chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fast heart rate reported by pt; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: EP5445) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: en5318), for Covid-19 immunization; Bnt162b2 (Dose 2, Batch/Lot No: el0142), for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart rate reported by pt".  No follow-up attempts are possible. No further information is expected.
pt recv vax & w/in 24hr p/ vax pt devel monoarticular arthralgia
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # H011333, exp :30-SEP-2013 ,subcutaneous,once). On an unknown date the patient experienced cellulitis-like reaction, and went to the Emergency Room (Hospital unspecified-treated and released). Episode of cellulitis was reported after introduction of ZOSTAVAX. The outcome of cellulitis-like reaction was unknown. This is one of the several report from the same source
After 15 min pt had a seizure. Last 1-3 mn. Pt hx hypoglycemia ate fruit snack 10 min before sz. Had blue lips and secretion EMS evaluated blu 147-Told to come to office. Pt has vomit and acting tired.
Patient was administered vaccine 23 hours after initial puncture.  Manufacturer has been contacted for stability report.
This spontaneous report as received from a doctors office, via wholesaler, refers to a 62 year old female patient with thyroid medicine and hormone medicine. No known drug reactions or allergies. On 17-MAR-2013 the patient was vaccinated with PNEUMOVAX23 0.5 ml (dosing information and route were not provided), lot # H014561. Concomitant therapies included SYNTHROID and PREMARIN. The patient had received this vaccine in the evening. The next day she was feeling very weak and had a low grade fever. The following morning she called the doctors office with complaints of redness around injection site, slight fever (temperature 102) and dizziness. The physician instructed the patient to go to ER. At the ER they confirmed it was cellulitis. While she was at ER she received Cephalexin. She was admitted to hospital after ER visit but she was discharged later on that same day (date unspecified). Date of incident was reported as 17-MAR-2013. It was reported that "as of today the patient feels fine". The relatedness for cellulitis, slight fever and dizziness is unknown for PNEUMOVAX23. It has been a little over five years since she had a pneumonia vaccine. Additional information has been requested.
Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; Vaccines administered after being in stored in fridge past 30 days; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event) in an 84-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) 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 EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days).    No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:same reporter
Fever X 5 days. Started on 3rd day after vaccination. Peak temperature Tmas 40 deg C. Mild diarrhoea present on day of vaccination.
Patient stated arm where vaccinated really started to hurt. Stated it was more on the dorsal side of the tricep. The pain did not subside and in 12 days she went to an urgent care where she received ice treatment. She stated she has been using ibuprofen frequently and that she still has limited movement in that arm although the pain has decreased slightly. She stated this hasn't affected her lifestyle significantly and she plans to follow up with her primary care doctor.
atient with a shellfish allergy who received the vaccine and developed an allergy; This spontaneous case was reported by a physician and describes the occurrence of ALLERGY TO VACCINE (atient with a shellfish allergy who received the vaccine and developed an allergy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (atient with a shellfish allergy who received the vaccine and developed an allergy). At the time of the report, ALLERGY TO VACCINE (atient with a shellfish allergy who received the vaccine and developed an allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported   Reporter did not allow further contact
Patient complains of pain at injection site since injection.  Now pain radiates down all the way to elbow.  She can not lift her arm still without pain.
Nurse reported that on 7/22/2000 the patient developed an area of warmth measuring 3.5 inches and described as the size of a "baseball" at the site of Acel-Imune administration. On 7/25/2000, the same area measured 2.5 inches. No treatment recommendations were made by a physician.
Pain at the injection site; This is a spontaneous report from a Pfizer Sponsored Program CEP 159558.  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization. The patient medical history included covid-19.  The patient Concomitant medications were not reported. It was reported the patient got the vaccine yesterday. He felt warm but doesn't have a fever. Pain at the injection site and inquired if he can put the ice pack on the injection site, currently it's on his neck to cool him off. The patient had covid in dec and putting ice on his neck helped him before. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Redness, itching & slight pain at injection site - slight swelling and warmness also at injection site. Noticed itching and tenderness at injection site yesterday (8 days after I was vaccinated). Still have some itching and tenderness but the redness is subsiding and overall my arm feels better today (approximately 24 hours after the onset of the reaction).   Overall the reaction is tolerable- I expect it to completely go away on its own in a few days and it will not prevent me from getting my second dose of the Moderna COVID vaccine.
Extreme fatigue Headache Nausea All lasted 2 to 3 days
Received immunizations in mid-morning. That afternoon developed 102.3 temp; also had focal seizure x2 - looked blue. Admitted to medical center - initially thought febrile seizure but then considered vaccines; EEG normal - septic w/u neg. Fine since - neuro follow up scheduled 6-1-16.
Felling ill immediately- diarrhea & loose stool for a few days, headache for a few days, muscle aches- pain in back & side (new), low grade fever daily since vaccine
IN NOV presented w/sx of severe joint pain, fever, sore glands (not swollen), chest discomfort & was originally dx bronchitis; noted to have thrombocytopenia; ususual amount of bruising; platelets 30,000;
8 days later experience extreme tiredness that lasted a couple of days. Also same day left arm pain and chest tightness.  I had an EKG which was fine and the doctor thought the symptoms were due to asthma.  Started taking a newly prescribed inhaler, which seemed to have alleviated the symptoms. This lasted a week and I'm still taking the inhaler.
This spontaneous report as received from a medical assistant refers to a 38 year old female patient with hypertension, depression, polycystic ovary disease and impaired glucose tolerance. After entering nursing school patient required M-M-R II series. On 21-APR-2013 the patient was vaccinated with the first dose of M-M-R II injection (dose and route not reported) lot # 0412AE, expired date 27-FEB-2014. On 21-APR-2013 the patient was vaccinated with the second dose of M-M-R II injection (dose, route and therapy type unknown, lot # 0412AE, expired date 27-FEB-2014). On 03-JUL-2014, titers were drawn. The patient was not reactive for measles and mumps. The patient did not seek medical attention and no treatment was given for the event. No adverse effects were noted. Outcome of the events was unknown. Additional information has been requested.
Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 10:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient was allergic to sulfa drugs. Concomitant medications included losartan potassium (LOSARTIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Feb2021 at 11:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 18:00, 4 days after the vaccination, the patient experienced vertigo. The event was ongoing even after 2 weeks of onset. 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 event. The clinical outcome of the event vertigo was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a pharmacist concerning a 23 year old female with hypertension and allergies who on 04-JUN-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included TOPROL XL TABLETS and ALLEGRA. On 29-JUN-2007 the laboratory data revealed elevated liver enzymes tests. The serum alanine aminotransferase (ALT) test reported 289 and serum aspartate aminotransferase (AST) test reported 102 (in August 2006 the ALT/AST tests were both reported to be in the normal range). Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information has been requested.
Patient stated that she immediately felt a "fluid like" presence in both ears after getting injection.  After waiting 15 minutes, she returned home (approximately one hour after)  and started feeling  "hot like".  She looked in the mirror and her face and upper extremities appeared "sunburned"  and she had hives on upper torso and neck.  She then presented to ER and was treated with Bendaryl 50mg, Solu-Medrol 40mg and Pepcid 20mg IV.  She was released after being monitored.
my immune system became suppressed,I had some issues with that (immune system); it was very itchy; rash in my neck,rash went down to my torso,rash moved to my arms, rash continued to move around my body; didn't receive second shot yet (>42 days following first dose); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNOSUPPRESSION (my immune system became suppressed,I had some issues with that (immune system)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNOSUPPRESSION (my immune system became suppressed,I had some issues with that (immune system)) (seriousness criterion medically significant), RASH PRURITIC (it was very itchy), RASH (rash in my neck,rash went down to my torso,rash moved to my arms, rash continued to move around my body) and PRODUCT DOSE OMISSION ISSUE (didn't receive second shot yet (>42 days following first dose)). At the time of the report, IMMUNOSUPPRESSION (my immune system became suppressed,I had some issues with that (immune system)), RASH PRURITIC (it was very itchy) and RASH (rash in my neck,rash went down to my torso,rash moved to my arms, rash continued to move around my body) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (didn't receive second shot yet (>42 days following first dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment medication were not reported.  Patient does not take any medication regularly and no treatment medications were reported  Patient has seen three doctors, and still has some of the rash.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Redness swelling surrounding injection site, diffuse itching sensation.  Treated with Benadryl, swelling not improved, itching has improved.  Swelling treated with Prednisone course on 12/7/15.
Dizziness/ lightheaded within minutes of vaccine followed by uncontrollable shaking for 2-3 hours Approximately 14 hours after I woke up uncontrollably shaking for an hour with low temp 96.3, and low BP 86/55 and headache and nausea. For the continual week following, I have experience elevated POTS symptoms along with new symptoms which include tingling and cold burning sensation in forearms and hands and legs and feet along with aching pains. I?ve been experiencing muscle spasms and cramping in the hand of the arm my vaccine was administered, and having a hard time gripping with this hand. And overall fatigue has been continual.
1st dose - nerve twitching in nose lasting for about 3 hours after receiving.  2nd dose - nerve twitching in arms (shaking when resting elbow on table) and legs (thigh area when sitting) lasting for several hours after receiving.
Fatigue; achy; headache; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 as a single dose for COVID-19 immunisation. On an unknown date in Apr2021 the patient experienced fatigue, achy and headache. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue, achy and headache was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day after shot notice large swollen lymph nodes on my (R) collar bone area, swelling continued up the (R) side of my neck and jawline and under my (R) armpit. Headache at (R) temporal area.
Pt received vaccine about 3:40pm, was advised to stay for 15 minutes. He went upstairs while he was waiting but came back about 10 minutes later at 3:50 pm feeling dizzy. He was instructed to sit w/ his feet up & given apple juice. At 4:08, he said he felt better & left.
I received the Covid-19 vaccine on 01/20/2021 and had tingling/slight numbness in my left arm (injection arm). Later in the evening I had the same feeling in my left leg and in my cheeks, lips, tongue and teeth. I felt like I had been numbed at the dentist, but was coming out of the numbness. It was like when the numbness is mostly gone and you're left with that tingling sensation, and your face feels puffy. It was basically that feeling in my face, left leg, and left arm. Those sensations are mostly gone today (the second day following), but not quite.
pt recvd vax;rt arm very painful;egg sized lump at inject site;redness 5" in diam from shoulder to elbow;overall achiness; T 100;tx w/ erythromycin,biaxin,dph & steroids over a period of 4 wks;seen urgent care;
Pfizer 3/20/21, 3/22/21. ? Positive on 12/2/22
Dizziness/Nausea; "Kind of hungry"; BP 152/87; HR 70-81, RR 14-16, SpO2 98%
Immediately after getting the shot I developed a metal taste in my mouth. I was sweating and shaky. By the time I got home, I had severe burning in both feet and legs. Sunday morning I woke up to severe neck pain and shoulder blade pain, stiffness in my neck and shoulders and a neuropathic burning in my feet.  I attributed it to an acute exacerbation of fibromyalgia that I develop after any flu vaccine.  It was 4 weeks before I began to feel better, then I developed a sensation of ringing or gurgling in my left ear, the same side that I got the shot in. It took two months for my hearing to clear up in that ear. It was not an infection, seasonal allergies or wax in my ear.
2 or 3 days p/vax pt devel pain @ the site of vax;pt then exp pain in rt arm & shoulder w/diff lifting arm;self medicated w/Ibuprofen & muscle relaxants;seen by MD who dx bursitis secondary to IM administration of vax;
Started as itchy palms and escalated to itchy hands.  Scratching woke me out of a dead sleep on Sunday morning.  After some research I started taking over the counter Benadryl as often as allowed.  The reaction started to fade within 3 days and was gone by the following Friday, November 5th.
administered Daptacel instead of Adacel to a 10 years old patient; administered Daptacel instead of Adacel to a 10 years old patient; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 10 years old patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that administered Daptacel instead of Adacel to a 10 years old patient.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  Information on the batch number was requested.  List of documents held by sender: none.