chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; The medical assistant is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX  (w032370  4/19/2025) Temperature: 37.2F; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 19-SEP-2023, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, as prophylaxis (lot number: w032370, which was determined to be valid, with an expiration date on 10-OCT-2024) (strength, dose, scheme, route and anatomical location of administration were not reported).  The administered dose underwent a temperature excursion of 37.2 degrees Fahrenheit for 18 hours. No previous temperature excursion was reported.   No additional adverse event was provided.
Injection about 15:40. Approximately 17:30 became dizzy light headed, face tingled and broke out in a sweat. Lasted about 30 min. Later arms and legs felt heavy x 12 hr.
7 Days after vaccine started with left axilla and arm tenderness, 8th day had itching and swelling at injection site, 9th day redness, swelling at injection site, area very warm to touch, malaise, muscle aches, headache.  I will start  antibiotics to rule out cellulitis vs vaccine reaction
Vaccine given 2/21/08 - complained of dizziness 2/22/08 and nausea.  2/24/08 - complained of chest pain - like fist in chest, dizziness, raspy throat, stuffy nose, pale, hands numb.  Went to ER - was admitted.  4/15/08 Reviewed hospital medical records of 2/24-2/26/2008. FINAL DX: acute coronary syndrome, HTN, dyslipidemia, obesity Records reveal patient experienced chest pain/pressure radiating to the back, dizziness, tingling of hands, SOB, nausea & some chest congestion.  Reported muscle aching since vaccination.  Chest pain resolved in ER s/p GI cocktail.  Transferred to higher level of care for cardiac catheterization.  4/25/08 Received additional med records from initial hospital which consisted of the cardiac cath report from transfer hospial which reveals well preserved LV contractility & mild nonobstructive CAD.  4/25/08 Also received hospital medical records of 2/26/208. FINAL DX: chest pain, non-cardiac origin; HTN; dyslipidemia intolerant of statins. Records reveal patient tolerated cardiac cath well & had no recurrence of chest pain.  D/C to home same day to f/u w/PCP & cardiology.
Patient states that she developed an itchy rash only on the arm where she received the vaccine.  it developed the day after the vaccine and persisted for about two week
The second evening after the shot I developed AFIB; chills; 101 fever; sweats; fatigue; This is a spontaneous report from a Contactable Consumer. A 73-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6200), the second dose, via an unspecified route of administration on 20Feb2021 on Left arm at single dose for covid-19 immunisation .  Medical history included 2 stents, ablation surgery from Jun2018, gall bladder and appendix removed, penicillin allergy.  Concomitant medication included ticagrelor (BRILINTA), metoprolol (METOPROLOL), olmesartan , pravastatin .  The patient previously took cipro [ciprofloxacin] and experienced allergy. He received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:En5318) on  30Jan2021 10:45 AM on left arm for covid-19 immunization. Approximately 10 hours after second pfizer vaccination (20Feb2021) he developed chills, then a 101 fever, sweats and overall fatigue. Symptoms lasted about a day and a half. The second evening (21Feb2021) after the shot he developed AFIB. He had surgery in Jun2018 to correct AFIB and have not had an occurrence since prior to this. The patient underwent lab tests and procedures which included body temperature: 101 on 20Feb2021.  Outcome of events was not recovered. No treatment received for all events.  Follow-up attempts are completed. No further information is expected.
This spontaneous report has been received from a physician via a company representative, referring to an unknown number of patients of unknown age or gender. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with ROTATEQ (strength, dose, lot # and expiration date were not reported) by oral route for prevention of rotavirus gastroenteritis. The physician reported that on unknown dates, the patients sought medical attention and were admitted to a hospital for an unknown number of days for treatment of rotavirus after the patients received ROTATEQ. It was unknown if laboratory diagnostic studies were performed. No further adverse event's information was available to report. The outcome and the causal assessment for the gastroenteritis caused by rotavirus with the suspect therapy were not reported. Upon internal review, the gastroenteritis caused by rotavirus was considered as a medically significant event. Additional information has been requested.
COVID-19 INFECTION (SNIFFLES, A SORE THROAT AND CONGESTION); OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a consumer via a company representative concerned an adolescent male. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 infection (sniffles, a sore throat and congestion), off label use, and product administered to patient of inappropriate age. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the covid-19 infection (sniffles, a sore throat and congestion), off label use and product administered to patient of inappropriate age was not reported. This report was non-serious. This report was associated with product quality complaint: 90000208213. This case, from the same reporter is linked to 20211251102 and 20211251230.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Per patient report, localized reaction started a few hours after.  Continues to worsen.   Arm now large, swollen, about the size of a golf ball per patient.  Red and hot to the touch.
This spontaneous report was received from a 78 year old female patient with no pertinent medical history and no drug reactions or allergies. Weight and height of the patient was reported as 117 (units unspecified) and 5 feet and 1 inch. On an unknown date in December 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included valacyclovir hydrochloride, naproxen, acetaminophen and Hydroco. On 02-MAR-2013, the patient experienced burning sensation along her right breast to her back and feels nerve pain. The patient was provided with a treatment (unspecified). The outcome of both the events was was unknown. The relatedness for both the events was unknown for ZOSTAVAX. Additional information has been requested.
Excessive sweating; Feeling feverish; Moderna Covid-19 vaccine administered to a 12 year old; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Excessive sweating), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine administered to a 12 year old) and PYREXIA (Feeling feverish) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine administered to a 12 year old). On 24-Jul-2021, the patient experienced HYPERHIDROSIS (Excessive sweating). 24-Jul-2021, the patient experienced PYREXIA (Feeling feverish). On 15-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine administered to a 12 year old) had resolved. At the time of the report, HYPERHIDROSIS (Excessive sweating) and PYREXIA (Feeling feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were provided No treatment drugs were provided.  The patient said that she brought her son to the pharmacy and the Pharmacy Technician asked the Mother if her son who was 12 years of age would like the Pfizer or the Moderna Covid-19 vaccine.. The callers son received his first Moderna Covid-19 dose on 15-Jul-2021.
redness; swollen; warm; itchy; painful; COVID ARM; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (redness), SWELLING (swollen), VACCINATION SITE WARMTH (warm), PRURITUS (itchy) and PAIN (painful) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) 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 LOSARTAN and ATORVASTATIN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), SWELLING (swollen), VACCINATION SITE WARMTH (warm), PRURITUS (itchy), PAIN (painful) and VACCINATION SITE RASH (COVID ARM). The patient was treated with CORTISONE at an unspecified dose and frequency; Aloe cream at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), SWELLING (swollen), VACCINATION SITE WARMTH (warm), PRURITUS (itchy), PAIN (painful) and VACCINATION SITE RASH (COVID ARM) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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 details also included ice.   This case was linked to MOD-2021-022327, MOD-2021-022327 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: No specific follow-up information recorded.
Within first 24 hours diffuse rash around neck and shoulders, red, hard and warm induration at injection site.
Entire upper arm to the elbow turned bright yellow, especially underside of arm and underarm, about 3 hours after receiving vaccine.  It remained yellow until approximately 14 hours after the shot was administered.  No pain or swelling associated with the discoloration.  Color was bright yellow.
Patient had red swollen area around the injection site on her left deltoid. It was warm to touch 48 hours after vaccination. Pt stated itstarted to get sore and red around 8-10 hours after injection.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 31-OCT-2012, the patient was inoculated with ZOSTAVAX at a physician's office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 17-FEB-2015, the patient was treated at the same physician's office for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a literature article concerning a 2 year old patient who was vaccinated with hepatitis B virus vaccine. Subsequently the patient experienced autistic symptoms, fever, and convulsions. Autistic symptoms and convulsions were considered to be other medical events (OMIC). It was also reported that another patient had the same symptoms (WAES0510USA09341). No further information is available. The literature article is attached as further documentation of the patient's experience.
No trauma Got dose, works as cleaner. Received in Left deltoid. Lot 013L20A Moderna.  For first 3 days, had typical pain she would receive from influenza vaccination 3 days after started to have redness at injection site as well as swelling.  Swelling subsided but as soon as swelling improved, pain got worse radiating from shoulder down arpit and to left hand.  Numbness and tingling also radiated distally.  3 ED visits--on 1/25 and two on 1/27 giving APAP, diclofenac gel, lidocaine patch, and sling.  Workup showed mildly elevated alk phos (129), CK normal 57, WBC unremarkable with absolute eois wnl.  XR imaging unremarkable.  No DVT L upper extremity.   Today, pain in deltoid controlled with APAP 500mg x 2 along with lidocaine patch.  But biggest concern for patient is the radiating pain and numbness / tingling down her L arm that has not gone away with anything. Reports significant pain in elbow radiating to lower arm at night.  Further workup is still pending.
R57.0 CARDIOGENIC SHOCK 11/11/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED    SECONDARY HYPERPARATHYROIDISM, RENAL ORIGIN R57.0 CARDIOGENIC SHOCK 11/11/2022 ATHEROSCLEROSIS OF AORTA
Hospitalized 7/11/22-7/13/22 RUQ pain, decreased appetite, nausea, fever,  cholecystitis with cholelithiasis, Covid PNA,
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-Aug-2020 and the estimated date of delivery was 02-May-2021. On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided  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. Concomitant product use was not provided by the reporter. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Internal review on 20-Jul-2021 resulted in updates to the pregnancy information.
Red knot at the site of injection; A spontaneous report was received from a pharmacist who is a 55-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a red knot at injection site.  The patient's medical history was not provided. No concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A, Exp. date: 11 May 2021) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient experienced a red knot at injection site. No treatment was administered for the event.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the event of a red knot at injection site was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Pt had flu shot on 12/6/10, evening of 12/7/10 child broke out in hives on arms, chest, back, face and neck, very itchy so took BENADRYL 12/8/10. Still with hives, took more BENADRYL. Seen in MD office at 4pm, 12/9/10 - called mom, no hives today.
pt recv vax & 2yr p/vax pt devel onset lesion on stomach;the reporter indicated pt was not sure;
About 28 hours after the injection, I began having episodes of Atrial Fibrillation and tachycardia. These only lasted for 5-20 minutes. The episodes were fairly frequent for about 48 hours then decreased frequency.  ( I have a device that records a 30 second ECG. so I have documentation of these episodes. I have never had an episode of atrial fibrillation but my sister has and that is why we have a device in the house Highest heart rate recorded was 185 beats per minute while sitting. )  I called my physician whose nurse suggested I consider going to the ER if the episodes continued. Because of the brevity of the episodes I did not feel like going to the ER would be helpful.
Pt received FLUMIST on 10/15/11 (2011); 3d later developed pain in both upper & lower extremities. Unable to walk. Admitted to hospital on 10/21/11; dx myositis. Treatment: IV hydration and ibuprofen for pain.
Sick; rash; Initial information received on 05-May-2023 regarding an unsolicited valid non-serious case received from non-healthcare professional.  This case involves a 64 years old female patient who experienced sick and rash after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization). Information on the batch number was requested.  On an unknown date, the patient developed non-serious event sick (illness) and rash (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (Sick and rash).  At time of reporting, the outcome was Unknown for the event sick and the event rash.
Narrative: states experiencing left sided chest pains/palpitations and temp 100 which he took tylenol for on 2/19/21. During time of call, 15:06, Patient was not experiencing chest pain. Patient stated he will go to local ER for evaluation
Patient reported red, swollen arm which was hot to the touch and painful. Patient also reported several days of lethargy.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 26Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 26Sep2021 at 11:00 as dose 3 (booster), single (Lot number: FE3592) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19May2023 at 12:00 as dose 4 (booster), single (Lot number: 004M21A), in left arm and on 14Jun2023 at 11:00 as dose 5 (booster), single (Lot number: AS71843), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diffuse large B cell lymphoma" (unspecified if ongoing), notes: On 01Aug, I will be 6 mos post R-CHOP chemotherapy for diffuse large B cell lymphoma.; "R-CHOP chemotherapy" (unspecified if ongoing), notes: for diffuse large B cell lymphoma. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19May2023 at 12:00, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" (Jul2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. with Paxlovid from 12Jul2023 to 16Jul2023.  Based on investigation result conclusion: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot FE3592; EP7534 and EN6204 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FE3592, fill lot FF2553 and the bulk formulated drug product lot FA9141. The final scope included the reported finished goods lot EP7534, fill lot EP7532, and the formulated drug product lot EP7528. The final scope included the reported finished goods lot EN6204, fill lot EN5335, and the formulated drug product lot EN5325. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300257325 same patient, different drug and event;
Patient said she remembers getting her vaccination. She had trouble remembering what year she was born.  I questioned her about that and she said she was having a really stressful day.  She had a water line broke at home and she had tons to get done. After she had the vaccination she took a seat on the bench outside the pharmacy.  After she had been seated a while.  We noticed she was talking on her phone.  She said that she was really confused and couldn't remember why she was at pharmacy.  She called her son, he came and took her to the hospital.  She was told that she was having a stroke.