chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom reports fever of 102 for four days, would go down with Tylenol, then up again. Rash over body, red bumps, baby irritable, not eating or sleeping well.
Caller states that she has spoken with the patient's physician regarding her daughter's symptoms and he told her that he has heard this a lot with the new Spikevax vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Caller states that she has spoken with the patient's physician regarding her daughter's symptoms and he told her that he has heard this a lot with the new Spikevax vaccine) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Caller states that she has spoken with the patient's physician regarding her daughter's symptoms and he told her that he has heard this a lot with the new Spikevax vaccine). At the time of the report, IMMUNISATION REACTION (Caller states that she has spoken with the patient's physician regarding her daughter's symptoms and he told her that he has heard this a lot with the new Spikevax vaccine) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746812.   Most recent FOLLOW-UP information incorporated above includes: On 23-Oct-2023: Live follow-up received contains non-significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746812:same reporter
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included irritable bowel syndrome (IBS) and IBD (inflammatory bowel disease). In February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced fever, burning sensation in face, injection site pain, erythematous rash, tiredness, injection site swelling, injection site erythema and injection site rash. On an unknown date, the outcome of the fever, burning sensation in face, injection site pain, erythematous rash, tiredness, injection site swelling, injection site erythema and injection site rash were recovered/resolved. It was unknown if the reporter considered the fever, burning sensation in face, injection site pain, erythematous rash, tiredness, injection site swelling, injection site erythema and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she experienced a red rash and burning on the face, under the nose on both sides, and the site of injection. The patient had swelling and soreness at the site of injection and also felt tired and had a fever. The patient stated that this started after a week and lasted till the end of March 2018. The patient visited her primary care doctor, and dermatologist for the symptoms she experienced.
I had extreme dizziness and extremely high blood pressure. I was unable to walk. I went to the ER and they did all kinds of tests, including a chest x-ray and blood panel, which came back normal. My blood pressure was 211 over something. I was prescribed  Meclizine hydrochloride and Amlodipine Besylate only if my blood pressure exceeded 160. I have not taken the blood pressure medication in the last 4 days. I was diagnosed with benign positional vertigo. For the blood pressure they don't know the reason for it being so high.
Dose number 2 listed above was given on 5/27/2021.  The patient develops Immune thrombocytopenic purpura with first abnormal labs on 7/1/2021. Platelets continue to drop and she was started on pulse dose steroid on 7/28/2021. She responded well and had normal platelets one week later. She relapsed 4 weeks later and is now undergoing further treatment with steroid.
Pt received the vaccine at pharmacy. Pt states she started to feel her throat closing shut, her lips started to swell, and was having a hard time breathing. The pharmacist gave a dose of epi IM and oral Benadryl and it corrected the issue.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very slight sore arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. No Medical History information was reported. On 26-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 PAIN IN EXTREMITY (Very slight sore arm). At the time of the report, PAIN IN EXTREMITY (Very slight sore arm) outcome was unknown. Not Provided. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications were not provided. Treatment medications was not provided. This case was linked to MOD-2021-065504.
Arm was sore 3-4 days. 2-3 after vaccine felt weak 7-10 days. Pt went to ER and was told it was a reaction to shot.
2nd dose given too early, 1st dose  2/17/21, 2nd dose 3/5/21
eosinophilia, cardiac tamponade/ pericarditis. Pericardial fluid was eosinophilic. One month later, he developed patchy pulmonary infiltrates.but biopsy was not obtained and ANCA was negative.
10FEB94 pt recvd vax & on 11FEB94 exp t102 @ 7AM-100 @ 7PM, gone on 12FEB94; vomiting approx 7 times from 7AM to 7PM; mom contacted MD who recommended 7-up & APAP & suppositories; nausea gone 12FEB94;
Blood clot?> loss of consciousness-> artificial coma ?> death 10 days after vaccination
This spontaneous report was received from a physician refers to a 71 year old male patient. On an unknown date approximately in 2010 (reported as 5 years ago) the patient was vaccinated with ZOSTAVAX VIAL (dose, route and lot# were not reported) for shingles prevention. Concomitant therapies included carvedilol as well as other (unspecified) cardiac medications, unspecified thyroid medication, simvastatin, warfarin and FLOMAX. Approximately on 04-JUN-2015 (reported approximately six days ago) the patient developed a vesicular rash in an unspecified region of his body and was diagnosed with an active case of shingles. Patient sought medical attention by an office visit. Treatment was given to the patient. The patient was prescribed VALTREX and TYLENOL II for pain. No product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of shingles was reported as not recovered/not resolved. The reporter did not provide the causality between the event and the suspect therapy. This is one of the two reports received from the same source. This case was linked to patient's wife case# 1506USA013078. Additional information has been requested.
Deep vein thrombosis; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19; Infection; This spontaneous report received from a health care professional via a regulatory authority(Vaccine )(VAERS ID: 1656422) concerned a 41 year old male, unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: unknown) dose was not reported, one total administered on 24-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-AUG-2021, the patient experienced suspected clinical vaccination failure, covid-19, deep vein thrombosis and infection (Breakthrough covid infection) and was hospitalized (date unspecified) for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deep vein thrombosis, covid-19, and infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000193189. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from regulatory authority department on 22-OCT-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2:This version updates- Product quality complaint investigation result. This updated information does not alter the causality of previously reported events .  20210920620-COVID-19 VACCINE AD26.COV2.S-deep vein thrombosis, covid-19,  infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210920620-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Violent vomiting 6 days later (Sat 3/13, 6 pm, 3 bouts), intestinal pain, then violent diarrhea (3/15, 7 pm, 3 bouts)
not feeling well; having a headache; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling well) and HEADACHE (having a headache) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Migraine (Migraines since 17 years old.). Concomitant products included SUMATRIPTAN for Migraine.    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well) and HEADACHE (having a headache). At the time of the report, MALAISE (not feeling well) and HEADACHE (having a headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received first dose of Moderna on 20-Jan-2021, second dose on 18-Feb-2021, third dose on 26-Oct-2021 and fourth dose on 01-Apr-2022. Patient was having headache and wanted to know if had headache before having the next vaccine can patient possibly take Tylenol and sumatriptan. It was also reported that this had nothing to do with the vaccine. Patient was never tested positive for Covid-19, and used some home tests when not feeling well, but every time the result was negative.
Chills, headache, body aches, nausea, vomiting, diahrea
This spontaneous report was received from a physician regarding a 14-and-a-half-year-old patient. The patient's relevant medical history, concurrent conditions and concomitant medications drug reactions/allergies were not reported. On an unknown date in July-2018, the patient was vaccinated with GARDASIL 9 (strength, dose, route, lot # and expiry date not reported) 1st dose for prophylaxis. On an unknown date in July-2018, immediately after the vaccination the patient experienced "dizziness and lightheaded-ness for 4 days. The outcome of dizziness was reported as recovered. Causality assessment was not reported.
This pt was seen Friday 5/13/05 for well child check and immunizations. He received his #2 MMR L deltoid and Dtap and IPV in R deltoid (#5, #4 in series respectively). Saturday 5/14 developed fever. On Sunday, Mom noted erythematous rash from radius scapula dorm to R elbow, arm circumference was 2 1/4" larger than L. Fever 102.9, Benadryl and Tylenol. 5/16/05 brings child in to show.
pt recvd vax;dizziness,fever,diaphoresis,shortness of breath,chest pain eve of vax;19apr94 f/u:approx 1-2 hrs p/ vax,devel chest pain,dyspnea,diaphorisis w/ P 108,BP 90/70 sxs gradually resolved;1 wk later pos tes results:serum drawn mar94;
Arm and armpit pain; Arm joint in back hurts; Arm joint in back hurts; This is a spontaneous report from a non-contactable consumer (reported for herself). An elderly female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm right on 05Feb2021 at 10:00 as dose 1, single for covid-19 immunisation at Other. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient has no reported allergies. On an unspecified date in 2021, the patient experienced arm and armpit pain and arm joint in back hurts. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 12Nov2020. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Received first dose without knowing I was pregnant. I have a high risk pregnancy and the baby is at risk of a spontaneous abortion I?ve being in bed since I knew I was pregnant.  I have intense abdominal pain, no hemorrhage just unknown pain.  Doctors told me to keep resting and just wait for a spontaneous abortion, I was given the fist dose and was advised to not take the second dose . I am know 11 weeks of painful pregnancy just waiting for something to occur. I recommend that woman who are in reproduction ages should first take a pregnancy exam before the vaccine so that nothing like what I am passing happens to someone else. Doctors say that if the pregnancy concludes at its last term the baby will have birth defects because of the vaccine. They recommend and abortion or just wait for a spontaneous abortion.
Information has been received from a registered nurse concerning a 9 year old male with no drug reactions/allergies and a history of a mild case of chickenpox in the April of 1995 who on 16-JAN-1996 was vaccinated with 0.5 cc subcutaneous of Varivax (lot# 610257/0750B). There was no concomitant medication. In 2004 the patient was diagnosed with a zoster/shingles. The patient's zoster was still present 5 months after the initial diagnosis (date unspecified). The zoster was not present at an examination 8 months after the diagnosis (date unspecified). No other information was available. Additional information has been requested.
fever up to 103F. Congestion. No vomiting/diarrhea. no rash. some increased in cough. not as active as normal. less oral intake. chest: ok.
Approximately 25-30 minutes after administration of vaccine, patient complained of a soreness of her right throat and felt a sensation of swelling. Clinical exam revealed a small area of erythema on right side of posterior pharynx. No edema was noted. No skin rash or changes. No soft tissue and no facial/throat swelling. Lungs were CTA bilaterally. VS remained stable. Treated with Benadryl 25mg capsule PO x1. Symptoms resolved within 20 minutes. Patient remained in observation for an additional hour. Discharged home in stable condition, symptoms completely resolved. Given PO Benadryl to take home use prn.
arm still sore; arm little warm to the touch; chills; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm still sore), VACCINATION SITE WARMTH (arm little warm to the touch), CHILLS (chills) and VACCINATION SITE SWELLING (Swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high, Thyroid disorder and Reflux gastritis.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm still sore), VACCINATION SITE WARMTH (arm little warm to the touch), CHILLS (chills) and VACCINATION SITE SWELLING (Swollen). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm still sore), VACCINATION SITE WARMTH (arm little warm to the touch), CHILLS (chills) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified for high blood pressure, thyroid, reflux.
I was fine all day with no sore shoulder until 8:00 when I started getting a headache, feeling cold.   I kept getting more uncomfortable , colder and getting body shakes.  By 10:00 I could hardly walk to bed because of uncontrollable muscle shaking, jaw chattering, and was unable to get warm.  I took Advil then.  It took about an hour to stop shaking and warm up in bed with my husband.  I felt terrible for the next 2 1/2 days, just horrible, unable to function.  I slept a lot.
Sore left arm still 3 days later.  Swollen eyes (especially left eye) and congestion.
I developed a 100.2 degree fever about 12-14 hours after vaccine administration. Took Ibu profen at about 14 hours and fever was gone when I woke up about 6-7 hours after that. I noticed a ringing tinnitus sound in my left ear at around 12 hours after vaccine administration. When I woke up the ringing sound was still there, and it did not completely fade until around 3 days later.
Feels weak; Diarrhea; Swollen glands on both sides of face and neck; Muscle soreness and aches; Nausea; chills; Headache; Extreme fatigue and exhaustion; Injection site soreness; Soreness to touch in left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness to touch in left arm), ASTHENIA (Feels weak), DIARRHOEA (Diarrhea), LYMPHADENOPATHY (Swollen glands on both sides of face and neck) and FATIGUE (Extreme fatigue and exhaustion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L217A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Renal disease (May start the Dialysis soon.) since an unknown date.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness to touch in left arm), FATIGUE (Extreme fatigue and exhaustion) and VACCINATION SITE PAIN (Injection site soreness). On 18-Jan-2021, the patient experienced ASTHENIA (Feels weak), DIARRHOEA (Diarrhea), LYMPHADENOPATHY (Swollen glands on both sides of face and neck), MYALGIA (Muscle soreness and aches), NAUSEA (Nausea), CHILLS (chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Muscle ache and Ache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness to touch in left arm), ASTHENIA (Feels weak), DIARRHOEA (Diarrhea), LYMPHADENOPATHY (Swollen glands on both sides of face and neck), FATIGUE (Extreme fatigue and exhaustion), VACCINATION SITE PAIN (Injection site soreness), MYALGIA (Muscle soreness and aches), NAUSEA (Nausea), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
A non-serious, spontaneous report of becoming extremely irritable was received from a consumer concerning 36-month-old female, subsequent to the administration of FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 21-Sep-2010, the patient received FLUMIST. For about 2.5 to 3 hours after receiving FLUMIST, the child was extremely irritable. The event resolved.
About 1 1/2 hrs after taking the 1st oral typhoid he developed hives and itching then became dyspneic. Given epinephrine by EMS and taken to ER. By the time he got to the ER he was back to normal.
This spontaneous report as received from patient's mother refers to her daughter, who was a female patient of unknown age. On an unknown date the patient was vaccinated with her first dose of GARDASIL (injection, strength, lot#, dose/frequency, route were unspecified). The patient experienced soreness in the arm after the vaccination. It was unspecified whether patient had sought medical attention or not. The outcome of soreness in the arm was unknown. Additional information is not expected.
he had some pain; her son noticed a lump under his skin where the vaccine had been administered; Vaccination site pain; This spontaneous report was received from the patient mother refers her son  a 13-year-old male patient.     The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-JUN-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.         On unknown day in July 2023, the patient experienced pain. It was reported that the patient had some pain initially with the vaccination, but that it went away (discrepant information, the patient status was reported as: not recovered). On unknown day in July 2023 (a few days ago), the patient experienced vaccination site pain and vaccination site mass. It was reported that the patient noticed a lump under his skin where the vaccine had been administered. The reporter stated that it was a decent sized lump and painful to the touch. The outcome of pain, vaccination site pain and vaccination site mass was reported as not recovered/not resolved.        The causality assessment was not provided.