chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Almost immediately after 4th vaccine injection (sitting in a chair): eyes rolled back, passed out, copious frothy sputum pouring from mouth, arms and hands contracted up to chest in seizure like movements, pale & diaphoretic. Nurse snapped what appeared to be an ammonia cap under his nose, and patted face and arms, calling his name. She said he was having a severe vasovagal response and would "come back." I could not feel a radial pulse and was ready to dial 911 and access need for CPR. I pulled out my EpiPen, but did not useno wheezing or signs of anaphylaxis. He regained consciousness after approximately 1 minute, asking how long he was out and reported feeling "detached." Nursed called doctor on call and reported reaction. Blood Pressure 98/60 and pulse 56 at 11:01 a.m. approximately 4-5 minutes after he regained consciousness. He slept most of the day and said he felt fine the next morning. I do not know which vaccines were injected into right arm and which were injected into left arm.
Pts mom took pt to ER with severe headache, and a temp of 104. This was at 2am on 7/30/2006, He also had a rash, erythematous papules on face, upper trunk and arms.
Itchy eyelids and tops of feet - very intense 9/15/11 took shower and BENADRYL for possible allergic rxn - med resolved itching (took BENADRYL 2 times).
Roughly an hour after vaccination, experienced light-headedness and dizziness. During the night, a mild fever and nausea. The next day, four episodes of vomiting, fever, dizziness, headache, and body aches. During the second night, fever rose to 101. The second full day, worse headaches, sensitive to light, chest tightness (hurt to breathe deeply, cough, and laugh) and body aches. Third full day, mild chest tightness. Only medication taken to treat adverse affects was ibuprofen.
First Shingrix shot on 5/28/20 caused pain within a couple hours in vaccination arm, shoulder and neck which eventually went away.  After the 2nd shot in the series on 8/20/20, this pain returned worse and still has not subsided as of 9/29/20.  Patient is seeing Dr. for treatment.
pt recv vax 27JUN96 835AM & 840AM fainted w/ ? sz activity;BP 112/80, P72 sibling saw pt staring straight ahead-unresponsive to twitching-slumped against wall;went to floor started coming around, in sitting position, felt nauseated-vomited
so sick; terrible headache; arm is hurting; feeling she is going to throw up; having chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (so sick), HEADACHE (terrible headache), VACCINATION SITE PAIN (arm is hurting), NAUSEA (feeling she is going to throw up) and CHILLS (having chills) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION COMPLICATION (so sick), HEADACHE (terrible headache), VACCINATION SITE PAIN (arm is hurting), NAUSEA (feeling she is going to throw up) and CHILLS (having chills). At the time of the report, VACCINATION COMPLICATION (so sick), HEADACHE (terrible headache), VACCINATION SITE PAIN (arm is hurting), NAUSEA (feeling she is going to throw up) and CHILLS (having chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   This case was linked to MOD-2021-248012 (Dose 2 case) (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant followup was received. Onset date of the event , event outcome and patient demographics were added.
Day after vaccine normal chills and fatigue.  Sore eyes and sore arm where vaccine was administered.  Subsequent day woke up with extremely itchy eye (right only) and growing lump in eye which grew throughout day.  Called health facility for university and on-call nurse said to go to ER.  ER said some allergic reaction possibly due to season (patient has not experienced any allergic reactions to her knowledge prior).
3 days post vax the pt developed 100 - 200 generalized lesions on his torso, legs, arms, neck and face which later became maculopapular. He also experienced a fever of 101.5F. The pt was seen by a communicable disease nurse at which time nearly all of his lesions had resolved. The nurse was not sure whether the child had chickenpox, but felt that the rash was the result of some viral infection. A throat culture was done with results pending. The child's fever persisted and he continued to feel poorly. No further information is available.
E.Coli Infection; Food Poisoning; A spontaneous report was received from a consumer, concerning a 71-year-old male patient who received Modern's COVID-19 vaccine (mRNA-1273) and developed E. coli Infection and food poisoning.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 25 Feb 2021, approximately three weeks prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch number:02A21A) in the left arm for prophylaxis of COVID-19 infection.  On 16 Mar 2021, the patient was diagnosed with E-coli infection which was considered as serious (medically significant) and food poisoning.   Treatment medication included unknown antibiotics for the events.   Action taken with mRNA-1273 in response to events were unknown.  The outcome of the events E. coli Infection and food poisoning were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Pt received Hep A And Hep B vaccine (child). Pt got pale and passed out for a few seconds on chair.  Pt vomited, First responders were called.  Pt was placed on exam table elevated feet. cold packs were placed.  Vitals were normal. Pt was observed for 30 minutes then released.
9pm- fatigue.   Vomit and diarrhea each of the following times. 11pm, 12:30am, 2am, 2:20am, 2:40am, 3am, 3:45am, 4:45am, 5:30am, 7am, 8am, 10:15am.   Chills and sweats prior and post vomit.   6pm - fever of 99.5. normal body temp is 97.5.
This spontaneous report as received from a registered nurse refers to a 13 month old patient. On 25-APR-2013 the patient was vaccinated with MMR II (dose 1, subcutaneous, concentration and lot number unknown). On the same day the patient was also vaccinated with PROQUAD (dose 1, subcutaneous, concentration and lot number unknown). No adverse effect was reported. Additional information has been requested.
4/7/21 new onset of Atrial Fibrillation-admitted to ICU from ED
After apparent 1st dose MMR developed generalized urticarial rash on arms, legs, and trunk. No wheezing or respiratory symptoms. Rash persists 48 hours after vaccine.
nurse asks if expired Menactra dose that she administered needs to be repeated with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health professional via Medical Information (GMI) (Reference number- 00594513) and transmitted to Sanofi on 10-May-2021.  This case involves a 20-year old female patient for whom nurse asked if expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] dose that she administered needs to be repeated (expired product administered) on 06-May-2021 (lot number: U6576AA and expiration date: 04-Apr-2021] at an 0.5 ml once dose via intramuscular route in the left deltoid for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination was not reported, and concomitant vaccination included INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]).  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  Disclaimer: 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.
Red, burning and itching rash at the shot site. Did not appear until days after shot. Continuing to spread.
Pt developed edema, erythema, and itching on left upper arm, elbow area, and proximal area of left forearm.
No adverse effects reported; patient were vaccinated with improperly stored ROTATEQ; Information has been received from a nurse referring to a 6 months old patient of unknown gender. The patient's drug reactions/allergies, pertinent medical history and concomitant medication were not provided.  On 20-MAR-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R021650, expiration date 27-MAY-2020 for prophylaxis (strength, dose, frequency and route were not provided). No adverse effects reported. The outcome of the events was unknown. The storage temperature of the rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was reported as -11.9 degrees Celcius for a time frame of 1 hour and 45 minutes. There was no previous temperature excursion. The call was due to a data logger. No product quality compliance provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1903USA010666: US-009507513-1904USA004568: US-009507513-1904USA004569: US-009507513-1904USA004570: US-009507513-1904USA004572:
Information has been received from a physician concerning a patient who was vaccinated with a third dose of Rotateq. Subsequently, 4 weeks after the third dose, the patient developed intussusception. It was noted that the patient's chart was not at the office so no further data was available at the time of the report. Upon internal review, the patient's intussusception was considered to be an other important medical event. Additional information has been requested.
Hot pain in my stomach area. Lymph nodes and rash under both armpits, and itching under both armpits. Recently got cellulitis on my lower left stomach area which has a lot of puss
SWELLING AROUND THE ARM AROUND 2 INCHES AND REDNESS ON LEFT ARM
Decedent had COVID -19 during the last week of November 2022  Forensic Pathologist requested that this be reported to you since the Pfizer Bivalent Booster was administered on 11?14/2022.
The morning after,  felt weak, tired, chills, lasted into Sunday. Constant diarrhea ever since the 2nd vaccine, not hungry in the morning
flu like; achiness; lymph nodes feel sore all over; joint pain; headache; feels feverish/slightly elevated temperature; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A71A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), ARTHRALGIA (joint pain), HEADACHE (headache) and PYREXIA (feels feverish/slightly elevated temperature). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), ARTHRALGIA (joint pain), HEADACHE (headache) and PYREXIA (feels feverish/slightly elevated temperature) outcome was unknown.            No concomitant medication were reported. She took an Excedrin last night and felt some better.   This case was linked to MOD-2021-365061, MOD-2021-364147 (Patient Link).
Information has been received from a physician concerning a 10 year old female with asthma who on 22-OCT-1999 received her first dose of VARIVAX (Merck) (Lot # not provided) and on 17-SEP-2008 received the second dose of VARIVAX (Merck), 0.5ml, subcutaneously (lot # 661651/0989X). There was no concomitant medication or drug allergy. On 07-OCT-2008 the patient experienced atypical varicella. The vesicular rash consisted of "about 20 lesions" with a distribution on the face and bilateral arms. No lab diagnostics studies was performed. The patient's atypical varicella persisted. The patient sought medical attention. Additional information has been requested. This is one of several reports received from the same source.
Pt had an abnormal high-pitch cry for 2 hrs & unconsolable all night;
This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Achy arm), PERIPHERAL SWELLING (arm swollen), ERYTHEMA (Red patch), PRURITUS (Itchy patch/its itchy) and SOFT TISSUE SWELLING (Swollen patch/its a little bigger than a baseball in circumference) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D25L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced PAIN IN EXTREMITY (Achy arm). On 10-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm swollen) and ERYTHEMA (Red patch). On 11-Jan-2021, the patient experienced PRURITUS (Itchy patch/its itchy), SOFT TISSUE SWELLING (Swollen patch/its a little bigger than a baseball in circumference), FATIGUE (Tired) and NAUSEA (Nauseated). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Achy arm), PERIPHERAL SWELLING (arm swollen), ERYTHEMA (Red patch), PRURITUS (Itchy patch/its itchy), SOFT TISSUE SWELLING (Swollen patch/its a little bigger than a baseball in circumference), FATIGUE (Tired) and NAUSEA (Nauseated) 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 product use was not provided by the reporter.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Pt received vaccine at 0814 and at approx. 1100 pt stated nausea and three episodes of vomiting.
1mo p/vax following problems occurred in arm where vaccinated: arm & shoulder pain; numbness of arm & hand; skin sunken in @ inj site; muscular weakness of arm & hand;
A Janssen vial that had been punctured for over 24 hours was administered to a patient.  This is beyond the 6 hour refrigeration window of viability that was studied by Janssen.  Janssen has no data on extended dating nor have they conducted studies that would reflect the efficacy of such a dose.
Information has been received from a registered nurse concerning a 51 year old female patient with a history of pneumonia "about 2 months ago", who was vaccinated on 03-OCT-2007 with her first dose of PNEUMOVAX 23 (0.5 mL). Subsequently, on an unspecified date in October 2007, the patient experienced elevated fever and lymphadenopathy that lasted for about 3 days. The patient was reported as recovered. Unknown medical attention was sought. No product quality complaint was involved. This is one of the multiple patients report from the same source. Additional information is not expected.
After receiving the vaccine I had chills, fever, and nausea for about 5 days. On 4/15/2022, I had an intense event of vertigo which was the first one I ever had. I also had an extreme nausea that went along with it. I ended up going to the ER. I was prescribed an anti-nausea medication. The symptoms had lasted for about 5 hours.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA) for Ulcerative colitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved.            No concomitant medications were reported.  Patient received Humira (1153187).  No treatment medications were reported.  The reporter did not provide any causality assessment for the event with Humira and Moderna vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Febrile 102F; Sore armpit; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 10-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), as dose 4, single (Batch/Lot number: unknown) at the age of 10 years for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: COVID prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3, manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 08Oct2023, outcome "recovered" (Oct2023), described as "Febrile 102F"; AXILLARY PAIN (non-serious) with onset 08Oct2023, outcome "recovered" (Oct2023), described as "Sore armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, axillary pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a female patient who on an unknown date was vaccinated IM "either with the first or third 0.5 mL dose" of GARDASIL. The nurse reported that when she gave the patient GARDASIL, the patient started to pass out. The nurse gave the patient water and she seemed okay. Later the nurse noticed the patient looked like she was having seizure. It was reported that the patient's mother was trying to blow air into the patient's mouth, but it is unknown if she tried to it during or after the patient looked like she was having a seizure. The patient sought unspecified medical attention. The patient's final outcome was unknown. Upon internal review seizure was considered to be another important medical event. Additional information has been requested.
Pt's husband called for help Pt found sitting pale semi responsive. Very pale wiffed ammonia inhalate help arrive. Pt taken to urgent care for observation.
October 3, I noticed redness under my right eye. I assumed it was eczema - it was kind of coming and going. The week of October 11th, the redness was persistent - Oct 17 went to Urgent Care - diagnosed with cellulitis and was given- Keflex - antibiotic for 10 days 4 times a day  - under my eye and on my eyelids. 10/28 stopped medicine (and it had cleared at this time). But it came back again, and I went to my primary care doctor on November 1st. She gave me Doxycycline and an eye drop - like Vancomycin; followed up with her yesterday and she had put me on Valtrex as well. I went to the eye doctor to rule out damage to eye and shingles. There is no damage to eye and there is no shingles. Today it is not itching or burning like it was but it's still there and it's red and it's still swollen (not as swollen as originally though). I am feeling a little bit weak; things are taking a little bit more effort to do than normal. I'm training in my marathon - I'm in my taper and I should be having energy rebound and I'm having the opposite. I am noticing unordinary weakness.  Note: I had the flu vaccine two weeks after my COVID-19 Dose 3 vaccine. I had it October 12th, 2021. I had in my right arm. I had that at my job.
Upset stomach; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Feb-2021, ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Tylenol 2 hours before receiving the vaccine.  Concomitant medications were not provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ lot # L022447, expiration date 26-FEB-2017; lot number L027719, expiration date 28-APR-2017) orally (dose not reported). The vaccines were exposed to the following conditions: temperature 1.5 degrees Centigrade for 1 hour. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
patient became dizzy and light headed, took blood pressure with automatic cuff and it was 90/60mmhg. patient then vomitted. patient has a history of panic attacks. patients girlfriend put a wet rag on his neck and pharmacist gave him some water. after 15 minutes patient's blood pressure was back to 108/80mmHg and he was feeling better
Occasional stomach cramps, diarrhea, dizziness/nausea, and exhaustion for 3 weeks.
Shot #1  Migraine, Nausea, Spins, Upset Stomach  lasting 8-10 days Shot #2 Migraine, Nausea, Spins, Diarrhea  lasting 6 days