chrisvoncsefalvay/vaers-outcomes huggingface dataset:
poor balance, difficulty walking unaided.  Walked in to pharmacy on 3/26 unaided and healthy and within 2 weeks was having to use a walking cane.   Walking became increasingly more  difficult and is now currently using a walker for short distances and a wheelchair for a long distances
right eye was blood shot, it was red; had to keep his eyes closed to keep light from coming in so he won't be in pain; had to keep his eyes closed to keep light from coming in so he won't be in pain; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 06Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that he was having some symptoms that has got worse and wanted to know if he should do something and wanted to know something what went with his eyes. His right eye was blood shot, it was red and daily amount of light that hits his eye was very painful so he had to keep his eyes closed to keep light from coming in so he won't be in pain. Patient was not able to give the lot number because it hurts too much when he tried to turn on the light to reach that (vaccine). Events started on Feb2021. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Raised bumps with a white center, white posture-like bumps on face, neck, upper chest, on eyelids, in eyebrows, inside eyes, on pupils of eyes, on lips, inside mouth, on ear lobes, inside ears, on nose, inside nostrils; tingling in tongue, runny nose, extreme fatigue, wooziness, challenges speaking at times,, itching. It is progressing to a different membrane everyday and I am not receiving any assistance.
Before pulling needle out of arm, patient complained about dizziness. Patient sat for about 30 minutes as dizziness improved. MD was notified, and told to eat something sweet and that it wasn't necessary to come in.
Vaccine was at noon. Began to feel body aches at 11pm. Took one Tylenol and went to bed. Woke up at 2:30am and was achey and uncomfortable but went back to sleep. Woke up at 4am and was very achey, had full body pain - skin, hair, joints, everything hurt. Took my temperature and had a low grade fever of 99F. Took two Tylenol and drank about 10oz of water. Fell back to sleep.  Woke up at 9am, was still achey but had some coffee. Had aches and pain all day until about 8pm when it finally subsided and I felt normal.
several heath issues; weight loss; passed away from seizure; This case was reported by a nurse via sales rep and described the occurrence of seizure in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In January 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced seizure (serious criteria death and GSK medically significant). On an unknown date, the patient experienced unevaluable event and weight loss. On an unknown date, the outcome of the seizure was fatal and the outcome of the unevaluable event and weight loss were unknown. The patient died in January 2022. The reported cause of death was seizure. An autopsy was performed.   It was unknown if the reporter considered the seizure, unevaluable event and weight loss to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient (high schools senior) received Bexsero.  The patient passed away from seizure over this weekend (date unknown). The patient had Men B vaccine (Bexsero) doctor said it stood out to her as the autopsy report on 18th January 2022, showed vaccine was in the system. The reporter did not know what caused the issue and might not be the cause of death, but patient had several heath issues past year and severe weight loss.  The reporter mentioned that the health care professional would call back tomorrow with more details as she was in a rush. Consent was not provided at this time by health care professional. Consent to follow up with GlaxoSmithKline sales representative was acquired. The reporter did not consent to follow-up. No other information was available.; Reported Cause(s) of Death: Seizure (vaccine was in the system)
This spontaneous report as received from a medical assistant refers to unspecified number of patients. No information on patients' pertinent medical history, concomitant medications, drug reactions or allergies was reported. On unknown dates in 2016 (after 02-MAY-2016), the patients were vaccinated with improperly stored doses of PROQUAD, lot # reported as L050900, expiration date: 14-JUN-2017, route of administration not reported. Lot # L050900 is an invalid lot number for for measles, mumps, rubella and varicella (oka-merck) virus vaccine live. On 02-MAY-2016, administered doses of PROQUAD underwent temperature excursions prior to being administered. Maximum temperature was reported as 7.5 degrees Fahrenheit for 30 minutes, 14.2 degrees Fahrenheit for 20 hours and 7.3 degrees Fahrenheit for 30 minutes. About 15 patients received at least one of improperly stored vaccines: PROQUAD and VARIVAX (captured in MARRS# 1607USA007633). There were no known adverse effects. This is a one of two reports from the same reporter source. Additional information has been requested.
A report has been received from a health professional (nurse practitioner) concerning two patients of unknown gender. This report refers to one them. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unspecified date, the patient started receiving a treatment with nasal FLUMIST. The patient developed bloody nose. The action taken with the suspect drug was unknown. The patient recovered from the event of bloody nose on an unspecified date. The report was considered to be non-serious by the reporter.
Site: Pain at Injection Site-Severe, Additional Details: Pt. had her Boostrix TDAP vaccine with me on 07/09/22.she called the pharmacy 33days(08/11/22) complaining about a severe pain that she has been experiencing on her left side.she states that she can barely move her left arm & that the pain is due to the vaccine she received.She also told me that she has a dr's appt today and followup MRI.I did apologized to her over the phone & told her to stop by the pharmacy for in-person apology.She did stopby at around 630pm.
vaccine administration error regarding Pfizer lot # GL0087 administered on 02/20/2023 with beyond use date of 02/17/2023 with recommendation to get booster at local pharmacy
Patient went doctor, he indicated that I was low sodium from bloodwork. It was a follow up doctor's visit.  The doctor didn't have 3rd dose and I went to the pharmacy to get it.  The next day ,I felt sick bad headache and body aches , fever 100.4. Went to ER and I was worried about my sodium level. Meds were given through IV.
This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of malaise (1st dose, refer US2018183676). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 2nd October 2018, less than a year after receiving SHINGRIX, the patient experienced feeling unwell. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that, another pharmacist told her that, the patient experienced not feeling good after SHINGRIX and even worse after the second dose. Caller did not had additional details about this report, as she mentioned she heard from another pharmacist. This case has been linked to the case US2018183672, reported by same reporter.
Patient cut left middle finger 11/4/09 - in for wound care and Tetanus update. Chart noted self reported Td 2000. Tdap updated 11/5/09. (There record noted 9/29/99 last Td record). Previous Tdap given 4/29/09. Unknown at time of visit and vaccine administration.
Stroke; Coma; This spontaneous case was received on 19-Nov-2021 from other non-healthcare professional (the patient's daughter) via The Regulatory Authority (reference number: SEQW21-05531) and concerned a 73-year-old, female patient.  The patient's concurrent conditions included allergy to statins, derivatives of penicillin, gabapentin, morphine, sulfa and lisinopril, allergy to red cabbage and high blood pressure which was maintained with medication. The patient's concomitant medications included multivitamin (vitamins NOS), D3 (colecalciferol), melatonin, Colace (docusate sodium), Miralax (macrogol 3350), atenolol, pantoprazole, Zoloft (sertraline hydrochloride), doxazosin, potassium chloride and Zetia (ezetimibe), all used for unreported indications. The patient's historical vaccines included Covid-19 vaccine (brand not specified) in February and March.  On 22-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 312836 and expiry date was 06-May-2022.  On 25-Oct-2021, three days after receiving Fluad Quadrivalent, the patient experienced stroke.  On an unknown date in 2021, the patient ended up with coma and was admitted to hospital for five days.  On an unknown date in 2021, the patient was discharged from the hospital.  The outcome of the events was not reported.  The reporter assessed the events as related to Fluad Quadrivalent. The reporter was inclined to the influenza vaccine as the reason for the stroke because it was the only uncommon thing the patient had got in the days before the stroke.  The events of stroke and coma were considered to be serious due to criteria of hospitalization and medical significance by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 73-year-old, female patient, experienced stroke, three days following vaccination with Fluad Quadrivalent. An unknown amount of time following vaccination, the patient ended up with coma as reported. Patient's concurrent condition included high blood pressure which may have contributed to the development of the events. More information regarding medical history and relevant diagnostic findings is needed. With the information currently available causality is unassessable.; Reporter's Comments: The reporter was inclined to the influenza vaccine as the reason for the stroke because it was the only uncommon thing the patient had got in the days before the stroke.; Sender's Comments: A 73-year-old, female patient, experienced stroke, three days following vaccination with Fluad Quadrivalent. An unknown amount of time following vaccination, the patient ended up with coma as reported. Patient's concurrent condition included high blood pressure which may have contributed to the development of the events. More information regarding medical history and relevant diagnostic findings is needed. With the information currently available causality is unassessable.
Pfizer bivalent vaccine was expired on 2/16/23 (that were remaining in the refrigerator), and was accidently administered to patient on 2/21/23. According to Pfizer, patient would need to be readministered for an additional dose for full protection, and for patient to report any side effects if any.
On 10/11/06 at about 3:30 pm. I became nauseated. I had diarrhea and vomiting and a low grade fever 100-101 on 10/12, as well as a achy joints and a headache. I stayed on clear fluids, tea for 48 hours and recovered. I've reacted to previous flu shots in past.
Headache onset 24 hours after first dose. Headache onset 1 hour after second dose. Continued headache, body aches 12 hours post second does. Continued headache, body aches chills, nausea and fever (102 max temp) 18 hours post second dose. Body aches, chill and fever until approximately 40 hours post second does. Continued headache and nausea with headache becoming severe 54 hours post second dose.
Narrative:  NOT DOCUMENTED IN SYSTEM, NO INFO ON WHERE/WHEN INFLUENZA VACCINE GIVEN
4 year old male patient guardian requested flu shot. There was an online appointment made for flu shot which was processed as such  through patient's insurance. After vaccine administration patients stated that she actually meant Pfizer Covid Vaccine
Blotchy, hyperpigmented lesions on right thigh with some induration at injection site.
arm soreness; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm soreness) and HEADACHE (headache). At the time of the report, VACCINATION SITE PAIN (arm soreness) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by the reporter. Treatment details were not reported by the reporter.
Injected with undiluted vial. pt received higher than intended dose. no adverse effects experienced thus far.
This spontaneous report as received from a pharmacist refers to an adult patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in March 2016 (reported as about a month ago), the adult patient was inadvertently administered a pediatric dose of RECOMBIVAX HB (route and site of administration, dose, lot number and expiration date were not reported). There was no adverse effects reported. Additional information has been requested.
Began having chills, no arm soreness, headache or joint pain. She does have gout which became inflamed. She had a red rash over her body, inner thighs, chest, arms, and had one giant hive that stretched across her chest from armpit to armpit. Itching all night. Profuse sweating. Went to dr the next day, the hive left a mark where it had been. The rash lasted about 36 hours. Hive left after taking an antihistamine.
neck problem; Ache; A spontaneous report was received from a consumer concerning a male  patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events neck problem, ache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the event(s) neck problem, ache.  Treatment for the event,included Tylenol, Physical Therapy.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), neck problem, ache was unknown.
Immediately after sitting down in the waiting area after receiving the shot, the pt reported feeling a strange pressure in their arm. Following this, the patient described the sensation of "blanking out". The pt fell off their chair and lacked alert conconciousness for roughly five seconds. When the pt came to, they appeared confused and twitchy, with wide eyes and an overall appearance of shock. Pt remained in their state for roughly a minute, before stating that they felt completely better. The pt had developed a sweaty back but didn't state that they felt overally hot. They didn't mention being in any pain. The local injection site appeared a bit red but nothing of significant note. Pt did bump their head on the side wall behind the chair, receiving a minor bruise. Pt was given some water to drink and was monitored for 30 minutes. They pt stated they felt fine. They had no past history of fainting with vaccines, thought pt claimed to have passed out like this before but only after suffering a head injury. After their wait, the pt was allowed to leave and assured us that they felt completely fine.
dose expired before administration; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 27-year-old female patient who received HBV (Engerix B) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 9th February 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient was administered with an engerix-B dose expired 2 days before the administration, which led to expired vaccine used. The reporter consented to follow up.
Small prickly rash all over back and parts of stomach.  Also larger  hives in the rash.  No pain or other issues  Just itchy
Starting the day of the immunizations, pt had stomach cramps, gas, and bloating. After about a week, she begun having diarrhea. She got her immunizations on 10/11/2022 and is still having stomach upset as of 10/31/22. She has tried to treat with immodium and pepto bismol. She is planning on following up with her doctor.
Pt feeling light-headed, dizzy, and sweating.  After 2-3mins noted to be diaphoretic and developed nausea.  Pt was given water and ice pack applied on neck and back. BP 93/40, HR 49 -- > 108/74, 62.  Pt started feeling better after a few mins of rest.  Pt reclined in his car w/ windows open.  Pt stable and released from vaccination site.  Hx of hives w/ Bactrim.
pt recv vax 27APR99 & devel hive-like rash w/16 large hives;no fever;f/u 4MAY99 revealed rash was 18 small dots that itched & were on ear, neck & arm;mom only felt forehead to check temp;
Flu shot given 9/30/02 at 3:30pm. 10//02 around 3pm arm began to become sore and warm to touch. Arm check 10/3/02 area slight warm to touch with no swelling. Cold to area, to take Advil and Benadryl.
pt experienced dizziness and headaches while on the waiting area,  became anxious and breathing shallow had some episode of nauseas, no vomiting, VS were stable, had BS; 175 HR; 78 BP:145/76 observed and hydrated on the medical tent for about 30 mins, EMS at site, patient stable.
Severe, intractable left lateral cervical pain, regardless of body or neck position (approx. C5,6,7 region) with radiation intermittently to proximal LUE
feeling feverish; headache; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2020, the patient received Shingrix. On 13th December 2020, 1 days after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient received a dose of Shingrix and was feeling feverish and headache. The patient was asking, how long can he/she expect the events to last.
88 year old / needed before Soliris; 88 year old received Bexsero; This case was reported by a consumer via interactive digital media and described the occurrence of drug use for unapproved indication in a 88-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included myasthenia gravis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug use for unapproved indication and inappropriate age at vaccine administration. On an unknown date, the outcome of the drug use for unapproved indication and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the patient. The patient asked does meningococcal B vaccine affect an 88 year old woman with myasthenia graves, which led to drug use for unapproved indication and inappropriate age at vaccine administration. It was needed before taking Soliris.
Pt recieved second dose of pfizer covid vaccine a week early. Initial dose was given on 11/5/21, second dose was given on 11/19/21
pt recv vax 28OCT95 & c/o numbness & tingling in lower arm;sx gradually lessened throughout the day & the pt recovered;
sore arm; bruised arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and CONTUSION (bruised arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and CONTUSION (bruised arm).        For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-028726 (Patient Link).   Reporter did not allow further contact
Arm  Where injection site occurred has lingering pain that will not abate. No reason for pain no movement. But nerve just keeps acting up and going crazy. May not be related but it is at the injection site
Myalgias, Malaise, Generalized weakness starting 1 day after PNEUMOVAX 23.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 16-OCT-2015, the patient was vaccinated with a dose of improperly store RECOMBIVAX HB, lot number L016427, expiration date: 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.