chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstrual cycle delayed by approximately 28 days. Vaccine received on day 18 of cycle and cycle lasted 57 days. All other cycles are consistently 27-30 days (until this cycle and cycle with booster shot).
Warm, painful, bright red band approximately 4 inches in width developed about 3 inches below injection site. Band encircled entire arm. Patient noticed approximately 24 hours after injection.
On 1/8/01, MD evaluated a knot on pt's head as a cyst. Pt was referred to another doctor. CT Scan ordered and on 1/24/01 was read as having no lesions or masses. Cyst on parietal area, resolved.
low grade fever of 99.9; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever of 99.9) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included VALSARTAN, LEVOTHYROXINE SODIUM (SYNTHROID) and ALPRAZOLAM for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (low grade fever of 99.9). In March 2021, PYREXIA (low grade fever of 99.9) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 99.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
One hour after injection, I had a hammering headache which continued in spite of taking Ibuprofen. During night had sweats and body ached something terrible - could not sleep. The following morning (5/16), I was terribly weak, tired, muscle pain and continued headache. Around 9 a.m. got the chills and shivering. Remainder of 5/16 I felt terrible - continued with symptoms mentioned above. Laid on sofa most of day because I was to weak to move. Had no appetite.  Called pharmacist at about 3:30 and he said that only thing I could do was take Tylenol. He mentioned that he'd had a male client that had reported similar side effects. Took 2 Tylenol around 9 p.m. and went to bed. Feel better this morning, 5/17, but still somewhat weak. I doubt that I will take the second injection as recommended. Have yet to discuss this with my doctor.
Pain in left arm 2 weeks post FLUVIRIN given 10/27/2008. Pain and difficulty with manage of motion, continues to get worse, Per patient.
Date place in refrigerator - 24-Nov-2021; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator - 24-Nov-2021) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date place in refrigerator - 24-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator - 24-Nov-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  It was reported that the expired lots were administered due to the confusion with expiry date printed in the carton and the expiration date when the code was scanned. The vials did not undergo temperature excursion. The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Patient claims left side blistering, slight facial droop, and paresthesia 2 weeks post injection. PMHx of shingles flare several years ago, when initial symptoms started.  Patient states symptoms returned post injection and have lingered.
This spontaneous report as received from a Licensed Practical Nurse refers to a 15 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided. On 26-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020,  for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293:
2 days after vaccinations, child developed a 10cm X 10cm area of erythema and induration.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 07-Sep-2020 and the estimated date of delivery was 14-Jul-2021. On 14-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 14-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2020, Pregnancy test: positive positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported. No treatment medication details was reported. Estimated date of conception was reported as 19-Sep-2020.
BLOOD CLOT; This spontaneous report received from a patient concerned a 49 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total,  dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JAN-2022, the patient developed a blood clot. Patient was seeing doctor for follow up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220204276-COVID-19 VACCINE AD26.COV2.S-Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Red, warm to touch welp, grows bigger in size every day, under & to the right of injection site, painful to touch. Injection site is red, as well.
Localized redness and swelling around injection site 13 days post injection, pt states itching
Left arm developed a red pruritic rash without  blister, which progressed down her arm
101.2 degree fever that broke on its own after about 3 hours; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) via Pfizer Colleague.  A 5-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 05Nov2021 15:30 (Lot number: 30155BA) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 06Nov2021 16:00, outcome "recovered" (06Nov2021 19:00), described as "101.2-degree fever that broke on its own after about 3 hours"; DIARRHOEA (non-serious) with onset 06Nov2021 16:00, outcome "not recovered", described as "Diarrhoea". The patient underwent the following laboratory tests and procedures: body temperature: (06Nov2021) 101.2. Therapeutic measures were not taken as a result of pyrexia, diarrhoea.  Additional information: Facility type vaccine Other. No other vaccine in four weeks. No other medications in two weeks. Adverse event 101.2-degree fever that broke on its own after about 3 hours. Diarrhoea that continues to persist. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Other medical history None. Awareness date 06Nov2021.  No follow-up attempts are possible. No further information is expected.
PATIENT RECEIVED VACCINE IN RIGHT DELTOID  ON 6/17/19.  ON 6/18/19, PER DR, PATIENT STARTED EXPERIENCING PAIN AT SITE OF INJECTION.  ON 6/19/19, STARTED NOTICING WAS GETTING WORSE, ITCHINESS IN NECK, FACE AND ARM, AS WELL AS SWELLING, REDNESS AND EXTREME PAIN. SAW DOCTOR ON 6/20/19, PATIENT WAS DIAGNOSED WITH CELLULITIS AND ALLERGIC SKIN INFLAMMATION OF THE RIGHT UPPER ARM.  PATIENT WAS PRESCRIBED CEPHALEXIN AND HYDROCORTISONE
having menstrual bleeding that lasted for 1.5 weeks/experienced menstrual bleeding and this is way after she went through menopause, that was three years ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "went through menopause" (unspecified if ongoing), notes: three years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: Unknown; , Anatomical Location: Left arm), for COVID-19 immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 09Dec2021, outcome "recovered" (Dec2021), described as "having menstrual bleeding that lasted for 1.5 weeks/experienced menstrual bleeding and this is way after she went through menopause, that was three years ago". The event "having menstrual bleeding that lasted for 1.5 weeks/experienced menstrual bleeding and this is way after she went through menopause, that was three years ago" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: biopsy: unknown results; investigation: unknown results. Reporter stated that she had been through all kinds of testing over the last 3 weeks and has had biopsies done and her physician could not find any other reason for her symptoms. Caller stated that her doctor had called her symptoms uncommon and random. Caller states when she asked the doctor directly were her symptoms caused by the vaccine the doctor did not say yes or no just that she could not say for sure. Reporter seriousness for experienced menstrual bleeding and this is way after she went through menopause was unspecified. Reporter stated that menstrual bleeding began on 09Dec2021. She was not experiencing this at the moment. It went away probably about a week and a half after it was first noticed, confirmed to be in Dec2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of both VARIVAX lot # N017700, expiry date 09-JUN-2019 or lot # N023960, expiry date: 01-SEP-2019 and M-M-R II lot # N009800, expiry date: 24-MAR-2018, lot # N013280, expiry date: 28-APR-2019 or lot # N034411, expiry date: 04-DEC-2019 for prophylaxis (strength, dose, frequency, route and anatomical location were not provided). It was unknown which of the lots of VARIVAX and M-M-R II were administered to the patient. Also, the nurse reported that sterile diluent(MERCK) used for reconstitution of vaccines was properly stored. No adverse effects reported. The temperature excursion and time frame for VARIVAX was between -14 degree C to -10 degree C (-9.9 degree C) for a time frame of 3 hours and 57 minutes and for M-M-R II was between 9 degree C to 25 degree C (13.4 degree C) for a time frame of 2 hours and 36 minutes. No previous temperature excursion was reported. Data logger was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004216: US-009507513-1808USA004217: US-009507513-1808USA004219: US-009507513-1808USA004220: US-009507513-1808USA004192.
The arm starting swelling and turning red, and was hot to the touch. By the following morning (16 hours after vaccination) the reaction was from the shoulder to the elbow. ER physician diagnosed cellulitis and prescribed antibiotic. By 7 pm (26 hours post-dose, and after two doses of antibiotic) the reaction had spread so significantly that went back the ER. Received UNASYN and vancomycin I.V. and was admitted to hospital for overnight observation.
fever; body aches; Feels weak; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (body aches), ASTHENIA (Feels weak) and DECREASED APPETITE (no appetite) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced PYREXIA (fever), MYALGIA (body aches), ASTHENIA (Feels weak) and DECREASED APPETITE (no appetite). Not Provided
Significant chills for 5 hours, fever, body aches, headache significant enough to impair my ability to work the following day.  No reaction occurred after first dose.  Reaction began with several hours of chills.
Patient was given 0.3 ml of undiluted Pfizer vaccine. Patient was in observation for 15 minutes per protocol and was not observed to have any undue affects.   Patient contacted that day, but was not responding to phone calls, so voice message was left to have her call the pharmacy. She returned the phone call in the morning and was informed of the error. I asked how she was feeling, her response was that she was suffering from a severe headache and that the error obviously was the cause of that symptom.
I had a general feeling of exhaustion that came on suddenly the afternoon of the immunization. (felt very much like a virus).  Swelling & redness about the size of an orange.  I had bone & joint pain that started around 10pm on day one.  Day two - 7am slight fever (100.6) exhaustion with increasing bone & joint pain.  Unable to perform daily activities.  Slept most of the day. Today is day 3- woke up @ 6am feeling better. No fever but still tired.  Arm is still very red & slightly swollen.  Of note- I had no reaction to my 1st dose.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received 27-OCT-2014 from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 21-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
This spontaneous report was received from a healthcare worker referring to a 9 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 12-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
She had a runny nose and developed a cough on  11/26/2022 and this lasted two to three weeks a RSV was positive, Influenza and  COVID-19 tests were negative, then around 12/25/2022 the same conditions started including a fever up to 101 degrees a COVID-19 test was negative.
This spontaneous report received from a registered nurse, via company representative, refers to a 14 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 20-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from the same reporter.  Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
knot on the arm the size of an egg over the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (knot on the arm the size of an egg over the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Food allergy (Allergy to Chocolate), Thyroid disorder and Cholesterolosis NOS. Concomitant products included SIMVASTATIN for Cholesterolosis NOS, LEVOTHYROXINE for Thyroid disorder, AMLODIPINE and CHLORTHALIDONE for an unknown indication.   On 24-Feb-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021 at 4:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE INDURATION (knot on the arm the size of an egg over the injection site). At the time of the report, VACCINATION SITE INDURATION (knot on the arm the size of an egg over the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In laboratory data doctor x-rayed the knot and it was something else. Treatment medicines was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Updated Reporter details, patient demographics, Medical history, concomitant medications, Event details, Reporter casuality On 30-Jul-2021: Significant Follow up appended for document attachment
Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 40-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 3rd November 2025) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Boostrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius one day before the vaccination (for 48 minutes).   This case is for 5 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118612:Same reporter. US-GSK-US2022118569:Same reporter. US-GSK-US2022118572:Same reporter US-GSK-US2022118570:Same reporter. US-GSK-US2022118568:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118614:Same reporter. US-GSK-US2022118615:Same reporter. US-GSK-US2022118616:Same reporter.
I woke up and my left side breast was swollen. It was just swollen I didn't take any medication. The armpits went down a few days, but my breast was still swollen so I went to see my OBGYN on November 15, 2021. I was sent to get a mammogram and a breast ultrasound. They found dust breast tissue, but they found nothing to be cancerous. I went back to my doctor March 4, 2022, and I was then sent back for the same test because she still felt the lump. I got my testing one on March 17, 2022, I was then sent to a breast cancer Specialist. I was told she had no explanation, but she didn't think it was cancer, so I just figured this was my new life. In Sept I took a flight and my breast swelled up again and I was sent for more test November 1, 2022. I am still waiting on my test to come back reaction left axillary lymph nodes I am still waiting on more test but in the meantime, I have started physical therapy.
Headache, Fever, took temp at work 99.5-99.8 @ 0700. retook temp 100.3 @ 104.5. temp taken 1115 was 98.0 in EOH Narrative:
Had 12M PE and imms on 10/23, Monday mom noted a few bumps/rash on random parts of body, tuesday a few more bumps head to toe in random spots, yesterday got better, much less spots, today all spots have resolved, today temp 101.5 rectal, no other new sx, will send to clinic for advice.