chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Oral thrush; soreness in throat and mouth; soreness in throat and mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 77-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration on 20Feb2021 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration on 27Jan2021 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Feb2021, the patient experienced oral thrush after second dose and woke up with soreness in throat and mouth. Therapeutic measures were taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events oral thrush, soreness in throat and mouth was recovering (as of 11Mar2021).   No follow-up attempts are possible. No further information is expected.
On 3-28-2008 patient received Dtap, Hib, Prevnar (PCV7) and Rotateq. Mom called office on 4-1-2008, stated on 3-30-2008 and 3-31-2008 noticed he had a spasm -neck, arms,  legs got stiff all of a sudden, for few seconds, no fever, suggested appointment. Patient seen 4-2-2008 by Dr. Doctor ordered labs (CBC w/dif, Mg, ionized Ca and CMP) and EEG (awake and asleep, if possible, within 1 week).  Also diagnosed oral fungal infection, nystatin suspension ordered and topical yogart to mouth.  On 4-2-2008 EEG set up for 4-8-08. Mom called on 4-7-08 requesting referral to Pediatric Neurology. Dr reviewed labs and agreed to refer to Peds Neurology, labs slightly increase Mg, Calcium, slightly increased eosinophils. Dr request patient be rechecked tonight at office ASAP or ER if mom thought patient having repeated seizures. Also request repeat electrolytes. Patient seen 4-7-2008 by Dr. Dr diagnosed Status Epileptic, requested Vaers be done and admitted to Medical Center. 8/6/08-records received for DOS 4/7-4/8/08-DC DX: Motor overflow/benign infantile spasms. Presented with spasms of upper extremities over past 8 days.
In August of 1999 pt experienced an ear infection with some stuffiness and an occasional cough. Pt also experienced malaise. On 09/04/1999 the pt started breaking out in a rash on the arms and trunk. The rash consisted of lesions that were round, red and pustular in the center. On 09/07/1999, pt experienced dermatitis with scattered mildly pruritic vesicles surrounded by an erythematous base. By 09/29/1999 the scabs were broken but pt was still having new rash breakout. A few nonspecific erythematous lesions were noted. They were not vesicular. Varicella titer was negative. Pt has sinusitis at the time. The pt also experienced a low grade fever.
I started getting symptoms of sore throat, runny nose, and headaches. My symptoms progressed and I had chest congestion with coughing. I took an at home COVID-19 test that was positive. I contacted my doctor and was told to treat the symptoms with OTC medications. I took Tylenol and cough medication. I did not seem to be getting better and my lungs hurt so I contacted my doctor again and was prescribed a steroid for 7 days. The steroids did help.
Red spots-face, head in hair, back, neck, stomach, groin area, arms and legs. Noticed today 1-24-07 at approx 12pm
Patient developed itching over chest and arms and stated she felt warm and mildly dizzy.  No hypotension, respiratory or GI symptoms to constitute anaphylaxis; deemed to have hives + mild vasovagal symptoms. Symptoms improved with administration of 25mg benadryl. Patient was given strict ER precautions given history of anaphylaxis to other medications in the past and patient was given rx for epi pen for home use if needed.
after giving the first dose it was noticed that we used an expired vial with no reported adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender patient and it was reported that "after giving the first dose it was noticed that we used an expired vial with no reported adverse event " and it involved vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED , (lot number: not reported  ; expiry date: 30-Jun-2021) via unknown route in unknown administration site for immunization.  It was reported by healthcare provider and their site was administering flu vaccines on 17-Oct-2022, after giving the first dose it was noticed that we used an expired vial with no reported adverse event (expired product administered) (latency: same day)  Action taken : not applicable.  Outcome: unknown   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.
This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP7534, Expiration Date- 31Jul2021) via an unspecified route of administration in left arm on 23Mar2021 11:15 as 1st dose, single dose (at the age of 51-years-old) and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8729, Expiration Date- 31 Jul 2021) via an unspecified route of administration in left arm on 13Apr2021 11:15 as 2nd dose, single dose for COVID-19 immunization. Vaccine was not administered at Military Facility. Patient did not receive any prior vaccinations within 4 weeks. Patient medical history included that she was over-weight. The concomitant medications were not reported. Patient is the only girl in the house and she noticed after her first dose she skipped her period that month (Apr2021), her period did not come, which does not happen to her. Patient added her period is every 26 days pretty reliably. She had a period 09Feb2021 and 06Mar2021 and she did not have period again until 29Apr2021 which was 28 days later. She skipped it sometime in early April, clarifies she should have had her period on 01Apr2021. After 29Apr2021 she got it 16 days later and now she is waiting for her next period. She did not know if her next period would be normal or not. She did not know if her body was readjusting. She did not think anything of it until she started hearing things here and there about vaccines affecting periods and vaccine shedding. On 23Mar2021, patient experienced soreness in her arm which was hurting. On 24Mar2021, she was also very tired and had joint aches/body aches. Around 11 days after first vaccine (on 03Apr2021) she had stomach issues, like diarrhea for 4 days or something. She did not eat anything weird or unusual. No one else had it so it could not be a virus. She mentioned it to them and asked could it be a side effect of the vaccine and they said sure, it could be. The adverse events did not result in the emergency room visit of physician office visit. The outcome of the event skipped period was unknown, of the event stomach issues/diarrhea was resolved on 07Apr2021, while for other events was resolved on an unspecified date in Mar 2021 (reported as 25Mar2021 or 26Mar2021). No follow-up attempts possible. No further information expected.
No adverse effects were reported; improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.  On 04-NOV-2019 or on 05-NOV-2019, the patient was vaccinated with an improper stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot# S004253 with expiration date on 21-OCT-2020 per oral for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of lowest temperature below 36°F/2 degrees Celsius (1.3C) for 2 hours 18 minutes with no previous temperature excursion.  There was no adverse effect reported.  This call was because of a data logger.  This is one of two reports from the same reporter.
Swell; Itchy; Red; Tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swell), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Tender) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swell), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Tender). At the time of the report, VACCINATION SITE SWELLING (Swell), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she takes other medications, but they weren't provided. No treatment details reported.
Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 7A7H4, expiry date 19th September 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The reported lot number 7H7H4 was updated to 7A7H4 as per sales data sheet. The medical assistant called to report that the patient experienced Shingles after having 1st dose of Shingrix. The reporter consented to follow up.
Pt recvd series of 3 hep B vax on 13NOV89,13DEC89 & 09MAY90. Titer 11-JUN-90 indicated pt non-responder.Pt recvd 1st booster 29JUN90 & 2nd 13AUG90 & titers p/ each indicater pt non-responder.
feeling off; light body ache discomfort; light body ache discomfort; left arm swollen-pain; left arm swollen-pain; headache; fatigue; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261), via an unknown route of administration on 03Feb2021, 13:15, Left arm at single dose for covid-19 immunisation at Hospital. The patient was not pregnant. Medical history included Diabetic type 2, HBP (high blood pressure), Depression. Not aware of known allergies. Concomitant medications received in two weeks included losartan 50mg, escitalopram 10mg. The patient didn't received any other vaccine in four weeks. Historical vaccine included first dose (at the age 52 years) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) on Left arm on 13Jan2021 19:00 at single dose for covid-19 immunisation. The patient experienced fatigue, headache, feeling off, left arm swollen-pain, light body ache, discomfort on 03Feb2021 at 19:00. No covid prior vaccination. Covid wasn't tested post vaccination. No treatment was received for events. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Nausea and vomiting, shivers, headache, pain at injection site, leg and feet cramps.
COVID-19 INFECTION; FATIGUE; YEAST INFECTION TO THROAT (FOOD TASTES BAD, THROAT DRY); YEAST INFECTION TO INNER EAR; 40LB WEIGHT LOSS SINCE VACCINATION; VERTIGO; ULCERS ON THE BACK OF TONGUE; LOSING VOICE; This spontaneous report received from a patient via a company representative concerned an 8 decade old female. Initial information was processed along with the additional information received on 03-MAY-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: UNKNOWN) dose was not reported, 1 in total, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The reporter could not recollect exactly when the patient's symptoms began, but stated that, the patient recollected that, the symptoms began in the week following receiving the JNJ Covid-19 vaccine. The reporter mentioned that, it was unknown to what extent the reported symptoms had resolved, if at all. On MAR-2021, the patient experienced yeast infection to throat (food tastes bad, throat dry), yeast infection to inner ear, 40lb (18.14 kilograms) weight loss since vaccination, vertigo, ulcers on the back of tongue, losing voice, and fatigue. Laboratory data included: Weight (NR: not provided) lost weight 40lb. On OCT-2021, the patient experienced covid-19 infection. The reporter stated that she was told the patient's family physician was aware of the patient's complaints, and the patient sought physician office visit for the reported events of yeast infection to throat (food tastes bad, throat dry), yeast infection to inner ear, 40lb weight loss since vaccination, vertigo, ulcers on the back of tongue and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the yeast infection to throat (food tastes bad, throat dry), yeast infection to inner ear, 40lb weight loss since vaccination, vertigo, ulcers on the back of tongue, losing voice, fatigue and covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000229232.; Sender's Comments: V0: 20220458906- covid-19 vaccine ad26.cov2.s- yeast infection to throat. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Info has been received from an RN concerning a 9 year old white male who on 6/25/01 was vaccinated SC in the left arm with the 1st dose of varicella virus vaccine live (lot 638497/1905K). The RN reported that on 1/21/06, the pt developed 5-10 lesions on his trunk and 2 lesions on his face that were at various stages. The pt was seen by a physician and was treated with Benadryl and Aveeno. No laboratory/diagnostic tests were performed. In 1/06, the pt's lesions resolved. No further info is available.
Pt complained of feeling nauseous and faint, with ringing in the ears and visual disturbances. Pt vomited. BP110/68 O2 100% RA P 86 RR16 Pt reported feeling better " a lot better" after resting and left the vacc site at 1250 pm
Initial report received on 27 January 2012 from a patient. This case is not medically confirmed. A 63-year-old male patient had received a first left arm dose of ADACEL (lot number not reported) on an unspecified date and about 5 minutes later had blood work drawn for continued follow-up care that revealed elevated blood sugar in the 200s. The patient stated he always runs in the 100s. Two days later, the patient had a HbA1C test completed which was a little high but in the range for a non-diabetic. The patient reported no other reactions. The patient had no concurrent illnesses at time of vaccination, and reported allergies to Penicillin, morphine, and ALLEGRA. He has a history of high blood pressure for which he takes a "high blood pressure pill". The patient declined to provide any other contact information, stating he did not want anyone contacted any further for this reaction. At the time of this report, the patient had recovered (date unspecified). No further information is expected. Documents held by sender: None.
(L) leg swelled from groin to ankle for 4 days when swelling subsided, got hives along the left side of his body for 3 days.
shaking/tremors in hand and arm that the vaccine was administered in for ~8-12 hours after receiving vaccine
About 10 mins into her OBS time her father who was sitting with her reported she told him she's not feeling good.  She c/o feeling dizzy and weak all over with no pharyngeal complaints initially  1215- 99%, HR, 180/120, A and O x 3, no pharyngeal erythema or swelling, uvula midline with no obvious swelling or erythema, speech is clear., PERRLA 1220- she's now c/o throat feeling different, speech started getting slurry, informed both patient and her father will initiate 911 to transfer to the hosp for further evaluation and management to prevent any further complications and both agreed. 99%, HR 85, color is clear with brisk cap refill to all fingers , moves extremities, lungs CTA,  1225- 158/90, 99%, 85 alert and oriented, sx no change. 1226- I don't think Epi is required at this time but medicated with bernadryl 25mg po due to still c/o throat not feeling good with no swelling on exam. stated weakness is better but still feels dizzy. 180/120, 99%, 80 She takes medications but unable to tell me what she takes. 1236  there is visual jerking of BUE, she was still answering questions appropriately.  she stated she feels jerky, looks pale, 168/98, 99%, 83.  1237- EMS arrived, she is alert oriented, no pharyngeal swelling or erythema with uvula midline.  1243- She was able to get up to strecher but looks very weak, EMS left and she was still in a stable condition, reassurance provided to his father. She tolerated water throughout until EMS arrived and care transfered. They left with patient in a stable condition.
Tingling down spine, arms and legs. Hands and feet numb and chest heaviness. These symptoms present 8 hours. Told pt to call 911 or go to ER.
pt recvd vax 14JAN93 & 5NOV93 lab eval showed HBsAg as well as anti-HBC to be pos; pt dx as having hepatitis bilirubin 12.7 & SGPT 1700;
mom presented to ER w/ c/o vomiting x 3 since evening, recvd DTP @ clinic earlier in afternoon; reports cold sx for 3 wks t103 in ER & redness & swelling lt thigh; mom reported that pt had unusual high pitched cry x several hrs;
On 2/17 mother reported that the left arm had become red and swollen after vaccination. She called Hospital ER, bud did not report this to me until 2/17 when she was in for a flu visit for another problem and this was mentioned as an after thought at the the end of the visit. On 2/17 child still had some induration of approximately 2 cm diameter but no redness and no obvious tenderness. No treatment given. I will recheck this on 2/27 when she returns.
This spontaneous report as received from a pharmacist refers to a 66 year old female patinet. On 31-AUG-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J009827, expiration date: 10-AUG-2014) (dose, strength, route were unknown) which was expired. No adverse effect reported. No PQC reported. Additional information has been requested.
dress syndrome; Burning sensation in skin; itching; Full body rash; Rash on feet and hands; Redness; This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (dress syndrome) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stevens-Johnson syndrome. Concurrent medical conditions included Eczema (Treatment of prednisone caused weaker skin and more breakage) since 1994, Psoriasis (Treatment of prednisone caused weaker skin and more breakage) since 1994, Anxiety since 15-Jan-2021 and Drug allergy (Lamotrigine allergy). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 15-Jan-2021 to an unknown date for Anxiety, DESOGESTREL, ETHINYLESTRADIOL (APRI) for Birth control.   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) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (dress syndrome) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced SKIN BURNING SENSATION (Burning sensation in skin), ERYTHEMA (Redness), PRURITUS (itching), RASH (Full body rash) and RASH (Rash on feet and hands). The patient was hospitalized from 26-May-2021 to 03-Jun-2021 due to DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS. The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form; PANTOPRAZOLE for Adverse event, at a dose of 40 mg once a day; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, prn and ACETAMINOPHEN for Adverse event, at a dose of UNK, prn. On 12-Jul-2021, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (dress syndrome) had resolved with sequelae. At the time of the report, SKIN BURNING SENSATION (Burning sensation in skin) and PRURITUS (itching) outcome was unknown, ERYTHEMA (Redness) and RASH (Full body rash) had resolved and RASH (Rash on feet and hands) had not resolved.            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.   This case was linked to MOD-2021-219189 (Patient Link).; 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.
Have not gotten my period for 5 months since receiving the vaccine. No cramps, no blood, nothing.
Hives for over 2 weeks - (Also had corn for the first time this day).