chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial severe pain at site of vaccination.  Arm became heavy after two hours and pt felt she could not move it. On the 27th developed increasing swelling and a bull's eye rash extending 8.5 cm in diameter at time of this exam
Noted approx 4" area around inject site red, hot & swollen; referred to MD tx w/ATB;
All of the following described symptoms lasted for 4 days before completely resolving. Patient's left arm from mid-upper arm to the top of the shoulder was sore, swollen, and red-hot to the touch. Patient was not able to lift or use arm for the duration of the symptoms. Patient was dizzy, had generalized body aches, with more significant pain in her back which caused her to stay in bed for a significant duration of the symptoms.
1st dose of Pfizer was taken / 2nd dose of moderna was taken; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (1st dose of Pfizer was taken / 2nd dose of moderna was taken) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 28-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (1st dose of Pfizer was taken / 2nd dose of moderna was taken). At the time of the report, PRODUCT ADMINISTRATION ERROR (1st dose of Pfizer was taken / 2nd dose of moderna was taken) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Information has been received from a nurse referring to a currently 36 year old female patient. The patient's medical history or concurrent condition were not provided. It was reported that the patient received 6 doses (confirmed the patient received a three dose series two times) of hepatitis b vaccine (manufacturer unknown) (strength, formulation, lot#, expired date, dose, route, duration were unspecified) and had not seroconverted. It could not be determined if the unspecified hepatitis b vaccine was a Merck product. The patient has sought medical attention via office visit. Unspecified blood work was performed with no result provided. The nurse also mentioned the patient was stuck by a needle today (15-MAY-2015). The patient's present status was reported as not recovered. Additional information has been requested.
no other adverse events; temperature excursion/ 15 C; This spontaneous report was received from a pharmacist and refers to a 4-year-old patient of an unspecified gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.  On 09-JUN-2021, the patient was vaccinated with improperly stored 1 time dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # T027114, expiration date was reported and also validated as 07-FEB-2022 (exact dose, strength, route of administration, anatomical location were not provided) for prophylaxis. The data logger registered, that the vaccine prior to administration was stored at the temperature of 15 degree Celsius (C) for 5 hours (product storage error temperature too high). No previous temperature excursion was detected. No other adverse event or product quality complaints were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA003417: US-009507513-2106USA003447: US-009507513-2106USA003425:
Progressively worsening generalized weakness and altered mental status. Finally presenting to hospital 8 weeks later after symptoms had significantly worsened.
No adverse event; patient was administered with the bivalent vaccine instead of the monovalent for their 1st dose of the primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was administered with the bivalent vaccine instead of the monovalent for their 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No relevant medical history or conditions, allergy,concomitant diseases and risk factor.     On 14-Feb-2023, 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 14-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (patient was administered with the bivalent vaccine instead of the monovalent for their 1st dose of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient was administered with the bivalent vaccine instead of the monovalent for their 1st dose of the primary series) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (patient was administered with the bivalent vaccine instead of the monovalent for their 1st dose of the primary series).    No concomitant medications were reported. An administrator of an urgent care reports that they had an incident in one of their locations where a patient was administered with the bivalent vaccine instead of the monovalent for their 1st dose of the primary series. The patient was in their facility now for the supposed 2nd dose of the primary series. No treatment medications were reported.
BODY ACHES; LETHARGY; CHILLS; INJECTION SITE PAIN; FEVER; This spontaneous report received from a patient concerned a 58 year old (White, not Hispanic or Latino) female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination on Right deltoid. No concomitant medications were reported. On 26-MAR-2021, the subject experienced body aches. On 26-MAR-2021, the subject experienced lethargy. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced injection site pain. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and chills, and had not recovered from body aches, injection site pain, and lethargy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210354457-Covid-19 vaccine ad26.cov2.s-Bodyache, Lethargy,. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210354457-Covid-19 vaccine ad26.cov2.s-chills, injection site pain and fever. This event(s) is labeled and is therefore considered potentially related.
Redness at injection site after about 4 hours, deltoid soreness then about 10 hours later fever, malaise, muscle aches, deltoid turning dark red that migrated down to my elbow during the next two days- first vaccine  @nd dose- after about 8 hours deltoid soreness, fever, redness at injection site, maiialise, weakness, weakness, the next day the weakness progressed to my thighs and could not walk for three days, then weakness progressed into trunk,  weak ness in thighs continued after three days of flu-like symptoms  made appointment with neurologist but could not get in for a month.  Some weakness continues in both thighs.
had hearing loss in one of the ear/hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got 2nd Covid vaccine (Pfizer Covid-19 Vaccine) and had every symptom that the patient saw online, after 3 days. The patient heard echo, the patient just want to say that had hearing loss in one of the ear after the 2nd vaccine and was not finding much on here, the patient had everything else but that's Friday (unspecified), the patient had the hearing loss in right ear. The patient never had this problem before. The outcome of event was unknown.  Information about batch/Lot number has been requested.
Several back operations of stimulator in the back and in pain management; This is a spontaneous report from a contactable Consumer. This adult female Consumer(patient) reported that:  An adult female patient received bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation. Medical history was none. No known allergies. The patient's concomitant medications were not reported. Patient was not pregnant a time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior to vaccination.  The patient experienced several back operations of stimulator in the back and in pain management on an unspecified date, resulted in disability or permanent damage. Post the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Pt recv vax on 12/7/98; on 12/12/98 pt exp eczema on legs
The morning after these vaccines, the patient was shaving for the 1st time & got some shaving gel up his nose. He complained of nausea & dizziness & sat down briefly. He then started shaving again and said "Dad, I can't see," he went limp, supported by his Dad. He was unconscious for 1 1/2 min. and "yellow" for 20 min, but recovered completely.
It was reported that a pt rec'd and injection of hepatitis A (brand name unknown). This report was rec'd from the pt's mother and has been confirmed by a physician. Later on the day of vaccination he reportedly began twitching, his shoulders started shrugging, his eyes started to blinking, he was unable to control the twitching, shrugging, or blinking. These events persisted and reportedly became worse. His mother reported that he began to have tics in his arm in 1998. He has reportedly been seen numerous times  by physicians. A neurologist performed and unspecified MRI study (results of this study were not provided) The mother reported that the neurologist made a diagnosis of Tourette's syndrome. The subject now has severe tics all over his body, his eyes rolled back into his head. Tx of Tourette's syndrome was not specified. On 9/10/02 info was rec'd from the neurologist indicating that the onset of the symptoms proceeded Havrix administration. It was reported that the onset of symptoms to have started in 1996 however the subject was 1st examined by the physician on 12/31/98. On the date of the exam, test were preformed. As of 8/28/02, the  neurologist reported the symptoms persisted. The reporting physician indicated that it was unknown if the events were related to hepatitis A vaccine. According to the neurologist, the pt's mother stated that her son incurred his 1st closed head injury with loss of consciousness when he was 1 1/2 yrs old. The reporting physician attributed the events to the closed head injuries.
After a few days, muscle/joint pain ....headaches.....Tiredness......injection sit pain.... all were bearable and strong to disappear when i waek after the short I got Horrible chills, completely out of control, had to wear my night guard to stop teeth from getting chipped, lasted 3 or four hours. Could not warm up, had two down comforters on. The chills eventually stopped but the headaches Intensified, also I could. Or move my near and shoulders. Went to the ER, they did not believe it had anything to do with the shot, I was there for 12 hours, had head exrays, spinal taps to test for meningitis, they searched for anything else I might have...nothing else.. they would not say if I should have the second shot, called pfiser this morning, they could not tell me if I should have the second shot, that I should aske my doctor.......If Pfiser  doctor  does not know if it is safe how could  my country doctor.
Swelling under left arm with some tenderness, chills headache, fatigue.  Patient had COVID 6 weeks prior to this presentation.  Patient given normal saline IV fluids. Clinical impression is cellulitis.  Patient is discharged home from ER and given a prescription for cephalexin
Pt is a 37 year old male that presents to the emergency room with complaints of pretty quick onset of swelling to his bilateral cheeks and upper lip that began just after his COVID vaccine today. He received his COVID vaccine about an hour prior to arrival to ED. He denies any tongue swelling, throat swelling, difficulty swallowing or shortness of breath. He has never had anything like this happen before. Since onset, it does not seem to have gotten worse.
Pt. states that after receiving the 2nd dose of Moderna 02/04/2021, started experiencing symptoms 07/10/2021 of Injection site pain in the left arm (with visible indentation). 07/12/2021 Emergency Room visit with X-Rays preformed (Normal), Referred to Ortho 07/2021 Contrast MRI preformed (Normal). Follow-Up appt 08/2021 no recommendations. Indentation has developed more but symptoms have subsided.
After getting the Tdap, patient slightly bleed, then passed out while sitting on the exam table. Patient fell on me, I called for Dr. she immediate came in the room and saw her. Patient was Observed for 30 minutes. She has an abrasion on her left shin. Patient left and was ok vitals were stabled.
Symptoms: itching, headache, stuffy ears, earache, sore throat and scratchy, muscle pain, scratchy eyes, pressure front of eyes, face rash, trouble tasting certain foods 1st 3 days, tongue is raw and painful, runny and stuffy nose, nausea and vomiting, stomach feels soar, congested. When to see doctor, prescribed triamcinolone ointment, benadryl and ibuprofen.
Fever, joint and muscle pain, fatigue , migraine headache, nausea lasting 2 days
Patient reports diarrhea, muscle weakness, low pulse, arrhythmias starting the day after her vaccines. Says she could barely move enough to get out of bed. Patient went to the Emergency room because of her low pulse and arrhythmias. She was put on Metoprolol to control her arrhythmia.
Expired Drug Used; This case was reported by a nurse via call center representative and described the occurrence of expired drug used in a male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number 49Z43, expiry date 30th June 2019) for an unknown indication.   On an unknown date, the patient received Fluarix Quadrivalent 2018-2019 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced expired drug used. The action taken with Fluarix Quadrivalent 2018-2019 season was unknown. On an unknown date, the outcome of the expired drug used was unknown.   It was unknown if the reporter considered the expired drug used to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were reported as follows: The age at vaccination was not reported.  Nurse on the line reporting the patient was accidentally given Fluarix that was already expired, which led expired drug used. The reporter consented to follow up. This case was linked with case US2019183549, reported by the same reporter.
fatigue; slight fever; This is a spontaneous report received from a contactable Consumer. The reporter is the patient.  A 68 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown), as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. Relevant medical history included:  high blood pressure  "HBP" (ongoing); "Uric Acid" (ongoing); "High Triglyceride" (ongoing); "Problem Urination" (ongoing). Concomitant medications included: LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE] taken for hypertension (ongoing); ALLOPURINOL taken for blood uric acid (ongoing); VASCEPA taken for blood triglycerides increased (ongoing); ALFUZOSIN taken for dysuria (ongoing).  The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "fatigue"; PYREXIA (non-serious), outcome "recovered", described as "slight fever".  Additional information: After the vaccination, of the first and second dose, the same symptoms only 12 hours after it occurred That's why I did my self-test listed in chronological order the result and date.  The lot number for BNT162B2 was not provided and will be requested during follow up.
10/21/2001 presented with lighter colored pigment changes over back and shoulder area. No open areas noted.
Renewed soreness and red rash/swelling on vaccine arm, presenting 9 days after vaccine
This spontaneous report as received from a registered nurse concerning a child who on 17-AUG-2012, was vaccinated with a dose of M-M-R II (lot# 1251AA, exp 01-AUG-2013). The nurse stated that the child might have been vaccinated with improperly stored M-M-R II. M-M-R II was exposed to 68 F for 9 hours and then on Wednesday last week "on 15-AUG-2012", the temperature went to 48F for 1 hour. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient received dose in left arm which is affected by previous cerebral infraction. Approx 12 hours late there is swelling to entire arm from shoulder to finger tips. Resident care staff have addressed with Tylenol and icing. Swelling remains 24 hours after injection.  No other symptoms or complications. Resident is located in an assisted living facility and remains under observation by staff.
Patient with history of anaphylaxis to previous vaccines and food/medication had immediate sensation of tongue itching and reported "tightness in throat" post vaccine. EMS administered 50 mg  Benadryl IM, recommended transportation to hospital which patient declined.
Sore arm for 3 days Wednesday, 03/31/2021 Fever- reaching 102.1 using digital mouth thermometer. Fatigue. Slept. Fever-free by 1am, 04/01/2021 Reported to work as teacher, worked a full day on 4/1/2021. No other symptoms
This spontaneous report was received from a male patient (also a physician) regarding himself. No current condition or medical history was reported. On 14-AUG-2015, the physician administered himself, improperly stored ZOSTAVAX (lot # L006392, Exp. 25-MAY-2016, 1 shot, 0.65 ml, subcutaneous). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Received Pfizer vaccines on  4/27/21, 5/18/21; COVID positive on 4/24/22 by PCR; admitted to hospital on 4/24/22 d/t fever, cough; pneumonia. Treated w/ remdesivir. Underlying cerebral palsy.
Received DTaP/Hib and Prevnar 5/7/03. 5/8 broke out with hives in AM per parents. Seen in office 2:30 5/8 confirmed.
mild arm pain/injection site pain; Mild redness/swelling at injection site; Mild redness/swelling at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (BNT162B2), on 26May2022 at 17:00 as dose 3 (booster), single (Lot number: FL8095) at the age of 11 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing). Concomitant medication(s) included: GARDASIL, on 09May2022 as single dose; MENINGOCOCCAL VACCINE, on 09May2022 as single dose; TDAP, on 09May2022 as single dose; DAILY MULTIVITAMIN. Vaccination history included: Bnt162b2 (dose number 2, product: COVID 19,, brand: Pfizer-BioNTech COVID-19 Vaccine,, lot number FK5127,, administration date Nov2021,), administration date: Nov2021, when the patient was 10 years old, for COVID-19 immunization; Bnt162b2 (dose number 1, product COVID 19,, brand Pfizer-BioNTech COVID-19 Vaccine,, lot number FK5127,, administration date Nov2021,), administration date: Nov2021, when the patient was 10 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 27May2022, outcome "not recovered", INJECTION SITE ERYTHEMA (non-serious) with onset 27May2022, outcome "not recovered" and all described as "Mild redness/swelling at injection site"; VACCINATION SITE PAIN (non-serious) with onset 27May2022, outcome "not recovered", described as "mild arm pain/injection site pain". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, injection site erythema.  Additional information: Adverse event: Very mild arm pain/injection site pain reported by patient when asked 24.5 hours post-dose. Mild redness/swelling at injection site 24.5 hours post-dose. No other AEs or reactogenicity events occurred at the time of reporting (24.5 hours post-dose). Adverse event start date: 27May2022. Adverse event country. Ae resulted in: None of the above. If patient recovered: Not recovered. If treatment ae: No. If covid prior vaccination: No. if covid tested post vaccination: No. Known allergies: NKA Other medical history: Eczema.  No follow-up attempts are possible. No further information is expected.