chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 15-16 days after the vaccine, I developed a severe case of shingles.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via an unspecified route of administration in the left arm on 01Mar2021 at 15:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to food, medicine or other products. Concomitant medications taken within two weeks prior to vaccination included bupropion hydrochloride (manufacturer: WELLBUTRIN XL), losartan (MANUFACTURER UNKNOWN), quetiapine fumarate (manufacturer: SEROQUEL), lurasidone hydrochloride (manufacturer: LATUDA) and alprazolam (manufacturer: XANAX) all from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, about 15-16 days after the vaccine, the patient developed a severe case of shingles. The event resulted in doctor or other healthcare professional office/clinic visit. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of shingles and included treatment with Antiviral medication, steroid, pain medication. The clinical outcome of the event about 15-16 days after the vaccine, the patient developed a severe case of shingles was resolved with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
On 03/02 I experienced these mild symptoms: tenderness and soreness at the injection site, and fatigue.  On 03/03 I started to experience these symptoms starting at 9:00 AM, body aches, headache, chills, dizziness, awful taste in my mouth, runny nose, nausea, which worsened to vomiting starting at 11:30AM and continued every 15 - 20 minutes until I was taken to Hospital at 3:37PM and was treated in ER with an IV of 1000cc's saline,  IV Zofran, IV of Reglan, and 650mg oral Tylenol just prior to discharge.
Expired dose of ACT-HIB was administered with no reported adverse event; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via Media information (under the reference: 00826716).  This case involved a 15-month-old and patient receiving HIB (PRP/T) VACCINE [ACT-HIB] 4 days after the expiration date of the vaccine (expired product administered).   On an unknown date, the patient received dose of suspect HIB (PRP/T) VACCINE [lot UJ384ABA, expiration date: 15-Oct-2021] via an unknown route at the unknown administration site for prophylactic vaccination  It was a case of actual medication error due to expired vaccine use. (latency: same day)  It was reported "Caller states a dose of ACT-HIB was administered 4 days after the expiration date of the vaccine. Caller was looking for information in regard to possible adverse effects as well as if they need to re-vaccinate."  At the time of report, no adverse event reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was 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.
Employee reported on 1/11/2013 that she developed a non- painful lump to injection site approximately one month after receiving the flu vaccine. She was referred to a Worker's Compensation provider. Biopsy on the lump was performed on 8/29/13. The diagnosis was: atypical dermal and subcutaneous spindle cell neoplasm C/W dermatofibrosarcoma protuberans.
pt seen on 1JUN95 w/in 3 days hx fever to 103 w/mouth sore, few trunkal vesicles;
SWELLING & REDNESS AT SITE. INCREASED IN SEVERITY UNTIL PATIENT WAS BROUGHT IN BY MOTHER TODAY. MOTHER STATED SHE HAD BEEN PLACING WARM COMPRESSES WHICH COULD HAVE INCREASED THE REACTION. PATIENT GIVEN AN ICE PACK & AN RX OF BENADRYL. ADVISED TO RETURN TOMORROW FOR FOLLOW UP.
Sudden tightening in throat, SOB, turned red with difficulty breathing, then had severe diarrhea for several hours after.  EMTs called. Declined transport to hospital.
left arm kind of hurt; feeling sweaty; no appetite; laid in bed all day feeling drained; shaking inside; shaking; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PAIN IN EXTREMITY (left arm kind of hurt), HYPERHIDROSIS (feeling sweaty), DECREASED APPETITE (no appetite) and FATIGUE (laid in bed all day feeling drained) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001a21a and 046A21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ASTHENIA (Weakness), FATIGUE (laid in bed all day feeling drained), NERVOUSNESS (shaking inside) and TREMOR (shaking). On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm kind of hurt), HYPERHIDROSIS (feeling sweaty) and DECREASED APPETITE (no appetite). On 24-Mar-2021, ASTHENIA (Weakness), FATIGUE (laid in bed all day feeling drained), NERVOUSNESS (shaking inside) and TREMOR (shaking) outcome was unknown. On 25-Mar-2021, HYPERHIDROSIS (feeling sweaty) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (left arm kind of hurt) and DECREASED APPETITE (no appetite) outcome was unknown. Not Provided          Treatment laid in bed and took deep breaths
Nausea, muscle hurts, dizziness, joints aching, lesser muscle strength.
pt recv vax & devel rash-like sx, then developing welts;called MD told to given pt DPH & aveeno bath; 15JUL96 pt doing better only rash like sx;no fever;
Breast tenderness - left side; and swollen. Underneath the breast it got hard and tender; flesh was really sore. My arm hurt but the concern was my breast. He told me to tell me to monitor the reaction and I think I took ibuprofen. It was about a week into it, it went away.
if she can take the second dose after getting covid after first dose.; This is a spontaneous report from Pfizer-sponsored program. A contactable female patient of an unspecified age received of first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medication were not reported. The patient observed that took covid vaccine the same time she had Covid. Inquiring if she can take the second dose after getting covid after first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Very red 4" long 1" wide sub-derm rash U or V persisted 3 weeks. Area still sensitive to inadvertent touch.
Post vax, the pt developed significant irritability and crying for 8 hours. Child also had a local reaction to both thighs.
Case PHEH2015US019685 is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 30 years old female patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
Received Hepatitis B series. First shot, no reaction. Second shot, arm ached significantly. Third shot, whole body ached, felt weak in arms (resolved by next day).
Patient noticed an after taste when she eats peppermint or a tomato based food beginning 4-5 days after second dose. The patient describes those flavors as being blunted with a "Smokey" after taste.
pt recvd vax at approx 20 to 30 yrs old & was vaxed w/2 doses of MMR & lab eval revealed neg titers; No further detials were provided;
2wks post vax developed edema & a papular vesicular rash, extending fr neck to forehead area w/inc edema until seen 16APR91;
Patient received Tdap and Menactra vaccines and had a syncopal epidose within 3-5 minutes which lasted only a few seconds. He also vomited
Severe pain and weakness of rt. arm (vaccine administered in rt. arm), temp to 102po, severe headache with light sensitivity, generalized muscle pain / aches, projectile vomiting. Symptoms lasted for 48 hr. Malaise lasted for additional 48 hr. Missed 2 days of work. (Health Care Professional).
Five days after receiving the 2nd Covid-19 shot, Patient started experiencing heart palpitations that last several hours each day. After this went on for almost three weeks, she decided to visit the Urgent Care on March 18th. They did an ECG and detected bigeminy. Patient had never had this condition prior to the 2nd vaccine. She has experienced heart palpitations now for 13 weeks since going to Urgent Care. These are intermittent. She will have them for several days in a row 4 to 6 hours during each day then they will go away for a few days then return for several more days in a row. Overall during the 16 weeks since the heart palpitations started, she has experienced them on 80% of the days.
Patient was given TWINRIX instead of KINRIX originally. KINRIX given right after error was discovered patient had no adverse symptoms.
Symptoms of Purpuric Dermatosis to bilateral lower extremities  and Elevated blood pressure  Outcome diagnosis: Henoch-Schönlein Purpura (HSP)
Driver called out for help said she was feeling lightheaded.    Closed eyes.  Skin warm and dry. color pink. BP 110/60 P 96 Sat 99%  Would not talk.  had a slight jerking of right arm.   Driver states has done this before but not with first dose.  Starting responding and took drink.
the sores were so bad; shingles; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 66-year-old Elderly female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: E19266), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (at the age of 66-year-old), as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included sarcoidosis from an unknown date and unknown if ongoing. The patient had no covid prior vaccination. The patient had no Known allergies. Concomitant medication(s) included Prednisone; Azathioprine; Gabapentine and 'Hydoxychor''all taken for an unspecified indication, start and stop date were not reported. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9261), via an unspecified route of administration, administered in Left arm on 30Jan2021 (at the age of 66-year-old), as single for covid-19 immunisation and had sores on her left back hip. The patient had no other vaccine in four weeks. The patient had not been covid tested post vaccination. On an unspecified date in 2021, after the second dose, the patient experienced sores that were so bad and shingles. It was reported that the shingles was diagnosed after the second does when the sores were so bad, she went to her internist who referred her to dermatologist and was diagnosed with Shingles. The AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received to treat the events. The patient outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible, information. No further information is expected.
Patient received TDaP IM right deltoid on 10/17/17. On 10/23/17 he returned to clinic and reported "severe right arm pain that radiated to his rib cage and torso" B/L. States pain was 10/10 x 3 - 5 days and now 6/10, but arm pain has resolved and pain only in ribs.
Patient reported runny nose that started the next day after getting vaccine. And reported pain in rib cage 4 days later. She says the pain recurs when she breaths deep.
Low grade fever (100.2F), flu-like symptoms, headache started early morning (2am) 6/12/2019 resolved by 8am 6/13/2019 Injection site reaction including swelling, itching and redness started evening 6/11/2019 (3'' diameter by 6/13/2019) continuing at this time. Ibuprofen prn
Initial report received on 30 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a seven-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4143AA received on 23 February 2012, C4156AB received on 26 April 2012 and C4193AA received on 21 June 2012 (routes and sites of administration not reported). The subject developed a paroxysmal cough with a whoop on 19 July 2012, 28 days after the last dose. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 26 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 31 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 13 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Around 12 hours after receiving the 2nd dose I developed a fever, my average temperature has been 97.3 for the last month and I am currently at 101.2. I have taken ibuprofen approximately 2 hours prior to developing a fever.
The initial spontaneous case, was received from other health professional on 15-Oct-2017, concerning a 39-year-old female patient. The patient's medical history and concomitant medications were not reported. On 02-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT59305 (as reported), expiry date: 17-May-2018). On 03-Oct-2017, one day after vaccination, the patient had nausea and vomiting. It was reported that, the patient had not taken any treatment medications for the events. At the time of this report, the patient recovered completely from the events. The reporter assessed the events as non-serious. Non-significant follow up received on 23-Oct-2017: It was reported that, the patient had not taken any treatment medications for the events.
This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Equilibrium problems after booster/Reaction continued on & off for 1 week, after booster) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F210, 002B21A and 013A71A) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced BALANCE DISORDER (Equilibrium problems after booster/Reaction continued on & off for 1 week, after booster). On 30-Oct-2021, BALANCE DISORDER (Equilibrium problems after booster/Reaction continued on & off for 1 week, after booster) had resolved. No Concomitant medications were provided. No treatment medications were provided.
Swelling, increased local temperature and marked erythema of site of injection on 8/15/12 - swelling and erythema worsened involving entire ant. surface of the (R) thigh - on 8/17/12 - when I examined child - erythema/swelling/local increased temperature - from medical to distal 1/3 ant. surface of the thigh.
Hives noted on left side of torso, right abdomen, right inner thigh/groin, right ankle, and top of right foot that have continued from 10/27-time of reporting
Breakthrough COVID infection in fully vaccinated patient. Positive date 09/08/2021.
Patient complained of burning sensation immediately after receiving vaccine and progressively worsening arm pain over the course of a few day after vaccine administration. Patient states arm pain did not resolve and was seen at provider's office 6/17/21 stating she has decreased range of motion to left arm and continues with left deltoid pain. X-ray of left shoulder and humerus were ordered along with physical therapy.
Headache; feeling really tired; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 22Mar2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 22Mar2021, outcome "unknown", described as "feeling really tired".  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant concerning a 13 year old female who on 29-JUN-2007 was vaccinated (route and site not reported) with the 1st dose of the GARDASIL (lot# not reported).  On 24-Aug-2007, the patient was vaccinated (route and site not reported) with the 2nd dose of the GARDASIL (lot # not reported).  The mother of the patient stated that her daughter had had abnormal periods since the 2nd dose.  The patient's periods were irregular from August to November.  The patient's mother also said that her daughter was new to getting her period and was not sure if it was the vaccine or her body adjusting.  The patient last period was November 2007.  The patient did not receive medical attention via hospitalization nor an office visit.  Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11Aug2023 to 16Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.,Linked Report(s) : US-PFIZER INC-202300281623 same patient, different drug/event.;
Coughing started about May 5, 2021, confusion started on about May 8, 2021, put on oxygen in Emergency room on May 9, 2021.  Admitted to hospital where he stayed until his death on June 18, 2021.
DIZZINESS; ACHES/PAIN; ARM SORENESS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 03:30  around 15:30 vaccinated in left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced aches/pain. On 07-APR-2021, the subject experienced arm soreness. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, dizziness, headache, aches/pain, and arm soreness. This report was non-serious.
Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Latex allergy.    On 22-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 DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Around 20-30 minutes after getting the shot my throat felt weird. Almost like there was a lump in the back. It went away after a few hours.
Doses administered out of vial that went through excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Doses administered out of vial that went through excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses administered out of vial that went through excursion). At the time of the report, PRODUCT STORAGE ERROR (Doses administered out of vial that went through excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided    Reporter did not allow further contact