chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's husband reported that the patient experienced "extreme" pain in the left shoulder and that it hurt to move. The husband also reported that the patient had difficulty in performing normal activities for two days. Then reported that "She's fine now" indicating unknown duration for recovery from pain after immunization.
2nd day after the vaccine both ears started ringing. (tinnitus) Lasted for about a week.
Severe itching all over body. Body swollen where itch sites. Has lasted over a month now. Has not gone away. Was given Benadryl and steroids. Has not helped.
Mother reported swelling at site of injection and fever. Dr then recommend ice for arm and MOTRIN for fever.
This spontaneous report was received from a nurse via company representative and refers to a 12-month-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 02-AUG-2017, the patient was vaccinated with a dose of VARIVAX one time injection (dose, route of administration, lot number and expiration date were not reported) as a regular chicken pox immunization. On the same day, the patient experienced a red diffused maculopapular rash on her body, face, soles of her feet, and palms. The patient had also low grade fever. On approximately 09-AUG-2017, about one week after the onset of the events, the patient recovered. The relatedness between the events and VARIVAX was not reported.
MODERNA COVID VACCINE #3 GIVEN 10/21/21, LOT #007C21B; pt lives in nursing home; 1/4/22 positive for COVID; no sx; O2 saturation 93-94% on RA; over time increase in lethargy; given Rocephin; condition continued to worsen; pt found expired in the facility
BODY ACHES; CHILLS; FEVER; This spontaneous report received from a health care professional concerned an 18 year old female. 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: 1808978, expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid muscle on 03-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021 18:00, the patient experienced body aches, chills and fever. On 03/Apr/2021 at 18:00; the patient had fever of 100.1 (unit not specified) and was treated with 2 extra strength Tylenol. At 22:00 the patient had fever of 101.0 (unit not specified) and patient was treated with 2 Ibuprofen 200 milligram. On 04-Apr-2021, at 14:30, the patient had fever of 102.9 (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and body aches. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210407171-covid-19 vaccine ad26.cov2.s-Body ache, Chills. This event(s) is considered unassessable. 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). 20210407171-covid-19 vaccine ad26.cov2.s-Fever. This event(s) is labeled per agency and is therefore considered potentially related.
On Sunday May 21st pt broke out with rash became progressively worse. Brought pt into clinic today 5/23/06 pt was given Zymine for rash.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 14-year-old female patient who received BEXSERO (batch number 148901A, expiry date September 2016). On 14th April 2016, the patient received the 1st dose of BEXSERO. On 14th April 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain (serious criteria other: serious as per reporter), feeling unwell, general body pain, fever and chills. In April 2016, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the feeling unwell, general body pain, fever and chills were unknown. It was unknown if the reporter considered the injection site pain, feeling unwell, general body pain, fever and chills to be related to BEXSERO. Additional details provided were as follows: This case was reported by a medical assistant. The reported injection site was right arm. The patient experienced fever, chills, body aches, general ill feeling within 4 hours of vaccination with BEXSERO. She also experienced soreness in her right arm at the injection site for 10 days. The symptoms resulted in an emergency room visit for the patient, but it was unknown if the patient was admitted to the hospital.
30 year old Received Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 30-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-JAN-2023, the patient received the 1st dose of Shingrix. On 21-JAN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 30 year old Received Shingrix). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 27-MAR-2023 The pharmacist reported that 30 year old patient who was not immunocompromised received the 1st dose of Shingrix. No symptoms reported. The pharmacist reported that 30 year old patient who was not immunocompromised received the 1st dose of Shingrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up via mail.
Less than one minute after vaccine administration patient stood up from clinic bed and sat in bedside chair and requested water. She then slumped forward and was guided to the ground by the provider. She had full loss of consciousness and was not responding to verbal stimuli. She appeared to have irregular breathing without evidence of cyanosis. She woke less than 30 seconds later and stated she was fine, she was returned to a seated position and began having multiple episodes of emesis. On follow up appointment patient reported that it took about 4 hours for her to feel back to her usual self.
I am putting 3 times the vaccine; feel like burn my head/burn in my brain; headache; fever; pain in all my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3(booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "I am putting 3 times the vaccine"; BURNING SENSATION (non-serious), outcome "unknown", described as "feel like burn my head/burn in my brain"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "pain in all my body".  Additional Information: Patient states that he had putting 3 times the vaccine and he felt like burn my head, headache, fever, pain in all my body, but the most is like burn in his  brain, he is worried about this burn in her brain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Thursday evening swelling in entire hand/arm; tightness and stiffness. Pain due to muscle stiffness.  Headache  Dehydration  Full body muscle pain and fatigue
Nosebleed on 8/29/03. On 8/30/03, pt complained of joint pain, abdominal pain and nausea. 2 nosebleeds on 8/30/03. On 8/31/03, pt was lethargic and experienced malaise all day. 9/1/03 complained of joint pain. 9/2/03 had swollen joints (knees) and difficulty walking. Visited Dr on 9/2/03. 1st blood tests performed. Visited Dr again on 9/4/03. Dr diagnosed Henoch-Schoenlein Purpura. Did hemoccult and UA. Put on steroid, Predaped. Out of school 9/5, 9/6 and 9/7. Returned to school on 9/8. Broke out with rash again on 9/8/03. Dr advised to keep pt at home. Back to Dr on 9/13 complaining of abdominal pain. Did another hemoccult and UA. Mother has not heard from results of those tests. Pt returned to school on 9/15/03. Rash still comes and goes. Joint pain is better.
On the evening of the vaccine administration, patient developed a raised quarter-size area over the injection site.  Overnight, his deltoid began to swell.  When seen 11/23, there was an orange circle surrounding the injection site.  It was no longer raised, but the entire deltoid was swollen, warm to the touch, and painful.  Rx ibuprofen and cold compressing.
Pt received covid 19 vaccine. While sitting during observation, PT began to feel nauseous and dizzy. EMT responded to evaluate PT. PT stated that he was feeling sick. PT went to bathroom and began to vomit. PT refused transport.
Severe headache different in nature from my normal migraines and not relieved by taking rizatriptan. Pain was throbbing and pressure in nature, 8/10 lasting approx. 10 hours. Also experienced fatigue during same time frame.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 79-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The caller reported that the patient received SHINGRIX 8 months ago and had a little soreness that went away after about 1 day. The reporter did not consent to follow up. This case linked with US2019050314, reported by same reporter for the same patient.
Administration of ZOSTAVAX 4-7-09, development of vesiculated, burning, itching lesions of back 4-11-09
pt recv vax 1989 & 1989 pt exp a low titer;the pt was again vaccinated in AUG96 & rubella titer in OCT96 was negative;
pt recvd vax 3JAN96 & gen urticaria devel w/hand & foot edema;reaction arthritis lt knee;examined 23 & 25JAN96;10JAN96 unk etiology-rx motrin orally;
Information has been received from a 59 year old female health professional with a history of pneumonia who on 20-OCT-2006 was vaccinated with her second dose of Pneumovax 23 (lot# 651319/1007P).  The patient's first dose was received 10 years ago.  On 20-OCT-2006, "within hours post vaccination", the patient's left arm became red, hot and swollen from the front to middle back of arm.  The patient indicated that it "felt like a tourniquet."  The patient went to the emergency room and was given oral antibiotics and was released from the ER.  The patient was not hospitalized.  Subsequently, the patient recovered from left arm being red, hot and swollen.  No product quality complaint was involved.  Additional information has been requested.
Pt expressed concern about pregnancy at screening visit, pregnancy test was done on day of vaccination. Pregnancy diagnosed 06Oct05 (LMP:12Aug05). No previous pregnancies. Other vaccines administered during pregnancy: Typhoid.
Information has been received from a medical assistant concerning a 69 year old female patient. The patient was allergic to penicillin and amoxicillin that caused hives. The patient was also allergic to egg and chicken. The patient had no medical history. On 19-MAR-2015, the patient was vaccinated with PNEUMOVAX 23 25/0.5 (unit not provided) (0.5 ml, lot#: K008409, expiry date: 04-MAR-2016, intramuscular). Concomitant therapies included CELEXA, SYNTHROID, pantoprazole, Vitamin B6 and Vitamin B12. On 19-MAR-2015, after receiving PNEUMOVAX 23, the patient experienced a temperature of 103 (unit not reported) and severe arm pain. The patient did not obtain any medical treatment for the events and had not sought medical attention. The patient recovered from the events on approximately 26-MAR-2015 (reported as after one week/ for approximately one week). The causality between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Rash on entire torso.  Small red itching bumps.  Awaiting doctor advise as to treatment.  Symptoms began 24 hrs after vaccine and have continually worsened over the next 24 hrs.  Completing this form at 48 hours post vaccine.
Fever, aches, pain at injection site, hoarseness, weakness, paleness, rapid heart rate upon exertion.
Crohn's Disease Flare; Crohn's Disease Flare/Related It to Stress after Losing Grandmother; Temperature elevation; Stress; Fatigue; Muscle pain; This is a solicited report based on information received by Pfizer from (Mfr. Control No.: 21K-163-3846093-00). A contactable consumer (patient) reported that a 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular on Mar2021 (at age of 32 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at Citrate free, then via subcutaneous from 18Dec2020 (Batch/Lot number was not reported) to an unspecified date, at Increased dosage Citrate free (1 in 1 wk) for Moderate to Severe Adult Crohn's Disease. Medical history included cerebral palsy. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular on Feb2021 (at age of 32 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization. In 2021, the patient experienced Stress, Fatigue, Muscle Pain and Temperature elevation after Got Covid Vaccine. On 21Mar2021, the patient experienced Crohn's Disease Flare/Related It to Stress after Losing Grandmother with HUMIRA (ADALIMUMAB). In 2021, The Crohn's Disease Flare/Related It to Stress after Losing Grandmother resolved. Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect. On 21Aug2021, the patient experienced Crohn's Disease Flare with HUMIRA (ADALIMUMAB). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was unknown. The outcome of the event "Crohn's disease aggravated (onset date 21Mar2021)" was recovered in 2021. The outcome of other events was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product ADALIMUMAB and BNT162B2 was not provided at the time of this report. Since no determination has been received, the case was managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events Crohn's disease flare up and other reported events and the suspect drug BNT162B2.   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.
Woke up at night after vaccine Pain was intense at vaccine site, radiated to shoulders, body aches, headache x3 days  Took Acetaminophen, slow resolution then resolved by day 4
Pt recv vax on 2/23/99; on 2/25/99 pt exp fever (103), diarrhea, rash of white bumps/red circles w/ itching, leg & arm pain; tx=antibiotic changed to Augmentin
localized rxn-redness, swelling, inc warmth @ lt deltoid inj site;onset 5 days s/p inj;(3rd dose s/p exposure);
neck veins constantly pulsates; my Blood pressure rose to 180/100; Heart palpitation; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 63-year, on 12May2021 17:00 (Lot Number: EW0168) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant. Concomitant medication included ascorbic acid (VITAMIN-C) and Benifber (in two weeks). The patient previously took penicilline and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, 1 hour after receiving the Pfizer vaccine (at 18:00 on 12May2021), the patient felt a heart palpitation. The next day occasionally. The 3rd day (On 15May2021), her neck veins constantly pulsates. On the Day 4 (on 15May2021), her blood pressure rose to 180/100. She visited the Emergency room and needed IV bolts Labatalol to bring down BP. And she was hospitalized for 1 day. The patient received treatment included EKG, v-q scan, BP med IV and lovevinox. The patient underwent lab tests and procedures which included COVID test (Nasal swab) on 17May2021 with negative result; D-dimer on an unknown date: 3000 (unknown units). The event outcome was recovered with lasting effects (recovered with sequel).  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be excluded. The case will be reassessed once more information become available. 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.
VACCINE ADMINISTRATION ERROR DOSE ADMINISTERED AFTER VIAL WAS PUNCTURED FOR 7.25 HOURS; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-OCT-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 12-OCT-2021, the patient experienced vaccine administration error dose administered after vial was punctured for 7.25 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administration error dose administered after vial was punctured for 7.25 hours was not reported. This report was non-serious.
HEAT/BURNING SENSATION UP LEFT TRUNK TO LEFT SIDE OF CHEST TO NECK/JAW TINGLING/NUMBNESS IN LEFT ARM/HAND
Injection site itching; Injection site redness; Nausea; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Injection site redness) and NAUSEA (Nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (Soreness) and NAUSEA (Nausea). On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, PAIN (Soreness) and NAUSEA (Nausea) had resolved and VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.
high pitched uncontrollable cry from 5-730OM; pt fell asleep; high pitched uncontrollable cry again from 9-11PM; given APAP;
h/a, abd pain, all reported by pt;Annual follow-up dated 09/27/00 information illegible.
Commencing approx. 3-4 hrs. after injection, I was experiencing some discomfort from my left shoulder across my chest and into my back. Hard to describe the symptoms. As time went on it became more intense, and oppresive. The pain/aching was from my breasts up to my neck. Felt confused, developed chills to the extent I had to go to bed. This was around 11:15 PM. I literally was shaking.  I took 2 Tylenol 650 Mg. tablets.  They helped a little with the discomfort, but not the shaking and shivering.  The symptoms continued all night, could not sleep, was up and down and felt I was shutting down. By 4 AM the sypmtoms seemed to be easing up, coming and going. Took 2 more Tylenol.After 7 am I fell asleep and slept until 11:15 AM. I have been getting flu shots for the past 11 years since I had quadruple by-pass and have never had a reaction. Have no idea if this was the shot or what....I felt pretty good, but extremely tired all day Sat.,I sent the original letter before I forgot half the symptoms...had trouble breathing, had to keep taking deep breaths, no pain in my lungs, just that overall aching and fatigue in the areas I described....I live alone and in the cold light of day, I should have called 911 or someone...That is how confused I was...kind of spaced out. Over-all feel I am in pretty good shape. I still work 11 hours a week. I don't think I will ever get the flu shot again...even though we will probably never know if this was the cause, or just a bug of some sort.
responsive seizure within 24 hours of the vaccine. Has had another response in seizure at 6 months of age to vaccine Dtap & Flu shot that has caused body to react in seizure and not fever. Seizure at 6 months was hypotonic episode in which daughter was non-responsive, body limp and eyes rolled back. The seizure at this time was grand mal seizure with convulsions and very slowed breathing. Daughter has now had 3 grand mal seizures and 8 focal seizures following the grand mal ones. 2 of the 3 were within 24 hrs of vaccination.
This spontaneous report as received from a health professional refers to a 5 year old patient. On 29-JUL-2014 the patient was vaccinated with a partial adult dose of VAQTA (lot#, expiration date and strength were unknown), 0.75ml was given. No adverse effects were reported. Additional information is not expected as we cannot contact the physician/health professional.
Fluzone HD injection.  Moderate pain in muscle at sight of injection.  Enough to cause difficulty sleeping.  Eased over night and better 24 hours later.  Slight headache.  No prior issues with flu shots. Similar issue for my 96 year old mother getting shot at same time except hers extended to arm and side. Both had restless night's sleep.  No fever or other issues so far (24 hours later).  First time for both of us having the HD version of the flu shot.