chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UNSPECIFIED SIDE EFFECT; This spontaneous report received from a patient concerned a female 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, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced unspecified side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effect was not reported. This report was non-serious. This case, from the same reporter is linked to 20210446494.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 13-FEB-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K006682 with expiration date of 17-DEC-2015; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
No immediate issues other than sore arm and fatigue.  It has been a week now of feeling down off and on (like being I'll with a fever, minus the fever) general malaise.  Had a bit of a red spot initially.  Seven days after the vaccine the injection site is red, warm to touch, and has become itchy!
Immunocompromised patient was given 4th dose of Moderna vaccine 11 days early. His vaccine dates are 3/31/21 (0.5ml), 4/28/21 (0.5ml), 12/27/21 (0.25ml) and now 4/16/22 (0.25ml). Because he is immunocompromised, patient should have received 0.5ml as a third dose and then 0.25ml as a 4th dose 4 months later. No other adverse reactions associated with his vaccination.
flu; sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 21-Nov-2020.  This case involves a patient of an unknown demographics who experienced flu (influenza) with the symptoms of sick (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was experienced flu (influenza) with the symptoms of sick (illness), (unknown latency) following the shot of INFLUENZA VACCINE.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
hives, Benadryl, Zyrtec 2.5ml qd bid, Zantac 1.5ml bid
uvula in my throat swelled / my uvula was larger than normal; uvula in my throat turned red /  my throat at home and saw it was red.; Allergy to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ENLARGED UVULA (uvula in my throat swelled / my uvula was larger than normal), PHARYNGEAL ERYTHEMA (uvula in my throat turned red /  my throat at home and saw it was red.) and ALLERGY TO VACCINE (Allergy to vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to sting (entire body covered in hives, severe itching, very low blood pressure, almost fainted, treated at ER) since 30-Jul-2015, Allergy to antibiotic (Dicloxacillan causes difficulty swallowing) since 24-Oct-1996, Allergy to antibiotic (Ciprofloxacin causes thigh muscle pain) since 2002, Drug allergy (Rosuvastatin causes neck pain, itchy rash on leg) since 15-Apr-2021 and Hypertension since 05-Jan-1999. Concomitant products included BENAZEPRIL HCL from 15-Jan-2016 to an unknown date and HYDROCHLOROTHIAZIDE from 15-Jan-2016 to an unknown date for Hypertension, ASCORBIC ACID, CUPRIC OXIDE, DL-ALPHA TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (PRESERVISION AREDS 2) from 01-Jun-2010 to an unknown date for Retinal drusen, PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ENLARGED UVULA (uvula in my throat swelled / my uvula was larger than normal), PHARYNGEAL ERYTHEMA (uvula in my throat turned red /  my throat at home and saw it was red.) and ALLERGY TO VACCINE (Allergy to vaccine). On 04-Feb-2021, ENLARGED UVULA (uvula in my throat swelled / my uvula was larger than normal) had resolved. On 05-Feb-2021, PHARYNGEAL ERYTHEMA (uvula in my throat turned red /  my throat at home and saw it was red.) and ALLERGY TO VACCINE (Allergy to vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter   This case was linked to MOD-2021-248974 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26APR2021, updated AE information On 06-Jul-2021: Significant follow-up received on 06JUL2021, updated reporter details, patient demographics, past medical history, patient received 2nd dose on 30APR2021; Lot no 026A21A, Concomitant medications, events end date added.
Eyes became extremely itchy, red, watering, swollen.  I also began sneezing and runny nose.  I took a Benedryl and within 20 minutes was feeling much better.  I continued the Benedryl every four hours through the night (set alarms) and was fine in the morning. Reaction started in the afternoon (1:00 p.m.).  Took Benedryl at 3:00 p.m., 7:00 p.m., 11:00 p.m., 4:00 a.m. (time changed).  I did not need any more at 8:00 a.m.
arm soreness; This is a spontaneous report from a Pfizer-sponsored program. A contactable female patient of unspecified age reported for herself that she was received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number-not reported), via an unspecified route of administration, on an unspecified date in Jan2021 as dose 1, single for COVID-19 immunisation. Medical history includes routine multiple health issues from an unknown date and unknown if ongoing. The patient routinely sees a neurologist and a rheumatologist for her multiple health issues. Concomitant medications were not reported. The patient states side effects were nothing from the first dose just some arm soreness, which was experienced on an unspecified date in 2021. The patient was never asked about medications or HX at vaccination location. Outcome of the event was unknown.  Information about Lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Patient states she's experiencing arm soreness that has lasted for a week and a half. It is so severe that she is not able to lift her arm up far and feels that the pain is around her left upper chest area also.
Patient vaccinated x2 (Pfizer: 05/19/2021, 06/12/2021)  Patient admitted to hospital and tested positive for COVID on 7/5/22
Redness, warmth, and raised at site.  BENADRYL (12.5/5ml) 2 tsp by mouth for itching.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Lower quadrant left arm swelling approx size of egg with erythema, warm to touch - warm compresses. Benadryl if worsens.
mom states pt has a pecan sized nodule in lt thigh were recv vax 23SEP97;was seen by MD on 22OCT97 & instructed to use warm moist compresses & RTC in 2wk;
I received my second Moderna booster for COVID-19 on 5/13/2022. My son tested positive for COVID-19 on 5/24/2022 after he had been exposed at school. I decided to also get a PCR test that day, and it yielded a negative result, which I got back on 5/25/2022. After my son's positive result from the PCR test came back on 5/25/2022, I decided to undergo another PCR test. This time, I got a positive result, which came back 5/26/2022. I also took a home antigen test the morning of 5/25/2022 and got a negative result. However, when I took another home test later that afternoon, I got a positive result. I then called my doctor, who prescribed me PAXLOVID. I took the PAXLOVID for 5 days and I never had any symptoms. After I finished the PAXLOVID on the fifth day, I took another home test and got a negative result. I continued to take home tests every day for the following week, and I never once had a rebound.
Site: Pain at Injection Site-Severe, Additional Details: Patient came in today stating his left arm hurt. He stated his arm hurt from mid-arm to elbow area. He thinks it's from the Pfizer vaccine but it has been 5 and 1/2 months. He did not symptoms at the beginning but says few days or week after his arm still hurts and has gotten worse. I advised him since it's been a while, he should see a doctor in which he says he is today.
flu like symptoms; warm at the site, and hot; lay down, heart palpitation; headache; fever, high fever; chills; site was red and swollen; body aches and pains; nausea; site pain/arm pain; swollen around the injection site; itches; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (warm at the site, and hot), PALPITATIONS (lay down, heart palpitation), HEADACHE (headache) and PYREXIA (fever, high fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension.    On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (warm at the site, and hot), PALPITATIONS (lay down, heart palpitation), HEADACHE (headache), PYREXIA (fever, high fever), CHILLS (chills), VACCINATION SITE ERYTHEMA (site was red and swollen), MYALGIA (body aches and pains), NAUSEA (nausea), VACCINATION SITE PAIN (site pain/arm pain), VACCINATION SITE SWELLING (swollen around the injection site) and VACCINATION SITE PRURITUS (itches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (warm at the site, and hot), PALPITATIONS (lay down, heart palpitation), HEADACHE (headache), PYREXIA (fever, high fever), CHILLS (chills), VACCINATION SITE ERYTHEMA (site was red and swollen), MYALGIA (body aches and pains), NAUSEA (nausea), VACCINATION SITE PAIN (site pain/arm pain), VACCINATION SITE SWELLING (swollen around the injection site) and VACCINATION SITE PRURITUS (itches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: high (High) high. On an unknown date, Body temperature increased: high (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The blood sugar and blood pressure was up, patient took an extra high blood pressure pill and an extra diabetic medication. caller chose not to disclose the names of the medications.   This case was linked to MOD-2021-329305, MOD-2021-329087 (Patient Link).
9:30am 5/1/14 - pt reports hives in mid section (ribs, belt line) and legs that started 4/30/14. I advised pt to use BENADRYL. I checked back with him at 6pm 5/1/14. He said symptoms are improved and clear.
Blood spotting on toilet paper after urinating, apparently coming from vagina. I am menopausal.; pimple on my lip that was bleeding; polyp in my cervix; This is a spontaneous report from a contactable consumer.  This 55-year-old (non-pregnant) female consumer (patient) reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0161) intramuscularly into the right arm on 26Apr2021 at 11:00 AM (at the age of 55-year-old) as single dose for COVID-19 immunisation. The patient medical history included hypothyroidism from 1987 and ongoing, thyroid disease, dermatitis contact from an unknown date and unknown if ongoing. Known allergies to Novocain, beauty products. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder and vitamin d3 (VITAMIN D3) taken for an unspecified indication, both from an unspecified start date and ongoing. The patient also received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0178) intramuscularly into the left arm on 04Jun2021 at 11:30 AM as single dose for COVID-19 immunisation. The patient previously took novocain and experienced drug hypersensitivity. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 29Apr2021, at around 12:00 PM, the patient experienced blood spotting on toilet paper after urinating, apparently coming from vagina. She was menopausal. She experienced pimple on her lip that was bleeding and polyp in her cervix. Events required visit to physician office. 3 days after vaccine, she had a pimple on her lip that was bleeding. At the same time, she had one or two drops of blood on toilet paper after urination. She knew it came from her vagina because she pressed into it with the toilet paper. After she saw some pink on the paper. When she pressed it was very red, but just one little drop. She called the doctor and he told she could have endometrial cancer and sent her for an ultrasound and biopsy. She insisted it had only been one/two drops to no avail. After the ultrasound on 18May2021, she was seen by an obgyn who informed that the ultrasound was normal and she did not need a biopsy. He observed a polyp in her cervix. He thinks that was what bleed. Bleeding never happened before or again. Treatment received was pelvic ultrasound. Device Date was reported to be 29Apr2021. Outcome was resolved on 29Apr2021 for all the events.  No Follow-up attempts needed. No further information expected.  Follow-up (25Jun2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included clinical course of events, dose 2 details.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
This case was reported by a pharmacist via sales rep and described the occurrence of localized itching in a 64-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included injection site induration (at Enbrel injection sites), injection site itching (at Enbrel injection sites) and injection site nodule (at Enbrel injection sites). Concomitant products included etanercept (Enbrel). On 6th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving Shingrix, the patient experienced localized itching, induration, nodule and condition aggravated. On an unknown date, the outcome of the localized itching, induration, nodule and condition aggravated were unknown. It was unknown if the reporter considered the localized itching, induration, nodule and condition aggravated to be related to SHINGRIX. Additional details were received as follows: The patient was taking Enbrel once a week 50 mg a week. The patient got SHINGRIX vaccine then got hard itchy nodules at Enbrel injection sites following SHINGRIX injection. The physician note says this got worse after SHINGRIX vaccination. The events might had occurred prior to vaccination but worsened after SHINGRIX vaccine. The duration of symptoms was 6 to 7 days after each Enbrel injection. The symptoms had not resolved. The reporter was unsure on if the patient had received 2nd dose of SHINGRIX shot.
My tongue has a tingling sensation. It's intensity ranges from very mild to moderate. I have been unable to determine if there foods or drinks that make it worse or time of day.
Fever, thigh not swollen. Hot to touch. Treated with Benadryl, warm compresses 5/29/03. Started Ceptalexin 5/30/03.
T102.5(ax) x 2 days; Tx APAP which brought fever down for about 4 hrs; Child back to normal by 5APR AM; Also crying when mom would put her down;
Severe pain to the Left side of my head, especially my ear, that's where the pain started approximately 2 hours after the vaccine, continued for approximately 24 - 48 hours. Felt "jittery" for 3 days, feeling like I would jump out of my skin.
Starting the next day when I woke up around 1am, I had a massive headache, fever (101.6), chills, body aches and my joints hurt. I tried to "chill out" until first thing in the am. I called my doctor asap to see if I needed to go to the ER. They said just to take Ibuprofen and Tylenol. I felt like I had COVID again, but was able to breath. The severe chills/shaking lasted for about a day. The fever lasted for about 8 days (low grade: 99-100), but the body aches and the headache lasted for 10 days. I visited my cardiologist later on, and they determined my heart rhythm had changed about 4 days after the vaccine. I have a pacemaker/defibrillator with a home monitor which tracked the change.
This case was reported by a consumer and described the occurrence of sick in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified the report. On "January 26th", the subject received 1st dose of Twinrix (unknown). The subject's wife reported that he was on the accelerated "system". He missed the second dose due seven days later as she was "away" and was then sick for a week. At the time of reporting the outcomes of the event was unspecified. Please see A0768979A for a report of the subject's wife who also became sick.
Seizure; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 05Mar2021 11:30 at a single dose for COVID-19 immunization. Medical history included epilepsy. Concomitant medication included levetiracetam (KEPPRA). On 07Mar2021 07:00 AM, the patient experienced seizure. The event resulted in Emergency room/department or urgent care. No treatment was received for the event. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient is not pregnant. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was recovered with lasting effects.   Information about lot/batch number has been requested.
I received the second Shingrix vaccination on Monday, Nov 14 (the first vaccination was on 8/10/22). On 11/16, I started to feel a tingling sensation in my navel area (right side of my body from my perspective). By Nov 17th, I noticed two red splotchy areas on my abdomen, which were mildly painful. On Sat, Nov 19, I went to the Urgent Care facility. I was seen by a PA and a doctor, who diagnosed me as having shingles. I took a 7 day course of Valtrex. As of today, 12/11, the shingles have mostly dried up but I still have a lingering nerve pain, although mild ,in the abdomen area. I should note that on the advice of my rheumatologist, for both vaccines, I stopped the mycophenolate for 2 weeks prior and one week after vaccination in order to get maximum benefit of the vaccine. I know there is no literature that suggests that one can get shingles from the vaccine. In my case, I believe that because I am immune compromised because of the mycophenolate, the 2nd vaccine started a chain reaction which resulted in a case of shingles. Although a mild case, I still contracted the disease. I did not have a reaction to the 1st dose of Shinghrix.
A spontaneous, non-serious report of fever, headache and tiredness has been received from a registered nurse concerning an 11-year-old female patient subsequent to FLUMIST use. Medical history and concomitant medications were not reported. On 08-Sep-2009, the patient received FLUMIST. After receiving FLUMIST on 08-Sep-2009, the patient developed a fever of 101 and complained of headaches and being tired. No further information was available. The outcome of the events, fever, headache and tiredness, was unknown.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M004328, expiry date: 26-JAN-2018) (incorrect product storage). Medical assistant reported that the vaccine underwent temperature excursion at unknown temperature for 23 hours. The vaccine was exposed to an unspecified temperature of 12 hours previously as well. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Swollen sore red and hot to touch.  Baseball sized red swollen area around site of injection. Fever of 101 degrees for two days, sweats and chills
Patient reported scratch/tightening throat. (Clinical Observer) administered Benadryl 12.5mg one time and observed patient. Patient alert, talking, no respiratory distress throughout. No signs or symptoms of facial, mouth, or lip swelling. Patient reported symptoms regressing as time passed. Patient was able to safely leave the site.