chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore in the back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Sore in the back) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced BACK PAIN (Sore in the back). At the time of the report, BACK PAIN (Sore in the back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. Treatment medication was not provided. Patient said that received the first dose a month ago and stated that this ache could not be due to the vaccine.
Swollen lymph node under left arm for 6 days; headache for 4 days; neck pain for 7 days; rash on chest for 1 day; shoulder pain for 7 days; dizziness for 7 days; general feeling of feeling sick for 6 days; nausea for 5 days; diarrhea for 1 day; fatigue for 6 days; 99 fever for 1 day
PT HASNT REPORTED ANY SIGNS OF ADVERSE EVENTS. REPORT BEING MADE BECAUSE VACCINE ADMINISTERED EXPIRED ON 10/16/2022.
Pt getting 1st pneumonia shot, right deltoid. Reported soreness at site but Sunday am (approx 30 hours later) noted larger amount of redness around injection site and raised bumps (hive-like down arm)  Contacted physician and was advised to take Benadryl and be seen if no improvement. Monday  Continues with milder symptoms today. 1/31/05 Wed follow up with doctor if worsens or no improvement.
immediate sensation in left chest and down left side at the moment on injection.  Sore shoulder developed during the next hour.  Difficult to sleep that night.  Painful to lift my left arm all day today.
Red area 2cm. round the site itching. Rash started Wednesday. Injection was given 5/25/07 Tdap.
Patient had redness and swelling at injection site, followed by increased pain and confusion. Patient reported to ER and was told that he had edema of the brain. He was given ibuprofen, the swelling came down and everything was normal after 2 days.
Injection site redness; Injection site hot; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number X39679 ?, the reported lot number does not macth with any GSK lot number, expiry date unknown) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR 13) for prophylaxis.   On 27th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and PREVNAR 13. On 28th July 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and Prevnar 13 on left deltoid. The next day after getting vaccination, the injection site became red and hot and was the same at the time of reporting. The reporter was unable to provide any additional information because the consumer was not in the pharmacy at the time of the reporting.
Threw up during the night 03/11/2021, felt like I had an ear infection, left ear, dizzy and tinnitus started.  Heartbeat in my left ear.  Feeling like it was full of water and needed to pop.  Went to urgent care on the 19th of March and she prescribed antibiotics for what was thought to be ear infection.  Heartbeat sound continued to get louder and louder until, I lost all hearing in my left ear. Steroids were finally prescribed by my regular physician and again by a ENT and they didn?t have any effect.
Approximately 6 months post vaccine I was diagnosed with COVID-19.  Symptoms where extreme fatigue, muscle aches, and severe cough. Couch still hasn't cleared and was prescribed inhaler.
Extreme somnolence, presyncope, headache. Somnolence/dizziness was the worst symptom -- patient was unable to work for the remainder of that day and appeared to be "sleep walking" to colleagues. By 4 p.m. patient was sent home to recover.  No pain at injection site. No myalgia, no rash.  Recovery was gradual, over three to five days. Patient was able to return to work the next day but could not get very much done and left a few hours early.  Patient remained well-hydrated but did not otherwise treat symptoms.  Patient would have gone to ER, but the local ER is rural and known for being a waste of time. Patient assumed that no anaphylaxis, rash, swelling meant no life-threatening reaction, and decided to wait at home.
Dose 1:  Had swelling, redness to site, mild rash, intense itching. (end of the day, and following three days) Dose 2:  Headache, sleepiness, slight fever 101.6, fatigue (night into day after.  Fatigue until 4/7/2021). Drank plenty fluids and rested, was unable to report to work on 4/6/2021, due to the slight fever and extreme fatigue and sleepiness.
A report was received from a health care professional on 07 November 2003 concerning a 33 year old male vaccinee who experienced sweating, shortness of breath, flushing, and later developed redness and swelling at the injection site, which was considered to be medically significant, on 06 November 2003 after receiving Fluvirin vaccine on the same day. On 06 November 2003 the vaccinee immediately experienced sweating, shortness of breath and flushing after vaccination and was admitted to the local emergency department where the attending physician informed the nursing staff that the vaccinee had a localized reaction. Later during the hospital visit, the vaccinee developed redness and swelling at the injection site. The vaccinee's symptoms resolved on the same day and he was discharged from the hospital. There was insufficient information to determine the reporter's causality assessment. Update 1, 12 December 2003: Further information was received from a health care professional indicating that the vaccinee experienced itching and swelling of his right arm, a sensation of throat swelling but no physical evidence of the neck or throat , with difficulty speaking, dizziness, cold chills and sweats within 20 minutes of receiving Fluvirin on 06 November 2003. The vaccinee's symptoms resolved on the same day. The vaccinee has a medical history of non-insulin dependent diabetes mellitus. Medications included fenofibrate, rosiglitance maleate, clomifene citrate and multivitamins. It was noted that the vaccinee became anxious  and nervous prior to Fluvirin administration and kept "clearing his throat". The ER report confirmed that the vaccinee experienced a local reaction to a flu vaccine.. The vaccinee was treated with hydroxyzine embonate and triamcinolone acetonide. The vaccine had previously received flu vaccine several years ago and had soreness of the arm but no noticeable reaction. Update 2, 02 April 2004: Further information was received from a health care professional indicating that the vaccinee experienced an allergic reaction to the Flu vaccine with symptoms of nausea, extreme pain in his right arm and neck pain on 06 November 2003. The vaccinee was also treated with hydroxyzine hydrochloride 25mg as required. On 06 November 2003 at 15:35, the vaccinee's blood pressure was 151/92mmHg, pulse rate was 72 bpm and respiratory rate was 20/min. The vaccinee was discharged at 17:04 and advised to return to the emergency room if he experienced any further problems. The vaccinee has a further medical history of heart murmur and high cholesterol. The vaccinee had no known allergies and no swelling of larynx was seen. No follow up pending, no further information available.
Developed difficulty breathing/swallowing.  Epi-pen administered and patient transferred to Emergency Department for evaluation and treatment (rec'd. intravenous epinephrine, Benadryl, and steroids as well as RX to continue oral Benadryl and steroids).
Flu symptoms n still has the flu from 26 th February till today 2nd March  2022
Information has been received from a physician concerning a 12 year old female who on 06-DEC-2007 was vaccinated intramuscularly with the first dose of Gardasil. On 06-DEC-2007 the patient experienced "blurred vision and felt faint." No further information was provided and no lot number was given. The reporter felt that blurred vision and felt faint were not related to therapy with Gardasil. Additional information has been requested.
indigestion; dizziness; light headed; After covid booster; chills; body ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) via a Pfizer sales representative, This consumer reported for a female patient that:  A female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing); "TIA" (unspecified if ongoing), notes: history of TIA so dizziness brought her memory to her last light headed experience. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "After covid booster"; CHILLS (non-serious) with onset Nov2021, outcome "recovered" (21Nov2021), described as "chills"; DYSPEPSIA (non-serious) with onset 22Nov2021, outcome "recovered" (23Nov2021), described as "indigestion"; DIZZINESS (non-serious) with onset 22Nov2021, outcome "recovered" (24Nov2021), described as "dizziness"; DIZZINESS (non-serious) with onset 22Nov2021, outcome "recovered" (24Nov2021), described as "light headed"; PAIN (non-serious) with onset Nov2021, outcome "recovered" (21Nov2021), described as "body ache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received a Flu vaccine on 11/20/23 at our clinic at 3:30PM. Later her spouse called and stated that she had already received a flu vaccine on 09/14/23 at a different clinic. NO adverse reactions or symptoms
Hospitalization: 1/11/2023 - 1/14/2023 (3 days) Presentation to the ED: dizziness, nausea, vomiting.  COVID + date: 1/11/2023. Treatment: no systemic steroids or remdesivir.  Discharge to: home.  Moderna 027A21A 3/11/2021 Moderna 026B21A 4/7/2021 Moderna 026D21A  10/26/2021 Moderna 054A22A 6/10/2022 Moderna Bivalent AS7167B 11/29/2022
A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 3 and half year old male who inadvertently received 0.5ml Fluvirin on 12/30/03. No adverse events were reported at the time of the event. No follow up pending. All information received.
Information has been received from a physician concerning a 14 year old female with no pre-existing allergies or illness at time of vaccination who has had her period since the 6th grade was vaccinated intramuscularly in the left arm on 01-Aug-2007 with the 1st dose of  GARDASIL (lot# 658488/0930U). The patient was concomitantly vaccinated with HAVRIX. The doctor stated that the patient has not experienced a period since the time of the vaccination. Per the doctor. The patient had 1 day of "spotting" mid September and one day of "spotting" midf October. The patient was vaccinated intramuscularly in the left arm with the 2nd dose of GARDASIL on 05-Oct-2007 (lot# 658558/1061U). The patient cycles had been regular a few years prior to receiving the vaccination. The patient received unspecified medical attention and was referred to a gynecologist. At the time of this report the patient had not experienced a period.  Additional information has been requested.  Additional information is not expected.
Reported pain / and soreness / at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows:  The patient received 1st dose of Shingrix in right arm. The age at vaccination was not reported.  After receiving 1st dose of Shingrix, the patient experienced pain or soreness at the injection site. In November 2020, the patient got 2nd dose of Shingrix. The patient had Flu vaccine the same day when patient received 2nd dose of Shingrix. The patient reported she did not have symptoms with the second dose but does not recall in which arm she got the vaccine. Lot and expiration were unknown for both doses. The reporter did not consent to follow up.
Pt received Yellow Fever at 1315 and 30 minutes or so later on his way home started to break out in hives and had an itchy throat.  He came back to clinic around 1450 and had vitals taken and was given Benadryl IM and put on an IV.  He left home around 1730 stable.
my chest became splotchy and I began itching from head to toe like I had spiders running all over my body.; This is a spontaneous report from a contactable consumer. A 26-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN 6198), via an unspecified route of administration, administered in Arm Left on 25Feb2021 12:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included Severely allergic to dust mites and Allergy-induced asthma from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. On 25Feb2021 12:30 PM patient experienced 30 minutes after the shot, my chest became splotchy, and I began itching from head to toe like I had spiders running all over my body. The patient was not received treatment medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Headache; Dizzy; sharp shooting pain at injection site.; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 28Jan2021(at the age of 28-year-old) as 1ST DOSE, SINGLE for COVID-19 immunization. Patient's medical history includes allergic reactions to ACE inhibitors.Patient's past drug was Tylenol. Patient's concomitant medications were not reported. On 28Jan2021 the patient experienced, Clinical course was reported as: Patient states that she was dizzy after the vaccine- almost immediately but it could have been anxiety, states she had a headache for about 24 hours, states the main thing she experienced probably about 8 hours after is that she would get sharp shooting pain at injection site. Stated that her doctor recommended her the vaccine for underlying conditions which she does not want to disclose on the report. She did stop taking any Tylenol beforehand just because she read something somewhere that she should. They monitored her longer than the 15 minutes because she has a history of serious allergic reactions to ACE inhibitors. The outcome of the dizzy and shooting pain was recovered on 28Jan2021 and headache was recovered on 29Jan2021.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Over the course of a few days after I slowly started to get a sore throat and hit flashes. By Saturday into Sunday of said week throat was so swollen it was hard to talk and swallow. Extremely painful. Hot flashes and high heart rate but no fever. Needed five days of 60 mg of prednisone to control throat swelling. After throat starts to feel better wide spread muscle aches out of no where and extreme fatigue ..
3 days later pt had cold in eyes eyes pink & draining w/crusting; called MD who suggested saline drops; pt was then sick w/flu like s/s for 3wks mom felt all 3 shot lowered resistance;
ZOSTAVAX given (R) arm proper placement on 11/12/13 8 x 10 cm hard, red, blistered area started on 11/13/13 hot to touch, swollen.
Body rash, nausea, diarrhea, headache, extreme fatigue, malaise, cough, sore throat, joint pain, low grade temperature, red sclera.
dizzy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy). At the time of the report, DIZZINESS (dizzy) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Vomiting; vertigo; headache; This is a spontaneous report from a contactable patient (consumer).  female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on the left arm, at age 37 years, first dose on an unspecified date, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting, vertigo and headache on 31Jan2021 10:00. Facility where the most recent COVID-19 vaccine was administered was at a Administration facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment was not received for the adverse event. Since the vaccination, the patient has nor been tested for COVID-19. The outcome of the event was not recovered. Case was reported as non-serious.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Extreme head and body aches, cold and hot flashes, high temperature, in bed for 5 days straight, couldn't move my neck or upper body without extreme pain.
PT SAID THAT SHE DEVELOPED CELLULITIS IN HER LEFT ARM AFTER GETTING THE FLU VACCINATION FROM THE DR AND PNEUMOVAX 23 FROM PHARMACY. VACCINATIONS WERE GIVEN IN THE SAME ARM. PT SAID SHE DEVELOPED A FEVER THAT WENT AWAY. DR PRESCRIBED AUGMENTIN FOR PT TO CELLULITIS (PT WAS ALREADY TAKING AUGMENTIN FOR UNRELATED SINUS INFECTION). PT SHOWED ME HER ARM WHICH WAS RED. PT SAID IT WAS GETTING BETTER.
being sick, terrible reaction; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine 3 days ago from the date of reporting and had a terrible reaction to the vaccine, but he/she would deal with 2 days of being sick versus actually getting shingles itself. Additional supportive information: The follow-up would not possible as no contact details were available.
Diagnosed as MS; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (Diagnosed as MS) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Anthrax Vaccine. Past adverse reactions to the above products included Allergy with Anthrax Vaccine. Concurrent medical conditions included Allergy to feathers (goose down), Pollen allergy and Plantar fasciitis since 1998.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced MULTIPLE SCLEROSIS (Diagnosed as MS) (seriousness criterion medically significant). On 15-Jun-2021, MULTIPLE SCLEROSIS (Diagnosed as MS) had resolved with sequelae. At the time of the report, PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included Gorgeous Hair, Skin, and Nails multivitamin, tid ongoing since 01 Feb 2020. No treatment information was reported.  Neurologist ordered blood tests and MRIs and diagnosed the patient with MS.  Company Comment: Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded. Some individuals experience immune response following vaccine administration resulting from  reactivation of an underlying undiagnosed condition.   This case was linked to MOD-2021-258762 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received on 16-Jul-2021 does not contain any new information. On 01-Aug-2021: Significant follow up contained patient's demographics and historical conditions. Events were also updated and combined into multiple sclerosis.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded. Some individuals experience immune response following vaccine administration resulting from  reactivation of an underlying undiagnosed condition.