chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient demonstrated vasovagal syncope immediately after injection--- temporarily unresponsive to commands, loss of control of muscles, significant pallor in lips/face. After 15-20 seconds patient more alert, responsive to commands. After approx. 20-30 minutes of monitoring patient awake, alert, tolerating PO without problems, ambulates with steady gait. Mom at BS during event, monitoring patient at home.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were provided. No treatment was provided.   This case was linked to MOD-2021-395985 (Patient Link).
it has caused problems with my heart fluttering; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient reported that they got the vaccine (both shots) and it has caused problems with their heart fluttering on an unspecified date. The patient was on meds and they have tripled the dose over several months & still not helping. Their doctor now says they may have to have an ablation to stop this. This was not one of the side affects listed. They would never have got the vaccine if it was listed. The ablation is a painful procedure and has 50% chance of not working & possibly causing more complications. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report has been received from a Certified Medical Assistant (C.M.A.) referring to unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients had been administered unspecified doses of ROTATEQ (lot number, strength, route of administration and dose were not provided), that underwent temperature excursions. No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient would stand up in assembly and feel faint these progressively got worse where she passed out on a lacrosse field and soccer fields and was for a brief time unresponsive,concussions did occur with 2 of these episodes. Her pulse at times was weakly palpable and it would take minutes to arouse her. These epiodes got worse and more frequent after each dose of Gardasil. She was seen by cardiologist had 2 tilt table test, had cardiac monitoring and EEG. She was placed on beta blockers florinef and mitodrine. Nothing worked episodes increased all thru high school she was forced to quit sports. Till this day in elevators, hot situations close quarters she will faint. She is off all medicines because her cardiologist saw no improvement. 10/29/09:  Vaccination record received, VAERS updated.
Pain in arm, generalized muscle pain, low grade fever (99.5), loose stool, significant fatigue, mild  nausea, mild headache. I am not able to continue my daily activities. I read that this may last another 1-2 days.
At 10pm the night after receiving vaccines, she developed fever to 38C, parents gave tylenol at that time, 1 hours later she developed seizure-like activity which lasted 2-3 min, at which point she was brought to facility by EMS. Seizure activity resolved on its own, no medication or treatment given.
Pt presented with substernal chest pain and shortness of breath, pt tested positive for coive. Pt decided to leave AMA.
Skin discoloration/possible blood clot on right calf. Occasional tingling in legs and arms.
Nausea; Body aches; Headaches; Low fever; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247), intramuscular, administered in Arm Left on 26Apr2021 09:00 (at the age of 33-year-old) as single dose for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247), intramuscular, administered in Arm Left on 05Apr2021 09:00 (at the age of 33-year-old) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. On 26Apr2021 18.30, the patient experienced nausea, body aches, and headaches, with low fever. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a female who "in the past few weeks," was vaccinated with a dose of GARDASIL. "Last Week," on approximately 09-SEP-2008 the patient experienced a migraine headache. On an unknown date, the patient recovered from migraine headache. The patient sought medical attention by phone. Additional information has been requested.
my arm immediately began having to feeling of falling asleep/ It is from the injection site down to my fingers; my arm immediately began having to feeling of falling asleep/ It is from the injection site down to my fingers; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unspecified route of administration, in left arm on 22May2021 at 13:00 (at the age of 42-years-old) as dose 2, single for covid-19 immunisation. Medical history included HBP, anxiety and shellfish allergy from an unknown date. Concomitant medications included buspirone; sertraline hydrochloride (ZOLOFT); amlodipine and metoprolol taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unspecified route of administration on 30Apr2021 (at the age of 42-years-old) in left arm for covid-19 immunization. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 22May2021 at 13:00 after receiving second dose, her arm immediately began to have feeling of falling asleep. On 20Jun2021, her arm continues to fall asleep. She can be swimming, doing nothing, sleeping, typing, resting or driving and it falls asleep. It was from the injection site down to her fingers. The case was assessed as serious (disability). No treatment was received for event. Outcome of events was not recovered.   Information on the lot/batch number has been requested. Further information is expected.
Fever (height not documented @ home) temp 100.8 in Er; Probable sz w/in 24 hrs of DTP 30mins of unresponsiveness during sleep; abnormal resp
Patient was given COVID booster dose 4 months post-primary series instead of at 5 months after
came to ER 2-3-21 c/o rectal bleeding x 2 weeks now severe
Reported to sick call with erythema and induration at anthrax vaccine injection site.  Noted ~3 cm diameter induration Lt deltoid area.  Tx with Keflex 500mg PO BID 10 days, warm copmress tid-qid.
Received Gardasil at 9A 12-8-21 (only vaccine)  Arm hurt and on way back to school had a praline flavored coffee and Motrin. Came home from school end of the day felt chilled and like skin burning (no rash). Later got fever and chattering teeth, uncontrollable rigors. Mom said Temp 105 (not 100.5) went to ER next AM after vomiting. No labs, No IVP's. Zofran
Pt developed swelling and about 5 x 5 cm area of erythema in left thigh after vaccination.
Four days after getting my first dose of the Pfizer vaccine I woke up at around 5:40 with a stabbing chest pain and difficulty breathing. This lasted for 15-20 minutes. Day five I was fine, however day 6 the pain came back around the night time like at 9:00. Days 6 and 7 I had trouble breathing at night. Lastly today, 8/14/2021 I have had pain in my upper chest near my right side for 5-10 minutes.
heart issues started 1-2 months after 2nd injection and have been ongoing now ive been diagnosed with autonomic dysfunction???
Soon after receiving the injection in my left arm, acute pain persisted for greater than one month, A lump presented two days later. The lump is still present along with discomfort. I presented to the general surgeon for evaluation.  An ultrasound was performed. The ultrasound findings as noted below. The surgeon recommended continued observation. I am aware of the discomfort daily in my arm.
Hot to touch sensation; Itchy Sensation; Redness; Swelling; Pain near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch sensation), VACCINATION SITE PRURITUS (Itchy Sensation), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Pain near the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch sensation), VACCINATION SITE PRURITUS (Itchy Sensation), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Pain near the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 01-Feb-2021, VACCINATION SITE WARMTH (Hot to touch sensation), VACCINATION SITE PRURITUS (Itchy Sensation), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Pain near the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax 1MAR94 & 8MAR94 devel a fever, on 10MAR94 devel a rash following day pt was treated in ER & eventually recovered; No further details were provided;
Patient informed immunizer that he did not have food in the 6 hours leading up to vaccination. Patient felt light headed within 5 minutes after vaccination. Patient rapidly lost consciousness and fell down within 6 minutes after vaccination. Patient regained consciousness within 1 minute and was alert and talking. EMS was called and evaluated patient. Blood sugar was at 98. Patient was advised to go to hospital because they were feeling lightheaded and unable to stand on their own. Patient's caregiver declined ambulance and chose to transport patient to hospital or clinic themselves.
child recv vax 9APR97 & 2MAY97 mom of the child broke out w/chickenpox & was seen by a dermatologist;
no adverse event; a dose of VARlV AX was administered intramuscularly to the patient; This spontaneous report has been received from a nurse referring to a 3-year-old female patient. The patient's medical history, concurrent condition and concomitant therapy were not provided.  On 24-MAR-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, intramuscularly (strength was not reported) (lot number U015677 has been verified to be a valid lot number, expiration date: 18-MAY-2023) for prophylaxis (Incorrect route of product administration). No additional adverse event reported.
parent reported fever of 102-103 on the evening of 4/27/19 and some atypical behavior of child, possibly hallucinating, appeared dazed per parent report, possibly seizure like activity. He was not evaluated on the evening of 4/27 but was seen in Urgent care on 4/28 and exam documented was of an alert, playful child with anterior cervical adenopathy but otherwise non focal
Bell's Palsy; Ill-defined disorder; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 72 years old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 24-AUG-2014, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unspecified date, Plaintiff was treated by physicians in a healthcare facility for the following injuries resulting from Plaintiff's zoster vaccine live (ZOSTAVAX) use: Bell's Palsy and other zoster-related injuries. The outcome of the events was unknown.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Bell's Palsy was determined to be a medically significant event.
Patient came into pharmacy 2 days after the injection on 5/17/15 and was concerned about itching and redness at the injection site.  Pharmacist recc antihistamine and topical corticosteroid.  Patient used recommended products.  I spoke to patient on 5/20/15 to follow-up since I was out of office when she initially came in, and she said that the redness kept spreading up/down upper arm and was the worse on 5/16/15.  She kept using OTC products with relief.  She said it was most red in the center with lightening color as it moved outward, the outermost ring being light pink.  She said there was no blistering, no breaks in the skin, and no signs of infection.  No fever and no swelling at any other site in the body.  When I spoke to her on the phone on 5/20/15 she said the itching and redness was improving and she still did not feel it was infection related.
spoke w/mom red raised since inj;28MAY seemed to spread to 3in redness, x 3 pinpoint raised looking pustules in center, tender;no drainage;2JUN redness appearing dec in size negative itchy;sl swelling, arm tender;
Patient states temperature 102, achy all over starting at 2:30am 9/20/07. Temperature at 1:30pm 99.8.
Slight headache within 20 minutes of vaccine. Very sore arm pain radiating from injection site for 2days plus.
Varivax # 8-9-02, Varivax #2 9-16-08.  Broke out with multiple vesicles full body Sept 27, 28.
Tingling, numbness in limbs Hard to walk Pain in legs Hands and feet cramping for long periods of time
Patient had her second Hep B vaccine on February 13, 2017. Sometime after the vaccine, patient, told medical supervisor she didn't feel well. Patient consistently told medical staff for about a month to follow that she was having issues that she felt were related to the vaccine. Patient set an appointment with an opthalmologist for the following months of pain and illness due to almost going blind.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer survivor" (unspecified if ongoing); "Prostate cancer survivor" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM, start date: Jun2008. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Mar2023) Negative; (19Mar2023) Positive. The events were reported as non-serious. The patient received PAXLOVID as treatment for COVID-19 from 06Mar2023 to 11Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A report was received from a health care professional on 12/23/03 concerning a female vaccine in her forties who experienced a circular rash and swelling at the site of administration approximately 12 to 24 hours after receiving Fluvirin on 12/20/03. Approximately 12 to 24 hours after receiving Fluvirin on 12/20/03 the vaccinee experienced a red, raised circular rash with soreness or tenderness and slight swelling at the site of administration. The vaccinee was treated with 1% hydrocortisone topically and recovered 2-3 days later. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
vaccinate an 18 y/o patient with Engerix B adult dose.; vaccinate an 18 y/o patient with Engerix B adult dose.; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.      Additional Information: GSK receipt date: 05th September 2022 Reporters comment:   The reporter reported that the 18 y/o patient received Engerix B adult dose The reporter consent to follow-up. Additional Supportive information: The 18 y/o patient received Engerix B adult dose which led to Overdose and inappropriate age at vaccine administration instead
Hives all over torso/back, arms/under arms, legs/behind the knees, neck and chin. NO wheezing or shortness of breath.; itching; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 04Jun2021 at 08:00 (Batch/Lot number was not reported) (at the age of 13-year-old) as single dose for COVID-19 immunisation. The patient medical history included COVID-19 from an unknown date to an unknown date. No known allergies. Since the vaccination the patient has not been tested for COVID-19. The patient's concomitant medications were not reported.  On 04Jun2021 at 10:00, the patient experienced hives all over torso/back, arms/under arms, legs/behind the knees, neck and chin with itching. No wheezing or shortness of breath. The events were serious, medically significant. The events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL. The patient outcome of the events was recovering.  Information about lot/batch number has been requested.
Returned to clinic two days after receiving vaccines.  Right upper arm to elbow red and warm to touch.  No pain noted. No fever.  Keflex 250mg, TID x 5 days ordered.
I felt awful - body aches, chills, severe headache - especially back of neck, all of my body felt like it was super sensitive, as if everything hurt.  Felt like I had been run over.
Patient received her 2nd dose of Shingrix on 8/05/19 and went on to work Around noon , patient began scratching behind her knees snd left thigh. Patient thought it was mosquito bites. , but later noted they werewelts in appearance. She did not recall any side effects with first dose given. Patient denied any shortness of air nor difficulty breathing nor swelling of throat , tongue or lips swelling or tingling. States she was also a little nauseated during the night of 8/05/19. Patient denied any heart palpitations nor increased heart rate or weakness. . Patient reported the symptoms on 8/06/19 to primary physician Dr. who prescribed Benadryl for itching and hydrocortisone cream for welts. Patient was advised to call back if symptoms worsened or if respiratory symptoms started to seek ER.
The patient reported tingling in left side of face from left ear to chin area after first dose of vaccine. (The lot number for Dose #1 is not readily available. The Lot # for dose number 2 was provided in this report.)   She stated that after he left the gem to get in his car he chose to follow up on the tingling at home.  The tingling in the jaw near the ear reduced after several days but remained in the left lower jaw area and has continued until now.  The clinical nurse practitioner in the 2nd dose observation area asked patient to remove mask and there was no obvious paralysis in the left jaw area and no signs or symptoms consistent with typical Bell's Palsy presentation.  1st dose was in the left arm, 2nd dose was in the right arm.
Information has been received from a pharmacist referring to a 69 years old female patient. The patient's medical history, concomitant therapy and concurrent condition were not provided. On approximately 29-SEP-2016, the patient received an injection of PNEUMOVAX 23 (dose was unknown; lot number M036161 with expiration date 06-MAY-2018) on her right arm. On 30-SEP-2016 (reported as one day after receiving the injection), the patient developed a warm red raised rash on the back of her arm behind the injection site. The patient called her doctor (contact information not specified) and was given a prescription for an unnamed antibiotic, which she "filled on 10-OCT-2016". At the time of reporting, the patient was recovering from the events. The causal relationship between PNEUMOVAX 23 and the events was unknown. Additional information is not expected as there is no consent to contact the pharmacist.
Patient reports that she began to feel tremor, chills, tingling all over body, abdominal cramp and nausea.
It seems I experienced every listed side effect, save for fatigue. That included fever, muscle aches, brain fog, nausea, gastrointestinal distress
pt given vax 1/7/99; surgery at  hospital for intussusception 1/14/99;
extreme tinnitus - started as white noise, then high pitch, with occasional crickets sound; visited ENT, no fluid behind ears, took one round of steroids but it didn't have any effect