chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult 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 13th June 2019, 2 days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist on the chat reporting a patient was experiencing Shingles. The rash was reported and the patient presented to an urgent care where they were diagnosed with shingles and an antiviral was prescribed. No further information was provided. The reporter declined to provide any patient identifiers. The provider who administered the vaccine was the pharmacist on staff using standing orders.
Initial and follow up information has been received from a registered nurse through the Pregnancy Registry for GARDASIL concerning a 14 year old female with a history of tinea versicolour and allergic rhinitis who on 17-OCT-2007 was vaccinated with her first dose of GARDASIL IM (lot# 657872/0515U) and was pregnant. Concomitant therapy included CLARITIN as needed for nasal symptoms. The patient sought unspecified medical attention in the office on 01-NOV-2007. On 02-NOV-2007 the patient had a positive urine pregnancy test (LMP reported as end of June 2007). The patient will be followed by her pediatrician. On 02-JAN-2008 the patient had an ultrasound which showed a single live intra-uterine pregnancy of 26 weeks. It was suggested she have another ultrasound for fetal anatomy. On 11-JAN-2008 the patient had a follow up ultrasound which showed normal progression of pregnancy. On 08-APR-2008, the patient had a fever of 102.5 and hypertension. It was also reported that the patient received prenatal care late. On 08-APR-2008 (39 weeks from LMP) the patient delivered a female infant weighing 6lbs. 8oz. There was "decreased fetal movement" detected and a caesarean section was performed. The child was sent to the NICU after delivery, the nurse suggested that it might have been precautionary, given the mother's health problems before delivery. The child being sent to the NICU after delivery and and decreased fetal movement were considered to be an other important medical event. Additional information has been requested. Initial information and follow up has been received from a nurse for the Pregnancy Registry for GARDASIL concerning a 14 year old female with a history of tinea versicolour and allergic rhinitis who on 17-OCT-2007 was vaccinated with her first dose of GARDASIL IM (lot# 657872/0515U) and was pregnant. Concomitant therapy included CLARITIN as needed for nasal symptoms. The patient sought unspecified medical attention in the office on 01-NOV-2007. On 02-NOV-2007 the patient had a positive urine pregnancy test (LMP reported as end of June 2007). The patient will be followed by her pediatrician. On 02-JAN-2008 the pateint had an ultrasound which showed a single live intra-uterine pregnancy of 26 weeks. It was suggested hse have another ultrasound for fetal anatomy. On 11-JAN-2008 the patient had a follow up ultrasound which showed normal progression of pregnancy. Subsequently, on 08-APR-2008 (39 weeks from LMP) the patient delievered a female infant weighing 6lbs. 8oz. The child was sent to the NICU after delivery for unknown reasume. On 08-APR-2008 the patient had a fever of 102.5 and hypertension. It was also reported that the patient received prenatal care late. The child being sent to the NICU after delivery was considered to be an other important medical event. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to 3 unspecified patients of unknown age and gender. Medical histories and current conditions were not reported. On an unknown date, the patients were vaccinated with incorrect storaged doses of ZOSTAVAX (lot number, expiration date and route of administration were not provided). No adverse events were reported. Concomitant medication was not reported. The outcome of patients vaccinated with incorrect storaged doses of ZOSTAVAX was unknown. Additional information has been requested.
fever; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (fever). On 23-Jan-2021, PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Relevant laboratory results were not provided.  Concomitant medication was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2021: No specific follow-up information recorded. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (fever). On 23-Jan-2021, PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Relevant laboratory results were not provided.  Concomitant medication was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2021: No specific follow-up information recorded.
suspected vaccination failure; shingles / got the shot, broke out with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot a couple years ago on the 6th May and broke out with shingles on the 26th of May. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting. Note: As the year when the patient received vaccine and when the patient experienced event was not reported, thus considering the worst case event suspected vaccination failure was captured in the case.
Sore throat, headache, chills, fever of 101.4, body aches - lasted 12 hours, took OTC Motrin
4 year old patient received GARDASIL 9 in error; This spontaneous report as received from a registered nurse referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 07-OCT-2020 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe (1 dose, lot # S023475, expiration date 26-MAR-2022; route was not reported) for prophylaxis (product administered to patient of inappropriate age) in error. Device was not available for evaluation (obtain was reported as false). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Flu like symptoms-fever-chills-body aches. Red and warm at injection site, warm to touch, painful. TX: MEDROL dose pack and SEPTRA DS 1 BID x 10 days.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, between 17-APR-2017 and 11-MAY-2017, the patients were vaccinated with doses of improperly stored GARDASIL 9 lot # M037770 with expiration date 01-JUN-2019 and lot # M043731 with expiration date 22-JUN-2019 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 47 to 77 degrees Fahrenheit for 75 hours. Digital data logger was not involved. The vaccine did not undergo previous temperature excursion. No adverse events were reported. The excursion was not detected because of a "data logger". Additional information has been requested.
Patient had symptoms of a cough and congestion reported on 03/29/2021. Symptoms have been continuing since. Loss sense of taste and smell, cough, congestion, and shortness of breath.
fatigue; minor fever; nausea; vomiting; hives returned on both hands and feet; This is a spontaneous report received from a contactable consumer. This 51-year-old consumer (patient) reported for herself that,  A female patient of 51-year-old received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN6200) (at the age of 51 year old), dose 2 intramuscular, administered in deltoid right on 17Feb2021 08:00 as dose 2, single for covid-19 immunisation. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN5318), dose 1 intramuscular, administered in deltoid right on 30Jan2021 08:00 as dose 1, single for covid-19 immunisation, the patient experienced, Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it)/Swell occurred 5 days post injection and remained for several days and Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat. Medical history included, psoriatic arthropathy from an unknown date and unknown if ongoing, systemic lupus erythematosus from Jun2019 to an unknown date Onset date: 10 years  Pertinent details: Onset after a reaction to a biologic (Humera), benzodiazepine derivatives from 2007 to an unknown date. Concomitant medication(s) included guselkumab (TREMFYA) taken for an unspecified indication from an unspecified start date and ongoing. It was reported on an unspecified date patient experienced fatigue, minor fever, nausea, vomiting on day 3 and hives returned on both hands and feet. The outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
No adverse event reported by patient. Filling out a VARES  report due to Prevnar 13 being given after recommendation change  for patient age group and before Prevnar 20 became available.     Patient will come for additional Pneumococcal vaccine 1 year from the date of Prevnar 13 dose.
Swelling and pain at axilla on left side. Was prescribed MEDRAL Pk, antihistamine and KEFLEX BID.
Patient was accidentally given booster shot of pfizer. Patient has no adverse event. Patient is doing okay
PT needed travel shots. Reported cold: temp - 97.8. Given Twinrix #1 at 11 a.m. Called at 11:50 to report that 5-10 mins post injection, he felt dizzy, as if he had been punched in the jaw and his arm burned and felt swollen. This lasted approximately 1 min. Only residual was swelling and soreness at site.
C/O dizziness "can't breath" observed tremor of hands states heart beating rapidly (AP=72/min)
Sore arm; A little weakness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ASTHENIA (A little weakness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and ASTHENIA (A little weakness). At the time of the report, PAIN IN EXTREMITY (Sore arm) and ASTHENIA (A little weakness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that after the first two doses of the vaccine she had a sore arm and a little weakness that went away quickly  Treatment information was not provided.   This case was linked to MOD-2022-448411, MOD-2022-448414 (Patient Link).
Dizziness when waking up morning after vaccine.  And swollen, painful lymph node in armpit region of vaccination arm.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). It was reported that the patient experienced hair loss. It was unknown if the patient sought medical attention. The outcome was not reported. This is one of several reports from the same source. Additional information is not expected.
vomiting and mild diarrhea; vomiting and mild diarrhea; Headache; wondering maybe she has a flu.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202100976009 (Pfizer).  A 44-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Jul2021 (Lot number: FA6780) at the age of 44 years as dose 1, single for covid-19 immunisation. Family history included: "immunodeficiency syndrome" (unspecified if ongoing), notes: she is a gene carrier for primary immunodeficiency syndrome. The patient's concomitant medications were not reported. The following information was reported: VOMITING (non-serious), DIARRHOEA (non-serious) all with onset 29Jul2021, outcome "recovering", and all described as "vomiting and mild diarrhoea"; HEADACHE (non-serious) with onset 29Jul2021, outcome "not recovered", described as "Headache"; INFLUENZA (non-serious) with onset 2021, outcome "unknown", described as "wondering maybe she has a flu.".  Additional information: Caller states she received the Pfizer COVID vaccine on Monday at 1PM, Yesterday evening she was vomiting and had mild diarrhoea. Wants to know if this is due to the COVID vaccine, wants guidance on if she should get a second one. Caller states that she is a gene carrier for primary immunodeficiency syndrome, wondering if that could have something to do with her symptoms or wondering maybe she has a flu.   No follow-up attempts are possible. No further information is expected.
pt recvd vax & devel generalized sz, nystagmus, fever, high pitch screaming, bending head & back as far backward as possible, stiffing body, loss of appetite, low muscle tone, sleeping more than should, imflamation of the brain;
patient received an expired dose of Menactra from her provider on 03-Sep-2019, no AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient (age reported as possibly 20-30) who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired in June or July 2019) lot number not reported via unknown route in unknown administration site, on 03-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  It was a case of actual medication error due to expired vaccine used.  It was reported that a female of unknown age (possibly 20-30) said she received an expired dose of Menactra from her provider on 03-Sep-2019. Consumer reported the Menactra expired in June or July 2019.  At the time of reporting no adverse reactions were 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.  Information on the batch number was requested.  List of documents held by sender: none.
Child was sleepy and irritable, then complained of head hurting then body and tummy hurting. Curled in ball for 5 hours whimpering with eyes closed, would not play, eat or speak. Then began vomiting.
About 1 1/2cm X 7mm slight raised red lesion.  Warm, mildly tender to touch.
Patient is a 75-year-old female with history of asthma and hypertension who presents with a chief complaint of nausea and diarrhea. Patient states for the past week she has felt "lousy." She describes nasal congestion, productive cough, nausea, and diarrhea. She states she had a couple episodes of emesis which has since resolved. She is most bothered by diarrhea which she states has been "pouring out of her"for the past several days. She has been able to drink water but has not had much of an appetite. Denies fevers. Denies shortness of breath or chest pain. She went to her PCP who prescribed for azithromycin for an unspecified infection per patient. Patient denies sick contacts. She lives in a senior community. She was fully vaccinated for COVID with last dose in March.
Case PHEH2016US025988 is an initial spontaneous report received from nurse on 05 Oct 2016. This report refers to a 65 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with single dose of FLUAD (batch number: 166002) at a dose of 0.5 ml into deltoid on 29 Sep 2016. On the same day, the patient experienced fever and hard chills after vaccine at evening (night). On 30 Sep 2016, the events were completely recovered on next morning. The outcome of events was completely recovered on 30 Sep 2016. The seriousness of the events was reported as non serious. The causality of events were not reported. Follow up report received from nurse on 03 Nov 2016: Patient detail updated (age), event details (onset and recovery date, seriousness) updated and updated narrative accordingly.
Day after initial dose was extremely fatigued and could barely function.  Day 8 afternoon had a burning sensation and raised red bump over injection site and again was extremely fatigued.  The burning sensation and redness lasted rest of day and was painful but not unbearable
Swelling in the bicep; This case was reported by a pharmacist via call center representative and described the occurrence of muscle swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced muscle swelling. On an unknown date, the outcome of the muscle swelling was unknown.   It was unknown if the reporter considered the muscle swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that the patient experienced swelling in the bicep. The doses were given within the past 2 months from the time of reporting and the swelling started within day after the vaccination. The reporter did not have any further information about the patient. This case has been linked with case US2019AMR167772, reported by the same reporter.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency, route of administration and indication were not reported, lot # M004330 with expiration date: 26-JAN-2018). Concomitant medications were not reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Flu; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a patient (unknown age and gender) who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Next day site of injection red and raised.  Child "picking", probably itchy.  Redness is 5 cm. in diameter, enduration (hardness) is 10 cm.in diameter.  No fever.  No other symptoms.  Phone physician who ordered Benadryl orally.
A daughter reported that her 72 year old mother received an injection of Pnu-Imune 23 on 8/21/00. Later that day, she developed an injection site reaction characterized by swelling and "severe" pain. She also developed a headache, malaise and generalized pain. Additional information received from the physician on 10/16/00, indicated that the pt did not report this to the physician's office.