chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 05Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing), notes: have had graves disease many years ago; "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: sulfa drugs; "Allergy to animal dander" (unspecified if ongoing), notes: Known allergies: animal dander. Other medication in 2weeks: No. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 04May2022 at 04:00, outcome "not recovered", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 04May2022 at 04:00, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) negative, notes: I tested negative Monday and Tuesday; (03May2022) negative, notes: I tested negative Monday and Tuesday; (05May2022) positive, notes: Tested positive quickly on antigen test on Thursday morning. Therapeutic measures were not taken as a result of drug ineffective, covid-19. It was reported that, Anti viral details: product Covid 19 Treatment, brand Paxlovid, treatment start date 26Apr2022, treatment stop date 01May2022, indication Treatment of Covid-19 started paxlovid on second, maybe third day of symptoms. Immediately started feeling better and by day after patient finished everything was gone except some minor hives/rashes that came and went. No treatment received for the adverse events.
Severe flu symptoms 102+ fever. Severe pain/soreness throughout injected shoulder. (Was forced to get this shot in order to keep job!)
Dizzy immediately after vaccine.  That night, slight fever, fatigue, headache, and sore muscles on left side of neck.  Next day fever went up to 100.5 at night,  fatigue, stomach ache, loss of appetite, ear ache, headache.  Drinking lots of water and herbal tea.  Eating mostly soup and fresh fruit.  Taking Tylenol PM tablet to sleep, both nights. Bed rest and sleeping during the afternoon 1-2  hours.  Today, two days after vaccine, feeling better.  Still tired, still eating bland food and  soup and tea.  Slight nausea.  Temp dropped to 97.8 degrees in am.
1 -500mg Tylenol taken at 3pm. At 8pm Chills started along with headache. 9pm Fever reached 101.5 and 1-500mg Tylenol taken. Slept under 2 blankets & fever broke at 12:45am. 3:30am woke up & headache was better & no chills. Got up at 8am. Slight headache & tired. 8:15 am 1-500mg Tylenol taken. 12:30pm no headache.
after having sex there is no sperm. this has never happened before. i just want you to know if i was planning on having any children i would not recommend takeing the shot
patient was given a Moderna Booster when he did not meet the age requirement of 18 years yet.
pt c/o itchiness after covid vaccine injection during 30 minute observation. Body assessment done, hives and redness at injection site on upper left and right arm, ice packs provided. c/o headache after ice, continued to monitor vital signs 3 sets taken all WNL, client refused IM Benadryl and stated she wanted to leave. At 2:56 pm client took Benadryl PO capsule. Pt education provided about care if any respiratory issues occur to call 911.   After extra 15 min observation, client denied any itchiness, no headache, no difficulty breathing, no redness noted, no acute distress, walked out with daughter at 15:20 stating she felt fine.
Hospice Care  Sepsis associated hypotension  Discharge Diagnoses: acute on chronic hypoxic/hypercapnic resp failure requiring intubation, acute on chronic CHF, severe COPD with likely exacerbation, possible CAP, likely medical non compliance
Left arm injection site - redness , warm, delayed allergic reaction ; fever of 100 degrees - 101.7 degrees for two days ,body aches, nausea, headache. Took tylenol , benadryl ,and felt a little better the third day.
Vaccine Failure - child was diagnosed with mumps 10/15/05.  Symptoms - fever (onset=10/13/05), malaise (onset-10/13/05), unilater parotitis (10/15/05)
Post vax the patient was seen with a 9cm x 7 cm area of erythema, swelling and warmth at the site of the flu shot.
Had episode of looking pale & lethargic lasting 20-30 min @ 7PM; no vomiting; low grade temp p/APAP; when seen in office color OK w/nl tone; lusty cry;
7/10/08 24 hours after vaccine administered, child fussy going for nap.  Mom said child smile blankly, eyes rolled back.  No shaking extremities.  Lazy, tired, temperature 104.3.  Seen at hospital.  No w/u done.  Seen 1/11/08.  Viral NBC persistent fever.  No future seizures.
He presents a vaccine card with two vaccines but not in state registry suspect it was altered. then got sx covid 4/26 and then tested positive 4/27; He presents a vaccine card with two vaccines but not in state registry suspect it was altered. then got sx covid 4/26 and then tested positive 4/27; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 36-year-old male patient received BNT162b2 (BNT162B2), on 03Jul2021 as dose 1, single (Lot number: EW0180) at the age of 35 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Other vaccine in four weeks: Unknown. Covid prior vaccination: Unknown. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "He presents a vaccine card with two vaccines but not in state registry suspect it was altered. then got sx covid 4/26 and then tested positive 4/27". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment for adverse event: Unknown. Covid test type post vaccination: Unknown. Covid test name post vaccination: Home Ag, Covid test date: 27Apr2022, Covid test result: Positive Device timestamp: 29Apr2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the drug ineffective, covid-19 cannot be completely excluded.
Started with measles like rash to trunk then spread to arms and legs. Fevers. PCP prescribed Medrol dose pack.
Information has been received from a pharmacist refers to a 52 year old male patient. The patient's medical history, drug history and concomitant medications are all unknown. On 29-JUL-2017 at 13:00, the patient was vaccinated with ZOSTAVAX at unknown dose, once (strength, route, lot#, expiration date were unknown) for prophylaxis. After the patient was weight lifting on 30-JUL-2017 at 10:00 (also reported as on 29-JUL-2017), he began experiencing an anaphylactic reaction at his home. The patient had not eaten nor been exposed to any chemicals. This anaphylactic reaction required the patient's wife to call 911 and have the patient transported to the emergency room. The patient's laboratory data was unknown. As of 30-JUL-2017, it was unknown if the patient would receive ZOSTAVAX in the future and the outcome of the anaphylactic reaction was unknown. Causality between the suspect therapy and the event was not reported. Upon internal review, anaphylactic reaction was determined to be medically significant.
developed sudden SOB after administered a shot 2 - 3 mins, radial pulse 206 bpm, tried to do valsalva maneuver, pulse 180 bpm after 1min. Notified staff member, monitored, was asked to take off mask and drink water, and got better after 20 mins.
Red, macular rash (approximately 6cm x 10 cm) on upper left deltoid, warm to touch.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE NON ST ELEVATION MI 12/27/2022,  11/16/2022,  11/20/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2016, the patient was treated by the physician for the onset of a vesicular rash which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient reports having possible shingles outbreak on face (rash, numbness, itchy eyes). Patient will go to urgent care/primary provider for treatment.
I had a rash that started (no pain of any kind) 2/20 faded in and out over a 2 week period- had blood work (all normal) and a biopsy (3/8) with the rash starting to be painful on 3/11. I had my first covid shot (3/15) and the pain only got worse. Boost results were: Henoch-Schonlein Purpura/Acute Leukocytoclastic vasculitis; It?s been bed-ridden pain (and under steroid, tylenol3, gabapentin, & colchicine medicated). Had first full week of minimal to no pain between the weeks of 3/18-3/26. Had 2nd dose on 3/30, and symptoms re-enflamed that night. *note had also had a baby 1/6, a hemorrhage due to retained placenta - had a D&C on 2/12. No way to know what is tied to what but I felt this was important to share
Breakthrough Case     COVID-19 (Pfizer) 1 66 Years 11 Months 03/15/2021  Pfizer EP7534   COVID-19 (Pfizer) 2 67 Years 04/05/2021  Pfizer EW0153
swelling of lips on rt side 2hrs post vax-expanded to entire rt side of face;rash on body-itch-red dot @ inj site
I started to feel physically drained about a few hours after receiving the shot. My arm became severely sore, I had a headache on and off most of the day, I had a fever and chills later on at night which resulted in night sweats, I felt nauseous and felt like I was going to vomit but did not actually do so, and I had body aches. I was severely tired and slept for 12 hours. I took ibuprofen for the headache which helped it to go away. The exhaustion lasted about 2 days, the nausea was about a day, the headache was 2 days, body aches were about a day and a half, and the sore arm is still sore but getting better.
Pregnant and received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant and received the vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect (No adverse event reported.). Concurrent medical conditions included Pregnant.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Jul-2020 and the estimated date of delivery was 01-May-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant and received the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant and received the vaccine) had resolved.        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.   No concomitant medications were provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Patient stated he received a voicemail from the pharmacy stating he received the vaccine from yesterday; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient stated he received a voicemail from the pharmacy stating he received the vaccine from yesterday) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 012A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient stated he received a voicemail from the pharmacy stating he received the vaccine from yesterday). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient stated he received a voicemail from the pharmacy stating he received the vaccine from yesterday) had resolved.            No Concomitant medications were reported. No Treatment medications were reported.
Hospitalized 8/13/21 with COVID pneumonia, required High flow nasal canula, developed AFIB w/ RVR during hospitalization,
dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 26th January 2022, the patient received Shingles vaccine. In January 2022, less than a week after receiving Shingles vaccine, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient received a shingle shot on Wednesday (from the date of reporting) and now (on the day of reporting) experienced dizziness. The patient asked that if this was a side effect to the shot. The follow-up could not possible as no contact details were available.
Beginning seven days following vaccination:  Redness, swelling, itching at injection site, increasing for two days then resolving in the subsequent two days.  Day of injection: Soreness at injection site lasting 3 days then resolving
sore arm; This spontaneous prospective pregnancy case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Asthma on 14-Nov-1990 and Hepatitis A on 31-Jul-2007. Concomitant products included FAMOTIDINE from 01-Jan-2021 to an unknown date for Heartburn, PRENATAL + DHA from 10-Feb-2020 to an unknown date.   On 14-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021 at 7:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 15-Sep-2020 and the estimated date of delivery was 22-Jun-2021. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2020, Glucose tolerance test: 28-mar-2021 passed 1 hour test.. On 11-Nov-2020, Ultrasound abdomen: 1-fetus and 17-dec-2020 placenta previa follow up schedule for 23-apr-2021.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment to the events not reported.   This case was linked to MOD-2021-009033 (Patient Link).
after I received the shot a few days later in rthe evening I had a little congestion and a slight cough. I had pain in my arm at the injection site for 3 days.  I called my Doctor and scheduled an appointment but I have not seen him yet.
PT REPORTED RT ARM NUMBNESS/PAIN APPROX 10 MINUTES AFTER INJECTION INTO LEFT ARM, IMPROVED AFTER ADDITIONAL 15 MINUTE WAIT.  Narrative:
abnormal vaginal bleeding 2 weeks after vaccine. Occurred 2 weeks after normal menstural cycle.
One day after receiving the Covid-19 booster on my left are I  noticed swelling in my left underarm. It is has doubled in size and is quite painful to touch. I"m not able to sleep on my left side There is no redness in the area.
Information has been received from a nurse practitioner concerning a female patient who on an unknown date was vaccinated with MMR II (Lot number 665095/0839Y). Nurse practitioner reported a patient self reported being given MMR II but the patient showed susceptibility to rubella. The nurse practitioner also stated she gave the patient a dose of MMR II but the patient was still showing susceptibility to rubella. It was unknown if the patient sought medical attention. At time of reporting, the patient's outcome was unknown. Additional information has been requested.
Extreme fatigue/weakness, headache, chills, dyspnea, chest pain, body aches
dizziness; redness; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ERYTHEMA (redness) and VOMITING (vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     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 DIZZINESS (dizziness), ERYTHEMA (redness) and VOMITING (vomiting). At the time of the report, DIZZINESS (dizziness), ERYTHEMA (redness) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter  Treatment information was not provided    Reporter did not allow further contact
Found dead in his home in bed. Had been deceased 1 1/2 days until found.
2 days after 2nd dose, when bandaid removed, skin was broken on approx quarter-sized blister at injection site. Large amt (sleeve wet & serous fluid dripped down arm) serous fluid drained. Add'l pea-sized, intact, fluid filled blister present beneath 1st blister. Non-intact blister continues to weep am. amt. Serous fluid 12 hrs later. Injection site mildly reddened and swollen. Arm sore, but no excessive pain.
Hard spot about 5-6 inches below site of injection as well as bold red area around this area that was hard.  about 4 inches tall and 3 wide on red area. pt states itching and warmth on touch
Chronic Neurological Lyme disease with treatment. Prior to vaccination. After Dose 2: Pfizer-BioNTech at 09:00PM, I experience a Shingles outbreak with blisters, underneath the areas of the blister, I experience face swelling, and body temperature changes 94.7 for temperature around this low, call out to doctor 11AM shingles. Prescheduled appointment to get a flushing IV on 03/17/2022 and after both vaccination due to issue with other pre-existing issue with Lyme and other vaccination. 03/23/2022 body temperature was dropping and was low 94.7 and 94.8 had to take Tylenol. No recovered and still having chills with body temperature and shingles is still present. Prior to vaccination COVID positive, 11/06/2021. COVID experience lasted 6 week and turned into pneumonia with high temperature. Tested negative after six weeks.
Aches and Pain, Felt feverish, Tired, Dizziness. All started about 2:00 pm and lasted until  11:00 pm when I went to bed. By next morning I was back to normal
After first vaccine, experienced moderate level hives on both arms and both legs for 7 days. Did not have hives on my core, neck or face.  The hives first appeared within an hour of the vaccine.  I took one benadryl capsule every 12 hours for 7 days to contain the allergic reaction.  I paused one time, skipping a 12 hour dose and the hives spread. The hives then subsided after restarting the benadryl.  After 7 days, the hives were mostly gone and I stopped taking benadryl.  No further reaction was observed.
My alergies has started 10 days after 2nd shot. I have red bumps all over my body with different shapes. They are itchy. I am using antihistamnes. Today still I am facing allergeies
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
patient received an expired dose of menactra with no reported adverse event; Initial information received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 years old male patient who received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] with no reported adverse event.  The patient's past medical history, vaccination(s) and family history were not provided.Patient had no medical treatment and no concomitant medication.   On 07-Nov-2022, the patient received a  0.5ml, 1 X(once) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7140AA and expiry date:04-Nov-2022) via intramuscular route in unknown administration site for Immunization.  On 07-Nov-2022 the patient developed a non-serious event of patient received an expired dose of menactra with no reported adverse event (expired product administered) (Latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Subsequent to receiving first dose of Lymerix, the pt experienced diarrhea which resolved approximately 8 hours later. Within a few hours of receiving second dose of Lymerix, the pt again experienced diarrhea which resolved 8 hours later. No treatment was given. The most recent information reports the outcome of the event as resolved.