chrisvoncsefalvay/vaers-outcomes huggingface dataset:
issues with balance; spatial awareness; Head feels heavy; walking slowly; He feels like he is going to fall over; 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 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 (Lot number: 201308A) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Flu shot (Flu shot about 20 years ago.), for Immunization, reaction(s): "extremely sick". The following information was reported: BALANCE DISORDER (non-serious) with onset 22Sep2021, outcome "not recovered", described as "issues with balance"; DISORIENTATION (non-serious) with onset 22Sep2021, outcome "not recovered", described as "spatial awareness"; HEAD DISCOMFORT (non-serious) with onset 22Sep2021, outcome "not recovered", described as "Head feels heavy"; GAIT DISTURBANCE (non-serious) with onset 22Sep2021, outcome "not recovered", described as "walking slowly"; FALL (non-serious) with onset 22Sep2021, outcome "not recovered", described as "He feels like he is going to fall over".  Additional information: States when he moves he feels like he had balance issues; it is like a spatial awareness issue, but he hasn't had a problem with that before. Also, his head feels heavy, which he thinks that is part of the spatial awareness issue, he notices the heaviness in his head especially with movement or when he nods his head up and down or right to left, but especially up and down. Received his 1st dose on 09Sep2021 and noticed these issues yesterday. persisting. States that if he walks slow he is pretty good, but if he walks fast or takes any turns, he feels like he is going to fall over. When reading the Lot number, states that it is hard to read the handwriting. The number 2 looks like it is a flipped C, and the number 13 could be a but he thinks it Is a 13. Indication was states that he has been feeling the pressure of what is going on in the country right now and felt like he was doing a better service to his community by getting the vaccine. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). NO Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). AE(s) following prior vaccinations: States that he hasn't gotten any vaccines in about 20 years. The last vaccine he received was the Flu shot about 20 years ago, he got extremely sick, like the sickest he has ever been in his life, and this is the reason he hasn't gotten a vaccine since then. It was like he had a bad case of the flu. No Lot/NDC/Expiry to provide. No medical history.  No follow-up attempts are possible. No further information is expected.
Pain in whole right arm  (injection side) Fatigue  Muscle Ache all over
Tenderness on the injection site; some aches and pains on her body; Can't get out of bed/she couldn't' stand up; Her arm was so sore/arm hurt a bit; Bone in body hurt and everyplace she has arthritis was worse; Bone in body hurt and everyplace she has arthritis was worse; Carpal tunnel reacted adversely; A prickly heat rash around her neck, down her chest between her breasts, it is ongoing and persisting; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via unspecified route of administration at arm left on 02Feb2021 08:00 AM at single dose for COVID-19 immunization. The patient's medical history included arthritis and she has had surgeries. Concomitant medication was not reported. The patient received her 1st dose of the Pfizer Covid vaccine on 02Feb2021 and said she was fine up until the night of the same day wherein she woke up from her sound sleep feeling absolutely in pain. Mentioned that the parts of her body where she had arthritis and her carpal tunnel acted up which she has never experienced before and said that she normally did not have problems like this. She also cannot get out of bed and said that her husband had to her help her out and she also had a rash. Currently, she was still experiencing tenderness on the injection site and some aches and pains on her body but not as bad as it previously was. The patient had bone in body hurt and everyplace she has arthritis was worse. The patient had the injection on 02Feb2021 at 8AM, and did ok with it, her arm hurt a bit, not bad, and that night she went to bed, and it was every bone in her body hurt and everyplace she has arthritis was worse, and her carpal tunnel reacted adversely, her arm was so sore, she can't believe it, now she has developed a rash. Her arm hurt that night, is a little tender now, it was not real red, just tender. Her husband had to help her out of bed, she could not stand up, she was not a baby, she has had surgeries, she responds well to that kind of thing, so this was unusual. Yesterday she was in bed all day, she did not get out of bed until 5PM. This all came on all of a sudden, she woke out of a sound sleep, she was totally terribly miserable. States her rash through lasted through yesterday, now she has developed a rash, a prickly heat rash around her neck, down her chest between her breasts, it is ongoing and persisting, but she is sure it will fade, she has had reactions to things before. No further details provided. She has not had any other tests or anything lately. No injections, none of that. Would like to know if she has to get her 2nd dose or not. The outcome of the events her arm was so sore/arm hurt a bit, bone in body hurt and everyplace she has arthritis was worse, Carpal tunnel reacted adversely was recovering/resolving. The outcome of the events rash, pain and cannot get out of bed/she could not stand up was unknown. The outcome of the events tenderness on the injection site was not recovered/not resolved.
A report has been received from a pharmacist concerning a male subject who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST Quadrivalent started on 28-Oct-2015. Pharmacist reports that boy received two doses of FLUMIST by mistake 10 days apart. FLUMIST Quadrivalent was continued. The outcome of the event of recd 2 doses 10 days apart is unknown. The report was considered to be non-serious.
Gout; Severe pain in feet; Initial information regarding an unsolicited valid non-serious case was received on 23-Nov-2020 from a consumer via The agency (Reference number- 00368889) and transmitted to Sanofi on 23-Nov-2020.  This case involves a 69-year-old female patient who experienced gout and severe pain in feet (pain in extremity), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history included Shingles (herpes zoster) and Bell's Palsy (facial paralysis) with on her right side (of face) but then facial paralysis came back on her left side a few weeks ago. She was put on Valtrex; 1500mg daily for 10 days, but as the medication began to wear off, her symptoms returned, but on the right side of her face. Her lab work came back positive for both mononucleosis and shingles antigens. She also stated that her blood work also shows evidence of Lupus, but she did not have any symptoms of that, so her doctors said they did not want to give her asymptomatic presentation a diagnosis of Lupus Past medical treatment included Valtrex. Past vaccination, concomitant medication and family history were not provided. She also reported that she had history of thyroid (hypothyroidism), hyper parathyroid (blood parathyroid hormone increased) and hashimoto's disease (autoimmune thyroiditis) and she was also immunocompromised.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious gout and severe pain in feet (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome were unknown for both the events.  There will be no information available on batch number for this case.
was diagnosed with sudden idiopathic hearing loss of my right ear with unrestricted hearing of the left ear; I started with pulsating tinnitus in my right ear several hours after my first Pfizer vaccination on March 15. I'm 62 years old with no prior hearing issues.; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration in Arm Left on 15Mar2021 13:30(at the age of 62 years old) as single for COVID-19 immunisation. Medical history included hypertension and sleep apnoea syndrome both from an unknown date and unknown if ongoing. Allergies to medications, food, or other products was none. Concomitant medication taken within two weeks included acetylsalicylic acid (BABY ASPIRIN), nebivolol hydrochloride (BYSTOLIC), dronedarone hydrochloride (MULTAQ), and tamsulosin (TAMSULOSIN) all taken for an unspecified indication, start and stop date were not reported. Other vaccine taken within 4 weeks of COVID vaccine included SHINGLES dose 2 administered on 23Feb2021. The patient did not have COVID prior vaccination. Reported as, "I started with pulsating tinnitus in my right ear several hours after my first Pfizer vaccination on March 15 (15Mar2021). I'm 62 years old with no prior hearing issues. I was diagnosed with sudden idiopathic hearing loss of my right ear with unrestricted hearing of the left ear by an ENT on March 19 (19Mar2021). I am on a 13 day progressive intervention of prednisone, which I started on March 20 (20Mar2021)." Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event with Prednisone. Since the vaccination, the patient was not tested for COVID-19. Outcome of all the events were not recovered.  Follow-up attempts are needed; information about lot/batch number has been requested.
Miscarriage at 11 weeks pregnant (last period Aug 13, 2022, miscarriage commenced Oct 28, 2022). Fetus death dated to approx 8 weeks 6 days. First pregnancy, no known risk factors. No smoking , no alcohol,  no drugs, no caffeine.
Dizziness; Rapid Heartbeat; tremors; vertigo; inability to walk well; cold sores around nose; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in Arm Right on 22Feb2021 11:00 (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included heart disease, neurological vascular, EPI, degenative disc disease from an unknown date and unknown if ongoing, known allergy: Penicillin, Iodine dye from an unknown date and unknown if ongoing. Concomitant medication(s) included clonazepam (KLONOPIN); atorvastatin (LIPITOR [ATORVASTATIN]); warfarin sodium (COUMADIN); omeprazole (PROTONIX [OMEPRAZOLE]) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), all taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Facility where COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Post vaccination, the patient had not been tested for COVID-19. On 22Feb2021 11:15, patient experienced dizziness, rapid heartbeat, tremors, vertigo, inability to walk well, cold sores around nose. Patient visited doctor or other healthcare professional office/clinic, emergency room/department or urgent care for adverse events. The patient underwent lab tests and procedures which included heartbeat: rapid on 22Feb2021. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Loss of taste; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    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 AGEUSIA (Loss of taste) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On an unknown date, the patient experienced AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Symptoms of difficulty breathing and swollen feet on 11/04/2022.  Treated at ER and ICU  at  Medical Center. Pericardial effusion due to pericarditis.  Drained 1 liter of fluid from pericardium. Fluid contained no infection nor cancer.  Determined to be idiopathic pericarditis. Prescribed Colchicine for 1 month to treat any recurring inflammation.
Administered first dose of the Moderna Covid-19 to a 17 year old patient.; Dizziness; A spontaneous report was received from a healthcare provider (HCP) concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness and inappropriate age at vaccine administration.  The patient's medical history was not provided.  Concomitant medications were not provided.  On 21 JAN 2021, the patient received her first of two doses of mRNA-1273 (lot number 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The HCP reported that in order to not waste any doses, the facility calls on family and friends to get the vaccine for no shows.  The HCP reported that the patient experienced dizziness a few minutes after the injection.  The patient hadn't eaten for 16 hours prior to taking the shot.  The patient was monitored, and it resolved within the hour.    Treatment for this event was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, dizziness and inappropriate age at vaccine administration was recovered.; Reporter's Comments: This case report concerns a 17-year-old female patient who was administered mRNA-1273 vaccine Lot# 042L20A (inappropriate age at vaccine administration) and experienced dizziness. The event of dizziness is temporarily associated with the product use and a causal association cannot be excluded. The event of inappropriate age at vaccine administration is assessed as not applicable.
Clinic participated in a vaccination event on Sunday, May 9th. The event offered two vaccines Pfizer and Johnson and Johnson. The individual who was preparing the final syringes accidently took a J & J vial with 2 doses remaining thinking it was an undiluted Pfizer vial. They then added diluent to the vial and drew 6 syringes for vaccination. 5 were utilized. This non therapeutic doses were given to 5 patients that attended the event. Clinic has already contacted the patients following guidelines and each patient is being offered another vaccination as recommended by the CDC. All patients have been notified  Corrective Action Plan 1.  Root cause analysis completed 2.  New team transitioned to site 3.  Protocol and process gaps identified and updated 4.  Alignment of vaccine operations under clinical leadership
Swelling in both thighs after admin of the vaccines. The thighs were bright red, hot and swollen to the touch. He began to have a hive on his upper lip. Benadryl was given and he was monitored for 20-30 minutes.
Three patients have been seen in follow-up visits and have reported mild injection site pain; Fatigue; This is a spontaneous report received from contactable reporter(s) (Physician) from a Pfizer sales representative.  An elderly patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Oct2023, outcome "recovered"; VACCINATION SITE PAIN (non-serious) with onset Oct2023, outcome "recovered", described as "Three patients have been seen in follow-up visits and have reported mild injection site pain". Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Additional information: it was reported she had prescribed the RSV older adult vaccine to approximately 7 patients. Three patients have been seen in follow-up visits and have reported mild injection site pain and fatigue.  Adverse events start date was reported Oct2023, and the patients recovered. No treatment was received for the adverse events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300362628 Same product and event, different patient;
Received vaccine and waited 15 minutes in office. Driving home (and 25 minutes after receiving vaccine), my tongue felt thick and was swelling; 10 minutes later both sides of face felt numb; then throat felt funny (like couldn?t completely swallow).  Was nearly home by then and called vaccine clinic and once I described reaction was told to take 25mg Benadryl every 8 hours.  If symptoms increased to go to emergency room.   Symptoms lessened within 6 hours or so.   2 days later (March 4) tongue started swelling  and felt achy and that continued  several  days.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported).  The patient "not long after began to not feel well".  The patient was then diagnosed with leukemia.  The physician heard this information from another source.  The physician is not the patient's physician.  The physician also mentioned that the patient and her parents will be moving soon.  Unspecified medical attention was sought.  The patient's outcome was unspecified.  Upon internal review, leukemia is considered to be an other important medical event.  Additional information has been requested.
just a bit sore and it is almost gone; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain (Verbatim: just a bit sore and it is almost gone).  The outcome of the pain was resolved.   It was unknown if the reporter considered the pain to be related to RSV vaccine.     It was unknown if the company considered the pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 29-SEP-2023 This case was reported by a consumer via interactive digital media. No side effects, it was just a bit sore and it was almost gone.
immediate heart palpitations and sweating. 2 days later tighteness of the chest and trouble breathing. trouble breathing for 7 days after vaccine along with fatigue and inability to tolerate exercise. up every single night trying to catch breath along with acid reflux. needed IV treatment, nebulizer, and supplements.
Patient with chronic SOB and wheezing was admitted with more severe SOB and coughing after being exposed to a COVID positive individual. She has been vaccinated. She is not requiring o2 above baseline, baseline o2 requirements of 3 L. Patient treated with Solumedrol (patient on chronic 10 mg prednisone), Vitamin C, Vitamin D, Vitamin Zinc, duonebs, doxycycline. Home o2 eval completed and patient not requiring o2 rest, activity (baseline 3L). Discharge to home with the following Rx's -Rx doxycycline 100 mg PO BID x 7 days -Rx Prednisone 40 mg PO daily x 5 days -Rx duo nebs Q 6 hours x 5 days then Q 6 hours as needed -Rx mucinex 600 mg bid -resume home prednisone 10 mg after 40 mg prednisone finished
Within one day on 8/4/00, the pt experienced flu like symptoms. He then stated he was "okay for ten days" until 8/14/00 when he developed a "very severe" neck pain, decreased sensation in extremities, muscle spasms, back spasms, right forearm spasms and his entire body ached. On 9/1/00 the pt reported a mild fever. He was not treated for the events. As of 9/1/00, the events were ongoing.
This spontaneous report as received from a nurse refers to an unspecified amount of patients. Concomitant medication and pertinent medical history were not provided. The nurse reported that RECOMBIVAX (injection, dose, route, frequency and indication were not provided) that underwent a temperature excursion had been administered. No adverse effect reported. This is one of several reports received from the same source (MARRS# 1406USA009879). Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (my lower legs are swelling), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (arm soreness at the injection site) and NAUSEA (nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Cardiovascular disease, unspecified, COPD and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, TADALAFIL (CIALIS) for Hypertension, APIXABAN (ELIQUIS) for an unknown indication. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm soreness at the injection site). On 01-Feb-2021, the patient experienced OEDEMA PERIPHERAL (my lower legs are swelling), DIARRHOEA (diarrhea) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, OEDEMA PERIPHERAL (my lower legs are swelling), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (arm soreness at the injection site) and NAUSEA (nausea) had not resolved. Diphenhydramine was given 15 minutes before second dose. This case was linked to MOD-2021-074433.
Muscle pain, headache, chills, fever; fever and chills started 12 hrs after injection, ended after 8 hrs with acetaminophen.
Had SOB, hypotension, irregular pulse after going for a run. NSR when I went to the ER. Cardiac arrhythmia unknown, hypertension, elevated troponin level-15, normal echo and cardiac catheter.