chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Regulatory Authority report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); agency report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in right 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: "immuno compromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "agency report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2)". Therapeutic measures were taken as a result of suspected covid-19. Patient received treatment with Paxloid for Covid 19, treatment start date, stop date: 22Apr2022 via oral route. Other medication in 2 weeks: Unknown. Adverse event: Wonderful result. Within two hours the patient's symptoms began to subside, and she was able to perform activities impossible hours before (as reported). Adverse event start date: 22Apr2022 (as reported). Adverse event start time: 02:30 PM (as reported). If treatment ae: No (as reported). Known allergies: Unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient presented with Wound Check to the hospital on 11/29/21 after a left below the knee amputation that she believes to be infected, as it is continuing to bleed. The patient explains that she is taking Doxycycline and Bactrim. She tested positive for COVID on 12/09.  Discharge plan was planed on 12/16. Pt remained very stable medically and asymptomatic for any covid related concern she wanted to finish her quarantine in the hospital and hence the discharge was  delayed and her stay for prolonged
Pt experienced immediate pain Lt upper arm that extended into upper Lt forearm and hand. Numbness/tingling immediately (-) weakness. Not subsided. (+) red left / elbow, Tinel ulnar nerve, tightness upper trapezius unit, (-) weakness, (-) swelling, aleve tx.
Information has been received from a nurse concerning a 22 month old patient who on 01-NOV-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# 670169/0339AA). The nurse mentioned that on 01-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Follow up information has been received from the registered nurse concerning the male patient with dermatitis, meningioma and no illness at the time of vaccination. The patient's medical history included bronchiolitis. The patient was vaccinated subcutaneously with lot# (670169/0339AA) dose 1 of VARIVAX (merck) on 01-NOV-2011 at 16:00hrs. No other co-suspects and no concomitant medications were reported. On 01-JUN-2012 the patient went to the clinic for rash described as "small vesicular appearing papules on an erythematous base, in various stages, on trunk, no lesions on palms or soles'. The patient was diagnosed with varicella. No lab diagnostics tests were performed. No treatment information was reported. The patient was seen on 10-JUL-2012 and had no rash, the outcome of the patient's events was reported as recovered. The relatedness for the reported events was not provided for VARIVAX (Merck). A lot check has been initiated. Additional information is not expected.
Pt here for 2nd dose of Pfizer. Pt states took 50mg  of Benadryl. Hx of allergic reaction to 1st dose, swelling throat and tickling sensation. Pt carries epipen as per PCP. PCP instructed Pt to take 50mg of benedryl 1 hour prior to vaccination. Pt did this. After dose today, Pt c/o tickle in throat and tongue. Pt noted to have horse speech but no other symptoms. PCP recommended taking additional 50mg benedryl if symptoms persist after 2nd dose. Called at 2:06pm. Arrived 2:10 and cleared at 2:12pm. Cleared for Pt to take another 25mg benedryl. Pt left at 2:35pm ambulatory and with speech back to baseline and driven home by husand.   VS at 2:05 BP 146/90 HR 72 Temp 97.8F O2 sat 100% on RA  VS 2:09 BP 112/70 HR 91 O2 sat 100% on RA
pain at injection site; body aches; headache; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 06Jan2021, the patient experienced pain at injection site, body aches and headache. Clinical outcome of the events was unknown.  Information about lot and batch number was requested.
Per mom one wk after had deltoid swollen, measured 3 x 2, still 2 wks after was red, itchy (mom has photos)
Dizziness, Fever, NauseaVomiting, chills, ocular pressure, fatigue Narrative: Employee states that he had vaccine on 12/23, starts having symptoms 3 days after vaccine. Employss noted nausea, fatigue, ocular pressure, chills and fever. Employee states he felt slightly better on day4. Symptoms worsened on day 5. Employee states resolution of symptoms as of 01/02/21.
consumer received a partial dose of the Pentacel described as the consumer only receiving the Dtap-IPV portion and not the ActHIB, no AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age patient who received a partial dose of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot, expiry date, route and site was not reported) as only receiving the DTAP-IPV portion and not the ACT-HIB, on 07-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting the patient had no adverse 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 Directive and Module VI of the 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. Information on the batch number was requested.
SWELLING OF INJECTION SITE. 4 INCHES WIDE BY 3 INCHES LONG. HOT AND HARD TO THE TOUCH.
Pfizer Covid vaccine - Second dose administered 4 days apart from first dose.  First dose 6/4/2021 Second dose 6/8/2021
pt recvd vax 10nov94; 13nov94 some numbness in hands; 14nov94 feet, legs, hands swollen; ringing in ears; 16nov94 face swollen;
25 yo female received 3rd dose GARDASIL on 4/16/10. She calls in today c/o that she felt approximately 1 hr after getting the shot. (she was under observation here x 20-25 min). C/o sickness, chest pressure->Went to ER 2 days later->no specific treatment. Currently asymptomatic.
I was 6 weeks pregnant at the time of vaccination. I later miscarried on 10/25/2021 (no heart beat at 8 week ultrasound). In November I observed heart palpitations that are always noticeable when I am at rest. On Dec 22 my PCP heard a heart murmur. I had an EKG on 12/29/2021 with PACs. I had an echocardiogram performed 12/29/2021 but at the time of this report, I do not have the results.
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On 05-AUG-2016 or 12-AUG-2016, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # M005714, expiration date 03-OCT-2017; strength, dose, frequency and route were unknown). The vaccines were exposed to temperature excursion of 11.5 degree Centigrade for 1 hour and 45 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
2"x3" diameter red raised area noted left arm Dtap injection site c/o pain (8/23/06). Rx: warm compresses (to area) and Tylenol (pain). Follow up office visit if worse.
Patient received PNEUMOVAX-23 vaccine in left arm on 9/12/18. (He received FLUAD in his right arm on this day, but that arm showed adverse reaction). Next day in the evening his left arm became warm, red, sore and had a low grade fever. Patient went to the doctor Friday afternoon and was diagnosed with cellulitis. He was given IV antibiotics Friday afternoon (9/14/18) and went back for a second course of IV antibiotics the following day.
She was instructed to sit on a  chair outside of the pharmacy for observation.   A bout  after 10 minutes  I heard someone is asking for help.  I  saw she was  sitting on the floor and complaining about dizziness and not feeling  good. We called 911.  She was able to talk to them and explain  her symptoms. Her mom came by  too.  they decided to take her . I called them  about 2.00PM.  and talked  to her mom. She was home and doing  well.
The vaccinator injected the vaccine in the right arm IM and as it was injecting, the needle disengaged from the syringe and some vaccine ran down the arm and the rest in the muscle. It is not known how much was injected into the site.It was a 0.5 ml dose of MOderna vaccine.
swollen lymph node; Hip ache; lower back aches; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 56-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: PGZER EP7534), via unspecified route of administration, in left arm on 20Mar2021 (at the age of 56-years-old) at 14:30 as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes and the patient was allergic to ace inhibitors. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21Mar2020 at 01:00, after the vaccination the patient experienced sore arm after first day, on third day i.e.,23Mar2021 with swollen lymph node in the same arm and hip and lower back aches. Therapeutic measures and treatments were not taken for the reported events. The clinical outcome of the events pain in arm, swollen lymph node, hip pain, and lower back aches was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Patient presented to Hospital ER via EMS with concern for febrile seizure that occured earlier that day.
Pt. started experiencing itching to hands, soles of feet & knees, day 2 after flu shot. Pain on points. Took BENADRYL starting on Saturday.
Fatigue, chills, temp, vomiting. ER admitted fluids meds. 5hr duration.
tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medications reported. no treatment details reported.
Patient developed Covid; Breathing dificulties; Hallucinating; Legs felt like rubber; Coughing; 104 fever; A spontaneous report was received from a consumer concerning a 79-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed COVID, 104 fever (pyrexia), hallucinating, legs felt like rubber (skin atrophy), coughing and breathing difficulties (dyspnoea).  The patient's medical history was not provided. Concomitant medications were not provided.  On 05 Feb 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 18 Feb 2021, patient was hospitalized for Covid infection. He had a fever of 104, hallucinating, legs felt like rubber, coughing, and breathing difficulties. Labs and treatment information was not reported.  Action taken with response to mRNA-1273 was not reported.  The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
I noticed whenever I ate anything I got bloated. I had terrible smelly gas. It was like when you have a stomach virus. It was continuous. It would come out randomly. I had no control over it. There was some diarrhea. In November I was prescribed an anti-spasmatic, hyoscyamine sulfate. Prior to that I was on an antibiotic, XIFAXAN. The other doctors were treating it as a symptom of irritable bowel syndrome. My colonoscopy did not show and evidence of irritable bowel syndrome.
This case was reported by a pharmacist and described the occurrence of arm soreness at injection site in a 21-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included arm soreness with previous flu vaccinations (Other). On 1 December 2013 the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 2 December 2013, 1 day after vaccination with FLULAVAL, the subject experienced arm soreness at injection site and unable to lift arm. The pharmacist reported the subject returned to the pharmacy noting that he has had continued arm soreness and inability to lift his arm since the day after received FLULAVAL on 01 December 2013. The subject had been applying ice and heat to arm, as well as taking ibuprofen. The pharmacist inquired about treatment recommendations. At the time of reporting the arm soreness at injection site and unable to lift arm were unresolved. Follow-up information received on 08 January 2014 via pharmacist who reported no action was taken with FLULAVAL. At the time of the report no other information was provided. The case was closed.
vaccination given at 1 pm. Pt began with lightheadedness at 9:30pm. Then patient developed shaking and chills. Skin hot to touch. headache onset 12 midnight. Complaints of " feeling lost"
Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 025B21A) for COVID-19 vaccination.     The patient's past medical history included Shortness of breath and Mastectomy (She has had a left mastectomy).   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization). The patient was hospitalized from 19-Jun-2021 to 21-Jun-2021 due to DYSPNOEA. On 21-Jun-2021, DYSPNOEA (Shortness of breath) had resolved.            No concomitant medications were mentioned.  No treatment details were reported.  Based on the current available information, the temporal association between the use of the product and the start date of the event appear unlikely, however, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information, the temporal association between the use of the product and the start date of the event appear unlikely, however, a causal relationship cannot be excluded.
'My' period is late by 3 weeks at the time of this report.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 12Apr2021, the patient's period was late by 3 weeks at the time of this report. The patient reported that usually it was very regular and had confirmed that she was not pregnant. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period was late by 3 weeks was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious spontaneous report of "we administered expired H1N1 LAIV" was received from a health professional concerning a 12-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 01-March-2010. On 15-March-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
p/vax pt exp pain @ inj site;by the next day the inj site was red, swollen & warm;pt seen by MD who noted that the deltoid muscle was swollen to nearly twice its nl size;also noted axillary lymphadenopathy;tx w/topical steroids, motrin, ice
Large red swollen lump, red, hot, tender, painful; no abscess; sore times three days.
Monday May 17: Started feeling mild but noticeable chest pressure. Tuesday May 18: Intense Chest pain/pressure late morning, calmed down by late afternoon. Wednesday May 19: Mild chest pain but not debilitating. Thursday May 20: Fully recovered.
Small bump at injection with minimal redness around site (L) thigh. Given prescription for BACTROBAN 2 % oint. Apply TID to affected area.
soreness at injection site, started about 5 hours after injection, lasted 18-24 hours
02/13/22 presents to EC ED for "right foot pain". PMHx of "depression and GERD".
10/12 4:30am child given H2O and burped,mother then heard noise and came back to the baby with back arches, foaming at moth (saliva, not food or milk) and Stiff. Mother picked up baby and gently shook her and she relaxed. She then had another similar stiffening episode. Total time about 5 minutes.  MR from Pediatrcian received which revealed that 2 days following vax with Pediarix, Prevnar, and HIB, infant was found by mother not breathing.  She was stiff, with back arched, and foaming at the mouth.  Infant would breathe when shaken, but would intermittantly stop.  911 was called. In the hospital pediatric GI, Neuro, and Cardiac work ups were negative.  Infant was D/C'd home on an apnea monitor. No further episodes noted. Hospital MR received for admission as above for an ALTE. Discharge DX: R/O seizure vs. apnea vs. reflux vs. arrythmia.
Joint pain and swelling in both wrists and fingers. Joint pain in shoulders with limited range of motion. Chronic fatigue.
FAINTED; BROKE OUT INTO COLD SWEAT; URINATED MYSELF; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 29 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included: drug allergy (drug type not reported). The patient had no medical history and concurrent conditions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not on any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 and since the vaccination the patient had not tested for COVID-19. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number not reported, dose number 1) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN, dose number 2) dose was not reported, 1 total, administered on 17-MAR-2021 18:00 on left arm for prophylactic vaccination which was an off label use and the second dose was an inappropriate schedule of vaccine administered (dose number in series 1).  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label use and inappropriate schedule of vaccine administered was not reported. Non-company suspect vaccine included: BNT 162 (Dose number in series 2) (batch number: FH8027,form of admin and route of admin were not reported) dose was not reported, administered on 21-DEC-2021 14:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 22-DEC-2021 at 11:30 AM, the patient experienced broke out into cold sweat, fainted and urinated myself in barbers chair while getting a haircut (Dose number in series was 2).  The action taken with BNT 162 was not applicable. The patient was recovering from broke out into cold sweat, fainted, and urinated myself. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20211259337-covid-19 vaccine ad26.cov2.s-Fainted. This event(s) is considered unassessable. 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).
Care given state he c/o arm being very sore and stayed in bed for the morning the next day. Was not reported till 02/11/05.
Fever of 103- 2 days resolved Body Aches- 2 days resolved Vertigo - 1 day resolved Loss of appetite - 8 days and going.  I lost my appetite after the 2nd shot and 9 days later I still have no desire to eat.  I am not nauseous, just not hungry even when I physically must be hungry
Swelling on arm, neck, side and shoulder, along w/pain, soreness, and patient feeling sick.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 28-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.