chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse or medical assistant communicated to a Pfizer sales representative. The other hcp reported similar events for two patients, this is the second of two cases. A patient of unspecified age ethnicity and gender received PREVNAR 13 (Lot Number: S35326, Expiry: Aug2018), via an unspecified route of administration in Jan2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced in Jan2018, 7-10 days post vaccination, a warm, red, induration or lump where the injections went with outcome of unknown. It was like a latent reaction. The administered product contained excessive sediment. The reporter explained that the office reported that it took 2 hours to get close to dissolving the sediment in the product and it was unlike it normally was. It was mentioned that normally they can get rid of it quickly. The reporter did not know if the 2 hour time frame was specific or meant to explain how difficult it was to get rid of the sediment. The product was properly stored and was sealed and intact with no damage when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018037099 same drug  same event, different patient.
Pt. c/o nausea and dizziness while sitting in Observation.  EMT and MD evaluated patient.  BP 178/101, 186/98 and 165/96 over a 10 minute period.  SPO2 99%.  Pt. has hx of HTN and reported taking her meds that am as Rx'd.  Pt. released home with spouse and will follow up with PCP on Monday.
Transverse myelitis. Paraparesis left side greater than right. Sensory level of T10. Medical records state abnormal vision. msv
Had a fever of 102 and arm swelling to size of fist and it was all red and painful. I could not eat for 6 days and lost 13 pounds in that time and the temp. finally broke on Sat. 11/02/2013.
the baby was born without the white stuff. The baby was hospitalized and eventually discharged; a pregnant mom received a COVID-19 vaccine while pregnant where the baby was born without the white stuff; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WHITE BLOOD CELL COUNT ABNORMAL (hospitalization), outcome "unknown", described as "the baby was born without the white stuff. The baby was hospitalized and eventually discharged"; EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "a pregnant mom received a COVID-19 vaccine while pregnant where the baby was born without the white stuff". The patient underwent the following laboratory tests and procedures: White blood cell count: without the white stuff.  Clinical course: It was reported that a pregnant mom received a COVID-19 vaccine while pregnant where the baby was born without the white stuff. The baby was hospitalized and eventually discharged. They did not know if it was the Pfizer and Moderna COVID-19 vaccine.  Optional Information: Was given very limited info about this occupancy and the person reporting, had very little info on this event. They were not sure if this was the pfizer/BioNTech or Moderna COVID-19 vaccine. Event took place after use of product.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Seizures/Spasms (they look like infantile spasm) But they have NO physical signs of the typical infantile spasm.  They started after ONE month shot of Hep B and got extremely worse immediately after TWO month shots. 2/23/09-records received for DOS 2/9-2/10/09-DC DX-infantile spasms. Seizure disorder.Neurology consult 1/14/09-evaluation for spasms that have occurred over the past 3 weeks but after recent immunization increased. Impression apparent infantile spasms, idiopathic.
Loss of appetite, nausea, headache, dizzy, neck ache (as described by patient).
Chills; Low grade fever of a 100; Tenderness at the site; Muscle pain; This is a spontaneous report from a contactable nurse (patient).  A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date unknown), via an unspecified route of administration on the right deltoid on 23Dec2020 11:30 at a single dose for COVID-19 vaccination. Medical history included borderline diabetes.  Concomitant medication included meloxicam. The patient experienced chills, low grade fever of a 100, ache at the injection site, tenderness at the site, muscle pain on 23Dec2020 14:00. Outcome of the events was unknown. Patient took TYLENOL for as treatment for the events.  Information about lot/batch number has been requested.
On 6/23 at 12:40 PM I was working at my desk treadmill in my home like I do every work day while walking 3 miles. I had sudden onset dizziness and nausea which was severe enough that I had to get off my desk treadmill and sit down.  I couldn't work well, and had to have my husband assist me to get up.  After 2 hours with no relief, I called the RN line with my insurance company and the RN I spoke with thought I was having a stroke and requested I call 911.  I did.  The paramedics found nothing really wrong, but elevated B/P when getting up from sitting to standing.  They did want me to go to ED and my husband took me.  The paramedics were fine with my husband taking me.  The two ED MDs who saw me over change of shift could not find anything wrong.  Given that the last time I experienced sudden onset dizziness was in 2012 when I had an ear issue, we all surmised it was probably an inner ear issue. The next morning, 6/23 I was fine and have been fine ever since.  I saw my ear NP on 7/1/21 and she could see nothing wrong either.   In hindsight I wish I had listened to my gut and avoided the 911 and ED drama.  I am an RN myself and knew I wasn't having a stroke.  In any event, I have no idea if this is a random symptom others have reported or not, but thought you should know.
Got shot, was waiting felt flushed and hot. Received Benadryl 50 MG.
give 13 doses from single vial; A spontaneous report was received from a healthcare professional concerning 13 unidentified patients who were administered 13 doses from a single vial of Moderna COVID-19 vaccine.  No medical history was reporter. Concomitant product use was not provided.   On an unknown date, the patients received planned dose of mRNA-1273 (lot # 016M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, a staff member gave 13 doses from a single vial of Moderna COVID-19 vaccine. The reporter inquired if lot was overfilled or if staff performed error in administration of vaccine.  Action taken with mRNA-1273 was not reported.  The outcome of event was unknown.; Reporter's Comments: This report refers to a case of Accidental underdose for mRNA-1273, lot # Unknown, with no associated AEs.
Swelling of leg in 24 hours - significant; 50% larger in leg of vaccine from hip to just below knee with red splotchy rash.
cyst on my left ovary; I was informed that I had a cyst on my left ovary, two in my uterus and three on my cervix; I was informed that I had a cyst on my left ovary, two in my uterus and three on my cervix; Abdominal pain; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 30Mar2021 at 09:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, high blood pressure, border line diabetes, hardening of arteries, and allergy to "most blood pressure medications," all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID-19 vaccine. Concomitant medication included semaglutide (RYBELSUS), diltiazem hydrochloride (DILT-XR), fish oil, and multivitamin, all from unknown dates for unknown indications. the patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported that on 09May2021, she started to experience abdominal pain and went to the emergency room on 12May2021. The patient was informed that she had a cyst on her left ovary, two in her uterus and three on her cervix. She believed all these had developed after the vaccine as she did not have any issues before. The patient reported she received treatment for the events and "follow-up" with an obstetrician/gynecologist (OBGYN). The clinical outcomes of abdominal pain and she had a cyst on her left ovary, two in her uterus and three on her cervix were not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sore arm and low-grade headache for 3-4 days. Day 1, approx 4 hours after Pfizer dose 1, got headache. Took  Aleve, headache gone. Day 2 at 1am, woke up with pretty bad arm pain ("why does my arm hurt so bad? Have I lifted too much weight at the gym?") and headache Did nothing; went back to sleep. Day 3, took Aleve again in the evening; headache gone. Day 4, mild headache. Day 5 and on, feeling fine. On Jan 5, for 4 days straight, I fell asleep at 6 and 7 pm. Normally I go to bed at 9am ( I get up at 4am). Felt fine enough to work, just tired at night more than usual. My 2nd dose is scheduled Jan 15 at noon.
Cannot find proof that she had her second Shingrix vaccination; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th January 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Cannot find proof that she had her second Shingrix vaccination). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-JUL-2023 The patient was self-reported this case. The patient reported that she can not find the proof that she had received second dose of Shingrix vaccine. The reporter stated that there was possible late dose for second vaccination. No further information was known. The reporter requested to consent the follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Tingling in fingers and toes moved up into hands and feet. Saw Dr. - referred to seen Dr. 1/8/08-records received for DOS 11/24/11/29/07-DX DC: Guillain-Barre sydrome. Admitted with progressive weakness over four to five days onset approximately two weeks after received flu vaccine. Noticed tingling in extremities, began in his feet and gradually worked up his legs and into his hands. Difficulty with walking unable to maintain gait and fell. Treated with IVIG. At discharge able to ambulate with a walker.
Following vaccine administration, client did not have vaccination card so staff went to write out a new card with today's dose. Client affirmed that today was his second (2nd) dose of Pfizer. Upon further  review of Immunization Registry client had received 2 previous doses  of Pfizer back in January and February. Client defrauded POD and claim to have only received 1st dose and presented with no vaccine card but an appointment in the system. Provider , NP was made aware. During post-vaccine observation, client did not exhibit any adverse reactions to vaccine, no signs or symptoms of allergic reaction. Client ambulated out of clinic.
I had a flu shot on 9/24. Onset of diarrhea began 2 weeks following Pfzier booster shot.  Has been continuous ever since 10/10/21 with a mild case 2-4 soft stools per day.  I have not had normal stools since 10/10.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (gender/age unknown). The patients' concurrent/historical conditions or concomitant therapies were not reported. On unknown dates, since 20-APR-2015 the patients were vaccinated with PEDVAXHIB (lot # J016188, exp. date 02-OCT-2016) (dose and route were not reported), which was exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a certified medical assistant referring to an unspecified patient of unknown age and gender. There was no concurrent condition and medical history reported. On an unknown date the patient was inadvertently administered a dose of improperly stored LIQUID PEDVAXHIB (lot # K026533, Expiration Date 07-AUG-2015, strength, dose and route not provided). There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
CONTRACTED COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (CONTRACTED COVID) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (CONTRACTED COVID). At the time of the report, COVID-19 (CONTRACTED COVID) was resolving.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality of humira as per reporter for event COVID-19 was no reasonable possibility. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
male patient received Imovax on 03May2019 or 04May2019, he missed his day 3 Imovax and received it on 09May2019 which the nurse considered day 6/ no AE; Initial information received on 13-May-2019 regarding an unsolicited valid non-serious case received from Other health care professional.  This case involves male patient (age unknown) who experienced received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patients past medical history, concomitant medication and family history were not provided.   On 09-May-2019, the patient received post exposure vaccination (5 dose series) a second dose 1ml of suspect RABIES (HDC) VACCINE lot number not reported via intramuscular route in unknown administration site and on 03 or 04-May-2019, the patient had received a first dose 1ml of suspect RABIES (HDC) VACCINE lot number not reported via intramuscular route in unknown administration site.  It was an actual medication error due to Inappropriate schedule of vaccine administered.  It was reported that male patient received Imovax on 03-May-2019 or 04-May-2019, he missed his day 3 Imovax and received it on 09-May-2019 which the nurse considered day 6.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  List of documents held by sender- none.  Information on the batch number was requested
This spontaneous report as received from a health professional refers to a 2 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose, dose number and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant (M.A) refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of GARDASIL (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified.   Follow up information was received from the medical assistant on 06-AUG-2014. The M. A. stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 51 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24 minutes. The M. A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time.   Follow up information has been received from M. A.  It was reported that a patient with 18 years old received a dose of GARDASIL with lot # J010668, exp date 29-APR-2016, on 10-JUN-2014. This is one of several reports received from the same reporter. Additional information is not expected, since all follow ups requested to complete the case were received.
Shingles of the eye occurred within two weeks of getting the 2nd covid booster. Patient was hospitalized twice: once, for pain from opthalmic shingles, and again due to shingles- related hyponatremia.
Rash on left arm near injection site that started 1.5 days after vaccinations and is still present today (4 days after). Rash is itchy and warm to touch.
no adverse event; Patient received 0.25ml of Bivalent booster instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (no adverse event) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     The patient had been diagnosed or tested positive for COVID-19. No chronic and acute illness at the time of vaccination and one month prior.  Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) for an unknown indication.    On 07-Oct-2022 at 5:00 PM, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 07-Oct-2022 at 5:00 PM, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml).    Patient received Dose 1 of Moderna on 25-Feb-2021 (batch number: 023M20A, left deltoid, dose of 0.5 ml) and dose 2 of Moderna on 25-Mar-2021 (Batch number: 016B21A, left deltoid, dose of 0.5 ml). No treatment information was provided.
The injection site bled and swelled instantly. The welt grew to about the size of a quarter over the next 5 minutes.
Vesicles noted on 2/24/2001 with discomfort; areas fading and drying by 3/3/01. MD confirmation.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot number M036728 and expiration date of 20-MAY-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1709USA011980: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
3:15 on saturday 2/13 i started getting body aches very badly, i was also getting shooting pains down my legs from my sciatic nerves.  Around 430pm i got a fever of 101.2 this is also around the time i started getting a very bad headache.  I didnt want ti drink or eat anything.  The smell of food made me very nauseous i went to bed around 6pm and work up ar 1030am on 2/14 i have less body aches, no headaches a slight temp of 99.0 and i noticed a small red bump at the injection site i didnt have before and under my left arm wherr my arm pit is the while area is swollen.
On 01/05/2023 my symptoms were mild to moderate. I started having chest pains. I did a COVID-19 at home and it was positive. I had to go to the emergency room the next day on 01/06/2023 and I was tested positive for COVID-19. The provider prescribed PAXLOVID and TESSALON PEARLS. I have now recovered from event.
Bleeding/bruising within 5 minutes of injection. Later that night/next morning: headache, neck and back pain, chills, sore throat. Advised to take TYLENOL/ADVIL and ice arm.
Dr. calls clinic (06May09) re 22 y/o AD WM SM w/ 10-12 tiny vesicular lesions surrounding primary SPV injection site RUE.  SM received primary SPV (RUE), AVA #1 and TYPHOID IM (LUE) on 29APR09.  Symptoms:  Edema/ erythema @ injection site 50-120mm with tiny satellite lesions around Jennerian Pustule.  Robust take primary SPV injection site RUE.