chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tachypnea throat tightness, short of breath, concern for anaphylaxis Narrative: Present to ED five days after vaccine w/c/o tightness in throat and shortness of breath; treated in the ED w/epinephrine, benadryl, famotidine and methylprednisolone and observed for two hours; prescribed Epi-pen for take-home. Discharged home.
no AE just an error in administrations.  Vaccine was expired by approximately 30-40 minutes at the time of administration.
Left side of face (cheek & along jaw) went numb/spread across to right side of my face then under jaw and upper neck.; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EP6955) via an unspecified route of administration, administered in left arm on 09Apr2021 10:00 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 09-APR-2021 10:45 , the patient experienced left side of face (cheek & along jaw) went numb then spread across to right side of my face then under jaw and upper neck. Outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Got / the new two part shots / have the shingles on my arm/Suspected vaccination failure; Have the shingles on my arm; Starting to blister on whole arm; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experiennced severe case of shingles before the original shot). Previously administered products included Shingles vaccine (the original shot).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. On an unknown date, the outcome of the vaccination failure, shingles and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the original shot as well as the new two-part Shingles shots and after three shots, the patient had the shingles on his/her arm and starting to blister on whole arm. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation for Shingles were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
VOMITING; HEADACHE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included smoker, and concurrent conditions included non-alcoholic, and penicillin allergy.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 12-MAY-2021, the subject experienced vomiting. On 12-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient recovered from vomiting on 13-MAY-2021, and headache on 20-MAY-2021. This report was non-serious.
not doing well; not able to walk without a walker; Legs wont hold her up; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not doing well), GAIT DISTURBANCE (not able to walk without a walker) and MUSCULAR WEAKNESS (Legs wont hold her up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not doing well), GAIT DISTURBANCE (not able to walk without a walker) and MUSCULAR WEAKNESS (Legs wont hold her up). At the time of the report, MALAISE (not doing well), GAIT DISTURBANCE (not able to walk without a walker) and MUSCULAR WEAKNESS (Legs wont hold her up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
ALLERGIC REACTION, INIT 12/8/2021 -- RECURRENCE OF SAME SYMPTOMS
Pt developed a 1 1/2 inch red, sore dot on right arm for 1 week after shot.
No adverse event; the patient had already received the Moderna Bivalent on 26Sep2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (the patient had already received the Moderna Bivalent on 26Sep2022) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No describe relevant medical history and conditions, allergy, concomitant diseases and risk factor. No history of Covid-19 diagnosis. No known allergies.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 12-Jan-2021, Moderna COVID-19 Vaccine on 10-Feb-2021, Moderna COVID-19 Vaccine on 01-Nov-2021 and Moderna COVID-19 Vaccine on 27-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   On 26-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2023, the patient experienced EXTRA DOSE ADMINISTERED (the patient had already received the Moderna Bivalent on 26Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (the patient had already received the Moderna Bivalent on 26Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (the patient had already received the Moderna Bivalent on 26Sep2022).    No concomitant medication was provided by reporter.  The nurse was report that they administered the Bivalent today, 12Jan2023, to a patient, who didn't have their vaccine card with them. Their protocol was to update their state's website after vaccination, so they were unaware until that time that the patient had already received the Moderna Bivalent on 26Sep2022.   No treatment medication was provided by reporter.
By 8 pm Thursday I had chills and a fever. Poured sweat the whole night. Nauseous most of that day and the next. Very low energy and spent quickly the whole day on Friday. I?ve been shakey. Vision blurred at times. Body aches constantly
High pitched crying, apnea, arching. Per follow up report-This is not a patient of this doctor.
Information has been received from a physician concerning a patient who in 2006 was vaccinated PO with the first 2.0 ml dose of Rotateq. In Late 2006 2 months after receiving the first dose, the patient threw up and had bloody diapers. Unspecified medical attention was sought. It was noted that the patient was not given the subsequent dosed of Rotateq. At the time of this report, the outcome was unknown. Upon internal review, blood diapers was determined to be an other important medical event. Additional information has been requested.
Arthus-Hypersensitivity reaction-severe swelling at arm and shoulder. Required surgical I & D. Onset about 2-6 hours. 06/22/2006-12 page medical records received from North Memorial Health Care, to include H&P and DC summary for hospitalization 2/19-2/22/06. Chief complaint: left shoulder pain. Receiving immunization and indicated that at the time of the injection she felt the shot hit something and had tingling immediately afterwards and pain. RX at office with Z-Pak for sinusitis. Pain increased, sought relief at ER, treated with Vicodin. Pain continued to increase and temperature reported, pain in shoulder when attempt to move, shoulder hot to touch. PMH includes hypertension and glaucoma and bilateral knee arthritis, eczema.  Hospital course included I&D with evacuation of large fluid collection with fibrinous debris from left shoulder on 2/20/06. Unclear as to why this occurred. Loose stools noted. Notes indicate that the injections may have caused a reaction in which case one has to consider avoiding the use of these injections in the future. It does not appear at this point that there is infection, but that still has to be entertained. She may have had a bursitis that was starting before the injections were given and this just aggravated the situation. DC diagnoses: left subdeltoid fluid collection of uncertain etiology. Hypertension, Glaucoma.  DC medications Clindamycin, Metronidazole, Percocet, Tigan, Cosopt, Lumigan, Lisinopril, Atenolol.
Swollen, hard, red, hot right upper arm at site of injection, felt weak day after.
This is a spontaneous report from a contactable other-HCP, parent's patient, via Pfizer sales representative. A male patient of an unknown age and ethnicity/race received the first dose of TRUMENBA at single dose on unknown date for immunization. Medical history and concomitant medication were unknown. On unknown  date the  patient experienced cellulitis from the shoulder to elbow. The outcome of the event was unknown. The information on the lot number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
patient reports neck pain, legs pain, sensory abnormalities starting about 2 weeks after her latest coronavirus booster.  She states she cannot think of any other factor or change to attribute to -  prior to developing these symptoms
3/7/21 ER to inpatient Admission   (covid positive 3/7/21) 3/11/21 Transferred to higher level of care  Date of Service: 3/8/2021            Chief complaint:  Chest congestion   HPI:  Patient is a 78 y.o. male with PMH significant for hypertension, obesity, coronary artery disease and CKD admitted to acute care from ED peR Dr with pneumonia due to COVID-19.  Patient presented to ER brought in by EMS from local residence.  Was complaining of chest congestion.  Patient had been seen in ER earlier same morning complaining of cough.  Was afebrile at that time.  Oximetry 95%.  Rapid COVID positive.  Patient given Decadron 6 mg IV, albuterol inhaler, zinc and BAM(bamlarnivimab 700 mg) IV x1.  Patient discharged home.  Return later that evening per EMS with shortness of breath.  Complaining that congestion was getting worse.  Was now febrile & had fallen trying to get out of recliner.  Vitals upon arrival-temp 102.8° pulse 87 respirations 24 blood pressure 169/71 oximetry 99% on 2 L. patient given Rocephin 1 g IV piggyback, azithromycin 500 mg IV piggyback, normal saline bolus 1 L & acetaminophen  1000 mg IV in ER.  Labs revealed mild leukocytosis white blood cell count 12.5.  Glucose elevated to a 9 but patient had received Decadron previously.  BUN 32 creatinine 1.8.  D-dimer 1240.  No CT chest obtained due to patient's renal status.  Patient subsequently admitted to acute care for further evaluation and treatment to include IV antibiotics supplemental oxygen pulmonary hygiene.  Patient has received 1st COVID vaccine and due to have 2nd vaccine on March 20.   Upon admission patient was continued on Rocephin and azithromycin IV piggyback & Decadron 6 mg IVPB.  Continued hydration fluids normal saline at 100 cc/hour.  Started on IV Remdesivir with loading dose.  DuoNeb nebulizers q.6 hours.  Patient continued on home regimen less Plavix.  Was started on Lovenox 40 mg subcu daily for DVT prevention.  Patient maintaining oxygenation on 2-3 L.  Had initially been on 2.  Was increased to 3 this morning due to decrease in oximetry down to 92%.  Patient continues with exertional dyspnea.  Does have loose nonproductive cough.  Is complaining of pain to the left lower chest wall with cough.  Describes as sharp.  Denies any actual chest pain.  No nausea vomiting.  Last BM yesterday described as normal.  Blood cultures pending no growth at present.  Is currently resting in bed. Is in negative air pressure room.  COVID precautions observed. CASE DISCUSSED WITH DR
loss of hearing; ear pains; This is a spontaneous report from a contactable consumer, the patient. This female patient of unknown age  (reported as (age: 80 unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  1, single dose via an unspecified route of administration on 25Jan2021 for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported.  On an unknown date in 2021, the patient had ear pain and loss of hearing. The events were reported as non-serious. The clinical outcome of ear pain and loss of hearing was unknown. The reporter was unsure if the events were related.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pt had a red streak about 3 inches long running down from her injection site. She also had severe body pain and chills all night. Had to leave work early the day of shot. Still has pain in neck and severe headache. Tylenol did not and still does not help.
DEATH; This spontaneous report received from a consumer concerned a 39 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Reporter stated that the patient took the vaccine and then died 3 days later (date unspecified). Reporter did not have any further information to provide. On an unspecified date, the patient died from unknown cause of death. It was unknown whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210611846-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This patient received the Covid shot and has a primary coded discharge of U07.1 Covid-19. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
Patient complained of itching at injection site the day following vaccination (Sunday).  On Monday she discovered a red bump, warm to the touch with constant itching and "sore" like pain 3/10.
Blisters on abdomen and legs. Nerve pain in legs. Painful urination (slight).
The main symptoms were severe tinnitus and swollen glands in the neck, painful. Those were the main things. I did also have a headache after the vaccine while waiting in the waiting area. Don't remember how long that headache lasted. There were a bunch of V-safe check-ins as they happened and I noted symptoms there. Severe tinnitus and swollen glands in neck lasted for 6 months. Tinnitus was really bad after vaccine. Other symptoms are in the V-safe check-ins. V-Safe Check-ins: pain at injection site, tiredness, headache, joint pain, moderate fatigue. Fever 100.8, pain and swelling at injection site, chills, nausea, abdominal pain, tinnitus, increased heart rate, ear pain, congestion. 05/06/2021, noted tinnitus, swollen lymph nodes, waking up with whole body in pain. Went to doctor for sore throat, ear pain and congested ears. 07/13/2021 joint pain. 10/12/2021 swollen lymph nodes in neck.
Approximately 3 weeks post vax the pt developed about 75-100 generalized varicella lesions with fever of 100.9 F. The rash was described as pruritus, papule vesicle. The pt sought unspecified medical attention. The reporter expressed concern with the vaccine lot administered to the pt. Subsequently the pt recovered. No further information is available.
Pt came into store to report adverse event on 10-16-2021 .  Pt received both flu shot & pneumonia shot both on same day (documentation shows both left) pt states got one in each but not sure which on which side.  Date was 10-10-2021.  Pt states both arms initially sore but by following thursday right arm was getting very painful.  He states he looked on line & was afraid the shot was given too high & may have bothered nerve or the bursa.  pt was advised to ice & take ibup or tylenol & follow up with his primary care physician. Pt staes will try to get into md on monday 10-17
Soreness and slight swelling under injection site (L) deltoid. Swelling and slight pain 2 inches above (L) wrist. Discomfort along (L) arm (descending from injection site to (L) wrist).
12/02/2021: Pt admitted due to acute resp failure w hypoxia due to covid 19 pna. Pt placed on 2L, O2 improved to 96%, wean as tolerated. Begin decadron, combivent, pulmicort, vit d, vit c, and zinc. covid positive 11/27. with fever on 11/22 12/03: continue therapy and monitor  12/04: pt required increase o2 requirements.  12/05: using 5L of O2 via NC  12/07: 4L of O2. drops to 87% when ambulating  12/08: Pt discharged . Room air o2 sats 89% requiring 4L of O2. continue decadron for a total of 10 days.
When I had both vaccine doses I had normal head pain discomfort associated general chest discomfort but pain on chest was very light and I thought it was something normal. I did not pay much attention and I took Naproxen and rested, but pain on chest was increasing to the point that on 10/19/21 I went to the medical since I was feeling fatigue because of the pain I felt shortness of breath and sever pain. I was referred to a Cardiologist assessment and analysis, but I have not been able to assume such cost for such evaluation. I visited my doctor to find out if it was an adverse effect I still have not been able to to analysis to find out any information
I lost my ability to taste certain foods - food did not taste good - I had trouble deciding what to eat - nothing tasted good except junk food, carbs. It lasted about 2 weeks. I didn't know it was a problem until I mentioned it to my doctor at my quarterly visit - she said it was a side effect of the coronavirus and wanted me to report it to you. So I didn't pay too much attention to what I was trying to eat, etc.
Patient fainted immediately after receiving full vaccination and then started seizure on ground for approximately 3-5 seconds before awakening
Patient reported that she had redness and heat at the injection site all the way down to the elbow in the days to week after the vaccine. At a week past the vaccination she developed a cold sore in her nose. About a week after that a Shingles rash developed on her back. The patient stated that this is the 12th time she has had Shingles and the first time she had shingles was after a dose of the old shingles vaccine Zostavax.
pt fell during shot (immunization) @ clinic c/o h/a in lt parietal area;
PT EXPERIENCED NIGHTMARES NIGHT AFTER VACCINES; INCREASED SLEEPINESS FOR 4 DAYS; RASH DEVELOPED OVER RA INJECTION SITE 3 DAYS AFTER SHOT GIVEN
Her flare ups on her skin; This is a spontaneous report from a non-contactable consumer via the Pfizer-sponsored program. A female patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 08Jan2021 to 08Jan2021 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported.  It was reported by the patient that she got the first dose of vaccine yesterday. She was prescribed Clindamycin as needed but it seems she needs to take it again because of her flare ups on her skin. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
no adverse effects; Expired dose of Gardasil 9 was administered; This spontaneous report was received from a registered nurse and refes to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 02-MAY-2019, the patient was vaccinated with an expired dose of human papilloma virus rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), one dose, intramuscularly, lot # M033583, expiration date: 14-APR-2019 (exact dose and anatomical location were not provided) for prophylaxis. No adverse effects were reported.  This is a non-valid case due to lack of patient identifiers.  Follow-up information was received from a medical assistant on 21-MAY-2019. The patient was 30-year-old female. Her concurrent condition included human papilloma virus (HPV) infection.  On 02-MAY-2019, the patient was vaccinated with an expired dose of human papilloma virus rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), one dose, intramuscularly in left arm, lot # M033583, expiration date: 14-APR-2019 as a first dose for prophylaxis. The reporter stated that she filled out the consent form and the patient signed the form for the vaccine, then she administered the injection. After the patient left, medical assistant was putting the information into the system and could not precede with filling out the form because of the expiration date on the medication. The patient did not receive any treatment.
large, raised hives on arm at shot location, happened on both my shots.  One in left arm, one in right.  Went to doctor and dermatologist said  it was hives from the shot.  Discoloration still on left arm
Severely anemic due to unusual profuse menstrual bleeding the week after vaccine.  As a result of lowered immune system, I got Covid-19 on September 4th and the illness has been much worse than when I contracted while unvaccinated, in March 2022.  There is absolutely no possibly of this being a coincidence. I truly hope this incident is taken into serious consideration. I made into year 3 of this pandemic perfectly healthy until I got this vaccine. Now I'm anemic and extremely sick with Covid.