chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: nausea; fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 44N5L, expiry date 13th September 2021) for prophylaxis.   On 24th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced nausea. On an unknown date, the outcome of the fever and nausea were recovered/resolved.   It was unknown if the reporter considered the fever and nausea to be related to Shingrix.  Additional details were provided as follows: Reported batch number 44N5L pertains to Shingrix adjuvant. On 24th May 2019, either the same day or the next day, the patient developed an intermittent fever. It lasted off and on for 10 days which was resolved till the time of reporting.  The patient also had nausea that developed later on and was resolved. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: fever; fatigue; malaise; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, fatigue and malaise. On an unknown date, the outcome of the fever, fatigue and malaise were recovered/resolved.   It was unknown if the reporter considered the fever, fatigue and malaise to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter stated that the patient is in his 60's. The patient received Shingrix on an unknown arm.  The patient developed fever, fatigue, and malaise that lasted approximately 2 to 3 days. The reporter did not provide any additional information.  This case has been linked with the case US2019AMR113702, reported by same reporter for the same patient.
Sex: F
Vaccine: TDAP
Symptoms: Nonspecific reaction
Clinical narrative: unspecified reaction; This case was reported by a physician via call center representative and described the occurrence of nonspecific reaction in a 58-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose. On an unknown date, unknown after receiving Boostrix, the patient experienced nonspecific reaction. On an unknown date, the outcome of the nonspecific reaction was unknown.   It was unknown if the reporter considered the nonspecific reaction to be related to Boostrix.  Additional details were provided as follows: The reporter reported that, the patient received unknown brand of Tdap, many years ago. The reporter stated that, it was unknown, if Tdap was Glaxosmithkline vaccine. The patient received Tdap vaccine many years ago, possibly childhood at another facility. The health care professional did not have batch number and expiry date of Tdap vaccine.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: redness at injection site; swelling at injection site; pain at injection site; rash around the arm; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   On 14th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain and rash. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain and rash were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced red, swollen and painful injection site on the arm and he had developed a rash that goes around the arm at injection site down to the elbow.  The reported batch number G723ZD was corrected to G72ZD as per sales data sheet.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal
Clinical narrative: weakness; feeling lousy; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number B37G7, expiry date 23rd May 2021) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th June 2019, 1 days after receiving Shingrix, the patient experienced weakness and feeling bad. On an unknown date, the outcome of the weakness and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the weakness and feeling bad to be related to Shingrix.  Additional details were provided as follows: Batch number of Shingrix was reported as B3767, which was corrected to B37G7 as per sales data sheet. The patient experienced weakness and was feeling lousy after receiving Shingrix vaccine. This case is linked to the case US2019109683, reported by same reporter.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th June 2019, 3 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provideda s follows: The case was reported by the patient's wife. The patient developed rash after receiving Shingrix vaccine. On 16th June 2019, the rash was daignosed as shingles, at urgent care. The consumer consented to follow up with herself, but declines healthcare professional follow up. The consumer did not have vaccine information for her husband's adverse event. This case is linked to case US2019109682, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Livedo reticularis, Rash erythematous, Rash generalised
Clinical narrative: rash all over body; Mottled skin; generalized rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th June 2019, the patient received the 1st dose of Shingrix. On 15th June 2019, less than a day after receiving Shingrix, the patient experienced red rash, mottled skin and generalized rash. On an unknown date, the outcome of the red rash, mottled skin and generalized rash were recovering/resolving.   It was unknown if the reporter considered the red rash, mottled skin and generalized rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix and by evening of same day she broke out into a rash all over her body. Stating solid red rash on both her upper arm on the elbows and mottled rash on the rest of her body. The patient stated it was beginning to decrease a little now. The reporter did not give consent to follow up. The patient would not provide additional information to complete this adverse reporting. The patient stated she would report it directly to the Centers for Disease Control.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles outbreak; itching; rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and rash. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received his 2nd Shingrix dose about 3 months prior to this report. The patient experienced itching and what he believed to be a mild case of Shingles along the axillary area and along his trunk. The patient had a rash that was about 1 cm in diameter. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation were unknown at the time of reporting.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope, Tuberculin test
Clinical narrative: Syncope; This case was reported by a physician via call center representative and described the occurrence of syncope in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA050A, expiry date 13th October 2019) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABX770AA, expiry date 31st July 2020) for prophylaxis and tuberculin purified protein derivative (Tuberculin Ppd) for product used for unknown indication.   The patient's past medical history included syncope (when gave blood).   On 17th June 2019, the patient received Menveo, the 1st dose of Bexsero and Tuberculin Ppd at an unknown dose and frequency. On 17th June 2019, less than an hour after receiving Menveo and Bexsero, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Menveo. The reporter considered the syncope to be related to Bexsero.  Additional information was provided as follows: The patient had history of syncope when she gave blood previously. The patient received Bexsero and Tuberculin PPD in left deltoid and Menveo in right deltoid. Within 5 minutes after receiving these vaccines, the patient had syncope. The healthcare professional (HCP) thought that Bexsero was the cause of syncope and wanted to know if GSK was aware of more reporting for syncope since Bexsero's approval in the US. The reporter had reported syncope previously in 2-3 times for different patients. The HCP recommended to patient and her mother to get 2nd dose of Bexsero. The reported batch number AVX770AA for Bexsero did not exist and was updated to ABX770AAas per the sales database.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On 10th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had first dose of Shingrix and experienced rash on the leg that resolved about 10 to 20 hours later.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Neck pain, Vision blurred
Clinical narrative: headache; neck pain; blurry vision; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced headache, neck pain and blurred vision. On an unknown date, the outcome of the headache, neck pain and blurred vision were recovered/resolved.   It was unknown if the reporter considered the headache, neck pain and blurred vision to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had first dose of Shingrix on an unknown date and experienced headache, neck pain and blurry vision all of which had resolved.   No further details were available. It was reported that the patient had first dose at a different pharmacy.
Sex: U
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: received Tenivac after temperature excursion/no AE; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of unknown demography who received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and reported that received Tenivac after temperature excursion/no AE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 16-May-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6101AA and expiry date: 23-Oct-2020 via intramuscular route in the left deltoid.  It was a case of actual medication error due to incorrect product storage.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: accidentally administered a 5th Pentacel injection exactly 1 month following her 4th Pentacel injection/no AE; accidentally administered a 5th Pentacel injection/no AE; Initial information received on 19-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a female patient of unknown age who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that accidentally administered a 5th Pentacel injection exactly 1 month following her 4th pentacel injection/no AE and accidentally administered a 5th pentacel injection/no AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate schedule of vaccine administered and extra dose administered.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: a 6 month old female received Pentacel t was only given the Dtap-IPV portion and not the ActHIB; Initial information received on 20-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past vaccination(s) included PENTACEL on 16-Apr-2019, Dose 2 and PENTACEL on 25-Feb-2019, Dose 1. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 19-Jun-2019, the patient received a third dose 0.5ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Dtap-IPV vial- LOT: 06216AB, expiry date 10-Oct-2020, ActHib (from the Pentacel Box that was not given: LOT: UJ013AA, expiry date 10-Oct-2020) via intramuscular route in left Vastus lateralis.  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that a 6 month old female received Pentacel t was only given the Dtap-IPV portion and not the ActHIB.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 50.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient was mistakenly given Daptacel that had expired; Initial information received on 20-Jun-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 50 years old male patient who was inadvertently vaccinated with a 0.5 ml an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5202BA and Exp. Date 16-May-2019) via intramuscular route in the left arm on 20-Jun-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  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: 0.5
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: a dose of expired Daptacel was administered today; Initial information received on 20-Jun-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone.   This case involves a 6 months old patient (gender not reported) who was vaccinated with an expired 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expiration date: 16-Mar-2019) (batch number, dose in series, route and site of administration were not reported) on 20-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Information on the batch number was requested.  Documents held by the sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Drug hypersensitivity, Injection site erythema, Injection site pain, Pyrexia, Vaccination site inflammation
Clinical narrative: allergic reaction to the Adacel; inflammation and redness and pain at the injection site; felt like she had a fever last night; Initial information received on 20-Jun-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 51 years old female patient who experienced vaccination site inflammation, fever and drug hypersensitivity while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (This was not her first dose.).  The patient's past vaccination(s) included Adacel. The patient's past medical history, medical treatment(s) and family history were not provided.  No other concomitant vaccines were taken.   On 18-Jun-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5609AA via intramuscular route in the left deltoid.  On an unknown date, The patient developed a non-serious inflammation and redness and pain at the injection site (vaccination site inflammation) and allergic reaction to Adacel following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 19-Jun-2019, The patient felt like she had a fever last night (pyrexia) 1 day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No lab test reported.  Final diagnosis was  vaccination site inflammation, fever and drug hypersensitivity .   The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]).  The patient outcome is reported as Unknown for the events.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Urticaria
Clinical narrative: Mother states pt developed rash/hives all over body approximately 1 wk after 12mo. shots.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Computerised tomogram head normal, Electroencephalogram normal, Gaze palsy, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: First time seizure (R56.9)  She developed left arm stiffness and left face twitching along with eyes staring upward. Pte unresponsive during this time. Episode lasted 2-3 mins and was found to be sleepy for about 30 mins afterwards. No fever, no vomiting, no diarrhea, no cyanosis
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging brain normal, Seizure, Septic screen, Somnolence, Unresponsive to stimuli
Clinical narrative: First time seizure (R56.9)  She developed left arm stiffness and left face twitching along with eyes staring upward. Pte unresponsive during this time. Episode lasted 2-3 mins and was found to be sleepy for about 30 mins afterwards. No fever, no vomiting, no diarrhea, no cyanosis
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Patient had low grade fever 6/19/19, 100. Systemic macular red scattered rash started 6/22/19 and has waxed/waned with heat until visit 6/24/19.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Local aches, pains, fatigue low grade fever
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Seven days after vaccine, patient developed hard warm to the touch lump under skin where vaccine was given, pain redness slight blistering that was starting to spread on leg.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: Seven days after vaccine, patient developed hard warm to the touch lump under skin where vaccine was given, pain redness slight blistering that was starting to spread on leg.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Eyelid injury, Head injury, Joint injury, Seizure
Clinical narrative: Approximately 1-2 minutes after vaccination, patient pitched forward off of exam table and hit his knees and then his head on the clinic floor. Patient appeared to convulse on floor for approximately 3 seconds, and then regained consciousness. Mother and nurse protected patient's head, and then lowered his head to the ground after convulsions ceased. There was a small cut (approximately 3 mm) above his right eye and below his eyebrow. Patient was alert and oriented and able to answer questions. Gave patient ice pack to place on eye and a Coke to drink. Patient drank entire Coke and after approximately 10 minutes sat up and then stood and was able to walk into waiting room. Patient reported having not eaten breakfast before arriving, had only had a Sunny-D to drink that morning. Mother reported that this had happened once before when patient had blood drawn.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: 6/20/19 mom stated baby had fever 104.5 and rash started. She then called insurance advice line and was told to give Tylenol and motrin. Mom states fever 101 on 6/23/19. Then 6/24/19 went to Urgent Care because rash was worse, temperature 98.2. Dr notified of event and ask mom to take picture and follow up appointment made for 6/26/19
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, aches, headache, tiredness, very sore arm (which was expected)
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This spontaneous report as received from a lawyer regarding a case in litigation refers to a currently 84 years old female patient.  No information was provided regarding concomitant medications, concurrent conditions or medical history.  On 25-MAR-2010 , the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX)  for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On an unknown date, the patient experienced herpes zoster. The outcome of herpes zoster was unknown.   The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; At 48 years old the patient was vaccianted whit Zostavax; This spontaneous report as received from a lawyer regarding a case in litigation and refers to a currently 56 years old female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. Approxuymatelly 08-SEP-2011, reported as "on or about  08-SEP-2011", the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) for routine health maintenance for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On an unknown date, the patient experienced shingles. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This spontaneous report as received from a lawyer regarding a case in litigation and refers to a currently 69 years old female patient.  No information was provided regarding concomitant medications, concurrent conditions or medical history.  In March 2014 the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX)  for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On an unknown date, the patient experienced herpes zoster. The outcome of herpes zoster was unknown.   The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: While immunizing the patient, some of the M-M-R II vaccine leaked out of the syringe; This spontaneous case was reported by a pharmacist referring to an adult patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, frequency, route, lot# and expiration date not reported) for prophylaxis.  While immunizing the patient, some of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccine leaked out of the syringe (incorrect dose administered).
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: one dose of GARDASIL 9 was administered to an unspecified pregnant patient on an unspecified date; No adverse effects reported; This spontaneous prospective pregnancy report was received from a physician and refers to a pregnant female patient of unknown age. There was no information concerning the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient became pregnant. The last menstruation period (LMP) and estimated delivery date (EDD) were not known. The outcome of the pregnancy was pending.  On an unknown date, the pregnant patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(exact dose, route of administration, injection site, lot# and expiration date were not provided) for prophylaxis.  There were no adverse effects reported. The causality assessment was not provided.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Injection site pain
Clinical narrative: feeling tired; injection site soreness; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2019, the patient received Shingrix. On 18th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and chills. On 19th June 2019, the patient experienced tiredness. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, chills and tiredness were unknown.   It was unknown if the reporter considered the injection site pain, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 18th June 2019, the patient experienced chills and soreness around the injection site. On 18th June 2019 evening, the patient took ibuprofen 600mg and was able to sleep. On 19th June 2019, the patient still felt very tired. The patient referred back to the health care professional if symptoms persist. This was all the information collected.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pain
Clinical narrative: feeling tired; injection site soreness; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2019, the patient received Shingrix. On 18th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and chills. On 19th June 2019, the patient experienced tiredness. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, chills and tiredness were unknown.   It was unknown if the reporter considered the injection site pain, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 18th June 2019, the patient experienced chills and soreness around the injection site. On 18th June 2019 evening, the patient took ibuprofen 600mg and was able to sleep. On 19th June 2019, the patient still felt very tired. The patient referred back to the health care professional if symptoms persist. This was all the information collected.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Cellulitis; Redness; Swelling; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative.  A 65-year-old female patient received the pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 02May2019 at a single dose for immunization.  Medical history included breast cancer, and type 2 diabetes mellitus; both from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, the patient experienced cellulitis (medically significant), redness, swelling.  The patient went to the emergency room (ER) for symptoms. The clinical outcome of the events was unknown.  The batch/lot numbers for the vaccine, pneumococcal 13-val conj vac (dipht crm197 protein), were not provided and will be requested during follow up.; Sender's Comments: Based on the limited information available the event cellulitis is attributed to an intercurrent medical condition that was unlikely related to suspected vaccine pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13). The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Nausea, Pain, Pain in extremity
Clinical narrative: Sore arm plus nausea, achiness, slight temp, tired, dizzy lasting 24 hours. Still has severe arm pain from shoulder to elbow.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Sore arm plus nausea, achiness, slight temp, tired, dizzy lasting 24 hours. Still has severe arm pain from shoulder to elbow.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site pain
Clinical narrative: Received injection approximately 3pm, around 10pm I had 100F temperature with very sore injection site, but no other symptoms. By 10am next morning, normal body temperature with sore injection site.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Hair growth abnormal, Injection site rash, Pruritus, Pyrexia, Rash
Clinical narrative: approximately 3-4 days after administration patient experienced rash on both sides of upper stomach which in her words looked like chicken pox.  It was itchy and she had a low grade fever for a few days.  She also had rash aroundthe injection site approximately 3-4 " diameter that appeared the next day after injection.   She also had increase in eyebrow hair that week.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: approximately 3-4 days after administration patient experienced rash on both sides of upper stomach which in her words looked like chicken pox.  It was itchy and she had a low grade fever for a few days.  She also had rash aroundthe injection site approximately 3-4 " diameter that appeared the next day after injection.   She also had increase in eyebrow hair that week.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain
Clinical narrative: Headache, joint aches (back, hip, general), pain at injection site.  Treated with acetaminophen and abated.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Neck pain, X-ray
Clinical narrative: Severe neck and back muscle pain. Physical therapy was partially effective, but the pain continues to this date in the lower back muscles. Treatment consists of naproxen and direct application of lidocaine  cream.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Poor quality sleep
Clinical narrative: Extremely sore throbbing arm. Woke him up from sleep.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Extremely sore arm. Unable to lift arm.
Age: 18.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Full blood count, Immune thrombocytopenic purpura, Leukopenia, Platelet count decreased, Pyrexia
Clinical narrative: 18 y/o female presents diffuse rash, which started 2 wks ago after she received a  series of immunizations, which got worse over last 2 days. reports subjective fever and reports rash is intermittently itchy. denies recent travels.  Exam rash is blanching, erthematous and diffusely over body. confluence to her lower extremities. patient reports she has never been vaccinated before.
Age: 18.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Thrombocytopenia, Vaccination complication
Clinical narrative: 18 y/o female presents diffuse rash, which started 2 wks ago after she received a  series of immunizations, which got worse over last 2 days. reports subjective fever and reports rash is intermittently itchy. denies recent travels.  Exam rash is blanching, erthematous and diffusely over body. confluence to her lower extremities. patient reports she has never been vaccinated before.
Age: 18.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: White blood cell count decreased
Clinical narrative: 18 y/o female presents diffuse rash, which started 2 wks ago after she received a  series of immunizations, which got worse over last 2 days. reports subjective fever and reports rash is intermittently itchy. denies recent travels.  Exam rash is blanching, erthematous and diffusely over body. confluence to her lower extremities. patient reports she has never been vaccinated before.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Loss of consciousness, Pyrexia
Clinical narrative: Patient went home after vaccination and started experiencing chills, fever, and eventually passed out the next day.
Age: 0.67
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash that started on face and has now spread down to her chest and upper back. Starting on 6/24 and continued currently.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Influenza like illness, Palpitations, Pyrexia
Clinical narrative: Night following vaccine administration patient states she had low grade fever and flu-like symptoms. The following day patient had no appetite. Vomited after eating a small amount of food that evening. That night patient states she had palpitations. She says she was tired the next day, but felt fine after that.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Night following vaccine administration patient states she had low grade fever and flu-like symptoms. The following day patient had no appetite. Vomited after eating a small amount of food that evening. That night patient states she had palpitations. She says she was tired the next day, but felt fine after that.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt received second dose of series on 6/22/19.  Nothing out of the ordinary occurred during or immediately following vaccination.  The patient waited at the pharmacy following her vaccination for about 10-15 minutes and seemed fine upon her departure.  We received a phone call from patient Monday morning stating that she had a "large goose egg" at her injection site.  She described it as "itchy, red, and painful."  The pharmacist on duty recommended taking benadryl, ibuprofen, and applying ice and to follow up with her dr if symptoms did not improve.  I called the patient at noon 6/24/19 to follow up with her.  She said that nothing had really changed since earlier that morning, but that she had taken both ibuprofen and benadryl.  I called Dr. to inform them of the reaction her patient was having.  I had to leave a message, but was told that they would give to the dr and follow up with the patient.  Tuesday 6/25 I called Dr.'s office for updates.  They had spoke with the patient Monday afternoon and told her to take benadryl three times daily and to apply ice pack for 20 minutes for 3 days.   Office staff informed me that the patient had called again Tuesday morning and said that she still had the "goose egg".  They were sending message to Dr. and awaiting her response.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Injection site induration, Oedema, Pyrexia
Clinical narrative: Patient developed erythema, edema, fever, and induration to left upper arm 2 days after.  Diagnosed with cellulitis.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Low grade fever, headache, body aches, extreme tiredness.  Took a shower in the morning  (6/24) after the injection and almost fainted.  Spent the entire day of 6/24 sleeping.  Called the pharmacist who confirmed these were side effects of the injection .  I have never had adverse reactions to any injections (flu shots, etc).  Feeling better today (6/25) but still have slight lingering headache.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Low grade fever, headache, body aches, extreme tiredness.  Took a shower in the morning  (6/24) after the injection and almost fainted.  Spent the entire day of 6/24 sleeping.  Called the pharmacist who confirmed these were side effects of the injection .  I have never had adverse reactions to any injections (flu shots, etc).  Feeling better today (6/25) but still have slight lingering headache.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Depressed level of consciousness, Gait disturbance
Clinical narrative: Patient states that within a few days his arm was in pain but it was tolerable. On May 22nd and 23rd patient states he felt extraordinarly weak and was unable to walk steadily and felt he was about to pass out. This had not occured in the past nor since so he feels it is related to the vaccination.
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects; Received improperly stored ROTATEQ; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 19-JUN-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # R025731 (expiry date: 14-JUN-2020) for prophylaxis (strength, anatomical location, route and dosage details were not reported) (Product storage error). The vaccine was stored at a highest temperature above 47 degree Fahrenheit (F)/ 9 degree Centigrade (46.5F) for a time frame of 30 minutes. The patient did not experience any adverse effects. There was no previous temperature excursion. The call was because of a "data logger". No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009509: US-009507513-1906USA009082: US-009507513-1906USA009522: US-009507513-1906USA009513: US-009507513-1906USA009514:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Received one dose of improperly stored VAQTA; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 20-JUN-2019, the patient was vaccinated with one dose of improperly stored hepatitis a vaccine, inactivated (VAQTA), lot # R035227 (expiry date: 01-JAN-2020) for prophylaxis (strength, anatomical location and route were not reported) (Product storage error). The vaccine was stored at a highest temperature above 47 degree Fahrenheit (F)/ 9 degree Centigrade (46.5F) for a time frame of 30 minutes. The patient did not experience any adverse effects. There was no previous temperature excursion. The call was because of a "data logger". No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009510: US-009507513-1906USA009082: US-009507513-1906USA009509: US-009507513-1906USA009522:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Received one dose of improperly stored VAQTA; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 20-JUN-2019, the patient was vaccinated with one dose of improperly stored hepatitis a vaccine, inactivated (VAQTA), lot # R034548 (expiry date: 29-DEC-2019) for prophylaxis (strength, anatomical location and route were not reported) (Product storage error). The vaccine was stored at a highest temperature above 47 degree Fahrenheit (F) /9 degree Centigrade (46.5F) for a time frame of 30 minutes. The patient did not experience any adverse effects. There was no previous temperature excursion. The call was because of a "data logger". No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009082: US-009507513-1906USA009513: US-009507513-1906USA009509: US-009507513-1906USA009522:
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: swelling; redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LG54, expiry date 25th September 2021) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix. On 12th June 2019, 1 days after receiving Shingrix, the patient experienced swelling. In June 2019, the patient experienced erythema of extremities. On 14th June 2019, the outcome of the swelling was recovered/resolved. On an unknown date, the outcome of the erythema of extremities was not recovered/not resolved.   It was unknown if the reporter considered the swelling and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received the Shingrix and developed swelling for 2 days and her arm was red from her shoulder to elbow. The swelling resolved after 2 days. The pharmacist last saw the patient on 14th June 2019.