chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RECEIVED HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned two male patients of 48 years old of unspecified race and ethnic origin. No past medical history or concurrent conditions were reported. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (suspension for injection, route of administration, and batch number were not reported) 0.25 ml for prophylactic vaccination (dose number in series 1). The reporter had not reported any adverse events following vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1822809 or 211A21A, expiry: unknown) dose was not reported, 01 total administered on 28-NOV-2021 for prophylactic vaccination (dose number in series 2). No concomitant medications were reported.  On 28-NOV-2021, the patient received a half dose of the Janssen Covid-19 vaccine for their booster dose (vaccine underdose and off label use) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202193, 20211201450, 20211202199, 20211202250, 20211201046, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211165041, 20211202379, 20211202371, 20211202246, 20211202207, 20211201443, 20211201392, 20211201362, 20211201304, 20211201179, 20211200769, 20211200723, 20211200717, 20211200675, 20211165041 and 20211201286.
Employee received the Flucelvax Quadrivant vaccine on 10/17/23 around 10:30am, she reported developing nausea and vomiting around 3:00pm - 4:00pm that day.  The employee also said she developed lip and hand swelling the day after the vaccine and her voice was horse.  She did not seek medical treatment and the symptoms resolved with OTC allergy medicine.  The employee notified Employee Health on 10/20/23 of the occurrence, by this time all her symptoms had resolved.  She denies any redness or swelling at the injection site.  She reports having the flu vaccine in the past without issue.
Severe itching to site of arm where vaccine administered, no hives or redness per patient, extreme swelling of arm at injection side and surrounding area, no treatment per patient.
No adverse event; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 3 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:master case
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 03-SEP-2014 the patient was vaccinated with first dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Father reports that after vaccines he felt like he was "holding a different baby" and that child lost head control for 1 month (normal now).
On the day of injection, my arm was sore as expected.  This lasted approximately 48 hours.  Nothing taken for pain.  About 10 days after my vaccination and about an hour after eating a meal at a restaurant that I have had before, I developed hives on my neck and face, itching on my neck, face, wrists and underarms and a scratchy sore throat with difficulty swallowing and itchy ears.  I went to an urgent care/ER and was given IV antihistamine and steroids and give a prescription for oral steroids for 3 more days, instructions to take OTC antihistamines for next couple of days and an Epi-pen.  While I don't think that the COVID vaccine caused this allergic reaction, it was the only "new" substance introduced to my body as the meal I ate was something I had eaten before without an allergic reaction.  Adverse event is under control and I'm following up with my family doctor.
Child developed fever and had febrile seizure at home Temperature 102.  Child is fine today.  Fever was treated in ER
Patient described a rash that developed on her face, in addition to dry and blistered skin. She reports the events started Sunday 5/20 3 days after receiving the vaccines.
Information has been received from a 26 year old female consumer w/ NKDA and a history of miscarriage (12/05/year unspecified) and no other past medical history who on 07/02/01 was vaccinated with a first dose of varicella virus vaccine live (site unknown). There was no concomitant medication. On 07/13/01, the patient developed symptoms of itching and swelling at the injection site. On 07/31/01, the patient was vaccinated with the second dose of varicella virus vaccine live in the right arm. There was no concomitant mediations. On 07/31/01, the day of the vaccination, the patient developed a "puffy, red blotch" at the injection site. After two days the blotch went away. The patient sought unspeicified medical attention. Additional information has been requested.
Reaction 3 days later- vomiting, headache, tiredness, chills and itching
03/24/2021-POSITVE COVID-19 Test   First dose no symptoms  1/10/2021 Second dose severe symptoms which sent me to the ER with chest pain, tachycardia, hypertension
Expected side effects were noticed roughly 15hrs after vaccine was received. At approximately 18hrs post vaccination elevated temperature was documented. My temperature continued to increase throughout the day. By 10pm on January 11th all symptoms experienced post vaccine had resolved.  Below is a timeline of events as well as measures taken during recovery phase.  - Severe chills associated with elevated temperature. Highest documented temperature  was 102.1 roughly 24hrs post vaccination. Severe muscle aches in bilateral lower extremities (during elevated temp only). Moderate bilateral hip pain (during elevated temp as well).  No were antipyretics taken during this event.  Oral water intake increased during these hours.
Patient had chest pain 3 days after 2nd vaccine, took to E.R. He had a low grade fever, and they did chest xray and ECG and those tests came back fine, he was given Decadron steroid dose at the E.R.  At day 6 his chest was hurting again from coughing very badly, having nasal congestion, headache, and vomiting. I took him back to the E.R. and found out he has a severe left ear infection. The E.R. department tested him for Covid which came back negative. They said the ear infection and viral things could be a response from his immune system from the vaccine. Patient is the only person in our house that is sick. We are at day 9 after the vaccine and he is still sick, still coughing very badly and he is taking Amoxicillin for the ear infection, Robitussin for the cough, and his Albuterol inhaler. We are following up with his regular doctor today to see if there is anything else or something different they can give him to help with all of the coughing.
intense back pain to the point worried about getting up the stairs from the parking garage about 30 minutes from shot this lasted about 30 minutes.   Swollen tongue and lots of drainage down back of throat with metallic taste, and then a sore mouth and throat.   This lasted 3 -4 days.  did treat with 1 benadryl  each night for  2 nights in a row.   and tyneol in the day.  Swollen tongue was not so I couldn't breathe but just hurt and "felt big" in my mouth with many bumps where it rested against my front teeth.   itching and small rash on the arm that got the shot (not at the site) (3 to 4 days on this and benadryl helped). and of course a sore arm just for a day.
WRONG TECHNIQUE IN DRUG USAGE PROCESS; INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204a21a,  expiry: 23-JUN-2021) .3 ml, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced wrong technique in drug usage process. On 02-JUN-2021, the subject experienced inappropriate dose of vaccine administered. On 02-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wrong technique in drug usage process, inappropriate dose of vaccine administered and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210607539 and 20210607725.
This spontaneous report as received from a medical assistant via a Company Representative refers to a female patient over the age of 65 years old. There were no concurrent condition and medical history reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX "1 dose, 1 time", subcutaneously (lot number and expiration date were not reported). No concomitant medication was reported. On an unknown date, the patient developed shingles and a rash. The patient sought medical attention via an office visit. The outcome of shingles and rash was reported as not recovered/not resolved. The patient received the treatment, an unspecified pain medication. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Less than 24 hours after injection, full body muscle aches, fever, fatigue, headache.
Patient was given doe1 of the Pfizer COVID-19 vaccination.  Shortly upon standing, the patient experienced an episode of syncope and fell to the floor hitting his head on the counter.  The staff immediately called 911 and the pharmacist provided supportive measures until First responders arrived.  First responders examined the patient and cleared him to go home with his parents.
tongue started tingling and then went completely numb, in which lasted several hours; tongue started tingling and then went completely numb, in which lasted several hours; headache; muscle pain; chills; mild allergic reaction; This is a spontaneous report from a contactable healthcare professional reporting on herself. A 45 (Unit: Unspecified) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 18Dec2020 as a single dose for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. On 18Dec2020, 45 minutes later after receiving the vaccine, the patient experienced her tongue started tingling and then went completely numb, in which lasted several hours. Then she experienced a headache, muscle pain, and chills. The patient inquired if she should receive the second dose of the Covid vaccine after experiencing side effects or a mild allergic reaction. The outcome of the events tongue started tingling and then went completely numb, headache, muscle pain, chills and allergic reaction was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
This is a spontaneous report from a contactable a physician. This physician reported similar events for two brothers. This is the first of two reports. A 15 year-old male patient of an unspecified ethnicity received the first dose of TRUMENBA (lot R4510, expiry date 01Jul2018) on 17Jul2017 at 0.5 ml single intramuscular in the left deltoid for routine vaccination. The patient medical history was none, concomitant medications were not reported. The patient experienced severe redness, swelling, and tenderness at the site of injection on 18Jul2017. Therapeutic measures were taken in response to the events and included the administration of BENADRYL and ibuprofen. The patient recovered after several days on an unspecified date in Jul2017. The events were considered non serious by the reporter. Sender's Comments: Linked Report(s): US-PFIZER INC-2017378572 same reporter/product/events, different patient; US-PFIZER INC-2017378572 same reporter/product/events, different patient.
Vomiting and diarrhea at the same time/ then chills and extreme fatigue then diarrhea continued for  two days this began  at about 8 pm the day of the shot.1/27 lasted until 1/30/2021.    Sunday am of 1/31  mild fatigue fading away.
Site of vaccine red and swollen 3-4 days (normal). Day after, tired, but 2 nites after, wide awake - weird feeling! Very achy in joints/muscles for next 10-12 days, and tired. (Husband had felt achy/tired for 2 days previous to my shot). I realize that there is a good likelihood that I picked up a bit of whatever bug my husband had (he got just before I had the vaccine) - combined with effects of shot, since some of the symptoms I had were similar to his, but manifested about 50X! Also could have been coincidental timing with minor backache I had just previous to shot but the aches I had (back, knees, etc) after shot were quite extreme for 10 days or so. Never had anything like that before!
BILATERAL PULMONARY EMBOLISMS; This spontaneous report received from a pharmacist concerned an 84 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25/MAY/2021) dose was not reported, 1 total dose administered on 10-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  10-MAR-2021 After administration of vaccine on 15-APR-2021, patient had bilateral pulmonary embolisms and was hospitalized in local hospital then triaged to heart institute, Reporter also report patient will get discharged soon.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral pulmonary embolisms was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 84 year-old male patient was hospitalized for bilateral pulmonary embolisms 36 days after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, social history, family history, diagnostic test results, corrective treatment, and outcome were not reported. Based on the limited information, the event is considered unclassifiable. Additional information is being sought.
Diagnosed with Bell?s Palsy. Right ear pain and headache radiating to right jaw and neck worsening over the course of 3 days. Patient started to notice numbness around right side of neck and right cheek. Initially thought severe ear infection. Numbness spread to right side of mouth and right eyelid after 24 hours. Symptoms worsened until affected right side of tongue. Patient prescribed antiviral and steroids.
Patient was given ROTATEQ oral vaccine on 5-5-16. Pt. has had 12 days of frequent loose BM's and having decrease in appetite.
Dizziness. Would come and go. I finally seen a phyiscan at immediate care and no problems were found. I was given a prescription for Antivert, a motion sickness pill and was told to follow up with another physian in a week. If it lasted longer to possibly get a brain scan.
Nausea within 48 hours - subsided; Nosebleed x 1 at 48 hours (5 in my lifetime 3 related to injury); Right knee swelling and discomfort at 5 days subsided 3 days; Right knee swelling and discomfort at 5 days subsided 3 days; new symptom Lethargy; exhaustion; muscle weakness; sedation/I felt like I was drugged.; She said I might have had Covid and not known it.; muscle ache; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm on 17Sep2021 10:00AM (at the age of 58 years old) (Lot Number: FC3183) as dose 1, single for covid-19 immunisation. Medical history included allergies to poppy seeds, mushrooms, sarcoidosis, thyroid nodule (benign), nosebleed at 48 hours. Concomitant medications included VITAMIN C; VITAMIN D3; ZINC; CoQ10; VITAMIN C, VITAMIN D3, VITAMIN B, Zinc, Reservatrol, CoQ10, Hair Skin Nails, all were taken for an unspecified indication, start and stop date were not reported. The patient previously took CODEINE and CIPRO, and experienced allergies. The patient was not pregnant at time of vaccination. The patient experienced nausea within 48 hours - subsided, nosebleed at 48 hours, right knee swelling, and discomfort at 5 days subsided 3 days, new symptom lethargy, exhaustion, muscle weakness, sedation/ felt like she was drugged, she said she might have had covid, and not known it, and muscle ache, all on 18Sep2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported events were nausea within 48 hours - subsided, nosebleed at 48 hours, right knee swelling, and discomfort at 5 days subsided 3 days - new symptom, lethargy, exhaustion, muscle weakness, and sedation started 24 hours after 14 days. Patient felt like she was drugged. She called the pharmacist at RA. She said she might have had Covid and not known it. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient said she received the 1st dose of the Pfizer- BioNTech Covid-19 Vaccine on 17Sep2021. Afterwards, she experienced severe lethargy, exhaustion, muscle ache, and muscle weakness. She said she felt like she was drugged. She said there was a "sedated feeling." She also said she had a nose bleed, right knee pain which lasted for a couple of days, and nausea which has already subsided. HCP said she is more concerned with the lethargy, and wants to know how long it lasts. She also wants to know if the 2nd dose would be worse or better. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
experienced ringing in her ears; body aches all over; Initial information regarding an unsolicited valid non-serious case via agency (Reference number- 00335425) was received from a consumer and transmitted to Sanofi on 28-Oct-2020.  This case involved a 36 years old female patient who experienced ringing in her ears (tinnitus) and body aches all over (pain), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On 21-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via intramuscular route in the upper arm for prophylactic vaccination.  On 21-Oct-2020, the patient developed non-serious experienced ringing in her ears (tinnitus) and body aches all over (pain), immediately after the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was body aches all over and experienced ringing in her ears.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient had not recovered from tinnitus and recovered from pain.
5 hours post #2 Moderna Covid 19 vaccine, developed fever, 102.9,  headache and full body urticaria. Patient refused steroids or benadryl. Taking Advil to control fever with good effect. Seen in clinic 4 days later with intermittent fever, headache and continued rash. Did a Covid 19 PCR NP swab, awaiting results.  Patient only PE finding is hard palate erythema and petechiae.
Hives all over body, redness and swelling on face and hands, high fever and runny nose.
t101.4, brief (less than 2 mins?), convuls, (shaking arms) & post-ictal drowiness; exam office neg exam t99.7;
Patient presented with parent for Pfizer Covid shot.  Mother advised that the patient has a history of fainting after vaccines.  Vaccine was administered, and approximately 1 minute later the patient did briefly faint.  After regaining consciousness, we elevated his feet and gave him a cool rag and water to sip.  Patient stayed in our vaccine room for about 15 minutes, reported he felt fine, and left.
This spontaneous report was received from a pharmacist via Pfizer, referring to a male patient on his 20's with a history of pneumonia and current condition of asthma. No drug reactions were reported. On an unknown date, the patient was vaccinated with PREVNAR 13 administered in left deltoid, intramuscularly, instead of PNEUMOVAX 23 (wrong drug administered). There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.
Fever, fatigue- slept entire next day, was fine 4/11/2021 8:00 am
Ten minutes after receiving the vaccine, patient complained of hoarseness. After 20 minutes, she complained of headache and sinus congestion and felt "unbalanced" for a few minutes. Vital signs throughout was stable with O2 sat 100%. After being observed for 45 minutes, her hoarseness resolved, still with headache but reports all other symptoms improved. Patient was discharged  home ambulatory with steady gait. Called clinic at 3:09pm and reported that she developed hives and took Benadryl 25mg.
Patient stated that when he got home he noticed some swelling and redness in left arm where the injection had been given.