chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Child received varicella on 10/23 and returned to clinic on 10/25  C/O redness and swelling at L arm site. Normal temperature recorded. Patient was given rocephin  IM for cellulitis. Patient returned next day to PCP, had temp. of 99 oral, 90% difference in redness, started on keflex oral antibiotic for 10 days.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Throat tightness
Clinical narrative: Throat tightness; This report was identified from a line listing obtained on request by the Company from the FDA (Agency# 697299) under the Freedom of Information Act and refers to a 12-year-old female patient. The patient's medical history included constipation. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 26-MAY-2017 at 03:45, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N002720, expiration date: not reported, dose 3, intramuscularly in the left arm for prophylaxis.   On the same day, few minutes after the injection patient complained of her throat feeling tight. Patient was observed by the provider for 30 minutes with another set of vitals completed on her. No hives, no swelling. Patient felt fine and after being monitored for 30 minutes with no other reaction other than her throat tightness, which resolved before patient left the clinic, was release. The patient was cleared and released at about 4:05 pm.  At the time of the report, the outcome of the event was reported as recovered on an unknown date. The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Follow up information has been received from a vaccine administrator. The primary reporter's demographics and the suspect vaccine administration information were updated.  Follow up information was received on 28-MAY-2019. It was reported that additional information had been requested. During a telephone call, the primary reporter was unable to identify the patient in this report. Date of vaccination and lot number were provided to assist in obtaining patient information. Additionally, the follow up correspondence process was reviewed and telephone and fax numbers were confirmed.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Headache, Pain, Pain in extremity
Clinical narrative: rash Left arm; arm soreness; warmth; red; itchy; Injection site lump; headache; chills; fever; body aches; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2019, the patient received the 1st dose of Shingrix. In January 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site itching, injection site lump, headache, chills, fever and general body pain. On 31st January 2019, the patient experienced injection site rash. In February 2019, the outcome of the injection site pain, injection site warmth, injection site erythema, injection site itching, injection site lump, headache, chills, fever and general body pain were recovered/resolved. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash, injection site pain, injection site warmth, injection site erythema, injection site itching, injection site lump, headache, chills, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The health care professional reported that the patient experienced a rash at injection site Left arm. After a few days the rash went away.  The patient also reported having a fever, chills, body aches, arm soreness, headache warm to touch, red, lumpy and itchiness at the injection site.  These symptoms appeared less than 24 hours after vaccine was administered and lasted for 3 days. No further information was provided.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Pyrexia, Rash, Skin warm
Clinical narrative: rash Left arm; arm soreness; warmth; red; itchy; Injection site lump; headache; chills; fever; body aches; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2019, the patient received the 1st dose of Shingrix. In January 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site itching, injection site lump, headache, chills, fever and general body pain. On 31st January 2019, the patient experienced injection site rash. In February 2019, the outcome of the injection site pain, injection site warmth, injection site erythema, injection site itching, injection site lump, headache, chills, fever and general body pain were recovered/resolved. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash, injection site pain, injection site warmth, injection site erythema, injection site itching, injection site lump, headache, chills, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The health care professional reported that the patient experienced a rash at injection site Left arm. After a few days the rash went away.  The patient also reported having a fever, chills, body aches, arm soreness, headache warm to touch, red, lumpy and itchiness at the injection site.  These symptoms appeared less than 24 hours after vaccine was administered and lasted for 3 days. No further information was provided.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: rash Left arm; arm soreness; warmth; red; itchy; Injection site lump; headache; chills; fever; body aches; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2019, the patient received the 1st dose of Shingrix. In January 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site itching, injection site lump, headache, chills, fever and general body pain. On 31st January 2019, the patient experienced injection site rash. In February 2019, the outcome of the injection site pain, injection site warmth, injection site erythema, injection site itching, injection site lump, headache, chills, fever and general body pain were recovered/resolved. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash, injection site pain, injection site warmth, injection site erythema, injection site itching, injection site lump, headache, chills, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The health care professional reported that the patient experienced a rash at injection site Left arm. After a few days the rash went away.  The patient also reported having a fever, chills, body aches, arm soreness, headache warm to touch, red, lumpy and itchiness at the injection site.  These symptoms appeared less than 24 hours after vaccine was administered and lasted for 3 days. No further information was provided.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Pain, Pyrexia
Clinical narrative: rash Left arm; arm soreness; warmth; red; itchy; Injection site lump; headache; chills; fever; body aches; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2019, the patient received the 1st dose of Shingrix. In January 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site itching, injection site lump, headache, chills, fever and general body pain. On 31st January 2019, the patient experienced injection site rash. In February 2019, the outcome of the injection site pain, injection site warmth, injection site erythema, injection site itching, injection site lump, headache, chills, fever and general body pain were recovered/resolved. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash, injection site pain, injection site warmth, injection site erythema, injection site itching, injection site lump, headache, chills, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The health care professional reported that the patient experienced a rash at injection site Left arm. After a few days the rash went away.  The patient also reported having a fever, chills, body aches, arm soreness, headache warm to touch, red, lumpy and itchiness at the injection site.  These symptoms appeared less than 24 hours after vaccine was administered and lasted for 3 days. No further information was provided.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: 4"x4" swelling & erythema & pain @ site       Sxs lasting 2 days     Rx : Tylenol & Ibuprophen & fluids Temp 101                                                                           Outcome : Improved after2 days , no lasting side effects to my knowledge extreme body ache mild headache & nausea
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: 4"x4" swelling & erythema & pain @ site       Sxs lasting 2 days     Rx : Tylenol & Ibuprophen & fluids Temp 101                                                                           Outcome : Improved after2 days , no lasting side effects to my knowledge extreme body ache mild headache & nausea
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 4"x4" swelling & erythema & pain @ site       Sxs lasting 2 days     Rx : Tylenol & Ibuprophen & fluids Temp 101                                                                           Outcome : Improved after2 days , no lasting side effects to my knowledge extreme body ache mild headache & nausea
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain
Clinical narrative: 4"x4" swelling & erythema & pain @ site       Sxs lasting 2 days     Rx : Tylenol & Ibuprophen & fluids Temp 101                                                                           Outcome : Improved after2 days , no lasting side effects to my knowledge extreme body ache mild headache & nausea
Age: 0.25
Sex: M
Vaccine: HEP, MMR, RV1, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood test, Dehydration, Diarrhoea, Vomiting
Clinical narrative: Patient developed diarrhea for 1 week after vaccines were administered per Dr.
Age: 0.25
Sex: M
Vaccine: HEP, MMR, RV1, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Patient developed diarrhea for 1 week after vaccines were administered per Dr.
Sex: F
Vaccine: DTAP, DTAP, DTAP
Symptoms: Expired product administered
Clinical narrative: administered expired product to patients.; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA150849, 2019SA150852, 2019SA150840, 2019SA150851 and 2019SA150850 (same reporter).  This case involves a 15 month old female patient who received fourth dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (formulation: unknown, lot: C52028A, expiry date: 17-May-2019) via unknown route in unknown administration site on 24-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ACT-HIB.  It was a case of actual medication error due to Expired vaccine used.  It was unknown if any adverse event was occurred.  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.  Event outcome was reported as unknown.  Documents held by sender: none.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Muscle fatigue
Clinical narrative: Body aches; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had side symptoms from the first injection of Shingrix, but the patient felt that the side symptoms were worse in terms of body aches. For tolerance after 2nd dose refer case US2019AMR087912.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Body aches; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had side symptoms from the first injection of Shingrix, but the patient felt that the side symptoms were worse in terms of body aches. For tolerance after 2nd dose refer case US2019AMR087912.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Erythema
Clinical narrative: Redness. Cellulitis
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Headache, Injected limb mobility decreased, Musculoskeletal disorder
Clinical narrative: Strong pain in arm of shot, red and hot to the touch. Can?t lift arm move than 45 degrees or pick up things. Muscle aches and joint aches all over. Low running fever, headache. Same reaction with both first and second dose of Shingrix.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Strong pain in arm of shot, red and hot to the touch. Can?t lift arm move than 45 degrees or pick up things. Muscle aches and joint aches all over. Low running fever, headache. Same reaction with both first and second dose of Shingrix.
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site pain, Injection site rash, Injection site warmth, Night sweats
Clinical narrative: On 5/14/19, rash noted at injection site.  Applied Benadryl Cream.  Soaked clothing with perspiration during sleep.  On 5/15/19, noted pain and warmth at site of injection. Rates  pain level at seven (7). States she has been taking Advil, Motrin and Aleve, but pain continues.  An area of hardness approximately 1 1/2 inch in diameter at site of injection.  Denies that she has had fever.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC13, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt given immunizations. Pt was mistakenly given DTaP, Hib, IPV (Pentacel) instead of DTaP, Hep B, IPV combined Vaccine. Pt also given separate HIB (PedvaxHIB) at the time of injections. Mistake caught after entering information into immunization registry. MD notified, observed pt, and spoke with Mom. Hep B vaccination ordered and given. Pt tolerated well with no adverse reactions. Mom given VIS, AVS, and immunization registry form.
Age: 61.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Fatigue, Mobility decreased, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Patient c/o Right neck pain and bilateral pain in thighs, "hard to get out of bed in the a.m. at first but then the pain goes away."  Getting a little better, but now my neck right side is stiff/sore and only my right thigh is sore."   c/o feeling fatigued and achy as well.N/A
Age: 61.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Pain in extremity
Clinical narrative: Patient c/o Right neck pain and bilateral pain in thighs, "hard to get out of bed in the a.m. at first but then the pain goes away."  Getting a little better, but now my neck right side is stiff/sore and only my right thigh is sore."   c/o feeling fatigued and achy as well.N/A
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative
Clinical narrative: the patient had a measles IGG indes, mumps index performed which showed no titres / no immunity to measles and mumps; the patient had a measles IGG indes, mumps index performed which showed no titres / no immunity to measles and mumps; This spontaneous report was received from a pharmacist and refers to a 72-years-old female patient. The patient's concurrent conditions included: essential thrombocythemia, herpes and shingles. It was reported that the patient had no drug reactions or allergies. On an unknown date reported as years ago, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administrations, therapy type, lot# and expiration date were not provided) for prophylaxis. Concomitant therapies included valacyclovir hydrochloride and hydroxyurea. On 02-MAY-2019, the patient had a measles immunoglobulin G (IgG) index, mumps immunoglobulin (Ig) index performed which showed no titers/no immunity to measles and mumps. There was no treatment given for the event. The outcome of the event was reported as not recovered/not resolved. The causality assessment was not recovered.
Sex: U
Vaccine: MMR
Symptoms: Injection site pain
Clinical narrative: dull pain" at the injection site "shortly after administration; Inappropriate route of vaccination; This spontaneous report has been received from a pharmacist referring to a 52 years old patient of unknown gender. The patient's concurrent condition, medical history and drug allergies information was not provided. Concomitant therapies included water, sterile (DILUENT FOR INTRON A).    On 06-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # N020924, expiration date 01-AUG-2019) (strength, dose and frequency were not reported) intramuscularly for vaccination against measles, mumps, and rubella.    The patient experienced dull pain at the injection site shortly after administration, that lingered for a little bit but then resolved. Pharmacist recommended patient apply ice to the area and take acetaminophen (TYLENOL) if necessary for treatment but did not know if patient did either. No lab/diagnostic tests were performed.  The causality between the dull pain at the injection site and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse effects; a patient was administered the second dose of VAQTA too soon; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-JAN-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) first dose, intramuscularly (lot#, expiry date and anatomical location was not reported) for prophylaxis. On 19-APR-2019, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) lot# R031045, expiry date: 18-NOV-2019, which was reported as too soon after the first dose, and was considered as an inappropriate schedule of product administration.  The outcome of the event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: a painful persistent rash located on her neck, back and torso/ herpes zoster/ painful outbreaks of shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for the prevention of shingles. On an unknown date, after receiving the vaccination, the pt suffered a painful persistent rash located on her neck, back and torso. As a result of these symptoms, she presented to a medical provider and was diagnosed with herpes zoster. Thereafter, the pt continued to suffer from painful outbreaks of the shingles. As a result, she has suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the event was not recovered. The event was considered to be related to  zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: she developed redness and swelling on the hand of the arm that received the Pneumovax; she developed redness and swelling on the hand of the arm that received the Pneumovax; This spontaneous report was received from a 67-year-old female patient, who was reporting on herself. The patient's pertinent medical history included high blood pressure and high cholesterol. She had no drug reactions or allergies. The patient's concomitant medications included olmesartan and atorvastatin.  On approximately 09-MAY-2019, reported as about two weeks ago, the patient was vaccinated with of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, intramuscularly in an unspecified arm (exact dose, site of administration, lot number and expiration date were not reported) to prevent pneumococcal infection.   On the same night as the date of the vaccination, the patient developed redness and swelling on the hand of the arm that received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection. The patient went to see a pharmacist and received an unspecified treatment. No lab diagnostics or studies were performed. The patient reported that it took her 10 days to recover (exact recovery date was not reported).  The causality between the events and the suspect vaccine was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was inadvertently administered a dose of VARIVAX, that had been improperly stored; No adverse effect reported; This spontaneous report was received from a physician assistant, referring to a patient of unknown age and gender. There was no information provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies.   On 19-MAY-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous, lot # R023513, expiration date on 16-AUG-2020 (dose and anatomical localization were not reported). The physician assistant reported that the patient was inadvertently administered a dose of with varicella virus vaccine live (Oka/Merck) (VARIVAX), that had been improperly stored. The lot of with varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored DILUENT MRK (unknown Lot# and expiration date). No adverse effect reported.  On unspecified dates, the doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent temperature excursions of -9 °C to 8 °C (1.7 °C)  for a time frame of 4 hours, which was called by the digital data logger. There were no previous temperature excursions reported.; Sender's Comments:  US-009507513-1906USA000538: US-009507513-1906USA000539:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: body aches and pains for a week; This spontaneous report was received from a healthcare worker via a company representative referring to a 12 years old female patient. The patient's concurrent conditions included anxiety. Her medical history, concomitant therapies and drug reactions/allergies were not reported.    On an unknown date in 2018, reported as a year ago, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# and expiration date were not reported), intramuscularly for unknown indication. Subsequently, the patient experienced body aches and pains for a week. No treatment was given for the event. No lab diagnostics/studies were performed. The patient did not seek medical attention. The outcome of the event was reported as resolved.   The causality between the event and the suspect vaccine was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 01-MAY-2016, the patient was vaccinated at a pharmacy with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for prevention of shingles in a pharmacy. Since receiving the vaccine, the patient has experienced a shingles outbreak (onset not specified). The outcome of the event was not reported. The patient suffered a personal injuries as a direct and proximate result of being inoculated with zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Herpes zoster, Neuropathy peripheral
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. The pt's relevant medical history, drug reactions/allergies and concomitant medication were not reported. The pt, through her attorneys, brought this cause of action for personal injuries suffered as a direct and proximate result of being inoculated with ZOSTAVAX, intended for the prevention of shingles. On 07-JUL-2011, the pt was vaccinated with ZOSTAVAX (dose, route, and lot # not provided). On an unknown date (reported as "since receiving the vaccine"), the pt experienced chronic shingles outbreaks, suffering from shingles over 13 times. At the reporting time, she was suffering from neuropathy and balding as a result of outbreaks on her scalp. The outcome of the events was not recovered. The reporter considered shingles, neuropathy, and balding to be related to ZOSTAVAX. Upon internal review, neuropathy was considered to be a medically significant event.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; inadvertently administered a dose of VAQTA (Lot#R006341/Exp: 4/21/2019) on 5/29/2019, that was expired; This spontaneous report was received from a nurse regarding a patient of unknown demographics. Information on concurrent condition, past medical history and concomitant medications were not reported. On 29-MAY-2019, the patient was inadvertently administered with hepatitis A vaccine, inactivated (VAQTA) of lot # R006341 with an expiry date of 21-APR-2019 (strength, dose, anatomical location not reported) for prophylaxis (expired product administered). It was also reported that patient had no adverse events.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On or about 15-JAN-2017, the patient received ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided) for its intended purpose: the prevention of shingles. As a direct result of the ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. Patient did not have a shingles outbreak until 07-JUN-2017. As a direct result of ZOSTAVAX, patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, patient sustained severe and permanent personal injuries. He suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The outcome of the events was not recovered/not resolved.  Causality assessment was related. Shingles outbreak was considered to be disabling.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects were reported; the patient was inadverently administered an expired dose of MMRII; This spontaneous report was received from a health professional (medical assistant) refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 30-MAY-2019, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin (rHA)) (strength, dose, frequency, anatomical location was unknown) of lot # N024696 and expiry date 07-APR-2019 via subcutaneous route for prophylaxis (expired product administered). The patient's concomitant therapies included sterile diluent. (lot# S000130 and expiry date 23-AUG-2021). No adverse effects reported. No temperature excursion reported. No product quality complaint (PQC) reported.
Age: 1.25
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received first dose 4/8/2015 at 15 months, received second dose 7/16/2015 at 18 months; no adverse effects reported; This spontaneous report was received from a nurse regarding a child patient. Information pn the patient's pertinent medical history, other concurrent conditions, drug reaction or allergy and concomitant therapy were not provided. On 08-APR-2015, (when the patient was15 months old), the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, frequency, route of administration were not provided) with therapy type of HSA, lot # K022448 and expiry date 13-MAY-2016 for prophylaxis and on 16-JUL-2015, (when the patient was18 months old), the patient was vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, frequency, route of administration were not provided) with therapy type of HSA, lot # L002421 and expiry date 23-JUL-2016 for prophylaxis (inappropriate schedule of product administration). No adverse effect reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: NO ADVERSE EFFECT REPORTED; 21 year old patient received one dose of pediatric formula VAQTA; 21 year old patient received one dose of pediatric formula VAQTA; This spontaneous report was received from a medical assistant refers to a 21 year old patient of unknown gender. Information on patient's medical history, drug allergies/reactions, concurrent conditions and concomitant therapies were not reported. On 23-MAY-2019, the patient was vaccinated with one dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (unspecified units) (lot # R035227, expiration date: 01-JAN-2020) via intramuscular route for prophylaxis. On 23-MAY-2019, patient received one dose of pediatric formula (incorrect dose administered) (product administered to patient of inappropriate age). No adverse effects were reported (no adverse event). The outcome of event was unknown. No product quality complaint involved in this case.
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: the patient received a pneumovax 23 vaccination in which he cant move his arm; This spontaneous report was received from a 65-year-old male physician (who is also the patient) via a company representative, refers to himself. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, lot# and expiry unknown), subcutaneous for prophylaxis. The patient reported that on an unknown date, he cannot move his arm (movement disorder). The outcome of movement disorder was reported as not recovered/not resolved. Causality assessment was not reported. Product quality complaints was not involved.
Age: 1.17
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects; inadvertently administered one dose of the adult VAQTA; This spontaneous report was received from a registered nurse refers to a 2 year old patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 30-MAY-2019, the patient was vaccinated with adult hepatitis a vaccine, inactivated (VAQTA) (50/1 unit/milliliter) (lot # R012739 and expiry date 09-AUG-2019, frequency and anatomical location and route of administration were unknown) dose 2, 1 dosage form for prophylaxis (also reported as booster) (product administered to patient of inappropriate age). On 24-FEB-2018, the patient was vaccinated with the first dose. No adverse effects reported.No product quality complaint (PQC) reported.
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: no adverse effect; the 44 year old patient received one pediatric dose of VAQTA; This spontaneous report was received from a health professional (nurse prescriber) refers to a 44 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 31-MAY-2019, the patient was vaccinated with one pediatric dose of hepatitis a vaccine, inactivated (VAQTA)(strength: 25/0.5) at a dose of 0.5 milliliter once via intramuscular route for prophylaxis (incorrect dose administered) (Lot # expiry date was not specified). No adverse effect reported. No PQC involved. The outcome of incorrect dose administered, and no adverse event was unknown.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a 11-year-old male patient. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant medications included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid(Tdap) and meningococcal ACYW conj vaccine (carrier unspecified)(MCV4). Approximately on an unknown date in November 2018 (also reported as about six months ago), the patient was vaccinated with first dose of GARDASIL 9, 0.5 milliliter dose for prophylaxis (route, anatomical location, lot # and expiration date were not reported) along with concomitant vaccines and the patient experienced an episode of syncope which happened in the physician's office. The patient sought medical attention. The GARDASIL 9 vaccine was the first shot of the two dose regimen. It was also reported that the patient had not come for his second shot. The outcome of syncope was reported as recovered. The causality assessment was not provided by the reporter. No product quality complaint was filed. Upon internal review, syncope was determined to be medically significant.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; The patient was inadvertently administered a dose of VARIVAX, that had been improperly stored; This spontaneous report was received from a physician assistant, referring to a patient of unknown age and gender. There was no information provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies.   On 07-MAY-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous, lot # R023513, expiration date on 16-AUG-2020 (dose and anatomical localization were not reported). The physician assistant reported that the patient was inadvertently administered a dose of with varicella virus vaccine live (Oka/Merck) (VARIVAX), that had been improperly stored. The lot of with varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored DILUENT MRK (unknown Lot# and expiration date). No adverse effect reported.  On unspecified dates, the doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent temperature excursions of -9 °C to 8 °C (1.7 °C)  for a time frame of 4 hours, which was called by the digital data logger. There were no previous temperature excursions reported.; Sender's Comments:  US-009507513-1905USA012089: US-009507513-1906USA000539:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; The patient was inadvertently administered a dose of VARIVAX, that had been improperly stored; This spontaneous report was received from a physician assistant, referring to a patient of unknown age and gender. There was no information provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies.   On 23-MAY-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous, lot # R023513, expiration date on 16-AUG-2020 (dose and anatomical localization were not reported). The physician assistant reported that the patient was inadvertently administered a dose of with varicella virus vaccine live (Oka/Merck) (VARIVAX), that had been improperly stored. The lot of with varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored DILUENT MRK (unknown Lot# and expiration date). No adverse effect reported.  On unspecified dates, the doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent temperature excursions of -9 °C to 8 °C (1.7 °C)  for a time frame of 4 hours, which was called by the digital data logger. There were no previous temperature excursions reported.; Sender's Comments:  US-009507513-1906USA000538: US-009507513-1905USA012089:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine; no adverse effect; This spontaneous report was received from Licensed Practical Nurse referred to unspecified number of patients of unknown age and gender.  Information regarding medical history, and concurrent conditions were not reported. The concomitant medication included sterile diluent. On an unknown date, the patients were vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant human albumin (rHA)) (M-M-R II) (lot # N023024 with expiry date 23-AUG-2019 and lot # N023142 with expiry date 24-AUG-2019), and varicella virus vaccine live (oka/merck)(VARIVAX) with lot # R010466 and expiry date 10-APR-2020, both via subcutaneous route for prophylaxis (dose was not reported). The suspect products were kept at a temperature of 54 degree Fahrenheit (F) for a time frame of 50 minutes. The previous temperature excursions were in the month of December 2018 at a temperature of 8 degree F for 20 minutes and on 01-FEB-2019 at a temperature of 7.2 degree F for 30 minutes. The digital data logger was involved. The reporter stated that, sterile diluent (manufacturer unknown) was stored in the correct storage temperature range. The patients did not experience any adverse effects. The product quality complaint was not involved.  This case was considered to be non-valid due to lack of patient identifiers.
Sex: U
Vaccine: VARZOS
Symptoms: Formication, Herpes zoster, Rash, Rash pruritic
Clinical narrative: shingles; right supraclavicular rash; extremly itchy; crawling up my Neck and shoulder; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (have in the mid of 1950s).   On 18th April 2019, the patient received the 1st dose of Shingrix. On 15th May 2019, 27 days after receiving Shingrix, the patient experienced shingles, rash, itchy rash and crawling sensation. The patient was treated with prednisone and acyclovir. On an unknown date, the outcome of the shingles, rash, itchy rash and crawling sensation were unknown.   It was unknown if the reporter considered the shingles, rash, itchy rash and crawling sensation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On about 15th May 2019 the patient developed a right supraclavicular rash. It became extremely itchy and felt at times that there were insects crawling up his neck and shoulder. On 23rd May 2019, the patient paid a visit to primary care physician, who diagnosed the problem as (the patient might have already guessed) shingles, a malady that never had before. The patient was given scripts for prednisone and acyclovir to hasten that recovery. The patient could not have found literature regarding the incidence of active herpes zoster during the Shingrix inoculation period.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 1st dose of Shingrix. On 14th May 2019, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of shingrix the middle of January 2019. On 14th May 2019, the patient was diagnosed with shingles. The patient asked when should get 2nd dose of shingrix.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Headache, Injection site pain
Clinical narrative: feeling like fainting/ dizziness; blood pressure went down; headache; soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix. On 15th May 2019, less than a day after receiving Shingrix, the patient experienced headache and injection site pain. On 16th May 2019, the patient experienced dizziness and blood pressure decreased. On an unknown date, the outcome of the dizziness and blood pressure decreased were not recovered/not resolved and the outcome of the headache and injection site pain were recovered/resolved.   It was unknown if the reporter considered the dizziness, blood pressure decreased, headache and injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's spouse. On the first day of receiving Shingrix, she experienced headache and soreness at the injection site. The next day after receiving Shingrix, the patient experienced dizziness and felt like fainting. Her blood pressure also went down to even 90/60 at some point. At the time of reporting, the patient still experienced the symptoms. It was reported that before receiving Shingrix and till the time of reporting, the patient received beta blocker and a blood pressure medication to reduce her blood pressure. The patient did not have high blood pressure but just received the medications to control blood pressure due to blockage. The reporter declined providing her information and provided only the patient's information.  The reporter declined to provide further information and closed the conversation.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Extensive swelling of vaccinated limb, Feeling hot
Clinical narrative: swelling; red of arm; arm was hot; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 73-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included egg allergy.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and extremities hot feeling of. Flu vaccine was discontinued. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities and extremities hot feeling of were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and extremities hot feeling of to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported but the patient was 73 years old, at the time of reporting. Around 1991, the patient received a flu vaccine, name unspecified and her arm became as big as a football and it was red and hot.  The physician advised the patient not to receive a flu vaccine again.  The patient never received a flu vaccine again.  The reporter did not consent to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain
Clinical narrative: abdominal pain; This case was reported by a pharmacist via call center representative and described the occurrence of abdominal pain in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   On 11th May 2019, the patient received the 1st dose of Shingrix. On 12th May 2019, 1 days after receiving Shingrix, the patient experienced abdominal pain. On an unknown date, the outcome of the abdominal pain was unknown.   It was unknown if the reporter considered the abdominal pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. 1 to 2 days after vaccination with Shingrix, the patient experienced diffuse abdominal pain (musculoskeletal in nature). On day 6, the patient recovered 50 percent and on day 7, the patient recovered 75 percent for abdominal pain. The current status of pain was unknown.