chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID-19 Vaccine EUA. Still being treated for symptoms one week later. Blanchable red rash on right neck, right shoulder, right & left chest 11 days after vaccination 5/3/21. Sensitive to sun. Originally thought it might be sun burn since I had been working out in garden several days, but I don't usually burn and it did not appear on all exposed areas of body (e.g. not on face, left shoulder, or arms). Then small red bumps appeared on right and left belly and upper thighs 12 1/2 days after vaccination 5/4/21.  I was out of town when this happened. Visited  Urgent Care on 5/5/21  - Not sunburn because blanchable and systemic. "Adverse effect of unspecified drugs, medicaments, and biological substances."  Immediately given steroid shot in butt, then put on 10 mg Prednisone (2 dys 5, 4, 3, 2, 1, 1/2 tabs for total quantity 31). Also over-the-counter Benedryl, Domboro Solution, and Hydrocortison Cream (1%) for rash. Before starting Prednisone, contacted primary care physician at  to confirm this was correct course of action. Still being treated but rash is getting better.
joint pains (ankles/hips/elbows)    possible rare condition called melorheostosis versus hyperparathyroidism versus other metabolic bone disorder
Daughter says Patient's right arm had a large red area of upper arm/bicep and that the arm was sore.  She said no swelling or evidence of a lump or knot and no systemic reaction or any other symptoms.  Patient was advised to use a cold pack for pain and contact his regular doctor.
No additional AEs or PQC reported.; Caller reported expired sterile Diluent used to reconstitute MMR II and was administered; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 28-DEC-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA, recombinant Human Albumin) (M-M-R II), lot number: U011995, expiration date: 15-APR-2023 (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis, which was reconstituted with an expired sterile diluent, lot number: T014300, expiration date: 03-DEC-2022 (dose, strength, route of administration and formulation were not reported) (expired product administered). No additional adverse events (AEs) or product quality complaint (PQC) were reported (no adverse event).
Systemic: small rash on stomach developed 2days after vaccine-Mild, Additional Details: rash on stomach & pt couldnt think of anything else that he had done/consumed/encountered that could have caused the rash...
Vascular issue; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and ANGIOPATHY (Vascular issue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.  No Medical History information was reported.  In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 17-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ANGIOPATHY (Vascular issue). At the time of the report, COVID-19 (COVID-19) had resolved and ANGIOPATHY (Vascular issue) was resolving.  No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This case was reported by a physician via call center representative and described the occurrence of lymphangitis in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced lymphangitis (serious criteria GSK medically significant), leukocytosis, lymphadenopathy, neck pain and induration. The patient was treated with clindamycin. On an unknown date, the outcome of the lymphangitis, leukocytosis, lymphadenopathy, neck pain and induration were not recovered/not resolved. It was unknown if the reporter considered the lymphangitis, leukocytosis, lymphadenopathy, neck pain and induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the left deltoid. Within 2 to 3 days after vaccination, the patient was experiencing pain radiating in the left side of the neck. Within 7 days after vaccination, the patient had a large painful induration. The patient seen in the hospital and was given a computerized axial tomography (CAT) scan and started on Clindamycin. The patient was diagnosed with lymphangitis, adenopathy and leukocytosis. The symptoms had not resolved. The call center representative was unable to get patient information because the physician was frustrated and unfortunately, hung up before this information could be obtained. Lab Comments: on an unknown date, the lab test was performed.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE MULTIPLE SUBSEGMENTAL PULMONARY EMBOLI WITHOUT ACUTE COR PULMONALE ACUTE PULMONARY EMBOLISM
In May of 2021 I got one spot of rash on my foot. The following month I had tow spots on my other foot. In July of 2021 I started to get some small hard spots that were on my feet and my hands. They were in between my fingers. A month after that it cropped up on my hands and feet. In September it started to spread up my arms. I have some bigger spots on my back, thigh arms. They are bumps and the center becomes white. It is starting to spread all over my body. I had some of the rash biopsied and they told me it was Lichenoid Inflammation. They are between my fingers and my toes. The bumps do not go away and I just keep getting more. As it spreads it just means that there are more spots. Sometimes the smaller ones go away but the bigger ones that are red stay. The worst area is on my hands. I tried some Cortisone cream and it did not work. They are uncomfortable when they first come out and they feel a little better once they are established. I have a large area that spreads up my left wrist is the biggest area. They do lighten up but they do not go away.
swollen lymph nodes on neck; pain in the injection site; general body fatigue; low grade fever; mild tummy ache; body aches; This is a spontaneous report from a contactable other health professional (other-HCP) (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot number: EI0142) intramuscularly at left arm on 30Dec2020 at 06:30 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history included known allergies: trees, grass, pollen, certain flowers, indoor allergens (don't know specifics). No other medical history. The patient was not pregnant. Other medications the patient received within 2 weeks of vaccination included loratadine/pseudoephedrine sulfate (CLARITIN D-12), drospirenone/ethinylestradiol betadex clathrate (YAZ) and mometasone furoate (FLONASE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events pain in the injection site, swollen lymph nodes on neck, mild tummy ache, body aches, low grade fever, general body fatigue; all occuring the day after injection, on 31Dec2020 at 06:15 AM. The events were reported as non-serious. Treatment received for events included tylenol took on 31Dec2020 at 8:40 PM. The outcome of event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Patient developed iron deficiency anemia as proven by hemoglobin of 10.7 and ferritin level of 11 when not more than one year prior to immunization, the hemoglobin was 13.5.   Patient underwent upper, lower, and capsule endoscopy in July 2021 and all tests were normal.   Patient recovered within 5 months and had a normal hemoglobin as of September 2021. his hemoglobin remains normal as of June 2022.
Fever >100.4,  Subjective fever (felt feverish),  New loss of taste or smell, Cough,  Shortness of breath or difficulty breathing,  Fatigue or tiredness,  Nausea or vomiting, Went to urgent care for COVID test at start of symptoms and was diagnosed with pneumonia. Then symptoms worsened and he was hospitalized at Hospital
At the 16 hour mark I became exhausted. Around the 20 hour mark I started having achiness in my joints. By the 24 hour mark my body ached all over even my armpits. At this time I didn?t notice a fever but around the 33 hour mark I felt like a fever had broken being awakened by feeling damp all over.  My right armpit continued to hurt until around the 48 hour mark.
sleeping most of the day; no appetite; very weak; excessive fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleeping most of the day), DECREASED APPETITE (no appetite), ASTHENIA (very weak) and FATIGUE (excessive fatigue) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced SOMNOLENCE (sleeping most of the day), DECREASED APPETITE (no appetite), ASTHENIA (very weak) and FATIGUE (excessive fatigue). At the time of the report, SOMNOLENCE (sleeping most of the day), DECREASED APPETITE (no appetite), ASTHENIA (very weak) and FATIGUE (excessive fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
After both rounds of the COVID vaccine I had heavy menstrual bleeding about 2 to 3 days post vaccine.  I have an IUD and do not get periods (for several years).    About 2 weeks after the second dose of the vaccine I also had water retention/swelling in my lower legs/feet with no other events or injuries.
The TDAP was administered 6/29/17 during prenatal visit. On 6/30/17 I began to experience headache, chills, and fever. Between 4 pm and 11 pm on Friday 6/30/17 the fever went to 101.5 x3.  During this period I used 1000 mg TYLENOL x3 as well as lukewarm baths. The chills and shaking were the most significant that I have ever experienced. Per recommendations from the OB office, I visited the ED as the fever was greater than 101. This was my first ever ER visit. In the ER fetal movement was fine and other than an elevated HR and low grade fever I was doing fine as well. In the morning of 7/1/17 I had chills followed by sweating. Of note, I had taken the TDAP in 2011 without incident.
On the evening of 5/15, patient started with a fever all night and it continues to morning of 5/17.  Patient specified that it was hard to get out of bed, felt very tired, that legs, arms do not want to work, and was moving very slowly/shuffling her feet and no appetite.  Mother called pediatrician on 5/16 and was sent to ER.  Patient went to ER Urgent Care clinic; patient was not admitted. Patient reports pain in her back--about her butt--and stomach pain.  It also hurts when she moves her chin to her chest and lifts her arms. Patient reports joint pain and stiffness. Per doctor, these adverse events are seen in women and teens not in young children.  Patient has been taking Motrin for fever.  Mother will follow-up with pediatrician in 3 days and was told to bring her immediately back to ER if any other symptoms occur.
The night after taking the vaccine I noticed both  of my legs from my calf down swelled including my ankles and feet. I contacted a nurse and was told top prop my legs up while sleeping and to not take any medication. The next morning everything was back to normal.
On 31st of Dec and Jan 1-- arm extremely sore.  on Sat jan 2 I started having mild allergy like symptoms.  Sunday night Jan 3, started to have congestion, headache.  only able to work appx 5 hours on Mon/ Tues bc weak, congested, headache, shortness of breath, chest hurting--got tested on Tues (jan 5, rapid test +).  off wed to Thurs of next week off quarantine on jan13..  same symptoms--headaches unbearable--some brain fog.  almost had to go to ER x2 for headaches.  no relieve.  Still not better on Jan 25th so went to family care clinic--chest xray, started on prednisone.   Jan 29th started on Toradol bc headaches not better.  same symptoms. I normally work 10 hour days-- currently I can only make it 6-8 hours d/t fatigue, head aches. more tired I get worse it gets.  I never take naps--I have had to take naps or rest during some days.   Got second shot on Feb 2nd--- so far, sore arm.  this afternoon headache still--shortness of breath is back and bad tonight.  fatigue.    I have had migraines since 18 and can usually manage--these are not as manageable.
Hand started feeling numb and swelling. Traveled up arm, throat, & left side of face and lips.
prescribed Paxlovid after vaccination/Treatment of COVID-19; prescribed Paxlovid after vaccination/Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster, single) (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "prescribed Paxlovid after vaccination/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown result. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid from 09Jun2022 to 13Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt. was in the office and received Vaqta (Hep A) and Bexsero (Men B) vaccines. She appeared well to clinical staff - check out staff. Shortly after leaving office & driving pt. started seeing black spots. Went to step on brake she doesn't recall anything else. ran into the car in front of her. No known injury. Upon impact of pt's car to the car in front of her the airbags did not deploy and neither occupants was transported to the hospital. No visible injuries. No treatment given.
Felt like a bloody nose, like blood running down his throat. Got up to go to restroom and spit out blood into the toilet.
From telephone correspondence received at manufacturer on 11/08/02, it was reported that a 59 year old adult female was vaccinated with Fluzone SV 2002-2003 USP (Lot # U0928AA) on 11/06/2002.  The next day she developed generalized itchy rash with red blotches.  Pt's condition remained unresolved at the time of report.
5 pt recv vax & p/vax exp burning localized rxn (sl erythematous warm rash);sx resolved w/in 24hr;
On 7/3/22, woke up with symptoms including productive cough, nasal congestion, fever, sore throat, fatigue. Went to an Urgent Care and received a script for Paxlovid. Took the med for the 5 days and symptoms decreased notably. Productive cough continued. Added Flonase and loratadine. Tested negative on 7/28/22. As of 8/1 feeling back to normal.
Information has been received from a consumer concerning her daughter, a 11 year old female patient, with no known drug allergies, joint pain and problems with bones who was vaccinated with her first and second doses of GARDASIL (lot number, site and route not reported) several months ago. There was no concomitant medication. A few months ago, the patient experienced a fever, vomiting, headache, blurred vision, trouble sleeping, chest pain and dizziness. MRI and other unspecified lab work were performed on an unspecified date (no result reported). The events persisted at the time of this report. An unspecified medical attention was sought. Additional information has been requested.
Headache, Myalgia, Diarrhea, NauseaVomiting, fatigue, chills Narrative:
Short term (6-10 hours) low grade fever after first dose. Vomiting, fever (100-102.5) for 2-3 days after second dose; difficulty breathing. Four weeks after second dose, chest pain, low-grade fever, and difficulty breating.
Information has been received from a healthcare worker referring herself. Healthcare worker reported on 23-FEB-2015 when she was administering a dose of PNEUMOVAX 23 (lot# was not reported) to patient, the needle separated from syringe and most of PNEUMOVAX 23 (lot# was not reported) dose spilled out before administration could be completed. A couple of drops of PNEUMOVAX 23 got into her eye and mouth and she experienced little bit of burning in her eye and nausea from anxiety which she was having about topical exposure. The outcome of the adverse events was not reported. This is one of the reports from the same source. Additional information has been requested.
Fever of 100 F, whole body aches, nausea, chills, sweats, inability to sleep
He had the vaccine, he fainted about 10 after vaccine, he was out for about 5-10 minutes.  He was incoherent for about that amount of time, nonresponsive.  He woke up and stated that he had nausea.  He was then okay and released to go home.  EMT's were called and they assisted in his care.
PATIENT WAS GIVEN WRONG VACCINATION. PATIENT WAS SUPPOSED TO GET PFIZER AND RECIEVED MODERNA FOR SECOND DOSE
pt recv vax 1995 & became pregnant & wished to have antibodies titer checked;lab eval on 23SEP96 revealed a negative IgG titer of 0.4 by EIA:no further details were provided;
extreme fatigue-slept 24 hrs, injection site pain, redness, swelling Narrative:  Other Relevant History:
killer sore throat( felt like strep and never moved from the same site)and severe itching in nose, throat and ear severe itching spread to the mouth, tongue, inside of lip, then to big welps around mouth and on chin, then welps and severe itching on buttocks and a huge welp and itching 1 1/2" by 3" at injection site. Very tired and did not feel well.  Low grade fever was sporadic.   Could not go to work. Called Dr. about symptoms and prescribe antiobiotic of Ceftin for the sore throat..  Sore throat went away after 24 to 48 hours of being on medicine. By day 10 all the skin reactions had calmed down and by day 12 was feeling good.  Dr. wanted me to report to you guys.  He was unsure if I should take the 2nd dose of vaccine.  He seemed confident throughout that this was an immune response to the vaccine.
no other reaction or symptoms; administered ZOSTAVAX instead of VARlVAX; This spontaneous report as received from a physician assistant and an office manager refers to a 24-year-old female patient. The patient's medical history and concurrent conditions were not reported. It was reported that, on an unknown date (within the 4 weeks before the administration of zoster vaccine live (ZOSTAVAX)), the patient received diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Tdap) and hepatitis B virus vaccine (unspecified) (manufacturer unknown).   On an unknown date, the patient had a titer done prior to receiving zoster vaccine live (ZOSTAVAX) and had no protection for chicken pox. It was reported that, physician assistant ordered varicella virus vaccine live (Oka/Merck) (VARIVAX) for the patient.   However, on 27-AUG-2020, the patient was vaccinated intramuscularly with the first dose of zoster vaccine live (ZOSTAVAX) (lot # S016663, expiry date: 27-AUG-2020, right deltoid) instead varicella virus vaccine live (oka/merck) (VARIVAX). There was concomitant medication.  The patient had no other reaction or symptoms associated with this administration. No prescribing drug treatment was required.
itchiness of the chest; mild facial swelling; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness of the chest), SWELLING FACE (mild facial swelling) and VACCINATION SITE PAIN (arm soreness) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B2 1A) for COVID-19 vaccination.     No past medical history was reported.     On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PRURITUS (itchiness of the chest), SWELLING FACE (mild facial swelling) and VACCINATION SITE PAIN (arm soreness). At the time of the report, PRURITUS (itchiness of the chest), SWELLING FACE (mild facial swelling) and VACCINATION SITE PAIN (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was included Benadryl and Prednisone.  No concomitant product was reported.
No adverse event. The vaccine was given 22 hours after the vial was punctured.  The event was discovered three days later which was a Sunday at 10pm at night.  The patient was notified the next day (12-28-20).  The patient reported no side effects and was feeling felt great.
as per pt's description given today 4DEC92 p/vax on 2NOV92 had few days of lt upper arm 10-15cm redness, swelling, warmth, tenderness;
tired; mild flu; temp 100; nausea; sore throat; congestion and everything; cough; bronchitis; This case was reported by a other health professional via call center representative and described the occurrence of tiredness in a 62-year-old female patient who received Flu Seasonal QIV (FluLaval Tetra 2019-2020 season) (batch number 2277M, expiry date 24th June 2020) for prophylaxis.   On 6th September 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 6th September 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced tiredness, influenza, fever, nausea, sore throat, nasal congestion, cough and bronchitis. On 7th September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the tiredness, nausea, sore throat, nasal congestion, cough and bronchitis were not recovered/not resolved and the outcome of the influenza was unknown.   It was unknown if the reporter considered the tiredness, influenza, fever, nausea, sore throat, nasal congestion, cough and bronchitis to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The case was reported by patient herself who was a health care worker. The patient had received FluLaval Tetra 2019-2020 season on left deltoid. The patient felt tired, had mild flu, temp 100, nausea ,sore throat ,congestion and everything, cough, bronchitis. On the day of reporting, it was her first day she did not have fever. The reporter did not consent to follow-up.