chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had his first dose 4th of March then a week after his first dose, he tested positive; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 04mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Mar2021, he felt some symptoms a week after his first dose, he tested covid-19 positive on 15Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a consumer via call center representative and described the occurrence of hospitalization in a 4-year-old patient who received KINRIX. On an unknown date, the patient received KINRIX at an unknown dose. On an unknown date, an unknown time after receiving KINRIX, the patient experienced hospitalization (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the hospitalization was unknown. It was unknown if the reporter considered the hospitalization to be related to KINRIX. Additional information: The reporter was the mother of the patient. She declined demographics and then she disconnected the call. No further details could be obtained.
Loss of consciousness. Screaming his head was exploding, high pitched scream. Ran into walls, seizures and memory issues. Would wonder in a circle.
petit mal seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose 4 (booster), single (Lot number: GL2092), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 2, single, Lot Number: EN6205, Anatomical location: Arm), administration date: 26Feb2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "petit mal seizures"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE , Lot Number: FH8028, Anatomical location: Arm), administration date: 11Nov2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "petit mal seizures"; Bnt162b2 (Dose:1, single, Lot Number: EM9809, Anatomical location: arm left, Time the vaccination was given: Morning), for COVID-19 immunization, reaction(s): "Petite mal seizures starting sometime shortly after 1st COVID". The following information was reported: PETIT MAL EPILEPSY (medically significant) with onset 2023, outcome "recovered" (2023), described as "petit mal seizures". The event "petit mal seizures" required physician office visit. Therapeutic measures were taken as a result of petit mal epilepsy.  Clinical course: Patient started having petit mal seizures after his initial shot series. His doctor finally got them under control with Xcopri. Since then each time he had gotten a booster he had had 1 or 2 seizures within a week. He never had seizures until the COVID shot. He was fine until he took a booster and then he had one the next day, then this year they got another booster since they were leaving the country, he had 2 seizures the next day. Called doctor and she said to let her know if any more occurred. He did not have any past the two. The reason reporter believed it was the vaccine was because each time he had gotten a booster, he would have at least 1 episode even though he had been taking Xcopri 200's daily. Boosters caused one seizure shortly after even when taking XCOPRI. Adverse event did not require visit to Emergency Room. Called with last booster because he had 2 seizures.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288375 same patient/product/adverse event, different dose number;US-PFIZER INC-202300288376 same patient/product/adverse event, different dose number;US-PFIZER INC-PV202300127998 same patient/product/adverse event, different dose number;
Menactra was given every 5 years, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves female patient (reported as old woman) who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via unknown route in unknown administration site on an unknown date in every five years.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to extra dose administered.  It was reported that she had the understanding for last 10 years that Menactra was given every 5 years like Adacel. Caller stated that now she is reading the insert and it says that it is given at ages 11, 16, and 23, and only given every 5 years if they have HIV." Indicated that this is not in our prescribing information. She states that she is an "old woman" and they get reviewed, the latest was two months ago, and no one ever called their attention to it and they never had one compliant about Menactra. She states that they have been giving Menactra every five years like Adacel.  At the time of reporting, no adverse reactions were reported.  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.  Information on the batch number was requested.
Fussy, felt warm-given APAP; vomiting; fever persisted x 5 days; highest temp recorded 100.2 R; fully recovered;
Eruption of 3 localized, clustered, itchy skin lesions on low back, resolved over 7 weeks, reoccured 8 weeks later, followed by another cluster on upper back, resolved. MD dx'd varicella lesions from Zostavax vaccine given on 10/15/14.
On 12/28/99, the pt developed a slight papular vesicular rash. Unspecified medical attention was sought. It was also reported that the lesions were pruritic and located on the pt's trunk and extremities.
PROQUAD that underwent a temperature excursion was admnistered; No additional adverse effects reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, or concomitant medication were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot number T034612 with expiration date 10-APR-2022 (dosage, route of administration and anatomical location were not reported) for prophylaxis, which underwent a temperature excursion, at 14 to 46°F (33F) for 8 hours 0 minutes and 0 seconds. There was no previous temperature excursion.  No additional adverse effect reported.  This is one of two reports received from the same reporter.
Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-JUL-2015 and 03-AUG-2015, the patient was vaccinated with improperly stored doses of M-M-R II lot # K016154 exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approx 2 1/2" x 5" area of redness with centralized swelling near injection site. Required "quick care" visit for abx an steroid ointment.
Patient was in observation/waiting area, got up to tell my tech that she wasn't feeling well.  My tech called to me to have me assist the patient and I had her sit down and then as we were talking she lost consciousness.  She was sitting so I had her head in my hands and she came back to consciousness in less then 10 seconds.  I had the tech call 911 as soon as she passed out.  I kept her talking and concentrated on her breathing until the emt's arrived and assessed her.  She stayed with us for over an hour and her significant other arrived to pick her up.  She called me later that evening, per my request, and she was feeling much better and had no further incidents, but was tired and feeling a bit off
Muscle cramps; Achy all over; A spontaneous report was received from a nurse concerning a 47 year old female patient, who received Moderna's COVID-19 vaccine and experienced muscle spasms and aches.  The patient's medical history, as provided by the reporter, included cancer in 2017 and Rocky Mountain Spotted Fever in 2019. Concomitant medications included Vitamin D3, Vitamin C, and occasionally Benadryl for sleep.  On an unknown date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the right arm for prophylaxis of Covid-19 infection.  On an unknown date, the patient experienced muscle cramps, muscle spasms and aches. She was feeling better at the time of the report. Treatment medications included Advil and Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, muscle cramps, muscle spasms and aches, was considered as resolving.; Reporter's Comments: Based on the 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.
pt w/swelling in lt arm-swollen shoulder to elbow, red, blotchy;MD recommended APAP;
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) to be not related.No concomitant medication were reported. No treatment medication were reported. Patient's anatomical location of vaccine was reported as deltoid. This case was linked to MOD-2021-313106, MOD-2021-356728 (Patient Link).
I had a headache that wasn't terrible. I had kind of a runny nose, and my throat was scratchy but not sore. I also had abdominal and kidney pain. The worst symptom was fatigue. I completed a home test for COVID 19 on October 6, 2022. I also had a rapid test. I was put on PAXLOVID due to a compromised immune system. The doctor advised me to drink lots of fluids. I started to feel better the 2nd day of taking the medication. Within 5 to 7 days, I was symptom free outside of the fact that I was pretty tired. The doctor advised me to contact my primary care doctor regarding when I should start back on my normal medications.
Acute class IIb right lower extremity ischemia secondary to occluded right superficial to popliteal artery stents s/p right common femoral to above-knee popliteal artery bypass with PTFE. deemed appropriate for discharge after 3 days. Hospital admission within 6 weeks of receiving the COVID vaccine.
Low white blood cell count after Moderna Covid-19 vaccine primary series; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (Low white blood cell count after Moderna Covid-19 vaccine primary series) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025821A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced WHITE BLOOD CELL COUNT DECREASED (Low white blood cell count after Moderna Covid-19 vaccine primary series). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (Low white blood cell count after Moderna Covid-19 vaccine primary series) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, White blood cell count: low (Low) Low white blood cell count after receiving her primary series of the Covid-19 vaccine..         No Concomitant medication were reported. No treatment medication were reported.  The patient received her second Moderna Covid-19 vaccine on date not given.
This spontaneous report as received from a pharmacist refers to a 50 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route, frequency, lot # and expiry date not reported) (inappropriate age at vaccine administration). No adverse symptoms were reported. Product quality complaint was not involved. Additional information has been requested.
ACUTE NON ST ELEVATION MI 4/11/2023 SHORTNESS OF BREATH ACUTE NON ST ELEVATION MI 4/11/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE NON ST ELEVATION MI 4/11/2023 NON-ISCHEMIC MYOCARDIAL INJURY ACUTE NON ST ELEVATION MI 4/11/2023 ACUTE NON ST ELEVATION MI
PATIENT INDICATED THAT SHE EXPERIENCED SIDE EFFECTS OF THE VACCINATION, PAIN AT SITE, FEVER NO NUMBER GIVEN, VOMIT TIMES 2 IN 24 HOURS, FLU ACHY FEELING AND SORENESS AND SHOULDER PAIN.
After my second shot (wednesday) I started getting flu like symptoms days later (saturday).  I didn't have a fever but felt achy.  The most concerning reaction was tightness in my chest.  I could not take a deep breath and eventually had to go to the Emergency Room, at the hospital.  I had muscle spasms in my chest so bad that they gave me muscle relaxers.  I did miss a day of work
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Lack of breath), INSOMNIA (lack of sleep), HYPOGEUSIA (no taste), COUGH (cough) and DRY MOUTH (dry mouth) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNEA (Lack of breath), INSOMNIA (lack of sleep), HYPOGEUSIA (no taste), COUGH (cough), DRY MOUTH (dry mouth) and FEELING ABNORMAL (felt bad). At the time of the report, DYSPNOEA (Lack of breath), INSOMNIA (lack of sleep), HYPOGEUSIA (no taste), COUGH (cough), DRY MOUTH (dry mouth) and FEELING ABNORMAL (felt bad) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-052962.
5mm of fluid around heart; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 12Aug2021 at 11:00 (Lot Number: FA7484) as dose 1, single for COVID-19 immunization.  Medical history included coconut allergy from an unknown date. The patient did not have COVID-19 prior to vaccination. Concomitant medication included estradiol (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported. On 12Aug2021, the patient had shortness of breath that has lasted a week. CT from the patient's ER visit on 12Aug2021, showed 5 mm of fluid around the heart and was prescribed Voltaren as treatment. The patient had a COVID-19 nasal swab test on 18Aug2021 with a negative result. The outcome of the event 5mm of fluid around heart was recovering while the outcome of the event shortness of breath was recovered on Aug2021.   No follow-up attempts are possible. No further information is expected
08/03/2003: Red, swollen serpinious area right thigh-minimal tenderness.  Allergic reaction vs cellulitis right leg.  Treatment Zyrtec syrup and augmentin 600/5.
Patient contacted the pharmacy to report that she had been vaccinated in the morning ( 9:30 am) and was presenting lip swelling at that time  (7:03 pm). She said she had taken Benadryl and we recommend that she go to the hospital for evaluation as she had not improved at all. we have tried to contact the patient we have left a message but we have not received a call back
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.    NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC and department of health, decided to offer the employee an additional COVID-19 vaccine dose.  Thanks.
4NOV95 1030 recvd vax & 5NOV95 0200 nausea, flushed, weak & h/a;0330 leg cramping, worse h/a,nausea/weakness;0335 gen tonic rxn, clenched teeth, posturing, x 72sec w/o incontinence;positive postictal;h/a, nausea, weakness lasted 1wk
concern for TTP/ITP given array of symptoms and thrombocytopenia started around the time of vaccination. he is currently admitted to the ICU for high concern for TTP (awaiting HIT panel, ADAMTS13, etc). admitted yesterday with AMS, kidney failure, sever thrombocytopenia (17k), new dilated cardiomyopathy (troponin increased to >2) and CT head findings concerning (waiting on stability of renal function to get MR for cavernous sinus thrombosis). he is undergoing PLEX, IVIG, receiving caplacizumab and decadron.
Patient contracted COVID after being fully vaccinated Cough, myalgia, fatigue, headaches, chills, congestion
RASH/HIVES 2 HOURS AFTER VACCINE- TREATED WITH 50 MG DIPHENHYDRAMINE AND ORAL HYDRATION
patient stated that she was feeling dizzy and seeing spots.  Her blood pressure was taken at it was 65/35. Her skin was very cool and clammy.  She couldn't remember her medications that she took and stated that she "was really tired."  Pupils were dilated and she couldn't make eye contact with me.  Blood work and EKG were done and looked good.  Patient was given 500cc of normal saline.  She felt much better and came back to clinic and we finished her appt. and clip her toenails.  I called to check on her on 4-26-23 and she had no complaints and felt fine.
hands were hurting; feeling fatigue; Joint pains; Muscles aching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hands were hurting), FATIGUE (feeling fatigue), ARTHRALGIA (Joint pains) and MYALGIA (Muscles aching) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (feeling fatigue), ARTHRALGIA (Joint pains) and MYALGIA (Muscles aching). On an unknown date, the patient experienced PAIN IN EXTREMITY (hands were hurting). At the time of the report, PAIN IN EXTREMITY (hands were hurting), FATIGUE (feeling fatigue), ARTHRALGIA (Joint pains) and MYALGIA (Muscles aching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: No specific follow-up information recorded.
Gave FLUZONE High dose at 1:30 PM on 10/19. Pt. experienced nausea, diarrhea, dizziness at 7:00 PM and did not fully recover till 3 PM the following day.
Serious Criteria: Other Medically Significant (OMIC). Initial report received on 11/Jan/2006 from a physician. An 18 month old male patient with no significant past medical history, and who was taking Amoxicillin for a cold and cough at the time of the vaccination, had received his fourth intramuscular injection of Tripedia, lot number U1396CA, in the left thigh on 10/Jan/2006 at 13:30. Eight hours post-vaccination at 21:30, the patient developed redness and swelling at the injection site. The patient also developed generalized ecchymosis and petechiae throughout his body that was confirmed via a phone conversation with the attending physician on 17/Jan/2006. The patient had not recovered from these events at the time of this report.
rash (L) and (R) arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash (L) and (R) arms) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030120A) for COVID-19 vaccination.     The patient's past medical history included Immune disorder (NOS).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash (L) and (R) arms). At the time of the report, RASH (rash (L) and (R) arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Hives on face, ears, and back approx 45 minutes after receiving Dtap, IPV, MMR. No cough or wheezing resolved with Benadryl.
I experienced a cough that would not go away when I went to the doctor the diagnosed it as a upper respiratory infection.
History of 3 viable pregnancies, live births. No miscarriages.  2nd vaccine 2/11/21, confirmed pregnancy 3/10/21, confirmed miscarriage 3/17/21.
pt recvd measles vax on 29JUL92 & approx 5AUG92 pt devel malaise & h/a; 8AUG92 pt devel low grade fever; next day devel a small raised pruritic red-looking rash over the back, chest & abdomen;