chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 2 influenza vaccines for the 2021-2022 flu season. First dose was on 8/26/21, patient then requested an influenza vaccine on 11/8/21. The pharmacy did not detect that the patient had already gotten one and administered. Patient was contacted, made aware of the situation and states he did not realize he had already gotten the influenza vaccine this season. He states he experienced no adverse effects.
Information has been received from a nurse concerning a male who on 26-JUL-2007 was vaccinated with varicella vaccine live (Oka/Merck). On 27-JUL-2007, the patient developed a sore left arm. The nurse mentioned the patient was given the vaccine may have got the varicella virus vaccine live IM instead of SQ. The nurse stated she would try to confirm this with the administering nurse. The patient sought unspecified medical attention. The reporting nurse called back and stated that she had spoken with the administering nurse and that there was no adverse event. The nurse reported that she misunderstood a message that was left for her by another nurse. Subsequently, the patient recovered. Further information has been received. The nurse called back and stated she has no further information regarding this patient. In addition she noted that there was no child involved in this report. Additional information is not expected.
Narrative:  91 yo M with hx of COPD, AF and flutter, CHF, HTN, HLD, and tachycardia received 2 doses of moderna vaccination on 01/14/2021 & 02/11/2021. Patient died at medical facility on 8/15/21 @ 0330 after being admitted for aspiration pneumonia, sepsis, hypokalemia and thrombocytopenia. Death is not likely due to the covid vaccination.
This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (Shortness of breath), THROAT IRRITATION (Scratchy throat) and HYPERSENSITIVITY (Hypersensitivity reaction) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Obesity, Penicillin allergy, Shellfish allergy and Oil allergy (Grape seed oil allergy.). Concomitant products included PREDNISONE for Asthma.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), THROAT IRRITATION (Scratchy throat) and HYPERSENSITIVITY (Hypersensitivity reaction). At the time of the report, DYSPNOEA (Shortness of breath), THROAT IRRITATION (Scratchy throat) and HYPERSENSITIVITY (Hypersensitivity reaction) 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.   Treatment activities for event was done with diphenhydramine (Benadryl) 25 mg oral and was monitored by an onsite nurse for 30 minutes. Patient felt better and was sent home.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: hypersensitivity form- Add medical history, allergies.
Febrile seizure at 02:00 following vaccines at 11:00AM.  No concurrent illness (ie. URI sx).  Was on bactrim for presumed MRSA but was at end of treatment. Medical Records received on 1/25/2005 states decreased mental status and eyes deviated right.
hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 04Oct2021 09:40 (Lot number: 30155BA) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot No: FC3183), administration date: 13Sep2021, when the patient was 65 years old, for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "recovering", described as "hair loss". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101797400 same reporter/drug/event, different pt;US-PFIZER INC-202101799476 same reporter/drug/event, different pt
My daughter was incorrectly given a reformulated adult pfizer (purple cap) vs the pediatric (orange cap)
Local swelling at injection site, mild erythema approximately 5cm x 5cm at (L) triceps SQ injection site. No fever, chills, or sign and symptom of infection. No systemic symptom of allergic reaction or cardiopulmonary, neurological or other complication.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 31-MAR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Started having fever up to 38.5C with headache, body pain and strong diarrhea on February 08 around 06pm, I was taking aspirin on the 08th and 09th of February. Temperature was dropping down for few hours and then was climbing up again. On the 10th started taking Tylenol, it helped better than aspirin. At this moment the only problem I have is a bad diarrhea, it?s pouring very bad. I don?t have any pain though.
Information has been received from a nurse practitioner concerning a 11 year old female who on approximately 11-AUG-2008 was vaccinated with a dose of GARDASIL. Concomitant therapy included MENACTRA and Tdap. While getting the shot the patient's mother had her arms around her for support. After the patient had received the dose of GARDASIL, the patient's eyes rolled back and she started to slide down. The nurse practitioner stated that this seemed like a fainting motion but the patient was conscious the whole time. Subsequently, the patient recovered. The patient was seen by physician to seek medical attention. No product quality complaint was involved. Additional information has been requested.
Lost feeling in my left arm from the shot site to the tip of my thumb; Got the second shot and it got worse; I cannot even push buttons on my telephone with my thumbs; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (BNT162B2) solution for injection, dose 2 (Lot number expiry date was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine dose 1 BNT162B2 (lot number and expiry date was unknown) via unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. Consumer stated, "To report adverse side effect, patient need help from Pfizer, patient need (sentence incomplete). The day after patient first shot, patient lost feeling in left arm from the shot site to the tip of patient thumb. Patient got the second shot and it got worse. Now, patient cannot even push buttons on patient telephone with thumbs. Patient need arm back, what do we get to reverse this thing?. Consumer was informed about the role of Pfizer Drug Safety. Mailing address: Consumer stated, "No, why? You know, patient worked for Pfizer for 5 years, you have patient mailing address (further clarification unknown). This was going nowhere; patient will do something else." And hung up abruptly. Further probing could not be done as consumer hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call     The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Labored breathing), HYPERHIDROSIS (Profusely sweating), CHILLS (Extreme chills) and VOMITING (vomiting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included LIRAGLUTIDE (VICTOZA), APIXABAN (ELIQUIS), METOPROLOL, SERTRALINE, AMLODIPINE, BUPROPION, ATORVASTATIN, TRIAMTERENE, ACETAMIDE and GLIMEPIRIDE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DYSPNOEA (Labored breathing), HYPERHIDROSIS (Profusely sweating), CHILLS (Extreme chills) and VOMITING (vomiting). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 01-Mar-2021, DYSPNOEA (Labored breathing), HYPERHIDROSIS (Profusely sweating), CHILLS (Extreme chills) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Chills and felt feverish one day after receiving Hep. A and yellow fever vaccines.  One week later, pt. started oral typhoid and was still experiencing chills.  No temp. measurement done up to this time. After 3rd oral typhoid, pt. experienced "convulsions." One week later her temp. was measured at 103.9 and she had inc. LFT's. She was hospitalized for 5 days in Chicago.  As of 7/20/2007, LFT's have returned to normal according to pt. 11/26/07-records received for DOS 5/24-5/27/07- DC DX: fever of unknown origin, abnormal liver transaminases, adenopathy. Seen for acute febrile illness of unknown etiology. Two week HX of fevers chills and rigors.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with one dose of ZOSTAVAX (Oka/Merck). Two days after vaccination, the patient developed a varicella-like rash. The patient sought unspecified medical attention. At the time of reporting, the patient's outcome was unknown. No further information is available.
Grandmother/legal guardian called clinic 3/12/12 approx 1:30pm. Stated the patient c/o dizziness since last evening. Denies sinus, inner ear or other symptoms. Denies new food, medication, drug or alcohol usage. Bp per grandmother is 101/59 and respirations normal. Instructed to call personal physican for appt or advice and informed that she could take Benadryl 1 dose tonight at bedtime with MD okay and that VAERS would be done and to expect contact. Informed that unlikely it is related to vaccine at this late time post vaccination but, to stay in touch.
SWELLING ARM; HARD LUMP UNDER THE SHOT; CHILLS; FEVER 102.2; EXCRUCIATING HEADACHES; This spontaneous report received from a patient. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180503, expiry: UNKNOWN) dose was not reported, administered in left Arm on 06-APR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102.2 (units unspecified). On 07-APR-2021, treatment medications included: paracetamol. On 07-APR-2021 01:30, the subject experienced chills. On 07-APR-2021 01:30, the subject experienced shivering. On 07-APR-2021 01:30, the subject experienced fever 102.2. On 07-APR-2021 01:30, the subject experienced excruciating headaches. On an unspecified date, the subject experienced swelling arm, and hard lump under the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and excruciating headaches, and the outcome of shivering, fever 102.2, swelling arm and hard lump under the shot was not reported. This report was non-serious.
Pt received a PPSV23 when she did not meet any risk factors, also within 5 hrs pt developed fever, chills, body ached and pain into chest. We saw pt 2 days later and pt still having muscle pain and achiness. Pt also received a Tdap when pt was given one here in our office in 2009.
Swollen lower face with rash, swollen lips, swollen throat, swollen tongue, throat hot on inside and outside, throat tightening, lungs heavy , not, and tightening. Body heavy. Mind disconnected. Happened with in 5 minutes of injection.
This spontaneous report as received from a registered pharmacist refers to a 70 years old male patient with blood pressure, cholesterol issues, kidney disease and with no drug reactions or allergies. The patient was vaccinated with the first 1 ml dose of RECOMBIVAX HB (Lot # 1369Z, expiration date 24-AUG-2013) on 09-MAR-2011, second 1 ml dose of RECOMBIVAX HB (Lot # not reported) IM on 08-OCT-2011 and third 1 ml dose of RECOMBIVAX HB (Lot # not reported) IM on 08-SEP-2012. No other co-suspects were reported. Concomitant medications included: calcitriol, unspecified heart medication and unspecified cholesterol medication. The pharmacist reported that "recently", the patient had serum titers drawn on an unspecified date that showed low titers for anti-HBs antibody. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Sudden onset today, 10-4-2019, of redness and swelling developed to left thigh.  Also was scratching the area.
This case was reported by a healthcare professional via sales representative and described the occurrence of cellulitis in a 5-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR II (non-gsk) ;Merck;unknown given on 19 May 2009; VARIVAX (non-gsk) ;Merck;unknown given on 19 May 2009. On 19 May 2009 the subject received 1st dose of KINRIX (.5 ml, unknown). On 21 May 2009, two days after vaccination with KINRIX, the subject experienced cellulitis and fever. At an unspecified time after vaccination with KINRIX, the subject experienced erythema of leg and warm to touch. This case was assessed as medically serious by GSK. At the time of reporting the outcome of erythema of leg and warm to touch were unspecified. The outcome of cellulitis and fever were resolved. The healthcare professional considered the events were probably related to vaccination with KINRIX.
Pt was give two doses of VARCELLA It was brought to my attention that nurse gave the wrong vaccine to patient. The patient and dad was already gone when nurse told me. She said that she pulled a varivax and what she thought was an MMR and drew them up and gave them Bralie. So she received a combination MMR/Varicella and a Varivax. I immediately called the dad and told him what had happened. I also contacted hospital and reported the mistake. I asked for any side effects that we should look for in patient. I was told that the research showed that the greatest risk with this situation is febrile seizures and recommended that the patient take Tylenol every 4 hours for the next 24 hours. I spoke with Dad again and gave him the information and gave very strong er warnings. Dad verbalized understanding of all. I informed our supervising physician and told him of the incident. Parents were called 3 hours after the incident and again today. Patient has not run a fever and has been playing, eating, and drinking well. Will continue to monitor progress.   Lot numbers of the vaccines: Varicella Lot #7024284 Exp 7-15-2022 Proquad Lot # 7027115 Exp 2-7/2022
This literature marketed report as received from a physician refers to a patient of unknown age and gender. Background: For mothers with chronic HBV infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decrease perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice. Objective: To investigate the effectiveness of a contemporary immunoprophylaxis protocol. Design: Observational study. Patients: 4446 infants born to 3253 HBV-positive mothers between 1997 and 2010. Measurements: Adherence to immunoprophylaxis, follow-up testing rates, maternal risk factors for HBV transmission, and transmission rates. Tests for HBsAg (HBV DNA, e antigen, and liver function tests) were completed for 3353 (85%) of all infants, 2945 (85%) of the 3473 infants with maternal e antigen testing, and 837 (93%) of the 904 infants with both maternal viral load and e antigen testing (after 1 July 2007). Among all children, 0.75% (25 of 3353 tested) were HBsAg-positive as of January 2012. All these 25 patients had hepatitis B immune globulin (H-BIG) and the first dose of RECOMBIVAX HB (lot#, dose, route not reported) within 12 hours of birth. 19 of the 25 patients had the second dose within 24 to 62 days of birth and the other 6 received it within 70 days of birth. Most of the 25 children (22 of 25) also received the third dose within the recommended 164 to 214 days and the remaining 3 received their third dose between 219 and 237 days (and received their second dose on time). Outcome of the event was unknown. The reporter considered the event to be related to RECOMBIVAX HB. This is one of 25 reports from the same source. Additional information has been requested.
STARTED WITH FEVER AT 101.8 DEGREES F THEN DEVELOPED BLISTERS ON PALLET. DAYS LATER STARTED DEVELOPING BLISTERS ON TASTE BUDS AND GUMS
Dizzyness, lightheadedness, weakness, sweating (hot/cold) and patient reported loss of hearing for 30 seconds.  Patient sat for observation for 30+ minutes, feet elevated, drank water, and ice pack was provided for patient to place on forehead until patient's symptoms resolved.
ADVERSE EVENT NOS; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unk) dose, start therapy date were not reported, and dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse event nos, and inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from adverse event nos, and the outcome of inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211004088 and 20211004677.
nausea, chills, confusion, headache, fever, vomit   it all started around 12-1 am with me feeling ill, headache and stomachache were first, then severe confusion, and then chills plus shaking followed, nausea was next. i also had a fever, and after that i had a severe anxiety attack which i believe was brought on by the symptoms i was experiencing. after i had calmed my heart rate remained pretty high or at least faster than it usually would be and i vomited at around 5 am, after i vomited i started recovering from my illness
This case was extracted from the VAERS database via QSCAN on 11 March 2009 (reference number 246876). A 55-year-old female patient received an intramuscular injection of FLUZONE SV '2005-'2006 USP (lot number U1771AA) on 05 November 2005. Approximately three hours after vaccination, the patient complained of her throat closing up, difficulty breathing, light-headedness, dizziness, coughing, and secretions from the eyes. She stated that it "felt like asthma". Later in the day she became achy all over, with ongoing eye secretions and cough. All events subsequently recovered.
6/21/2022 Fetal demise & preterm delivery. The patient presented to emergency department (ED) for cramping & vaginal bleeding at 21 wk 2 days gestation pregnant. Sent to obstetrics (OB) for evaluation & after watched for a couple hours sent home. Returned to the ED complaining of having miscarried at home about 10 min prior to arrival. Arrived with only the deceased fetus (still in amniotic sac) delivered and still attached to placenta via umbilical cord. Once taken from her car to the ED the OB MD used ring forceps to assist in the delivery of the placenta.
Client received CanSino COVID vaccine. No reaction. CanSino vaccine not approved. Janssen given as an alternative on 9/28/2021.
In two days my calf started hurting and feeling like sore muscle and stayed like that for about 3-4 days. Following that I started having pain around my joints and especially excruciating pain around my bunion and it is persistent. I also feel more anxious in daily life and experiencing heart pulpitations.
6 month old infant developed high fever & high pitched screaming. Vial contained sediment.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored with VARIVAX (dosing details were not reported) (lot # M025865, expiry date: 24-MAY-2018) for prophylaxis, which was stored at a temperature of -14.24°C for 30 minutes. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact. Sender's Comments: US-009507513-1612USA008789.
Headache, nausea, heartburn, chills, pain in arm pit on same side as shot was given and tiredness.
Patient has fibromyalgia and experienced a flare after having the vaccine. She ended up in the ED and rates her pain at 10/10.
Since vaccine, pt has had allot of problems with joint, stiffness and pain. On 11/9/99, pt went to hospital with problems, had several tests that are still ongoing, no results yet.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).A 72-year-old female patient received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Barretts oesophagus" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL HCT [HYDROCHLOROTHIAZIDE;LISINOPRIL] oral; ATORVASTATIN oral; OMEPRAZOLE oral; MELOXICAM oral.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (02Aug2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive, at home test,; (25Jul2022) Negative, notes: negative at home test on 25Jul2022; (28Jul2022) Positive, notes: positive at home test on 28Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: covid rebound, tested positive, at home test, 16Jul2022 treated with paxlovid x 5 days (atorvastatin held x 14 days), negative at home test on 25Jul2022. Symptom recurrence on 28Jul2022 with positive at home test on 28Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Breakthrough COVID beginning 6/28/2022 positive test 6/29/2022, disease still progressing 7/1/2022
Client C/O dizziness post second dose of Pfizer.  No chest pain, headache, any other discomfort.