chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ) 5 mg tablets.  The patient experienced sore arm on an unspecified date. Patient stated that she just got her COVID shot and had to stop taking the tofacitinib citrate for one week, she had a sore arm but that's all. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
Client stated that she had cold symptoms, fever, dizziness and shortness of breath. She treated the fever at home and rested. Client did not seek medical help.
Ocular Respiratory Syndrome patient experienced sinus congestion and eye drainage approximately 24 hours after vaccine administered (deltoid) progressed to cough, increased rhonchi catarrhal film over eyes  pseudoephedrine administered  cefazolin 1 gm IVPB (x 2 or 3 doses) levofloxacin
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. During the time period of 30-OCT-2015 through 04-NOV-2015, the patients were vaccinated with improperly stored VAQTA (lot # L018498, expiration date 28-APR-2016) (dose and route were not reported). No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Red rash-painful. Right C4 Dermatone, 3 large group of vesicles (10 or so)
Patient started having numbness and tingling on the left side, primarily face starting approximately 1 week after vaccine administration and continuing for 1 month.  These symptoms were periodic throughout that month.
Resting Pulse rate up approx 10-15 bpm, blood pressure higher and pressure felt in head.  Hear fluttering when exerted during cardiovascular activities.  Brain fog, slower to complete thoughts and remember words.  Low energy.
Impression: SIDS. 9/3/03 Per review of autopsy report, final COD was confirmed as SIDS.
Sore arm followed by chills, fever and tiredness (persisted for 30 plus hours). Took ibuprofen to break fever. None of these side effects occurred after first two Pfizer shots.
Moderate to Severe burning throat, ear pressure, Moderate tight chest, Mild to Moderate Asthma exacerbation
itchy rash, hot and sore to the touch, at site of injection; still there more than 24 hours after it showed up
Patient seen on 07/27/2006 and diagnosed with shingles.  The course of treatment was acyclovir 200mg  one teaspoon four times a day for five days.
headache, arm swollen, can't move arm, can't get out of bed she is in so much pain
Per Case Management - patient treated at hospital for  "who had a bad MI on the 23rd of June, he is coming off ECMO and remains intubated in the ICU". Cardiologist may be contacted regarding
On 11/14/00, at 16:00, had pain, swelling and erythema at site of injection. On 11/15/00, had fever and myalgia in right arm early AM. On 11/15/00, also had swelling, inflammation, myalgia deltoid, tricep and bicep muscles in right arm. On 11/16/00, at 10:00, had swelling, inflammation and myalgia in right arm.
This case was reported by a healthcare professional (nurse) and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included meningococcal ACWY vaccine (non-gsk); Merck; unknown; unknown given on an unspecified date. On an unspecified date the subject received a dose of BOOSTRIX (unknown details). At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site redness, swelling injection site and injection site pain. The nurse reported that the BOOSTRIX and MENACTRA were administered "at separate sites" but did not provide additional details. At the time of reporting the outcome of the events were unspecified.
small dots around injection site; hives all over her body; itchy bumps all over her body; rashes bumps all over her body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (small dots around injection site), URTICARIA (hives all over her body), RASH (rashes bumps all over her body) and PRURITUS (itchy bumps all over her body) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (small dots around injection site), URTICARIA (hives all over her body), RASH (rashes bumps all over her body) and PRURITUS (itchy bumps all over her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (small dots around injection site), URTICARIA (hives all over her body), RASH (rashes bumps all over her body) and PRURITUS (itchy bumps all over her body) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Day 2 my knee started to bother me, day 3, I couldn't walk.  My leg was swollen and very painful.  I still cannot walk without a  cane today
Hyperpyrexia (104) pt was hospitalized elsewhere by mother's history for septic workup, LP, etc.  Nurse follow up on 08/23/04 states: "Per review of d/c summary, please add viral illness, irritability & excessive crying - time not specified. Fever was confirmed."
Anaphylatic Reaction: Lip swelling, rash, vomited approximately 45 minutes after vaccine administered. Patient sent to ER VIA 911 given EPI-PEN x's 2, kept for observation. Given EPI for home use PRN.
Within 1 week of vaccination developed blood clot to 4th finger of left hand.  No prior history of clotting disorders or other medical conditions or medication use. No adverse reactions to first or second Phizer COVID vaccination. This event was triggered by the third dose. Treatment course includes initiation of Aspirin 325  daily.
SEVERE GENERALIZED PAIN, DIFFICULTY WALKING DUE TO SEVERE PAIN AND SWELLING, UNCONTROLLABLE DIARRHEA, WEAKNESS.
weakness in the legs; flushiness in the face; incontinence of urine; Low grade fever; extreme fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MUSCULAR WEAKNESS (weakness in the legs), FLUSHING (flushiness in the face), URINARY INCONTINENCE (incontinence of urine), PYREXIA (Low grade fever) and FATIGUE (extreme fatigue) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bedridden and Walker user.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weakness in the legs), FLUSHING (flushiness in the face), URINARY INCONTINENCE (incontinence of urine), PYREXIA (Low grade fever) and FATIGUE (extreme fatigue). At the time of the report, MUSCULAR WEAKNESS (weakness in the legs), FLUSHING (flushiness in the face), URINARY INCONTINENCE (incontinence of urine), PYREXIA (Low grade fever) and FATIGUE (extreme fatigue) had resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant and treatment medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up was received on 04-MAY-2021. All reported events' outcome were updated to recovered/resolved.
patients received the vaccine and were sick; This spontaneous case was reported by a consumer and describes the occurrence of   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 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medications were reported Treatment information was not provided.
In 2 days after the vaccination the upper RIGHT arm has become swollen and painful. Application of ice and massaging did not help. Tylenol 325 mg was taken every 4-6 hours for two days. The pain has subsided and the swollenness decreased in about one week. However, the muscles of the upper right arm continue to be painful while moving the arm and they must have contracted as the range of motion of the arm is limited now comparing to the pre-vaccination time. The muscles are still painful when trying to stretch the arm behind the back. NOTE: the report cannot be ascribed to a local infection by the needle, because the same result has occurred to the LEFT upper arm after the second vaccine dose.
Upon injection I immediately felt "PINS" stabbing  my hands, arms, neck, face and feet. After 30 minutes of injection sudden severe headache (lasted 1 hour) nausea for 1 1/2 days, 1 bout of diarrhea, earaches, sinus aches intermittently for 2-3 days. (Of course the usual side effects of minor arm pain at injection site the day after injection along with chills, low grade fever and lethargy for 2 days.)
This spontaneous report was received from an adult female physician reporting on herself. The patient's concurrent and historical conditions were not reported. On an unspecified date in 1985, the patient was vaccinated with RECOMBIVAX HB (lot number and expiration date were not provided), dose, route, anatomical location were not reported. There was not concomitant medication reported. On an unknown date, the patient stated that she had temporary issues with numbness. On an unknown date, the patient's Hepatitis B surface Ab was 6 (units not provided). On an unspecified date in 1990 her levels were good (values not specified). At the time of the report, the outcome of hypoaesthesia was unknown. Additional information has been requested.
Received 1st / on 07/20/2019 and is back for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received HAV (Havrix 1440 adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 adult (1st dose received on 20th July 2019).   On an unknown date, the patient received the 2nd dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The pharmacist reported patient was late for Havrix Adult 1440 dosing series. It was unknown if 2nd vaccine was administered The reporter was consulting with MI to determine appropriate dosing scheduling. The reporter consented to follow up. Note : As per source document, it was unknown if 2nd vaccine was administered hence conservatively event incomplete course of vaccination was captured in the case and clarification has been raised for the same.
Patient is fully vaccinated.  COVID + on 12/1/2021.  Hospitalized from 12/1/2021 to 12/13/2021.  Patient expired. Admitted with COVID 19,  Pneumonia due to COVID, acute hypoxic respiratory failure.  88-year-old gentleman with a significant known history for peripheral arterial disease/chronic bronchitis/coronary artery disease status post intervention/stent placement, presented due to complaint of shortness ofbreath which has been progressively getting worse.  The patient was saturating 95% on 15 L non-rebreather, up from 69% on home 4 L nasal cannula. CT PE protocol :No evidence of acute pulmonary embolism; Worsening in aeration of the right lung; Stable left lung infiltrates.  Treatment:  remdesivir, decadron.  Afib with RVR, Metoprolol given. Hyperkalemia. D dimer 3,521.
2 weeks after getting the vaccine I started having diarrhea with cramping and pain. I tried all types of treatments and nothing worked. There was only one thing that worked, I believe it was a probiotic. I went to the ER and they gave me a really strong medication to help resolve the diarrhea. It did not work and the staff were amazed that it did not work. They did all tests possible, including microbial test for intestinal parasites. They all came back normal. I was scheduled for a colonoscopy but the diarrhea resolved so I did not have it. Towards the end I tried another probiotic that was more intense. It was an over-the-counter medication.
Feverish, body aches, and dizziness. Symptoms dissipated after 24 hours.
Began with vomiting/diarrhea, headache, dizziness & fever at midnight following vaccination, lasting approx 12 hrs. Reported continued mild headaches off & on 3/5 & 3/6, gave TYLENOL (1 cap). Fever subsided Sat am, nausea persisted until Sat 3/5 pm. Feeling better 3/6. Also reports shortness of breath & HA when climbing stairs 3/5, 3/6 & 3/9.
12 hours from vaccine #2, I started with rigors, myalgias/arthralgias, severe headache, temperature 100-101, nasal congestion, and profound fatigue.  Symptoms resolved after 36 hours with Tylenol/Advil and supportive care.  Sent for COVID Rapid PCR which was negative; missed 1 day of work.
Chills, excessive shivering, nausea, headache, fever. Shivering, shaking helped buys of a heating pad in the middle of the night. Headache lasted 24 hours, nausea about the same.
CHILD'S DATE OF BIRTH AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY PERSON IDENTIFYING AS MOTHER. CHILD IDENTIFIED IN DATABASE WITH DIFFERENT DATE OF BIRTH.  CHILD IS TOO YOUNG FOR VACCINE ON 5/14/2021.
Significant sharp pain in mid upper left arm of area near injection site and spread to upper arm and lower shoulder. Range of motion became restricted to approx. 20 degrees less than normal extension upwards. Subsided substantially in about 48 hours. Have had flu vaccines in previous three consecutive years, but never any reaction.
Patient was at a shot exercise for his second dose of Pfizer COVID Vaccine, he got his second vaccine and went to the next table where he then got another dose of vaccine. Thus got 2 second doses.
Tic disorder; "Cringing", clenched jaw, hands balled into fists, excessive blinking, grimacing. Disorder changes in frequency. At it's worst, it occurs every 15 seconds. At best, a few times per/day & will sometimes disappear for weeks at a time. The disorder has continued off & on for almost a year.
Amenorrhea. Period is 3 weeks late, still hasn't come, even after my doctor prescribed Prevara. I have never had a late period before (except when pregnant)
The patient received a second dose of the vaccine and was only was only correspondent to one dose 10/15/2022 second dose 11/22/2022.
PATIENT PASSED OUT WITHIN 10 SECONDS AFTER SHOT GIVEN.  PT WAS SWEATING PROFUSELY AND LOOKING PALE.  PT BECAME UNRESPONSIVE FOR ABOUT 7 SECONDS.  SHE HAD PULSE AND WAS BREATHING NORMALLY.  SHE WAS GIVEN ICE PACK AND SHE HELD IT NEAR HER CHEST.  SHE BECAME UNRESPONSE AGAIN.  911 WAS CALLED.  PT BECAME RESPONSIVE AGAIN AFTER A FEW SECONDS.  SHE WAS GIVEN COLD WATER TO DRINK.  SHE DRANK A FEW SIPS AND CLAIMED SHE WAS OK.  SHE WAS SWEATING PROFUSELY BY THEN AND WAS STILL VISIBLY PALE.  PARAMEDICS CAME AND TOOK OVER.
Patient required hospitalization due to breakthrough infection. He received Pfizer vaccine (2nd dose in series) on 04/07/2021. Hospitalized from 08/10/21 - 08/14/21. Below is copied from discharge summary:   Pt responded quickly to supportive care, breathing comfortably on RA, tolerating PO route, hemodynamically stable and asking to go home. Answers all orientation/capacity questions appropriately.   65 y/o AAM with PMH of HTN, DM, and "heart surgery" BIB EMS for AMS. Found to be hypoglycemic in the field in the 30's and was given dextrose. Per EMS run sheet call was placed by patients girlfriend and it was initially thought to be cardiac arrest but patient never lost pulses. Patient seems to be confused on exam but is A&Ox3. Says hasn't been feeling well over the past few days and his abdomen has been hurting him. Denying any HA, Cp, sob, cough, N/V, dysuria, hematuria, hematochezia, melena. Denies tobacco, ETOH or illicit substance use.
I was fatigued, a little tired. In May I tested negative but I was not sick, it was just a requirement to travel. In July I got sick I went to the doctor, I had fever, fatigue, nausea, diarrhea, difficulty breathing, body ache, I had the test again and it was negative but the doctor said it was Long COVID-19.
PSORIASIS FLARE UP/ DRY SKIN ON SHINS; FELT FATIGUED AND WORN DOWN FROM MODERNA; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS FLARE UP/ DRY SKIN ON SHINS) and FATIGUE (FELT FATIGUED AND WORN DOWN FROM MODERNA) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FATIGUE (FELT FATIGUED AND WORN DOWN FROM MODERNA). On an unknown date, the patient experienced PSORIASIS (PSORIASIS FLARE UP/ DRY SKIN ON SHINS). At the time of the report, PSORIASIS (PSORIASIS FLARE UP/ DRY SKIN ON SHINS) had not resolved and FATIGUE (FELT FATIGUED AND WORN DOWN FROM MODERNA) outcome was unknown.            No concomitant medication was reported. On an unknown date, the patient experienced PSORIASIS FLARE UP/ DRY SKIN ON SHINS. In 2021, the patient experienced FELT FATIGUED AND WORN DOWN FROM MODERNA. Patient had dry skin on shins and felt fatigued and worn down from Moderna vaccines. He agreed to have physician contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported.  Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of PSORIASIS FLARE UP/ DRY SKIN ON SHINS with SKYRIZI(RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the event(s) of FELT FATIGUED AND WORN DOWN FROM MODERNA with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I woke up and had a head cold, congestion, achy joints, and sinus drainage.  I developed a low grade fever and I had the home test and I had taken a COVID-19 test and it was positive.  I went thru the drive thru clinic and spoke with them and they did prescribe me an antiviral that was Molnupiravir and then Azithromycin.  I am no longer experiencing symptoms at this time, they lasted about 4-5 days and now I feel like I am back to normal.
Hidradenitis suppurativa flare up; Delay wound healing; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa flare up) and IMPAIRED HEALING (Delay wound healing) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 041620A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    The patient's past medical history included Non-smoker, Alcohol use (One glass of beer once a month), Itching, Fever, Loss of sensation, Loss of smell, Cough, Fatigue, Loss of taste, COVID-19 from February 2020 to March 2020 and Shortness of breath (Worsened shortness of breath). Concurrent medical conditions included Hidradenitis suppurativa, Asthma and Latex allergy (Latex allergy manifested by itchiness). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma.   In October 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In April 2021, the patient experienced HIDRADENITIS (Hidradenitis suppurativa flare up) and IMPAIRED HEALING (Delay wound healing). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, HIDRADENITIS (Hidradenitis suppurativa flare up) was resolving and IMPAIRED HEALING (Delay wound healing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2021, Drug specific antibody present: Body created Humira antibodies..         On an unknown date it was reported that Humira had stopped working. On 23 Jun 2021, the patient experienced Humira antibodies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of Humira antibodies, hidradenitis suppurativa flare up and delay wound healing with HUMIRA 40MG/0.8ML(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Humira stopped working was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Serve days after the first dose. I noticed increase heart rate90 to120 and high BP 180/94 to 112/70. Never had a heart issue or high BP. My BP went down to normal after several weeks and so did my pulse rate. After second  shot several days late pulse rate 90-128. Bp stayed normal. I  have some shortness of breath this time.  I HAVE FALLEN IN THE LAST TWEEK TWICE FLAT ON MY FACE FOR NO RE  on 3/15 Dr ordered ZIO for two weeks. My EKGs have always been normal and so have my pulse and BP.
Over Spring 2022 Hospital: Two ER visits for "heart attack" symptoms, one hosp adm for tests-negative.   Oct., 2022 Hospital, Third ER visit for "heart attack" symptoms - tests negative.  03/06/2023 Hospital: Fourth ER and Hosp admission for "heart attack" symptoms - tests negative.  03/15/2023 Post hospital visit.  Normal readings.