitution video. I spoke with a Pasteur Customer Service Representative and they will contact the caller."  No treatment required post administration was provided to the patient.  At time of reporting, no adverse event was reported and the outcome was unknown for the 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 the 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: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Underdose
Clinical narrative: Vaccinator pushing the needle into the arm she was pushing on the plunger at the same time, so part of the medication went on his arm and the subcutaneous tissue into the muscle. with no adverse event, the full dose was not administered; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Regulatory Authority (under the reference 00838646).  This case involves a 47 years old male patient whom vaccinator pushing the needle into the arm, pushing on the plunger at the same time so part of the medication went on his arm and the subcutaneous tissue into the muscle (exposure via skin contact) and the full dose was not administered (underdose) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient had no other concomitant vaccines.  On 01-Nov-2021, the patient received a first dose of suspect FLUZONE QUADRIVALENT (total, once, lot UT7377LA and expiration date: 30-Jun-2022) via intramuscular route in the left deltoid and 2nd dose were administered on unknown dates (lot number and expiration date not provided) via intramuscular route in right deltoid for prophylactic vaccination.  It was an actual medication error due to exposure via skin contact and underside (same day latency).  No adverse event was reported.  It was reported "Caller stated that they had an administration error involving FLUZONE QUAD PFS. the full dose was not administered to the adult patient. the vaccinator plunged the plunger before injecting the vaccine. she repeated the dose, but needs guidance for future reference. Caller states yesterday she was injecting a consumer and as she was pushing the needle into the arm she was pushing on the plunger at the same time so part of the medication went on his arm and the subcutaneous tissue into the muscle. Caller repeated the dose yesterday and called the Communicable Disease Center (CDC) to find out what to do."  At time of reporting, the outcome was Unknown for the reported events.  There would be no information on the batch number for the another dose.
Age: 3.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received Tdap/ADACEL instead of the DTaP/DAPTACEL with no reported adverse event.; Adacel was mistakenly given to a 3-year old patient with no adverse event reported; Initial information was regarding an unsolicited valid non serious case was received from an other health professional via Medical Information (MI) (Reference number- 00838697) and transmitted to Sanofi on 02-Nov-2021.  This case involves a three-year-old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of the DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered and product administered to patient of inappropriate age).  The patient's past vaccination(s) included DAPTACEL on 16-MAY-2018, on 16-JUL-2018 and on 17-SEP-2018.  The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided.  On 21-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection, lot U7184AA, expiry date unknown) via an unknown route in the left thigh for prophylactic vaccination.  It was an actual medication error due to wrong product administered and product administered to patient of inappropriate age. (latency: same day).  It was reported "Adacel was mistakenly given to a 3-year-old patient as the fourth dose in the diphtheria/tetanus/pertussis pediatric series. A patient received doses of Daptacel on 16May2018, 16Jul2018, and 17Sep2018. Then on 21Oct2021 for his fourth dose, Daptacel was intended, but instead Adacel was mistakenly administered in the left thigh."  At 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 the 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: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: an extra dose of FLUBLOK was inadvertently given to a patient with no adverse event; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non health care professional via Media Information (under reference 00838813).  This case involves a 59 years old female patient who received an extra dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 26-Oct-2021, the patient received dose of the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot 2FAA2132 and expiration date: 30-Jun-2022) via intramuscular route in the left deltoid and On 02-Nov-2021, she received dose of same vaccine (lot 2FAA2118 and expiration date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered (same day latency).  It was reported "He wanted to know if there are any symptoms or special circumstances that the patient should be aware of with an extra dose of Flublok."  At 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 the 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: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: ten year old patient received MENACTRA before age 11 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Medical Information (MI) (Reference number- 00840352) and transmitted to Sanofi on 03-Nov-2021.  This case involves a 10-year-old female patient who received a dose (once) of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] before age 11 (lot and expiry date not reported) via unknown route at an unknown administration site on 28-Aug-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  It was reported "HCP requests counseling on revaccination of MENACTRA; ten year old female was given MENACTRA on 28AUG2020 before age 11; the patient's school says the child needs to be revaccinated."  At the time of report, 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 the 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.  There will be no information available on batch number for this case.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Muscle spasms, Pyrexia, Tremor
Clinical narrative: Uncontrollable chills/shaking for an hour, 102 fever, headache and muscle cramps
Age: 30.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Adnexa uteri pain, Ovarian cyst
Clinical narrative: pain in the ovaries and cyst in one ovary
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electromyogram, Neuropathy peripheral
Clinical narrative: Periodic Peripheral Neuropathy in hands and feet occurring once every 2-3 weeks for a period of 24-36hrs from May 2021 to September 2021. From September 2021 to November 2021 symptoms increased in intensity and shifted from hand to feet and from side to side frequently. Symptoms eased and ceased around 11/5/2021.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: no additional AEs reported; reconstitued with the adjuvant suspension component for SHINGRIX; This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  The reporter stated, that on 14-OCT-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) at the dose of 0.5 ml, subcutaneously, lot # U002400, expiration date reported and also validated as 22-JAN-2023 (strength and anatomical location were not provided) for prophylaxis, but the vaccine was reconstituted with the adjuvant suspension component for varicella zoster vaccine rge(cho) (SHINGRIX) at the dose of 0.5 ml, lot # 7S3NF, expiration date 18-DEC-2022 (strength was not reported) instead of sterile diluent supplied with the varicella virus vaccine live (oka/merck)(VARIVAX) (wrong solution used in drug reconstitution).  The Merck sterile diluent was was not administered. The reporter denied further adverse event (AE) (no adverse event). No additional information was provided.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, Medication error
Clinical narrative: a patient received GARDASIL and may not have completed the series with GARDASIL; a patient received GARDASIL and may not have completed the series with GARDASIL; No additional AE reported; This spontaneous report was received from a pharmacist referring to a currently 35 years old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, frequency, route, lot# and expiration date were not reported) for prophylaxis.         It was reported by the pharmacist that the patient may not have completed the series with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (circumstance or information capable of leading to medication error and inappropriate schedule of product administration). No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: It did not help me/Suspected vaccination failure; It did not help me; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination  failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. 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 Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingles vaccine and it did not help him/her. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Note: The case was kept conservatively valid
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/had 3 shingles and get shingles; shingles; had 3 shingles vaccine; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 3 doses of Shingles vaccine and still had shingles. The patient received 3rd dose of Shingles vaccine which led to extra dose administered. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/had the shingles shot & got the shingles; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. 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 Shingles vaccine.  Additional details provided were as follows: The case was reported by patient's brother's wife. The age at vaccination was not reported. The patient had the shingles shot and still got the shingles bad. The reporter stated that they would not ever get the shingles shot as Medicare would not pay for it anyway and even if they did, they still would not get that crazy shot. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case was linked with case US2021AMR231046, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR231046:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix over 2 yeas ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over 2 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose. The healthcare professional consented to follow up. This case had been linked to the case US2021226679, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021226679:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that his little brother got the vaccine and on an unspecified date, the patient died from it. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211124581-COVID-19 VACCINE AD26.COV2.S-Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Burning sensation, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: INTENSE INSOMNIA; KIDNEY PAIN; SEVERE INCONTINENCE; BODY ACHES; SLEEP ISSUES; FEELING LIKE ACID HAS BEEN POURED ALL OVER BODY; SPINE WAS HOT TO THE TOUCH; OTHER AUTONOMIC PROBLEMS; BRAIN FOG; BARELY ABLE TO FUNCTION; SHIFT TO PAIN IN UPPER EXTREMITIES, CHEST, BACK, SHOULDERS, HEAD, NECK, AND OCCASIONALLY IN THE LOWER EXTREMITIES; VERY SWOLLEN AND TENDER LYMPH NODES; SEVERE HEADACHES; ABSOLUTELY EXHAUSTED; ACUTE PRESENTATION OF INTENSE TINGLING IN  HANDS, ARMS, FEET, LEGS, AND LIPS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-OCT-2021, the patient experienced acute presentation of intense tingling in hands, arms, feet, legs, and lips. On an unspecified date, the patient experienced intense insomnia, kidney pain, severe incontinence, body aches, sleep issues, feeling like acid has been poured all over body, spine was hot to the touch, other autonomic problems, brain fog, barely able to function, shift to pain in upper extremities, chest, back, shoulders, head, neck, and occasionally in the lower extremities, very swollen and tender lymph nodes, severe headaches, and absolutely exhausted. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) found nothing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe incontinence, body aches, and spine was hot to the touch, had not recovered from severe headaches, sleep issues, intense insomnia, other autonomic problems, and the outcome of very swollen and tender lymph nodes, kidney pain, acute presentation of intense tingling in hands, arms, feet, legs, and lips, shift to pain in upper extremities, chest, back, shoulders, head, neck, and occasionally in the lower extremities, feeling like acid has been poured all over body, absolutely exhausted, barely able to function and brain fog was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Incontinence, Insomnia, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: INTENSE INSOMNIA; KIDNEY PAIN; SEVERE INCONTINENCE; BODY ACHES; SLEEP ISSUES; FEELING LIKE ACID HAS BEEN POURED ALL OVER BODY; SPINE WAS HOT TO THE TOUCH; OTHER AUTONOMIC PROBLEMS; BRAIN FOG; BARELY ABLE TO FUNCTION; SHIFT TO PAIN IN UPPER EXTREMITIES, CHEST, BACK, SHOULDERS, HEAD, NECK, AND OCCASIONALLY IN THE LOWER EXTREMITIES; VERY SWOLLEN AND TENDER LYMPH NODES; SEVERE HEADACHES; ABSOLUTELY EXHAUSTED; ACUTE PRESENTATION OF INTENSE TINGLING IN  HANDS, ARMS, FEET, LEGS, AND LIPS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-OCT-2021, the patient experienced acute presentation of intense tingling in hands, arms, feet, legs, and lips. On an unspecified date, the patient experienced intense insomnia, kidney pain, severe incontinence, body aches, sleep issues, feeling like acid has been poured all over body, spine was hot to the touch, other autonomic problems, brain fog, barely able to function, shift to pain in upper extremities, chest, back, shoulders, head, neck, and occasionally in the lower extremities, very swollen and tender lymph nodes, severe headaches, and absolutely exhausted. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) found nothing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe incontinence, body aches, and spine was hot to the touch, had not recovered from severe headaches, sleep issues, intense insomnia, other autonomic problems, and the outcome of very swollen and tender lymph nodes, kidney pain, acute presentation of intense tingling in hands, arms, feet, legs, and lips, shift to pain in upper extremities, chest, back, shoulders, head, neck, and occasionally in the lower extremities, feeling like acid has been poured all over body, absolutely exhausted, barely able to function and brain fog was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pain in extremity, Paraesthesia, Renal pain
Clinical narrative: INTENSE INSOMNIA; KIDNEY PAIN; SEVERE INCONTINENCE; BODY ACHES; SLEEP ISSUES; FEELING LIKE ACID HAS BEEN POURED ALL OVER BODY; SPINE WAS HOT TO THE TOUCH; OTHER AUTONOMIC PROBLEMS; BRAIN FOG; BARELY ABLE TO FUNCTION; SHIFT TO PAIN IN UPPER EXTREMITIES, CHEST, BACK, SHOULDERS, HEAD, NECK, AND OCCASIONALLY IN THE LOWER EXTREMITIES; VERY SWOLLEN AND TENDER LYMPH NODES; SEVERE HEADACHES; ABSOLUTELY EXHAUSTED; ACUTE PRESENTATION OF INTENSE TINGLING IN  HANDS, ARMS, FEET, LEGS, AND LIPS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-OCT-2021, the patient experienced acute presentation of intense tingling in hands, arms, feet, legs, and lips. On an unspecified date, the patient experienced intense insomnia, kidney pain, severe incontinence, body aches, sleep issues, feeling like acid has been poured all over body, spine was hot to the touch, other autonomic problems, brain fog, barely able to function, shift to pain in upper extremities, chest, back, shoulders, head, neck, and occasionally in the lower extremities, very swollen and tender lymph nodes, severe headaches, and absolutely exhausted. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) found nothing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe incontinence, body aches, and spine was hot to the touch, had not recovered from severe headaches, sleep issues, intense insomnia, other autonomic problems, and the outcome of very swollen and tender lymph nodes, kidney pain, acute presentation of intense tingling in hands, arms, feet, legs, and lips, shift to pain in upper extremities, chest, back, shoulders, head, neck, and occasionally in the lower extremities, feeling like acid has been poured all over body, absolutely exhausted, barely able to function and brain fog was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: INTENSE INSOMNIA; KIDNEY PAIN; SEVERE INCONTINENCE; BODY ACHES; SLEEP ISSUES; FEELING LIKE ACID HAS BEEN POURED ALL OVER BODY; SPINE WAS HOT TO THE TOUCH; OTHER AUTONOMIC PROBLEMS; BRAIN FOG; BARELY ABLE TO FUNCTION; SHIFT TO PAIN IN UPPER EXTREMITIES, CHEST, BACK, SHOULDERS, HEAD, NECK, AND OCCASIONALLY IN THE LOWER EXTREMITIES; VERY SWOLLEN AND TENDER LYMPH NODES; SEVERE HEADACHES; ABSOLUTELY EXHAUSTED; ACUTE PRESENTATION OF INTENSE TINGLING IN  HANDS, ARMS, FEET, LEGS, AND LIPS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-OCT-2021, the patient experienced acute presentation of intense tingling in hands, arms, feet, legs, and lips. On an unspecified date, the patient experienced intense insomnia, kidney pain, severe incontinence, body aches, sleep issues, feeling like acid has been poured all over body, spine was hot to the touch, other autonomic problems, brain fog, barely able to function, shift to pain in upper extremities, chest, back, shoulders, head, neck, and occasionally in the lower extremities, very swollen and tender lymph nodes, severe headaches, and absolutely exhausted. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) found nothing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe incontinence, body aches, and spine was hot to the touch, had not recovered from severe headaches, sleep issues, intense insomnia, other autonomic problems, and the outcome of very swollen and tender lymph nodes, kidney pain, acute presentation of intense tingling in hands, arms, feet, legs, and lips, shift to pain in upper extremities, chest, back, shoulders, head, neck, and occasionally in the lower extremities, feeling like acid has been poured all over body, absolutely exhausted, barely able to function and brain fog was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned a patient of unspecified age and sex, race and ethnicity. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, therapy start date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter stated that he had a friend who died shortly after the covid vaccine with no other explanation for death. On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211125834-COVID-19 VACCINE AD26.COV2.S-Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Flushing, Nausea, Paraesthesia
Clinical narrative: FEELS SKIN FLUSHING (IN BACK OF LEGS, ARMS, NECK AND CHEEKS AND GOES AWAY AND THEN COMES BACK BUT NOT GOT WORSE SINCE THEN); FEELS TINGLING (IN BACK OF LEGS, ARMS, NECK AND CHEEKS AND GOES AWAY AND THEN COMES BACK BUT NOT GOT WORSE SINCE THEN); NAUSEA; This spontaneous report received from a patient via a company representative concerned a 53 year old male. The patient's weight was 215 pounds, and height was 69 centimeters. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: The patient had not experienced any weakness and did not get sick or anything like that. The patient was taking allergy nose spray. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. Concomitant medications included quetiapine fumarate for drug used for unknown indication. On NOV-2021, the patient experienced nausea. On 09-NOV-2021, the patient experienced feels skin flushing (in back of legs, arms, neck and cheeks and goes away and then comes back but not got worse since then). On 09-NOV-2021, the patient experienced feels tingling (in back of legs, arms, neck and cheeks and goes away and then comes back but not got worse since then). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feels skin flushing (in back of legs, arms, neck and cheeks and goes away and then comes back but not got worse since then), and feels tingling (in back of legs, arms, neck and cheeks and goes away and then comes back but not got worse since then), and the outcome of nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20211124555.