chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster. During 2016, the patient was treated at physician office for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. 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. Additional information has been requested.
My Rheumatoid Arthritis had been in remission for three years. After the first Pfizer shot I had joint pain all over my body, extreme fatigue. Three months later I am still have joint pain and fatigue.
Second Vaccine: A little Itchy; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 86 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 03Mar2021 (Lot number: EN6203) at the age of 86 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pacemaker" (ongoing); "Bovine valve implant" (unspecified if ongoing); "Abdominal Aneurysm with 2 Stents" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Suspect Products: Pfizer Covid 19 Vaccine, First Dose: 10Feb2021 Lot: EN6203), administration date: 10Feb2021, when the patient was 85 years old, for Covid-19 immunization, reaction(s): "First Vaccine: A little achy". The following information was reported: PRURITUS (non-serious) with onset Mar2021, outcome "recovered", described as "Second Vaccine: A little Itchy". Therapeutic measures were taken as a result of pruritus.  Additional information: It was reported that, he had both shots and also had the first booster shot and those 3 shots he had no reaction whatsoever. Caller states the route of administration was arm intramuscular. Caller states again, he has had all 3 shots, with no reaction, whatsoever, except the first time he was a little achy, but he took an aspirin and the achiness went away. Caller states with the second, he was a little itchy, but he took a Benadryl and it knocked out the itchiness from the second shot and he has been fine ever since.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200341897 same patient, product, different dose
Moderna COVID-19 Vaccine- EUA: Patient in clinic for 2nd dose of Moderna in primary series. Upon review of administration paperwork, patient was administered booster dose instead of primary dose. Attempted to contact patient twice. No answer. Voicemail left.
Significant fatigue, loss of appetite, nausea, mild headache, dry eyes all within hours of vaccine.  Symptoms continue after 7 days with only mild improvement.
Pneumococcal 23 vaccine given 02/18/2005, patient left in good health.  On Tuesday 02/22 nurse spoke to Mom who informed that patient has redness and swelling all the way down arm, vomiting, and fever since 02/18.  Patient sent to ER for evaluation.
stomach ache; She tested positive for Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache) and COVID-19 (She tested positive for Covid-19) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 immunization.     No Medical History information was reported.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 17-Jan-2021, the patient experienced COVID-19 (She tested positive for Covid-19). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). The patient was treated with IBUPROFEN (ADVIL HEADACHE & MIGRAINE) for Adverse event, at an unspecified dose and frequency. On 16-Jan-2021, ABDOMINAL PAIN UPPER (stomach ache) outcome was unknown. At the time of the report, COVID-19 (She tested positive for Covid-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     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.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.. Based on the current available information and temporal association between the use of the product and the start date of abdominal pain upper, a causal relationship cannot be excluded.
Tested positive on 07May2022. Started Plaxlovid the same day. Negative after 3 days. Took all 5 days of Plaxlovid. Tested negative for 3 consecutive days beginning 10May2022. No symptoms.Tested positive; Tested positive on 07May2022. Started Plaxlovid the same day. Negative after 3 days. Took all 5 days of Plaxlovid. Tested negative for 3 consecutive days beginning 10May2022. No symptoms.Tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 at 19:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm 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: "Diabetes" (unspecified if ongoing); "mycosis fungouties" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 09Oct2017, stop date: 02Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "recovered" and all described as "Tested positive on 07May2022. Started Plaxlovid the same day. Negative after 3 days. Took all 5 days of Plaxlovid. Tested negative for 3 consecutive days beginning 10May2022. No symptoms.Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive, notes: Tested positive on 07May2022; (09May2022) Negative, notes: Started Plaxlovid the same day. Negative after 3 days; (10May2022) Negative, notes: Tested negative for 3 consecutive days beginning 10May2022; (11May2022) Negative, notes: Tested negative for 3 consecutive days beginning 10May2022; (12May2022) Negative, notes: Tested negative for 3 consecutive days beginning 10May2022; (19May2022) Positive, notes: Tested positive again on 19May2022; (27May2022) Negative, notes: Tested negative on 27May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Breakthrough case admission after three vaccines Pfizer 3/3/21 Lot# En6198;  Pfizer 3/24/21 Lot# En6208 ; Pifzer 10/22/21 Lot# FH8028
Vaccines were administered at 3:00 pm. That night boths were swollen and maculopapular rashes, on the arms that progressed to lower; (+) fever of 101-102 degrees C and chills with vomiting. Lost of appetite with severe tiredness; in bed with no energy x 1 week, dizzy getting up. On 8/18, developed papular rashes early in am starting on the back and itchy; progressed to general, (+) vomiting. Lost weight. Client went to pharmacy - given CLARITIN 10 mg, taken at 6 pm. By 11:30 pm, rashes started disappearing. Client got up and well today 8/20. Able to retain food - grapefruit, cereal, donut. Client came back to clinic today; not in distress, alert, oriented.
pt recv vax & 14JAN99 & by Thursday evening, devel pain, redness & swelling site; since then, redness has extended slowly down to elbow & by today;site of inj appears clear;area below inj site is swollen, tender & red;
11/2/2021: Received vaccine in morning. Later that evening had multiple heart palpitations. When sleeping, I kept waking up with fever. Body felt hot with sweats. 11/3/2021: Continued with palpitations. Very fatigue throughout the day. In evening, fast heart rate lasted hours. Chest tightness and some pain in the evening. 11/4/2021: Continued with some palpitations. Continued with chest tightness and pain. I went to ER that afternoon. 11/5/2021: Palpitations mostly stopped. Chest pain and tightness better. 11/6/2021: Symptoms 90% better overall.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) 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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion).    Concomitant product use was not provided.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use. No treatment information was provided. This case contains information for the 22nd of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:master case
I had COVID arm eight days after my first vaccine. I still had COVID arm when I received my second vaccine, on my right arm. About 8-9 days later I broke out in a rash. In the middle of might, burning and itching on my arm, seemed I developed auto-immune disorder, I also developed a skin liken sclerosis, never had that before, think it is related to the T-cells. on my neck. At the same time, I developed two different symptoms, liken sclerosis which I have never had before and also my breaking out in rash on my neck and it is right above my thyroidectomy scar. I have this redness around my neck and have not been on the sun. I still have the rash and still dealing with the COVID arm. I also experienced a fever and had rapid heartbeats. My T-cells went crazy and I am concerned what is going on with me. I also have some auto immune disease. I still have the rash and still dealing with the COVID arm.
Patient had Rotateq on 9/29/06 and 12/8/06 and was diagnosed with intussusception on 12/20/06. Patient's symptoms were vomiting and lethargy.  It was reduced with a barium enema.  She is undergoing a UGI with small bowel follow through today to rule out malrotation.  2/5/07 Received medical records from hospital which reveal patient experienced vomiting & lethargy for 5 days & was admitted to hospital 12/20/06-12/21/06.  Exam revealed patient was dehydrated.  IS was suspected, successfully reduced & patient was admitted for overnight observation s/p reduction due to possibility of malrotation or mobile cecum.  Ped surgery consult done FINAL DX: Intussusception, reduced by BE.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 11-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 17-NOV-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Allergic reaction to shrimp (previously never a problem  Then "Covid Arm" on day 8, with severe headache, nausea,  severe fatigue, fever, dizziness and diarrhea until day 14
Apprx. 30 mins after MMR vaccine, EE C/O feeling dizzy, soreness at site of injection, anxious. VSS
Confirmed case of Multisystem Inflamamtory Syndrome (MIS-C), onset 12/27/21
PM 17NOV98 devel drooping mouth especially lt side but this did also appear on rt @ times;rt eye affected also weak dx as Bell's Palsy viral infect;tx w/pred, eye gtts;MD does not feel this is vaccine related;
Patient admitted to hospital with 3 pulmonary emboli and hypoxia on 12-27-21
Slight fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) and MYALGIA (Body aches) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 633H21A, 021C21A and 042K21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Tested positive for COVID-19) in November 2020 and Feeling unwell in November 2020.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, the patient experienced PYREXIA (Slight fever) and MYALGIA (Body aches). At the time of the report, PYREXIA (Slight fever) and MYALGIA (Body aches) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant information was not provided.  Patient reported to have an hybrid immunity as the patient experienced COVID-19 in Nov 2020 prior to vaccination.  Treatment information was not provided.   This case was linked to MOD-2021-409895, MOD-2021-409904 (Patient Link).
got deathly ill; Initial information regarding this unsolicited valid non-serious social media case  was received from a consumer (patient) and transmitted to Sanofi on 13-Dec-2020.  This case involved a unknown patient who got deathly ill (illness), after receiving vaccine INFLUENZA VACCINE was reported.  The patient's past vaccination(s) included INFLUENZA.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose 2 of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, It was reported that patient never had a flu shot until three years ago. Health care provider convinced patient and was at the age needed one. So patient got it and got deathly ill. The next year they told patient to get another one and again patient got deathly ill. No shots for patient.  Relevant laboratory test was not reported.  Final diagnosis was illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
ACUTE ST ELEVATION MI, UNSPECIFIED 4/18/2023 ACUTE MI ACUTE MI 4/17/2023 ACUTE MI ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/18/2023 ACUTE MI
Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe
sudden feeling of dizzyness. started by feeling wobbly, just something that felt "off". within an hour i felt like my balance was off. standing and sitting didn't feel quite enough, started to feel that hotness and start of naseau, but laying down to left side and then sitting up seemed like a head rush. then within maybe another 20 min, definite dizzyness. when looking up to the ceiling, visibly looked like world spinning. but not as visible looking down. no change in vision though. felt okay to lie down and sleep. pretty intense for a couple of hours. but better by morning. worked from home as usual. felt mildly wobbly when moving around fast or animated. all gone by 6pm/supper. ate fine all day. drank fine.
postherpetic neuralgia; multiple outbreaks of herpes zoster; multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered multiple outbreaks of herpes zoster (herpes zoster and herpes zoster reactivation) and post herpetic neuralgia (PHN). As a result of those symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster, herpes zoster reactivation and PHN were considered as disabling events by the reporter.
she has been sick as a dog; stool green; bleeding from the bowels; internal and external hemorrhoids; nausea and vomitting; nausea and vomitting; no appetite and weight loss; no appetite and weight loss; loose bowels; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old female patient received the second dose of bnt162b2 (BNT162B2) at the age of 69 years, via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER8727) as a single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient received the first dose of BNT162B2 (lot: EN6205) on 05Mar2021 at the age of 69, for Covid-19 immunisation and experienced not feeling good.  The patient experienced loose bowels on 26Mar2021; bleeding from the bowels, internal and external hemorrhoids, nausea and vomiting, no appetite and weight loss on 07Apr2021; and she has been sick as a dog on an unspecified date. The patient further reported that she has been sick as a dog, clarifies this started after her second dose of the Pfizer Covid vaccine. Stated she was given some medication to help stop her loose bowels, called dipheni-atrop, 2.5mg, states to take it for three days as needed for loose stool four times a day, started the medication on 30Mar2021 but stopped taking it because it was not doing any good. The patient has lost 7lb. The patient was taking iron and was turning stool green, it bothered her to see the stool green, so she stopped taking it too. Last night the patient drank two sips of soft drink  and ate a cucumber and a cup of soup and just sat down and started vomiting. States after the second dose this started, the nausea and vomiting, no appetite, lost weight, loose stools, hemmorhoids internal and external, bleeding in the stool. States doctor wanted a stool sample but she has not been able to get one. The outcome of the event bleeding from the bowels was recovering, she has been sick as a dog was unknown and not recovered from all the other events.