chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 103F; Body aches; Extreme Fatigue; Extreme itchiness on face and neck; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 19Apr2021 at 09:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient had just seasonal tree pollen allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 29Mar2021 at 09:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 19:00, the patient experienced fever of 103F, body aches, extreme fatigue, and extreme itchiness on face and neck with no airway compromise. On the same day, the patient underwent body temperature test and the result was 103 degrees Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever of 103F, body aches, extreme fatigue, and extreme itchiness on face and neck with no airway compromise was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Headache, muscle ache, fatigue. labored breathing  but not severe enough to go to the Emergency Room.
Sore arm at injection site day of vaccine.  Next day, flu like symptoms.  Fever, chills, achy joints, fatigure. This was a booster.
Very weak, couldn't stand up, sweats, chills felt worse than I ever have it was scary.  I've never had a reaction from a flu shot - I wonder if it was because of the COVID Vaccination.
nauseous; Vomiting; Chills; Headache; A spontaneous report was received from a Consumer concerning a 30 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea ,vomiting ,chill, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 22-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:011LZ0N) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  Laboratory details are not provided. He took Ibuprofen to treat his symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events nausea, headache, vomiting, chills, which events were ongoing.  The reporter assessed the events, nausea, vomiting, headache, chills as related to study drug.
Nausea, dizziness, fainting x 3 weeks, "cyst in arm that something came out of, like a little ball, I pinched it to try to squish it, and it was hard".  Per patient, arm then bled.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 03-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number reported as R021930 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  Lot number R021930 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001841: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965: US-009507513-1907USA000989:
Got covid shot and died; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Got covid shot and died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 30-Mar-2021 The patient died on 30-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided   Concomitant medications were not reported.  Treatment medications were not reported.  Company Comment - This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected event of Death. The event occurred 22 days after receiving an unknown dose number of mRNA-1273 Vaccine with a fatal outcome. The rechallenge was unknown since only information about an unknown dose number was disclosed. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected event of Death. The event occurred 22 days after receiving an unknown dose number of mRNA-1273 Vaccine with a fatal outcome. The rechallenge was unknown since only information about an unknown dose number was disclosed. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
After injections were given a small, round, red area appeared on the left forearm. Patient was breathing normally with no sign of respiratory distress. Dr. was alerted of possible reaction to vaccines with no noticeable signs of reaction at injection site. Parent refused BENADRYL at that time, a topical ointment was applied. Parent was advised to give patient BENADRYL if condition worsened.
Apparent vaccine administration error: photo showing that vaccinator gave the injection approximately halfway down patient's upper arm, close to where a subcutaneous injection would be given. Patient reports the vaccinator "pinched" the area prior to injection, which would indicate subcutaneous injection technique. I can provide a picture of injection site location, if needed.
Mom called and stated pt had a fever "up to 104 degrees and was breathing rapidly. I called a RN friend that advised BENADRYL and Ibuprofen". "We were out camping, he is doing better now". Just wanted us to be advised.
Fever for 5 days.   104.0  on day 1,2, and 3  post injection.  Then fever of 100.4  on day 4 and 5 post injection.   Severe headache for 7 days post injection. Severe muscular skeletal pains requiring bed rest for 5 days post injection. The injection site was extremely sore for 5 days. The fever was treated with Tylenol he six hours PO. There was no visit to an ER or doctor.
broke out in a complete rash-all over entire body;dx rxn to MMR vax;
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAY-2016, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated at a medical group for a blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
This spontaneous report has been received from the medical assistant refers to a female patient of approximately 1 year old. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included Diluent Mrk Inj used to reconstitute the VARIVAX was properly stored. On an unknown date in 2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot# N035937 and expiration date: 18-DEC-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (degrees F) to 14 degrees F (also reported as "9F") for a time frame of 10 minutes; and of 15 degrees F to 46 degrees F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter.
severe headache for 72 hours bump beginning under skin 24 hours after injection, small bumps under the surface appear 72 hours later, today (1/12) bumps appearing around injection site
Muscle pain; weakness; joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 administered in Arm Left on 14Jan2021 12:00 (Batch/Lot Number: EL1283) at age of 48-year-old as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medications included atorvastatin calcium; venlafaxine hcl; capsaicin, menthol (ALLEVESS).  No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The patient experienced muscle pain and weakness, joint pain, fatigue on 15Jan2021 12:00. The outcome was not recovered.  The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received included Blood tests, neurological tests, x-rays.  Follow up attempts needed. Further information is expected.
Rapid heart rate for 48 hours; Shortness of breath; Menstrual cycle day 2 when got vaccineand it stopped that night; This is a spontaneous report from a contactable healthcare professional, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included Severe Acute Respiratory Syndrome (SARS) prior to 4 years. The patient had no allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 15:30, the patient experienced rapid heart rate for 48 hours and shortness of breath. The patient was on the second day of menstrual cycle and it had stopped that night. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rapid heart rate was resolved on 01Apr2021, while that of shortness of breath and shortened menstrual cycle were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Received Moderna Covid-19 vaccine as a booster dose after Novovax; Severe Swelling; cramped stomach; feverish; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Severe Swelling), ABDOMINAL PAIN UPPER (cramped stomach), PYREXIA (feverish) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna Covid-19 vaccine as a booster dose after Novovax) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Novavax (in a clinical trial at location) in December 2020. Past adverse reactions to the above products included No adverse event with Novavax.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced SWELLING (Severe Swelling), ABDOMINAL PAIN UPPER (cramped stomach) and PYREXIA (feverish). On 22-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna Covid-19 vaccine as a booster dose after Novovax). On 22-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna Covid-19 vaccine as a booster dose after Novovax) had resolved. At the time of the report, SWELLING (Severe Swelling), ABDOMINAL PAIN UPPER (cramped stomach) and PYREXIA (feverish) outcome was unknown.            No Concomitant Medications details were provided. No Treatment Medications details were provided. Area of severe swelling was not specified.
So we got the shot on a Thursday night, and the follow day I worked on the car. My back and muscles started tensing. The following night the muscle tightness and soreness got worse. It also was followed by finger numbness. A week later the numbness got worse, and I also started having massive anxiety attacks. Only thing that could calm me was driving around. I felt like a lunatic. A week later I went to the doctor, they did an EKG to check my heart and gave me an anxiety medication that I consider a sleeping pill because I was knocked out which was nice because I had not slept in 4 days. The anxiety was still there when I woke up. I week after I was given a different anxiety medication, and about 2 weeks after taking the vaccine and around May 10th because it was time for pre surgery for bladder cancer. I went through the surgery worried about the anxiety so I was knocked out before I was moved out the room. I still take the nefopam for the anxiety and the finger tip numbness is still going on. I also have leg numbness that still is there we are 6 weeks out. I was put back on chemo for the cancer a week ago.
This spontaneous report as received from a Medical Assistant refers to a female patient. The medical assistant reported that an unspecified patient's mother reported to her that the daughter of the mother's friend experienced heavy menstrual bleeding after receiving GARDASIL (dose, frequency and route not reported). The patient's outcome was unknown. This is one of several cases from the same source. Additional information has been requested.
Note: I also received a flu shot at the same time.  My wife ask me the night of my shot if I felt anything. A bit of a sore arm as usual and a ringing in my left ear. Noticed the ringing from time to time over the next two weeks. Then around 11/21 noticed that the ring was constant and a bit stronger. It would sometime pulsate, like it was in the rhythm of the heart.  A few days later, Thanksgiving weekend it was now loud enough that I couldn't sleep without a sleep aid. As been very consistent since then.
Annoying clanking noise in right ear; This is a spontaneous case, initially received from other non-health professional via Agency [reference number: SEQ19-05651] on 25-Oct-2019, concerning a 77-year-old, female patient.   The patient's relevant medical history included stent for brain aneurysm. It was reported that stent was put two weeks ago and will be needed another procedure in 3 weeks.    The patient's concomitant medications were not provided.  On 24-Oct-2019, the patient was administered Fluad TIV [influenza vaccine, inactivated influenza virus surface antigen, egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiration date: not reported] for influenza prophylaxis.   On 25-Oct-2019, the patient noticed an annoying clanking noise in her right ear.  At the time of follow up reporting, the patient had not recovered from the event. It was reported that the patient was supposed to visit ear, nose and throat clinic (ENT) to receive second steroid shot in ear to attempt to relieve the tinnitus.  The reporter assessed the case as non-serious but did not provide causality.  Follow-up received from other non-health professional on 12-Nov-2019: Indication for vaccination added. It was confirmed that the event was ongoing, and the patient was supposed to receive second dose of steroids. The narrative was amended accordingly.  Company comment: The event developed day after administration of Fluad vaccine. Causality assessment is confounded by patient's medical history. Based on the available information the event of tinnitus was assessed as related to the suspect vaccine.; Sender's Comments: The event developed day after administration of Fluad vaccine. Causality assessment is confounded by patient's medical history. Based on the available information the event of tinnitus was assessed as related to the suspect vaccine.
Tested positive for covid-19 with Binax Now antigen self-test by Abbott on night of 03/21/2022. Symptoms of headache and head congestion progressed over next few days to sore throat and cough (painful when coughing), then to chest congestion, some shortness of breath on exertion and some tiredness, but no fever.  Head and chest congestion and sore throat cleared after 5 or 6 days. Consulted Dr. by phone on 03/24/2022 and began 2 week prescriptions of Fenofibrate 135mg and Dexamethazone 6mg.  It is now 3 weeks since positive test and symptoms that linger are some shortness of breath, some tiredness, and no morning erection.
the shot burned "like hell"; This is a spontaneous report received from a Pfizer Sponsored Program  from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included having a lymphatic condition were periodically under right arm accumulates liquid and she needed to have it drained, caller stated she had this for the past 4 to 5 years. The patient's concomitant medications were not reported. Patient asked questions if vaccine was known to effect lymph nodes? Patient also stated that when she received her first dose, the shot burned "like hell". Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recv vax on 9/23/98; on 9/24/98 pt exp fever (101-105), headache; pt imp 9/27/98
Within 5 minutes of receiving vax, pt had a staring spell followed by tonic-clonic seizure.   Doc 208117 states the following: patient with history of developmental delay and seizures.
Large local reaction. Developed approx 48 hours after vaccination. Used OTC antihistamine/NSAIDS/topical steroids.
COVID-19 Infection; COVID-19 Infection; This is a spontaneous report received from a contactable other hcp. A 46-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in arm left on an unspecified date (age at vaccination 45 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included high blood pressure, high cholesterol, and osteoarthritis from an unknown date and unknown if ongoing. The patient's known allergies were none. The patient was not tested for covid prior to vaccination but was tested positive after vaccination. The patient did not take any other vaccine in four weeks. The patient's historical vaccine included BNT162B2 (1st dose was taken by patient via intramuscular in left arm on 03Mar2021,11:15 am, lot number: EN6203, age 45 years). Concomitant medications included atorvastatin (LIPITOR), amlodipine besilate (NORVASC) and celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported. The patient experienced covid-19 infection (drug ineffective) and covid-19 positive on 08Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Jul2021 Nasal Swab (rapid). The patient did not take the treatment for events. The patient was not admitted to hospital, awareness date was reported to be 11Jul2021 and device stamp date was 13Jul2021. The outcome of the events was not resolved.; Sender's Comments: Based on the known safety profile of the drug, a causal association between the reported events of drug ineffective, covid-19 and suspect drug bnt162b2 cannot be excluded.
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 05-AUG-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.