chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a female patient of unknown age. On 04-MAR-2014 the patient was vaccinated intramuscularly with the first unspecified dose of GARDASIL (lot number and expiration date not reported). On 04-APR-2014 the nurse practitioner called the patient to remind her that her next dose of GARDASIL was due. The patient told the nurse that she was 2 months pregnant. The method used for determining that the patient was pregnant was unspecified. No known adverse effects. The patient became pregnant with Last Menstrual Period (LMP) in February 2014. Initial exposure to GARDASL was at 3 weeks. The pregnancy outcome was pending. Additional information has ben requested.
Received as recommended during pregnancy, due date 07/04/2019. No previous complications. Extreme headache and fatigue. Temperature of 100.3.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 07-APR-2015, the patient was inoculated with ZOSTAVAX at an internal medicine physician office for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In or about November 2016, the patient was treated by a physician for the onset of a severe rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 07-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J007059 (expiration date 31-JUL-2014), 0.5 ml, intramuscular. No adverse effects reported. The outcome was unknown. Additional information has been requested.
This spontaneous report was received from a 70 year old consumer reporting on herself a patient. The patient's concurrent conditions included rheumatoid arthritis, immune system disorder reported as weakened immune system and drug reactions or allergy to CIMZIA. In 2013, reported as "about 2 years ago", the patient was vaccinated with doses of Hepatitis B Vaccine (manufacturer unknown), IM (anatomical location, lot # and expiration date were not reported) and doses of Hepatitis A Vaccine (manufacturer unknown) IM (anatomical location, lot # and expiration date were not reported). It was reported that the patient had a three dose series of doses of Hepatitis B Vaccine (manufacturer unknown) and Hepatitis A Vaccine (manufacturer unknown). It was unspecified if the patient received three doses of Hepatitis A Vaccine (manufacturer unknown) and three doses of Hepatitis B Vaccine (manufacturer unknown) separately, or the patient received three doses of an unspecified combination Hepatitis B Vaccine (manufacturer unknown) and Hepatitis A Vaccine (manufacturer unknown). Concomitant therapies included ENBREL. The patient stated that on an unspecified date in 2014, after receiving Hepatitis B Vaccine (manufacturer unknown) and Hepatitis A Vaccine (manufacturer unknown), she had blood work that resulted in no titers for either vaccine. Additionally, the patient stated that she was on ENBREL while receiving the three dose series and stated that it was not working. No treatment was given for the adverse events. The patient sought medical attention by visiting office. The outcome of hepatitis B surface antibody negative and hepatitis A antibody negative was reported as not recovered. The relatedness between the events and suspect therapies was not provided. Additional information is not expected, no contact details were provided.
Fever of 99.5; Body aches; chills; red face; feeling flushed 5 hours after 1st shot; Headache for next two days; This is a spontaneous report from a contactable other hcp (patient). A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on 15Dec2020 10:00 at single dose (Left arm) for COVID-19 immunization. Medical history included Covid 19. Patient is not pregnant. Patient had no known allergies. Concomitant medication included pseudoephedrine. Facility type vaccine: Hospital. There was no other vaccine in four weeks. On 15Dec2020 15:00, it was reported that patient had Fever of 99.5, body aches, chills, red face, and feeling flushed (5 hours after 1st shot). Temp increased to 100.6 so I took Aleve and I felt better in 30 min. Headache for next two days. After second shot, fever of 99.6 and body aches with chills after 12 hours. Took Aleve and fever was gone felt fine by noon next day. The patient underwent lab tests and procedures which included Nasal Swab: negative on 18Dec2020. Therapeutic measures were taken as a result of fever of 99.5. The outcome of the events was recovered on an unspecified date.  Information about lot/batch number has been requested.
immobile for a day; cannot walk; sore arm; weakness; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 77-years old) (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. Medical history included Hashimoto's disease from an unknown date and unknown if ongoing, Diagnosed 35 years ago, hypermobility syndrome from an unknown date and unknown if ongoing, Diagnosed 20 years ago, "anomia" (unspecified) from an unknown date and unknown if ongoing, Diagnosed 25 years ago, and thyroid high from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken for thyroid disorder, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported; and diazepam (VALIUM) taken for an unspecified indication, start and stop date were not reported. The patient experienced immobile for a day on an unspecified date, cannot walk from kitchen to the other room on an unspecified date, she is so weak which lasted one day and was bearable on 15Feb2021, and sore arm on an unspecified date. The patient underwent lab tests and procedures which included investigation: has antibodies, they are there but not very strong on an unknown date. The clinical outcome of the events immobile, gait disturbance and pain in extremity was unknown; asthenia was recovered on an unknown date Feb2021 (lasted one day).   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021409340 Same patient, different dose and event
This spontaneous report as received from an unknown pharmacist via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). On an unknown date, the patient experienced swelling of the right side of the arm six weeks after receiving ZOSTAVAX. Treatment was not rendered for the event. The patient sought medical attention for the event (saw the doctor). It was unspecified whether lab diagnostic studies were performed. Outcome of the event was unknown. Causality was not reported. Additional information is not expected.
Pt. states that after receiving the 1st dose of Moderna 05/02/2021, started experiencing symptoms 05/30/2021 of Swelling in the arm, arm pain, numbness in the leg (right side), Right side of the face numbness 08/03/2021 (5weeks_Bells palsy). Tingling in the right foot, pain in the neck moving up to the right cheek. Primary visit 08/03/2021 recommended MRI preformed 08/03/2021. Has lost feeling along the right side of the face still occurring.
By 7:30 pm:  severe headache, moderate muscle aches, moderate fatigue, hot/cold flashes
No adverse effects reported; was vaccinated with an improperly stored PROQUAD; This spontaneous report was received from a medical assistant, regarding a 4 year old male patient. The patient's illness at the time of vaccination were reported as none. His pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (DTAP-IPV).  On 06-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012240: US-009507513-1910USA007637: US-009507513-1910USA012349: US-009507513-1910USA012351: US-009507513-1910USA012352: US-009507513-1910USA012981: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012356: US-009507513-1910USA012357: US-009507513-1910USA012358: US-009507513-1910USA012359: US-009507513-1910USA012360:
Report A0366401A describes limb swelling in a 4 year old female vaccinee who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not provided. During the week of 4/15/02, the vaccinee received her fifth injection of Infanrix in her left arm. An unspecified time later that week, she experienced redness and swelling from the left deltoid to the left elbow. Treatment and outcome were not provided. The vaccine provider considered these events to be probably related to Infanrix administration. Please refer to case numbers A0366403A and A0366404A by the same reporter.
Severe fever over 105.  Lost all muscle control and motor skills.  Paleness.  Loss of appetite.  Extremely fussy.  Weak and lethargic.
Came in to immunization clinic for Smallpox vaccination and other deployment shots on 1 Feb 2010. 21 Feb 10 at night noticed red swollen marks around smallpox site and spreading thru left chest. Seen MD off base but returned to base for evaluation. Came into clinic the next day 22Feb10. Advised to be grounded by Flight medicine.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On 05-JAN-2015, the patients was vaccinated with GARDASIL (dose, lot number and frequency was unknown) which underwent unsupported temperature excursions. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of the several reports received from the same source. No further information provided. Additional information has been requested.
He received the first Moderna vaccination 2/26/2021, and thought the 2nd dose was due in 3 weeks.   His card indicated he was to return in 4 weeks.   He took his card with him and provided it to the clinic staff and received the 2nd vaccine on day 19.    He reports no ill effects.
feels really really nervous; HCP strongly thinks the vaccine was administered subcutaneously; soreness in the triceps area; This spontaneous case was reported by an other health care professional and describes the occurrence of NERVOUSNESS (feels really really nervous), INCORRECT DOSE ADMINISTERED (HCP strongly thinks the vaccine was administered subcutaneously) and VACCINATION SITE PAIN (soreness in the triceps area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced NERVOUSNESS (feels really really nervous), INCORRECT DOSE ADMINISTERED (HCP strongly thinks the vaccine was administered subcutaneously) and VACCINATION SITE PAIN (soreness in the triceps area). On 15-Jan-2021, INCORRECT DOSE ADMINISTERED (HCP strongly thinks the vaccine was administered subcutaneously) had resolved. At the time of the report, NERVOUSNESS (feels really really nervous) and VACCINATION SITE PAIN (soreness in the triceps area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Severe chills; fever; total weakness unable to move any part of body within 8 hr. after receiving vaccine. Slept thru next day.
Patient felt lightheaded and Diaphoretic. I had him sit down. Called 911. They checked his vitals. Pt given water. Patient declined to go to ER. States he always feels that way after any kind of shot given. Released after 10-15 mins.
first dose of Shingrix on 12/12/2019 and didn't come in to get the second dose due to COVID pandemic; patient received the first dose of Shingrix on 12/12/2019; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 1-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 12th December 2019, the patient received the 1st dose of Shingrix. On 12th December 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the social problem and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The pharmacist reported that, the patient did not come in to get the 2nd dose due to COVID pandemic and its been over a year. At the time of administration of 1st dose of Shingrix, the patient was less than 50 years of age, which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up. The case had been linked with US2020102684 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020102684:Same reporter
On 3/30/2023, I got a runny nose and mild muscle aches in the afternoon. On 3/31/2023, I thought I had a bad cold. I had a headache that wouldn't go away with TYLENOL, head congestion, sore throat, muscle aches, and a mildly elevated temperature. By the evening, I decided that it was unreasonably bad for a cold, so I took a home antigen test, which yielded a positive result. I called my doctor's office and got an urgent care appointment for the evening of 3/31/2023. I was prescribed PAXLOVID, which I began taking 4/1/2023. I felt marginally better on 4/1/2023 just before I began the PAXLOVID. I have been getting better since then. I get a cough, but at this point, I don't think it's too bad. I don't think any of the congestion has entered my lungs. The muscle aches and headache were present only on 3/31/2023, and at the time of this writing, I feel like I am recovering from a cold.
Severe chills and pain in arms, shoulders, back, butt, legs.  Difficult to move arms and legs. Felt very heavy and painful to move.  Fell asleep around 6:00 p.m., waking occasionally.   These symptoms started around 4:00 p.m. and lasted through the night.  By 7:00 a.m. the symptoms had lessened.  Throughout the next 2 days I had soreness in thighs, butt, and arms, a few hot flashes and mild chills. It's now the fourth day after the vaccine was administered and I'm much better: no chills, no hot flashes, no hurting (except for right upper arm) and I'm off the couch.
Little lumps inside his forearms, calf muscle, and veins,some are small and some are the size of little socket holes; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Little lumps inside his forearms, calf muscle, and veins,some are small and some are the size of little socket holes) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced MASS (Little lumps inside his forearms, calf muscle, and veins,some are small and some are the size of little socket holes). At the time of the report, MASS (Little lumps inside his forearms, calf muscle, and veins,some are small and some are the size of little socket holes) had not resolved.            Concomitant medications were not provided by the reporter. Treatment information was not provided. Patient was slim and could see the veins easily, he had seen 20-30 or more small lumps and he had never seen them there before. He noticed these small lumps look like blood clots. Some are small, and some are the size of little socket holes, or like filling bubble on the floor. It has been 6 months now since his vaccination. He's concerned whether these are blood clots.
Edema /swelling; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm left on 15Apr2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, interstitial cystitis, hypothyroid and migraine with aura. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTIN) and steroid dose pack (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm left on 24Mar2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 09:00, the patient experienced edema/swelling that had not resolved. The patient had been to her nephrologist, cardiologist, and endocrinologist and no one could find a reason for the edema. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 27May2021, the patient underwent nasal swab COVID-19 test and the result was negative. Therapeutic measures were taken as a result of event and included treatment with furosemide (LASIX). The clinical outcome of the event edema /swelling was not resolved at the time of this report.
Dizziness, got up in middle of night dizzy, less dizzy by 8 am but worn off since then. Feels a bit tired now but not dizzy. A bit of soreness in arm.
Patient got vaccine about 10AM.  A little later, I walked out to check on her and asked "How you doing?" and she said "Not very well".    Stated she was feeling nausea, might need to vomit, felt hot, felt strange, like a brick on her chest.  Ambulance arrived and took her to e.r. at 10:30AM.  She returned to our pharmacy at 11:45AM and said it must have been a panic attack.  She was doing fine, looked good, and she said she had no food before the vaccine, only black coffee.   She had since eaten and felt much better.
Rash over entire body. Fever over 105 degrees F. Convulsions.
Initial reaction - hives, itching noted on November 5th.  Resolved over the next day or two.  He had his annual evaluation in December when he was noted to have a leukopenia that prompted a referral to hematology. Repeat blood test at the end of December with the hematologist showed ongoing leukopenia, although slightly improved. He was also noted to have liver enzyme elevations at that time. In January he had what was presumptively diagnosed as gout in left great toe. This resolved with prednisone and short course of colchicine. He presented on February 14 with shortness of breath, non-productive cough, and a papular rash on his right chest. Lab showed normal blood chemistries, ongoing but slightly improved leukopenia, mild anemia, and an elevated IgE. D-dimer was also elevated. CTA of lungs showed significant PE on right affecting all three lobes, less extensive on left and pulmonary infarcts. Currently on Eliquis
pt recvd vax & w/in 5 mins p/inject exp injection site redness, swelling & welting; addtly exp tingling in hand; tx Adrenaline;
Initial unsolicited case received from an office manager in a physician's office on 06 January 2015. A female patient with no reported medical history received FLUZONE HIGH DOSE (lot number U5022BA, expiration date 29-APR-2015) on 25 September 2014. Three hours after vaccination, the patient experienced throat swelling and a fever of 101 degrees. She reported feeling sick for three days afterwards. She did not notify her physician or go to the emergency room. Outcome was not reported. Documents held by sender: None.