chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had shingles after shingles shots/suspected vaccination failure; bad case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (had the original shingles shot several years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shingles after shingles shots/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: bad case of shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient had a bad case of shingles last year even after having the original shingles shot several years ago and the new two shot series of shingles a couple of years ago.  The reporter stated that the TV (television) ads small print said it did not work for everyone-bummer. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
High fever; chills; body and joint aches; body and joint aches; severe headache; difficulty sleeping; diarrhea (1st dose only); lose of taste and smell; lose of taste and smell; This is a spontaneous report from a contactable other hcp (patient).   A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: E49899, dose 1 via an unspecified route of administration in right arm on 22Dec2020 at 15:15 as 1ST DOSE, SINGLE for covid-19 immunization (48-years-old at the time of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. The patient relevant medical history included asthma, back injury, drug hypersensitivity, allergies: NSAIDS, mushroom allergy, seafood allergy, (Allergies to medications, food, or other products: Yes, sodium benzoate, ASA, NSAIDS, mushrooms, seafood). The patient concomitant medications included Multivitamin, D3, Iron, Mg Citrat and flax seed oil. The patient previously took sodium benzoate and experienced drug hypersensitivity, ASA, and experienced drug hypersensitivity. On 04Jan2021, the patient experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, diarrhea (1st dose only), and loss of taste and smell. No treatment received for the adverse event. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. On 05Jan2021, the patient underwent lab tests and procedures which included sars-cov-2 test was negative (Covid test type post vaccination was Nasal Swab).  Follow-up attempts are completed. No further information is expected.
erythema, edema, warmth entire right upper arm urticaria over entire body.  No breathing distress and fever 100.4.
Patient presented to the ED and was subsequently hospitalized for Right distal ureteral calculus within 6 weeks of receiving COVID vaccination.
Since approximately 3/29/21 I have been developing many red raised rashes on my legs, mainly, but also on my arms, hands and sole of my right foot. Some of the rashes are painful, some are puffy. I've been taking an antihistamine once a day. I have taken photos, which I can submit if they would be helpful.
sore at sight of injection. red swelling continues to extend past injection site down the arm over night, face feels like swelling. after injection about 30 minutes felt confused a little foggy. overall felt odd so took two acetaminophen, 100 mg and went to bed, next day felt better but redness at site had spread down my arm, took two Benadryl and felt better Had only one Benadryl so took it. pharmacy will deliver more tpday and will continue and call doctor today.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: PATIENT EXPERIENCED DIZZINESS POST IMMUNIZATION. RESOLVED BEFORE 15 MINUTE OBSERVERSATION PERIOD COMPLETE. LEFT PHARMACY AFTER 15 MINUTES STATING IT HAD RESOLVED.
2nd dose not received between day 25-35 of the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not received between day 25-35 of the 1st dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not received between day 25-35 of the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not received between day 25-35 of the 1st dose) 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.   Patient went for second dose Pharmacist declined to the patient information due to HIPPA.   No relevant concomitant medications were reported.  No treatment information was provided.
pt recv vax 11NOV94 & 22NOV94 pt devel gen maculopapular rash & a fever of 102; reporter felt that there was a problem w/this particular lot;
severe redness at the injection site appeared 4 days post injection, diameter 20 cm, round shape, duration 3 days, vertigo 5 days post injection duration continois 20 hours, still present from time to time
body ache; weakness; Extreme nausea; feels like the flu; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (body ache), ASTHENIA (weakness), NAUSEA (Extreme nausea) and INFLUENZA (feels like the flu) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Stevens-Johnson syndrome and Breast cancer (removal and repair in 2013). Previously administered products included for Product used for unknown indication: Tylenol. Past adverse reactions to the above products included No adverse event with Tylenol. Concurrent medical conditions included Penicillin allergy, Drug allergy (Keflex,Stevens-Johnson syndrome reaction) and Irritable bowel syndrome. Concomitant products included VITAMINS NOS, FISH OIL, POLYCARBOPHIL CALCIUM (FIBER), CALCIUM, DOCUSATE SODIUM (STOOL SOFTENER) and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MYALGIA (body ache), ASTHENIA (weakness), NAUSEA (Extreme nausea) and INFLUENZA (feels like the flu). At the time of the report, MYALGIA (body ache), ASTHENIA (weakness), NAUSEA (Extreme nausea) and INFLUENZA (feels like the flu) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drugs were reported.   This case was linked to MOD-2022-588873, MOD-2022-589013, MOD-2022-589031, MOD-2022-589106 (Patient Link).
Dr is a family practice physician and our staff is very knowledgeable on vaccinations and proper dosing. Unfortunately dr entered an order for DTAP on a chart of a patient of age 11. The MA drew up to DAPTACEL (.5ml) and it was given to the patient . It was not realized until entered into MCIR. There was no reaction from the patient. We have verified no other steps need to be taken, other than retraining on proper age dosing of immunizations. Age stickers have been place on the shelves of our vaccines as reminders to the staff.
About nine hours after receiving the shot, I experienced a rather severe shaking and quivering sensation throughout my entire body.  This lasted until I finally went to sleep, at least an hour.  My body was "jiggling" is about the best way I can describe it.  It was rather scary.  Did not sleep well, had a fever and horrible body aches all day, headache, nausea, and extremely tired.  The quivering did not occur today.  I still have a slight fever (33 hours after receiving the injection)
excursions reached 52.6 F and the total amount of time out of range was 32.25 hours with no other reported adverse event; seven patients had been administered vaccines post excursion with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a consumer/non-hcp received on 26-Apr-2022.  This case involves 7 patients of unknown age and gender who experienced excursions reached 52.6 f and the total amount of time out of range was 32.25 hours with no other reported adverse event and seven patients had been administered vaccines post excursion with no adverse event while receiving vaccine IPV (VERO) [IPOL].  This case is linked to case 2022SA152239(CLUSTER).  The past medical history, medical treatment(s), vaccination(s) and family history of the patients were not provided.   Reportedly, temperature excursions reached 52.6 F and the total amount of time out of range was 32.25 hours with no other reported adverse event (product storage error). On an unknown date, the patients received suspect IPV (VERO) at unknown dose, formulation, frequency, route (lot T1E871M, expiry date: Oct-2022) in unknown administration site as prophylactic vaccination (Product administration error).  It was reported "Caller states that she called previously to report a temperature excursion. States that she needs to update time of the temperature excursion from 3420 minutes (57 hours) to 32.25 hours. Caller also reports that seven patients had been administered vaccines post excursion. Caller did not clarify which vaccines the patients received. This situation is reported as a medication error due to temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data and was due to human error."  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.  Additional information was received on 29-Apr-2022 from a consumer: Case updated from a non-valid case to a valid case. Event verbatim updated for product storage error. Event of product administration error added, Text updated accordingly.; Sender's Comments:  01078543:Please see inquiry #01078543 for General Vaccine information
Shortness of breath, near syncope, decreased hearing, fever 101.7 degrees F, fatigue, imbalance in standing but dizziness, soreness to right upper extremity( injection site), pallor lips and face Denies palpitation, nausea, headache.
Patient has been diagnosed with bicep tendinitis and has been prescribed exercises to complete over the next 3 weeks. Patient has been given the option to pursue physical therapy and cortisone shots if symptoms do not resolve in 3 weeks.
Shivering; cold sweat; This is a spontaneous report from a contactable pharmacist (Patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after the vaccination, the patient experienced shivering and cold sweat. The seriousness of the events was reported as non-serious. The clinical outcome of the events was unknown.  No follow-up attempts are possible; No further information expected.
Severe joint pain, chills, headache, extreme lethargy - lasted approx 36 hours
9/5 Pt. called today-to inform us of "possible reaction" to 7/28 vaccines. c/o arm pain at site of Hep. A inj.- "shooting pains" up and down arm, continuing for 2 days. Also had cold sx that wk. Saw PCP (7/30 who stated? if ocld or shot rxn since she "felt so ill all over" she had difficulty getting out of bed. "organs hurting when abd. pressure and back pains. Rested 2 days-no other sx.
Injection site is very sore; Low-grade fever; Slight headache; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 months before the time of reporting).   On 10th March 2020 18:00, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, fever, headache and muscle pain. On an unknown date, the outcome of the injection site pain, fever, headache and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, headache and muscle pain to be related to Shingrix.  Additional information was provided as follows: The patient received the shingles shot a day before reporting around 6 PM. The patient had a low-grade fever and a slight headache muscle aches and the injection site was very sore. The patient wanted to know how long should he/she expect the side effects to last.
Sore arm and a headache and was tired for 2-3 days after. Resolved after 2-3 days.
Pimple like bump on right arm (back of) blistered bloody drainage. Red rash on back of arm between elbow & blister. No fever, sweating didn't feel well. 1 red bump still on arm, very faint rash.
Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old female patient who only received ACTHIB portion of (mixed with reconstituted with sterile diluent) PENTACEL without the DTAP IPV portion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapies included Rotavirus and PREVNAR 13. Vaccines taken on an unknown dates. On 29-Nov-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number C5529AA via unknown route in left thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. It was not reported if adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain started in ankles, progressed to knees, hips, shoulders, elbows & settled in wrist for almost 1 wk. Ice cold inside & out w/ very strong tremors entire body shook for appox. 12 to 15 mins. Returned to Dr's office on 10/19/12. Seen by PA. Normal examination for "seizure" & no treatment received. I don't think I will receive flu vaccine in future years based on this reaction.
I started bleeding on 06/02/21 from what i though was a regular menstrual cycle and have been bleeding ever since. I have been to the Dr. twice, for heavy, abnormal bleeding and abnormal clotting . First Dr.  visit was on  06/15/21, bleeding for two weeks I was put on medication to control it, I was sent to do an ultrasound on 6/30/21, and had a biopsy done on 7/1/21.  Results pending until the 20th of July 2021.  To this date I am still bleeding however it is controlled by medication. If I skip my medication for a day I will start to bleed heavy. I have been bleeding for a month and ten days.
In patient's own words she states "MS flared after Pfizer COVID vaccine. She had severe rxn, it laid me flat on my back for two weeks, I was hospitalized, and it almost killed me."
I had the typical mild arm pain and body aches. The major adverse even that i noticed was severe depression. I would just cry for no reason. I had no symptoms the first 2 vaccines (not even arm pain), but this third one is really affecting me. I'm only reporting the depression because multiple coworkers and mentioned depression after their 3rd shot as well. it's been 3 days and I'm still crying for no reason.
Patient called call center 4/22/21. Pt c/o headache since Tuesday (4/20/21). Pt said she took 1tab tylenol yesterday without relief. Per pt, she received a pfizer covid-19 vaccine on Friday, 4/16 at expo. Pt said she had arm pain and felt very tired until Monday, when she started to feel "normal" and on Tuesday pt developed a headache and headache has been lingering since. pt was scheduled with urgent care provider for visit on 4/23/21.
Diarrhea, vomiting, chills, sore throat, dizzy spells.
Flu like symptoms; Sick and pain; Headache; Nausea; Sick and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), the patient's child.  A female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 13Mar2021, outcome "unknown", described as "Flu like symptoms"; PAIN (non-serious), ILLNESS (non-serious) all with onset 13Mar2021, outcome "unknown" and all described as "Sick and pain"; HEADACHE (non-serious) with onset 13Mar2021, outcome "unknown", described as "Headache"; NAUSEA (non-serious) with onset 13Mar2021, outcome "unknown", described as "Nausea".  Additional information: Patient has no fever.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I got covid-19 vaccine in campus 12/30/2020 around 11 Am . I felt sick around 11 pm (12 hours later , 12/30/2020). I felt dizziness , Chills , facial swelling and body aches for 24 hours . I took Benadryl and Tylenol  every 8 hours . I felt better in 1//1/2010  around noon.
Pt recv vax on 3/4/99; on 3/5/99 pt exp sore LA, swollen axillary node below vax site, macular patch at vax site w/ tissue atrophy
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 11:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 11:55 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 58.70 for dose administered on 02-Mar-2021 and 58.78 for dose administered on 30-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A administered on 02-Mar-2021 underwent temperature excursion with temperature range of 27, 29, 32, 33, 35, 36 degrees Fahrenheit from 09:00 AM to 03:00 PM. This vial was moved to fridge on 24-Feb-2021 and BUD date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021.  Batch number 019B21A administered on 30-Mar-2021 underwent temperature excursion with temperature range of 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and BUD date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.