chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness and tingling from left ear down my arm to my left fingers.  It started the afternoon of my second dose and still happens three months later.
strange sensation in the front of head; weird taste in mouth; right above eyes where it felt like something was tingling/ coarsing through a vein; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm right on 27Mar2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, visual impairment and also reported to have a very bad eyesight in left eye and had a posterior vitreous detachment back in 2015. The patient did not report any allergies to medications, food, or other products. Concomitant medications included sertraline hydrochloride (ZOLOFT) 25mg from unknown date; for unknown indication and famotidine (MANUFACTURER UNKNOWN) 5mg from unknown date; for unknown indication. 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 COVID vaccine. On 27Mar2021 at 16:00 the patient experienced strange sensation in the front of head, and around the forehead right above eyes where it felt like something was tingling/ coarsing through a vein (localized tingling). Patient had a very bad eyesight in left eye and had a posterior vitreous detachment back in 2015. It felt like something was happening like that when floaters started occurring in eye. Patient also felt a weird taste in mouth like when something drips down the back of your throat. This occurred a second or two after the forehead feeling and felt like if you snort something and you could taste it in your mouth slightly. Patient further stated that both of these things lasted less than a minute, possibly only like maybe up to 40 seconds. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. Patient did not receive any treatment for the events. The clinical outcome of the event strange sensation in front of head, right above eyes where it felt like something was tingling/ coarsing through a vein (localized tingling) and weird taste in mouth were recovered on 27Mar2021 at the time of this report.   No follow-up attempts are possible. No further information is expected.
lt arm pain in upper arm began a few hrs p/inj;pain did not subside;4NOV95 onset of gen malaise, arthralgias;devel fever 101 5NOV & 6NOV;h/a, mild sinus congestion, sore throat, weakness x 3days;total duration of illness x 5 days;
pt recv vax & exp a very severe inj site rxn;no further details are known as of the date of this report;
FELT LIKE HAD BEEN HIT BY A MACK TRUCK; FEVER; BAD HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced felt like had been hit by a mack truck, fever, and bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like had been hit by a mack truck, fever, and bad headache. This report was non-serious.
Patient called to inform me he is experiencing red blotchy quarter-sized spots on his legs, front and back of torso, and neck. He said they are not real itchy but they just look bad. He had an appointment with his dermatologist that day.  12-21-09
Breakthrough case admission after 2 vaccines Pfizer 10/9/21 Lot# FF8839;  Pfizer 10/30/21 Lot# FF2590
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 17 months old patient of unknown gender. On 06-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 17-AUG-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660974 with expiration date 20-APR-2021) (strength and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Patient reported feeling light headed and dizzy immediately after standing up after the vaccination.  After sitting back down, patient reported feeling nauseous and sweating a lot.   Patient was treated with a cool wet compress to forehead and neck and offered water to drink.  Patient reported that he had not eaten all day and had been feeling anxious about getting his vaccination.  After about 15 minutes patient was feeling better.
Low grade fever of 100.1 F, muscle aches all over my body. Headache,  flu like symptoms
inc temp spiked 105 R @ 120AM 8OCT97 duration approx 45min to 1hr w/APAP q 4hr;
Acute leukemia; Light headedness; Too week to walk; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE LEUKAEMIA (Acute leukemia) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high (High blood pressure). Concomitant products included ATENOLOL for Blood pressure high.   On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In 2021, the patient experienced DIZZINESS (Light headedness), GAIT DISTURBANCE (Too week to walk) and FATIGUE (Fatigue). On 26-Aug-2021, the patient experienced ACUTE LEUKAEMIA (Acute leukemia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 26-Aug-2021 due to ACUTE LEUKAEMIA. At the time of the report, ACUTE LEUKAEMIA (Acute leukemia), DIZZINESS (Light headedness), GAIT DISTURBANCE (Too week to walk) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: normal (normal) normal. On 26-Aug-2021, Haemoglobin: 5.5 (Low) Decreased. On 26-Aug-2021, White blood cell count: 0.2 (Low) Decreased.         No treatment medications were reported. Patient was hospitalized with acute leukemia with 5.5 hemoglobin and 0.2 white blood count and was complaining of fatigue and light headedness for the last month. For past two weeks he has been too week to walk. Patient's last bloodwork up in February 2021 was normal.  Patient does have high blood pressure and takes Atenolol.  Patient was not sure the vaccine was related and did not know exact date of first dose and did not have lot numbers.  Company Comment: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol. Concomitant products included PRENATAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;S for Supplementation therapy, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 04-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Nov-2020 and the estimated date of delivery was 26-Aug-2021. On 04-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  On 04-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, Pregnancy test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Patient stated that she noticed in the morning of 8/28/18 that her arm was red and swollen. Redness extended length of her bicep. Her arm still looked red and swollen but she stated it was looking much better than the day before. She said it is warm to the touch.
Popcorn popping in lungs (maybe asthmatic reaction) - -night of vaccine only muscle pain in arm -day of and after vaccine irritability due to feeling of body sensitivity -night of vaccine only Intense spinal/back muscle pain -day following vaccine. Entire day bodily fatigue -day of and after vaccine  slight headache -night of and day after vaccine  Mild to severe dizziness -hours following vaccine  Fainting occurred after vaccine, however I faint after any shot or blood draw
Nov 21-Dec21 Chest pressure discomfort, shortness of breath, rapid abnormal heartbeat. Heartbeat over 168 bpm while sleeping. Pre-vaccine heart never came close to this rate per FITBIT log. Went to Urgent Care 1-3-22-EKG and blood test. D-Dimer 1.25. Went to emergency room. EKG, blood test CT Scan. CT Scan showed blood clot upper left lung. Prescribed Eliquis.
I started getting hives all over my body 5 days after vaccine. I still get hives every night since and doesn't go away when taking Benadryl. Hives are big, hot and really itchy.
This initial spontaneous case, received on 13-Oct-2017, was reported by other non-health professional and concerns a 6-year-old female patient. The patient's medical history and concomitant medications were not reported. On 03-Oct-2017, the patient received FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195210, expiry date: Mar-2018). On 06-Oct-2017, after administration 4 days of vaccination, the patient had rapidly developed neurological tick. Treatment measures associated with event was neurologist appointment on 16-Oct-2017. It was reported that, tick had not improved, but movements related to tick were changed and frequent. The patient did not receive any treatment medication for the event. As per the reporter, agents such as wheat, unspecified medications and foods could have triggered the event. The outcome of the event was not recovered. The reporter assessed this case as non-serious. Follow up report received on 19-Oct-2017: The outcome of the event from unknown to not recovered was updated. It was reported that, tick had not improved, but movements related to tick were changed and frequent. The patient did not receive any treatment medication for the event. As per the reporter, agents such as wheat, unspecified medications and foods could have triggered the event. The narrative was amended accordingly.
Pt got PNEUMOVAX and FLUVIRIN shots on same arm (L) given 1 1/2 inches part (pt did not want on different arms). Pt got swelling but had gone down after 1 days. Asked pt to call MD if condition got worse. Pt is taking ibuprofen for pain and swelling.
Light headache and light body ache. I took Tylenol and put ice bag. It last 1 day 1/2.
If vaccine received: Yes/ vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment, brand: Paxlovid; If vaccine received: Yes/ vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment, brand: Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 06Apr2021 as dose 2, single (Lot number: EW0150), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; FAMOTIDINE; CETRIZINE; ESCITALOPRAM; DICLOFENAC SODIUM; HYDROCHLOROTHIAZIDE; CALCIUM CITRATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "recovering" and all described as "If vaccine received: Yes/ vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment, brand: Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks product: Vitamins, No known allergies reported. On 26Apr2022 Recurrence of covid symptoms and increased viral load after completion of Paxlovid five day course and apparent recovery   Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-BioNTech Covid-19 Vaccine lot FH8028, EW0150 and EN6207 were investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8028, fill lot FH4341 and the bulk formulated drug product lot FH4347 and lot EW0150, fill lot EP8690 and the formulated drug product lot EP8587 and lot EN6207, fill lot EN5340, and the formulated drug product lot EN5328. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or ADR were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Information has been received from a 75 year old male consumer with a history of shingles "once or twice many years ago" and no other reported allergies or history who approximately 20-JUN-2006 was vaccinated with a dose of varicella-zoster virus vaccine live.  Concomitant therapy included finasteride (MSD), pravastatin Na (PRAVACHOL), levothyroxine Na (SYNTHROID) and probenecid (BENEMID). About 4 weeks after vaccination, on approximately 18-JUL-2006, the patient developed a high fever and felt very sick with chest congestion and flu-like symptoms.  He said was seen by his doctor and the doctor's diagnosis was that he had a bacterial infection.  Subsequently, the patient recovered.  There was no product quality complaint involved.  Additional information has been requested.
12/22/2020 Covid vaccine Pfizer Lot#EK9231 01/12/2021 Covid vaccine Pfizer Lot#EL3249 04/02/2021 Covid exposure to boyfriend 04/05/2020 ill "head cold" 04/06/2021 Tested positive for covid with PCR test 04/16/2020 Potential to RTW
I had a fever about five days after my COVID-19 shot. That then started me coughing and then I had a headache, sore throat, and was fatigued. I took several COVID-19 home tests and they were all negative. I was managing the symptoms with OTC medications but by mid-November I had my usual tell that I have bronchitis which is the middle of my back gets very itchy and I cannot get it stop. I was put on two rounds of antibiotics those helped and I did get better.
nl delivery, return for 2 month well baby check up, recvd vax listed below (pt appeared to be healthy); 1 day p/vax arrived in ER DOA w/high core temp;
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 24-SEP-2013, the patient was vaccinated with ZOSTAVAX (19400 PFU) (lot # J004268 and expiry date 12-JUL-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he  thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would had been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported tha the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperature up to 21F. he stated the time frame of the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his records didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot# was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported and administered. This is one of several reports from the same source. Additional information has been requested.
Rash on his, it was a full body rash and lasted approximately 3 months; This is a spontaneous report from a contactable consumer. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. Medical history included heat rashes (further not clarified) sometimes on his waist but that was it. There were no concomitant medications. On an unspecified date, the patient experienced rash on his, it was a full body rash and lasted approximately 3 months. He went to urgent care and got a Cortisone shot after 2 weeks of rash and it didn't really work and then he took during the day cetirizine hydrochloride (ZYRTEC) and he also took diphenhydramine (BENADRYL) at night. He did go to the ER but all the blood work were normal. The outcome of the event was recovered on an unspecified date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt. began to have bolding hair around the nape. We visited a specialist for diagnosis and treatment. A topical ointment was prescribed which did not help.  The balding areas began to spread. The medication was changed, and the balding areas continues to spread.
Fever of 102.3; chills, sweats, nausea, dizzy, weakness.
pt recvd vax 26OCT95;fever 102 27OCT followed by abd pain, vomiting, sweating;28OCT hosp ER T102;adm for hydration; BX 305; progressive liver failure, SGOT 544, LDH 5099; congestive heart failure, coma;autopsy massive faulty degen of liver
Mild fever (peaked at 101f), mild nausea,  severe fatigue. Started about 24 hours after the shot, lasted about 20 hours after that.
This case was reported by a physician and described the occurrence of swelling injection site in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (unknown arm). At an unspecified time after vaccination with FLULAVAL, the subject experienced swelling injection site (arm). At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with FLULAVAL. The physician reported 3 subjects who had experienced adverse events following vaccination with FLULAVAL. This is case 2 of 3 (see case IDs A0949929A and A0949934A for details of the other reports).
pt was inadvertently given DTP instead of Td; w/in 24 hrs p/vax pt was sent to the ER & was febrile 104, dehydrated, & delirious; pt was hydrated, & sent home;