chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient shows no symptoms or adverse reaction one hour after vaccination. pharmacist counseled patient the potential side effect from getting the concentrated dose without diluting the dose. and pharmacist also let patient know that pharmacist will contact manufacture for further guidance.
Period came a week after my last period. Was brown and lasted two days longer than a normal one. I usually always have regular periods. After my normal cycle it has been 60 days since a regular period.
Pt passed out after vaccine was given, pt states that "I don't like shots and this always happens when I get shots". Episode was not related to the vaccine.
This individual received a Moderna vaccine instead of a second Pfizer dose. There were no apparent side effects.
slept all 3 days; body aches; mild nausea; Exhaustion was much worse; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept all 3 days), PAIN (body aches), NAUSEA (mild nausea) and FATIGUE (Exhaustion was much worse) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced HYPERSOMNIA (slept all 3 days), PAIN (body aches), NAUSEA (mild nausea) and FATIGUE (Exhaustion was much worse). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (slept all 3 days), PAIN (body aches), NAUSEA (mild nausea) and FATIGUE (Exhaustion was much worse) outcome was unknown.            Concomitant medication was not provided Treatment medication include tylenol .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-106884 (Patient Link).
2 EPISODES OF SHORTNESS OF BREATH, LIGHTHEADED, RAPID HEARTRATE, NAUSEA. WENT TO ER AND CT SCAN SHOWED MULTIPLE BLOOD CLOTS IN LUNGS AFFECTING RT VENTRICLE, BLOOD CLOTS IN LEFT LEG. TRANSFERRED PER AMBULANCE TO ANOTHER HOSPITAL.  MASSIVE BLOOD CLOT AFFECTING RT VENTRICLE-HEART. EKOS DONE TO BREAK UP CLOTS. STARTED ON BLOOD THINNER, COMPRESSION STOCKINGS.HEPARIN DRIP FOLLOWUP WITH PULMONOLOGIST, CARDIOLOGIST, HEMATOLOGIST
Patient's mother reported that patient was "breaking out" a little while later patient was being taken to the Emergency Room for swelling in the face and rash.
Received vaccine around 1030 am, began to experience moderate headache and aches within 1 hour. Throat soreness and hoarseness developed within 3 hours of vaccination. Watery, itchy eyes and increase in heart rate (100-110). Received assessment and treatment at ER at 1850, given benadryl 25mg and prednisone 20mg.
I experienced fatigue, chills, and a very sore arm for the few days following the shot.  About a week later I started experiencing weird heart issues that continued off and on for the next week.  These symptoms included sharp pain over the heart, chest constriction to where it woke me up at night, general chest pain, and the feeling that my heart was out of its normal rhythm.  Symptoms began dissipating after 1 week.
fever 103.8 , chest pain !, chills, muscle aches, unable to walk legs felt weak , horrific headaches, unable to hold my head up
Patient described her armpit (of the arm that got the vaccine)  being very swollen and tender. She got the vaccine on Friday and she called with this complaint this morning (Sunday).
on 08/09/2021 patient developed chest pain - which caused her to go to ED
Client received vaccinations, immediately went to another administration table and stood where sibling receiving vaccines.  Without warning, client fell toward table where sibs vaccines being administered.  Hit head on table, falling under table.  Did not hit head on floor.  Client turned to side, breathing good, not responsive, very pale.  Became alert within a few minutes,  answering questions and turned to back with feet elevated.  Cut on fore head above right eye and just below hair line.  Minimal bleeding, ice applied to forehead.  Sucker given.  After 5-10 minutes, client stood and moved to chair.  Refused snack and juice offered.  Continued to be alert and oriented, no longer pale, not dizzy, skin cool and dry.  After five minutes, walked client in room.  Walked to car with parents.  Parents advised to take client to emergency room for further evaluation.
started with just injection spot swelling and red bumps, after 2wks its full upper body. Including arms, elbows, back, groin area, buttocks, belt line/waist, down the tops of the legs.
6 days later chills lymphadenopathy left tonsillar lymph node Narrative:
Face looked sunburnt red for about 20 minutes; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Face looked sunburnt red for about 20 minutes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).   On 08-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced ERYTHEMA (Face looked sunburnt red for about 20 minutes). On 06-Apr-2021, ERYTHEMA (Face looked sunburnt red for about 20 minutes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-071175 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non-significant follow-up. Event duration has been changed.
This spontaneous report as received from Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates, multiple unspecified number of patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L024132, expiry date 21-JAN-2017) dosage regimen and route unknown. Concomitant medications were not reported. On an unknown date in November 2015, the vaccine was subjected to a temperature excursion of -1.5C for a time frame of 10 hours and 45 minutes. On an unknown date in December 2015, the vaccine was subjected to a temperature excursion of -0.6 C for a time frame of 10 hours and 30 minutes. On an unknown date in January 2016, the vaccine was subjected to a temperature excursion of -199.9 C for a time frame of 7 hours, 15 minutes, and -29 C for a time frame 12 hours and 15 minutes. On an unknown date in February 2016, the vaccine was subjected to a temperature excursion of -1.6 C for a time frame of 10 hours. On an unknown date in March 2016, the vaccine was subjected to a temperature excursion of -1.6C for a time frame of 9 hours and 30 minutes. On an unknown date in April 2016, the vaccine was subjected to a temperature excursion of -6.2 C for a time frame of 6 hours. No adverse effects were reported. Product quality complaint (PQC) was not filed. This report is one of the several reports received from the same reporter. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 4:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 4:03 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 80.07.  No concomitant medications was reported.  On 11-Jan-2021, excursion time was 09:00 AM temperature was 34 and at 02:00 PM, temperature was 35, total doses given for the day was 98, condition of vaccine prior to administration was not frozen, The vial was initially moved to the fridge on 08-Jan-2021 and beyond use date was 07-Feb-2021. Product moved to clinic on 11-Jan-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  No treatment medication was reported.
pityriasis rosea flared up EXTREMELY fast. In places i've never had it before for example on my neck or all over my arm where the vaccine was injected. It happened a few days after i got the vaccine
Headaches went away after receiving the vaccine/his neck muscles are not that tight anymore and he hasn't gotten the headaches; This is a spontaneous report from a contactable physician (patient). A 53-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in arm left on an unspecified date (Batch/Lot number was not reported) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in arm left on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included high cholesterol, blood pressure high and severe migraine headaches and tension headaches (used to get them every 2-3 days) from an unknown date and unknown if ongoing. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified start date and ongoing and nebivolol hydrochloride (BYSTOLIC) taken for blood pressure high from an unspecified start date (taking for 15 years) and ongoing. Patient had not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Physician stated that he used to get severe headaches for 30 years and since he got the Covid vaccine his headaches have gone away. He stated that he has gotten both doses of the covid vaccine but doesn't remember the dates and stated that the headaches went away right away after getting both doses of the vaccine. He got the 1st dose within the first couple of weeks after it came out because he is a physician. He stated that he had severe migraine headaches and tension headaches and he used to get them every 2-3 days, but since he got the vaccine his neck muscles are not that tight anymore and he hasn't gotten the headaches. States that he has noticed the neck muscles but it's not that much different, it's mostly the headaches that are the biggest difference. He also mentioned that he has been on the concomitant medications for many years and was getting the headaches while taking them. The only thing that has changed recently was that he got the vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11/30/15 - 12/3/15: Nausea, vomiting, low grade fever.
Patient is 40 Years Old Male. Pt. stayed in hospital for a few days recently with the Dx of myelitis, poss. due to TDaP vaccine. On 10/5/2017, pt had flu shot and Tdap vaccine here for preventive care as routine as well indicated as a construction worker. A few days later pt had dull headache moderate, and pt felt very tired. Gradually pt felt numbness below the lower back level. Then pt's headache became worse not responded to OTC pain med. On 10/13, pt C/O intolerable headache, pt RTC and NAPROSYN was given, pt's Sx is still not responded at all. Next day on 10/14, pt went to ER, and admitted as myelitis, pt stayed there for a few days, had CSF/ brain MRI and other test. Pt was given IV steroids for 3 days, his headache resolved, and his numbness is subsiding. However pt C/O he had been unable to ejaculate. Up to today, pt's numbness resolved, and his ejaculation problem has improved, but not resolved yet. Pt is going to repeat brain MRI on 11/22/2017 and F/U with neurologist.
This spontaneous report was received from an administrator concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL injection (strength, dose, lot number and expiration date were not reported) for prophylaxis. According to the reporter, GARDASIL doses were exposed to the following temperatures excursions: below 32 degrees Fahrenheit (F) with a lowest temperature of 25 F. The timeframe was unspecified by the reporter. There was no previous termperature excursions. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004259: US-009507513-1706USA004260: US-009507513-1706USA004262: US-009507513-1706USA003526.
Shingles; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Feb2021 as, SINGLE DOSE for covid-19 immunisation. The patient 's medical history and concomitant medications were not reported. On 08Mar2021, the patient experienced shingles. The patient received second dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 as, SINGLE DOSE for covid-19 immunisation. It was mentioned by patient that "on 18Mar got the second vaccine and was just wondering if there is any correlation between vaccine and shingles. as it is cleared on 30Mar2021".The outcome of the event was reported as recovered. on 30Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Herpes zoster 11/29/2001 improved (tx Zovirax).
Patient received Pfizer COVID vaccine on 1/18/21 and 2/8/21. On 1/30/22, patient was diagnosed with COVID19 (external result). On 2/5/22, patient admitted to our inpatient facility with acute hypoxic respiratory failure due to COVID-19 pneumonia and acute kidney injury. As of today (2/7/22), patient is still admitted in the med/surg unit.
Possibility that vaccine was overdiluted with 1.8mL instead of 1.3mL prior to administration.
Confirmed breakthrough Case  COVID-19 (Moderna) 1  03/07/2021 Hospital Moderna 023M20A   COVID-19 (Moderna) 2  04/08/2021 Hospital Moderna 018B21A   COVID-19 (Moderna) 3  07/18/2022 Moderna 037A22B
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 81-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles and pain. On 9th August 2018, the patient received Shingrix (intramuscular) 50 ug. On 10th August 2018, 1 days after receiving Shingrix, the patient experienced tiredness, upset stomach, lethargy and headache. In August 2018, the patient experienced pain localized and skin irritation. On an unknown date, the outcome of the tiredness, pain localized, upset stomach, lethargy and headache were not recovered/not resolved and the outcome of the skin irritation was unknown. It was unknown if the reporter considered the tiredness, pain localized, upset stomach, lethargy, headache and skin irritation to be related to Shingrix. Additional details were provided as follows: The next day after receiving vaccine the patient started experiencing bad headaches, she is tired and lethargic and her stomach did not feel well. She was experiencing these symptoms at the time of reporting. After getting Shingrix, the patient had a feeling in the area where she previously had shingles. It was not like last time, only a little painful and really just an annoyance. She did not have a rash. She thought that it felt like shingles but much less severe.
fuzzy; confused; got really hot; dizzy; flash of heat; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6207) intramuscular in the right arm on 10Mar2021 (time the vaccination was given: 08:45-09:00) at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had no family medical history. There were no additional vaccines administered on same date of the Pfizer suspect. No previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations within 4 weeks. Adverse event (AE) following prior vaccinations were noted as none (never had a reaction to a vaccine before). It was reported that the patient would like to know if she should receive her second dose of the Pfizer BioNTech COVID-19 vaccine based on the side effects she experienced after receiving her first dose yesterday. She already has an appointment scheduled for second dose. She waited in store 10 minutes after receiving it and felt fine. On the drive home, she felt a little fuzzy or confused and then got really hot and felt a little dizzy, but that went away within 15 minutes. It was further stated that within 15 minutes of getting the vaccine on 10Mar2021, she "got kind of fuzzy" (felt fuzzy) and first confused 09:10, then felt hot and then dizzy 09:15; these events were assessed as serious medically significant. Additionally, she experienced a "flash of heat that went through her body" on 10Mar2021 which went away within 10 minutes. No ER or physician's office required.  She felt like if she just got some water, she would be fine. No test was done. The feeling of confusion was what lasted the most and the dizziness did not last very long. The outcome of the events was recovered on 10Mar2021. The events felt fuzzy, confused, hot and dizzy was related to BNT162B2 per reporter.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events fuzzy, confused, feeling hot and dizzy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt received vaccine on 06/14/2000. On 06/27/2000 parent noticed tiny blisters, rashes on trunk and limbs. Pt brought to the clinic on06/29/2000 and 30 tiny vesicles noted. Pt afebrile by pruritus. Treated with Aveeno bath, Benadryl and Tylenol.
swelling  and redness on underside of left arm and swelling of left hand also noted was tingling and numbness in the hand.
Patient came back to pharmacy stating her arm was itching - removed bandaid and told her to take BENADRYL and apply hydrocortisone cream.
had taken the shingle shot and still had the shingles/ suspected vaccination failure; still had the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had taken the shingle shot and still had the shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still had the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 01-MAR-2023 This case was reported by a patient via interactive digital media. The patient had taken the shingle shot and still had the shingles but fortunately it was a light case of them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Pt recvd OPV/DTP/HIB & became hyporesponisve for 24 hrs p/injects;