chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It felt like a viral meningitis; arm soreness; feel some tension; migraine headache; body started shaking; chills/Rigors; temperature 104; I had sensitivity that I never had; headache; photophobia; Sinophobia; paresthesia/tingling sensation along my upper extremity; I felt like I was freezing; I didn't feel comfortable; vertigo; nausea; hard time to focus; This is a spontaneous report from a contactable other health professional (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  He didn't have any allergies. He was in good health, no underlying issue. He never had a surgery. In Jan2021, patient got the vaccine last night around. It started with arm soreness. Around 10:00 am he started to feel some tension, migraine headache. Around 11:00 he felt his body started shaking. He had chills, rigors and temperature 104. For 5-6 hours he had sensitivity that he never had. Patient had a headache, photophobia, sinophobia, paresthesia and tingling sensation along his upper extremity. he felt like he was freezing. He didn't feel comfortable. It resolved afterwards, he felt no weakness, no facial paralysis. It felt like a viral meningitis. He also had vertigo, nausea and hard time to focus. Outcome of events were unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event viral meningitis with BNT162b2 can not be fully excluded.  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.
IN BAD SHAPE/TRYING TO GET STRENGTH BACK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced in bad shape/trying to get strength back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of in bad shape/trying to get strength back was not reported. This report was non-serious.
Sweats; Throwing up; Fever; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), VOMITING (Throwing up), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-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 HYPERHIDROSIS (Sweats), VOMITING (Throwing up), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sweats), VOMITING (Throwing up), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.
arm started hurting; said that I do have acids reflux but not this severe; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started hurting), GASTROOESOPHAGEAL REFLUX DISEASE (said that I do have acids reflux but not this severe) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011520A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal), Gas in stomach and Anxiety. Concomitant products included PANTOPRAZOLE for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm started hurting), GASTROOESOPHAGEAL REFLUX DISEASE (said that I do have acids reflux but not this severe) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (arm started hurting), GASTROOESOPHAGEAL REFLUX DISEASE (said that I do have acids reflux but not this severe) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100 degree fahrenheit (High) not more than 100 degree fahrenheit.         This case was linked to MOD-2021-403246, MOD-2021-407450 (Patient Link).
This spontaneous report as received from a physician refers to a 65 year old female patient who in February 2013, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The physician reported that on 31-JUL-2013, the patient developed shingles after receiving ZOSTAVAX. At the time of the report, the patient had not recovered from shingles. The patient sought medical attention by speaking with the physician. The relatedness for shingles and ZOSTAVAX was unknown. Additional information is not expected.
pt recv vax 17OCT95 & 2APR96 devel varicella w/chickenpox-like rash & t1o2;pt was not seen by MD & pt recovered;
After going to bed, woke up with shaking chills. Went back to sleep and woke up at 1:00 am feeling a little lightheaded and warm. Took temperature and it was 99.7.  Took temp again at 1:30 and it was 101.3. Took 2  Tylenol. Dozed on and off during the night and  in the morning, had a headache and sore neck and shoulders.  Had a low grade fever all day Sunday.  Slept off and on all day.  Felt a little better in the evening- temp was gone.  Monday morning woke up feeling fine.
Heavier periods.  Large clots.  Longer duration or period. That has continued for many months
pt recvd vax & w/in 24 hrs pt devel soreness @ inj site; the pain had not resolved as of 5 wks p/inj & pt is unable to raise arm above head as a result of pain; Reporter indicates that it is likely that inj was given w/21 gauge, 1in needle
CHILLS; FEVER; EXTREME EXHAUSTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced extreme exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and extreme exhaustion was not reported. This report was non-serious.
Bell's Palsy including any and all of its sequelae; Bell's Palsy; This spontaneous report was received from a lawyer and a 65 year old female patient regarding a case in litigation on 18-MAR-2021. The patient's concurrent conditions, concomitant medications, medical history, drug reactions or allergies were not reported. On 27-SEP-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) as prophylaxis. On 30-SEP-2013, as a result of her receipt of zoster vaccine live (ZOSTAVAX), plaintiff was caused to suffer Bell's Palsy, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress. At the reporting time, the outcome of Bell's Palsy, including any and all of its sequelae was considered as not recovered. The reporters considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered the event of Bell's Palsy, including any and all of its sequelae to be disabling. Upon internal review, Bell's Palsy was determined to be medically significant.
Information has been received from a physician concerning an 8 year old female with no pertinent medical history and no history of drug reactions or allergies who on an unspecified date was vaccinated with VARIVAX (Oka/Merck) (lot#: 660083/0488X) and hepatitis A vaccine (manufacturer unknown). On 12-JUL-2008 the patient developed a severe injection site reaction with pain. The patient went to the emergency room, but was not admitted. The patient's outcome was not reported. Additional information has been requested.
"Very itchy rash" at injection site, 2-3 inches diameter, bright pink, has gradually faded over last 4 days (site of ZOSTAVAX).
This report was received from Pfizer inc. and was assigned manufacturer report number 2011131829 for PREVNAR. Information has been received from a medical assistant concerning a 28 weeks female patient who on 01-APR-2011 was vaccinated with the first dose of ROTATEQ. On the same day the patient received the first dose of hepatitis B vaccine, recomb (manufacturer unspecified), the first dose of PREVNAR and the first dose of PENTACEL. There was no concomitant medication. On 01-APR-2011 the patient experienced hives following administration with the vaccines. At the time of the report the patient was recovering. This was originally reported by a medical assistant. Additional information has been requested.
Started with chills the first evening and heart rate 85-95 BPM while resting. This was followed by moderate nausea without vomiting. This was followed by two episodes of diarrhea. The next two days had periods of moderate nausea and temperature not higher than 99.2 F.  Took Tylenol for the fever. Appetite was suppressed but ate a bland diet with lots of fluids. By day three symptoms had resolved..
1st side effect - Left Arm was used for shot/s because patient has been experience frozen shoulder on the right side.  Patient has been experience significant shooting pain in left arm since injection.  Patient was told to move arm around to help.  This has done nothing for alleviating the side affect.   2nd side effect - patient has not had period since the second shot of Moderna.  Patient tracks periods on an called Flo and it can be seen through data her period was normal and consistent until the Moderna shot and now her periods have stopped.
Red large bump, itchy, hot and about the size of a silver dollar. Say my doctor today and was advised to apply ice .
patient was given fluzone hd and arexvy vaccination on 9/26/23 and said she experience pain on left side of stomach and lower back pain, if laying down on left side she experience less pain, but if stand up or sitting up her pain increase . Patient informed also her blood sugars is high in the 200s and 300s in the last 2 days and she did not eat in the last 2 days. Her blood sugar is currently 313 advise her to go to urgent care or E.R. since her blood sugars high in last 2 days. Patient said she thinks the side effects may not be from the vaccines. The side effects were also reported by her friend who stated from the vaccinations , but patient states may not be from vaccination.
Itching, redness, swelling, tenderness et warmth to injection site after PCV23.
7/22/21 ER visit:  Swelling Right face and ear.  IV Benadryl, Pepcid, Solumedrol received. Diagnosis:  allergic reaction   Improved and discharged same day on Prednisone 7/29/21 ER:  Facial angioedema, throat tightness, wheezing on exam.  IM Epinephrine x 2, Benadryl, Solumedrol.   Diagnosis: Anaphylaxis Improved and discharged same day on Prednisone 8/2/2021 ER:  Left sided facial numbness, Foreign body sensation back of throat.  IV Benadryl, Solmedrol.  Diagnosis:  Allergic reaction  Discharged home on prednisone
9 July -- Shingles vaccine administered (no early reactions) ;  12 July -- Pain in lower right jaw (thought to be a toothache) began in late morning, but tremors in hands began in late afternoon, causing a visit to the ER; diagnosed as a possible tooth abcess; began penicillin for 10 days ; 14 July -- Dentist visit; x-rays did not show any tooth problems ; 15 July -- Multiple blisters inside mouth ; 16 July -- Additional blisters on lips and nostrils ;  Slow but steady improvement in symptoms over next several weeks (including healing over a spot of bare jaw bone that was underneath one of the mouth blisters) ; 15 August -- all symptoms gone / mouth completely healed.
9 days after vaccine developed pain and redness at injection site, raised round the cone shaped 4 inches in diameter. area hot to touch. Went to ED and started Keflex 500mg QID for cellulitis, area grew larger for 2 more days then started to reduce.
Spreading itchy rash, including sizable wheel and vesicles at site of injection.  No respiratory, cardiac, or throat symptoms.  Placed on prednisone with good effect -- less itching, rash nearly resolved.  Also placed on antibiotics as precaution, however more likely hypersensitivity reaction based on appearance.
Severe Vertigo, 2nd day after vaccination. No prior history  of vertigo or vertigo like symptoms.
Arm where vacine was administered started to become slightly red, tender, achy and itchy late on Tuesday, but it was easy to ignore until Thursday when it had grown in pain and size. Doctor's visit on Thursday evening. By Friday morning it was VERY red, tender, and itchy and the elbow and fingers on that hand were achy too.
Patient was administered vaccine in error prior to indicated age. Error was discovered upon arrival for second dose. Patient and father was advised not to receive second dose at this time and to wait until she turns 16 years or eligibility/CDC recommendations expand.
Pt recvd vax NOV91 & exp arthralgia, paresthesia, numbness of fingers, & shoulder & knee pain;
She mentioned that her son has been throwing up on and off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Feb2022 (Lot number: FK5618) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hard for him to breathe" (unspecified if ongoing), notes: He does not have asthma, but when he gets sick it is hard for him to breathe; "bad allergies" (unspecified if ongoing), notes: diagnosed for years; "he gets sick" (unspecified if ongoing), notes: when he gets sick it is hard for him to breathe. There were no concomitant medications. The following information was reported: VOMITING (non-serious) with onset Feb2022, outcome "not recovered", described as "She mentioned that her son has been throwing up on and off". Therapeutic measures were taken as a result of vomiting.  Additional information: Patient mother mentioned that her son has been throwing up on and off. She wanted to know if vomiting or throwing up is a commonly known side effect. She also wanted to if it is going to be permanent. Today he threw up twice and two days ago he threw up once. She is trying to figure out if it is normal. First dose Pfizer covid vaccine: 24Feb2022 in the afternoon. Thinks he received it in his right side, arm. She sees PF12ER and under that reads FK5618.Clarifies on Sunday he threw up four times and the next day he threw up once then was fine, then then two days later he throws up again, it is not every day. Unknown exact date of when he first threw up, but the first time he threw up, he only threw up once. Treatment: she usually gives him cough and asthma medicine. In Dec2021 two of her kids were positive for covid and some were negative. She was told to quarantine for two weeks and get retested. When they were retested, one was still positive, and everyone was negative and decided to get the covid vaccine. He does not have asthma, but when he gets sick it is hard for him to breathe so she gives him asthma medication. She has other children that have asthma.   Follow-up attempts are completed. No further information is expected.
Dizziness, Headache, Myalgia, JAW PAIN Narrative:
This spontaneous report as received from a medical assistant via a social media site refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number not reported) (dose and route not reported). Concomitant medications were not reported. On an unspecified date the medical assistant reported that the patient experienced "chronic pain due to an aluminum allergy," while using GARDASIL. The patient sought medical attention in an office visit on an unspecified date. At the time of the report the patient's outcome was unknown. Additional information is not expected.
At first nausea, vomiting, diarrhea and achy all over. Temperature was 101.7. About two days later the nausea, vomiting and diarrhea stopped temp went down to 99. Muscle and joint pain increased in severity. I attributed it to Fibromyalgia and Chronic Pain Syndrome. The pain has continued to spread to areas where I have not had chronic pain or Fibromyalgia in the past. Muscle cramps are now in groin, left shoulder, neck, and shins. All joints are painful and getting worse. Only relief is taking Xanax and muscle relaxers prescribed by doctor. Difficulty walking, I have been using a cane or walker.  Temp 100 at this time
Vaccination was at 1pm. At 2am I got a horrible headache- stabbing pains in the back upper right ?corner? of my head. Couldn?t sleep. I would test the frequency every once and a while. I had 1-4 sharp pains every minute. I talked to my doctor at 2pm that day. She said I could take 800mg Ibuprofen/8 hrs. That worked. Had to do this for 2 days after my shot. I was very tired. I was fine after that.
COVID-19; low blood pressure; A spontaneous report  was received from a consumer concerning a 68-year-old, female patient who experienced COVID-19 and low blood pressure/hypotension.   The patient's medical history included lupus. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unknown date. On an unknown date, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient contracted COVID-19 since an unknown date. They also experienced low blood pressure.  The laboratory investigations included blood pressure performed on an unknown date with result 91/50. The patient was hospitalized on an unknown date and was discharged after two days, date unknown.  Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, COVID-19 and hypotension were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded except for the event of COVID-19. The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II lot # M015930 with an expiration date 29-MAR-2018 for prophylaxis (dose and route of administration were not reported) reconstituted in properly stored sterile diluent (STERILE DILUEN) (lot# reported as N004801 with an expiration date 09-JUL-2019). There was no adverse effect reported. Administered dose of vaccine experienced the temperature  excursion from 9 to 25 degrees Celsius for 2 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA008179:
feels dragged out and a little shaky; feels dragged out and a little shaky; This is a spontaneous report from a contactable Consumer or other non-health professional (patient).  A 78-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via intramuscular route of administration, administered in right arm on 02Feb2021 at 14:30 hours as 1st dose, single dose (at the age of 78-years-old) and on 23Feb2021 at 14:30 hours as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Feb2021, patient felt good. On 04Feb2021, patient feels dragged out and a little shaky. Patient stated that in two weeks she has to go back for second. She and her husband got their first shot on Tuesday, 02Feb2021. They felt good the net day. Today she feels dragged out and a little shaky. Patient asked was that normal. The case was classified as non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This 78-year-old consumer reported in response to Non-HCP coversheet and questionnaire sent.  Follow-up attempts are completed. No further information is expected.
Severe pain in entire arm lasted 2 weeks, and numbness in hand. Numbness continues four and half months out and redness in hand.
Hospital employee given influenza vaccine, then went home. Injection site became red, hot, raised (about 3 by 4 inches). Reported to infection control nurse on 12/12/2001. Still red and hot.
Intracranial hemorrhage 2 days after vaccine. Initially thought to be hypertensive hemorrhagic stroke but his wife informed us that he got the vaccine on Monday and had been feeling sick with chills. She found him unconscious in his bathtub. He was taken to the OR with neurosurgery for craniectomy, and remains intubated, critically ill at this time.
This spontaneous report was received from a Certified Nurse Practitioner and refers to a 20 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with M-M-R II, dose, frequency, route, anatomical location, lot number and expiration date were not reported), for prophylaxis. On 14-JAN-2017, a blood titer's test was performed to the patient and the patient "failed to seroconvert" (measles antibody negative, rubella antibody negative and mumps antibody test negative).  No adverse events were reported. Product quality complain was not involved. At the time of reporting, the outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was unknown, and, the reporter did not assess the causal relationship between those events and the therapy with M-M-R II. This is one of several cases from the same patient.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA005671: US-009507513-1702USA005672: