chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown), 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received: treatment with Paxlovid.
About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't feel right." No SOB. C/o 7/10 migraine headache. Nausea but no vomiting. Frontal lobe pain. Dizzy. Felt like she was drunk.  BP 136/29, HR 79. Became slower to respond to questions and a rapid response was called. Transported to ED for observation where patient received acetaminophen 975mg po x 1 and metoclopramide 10mg po x 1. Patient declined NS 1L bolus. Per ED note, patient presented with likely vasovagal episode after receiving COVID-19 vaccination. Patient's symptoms improved and patient was discharged home.
VAGINAL BLEEDING; This spontaneous report received from a patient concerned an elderly, white, female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lung cancer (2002), breast cancer (2007) and endometriosis, and other pre-existing medical conditions included: patient had history of fertility treatments for 8 years in 1960s. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: Unknown, and expiry: Unknown) dose was not reported, one total administered on 09-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Five days after vaccination, on 14-APR-2021, the patient began bleeding vaginally. The patient had bleeding again on an unspecified date, was admitted to the hospital on 20-APR-2021, stayed several days and received a blood transfusion. The patient was discharged from hospital on an unspecified date in APR-2021. The bleeding resolved after the hospital stay and patient had two transvaginal ultrasounds, the second being only a few weeks ago, with appearing normal results. The results of the first transvaginal ultrasound scan was not reported. On an unspecified date the patient visited emergency room/department. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaginal bleeding on APR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210942041- Covid-19 vaccine ad26.cov2.s- Vaginal bleeding. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR, via an unspecified route of administration, on an unspecified date, as a single dose and methotrexate via an unspecified route of administration, on an unspecified date, at an unspecified dose, for an unspecified indication. Medical history and concomitant medications were not reported. The patient experienced PREVNAR bruising on an unspecified date with outcome of unknown. The action taken with methotrexate was unknown. Follow-up (20NOV2015): Follow-up attempts are completed. No further information is expected.
Suspected vaccination failure; Shingles very mild case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced shingles on an unknown date, couple of years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had the Shingles a couple of years ago and the patient had shingles shot, and experienced a very mild case and they didn't last long. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator included 14Jan2022.  The administration of vaccine included 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022. The vial did not undergo any temperature excursions. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-492833 (Patient Link).
Feeling cold, headache,cough, extreme tiredness  Took ASEA cell stimulating molecules, 1 Tylenol, slept 10 hours and was fine
Patient reports pain and stiffness in shoulder and limited range of motion starting the day after getting the vaccination. Has not improved and still has limited range of motion day 15 post vaccination.
She bleed at the injection site .  Held cotton ball to injection site for about 1&1/2 minutes until the bleeding stopped.  There was swelling at injection site.  About 2 minutes later after Band-Aid had been applied she passed out and fell to the left.  Immunizer caught her just as her head hit the counter top.  Held her until she came to for about one minute.  Room was closed and could not call for help.  Patient then put her head between her legs and started to feel better and decided to walk out of immunization room after about 5 minutes to sit in waiting  room.   Got her a bottle of water and patient said she wanted to lie down.  Went to immunization room and patient laid down for about 15 minutes.  Immunizer kept her talking and watched for any reactions.    Patient then said she was okay and sat in waiting room for another 10 minutes before leaving.
administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022 at 3:19 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Nurse reports that they administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients between 22Feb2022-03Mar2022.  The vaccines were initially placed in the refrigerator on 19Jan2022.  Reported that vial did not undergo any temperature excursions.  No concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2022-502124 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up received contains, Non Significant Information.
passed away; This is a Spontaneous report Facilitated Collect based on the information received by Pfizer. A contactable consumer (wife) reported a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications was not reported. The patient experienced passed away on an unspecified date.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death
This spontaneous report was received from a pharmacist  and refers to a  unspecified patients of unknown ages and genders. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 which had lots # of M039060 and N010105 with expiration dates of 22-MAY-2018 and 15-NOV-2018 respectively, for prophylaxis. No adverse effects reported. Temperature: 47°F to 77°F, Time frame: 5.5 hours, Previous temperature excursion: Yes, 47°F to 77°F for 7.5 hours. Was call because of a "data logger": No.
Left arm - rash developed away from injection area - between mid arm and elbow, inside; pt present - red rash/contained/itching/area warm/slight swell
Lump above left collarbone. Size about 1.5-2? in diameter. Size reduced  the following day on 7/13/21.  Maybe a swollen lymph node? Slight pain during swim practice when rotating arm.
Headache; fluid filled vesicles around injection site; injection site itchy and hot to touch.
EXPOSURE DURING BREASTFEEDING; This spontaneous report received from a patient concerned a bay of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the baby experienced exposure during breastfeeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exposure during breastfeeding was not reported. This report was non-serious.
Redness at the site, soreness, pain at the site as well. Started about a day after vaccine.
Infant developed hives over entire body several hours after vaccine. MR received from hospital which documents three separate ER visits (10/17,10/18, and 10/20/2006) for generalized welts over the childs body, which began on the day of Flu vaccine.  Initially thought to be an allergic reaction to Augmentin, which the child was taking for otitis media and an URI(resolved). Augmentin was stopped 10/17/06 but welts persisted despite tx. with Benedryl and Decadron IM. Third ER visit on 10/20 resulted in tx with Benedryl and Solumedrol IV. Dicharged home to F/u with PCP. Dicharge DX: Erythema Multiforme, allergic reaction with rash.
Severe cold and shivering. Severe light-headedness, fainted,  body aches, headache
7 hrs after injection, right Arm with injection swelled up from elbow to shoulder, and moderate pain in arm and neck muscle aches. 24 hrs after injection, swelling also occurred in opposite (left) arm, but subsided in injection (right) arm.  After 48 hrs of vaccination, swelling is almost gone, but still mild aches in neck and left arm.
Redness and swelling at vaccination site about one week after vaccination. Area about 4 inches in diameter.
tingling in both of my feet and felt spaced out/I had tingling in my fingers; tingling in both of my feet and felt spaced out; My blood pressure was way up 179/93 and my pulse rate was up; My blood pressure was way up 179/93 and my pulse rate was up; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration was not reported) via an unspecified route of administration as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that she visited site for second vaccine and had an issue with the first one. The first one she ended up in ER because she had some tingling in both of her feet and felt spaced out. Her blood pressure was way up 179/93 and pulse rate was up. She had tingling in fingers. The events were considered as serious (hospitalization) by reporter. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Patient received and immunization of HAVRIX 1440UNIT     INJ, on  08/19/2023,  approximately 2 hours after patient received the injection patient noted he had a bad migraine headache. On 08/20/23 patient was feeling somewhat better.  On 08/21/23 pt still had a migraine which became very severe as the afternoon and evening went on and pt developed very high blood pressure, vision abnormalities and went to the ER where he was treated for a hypertensive incident and then observed for some time before being released.
Fever of 102.1 over 2 days controlled with Advil; facial swelling.
Patient sent here from PCP, FNP for us to look at her left arm. Covid vaccine Moderna given 12/24/20. States the injection site was sore and had a knot after receiving. Saw PCP 1/4/20 redness and dx with cellulitis.  Patient stated to RN redness started Monday 1/4/20. Was given antibiotics per PCP.
I had body hives for 24 hours; This is a spontaneous report from contactable nurse (patient).  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On an unspecified date in Dec2020, the patient had body hives for 24 hours. The patient recovered from the event on an unspecified date in Dec2020.  Information on the lot/Batch number has been requested.
This spontaneous report as received from a 76 year old female patient with chronic back pain and diabetic and she was allergic to "Norontin, Lyrica, Cymbalta". She said she received a dose of ZOSTAVAX injection 1 "in the left arm" for prevention of shingles in 2009 and broke out with shingles 12-JUN-2010 and was still experiencing nerve pain. She had sought medical attention and was given antiviral pills for treatment. Regular lab work and basically everything was pretty normal. She had a bunch of concomitant therapies for the shingles and she had a salve that she used that helped morphine. The outcome was unknown at the time of report. Additional information has been requested.
she was an epileptic and she do take anti-seizure meds. She have had 3 seizures in the last 24 hours; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER 8731), via an unspecified route of administration, administered in Arm Left on 09Apr2021 15:15 as [SINGLE DOSE] for covid-19 immunisation (Age at vaccination: 37 years). Medical history included epilepsy. Concomitant medications included lamotrigine and hyoscine butylbromisde (COLOSPAN). On 13Apr2021, 13:00 the patient stated that she was an epileptic and she do take anti-seizure meds. She have had 3 seizures in the last 24 hours. The patient was not pregnant. The patient did not have covid prior vaccination and was not test post vaccination. The patient did not received any treatment for the event. Outcome of the event was not recovered.
Mother reported rash and fever. Occurred 2wks after receiving MMR ll.   Roseola vs Rash from Measles vaccination. Mother was advised to monitor and recheck next week.
Patient received pneumonia shot on 10/17 and came in to the store on 10/26. Patient said she believed she had had a reaction to the shot and showed me her arm and there was a large red spot she said it had been inflammed and hot to the touch I told her to try benadryl to help with the inflammation and swelling. She then mentioned that she had had a headache since the day she got the shot and woke up this morning with a stiff neck. I advised the patient to go to the doctor and get checked out and also put a note on her profile that she had a reaction to the shot.
Symptoms after 1st & 2nd shot; Extreme migraines, muscle aches, chills, nauseous, and fatigued. Symptoms from 2nd shot (2 weeks after): Still have extreme migraines. Treatment: None, was told it would go away with time but has not gotten better. My migraines interfere with my everyday life. Hard to function.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media via company representative concerned a patient of an unspecified age, sex, race and ethnicity. Initial information processed with additional information received from department on 22-NOV-2022. The patient's height, and weight were not reported. The patient was healthy. The patient had previously received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with dose 1 of covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) as booster (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. 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 following vaccination with booster shot of covid-19 vaccine ad26.cov2.s (Unspecified manufacturer), the patient got so sick and was hospitalized (date unspecified) from covid which was a suspected covid-19 infection (Dose number in series 2). The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. It was reported that "One of my friends healthy took the shots booster and got so sick in the hospital from covid. Other friends got it. I got it and it was not that bad I took the vitamins it said to take". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000260239 and 90000260240. The suspected product quality complaint has been confirmed to be voided (did not meet criteria, as this report states the reporter has friends with covid after vaccination. There is no product quality issue described in the information reported as there is no timeline for date of vaccination to contracting covid, no brand of vaccination mentioned, and no positive confirmatory test reported to determine vaccination failure) based on the evaluation/investigation performed. Sender's Comments: V0:20221148369-suspected covid-19 infection. The event is deemed to be scientifically implausible, i.e. there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.
Received vaccine approx. 6:15pm Started with symptoms at 9:15pm. Had difficulty breathing, wheezing and coughing spasms. fine red rash noted on her neck and side of face. She went to hospital by 10:20pm where she received epinephrine injection and IV Benadryl. She remained under observation until 5am.
After the second dose I had Mucinous Carcinoma of the eyelid. I went to the doctor on 02/08/2021. I had 3 surgeries done and they removed the margins so I did not have to have any chemo or radiation. I had to have plastic surgery to take them off.  After the third dose (046C21A, 9/11/2021) I broke out on the lower part of my neck and back of my neck. It spread out to my shoulder in the back. They gave me a steroid shot and some medicine to put on it and it went away. So far I have not had any more problems with that.
Within 4 hours of receiving vaccination my arm blew up 3-4 inches all around, fever 103 for 3 days.
3 hours after shot itching on entire left side small itchy rash on left ankle.  12 hours after shot low grade fever,  dizzy, shaking, chills, induced asthma attack had to use rescue inhaler for several hours, hurt to expand lungs  extreme joint pain .  This lasted for 24 hours.  Took advil for fever and joint pain relief
Pt recvd vax & devel inject site pain, induration, swelling, sting & itching; placed an ice pack on the site for stinging & dph cream for itching; area remained raised & brown for 2 wks;
p/vax pt exp severe joint pain which was treated w/tetracycline;pt was not hosp;pt condition unk;