chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 6 year old male with no drug allergies who on 14-MAY-2003 was vaccinated with VARIVAX vaccine (Merck) (Lot # unspecified), 0.5 ml, subcutaneous. Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) VARIVAX vaccine (Merck upgrade process) (Lot# 657535/05441U) received on 07/17/2007. On 24-MAY-2008 the patient developed chickenpox. He was seen by his physician on 28-MAY-2008 and the diagnosis was confirmed. The nurse mentioned that "the severity level was a 2."  Meaning that the patient experienced between 50-500 lesions. On 06-JUN-2008 a call was received from the nurse. She explained that the patient never really had full blown pustules. Per mother, it was more pimple-like. Subsequently, there were no scabs and the patient recovered from the event. No further information is available.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
I had major heart surgery; Didn´t get the 2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of cardiac operation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced cardiac operation and incomplete course of vaccination. On an unknown date, the outcome of the cardiac operation and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the cardiac operation to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine and It had been more than 6 months after that he/she had major heart surgery. Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient asked what were the consequences of getting the 2nd shot almost 9 months after the first, was it safe. The follow-up would not possible as no contact details were available.
I have the Nexplanon implant and have not had a period since I had it. Two days after my second dose of the Covid vaccine I am now having a full period.
Low grade fever - taking Tylenol every 6 hours; headache; dizzy; neck pain; pain in lower chest; tired.  As of 12:23 pm on 4/13, still experiencing low grade fever.  Neck pain has reduced, no longer dizzy and pain in lower chest subsided
7JUN93 115PM mom states pt had body rash; also ROM given ATB & APAP; mom states fever began 2JUN93 & rash broke out 2 days later;
24 hrs after receiving HEP A & MENACTRA pt. felt achy, left knee pain - occasional limp
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; Covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient previously received a COVID-19 Vaccine. The patient did not have any no Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, latency 5 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details were product-COVID 19 Treatment, brand-Paxlovid, Treatment start date-03May2022, Treatment stop date-08May2022. Reported Event: Explosive diarrhea and GI symptoms after ending full course of Paxlovid. Adverse events start date was 08May2022 if patient recovered was Recovering. If treatment ae was no. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
Onset of redness, swelling and tenderness 8x9cm at injection site without fever, dyspnea of fluctuance. TX with ice, Abx and f/u and NSAID.
I had typical side effects for about 24 hours after the first dose.  One day before my second dose I noticed cold/flu-like symptoms.  Two days after my second dose I tested positive for covid.
Adult pt received pediatric dose; Adult pt received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 59-year-old male patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st December 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 1st December 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The HCP reported that the 59 year old patient received pediatric dose of the Engerix-B, which led to underdose and adult use of a child product. No reactions reported. The reporter did not consent to follow-up.
First vaccine, I was sick for a week. Second,I am 5 days in and still feel bad. Not as bad as Sunday but so fatigued, headache, nauseous, but not as bad as before and achy. Brain fog is moderate.
Temp began 4PM, diarrhea continuing to 28JUN, pt had vomiting x 1, no problem w/previous immun, taking APAP;
I got the vaccine on February 1, I experienced pain in my arm. A week has passed and my arm had swollen and it became red and abnormally large. It took about a week until it disappeared but it feels and looks as if I have a bump under my skin. My daughter is a medic so I got my blood work and urinalysis done with her.
Flulike symptoms, 101-102 temp, aching all over body, swelling on face, lips, and inside throat that didn?t start until the next morning and continued throughout the day.  Swelling continues still.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 42 year old male. Initial information was processed with the additional information received on 03-FEB-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, 1 total, administered to right arm on 31-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-FEB-2022, the patient experienced runny nose, slight headache, cough (suspected covid-19 infection) and tested positive for covid-19 using a binax now take home antigen test (suspected clinical vaccination failure). Laboratory data included: COVID-19 antigen test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000216067.; Sender's Comments: V0: 20220208065-- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
DTaP, IPV, MMR given, 5 minutes later Mom says he told her he didn't feel good.  She took him to bathroom where he threw up, I say pt. then, he was pale, no color around his muth, listless, pt was laid on couch with feet elevated, color and alertness returned after 10 minutes.
crying x 4 1/2hrs p/vax; high pitch cry;unconsolable
ERYTHEMATOUS PAPULAR RASH ON FACE, WARM TO TOUCH.   BENEDRYL 50 po x1 VITALS Q 5 MIN
Information has been received from a health professional concerning a 7 yr old female who on 01May00 was vaccinated with a dose of varicella virus vaccine live. On 30Sep05 the pt had a chickenpox breakthrough. It was reported that the pt's mother called the school the report that the child had a generalized rash over her body, with about 30 pox and a temp of 103. The pt was out of school the week of 03Oct05, and returned back to school on 11Oct05. The pt fully recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that there was no additional information to be reported. Additional information is not expected.
Female patient 41 year old, refers to EMT, not feeling good after 15 minutes after receiving vaccine not feeling good and needed of air and dizzy and cold to the touch. At 9:55 am vitals are taken 85 pulse, 99% saturation, 110/70 BP Dxt 101. Dr. is consulted and recommend to position the patient in Trendelenburg position for 30 minutes in observation. Re-evaluation at 10:30am P 75, Sat99%, BP 90/60. At 10:40am pressure is taken 100/80 BP and we consult with the patient and refers feeling better.
Varicella injection red indurated area without drainage, slight warmth to touch present. Area measures 20 cm L x 1cm W, no temp. Varicella injection given 7/30/08 at 12:08 pm. Mom noticed red area within 24 hrs of vaccine. Benadryl and Alternate warm and cold compresses L arm.
prescribed the medicine for COVID; prescribed the medicine for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hospitalization" (unspecified if ongoing), notes: I have already been in the hospital. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "prescribed the medicine for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: prescribed the medicine for COVID.  Clinical course: Patient was just prescribed the medicine for COVID, the Paxlovid. Patient had not taken yet. Patient just got it yesterday. Patient was reading some other side effects and stuff. Patient stated, Yes because patient was just kind of leery like patient said he/she mean patient knew patient  need to take it but patient was just kind of leery of the side effects. Patient mean had not got booster yet. Patient had gotten the first two shot but they were Pfizer (Further not clarified over the call hence suspect captured as Unspecified shot and Is this a Pfizer product checked as Yes). Patient was not saying patient did not trust Pfizer but patient was just leery of what patient read on the side effects. Patient knew patient need to take it but patient hope it did not make patient worse than what patient was now (Further clarifications unknown hence event captured as per verbatim; prescribed the medicine; Paxlovid). patient stated, Okay because that only patient had already been in the hospital and suffer (Further clarifications unknown) and patient did not want to go back because of the side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
approximately 45- an hour after the injection I had some rapid heart rate and shortness of breath. Around lunch I had a hard time swallowing  with more shortness of breath and rapid heart beat .  My arm became increasingly  sore throughout the day with a swollen lump protruding from my sleeve. That afternoon around 5 pm when I got home from work I decided to take off my shirt to look , a red rash had begun to form up my arm into my left  shoulder.  I applied ice and took Ibuprofen 800 mg . The next morning I awoke to a very swollen arm with a large knot at the injection site. I hurt from the injection site all the way up to my neck. The Rash and pain continued for a couple more days into the weekend. I consult my physician and was told to continue Benadryl and Zyrtec.  One week after receiving the vaccination I did not feel well and was sent to the CRNP for employee health. I had muscle aches, body aches, low grade temp, sinus pressure, tired, sore throat. I was given a covid, flu A&B test which all came back negative. Over the next  two weeks I have experienced extreme fatigue, random low grade temps, muscle aches , sore throat, and neck soreness.
Upon awakening, there were multiple red, tiny raised papules (vesicular) (perioral) on her upper lip, philtrum and on the skin of the chin.  The upper lip was slightly swollen.  She was itching as well.  It worsened over 12 hours, became more itchy/swollen.  After 6.25mg of diphenhydramine and 12 more hours, the papules are resolving.  The upper lip (including the vermillion) has a residual patch of erythema/mild swelling that appears more flat and is hopefully resolving.  She had a mild cough & slight runny nose during the 1st 48 hours after the H1N1 nasal mist vaccine.  There were no oral ulcers/lesions.
Patient spoke with staff and stated that she had developed a rash on her arm and now is spreading to her back. Staff recommended taking oral Benadryl and contacting her doctor in the morning
Lower right leg vein popped out about 1/2-3/4" - didn't feel anything; Lots of petechiae from back to feet; Blood blisters; Turned into bruise; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 07Mar2021 21:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included allergies: anesthesia and thrombocytopenia that developed during childbirth (went away after a few weeks). The doctors said that it may have been a drug reaction. Concomitant medication included omeprazole (PRILOSEC). The patient previously took codeine and experienced allergies -severe nausea. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 08Mar2021 18:00, patient's lower right leg vein popped out about 1/2-3/4" but did not feel anything. It later turned into a bruise. Lots of petechiae from back to feet and blood blisters noticed; large on torso. AE resulted in: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for AE. It was also reported that the events caused hospitalization. Platelets were tested last week (unspecified date in 2021) and are on low end of normal range. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Stated couldn?t see blurred vision sweaty fainted was out for 15 minutes didn?t wake up until got to the hospital had just left pharmacy at 11:25 arrived at the hospital daughter woke up didn?t realize she passed out they check her sugar it was 70.
Diagnosed with COVID / The first vaccine was 17Dec and then she tested positive 31Dec; Diagnosed with COVID / The first vaccine was 17Dec and then she tested positive 31Dec; This is a spontaneous report from a contactable Pharmacist. A 64-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: UNKNOWN), via an unspecified route of administration on 17Dec2020  (at the age of 64 years) as a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020,  the patient was diagnosed with COVID-19. The first vaccine was 17Dec2020 and then she tested positive 31Dec2020. The event was reported medically significant. The patient had lab tests which included sars-cov-2 test: positive on 31Dec2020. The patient went to the emergency room (ER) at the time she was diagnosed with COVID. She was there in the ER overnight. After being diagnosed with COVID she was prescribed Flovent, Flonase, Pro-Air. The clinical course was as follows: Pharmacist had a patient who received the first dose of COVID Vaccine on 17Dec2020 and after receiving the first dose patient was diagnosed with COVID two weeks later on 31Dec2020. The patient received infusion therapy of antibodies clarified as, as spelled out,  Bamlanivimab on 01Jan2021. They are debating since it is coming up on 90 days after the first one and receiving the infusion therapy how to proceed. They are wondering if patient needs to restart the series or can she just pick up where she finished and get the second shot. The pharmacist stated she is thinking the patient would only need to get the one remaining, finish up by getting the second shot,  but she was calling to double check. Others are debating saying the patient needs to get the whole series over again. The clinical outcome of the event diagnosed with COVID-19 was unknown.  The pharmacist reported Diagnosed with COVID - Unrelated to COVID vaccine; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Case number PHEH2014US004151 is a combined initial and follow up spontaneous report from the pharmacist received on 27 FEB 2014 and on 28 FEB 2014. This report refers to a male child who was accidently vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly on 10 JAN 2014. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 27 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
have cold symptoms; Cough; Fever; Stuffiness/Congestion; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 26Jan2021 at 15:00 (at the age of 40-years) as single dose for COVID-19 immunisation. Medical history included diabetes and hypertension. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included jardiance, atorvastatin, unspecified vitamins and some unspecified prebiotics. On 28Jan2021, the patient had cold symptoms, cough, stuffiness/congestion and fever. The patient did not receive treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  The batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
administration of expired dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix 1440) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 13th July 2022, the patient received Havrix 1440. On 13th July 2022, unknown after receiving Havrix 1440, the patient experienced expired vaccine used. On 13th July 2022, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-Jul-2022 Reporter's Comments: HCP reported administration of expired dose of Havrix to a patient. At time of call, patient's Date of Birth was unavailable. Additional Supportive Information: The patient received vaccine on 13th July 2022 which was already expired on 18th June 2022.
INJECTION SITE PAIN/SORE ARM; LUMP AT INJECTION SITE; REDNESS AT INJECTION SITE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022) dose was not reported, once a total administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced injection site pain/sore arm. On 06-MAR-2021, the subject experienced lump at injection site. On 06-MAR-2021, the subject experienced redness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain/sore arm, lump at injection site, and redness at injection site. This report was non-serious.
Wife called 4-9-12, said arm spot was red at injection site from 3-22-12. Said light soreness, some itching. Said had BACITRACIN at home & wanted to use some.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Severe, Additional Details: . After covid vaccine was given pt sat in waiting aread then after about 2 minutes began to feel woozy, loss color, and hr dropped. ambulance was called, upon their arrival bp and hr was still low pt was taken to er. I called the mom after about 30 mins to check on honesty and she informs med ekg was fine, hr and bp increased and color came back and honesty was doing much better.
2-3 inch diameter ecchymosis (dark purple) at injection site of left deltoid, no pain, just discoloration, shown to pharmacist on 12/10/10