chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Erythema multiforme-onset on 4-29-07.    06/11/2007 MR received for an o/n admission 5/2-3/2007 for worsening rash x 1 day.  Child seen in office 5/1 for diffuse erythematous rash rash all over trunk, face etc. which ranged from 1 to several cm.  Abx for prior otitis media were changed and Benadryl given.  Rash continued to worsen.  PE: diffuse rash of target lesions and erythematous plaque-like lesions.  The center of many of the target lesions were ecchymotic.  R TM red and bulging. Nasal crusting.  Otherwise WNL. By DOD lesions were fading.  Temps continue in the 100.5'F range. D/C DX:  Erythema multiforme.  Fever with leukocytosis, improved. Abnormal liver enzymes.  Acute otitis media, untreated.
This spontaneous report was received from a nurse referring to a 3 year old patient. Information about current condition, concomitant medication and medical history of patients was not provided. On an unknown date the patient was administered with PNEUMOVAX 23 lot # K004483, expiration date 16-AUG-2015 for prophylaxis (strength, dose, and frequency were not reported). No adverse event was reported. Action taken regarding therapy with PNEUMOVAX 23 was unknown.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 23th of 190 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
After take the vaccines now blood work shows i am a diabetic, was not before take the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of DIABETES MELLITUS (After take the vaccines now blood work shows i am a diabetic, was not before take the vaccine) 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.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIABETES MELLITUS (After take the vaccines now blood work shows i am a diabetic, was not before take the vaccine) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS (After take the vaccines now blood work shows i am a diabetic, was not before take the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: normal (normal) no blood work shows i am a diabetic. On an unknown date, Blood test: abnormal (abnormal) Blood work shows as  diabetic.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Company comment:  This case concerns a patient with no reported medical history who experienced serious unexpected event of diabetes mellitus, that occurred after the 2nd dose of the mRNA-1273 however, the exact time to onset was not provided. Reportedly, the patient denied having any sings or symptoms of diabetes prior to vaccination . The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient with no reported medical history who experienced serious unexpected event of diabetes mellitus, that occurred after the 2nd dose of the mRNA-1273 however, the exact time to onset was not provided. Reportedly, the patient denied having any sings or symptoms of diabetes prior to vaccination . The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pfizer vaccine was administered - reported by patient  J96.00 ACUTE RESPIRATORY FAILURE 2/23/2022 ATRIAL FIBRILLATION, PAROXYSMAL J96.00 ACUTE RESPIRATORY FAILURE 2/23/2022 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 2/23/2022 CHOLELITHIASIS
Had covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Had covid arm) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), DIGOXIN, ISOSORBIDE, LOSARTAN, MAGNESIUM OXIDE, METOPROLOL and SPIRONOLACTONE for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE REACTION (Had covid arm). The patient was treated with TRAMADOL at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Had covid arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-080282 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080282:1st dose
Fever of 101 to 102.5 F; chills; bad headache; terrible night, no sleep; he is not taking a shower and then laying down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 06Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid 19" (not ongoing), notes: he actually had Covid 19 virus a year ago, beat Covid in a week. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, After the first dose of the Pfizer Covid-19 Vaccine the patient was fine.), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovering", described as "Fever of 101 to 102.5 F"; CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "bad headache"; INSOMNIA (non-serious), outcome "unknown", described as "terrible night, no sleep"; FATIGUE (non-serious), outcome "unknown", described as "he is not taking a shower and then laying down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: Reporter was the father of a 18 year old patient who received the second dose of the Pfizer COVID 19 vaccines on 06Jan2021. He had been experiencing the fever of 101 to 102.5 F, chills, bad headache, terrible night, no sleep, describes it as much worse than he felt when he actually had Covid 19 virus a year ago. After the first dose of the Pfizer Covid-19 Vaccine the patient was fine. After the second dose of the Pfizer Covid-19 Vaccine the patient had a terrible night, couldn't sleep, had chills. Patient woke up, reporter guessed patient was up, and his fever had gone up to 102.5-unit/degree of measurement not provided. Patient had really bad chills. Patient had been drinking a lot of water, has had about 3-38 ounce bottles of water. Patient took a Motrin, Ibuprofen-unable to clarify if this was 2 different products, or the same product. The patient lay down but his fever was up to 102.5. The patient was a really healthy kid, he never gets sick; They are concerned that maybe patient was exposed to COVID and then got the second dose of the Pfizer Covid-19 Vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
cold symptoms; rash; itch; pain near site; This is a spontaneous report from a contactable consumer (patient).   An 80-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269) via intramuscular on 10Feb2021 (at the age of 80 years old) as dose 2, single for COVID-19 immunisation. Medical history included ongoing thyroid disorder, ongoing cholesterol, and gastrooesophageal reflux disease. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for cholesterol, and famotidine (PEPCID [FAMOTIDINE]) taken for gastrooesophageal reflux disease. The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247) via intramuscular on 20Jan2021 as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient experienced cold symptoms, rash, itch, pain near site. The vaccination facility type was reported as hospital. Prior vaccination (within 4 weeks) was reported as none. The outcome of pain near site was unknown; outcome of all the other events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Sore Throat - Congestion - body pains - severe chills & shivering Started letting up in 2 1/2 hours. 1 asprin.
This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Left breast is a little sore in one spot.), VACCINATION COMPLICATION (Side effect), BREAST SWELLING (Left breast does feel a little more swollen), SWELLING (It may be swollen) and LYMPHADENOPATHY (Lymph node side effect) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 vaccination: Pfizer BIONtech COVID-19 Vaccine (1st dose of COVID-19 Vaccine) on 05-Apr-2021 and Pfizer BIONtech COVID-19 Vaccine (2nd dose of COVID-19 Vaccine) on 27-Apr-2021.On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 14-Nov-2021, the patient experienced BREAST PAIN (Left breast is a little sore in one spot.). In November 2021, the patient experienced VACCINATION COMPLICATION (Side effect), BREAST SWELLING (Left breast does feel a little more swollen), SWELLING (It may be swollen) and LYMPHADENOPATHY (Lymph node side effect). On 13-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, BREAST PAIN (Left breast is a little sore in one spot.), VACCINATION COMPLICATION (Side effect), BREAST SWELLING (Left breast does feel a little more swollen), SWELLING (It may be swollen) and LYMPHADENOPATHY (Lymph node side effect) outcome was unknown. No concomitant medications were provided. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes:On 17-Nov-2021: Follow-up received on 17-Nov-2021 contains non significant information.
"Extreme pain" in rt. arm where Hep B was given.  Pain cont. for several hours then began vomiting twelve hours later.  Also ran temp of 102 degrees.  Took ibuprofen.
My vaccine was 12 noon.  I had a bad nights sleep, tossing and turning all night. Woke up 7:30  with a splitting headache, just like when I had COVID in March 2020.   Took 8hr arthritis pain relief (acetaminophen) as the day progressed I continued to feel worse flu like symptoms; Took 2 Advil liquid gels around 1 or 2 felt better and I continued to work until 7:00.pm. I checked my temperature when I got home around 8:30 and I had 100 degree fever took Advil and went to bed; Woke up around 12:30 took temperature and it was normal woke up at 6:30 took temperature and it was normal again at 9:30 it was normal; Felt good so did a lot of things around house and about 1:30 I started to feel tired  I took my temperature and it was 99 degrees.  This went  on and off all afternoon and evening.  Took Advil around 2:pm and again at 11:00 went to bed and woke up Friday morning with no issues.  It is now Tuesday evening and I have not had  any symptoms or fever since Thursday
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pinkish on left arm of injection), VACCINATION SITE PRURITUS (Itchiness on left arm of injection), VACCINATION SITE PAIN (Tenderness left arm of injection) and VACCINATION SITE ERYTHEMA (Redness on left arm of injection) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy. Concomitant products included METFORMIN for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Pinkish on left arm of injection), VACCINATION SITE PRURITUS (Itchiness on left arm of injection), VACCINATION SITE PAIN (Tenderness left arm of injection) and VACCINATION SITE ERYTHEMA (Redness on left arm of injection). At the time of the report, VACCINATION SITE DISCOLOURATION (Pinkish on left arm of injection), VACCINATION SITE PRURITUS (Itchiness on left arm of injection), VACCINATION SITE PAIN (Tenderness left arm of injection) and VACCINATION SITE ERYTHEMA (Redness on left arm of injection) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient's concomitant medications include statin (unspecified).
The patient received a COVID-19 booster dose that was later found to be involved in a temperature excursion of 34 hrs. at max temp of 8.54 Celsius. The manufacturer was unable to provide additional stability information that applied to this excursion. The patient/parent was notified.
About 12hrs p/receiving shots, pt awoke w/t104, then had tonic clonic movements of entire body & gaze to rt; Was unresponsive for about 5min; In ER was alert & responsive w/good color, tone & PE x/for fever;
Red, itchy bump on arm where vaccine was administered. This is a known side effect. Will monitor for worsening signs or symptoms.
Didn't feel right felt pain in jaw, felt golf gall size in gland with to walk in clinic was prescribed some antibiotics
This is a spontaneous report received from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 23Mar2021 at 09:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Other vaccines received within four weeks prior to the COVID-19 vaccine was reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 23Mar2021, the patient had undergone nasal swab test and the result was pending. On 23Mar2021 at 22:30, patient experienced general body pain (body ache), joint pain, headache and chills. No treatment was received for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the general body pain (body ache), joint pain, headache and chills was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Patient received vaccine, less than 10 minutes later patient was laying on ground 7 feet from the pharmacy and did reported waking up on the ground
Vision Issues, Floaters in vision, Raised blood pressure, heart palpitations, and possible TIA. Discovery of Long Covid or PASC for almost 6 months and counting after receiving the vaccine. Strong disorentation, Unable to drive or to work due to the dizziness, visual issues, brain fog, body pains, muscle twitches, heart issues, and high blood pressure.
Moderna vaccine was stored in refrigerator, not freezer. Then given after the 30-day expiration.
Swollen lymph nodes Right side of body neck, underarm and groin areas; Fever; Headache; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 07Apr2021 at 1545, as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, melanoma and squamous cell skin cancers and small intestines bacterial overgrowth and also had drug allergy to erythromycin antibiotic. The patient did not take any concomitant medications within two weeks of vaccination. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 at 1730, as a single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19 and also did not receive any other vaccine within four weeks of vaccination. Since the vaccination, patient not tested positive for COVID-19. On 04Apr2021 at 0300, the patient experienced Swollen lymph nodes on the right side of body at neck, underarm and groin areas and also had fever, headache and diarrhea. Therapeutic measures were not taken. The clinical outcome of all events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
On 08/16/2022 I had vaccination. I knew that I had been exposed to COVID-19 on 09/07/2022 and I tested COVID-19 Positive on 09/12/2022. I was prescribed Plaxovid and Vitamin C Vitamin D and Zinc.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/8/2023 ALZHEIMERS DISEASE
Information has been received from the Merck Pregnancy Registry from a physician concerning a 15 year old white female with penicillin allergy and no reported medical history who on 21-AUG-2007 was vaccinated with her first dose of GARDASIL (Lot #6578621/0387U) and was pregnant (noted as her first pregnancy). ECD is 12-MAY-2007 and patient's LMP was 06-AUG-2007. Concomitant therapy included azithromycin (manufacturer unspecified). Lab tests included a prenatal screen (no results reported). On 04-SEP-2007 the patient experienced sinusitis. From October 2007 to May 2008 the patient took prenatal vitamins daily. On 18-OCT-2007 an ultrasound was performed to assess fetal development and was normal. Follow up information reported that on 30-APR-2008 the patient vaginally delivered a full term, live born, normal and healthy female who weighed 7 pounds 6 ounces, 19 3/4 in length apgar score 9/9 and a head circumference of 13 3/4. It was reported that the infant had a small congenital anomaly. According to the nurse, the physician's notes also indicated "bilateral hands with rudimentary 6th digit." The nurse stated that it was also noted that there is a positive family history of similar digits. There were no other anomalies and no complications for mother or baby. Additional information has been requested.
Pt has a history of paroxysmal atrial fibrillation and breast cancer.  Pt was admitted due to atrial fibrillation and COVID-19.
Pt received vaccine on 4-29-13. Left arm, lower upper aspect, no fever. Elbow to shoulder - red, swollen rash under arm. Pt noticed 5-1-13. Dr rx given for cephalexin 5-2-13.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L022446, Expiry: 14-FEB-2017, Lot# L026741, Expiry: 20-APR-2017) (route and dose unspecified). The vaccine was stored at 34 F for 24 hours (data logger: yes). There were no previous temperature excursions. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Nurse had my daughter sitting on the edge of the exam table.  She administered HPV and my daughter fainted, fell off exam table head first and had a mild jerking episode.  She was pale and had a headache when she woke up.  She was hoarse and weak and couldn't speak easily.
Pt recvd 3 doses of Hep B 13JUL88, 13AUG88, & 13JAN89; pt's husband was pos for hepatitis antibody but DEC91 pt tested & titer results were neg;
Low grade fever and chills started 10 hours. Body aches , low grade 101 fever for 48 hours after. Most concerned with heart palpitations that were happening at least 30 times an hour for the first week. It lessened to a few an hour the 2nd week. This is the 3rd week and they are not as frequent but still occurring.
Pt recvd vax & 3 to 4 days following vax devel a papule over the inject site;
Sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6206 6121, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 08Mar2021 at 11:15 (at the age of 60-years-old) as dose 1, single for COVID-19 immunisation. Medical history included asthma and diabetes both from an unknown date. Concomitant medications included montelukast and sitagliptin phosphate (JANUVIA) both taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient experienced sore shoulder on 08Mar2021 at 16:00. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Heart palpitations And racing heart . First occurrence about 1 mth after first dose.  I have these feelings at least every other day and sometimes I feel like it is harder to breath.
Nausea and Vomiting Received PO Zofran in clinic and sent home with prescription
Headache within 2 hours, lasting >24 hours; fever and chills after 8 hours; intense body aches