chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flare up of Herpes Simplex Keratitis in left eye.  No other reason for immediate flare up 1 day after receiving shot #2.; This is a spontaneous report from a contactable consumer (patient).   A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 05Sep2021 11:15 (Lot Number: FC8448) as single dose for covid-19 immunisation.  The patient had received the first dose of the same vaccine on 15Aug2021 11:15 AM via unspecified route at the left arm from lot FC3181. Medical history included epilepsy, penicillin hypersensitivity. Concomitant medication included influenza vaccine (FLU) taken for immunization on 15Aug2021 at the Right Arm.  The patient experienced flare up of herpes simplex keratitis in left eye on 06Sep2021 06:00 with outcome of recovering.  Therapeutic measures were taken as a result of flare up of herpes simplex keratitis in left eye. The patient was not tested positive for the Covid post vaccination. No covid prior vaccination.   Follow-up attempts are completed. No further information is expected.
Feeling of tiredness and pain at injection site lasting 2 days after receiving the injection. 3 days after receiving the COVID vaccine the lymph nodes under right arm began to swell with mild pain and itchiness. Taking acetaminophen and ibuprofen at staggered times for pain. If pain and itchiness last longer than 10 days I will contact someone.
Patient said his arm was fine for 2 days after shot was given. He insisted that he get both FLUAD and PNEUMOVAX in the same arm. Seperated the shot by an inch or more. After 2 days he said the PNEUMOVAX site was still red and slightly swollen and his arm hurt to move it up and down. ALEVE seemed to help. I suggested a warm compress as well. He said it was somewhat better but it has been 2 days like this. He brought this to my attention today so I thought it was best to fill out form to report. After further investigation he had told me he had gotten the PREVNAR 13 in 2016 but had not gotten the 2nd pneumonia shot. So he asked if he could get it along with his flu shot. I went on GRITS and found that he got PREVNAR 13 in 9/16 as he stated but he also got the PNEUMOVAX 23 on 1/18 which he did not remember getting. So it was actually too early to administer another pneumonia dose at this time it had only been a little over 10 months.
Almost immediately after receiving the vaccine I got injection site redness which is pretty normal for me so I wasn't concerned. But within 48 hours I began to get itchy hives on my neck, chest, and face which began to spread to full body. Antihistamines were helping sometimes, but not every time. Since then, I have been experiencing daily bouts of hives and strange dermatological issues like redness appearing in the shape of scratches on my stomach and other parts of my body or random spots of itchiness in my face and hair line. It seems to be unpredictable on when it will flare up. It seems to be primarily on my face and chest but also on the bottom of my feet on and on my  hands. I have tried antihistamine creams as well that haven't really worked either. It has been going on long enough at this point that I have set up an appointment to have full blood panels done to try to determine a cause. Also, around a month ago, I passed out and my daughter called EMS and I was transported my ambulance to the local hospital where I was evaluated and they advised that you hydrate and monitor for any future issues.
Hives covering entire body; Rash appeared Monday morning on arms and started spreading; Itching; Swelling under arms; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives covering entire body), PRURITUS (Itching), PERIPHERAL SWELLING (Swelling under arms) and RASH (Rash appeared Monday morning on arms and started spreading) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PRURITUS (Itching) and PERIPHERAL SWELLING (Swelling under arms). On 05-Apr-2021, the patient experienced URTICARIA (Hives covering entire body) and RASH (Rash appeared Monday morning on arms and started spreading). At the time of the report, URTICARIA (Hives covering entire body), PRURITUS (Itching), PERIPHERAL SWELLING (Swelling under arms) and RASH (Rash appeared Monday morning on arms and started spreading) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product  was used by patient.  No treatment medication was taken for events.  patient had experience similar allergic reactions in the past and reports skin peeling "like being badly sunburned" when it resolves.
Redness at injection site.  First Started out as a patch about 2  to 3 inches wide inches by 3 inches long after approximately 2 weeks.   Has now doubled in the last two days.  If still about 2 to 3 wide but is now about 6 inches down my arm.  Only slightly itchy rarely
4 hours of extreme chills and muscle spasm like shaking followed by 4 hours of 103.6-degree fever. Terrible body aches and muscle aches made it impossible to sleep. Arm pain radiating down from injection site to elbow and hand. 24 hours later - fever coming down to low-grade and extreme body aches. Whole body feels uncomfortable - no appetite. Miserable.
DIFFICULTY BREATHING; HIGH FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included hydroxyzine for allergy.  On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever and difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case was assessed as non-serious.
EDEMA, ERYTHEMA 1"X 2" TO RIGHT DELTOID. TX-ICE PACK PRN PAIN AND BENADRYL FOR AGE PRN ITCH.
Headache 24 hrs later Full body ache 24hors later for 24 hours Large red welt ?covid arm) around injection site, itchy, hot to the touch
Swelling, redness, entire right tricep, bicep area.  Warm to touch.
2 hours after  vaccine  I developed a headache which lasted until the evening  and at injection site  started to become swollen and painful  and lasted 2 days . Then on  04/05 1921 I woke up with a swollen and pain at injection site  on left arm and the right side and back side of my neck hurting and stiff. It has slowly subsided  however still  continues.  I am  feeling more tired than normal.
SKIN RASHES, FEVER 2 DAYS AFTER RECEIVING PCV13 & Hib vaccine. Given Tylenol and Benadryl Liquid.
Pt. met with me on December 9, 2022  with 3 months of left shoulder pain since receiving the shingles vaccine in the left deltoid on 9/7/2022. She reports that the injection was painful, but not more than usual, and she does recall it was several cm down the deltoid.  2 days after the vaccine she got a fever and a ring of redness and some swelling around where the injection had been given. She thought it would just get better. She has been exercising, doing pilates, and sometimes it is sore after those activities, but particularly sore if she bumps it or sleeps on that side. She has lost some range of motion to abduction and extension. When I met with her in the office I gave her some ROM exercises and  recommended a formal PT referral and her first appt is happening later this week, however she is meeting with me today as the pain has continued to worsen and she would like to consult with ortho.
mom relates pt was limp, pale, & eyes rolled back for a few seconds; no temp or rash drove to MD & was OK;
He didn't wake up; short of breath; Inappropriate age at vaccine administration; This case was reported by a consumer via interactive digital media and described the occurrence of death nos in a 40-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced death nos (serious criteria death and GSK medically significant), shortness of breath and inappropriate age at vaccine administration. On an unknown date, the outcome of the death nos was fatal and the outcome of the shortness of breath and inappropriate age at vaccine administration were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death nos and shortness of breath to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was 40 years old who received vaccine, which led to inappropriate age at vaccine administration. The reporter stated that, the patient became short of breath and went to bed instead of going to the hospital and did not wake up.; Reported Cause(s) of Death: Death NOS
Information has been received from a medical assistant concerning a 27 year old female patient who on 23-JAN-2009 was vaccinated with the first dose of RECOMBIVAX HB and on 23-FEB-2009 received IM the second 0.5 mL dose of RECOMBIVAX HB (LOT # 662115/1263X thimerosal free). Approximately two hours after receiving the second dose of hepatitis B vaccine, the patient experienced stomach upset. The patient was seen by the physician. It is unknown if the patient recovered. It was also reported that on the same date two other patients were vaccinated and experienced the same adverse event. Additional information has been requested.
passed out; Unfortunately hit my head.; felt light headed; slightly nauseous; intense right knee pain; temperature of 99.6; flu-like symptoms; This is a spontaneous report from a contactable Other Health Professional (patient). A 63-year-old non-pregnant female patient received bnt162b2 (Pfizer Brand COVID 19), dose 2 intramuscular, administered in left arm on 26Feb2021 12:00 (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination. The patient has no known allergies. Concomitant medication included levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Pfizer Brand COVID 19), dose 1 intramuscular, administered in left arm on 05Feb2021 11:30 AM, (Lot Number: EM9810) for COVID-19 immunisation. There was no other vaccine in four weeks. On 27Feb2021 07:45, the patient passed out, unfortunately hit head, felt light headed and slightly nauseous. It was also reported that patient had intense right knee pain, a temperature of 99.6 and flu-like symptoms. The events were also described as follows: 18hrs after the injection, I had intense right knee pain that lasted for 24hrs. Also in that same time period, I felt a huge rush of energy come over me and passed out. Unfortunately hit my head. I had a temperature of 99.6 and flu-like symptoms that lasted 24hrs. For 4 days I felt light headed and slightly nauseous but that could have been due to hitting my head. Called 911, EMT evaluation and the patient received treatment for events. Outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events and other events.  There is limited information provided in this report.  This case will be reassessed once additional information is available.  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, as appropriate.
Patient received expired vaccine of Moderna COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine of Moderna COVID-19) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine of Moderna COVID-19). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine of Moderna COVID-19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-378217 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow-up received contains non-significant information.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date in 2017, the patient may had received an unspecified improperly stored dose of VARIVAX lot # M039318 expired on 20-SEP-2018 for prophylaxis (strength, dose and route of administration were not reported) which was reconstituted with sterile diluent (manufacturer unknown) that was stored properly. On 14-JUL-2017, the vaccine was stored at a temperature of 15°F to 46°F during a time frame of 1 hour 40 minutes. On 15-JUL-2017, an excursion ocurred at a 15°F to 46°F for 3 hours 6 minutes. The call was due of a data logger and no adverse effects were reported.
Patient said  after second dose of Moderna, he experienced soreness on the roof of his mouth. It was painful to swallow. He did not experience any adverse events after the first dose. Advised him that if it get's worse, he needs to go see his doctor.
Information has been received from a nurse practitioner concerning a 25 year old female patient with obesity and no drug reactions or allergies who on 15-MAR-2010 was vaccinated with a 0.5 ml first dose of GARDASIL (Lot number 663559/1178Y, expiration date 11-NOV-2011) IM. On 17-MAY-2010 the patient was vaccinated with a 0.5 ml second dose of GARDASIL (Lot number 665768/1377Y, expiration date 29-JUN-2012) IM. The nurse reported that the patient developed swelling of her throat 15-30 minutes after receiving her second dose of GARDASIL. The patient was treated with BENADRYL. The patient reported that she felt there was still some swelling on the left side of her throat on 18-MAY-2010. No laboratory tests were performed. At the time of the report the patient was recovering. The patient sought medical attention by an office visit. Additional information has been requested.
Stomache pains learning disability- memory loss/processing. 03/07/2008 Vax record, OT(11/30/07) and speech/language evals (11/5/07)received from parent. Speech/language eval reveals a severe language processing disorder.  Significantly below grade level in written language with decreased short term memory. OT eval (+) for neurological processing defects and difficulty in receptive language. 03/19/2008 Vax record with lot #'s obtained from provider and updated in database.  MR received showing WCC on 6/6/05 with normal vision, hearing and development noted.  2OVs in 8/05 for c/o abdominal pain with dx: pharyngitis/abdominal pain-noted to be resolved by 8/26/05.  Otolaryngology consult 8/19/05 noted speech and language appropriate for age.  Multiple sick visits until 2/2007 including w/u for abd pain which was (-). No further WCCs
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned 34 patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 26-MAY-2021, and dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sudden swelling, heat, and itching below the injection site while at rest occurred approximately 1 week after receiving 1st dose.  Prior to that I only experienced minor soreness in my left arm on the day after the injection.
10 days after Moderna Booster shot, incredibly itchy hives all over patient's body, including on skin, inside ear canals and vaginal canal; tight (slightly swollen) throat.  Still continuing nearly 5 weeks after shot (as of 1/2/22).  Also continuing metallic taste in mouth.  Did not have this reaction for first or second dose.  Allergist prescribed 5mg of prednisone for 5 days and OTC antihistamines at a 2x dosage, which helped provide some relief from symptoms, but they continued post-prednisone course, when patient also reduced antihistamines to recommended amount.
Constant headaches, nausea, nose bleeds, body aches and pains, chest pains, difficulty breathing, dizziness and lightheadedness, slurred speech, blurry vision, sore throat, brain fog, and extreme fatigue. This has been non-stop since 3 days post the first vaccine. I underwent COVID testing prior to the vaccine and on 9/01/21 that both came back negative.
Starting at 9pm day of vaccine: Debilitating heading for 3 days. Fever. Chills for 4 days. Extreme exhaustion. Tight chest. Inability to run any distance. Lingering fatigue and occasional chills for 3 additional days. It was about 3 weeks before I stopped feeling tired.
1 day after flu shot given, pt c/o weakness, fever of 103 degrees, not able to walk (secondary to weakness) & did have fever, (happened at school). Denied CP / SOB / N/V /dizziness / no chills no shakiness. No rash.
On 1/13/2022, patient began experiencing hives on abdomen and intense itching. Over the next two days, itching continues and hives appear on neck, scalp, abdomen, and chest. On 1/16/2022, the itching continues and the skin reaction changes to long raised lines/skin writing where the skin is touched (dermatographia). The itching is more intense in the evening. The itching is reduced with use of benadryl, zyrtec, and witch hazel, but the skin writing continues to occur. At the time of this report, 1/19/2022, patient is still experiencing these symptoms.
10APR97 pt devel rash prickly heat type on cheek & ear;t99;rash persisted 5 days & is not deminishing 12APR-14APR;pt emesed 10x;pt seen by MD 13APR dx as having fifth's disease;pt ears were sl red, pt irritability inc & sleeping more than;
Light headed (slight dizziness) about an hour after receiving the vaccines.  This continued off and on until today. Fever of 102+F that started after midnight (13 hours after injections) and lasted until about midnight (25 hours after injections).  Continued to have over 100F until yesterday morning (46 hours after injections). Nausea and threw up  morning after the injections.  Not much appetite the past 3 days.  When I eat, my stomach is upset. Redness around the injection sites.  Today, redness is slight, but still a hard lump and a lot of pain without NSAID.  Taking ibuprofen, which is helping now but didn't help much the 2nd day.  Chills during the night on the first night after midnight when fever spiked.  Fatigue.  Muscle aches and nerve pain until yesterday.  Have been in bed for 3 days.
Headache, Myalgia, Arthralgia, Fever,  chills, fatigue  Narrative:   Other Relevant History:
This spontaneous report was received from a quality control individual at a medical facility refers to a patient of unknown age. On 09-NOV-2012, the patient was vaccinated with a dose of MMR II (lot # 0234AE, exp: 26-JAN-2014) (Dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who were administered MMR II that was exposed to an unsupported temperature excursion (10.1 C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.
got vaccine on 9/4/07 (Gardasil #2) started with itching 9/5/07 @ 4 pm and swelling of arm on 9/6/07
Pt experienced feeling bad, approx 2 hours post shot. Also experienced headache, stomach ache, fever. Sent home from school with fever, didn't respond to tylenol. No emesis or diarrhea
45 minutes after receiving vaccine he started to have a headache which progressed to feeling like his head was going to "explode".  Went to ER, referred to a neurologist who prescribed medication which helped minimally.  Headache finally went away after 3 months.
a metallic taste in his mouth; a little sore on injection arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) on 23Mar2021 as single dose administered in arm for covid-19 immunization at the age of 59-year-old. The patient medical history and concomitant medications were not reported. The patient experienced a little sore on injection arm in Mar2021. The patient also reported a metallic taste in his mouth when he got the vaccine on 23Mar2021. The outcome of events is unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Received vaccine at 10:00am. Once in observation pt complained of diaphoresis, nausea and vomited twice. She also complained of heartburn. She chose to go to the hospital in a private vehicle.
got the flu every year within 2 days of the shot; Initial information received on 14-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer.   This case involves a female patient of unknown age and her husband reported got the flu every year within 2 days of the shot while receiving vaccine influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "got the flu every year within 2 days of the shot (influenza)" (unknown latency) following the administration of influenza vaccine.  It was reported that the patient got the flu every year, within 2 days of the shot (onset and latency: unknown). Further reported that after she had stop taking the shot, she has not had the flu in over 4 years."  It is unknown if there were lab data/results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.