chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; sore muscles; sore joints; chills; This is a spontaneous report from a non-contactable consumer (patient). A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was unknown), via an unspecified route of administration, in Left Arm on 11Apr2021 at 08:30 (at the age of 65 years old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration were not reported), via an unspecified route of administration, in Left Arm on 14Mar2021 at 10:00 at single dose for COVID-19 immunization. The patient had most recent COVID-19 vaccine at hospital. The patient experienced headache, sore muscles, sore joints and chills on 11Apr2021. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Got vaccine 4/21/21; local reaction started 5/3/21; developed new onset wheezing and SOB diagnosed 5/5/21, treated with prednisone, albuterol and epi injection.
Headache, Myalgia, Fever, headache for 3 days straight Narrative: employee did not seek medical care but took 800mg ibuprofen prn x 3days til headache left
no adverse event; improperly stored vaccine in use; This spontaneous report was received from a registered nurse refers regarding a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history and drug reactions/allergies were unknown. The patient's concomitant therapy included sterile diluent. On 20-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (therapy type: digital data logger) (dose, frequency, anatomical location were unknown) (lot # S005078 and expiration date: 19-FEB-2021 or lot # R019237 and expiration date: 04-JUL-2020) ) for prophylaxis (Product storage error).  It was reported that there were no adverse effects. The administered dose of the vaccine experienced a temperature excursion in the range -14 degree Celsius to - 10 degree Celsius (-9.4 degree Celsius) as recorded by a data logger. The time frame was unknown. The vaccines had no previous temperature excursion.
After administration pt reported feeling light headed. She sat down with head covered for 20 mins and felt fine after.
I noticed a flutter in my heart. Then, I began to have numbness and tingling in my hands. These are still ongoing as of today. I went to the doctor about this. They referred my to a cardiologist for Echocardiogram. I was also referred to a neurologist for an EMG test, which is a nerve test, shows little to no nerve conduction. They did also did blood work, vitamin d deficiency.
Within 30 minutes started a dry cough which lasted for 3 weeks.  (Had a dry cough off and on before but had gotten better, possible long haul from flu last Feb/March that lasted 3 weeks.  Not tested, so could have been Covid 19.) Severe chills and joint pain and fever like symptoms through out the night. - Better in the morning but still slight flu like symptoms, but only lasted 48 hours.  However, the dry cough lasted 3 weeks.
p/5th rabies inj, next AM tingling of lips; devel numbness lt side of face; lt arm weakness-decreased sensation-numbness of lt leg 2 days later
pt recvd vax;almost immed p/vax mom noticed some toe walking,over next wk devel sl abnl gait & sl limp;deep tendon reflex +2 out of +4 & symmetrical & toes are downward;no evidence of muscular atrophy;poss sciatic nerve damage or irritation
This spontaneous report as receive from a Registered Nurse refers to an unknown number of patients. It was reported that on unspecified dates, an unknown number of patients were vaccinated with GARDASIL (lot#, expiration date, dose, route of administration and indication were not provided) that had been improperly stored. No adverse effects were reported. No further information was provided. Additional information has been requested.
The following day after receiving the shingles shot I experienced Pain and soreness rightarm and top of neck. A few days later I started having shortness of breathe . I spoke with my primary care doctor and he completed a chest xray and a covid test which came negative.
pt admitted to hosp with acute on chronic systolic heart failure; CRTD placed; pt c/o weakness, poor appetite, food tasted like "cardboard"; positive COVID test; DNR; O2 @6L/M via face mask; pt's condition worsened and he passed away in the hospital
Headache, severe itching, shaky, rash on face & neck in evening-on 11/17/09 rash spread to abdomen & legs-eyes swollen mild shortness of breath. Perednisone, x 6 days, DECADRON 4mg IM, BENADRYL 25mg po.
Since patient has had vaccinations sleep patterns changed. He was a faithful slppeing with regular naps and sleep patterns. Mother notes that she finds most days patinet will not nap or sleep as before. Mother has also noted significant behaviorial changes. Mother notes that patient diregulated behaviorial outbursts with inconsolable melt downs where he flops backwards and screams at this top of his lungs.  These behaviors had not happened prior to vaccinations. Mother also staes that patient will scream "hold me" then she picks him up and patinet will push her away and says "don't hold me".
Had symtoms of a TIA stroke.  Did MRI, CatScans, Ultra Imaging, EKG, and several other tests, but found no hemoraging in brain area.  Got suddenly dizzy in where I could not stand straight, equalibrium was totally off, felt nausea, then threw up .  Went to ER at hosipital and basically was feeling alright but extremely tired.
Patient states got flu shot 10/07/16, went running on 10/8, vision became blurry. Had to go to MD office, MD did MRI and physical exam. Everything came back normal. MD advised might be flu shot.
anterior cervical lymphadenopathy 2 days after receiving 2nd Pfizer vaccine
Information has been received from a physician assistant and a 58 year old male with a history of cataract operation and herniotomy and no allergies or drug reactions, who in March 2008, was vaccinated with ZOSTAVAX. There was no concomitant medication. On 14-MAR-2008, the patient reported that he got electrocardiogram test done regularly, but with the last two, electrocardiogram readings were abnormal. The patients also reported that his regular heart beat was around 80 beats or so and he through the reading about 20 beats were "weird." The patient reported that he felt fine, he had no pain and no shortness of breath, etc. The physician wanted him to come back for a stress test. The patient stated he was not sure if ZOSTAVAX is causing this effect with his electrocardiogram readings. Additional information has been requested.
This is a prisoner in our Treatment Program with a diagnosis of Schizophrenia.  He has Hyperlipidemia as a medical diagnoses.  This prisoner forgot that he had received his first vaccine on 03/10/2021 and got in line and received his second dose within 10 days.  Prisoner was assessed after realization was made on incident.  No medical complaints or issues.  Weekly monitoring will continue for 3 weeks.
This spontaneous report was received from a nurse and refers to a 12-year-old patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, when the patient was 10 years old, they were vaccinated with GARDASIL (dose, route of administration, lot # and expiration date were not reported). On an unknown date, when the patient was 12 years old, they were vaccinated with GARDASIL 9, 0.5 ml via intramuscular route (lot # and expiration date were not reported). No adverse effects were reported.
Sore throat; Intermittent Cough; Rash on injection site (the size of a half dollar); This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (Intermittent Cough) and INJECTION SITE RASH (Rash on injection site (the size of a half dollar)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), COUGH (Intermittent Cough) and INJECTION SITE RASH (Rash on injection site (the size of a half dollar)). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), COUGH (Intermittent Cough) and INJECTION SITE RASH (Rash on injection site (the size of a half dollar)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
approx 1 min p/vax pt became pale & loss of consciousness lasting approx 15 sec p/regaining consiciousness pt c/o h/a & nausea;
Sarted feeling noxious; Body aches; Vomiting; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Sarted feeling noxious), MYALGIA (Body aches), VOMITING (Vomiting) and CHILLS (Chills) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-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) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced NAUSEA (Sarted feeling noxious), MYALGIA (Body aches), VOMITING (Vomiting) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NAUSEA (Sarted feeling noxious), MYALGIA (Body aches), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.            This case was linked to MOD-2021-176270 (Patient Link).
Narrative: COVID infection following completion of COVID vaccine series 04/20/21 COVID vaccine dose #1 05/11/21 COVID vaccine dose #2 06/16/21 Preop COVID NEGATIVE 08/02/21 Pt presents for preop COVID test with no symptoms; COVID POSITIVE 08/03/21 Pt reports he had symptoms 5-6 weeks ago, went to hospital, and tested COVID NEGATIVE; completely asymptomatic at this time 08/12/21 Pt presents to screening requesting COVID test but unable to retest during quarantine as likely to obtain positive result; pt reports he remains asymptomatic
SUSPECTED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report was received from a male patient of unspecified age, race and ethnicity. 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 administration was not reported, batch number: 202A21A , and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date, in APR-2021 for prophylactic vaccination. It was unknown if the product was stored in appropriate temperature conditions and if it was properly stored from receipt to administration. No concomitant medications were reported.  On 21-JUL-2021, the patient was tested positive for coronavirus disease (COVID-19) (suspected clinical vaccination failure and confirmed covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186828. The suspected product quality complaint has been confirmed to be not voided (the reported allegation could not be confirmed. A manufacturing related root cause could not be identified) based on the PQC evaluation/investigation performed.; Sender's Comments: V0 20210747956- JANSSEN COVID-19 VACCINE-Suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I believe the am or pm are accurate, but not a hundred percent sure. Anyway the adverse events were sudden BP elevation which lead to admission. One week later recurred and admitted again.  Secondary hypertension workup negative. Labile blood pressure elevation and hypotenstion over one month with neurological symptoms, including but not limited to numbness, "electrical sensations" burning skin, weakness. Peaked around 4 weaks then continued quite severely, but less dramatic. Developed irregular heart beat and admitted again. As of this date, weakness symptoms are much improved. Sensory symptoms better, but still present with various other, neurological and cardiac symptoms still present.
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.  Company comment: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred after the first dose of mRNA-1273. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-460571 (Patient Link). Sender's Comments: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred after the first dose of mRNA-1273. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Right leg has redness, swelling, hardness that started 05/11/05. TX: Benadryl, cool compresses, and gentle massage.
Swollen lymph nodes for 5 days, and Pulsatile tinnitus, and constant tinnitus that is still ongoing since first Moderna shot.
I have some rashes in different area of my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "not recovered", described as "I have some rashes in different area of my body".  Additional information: The reporter reported health issue that happened after getting 4th dose of COVID vaccine. Around last Aug the patient got 4th dose of vaccine. After couple weeks the patient realized that the patient have some rashes in different area of body. In the past months, the patient have been trying to find a suitable solution to improve this problem by referring to specialist doctors, but so far have not gotten any results and still in suffering because of rashes on body.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient got vaccine dose 1 of primary series and started her period very heavy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 31Dec2020 as dose 1, single (Lot number: EJ1685) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: I was covid + (positive). Concomitant medication(s) included: CETIRIZINE; ATORVASTATIN.  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 2021, outcome "recovered", described as "The patient got vaccine dose 1 of primary series and started her period very heavy".  Additional information: The patient got vaccine dose 1 primary series while she was having COVID and without her knowing. Few days later, she started her period very heavy. Changing super abs tampons every 30mins same as in Dec2020. She have read case reports of heavy menstrual cycles post COVID infections and from vaccine. Next period was heavy but not as much then it went back to normal. Sender's Comments: Linked Report(s) : PFIZER INC-202201360950 Same reporter and drug, events separated in time;
20 hours after receiving jab #2, I felt dehydrated, nauseated, really achy, tired, & developed a pounding headache. I took 2 Tylenol Arthritis Strength (650 mg each) at 5 PM on 03/31/2021, & all my symptoms disappeared in about one hour. Relief!
Started breaking out in hives within 15 minutes of her injection.  Hives lasted for 3 hours.  Took Benadryl 2 hours before her shot.  And took albuterol before shot as well.  For 24 hours, she used rescue inhaler.  And then next day, she was okay.  Also headache, chills was 6 hours.
sore throat; headache; chills; 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 rsv vaccine prot.subunit pref 2v (ABRYSVO), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2023, outcome "unknown"; HEADACHE (non-serious) with onset 2023, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 2023, outcome "unknown", described as "sore throat". Additional information: Patient stated she received Abrysvo vaccine on Monday. Patient asked if sore throat, headache and chills have been reported as side effects from the vaccine. Patient stated, no fever, runny nose and no positive covid test so far.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It was reported that a 14 year old male received a TD Adult vaccination on 3/9/00. Reportedly, 17 days post vax, on 3/26/00, the pt developed severe muscular tightening of his left shoulder and then right shoulder which lasted approx. 3 minutes, each side. In the evening of 3/28/00, the pt experienced severe tightening in the lower back which caused arching of his back and his left leg to go out to the left side, unable to put down, pt actually fell out of bed. This entire episode lasted approx. 7 minutes, then totally resolved. The pt denies any muscle weakness or soreness. Shortly after the muscle spasm on the 28th, the pt noticed an area under his right eye could produce "squeaking" sound, which persisted for the rest of the evening. This experience resolved in the morning of 3/29.
I was going to my heart Doctor for a normal check in and was diagnosed with AFIB which was new since having had my COVID-19 Vaccine. I have had to change medications and also was diagnosed with AFLUTTER as well with my heart. I had a pace maker put in in June of 2021.  In February of 2022 I had woken up with what I thought was just terrible diarrhea but due to a medication I was bleeding internally and was passing out my wife had to call emergency number and I was taken to the ER and in the hospital.  I had been experiencing great fatigue but that was really the only thing  I was experiencing symptom wise.  I have since had a  permanent heart implant put in May of 202 because of that intestinal bleed. I have also had my migraine medication and Botox shots stop working for my migraines and have to change my medications and shots to manage them. The fatigue is really what has lasted and I am wobbly and dizzy.
Skin sensitivity, high fever for 12+ hours, chills, collapsing, headache, body aches
Got a head around 10:00 pm and got a fever around 10:30 and got really bad back pains as well as my left arm hurting a lot. Thankfully my fever broke around 12:30am but I continued to have aches and pains throughout the next day as well as having shivers and sweating at certain points.
Patient developed shortness of breath, hemoptysis and acute kidney injury 1 month after dose number 2. Symptoms of shortness of breath began approximately 2 weeks following second shot. Patient then underwent full pulmonary, rheumatology and nephrology workup including kidney biopsy, which was positive for pauci immune crescentic glomerulonephritis.
"COVID Arm" (as explained on the internet) - Rash around injection site  began 8 days after injection with itching, stinging, soreness, warm to the touch, swelling.  Rash area approximately 4 x 7 inches.  Currently (2/15/21) no rash, but still some itching and soreness.
Pt received flu shot on 9/6/23  in left arm at pharmacy. Patient reported to pharmacy on 10/11/23 complaining that her arm is still radiating pain and is getting worse each day. Pt states that her arm started hurting right after the shot but she thought the pain would go away. She states she believes that the shot was given too high in the arm and is concerned about potential nerve damage. She has NOT seen the Dr yet about this issue but is scheduling an appointment.
FLUBLOK to patients under 18 years of age (with no adverse event); Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 2 year old male patient who received 0.5 mL dose of influenza quadrivalent recombinant vaccine (Flublok QIV) (lot number: UJ509AA, expiry date: 10-MAY-2021) via intramuscular route in the left deltoid as prophylactic vaccination on 29-Dec-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  It was a case of an actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  It was reported that, administration of FLUBLOK to patients under 18 years of age. Caller reports FLUBLOK had been administered to 11 pediatric patients.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001-83-EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.