chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; chills; uncontrollable shaking; itching at injection site; pain in injection site; cellulitis in right  arm; Pregnant patient; This is a spontaneous report from a contactable consumer. A 38-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 38-years-old via an unspecified route of administration, administered in arm right on 25Feb2021 23:30 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and alprazolam (XANAX), both taken for an unspecified indication, start and stop date were not reported. The patient had known allergies to Bactrim. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on the right arm on 05Feb2021 (lot number: EM9810) 11:00 for covid-19 immunisation. The patient experienced cellulitis in right arm, fever, chills, uncontrollable shaking, itching at injection site and pain in injection site on 26Feb2021 08:00. The mother reported she became pregnant while taking bnt162b2 on 25Feb2021 23:30. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 28Oct2021. Last menstrual period was on 15Jan2021. Therapeutic measures were taken as a result of the events which included treatment with cefalexin. The outcome of maternal exposure during pregnancy was unknown while the patient was recovering from all of the other events.
Lt. arm pain 30 min after pt. got home from clinic/PNEUMOVAX. To ER - still having pain and decreased ROM.
Sore arm (entire upper into neck), fatigue, extreme dizziness, headache, chills, sweats, fever (102). Muscle/body aches.
While waiting for elevator, my daughter said she felt light headed and she leaned against me and fainted. I called for help and medical personnel came over. She was taken to observation room for a few minutes until she fell better.
papular lesions on erythematous base in various places, fussy, fever 101 x 3 days;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. In 2009, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2009, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
pt recv vax 24NOV97 & 25NOV97 pt exp pain in upper rt arm near the inj site, as well as muscle pain through the neck & shoulders;could not move neck & could not roll over in bed x 3noc;also exp tiredness & weakness;
Pt received vaccines at 11:30 on 3/20/00. Pt then experienced subjective high fever in early hours of 03/21/01; accompanied by chills, sweats and weakness. Pt described induration from IPV/YF/SC injections at about the size of a quarter each. Pt's fever (subjective) came down and induration decreased as the day went on and denies taking ibuprofen.
bad reaction and went to ER; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (bad reaction and went to ER) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (bad reaction and went to ER). At the time of the report, ADVERSE REACTION (bad reaction and went to ER) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included IV. No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Non-Significant Follow up received and Contact details were updated.
PT WAS GIVEN PFIZER AT ONE SIRE CAME TO OUR SIRE TO GET THE 2ND COVID VACCINE. I WAS GIVING MODERNA ALL DAY AND THOUGHT THEY WERE HERE FOR THE MODERNA. I NEGLECTED TO ASK FOR THEIR CARD BEFORE GIVING THE INJECTION AND SAW AFTERWARD THAT THEY WERE PREVIOUSLY GIVEN PFIZER FOR 1ST DOSE. THEY SAT HERE IN CLINIC 30-40 MINUTES AFTER WITH NO REACTION. HAVE CHECKED ON THE PT MORE THAN ONCE AND IS DOING WELL AND NO REACTION TO DATE.
This spontaneous report was received from a female patient of unknown age concerning herself via other company Pfizer. The patient was allergic to iodine contrast dye which was used 10 years ago with a CAT scan, the patient had huge hives and facial swelling on an off 4 months after. Concomitant therapies included levothyroxine sodium since 10 years. Approximately in 2013 (3 years ago) the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and the patient experienced sore muscles. The outcome of sore muscle was unknown. The reporter did not assess the causality of the event with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Additional information has been requested.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Medical History was provided by Reporter No Concomitant Medications were  provided by Reporter
tremendous hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (tremendous hair loss) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0461321A and 0081321-2A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-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 experienced ALOPECIA (tremendous hair loss). At the time of the report, ALOPECIA (tremendous hair loss) outcome was unknown.            The patient reported that the symptoms stared 6 weeks after vaccination and had no other symptoms. Mentioned that he had not hair loss before and was been lasting 3 months. The patient was not tried any treatments.
screaming, eyes rolled back, temp 101-102, pale, still; treatment-APAP;
Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy; Sore breast; Big red blotch on the left breast; Glands on her left under arm is very sore; Arm very sore; Achy; Chills; Not feeling well; Eyes are watery; Flu like symptoms; Skin was inflamed; This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCOMFORT (Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy), BREAST PAIN (Sore breast), RASH MACULAR (Big red blotch on the left breast), MALAISE (Not feeling well) and LACRIMATION INCREASED (Eyes are watery) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 039B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced MALAISE (Not feeling well), LACRIMATION INCREASED (Eyes are watery), INFLUENZA LIKE ILLNESS (Flu like symptoms), DERMATITIS (Skin was inflamed), VACCINATION SITE PAIN (Arm very sore), MYALGIA (Achy) and CHILLS (Chills). On 20-Nov-2021, the patient experienced BREAST DISCOMFORT (Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy), BREAST PAIN (Sore breast), RASH MACULAR (Big red blotch on the left breast) and LYMPHADENOPATHY (Glands on her left under arm is very sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 20-Nov-2021, MALAISE (Not feeling well), LACRIMATION INCREASED (Eyes are watery), INFLUENZA LIKE ILLNESS (Flu like symptoms), DERMATITIS (Skin was inflamed), VACCINATION SITE PAIN (Arm very sore), MYALGIA (Achy) and CHILLS (Chills) had resolved. At the time of the report, BREAST DISCOMFORT (Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy), BREAST PAIN (Sore breast), RASH MACULAR (Big red blotch on the left breast) and LYMPHADENOPATHY (Glands on her left under arm is very sore) outcome was unknown.  Concomitant medication information was not provided by the reporter.This case was linked to MOD-2021-395698 (Patient Link).
Administered an expired Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received HAV (Havrix adult) (batch number 2BA99, expiry date 16-DEC-2022) for prophylaxis.   On 13-APR-2023, the patient received Havrix adult. On 13-APR-2023, an unknown time after receiving Havrix adult, the patient experienced expired vaccine used (Verbatim: Administered an expired Havrix). The outcome of the expired vaccine used 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 Information: GSK Receipt Date: 14-MAR-2023 The reporter was a medical assistant. The reporter reported that they inadvertently administered Havrix vaccine in their facility which was expired. The reporter wanted to know should this vaccine be re administered. The reporter did not consent to follow up. The patient received a Havrix which was already expired, which led to expired vaccine used.
severe drowsiness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (severe drowsiness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (severe drowsiness). At the time of the report, SOMNOLENCE (severe drowsiness) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-117202, INC.-MOD-2021-117202 (Patient Link).
pt states discovered raised red rash on lower arms, anterior neck & @ inject site on arrising on 30OCT94; some urticaria; inject site also warm & tender to touch-1" diam; NKA; advised to consult MD;
Redness, swlling to the site extending over right thigh and then peeling of skin after it healed
Client experienced complete loss of consciousness with associated flaccidity/loss of muscle control within 1 minute of adminstation of Gardasil.  Loss of consciousness lasted 1-2 minutes. Lowered client to the floor where she regained consciousness but maintained extreme pallor for the duration of her stay.  BP upon recovery 96/64.
24 hours post: sore arm mild headache, achy joints, fatigue, low grade temp (99-100) this lasted for 78 hours  6 days post: redness around injection site, itchy, warm to touch this lasted up to day 8 post injection
Possibly received an expired dose of the vaccine/ she received they said it was from an expired lot.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Possibly received an expired dose of the vaccine/ she received they said it was from an expired lot.) 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 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Possibly received an expired dose of the vaccine/ she received they said it was from an expired lot.). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Possibly received an expired dose of the vaccine/ she received they said it was from an expired lot.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported
Information has been received from a registered nurse concerning an 11 year old white female student with no known drug allergies, who on 09/09/2002 at 15:00 was vaccinated intramuscularly in the left hip with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 642439/0234M) that had been "reconstituted" with diphtheria toxoid/pertussis vaccine/teta (Lot # V0306AC).  There was no illness at the time of vaccination.  At 15:00 on 09/09/2002, the patient developed redness and slight swelling at the injection site.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  Additional information is not expected.
Information has been received from a health professional concerning a 10 year old white male who at 9:40 on 13 JUL 2007, was vaccinated subcutaneously into left arm with a booster dose of varicella virus vaccine live (Oka/Merck) (Lot # 657647/0535U). On 14 JUL 2007, the following day, the patient developed a 2 inch non vesicular welt at the injection site, that was warm to touch and slightly painful. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Patient received dose #1 of Moderna on 7/27/21, dose #2 on 9/3/21 and dose #3 (booster) on 11/13/21.  The booster dose was administered approximately 4 months too soon.  No known adverse reaction(s) due to early administration.
Patient was accidentally given the updated Pfizer Pediatric COVID-19 Bivalent booster instead of the primary Pfizer Pediatric COVID-19 Monovalent, this was their first vaccine for COVID-19 and they should have received the older Primary Monovalent version of the vaccine. The Patient did receive the pediatric version which is age appropriate, only the valency of the vaccine is incorrect. No adverse effects were reported to pharmacy, Father is informed and actually preferred the Bivalent dose, however I explained the child will require a monovalent dose for the second dose, patients pediatrician has also been informed, was informed by myself on 1/10/2023 at 1:45PM.
mild discomfort at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received dose of bnt162b2 (BNT162B2, Batch/Lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INJECTION SITE DISCOMFORT (non-serious), outcome "unknown", described as "mild discomfort at the injection site".  No follow-up attempts are possible. No further information is expected.
Mother reports patient had mild swelling, pain & redness at injection sight the first 2 days after administration. The evening of 7-25-12 his condition worsened. Mother states patient's left arm was painful, swollen & red from the elbow to the shoulder & firm to the touch, states also that there was some swelling into the left side of the neck & reports swollen tonsils. She notified child's doctor & was told to come to their office at 11:30 AM the next morning. FNP-C reported to HD that patient had local reaction to Tdap vaccine & is improving witn no loss of motion or use & no fever. Tx recommended by NP was OTC loratidine & cool compress. 7-27-12 @ 4:00 PM this nurse called patient's mother, & she reported that child is slowly improving, still without serious s/s.
Body aches,sore arm; headache; soreness at the vaccination site; Super tired; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Body aches,sore arm), FATIGUE (Super tired), CHILLS (chills) and HEADACHE (headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included Aspirin                                                        Blood clot disorder for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (Fever), FATIGUE (Super tired) and CHILLS (chills). On an unknown date, the patient experienced MYALGIA (Body aches,sore arm), HEADACHE (headache) and VACCINATION SITE PAIN (soreness at the vaccination site). At the time of the report, PYREXIA (Fever), MYALGIA (Body aches,sore arm), FATIGUE (Super tired), CHILLS (chills), HEADACHE (headache) and VACCINATION SITE PAIN (soreness at the vaccination site) outcome was unknown. Not Provided
pressure in ears, ringing like tinnitus.  Never had pressure or tinnitus like this and never this duration
Confirmed Breakthrough  1st Dose - 4/8/2021 - Pfizer - EM9810 2nd Dose - 4/29/2021 - Pfizer - EM9810 3rd Dose - 10/27/2021  Pfizer - EW0162
Discharge Provider: MD Primary Care Provider: DO Admission Date: 3/3/2023 Discharge Date: Mar 4, 2023  PRESENTING PROBLEM: Acute kidney injury [N17.9] COVID-19 [U07.1]   HOSPITAL COURSE: Pt. is a 78 year old female with PMH of HTN, DM2, and mild dementia. Pt. reportedly has had generalized weakness and fatigue since 2/24/23. She was tested on 2/28/23 for COVID and found to be positive. Since then the patient has had worsening generalized weakness and fatigue for which she presented to the ED. Vitals have been stable on room air. Labs found to have a mild elevated creatinine and she was admitted to the hospital. Pt. reported poor oral intake and it was felt her AKI was pre-renal. She was given IVF over night and her creatinine improved back to baseline. Pt.'s generalized weakness improved with hydration. PT/OT recommended home with assist with home PT/OT. Pt. will follow up with her PCP outpatient. She is discharging in improved and stable condition.
April 2, 2021 Friday morning I had a severe nose bleed. I had my son drive me to the ER. They packed my nose and sent me home. That evening around 4:00 pm it was still seeping so I went back to the ER. They didn?t want to do anything with it because they had it almost stopped. It stopped the next day. Packing stayed in all weekend until Monday morning when I returned to the ER to have it removed as per instruction. I followed up with Dr.  that Thursday and he cauterized two spots in my nostril.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates between 01-SEP-2015 and 09-SEP-2015, the patients were vaccinated with ROTATEQ (lot # K019370 and expiration date 16-JUL-2016, lot# K023537 and expiration date 22-JUN-2016, lot# L004466 and expiration date 02-AUG-2016) (dose and route were not reported) that were improperly stored. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
13:40 roof of mouth became swollen-returned to office and told supervisor-by this time throat felt tight and this worsened and was taken to clinic and given Benadryl and tegaderm removed.
The patient has a history of COPD and heavy tobacco use. She was brought to the ED via EMS on 4/28 for respiratory distress. Per EMS, the patient began having shortness of breath the night before and called EMS due to this. Upon EMS arrival, the patient was on 4L nasal cannula with oxygen saturations in the 70s. A COVID PCR test performed in the ED resulted positive. Ultimately, she was admitted 4/28 /23. Discharge diagnoses include sepsis secondary to possible superimposed bacterial pneumonia, COPD exacerbation, acute on chronic hypoxic and hypercapnic respiratory failure, and COVID pneumonia, among other diagnoses. The patient was intubated on 4/28 while in the ED, and was extubated on 5/2. She was discharged 5/26/23.
On 8-9-2010 client was given H1N1 0.1 ml. intradermally instead of TB - PPD in the left inner forearm. 8-10-2010 Noted warmth to site and some itching. 8-11-2010 Observed - note 4 cm x 4 cm area, red, slightly warm, itchy. Recommended antihistamine and cool pack to site. 8-13-10 - Fading - no c/o.