chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A patient who received Pentacel vaccine, was inadvertently administered a dose of IPOL as well, hence received 2 polio vaccine doses in the same day, no AE; Initial information received on 13-Aug-2020 regarding an unsolicited valid non-serious case from other health professional (clinical manager).  This case involves a 4-year-old female patient who was vaccinated with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], was inadvertently administered a dose of IPV (VERO) [IPOL] as well, hence received 2 polio vaccine doses in the same day (extra dose administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient had received no other vaccines or concomitant medication.   On 13-Aug-2020, the patient received fifth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ329AAA and expiration date: 04-Apr-2021) via unknown route in unknown administration site and on also received a 0.5 ml dose of suspect IPV (VERO) (multi dose vial, lot P1F541M and expiration date:07-Dec-2020 ) via unknown route in unknown administration site as prophylactic vaccination.  It was an actual medication error due to extra dose administered (same day latency).   Reporter stated that the Pentacel was given, so that the patient received an extra Hib vaccine dose by getting the Pentacel.  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.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient was given only the diluent portion of the pentacel vaccine/ No AE; Initial information received on 14-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional.   This case involves a 4 months old male patient who was given only the diluent portion of the suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (0.5 ml, lot UJ189AAA and expiration date: 06-Apr-2021) via unknown route in the right thigh as prophylactic vaccination on 12-Aug-2020 (product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination on 12-Aug-2020.  It was an actual medication error case due to inappropriate reconstitution technique (latency same day).  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.
Age: 1.42
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: Quadracel was given to a 17 month old patient/no AE; patient was very behind on some vaccines so doctor ordered Quadracel and it was also administered/No AE; Initial information received on 20-Aug-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17-months-old-female patient who was vaccinated with fourth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] as she was very behind on some vaccines so the doctor ordered Quadracel instead of Pentacel and also administered it (batch number and expiry date not reported) via unknown route in unknown administration site on 24-Jul-2019 for prophylactic vaccination (product administered to patient of inappropriate age and off label use).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due inappropriate age at vaccine administration.  No adverse event symptoms experienced by the patient.  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 batch number for this case.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a patient was vaccinated with liquid portion of the Pentacel vaccine, and the vaccine was not reconstituted first, No AE; Initial information received on 24-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional .  This case involves a patient of an unknown age and gender who was vaccinated with liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination on an unspecified date and the vaccine was not reconstituted first (product preparation issue).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique (latency same day).  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.  There will be no information on the batch number for this case.
Age: 1.67
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: a 20 months old male patient was inadvertently administering ActHib with a wrong diluent, No AE; Initial information received on 25-Aug-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 20 months old male patient who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB] (lot number UJ121AAE and expiry date: 05-Dec-2020) via an unknown route in the right thigh for prophylactic vaccination on 19-Aug-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination.  It was an actual medication error case due to wrong solution used in drug reconstitution (Product preparation error) (same day latency).  It was reported that the nurse had inadvertently reconstituted ActHib with the wrong diluent. The product was administered to a 20-months-old baby on August 19, 2020.   No adverse reactions reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 88.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 80 year old female patient inadvertently received the fluzone quadrivalent instead of fluzone high dose, no AE; Initial information received on 25-Aug-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2020SA228800.  This case involves a 88 year old female patient who inadvertently administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (wrong product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing has cancer and receives chemo.   On 24-Aug-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ428AA and expiry date: 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered and product administered (same day latency).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient had been inadvertently administered an expired ActHib, no AE; Initial information received on 02-Sep-2020 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves a 15-month-old female patient who was inadvertently administered an expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant vaccination included a dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunization.  On 01-Sep-2020, the patient received 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ077AAA and expiry date: 21-aug-2020) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: nurse was administering a Fluzone Quadrivalent to a 30 months old boy, he grabbed vaccine during administration and threw it across the room, approximately half of it may have been received/No AE; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 30 months old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number UJ430AB, expiration date: 30-Jun-2021) via intramuscular route in the left thigh as prophylactic vaccination on 09-Sep-2020.  It was reported that while administering a Fluzone Quadrivalent to a two and a half year-old boy, he grabbed the vaccine during administration and threw it across the room and the nurse was not sure about how much of the vaccine was administered, approximately half of it may have been received (PT: underdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any concomitant medication.   It was a case of vaccine underdose (same day latency).  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: UNK
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: while administering FLUZONE HIGH DOSE vaccine there was a needle issue and patient may have received a partial dose/No AE; while administering FLUZONE HIGH DOSE vaccine there was a needle issue and patient may have received a partial dose/No AE; Initial information was received on 09-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist .  This case involves a patient with unknown demographics who may have received a partial dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] because there was a needle issue (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  It was a case of vaccine underdose and needle issue (latency same day).  They were administering the FLUZONE HIGH DOSE vaccination and there was a needle issue and the patient may have received a partial dose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received two doses of adacel within 10 months /no AE; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on 17-Oct-2019 and then again on 17-Aug-2020 (batch number U6702AA; expiry date 20-Jun-2022 and dosing details 0.5 mL) via unknown route in unknown administration site for prophylactic vaccination (extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  It was an actual medication error case due extra dose administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 17 year old patient received an additional Menactra dose after having prior dose in Aug 2019, no AE; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 17 years old female patient who an additional MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] dose after having a prior dose in Aug- 2019 (date unknown) (extra dose administered).  The patient's past vaccination  included Menactra on 21-Feb-2015 as prophylactic vaccination.  Medical history, medical treatment(s) and family history were not provided.  The patient did not receive any concomitant medications.   On an unknown date in Aug-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site and again on 09-Sep-2020 she received a 0.5 ml third dose of the same vaccine (lot U6565AA and expiration date: 28-Mar-2021) via intramuscular route in the left deltoid as prophylactic vaccination. It was a case of actual medication error due to extra dose administered (latency same day).  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: M
Vaccine: UNK
Symptoms: Laboratory test abnormal, Mobility decreased, Typical aura without headache, Vertigo
Clinical narrative: vertigo and could not get out of bed; Initial information received on 10-Sep-2020 regarding an unsolicited valid serious case from a consumer or non-healthcare professional (patient's wife) .  This case involves an 83-years-old male patient who experienced vertigo and could not get out of bed (vertigo), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, concomitant medication and family history were not provided.  The patient had vertigo after receiving FLUZONE HIGH-DOSE QUADRIVALENT 5 years ago.  On an unknown date, four years ago, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious vertigo and could not get out of bed (vertigo) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient eventually went to the hospital and was better as the year went on.  Laboratory details were not reported.   Additional Description of event: the patient had a bad reaction to the Fluzone High Dose 4 years ago and 5 years ago then skipped it for 2 years. The patient had a prescription for vertigo last year after he was in the hospital but it has lapsed this year. The patient was tested by 3 neurologist and they said his vertigo was part of the migraine family, however it was reported that the but he does not get headaches. Neurologist prescribed him an allergy pill.  Caller did not have the lot number for either flu shot her husband had taken.  Outcome of the event was unknown at the time of report.  Batch number requested..; Sender's Comments: A 83-years-old male patient who presented vertigo unknown latency following the vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. Time to onset is not clearly defined. Medical history, concomitant medication and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information and considering the advanced age of the patient, role the vaccine cannot be assessed.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: frozen (thawed out) FLUZONE QUADRIVALENT was given to a patient which was left for the day by nurse and stated their refrigerator was not out of range/ No Ae; Initial information was received on 10-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 48 years old female patient who received frozen (thawed out) vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] which was left for the day by nurse and stated their refrigerator was not out of range (product storage error) on 10-Sep-2020.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On 10-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ452AB and expiry date 30-Jun-2021) via intramuscular route in an unknown administration site Prophylactic vaccination.  Case details: Reporter stated that there was the only one in the bubble wrap that was delivered that was frozen and the nurse has left for the day. Stated that their refrigerator was not out of range. Dose was given yesterday to non-pregnant female and no other vaccines given during that visit that day.   It is a case of actual medication error due to product storage error temperature too low.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin warm, Tenderness
Clinical narrative: Patient noting redness, swelling and pain around the site where she received a Pneumovax vaccination the day before.  She states it was given a little bit lower on the arm than normal. Since then she was having increasing redness with warmth and pain spreading up her arm. She denies any itching or drainage. She applied ice packs and elevated her arm without any improvement. Denied any fever or chills. Denied any chest congestion, shortness of breath, chest pain or any other allergy symptoms. Upon exam  Right upper arm with diffuse area of erythema, warmth and tenderness. Extends from lateral side to medial side proximal to the axilla. Full RoM in all extremities. No joint erythema or tenderness. No clubbing, cyanosis, edema or deformity noted. Distal pulses present and equal.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient passed out and fell walking out of the store, then regained consciousness upon falling to the floor. Patient was given water, EMR was called to evaluate patients vital signs.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 56-year-old female patient. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 11-OCT-2015 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. As a result of her receipt of zoster vaccine live(ZOSTAVAX), she was caused to suffer shingles on or about 14-DEC-2015, including any and all of it sequelae. Subsequently the patient was treated by a provide for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the patient suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences. Patient has endured substantial pain and suffering. She has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. Patient claimed that she has lost past earnings and has suffered a loss of earning capacity. She has suffered and will continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. Patient's injuries and damages are permanent and will continue into the future. She sought actual and punitive damages. At the reporting time, the outcome of the shingles was considered as not recovered. The causality between the event and zoster vaccine live(ZOSTAVAX) was assessed as related by the lawyer.  The event shingles was assessed as serious due to disability.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; break out; This case was reported by a physician and described the occurrence of suspected vaccination failure in a adult 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), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. After receiving Shingles vaccine, the patient had shingles. The patient had a break out. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided. This case was linked with case US2020AMR183095, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR183095:original case US2020AMR183095
Sex: U
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder, Myalgia, Pyrexia
Clinical narrative: fever; gastro; myalgia; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient 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 fever, gastrointestinal disorder and myalgia. On an unknown date, the outcome of the fever, gastrointestinal disorder and myalgia were not recovered/not resolved.   It was unknown if the reporter considered the fever, gastrointestinal disorder and myalgia to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported but selected as an adult as per the vaccine indication. The patient would like to know, what to take to manage severe side effects of Shingrix that he/she had experienced like fever, gastrointestinal disroder and myalgia.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: neuralgia; This case was reported by a consumer via interactive digital media and described the occurrence of neuralgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2020, the patient received Shingrix. On 10th September 2020, 20 days after receiving Shingrix, the patient experienced neuralgia. On an unknown date, the outcome of the neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the neuralgia to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported but was selected as adult as per the vaccine indication. The patient was experiencing side effects after the dose of Shingrix. He/she visited the doctor with ongoing symptoms and now was diagnosed with Neuralgia.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: High temperatures; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Bexsero and high temperatures occurred after Bexsero vaccination. No other information was available.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Decreased appetite, Fatigue, Nausea
Clinical narrative: loss of appetite; weight loss; nausea; fatigue; This case was reported by a consumer via call center representative and described the occurrence of appetite lost in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 27th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2020, 2 days after receiving Shingrix, the patient experienced appetite lost, weight loss, nausea and fatigue. On 1st August 2020, the outcome of the nausea and fatigue were recovered/resolved. On an unknown date, the outcome of the appetite lost and weight loss were not recovered/not resolved.   It was unknown if the reporter considered the appetite lost, weight loss, nausea and fatigue to be related to Shingrix.   Additional information was provided as follows: The patient experienced fatigue, nausea, weight loss and loss of appetite after receiving the first dose of Shingrix in right deltoid. Fatigue and nausea were resolved after 3 days. The patient had lost ten pounds but gained four back. The patient had visited her physician and a CT scan, X-rays and blood work were unremarkable. The reporter consented to follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Weight decreased, X-ray normal
Clinical narrative: loss of appetite; weight loss; nausea; fatigue; This case was reported by a consumer via call center representative and described the occurrence of appetite lost in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 27th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2020, 2 days after receiving Shingrix, the patient experienced appetite lost, weight loss, nausea and fatigue. On 1st August 2020, the outcome of the nausea and fatigue were recovered/resolved. On an unknown date, the outcome of the appetite lost and weight loss were not recovered/not resolved.   It was unknown if the reporter considered the appetite lost, weight loss, nausea and fatigue to be related to Shingrix.   Additional information was provided as follows: The patient experienced fatigue, nausea, weight loss and loss of appetite after receiving the first dose of Shingrix in right deltoid. Fatigue and nausea were resolved after 3 days. The patient had lost ten pounds but gained four back. The patient had visited her physician and a CT scan, X-rays and blood work were unremarkable. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Chills, Headache, Influenza virus test, Pyrexia
Clinical narrative: FEVER, HEADACHE, CHILLS, DRY HEAVING
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Retching, SARS-CoV-2 test, Urine analysis
Clinical narrative: FEVER, HEADACHE, CHILLS, DRY HEAVING
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Four hours after injection arm developed pain, swelling all the way to the elbow; redness, warmth. I took ibuprophen and applied ice for two days. I had site examined by physician on day three. By day four it resolved.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: My son is having redness and hot area to the touch on both thighs in the area given the vaccine. My son was evaluated by the pediatrician on September 15, 2020.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Blood test, CSF protein increased, Central venous catheterisation, Computerised tomogram, Gait disturbance
Clinical narrative: On August 20th my toes started going numb by the 22nd my entire foot was numb as well as my hands. I saw my primary care provider on the 24th where they diagnosed me with a pinched nerve giving me a 6-day dose of prednisone as well as an anti-inflammatory and prescribed PT which I did through Saturday Aug 29th when I became unable to barely walk on my own. I saw a spine Ortho on the 31st who immediately diagnosed it as being neurological and sent me straight to the emergency room where the attending ER doctor immediately suspected Gillian Barre syndrome. I was admitted. At that point I had numbness in my tongue and around my mouth.  The next day I was given a spinal tap to confirm GBS my protein level was over 400. A port was inserted into my neck and I started plasma pharesis that afternoon and it continued for 5 days. After completion of plasmapheresis I was discharged after being in the hospital for 6 days to outpatient PT. Since leaving the hospital on a walker I progressed to a cane and can now walk on my own short distances. I still have numbness and tingling in my feet and just a little in my hands.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral, Lumbar puncture abnormal, Nerve compression
Clinical narrative: On August 20th my toes started going numb by the 22nd my entire foot was numb as well as my hands. I saw my primary care provider on the 24th where they diagnosed me with a pinched nerve giving me a 6-day dose of prednisone as well as an anti-inflammatory and prescribed PT which I did through Saturday Aug 29th when I became unable to barely walk on my own. I saw a spine Ortho on the 31st who immediately diagnosed it as being neurological and sent me straight to the emergency room where the attending ER doctor immediately suspected Gillian Barre syndrome. I was admitted. At that point I had numbness in my tongue and around my mouth.  The next day I was given a spinal tap to confirm GBS my protein level was over 400. A port was inserted into my neck and I started plasma pharesis that afternoon and it continued for 5 days. After completion of plasmapheresis I was discharged after being in the hospital for 6 days to outpatient PT. Since leaving the hospital on a walker I progressed to a cane and can now walk on my own short distances. I still have numbness and tingling in my feet and just a little in my hands.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Paraesthesia, Plasmapheresis, Walking aid user
Clinical narrative: On August 20th my toes started going numb by the 22nd my entire foot was numb as well as my hands. I saw my primary care provider on the 24th where they diagnosed me with a pinched nerve giving me a 6-day dose of prednisone as well as an anti-inflammatory and prescribed PT which I did through Saturday Aug 29th when I became unable to barely walk on my own. I saw a spine Ortho on the 31st who immediately diagnosed it as being neurological and sent me straight to the emergency room where the attending ER doctor immediately suspected Gillian Barre syndrome. I was admitted. At that point I had numbness in my tongue and around my mouth.  The next day I was given a spinal tap to confirm GBS my protein level was over 400. A port was inserted into my neck and I started plasma pharesis that afternoon and it continued for 5 days. After completion of plasmapheresis I was discharged after being in the hospital for 6 days to outpatient PT. Since leaving the hospital on a walker I progressed to a cane and can now walk on my own short distances. I still have numbness and tingling in my feet and just a little in my hands.
Age: 58.0
Sex: M
Vaccine: VARCEL
Symptoms: Burning sensation, Electromyogram, Magnetic resonance imaging spinal, Neurological examination, Paraesthesia
Clinical narrative: burning, tingling of b/l UE and LE,  progressively worse and also occurred on other areas of his body, no weakness, no rash or numbness.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Morning following vaccination redness and swelling at injection site, nausea, stomach ache, headache, low grade fever. Tenderness at injection site still the same 3 days after vaccination, other symptoms still present but lessened.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Morning following vaccination redness and swelling at injection site, nausea, stomach ache, headache, low grade fever. Tenderness at injection site still the same 3 days after vaccination, other symptoms still present but lessened.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chills, Malaise, Nausea, Pain
Clinical narrative: Chills, nausea, body aches across my back plus both arms, severe arm pain where I received the vaccine - I could barely move that arm. I?ve never been shot with a bullet, but that?s what it felt like if I could imagine such a thing. I had general malaise, as if I were coming down with a horrible sickness.  It lasted until Friday, the worst days being Wed and Thurs.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Chills, nausea, body aches across my back plus both arms, severe arm pain where I received the vaccine - I could barely move that arm. I?ve never been shot with a bullet, but that?s what it felt like if I could imagine such a thing. I had general malaise, as if I were coming down with a horrible sickness.  It lasted until Friday, the worst days being Wed and Thurs.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Hypersensitivity, Rash macular, Skin warm, Swelling
Clinical narrative: Parent reports that area is red, swollen, blotchy and hot to the touch.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Positron emission tomogram abnormal
Clinical narrative: Patient reported today (9/17/2020) that on 8/25/2020 she noticed a knot, swelling, and tenderness at the site of her HPV injection that occurred 4 weeks prior to incident (8/4/2020). Patient had her PET scan due to her diagnosis of Hodgkin's Lymphoma and the site of the injection showed up on the PET scan.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Ear pain, Erythema
Clinical narrative: Headache within an hour of injection, by evening, severely ill: Fever, Severe shaking and chills, Spinal pain, Stomach pain, cold to the bone, especially feet, exhaustion, pain at injection site, in bed for three days.  Cold, off and on for weeks and still experiencing waves of exhaustion. Within those first few days of being sick, other symptoms arose and still experiencing:  Pain in arm with lump, arm goes completely numb if any pressure applied to it while in bed...can not even lean a little to my left side less alone sleep on left side. Spinal pain, bottom of feet pain, pain radiates from injection site to neck and shoulder, muscle cramping, swelling on left side of body, shooting, stingy pain in eyes, all joints are very stiff and feel arthritic, waves of exhaustion. Swelling of lymph nodes on left side of neck, that when touched severe pain shoots up to my ear and ear turns red and warm, very painful. After being completely healthy, I now feel crippled since this vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Fatigue, Feeling cold, Headache, Hypoaesthesia
Clinical narrative: Headache within an hour of injection, by evening, severely ill: Fever, Severe shaking and chills, Spinal pain, Stomach pain, cold to the bone, especially feet, exhaustion, pain at injection site, in bed for three days.  Cold, off and on for weeks and still experiencing waves of exhaustion. Within those first few days of being sick, other symptoms arose and still experiencing:  Pain in arm with lump, arm goes completely numb if any pressure applied to it while in bed...can not even lean a little to my left side less alone sleep on left side. Spinal pain, bottom of feet pain, pain radiates from injection site to neck and shoulder, muscle cramping, swelling on left side of body, shooting, stingy pain in eyes, all joints are very stiff and feel arthritic, waves of exhaustion. Swelling of lymph nodes on left side of neck, that when touched severe pain shoots up to my ear and ear turns red and warm, very painful. After being completely healthy, I now feel crippled since this vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint stiffness, Limb mass, Lymphadenopathy, Muscle spasms
Clinical narrative: Headache within an hour of injection, by evening, severely ill: Fever, Severe shaking and chills, Spinal pain, Stomach pain, cold to the bone, especially feet, exhaustion, pain at injection site, in bed for three days.  Cold, off and on for weeks and still experiencing waves of exhaustion. Within those first few days of being sick, other symptoms arose and still experiencing:  Pain in arm with lump, arm goes completely numb if any pressure applied to it while in bed...can not even lean a little to my left side less alone sleep on left side. Spinal pain, bottom of feet pain, pain radiates from injection site to neck and shoulder, muscle cramping, swelling on left side of body, shooting, stingy pain in eyes, all joints are very stiff and feel arthritic, waves of exhaustion. Swelling of lymph nodes on left side of neck, that when touched severe pain shoots up to my ear and ear turns red and warm, very painful. After being completely healthy, I now feel crippled since this vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Peripheral coldness, Pyrexia
Clinical narrative: Headache within an hour of injection, by evening, severely ill: Fever, Severe shaking and chills, Spinal pain, Stomach pain, cold to the bone, especially feet, exhaustion, pain at injection site, in bed for three days.  Cold, off and on for weeks and still experiencing waves of exhaustion. Within those first few days of being sick, other symptoms arose and still experiencing:  Pain in arm with lump, arm goes completely numb if any pressure applied to it while in bed...can not even lean a little to my left side less alone sleep on left side. Spinal pain, bottom of feet pain, pain radiates from injection site to neck and shoulder, muscle cramping, swelling on left side of body, shooting, stingy pain in eyes, all joints are very stiff and feel arthritic, waves of exhaustion. Swelling of lymph nodes on left side of neck, that when touched severe pain shoots up to my ear and ear turns red and warm, very painful. After being completely healthy, I now feel crippled since this vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Sleep disorder, Spinal pain, Swelling
Clinical narrative: Headache within an hour of injection, by evening, severely ill: Fever, Severe shaking and chills, Spinal pain, Stomach pain, cold to the bone, especially feet, exhaustion, pain at injection site, in bed for three days.  Cold, off and on for weeks and still experiencing waves of exhaustion. Within those first few days of being sick, other symptoms arose and still experiencing:  Pain in arm with lump, arm goes completely numb if any pressure applied to it while in bed...can not even lean a little to my left side less alone sleep on left side. Spinal pain, bottom of feet pain, pain radiates from injection site to neck and shoulder, muscle cramping, swelling on left side of body, shooting, stingy pain in eyes, all joints are very stiff and feel arthritic, waves of exhaustion. Swelling of lymph nodes on left side of neck, that when touched severe pain shoots up to my ear and ear turns red and warm, very painful. After being completely healthy, I now feel crippled since this vaccine.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Bump at injection site, redness, pain, and itching
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, IPV
Symptoms: Dizziness, Hyperhidrosis, Tachycardia
Clinical narrative: dizziness, diaphoresis, tachycardia
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Dysstasia, Feeling abnormal, Gait inability, Nausea
Clinical narrative: Onset 12 hours post injection of severe dizziness nausea lasting 24.  I was unable to stand or walk for 12 hours.  Mild symptoms lasted a further 24 hours with slight dizziness, inability to walk in a straight line, and a general foggy feeling in my head.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, SARS-CoV-2 test, Streptococcus test negative
Clinical narrative: Patients mother stated child developed a fever approximately 6 hours after administration of vaccine what was a maximum of 104F upon checking at home.  Patient was given ibuprofen at home, then taken to the emergency room to be treated for the fever.  Patient is still recovering at this time.
Age: 58.0
Sex: M
Vaccine: FLUR4, TDAP, VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: A day after shingrix vaccine, pt states he broke out in shingles rashes and blisters in multiple patches around his body. Too painful to wear a shirt. Went in to be evaluated by his MD and MD confirms a case of shingles after shingrix vaccine. MD states this is her 2nd patient case where shingles occurred after getting a shingrix vaccine.
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Patient stated that he was fine in the morning, but vomited and had diarrhea throughout the night.
Age: 84.0
Sex: M
Vaccine: FLUA4
Symptoms: Facial paralysis
Clinical narrative: patient sat for 15 minutes. after walking out of pharmacy and saying good bye, pt family called about 30-60 mins later stating that pt face drooping and possible tia/stroke. this was on 9/16/2020. vaccine giving around 4pm. reporting vaers today 9/17/2020. followed up with pt 9/17/2020 9am left message no answer.  pt was advised to call ambulance last night.