chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had two heart attacks shortly after I received my first shot; Months later I experienced another failure; Heart is enlarged; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Had two heart attacks shortly after I received my first shot) and CARDIAC FAILURE (Months later I experienced another failure) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that patient never had any health problems until Moderna vaccination.     On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Had two heart attacks shortly after I received my first shot) (seriousness criterion medically significant), CARDIAC FAILURE (Months later I experienced another failure) (seriousness criterion medically significant) and CARDIOMEGALY (Heart is enlarged). At the time of the report, MYOCARDIAL INFARCTION (Had two heart attacks shortly after I received my first shot), CARDIAC FAILURE (Months later I experienced another failure) and CARDIOMEGALY (Heart is enlarged) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant drug was reported.  The patient had two heart attacks shortly after receiving first shot. Patient stated Cardiologists said that the vaccine might have been a factor in its failure.  No treatment drug was reported.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) events of Myocardial infarction(AESI) and Cardiac failure (AESI), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient reported that the heart was enlarged. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) events of Myocardial infarction(AESI) and Cardiac failure (AESI), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient reported that the heart was enlarged. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient got bruises about 2 inches in diameter at injection site, painful and little numb (little sleepy arm per patient's word) since yesterday after she got home from vaccination. She is able to move her arm when I asked her to move and lift her arm. She was ok, no reaction with her first dose in 12/15/2017.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-JUL-2016, the patient was inadvertently administered with two doses of PROQUAD, subcutaneously (dose, frequency and lot information were unspecified) that was improperly stored (incorrect product storage), (overdose), (medication error). No adverse effected reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
I received the vaccine on December 29th, 2020. The vaccinated arm didn't really hurt until the next morning when I woke up I could barely move my arm.  Around 10:00am  I started getting chills and having sweats. Over the next hour I became severely fatigued even with taking my adderall that morning. My body started tingling, I felt dissociated, had a headache, and a little light headed. Almost a little drunk feeling. I went home from work and slept most of the day.  When I woke up in the evening around 9pm I was sweaty, and my muscles and joints hurt. I took my temperature and it was  100.6.  The next morning on December 31st I no longer had a fever. My temperature was 98. something. The next several days and even now I continue to feel severely fatigued, and slightly dissociated. However, each day I seem to feel the side effects a little less.
HEADACHE; HAD A ROUGH NIGHT; This spontaneous report received from a patient concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On 12-APR-2021, the subject experienced had a rough night. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had a rough night and headache was not reported. This report was non-serious.
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a adult female patient who received INFANRIX (batch number F37NC, expiry date 13th September 2015). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: INFANRIX given to an adult instead of Tdap.
This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 15:00 (Batch/Lot Number: EN6203) age at vaccination of 78-years-old, as single dose and dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 15:00 (Batch/Lot Number: ER2613) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization.  Medical history included hypersensitivity from an unknown date and unknown if ongoing (Erythromycin and iodine contrast fluid). Concomitant medications included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported. After 5 weeks from vaccination the patient still experienced pain in upper arm, severe pain in left shoulder with limited use of arm/inability to freely move arm. Physician Office Visit was required and MD prescribed lidocaine patch (that not help) and now patient was taking Prednisone pack. May require orthopedic intervention. The patient was not recovered from the events.
Injection was placed below the deltoid, hitting tendon/nerve, resulting in immediate and lasting pain.  Pain continued up through shoulder, neck and jaw (swollen lymph nodes) over the course of 2 days, which continued until I consulted a massage therapist who worked it out. Had continuous night sweats for 12 days, followed by post-nasal drip, for which I obtained medication.
Light headedness, headache, vertigo, weakness, tingling in left arm and left leg.
September 11, 2010: Patient reports to hospital with fatigue and lower extremity weakness and numbness. He had been having headache and felt lightheaded for "the past couple days." It was reported that patient received the flu vaccine two weeks prior at a pharmacy. Neuro ordered IVIG and plasmapheresis. Pt received two treatments of IVIG and deteriorated then plateaued. Pt was discharged with a diagnosis of HTN with treatment.
Info has been received from a health professional concerning a 20 month old white male who in the AM of 9/27/04 was vaccinated, SC, with a 0.5ml 1st dose of varicella virus vaccine live. On 5/26/05, the pt experienced breakthrough varicella. The pt had a few papules on the trunk which scabbed and a lesion on the scrotum. The pt was seen at the physician's office and treated with acyclovir. Subsequently, the pt recovered. A product quality complaint was not involved. The pt's 10 year old brother experienced herpes zoster after vaccination with varicella virus vaccine live and the 8 year old sister developed varicella after vaccination with varicella virus vaccine live. No further info is expected.
After 20 hours, red area around vaccination site, warm to the touch, persisting until present time, April 8, 1:45 pm.  Slight itchiness around site.
Prevnar was administered on 10/28/02. The following day patient had difficulty breathing and low hematocrit. Admitted to PICU for respiratory failure/rule out sepsis. Patient is a 24 week gest. preemie. The discharge summary states, "sepsis." Baby remaines in the PICU as of 11/1/02 in critical condition. Lab studies indicate child has group B Strep Sepsis and para-influenza.
Approximately 3 AM on morning following vaccine administration, pt experienced generalized tonic-clonic seizure of duration approximately 45 minutes. Transported to ED via EMS. Received Ativan x 2 dose and phenobarbital and admitted to pediatric ICU. Fever noted on presentation to ED. Discharge Summary received 1/06/2005 states inflammed tympanic membrane and rhonci.
Immediately  began to tingle in both arms,legs.  Blood pressure over 200, heart rate 115.  Extremely weak.  In a fog.  Heart racing.  Got the chills and very shakey.  Doctor(s) and nurses monitored my vitals, then transferred me to ER for monitoring.  Blood pressure down to 170, heart rate normal range.  Tingling and weakness still happening.  A little after an hour of this happening and my pressure still at 170, they allowed me to go home.  I rested.  The next 24-48 hours, I had a headache and felt nauseous, not votmitting.  Tylenol helped.  By 3rd day, felt fine.
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2022, 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 02-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Patient did not report any adverse event.  No treatment medications were provided.
6/15/2021 at 5:00am started with diarrhea, nauseated 6/16/2021 continued with diarrhea, nauseated, chills, joint aches, headaches, tired and muscle weakness.
Four other children going to same day care reported chickenpox within same time frame. Four of the five children have had varicella immunization.
Patient started having arm mobility pain and limited range of motion about 3 days after receiving the Boostrix vaccine. It has been over 3 weeks and pain has not gone away.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient's medical history included a diagnosis of eczema. The patient was vaccinated orally with a dose of ROTATEQ on approximately 30-MAY-2012. Other suspect therapies included PREVNAR 13 and PENTACEL. The physician reported that the patient developed histiocytosis, another term for lymph node swelling after receiving ROTATEQ. The patient was 8 months old now but was 6 months old when they received ROTATEQ. The patient had a biopsy and surgery done to remove the lymph node that was inflamed. Hospital duration was unspecified. The outcome of events was reported as recovering/resolving. Additional information has been requested.
One week post vax, the pt experienced a headache, arthralgias, and myalgias. The information received on 9/6/00 reported the symptoms as ongoing. Additional information has been requested.
Swelling in the neck and shoulder area--gained 2 pounds from the swelling---took about three days to go away although soreness at the site of shot continued for more than 1 week.
I received a 3rd dose of the Pfizer-BioNTech COVID-19 vaccine on the afternoon of Wednesday (9/22/21). I experienced some muscle aches and fever on Thursday (9/23/21) and Friday (9/24/21). On the evening of 9/24/21 at around 9:00 PM, I experienced some chest pain. By the morning of 9/25/21, the pain had become severe and I visited the emergency room. After being evaluated in the emergency room as described below, I was admitted to the hospital. A number of tests and diagnostics (also described below) was conducted. I was diagnosed with acute myocarditis / perimyocarditis. I was prescribed Colchine (3 months), Prednisone (tapering over 14 days), Ibuprofen (as required to treat inflammation), and Famotidine (as a prophylactic for my stomach). Follow up appointments with cardiologist and a clinician were scheduled for 10/5 and 10/6. Follow-up lab ordered as described below. Follow up with doctor scheduled in December.
Bell's palsy; This is a spontaneous report from a contactable other HCP.   This 23-year-old non-pregnant nurse reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 01Feb2021 at 08:30 as dose 2 on left arm, single for COVID-19 immunization. The medical history of the patient and medications received in last two weeks were reported as none. The patient had no known allergies, was not diagnosed with COVID-19 prior to vaccination, had not been tested for covid-19 since vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. On 10Apr2021 at 07:00 AM the patient experienced Bell's palsy. The event resulted in physician office and emergency room visit. Therapeutic measures were received with 14 day course of prednisone, valacyclovir and eyedrops. The patient recovered/resolved with sequel. The device date was 28Jul2021.  Information about Batch/Lot number was requested.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the event Bell's Palsy and suspect drug BNT162B2 cannot be excluded. 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.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date / Date the vial was initially stored in the refrigerator: 29Dec2022/BUD: 28Jan2023), PRODUCT STORAGE ERROR (Vial was initially stored on 29-Dec-2022, BUD: 28-Jan-2023, drug administered on 02-Feb-2023) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.
Numbness down (R) arm to hand. Felt "woozy" in the car; passed out after returning home, fell on floor; was unconscious for 2 hrs. Developed H/A, knot on her head. Took Advil, better next day.
Client became dizzy after rec. vaccines; syncopal episode. She was out for less than 1 minute, father and nurse caught her and lowered to the floor. Can follow commands and verbalize needs.
Vaccine was given in the right arm. Patient reports onset of posterior right shoulder pain the evening of the vaccination and the next day woke up with right hand edema and numbness.
Pt did not seroconvert p/ 3 Engerix-B  doses.
When patient scheduled a COVID appointment online he changed his birthdate to 2002 so it appeared he was 18 at the time of immunization, but he was actually 17.
Patient had sensitivity reaction such swelling, redness and warm feeling in the whole upper arm of the injection site that appeared 2 days after vaccination
A few hours after receiving a pneumonia vaccine too high in my left shoulder I experienced local arm pain which through the night worsened until I had pain at the top of my shoulder, around my shoulder joint and today down the front of my left arm. Have been treating it with ibuprofen. Red and painful to touch. Planning on going to urgent care tonight.
I have had both shingles vaccines, I have had shingles 2 times since/suspected vaccination failure; I have had shingles 2 times since.; The worse pain I have ever dealt with the 2nd time; Stress; sheer exhaustion/tired; This 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, stress and exhaustion. On an unknown date, the outcome of the vaccination failure, shingles, pain, stress and exhaustion were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, stress and exhaustion to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 23-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got of shingles 2 times since. It was the worst pain he/she had ever dealt with the 2nd time. The patient took medications, it was horrible. The patient was thankful he/she took the shots, thankful it was no worst and stated he/she had to believe the vaccines helped at least some, if any worst, he/she could not have handle it. The patient stated that, in all fairness, he/she had a daughter that was in a car accident and she was hospitalized for 5 months. The patient had them during that time and he/she believed the stress and sheer exhaustion was what caused him/her to have them and stated, learning how to care for her was taxing. The patient stated that, they still bother him/her some when he/she was tired, but nothing like at first. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Hospitalized post 10 days quarantine for fecal impaction and COVID infection "very mild"
Received the second dose of the COVID vaccine on 1/8/2021.  She had some side effects including injection site soreness, chills, and fatigue over the weekend following the vaccine. The fatigue has been present all week and got worse last night (1/13). Her temperature has been fairly normal since the second dose, but today (1/14), her temperature went up to 100.1 and has been fluctuating throughout the day, staying mostly at about 99.4.  States she does not feel sick, but reports feeling "off."  Reporting the symptoms because it feels like they are continuing well after receiving the vaccine. Also reports that her arm was a little itchy over the weekend around the area where she received the injection
befor she could get second shot she got covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (befor she could get second shot she got covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (befor she could get second shot she got covid). At the time of the report, COVID-19 (befor she could get second shot she got covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.
SICK; This spontaneous report received from a patient concerned a 5 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received esketamine (nasal spray, solution, route of admin not reported ) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s, and esketamine was not applicable. The outcome of sick was not reported. This report was non-serious.