chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was given 4 vaccines at his 3/1902 appt.  They included Hib, DTaP, chickenpox and pneumococcal.  On 3/28/02 4pm patient was very warm, rectal temp=104.5.  Given one dose childrens tylenol.  On 3/29/02 5am patient awoke with rectal temp 104.9 and had multiple red bumps on face, abd, back, arms and legs (about 24 total).  He was given another dose of childrens Tylenol.  At 9am he was taken to urgent care and seen by on call Dr. At that time his temp had returned to 98 and the bumps remained.  They appeared like small blisters with a red surrounding area.  All appeared to be at the same stage.  Dr. remarked that since they all appeared at the same stage probably not chickenpox.  Suggested use of childrens Tylenol and Benadryl for symptom management.  Pt continued to have temps in the 100-102 range Sat.3/29 and Sun. 3/30. Monday 4/1 I phoned his primary Dr. to notify of the events.  His RN, remarked that even if it were chickenpox we would not need to treat differently. Today 4/2 he is afebrile and has 30-40 bumps remaining with some starting to scab.
This spontaneous report as received from a certified medical assistant refers to a pediatric patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VAQTA, 0.5ml, intramuscular, third dose (lot number not reported). Concomitant medication was not reported. No adverse effect reported. This is one of several reports from the same source (1407USA011285, 1407USA011905, 1407USA011906, 1407USA011908, 1407USA011909, 1407USA11910). Additional information has been requested.
I have been very fatigued since getting the shot. Far more than normal and it has been over 3 weeks.
Day 2 severe pain in upper arms and shoulders (both).  Same pain as I experience after a nuclear stress. test.  Vaccine site was badly inflamed and itchy for next 4-5 days..  Also noticed a scale-y patch at the injection site.  Use Cortizone on it and it made the pain in my left arm and shoulder really hurt.   Severe diarrhea all day the 18th.  No known reason for it.  19th very tired.  20th unable to go to sleep all night.  Body aches travelled up and down my body.  3/21, up at 1:30, took shower and started to fix breakfast.  Suddenly felt like I was going to vomit.  Very sweaty and dizzy on the way to the bathroom.  Threw up, no diarrhea.  Vomit was yellow, foamy liquid.  3/22 left shoulder much pain at bedtime.  Took tramadol and applied heat pad to shoulder.  Shoulder still has issues.
Gave Bivalent Pfizer 12 and up instead of Bivalent Pfizer 5-11.
Vaccinated with booster dose of Moderna on 12-22-21 Pt started having SOB, cough and chest congestion 12-26-21  12-29-21: presents to ED and tests positive for COVID-19 - symptomatic (note: booster given on 12-22-21, therefore did not have full protection form vaccine when tested positive) in ED pt was given 2L O2, remdesivir and steroids 12-30-2021:discharged home on room air, prednisone 1-6-21: pt returned to ED with worsening cough and SOB CXR showed improvement from 12-29-21 and patient was sent home with albuterol, benzonatate, guaifenesin and incentive spirometry
shot 5/14 Nothing 5/15: Fever, chills headache, muscle aches and pains, fatigue, loss of appetite. 5/16: Headache, nausea, fatigue, sore arm 5:17: headache, nausea, throbbing at injection site, fatigue Filling this out at 8:50 am on 5/17 so don't know what future symptoms i will have
The day I received the shot there was some pain and a hive appeared. It was about .5 inch thick and 1.5-2 inches long at the injection site. I got the shot on Friday and by Monday afternoon those symptoms had disappeared. Nine days after receiving the shot (about 5 days after reaction disappeared) the same reaction came back. The bump does appear to be a hive. I have not seen a doctor about this, I have not had insurance and have not recently been to the doctor. It is swelled and is very itchy but there is no arm pain.
1st dose was 3-weeks prior and had sore upper arm for 2-days with no other problems. Second dose had much less soreness however on day 2 developed a slightly nauseating stomach which lasted a few hours.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concomitant medications, current conditions nor medical history were reported. On 12-JUL-2017, the patient was vaccinated with a expired dose of VARIVAX (Lot No. L025210, exp. date 07-JUL-2017) (site and route not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date not reported).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-FEB-2014, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and for the prevention of long-term shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at an eye care center for the onset of a severe vesicular rash which was diagnosed as 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.
Referred to the ED from clinic with concerns for pneumonia. She has been ill since the week after Christmas. She has had cough with tenacious secretions that are difficult to cough up. She was short of air a couple of days ago, but that has improved in the past few days. She has no fever or chills, CXR in clinic suggested possible pneumonia. She has no chest pain, palpitations nausea, vomiting, diarrhea or abdominal pain. She has no leg pain or swelling.
1. The following day I had a fever of 101, chills, headache and nausea which lasted for about 10 hours 2. Severe exhaustion for 4 or 5 days 3. Missed menstrual cycle (delayed menstrual cycle by 3 weeks) 4. Consistent diarrhea for the next month
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 31-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlISD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 528 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
A non-serious spontaneous report of given FLUMIST that expired two weeks ago was received from a health professional concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 18-Dec-2012. On 21-Dec-2012, expired FLUMIST was administered to the patient. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 04-Apr-2012: The patient did not develop any late occurring adverse events.
Pt was given Td injection on 6/12/13 10:30 AM. Pt called on 6/24/13 and left msg. Unable to reach pt until 6/25/13. Pt c/o bone/muscle aches and stiffness that occurred the morning after injection. Wrists, legs, hands, feet very stiff. No fever. Taking TYLENOL ES 500 mg 2 in AM / 2 in PM. Pt has follow up appt on 6/27/13.
Muscle pain, feels tired and weak. He is sore all over, has an upset stomach and shivers all through the night. Cannot move
CHILLS, FEVER, POUNDING SEVERE HEADACHE, NAUSEA, ACHY BODY, FATIGUE, SORE THROAT, COUGH.  SEVER HEADACHE LAST MORE THAN 24 HOURS, THEN WAS LESS SEVERE BUT CONTINUED FATIGUE, SORE THROAT, COUGH LASTED ALL WEEK. FEVER LASTED MORE THAN A WEEK, AND WOULD COME AND GO FOR A COUPLE WEEKS.
The Moderna COVID-19 primary vaccination series caused me to have tinnitus in spring 2021. The 1st dose of the Shingrix vaccine caused it to be much worse! I am so fearful now to get the 2nd dose!
Breakthrough case admission after 5 vaccines ; mOderna 2/4/21 lot# 013M20A;  Moderna 3/4/21 lot# 030A21A;  MOderna 11/8/21 lot# 004F21A;  Moderna 5/16/22 lot# 038A22A;  Moderna 10/20/22 lot# 062F22A
Severe poison ivy like rash limited to both hands, no other spread - same reaction also occurred with first round
After injection of Varicella child was holding breath, body became limp, moving slowly with glazed look in eyes as if she was confused.  Picked up child and called for Dr, at which time he did a full body assessment, child was crying and in mothers arms.  Child and mother were placed in another room for observation for 10 minutes at which time Dr allowed them to go home.  I called VFC and spoke with Dr she said this was not a typical reaction and to wait at least 4 weeks before giving the next set of immunizations.
Patient was given 1st dose of Moderna vaccine.  Patient was only 17 at the time shot was given.
Well child exam yesterday by NT with kindergarten immunizations administered. Received MMR, DTAP and IPV. Mom states he was fine all evening. She checked on him around 3am and seemed fine. He got up around 0750 and mom noticed face appeared a little swollen with red patches on his cheeks. Knees and ankles are moderately swollen. Elbows, wrists and hands feel swollen. Mild local injection reaction at top of left thigh. No known food allergies. Has had rash and hives with antibiotic use. This included cephalosporins, penicillins and one other that mom can't remember right now. States last antibiotic > 1 year ago (doesn't know name) was given with DECADRON shot. He did not have any problems with this. Maternal grandmother had severe reaction to Hep B vaccination 15 years ago. He also had Lupus.
I received a Moderna Covid-19 booster and subsequently developed full body hives and itching that required medical attention. After seeing an urgent care physician and now several appointments with an allergist for unresolved hives, and having been perscribed and taken a course of Prednisone, two Zertec daily for 50+ days, the hives persist and have moved into a "chronic" categorization. I'm no being prescribed monthly injections of Omalizumab to hopefully alleviate the situation. The allergist who I am seeing happened to coauthor what I'm told the largest study on adverse skin reactions, including hives, to mRNA vaccines including and especially the Moderna vaccine. She's a physician at the Hospital. I am 37 year old male who, prior to this, as in excellent health and had never experienced an allergic reaction.
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.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "history of juvenile rheumatoid arthritis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received other medication in 2 weeks. Anti-viral details product: COVID 19 treatment, brand: Paxlovid, treatment start date: 15May2022 and treatment stop date: 20May2022, indication: treatment of COVID-19. Started Paxlovid on day 2, symptoms cleared by day 6, returned on days 12-15 and counting. Device timestamp: 30May2022.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose number unknown, single (Lot number: 330368D) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had Paxlovid Treatment from 02Jul2023 to 07Jul2023. Patient didn't had any Known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300249718 same patient, different drug/event;
This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding Mother received Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding Mother received Vaccine). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding Mother received Vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-257990 (Parent-Child Link). See case MOD-2021-257990 for details regarding the child case.
States that the pain radiates down her arm at times and up her neck. Reports a sharp pain when she moves her shoulder in certain positions. Denies pain radiating to jaw or chest, or SOB. States that she has limited ROM in the shoulder. Denies any fever, redness or swelling.
At the time of administration, patient commented how quick and easy the vaccine was. About 4 hours after administering the vaccine, the patient said she had a constant, excruciating pain shooting up her neck and down her forearm. She said she could not move her arm. She told me I gave her the vaccine too high and her doctor told her there was nerve damage. I spoke with MD who I reassured that I had proper technique. He speculated possible nerve inflammation/irritation. He prescribed steroids and a narcotic and will follow up with the patient next week.
Chills; Fever; aches; headache; exhaustion; Booster; Off-label use; This is a spontaneous report from a contactable other hcp (patient). A 72-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: 30130BA), dose 3 via an unspecified route of administration, administered in Arm Left on 29Sep2021 as dose 3 (booster), single for covid-19 immunization (at the age of 72-years-old ). Medical history included, High blood pressure. Patient had Known allergies. Patient received no other vaccine in four weeks. Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN POTASSIUM AND HCTZ); temazepam. Historical Vaccine included BNT162B2 (Lot NUMBER: EN6202) as dose 2, single on 08Feb2021 and BNT162B2 (Lot NUMBER: EL9269) as dose 1, single on 01Mar2021 for COVID-19 immunisation (at the age of 71 years). On 29Sep2021, the patient experienced chills, fever, aches, headache, exhaustion, off label use and booster.  It was reported that the events went on for nearly 10 days. Each time she got another shot the side effects are worse and last longer. Patient received no treatment for the events. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Outcome of the events were recovering.   Follow-up attempts are completed. No further information is expected.
20OCT95: pt cont to c/o pain in rt upper arm, refuses to use arm, no redness, swelling;APAP/heat to area x 4 days;x-ray RT UA r/o tx, vax into elbow joint causing soreness;further tx depends on pt's ability next 2wks to regain ROM on own
Patient had open heart surgery (Oct. 21, 2009) and was hospitalized for 10 days. Prior to leaving the hospital, he received the seasonal flu shot and pneumonia shot. While in rehab, he required re-hospitalization due to Guillain Barre syndrome.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were not reported, lot # L017404 with expiration date: 15-AUG-2017). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
pateint received vaccine and about 15 minutes later felt a heaviness in her arm and some pins and needles sensation in hand, arm and left leg.   NO rash, no itching, no notable other side effects;  denies palipations, shortness of breath, no pain , no hives, no cough or swelling
Jynneos administrated 8 weeks, 4 days after it was thawed; Jynneos administrated intradermally at a dose of 0.1 ml; Case reference number US-BN-2022-004185 is a spontaneous case report initially received on 12-Oct-2022 from nurse via Agency (reference number: USBAV22-1690) and concerns a male patient.  The patient's medical history and concomitant medications details were not provided.  On 12-Sep-2022, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00016) at a dose of 0.1 ml, administrated intradermally (explicitly coded as 'Intradermal injection'), for the indication reported as monkeypox/smallpox prophylaxis.  On 12-Oct-2022, 30 days after the first dose, the patient was vaccinated with a second dose of Jynneos vaccine (batch number: FPD00016) at a dose of 0.1 ml, administrated intradermally.  Nurse reported that it looked like vaccine expired 8 weeks after it has been thawed and added that someone administered it to the patient 8 weeks and 4 days after it was thawed. 08-Oct-2022 was the expiration date, and vaccine was administered on 12-Oct-2022 (explicitly coded as 'Expired product administered').  Additional information received on 12-Oct-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: A male patient born in 1956 was vaccinated with the first dose of Jynneos vaccine on 12-Sep-22, at a dose of 0.1ml administered intradermally, which is coded as intradermal injection for monkeypox/smallpox prophylaxis. On 12-Oct-22, 30 days following the first dose, the patient was vaccinated with a second dose of Jynneos vaccine. The vaccine was also administered intradermally, at a dose of 0.1ml. Reportedly, 08-Oct-22 was the expiration date and vaccine was adminsitered on 12-Oct-22 which is considered expired product administered. Both events are listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection and expired product administered are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: A male patient born in 1956 was vaccinated with the first dose of Jynneos vaccine on 12-Sep-22, at a dose of 0.1ml administered intradermally, which is coded as intradermal injection for monkeypox/smallpox prophylaxis. On 12-Oct-22, 30 days following the first dose, the patient was vaccinated with a second dose of Jynneos vaccine. The vaccine was also administered intradermally, at a dose of 0.1ml. Reportedly, 08-Oct-22 was the expiration date and vaccine was adminsitered on 12-Oct-22 which is considered expired product administered. Both events are listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection and expired product administered are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.
Pt. three days ago was camping, where he noted the beginning of numbness of all his fingers. This then progressed to a weakness. Pt. states he had no vision change/motor or sensation or swallowing change. Per pt. the pt wife noted three days ago he couldn't talk right for about five minutes. The sx did not change except he noted this morning at 0430 he became progressively weaker. It started in the legs and was accompanied by SOB (worse SOB than usual). On 6/5/15 neurology believed symptoms to be due to GBS versus CDIP, myasthenia gravis, or critical illness neuropathy. Patient also started receiving an 8-day course of IVIG at 0.4g/kg/day (normally a 5-day course, but patient didn't initially respond and therefore treatment was extended). Patient was on acute care medicine from 5/23/15 to 6/6/15 when he was transferred to the ICU. He required intubation and ventilation on 6/7/15, which progressed to a tracheostomy on 6/22/15. Patient slowly began to recover from weakness but now requires extensive rehabilitation. Globulin, immune 44.8 gm every day.
This case was reported by a physician via a representative and described the occurrence of seizure in a 12 year old female subject who was vaccinated with Boostrix for prophylaxis. Previous and/or concurrent vaccination included hepatitis A vaccine given on 22 September 2005. Concurrent medications included Tuberculin PPD (PPD). On 22 September 2005 the subject received unspecified dose of Boostrix (unknown). On 22 September 2005, immediately following the vaccination with Boostrix, the subject experienced seizure manifested by his eyes rolling back in head and series of convulsions that lasted a couple of minutes. The pt was taken to the hospital but was released. This case was assessed as medically serious (OMIC) by the manufacturer. On 22 September 2005, the event resolved.
Chills, fever, stomach cramps, vomiting, body aches, sore arm
ARM PAIN; PAINFUL VACCINE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 around 16:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced extreme fatigue. On 15-MAR-2021 around 16:00, the subject experienced painful vaccine. On 16-MAR-2021, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm pain, had not recovered from extreme fatigue, and the outcome of painful vaccine was not reported. This report was non-serious.