chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Light headedness and dizzy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had his/her vaccine today (on 11Apr2021), it made him/her dizzy and light headed. And the patient asked, "Can I still take my potassium medicine that I take daily?  My potassium pill, that I take daily for my cholesterol and I took my blood pressure pill before I had vaccine. I want to confirm do we still take it or should you wait till the next day". Events outcome was unknown.  Information on the lot/batch number has been requested.
Raised red area (palm-sized) on upper arm, at injection site; tender to touch, hot to touch, and itchy. Mild chills and general unwell feeling as the day went on. Increased pain in shoulder as day went on. Improved after 24 hours, but raised red area still visible, warm and tender.
Noticed redness at injection site and and just below injection site around 2 am Tuesday, February 23, 2021.   It's not painful to the touch and does not itch.  Some areas look like "welts".
pt devel 1 1/2 inch irregularly shaped reddened area @ inj site 5 mins; p/vax given area raised; no itching; no resp sx; observed in clinic for 25 mins following inj; reddened area completely gone few hr p/inj;
No adverse event; patient was administered a half dose of the Bivalent booster instead of the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient was administered a half dose of the Bivalent booster instead of the full dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient had comorbid conditions.   On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient was administered a half dose of the Bivalent booster instead of the full dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient was administered a half dose of the Bivalent booster instead of the full dose) 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 was administered a half dose of the Bivalent booster instead of the full dose).    No concomitant drug was reported. It was reported that a technician gave 0.25 ml of the Bivalent booster to patient. The CDC website says to re-administer the dose. No treatment drug was reported. This case contains information for the 5th of 5 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-654604, US-MODERNATX, INC.-MOD-2022-654608, US-MODERNATX, INC.-MOD-2022-654610, US-MODERNATX, INC.-MOD-2022-654609 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-654604:Patient 1 US-MODERNATX, INC.-MOD-2022-654608:Patient 2 US-MODERNATX, INC.-MOD-2022-654610:Patient 3 US-MODERNATX, INC.-MOD-2022-654609:Patient 4
Sore Arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Sore Arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included HRT since an unknown date. Concurrent medical conditions included Asthma chronic. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 24-Mar-2021, 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 (Sore Arm). At the time of the report, VACCINATION SITE PAIN (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was mentioned as patient took HRT. No treatment information was reported. Case is non-serious, no CC is required.   This case was linked to MOD-2021-313517 (Patient Link).; Sender's Comments: Case is non-serious, no CC is required.
Pain, redness, and swelling at the injection site Muscle pain Tiredness headache fever-up to 101.7 Chills
Grandmother left voice mail on 6/19/19 to report episodes of diarrhea alternating with formed stool on 6/9/19, day two post vaccination, followed by a rash on 6/19/19 day 12 post vaccination. Child had  poor appetite and low energy, though continued to eat and drink. Temporal temps read 99 F. A once daily dose of Tylenol was given next 4-5 days to treat.  On 6/19/19  a mild rash was noted over his back and neck. This lasted for about 2 days, spread to the chest and toward his face. Benadryl was given once daily. Child did not complain of itching. Once the rash erupted, the child's energy returned to normal, as well as his appetite. The rash faded within two days. The nurse was able to reach the grandmother for details on Monday June 24 2019. At that time the child was fully back to normal.
VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; no adverse event; VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular use), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE).    Concomitant medications were not reported.  It was unknown if the patient experienced any additional symptoms/events. Treatment medications were not reported.
Her first visit to our clinic: Administered flu vaccine in left arm (no signs or symptoms); administered HPV in right arm and as the patient was talking she closed her eyes and fell forward (hyporesponsive collapse) onto my lap. I slowly transferred her to the floor and had another employee call dad in the room. Patient arms and legs went rigid for about 8 seconds and then she opened her eyes and came to. Dad was now in the room and stated she has done this before with a finger stick. He stated he and she also faints with vaccines and blood draws. Patient sat up without assistance, spoke clearly and appropriately, and stood without assistance. Observed for an additional 10 minutes, patient denied dizziness and other symptoms. Walked out of clinic and dad stated she will be back in 2 months for her second dose of HPV.
Within a day of getting the first shot, my eyes became very itchy, particularly my left eye. It is either really dry and itchy or watering, this goes on all day. I got the shot on the 24 of June, and I am still dealing with this to this day July 3.  As well it's like my immune system is less robust, as I have gotten insect bites and scratches from gardening, where I have instant welts and the bites were intensely itchy for almost a week, as for the scratches from gardening I got welts on my skin where the scratches were.  Eye drops, Antihistamines that usually work very well, have pretty much no effect. Including the anti- ich cream for the bites all not effective or very minimal. The only other issue was an extremely sore arm the third to fifth day after the shot. These reactions are extreme by my experience and the fact that the remedies I usually use for minor seasonal allergies are of no use. If the eye issues don't resolve by next week I will be seeing the doctor.
Feeling was just odd; Feeling Jittery; Different taste in my mouth; Dryness in my mouth; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling was just odd), FEELING JITTERY (Feeling Jittery), TASTE DISORDER (Different taste in my mouth), DRY MOUTH (Dryness in my mouth) and DIZZINESS (Light headedness) in a female 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 (No medical history was reported).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling was just odd), FEELING JITTERY (Feeling Jittery), TASTE DISORDER (Different taste in my mouth) and DRY MOUTH (Dryness in my mouth). On an unknown date, the patient experienced DIZZINESS (Light headedness). At the time of the report, FEELING ABNORMAL (Feeling was just odd), FEELING JITTERY (Feeling Jittery), TASTE DISORDER (Different taste in my mouth), DRY MOUTH (Dryness in my mouth) and DIZZINESS (Light headedness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient returned to immunization clinic for 2nd dose of vaccine.   He reported that he had a stroke approximately 1 month after his COVID vaccine.  I advised nurse to not vaccinate today as this may be a vaccine adverse event.
Received only diluent ASO1B / without gE antigen reconstituted; Received only diluent ASO1B / without gE antigen reconstituted; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number br7b3, expiry date unknown) for prophylaxis.   On 24th June 2021, the patient received Shingrix. On 24th June 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, the patient received only diluent ASO1B from Shingrix vaccine without gE antigen reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up
Redness in arm; Some kind of headachy feeling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in arm) and HEADACHE (Some kind of headachy feeling) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 01-Jan-2020 to 12-Jan-2020.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ERYTHEMA (Redness in arm) and HEADACHE (Some kind of headachy feeling). At the time of the report, ERYTHEMA (Redness in arm) and HEADACHE (Some kind of headachy feeling) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the patient had a blood test 8 months later after the COVID and found that she had antibodies and donated her plasma.  No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-460387 (Patient Link).
Patient got part of the Menveo vaccine. The MenA Lyophilized conjugate component was mixed with a sterile diluent and administered to the patient. It wasn't until after vaccine was given that it was noticed by another employee. Provider was notified, and patient is currently being contacted by the office to let know she will need to be revaccinated.
Site: Redness at Injection Site-Mild, Additional Details: Pt got the Moderna booster shot 0.25ml on 12/20/21.  Pt was suppose to get Pfizer booster shot 0.3ml.   Pt received 2 COVID SHIELD vaccines.  The 2nd covid shot was on 7/17/21.   Pt was scheduled to have a Moderna booster shot at Pharmacy.  There was a miscommunication from Pharmacy side to store side on what vaccine to give patients.   *Pt did NOT have any side effects at injection sites. * Only side effects listed above.
Pain, large red raised circle taking up large portion of arm  lasting 4 days, low grade fever, headache, nausea
Patient developed fever, chills, body aches, ocular migraine and then developed cramping and abdominal pain.  Symptoms lasted 3 days and then resolved completely.
Information has been received from a health professional concerning a 41 year old female with a history of high cholesterol and no known allergies who "thinks she may have received measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live in grade school". There was no concomitant medication. On 03-JAN-2006 the patient had a titer done which was negative for rubella and mumps, but positive for measles. It was reported that the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. 05/30/2007 Additional information indicated that on 03-FEB-2006 the patient was vaccinated with a dose of MMR II (lot # 348474/0314P). Concomitant vaccination on 03-FEB-2006 included a dose of VARIVAX (Oka/Merck) (MSD) (lot # 309993/0896R). The registered nurse reported that the patient didn't have a reaction to the MMR II given on 03-FEB-2006. No further information is expected.
Moderna, first injection.   Rapid heartbeat, lasting sometimes 20 minutes, with lengths of time up to 4 hours in between event. This has not subsided.  Moderna, second injection, Lot 020F21A, date: 08/31/21 Rapid heartbeat, lasting sometimes 20 minutes, with lengths of time up to 4 hours in between events.  Today is 10/15/2021 and this continues.
aphthous ulcer to distal, right-sided tip of tongue, developed two days after getting vaccine
Information has been received from an office manager concerning her 19 year old daughter with penicillin allergy. The family had a history of MS. On approximately 31-OCT-2009 she was vaccinated with a second dose GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 31-DEC-2009 the patient had ongoing numbness in her arms and legs. The patient had blood samples tests done (results not reported). The patient sought medical attention with a physician. At the time of this reported the patient had not recovered. Follow up information has been received from the office manager concerning her daughter. She stated that her daughter's blood tests revealed a vitamin B12 deficiency. The patient had recently received three vitamin B12 injections. It was reported that the patient had some improvement. The patient's mother stated that the patient's physician did not think that the patient's symptoms were GARDASIL related. Additional information is not expected.
Employee complains of pain in left deltoid preventing movement without pain. Was evaluated by a MD at local health works location on 1/27/2020  who stated there is no noted adverse affect apparent on examination. Employee described vaccination injection point, as well as process and MD stated she reassured her all was done correct. MD did recommend modified duty x2 week (no lifting more than 5 lbs and no overhead lifting) and followup at the 2week mark
rapid onset of aches and chills that in the beginning caused fairly violent shivering as a fever built up; rapid onset of aches and chills that in the beginning caused fairly violent shivering as a fever built up; rapid onset of aches and chills that in the beginning caused fairly violent shivering as a fever built up; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 13:00 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) and known allergy to penicillin. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 29Mar2021 at 14:00 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. On 21Apr2021 at 01:00, about 12 hours after receiving the second dose of vaccine, the patient experienced a rapid onset of aches and chills that in the beginning caused fairly violent shivering as a fever built up. The patient took multiple readings as he bundled up and turned up the heat with temperature climbing to 100.3. 12 hours later symptoms continued although were improving. The patient once had a similar reaction to a flu shot in the past. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 21Apr2021, the patient underwent body temperature test and the result was 100.3 (unspecified unit). Therapeutic measures were taken as a result of events and included treatment with 400mg of ibuprofen from 21Apr2021 and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events aches, chills and fever were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
I lost my sense of smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 13Sep2021 as dose 2, single (Lot number: FD3184) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, lot# FD8448), administration date: 23Aug2021, for COVID-19 immunization. The following information was reported: ANOSMIA (non-serious), outcome "not recovered", described as "I lost my sense of smell". The event "i lost my sense of smell" required physician office visit.  Additional information: the patient reported that: "I am writing in regards to the Pfizer Covid injections I received on 23Aug2021 (lot# FD8448) and 13Sep2021 (Lot# FD3184). I lost my sense of smell. I have been going to the doctors office every 6 months for check ups on when will I regain my sense of smell. My doctor advised me it was time to contact manufacturer in regards this matter. Its been almost 2 year and I still have not gotten my sense of smell back. I would like to fill an insurance claim with Insurance Company. I was not advised that I would permanently loose my sense of smell upon taking the injection. " it was also added that "I lost my sense of smell once I was vaccinated, my internal medicine doctor keep saying give it 6 months . Give it another 6 months. My body was compromised and I have to keep going to these specialist to get sense of smell back. I need to file an insurance claim. "
6 days after receiving Bexsero vaccine, he develop a hive/urticarial-like rash around where the injection site was.  The area right where he received the vaccine was clear and then flat-topped red papular rash spread from there, some of the lesions coalesced.  No other rash.  No other sxs at that time.  Treatment was to continue Allertec, could try dose of benadryl and apply cool compresses.  Resolved on its own.  Unsure how many days for it to resolve.
Patient is 8 years old and was given pfizer vaccine for 12 years and older. No known adverse effect as result of this at this time.
This spontaneous report as received from a healthcare worker refers to a physician of unknown age and gender. There was no information about concomitant medications, pertinent medical history, drug and allergies provided. On an unknown date, the patient was vaccinated (as a child) with unspecified dose of hepatitis B vaccine (manufacturer unknown) (reported as unspecified hepatitis B vaccine) injection (lot#, expiration date, frequency, indication, route and site of vaccination were not reported). Subsequently, on an unspecified time after receiving the hepatitis B vaccine (manufacturer unknown) the patient had titers drawn, which showed that the patient had no immunity to hepatitis B. There was no product quality complaint (PQC) involved. The outcome of the event was unknown. The relatedness between the event and hepatitis B vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Menses were delayed significantly after each pfizer vaccine.  After menses occurred, menses lasted much longer than is typical (~17 days).