chrisvoncsefalvay/vaers-outcomes huggingface dataset:
improperly stored dose of V ARlV AX was administered to the patient on 15 FEB 2022; This spontaneous report has been received from a medical assistant referring to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.   On 15-FEB-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliters (ml) (route of administration, anatomical site of vaccination and vaccine scheme were not reported; lot number U008181 has been verified to be valid, expiration date reported and established as 08-FEB-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of 9 degrees Fahrenheit (F) during a time frame of 293 hours and 14 minutes (product storage error). There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA008282: US-009507513-2202USA008270: US-009507513-2202USA007865:
Rash that began on neck and extended down chest, abdomen, back. Extreme irritability.
Irregular, erythematous 1.5 cm diameter slightly raised rash on lateral aspect of left thigh. Does not itch. Not crusty, vesicular, or pustular.
At onset: stiffness, pain, swelling, redness in arm. Next morning and for 36 hours following: fever, severe pain/stiffness/redness--which was spreading significantly--and swelling in arm. Difficulty in moving or lifting arm. Went to ER morning of Nov. 12 and diagnosed and treated for cellulitis. Kept in hospital for 36 hours for treatment and observation. At end of treatment, attending decided not cellulitis, but cellulitis-like reaction. Redness and swelling in arm remained for another full day.
because son received vaccine , not sure about age,(may be under 18 years of age); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (because son received vaccine , not sure about age,(may be under 18 years of age)) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (because son received vaccine , not sure about age,(may be under 18 years of age)). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (because son received vaccine , not sure about age,(may be under 18 years of age)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No  concomitant medical  provided by the reporter. No treatment information provided by the reporter.
Patient stated that she had swelling in her arm. She felt dizzy the day after the injection and went to her doctor. The doctor suspected this reaction to be an adverse event.
COVID-19; This is a spontaneous report from a contactable physician. A 55-year-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller is a physician who states he has a patient who received his first dose of the Pfizer BioNTech COVID-19 vaccine 5 days ago (15Apr2021) and now has COVID-19 (onset date not reported). Physician would like to know if the patient were to receive monoclonal antibodies as part of his treatment, would he have to wait 90 days before receiving his second dose of the vaccine. The event was assessed as non-serious by the physician.  Information about lot/batch has been requested.
Very sore arm; Very tired; Can't sleep well; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th September 2022, the patient received the 2nd dose of Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm, fatigue and sleeplessness. On an unknown date, the outcome of the pain in arm, fatigue and sleeplessness were unknown.   It was unknown if the reporter considered the pain in arm, fatigue and sleeplessness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-Sep-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the second shot yesterday (day before reporting). The patient experienced sore arm, very tried and could not sleep well. The patient was guessing that this was a small price to pay for a few days compared to actually getting it (shingles). Additional Supportive Information: The follow up would not possible as no contact details were available.
Ag test 25Apr positive; Ag test 25Apr positive; cold symptoms congestion; cold symptoms congestion; travel to NYC by plane returned 4/21, then cold sx congestion and ST started 4/23 then Ag test 4/25 positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 43-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL3247), on 23Feb2021 as dose 2, single (Lot number: EL3247) and on 19Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), NASAL CONGESTION (non-serious) all with onset 23Apr2022, outcome "recovering" and all described as "cold symptoms congestion"; ELECTROCARDIOGRAM ST SEGMENT NORMAL (non-serious) with onset 23Apr2022, outcome "recovering", described as "travel to NYC by plane returned 4/21, then cold sx congestion and ST started 4/23 then Ag test 4/25 positive"; VACCINATION FAILURE (medically significant) with onset 25Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 25Apr2022, outcome "recovering" and all described as "Ag test 25Apr positive". The patient underwent the following laboratory tests and procedures: Electrocardiogram ST segment: (23Apr2022) Unknown; SARS-CoV-2 test: (25Apr2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, nasopharyngitis, nasal congestion, electrocardiogram st segment normal.Clinical course: Unknown the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown the patient diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported events of vaccination failure,covid-19. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
bilateral jaw pain x 1 week;  night >24 hours after vaccine had episode of nausea, and possible vasovagal event including dizziness, sweating, palpitations and right arm pain lasting ~15 minutes or so
lost appetite; blister on it's lip; lip got swollen; Had Chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost appetite), LIP BLISTER (blister on it's lip), LIP SWELLING (lip got swollen) and CHILLS (Had Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver transplant in 2012.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (lost appetite), LIP BLISTER (blister on it's lip), LIP SWELLING (lip got swollen) and CHILLS (Had Chills). At the time of the report, DECREASED APPETITE (lost appetite), LIP BLISTER (blister on it's lip), LIP SWELLING (lip got swollen) and CHILLS (Had Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information included Valacyclovir for 5 days.   This case was linked to MOD-2021-101635 (Patient Link).
Woke up 4 am with dry mouth, headache, lethargic,  muscle pains throughout body, nausea, tight breathing,  and headache.  Stomach upset as well. Got worse throughout day so I left work at lunchtime and slept for 4 hours.  Started to feel better.  Slept fairly well but sweats throughout night.   In morning clammy, injection site still very sore,,,all condition there but 60% better than previous day.
By 9pm on the day of the shot, chills/fever started, by midnight fever was extremely high, bad headache, lower back pain, mild sore throat, could barely walk to the bathroom or walk around my apartment. I couldn?t eat because eating made me feel nauseated. All I could do was drink water. This continued into the next day (Sunday). I slept almost the entire day. I had to call out of work on Monday due to severe exhaustion.
She complained of SOB, and fatigue since getting the vaccines but it got worse and she came to the hospital for evaluation. She was also found to have acute kidney injury.
Delayed urticaria (itching, hives) that lasted about a month, body remains itchy on occasion but hives rare now.
During car ride home after vaccines administered vision became black for a few seconds, diaphoresis & dizziness & pallor. Ate crackers & drank lemonade & felt better. Color returned. Throughout the afternoon & evening was dizzy whenever stood up. Felt fine, asymptomatic 8/25 when awoke. No further symptoms
Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of TDAP (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposure in utero, thus 50 (0.7 percentage) neonate patients had blood pH 7.0 or less. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
7/2/19--given immunization as noted--no reaction noted at that time. 7/6/19 in late afternoon-early evening patient began with fever--100 F, general body aches, "nagging" headache. Denied any unusual activity or insect bites as he had been outdoors during that time. Patient has been taking Aleeve and has had some relief of symptoms reported today. Recommended patient see PCP or go to Urgent Care for evaluation due to distance from clinic. Declined by patient as he was getting to travel for business. Recommended patient continue current plan of care--rest, fluids, OTC pain medications and go to Urgent Care or ED is symptoms do not improve or get worse. Patient verbalized understanding and to contact clinic.
Pt initially received Moderna 007C21A on 5/17/21 and today 7/31/21 was given Pfizer EW0217  due to vaccine availability at the event and pt status. Pt insisted and verbally gave consent in getting Pfizer vaccine today despite given the option to receive same vaccine as first dose in a different clinic and different date/times.
Her fever spiked suddenly from low-grade to 104.5 and she had a febrile seizure.
After the first vaccine on the spot I had shortness of breath and complications felt like panic attack. Paramedics came and gave me Benadryl and was ok. I later received the second dose and it was a lot worse my throat started closing off I got a bright red neck had heart complications with high heart rate. I was giving Benadryl and went home. Soon as the Benadryl started wearing off the symptoms started to come back and then I went to the hospital. In the hospital I was given Benadryl and was instructed to take it every 6 hours for 4 days then was instructed to take an antihistamine and Claritin. This lasted about a week and was very sick as if I had poison in my veins for about two months. Felt very achy and lethargic. Felt pain in my arms veins. Have yet to recover.
a rash and swelling at the injection site; a rash and swelling at the injection site; This spontaneous report was received from an office manager and refers to a 48-year-old male patient. There was no information about the patient's concurrent condition, concomitant medication and medically history provided.  On 25-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot number S013490, expiration date 06-MAR-2019, for vaccination (dose and route of administration was not provided).  On 27-SEP-2019, the patient experienced rash and swelling at the injection site. The patient sought medical attention and he called medical practice.  The outcome of the event was unknown. The causality assessment was not provided.  The office manager is requesting a lot check.; Sender's Comments:  US-009507513-1910USA003395: US-009507513-1910USA003334:
4 days after vaccination, I noticed the site on my arm was throbbing, raised, swollen. I woke up in the night, almost fainted, feeling nauseous, vomitting, and feeling flushed, adrenalized, and weak.  The "episode" lasted about 4 hours. After that episdoe, I was nauseous, dizzy, had a high pitched sound in my ears, upset stomach and weakness. I had a second episode 2 days later and went to the ED, where the doctor said it was likely "some kind of weird reaction".  He said I should get checked out by the gastroenterologist since the most pronounced symptom was upset stomach/nausea. He said it would subside over time and recommended Benadryll. That was over a month ago and I am still having symptoms. I have lost 10 lbs, have difficulty digesting food, little or no appetite, exacerbated anxiety, headaches, inflammation, feeling of being flushed like an allergic reaction, intermittent nausea, and cognitive symptoms. I'm waiting to see the gastroenterologist.  I've taken antacids, allergy meds, and Tylenol with little effect.
pt recvd vax 30AUG94 & pt states that few hrs later devel pain, swelling @ site of inject, chills, fever, h/a, malaise; t100-101.3 w/APAP q 4-6 hrs; 1SEP94 inject site swollen, tender to touch, warm to touch; c/o much difficulty & pain;
nausea, temperature 101 controlled by Tylenol, body aches, chills, fatigue
Rc'd vaccine 10/7/16 on 10/9/16 developed SOB and fever-lethargic and had diarrhea 10/9/16 to 10/14/16 went to emergency room and found to have low mag level. Main complaint after vaccine was lethargy and sleepy all day. Patient feels vaccine cause lethargy and fever for longer than expected.
I was not feeling well, vomited and thinking I had the flu. I did home COVID-19 that came back positive so I called my PCP and made a appointment for a telehealth visit. My PCP called in the Paxlovid to my pharmacy and I am now feeling better although I did get a rebound case of COVID-19.
Flu like symptoms: Fever, chills, severe headache, body aches, nausea lasting from 6 p.m. for 18 hours
21 hours lost vaccine-chills fever aches shivering   6 days enlarged bartholin gland  on right side
sore and heaviness on the injection site; heaviness on the injection site; This is a spontaneous report from a contactable Nurse (patient) via Pfizer sales representative. This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient posted on Social Media that she was injected with COVID 19 vaccine. As per her comment, after 8 hours she experienced sore and heaviness on the injection site. Outcome of the events was unknown.   Information on Lot/Batch number has been requested.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case was created for 166th of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2023-704335: Master case
Information has been received from a 51 year old female, with stomach discomfort, osteopenia, lactose intolerance, irritable bowel syndrome, and an allergy to risedronate sodium (ACTONEL) and a history of spinal medication, who on 08-MAR-2006 was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included pantoprazole sodium (PROTONIX), salcatonin (MIACALCIN, "MYACALCIN") and aspirin.  On 08-MAR-2006 the patient developed injection site reaction (including swelling, redness and pain, difficulty moving the left am and difficulty putting weight on the left arm.  The reaction lasted 6 days and the patient recovered on 14-MAR-2006.  Unspecified medial attention was sought.  No product quality compliant was involved.  The patient also experienced stomach upset while on therapy with alendronate sodium.  Additional information has been requested.
The next morning after the vaccine I woke up with a 102 fever which lasted about 24hrs.  I developed a sharp stiff pains in the left side of my neck which went over to the right side which remainded so about 2 days later I went to urgent care and was prescribed a muscle relaxer and pain reliever and within 5 or 6 days after the vaccine all symptoms finally subsided