chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID19 within 5 days of being exposed to another COVID positive person who also received both doses of the BioNTech vaccine.; Tested positive for COVID19 within 5 days of being exposed to another COVID positive person who also received both doses of the BioNTech vaccine.; This is a spontaneous report from a contactable consumer or other non hcp.  A 60-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date in March2021 as dose 1, single and patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 as dose 2 single, both for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient known allergies were reported as unknown. Patient did not have covid prior vaccination. Patient did not receive other vaccine in four weeks. Patient had tested for covid post vaccination. On 08Aug2021 the patient experienced tested positive for covid19 within 5 days of being exposed to another covid positive person who also received both doses of the biontech vaccine. On 07Aug2021 the patient underwent lab tests and procedures which included Nasal Swab, covid test name post vaccination-Rapid test (sars-cov-2 antibody test): positive. Patient did not receive treatment for the events. Outcome of the events was not resolved.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
Mild 2cm localized erythematous rash without induration L thigh. Tx: Benadryl 12.5mg/5ml-2.5ml given.
Patient came in complaining that on the second day after the shot, she had a fever and arm was swollen. Looked like there were blisters on her arm as well.
Extreme fatigue, headache, nausea, and chills beginning upon waking the next day until about 6pm (12 hours).  First day extreme soreness at injection site, unable to lift arm past 45 degrees; pain and tightness through shoulders and back of neck.  Other symptoms abated after 36 hours, but arm and neck soreness gradually declined over 72 hours.
Did not get 2nd dose because it was not available; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comments: The consumer reported they received 1st dose of Shingrix and did not get 2nd dose because it was not available.  The consumer called GlaxoSmithKline to ask if they needed to get the second dose or restart the series. The reporter did not consent to follow up. Additional Supportive Information: The patient did not receive 2nd dose of Shingrix because it was not available, due to product supply issue.
FEVER, SHAKING, ACHING ALL OVER, DIZZY, HEADACHE, COULD NOT WARM BODY UP,
This spontaneous report as received from a other health care worker refers to a 18 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. On 04-AUG-2015, the patient was inadvertently given the adult formulation of VAQTA (route of administration, dose, lot number and expiration date were not reported). There was no adverse effects reported. There was no product quality complaints reported. Additional information has been requested.
Got a fever, chills, muscle aches, headache, fatigue. Took Tylenol. Had symptoms through the night, slightly better in the morning. Tylenol seemed to help a little. Gradually better through the day, then worse toward the evening, though not as bad as the first night.
Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient; No adverse event; Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 3:31 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 22-Sep-2022 at 3:31 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient).    No concomitant product use was reported.  It was unknown whether the patient was diagnosed/tested positive for COVID-19.  The patient received previous 3 dose of vaccine intramuscular in deltoid.  Anatomical location of bivalent vaccine was reported as deltoid.  It was reported that the vaccines had undergone several temperature excursions in August 2022.  Refrigeration excursions identified and vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions reported for any patient at the time of report.  No treatment drug information was provided.
Patient experienced nausea, vomiting and lightheadedness after receiving the Pfizer COVID vaccine on 2/6/21. She brought to the ED and given 4mg of Zofran and felt better after observation.
24 hours after the vaccines were administered, the patient developed swelling, redness and warmth.
Information has been received from a registered nurse concerning a 9-year-old male who on 25-SEP-2000 was vaccinated with his first dose of Varivax. On 17-DEC-2006, the patient experienced 10 to 12 vesicular lesions. On 21-DEC-2006 (Day 5), it was noted during an office visit that the 10 to 12 lesions were mostly broken open with scabs. Treatment was not specified. It was noted that there were reports of chicken pox in school. Subsequently, the patient recovered. It was also reported that the patient's sister experienced vesicular rash (WAES # 0701USA04729), and had also been vaccinated with Varivax. Additional information is not expected.
grand mal seizure; pain in the muscle where the injection was given (sore arm); body aches; fatigue; memory loss; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A male patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021, in arm, for COVID-19 immunisation. The patient was a cancer patient who was taking chemotherapy. On 20Feb2021 the patient experienced grand mal seizure and was hospitalized on the same day. On an unspecified date in Feb2021 the patient also experienced pain in the muscle where the injection was given (sore arm), body aches, fatigue and memory loss. The patient had never had a seizure before and has had memory loss with these seizures as well (had another one in the hospital very early on 22Feb2021 morning). Events outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Grand mal seizure cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
70 y.o. F w PMH of ESRD on HD, Bipolar disorder, Cognitive impairment/Dementia with activated POA/court appointed lives in (Privacy) SNF, hx of VTE, SDH s/p resection, paroxysmal a-fib who presents with the hospital as a transfer for a clotted fistula. She was admitted on 2/11 at the hospital for a very large left pleural effusion and CAP. She had 2 L drained via thoracentesis which was exudative in nature. Did not require a chest tube. She was initially started on IV vancomycin, cefepime and was transitioned to IV rocephin and azithromycin.   She also tested positive for COVID 19 and was given IV dexamethasone.
IT WAS NOT AN ADVERSE EVENT , BUT A MEDICATION ERROR. THE COVID-19 BIVALENT WAS MISTAKENLY DILUTED INSTEAD OF THE MONOVALENT AND ADMINISTERED TO PATIENT. DR  SPOKE MOM , THE PATIENT IS FINE. THE DR ALSO CALLED CDC , SHE WAS TOLD THAT THE PT DO NOT NEED ANY MORE DOSES OF COVID-19 VACCINE.
Bruising reaction covers 6 inches in diameter and stiff neck; patient was prescribed anti-inflammatory and pain reliever by physician.
2 y/o pt received DTaP and Hib-PRP-T on 12 Aug 2022. Pt was later seen by pediatrics for a hematoma and secondary cellulitis from one of these vaccines.
Dizziness; Body aches.; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN (Body aches.), PYREXIA (Fever) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DIZZINESS (Dizziness), PAIN (Body aches.), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness), PAIN (Body aches.), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included high blood pressure medications treatment information was not reported by reporter For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Second dose details was added
I had notice a small amount of hair loss in early March.  But in May, it had rapidly increased by an alarming rate. The dermatologist (listed on this form) put me on Clobetasol for scalp irritation which cleared up however my hair continues to fall out. She diagnosed it as telogen effluvium (TE(. Initial thoughts are that perhaps my covid-like illness in the Fall triggered the initial onset of TE and the vaccines exacerbated it since the worst of it came a month after the second shot and continues today.
pt recvd vax 2NOV92 & 8-10 hrs later exp a fever of 104, macular rash & irritability; taken to ER-spinal tap & chest x-ray results pending; 4NOV t104.5; rx included pediaprofen for the 1st 24 hrs; fever 99; then elevated to 104.5;
Ptat complains of pain, discomfort and as her note said "paralyzed" (note attached). MD evaluation noted bruising & discomfort.
Patient said that he called 911 with SOB, and he was admitted to the hospital and he stayed in the hospital for about 2 weeks. He is unsure of the date that he went into the hospital. Pt said he had a blood clot in both lungs.
Severe left arm pain. Patient went to urgent care transferred to ED d/t severity of pain (10/10) and it radiating into left chest. (EKG normal) Patient was unable to make a fist or raise arm. It has improved the next day.
Experienced nausea, vomiting, fever, headaches, and light headed after about 12 from injection. Symptoms persisted for about 9 hours after they started
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-AUG-2016, the patient was prescribed and inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), at physician office as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or herpes zoster. On or about 11-JUL-2016, the patient was treated by a physician for the development of herpes zoster. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
after the first dose she had a sore left arm at the injection site; pretty bad muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (after the first dose she had a sore left arm at the injection site) and MYALGIA (pretty bad muscle aches) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Birth control (Nexplanon (gets replaced every three years)) since an unknown date. Concomitant products included ETONOGESTREL (NEXPLANON) for Birth control.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (after the first dose she had a sore left arm at the injection site) and MYALGIA (pretty bad muscle aches). At the time of the report, VACCINATION SITE PAIN (after the first dose she had a sore left arm at the injection site) and MYALGIA (pretty bad muscle aches) had resolved. Not Provided          Treatment included Tylenol   This case was linked to US-MODERNATX, INC.-MOD-2021-077256 (E2B Linked Report). This case was linked to MOD-2021-077256 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077256:Dose2
Rash on the chest, back and upper arms. Rash was rash, Scattered and raised. Ichy. Started 24 hours after vaccine
abdominal rash; This case was reported by a pharmacist and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The patient had no history of allergic reaction. The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The reporter need to know if patient needs to avoid getting the second dose of Shingrix vaccine due to occurence of abdominal rash. The reporter asked should rechallenge occur at doctors office.
Covid19 breakthrough.  1st vaccine on 01/26/2021.  75y/o PMH arthritis, HTN, HLD, CHF s/p CABG, Pacemaker, and smoker presents to ED via EMS for Covid PNA.  Pt c/o cough, SOB, chest pressure.  CXR-interstitial prominence, pt with inspiratory and exp wheezing, O2 on 2L NC 98%.  Pt received steroids and Remdesivir.
Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter reported that she heard at the pharmacy that some people were having flu like symptoms from Shingrix that were lasting longer than a day or two. Reporter did not consent to follow-up.
Patient came to clinic for left shoulder pain on 7/29/21 that he reports began immediately with injection of COVID-19 vaccine on 4/11/21. Pain progressively got worse over the next few days and has stayed the same since. Worse with lifting and exam consistent with tenderness at insertion of biceps tendon. Concern for SIRVA (shoulder injury related to vaccine administration.)
Nausea and warm feeling with increased feeling of "heat" in neck as symptoms progressed. Flushing became evident. She stated that her throat "felt funny" as symptoms continued.  No respiratory distress noted but continued to express concern about throat symptoms and flushing.  Refused Diphenhydramine HCL. Refused Epinephrine. Ambulance called and transported to Medical Center for evaluation and treatment.
Case number PHEH2015US027167, is a combine initial spontaneous report received from a pharmacist on 23 Dec 2015 and 24 Dec 2015. This report refers to a 16 years old female patient. Past medical history and concomitant medication was not reported. This 16 years old female patient vaccinated with FLUCELVAX (batch number and expiry date: not reported) on an unknown date. No adverse event was reported following this administration error.
tinnitus, mostly in left ear - 3 days after vaccine neuropathy, pain and tingling all over - 4 days after vaccine numbness - started in right foot, slowly progressed to left foot my  One Medical doctor confirmed my diagnosis and then when my numbness started, my doctor sent me to the emergency room. ER at denied any connection to the vaccine, focusing instead on vitamin deficiency possibilities and my poor back/neck spine issues. However, they ruled out the back/neck as causes and sent me home with no treatment, focusing on vitamin deficiencies. Vitamin lab results have returned and are just fine, so it's not vitamin related. Neurology in the ER totally denied that the vaccine would cause this, so all I have now is low dose gaabapentin prescribed by my internist, and it's providing very little relief. Quite frustrating
Awoke with severe aches in all joints, fever of 101, lethargic, nausea. Extremely tired approx 17 hours after vaccine was administered.
31OCT91 8PM "ice cold" feeling, no temp check; went to bed-felt hot, face flushed, sl nauseated; loss of appetite in AM; some diarrhea; arm swollen & hard to elbow for 3-4 days; also reddened & warm to touch;
Received 4 year old vaccinations left upper arm has some swelling. No fever, pain, here for shots only today 3/22/07
Nausea, Palpitations in chest, Dizziness, Chest pressure, Intense headache,
A report has been received from a Health Professional concerning, Female subject, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included CEREBRAL PALSY. FLUMIST started on an unknown date. A nurse told him that last season, when giving FLUMIST to a MS patient, the patient moved and was stabbed in the nose and it started bleeding. The outcome of the event of BLEEDING and PATIENT WAS STABBED IN THE NOSE DURING ADMINISTRATION OF FLUMIST is unknown. The report was considered to be non-serious. Follow-up information insignificant information received by AstraZeneca/MedImmune on 04-Oct-2013 from HCP: Last season for receiving FLUMIST was updated. Added the patient gender and concomitant diseases. Updated the reporter's information and narrative.
Information has been received from a registered nurse concerning a 77 year old female who on 17-OCT-2007 was vaccinated with one 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot# 658082/0744U). On 18-OCT-2007 the patient experienced 3 blisters, one close to the injection site, one on both her left and right arm. The right ring finger blister was described as a scaly patch. The patient called the physician's office for medical attention. "The spots have all since cleared up therefore no sample will not be sent." The patient was recovered. There was no product quality complaint. Additional information has been requested.
TOOK VIVOTIF 15 MINUTES AFTER EATING; This spontaneous case report (PVX2019-2872) was received from a consumer on 21-Nov-2019. It described a female consumer who "took Vivotif 15 minutes after eating" (PT: Product administration error), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif 15 minutes after eating on 21-Nov-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the event "took Vivotif 15 minutes after eating" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif 15 minutes after eating" was considered as not applicable.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer) for a  program (159558). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 1, single, and administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome unknown, COVID-19 (medically significant) with onset 13Dec2021, outcome unknown. The patient underwent the following laboratory tests and procedures sars-cov-2 test (13Dec2021) positive.  The reporter stated that she is calling on behalf of her son (16 years old), he mentioned that her son got the 2 doses of the Pfizer vaccine last Jun2021, she mentioned that her son got an appointment for the booster shot last 15Dec2021 however her son tested positive last 13Dec2021 with covid-19 virus. She wants to ask if her son is eligible to get the booster shot after all.   The lot number for bnt162b2 was not provided and will be requested during follow up.