chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAPIPV, DTAPIPV, MMRV
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Quadracel reached 33.5C [Incorrect product storage] 14 years old patient received quadracel [Inappropriate age at vaccine administration]  Case Description: Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a 14 years old patient (gender not reported) who was vaccinated with a 0.5 ml first dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5635AA and Exp. Date 18-Jun-2021) via intramuscular route in unknown administration site on 09-Jul-2019. This vaccine was reached at 33.5C.  The patient's medical history not reported and concomitant vaccine included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) received 0.5 ml dose via intramuscular route on 09-Jul-2019 for Immunization.  It was an actual medication error case due to inappropriate age at vaccine administration and incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPV, DTAPIPV, MMRV
Symptoms: Product storage error
Clinical narrative: Quadracel reached 33.5C [Incorrect product storage] 14 years old patient received quadracel [Inappropriate age at vaccine administration]  Case Description: Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a 14 years old patient (gender not reported) who was vaccinated with a 0.5 ml first dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5635AA and Exp. Date 18-Jun-2021) via intramuscular route in unknown administration site on 09-Jul-2019. This vaccine was reached at 33.5C.  The patient's medical history not reported and concomitant vaccine included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) received 0.5 ml dose via intramuscular route on 09-Jul-2019 for Immunization.  It was an actual medication error case due to inappropriate age at vaccine administration and incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, PNC13, RVX
Symptoms: Product storage error
Clinical narrative: Pentacel reached 33.5C [Incorrect product storage]   Case Description: Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658 and 2019SA192660 (same reporter).  This case involves a four months old patient (gender not reported) who was vaccinated with a 0.5 ml second dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ097AAA and Exp. Date 19-Sep-2020) via intramuscular route in unknown administration site on 09-Jul-2019.  The patient's medical history not reported and concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) both received 0.5 ml dose via intramuscular route on 09-Jul-2019 for Immunisation.  It was an actual medication error case due to incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  List of documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Itching, swelling,  red and hot zone
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: Body aches, malaise
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Influenza like illness, Injection site pain, Nausea
Clinical narrative: I received 2 doses and the reactions were the same for both.  Flu-like symptoms starting about 24 hours after receiving shot including: nausea, all over aching, weakness, tired. These symptoms lasted for about two days.  I had very strong pain at the injection site -very  tender to the touch for days.   In addition, after the second shot (I don?t remember if this was an issue following the first shot) I?ve felt weak for several weeks following the vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: I received 2 doses and the reactions were the same for both.  Flu-like symptoms starting about 24 hours after receiving shot including: nausea, all over aching, weakness, tired. These symptoms lasted for about two days.  I had very strong pain at the injection site -very  tender to the touch for days.   In addition, after the second shot (I don?t remember if this was an issue following the first shot) I?ve felt weak for several weeks following the vaccine.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The patient received an adult dose of Hepatitis A Vaccine when she should have had a pediatric dose. The patient did not experience an adverse reaction to the vaccine.
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Exposure during pregnancy, Fatigue, Haemoglobin, Pregnancy test urine
Clinical narrative: The reporter believes both doses were administered while the patient was pregnant; gained weight; feeling tired; This report has been received from a registered nurse, referring to a 16 years old female patient with depression. The patient has no drug reactions or allergies. Her concomitant therapies included sertraline hydrochloride (ZOLOFT) and meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO).  On 30-APR-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R023607, expiration date was unknow by the reporter, but upon internal validation established as 06-MAY-2021) 0.5 milliliter, injection on left deltoid. On 03-JUN-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R028762, expiration date was unknow by the reporter, but upon internal validation established as 21-JUN-2021) 0.5 milliliter, injection on left deltoid, indication was reported as routine vaccination due to age. It was reported that on the same day (03-JUN-2019), the therapy ended.   The nurse reported that the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) while pregnant. The reporter believed that both doses were administered while the patient was pregnant. However, the pregnancy gestation was not provided. The date of last menstrual period and Estimated date of delivery were unknown. At the reporting time, the outcome of the pregnancy was unknown. In addition, on an unspecified date in 2019, the patient experienced feeling tired and had weight gained. The patient sought medical attention and on 05-JUL-2019, a urine pregnancy test was performed in physician's office. In addition, on an unspecified date, blood work and hemoglobin test were also done. However, all the results were not provided. No treatment was given for the adverse events (AE). The outcome of feeling tired and weight gained were unknown. The reporter did not provide the causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Sex: F
Vaccine: HPV9
Symptoms: Weight increased
Clinical narrative: The reporter believes both doses were administered while the patient was pregnant; gained weight; feeling tired; This report has been received from a registered nurse, referring to a 16 years old female patient with depression. The patient has no drug reactions or allergies. Her concomitant therapies included sertraline hydrochloride (ZOLOFT) and meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO).  On 30-APR-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R023607, expiration date was unknow by the reporter, but upon internal validation established as 06-MAY-2021) 0.5 milliliter, injection on left deltoid. On 03-JUN-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R028762, expiration date was unknow by the reporter, but upon internal validation established as 21-JUN-2021) 0.5 milliliter, injection on left deltoid, indication was reported as routine vaccination due to age. It was reported that on the same day (03-JUN-2019), the therapy ended.   The nurse reported that the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) while pregnant. The reporter believed that both doses were administered while the patient was pregnant. However, the pregnancy gestation was not provided. The date of last menstrual period and Estimated date of delivery were unknown. At the reporting time, the outcome of the pregnancy was unknown. In addition, on an unspecified date in 2019, the patient experienced feeling tired and had weight gained. The patient sought medical attention and on 05-JUL-2019, a urine pregnancy test was performed in physician's office. In addition, on an unspecified date, blood work and hemoglobin test were also done. However, all the results were not provided. No treatment was given for the adverse events (AE). The outcome of feeling tired and weight gained were unknown. The reporter did not provide the causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported.; missed the administration of the next dose and was administered the second dose of GARDASIL 9 (lot number R023607, expiration date 5/6/2021) late, on 7/9/2019; Information has been received from a nurse referring to a currently 18 years old patient of unknown gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  The reporter reported that the patient was administered one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date was unknown by reporter) for prophylaxis when the patient was 11 years old, on an unspecified date in August 2011. The reporter reported that the patient missed the administration of the next dose and was administered the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (intramuscular, lot# R023607, expiration date was 06-MAY-2021; strength and dose were not reported) for prophylaxis, on 09-JUL-2019 (Inappropriate schedule of product administration). No adverse effects were reported.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: no adverse effects; The primary reporter reported that the patient was "administered the first, second and third dose in the GARDASIL series". The primary reporter reported that the patient was then "inadvertently administered a dose of GARDASIL 9.; The primary reporter reported that the patient was "administered the first, second and third dose in the GARDASIL series". The primary reporter reported that the patient was then "inadvertently administered a dose of GARDASIL 9.; This spontaneous report was received from a nurse and refers to a 17-year-old male patient. The patient's concurrent conditions,   medical history, drug allergies/reactions and concomitant medications, if any, were not reported.  On 06-AUG-2013, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) first dose and on 21-NOV-2013, he received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration and anatomical site of vaccination were not provided; lot number and expiration date were unknown); then on 24-APR-2014, with the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration and anatomical site of vaccination were not provided; lot number H020901; expiration date not reported, but upon internal validation established as 05-JUL-2015); all administered for prophylaxis.  On 29-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration and anatomical site of vaccination were not reported; lot number R036914 and expiration date on 23-SEP-2021) for prophylaxis (interchange of vaccine products and extra dose administered). In addition, no adverse effects were reported.
Age: 0.5
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The physician who put the order in for Gardasil 9, is no longer at the clinic. They physician ordered it as part of a "routine" vaccination.; In Nov/Dec of 2018, a nurse administered GARDASIL 9 to a 6-month old infant male.; This spontaneous report was received from a registered nurse via company representative, concerning to a 6-months-old male patient. The patient's pertinent medical history, previously drugs reactions or allergies and concomitant therapies were unknown by the reporter.   On an unspecified date in 2018 (reported as November or December 2018), the infant was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), in the thigh; the physician ordered it as part of a routine vaccination (formulation, strength, dose, dose number, lot number, and expiration date were unknown by the reporter). The physician who put the order in for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), was no longer at the clinic. Additional information about the event was unknown by the reporter.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Chest pain, Dyspnoea, Inappropriate schedule of product administration
Clinical narrative: difficulty breathing; chest pain; the second dose of HPV series was not administered in the dosing schedule; This spontaneous report as received from a physician refers to a 19-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in July 2019 (reported as one or two days ago), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), for prophylaxis (frequency, route of administration, lot # and expiration date were not reported). The second dose of the vaccination series was not administered in the appropriate dosing schedule for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unknown date in July 2019 (reported as the next morning), the patient had difficulty breathing and chest pain. The patient went to the emergency room on an unknown date. The outcome of the events was unknown.  The causality between the suspect vaccine and the dyspnea and chest pain was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation involving a male patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     On an unknown date in 2016, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot/batch # and expiration date were not reported).     Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles.  As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX) use the pt suffered and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was not reported.  The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect reported; Inappropriate route of vaccination; This spontaneous report was received from a physician referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 01-AUG-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, frequency, lot# and expiration date not reported) intramuscularly, rather than subcutaneously (incorrect route of product administration), for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; an improperly stored dose of VARIVAX was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 22-JUL-2019, the patient received an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route and anatomical location were not reported), lot # R020672 with expiration date 18-JUL-2020 and lot # S005084 with expiration date 19-FEB-2021, for prophylaxis. The doses of the vaccines were reconstituted with properly stored sterile diluent. The doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to a temperature excursion of 6 Fahrenheit degrees (°F) to 14°F (6.4 °F) during a timeframe of 15 minutes, which was detected by a digital data logger. There were no previous temperature excursions. No adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improper stored doses of PROQUAD my have been administered to unspecified patients; This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  Between the dates of 07-JAN-2019 and 01-MAY-2019, the patients received improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route and anatomical location were not reported) lot # R018776 with expiration date 29-DEC-2019 and lot # R027988 with expiration date 30-MAR-2020, for prophylaxis. The doses of the vaccines were reconstituted with properly stored sterile diluent.   The doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were exposed to a temperature excursion of -14 Centigrade degree (°C) to -10°C during a timeframe of 17hours and 21 minutes, and a temperature excursion of -9°c to 8°C (-9.3°C) during 30 minutes, which was detected by a digital data logger. There were no previous temperature excursions. No adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Cervical dysplasia, Maternal exposure during pregnancy, Smear cervix abnormal
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. No information was provided regarding the patient's concomitant medication. The patient's medical history included (low-grade squamous intraepithelial lesion (LSIL) cervical dysplasia, spontaneous abortion and current condition included migraines.  On 22-APR-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # N023828, expiry date: 25-JUN-2020) (route of administration and anatomical locations were unknown) for prophylaxis.  On 24-JUN-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis. Birth defect in previous pregnancies and infant complications were unknown. The patient had a history of two previous pregnancies and one of them was spontaneous abortion.  On 27-JUN-2019, the ultrasound showed viable pregnancy (maternal exposure during pregnancy). On an unknown date, pap smear test showed low-grade squamous intraepithelial lesion (LSIL) The last menstrual period (LMP) and estimated due date (EDD) was not known. The pregnancy outcome was unknown. The outcome of maternal exposure during pregnancy was unknown.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Pain
Clinical narrative: Myalgia; aches and pains all over; headache; arthralgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (1st dose received in April 2019 and experienced myalgia, general body pain, headache and arthralgia, refer linked case US2019130912).   In June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced myalgia, general body pain, headache and arthralgia. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the myalgia, general body pain, headache and arthralgia were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, general body pain, headache and arthralgia to be related to Shingrix.  Additional information received were as follows: No lot number and expiry date was available. The patient experienced myalgia, headaches, and aches and pains all over. The events had not subsided. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Adverse event, Death
Clinical narrative: side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, less than a day after receiving Bexsero, the patient experienced adverse event (serious criteria death). On an unknown date, the outcome of the adverse event was fatal. The reported cause of death was adverse event.   It was unknown if the reporter considered the adverse event to be related to Bexsero.  Additional details were reported as follows: This case received from media. The reporter knew someone who's daughter took the vaccine and died within 24 hours from side effects. As per the reporter for extremely rare disease versus the side effects, its worth the risk not paying for your (GSK) vaccine.; Reported Cause(s) of Death: Adverse event
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tired; This case was reported by a physician via call center representative and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 29th July 2019, unknown after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and had very tired since then and asked did you know how long that was supposed to last because read that it was a side effect. The reporter did not consent to follow up. The potential adverse event unsure if it was a GlaxoSmithKline vaccine or Zostervax as no additional information was provided by the anonymous health care professional.  The health care professional refused to provide any contact information or further description of potential adverse event. Anonymous the health care professional disconnected chat prior to completion of chat.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: unbearable pain at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On 5th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Pharmacy Intern. The pharmacy intern stated that the patient experienced unbearable pain at the injection site for the first 2 to 3 days after injection even after taking Alleve.  At the time of the reporting, the patient had pain on the scale of 2 out of 10.  No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Rash
Clinical narrative: Flu; Rash on arm; This case was reported by a pharmacist via call center representative and described the occurrence of influenza in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza and rash. On an unknown date, the outcome of the influenza and rash were unknown.   It was unknown if the reporter considered the influenza and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called to report that the patient developed flu and rash on arm after receiving Shingrix. The reporter gave consent to follow up. The reporter did not have lot or expiration date.
Sex: M
Vaccine: DTP, MMR
Symptoms: Abnormal behaviour, Eye movement disorder, Gaze palsy, Head injury, Loss of consciousness
Clinical narrative: seizures and convulsions; collapsed few minutes after the shots/blacked out; his eyes rolled up; head injury; behaviour changed and he doesn't look the same smart super intelligent kid; Initial social media information received on 30-Jul-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 10 years old male patient who experienced Convulsive seizure associated with Loss of consciousness, Gaze palsy, Head injury and Abnormal behavior, while he received vaccines DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE and MMR VACCIN (unknown manufacturers).  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a single dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient received a single dose of suspect MMR VACCIN not produced by Sanofi Pasteur lot number not reported.  On an unknown date, the patient collapsed few minutes after the shots, was blacked out (Loss of consciousness) with head injury and experienced seizures and convulsions (Convulsive seizure) with his eyes rolled up (Gaze palsy) few minutes post vaccination, patient also had behaviour changed (unknown latency) following the administration of DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE and MMR VACCINE. The events (Convulsive seizure, Loss of consciousness, Gaze palsy and head injury) were assessed as medically significant.  No lab test was reported.  Final diagnosis was Convulsive seizure associated with Loss of consciousness, Gaze palsy, Head injury and Abnormal behavior.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: Patient experienced Loss of consciousness, Gaze palsy one day after vaccination and thereafter and Abnormal behavior (unknown latency) after vaccinations with MMR VACCIN and DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE .Time to onset is compatible with the role of vaccine for all events, except Abnormal mental state. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of an individual vaccine cannot be assessed.
Sex: M
Vaccine: DTP, MMR
Symptoms: Seizure, Syncope
Clinical narrative: seizures and convulsions; collapsed few minutes after the shots/blacked out; his eyes rolled up; head injury; behaviour changed and he doesn't look the same smart super intelligent kid; Initial social media information received on 30-Jul-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 10 years old male patient who experienced Convulsive seizure associated with Loss of consciousness, Gaze palsy, Head injury and Abnormal behavior, while he received vaccines DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE and MMR VACCIN (unknown manufacturers).  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a single dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient received a single dose of suspect MMR VACCIN not produced by Sanofi Pasteur lot number not reported.  On an unknown date, the patient collapsed few minutes after the shots, was blacked out (Loss of consciousness) with head injury and experienced seizures and convulsions (Convulsive seizure) with his eyes rolled up (Gaze palsy) few minutes post vaccination, patient also had behaviour changed (unknown latency) following the administration of DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE and MMR VACCINE. The events (Convulsive seizure, Loss of consciousness, Gaze palsy and head injury) were assessed as medically significant.  No lab test was reported.  Final diagnosis was Convulsive seizure associated with Loss of consciousness, Gaze palsy, Head injury and Abnormal behavior.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: Patient experienced Loss of consciousness, Gaze palsy one day after vaccination and thereafter and Abnormal behavior (unknown latency) after vaccinations with MMR VACCIN and DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE .Time to onset is compatible with the role of vaccine for all events, except Abnormal mental state. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of an individual vaccine cannot be assessed.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: Headache Muscle aches - like the flu Soreness at site of injection
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Pallor
Clinical narrative: Pt became pale and started feeling faint, needed to lay down, rested x 20 minutes then recovered.  Remained oriented, did not LOC. Was able to leave clinic without further intervention.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Flushing, Pallor, Peripheral coldness
Clinical narrative: After the patient checked out and left the office, patient mother called the office back approximately 1014 am.  Patient mother stated that the patient had a possible reaction to vaccinations received today.  Symptoms:  Flushed skin, cold extremities, and pale lips.  Per Dr., patient should be brought back into the office to be assessd by her. New vitals obtained, WNL, patient alert and oriented x3, warm extremities, and skin color normal.  Patient given water and informed by Dr. to lay down for a few minutes before getting up to ambulate.  Patient mother educated on the delayed vagal response that some patients have after injections and to make sure that he gets plenty of hydration and some electrolytes throughout the day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: Left upper thigh with erythematous lesion, fading at edges
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Fall, Loss of consciousness, Seizure, Syncope, Vomiting
Clinical narrative: Patient fainted, hit the floor, and began to seize. His mother was present.  We called 911 and attended to patient. He came back to consciousness after 3-5 minutes, sat up and began to vomit. We got him sitting up and talking. First responders arrived and assessed patient. He and his mother left walking out the door with first responders to their car.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site inflammation, Injection site joint pain, Injection site pain, Pyrexia
Clinical narrative: Localized inflammation at injection site, arm pain from elbow to shoulder, possible swollen axillary glands (by patient report, not felt on day of exam), fevers (Tmax 101), subjective shoulder joint pain  Treated with NSAIDs, topical steroid cream for local injection site and close monitoring
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Allergy to vaccine, Chest pain, Hypoaesthesia, Pruritus, Rash
Clinical narrative: mom states immediate rash and itching within 30 min of vaccine following chest pain and numbness in hands. mom then took child immediately to local ER.  mom states child was given Benadryl and a steroid shot while in ER, was written a prescription for Medrol dose pack to take and was advised to not receive another dose of meningits vaccine due to allergic reaction
Sex: U
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), injection, subcutaneously (dose, lot # and expiration date were not reported) for prophylaxis. On an unknown date, reported as 10-12 days later, the patient developed fever. The patient sought medical attention by calling the physician. The outcome of the event was unknown. No causality assessment was provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pain, Swelling
Clinical narrative: pain; didn't feel well; redness; swelling for at least a week; This case was reported by a other health professional via sales rep and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, feeling unwell, swelling and erythema. On an unknown date, the outcome of the pain, feeling unwell and erythema were unknown and the outcome of the swelling was recovered/resolved.   It was unknown if the reporter considered the pain, feeling unwell, swelling and erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by the medical assistant. The age at vaccination was not reported. The patient experienced swelling for at least a week, redness, pain and did not feel well. The reporter agreed to follow up from GlaxoSmithKline (GSK).
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Red bump below injection site; Red bump below injection site; This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2019, the patient received Shingrix (intramuscular). In July 2019, less than a week after receiving Shingrix, the patient experienced local swelling and erythema. On an unknown date, the outcome of the local swelling and erythema were unknown.   It was unknown if the reporter considered the local swelling and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The health care professional stated that patient noticed a red bump formed 2 inches below the injection site, after she got the vaccine. The case has been linked to the case US2019138559, reported by same reporter.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Hypersomnia
Clinical narrative: About an hour after the shots, I started feeling dizzy and sick to my stomach.  My arm at the site of the Shingrix shot was extremely sore and warm to touch.   By the next afternoon, I was running a low grade fever (100 - 101), nauseous, diarrhea, headache, off and on dizzy, shaky, and fatigued.   Slept all day Sunday and Monday.  Today, I am feeling better but not 100%.  My stomach is still a bit nauseous.  My arm is not as sore as it was but is still a bit warm.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Injection site warmth, Malaise, Nausea, Nervousness
Clinical narrative: About an hour after the shots, I started feeling dizzy and sick to my stomach.  My arm at the site of the Shingrix shot was extremely sore and warm to touch.   By the next afternoon, I was running a low grade fever (100 - 101), nauseous, diarrhea, headache, off and on dizzy, shaky, and fatigued.   Slept all day Sunday and Monday.  Today, I am feeling better but not 100%.  My stomach is still a bit nauseous.  My arm is not as sore as it was but is still a bit warm.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: About an hour after the shots, I started feeling dizzy and sick to my stomach.  My arm at the site of the Shingrix shot was extremely sore and warm to touch.   By the next afternoon, I was running a low grade fever (100 - 101), nauseous, diarrhea, headache, off and on dizzy, shaky, and fatigued.   Slept all day Sunday and Monday.  Today, I am feeling better but not 100%.  My stomach is still a bit nauseous.  My arm is not as sore as it was but is still a bit warm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: RASH ALL OVER THE BODY INCLUDING FACE. ITCHING ALL OVER. IT LOOKED LIKE CHICKEN POX. THE RASH LASTED FOR 3 WEEKS WITH NO RELIEF.  NO MEDICATION WAS PRESCRIBE FOR THESE SYSMPTOMS.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash, Rash
Clinical narrative: Developed rash on both arms and legs on car on way home from receiving vaccine in our office. Returned to office for evaluation. No facial swelling, cough,wheeze or vomiting. Given Benadryl in office.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Burning sensation, Injection site reaction, Muscle fatigue, Oedema peripheral
Clinical narrative: 1st adverse side effect was swollen right armpit with pain felt deep inside armpit starting on 7/29 immediately after waking up.  2nd adverse  side effect was both arms swelling, tingling and burning , and total muscle fatigue from shoulder down to fingers starting on  8/1 mid-morning .  1st adverse side effect has mostly gone away, but 2nd adverse side effect is still in full effect as of  8/6 with little to no improvement.  Have returned to the Urgent Care facility that vaccine was given twice on 8/1 and on  8/3  regarding the 2nd adverse effect.  On return visit on 8/1 was told we needed to give it a few days to see if any improvement.  On 2nd return visit on 8/3 after no improvement was prescribed 800 mg ibuprofen twice daily to reduce swelling and other symptoms.  800 mg ibuprofen has helped marginally at best, also using hot/cold compress  regularly with hot compress helping to alleviate symptoms most effectively, but not entirely.  During 2nd return visit on 8/3, was told by PA that symptoms may go away in a couple of days or may never go away.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: 1st adverse side effect was swollen right armpit with pain felt deep inside armpit starting on 7/29 immediately after waking up.  2nd adverse  side effect was both arms swelling, tingling and burning , and total muscle fatigue from shoulder down to fingers starting on  8/1 mid-morning .  1st adverse side effect has mostly gone away, but 2nd adverse side effect is still in full effect as of  8/6 with little to no improvement.  Have returned to the Urgent Care facility that vaccine was given twice on 8/1 and on  8/3  regarding the 2nd adverse effect.  On return visit on 8/1 was told we needed to give it a few days to see if any improvement.  On 2nd return visit on 8/3 after no improvement was prescribed 800 mg ibuprofen twice daily to reduce swelling and other symptoms.  800 mg ibuprofen has helped marginally at best, also using hot/cold compress  regularly with hot compress helping to alleviate symptoms most effectively, but not entirely.  During 2nd return visit on 8/3, was told by PA that symptoms may go away in a couple of days or may never go away.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Total fatigue for two day after the shot, third day left arm aching, upper arm turned a bright red (wife thought I was sun burned, and so did the pharmacist), and I was running a fever of over a 100. As of this writing the fever and redness is reduced, but still sore.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dyspnoea, Insomnia, Tachycardia
Clinical narrative: insomnia, tachycardia, shortness of breath, chest tightness; lasted for 12 hours starting the evening of the day of the shot
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Anxiety, Blood lactic acid, Dyspnoea, Full blood count, Metabolic function test
Clinical narrative: Patient presents with left arm pain, mild neck stiffness and myoclonic jerking with some shortness of breath and anxiety after receiving her third meningitis shot today around 3:30pm.  I think this is a reaction to the vaccine which is mimicking the symptoms of the disease which she has been vaccinated against.  She is awake and alert and nontoxic-appearing.  No meningismus.  No rash.  She is tachycardic but no fever.  She is having some myoclonic jerking. ( PER THE ER NOTE)
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Musculoskeletal stiffness, Myoclonus, Pain in extremity, Tachycardia
Clinical narrative: Patient presents with left arm pain, mild neck stiffness and myoclonic jerking with some shortness of breath and anxiety after receiving her third meningitis shot today around 3:30pm.  I think this is a reaction to the vaccine which is mimicking the symptoms of the disease which she has been vaccinated against.  She is awake and alert and nontoxic-appearing.  No meningismus.  No rash.  She is tachycardic but no fever.  She is having some myoclonic jerking. ( PER THE ER NOTE)
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: Patient was accidentally given 1 extra dose of MMR after staff member transcribed the vaccine record. MMR dose #1 was annotated on the front of the shot record under the MMR sub-section. MMR dose #2  was annotated on the back of shot record under the other sub-section.
Age: 60.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chills, Headache, Influenza like illness, Injection site pain
Clinical narrative: Flu like symptoms, fever 99.9, chills, headache, muscle pain,  no energy, "felt like I was 100yrs old."   Pain to left arm muscle where injection was given
Age: 60.0
Sex: F
Vaccine: MENB
Symptoms: Myalgia, Pyrexia
Clinical narrative: Flu like symptoms, fever 99.9, chills, headache, muscle pain,  no energy, "felt like I was 100yrs old."   Pain to left arm muscle where injection was given
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Injection site warmth, Musculoskeletal disorder, Pain
Clinical narrative: swelling at shot location for 4 days, fever at shot location 4days ,headache for 2 days . extreme pain 3days ,pain for 4 more days finally went away by August 4th. Could not do anything with arm for 2-3 days because of pain and swelling.
Age: 61.0
Sex: F
Vaccine: MENB
Symptoms: Feeling abnormal, Influenza like illness, Loss of control of legs, Mobility decreased, Pain in extremity
Clinical narrative: Sore arm shortly after vaccine administered.  The next day could not lift arm and had felt like I had the flu.  Could not feel my legs and when getting up legs buckled as no sensation. Lasted a couple of hours and then went away and thought might be getting Guillain-Barre syndrome.  Felt horrible for about 5 days and could use my arm after 2 days.