chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 12 month old male who on 15-JUN-2005 was vaccinated SC in the left thigh with a first dose of Varivax (lot # 648052/1351N). There was no illness at the time of vaccination. ON 22-JUN-2005, the patient developed varicella disease and subsequently recovered on an unspecified date. Additional information is not expected.
Severe headache, chills, fever,body aches lasted approximately 24 hours treatment tylenol
fever; chills; headache; bad body aches; continuous migraine; developed bad body sweats; This is a spontaneous report from a contactable Other HCP reporting for herself. A 29-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number eL0142), intramuscular on 05Jan2021 10:00 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at time of vaccination was 29 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) intramuscular administered on 16Dec2020 at 03:00 PM at single dose in right arm. Medical history included hypothyroidism, polycystic ovarian syndrome, low vitamin D from Apr2020, was diagnosed with COVID19 in Apr2020. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), spironolactone, ergocalciferol (VIT D) birthcontrol pill. On 16Jan2021 at 03:00 PM, all of a sudden developed fever, chills, headache and bad body aches out of nowhere. Fever continued to progress despite Tylenol. Went to the hospital she worked at, and was COVID (Nasal Swab) and respiratory panel tested same night as symptom development at 11pm. Both have since come back negative. The fever and symptoms lasted for another 24 hours and the patient also developed bad body sweats even after fever had been broken. She had no other symptoms like congestion or sore throat that would signify another cause of the fever and symptoms, and  ears and throat where checked at the hospital. The headache she had was similar to the headache when she had covid back in Apr2020. The headache was icepick like along with a continuous migraine. The only thing she did differently was the day before symptom onset, she did a pretty high intensity cardio workout for an hour. The events resulted in emergency room/department or urgent care and were resolving. No treatment was given other than Tylenol for fever.
administrated less than the recommended dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2021, the patient received the 2nd dose of Shingrix. On 27th November 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administrated less than the recommended dose of Shingrix due to a leakage in the syringe. The needle was not appropriately attached to the syringe causing the vaccine liquid to leak. No further events were reported. The reporter agreed to be contacted for follow up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 19Apr2021 as dose 2, single (Lot number: EW0169), in left arm and on 18Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 47 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Narcolepsy" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: SUNOSI, start date: 25Apr2022; TRAZODONE, start date: 05Apr2021; VITAMIN D [COLECALCIFEROL], start date: 05Mar2018; QVAR REDIHALER, start date: 11May2022, stop date: 17May2022; SHAKLEE'S VITALIZER MULTIVITAMIN, start date: 30Oct2019; also reported as other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Negative; (25May2022) Positive, notes: I tested positive on a rapid at home test. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started from 11May2022 to 16May2022. Clinical course was reported as, the patient tested negative on 16May2022 and felt fine. She started noticing mild symptoms again around 22May2022 which she first assumed were allergies. But then she tested positive on a rapid at home test on 25May2022. No therapeutic measures were taken as result of symptoms. The patient was not recovered from the symptoms.
Increased BP 138/101 flushed skin light headed P 115 feeling heart racing
I had arm pain that radiated from the injection site down to my elbow. I was unable to raise my arm or move it in any direction for 3 days.
Information has been received from a physician concerning a 12 year old female with no drug allergies or history of chicken pox, who was vaccinated on 25-JUN-2007 with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot# 656825/0307U) in the right arm. There was no concomitant medication. On 01-JUL-2007, the patient developed shingles around the left eye described as itchy and slightly painful. The physician described the shingles lesions with approximately 8 wet vesicles in a linear pattern below the left eye. There was no recent exposure to chicken pox or shingles. Unspecified medical attention was sought. Lab diagnostic studies included a maximum body temperature of 98.4 F. No specimen was obtained for PCR. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
the day following vax pt exp arm muscle contracting, twitching & tightening lasting 10 days. addl info requested
In 11 days I had mark on the place of vaccine 2.5cmx2.5cm, in 2 days size was 8.5cmx4.5cm. It was red color, warmer than other hand. I didn't have any pain. In 4 days it was nothing there.
Patient received the Pediatric Moderna COVID-19 Vaccine (Primary series for 6-11 year old) instead of the Moderna COVID-19 bivalent booster. Patient had no reaction following vaccination and was discharged. Error was not noted by the LVN who administered until after patient was discharged during her documentation of the vaccine administration. I was notified of the error, and I reported to doctor of the incident as well.
Arm slightly sore at the injection site starting in the evening on the day of vaccination; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER2613), via an unspecified route of administration on arm Left on 24Mar2021 01:15 PM at single dose for COVID-19 immunization. The patient medical history included hypertension. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 The patient Concomitant medications included lisinopril hydrochloride, nasacort, Claritin, Benadryl. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 24Mar2021 07:00 PM, the patient experienced Arm slightly sore at the injection site starting in the evening on the day of vaccination. The patient did not receive any treatment for the events. The outcome of the events was recovered.  Follow-up#01(16Apr2021): Upon follow up, new information included patient concomitant medications.  No follow-up attempts are needed. No further information is expected.
Delayed redness at injection site, approximately size of silver dollar. Area is warm and localized pain.
Pt came in around 430PM on 9/26/2018 to show the pharmacist the reaction beyond his injection site. Area had involved most of bicep and interior of left arm above the elbow. No reaction below elbow, tricep or lower arm/hand. Area was extremely hot to the touch and mildly swollen. I asked pt to ice the area, elevate the arm take TYLENOL for the pain and take oral BENADRYL and apply a little topical BENADRYL GEL. I warned him to see MD immediately if hot red area spreads or lower arm/hand swells.
12 days after injection, pt notes itching, swelling, redness and increased temperature on the L upper outer arm, the same arm where she had the injection
Symptoms started 01/22/05 around 3:15 PM, after injection. Site bled after injection requiring pressure dressing. After 30 minutes, redness began. By 9 PM, redness was the size of a golf ball.  Redness continued to increase and blisters formed at the inection site.
A little off with his food; A little arm puffiness; Fatigue/more tired; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (A little off with his food), PERIPHERAL SWELLING (A little arm puffiness) and FATIGUE (Fatigue/more tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced EATING DISORDER (A little off with his food), PERIPHERAL SWELLING (A little arm puffiness) and FATIGUE (Fatigue/more tired). At the time of the report, EATING DISORDER (A little off with his food), PERIPHERAL SWELLING (A little arm puffiness) and FATIGUE (Fatigue/more tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient came to the pharmacy on 02/23/2023 saying he had swelling and redness in his right elbow 3-4 days after Shingrix administration. He referred to his doctor and his doctor advised him to take Ibuprofen. The swelling became less and redness disappeared. There is still swelling in his right elbow.
Increasing levels of overall body fatigue, headaches, mental sluggishness (fog), mild depression over 6 day period following administration.  The symptoms feel the same as those I experienced with Lyme disease prior to treatment. Unable to  work.
Headache at about 8 p.m., at 7 a.m. the following day had chills, fever, diarhea, and throwing up.
No additional AE reported; the product had a temperature excursion on 9/8/2021; RECOMBIVAX HB expired on 11/3/2022 and a dose was administered to a patient on 11/7/2022; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 08-SEP-2021, that the product hepatitis b vaccine (recombinant) (RECOMBIVAX HB) had a temperature excursion (product storage error). The details of the temperature excursion were unknown at the time of the call. On 07-NOV-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # T022566, expiration date: 03-NOV-2022, formulation was not reported, but upon internal validation established as vial, administered for prophylaxis (therapy type: thimerosal free, strength, dose and route were not provided) (expired product administered). No additional adverse event (AE) reported (no adverse event).
SEVERE SHAKING; 102 F FEVER; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was not on birth control.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced severe shaking. On 17-MAY-2021, the subject experienced 102 f fever. On 17-MAY-2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine  was not applicable. The patient recovered from severe shaking on 18-MAY-2021, and had not recovered from 102 f fever, and severe headache. This report was non-serious.
Initial information received on 14-Jun-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves patient (age and gender not reported) who was given a dose of an expired MENACTRA vaccine, while the patient received vaccine MENACTRA. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of MENACTRA (lot U553988, expiry date: 25-Apr-2018, route and site of administration were not reported). It was a case of actual medication error due to expired vaccine use. It was not reported If the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
After having my 1st dose of the Pfizer vaccine, I have had trouble walking,  reoccurring and constant dizziness, lower back pain with numbness on the left side of my body,  major fatigue, and trouble thinking clearly.  I had NONE of these symptoms prior to getting the vaccine!! I am in pain EVERY DAY!
Upon receiving the vaccine, patient immediately jumped and felt a burning sensation. Patient developed pain in shoulder, arm and neck within minutes. She complained of arm feeling hot/pin and needle sensations, as well as, stiffness for at least 24-36 hours after vaccination. Last update, patient felt slightly better but not completely recovered. Patient to follow-up with MD if symptoms did not resolve.
Chills, fever,  body aches, legs cramps, woke up drenched from sweats, and diarrhea
6/29/18 Parent was contacted and informed that child was given "extra" doses that were not needed and that she may have increased site soreness. No adverse events reported by parent.
Extreme fatigue; headache; body aches; patient received the first dose of BNT162B2 on 19Jan2021 and the second dose on 02Feb2021; patient received the first dose of BNT162B2 on 19Jan2021 and the second dose on 02Feb2021; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 02Feb2021 10:15 AM (batch/lot number: EL9263) at 42 years old as 2ND DOSE, SINGLE for COVID-19 immunization. The patient received the vaccine at a Health Clinic. The patient's medical history included hypertension and hypothyroidism, both from an unknown date and unknown if ongoing. Patient had no known allergies. The patient was not pregnant.  Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included labetalol (LABETALOL) and levothyroxine (LEVOTHYROXINE), therapy dates and indications for both were not reported. The patient received these medications within two weeks of vaccination. The patient has not received other vaccines in four weeks prior to BNT162B2. The patient previously received BNT162B2 via an unspecified route of administration, administered in the left arm on 19Jan2021 01:15 PM (batch/lot number: EL1283) at 42 years old as 1ST DOSE, SINGLE for COVID-19 immunization. The patient received the first dose of BNT162B2 on 19Jan2021 and the second dose on 02Feb2021. On 03Feb2021 05:00 AM, the patient experienced extreme fatigue, headache, and body aches. The patient did not receive treatment for the events extreme fatigue, headache, and body aches. Outcome of the events extreme fatigue, headache, and body aches was recovered on Feb2021.   No follow-up attempts are possible. No further information is expected.
Approx. 10 mins after H1N1 shot (1:07 PM), patient felt dizzy and then fainted. Patient very pale (greenish pale face, white lips) and floppy limbs. Patient responsive, skin warm and dry. Patient could not sit, stand, or walk. Knees/feet turned in when nurse tried to stand her up. At 1:10 PM, patient carried to nurse's office, where patient vomited. Patient alert and responsive, but very pale. Patient's legs elevated, then she could squeeze nurse's hands and began to regain motor control. At 1:15 PM, BP=98/78, HR=96, lips pink but still pale. At 1:30 PM, patient could sit and stand. Patient remained pale with headache and stomach ache until 3:30 PM.
the vanishpoint syringe did not depress correctly and the patient did not receive the full dose of vaccine
With in 24 hours, became hot; Light headed; Felt clammy; Felt sick to my stomach; Vomited; Very weak; slept another 8 hours; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on an unknown date in Feb2021 at 11:00 (at the age of 79-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and levothyroxine sodium (EUTHYROX); both from an unknown date for an unknown indication and was unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on an unknown date in Feb2021 at 11:00 as a single dose for COVID-19 immunisation. On an unknown date in Feb2021, within 24 hours, the patient experienced, hot and light headed. She felt clammy and began to shed the layers, she felt sick to her stomach and vomited. It was reported that she never throws up, the last time she did was when she was 7 years old. She made it to her living room couch and slept 5 hours, she was still very weak, made it to bed and slept another 8 hours. She didn't take her temperature and when she woke, she was more herself but remained weak for several more days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room department or urgent care. No therapeutic measures were taken for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt hot, light headed, felt sick to her stomach, slept for 8 hours and vomited was recovered on an unknown date Feb2021.  No follow-up attempts are needed. No further information is expected.
Patient's wife texted school nurse as he is an employee of school district.  She reported after patient left the school from receiving his vaccine, he began feeling lightheaded, low pulse in the 50's, dizzy, and shortness of breath. Patient has a history of bilateral PE and takes blood thinner.  Patient was taken to the Emergency Department by his wife.
This case was reported by a physician via call center representative and described the occurrence of sinus congestion in a 89-year-old female patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, less than a week after receiving Seasonal Influenza vaccine, the patient experienced sinus congestion, respiratory tract congestion and fever. On an unknown date, the outcome of the sinus congestion, respiratory tract congestion and fever were unknown. It was unknown if the reporter considered the sinus congestion, respiratory tract congestion and fever to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient presented to her clinic with congestion in her sinuses and chest 2 days after receiving flu vaccine. X-rays showed some cloudiness in her sinuses and she had a slight fever. The patient had required an emergency room visit. This case had been  linked with case US2016159850 and US2016159851, reported by the same reporter.
2nd Moderna vaccine administered on 4/29. (First dose 4/1). Arrived to hospital via ambulance on 4/30 unresponsive and hypoxic.  Temp 102.2 .  Patient responsive only to painful stimuli.  Patient was intubated and admitted to ICU.  Noted to have WBC 12.0 and 'patchy left lower lobe opacities suspicious for pneumonia" on chest x ray.   Lumbar puncture positive for human herpesvirus 6.  ( Reportedly receives Ocrevus q 5 months for MS).  He was extubated on 5/1.  Reports feeling fine the day before receiving his second COVID vaccine. After second dose he reports that he felt very tired and has no recollection of being transported to hospital.  Patient is currently on room air with mild SOB awaiting transport to SNF.
Approximately 2 weeks after receiving Varicella, MMR & Hep A vaccine, pt developed rash. Parent describes rash red, non raised, no itchy, et "appeared as red dots." "Does not bother" pt. Rash on front et back of trunk. Pt had low grade fever during this time for two day. "I know it's from teething." Mother reports not taking child to doctor during incident. Lasted couple days.
Patient had a sore arm on the evening of vaccination.  The next morning at 8am he had a fever of 103 degrees, violent shaking, and his lips were numb.  He was transported by ambulance to the ER and admitted.  He received IV therapy and acetaminophen.  He states he vomited February 4th.  An X-ray was performed on his abdomen and he was given a diagnosis of Ileus.  The next day, February 5th, he was able to have a BM and eat.  After he was able to eat, he was released from the hospital.  Shortly after being released from the hospital his lips started breaking out in fever blisters.  He estimates he had 50 or so cold sores and his lips were extremely swollen and red.  After seeing his regular health care provider, he started a round of Valcyclovir.  On February 10th, the date he reported the adverse reaction, he stated his lips were getting better and he still had more Valcyclovir to take.
Rash occurring bilateral legs, arms, face, chest, feet and hands. Erythema only. No fever. Benadryl prescribed 1/2 tsp TIO to PRN.
The patient cannot lift the left arm or cannot even carry a coffee cup, doctor suggested to go for MRI.