chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIARRHEA; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 61.4 kilograms, and height was not reported. The patient's concurrent conditions included: primary pulmonary hypertension. 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. Concomitant medications included sildenafil citrate. On an unspecified date, the patient experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea. This report was non-serious. This case, involving the same patient is linked to 20210818697.
No adverse effects reported; patient received PROQUAD which was administered with expired DILUENT MRK INJ; This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 13-MAR-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) lot # R015742, expiration date 02-DEC-2019 (dose and route of administration were not provided), which was administered with expired sterile diluent, lot number L028663 (dose, route of administration and expiration date were not provided), for prophylaxis. No adverse effects reported.
1/4 2pm stuffy sinuses/slight nausea, injection site hard, increased warmth, sore. 8pm - feeling very cold, intense chills and shaking by 10pm, temp 99.8, 100.4 @  midnight. Started dosing with 1000mg Tylenol q 6hours ATC. 1/5 6am - temp 102.8, cont with Tylenol. Temp never below 100.8 all day, slept a lot. Noted white circle around injection site, redness extending down deltoid, edema and firmness. 6 pm - temp at 102.3, by 9 pm finally feeling temp ?break? (started perspiring). 11 pm - temp at 99.9.  1/6 7 am temp at 100.6, injection site/arm still red but not as painful and is itchy now. 1 pm - temp at 98.9. Stopped taking Tylenol. 11 pm - temp 100.3. 1/7 8 am - temp 98.4 and have remained afebrile. L arm with decreased soreness, still red and itchy.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2020 at 12:00 as dose 1, single (Lot number: EK3730), in left arm, on 11Jan2021 at 11:00 as dose 2, single (Lot number: EL3246), in left arm and on 27Sep2021 at 12:00 as dose 3 (booster), single (Lot number: Ff2589) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: IRBESARTAN, start date: 01Jan2015; LIPITOR, start date: 01Jan2015, stop date: 22Apr2022; FAMOTIDINE, start date: 01Jan2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included: COVID-19 was treated with Paxlovid from 22Apr2022 to 27Apr2022. On 2May2022 the symptoms rebound after completing Paxlovid treatment and the patient was recovering. No known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Pediatric dose was given to adult 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 adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (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 adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (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 adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (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 adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion).    This case was reported for patient 20 out 104. Concomitant medication list 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. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:same reporter master case
Engerix-b as a tird dose for a Hep A-B; Received an Engerix-B instead of Twinrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 29-year-old female patient who received HBV (Engerix B) (batch number 2793Z, expiry date 12th May 2022) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2021, the patient received the 3rd dose of Engerix B. On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 21st October 2021, unknown after receiving Engerix B and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the wrong vaccine administered and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received an Engerix-B dose as a third dose for a Hepatitis A-B vaccination instead of a Twinrix dose which led to wrong vaccine administration. Till the time of reporting, the patient did not receive a dose of Hepatitis A vaccine, hence incomplete course of vaccination was captured for Hepatitis A. The reporter consented to follow up. Note:It was unknown if patient received Hepatitis A vaccine dose till the time of reporting, hence incomplete course of vaccination was captured for Hepatitis A conservatively.
This spontaneous report received from a physician referred to a 57 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-MAY-2017, the patient was vaccinated with PNEUMOVAX 23 in her right deltoid intramuscularly (lot: N010105, expiry date not reported). She called complaining of arm pain and then called on 25-MAY-2017 stating her arm was now immobile and she was still sore from the shot. She was given DEPO-MEDROL shot along with kewalo (as reported). A couple of days later, the patient was better. At the time of this report, patient recovered from the events. Causality assessment was not reported. Additional information has been requested.
Post vaccination reports feeling nauseous and sweaty, denies any additional symptoms  / complaints. Medical monitoring x 30 min. w/ vital assessment: BP 120 / 68 P 74 RR16 O2 sat 95% RA. All symptoms resolve and released from facility w/daughter.
Patient came in around 1320 today 7/11/16 after his visit this morning with diffuse erythema and hives over his entire body after receiving MMRV, Dtap, Polio vaccines in clinic around 1200 today. We gave 8.5 ml of BENADRYL and monitored in office for 45 min. At time of discharge pt's hives were no longer visible and erythema had decreased. Pt d/c home with mom.
This spontaneous report was received from a Registered nurse regarding an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Patient with 2 COVID vaccines who admitted to hospital with hypoxia and positive COVID PCR.  Provider d/c note:  "94 YO female presents due to worsening dyspnea. Found to be COVID 19 positive and severely hypoxic therefore she was admitted.    During her stay, she was started on Remdesivir and steroid which helped with her symptoms. She was able to be weaned off of oxygen but a prescription is available sent by ER department. Her hospitalization stay was mildly complicated by transaminitis likely Remdesivir induced. Her hepatic function started to improved after stopping Remdesivir. This was communicated to her daughter. Stable for discharge with strict return precautions given. "
01/28/21 WOKE UP WITH HIVES ALL OVER BODY WITH FLU LIKE SYMPTONS, SLEPT ON AND OFF MOST OF THE DAY. BY 6:00 PM ON 01/28/21 THE HIVES HAD SPREAD AND IT LOOK LIKE A SEVERE SUNBURN ALL OVER, HIVES WERE ITCHING AND BURNING SEVERLY,   HAD A TEMP. OF 101. WENT TO URGENT CARE AT 6:45PM ON 01/28/21 AND WAS SEEN BY A DOCTOR.  WAS GIVEN A SHOTOF DEXAMETHASONE IN MY RIGHT  HIP, A PRESCRIPTION FOR HYDROXYZINE HCL 50MG -QTY. 20 TABLETS  AS NEEDED FOR ITCHINGAND PREDINSONE 10MG  TABLET TO TAKE FOR 8 DAYS
5/1/14 approximately 12 hrs after vaccine felt feverish, achy, tired, slept after taking ibuprofen. Noticed redness and pain at injection site which persists today 5/5/14 at 9 am. Nausea no vomiting, diarrhea, headache. Still feels very tired and has redness at site o/w better but not resolved.
Severe angiodema to face and lips, determined to be caused by Lisinopril, but all subsequent BP drugs caused allergic reaction, increasing in severity.  Fatigue, severe and on-going headaches, severe tinnitus, mid fog, sore throat, congestion, chills and sweats.  Unable to resolve via allergy testing, change in meds.
a little hoarse; a little cough; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient felt a little hoarse, a little cough since she had her vaccine. The outcome of the event was unknow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
At approximately 10 PM, the child complained of dizziness, abdominal cramping, later complained of difficulty breathing. Dad later called for medical help. He was encouraged to seek medical care. Went to the hospital. Left hospital at 6:30 AM and saw MD.  MD felt it was a vaccine reaction, probably the Hep B. Pt was given Advil.
Heavy periods and spotting in the months following the 2nd vaccination - in May and June I had 2 periods/rounds of heavy spotting. Difficult to tell if the spotting is another period or just spotting, but bleeding occurred  again ~18 days after each period. Normal cycle for me is every 33 days.
The first thing I notices was my heart wasn't beating regularly. I then stopped every time I noticed I would give myself a moment and go lay. After about 15minutes of rest I was able to return to my activity. I would get very dizzy, and it wasn't brought on by exercise. I would be doing normal things...I reported to the doctor and didn't get much feedback. I went and got a smart watch to help me track this issue. I took an EKG on my smart watch, and the numbers were 30 PVC per minute and then I took my report to my doctor. They told me to come in and I was referred to a cariologist. I was on Holter Monitor to confirm the runs of the PVC, i was  also given a ECHO test that showed no additional damage. and an injection refraction of 45that was unchanged. I was then put on a beta-blocker, and I set to take 5 milligrams 2x a day. The side effects were intolerable to me. I had tingling in my hands and feet, and they would turn colors and they would Vaso constrict and turn blue and I had zero feeling. I stopped taking the full dose .25 to 5 milligrams at night only and this did help the PVC. This process took some time to master but it did work.
05/28/21 around 22:30 waves of convulsions including uncontrolled shacking of the hands and upper body followed by chills and high body temperature. This lasted for until about 03:00 05/29/21. 05/29/21 consisted of mainly being in a bedridden state of fatigue, sleeping, loss of appetite, swollen and inflamed lymph glands particularly under the armpit of the injection site arm, soreness and pain in the injection site arm, headache, aches and pains throughout the entire body, and the inability to walk or stand for long periods of time. 05/30/21 lymph glands are still inflamed and swollen (particularly as stated above under the armpit of the arm that got the injection), head stills persists, along with some fatigue, and loss of appetite.
I am not sure if this is a reaction but 3 weeks after the first vaccination I developed painful spots in my fingers that now have continued for 10 days and some new have developed and the old ones have changed it seems to me as a vasculitis of some kind I will see my PCP on 2/19/21 but for now I am going to skip the second dosage
0954 patient c\o throat tightness and coughing. C\O racing pulse. B\P 117/73, pulse 63, resp. - 20. O2 sat % 98%. Kenalog 20mg given IM per provider orders. 1032 vs - 118/77, 56 and 18. Pt discharged at 1100 alert and no distress.
This spontaneous report was received from a registered nurse referring to an unknown number and gender of patients. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 03-MAY-2018  and 04-MAY-2018, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot number N032569 with the expiration date 18-JUN-2019 and Lot number N034400 with the expiration date 10-MAY-2019) (dose, strength, administration route was not reported) for prophylaxis; VAQTA (Lot number N026997 with the expiration date 10-NOV-2018)  (dose, strength, administration route was not reported) for prophylaxis and GARDASIL 9 (lot number N013276 with the expiration date 21-JAN-2020) (dose, strength, administration route was not reported) for prophylaxis some of the patients. The nurse also reported that since 08-MAY-2018, another patients also were vaccinated with improperly stored doses of ROTATEQ (dose, strength, administration route was not reported)  (lot number and expiration dates reported as: N032569, 18-JUN-2019 and N034400, 10-MAY-2019) for prophylaxis, and VAQTA (dose, strength, administration route was not reported) (lot number and expiration date: N026997, 10-NOV-2018) for prophylaxis. Temperature excursion was at 0 degrees C to 1 degrees C for 1 hour and 11 minutes, without previous exposures, also -1.5 Celsius for 6 hours and 43 minutes; 9 Celsius to 25 Celsius (9.5 Celsius) for 1 hours and 23 minutes, with no previous temperature excursion, the call was due a data logger. No adverse effects were reported. This is a non valid case due to lack of patient identifiers.
pt had an adverse rxn of varicella-like rash to the varicella vaccine;
I found out I was pregnant on my second dose vaccine. I had fatigued, muscle aches, chills.    For my first dose, I experienced severe left arm soreness at the injection site.  As of today, I do not have any of these symptoms.
She was light headed and dizzy passed out the next day after injection, started getting migraines, was nauseated, has 10 lbs. Can't eat, doesn't want to eat, light sensitive, hurts when she walks and can't drive anymore.  She has never had migraines or experienced any of these symptoms before her second injection of the COVID vaccine.
Widespread pain, stiffness, sleeplessness due to pain, unrelieved by nsaids, asa, apap, Benadryl.  Severe fatigue and discouragement as these reactions were so severe it was difficult to work as my usual level and I had to turn down work. These symptoms continued without reprieve and on 12-4-13 I visited a rheumatologist where I received a new diagnosis of fibromyalgia. It has been 4 months and I am only now STARTING to feel better, however, I have not recovered to the same level I was when this all started.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-APR-2016 the patient was vaccinated with an improperly stored dose of MMR II (lot#I023386, expiration date 25-JUN-2017, dose and route unknown) and an improperly stored dose of (Oka/Merck) VARIVAX (lot# reported as I04688, expiration date 23-NOV-2017, dose and route unknown). The temperature and time frame were at 14.9 Celsius degree for 280 hours. There was no out of range before. No adverse events were reported. Lot number I04688 is an invalid lot number for (Oka/Merck) VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was not happy when noticed little air left inside Boostrix syringe as pharmacist didn't pull the plunge all the way to the upper most level before injection, she thinks some air injected into her "vein:" that caused her pain and possibly injury.
I had a terrible sore throat, fever, body aches and pains, and a very bad, dry cough that wouldn't go away. I had digestive issues, I vomited for two days. I called and told my doctor about my symptoms. I took several at-home COVID-19 tests which all came back positive. My doctor prescribed me PAXLOVID half-dose. It took a couple of days, but it helped reduce the symptoms. At this moment, it's been over two weeks and I'm starting to feel better. I finally got a negative COVID-19 test as of two days ago (11/23/2022).
pt recvd vax; 3-4 diam erythematous area at inject site; area itchy;
Can Hardly Move when Sick (2 days on, 2 days off); Flu like symptoms comes and goes every 2-3 days; Dizzy comes and goes every 2-3 days; Wheezing comes and goes every 2-3 days; Coughing only when Fever Starts; Sick/Sick 2 days on, 2 days off; Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick/Sick 2 days on, 2 days off), PYREXIA (Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range)), HYPOKINESIA (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days) and DIZZINESS (Dizzy comes and goes every 2-3 days) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced ILLNESS (Sick/Sick 2 days on, 2 days off) and PYREXIA (Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range)). On 29-Jun-2021, the patient experienced HYPOKINESIA (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days), DIZZINESS (Dizzy comes and goes every 2-3 days), WHEEZING (Wheezing comes and goes every 2-3 days) and COUGH (Coughing only when Fever Starts). On 26-Jun-2021, ILLNESS (Sick/Sick 2 days on, 2 days off) outcome was unknown. At the time of the report, PYREXIA (Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range)), HYPOKINESIA (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days), DIZZINESS (Dizzy comes and goes every 2-3 days), WHEEZING (Wheezing comes and goes every 2-3 days) and COUGH (Coughing only when Fever Starts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were not provided.
Tested postive on 08-16-2021 for Covid . Admitted to hospital on 08/23/2021. Stayed in Hospital until 09/05/2021 being treated for Covid. Released with Oxgen