chrisvoncsefalvay/vaers-outcomes huggingface dataset:
So I noticed, three days after my vaccine that it was still warm to touch and itchy. When I looked at it, it was the size of a quarter and then kept growing and growing several inches. My DR saw me and said maybe you shouldn't get the second shot but I wanted to get the second shot so I did. Later on I read an article that said it was called COVID arm, so I felt better that I wasn't the only one. It wasn't really painful or anything, just itchy and warm to the touch. The DR had told me to take Benadryl and he prescribed me a cream for eczema (Triamcinolone  acetoamide) because he didn't really know what to do. He said if I was going to get the second shot, then to take Benadryl before (which I did).
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old female. Neither the patient's past medical history nor concomitant medications were reported. The product expired on 04-Mar-2012. On 06-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was obtained on 16-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Redness and swelling on and around site, treated with cold compresses, TYLENOL.
Erythematous, tender to palpitation. Anterior aspect of left arm. Plaque about 4cm in diameter.
Numbness to left arm and across upper back starting AM after vaccination (7/8/04). Client called in with these complaints , mother unavailable to talk to.  Ibuprofen, rest and to return phone call to LHD on 7/9/04 with update. To seek PCP if worsens or no improvement. Attempted PC 7/9/04 to client x 2, line busy; attempted PC to client 7/13/04 x2 busy. Client has not called back to us for update.
Chest pain,  shortness of breath headache,  developed into pericarditis treated with non-steroidal oral medication X 5 days
Chills, Fever 101.8, vomiting, diarrhea, muscle cramping, exhaustion, dizziness, dehydration.  This was from 2/27/21 at 0130 to 2/28/21.  The symptoms were the worst from early morning (6am) (Saturday)  2/27/21 through late evening (2200) 2/28/21(Sunday) .  The muscle cramping and exhaustion lasted until 3/1/21. I did not eat until late on 3/1 I did not start to feel better until 3/3/21
Pt was given vaccines; was very nervous at the time - walked out clinic and fainted before getting in her car. Pt. brought into clinic very pale, weak. Given alcohol to breathe fresh air fanned on her. Suggested she drink O.J. or a Coke.
Vaqta expired 5/4/22, and was administered on 5/13/22.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm, fever, dizziness, headache and tiredness. On an unknown date, the outcome of the pain in arm and fever were recovered/resolved and the outcome of the dizziness, headache and tiredness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, fever, dizziness, headache and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had her 2nd shingles shot a little over a week ago, from the date of reporting. The patient no longer had the soreness on her arm and light fever, but she at the time of reporting felt dizzy, headache, and tired. The patient was wanted to know how long should she expect this to last.
Client stated that during her 15-minute observation period, she experienced numbness and tingling in her lips, which resolved within 4 minutes. She stated the sensation continued periodically for 2 days following the vaccine and lasted 3-4 minutes each time. She reported additional symptoms of headache for 2 days following first dose Pfizer COVID vaccine. 3 days following her first dose, her left middle finger became swollen, red, tingling and numb. She stated her left, middle finger issue resolved in 3 days.
I am post menopausal and I had heavy vaginal bleeding that started 48 hours after both my vaccine doses that lasted 24 hours.
Breakthrough case admission after 2 vaccines Pfizer 7/25/21 Lot# FA7485;  Pfizer 8/15/21 Lot# FA7484
Three days after receiving the second Moderna COVID-19 vaccine I developed a case of shingles on the right side of my face. I was diagnosed by my primary care physician, who prescribed a one week course of antiviral medication. The shingles took several weeks to resolve.
Patient received  1 dose of Moderna COVID-19 vaccine at age of 16 yrs; per Immunization Registry received a 2nd vaccine (Pfzier) on 04/24/21.
The pt experienced a loss of hearing in the right ear. Treated with Antivert ear drops and antibiotics. No vaccine listed.
My smart watch alerted me to my oxygen levels had been lower for the last two months, a nursing student in my home helped me with an oxygen machine which I begin to use. My doctor hospitalized me where I stayed in ICU after 28 hours in the ER, I stayed hospitalized for seven days and recovered well with a ventilator I now use at night. Things are now back to relatively normal.
Vommiting, full body aches, chills, fever, headache, diarrhea
Headache for a week, no fever, but had three nose bleeding, on the day ten (3/19/21), blood vessel in the left eye ruptured. it was during day time and felt like needle shot on the left eye.
8/28/12- Received PNEUMOVAX and Flu (TIV) in left deltoid. 8/30/12- Returned with swelling, erythema, and heat over the administration site. Patient received steroid taper to treat.
RA flare up. Mild joint pain beginning 3 weeks after Shot 1. Blood tests 3 days  prior to Shot 2  revealed no inflammatory issues/platelet count normal do Rheumatologist approved getting Shot 2.  RA symptoms have continued  and progressively worsened  (today is day 16 following Shot 2. Severity of joint pain has increased as well as number of joint affected.  Over last 3 days,  Experiencing  additional symptoms, including difficulty swallowing and cramps/pain on side of abdomen. Limiting work and daily function.  Blood test on day  10 show normal platelet count and reduced  WBC/absolute monocyte count.
Face swelled up on one side; all joints hurt, but where  I broke my elbow and wrist it felt like I broke it all over again; chills; skin hurt and felt like it was on fire, still hurts, not on fire anymore; my uterus and ovaries hurt so bad I could not even walk.
low grade fever x 6 hours severe body aches x 24 hours severe heartburn x 12 hours low grade headache x 4 days
Unspecific AE; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unspecific AE) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Unspecific AE). At the time of the report, VACCINATION COMPLICATION (Unspecific AE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
severe vertigo and nystagmus; severe vertigo and nystagmus; labyrinthitis; vestibular neuritis; This is a spontaneous report from a contactable physician (reporting for himself). A 37-year-old male patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via intramuscular route on his right arm on 16Dec2020 15:00 at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient had no known allergies and had no COVID prior vaccination. There were no concomitant medications. On 24Dec2020 at 19:00 (reported as 8 days after vaccine), the patient experienced severe vertigo and nystagmus. Presumed diagnosis vestibular neuritis or labyrinthitis. It has now been one month since onset of symptoms. Much improved but still some persistent vertigo. The reporter was thinking that the events were unlikely to be due to COVID-19 vaccine but given uncertainty of etiology, he thought he should report it. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included nasal swab and polymerase chain reaction (PCR): negative on 02Jan2021. The patient had no prior vaccination. Therapeutic measures were taken as a result of onset of severe vertigo, nystagmus, "vestibular neuritis" and "labyrinthitis" which included prednisone. The outcome of the event vertigo was not recovered while recovering for the event nystagmus, "vestibular neuritis" and "labyrinthitis".  Information on the lot/batch number has been requested.; Sender's Comments: The reported events vertigo, nystagmus, vestibular neuritis, and labyrinthitis are likely intercurrent and are unrelated to suspect drug BNT162B2.
Began to scream, became unresponsive, opened eyes, then limp. Seemed to stop breathing, became very pale. EMS transferred home to ED -> hospital. Occurred Dec 11, 2017. Apnea and hypotension. Dec 26, 2017 similar episode but did not stop breathing. Jan 1, 2018 eye squinting episode, eyes rolled back.
administered in the arm subcutaneous instead of intramuscular/no AE; Initial information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 61 years old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was reported.   On 10-Sep-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QSAA1907 via subcutaneous route in the right deltoid.   It was of actual medication error due to Inappropriate route of vaccination..  It was unknown whether adverse event was experienced..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Diagnosed with "vulvar aphthous ulcer." It started on Thursday 1/20/22 and within 24 hours became extremely painful and swollen. Child could barely walk or pee. Doctor prescribed clobetasol cream and advised 600mg of ibprofen every 6 hours. Said it takes 3-4 weeks to heal. Child missed 2 weeks of school due to not being able to walk or sit for long periods of time.
headache; redness at the injection site; This case was reported by a physician via call center representative and described the occurrence of headache in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced headache and injection site erythema. On an unknown date, the outcome of the headache and injection site erythema were unknown.   It was unknown if the reporter considered the headache and injection site erythema to be related to Shingrix.  Additional information was provided as follows: The batch number and expiration dates were not provided as the reporter did not have the information. The patient received Shingrix and experienced headache and redness at the injection site.  The reporter asked if the patient could receive the second dose. The reporter consented to follow up.
Patient's wife called reporting finding her husband in bed and he was shaking and not able to move. Altered mental status. Temp 102 B/P and blood sugar within normal limits. 911 was called for patient and he was transfered to the ER.
Tinnitus in both ears noticed days after second vaccine.  Still have the buzzing sound in both ears.  Hard to tell but seems like left ear a little more.
Client reported feeling "itchy all over, and burning of her skin".  Client denied hives or other rashes. Client states her lips might have been swollen - she is unsure, also states she had trouble sleeping.
Lightheaded, felt cold, back of neck/head started to hurt, upset stomach. Home with parent.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Jul2023 at 13:00 as dose 6 (booster), single (Lot number: GK0928) at the age of 72 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: SYNTHROID, start date: Jan2000; SERTRALINE, start date: Jan2000. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19Oct2023 to 24Oct2023.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events cannot be excluded,Linked Report(s) : US-PFIZER INC-202300350759 Same patient, different drug/AE;
Autopsy pending = Final cause of death. Most likely acute myocarditis. Questionable viral awaiting final culture results. Child has mild temperature 100., and URI. Autopsy states cause of death as myocarditis.
body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and MYALGIA (body aches) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches) and MYALGIA (body aches). At the time of the report, HEADACHE (headaches) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's consent to follow-up was given.  Concomitant product use was not provided.  Treatment product information was not provided.
Patient was flushed, could not hear, was feeling nausea, and fainted for few seconds. I administered Epi 0.3mg and called 911. Paramedics arrived and patient was taken to the hospital.
i caught the full blown covid 19; This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced i caught the full blown covid 19. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After few minutes of vaccine administration, patient started reporting difficulty  breathing and spasm of back. Pharmacy team contacted 911 and Pharmacist administrate Epinephrine injection Once more help arrived, after getting patient's  consent to go which hospital, they took patient with them.
Pt. reports 2 minutes after getting his vaccine feeling lightheaded and dizzy.  Pt. passed out.  Woken up with ammonia inhalant.  VS: 1558 No BP, OxSat: 90%, HR: 59x min.  4PM BP 120/82, OxSat 98%, hr: 73X min. 4:19PM BP 126/80, hands "tingling, ears still ringing".  4:35PM pt states he is "back to normal" Pt exit the facility with his wife.  He was advised to report this to his PC and get medical advise before getting his booster.
Breakthrough case admission after 3 vaccines Pfizer 4/20/21 Lot# EW0164;  Pfizer 5/11/21 Lot# EW0182;  Pfizer 11/23/21 Lot# FJ1620;
49 year old male came in to our immunization clinic for three travel related vaccinations with no known history of adverse events/side effects from previous vaccinations. Patient received the vaccinations and waited in the same room while I prepared his immunization record. Patient was pleasant to talk with and appeared to have no immediate issues while we reviewed his record and he gathered his coat and was escorted to the front desk. When I saw our client again, he was on his way back into the clinic area to be assessed for not feeling well. As he came closer, he was pale and diaphoretic walked through the doorway and lost function of his hands at which point he dropped his paperwork. He had a brief syncopal episode that lasted under 10 seconds at which time staff was able to guide him to the floor where we laid him down in right lateral recumbent position. He came to and stated that he was cloudy and dizzy. No anaphylaxis, no tremors noted. He denied chest pain or shortness of breath. He had a pulse of 40 bpm, with a regular rate and rhythm, a manual blood pressure of 80/52, respirations even and easy at 14 and GSC of 15. We called paramedics and they transported him to definitive care as his heart rate on ECG remained in the low 40s.
On 10/31/21, two days after my 3rd, booster vaccine (given 10/28/21) I was both bitten by insects and exposed to poison ivy on my left, injection arm.    I scratched until both sites scabbed and then infection and swelling set in on that arm.  This was  not centered around the injection site, but rather around the insect bite/poison ivy sites.  Two weeks later I was prescribed antibiotics for a suspected case of cellulitis by my doctor but did not take them, as the infection was beginning to clear on its own.  As of 12/4/21 I still have a slight rash and itching on my left arm.
This spontaneous report was received from a registered nurse regarding a 42 year old female patient. On an unknown date in October 2012, the patient was vaccinated intramuscularly with a dose of 0.5 milliliter (ml) PNEUMOVAX 23 (lot # H011780, expiry 16-FEB-2014) in the left deltoid muscle. The patient was also concomitantly vaccinated with a dose of FLUZONE (manufacturer unknown) in the same anatomical location. On an unknown date in October 2012, the patient experienced redness, swelling and pain at both injection sites which did not develop for 24 hours. She stated that the patient did not seek treatment for the injection site reactions and has since recovered. The causality for redness, swelling and pain at both injection sites with PNEUMOVAX 23 was unknown. Additional information has been requested.
Patient contracted covid-19 virus after second vaccination; lack of effect; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient contracted covid-19 virus after second vaccination) and THERAPEUTIC PRODUCT EFFECT DECREASED (lack of effect) 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) (unknown route) 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 COVID-19 (Patient contracted covid-19 virus after second vaccination) (seriousness criterion medically significant) and THERAPEUTIC PRODUCT EFFECT DECREASED (lack of effect) (seriousness criterion medically significant). At the time of the report, COVID-19 (Patient contracted covid-19 virus after second vaccination) and THERAPEUTIC PRODUCT EFFECT DECREASED (lack of effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.  This case concerns a patient of unknown age and gender with serious unexpected events of COVID-19, and therapeutic product effect decreased. Event onset with unknown latency after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a patient of unknown age and gender with serious unexpected events of COVID-19, and therapeutic product effect decreased. Event onset with unknown latency after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
fever over 103 for 3 days, loss of apetite, body aches, fast breething, fussiness
c/o warm & sore @ site on inj;c/o red spots radiating to lt arm pit;c/o sl chills, h/a;
This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSFUSION (got a blood transfusion) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSFUSION (got a blood transfusion). At the time of the report, TRANSFUSION (got a blood transfusion) outcome was unknown. Not Provided. 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 medications were not provided. Treatment information was not provided.
Very sore left arm. Worse soreness than a flu shot. Hurt to lift arm and lay on it. Severe soreness lasted about 24 hours.  Mild sore throat but unknown if related to vaccine or if normal seasonal allergies.
pt recv vax JUN95 & 15MAY97 pt devel rash that consisted of less than 50 lesions;
iNJECTION SITE PAIN/SORENESS Narrative: iNJECTION SITE PAIN/SORENESS START APPROXIMATELY 2 AM DAY 2. LASTED <24 HOURS  Other Relevant History: