chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gastrointestinal symptoms; fever of 103 F; seizure like activity; profound wave of nausea, passed out; profound wave of nausea, passed out; dehydration; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure like activity), NAUSEA (profound wave of nausea, passed out), LOSS OF CONSCIOUSNESS (profound wave of nausea, passed out), DEHYDRATION (dehydration), GASTROINTESTINAL DISORDER (gastrointestinal symptoms) and PYREXIA (fever of 103 F) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced SEIZURE (seizure like activity) (seriousness criteria hospitalization and medically significant), NAUSEA (profound wave of nausea, passed out) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (profound wave of nausea, passed out) (seriousness criteria hospitalization and medically significant), DEHYDRATION (dehydration) (seriousness criterion hospitalization) and PYREXIA (fever of 103 F) (seriousness criterion hospitalization). On 25-Jun-2021, the patient experienced GASTROINTESTINAL DISORDER (gastrointestinal symptoms) (seriousness criterion hospitalization). The patient was hospitalized on 03-Mar-2021 due to DEHYDRATION, GASTROINTESTINAL DISORDER, LOSS OF CONSCIOUSNESS, NAUSEA, PYREXIA and SEIZURE. At the time of the report, SEIZURE (seizure like activity), NAUSEA (profound wave of nausea, passed out), LOSS OF CONSCIOUSNESS (profound wave of nausea, passed out), DEHYDRATION (dehydration) and GASTROINTESTINAL DISORDER (gastrointestinal symptoms) outcome was unknown and PYREXIA (fever of 103 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 103 (High) 103 F fever. On 03-Mar-2021, Computerised tomogram head: unknown did not find anything..         Concomitant products were not provided.  At the hospital the patient was treated for dehydration. patient was due for an endoscopy to be performed on 24 Aug 2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pain in left arm from shoulder to finger tips. Inflammation from shoulder to elbow. Started feeling pain a week after shot. Has had severe pain since then. Hurts to move arm and hurts to the touch, when touching the arm. The pain is a burning sensation throughout the arm when she is moving her arm. It also is a steady burning sensation when she is resting her arm but not as severe as when she is moving her arm. Any movement in her arm brings her pain, even to just buckle herself up in the car.
Sudden extreme muscle weakness.  Fell to the floor.  Could not use arms or legs to get up.  Was on the floor for several hours until someone came home and called for ambulance.
she said she developed superficial phlebitis; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program COVAX US support. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16May2021 as single dose for COVID-19 immunization. Medical history included Blood clots. The patient's concomitant medications were not reported. On May2021, she developed superficial phlebitis. Stated, she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 16May2021. Afterwards, she said she developed superficial phlebitis. She said she previously had issues with blood clots so when she heard that there were reports of blood clots with the Johnson and Johnson vaccine, she specifically selected the Pfizer Covid vaccine. She wants to know if the reaction she had is a known side effect of the vaccine, what she should do, and if there are any protocols on how to treat it. The outcome of the event was unknown.
Client admitted to  Hospital on 5/11/2022 with altered mental status. Client had known metastatic disease to the brain and had just started radiation. Covid positive status could be a creatinine attributing factor to the change in mental status. Lungs reported as clear to auscultation and client in no respiratory distress.  Reported died on 5/21/2022 at Hospice - primary cause: metastatic lung cancer; contributing cause: Covid-19 Submitter does not have access to full medical record. For further medical record information, please contact.
Case number PHEH2016US023470, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 38 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in right arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error (incorrect product storage). The case was assessed as non serious by the nurse.
Suspected vaccination failure; I get shingles which I never had, every few months; Painful but not dehabiliting; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient regretted for getting the Shingles vaccine because the patient got shingles which they never had. The patient got those shingles every few months, it was painful but not dehabilitating.  The patient wished that they never had gotten the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting.
Rash on arm which turned to blisters; Could not pick head up off pillow; She had a reaction; A couple of days of vertigo; Rash on arm which turned to blisters; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Rash on arm which turned to blisters), HEAD DISCOMFORT (Could not pick head up off pillow), VACCINATION COMPLICATION (She had a reaction), VERTIGO (A couple of days of vertigo) and RASH (Rash on arm which turned to blisters) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis and Drug allergy (most pain medications). Concomitant products included RISEDRONATE SODIUM (ACTONEL), NITROFURANTOIN, FAMOTIDINE, ESTROGENS CONJUGATED (PREMARIN) and GABAPENTIN for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLISTER (Rash on arm which turned to blisters), HEAD DISCOMFORT (Could not pick head up off pillow), VACCINATION COMPLICATION (She had a reaction), VERTIGO (A couple of days of vertigo), RASH (Rash on arm which turned to blisters) and HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, BLISTER (Rash on arm which turned to blisters), HEAD DISCOMFORT (Could not pick head up off pillow), VACCINATION COMPLICATION (She had a reaction) and RASH (Rash on arm which turned to blisters) outcome was unknown, VERTIGO (A couple of days of vertigo) had resolved and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took aspirin through Excedrin when it got really bad. She also had multiple sclerosis and had took Actonel, nitrofurantoin, famotidine, Premarin and vitamins and calcium. Caller had this problem (vertigo) with other medications like gabapentin. Patient HCP told her not to get the second dose. Caller was allergic to most pain medications.
I am not sure if this is related to vaccine or not.  On Feb 5 one side of my face was drawn up for about a minute, like a muscle spasm. Since that time that side of my face twitches when I smile. It is on my right side between my lip and my eye.
Pt fainted in 15 minute waiting area falling on R/side forehead.  able to answer questions after 45 seconds.  Taken to Observation Area per w/c to lie down.        3PM - BP 118/64 P 69 R 16  Neuro checks good, no confusion.      3:20PM - Sitting up & walking.  Able to walk out w/o assistance.
THEY ARE HAVING TROUBLE SOURCING VACCINE FOR THE SECOND DOSE; Product availability issue; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (THEY ARE HAVING TROUBLE SOURCING VACCINE FOR THE SECOND DOSE), PRODUCT AVAILABILITY ISSUE (Product availability issue) and NO ADVERSE EVENT (no adverse event) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (THEY ARE HAVING TROUBLE SOURCING VACCINE FOR THE SECOND DOSE), PRODUCT AVAILABILITY ISSUE (Product availability issue) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (THEY ARE HAVING TROUBLE SOURCING VACCINE FOR THE SECOND DOSE), PRODUCT AVAILABILITY ISSUE (Product availability issue) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTRATION INTERRUPTED (THEY ARE HAVING TROUBLE SOURCING VACCINE FOR THE SECOND DOSE) and PRODUCT AVAILABILITY ISSUE (Product availability issue).    No concomitant medications were reported. The patient received first dose of moderna primary series at another health care facility. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Apr-2023: Non-significant follow up received: Reference Id's were updated
severe debilitating dizziness; 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 female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 08Apr2021, outcome "unknown", described as "severe debilitating dizziness".  Additional information: The patient "I had the normal side effects that are listed on the information sheet" reporting that they started about 5 minutes after getting the vaccine. Caller reports that 9 days after the shot, she experienced "severe debilitating dizziness".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a female patient with an egg allergy-IgG (also reported as many allergies) who was vaccinated with the first booster dose of MMR live "when she was younger". It was reported that the patient missed the second dose. The reported indicates that she had labs done and her " immune levels for measles were low". It was reported that the patient did not want to provide any additional information. Unspecified medical attention was sought. Additional information is not expected.
Recurrent headaches, stomach cramps, malaise over many days;  much less now, but still experiencing nightly headaches and malaise as of this morning (4/4)
Irritable, warm but normal temp, 4 vesicular and papular lesion, starting near injection site on left leg but then other leg, chest and back.  Most recent (papular) lesion yesterday.
This spontaneous report was received from a pharmacist, and refers to a 65 year old patient of unknown gender. No information was provided regarding the patient's medical history or concurrent conditions. On 15-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU, lot number M038350, expiration date 06-DEC-2017, for prophylaxis (route of administration was not reported). The dose of ZOSTAVAX was reconstituted with sterile diluent(MERCK STERILE DILUENT) which was not expired (lot number M044949, expiration date 18-JUN-2019). No adverse effects were reported. This is one of two cases received from the same reporter.; Sender's Comments: US-009507513-1712USA011549:
PENIS IS SMALL; This spontaneous report received from a patient concerned a male of unspecified age. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced penis is small. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of penis is small was not reported. This report was non-serious. This report was associated with product quality complaint: 90000207754.
On 8/17/2021, I was diagnosis with COVID-19. I had no sense of taste or smell, sore throat, and a low grade fever. Symptoms lasted approximately 5 days. I did go to the doctor and got tested. I was prescribed steroids and an inhaler.
Rash on the face around both eyes, mouth and preauricular area that looks like eczema. Feels like a burn and its red. I have never had any rash or allergic reaction, and this continues to occur without cause after my immunization
Tingling in head; Modest case of shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (the patient had history of shingles twice after receiving older shingles vaccine.).   On 3rd September 2019, the patient received the 1st dose of Shingrix. On an unknown date, 28 days after receiving Shingrix, the patient experienced shingles and tingling. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the tingling was unknown.   It was unknown if the reporter considered the shingles and tingling to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left upper arm. Approximately 4 weeks later patient had a modest case of shingles that lasted approximately 8 days. The reporter mentioned first sign was tingling in her head. The reporter mentioned that both of those instances as well as this instance described as modest, not significant and no eruptions. The reporter consented to follow up.
Patient had increased irritability, excessive crying, breathing worrisome, decreased PO intake. Had US to R/O intussusception 3/10/18.
Patient is 16 years old and received a Janssen covid vaccine. No adverse events reported since vaccination.
Lightheadedness/almost fainted; Nauseous; Headache; fluish sick; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Feb2021 11:30 (Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included artificial heart valve from Jun2018 and ongoing, transient ischemic attack (TIA), high cholesterol, blood pressure (abnormal), all from an unknown date and unknown if ongoing. Concomitant medications included apixaban (ELIQUIS) tablet taken for transient ischemic attack from Oct2019 and ongoing; rosuvastatin tablet taken for high cholesterol from an unspecified start date and ongoing; metoprolol caplet taken for blood pressure from Nov2020 and ongoing. The patient previously received first dose bnt162b2 (BNT162B2), administered in Arm Left on 22Jan2021 13:00 (Lot Number: EL9263) for COVID-19 immunization. Patient was reporting reaction to Pfizer COVID vaccine. Patient stated he read some articles to call and reported if you have a type of reaction or something after having the COVID vaccine. Patient had second COVID vaccine on 14Feb2021. Three or four days later (as reported), he began feeling lightheaded, nauseous and headaches beginning around 18Mar2021 or 19Mar2021. Patient reported he almost fainted a few times and it had gotten progressively worse. The patient reported having headaches not every day, but pretty much close to every day, 4 out of 5 days a week. Patient reported sometimes the headaches were bad and sometimes constant. Patient was hospitalized and had every test known to mankind. The patient reports actually being kind of fluish sick for 2 days after having vaccine, the normal feeling that every one says they have. He completely recovered; started night of the 14Feb2021, lasted next two days and then totally gone on 16Feb2021. Blood thinner stopped a couple of days before the shot per his doctor. Patient stated that every test he had was negative, nothing that would cause the symptoms.  He had a Computerized axial tomogram (CAT) scan with dye; CAT scan without dye; carotid artery tested; echocardiogram; left the hospital said they didn't find anything to cause it. After talking to people and reading, he decided to call Pfizer. All results came back negative. Vaccination Facility Type was community center - other. Vaccine was not administered at Military Facility. No additional vaccine was administered on same date of Pfizer COVID vaccine. No additional vaccine was administered. Adverse events lightheadedness, nauseous, headache required a visit to Emergency Room. The patient was hospitalized for 2 days from 29March2021 to 31March2021 due to lightheadedness, nauseous, headache. The outcome of event fluish sick was recovered on 16Feb2021, of other events was not recovered.  Follow-up attempts were completed. No further information was expected.
PATIENT LEFT AFTER WAITING IN STORE FOR 15 MINUTES..SHE DROVE HOME AND WHEN SHE TRIED TO GET OUT OF CAR SHE FELT WOOZY.  SHE TRIED TO HOLD ONTO HER CAR AND BLACKED OUT.  A NEIGHBOR SAW HER  AND CALLED 911.  PATIENT WENT TO HOSPITAL AND HAD A PACE MAKER PLACED IN AND ALSO SURGERY FOR HER BROKEN ANKLE THAT SHE INCURRED WHILE TRYING TO GET UP AT HOME.  SHE WAS IN HOSPITAL FOR 30 DAYS AND HAS BEEN RELEASED.
Information has been received from a person working in a physician's office concerning a 6 year old male who on 31-MAY-2001 was vaccinated with a dose of Varivax. On 22-MAY-2006 the patient experienced a rash on his lower abdomen and penis. It was reported that the patient was afebrile. Subsequently, the patient recovered on 22-MAY-2006. Additional information is not expected.
On 10/22/02 day after vaccines, mother noted pt's left thigh to have redness, swelling, without pain. No fever pt remained playful. By 10/23/02, redness and swelling remained but was less.
At approx. 11:05 I injected patient with the vaccine, as I began to explain the accompanying documents he said, "I think I am having a reaction" I listened. He said, "I feel hot".... at 11:11 am. I observed droplets of sweat on his forehead and offered him some Kleenex and observed his arms to be clammy as I took his temperature to be 96.8 degrees and his blood pressure 132/112. I called for my technician to bring me an adult dose Epi-pen and my cell phone..  I continued to personally monitor the patient.  At 11:15 he said "I think it's starting to come back" I assumed he meant he was starting to come back from the reaction, at 11:19 am his temperature was 97.0 degrees.  At 11:28 I was called out of the area, before I left I instructed a technician to personally sit with the patient until I returned. At 11:33  am I went back to the patient and took his blood pressure, it was 112/79. His arms did not feel clammy, his face had cleared. At 11:36 am the patient said he felt well enough to leave.
Back and blue marks on injection site; 3 inch swelling of injection site; Sore arms; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE BRUISING (Back and blue marks on injection site), PAIN IN EXTREMITY (Sore arms) and INJECTION SITE SWELLING (3 inch swelling of injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 immunization.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arms). On 30-Jan-2021, the patient experienced INJECTION SITE BRUISING (Back and blue marks on injection site) and INJECTION SITE SWELLING (3 inch swelling of injection site). At the time of the report, INJECTION SITE BRUISING (Back and blue marks on injection site), PAIN IN EXTREMITY (Sore arms) and INJECTION SITE SWELLING (3 inch swelling of injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient wanted to know if these were usual events seen after vaccination. Treatment information was not provided. Concomitant medications were not reported.  Follow-up was performed on 19-Apr-2021. Patient stated his events were resolved. He also withdrew consent to contact him for follow-up.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Outcome resolved
The patient stated she had what she called a "mini stroke" while at the hospital with her daughter, who was having a baby.  She passed out and when she came around she had a hard time talking.  The doctor ran test on her for a stroke but nothing showed up the the tests.  This was approximately a week after having the covid  shot