chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy skin all over his body; Red hives at itching site; Red hives at itching site; Uneasiness in stomach; This is a spontaneous report from a non-contactable consumer or other non HCP. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itchy skin all over his body, red hives at itching site, and uneasiness in stomach. It was reported that, callers husband had first dose of vaccine. Shortly after husband experienced itchy skin all over his body, red hives at itching site, no high temperature and uneasiness in stomach. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore knuckle joints opposite hand; sore shoulder same arm as injection; sore arm at injection site; This is a spontaneous report from a contactable other health professional (patient). A 65-year-old non-pregnant female patient received bnt162b2 (BNT162B2), (Batch/Lot Number: EN6200) via an unspecified route of administration, administered in Arm Left on 17Feb2021 12:30 PM (age at vaccination was 65 years old) at an unknown single, for COVID-19 immunization. The patient's Medical history included cancer. The patient was not pregnant. The patient previously took morphine, codeine, Percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol], lidocaine and had allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. The patient received other medications in two weeks prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications in two weeks prior to vaccination The patient did not receive any other vaccines within four weeks prior to the vaccination.The patient's concomitant medications were not reported. The patient experienced sore knuckle joints opposite hand, sore shoulder same arm as injection, sore arm at injection site on 18Feb2021 03:00. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included Nasal Swab PCR test: negative on 03Mar2021. The outcome of the events was recovered on unspecified date  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 15:30 as dose 4 (booster), single (Lot number: GJ3277) at the age of 44 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0150), in left arm, on 27Apr2021 as dose 2, single (Lot number: EW0174), in left arm and on 02Jan2022 as dose 3 (booster), single (Lot number: FJ1614), in left arm for covid-19 immunisation. The patient's relevant medical history included: "I am a smoker, which was why I was eligible for paxlovid" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Nov2022) Positive, notes: Tested Positive on 14Nov2022; (19Nov2022) Negative, notes: Completed the course of treatment on 19Nov2022 and tested negative the same day; (21Nov2022) Positive, notes: By noon on 21Nov2022, was sick again, and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Patient was treated with Paxlovid from 14Nov2022 to 19Nov2022 (lot number: GF6450) for COVID-19. Patient tested positive on 14Nov2022, started Paxlovid that evening and was symptom free by 17Nov2022. Completed the course of treatment on 19Nov2022and tested negative the same day. On 21Nov2022 started with sore throat, then stuffy nose, then a fever. By noon on 21Nov2022, patient was sick again and tested positive. On the day of this report, on 26Nov2022, patient is still sick, still have a fever. Not better or worse but just feels like all Paxlovid did was postpone the illness.
Large red area around the injection site, right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Large red area around the injection site, right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0AD8418 and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Large red area around the injection site, right arm). At the time of the report, VACCINATION SITE ERYTHEMA (Large red area around the injection site, right arm) outcome was unknown. Not Provided          Patient has been applying Alcohol rubs. No relevant concomitant medications were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Leukemia developed after second shot; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. It was unknown if the patient was diagnosed with COVID-19 since the vaccination. The patient previously took 1st COVID-19 vaccine shot and got lymph nodes swelled. On unspecified date, the patient experienced leukemia after second shot. The outcome of the event was unknown.  follow-up attempts are possible. further information is expected
Started with a few warts on leg, spread to hands and now her entire forehead covered in warts- she is under a dermatologists care- considered a severe outbreak of warts- because of our concerns of this vaccine we only had one dose.
15 yo received Moderna Vx; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (15 yo received Moderna Vx) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (15 yo received Moderna Vx). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (15 yo received Moderna Vx) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.  List of concomitant medication were not given.   This case was linked to MOD-2021-163988 (Patient Link).
Maternal exposure during pregnancy; tired; soreness at injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and FATIGUE (tired) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 031A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: ALCOHOL (1-2 drinks, 3 x week) in 2001 and MARIJUANA (on occasion) from 2002 to 2015. Concomitant products included MAGNESIUM (MAGNESIUM 6) for Pregnancy, ONDANSETRON and DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (DICLEGIS) for Vomiting, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 03-Aug-2020 to an unknown date for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. The patient's last menstrual period was on 31-Aug-2020 and the estimated date of delivery was 27-May-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and FATIGUE (tired). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved and FATIGUE (tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, Pregnancy test: positive (Positive) positive. On 03-Mar-2021, Glucose tolerance test: normal (normal) normal. On 03-Mar-2021, Treponema test: normal (normal) normal. On 03-Dec-2021, Alpha 1 foetoprotein: normal (normal) normal. On an unknown date, Full blood count: normal (normal) normal. On an unknown date, HIV test negative: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date Ultrasound scan, genetic testing, and Chromosome 13+18+21+x+y+aneuploidy  was done and reports were found to be  normal.  Patient  used to smoke 2packs cigarettes/week 6times/week.  Treatment information not provided. On 10 Nov 2017 patient had previous delivery wherein in patient gave birth to one fetus who was born Live with full-term birth. The Gestation Period of current pregnancy was 25 weeks.   This case was linked to MOD-2021-124845 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: AE dose 1, Reporter address, HCP information, Preg. hx, Preg. exams, Preg. products.
A couple of days after receiving my second booster, on 04/08/2022, I was out and about and visited a friend at a rehabilitation center; after leaving the visit, my body felt aching and my breathing became labored. Later that night, I would cough for a periods of time. I went to the bathroom and kept coughing; it felt like I had severe heartburn which aggravated the coughing. The coughing continued for the next couple of days until I called my insurance on Sunday who suggested to go to an urgent care to get tested. Before going to the urgent care, I took an at-home COVID-19 test that came back positive; when I went to the urgent care shortly after, the rapid test they took came back positive and the PCR test as well came in positive the day after. They prescribed me Paxlovid to help my symptoms, and I begin feeling better and recovering a couple of days after. I isolated until Monday, 04/18/2022 and tested negative and resumed my normal working this week.
This spontaneous report as received from a pharmacist refers to a 63 year old female patient who was allergic to Demerol, latex and sulfa. On 22-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number # H022152, expiry date was 18-MAR-2014), 0.65 milliliter (ml), subcutaneously. The reporter stated that since the patient was allergic to latex the pharmacist had used latex free gloves, syringe and bandage. The reporter had observed that the injection area was a little red just after receiving ZOSTAVAX on 22-APR-2013. The patient sought medical attention, contacted an unspecified physician who prescribed a MEDROL dose pack on 23-APR-2013 yet the patient stated that her condition was getting worse. On 24-APR-2013, the patient had described the area to be red and the size of a dollar bill and also reported that site as hard. The outcome of injection area to be red was reported as not recovered/not resolved. The outcome of the site was hard was unknown. Additional information has been requested.
chicken pox 25MAY98 confirmed by MD-mild case less than 50 lesions;
Became nauseous, had chills, aches, and really tired for 24 hours (saturday). Sunday was a bit better, but still had stomach flu symptoms. Monday a bit better but feel weak.
Six weeks after my second Moderna shot, I had 10 days of a MenstruaL cycle, which I had not had for 22 years (since I  was 48).  Being 70 years old, I spoke to my doctor who was performing my colonoscopy when this occurred, and she and her nurses noted they had seen this in women over 60 recently who had the Moderna vaccine and I did bleed quite a bit from my vagina during the coloscopy; I also had bleeding hemorrhoid's which had re-engaged in bleeding about the same time.  While I am fine now, it was concerning to have a full period at age 70, and I am scheduled to go to a gynecologist this Wednesday.
2d s/p imm pt returned to clinic with redness, hot and hard right upper arm. Rx given with recheck in 3d.
This case was reported by a nurse via call center representative and described the occurrence of injection site warmth in a 7-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9A7JS, expiry date unknown). Co-suspect products included DTPa (INFANRIX) (batch number LY27Z, expiry date unknown). Concomitant products included SINGULAIR, ALLEGRA and Flonase. On 14th September 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml and the 1st dose of INFANRIX (intramuscular). On 14th September 2016, not applicable after receiving FLUARIX QUADRIVALENT and an unknown time after receiving INFANRIX, the patient experienced inappropriate age at vaccine administration. On 16th September 2016, the patient experienced injection site warmth, injection site swelling and fever. On an unknown date, the outcome of the injection site warmth, injection site swelling and fever were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the injection site warmth, injection site swelling and fever to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the fever to be related to INFANRIX. Additional details were provided as follows: The patient received FLUARIX on Right thigh. The patient received INFANRIX on Left thigh at the age of 7 years, which led to inappropriate age at vaccine administration. The swelling and warm to touch at the injection site was on the side of the FLUARIX and not the INFANRIX. The nurse reported that the physician believed that the side effects listed above were from the FLUARIX, not the INFANRIX. Two days after receiving FLUARIX QUADRIVALENT and INFANRIX, the patient experienced fever. The reported lot number (9A7J5) for FLUARIX did not exist and was updated to 9A7JS as per the sales database. The reported lot number (LY272) for INFANRIX did not exist and was updated to LY27Z as per the sales database.
The patient completed the Moderna COVID vaccine series  on 3/29/21, then received the Pfizer COVID vaccine on 4/11 and 5/2.
Sleep apnea; Enlarged prostate; had COVID after taking 1st COVID vaccination shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had COVID after taking 1st COVID vaccination shot), SLEEP APNOEA SYNDROME (Sleep apnea) and PROSTATOMEGALY (Enlarged prostate) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced COVID-19 (had COVID after taking 1st COVID vaccination shot). On an unknown date, the patient experienced SLEEP APNOEA SYNDROME (Sleep apnea) and PROSTATOMEGALY (Enlarged prostate). In 2021, COVID-19 (had COVID after taking 1st COVID vaccination shot) had resolved. At the time of the report, SLEEP APNOEA SYNDROME (Sleep apnea) and PROSTATOMEGALY (Enlarged prostate) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events with Humira was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Breakthrough case admission after 3 vaccines Pfizer 5/30/21 lot# Ew0186;  Pfizer 6/24/21 lot# Ew0180;  Moderna 8/26/22 lot# 057A22A
10 days after receiving my first Pfizer shot I suffered a stroke that was caused by a blood clot. I was unable to speak for a short time the morning of 4/1/2021 and went to emergency room at. My speech had already returned and I was no longer having symptoms. There were numbers tests and scans run and it was confirmed that I had a stroke that was caused by a blood clot. There were no obvious issue present to why I would have had this happen.
Patient called 9/28/09 to report arthralgia occurring about 2 weeks after receiving MMR vaccine.  Has begun to resolve as of two days ago, 9/26/09
After receiving vax pt experienced polymyalgia rheumatica. Pt is recovering after treatment. The reaction has been described as progressive myalgia which became localized to peMC and shoulder girdles. Pt was treated with prednisone.
jaw joint pain; neck stiffness and pain; neck pain; This case was reported by a consumer via call center representative and described the occurrence of temporomandibular joint arthralgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, less than a week after receiving Shingrix, the patient experienced temporomandibular joint arthralgia, stiff neck and neck pain. The patient was treated with prednisone. On an unknown date, the outcome of the temporomandibular joint arthralgia, stiff neck and neck pain were unknown.   It was unknown if the reporter considered the temporomandibular joint arthralgia, stiff neck and neck pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient experienced jaw joint pain and stiff and painful neck. He recently treated with a prednisone shot to help. The patient did not consent to follow-up.
received Menveo reconstituted with non-GSK diluent; received Menveo reconstituted with non-GSK diluent; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 10th August 2021, the patient received Menveo. On 10th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received a Menveo vaccine reconstituted with a non-GSK diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. No information about lot number at the moment of the call.
started to become confused, not able to complete simple tasks, change in personality, has been unable to return to work since 3/2/2021
Information has been received from a medical assistant concerning a 61 year old female patient with fibromyalgia, basal cell carcinoma of the nose, obesity and sulfa allergy and lactose allergy and a history of childhood measles and chickenpox who on 15-JAN-2010 was vaccinated IM with a dose of ZOSTAVAX (Merck) (lot # 664633/0741Y). There was no concomitant medication. In January 2010, the patient developed a "flare-up of shingles" after administration of ZOSTAVAX (Merck). The patient ordered the complete blood cell count (CBC), lipid profile, sed rate, thyroid-stimulating hormone test (TSH), vitamin D, urinalysis test (UA) on 20-OCT-2010, no results received yet. At the time of reporting, the patient had not recovered. Patient sought unspecified medical attention. Additional information has been requested.
Pfizer pediatric vaccine LOT FL8095 (Expired 08/31/2022) was administered on 09/13/2022.
Large blood clot in right leg leading to large pulmonary embolisms in both right and left lungs. Hospitalized overnight on Heparin. Currently taking Eliquis
Day after shot, mid day. Extreme tiredness, slight chill, slight temperature.  Very sore arm
This spontaneous report was received from a doctor of pharmacy concerning an approximately a 66 year old male patient with diabetes. There were no drug reactions or allergies. On 18-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J001006 and 24-APR-2014 respectively, dose unspecified), intramuscular. No concomitant medications were reported. On 18-JUN-2013 (subsequently), the patient developed an injection site reaction. The injection site was warm, hard and itchy. The patient sought medical attention (contacted pharmacist). No treatment was given. The outcome of the events was reported as not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.