chrisvoncsefalvay/vaers-outcomes huggingface dataset:
raging diarrhea; This is a spontaneous report from Pfizer-sponsored program Pfizer . A contactable consumer (patient) reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported) an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. After receiving my first shot, the patient developed raging diarrhea. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient presented with generalized weakness, malaise, shivering, chills, being off balance, worsening memory issues and subjective fevers. Upon admission found to have hyponatremia. Also found to have thrombocytopenia, leukopenia and diagnosed with Hemophagocytic lymphohistiocytosis (HLH), hypofibrinogenemia secondary to HLH.  Patient remains hospitalized and has been started on etoposide & dexamethasone per HLH-94 protocol.
I had a sore arm for about two days after receiving the vaccine. I tested positive for COVID-19 on 05/23/2023. I contacted my doctor via telehealth and got a prescription for PAXLOVID. I have all the side effects listed for PAXLOVID. I also have a tingling in my arm and a rash. I was advised to keep taking it unless I have worse symptoms.
This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (dose left out at 2:36 pm administered at 9:00 am the next day) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch#  unknown) for COVID-19 immunization. No medical history reported. On May 14, 2021, patient received second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On May 14, 2021, patient administered expired product (dose left out at 2:36 pm administered at 9:00 am the next day). At the time of the report, administered expired product (dose left out at 2:36 pm administered at 9:00 am the next day) outcome: unknown. Concomitant product use not reported. No treatment details added.
2 weeks from vaccine large blister on big toe, tiny blisters on right toes; pins and needles; red dots on both feet; rash & hives whole body, pins & needles; rash & hives whole body, pins & needles; chills; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613) dose 1 via an unspecified route of administration, administered in the right arm on 25Mar2021 15:30 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia and allergy to sulfa. Concomitant medications included methotrexate, celecoxib (CELEBREX),  metoprolol and duloxetine. The patient did not receive any other vaccine within 4 weeks. The patient did not have COVID-19 prior to vaccination. The patient did not test positive for COVID-19 after vaccination. Exactly 1 week after the vaccine on 01Apr2021 at 19:00, the patient experienced red dots on both feet, rash and hives whole body, pins and needles, chills. Two weeks after the vaccine, the patient had a large blister on big toe, tiny blisters on right toes. This resulted in a Doctor or other healthcare professional office/clinic visit. The patient was treated with an injection of Solu Medrol. The outcome of red dots on both feet, rash and hives whole body, pins and needles, chills, blisters was not recovered.
This spontaneous report has been received from a medical assistant refers to a 14 year old female patient. On 27-JUN-2014 at 05:08 PM the patient was vaccinated with the first dose of GARDASIL (dose and route not reported, lot # J013323, expired date: 12-FEB-2016) in the right deltoid that was improperly stored. There was no illness at time of vaccination or pre-existing allergies, birth defects, medical conditions. There was no adverse event following prior vaccination. Medical assistant confirmed that GARDASIL was administered according to the dose and route recommended in the prescribing information. No adverse effect were reported. No product quality complaint (PQC) was reported. This is one of several reports from the same source. Additional information is not expected.
ipol was administered to a patient intradermally with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 52 years old female patient who experienced ipol was administered to a patient intradermally with no reported adverse event while receiving vaccine Ipv (Vero) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2022, the patient received a  0.1 ml once of suspect Ipv (Vero) Suspension for injection (strength: unknown) (batch number: V1A022M and expiry date: 17-FEB-2024 ) via intradermal route in left forearm for immunization  On 26-SEP-2022 the patient developed a non-serious ipol was administered to a patient intradermally with no reported adverse event (incorrect route of product administration) same day following the administration of Ipv (Vero).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event ipol was administered to a patient intradermally with no reported 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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
TOUNGE SWELLING , FELT HOT  5 MIN AFTER POST INJUCTION.  EPINEPHRINE GIVEN.  ED VISIT
p/vax mom given education red: vaccines; they advised around the clock APAP for the first 1-2 d p/vax; pt died
Client awoke 4/12/10 extreme body pain both thighs and upper arms and weakness which lasted 7-10 days states high BP x 10 days. Saw MD 4/14/10. Started TYLENOL TID on 4/14/10 - helped some with pain. No fever until 4/21/10. Still c/o hamstring pain.
Lightheadedness Tingling and swelling to left arm ( injection site)   NP applied pressure to injection site and swelling to left arm resolved.
No additional AE.; an improperly stored vaccine was administered to a patient / freezer out of temp range; This spontaneous report was received from a registered nurse and refers to a 20-month-old (reported as 19-month-old) female patient. She was a premature baby (36 weeks, 3118 grams birth weight). The patient had no medications, allergies, medical or surgical history. She had no siblings.  On 18-OCT-2022, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) (first dose) 0.5 milliliter via subcutaneous route in right vastus lateralis, lot #W005206, expiration date 14-FEB-2024, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (first dose) via subcutaneous route in left vastus lateralis, lot #U022983, expiration date 22-JUL-2023 (exact dose was not reported), hib vaccine (HIB) (fourth dose) via intramuscular route in left vastus lateralis, lot #335N9, expiration date 25-MAY-2023 (exact dose was not reported), diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) (fourth dose) via intramuscular route in right vastus lateralis, lot #LS444, expiration date 16-SEP-2023 (exact dose was not reported) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (fourth dose) lot #FMS700, expiration date 31-JUL-2024 (exact dose, injection site, route of administration were not reported) for prophylaxis.  Administered doses of vaccines experienced the temperature excursion of 10.8 degrees Fahrenheit (F) for 18 hours 30 minutes. Freezer failed, the vaccines were moved to the back up location. Temperatures out of range multiple times due to odd cycle. The reporter was not aware of excursions until 21-OCT-2022. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There was no adverse event reported. No prescription drug treatment for the experience was required. The medication error occurred during storage in clinical practice. After excursion found, no further doses were given. The vaccines were not available for evaluation. The single use vaccines were used according to the instruction leaflet and were administered by trained healthcare professional in the private doctor's office/ hospital; purchased with private funds.  This is one of several reports received from the same reporter.
This is a spontaneous report by a non-contactable consumer: This female consumer received PREVNAR 13 single dose on an unknown date. Relevant medical history was and concomitant medications were none. Vaccines given on the same day and within the last four weeks were unknown. In 2013, shortly after she was administered with PREVNAR 13, she mentioned that she got a collapse like a really bronchitis and cold which had been dragging on to about two or three months now. Relevant sibling information lab was unknown. Relevant data was none. At the time of the report she had not recovered from the above mentioned events. No follow-up attempts possible. No further information expected.
Pt says her arm swole up. Her under arm got red, her joints hurt and she had a headache. This lasted a week she says.
Soreness onset about 10 hr. post. By 24 hr. (R) arm immobile due to extreme pain. Returned to ER for injection of anti-inflammatory and arm sling. Pt. unable to work or drive. Now taking Hydrocodone 10/325 and P.T. for range of motion in shoulder. Minimal improvement as of 6/1/11.
All of the liquid ran (dripping) down his arm and fingers; A spontaneous report was received from a healthcare professional concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event, all the liquid ran (dripping off) down his arms and fingers.  The patient's medical history was not provided. Concomitant medications were not reported.  On 07-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.  On 07-Jan-2021, the patient received the vaccine and all the liquid ran (dripping off) down his arms and fingers.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event all the liquid ran (dripping off) down his arms and fingers was considered resolved.  The reporter did not provide a causality assessment of the event.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Significant inflammation at the injection site and surrounding tissues extending from shoulder to elbow along with headache, and fever.
This spontaneous report was received from a medical assistant refers to an unspecified patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. From 13-NOV-2016 to 16-DEC-2016, the patients were vaccinated with improperly stored doses of VARIVAX, subcutaneous, lot# M000756 with expiry: 06-JAN-2018 and lot# L042267 with expiry: 27-OCT-2017, for prophylaxis. The vaccine lot#s had temperature excursion of 22.53 degree Fahrenheit for 7 hours 36 minutes. It had no previous temperature excursion. The call was because of data logger. This is one of two cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA009714:
I had ringing in my ears, bilateral headache, chills and sweats, no appetite with nausea, my urine was brown on two occasions, my mouth is dry, I was anxious especially at night, I was unable to sleep for very long. And I was very weak and exhausted. I am only feeling a little better today.
The patient felt pain after the injection and had to lie down. It was several days until the whole body pain went away.
If I move my arm (the one that received the vaccine) I get a shooting pain right where the shot went in. It doesn't happen everytime I use my arm but it is becoming more frequent. It hurts so bad I have to stop whatever I am doing until the pain subsides which is after a few seconds. It has been months since I have had this pain but for the past week it has come back and is very uncomfortable.
Pt developed intussusception in November 1989. Baby would awake crying then go unconscious. This continued from 8 am until surgery at 7 pm.
Information has been received from a pharmacist concerning an 81 year old female with no medical history of shingles (even though she had taken VALTREX in 2007), with no allergies/drug reactions who on 24-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number 665431/1744Y, expiration date: 11-MAR-2011), SQ on the left arm. Concomitant therapy included gabapentin and "eye drops" (Manufacturer unknown). The pharmacist stated that the patient who received ZOSTAVAX (Merck) developed redness, swelling and two bumps at the injection site of the left arm. No laboratory diagnostics studies were performed. At the time of the report, the patient was recovering from redness, swelling and two bumps at the injection site. The patient sought medical attention by phone call. Follow up information was received from the physician who reported that on 24-JUL-2010, the 81 year old female retired patient (also reported as 82 year old) with hypertension and hypercholesterolaemia was vaccinated with the first dose of ZOSTAVAX (Merck) into her left deltoid at a pharmacy. There was no illness at time of vaccination. On 26-JUL-2010 at 11:21, the patient experienced redness, swelling at injection site, two areas of erythema each about 2-3 cm, and some diffuse induration about 4-6 cm overall. It was reported no streaking. Subsequently the patient recovered. The patient did not seek medical attention. Additional information is not expected.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with a dose of RECOMBIVAX HB for prophylaxis (dose, route, lot/batch # and expiration date were not reported) reconstituted with diluent MRK (STERILE DILUENT) (dose, lot/batch # and expiration date were not reported). It was reported that, on multiple unknown dates, the patients "had low titers when tested" to RECOMBIVAX HB (hepatitis b antibody negative), tested byan unspecified titer test. The primary reporter reported that an unspecified amount of the patients were treated byre-vaccinating with a dose of RECOMBIVAX HB (dose, route, lot/batch # and expiration date were not reported) reconstituted with diluent MRK (STERILE DILUENT) (dose, lot/batch # and expiration date were not reported). The outcome of hepatitis b antibodynegative was not reported. The causality between hepatitis b antibody negative and RECOMBIVAX HB was not reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009678:
pale, clammy, warm, low blood pressure treatment - put client into Trendelenburg position, gave water and snack, took vitals, monitored for extra 20 minutes
patient was given Adacel instead of Infanrix. I have told my superviser and his parents.
injection arm soreness; chills; neck pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection arm soreness), CHILLS (chills) and NECK PAIN (neck pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced INJECTION SITE PAIN (injection arm soreness), CHILLS (chills) and NECK PAIN (neck pain). At the time of the report, INJECTION SITE PAIN (injection arm soreness), CHILLS (chills) and NECK PAIN (neck pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Adult patient received the dose after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022).    This case contains information for the 13th of 56 patients described by the reporter.  Concomitant medication was not provided.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Doses were administered after 30-day use by date or after manufacturer date of expiry. It was unknown to HCP when the vials were stored in the refrigerator and when the doses were administered. The vial did not undergo any temperature excursions.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125: case (1 of 56 patient)
This spontaneous report was received from a physician and refers to a patient of unknown age (reported as college aged) and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with PROQUAD, subcutaneous for prophylaxis; dose, strength, lot# and expiration date were unknown. PROQUAD, was administered to a patient of inappropriate age. No adverse event was reported. The outcome of drug administered to patient of inappropriate age and no adverse event was unknown.
Body aches, fever, fatigue, chills, sweats for 2 days following vaccine.
Pt received Pfizer vaccine on 4/1. Pt tested positive for COVID on 4/6 and hospitalized on 4/6 for SOB.
Severe tinnitus.   I had tinnitus prior to the vaccine that I acquired in June of 2020 from taking Wellbutrin.  In the 2-3 months prior to the Moderna vaccine the tinnitus had quieted down to very tolerable levels for the most part - but would increase during times of stress.   Starting maybe 4-7 days after the first dose of the vaccine my tinnitus is now louder than ever and nonstop 24/7.  I also have had sporadic flashes of earache pains in my right ear...my right ear is where the tinnitus is loudest (was also where it was loudest prior to vaccination)
BP at triage was 175/100 / prescribing a diuretic to lower BP as it would reach 180/100; not feeling well; Vomited twice; seeing double; Lower back ache; Fever; Chills; Headache/massive headache; flu-like reaction; This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 47-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 01Apr2021 (Lot Number: ER8732, unknown expiration; at the age of 47 years old) as dose 2, single for COVID-19 immunisation.  Medical history included GERD, endometriosis, hiatal hernia, allergies to Sulfa, and allergy to PCN. Concomitant medications included fluticasone propionate (FLONASE); cetirizine hydrochloride (CETRIZINE); calcium; and unspecified multivitamins.  The patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6204; at the age of 47 years old) on 11Mar2021 at 10:30 am in the left arm for COVID-19 immunization. On 01Apr2021 at 12:00 am (within 24 hours), the patient experienced flu-like reaction (fever, chills, lower back ache, and headache). On 03Apr2021 (close to 48 hours), the patient had a massive headache, seeing double, and vomited twice. On 04Apr2021 (3 days after this episode), the patient went to ER due to not feeling well and BP at triage was 175/100. BP still high after this. The patient went to urgent care on 10Apr2021 (video visit), prescribing a diuretic to lower BP as it would reach 180/100. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient received hydrochlorothiazide 25 mg QD as treatment for blood pressure.  The patient is recovering from the events.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Hypertension and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient reported onset of chest tightness 30min after receiving his first pfizer covid-19 booster.  Patient reported he had similar symptoms after the second dose last year.  At that time (after 2nd dose symptoms) patient was evaluated by a provider and diagnosed with chostrochondritis.  Patient states he is unsure if the symptoms are anxiety related.  Vitals signs obtained, stable.  Pulse ox 98% on RA Respirations unlabored, Lung sounds clear bilat, EKG normal.  troponin drawn
27MAY97 faint p/inj-recovered;28MAY97 TC from mom t101 p/advil;28MAY97 seen by MD; t104;
Information has been received from a consumer concerning a "3.5 year old" male patient with no pertinent medical history and no drug allergies, who was vaccinated with an unspecified vaccine at two months of age and started having health issues since. The patient started having constant ear infections and serious gastrointestinal issues. "At two months of age" he received "one dose" of MMR II, and "after getting the vaccine", "it seemed like he was slipping even more". It was reported that the patient "has autism". The patient sought unspecified medical attention. At the time of the report, the patient's status was not recovered. No further information is available.