chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 50-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included belimumab (Benlysta) unknown for an unknown indication. On an unknown date, the patient received SHINGRIX at an unknown dose and Benlysta at an unknown dose and frequency. On an unknown date, less than a year after receiving SHINGRIX and unknown after starting Benlysta, 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 SHINGRIX and Benlysta. Additional details were reported as follows: The age at vaccination was not reported. Since two years patient was receiving Benylsta and about three months before the date of reporting, the patient received SHINGRIX. The patient broke out with Shingles. This case was considered as suspected vaccination failure case since the primary vaccination schedule was unknown at the time reporting.  The reporter agreed to follow up from GlaxoSmithKline.
rash around neck and chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash around neck and chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash around neck and chest). At the time of the report, RASH (rash around neck and chest) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  No concomitant medication was reported No treatment medication was reported
Itchy rash on right leg that moved to left leg, face, under left arm, both elbows & lower back on right side Gradually worsened on right leg until it was purple & swollen & with peeling, burning skin. Took prednisone three different times over the course of a month. Also got nauseous & sick one day with headache and extreme tiredness & loss of smell. Took covid test- negative. Went to dermatologist who said it was extreme dermatitis & Excema. Rx given of topical steroid. Symptoms subsided after 2 weeks. Still have excena on one elbow & face- forehead, ears & chin.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 04-FEB-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
6cm x 4 cm erythema over thigh at site at 36 hours after administration site of DTaP.
Body aches; Diarrhea; Severe headache; Vomiting; This is a spontaneous report from a contactable healthcare professional, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient did not had any allergies to medications, food, or other products. The patient received unspecified other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0202) via an unspecified route of administration in the left arm on 03Mar2021(at the age of 59-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was 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 31Mar2021, the patient experienced severe headache, vomiting, diarrhoea and body aches for four days. The patient received treatment for the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events of headache, general body pain, vomiting and diarrhoea was recovered on 04Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
had shot still got shingles/ suspected vaccination failure; Shingles; Very painful; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shot still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and still experienced shingles. The patient stated that it was very painful. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
No additional AE's and no PQC's were reported.; A nurse reported that an expired dose of GARDASIL 9 was administered to a patient.; This spontaneous report was received from  nurse and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions previous drugs reaction or allergies and concomitant therapies were not reported.  07-SEP-2022, the patient was vaccinated  with an expired vaccine of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Expired product administered) use as directed to prevent human papilloma virus infection, lot #T007024, expiration date: 23-APR-2022, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse event were reported.
This spontaneous report was received from Medical assistant regarding a 52-year-old patient of unknown gender. The patient's concurrent condition, medical history, drug reactions or allergies were not reported. On 10-APR-2018, the patient was vaccinated with a dose of PROQUAD lot # N010867 (dose, units, frequency and route were not reported) for prophylaxis and sterile diluent (manufacturer unknown) (lot number and expiration unknown by reporter). On the same day, the patient was also vaccinated with a dose of VARIVAX lot # N015476 (dose, units, frequency and route were not reported for prophylaxis and sterile diluent (manufacturer unknown) (lot number and expiration unknown by reporter). No adverse effects reported. No product quality compliant (PQC) was reported.
Pt vaccinated with MMR was 6 wk pregnant when received the vaccine. Subsequently delivered prematurely at 27 wk. FBW 750gm
Patients left deltoid area with a 1 cm bruise, and a much larger 5 cm X 6 cm area of erythema, raised and warm to touch, somewhat tender to palpation.
Approximately 10 days after vaccination, I experienced a severe Shingles outbreak.  The worst Shingles outbreak I have ever had, while I had previously had Shingles approximately every 5-6 years for the past 45 years.  The severity of this case was markedly different from any other Shingles outbreak I have ever had. Previously, I did have both the Varivax vaccination (approx 10 years ago) as well as two doses of the Shingrix vaccination (approx 3-4 years ago).
5/14/21 - day 1 after vaccine dose #2 - had fevers, body aches, chills, fatigue.  5/15/21 - day 2 after vaccine dose #2 - began to have chest pain that started out at 5/10 and then became constant and persistent sharp, 10/10 chest pain that was worse with lying back and improved with sitting up and leaning forward.  Pt went to Urgent Care, had ECG done and demonstrated ST wave changes where he was brought to ED and ECG confirmed ST/T wave changes and Troponin T was elevated to 1.62 - thus with these findings and the chest pain that was consistent with pericarditis - diagnosis of myopericarditis was made.
vivid hallucinations lasting 48 hrs.  saw clowns, ants on floor and crawling up walls,  Piles of dirt on floor and furniture that must be cleaned.  people sitting on furniture.  Man sleeping on patio, people having picnic in back yard,  backyard completely relandscaped.  floor covered in snakes and lizards, then bedroom full of puppies.  She became very agitated if you disagreed.  Insisted on  cleaning 'dirt'.  slept 2 hrs first night.  Second night finally went to bed at 4 AM.  Woke up at 10 AM and was fine.  She has bad knees, and they hurt from all the night's activities.  She was combative at times, and insisted that you help clean, sweep, remove 'snakes', etc.
This spontaneous report as received from a medical assistant refer to a 3 years old Child, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported). Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 29-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 29-Jul-2022).    No concomitant product use was reported. Patient received half dose. Vial did not undergo any temperature excursions. No treatment information was provided.
AFTER 2-3  WEEKS AFTER THE SECOND DOSE, STARTED FATIGUE, SOB, COUGHING CAME TO SEE ME, HAD CHF , REFERRED TO A CARDIOLOGIST DR, MD, WHERE HE HAD ECHO DONE WITH NML CHF AND SEVERE LVH.  HE HAD A COVID TEST NEGATIVE.
11 year old child returned to clinic with complaint of right arm swelling. Patient received influenza injection in right arm on 3/4/10. On 3/5/10 patient was evaluated and seen by MD. Prescription for KEFLEX 250mg PO every 6hrs x 1 week was given and patient was instructed to return to clinic in two days. Patient was seen on 3/8/10; resolved swelling and decreased redness was noted by MD. Patient to return to clinic in three days for follow up. Patient was instructed to complete medication and to report to emergency room if any increased swelling or pain occurs.
5 doses were given from a vial exposed to several temperature excursions; 5 doses were given from a vial exposed to several temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions) in an 87-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drug information was provided.
Some reason after vaccine side effects of joint pain, muscle soreness went away so did my hip pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program ]. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hip pain and inflammation in my right hip, muscle soreness and joint pain. The patient's concomitant medications were not reported. On an unspecified date, patient experienced some reason after vaccine side effects of joint pain, muscle soreness went away so did my hip pain. Patient inquired if vaccine boost her immune system. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
accidentally given an ADACEL vaccination instead of the intended varicella vaccination with no reported adverse event; patient receiving 2 Tdap vaccinations within 2 days with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 13 years old female patient who had accidentally given an diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] vaccination instead of the intended varicella vaccination and patient receiving 2 tdap vaccinations within 2 days with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for Prophylactic vaccination.  On 14-Feb-2023, the patient received 0.5 ml (milligram) (once) (standard: strength) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (With unknown lot number and expiration) via intramuscular route in the deltoid NOS for immunization.  On 14-Feb-2023, caller reported that patient had accidentally given an adacel vaccination instead of the intended varicella vaccination with no reported adverse event (wrong product administered) and patient receiving 2 tdap vaccinations within 2 days with no reported adverse event (inappropriate schedule of product administration) (latency: same day) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  It was also reported that Pharmacist asked if there was anything to look out for such as seizures so that he could inform the patient's parents?.  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both events.  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 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.
Several canker sores appeared. Has been 6 days and still have them.  Seems as if a couple more are developing.
Morning after shot lip swelled out to my nose! - Next day, sores appeared in mouth (upper lip area and gums inside mouth) had fever 1st day couldn't eat, went to dentist and he said rinse w/salt water and take BENADRYL - 2 more days no change - went back to Clinic and got strong antibiotics - Better now 2 weeks later.
Nausea & dizziness; next morning woke up with "crusty eyes", face slightly swollen, eyelids swollen, large puffy bags under eyes, "top of head from eyes up felt heavy", heart fluttering on & off for 2 weeks, tired & dizzy, slept 13 - 14 hours/day. Lasted about 3 weeks, broke out in fever blister 3 weeks later. Advised she see MD to culture the blister.
SEVER COLD; FEVER; SHORTNESS OF BREATH; THROW UP; COUGH; SEVERE BODY PAINS; WEAKNESS; CONSTANT HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 21 year old female. 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, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced throw up. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced severe body pains. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced constant headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021 20:30, the subject experienced sever cold. On 10-APR-2021 20:30, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever cold, and fever on 11-APR-2021, and had not recovered from constant headache, cough, shortness of breath, nausea, severe body pains, weakness, and throw up. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
A lot of leakage as dose was being administered/ dripped up to her fingers; Syringe was cracked; A spontaneous report was received from a consumer, concerning 32-year-old of old female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and where a lot of leakage as dose was being administered/ dripped up to her fingers as syringe was cracked.  The patient medical history was not reported. Concomitant medication was not reported.  On an unspecified date, prior to onset of events the patient received first of two planned doses of vaccine (batch: unknown) for prophylaxis of COVID-19 infection. On17-Feb-2021, the patient received second of two planned doses of vaccine (batch no unknown) for prophylaxis of COVID-19 infection.  On 17-Feb-2021 the patient experienced a lot of leakage happened in second dose. It dripped up to her fingers as syringe was cracked. Treatment taken information was not reported.  Action taken in to (mRNA-1273) COVID-19 in response to events were not reported.  The outcome of events a lot of leakage as dose was being administered/ dripped up to her fingers as syringe was cracked were considered resolved on 170-Feb-2021.; Reporter's Comments: This report refers to a case of Product administration error - Incorrect dose administered and Syringe issue for mRNA-1273, lot # unknown,  with no associated AEs.
Diffuse hives appeared on patients body several hours after receiving his first Covid vaccine.  Dad not sure if was less than 4 hours after vaccination. He had no breathing issues or vomiting. The hives lasted for 2-3 days.
This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Feeling like a bad flu), SECRETION DISCHARGE (lungs filled up and was able to hack out a lot of mucus), VACCINATION SITE PAIN (Sore left arm at the injection site), HEADACHE (slight headache) and NAUSEA (Nausea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0338214 and 007CZ4) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included DICLOFENAC DIETHYLAMINE (VOLTAREN [DICLOFENAC DIETHYLAMINE]) for Arthritis. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feeling like a bad flu), VACCINATION SITE PAIN (Sore left arm at the injection site), HEADACHE (slight headache), NAUSEA (Nausea), CHILLS (Chills on and off) and FATIGUE (Extremely tired). On 18-May-2021, the patient experienced SECRETION DISCHARGE (lungs filled up and was able to hack out a lot of mucus). On 20-May-2021, SECRETION DISCHARGE (lungs filled up and was able to hack out a lot of mucus) and HEADACHE (slight headache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Feeling like a bad flu), VACCINATION SITE PAIN (Sore left arm at the injection site), NAUSEA (Nausea), CHILLS (Chills on and off) and FATIGUE (Extremely tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information were not provided. Action taken with mRNA-1273 in response to the event/s was not applicable. This case was linked to MOD-2021-162274.