chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna booster administered at the clinic on 11/19/21 was expired (Moderna recommends vials be used within 12 hours of opening).  No treatment needed. No adverse side effects.
This spontaneous report was received from a nurse, concerning multiple unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse informed that on an unspecified date, multiple patients were vaccinated with improperly stored doses of M-M-R II lot #N001531, Expiration date 13-ENE-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis which was reconstituted with a properly stored sterile diluent( MERCK STERILE DILUENT); GARDASIL 9 lot #N015089, expiration date 20-OCT-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis; LIQUID PEDVAXHIB lot #N000238 and N007750 respectively, expiration dates 25-OCT-2019 and 29-NOV-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis; and with PNEUMOVAX 23 lot #N020501, expiration date 03-MAR-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse reactions were reported. The temperature of excursion was reported as 47°F to 77°F (47.8°F) during a time frame of 1 hour and 5 minutes. There was no previous temperature excursion reported. There was a digital data logger involved.
started with feeling dizzy then feeling sleepy, cold and difficulty in breathing after that the fever started with extreme body pain  the fever continued for 9 straight hours next day had a fever for 2 hours and the body pain continued with the headaches, coughing and the breathing problems after 4 days the fever was gone but the body pain and the breathing was still affected now it has been 2 weeks since i got vaccinated and my body still hurts and i have problems with breathing after talking for a while, walking fast, screaming or even just cleaning my room for like 5 mins.
shallow breathing, shakey, goose bumps for over an hr; off & on during noc p/vax the day a/;
Flu shot given (R) deltoid approximately equal to 4:45 pm 9/12/11. Arm felt heavy afterward. Became increasingly painful by 8 pm. Pt. took TYLENOL without relief. Following day used ice & heat - no relief. 9/14 developed redness, warmth & itchy red papular/vesicular rash over (R) deltoid. Responded to MOMETASONE cream today. Rash less itchy. Still with pain (R) deltoid to (R) elbow & (R) scapula. Decreased ROM D/T pain. Now will try ADVIL & continue MOMETASONE for rash. T 98.5 B/P 112/74.
This case was reported by a healthcare professional and described the occurrence of injection site rash in a 8-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). On 11 January 2014 at 14:30 the subject received a dose of KINRIX (unknown, right arm) as the 5th dose in the series. On 11 January 2014, at the time of vaccination with KINRIX, the subject experienced inappropriate age at vaccine administration. On 12 January 2014, 1 day after vaccination with KINRIX, the subject experienced injection site rash. Immunization serious was not delayed or discontinued. KINRIX is approved for use in children 4 through 6 years of age. On 14 January 2014 the injection site rash was noted to have improved. The healthcare professional considered the events were probably related to vaccination with KINRIX.
The patient received Varicella and was not supposed to.  Just making sure no contradictions with other vaccines given.  Hep A and Kinrix.
This spontaneous report was received from a licensed practical nurse (LPN), referring to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot number M041770, expiration date 26-JUN-2018; lot number M045546, expiration date 12-JUN-2018; lot number reported as "N0047898", expiration date 31-OCT-2019; for prophylaxis. Lot number N0047898 is an invalid lot number for ROTATEQ. The data logger registered a temperature excursion of 47.49 Fahrenheit (F) for 13 minutes. There was not previous temperature excursion. No adverse effects were reported in any patients. This is one of two cases from the same reporter.; Sender's Comments: US-009507513-1708USA007538:
Fever/Chill within 24 hours; Fever/Chill within 24 hours; chest pain; shortness of breath; Told to take advil for heart inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 16:30 (Lot number: FC3183) at the age of 15 years as dose 2, single and administered in arm left, administration date 06Aug2021 16:30 (Lot number: FA7483) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: CARDITIS (medically significant) with onset 2021, outcome "unknown", described as "Told to take advil for heart inflammation"; PYREXIA (non-serious), CHILLS (non-serious) all with onset 30Aug2021 02:00, outcome "recovered" (2021) and all described as "Fever/Chill within 24 hours"; CHEST PAIN (non-serious) with onset 30Aug2021 02:00, outcome "recovered" (2021), described as "chest pain"; DYSPNOEA (non-serious) with onset 30Aug2021 02:00, outcome "recovered" (2021), described as "shortness of breath". The events "told to take advil for heart inflammation", "fever/chill within 24 hours", "fever/chill within 24 hours", "chest pain" and "shortness of breath" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pyrexia, chills, chest pain, dyspnoea.  Clinical course: Injection was on Friday and produced usual side effects. Fever/Chill within 24 hours. At 48 hours chest pain and shortness of breath occurred. Told to take advil for heart inflammation. No Covid prior to vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
my arm was heavy and painful to lift/my husband had it too; my arm was heavy and painful to lift/my husband had it too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "my arm was heavy and painful to lift/my husband had it too". Additional information: Caller received the Pfizer Covid 19 Vaccine booster dose and has a swollen arm pit, and it was painful. On Wednesday, 09Feb2022, caller got the booster dose and the next day her armpit was swollen and painful. She got it on the left-hand side, the injection site was tender but under her armpit was painful. After she got the first and second dose and she did not have this, but her arm was heavy and painful to lift, which she knows others experience that too, her husband had it too after the first and second dose. Response: Spoke from attached Pain at injection site, muscle pain and joint pain were reported. As well as swollen lymph nodes which may be found under arm pit. Persons 18 Years and Older: Local reactions lasted between 1 and 2 days and systemic reactions lasted around 1 day. Swollen lymph nodes (lymphadenopathy) were also reported and generally resolved within 10 days.   Follow-up attempts completed. No further information is expected.
Vertigo, syncope and nausea. Started September 24th and getting worse since. Went to ER September 29th, had an EKG done and had an IV. Left with medications (antivert and zofran). October 9th started dealing with car sickness that Ive never dealt with previously.
Pt developed a localized erythematous, pruritic reaction at site of vaccine administration on left upper extremity. Pt noted itching and mild redness on day after administration. Area increased in size and became edematous and she noted tenderness and "bumps" in left axilla that resolved overnight. 2 days after vaccine administration she presented to the clinic for evaluation of reaction. At that time, a 5cm by 5cm area of erythema and edema was present on left upper arm. Area was soft, nontender, pruritic, without induration. There were no other signs or symptoms of allergic reaction.
Patient verbalized feeling dizzy shortly after shot administration. He went unconscious for less than a minute and appeared to convulse. He was snoring and abruptly came back to consciousness. He was sweaty and lightheaded. Patient was instructed to lay on the floor with his feet elevated. He felt much better after resting.
lt knee & leg swollen, warm & red, very fussy mom called office w/these complaints @ 650PM 16APR98;tx motrin & compresses to area;
PATIENT REPORTED FEELING LIKE HE COULDN'T CATCH HIS BREATH AND CHEST TIGHTNESS ABOUT 10 MINUTES AFTER VACCINATION. HE DIDN'T APPEAR TO BE IN RESPIRATORY DISTRESS BUT LOOKED A LITTLE PALE. WE CALLED 911, PARAMEDICS CAME AND UPON CHECKING HIM OUT THEY SAID THE PATIENT APPEARED TO HAVE HAD A PANIC ATTACK. HE DIDN'T LEAVE WITH THE PARAMEDICS SINCE HE STARTED FEELING BETTER AND OPTED TO GO HOME TO REST AND RECOVER.
Patient admitted on 11/1/2021 at 25w6d for preterm labor, and underwent emergent primary low transverse cesarean section for transverse lie. Patient was stable postoperatively. She delivered a viable female infant weighing 1000g. Patient is Rh (+) blood type, GBS unknown. The patient had an uncomplicated postoperative course, meeting all post-op goals. Hospital admission within 6 weeks of receiving the COVID vaccine.
Patient received Bivalent for her first dose of Covid instead of the primary series for ages 12+ up. Mom notified of immunization error. DPH notified. Patient has not had a reaction.
The second one, she was just a little bit tired the second day; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Lot number: EN6206) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Osteopenia" (unspecified if ongoing), notes: diagnosed a number of years ago. that is why she takes Vitamin D; "allergic to penicillin" (unspecified if ongoing); "allergic to antibiotic drug" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; CALCIUM taken for osteopenia (ongoing). The patient took no other medications other than Vitamin D and a Centrum Multivitamin. Prior Vaccinations within 4 weeks of the suspect vaccine was none. Past drug history included: Tamiflu, reaction(s): "Rash"; Z-pak, reaction(s): "Rash". Vaccination history included: Bnt162b2 (Dose 1, Lot as EN6200, Anatomical Location: she is thinking left arm but she can't be sure), administration date: 03Mar2021, when the patient was 68 years old, for COVID-19 Immunization, reaction(s): "With the first one, she had absolutely no reaction.". The following information was reported: FATIGUE (non-serious) with onset 25Mar2021, outcome "unknown", described as "The second one, she was just a little bit tired the second day". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101816544 Same patient/drug and different dose/AEs.
Patient reported to pharmacy that she developed dry cough about one week after she received the vaccine. According to pt. this happened last year as well, and lasted about three weeks.
received COVID vaccine at 0915 developed right facial numbness-eye, cheek, ear and neck at approximately 1000. No facial droop observed.
This spontaneous report was received from a nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 08-AUG-2016, the patient was vaccinated subcutaneously with the first dose of GARDASIL (dose and frequency were not reported) lot # M014929 with expiration date of 27-MAY-2017 for prophylaxis. On 12-OCT-2016, the patient was vaccinated subcutaneously with the second dose of GARDASIL (dose and frequency were not reported) lot # M014929 with expiration date of 27-MAY-2017 for prophylaxis. There were no previous temperature excursions occurred for the vaccine. On 27-FEB-2017, the patient went to the nurse's office to receive the third dose of human papillomavirus (HPV) with GARDASIL 9 subcutaneously for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.  Additional information has been requested.
Minor sore arm (after 2nd dose); Nice red arm (after 2nd dose); Patient received vaccine at the age of 14; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Minor sore arm (after 2nd dose)), ERYTHEMA (Nice red arm (after 2nd dose)) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received vaccine at the age of 14) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 55442 and 54615) for COVID-19 vaccination.     Concurrent medical conditions included ADHD. Concomitant products included DEXAMETHASONE, OFLOXACIN HYDROCHLORIDE (FOCALIN [DEXAMETHASONE;OFLOXACIN HYDROCHLORIDE]) for ADHD, GUAIFENESIN for Sleep disorder, MELATONIN for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received vaccine at the age of 14). On an unknown date, the patient experienced PAIN IN EXTREMITY (Minor sore arm (after 2nd dose)) and ERYTHEMA (Nice red arm (after 2nd dose)). On 15-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received vaccine at the age of 14) had resolved. At the time of the report, PAIN IN EXTREMITY (Minor sore arm (after 2nd dose)) and ERYTHEMA (Nice red arm (after 2nd dose)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications was not reported. The patient is in the TeenCOVE clinical study trial. it was reported that he  got the red arm because they were not sure if he received placebo.   This case was linked to MOD-2022-452775, MOD-2022-452102 (Patient Link).
Wife reported symptoms of all-over tingling, increased heart rate , and increased BP.  Patient took over-the-counter Benadryl and symptoms subsided.
Light-headedness upon administration; stayed home from work days 3 ^ 6, plus intervening weekend with low-grade fever, fatigue, body aches, axillary adenopathy.
1 day after the vaccine the site of my c-section scar became puffy and inflamed.  I had some pain and irritation at the site of the scar.  Scar is over a year old.  Pain and puffiness lasted about a day.  I had other known reactions to the vaccine such as fatigue, fever, joint pain.
COULDN'T GO OUT BY WALK; HEADACHE ON LEFT TEMPLE; FELT ASLEEP; CHILLS; FEVER; This spontaneous report received from a patient concerned a 50 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to shellfish. The patient experienced drug allergy when treated with morphine. 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 12-MAY-2021 10:49 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the subject experienced felt asleep. On 12-MAY-2021, the subject experienced chills. On 12-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 104.2 (unit not reported), 102.8 (unit not reported), 101.8 (unit not reported). On 13-MAY-2021, the subject experienced couldn't go out by walk. On 13-MAY-2021, the subject experienced headache on left temple. Laboratory data included: Body temperature (NR: not provided) 99.9 (unit not reported), 98.8 (unit not reported). Treatment medications included: ibuprofen. Additional treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on left temple on MAY-2021, and was recovering from chills, fever, felt asleep, and couldn't go out by walk. This report was non-serious.
Pain and soreness was felt the fist 2 days after vaccine however on the 6th day pain 20/10, numbness, all the way to thumb was felt on L arm, swelling, redness, itching, hives and pain only on L arm and temp of 99.4. Pain in L thumb still hurts even more than a month later sometimes is even hard to pop out pill or open or hold stuff with that hand and thumb. Benadryl ibuprofen tylenol was taken for 1st and second dose. Did not help much!!
1 day after shot I developed a red circle rash around injection spot. Was itchy and had some blisters in the center. The next day, 2 days after shot,  I developed another red rash around the original circle and this was bright red and the size of  a softball. It has now been a week and it is not completely gone. It has been getting better and now the 2nd bigger rash is gone but the original one is still there but not as red.
3rd vaccine got hot knot in arm that had streaks, got 4th shot in other arm and doing it again
Tinnitus started roughly two weeks after the booster shot, accompanying with identified hearing loss in high frequency range.  Currently started taking prednisone 60mg on 12/18/2021
Patient indicated she had not received any  COVID-19 vaccine previously; however, upon trying to log the Moderna vaccine in, it was observed that she had received 2 previous doses of Pfizer from the Department here in our town. When the patient was asked about this she indicated she didn't know what she got at the Department. Her story changed multiple times.
After the Pfizer covid 19 vaccine I developed acute kidney inflammation and was hospitalized twice, May 5, and May 8, 2021 for kidney glomerulonephritis, urine was brown, white powder was discharged to the toilet when urinating, severe pain and kidney inflammation lasted for over 7 days from May 1 to May 10. Blood in urine was detected and additional tests indicate abnormal creatine, poor eGFR and near complete kidney failure.
Pt devel chills & fever approx 30 min p/receiving Typhoid vax; Temp inc to 101 & pt exp generalized malaise & body aches for 24 hrs; This was the first shot of the immun series;
Pt had a redness, swelling, itchy at site of injection about 7" area
This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients' were vaccinated with improperly stored doses of PEDVAXHIB (dose, and route not reported) from lot # M025192 with expiry date of 21-MAR-2019. The vaccine was exposed to a temperature of 29.3 Fahrenheit for 16 hours and this was logged on a digital data logger. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
pt recv vax 23APR97 & 6MAY97 pt devel two pimple-like spots on rt arm @ the site of inj;
Approximately 10 minutes after vaccination, mother called out for help. Upon entry to the exam room, pt was noted to be sitting in a chair when he became rigid, lifted from the chair, and bent to the side.  Episode seemed to last a few seconds. APRN was able to lift the patient to the exam table and complete an assessment. Patient appeared lethargic, sweaty, and pale in color. A blood pressure, heart rate, O2, and blood glucose were all taken and all noted to be with normal limits. The patient was given crackers and juice and monitored for 30 minutes, until nausea and dizziness subsided. Education was given to parents for home care and symptoms to continue to watch for.
Patient presented to pharmacy for second Moderna dose. Paperwork was run correctly by pharmacy staff and consent form had large orange M at top of it to indicate patient needed Moderna vaccine. Immediately after she gave vaccine, nurse realized she had made an error and gave Pfizer vaccine to patient instead of Moderna second dose. Patient was notified and seemed understanding.
Within 2 weeks of Moderna dose #2,  I developed heart palpatations that lasted 6 to 8 weeks.  ( Occurred again after my Moderna booster dose received 11-12-21).   I also developed hypertension, diagnosed March 2021.
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate free. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had not resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  In 2021, the patient experienced arm sore from getting the moderna covid booster. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity received in the moderna were missed to be booked-in.
Did not get good response to 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not get good response to 2 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Rheumatoid arthritis.   On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 VACCINATION COMPLICATION (Did not get good response to 2 doses). At the time of the report, VACCINATION COMPLICATION (Did not get good response to 2 doses) outcome was unknown.            Patient was on a medication for rheumatoid arthritis.  No treatment information was provided.   This case was linked to MOD-2021-335290 (Patient Link).