chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 05-APR-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, route of administration and anatomical location were not reported), as prescribed and/or administered by a pharmacist at a pharmacy, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for herpes zoster was unknown.
I have begun having severe hot flashes after receiving the shot.   I have not had them in several years and am 6 years post menopausal.  The start coincided with the shot and getting Covid 5 days after the shot.
FLU; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via social media  through a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received two doses of covid-19 vaccine (unspecified manufacturer), (Dose number in series 1), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered start therapy date were not reported for covid-19 prophylaxis. The patient had no issues following two doses of vaccination (Dose number in series 1). The patient received booster with covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (Dose number in series 2).  The patient had no issues following booster vaccination. It was reported "I had no issues until the 2nd booster (Dose number in series 2). The patient received second booster with covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The product was associated with Off label use (Off label dosing frequency) (Dose number in series 3). 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 flu (Dose number in series 3) and it was reported as "I had no issues until the 2nd booster. Got the new one and flu. Not much" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu and off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220941610.
Developed fever approximately 8 hours after vaccine.  (105 degrees F).  Next AM, joint and muscle tenderness;  "whole body" 5x responded to Ibuprofen.
Redness at injection site x 7 days. Fairly vigorous 10 cm x 15 cm. No systemic symptoms. Topical steroid can help W/ inflammation.
Immune thrombocytopenic purpura following Pfizer-BioNTech COVID-19 Vaccine with presenting features of petechiae, gum bleeding, epistaxis, and subconjunctival hemorrhage; This is a literature report for the following literature source(s): A 67-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (ongoing); "DM" (ongoing); "hypothyroidism" (ongoing); "depression" (ongoing); "B12 deficiency" (ongoing); "headaches" (ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNE THROMBOCYTOPENIA (medically significant), 14 days after the suspect product(s) administration, outcome "unknown", described as "Immune thrombocytopenic purpura following Pfizer-BioNTech COVID-19 Vaccine with presenting features of petechiae, gum bleeding, epistaxis, and subconjunctival hemorrhage". The patient underwent the following laboratory tests and procedures: Platelet count: 3 x10 3/mm3. The patient had symptoms 14 days after the first dose.; Sender's Comments: Based on the temporal relationship, the association between the event immune thrombocytopenia with BNT162b2 can not be fully excluded.  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.,Linked Report(s) : US-PFIZER INC-PV202200080418 Same article/drug/patient/event and different dose.;
ACUTE ST ELEVATION MI, ANTERIOR WALL 7/12/2021 ATRIAL FIBRILLATION, UNSPECIFIED CARDIOGENIC SHOCK 7/12/2021 ATRIAL FIBRILLATION, UNSPECIFIED ACUTE ST ELEVATION MI, ANTERIOR WALL 7/12/2021 ATRIAL FIBRILLATION, UNSPECIFIED CARDIOGENIC SHOCK 7/12/2021 ATRIAL FIBRILLATION, UNSPECIFIED ACUTE ST ELEVATION MI, ANTERIOR WALL 7/12/2021 AORTIC VALVE STENOSIS    CARDIOGENIC SHOCK CARDIOGENIC SHOCK 7/12/2021 AORTIC VALVE STENOSIS    CARDIOGENIC SHOCK ACUTE ST ELEVATION MI, ANTERIOR WALL 7/12/2021 AORTIC VALVE STENOSIS CARDIOGENIC SHOCK 7/12/2021 AORTIC VALVE STENOSIS ACUTE ST ELEVATION MI, ANTERIOR WALL 7/12/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA CARDIOGENIC SHOCK 7/12/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE ST ELEVATION MI, ANTERIOR WALL 7/12/2021 ACUTE UTI CARDIOGENIC SHOCK 7/12/2021 ACUTE UTI
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The health care professional reported that two people had pain at the injection site for 24 hours after a SHINGRIX vaccination. The patient or vaccine information was not collected during chat. This case was linked with case US2018079508, reported by the same reporter.
8 AM administration vaccines. Mild soreness to (L) arm injection site. 4PM nausea, chills, facial flushing, intense body aches 7-11PM especially neck and back. Temp 10PM-11PM-100.6 orally. Fatigue continued and body aches, headaches 9/28-9/30 improving daily.
Red, firm area at site of injection with erythema surrounding area (4" by 4").  Some pain, swelling.
Seizure X 2, pm after shots and fever 104-104.8 following am. 11/8/06-Assessment: seizure with no significant fever at the time of seizure but increasing within 30 minutes after seizure. No source for fever. Temp in ER 104.8 DX in ER with febrile seizure, bronchilotis and left eye conjunctivitis. Following morning second seizure.  Temp in ER 101.7 subsequent temp in ER 104.6. PMH: Hospitalization at 2 months for respiratory synctytial virus. Similar episode of seizure type activity prior th that admission where he stopped breathing and wondered how close to having his two month old shots. Records revealed seizure activity occurred 2 days after first DTaP vaccine. Recommend DP vaccine only.
Woke up sweating on Sunday morning; Spent most of the day in bed on Saturday; headache; muscle cramps in upper leg; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle cramps in upper leg), ABDOMINAL PAIN UPPER (Stomach pain), BED REST (Spent most of the day in bed on Saturday), HYPERHIDROSIS (Woke up sweating on Sunday morning) and HEADACHE (headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced MUSCLE SPASMS (muscle cramps in upper leg), ABDOMINAL PAIN UPPER (Stomach pain) and HEADACHE (headache). On 20-Mar-2021, the patient experienced BED REST (Spent most of the day in bed on Saturday). On 21-Mar-2021, the patient experienced HYPERHIDROSIS (Woke up sweating on Sunday morning). On 21-Mar-2021, MUSCLE SPASMS (muscle cramps in upper leg), ABDOMINAL PAIN UPPER (Stomach pain), BED REST (Spent most of the day in bed on Saturday), HYPERHIDROSIS (Woke up sweating on Sunday morning) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details pertained to the events were provided.
Pt began stuttering w/in 48 hrs p/immun; Seen in the office 28JAN91 & referred for consultation; Referral MD states "no relationship to vax can exist";
had bleeding sores in his mouth; had bleeding sores in his mouth; platelets were dropping; multiple platelet transfusions; This case was reported by a consumer via call center representative and described the occurrence of oral ulceration in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immune thrombocytopenia.   On 13th May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than 2 weeks after receiving Shingrix, the patient experienced oral ulceration (serious criteria hospitalization), oral haemorrhage (serious criteria hospitalization), platelets decreased (serious criteria hospitalization) and platelet transfusion (serious criteria hospitalization). On an unknown date, the outcome of the oral ulceration and oral haemorrhage were unknown and the outcome of the platelets decreased and platelet transfusion were not recovered/not resolved.   It was unknown if the reporter considered the oral ulceration, oral haemorrhage, platelets decreased and platelet transfusion to be related to Shingrix.     Additional Information: GSK Receipt Date: 1-Jun-2022 Reporter's Comments: Patient's wife reported this case. The patient received a dose of Shingrix and was hospitalized because he had bleeding sores in his mouth and his platelets were dropping.  The patient's platelets were 123,000 in labs prior to getting the vaccine. It dropped to 2000. The patient was still in hospital, 11 days. During hospital visit he received multiple platelet transfusions and was put on medicine. The reporter did not consent to follow-up.
Body aching, chest tightness w/ sl SOB; no rash, no wheeze;
I had no AE to the vaccine but again my cycle was delayed. The last time my cycle began was 7/1 and this time it didn't begin until 8/24 which lasted for 11 days which was totally abnormal for me. It was a whole full cycle for the entire 11 days and I am normally a 5 day runner. 1/5 I was fatigued and extra tired I took an at home COVID test and on 1/6 I tested positive to COVID. I got really sick on Friday but to date I am still slowly recovering but feeling just a little better today. I am currently taking the Antiviral Molnupiravir to help recover from the COVID-19.
pt recv vax & could not stand or ambulate;pt was adm to ICU 24APR97;MRI of the head was negative;pt scheduled for spinal MRI;
A report has been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning a 27 year old female patient enrolled in a study. FLUMIST (intranasal) was administered on an unknown date. The patient experienced anaphylaxis. The outcome of the event of anaphylaxis was unknown. The company physician considered the serious criteria for the event of anaphylaxis as: Important medical event. The company physician considered the causality between Suspect FLUMIST with the event of anaphylaxis to be Yes.
MD reports an inc number of inject site reactions, specifically induration, in pts who have recvd either of 2 lots (316976 & 318907); The inc is approx 70% of pt as compared w/usual 20%;
pt recvd vax; exp inconsolable crying & low grade fever which lasted 24-36 hrs; recovered
A couple days after receiving the shot a rash started at the site of the injection.  This rash now covers the entire body.  Constant intense itching, occasional burning, and pain in some areas.  PCP and dermatologist were both consulted.  Biopsy of arm, three rounds of blood work, and urine sample were analyzed.  Benadryl does not help.  Oral and topical antibiotics and steroids have been tried in multiple rounds with no apparent benefit.  Rash only responds to scalding hot shower for temporary relief to allow patient to sleep.
Tired, Sleepy, Chills, Fever, Sweats, Constant Diarrhria, headache. I slept and had the runs for 5 days. On the 6th day I went to the hospital for intraveneous fluids.
- 9:02 AM (2 minutes after vaccination) tachycardia with heart rate of 150-160 bpm. After about 15-20 minutes at 150-160 bpm the heart rate started decreasing slowly, was at 120 bpm 30 minutes after vaccination, 100 bpm 45 minutes after vaccination, about 90 bpm 60 minutes after vaccination. My usual heart rate while sitting is between 60 and 80 bpm. - Feeling of warmth in chest area about 20 minutes after vaccination, went away within the hour  - Weird feeling in throat, it felt like it was more difficult to swallow (started at 10:20 AM, 1 hour and 20 minutes after vaccination, went away within a few hours) - Overall weakness the rest of the day (I felt like after a colonoscopy or some other medical procedure)
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly store dose of GARDASIL 9 lot number N020352 and expiration date of 10-APR-2020, 1 injection, intramuscularly for prophylaxis (dose was not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of  47°F to 77°F with a time frame of 5 hours. There was no previous temperature excursion. A "data logger" was involved. There was not product quality complaint involved.
Severe chronic uticaria, wheals, non stop burning, rashes, welts. Severe for 14 days, and is now ongoing and intermittent
Fever; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in the left arm on 19Mar2021( at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not take any concomitant medications. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in the left arm on 26Feb2021 at 07:45 ( at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination the patient had been tested for COVID -19. On 25Mar2021 at 13:00 the patient experienced fever which began 6 days after second injection and now it was over 72 hours with fever. The patient underwent lab tests which included PCR test on 26Mar2021 and tested negative. The clinical outcome of the fever was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of COMVAX (lot number J013884; expiration date 19-AUG-2016) 0.5 ml "SDV;PK/10" (route of administration and anatomical location were not reported). On an unspecified dates, the COMVAX had five temperature excursions: 40 hours, 712 hours, 72 hours, 28 hours and 488 hours. The lowest recorded temperature was 28 F (-2.222222222 Celsius) while the highest recorded temperature was 47 F (8.3333333333 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
On 2/22/01, seen in clinic with bilateral otitis media and given Amoxicillin and Augmentin. Had a few papules around mouth. On 2/24/01, at 09:55, pt had a generalized tonic/clonic seizure at home. Came to ER with temperature of 36.3C. Acting normal at 12:00 and 14:00, had another seizure (each lasting about 45 seconds). Admitted; afebrile for 3 days.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions/allergies were unknown. On 01-DEC-2018, the patient was vaccinated with VARIVAX via intramuscular instead of the subcutaneous route (incorrect route of product administration) (lot # R018140 and expiry date: 25-JUN-2020) for prophylaxis (dose, frequency and anatomical location not reported). No adverse effect reported (no adverse event). No product quality complaint. Outcome of incorrect route of product administration was not reported.
Mom first notice rash on face. Later spread to stomach, and a little on arms. None on legs. Rash described as flat with the skin; 0 raised lesions; red in "cottage cheese" pattern. 0 fever. Child otherwise acting well/normal.
Pt developed a red, blotchy rash, noticed approx. 6-7 hours, post vax. Rash covered back, chest and abdomen in patches with a few small "wheals". Rash slightly worse the next day but improved on the 2nd day, post vax.
headaches, body aches, extreme fatigue, upset stomach, fever, swollen gland still suffering after 5 days
1/16/2022 - Breakthrough case of COVID-19, tested positive on rapid test initially, then on RT-PCR 2 days later.  Signs/Symptoms: Low grade fever, headache, fatigue, sore throat, congestion, post nasal drip, minor cough.
WIFE CALLED AND SAID HIS ARM WAS RED AND SLIGHTLY SWOLLEN FROM INJECTION SITE TO ELBOW. ADVISED HER TO HAVE HIM SEE A DR. ALSO ADVISED TO USE A COOL COMPRESS AND ADVIL/ALEVE,TYLENOL FOR PAIN/SWELLING.
Patient called pharmacy around 9:15 am complaining about  side effect after receiving Moderna  Covid 19 vaccine 2nd dose. Patient was advised to see doctor immediately. Patient stated that he didn't had any reaction after getting first dose of Moderna Covid 19 Vaccine (Lot - 027L20A - Site : LD - IM) on 01/05/2021.  As per patient, on Wednesday 02/03/2021 around 3 am woke up with high fever( 102.7), chills, body sore, joint muscle pain and feeling tired.  On Thursday 02/04/2021 around 2 am had fever (99.7), leg pain, low back pain  and swelling in left armpit. Has appointment with physician at 10:45am.
mom called 10AUG stated pt was sick all weekend 9JUL had fever 104 & turned all red; wasn't seen by MD; better today fever down;
States "had h/a & flu-like sx the day p/last shot, but took a couple ASA & felt better";
Pt. had Moderna booster 10/28/21.  Pt. today started with headache, muscles aches, leg cramps and fever 102.4
hair falling out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 10:00 (Lot number: EN6203) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "recovering", described as "hair falling out".  Additional information: It was reported that the initial case was missing the following minimum criteria: ICH-Unspecified number of patient. Upon receipt of follow-up information on 27Aug2021, this case now contains all required information to be considered valid. Prior vaccinations, Relevant test: None. Patient had also received the 2nd dose.   No follow-up attempts are possible. No further information is expected.
Sudden onset insomnia, hypomania, anxiety and panic attacks followed by 5 days of psychosis with mental status change.
21 yr old female with localized rxn to Anthrax vaccination; + erythema. warmth, itching at site. Redness extending from proximal arm to elbow on underside.
UTI progressing to kidney infection (burning with urination, increased frequency of urination, back pain), progressively worsening from Saturday until 1.5 days after beginning antibiotics.
Swollen at site of injection, sore and warm to touch and tender armpit, onset 1 day after injection. Looks like red and is somewhat hard.
Pt. died in bed approx. 48 hours after receiving 1st set of 3  immunizations. Records received 3/31/08-final autopsy report. COD: Probably Sudden Infant Death Syndrome. Petechial hemorrhages, epicardial, pleural.
injection site extremely sore and could not lift arm - this lasted several days .. i can still feel where injection was given to this day. Had headache on and off for days Experienced hives - in various areas .. not heavily but still had some Felt sickish and weird and very anxious. Not sure about taking second dose as it is scaring me.  Had an injection in other arm for pain about 45 years ago and still hurts till this day
Patient presented to the pharmacy with a red, tender to touch and hot to touch left arm. She had already been to her doctor and he prescribed keflex and prednisone for her to take.
1 hive to left thigh, redness at injection site closer to flu injection, redness on left side of forehead, given 4ml of Children's BENADRYL.
Received second dose of Pfizer vaccine in January 2021. Miscarried a baby after 5 weeks in June 2021.
Patient developed wheezing, hives, and flushing within 10 minutes of vaccine administration.  He was treated with epinephrine, Albuterol aerosol, and Prednisone.
received hepatitis B vaccine at employee health and 15 minutes later developed urticaria.  Was treated at the ED which is adjacent to employee health. She received oral diphenhydramine and oral prednisone.
Vaccine was stored in freezer too long resulting in a temperature excursion. Elevated BP.