chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm became very sore, to the point of near complete immobility, 4 hrs after injection. The condition has not improved, and it is now 39 hours after injection. Regular, everyday tasks are very difficult. Pain is about a 7.5/10.  Also, 24 hrs after injection I experienced a fever. The fever lasted for 12 hours without coming below 103 degrees, and went up to 105.2 degrees at its highest. This was accompanied by extreme chills. I have also have body aches, which are likely a result of the fever, and the fact that I haven't slept in 2 nights because of these side effects.
Pt recv vax on 11/11/98p; on same day pt exp red/painful vax site
itchy; bumpy; pustules; warm to touch; 6inch by 3 inch red spot at injection site; feverish; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), MASS (bumpy), PUSTULE (pustules), FEELING HOT (warm to touch) and VACCINATION SITE ERYTHEMA (6inch by 3 inch red spot at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) 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 VITAMIN D3 for an unknown indication, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced PRURITUS (itchy), MASS (bumpy), PUSTULE (pustules), FEELING HOT (warm to touch), VACCINATION SITE ERYTHEMA (6inch by 3 inch red spot at injection site) and PYREXIA (feverish). At the time of the report, PRURITUS (itchy), MASS (bumpy), PUSTULE (pustules), FEELING HOT (warm to touch), VACCINATION SITE ERYTHEMA (6inch by 3 inch red spot at injection site) and PYREXIA (feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a Licensed Vocational Nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB, lot # K016005, expiration date 27-AUG-2016 (dose, route of administration and indication were not reported). Concomitant therapy was not provided. No adverse effects were reported. Additional information has been requested.
Fatigue, headache, muscle pain, chills and elevated temperatures/fevers.  Morning  temperatures were 100.0 F, 99.7 F and 100.4 F and by the afternoon they were elevated to 101.2, 101.4 and 101.5.  Ibuprofen was then taken to bring down the fever and for comfort. Fever controlled well with ibuprofen.  Fatigue, headache, muscle pain and chills started about 12 hours after the vaccine was administered and persisted past 24 hours after the vaccine was administered (still present as I am filling out this form).
4-22-2010:TC from pt's mother c/o edema, redness, and "fever" with Ld where immunization given on 4-19-10; states she saw Dr pt'd PMD yesterday 4-21-10 and was tx'd with antibiotic for "cellulitis", TC with Dr office verified 4am area redness and edema; ) fever; tx'd with POC.
Loud ringing in both ears, tinnitus, had to take steroids, still having ringing in ears today.
Sore arm getting worse after 3-4 weeks not better hurts to lift arm like fixing hair, fastening bra etc.
Patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer booster. No adverse reaction occurred; medication administration error due to Pfizer monovalent/bivalent vials looking similar.
Hives covering stomach and back. Benadryl at onset and followed up by physician visit.
Received dose after the 6hrs punctured vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose after the 6hrs punctured vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021 at 6:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose after the 6hrs punctured vial). On 10-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received dose after the 6hrs punctured vial) had resolved.        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.   The vial was opened at 9am and the dose was given at 6pm. No relevant concomitant medications were reported. No treatment information was reported.
nerve zings that feels like a battery is being hooked to his arm; feels like electrocution makes him jump up crazy; Might be nerve damage; Sore arm/Hurt/now getting nerve zings; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (nerve zings that feels like a battery is being hooked to his arm), ELECTRIC SHOCK SENSATION (feels like electrocution makes him jump up crazy), NERVE INJURY (Might be nerve damage) and VACCINATION SITE PAIN (Sore arm/Hurt/now getting nerve zings) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 001B21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (nerve zings that feels like a battery is being hooked to his arm), ELECTRIC SHOCK SENSATION (feels like electrocution makes him jump up crazy), NERVE INJURY (Might be nerve damage) and VACCINATION SITE PAIN (Sore arm/Hurt/now getting nerve zings). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (nerve zings that feels like a battery is being hooked to his arm), ELECTRIC SHOCK SENSATION (feels like electrocution makes him jump up crazy), NERVE INJURY (Might be nerve damage) and VACCINATION SITE PAIN (Sore arm/Hurt/now getting nerve zings) outcome was unknown.            No concomitant medications were reported. The patient stated that it was not swollen and mentioned that he had no issues with the shot in the past.
Within about 5 days I was unable to sleep at all. I was pacing back and forth uncontrollably in my room, and my skin had a burning sensation. The left side of my head/ear developed a constant movement of fluid type feeling that has driven me insane. I barely sleep months later. I also suffer from cold chills at night and the moving fluid in my ear feeling will not go away. I have NO energy whatsoever. I cannot make proper judgements anymore. My entire life has been ruined. I have had four in patient hospitalizations, all unable to help me move forward.
The vaccine made me violently ill. I was taking advil and tylenol and still had a fever of 103. Violent shaking and chills. Diarrhea and vomiting. This was not mild at all. This was just the first dose.
Flare of autoimmune hepatitis with AST/ALT 10x prior levels.  Patient had been in remission for 4+ years off medications prior to vaccination.
Needle popped off of patient's arm, as the medicine flowed down her arm. There was small droplet of blood from the needle prick, which I placed gauze and pressure to stop before administering a bandage. I administered another Janssen vaccine at patient's request, almost immediately. Patient was last seen returning to work and interacting with residents, after the 15 minutes of observation.
Patient presented to off site clinic looking for her second shingles vaccine. After receiving the shot, upon billing to her insurance, we were made aware that she had already had 2 doses of SHINGRIX.  Patient received a 3rd dose of SHINGRIX.
Lethargy and projectile vomiting for 24 hours. Also low grade fever. No treatment (I was not notified by foster parent).
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-AUG-2016 and then on 26-OCT-2016, the patient was vaccinated with the first and second doses of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The third dose of GARDASIL 9 was administered early, on 28-DEC-2016  (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
This is a literature case in which a 5-month-old girl who was referred for a skin rash after vaccination, which we determined to be due to haemophilus b antigen, as well as a logical methodology for evaluating such reactions. A 5-month-old girl experiencing a blotchy skin rash 5 minutes after receiving two vaccines, which resolved after 20 minutes without treatment. There was no associated shortness of breath or wheeze. The patient was advised not to perform skin testing due to the mild nature of the reaction and the desire to avoid excessive skin tests in this very young patient. The vaccine antigens were individually administered each at the next recommended dosing interval, in challenge doses. The selected alternative preparations were administered based on subsequent reactions and components of the individual vaccines, using the CDC's vaccine Excipient and Media Summary which lists all component of commercially available vaccines. Haemophilus b antigen was determined to be the causative agent.  Identifying the causative agent in a patient with a vaccine reaction is critical to minimize the chance of reaction recurrence which, if IgE-mediated, could be life-threatening upon reexposure. Concurrently, the necessity of immunization cannot be overstated. Many reactions are often attributed to vaccine excipients. In this case, careful evaluation demonstrated that the rash was in response to the hemophilus b antigen itself. The logical methodology was presented to ascertain the causative agent(s) following a minor vaccine reaction, so that they may be avoided when possible, while allowing for safe administration of the necessary immunizations. A 5-month-old female patient (date of birth not reported), whose medical history and concomitant medication were not reported, had received a dose of PENTACEL vaccine (batch number, dose number, route and site of administration were not reported) on unspecified date. On an unspecified date, with in 5 minutes of vaccine administration the patient experienced blotchy rash. The patient was advised not to perform skin testing due to the mild nature of the reaction and the desire to avoid excessive skin tests in this very young patient. Complimentary investigation and corrective treatment were not reported. The patient was recovered on an unspecified date after 20 minutes of onset. Documents held by sender: None.
5 y/o are now sick in the ER.; giving doses of the vaccine to 5 y/o; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (5 y/o are now sick in the ER.) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (giving doses of the vaccine to 5 y/o) in a 5-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (5 y/o are now sick in the ER.) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (giving doses of the vaccine to 5 y/o). At the time of the report, ILLNESS (5 y/o are now sick in the ER.) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (giving doses of the vaccine to 5 y/o) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Non-Significant follow up appended-Contact info updated
Headache; Fatigue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). Reported in response to consumer letter sent via follow-up letter. The reporter is the patient.   A 68 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 03Mar2021 (Lot number: EN6205) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Date/Time: 10Feb2021, Time: AM, Anatomical site of injection: arm, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 10Feb2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue".  Additional information: Dose:2nd, Date/Time: 03Mar2021 Time: AM, Site and Route of injection: Anatomical site of injection: ARM Route of administration: Intramuscular Batch/Lot number: EN6205, no prior vaccinations, no relevant tests and no specific relevant test for thromboembolic events with thrombocytopenia. Don't know what half these treatments. Unit 2 dose- headache + fatigue.  Follow-up attempts are completed. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to BIAXIN and codeine allergy. Previous and/or concurrent vaccination included TWINRIX (GlaxoSmithKline); unknown; unknown given on 24 September 2010. On 24 September 2010 at 11:00 the subject received 1st dose of BOOSTRIX (.5 ml, unknown right arm). On 24 September 2010, 30 minutes after vaccination with BOOSTRIX, the subject experienced an injection site reaction described as raised and swollen at injection site, injection site warmth, injection site pruritus and injection site redness. At the time of reporting the swelling at injection site, injection site warmth, injection site pruritus and injection site redness were worse. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. Follow-up information received on 02 November 2010 noted that the events resolved.
presented to ED with complaint of right leg pain. States the pain has been on going for the past 1 month. States the pain is gradually getting worse and now it is to the point that she cannot bear weight on right leg. Describes the pain as constant, sharp, stabbing, with numbness radiating down to the right toes. Denies any trauma or rash. States it is worse with any kind of movement. Denies additional symptoms including fevers, chills, chest pain, sob, nausea, vomiting, abd pain, dysuria, hematuria, or changes in bowel habits.
Febrile seizure. Per report patient's legs went straight and stiff, and started shaking for approx. 2 min.
Patient complains of left arm pain, numbness, weakness, unable to bear weight since having flu vaccination 2/15/19. Site on left deltoid appears yellow halo around it, not visually swollen or red.  Patient does not have MD to seek care from.
Patient was given undiluted pediatric pfizer vaccine. No symptoms or adverse reaction has been reported yet.
33 y/o male with new onset erythematous rash 3 days s/p smallpox vaccine administration.  Rash is erythematous, blanching rash with slightly raised scale on bilateral arms and right cheek.  Rash is quite pruritic.  Pt is afebrile, and in otherwise good health.  NO history of skin disorders other than dry skin in winter.
This spontaneous report was received from a pharmacist via company representative referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (anatomical route of vaccination, dose number, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patients developed pain at the injection site (injection site pain). Furthermore, no product quality issue was involved. At the time of the report, the outcome of injection site pain was unknown. Additionally, the reporter did not provide for causality between the adverse event and vaccination with PNEUMOVAX 23. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding their current conditions and medical history was provided by the reporter. On an unknown date since 30-DEC-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB (strength, dose, route and indication not reported) of lot # J012567 and expiry date: 30-JAN-2016. Concomitant medications were not mentioned. The vaccine was stored at 58.5 degree Fahrenheit for a time frame of 24 hours which was outside of the recommended range (incorrect product storage) and administered to patients. There was no previous temperature excursion. No adverse events have been reported. No additional information was provided. Product Quality complaint was not filed. Additional information has been requested.
Information has been received from a physician concerning a 13 year old female who back in August-2008, was vaccinated with GARDASIL. Lot number was not available. The physician reported that 5 to 10 minutes after the patient received GARDASIL she passed out and then had seizure. The patient sought medical attention. On an unknown date the patient recovered. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Generalized allergic dermatitis (rash) noted on patient's trunk. Treated with a 3 day course of prednisone 20mg PO daily, cetirizine 10mg PO daily for 7 days, and ranitidine 150mg PO twice daily for 7 days.
Got 1st dose and developed HZ 4 days later/now has shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2022, the patient received the 1st dose of Shingrix. In September 2022, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The reporter reported that, a patient was vaccinated Shingrix and developed herpes zoster 4 days later.  The reporter did not have batch or expiration date because patient was vaccinated in a different facility (pharmacy).  The first attempt to get adverse event information was declined, patient details were share after second attempt. There was no opportunity to ask healthcare professional for follow up with team since mentioned only had a few minutes to go over the call.
The adverse events are side effect perhaps but extremely strong.  Lightheadedness x 1.5 days, feeling shaky and short of breath- afternoon of injection  Significant headache x 48 hours (note: still having intermittent HA associated with 1st dose.) Significant arm pain (injection site)- 2 days Feeling shaky in legs- evening of injection Low grade fever x 48 hours, ongoing intermittently Waking at night several times- this does not happen to me. Waking overnight last night (AM of 1/16/21) with right hand numbness that lasted for some time.  Extreme, extreme fatigue- the worst lasted 48 hours post vaccination.  Still continuing but not as severe as the first 48 hours. Body aches, particularly (but not only)  right hip and knee that have arthritis- worst sx ~ 36 hours post vaccination.  Ongoing intermittently. Heart palpitations but unable to determine if related to vaccination. Chest pain, mid-left sternal, intermittent, ongoing.  More of a muscular pain/discomfort.  Note: for 1st injection had some similar "side effects" but also some that were different.
Parents noted that pts face, shoulders & upper chest were covered w/red blotches almost immediately p/vax; no resp distress or inc RR; pt taken to ER for observation;
"increased fatigue, mild cough shortness of breath, headache and then some isolated left leg pain.  Patient denies any trauma, any swelling, nonpainful to the touch no difficulty walking or specific joint pain.  Patient has no prior history of blood clots or DVTs, not currently on OCPs"
passed out cold and was snoring; passed out cold and was snoring; vomiting; This spontaneous report was received from a vaccine coordinator/nurse via a field representative and refers to a 15-year-old female patient. She was in good health and had no significant medical history. Her concomitant therapies included influenza virus vaccine (unspecified) (reported as flu vaccine). There was no information about patient's drug reactions and allergies.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, frequency, lot#, expiration date anatomical location and route of administration were not reported). No problems were noted after the first vaccination. On 12-OCT-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter, via intramuscular route (frequency, lot #, expiration date and anatomical location were not reported) as vaccination against human papilloma virus (HPV). On the same day, within 5 minutes after vaccination, the patient passed out cold and was snoring. It was stated that when the patient came to, she started vomiting. The patient had not eaten anything prior to coming to the office. She did not seek medical attention and did not receive any treatment for the events. The nurse stated that they followed up with the patient later that day and after some sleep, she felt much better.  The patient recovered from the events on the same day (12-OCT-2020). The causality assessment was not provided.  Upon internal review, the event of passed out cold was determined to be medically significant.
A pharmacist reported that a male heart transplant recipient received an injection of flu vax and was subsequently rejecting the heart transplant.