chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 26-MAY-2017 from a lawyer and a male patient of unknown age regarding a case in litigation. The patient was inoculated with ZOSTAVAX (dose. route, lot number and expiration date were not reported) on or about 06-NOV-2013 as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-JUL-2015, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. On or about 17-NOV-2015, the patient was treated by another physician for herpes zoster which caused an infection in the eye and eyelid. On or about 23-NOV-2015, the patient was treated again by his physician for ongoing and worsening symptoms, which the physician then diagnosed as post herpetic neuralgia. As a direct and proximate result of these malfunctions, 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. Upon internal review herpes zoster which caused an infection in the eye was considered medically significant. Additional information has been requested.
Nausea, Headache, Excessive Vomiting, Chills, Aches: No Treatment.
COVID pos on 08/02 I had a sore throat; headache; rhinorrhea and fatigue. I was prescribed a course of Paxlovid which I completed. On 8/12 I tested pos with a rebound case of COVID. This time my side effects were much worse than the first time that I had COVID. I had fatigue; sore throat; headache and head congestion.
Patient came to pharmacy with rashes all over her body. I noticed the redness on her arms and neck. I gave her 8 ml of liquid Benadryl.
abdominal pain, nausea, vomiting, diarrhea. also diagnosed with acute cholecystitis,  on 10/17, but tested positive for COVID on 10/23/22. Tested due to felling warm an chills, with elevated temperature on 10/23 ( 101.7)
Three days later I had full blown case.; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles several times a year).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient had reoccurring shingles, his/her doctor thought he/she should have the vaccine. The patient received shingles vaccine and 3 days later had full blown case of shingles. The patient stated that, shingles was not preventable, if you had the virus (chicken pox)you were more than likely to get shingles than not get shingles.  The patient also stated that, he/she got shingles several times a year and in between had gotten the shingles vaccine and it only brought them on again.
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022), EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and NO ADVERSE EVENT (No adverse event) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022), EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022) and EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used).    Concomitant medications were not reported.  They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions. Treatment medications were not reported.
Legs are swelling; Leg discomfort; Itchy legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Legs are swelling), LIMB DISCOMFORT (Leg discomfort) and PRURITUS (Itchy legs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042A18A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Legs are swelling), LIMB DISCOMFORT (Leg discomfort) and PRURITUS (Itchy legs). At the time of the report, PERIPHERAL SWELLING (Legs are swelling), LIMB DISCOMFORT (Leg discomfort) and PRURITUS (Itchy legs) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.  Lab details were not provided.  Patient also stated his legs are swelling, begin to have discomfort, itch, and feels like thrombosis. Declined to provide consent for HCP or any other information.  Company Comment :Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to MOD-2021-279438 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
- Fever body aches, arm pain. Approx 1 in redness @ injection site. - Recommended IBUPROFEN 600 mg q 6 hrs prn. - Went to ER - 5-27-09
Narrative: 09/02/2020 COVID swab, result: not detected COVID infection following COVID vaccine series 01/11, Pfizer, dose #1 02/02, Pfizer, dose #2 08/09 pt cc: cough, chills, fatigue, loss of taste or smell, rhinorrhea, dyspnea exposure: unknown 08/10 -08/18 pt symptoms continue 08/13 COVID swab, result: detected 08/13 SARS-COV-2 LINEAGE AY.3.1 08/13 SARS-COV-2 CLADE 21A DELTA 08/19 clinically resolved
Took Advil and symptoms were relieved.  Chills, fever, headache, injection site pain, malaise, new or worsened joint and muscle pain
ADVERSE EVENT NOS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious.
This literature marketed report as received from health professional refers to a 15 year old male patient. Patient's current condition reported as chronic mucocutaneous candidiasis (CMC) and type 1 diabetes. On an unknown date, at the age of 13, the patient was presented with recurrent sinusitis and mucocutaneous fungal infections. There was no history of pneumonia or serious bacterial infections. On an unknown date, daily DIFLUCAN was given with dramatic improvement in his skin and oral candidiasis. On an unknown date, the patient was vaccinated with PCV 23 (manufacturer unspecified) injection, booster dose (dose and route of administration unspecified). On an unknown date, at the age of 15, he was admitted to the pediatric intensive care unit with respiratory insufficiency due to pneumonia (hospitalization) complicated by pleural effusion requiring chest tube decompression. On an unknown date, the patient was discharged. On an unknown date, he was readmitted shortly after discharge for refractory pneumonia (hospitalization) and positive enterovirus PCR. On an unknown date: Autoimmune regulator (AIRE) gene and quantitative immunoglobulins were normal. Polysaccharide response was poor despite repeat boosting with PCV 23 (manufacturer unspecified). On an unknown date, Tetanus and diphtheria titers were protective. Stool alpha anti-trypsin and neutrophil oxidative burst were normal. Lymphocyte enumeration was persistently abnormal and mitogen stimulation shows reduced T-cell proliferation. HIV PCR was negative. Adenosine deaminase and purine nucleoside phosphorylase were normal. Toll-Like Receptor assay (TLR assay) showed absent toll like receptor 3 (TLR3) function but normal toll like receptor 1-8 (TLR1-8) function. Further evaluation confirmed a heterozygous L412F mutation of toll like receptor 3 (TLR3) and a heterozygous mutation in the DNA-binding domain of signal transducer and activator of transcription (STAT 1). Conclusion the combination of toll like receptor (TLR) and signal transducer and activator of transcription (STAT) gene mutations may produce a severe form of chronic mucocutaneous candidiasis (CMC). The patient was clinically stable until age 15 and both immunoglobulin replacement and bone marrow transplant (BMT) are treatment considerations. The outcome of events pneumonia and refractory pneumonia was unknown. The reporters assessment for the events pneumonia and refractory pneumonia with the PCV 23 (manufacturer unspecified) was unknown. Additional information has been requested.
The administration of Prevnar to an adult instead of the intended adult Vaccine Pneumovax. The work "pneumococcal", which appears in the labeling of both vials, caused the confusion (error). The field alert is being issued for a product confusion event.
Information has been received from a physician concerning a 4 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The physician reported that in December 2005, the patient developed breakthrough chickenpox characterized by 50-60 lesions. Unspecified medical attention was sought and the patient was treated with Acyclovir. Subsequently, the patient recovered. There was no product quality complaint. Additional information is not expected.
LARGE BLUE/PURPLE BRUISE AFTER VACCINATION; LARGE HEMATOMA; This spontaneous report received from a health care professional concerned a 60 year old male. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced large blue/purple bruise after vaccination, and large hematoma. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the large blue/purple bruise after vaccination and large hematoma was not reported. This report was non-serious.
Started getting muscle soreness 8 hours after injection, which got worse and worse for 3 hours, then slowly subsided. Got chills 10 hours after injection, which subsided within 5 hours. Had a fever 12 hours after injection, slept it off. Headache after waking up next day
feels like she got COVID but not yet tested for it.; loss of test; fever; headache; runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), COVID-19 (feels like she got COVID but not yet tested for it.), AGEUSIA (loss of test), PYREXIA (fever) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced RHINORRHOEA (runny nose) and HEADACHE (headache). On 20-Feb-2021, the patient experienced AGEUSIA (loss of test) and PYREXIA (fever). On an unknown date, the patient experienced COVID-19 (feels like she got COVID but not yet tested for it.). At the time of the report, RHINORRHOEA (runny nose), COVID-19 (feels like she got COVID but not yet tested for it.), AGEUSIA (loss of test), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Fatigue; headache; muscle aches; weakness; fever, chills; nausea; vomiting; cough/runny nose.
Left arm redness, warmth, itchiness onset ~1 week after 2nd Moderna vaccine.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EP6955) at the age of 72 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: EN6201), administration date: 23Feb2021, when the patient was 72 years old, for COVID-19 immunisation. The following information was reported: MIGRAINE (non-serious) with onset 15Mar2021, outcome "unknown", described as "Migraine headache/have had a constant headache for the last two weeks". Additional information: The patient is wondering if there's something he can take to get rid of it. He doesn't know how he can get rid of this headache. When probed for medical conditions and laboratory test performed, he stated that no medical condition and no relevant lab test performed. No follow-up attempts are possible. No further information is expected.
8x10 cm erythematous, swollen, warm area.  No fluctent very tender.
Varicella vaccine 4-16-10 then developed fever + rash started 4-21-10, crops of red bumps, fluid-filled vesicles, pruritic.
pt recvd vax & had a temp of 101 ax; APAP given; 430PM same day mom brought pt back in w/t104.3 on APAP; fever dropped the next day-gone by Tuesday;
Information has been received from a immunization consultant that she heard from the school nurse concerning an approximately 7 year old female who on 08-OCT-2004 and 07-OCT-2008 was vaccinated subcutaneously with a first and second dose of VARIVAX (Merck) (lot # for the 1st dose of 644795/0335N). It was reported that the patient who had 2 doses of VARIVAX (Merck) and broke out in chicken pox. The patient's symptom improved on therapy. As of 08-SEP-2010 the patient's outcome was unknown. Follow-up information received from the Immunization Consultant, Supervisor indicating that she did not have the lot number for the second dose of VARIVAX (Merck) that was administered on 07-OCT-2008. The patient developed a generalized rash, less than 50 lesions which were mostly fluid filled and itchy. The patient had developed a fever (temperature unknown to reporter). The patient was diagnosed with chickenpox on 07-SEP-2010. The reporter thought that the patient had recovered and was back to school. The Immunization Consultant, Supervisor did not have any additional information and stated that she would call back it she did receive additional information.
This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 26-JUN-2014 the patient was vaccinated with second dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J014584, expiry date: 16-JAN-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, , 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA01304 (same reporter link).
This spontaneous report was received from a healthcare worker refers to a male patient of unknown age. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 31-JUL-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) 0.5 ml (lot# K008823, expiration date 19-JUN-2015) subcutaneously. It was the patient's second dose of this vaccine (date of the first dose of VARIVAX (Merck) was not reported). No adverse effects were reported. No product quality complaints (PQC) was involved. Additional information has been requested.
6/25/2022 11:10am vaccine 6/27/2022 12:25am woke up from night sleep crying, escalated to inconsolable crying/screaming as she has never cried/screamed before.  Checked temperature, normal.  Gave infant Tylenol.  Eventually fell asleep after crying/screaming in mother's arms for 20+ minutes, refused breast (which is normal comfort).
Client verbalize tingling of the tongue and mild swelling of the lips after receiving the vaccination.  Client was evaluated by onsite paramedic and physician.  9:55 am client symptoms resolved and release at 10:03 am.  Accompanied by daughter.
Patient called to report localized injection size reaction at 2:15pm. Patient states that area the size of hand was swollen, red and warm to the touch. Patient also states area was hard to the touch. Otherwise no allergies to latex or anything was reported. Patient usually gets annual flu shot with no issues. Patient will continue to monitor at this time.
Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respiratory issues. Patient chose to leave facility and went to a store where she purchased Benadryl and took 25mg orally. Patient returned to site where vaccine was given (which is also her place of employment). Nurse evaluated patient and rash noted on chest. Blood pressure elevated to 220/115 and heart rate 120. Physician evaluated patient. EKG performed and patient found to have sinus tachycardia. Benadryl 25mg and Kenalog 40mg administered intramuscularly. Blood pressure came down to 150/104 which patient reported was close to her recent baseline as she recently had a medication adjustment. After approximately 15 minutes patient no longer felt flushed. Patient was instructed to take and additional dose of Benadryl 50mg orally that evening and a Prednisone dose pack was prescribed.
Phone call from Dr. office requesting information on what vaccines given information supplied. It was later reported by a family member that infant was sent home from that office later went to a facility possibly on 08/04/2012 and was seen possibly at ER for seizures and transferred to another hospital by ambulance.
This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown gender and age, who on unspecified dates received an improperly stored dose of PEDVAXHIB, intramuscular injection, lot number L042257, expiration date 17-AUG-2018 and another lot number reported as L042259, expiration date 18-AUG-2018 (dose, route and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
tc from pt on 23OCT92 1101AM reports havin a flu shot 1 wk ago & had chills, sweats, pain & dizziness has been taking Ubuporfen since that time; speech was noticeable slurred;
Within 3 hours of getting DTAP/IPV/Flu vaccine, his lips and face started swelling.  No respiratory distress noted, just large facial swelling and hives.
Tested positive for COVID-19; A spontaneous report was received from a consumer concerning a 69-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for COVID-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event tested positive for COVID-19.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 9 Feb 2021, the outcome of event tested positive for COVID-19 was unknown.