chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 032A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 since an unknown date. Concurrent medical conditions included Pollen allergy and Dust allergy.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On 12-May-2021, PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Body temperature: 103.5 f (High) 103.5 F.         It was reported that 12 hours after the second vaccine dose, the patient experienced fever (temperature 103.5 degree F) that started at 1 AM and lasted till 4PM.  At 4PM, he started to sweat profusely over the next 3 hours as the fever broke. By 8PM, he was back to normal. The seriousness of the side effect was reported unknown. Concomitant medications were not provided. Treatment information was not reported.
On 15SEp92 about 645PM pt broke out w/rash from ankles up to the neck area; 11PM gave pt DPH; the itching & rash diminished p/about 30mins; 16thSEP again had some rash to appear;
I was miserable .   Was hard to walk from my bed to toilet. 20 feet. Couldn't eat. Felt like my eyes were exploding. Threw up. Muscles and joint pain 8/10. Weak.  Could not sleep night of injection
COMPLAINT OF A LOCALIZED RASH TO LEFT LEG STARTED 1/21/2021
-Had dizziness with dosing and fatigue -Abnormal labs - immature granulocytes on 10/11/21 and 1/28/22 Hemoglobin 10.8 on 10/11/21 11.1 on 1/28/22
Abdominal pain; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Diarrhea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Pepto-Bismol was administered as treatment for the events.
pt recv vax 26SEP97 & 17OCT97 pt devel elevated ASt & ALT levels;
This event was received from a health care professional on 19 February 2009. A four-year-old female, with a history of asthma and thrombocytopenia. received intramuscular injections of DAPTACEL (lot number C2798AA), MMR (Merck, lot number 066X), and Varicella (Merck, lot number 1017X) in the right thigh on 16 February 2009. She also received in intramuscular injection of IPOL (lot number A0298-2) in the left thigh. She subsequently developed an area of redness and swelling on the right thigh, spreading down the knee and around to the back of the leg. Outcome was unknown.
after the second shots I have never had a breakout since; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2021 as dose 2, single (Lot number: ER8729) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Herpes", start date: 1983 (unspecified if ongoing), notes: He had Herpes for 40 years; the herpes that he had was gone after he took the vaccine. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: ER8727, The very one of the Shots I had a very light Break out), administration date: 22Mar2021, when the patient was 64-year-old, for COVID-19 Immunization, reaction(s): "The very one of the Shots I had a very light Break out". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "recovered", described as "after the second shots I have never had a breakout since". Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information: He had Herpes for 40 years, the herpes that he had was gone after he took the vaccine. The very one of the Shots he had a very light Break out, and after the Second Shots he have never had a Break out since. Not reporting any issues (side effects, complaints, etc.) with a Pfizer product. Reported issue occurred after use of a Pfizer product. 20Oct2021, Pfizer Lot: FG3590. Booster 29Sep2022 Pfizer Lot: GH9694. Patient fine now.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300043098 same reporter/patient/AE, different dose;
Information has been received via the internet concerning a 21 year old female who was vaccinated with GARDASIL.  The patient died 4 days after vaccination.  The cause of death was unknown.  No further information is available.
Varicella- information has been received from a licensed practical nurse concerning a 7 year old female who on 31 May 1996 was vaccinated with one dose of varicella viurs vaccine live SC in the left arm.  On 28 feb 2000 the patient experienced a varicella rash on the legs, chest, back, buttocks, and neck.  The lesion were itchy and fluid-filled.  Diphenhydramine HCL (Benadryl) was prescribed.  Subsequently, the patient recovered.
Information was received on 09-NOV-2016 from an unspecified reporter, regarding a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of {PNEUMOVAX 23 0.5ml, lot number M003027 (dose, expiration date and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Erythema, blisters at vaccine site, painful. Tx with KEFLEX for possible cellulitis.
A few months after my first and second Pfizer Covid vaccine I developed a tremor in my hands and body. I have seen multiple neurologists who say my tremor doesn't present as normal for essential tremor or other disorders where tremors show up typically. It only just occurred to me that the tremor developed pretty shortly after vaccination and it got worse in the last couple months following my booster shot in January 2022.
Patient noted severe stomach pains 8 hours after vaccination, no vomiting or diarrhea. She then developed a flat red rash over entire body which was very itchy. She took Benadryl with good results for 2 days.
Severe local rxn w/swelling, erythema, tenderness, resolving over 7 days;
PT C/O WARM SENSATION IN HER THROAT, THAT SLOWLY DISSIPATED AND A MEDICINE LIKE TASTE IN HER MOUTH . BP 138/92 HR 92 SpO2 98%
Starting 4 hours after the vaccine, over the next 8 hours fever rose continuously up to 104F, accompanied by episodes of tachycardia (up to 140 bmp) and severe pain in all bones, leaving patient extremely weak and unable to move for about 16 hours.  Most symptoms subsided completely within 30 hours after the vaccine was administered, but a general state of fatigue remained for another week.
Recvd injection 31Oct90- 15Nov90 numbness in lt arm-hand-went to ER-Adm for observation over night. DX virus-infection-still very tired. Had neurological evaluation.
Bodily fatigue, sore arm and pec, light congestion. All within a day or two of vaccination.
LEARNING DISABLED, AUTISM.  No new terms reported in MedRecords rec/d 244217.
My arm become sore and uncomfortable to move approximately 4 hours after the shot.   The next morning  2/18/21 I had body aches, chillls, marked tiredness, arm soreness,  headache, and nausea.  These symptoms lasted until the next morning 2/19/21. I took a total of 3000mg of Tylenol during the course of 2/18/21 Please note that I had a much stronger reaction with my first dose and I did report this.  I also had Covid in November 2020
After 6 plus months after my second shot, on November 5, I had a systemic hives reaction that has now lasted 9 weeks. I went to see an allergist and he recommended that I still get the booster shot, which I did on 11/30/21 (lot # 030H21B).  I am still experiencing hives.
mom says p/vax on 7JUL97 pt ran t102 x 1wk & pt cried cont for longer than 3hr;pt was not actually seen by MD until 14AUG97 & then 2SEP97;MD wrote order child no DTP be given;
Sudden nausea, vomiting, diarrhea approx 10 hours after second dose of Moderna covid 19 vaccine. This was followed by intense chills, muscle pain, fever and headache similar to flu with on abs off again GI symptoms. Lasted 36 hours and required me to miss two days work.
Woke with drooping left face, drooling L. mouth, draining L eye, L. eye not closing completely, numbness left face. same by clinic visit on 01/29/2010. did not keep F/U appts. Contacted by phone 02/01/2010, dad reported same.
14 year old / received / Twinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old male patient who received HAB (Twinrix) (batch number 3Y7NL, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th August 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 6th August 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: A14 year old patient received a dose of Twinrix, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up.
Redness, swelling, heat, pain from injection site to elbow; pain woke her up the same night
This spontaneous report was received from a physician referring to a 63 years old female patient. The patient's medical history, concurrent conditions, drug and allergy history were not reported. On 01-NOV-2015, the patient was vaccinated with ZOSTAVAX 19400 plaque forming units (PFU), by subcutaneous route, lot # K014836 (dose and expiration date were not provided) for prevention of herpes zoster. The patient's concomitant therapy was not reported. On 15-APR-2017, the patient developed a mild case of shingles (herpes zoster) after having previously being vaccinated with ZOSTAVAX. The patient sought the physician for medical attention, she was prescribed 1 gram of valacyclovir 3 times a day for 21 days to treat her shingles, however the patient still had "scarring and red dots from the shingles". At the reporting time, the causality assessment between ZOSTAVAX and shingles was unknown. Additional information is not expected, because there was no consent to contact reporter.
Information has been received from a medical assistant referring to a 2 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-JUN-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same course. Additional information has been requested.
Fatigue, fever, chills, and muscle aches for roughly 36 hours after vaccination
No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant female patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported.   This is one of several reports received from the same reporter.
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (bodyaches) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 007M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), GABAPENTIN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (chills) and MYALGIA (bodyaches). On 05-Mar-2021, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) on 05-Mar-2021 for Fever, at an unspecified dose and frequency. On 05-Mar-2021, CHILLS (chills) and MYALGIA (bodyaches) had resolved. At the time of the report, PYREXIA (fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 100 deg (High) fever. Patient's concomitant medications included unspecified blood pressure medicines. The patient took ACETAMINOPHEN and ASPIRIN as treatment for fever. This case was linked to MOD-2021-036365.
pt recv vax & 10min post vax mom brought pt back w/hives & looking pale;pulse rate 96, resp rate 16t;PA ordered DPH;pt kept @ clinic for 30min for observation then sent home w/DPH;
Information has been received from a medical assistant concerning multiple, unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (strength, frequency and route not reported, lot # L040458 and Expiration date 04-FEB-2018, another lot # was reported as M009377 with expiration date 17-JUN-2017). The vaccines were exposed to 11.7 degree Celsius for 84 minutes. There was no previous temperature excursion. The temperature was back in range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Client is age 12 and received the Pfizer 5-11 formulation at an offsite clinic (School). Multiple safeguards to prevent this type of error were in place, including color-coded wristbands, staff education prior to the clinic and just-in-time training at clinic, only one vaccine type per vaccinator station, and at least 2 points in clinic flow where age and vaccine type are verified. This error was discovered upon record review, and the client's guardian was informed immediately upon discovery on 12/16/21. Per agency guidance, the client may receive an age-appropriate dose of Pfizer vaccine in 21 days to complete the vaccine series; this was discussed with the client's guardian. Client's guardian reported that client did not experience any adverse effects after vaccination. This error will be discussed with the vaccine team to identify any adjustments to offsite clinic processes to prevent this type of error in the future.
Right shoulder pain, right arm weakness. Clinically consistent with brachial plexopathy/parsonage turner syndrome. EMG/NCS done today confirms upper/middle trunk brachial plexopathy.
THREW UP; This spontaneous case (PVX2019-1538) was received from a pharmacist on 13-Jun-2019. It describes an 18-year-old male consumer who threw up, after the administration of Vivotif for an unknown indication.  Case report: The consumer threw up 15 minutes after taking the final dose of Vivotif.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that the consumer  threw up after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer  threw up after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible.
SOB, fatigue, then AFlutter Pt received dose #1 covid vaccine on 3/2/2021. Pt noticed increased shortness of breath and fatigue the next day. Pt presented to the ED on 3/14/2021 with complain of worsening shortness of breath which had worsened over the past 2 weeks. In the ED, his EKG showed a flutter with 2:1 heartblock. COVID-19 swab is negative, procal is negative, d-dimer is negative. He was tachycardic to 130's and short of breath when talking to the physician. Otherwise stable. Per MD note: "ASSESSMENT AND PLAN: #New onset Atrial Flutter with 2:1 block, poa-noticed on EKG, troponin was negative, tachycardic to 130's, no chest pain- Diltiazem to attempt to rate control, will use Dilt drip if necessary-F/u EKG and troponins, monitor carefully for ischemia- Will obtain TTE and TEE cardioversion tomorrow- Apixiban for AC" Pt was admitted on 3/14/2021 for procedures. Pt was discharged on 3/17/2021. On 4/2/2021 pt presented for his appointment for dose #2 covid vaccine and reported this ADR to dose #1 covid vaccine. Pt decided he wanted to proceed with his vaccination & received his dose #2 today (4/2/2021).
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves an unknown age female patient. The vaccine was reported to have an excursion for 45 minutes, but caller states the excursion was actually for 9 days, starting in May, and ranged from 48-49 f, vaccines were used before they found out about the excursion. The patient received MENACTRA. This is actual medication error case as the patient received vaccine which was incorrectly stored. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On an unknown date, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine lot U5833AA, exp date 25-February-2019 via intramuscular route in unknown administration site. It was not reported if the patient experienced any adverse event. Lab data, corrective treatment: not applicable. Outcome: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. Documents held by sender: none.
Within 2 hours of the shot, I had severe heart burn that lasted into the night. I woke up multiple times with diarrhea and stomach pains, which led into Saturday. By Saturday, heartburn was gone but still having stomach pains, nausea and diarrhea and flu like symptoms. Monday starting increasing stomach pains and nausea and by midday Tuesday, the stomach pains were very severe. I went to doctor, who sent me for a CT scan to find my appendix was very inflamed and I had to have emergency surgery to have it removed. When asked why I didn?t come sooner, I said I thought it was just a side effect of the vaccine. I was told I was lucky it didn?t rupture. Please note I never had issues with my appendix or any stomach issues prior
pt reports rash & fever started several hrs p/MMR given; tx for pneumonia 20FEB93 sz 26FEB93 seen in ER & MD felt drug reaction; also exp loss of feeling, severe pain in joints, problems w/thought proceess, dec strength;
Dizziness began 10 days afterwards; received prescription for vertigo; fatigue began within a couple of days of vaccination; This is a spontaneous report from a contactable Other Health care professional (patient). A 71-year-old non pregnant female patient received (BNT162B2, Solution for injection, Lot number: EN5318,), via an unspecified route of administration on 04Feb2021 02:15 PM left arm as single dose for covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history was not reported. Concomitant medication included Glucosamine, chondroitin, fish oil, D3, Carnitine. No other vaccine was taken in four weeks. Covid was no tested prior vaccination. Covid was tested post vaccination. No Known allergies. The patient experienced fatigue began within a couple of days of vaccination, Dizziness began 10 days afterwards. Dizziness was debilitating, contacted my physician and received prescription for vertigo on an 08Feb2021 and corrective treatment included Meclizine 25 mg.1xdaily. The patient had a physician office visit. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
11 days after modern vaccine injection site still warm painful Also checking if 26 days between shots sufficient Had vaccine 1/7  Second dose scheduled 2/1