chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received first dose / around November 2020 / would like to wait for her mom to get second dose until RA symptoms stabilizes; patient was diagnosed with Rheumatoid Arthritis (RA); This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. In April 2021, between 4 and 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant). On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the rheumatoid arthritis was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the rheumatoid arthritis to be unrelated to Shingrix.  Additional details were provided as follows: The case was reported by patient's daughter. The patient received 1st dose of Shingrix around November 2020. In April 2021, the patient was diagnosed with rheumatoid arthritis. The reporter did not think rheumatoid arthritis was caused by Shingrix. The reporter concerned if the second dose will aggregate rheumatoid arthritis and would like to wait for the patient to get the second dose till the rheumatoid arthritis symptoms stabilizes, which led to incomplete course of vaccination. No other information was provided. The reporter did not consent to follow up.
She sat down and got her vaccine, and the woman administering the vaccine was sitting down and jabbed her with the needle from an angle and it hurt.  She was okay otherwise but the next day around 10:00 she went to visit her mother and then felt dizzy and not able to drive home, but her brother was with her who drove her home.  She went home and laid down and had a 3+ hour nap and was fine once she woke up.
chronic kidney disease; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 immunisation. The following information was reported: CHRONIC KIDNEY DISEASE (medically significant), outcome "unknown". Clinical course: Patient would like to know if she could get another booster shot. Patient also stated that she had a chronic kidney disease. She took the Covid 19 vaccine and she had a chronic disease.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient given booster only 3 months after his 2nd dose instead of 6 months. No adverse reaction occurred.
Headache, Fever & Rash Narrative: Day 1-2 rash, fever, chills and headache.
Fine red rash on trunk, front and back. No fever, uticaria, or any other s/s.
Two to three minutes after vaccination, the patient felt weak, sweating, cold hands and had his eyes closed. His face turned completely white. But he remained consciousness till he went to ER 911 people took him to ER.
Lt arm was swollen, red & hurt x 2 days beginning 24OCT91; 9NOV91 pt felt nausea, chills, very hot, h/a; pt didn't take temp; pt had muscle aches especially back of neck from 9NOV91 x 3 days; Pt took ASA & Tetracyline & fluids;
pink eye/eye infection; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE INFECTION (pink eye/eye infection) and PAIN IN EXTREMITY (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Mar-2021, the patient experienced EYE INFECTION (pink eye/eye infection). At the time of the report, EYE INFECTION (pink eye/eye infection) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had been to a doctor and was told that pink eye is a side effect of the vaccine. Concomitant medications were not provided. Treatment information was not reported.
PARENT NOTED LAST NIGHT (01/23/2013), RIGHT UPPER ARM AREA WHERE SHOT WAS GIVEN: REDNESS, REDNESS MEASURED 2in.x4in-OVAL SHAPE, WARM TO TOUCH, HARD. NO FEVER. USING ICE, IBUPROFEN AT NIGHT.
Myopericarditis, pericardial effusion presumed hours to smallpox, but pssible coincidental to viral, mycoplasmal or other infection.
The patient has stated that she has been having cases of minor swelling, puffiness, and slight numbness and tingling over the recent twelve days, following the first dose of the COVID vaccine. She reports having several different reactions to where she has swelling in her upper or lower lip, numbness near her cheek area, and slight puffiness under her left eye. Not all of these events occur at the same time, rather they seem to occur on seperate occasions. The sights of these events seem to rotate around the facial area as well.  She reports that she has been self-medicating, taking chlorpheniramine 4 mg, as an over-the-counter oral tablet. This antihistamine medication appreas to help reduce the swelling and puffiness.  An allergy specialist that she visited within the last week, also recommended that she continue to take that antihistamine medication. As per the current CDC recommendations, I have stated that it would be most appropriate for her to not receive the second dose of the COVID vaccine.  She will continue to monitor her symptoms, and continue to take the antihistamine medication as she has been taking it previously.
arm  was so swollen; it was swollen, it was red, it had a big red area on it; arm  was so swollen; it was swollen, it was red, it had a big red area on it; Nauseated; patient had her second pneumonia shot; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (brother in law and herself). This is first of two reports. A 66-year-old female patient received the 2nd dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer unknown, lot number and expiration date: unknown), via an unspecified route of administration on an unspecified date in 2019 (reported as this year) at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patent was previously administered the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in 2018 at an unspecified age for immunization. The patient reported that she had her second pneumonia shot and she do not know what's it called. Patient further stated that she got her first one last year and her last one this year. The patient also reported that in that afternoon (unspecified date), her arm was so swollen at the top where the shot was, it was swollen, it was red, it was (incomprehensible word) and it had a big red area on it and it stayed there for 5 days just like that, and she also got real nauseated. Outcome of events was unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019434230 same reporter and drug, similar event, different patient
about 4 hrs p/vax t103 ax x 3 days, off & on; vomiting, diarrhea, irritability; swelling & redness @ inject site x 3 days; several episodes of high pitched screaming x 2 hrs for ea day x 3 days;
(L) arm slight swollen - pain on site of vaccine given DTAP # 4 - "pus" bubble "popped" burst. Treatment: TAC 0.1 oint & Bacitracin ointment given.
pt recv vax & exp sensation of throat closing up;pt was seen in ER where dx of anaphylaxis was made;pt tx w/unspecified med & recovered;
This case was reported by a pharmacist and described the occurrence of seizure in a 2 year old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Dtpa, unknown manufacturer). On an unspecified date the pt received a dose of Dtpa. Approximately one week following the administration of Dtpa, the pt experienced a seizure. The pt required medical attention. On an unspecified date, the event resolved. Seizure was assessed as medically serious. (OMIC)
Patient?s arm is red, sore and swollen. It was better today but they just reached out to us to see if this was typical.
Abnormal menstrual cycle:   After the 1st dose the menstrual cycle was delayed by  1 week  (onset July 17, 2021), was heavier than usual.  It lasted  3 days, however,   two days later I experienced spotting which lasted 4 days.  After 2nd dose the menses has been missing.  Historically my menstrual cycle has been exactly 29 days.
Client had hives which had started the day before receiving the vaccine. Nurse gave client Benadryl a couple minutes after receiving vaccine because of itchiness. Client stated that Benadryl did not help the day before but Pepcid did help. At 9:53am client stated she felt the same but had no difficulty breathing. Released to personal vehicle.
This case was reported by a consumer via interactive digital media and described the occurrence of varicella-like rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced varicella-like rash. On an unknown date, the outcome of the varicella-like rash was unknown. It was unknown if the reporter considered the varicella-like rash to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced a very chicken pox like rash. The follow-up would not possible as no contact details were available.
6 seizures as a reaction from the Dtap shot. Each seizure less severe than the previous one. No fever was ever detected.
Two days after Injection started with fatigue, weakness, thirst, light dizziness.  Next morning had bad chest pain, shortness of breath, weakness, and dizziness. Went to Emergency Room with same, heart rate down to 44 bpm and PVC's.  Spent 21 hours in Emergency Room, Ejection Fraction at 35%.  Discharged to primary Care Doctor.  Met with Primary Care Doc (day 6) and was referred to Cardiologist.   Met with Cardiologist (day 15), admitted to Hospital straight from Doc Office. Next day Heart Cathe. Overnight Heart Rate got down to 30-32bpm.  Sent home with Life Vest (wearable defibrillator Unit).  Started CHF Program for 6 weeks. Started Meds and heart rate got up a bit and Ejection fraction up to 44%
WEAKNESS, DIZZINESS, HEADACHE, NO SYNCOPE, NOT EATEN SINCE 5PM DAY BEFORE, CODE GREEN CALLED.  SX RESOLVED, REFUSED TRANSPORT.
This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced chills. On 29-MAR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99 F. On 06-APR-2021, the subject experienced hives kind of rash on both legs from belly button down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever on MAR-2021, was recovering from hives kind of rash on both legs from belly button down, and the outcome of chills was not reported. This report was non-serious.
Client received just NS  instead of Pfizer COVID vaccine. Client was notified and recommended to return for a correct dose. Client returned on 04/24/2021 and received a correctly mixed dose of Pfizer vaccine. Lot number ER8735, intramuscular, in left deltoid.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    This case contains information for the 14th patient out of 77 patients as described by the reporter.  Concomitant medications were not reported.  It was reported that the vaccine was administered to 77 patients before it was known if the vaccine was ok to use after the excursion.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
pt recv vax 3JUL97 & 13JUL97 temp up to 103, lasting approx 3 dasy had used APAP q 4hr until fever broke;16JUL97 rash on body, face & chest & spread over entire body used DPH & cool  H20;
Jannsen COVID-19 Vaccine EUA Had a high fever, worst pain I?ve ever felt. Was up until 5 am shaking and in serious pain. Lower back hurt really bad and my legs were sore.  Hurt so bad it motivated me to fill out this form.
At the time I gave the immunizations there were no signs of any adverse events( normal). When patient came back, her arm was red from immunization. No temperature of  child (alert).
Admitted to the hospital on 9/27/21, at that time tested negative for COVID by NAAT. On 10/07/2021 tested negative for COVID by NAAT. On 10/14/21 tested Positive for COVID by NAAT in preparation to be discharged to acute Rehab. Repeat testing by PCR for COVID on the same day was negative.
It was swollen, red and warm. Patient was seen by a doctor; was Rx Keflex antibiotics and warm soaker
On March 1, I developed bed-shaking chills, fever to 101 and diarrhea lasting for several hours.  Resolved without treatment.
No additional AEs; a patient was inadvertently administered GARDASIL 9 today (14JUN2021) that was expired; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 14-JUN-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, formulation, concentration, vaccination scheme frequency, route of administration, anatomical site of vaccination were not reported; lot number R009615 has been verified to be valid, expiration date reported and validated as 07-DEC-2020) (expired product administered). No additional adverse events (AEs) reported.
The first couple of days I felt like I had a bad cold. I was talking to a friend who said I sounded bad and should take a COVID-19 test, I did use a home COVID-19 test, it came back positive. I went to an urgent care to get some medication to help me get over this quicker. I was prescribed, LAGEVRIO. On the second day I had a fever that lasted for three days then went away, I coughing that has lingered, my fatigue has lingered. Any other symptoms that come up such as a runny nose, sore throat, headache only lasted for a day.
MMR injected into (R) thigh SC. Patient immediately cried. Almost immediately, a large red area developed at the injection site. Flat erythematous circular lesions on forearms, upper arms and near injection site. Flushing of both cheeks also occurred.
This spontaneous report as received from a physician via company representative refers to an unspecified patient of unknown age and gender. The physician reported that an unspecified patient informed her about having read on an unspecified article that another unspecified patient on an unknown date was vaccinated with GARDASIL (Injection, strength, route, anatomical location, dose number, lot # and expiration date not reported). Concomitant therapies were not reported. According to the patient who reported to the physician, the article stated that the GARDASIL caused an unspecified cancer in the unspecified individual on an unspecified date. The outcome of this event was unknown. Causality was not provided by the reporter. Upon internal review, "cancer" was considered as medically significant event. Additional information is not expected because the reporting physician did not consent for further follow up.
Immune thrombocytopenic purpura: Patient developed petechiae and ecchymoses on the day after vaccination (11/24), and she was found to have a platelet count of 8 on 11/26. She will be hospitalized for close monitoring of her platelet levels and treated with IV steroids.
She did not feel well after the vaccine.  She was checked out by EMS and was told to call them if it got worse.  Left the store a few minutes after EMS told her to let them know if she got worse.
Vertigo (fairly severe), malaise, difficulty concentrating, lethargy, soreness at injection site, loss of appetite, mild muscle weakness. After 36 hours, only soreness at injection site and residual vertigo and mental "fogginess".
Information has been received on 17-JUL-2017 from a consumer reporting on herself as a 63 year old female patient with penicillin allergy. The patient's medical history included sleep disorder and sciatica pain. On 12-JUL-2017 (also reported as 13-JUL-2017) the patient was vaccinated with ZOSTAVAX lot # M040146, expiration 26-DEC-2017, subcutaneous in the left arm for prophylaxis to prevent shingles.    Concomitant therapies included metformin, duloxetine hydrochloride, naproxen (reported as "nexproxin") and "levitroinin." The patient stated that about 4 hours after she received the ZOSTAVAX vaccine she was "incapacitated" and slept for 3 ½ hours. After she woke up she had pain going up her neck, "like meningitis." The pain, she said then traveled behind her ears and she had a severe headache. The patient reported she has a walnut size bump on her left arm injection site, along with skin blotches, and itchiness at the site. The outcome of "incapacitated", slept for 3 ½ hours, pain going up her neck, "like meningitis," pain, she traveled behind her ears, severe headache, and a walnut size bump on her left arm injection site, along with skin blotches, and itchiness at the site was unknown. The causality was not reported. Information has also been received on 17-JUL-2017 from a pharmacist. The pharmacist clarified that the date of ZOSTAVAX administration was on 12-JUL-2017. No additional information was provided. Additional information has been requested.
He received his Moderna COVID-19 vaccines on April 30 and May 28, 2021.  Around June 14, 2021, he went for a COVID-19 test because of intermittent low-grade fevers (up to 100-101 Fahrenheit) and body aches, fatigue, poor appetite since the Sunday prior with no other symptoms going on from June 11-12.  COVID-19 test was negative.  Fever abated by the last week of June, but then he started to feel dizzy while walking and was experiencing numbness and tingling in the BILATERAL hands.  He lost 25 pounds in 2 weeks due to his illness.  He got better from fever after 1 week, then still had nighttime fevers for another week.   -Late June?beginning of July 2021: Numbness and tingling and dysesthesia in the BILATERAL hands and BILATERAL feet; mildly imbalanced walking; fatigue Symptoms were keeping him awake at night   -July 7, 2021: Numbness of the perineum; erectile dysfunction; balance problem; BILATERAL feet heaviness -- > MRI brain showed greater than 20 supratentorial and infratentorial lesions as well as cord lesions, consistent with demyelinating disease
102 F Fever; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 F Fever) and FATIGUE (Exhausted) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant (multiple ). Concomitant products included TACROLIMUS (PROGRAF) for Immunosuppressant drug therapy.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (102 F Fever) and FATIGUE (Exhausted). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (102 F Fever) and FATIGUE (Exhausted) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 °F (High) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly patient is taking antibiotics and a nasal rinse.
None that we are aware of, only reporting because patient is 60 and was given a Fluad 65+ shot meant for people over the age of 65.
Severe Migraine for 6 days then reduced to mild headache for 2 more days. Diarrhea for 2 days. Cough for 8 days. Muscle aches for 24 hours. 102 fever for 24 hours. Overall feeling of malise for 3 days.
hives, nausea/vomiting, hypotension; admitted to hospital for anaphylaxis.