chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster; Booster sparked a severe migraine episode; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). 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, Got a more severe reaction than the initial two. I had Botox injected a little over a month ago for migraines), for COVID-19 Immunization, reaction(s): "Got a more severe reaction than the initial two"; Covid-19 vaccine (Dose: 2, Got a more severe reaction than the initial two. I had Botox injected a little over a month ago for migraines), for COVID-19 Immunization, reaction(s): "Got a more severe reaction than the initial two". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; MIGRAINE (non-serious), outcome "unknown", described as "Booster sparked a severe migraine episode". The event "booster sparked a severe migraine episode" was evaluated at the emergency room visit.  The patient recently took the booster shot and got a more severe reaction than the initial two. The patient had Botox injected a little over a month ago for migraines and the booster sparked a severe migraine episode that had to go to the ER. Please do some research on this so other migraine sufferers with Botox treatment are aware. Perhaps the serum can be altered to avoid this reaction.  The lot number for bnt162b2 was not provided and will be requested during follow up.
- Elevated temperature noted, patient notes he felt feverish for one day.  Sweating lasted one day following immunization. - Since immunization patient reports consistent to worsening grip strength and  shooting pains in the arm. Thumb also involved in grip decrease.
Information has been received from a health professional concerning a patient who was vaccinated with 0.5 ml dose of varicella virus vaccine live (Oka/Merck). It was reported that patient developed "significant amount of erythema" 3 days after vaccination. At the time of report, the patient was fine and was recovered. Unspecified medical attention was sought. A product quality complaint was not involved.
1900 - leg (left) is swollen "size of golf ball from thigh to knee. Area is warm to touch. Fever 101 degrees. Gave TYLENOL. He fell asleep at 2200 after hours of irritability. Slept all night. Next morning mom reports she repeated TYLENOL. "Swelling has gone down". She called her physician.
Information has been received from a healthcare professional concerning a 45 year old female who on 8/30/05 was vaccinated subcutaneously with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine lot 649914/0578P. On approximately 8/31/05 the patient experienced erythema and soreness at the injection site. Unspecified medical attention was sought. The patient recovered without treatment within 48 hours. The reporter would like to know if there have been any other problems with this lot number. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
wasn't able to sleep; after 6 days, I was scratching my arm/ itching a lot in both arms and legs below the knees/ still itching in the legs; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (wasn't able to sleep) and PRURITUS (after 6 days, I was scratching my arm/ itching a lot in both arms and legs below the knees/ still itching in the legs) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), BENAZEPRIL, FOLIC ACID, METFORMIN and PRAVASTATIN for an unknown indication.    On 14-Feb-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 INSOMNIA (wasn't able to sleep) and PRURITUS (after 6 days, I was scratching my arm/ itching a lot in both arms and legs below the knees/ still itching in the legs). At the time of the report, INSOMNIA (wasn't able to sleep) and PRURITUS (after 6 days, I was scratching my arm/ itching a lot in both arms and legs below the knees/ still itching in the legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included Tylenol and Hydrocortisone
dizzy, diaphoretic taken to EMS for monitoring bp:106/57 hr 88 o2: 97%
Generalized papular pruritic rash started 2 days after receiving the vaccine.  Started on buttocks and spread to back, legs, arms, neck, scalp.  On exam rash is somewhat concerning for varicella but without pustules or vesicles.  Recommend use of loratadine for pruritus.  Pt to follow up in 2 days to see if develops pustules/vesicles which would be more c/w varicella.  Advised pt avoid physical contact with immunocompromised family members (wife is pregnant).
re-occurring shingles that has existed for 20 years/shingles; This is a spontaneous report from a contactable consumer.   A 72-year-old male patient received bnt162b2 (BNT162B2), via an unknown route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing Plaque psoriasis, ongoing Brace user, ongoing Psoriatic arthritis, ongoing Heart disorder, ongoing Pacemaker complication, ongoing guttate psoriasis. Concomitant medications included etanercept (ENBREL) taken for psoriasis, psoriatic arthropathy, ankylosing spondylitis from 2001 to an unspecified stop date; loratadine (LORTAB) taken for an unspecified indication, start and stop date were not reported; clonazepam (KLONOPIN) taken for an unspecified indication, start and stop date were not reported. On an unknown date in Jan2021, the patient received the shingles vaccine for immunisation. On an unknown date in Feb2021 (three weeks ago prior to this report), the patient received the first dose of COVID-19 (coronavirus disease). On 27Feb2021, the patient was diagnosed with shingles. The patient had a case of re-occurring shingles that existed for 20. The patient stated that it always occurred at the base of his spine with a size of a golf ball and he had extreme pain and a deep itch with it. The patient consulted a doctor and he was prescribed acyclovir which he started taking on 28Feb2021. The patient stated that he was now wondering if he should have the second dose of COVID-19 vaccine. It was also reported on an unknown date, the patient was treated with an unspecified antiviral medication. The outcome of the event was recovered on an unspecified date in 2021.  Information regarding lot/batch number has been requested.
She got her vaccine, had no problems.  Gradually over the following months she started with hot flashes in her face and a real headache.  The headaches are not so bad, but the face is getting hotter, burning up face.  Burning from the neck up.  She went to her doctor several times to find out what her problems were who said she did not know.  She ran into a nurse who said that in the hospital they have found a lot of people having the same affect.  She is worried about what it is.  She has had testing done because she has a cardiologist, there is nothing wrong with it, and goes for a check up.  She went and got a CAT scan and he noticed that there were a few cysts, masses in different parts.  She has one on her thyroid and is due to get a biopsy tomorrow.  She has had others that have checked out fine, as well as MRI.  She did not have these problems prior to her vaccine. She said her face is bright red while speaking to me and that her eyes are red too.    Her face got so hot one night she went to the ER and they gave her Benadryl which did not help.
Mom called on 5/29/03 stating child has had 103.6 degree temp since Monday 5/26/03. Is alternating Tylenol and Motrin with lowered fever for only 1 hour. Mom hasn't called MD. Appetite lowered, but continuing fluids. Has about 7 vesicles on chest. Instructed to see MD have checked for illness vs shot reaction. The follow up received on 7/25/03 states, called the pt's home for follow up regarding report of fever and vesicles pt was reported to have. Pt's mother stated that baby was seen by an MD on 5/29/03. She stated that baby was diagnosed to have had tonsilitis. Baby is better now. Fever and vesicles have resolved, mother reported. No further action taken.
J/J shot in April.  Pfizer for Booster in December.  The next morning, my hearing felt muffled. I thought the symptoms of feeling ill after the booster might be kicking in. I ignored it even though it got worse. Then I started having ringing in my ears throughout the day and at night. My hearing remains muffled and it can sometimes be hard to hear and the ringing also has continued a week after the booster. I am hoping it is a temporary side effect that goes away soon.  I have no other symptoms. Sharing because I looked it up and saw that other have experienced the same and I wanted the side effect documented.
Arm pain; Stomach Ache; Chest pain; Fever (102°F); Nausea; Headache; Felt tired; Intense heart bit like tachycardia/Heart pounding; Ears pounding; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), ABDOMINAL PAIN UPPER (Stomach Ache), CHEST PAIN (Chest pain), PALPITATIONS (Intense heart bit like tachycardia/Heart pounding) and EAR DISCOMFORT (Ears pounding) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM for Anxiolytic therapy.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced PALPITATIONS (Intense heart bit like tachycardia/Heart pounding) and EAR DISCOMFORT (Ears pounding). On 23-Oct-2021 at 10:00 AM, the patient experienced PAIN IN EXTREMITY (Arm pain), ABDOMINAL PAIN UPPER (Stomach Ache), CHEST PAIN (Chest pain), PYREXIA (Fever (102°F)), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Felt tired). On 24-Oct-2021 at 10:00 AM, PAIN IN EXTREMITY (Arm pain), ABDOMINAL PAIN UPPER (Stomach Ache), CHEST PAIN (Chest pain), PALPITATIONS (Intense heart bit like tachycardia/Heart pounding), EAR DISCOMFORT (Ears pounding), PYREXIA (Fever (102°F)), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Felt tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Body temperature: 102 (High) 102°F.         No treatment drug details was reported.
Patient returned to pharmacy 2 days after vaccination with a red area on her left arm. The spot is at the site of the second injection on that arm, the lower of the 2. The red area is swollen and hot.  Patient says it's uncomfortable and does not let her get restful sleep. We advised the patient to take Benadryl and ibuprofen over the counter to treat the reaction. Patient stated she has both of those at home. She also wanted to take Tylenol in between the ibuprofen doses. We advised the patient to back in to the pharmacy tomorrow for the pharmacist to check up on the reaction. Also, we let her know that we would contact her primary care provider about the reaction, document it on her pharmacy file, and fill out this form.
On 3/2/01, pt had pain, induration and erythema; no increased temperature. On 3/3/01, 70 X 110mm with induration and no increased temperature.
This spontaneous report as received from a registered nurse refers to a patients under 50 year old. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot# unspecified). This is one of two reports from the same reporter. Additional information is not expected.
Site of varicella vaccination noted to be sl. swollen reddened area approx 4-5cm & warm to touch.
leg pain constantly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN taken for pain in extremity. Vaccination history included: Pfizer-biontech covid-19 vaccine (1st dose -13Mar2021), administration date: 13Mar2021, for covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "leg pain constantly". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient has been taking Ibuprofen for leg pain constantly. Did not advise her doctor and vaccination provider about her pain medications and asking if it is ok to take Ibuprofen. she did not remember if it was ok to take Tylenol or Ibuprofen and wanted to know which one, she can take. Said that she normally takes Ibuprofen, and has been prior to taking the vaccine; also, she has already received her second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient c/o localized skin reaction, muscle cramping/pain in bilateral feet and HA.
Information has been received from an employee in a physician's office concerning a 13 year old female who on approximately 10/22/2001 was vaccinated with a second dose of hep b vaccine recombinant. On approx. 10/27/2001 the pt was taken to an ER by her mother for a fever and dizziness. The pt received unspecified treatment, was released from the ER and was reported as not hospitalized. The physician's office employee further reported that the pt's mother felt that the reaction was due to "thimerosal" despite having received a thimerosal free hep b vaccine recombinant vaccination. Additional info has been requested.
cellulitis to varicella site-swelling x 4 days-tx'd with abx
patient received a dose from an expired vial.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired vial.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired vial.). On 31-Jan-2022, EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow-up information included no new information.
Systemic: Fainting / Unresponsive-Medium, Systemic: Hyperventilation-Mild, Additional Details: Pt fell to the ground and bumped his head on the wall. Pt's father was there and did not want us to call an ambulance. Pt walked out by himself without assistance.
Bilateral otitis; This spontaneous case was reported by a health care professional and describes the occurrence of EAR INFECTION (Bilateral otitis) in a 9-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Nov-2022 at 8:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Dec-2022 at 3:37 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 01-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EAR INFECTION (Bilateral otitis). On 10-Feb-2023, EAR INFECTION (Bilateral otitis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  The patient had never been diagnosed with/tested positive for COVID-19.   This case was linked to MOD-2023-713290 (Patient Link).
Pt. states that after receiving the 1st dose of Moderna 06/24/2021, started experiencing symptoms 06/26/2021 of the left leg swelling. Primary visit 06/26/2021 with recommendations for Ultrasound 06/27/2021. 5 DVT blood clots were located in the left leg. (Estimated) 07/15/2021 addressed.
Progressive pain and weakness starting in (R) shoulder moving to (L) leg @ hip, then to (L) shoulder, to (R) leg, and eventually to upper back between shoulders. Some slight difficulty with speech and chewing.
Welts all over , rash all over, swelling of the arms and hands, blanching, bruising, itchy scalp.
patient developed rash on injection site. started as sore red patches then progressing to large, swollen, circular, red patch about 8in long and 6 in wide that wrapped around the patient's arm. rash is painful and hot to the touch. patient complained of general fatigue and discomfort. swelling has gone down considerably on 11/5/2020 but is still red.
Severe body chills and shaking 11:45 PM next day. Fever started next day. Fever reached 103 degrees. I became unresponsive. Wife called for ambulance. No memory of event. Taken to local hospital ER. Tests run, CT, blood work. Admitted to hospital overnight for observation, Severe Diarrhea
Awakened at 5:45 a.m. had body aches, chills, nasal congestion, lethargy/exhaustion
Sore throat, Temp, vomitting, cough, runny nose, chills began early morning of 10/30/2009. Parent did not report time of onset. Parent indicated that she suspected the LAIV vaccine. However, child possibly exposed prior to vaccination. Local schools reporting high incidence of H1N1 Flu illness. No medical care being sought at time of report.
Patient returned to pharmacy 4/18/08 stating that her shoulder was hurting as a result of vaccination given 12/31/07.  Vaccine provider was not present.  Patient won't return calls.  No other information.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored one dose of PROQUAD (Merck) (injection, dose: 0.5ml, subcutaneous, lot number and expiration date were not reported). No adverse effect was reported. Additional information has been requested.
Fever Lymph nodes swollen, - scheduled w/ PCP for assessment, Narrative:
COVID Fog and was out of it; slipped and fell; fractured my ankle; Pain in the left Arm; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (COVID Fog and was out of it), FALL (slipped and fell), ANKLE FRACTURE (fractured my ankle), VACCINATION SITE PAIN (Pain in the left Arm) and MYALGIA (Body ache) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 02-Feb-2021.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced FEELING ABNORMAL (COVID Fog and was out of it), FALL (slipped and fell), ANKLE FRACTURE (fractured my ankle), VACCINATION SITE PAIN (Pain in the left Arm) and MYALGIA (Body ache). On 17-Apr-2021, FALL (slipped and fell) had resolved. On 18-Apr-2021, VACCINATION SITE PAIN (Pain in the left Arm) and MYALGIA (Body ache) had resolved. On 20-Apr-2021, FEELING ABNORMAL (COVID Fog and was out of it) had resolved. At the time of the report, ANKLE FRACTURE (fractured my ankle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.  On an unknown date, the patient was seen by his cardiologist and had an electrocardiogram performed which showed a new finding of a left bundle branch block.  On 17 Apr 2021, approximately 25 minutes after receiving the first dose of the Moderna COVID-19 vaccine, the patient slipped and fell and fractured the ankle. The patient has been seen by physical therapy and had 14 treatments of electro stimulus on the ankle.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received on 14 Jun 2021, included lab data and addition of two new events.
This spontaneous report has been received from a pharmacist referring to a 16 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. In July 2016, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (route of administration, lot number and expiration date were unknown). Then, next also, on 30-APR-2017, the patient was vaccinated with the second dose of GARDASIL 9 via intramuscular route for prophylaxis (lot number and expiration date were unknown).
Approximately 12 hrs after injection, (11:30pm) severe chills (duration 1 hr). Approximately 12 hrs after that (11:30 am, severe discomfort in upper body (deep), duration 1.5 hrs. Repeat discomfort 2nd time 4 hrs later, duration 1.0 hrs. Discomfort 3rd time 4 hrs later, duration .75 hrs,
Patient began noting spreading rash starting 3 days after vaccination that moved from shoulder across chest almost reaching other shoulder. Patient self treated with Clobetasol cream he had from another rash on inside of elbow while waiting for the doctor appointment scheduled a few weeks out. Patient finally began feeling recovered just over 2 weeks after vaccine, still waiting to see MD.
Received 2 immunizations, one to (L) ant. forearm on Sat 8-7-10. Entire ant. surface of forearm became swollen, red, painful. Seen in ER on 8-9-10 with follow-up with family physician on 8-10-10. Today 5cm x 6cm area of redness, induration. Vaccine give in forearm not deltoid.
Swelling of arm at site of injection (40x50cm).  Swelling went down some but was still present 2 days later so student returned to clinic and was seen by a Nurse Practitioner.  Swelling was going down, advised to take Ibuprofen or Acetaminophen and use ice for discomfort and to return to clinic if further discomfort.