chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a consumer on 05-Jan-2017. This case involves a 55 year old male patient who was vaccinated with a dose of ADACEL Batch number- U5489AA intramuscularly in left deltoid and MENACTRA batch number- U5513AA intramuscularly on right deltoid (expiration date, dose, dose in series were not reported for both) on 06-Dec-2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination was denied. Any other vaccinations within four weeks of vaccinations was also denied. On 07-Dec-2016, 24 hours following vaccination of ADACEL patient experienced pain in left deltoid which persisted and had trouble raising his left elbow above shoulder. Laboratory investigations were none and corrective treatment were not reported. The outcome of events were reported as not recovered. List of documents held by sender: none.
Developed shortness of breath  and low oxygen saturation the week of 1/22/23 resulting in a dr visit on 1/27/23. Found to have bilateral pulmonary embolii on cat scan. Admitted to hospital for 3 days for heparin therapy and followup echocardiogram and doppler studies. No history of recent travel, surgery or injury. Found to have a DVT behind left knee on Dopler studies. Discharged on Eliquis with outpatient followup
Initial report was received on 24 September 2014 from a health care professional , who is also the patient. A 51 year-old female with a history of allergies to erythromycin (anaphylaxis) and DILANTIN (rash) had on an unspecified date in 2010 an intramuscular injection of FLUZONE (lot number and site of administration not reported) and five days later, experienced a headache. The patient described it as a tension headache but slightly worse. The headaches progressed to occur almost daily. In December 2010, the patient was hospitalized. The patient had a CT scan, MRI and EEG all was negative. She was evaluated by a neurologist. According to the patient, the headaches lasted six months and then resolved in 2011. The patient continued to receive the flu shot each year with the same result but less than 2010. According to the reporter, she thinks that this happens no matter who the manufacturer happens to be. The patient's outcome was recovered. Documents held by sender: none.
First I was constantly coughing all night long.  had a dry hack for the whole night. I thought it was a cold because that night I tested negative. The following day my son said I need to get Paxlovid so I had to go to the emergency room. They did blood, work, x-ray, oxygen test, blood pressure. All the tests came back fine. They tested for COVID-19 and that came back positive. I took the medicine but I ended up vomiting them back up. It was perfuse, it lasted the rest of the afternoon. I was given a nausea medicine, Ondansetron, to keep the medication down. I also had diarehea. I didn't have a fever. I was told to check after 5 days to see if I was still positive. My whole abdomen was aching from coughing so much.
Sore left arm, bruise. Very sore, swollen lymph node. Sore upper left arm.  No fewer and no other concerns.  As of 3/13/21 still slight soreness.
received the first COVID vaccine on 7/12/22 without incident received the second COVID vaccine on 8/9/22: that night she developed fevers without other symptoms. 8/10/22 in the evening no further fevers. And then Hives throughout her body developed on 8/11/22
No menstrual cycle. Month of vaccine. Long term changes to menstrual cycle. Weak menstrual cycle.
None. Expired vaccine 10/25/2022. GIVEN 02/17/2023
Dizziness, Tachycardia, anxiety Narrative:  Employee was had nausea, felt like her head was full, tachycardic, nervous, anxiety, felt faint
Nausea; Fatigue; Muscle aches; This case was reported by a consumer via sales rep and described the occurrence of nausea in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced nausea, fatigue and muscle pain. On an unknown date, the outcome of the nausea, fatigue and muscle pain were recovered/resolved.   It was unknown if the reporter considered the nausea, fatigue and muscle pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced nausea, fatigue, muscle aches lasting for 3 days.
Client note "small amount of swelling and pain below both ears" began morning of 3/8/11. Instructed by PA to avoid pregnant women and comfort measures: ice to swollen areas, TYLENOL prn. Becomes worse or symptoms increase, call P.A.
Patient had redness, swelling and pain at site of vaccine. Contacted PCP and was able to get an antibiotic called in for her.
Began with upset stomach, nausea, shortly after shot. Then developed difficulty breathing, shortness of breath. To2 puffs of Primatene mist inhaler (contains epi), with slight improvement. Repeated zyrtec and inhaler, and finally symptoms subsided.
I was administered the wrong vaccination- was supposed to receive DTaP, was given HPV vaccine, which is not indicated in pregnancy.
10 cm x 10 cm area of cellulitis at right thigh. Treated with atrilemtine (?) and Zyrtec 2.5 mg.
Rash on lower right back consistent with shingles per MD. 2 days after SHINGRIX Vaccine. Pt given ZOSTAVAX back in 2015. Started on VALTREX 1g PO TID for 7 days.
Severe urticaria covering most of the body beginning in December 2021 and continuing to present.
patient was accidently given monovalent instead of bivalent Pfizer vaccine at 10 am 09/22/2022. pharmacy reschedule patient for bivalent vaccine 2 months from 09/22/2022.
the skin in these areas burns; Itching; her lips peels off; the skin peels off; Nausea; first lesion around her right eye / getting several lesions above her right eyebrow, on the right eyelid and on the far outside corner of her right eye / lesions were red; Shingles; This case was reported by a consumer via call center representative and described the occurrence of skin lesion in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number TE493, expiry date 19th October 2021) for prophylaxis.   On 16th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th August 2019, 2 days after receiving Shingrix, the patient experienced skin lesion and shingles. On an unknown date, the patient experienced burning sensation skin, itchy skin, peeling lips, skin peeling and nausea. The patient was treated with valaciclovir (Valacyclovir) and famciclovir. On an unknown date, the outcome of the skin lesion and shingles were recovered/resolved and the outcome of the burning sensation skin, itchy skin and peeling lips were not recovered/not resolved and the outcome of the skin peeling and nausea were unknown.   It was unknown if the reporter considered the skin lesion, shingles, burning sensation skin, itchy skin, peeling lips, skin peeling and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. On 18th August 2019, the patient got 1st lesion around right eye. On 19th August 2019, the patient went to physician and told that, it was shingles. The patient ended up getting several lesions above her right eyebrow, on the right eyelid and on the far outside corner of her right eye. The lesion were red and round. The patient stated that, the lesions were resolved but but the skin in these areas burns, itches, and the skin peels off. The patient also reported that, the skin on lips peels off. The symptoms were less than they were the first three weeks. The patient received valcyclovie and experienced nausea, so the patient stopped that product and took a full course of famciclovir. The reporter consented to follow up.
Pts. Mother calls me and pt. apparently started having some diarrhea yesterday 48 hours after vaccine.  Stated he became crampy in morning. stated his right forearm hurt and his right vaccine site was sore. Pt received the Menn A in his right arm on 6/12/23.  Pt last night had low grade fever 100.5 generalized body aches and vomited a few times and had loose stools.  States he did eat raw hot dog the day before as well , but others did also and did not get ill.  Today he still has no fever, feeling a little better still a little worse stools. I offered a visit today for evaluation. Mother wanted to wait another day. I told her pt. should be seen today if he has a fever, does not continue to improve, if the site with redness does not continue to improve.  We discussed the importance of hydration .  We discussed that with it being more than 24 hours after vaccine may not be vaccine related but the fact he had two vaccines could have potentiated a bug he picked up. Pt works outside in sun all day at the park and recreation so perhaps this work in heat could have potentiated a more intense response.   Mother verbalized understanding.
Within 5-10 minutes of administration, child began complaining of burning sensation in hands and feet, then ears.  progressed to circumoral cyanosis, coughing, nausea.  Administered:  0.3ml Benadryl IM and 0.15ml Epinephrine SQ.  EMS transported to ER where evaluated by MD.  Treated with Prednisone and given Prednisone to take at home
Tinnitus has worsened greatly.  Ringing would only occur sporadically in silent rooms.  Now ringing is persistent.
Shingles; Information has been received from a lawyer regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. In or about 2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a physician at a medical center for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the pt was treated at a physician office for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of herpes zoster was considered as not recovered. The lawyer considered herpes zoster be related to zoster vaccine Live (ZOSTAVAX).
Injection site reaction that has been red, hot sand feel hard.   The size of the area grew to 2.75 inches by 3.5 inches.   10 days post reaction the site continues to feel hot and the integrity of skin is hard and red.  The size has decrease.
~ 2 minutes after shot, extreme dizziness, nausea, difficulty breathing, tingly arms, weakness in legs.
This is spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date in June 2016 (reported as "between 16-JUN-2016 and 17-JUN-2016), the patient was vaccinated with improperly stored doses of M-M-R II (which had a lot number of L027591 and an expiration date of 23-JUL-2017; however, the therapy type was not reported) and VAQTA (the lot number and expiration date were unknown) (the dose, dosage number, route of administration and anatomical location, for both vaccines, were unknown). No concomitant medications were reported. The vaccines experienced a temperature excursion of 16.1 degree C for a time frame or 22 hours and was called out due to a data logger. There were, reportedly, no previous temperature excursions. Despite being vaccinated with such improperly stored vaccines, no adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient became light headed and fainted shortly after receiving vaccination. Patient recovered shortly after at least 10 seconds.
Vaccine did not work for him/antibodies test came negative; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Vaccine did not work for him/antibodies test came negative) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 028B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DRUG INEFFECTIVE (Vaccine did not work for him/antibodies test came negative). At the time of the report, DRUG INEFFECTIVE (Vaccine did not work for him/antibodies test came negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Antibody test negative: negative (Negative) antibodies test = negative.         Concomitant product used was not provided by the reporter.  This patient has experienced no symptoms after vaccination administration.  No information regarding expiration date of vaccine reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
FAILURE TO THRIVE; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned an neonate male. The mother of neonate was enrolled in a non-company sponsored study. The patient's weight was 3.68 kilogram, and height was 53 centimeters. The patient had no birth defects, genetic or inherited disorders have been diagnosed since birth. The patient's mother had 2 previous stillbirth, and 2 previous miscarriage, and concurrent conditions included: vaginal bleeding, and smokers cough. The mother had no history of exposure to tobacco, drugs for recreational use or alcoholic beverage. The mother's Last menstrual period was calculated on 22-DEC-2020 and On 16-SEP-2021 (gestation age of 38 weeks and 2 days), the mother delivered a live, male, full-term neonate via caesarean method of delivery (C-section). Delivery was induced due to gestational high blood pressure and as the labor was not progressing (primary indication). The neonate's birth weight was 7 pounds and 1 ounce, baby length 21 inches. The mother of neonate initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: Unknown) dose was not reported, frequency time 1 total was administered on 26-MAY-2021 (gestation age of 22 weeks and 1 day) (fetal exposure during pregnancy) for Covid-19 immunization. Concomitant medications included Prenatal plus (minerals NOS (unspecified)/vitamins NOS (unspecified).  On an unspecified date in SEP-2021, the patient had hearing test (NR: not provided) but the result was not reported. On 15-Oct-2021, the patient developed failure to thrive and was admitted to the hospital. On the same day, he tested negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 16-SEP-2021, and the outcome of failure to thrive was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and failure to thrive was related, and between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This is linked to 20210800799 (mother case).; Sender's Comments: V0: 20211119816 -COVID-19 VACCINE AD26.COV2.S-Failure to thrive. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).. 20211119816-COVID-19 VACCINE AD26.COV2.S-Fetal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I received the Moderna vaccine for my 1st and second shot. On January 11th I got the Pfizer booster shot and within 5 minutes I started experiencing an allergic reaction. My face and neck felt hot and I broke out in a rash. In the ambulance I started feeling like I was going to be violently ill and was given a nausea med via IV that helped immediately. I experienced abnormal heart symptoms. The ER gave me anxiety meds by IV but my heart kept jumping up to 140 bpm (on my fitbit) randomly for some time then coming back down to 70-80 bpm. The following three days I felt like I had extremely high blood pressure. Doing activities like blow drying my hair would spike my heart rate back up over 130. I would have to take breaks a lie down. Sometimes while watching TV my heart rate would randomly accelerate to 130 for no reason. Now I still have these side affects but I am used to them and they are less intense. I have adjusted my lifestyle and significantly cut back on my activity level. I am 5'9 weigh 134 pounds and I was in great shape prior to this working out 5x a week and weightlifting.
Stroke with aphasia. Was in the hospital for shortness of breath, being evaluated. Woke up in the morning with acute onset of aphasia. Swallowing and motor strength good. Does have history  of strokes in the past but didn't have residual deficits.
Blistered lips and extreme skin flushing on the face began 5 days after the vaccine was administered. Consistent fevers of over 101 degrees for 3.5 weeks. Tried to seek help for most of that time but neither my doctor nor any urgent care in the area would see me because I had a high fever even though I had negative covid tests. Experienced fatigue and cognitive decline and confusion with extremely high fevers. Went to the emergency room with 104 degree fever and they could find no cause. They referred me to infectious disease doctor who put me on steroids to reduce what he called a heightened immune response to the vaccine. The steroids seemed to end the response and fevers.
Noted vision deficits at an optometry exam - went to ER for stroke workup, demyleniation was noted in the brain, follow up MRIs were consistent with Multiple Sclerosis. Unclear if this started before or after the vaccine.
PT IS 209lbs, 28 wks 2 days, EDD:12/04/2022
Mouth and tongue feel raw, I can't eat anything with tomato sauce, or other spices.
Information was received on 20-OCT-2016 from a 55 year old female consumer who was reporting on herself. The patient's medical history included previous episode of shingles. She has a history of "many reactions to unknown medications". The patient was taking concomitant medications but they were not reported. On 19-OCT-2016, the patient received a dose of ZOSTAVAX (lot, dose, route and site were not reported). On 20-OCT-2016, the patient reported that she had a rash around the injection site after receiving ZOSTAVAX. The patient also reported that she was developing a headache. The patient has not yet recovered from the events. The patient did not receive treatment but did speak with a pharmacist. The causality was not specified. The pharmacist had previously reported this information but that case could not be located. Additional information has been requested.
Patient received a expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Kinrix, which led to expired vaccine used. The patient seek advice. The reporter consented to follow up.
Fatigue, Hot flashes, nausea, dizziness, Diarrhea, stomach pain, UTI
stomach ache; dizzy; Migraine; Head was really foggy  she could not concentrate; experienced some allergic reactions; itchiness all over the body; diarrhea; body ache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. Medical history included allergic to Sulfa (almost died when she had it) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unknown date in 2021, the patient experienced some allergic reactions like itchiness all over the body, diarrhea, body ache, stomachache, was dizzy, had migraine for 3 weeks, and head was really foggy she could not concentrate. When patient went to get the second dose of the vaccine, the pharmacist told her that due to her allergies, she should not had gotten the first dose because sulfur was a component of the vaccine and would not give the patient her second dose. The patient wanted to know if sulfur was a component of the vaccine. Response from Pfizer mentioned that Sodium Chloride is listed as an ingredient of the Pfizer BioNTech COVID-19 vaccine and Sodium Chloride may contain trace amount of sulphate which can be converted to sulphite. The patient wanted to know if she can get the second dose of the Pfizer COVID-19 vaccine considering her allergy to sulfur drugs and her experience (some allergic reaction) with the first dose of the vaccine. The outcome of the events migraine and head was really foggy she could not concentrate was resolved on an unknown date in 2021. The outcome for the other events was unknown. The patient declined to make a report.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Breakthrough case admission after 5 vaccines Moderna 3/19/21 Lot# 006B21A;  Modern a4/16/21 Lot# 043B21A;  Moderna 2/8/21 Lot# 029H21B;  Moderna 4/13/22 Lot# 002M21A;  Pfizer 12/21/22 LOt# GJ3275
I had tingling/swelling in tongue and body itching for 30 minutes post vaccine, then felt light headed/dizzy and almost passed out. Then about 8 hours later I noticed my arm was swollen, hard, red, puffy and hot at injection site.  It continued to get worse the next day. I was extremely tired and felt " like I was hit by a truck " for almost 2 days later. Pain in arm continued for a couple days later.