chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representative refers to an 11 year old female patient. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On 18-JUL-2017, the patient was vaccinated with a dose of GARDASIL 9 (lot # reported as N007931, expiration date 17-NOV-2019) (dose, dose number and route were not reported) for prophylaxis. On 18-JUL-2017, the patient "fainted" in the examination room after having an injection of GARDASIL 9. The patient did not receive treatment and not seek medical attention. The outcome of syncope was reported as recovered/resolved on 18-JUL- 2017. There was no product quality complain reported.
Behavior-emotional outburst (no treatment). Normally get flu like symptoms that are controlled with ibuprofen.  I took 3 200mg tablets at 11:00 and 22:00 day of vaccination.
INJECTION WAS GIVEN  AFTER ALLOWED TIME FROM FIRST VIAL PUNCTURE
rt arm became sore same day of inj then painful next day;On 3rd day had red splotchy erythematous areas around & below inj site;saw MD 30OCT97 & dx rxn to pneumovax;
tested positive on 20May; tested positive on 20May; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 05Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "unknown" and all described as "tested positive on 20May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Facility type vaccine reported as Workplace clinic. It was unknown if other vaccine in four weeks. It was unknown if Covid prior vaccination. Covid was tested post vaccination. Adverse event reported as wife was sick with COVID 17May then he had sx 19May and tested positive on 20May mild sx ST nasal congestion. Covid test post vaccination was reported along with result.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
migraine headache.  Never had a migraine before.  behind right eye severe pain mild nausea tingling right side of nose
slight soreness in both the doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight soreness in both the doses) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, 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 experienced VACCINATION SITE PAIN (slight soreness in both the doses). At the time of the report, VACCINATION SITE PAIN (slight soreness in both the doses) outcome was unknown.            Concomitant medications were not provided.  Action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-029681 (Patient Link).
Have to pee constantly.; Pain and burning while urinating; This is spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ew0178 and expiration date not provided), via an unspecified route of administration, in arm left, on 26May2021 18:15  (at the age of 51-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history and concomitant medications were "none". Patient was not diagnosed with COVID-19 prior to vaccination. Patient had no known allergies, no other medical history. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. On 27May2021, the patient had to pee constantly, and had pain and burning while urinating. The adverse event result in doctor or other healthcare professional office/clinic visit. Patient had not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of events and included treatment with antibiotics. The outcome of the events was not recovered.
FLU LIKE SYMPTOMS AND SEVERE BODY ACHES. VOMITING AND HEADACHE ALSO OCCURRED.
Shaking; Vomiting/puking; Diarrhea; Joint pain; Fever; Chills; Muscle pain; Headache; I can't eat; Gagging; I haven't been able to sleep; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 13:00 (Lot number: FH8030) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: RAMIPRIL taken for hypertension; AMLODIPINE taken for hypertension. Vaccination history included: Bnt162b2 (Dose 1, Single (The first two, patient got at the health department)), for COVID-19 immunization; Bnt162b2 (Dose 2, Single (The first two, patient got at the health department)), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021 13:00, outcome "unknown", described as "Booster"; TREMOR (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Shaking"; VOMITING (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Vomiting/puking"; DIARRHOEA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Diarrhea"; ARTHRALGIA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Joint pain"; PYREXIA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Chills"; MYALGIA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Muscle pain"; HEADACHE (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Headache"; INSOMNIA (non-serious) with onset 21Nov2021 09:30, outcome "unknown", described as "I haven't been able to sleep"; RETCHING (non-serious) with onset 22Nov2021, outcome "unknown", described as "Gagging"; EATING DISORDER (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "I can't eat".  Additional information: Patient had no prior vaccination (4 Weeks). On 21Nov2021, since morning at 9:30 hours, patient had not been able to sleep. On 22Nov2021, at 01:00 hour (morning), patient was shaking so bad and mean puking, it was happening, and stated that this was supposed to be good for her. So, patient mean it just doesn't make any sense. Patient mean, that she can't eat, had diarrhea, vomiting, joint pain, fever, chills, muscle pain and headache. On 22Nov2021, patient opened the refrigerator to get even a drink and she just started gagging. Patient stated that this is how the government is helping us. Patient stated that she had to call and tell somebody that this booster shot, this was cruel and inhumane.   Follow-up attempts are completed. No further information is expected.
Immediate pain in left arm.  Pain continued to get worse over the weekend with burning and tingling in arm and front and rear shoulder. Sought treatment at an urgent care. Later sought treatment with primary physician. By this time I was experiencing what felt like a deafness in the forearm as well as some tingling. Sunlight, air from fan or cold air from a/c worsens the pain. I was prescribed gabapentin. Dose was increased at a later date. Meds do hope somewhat but not completely.  Was sent to a neurologist with in office test done. I am currently scheduled for more tests in August.
Pt vaccinated DTP/OPV/HIB developed rash-hives 20DEC90.
11 Sept 2013 small bumps were just below my hair line on the right side. 14 Sept I had blisters on right side of head in scalp and ear. 14 Sept 2013 I went an Emergency Dept, the doctor said I had shingles, I told him I had the vaccine in 2007 and he said well you have shingles I was given Prescription. I still have a lot of pain in my scalp but the blisters healing.
First Ever episode of retinal migraine involving loss of vision entire right visual field.  Severe headache. Lasted > 6 hours.   Started less than 24 after shot.  Several very minor visual  migraines over following week,  without HA.  1 week later:  2nd retinal migraine right eye with HA lasting 4+ hours.
FLU LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-APR-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
pain in upper arm for 3 weeks now, decreased range of motion because of it. using ibuprofen & hot packs with no relief
Received DTaP No. 4 on 7/19/04. That evening with redness and swelling at injection site. Seen in clinic on 7/21/04: now somewhat improved. Symptomatic care with Benadryl and Hydrocortisone.
On 4/23/21 she presented to the ED with 4 day history of left sided weakness and slurred speech. She was hypertensive on arrival 249/121. In the emergency room labs remarkable for platelet count 92, INR 1.0, glucose 170, GFR 70.7, AST  48, alkaline phosphatase 167, troponin I 0.039.  COVID-19 and other viral serologies not detected.   CT of the brain showed a small subacute infarct in the right body of the corpus callosum. MRI  advised by radiology. Patient received aspirin, amlodipine 10 mg, enalapril 1.25 mg IV then 0.625  mg IV for uncontrolled hypertension.  MRI of brain reveals small subacute infarct involving the body of the  corpus callosum, and punctuate acute infarct to the posterior left frontal lobe.  Angiogram of brain was performed revealing focal severe stenosis of the mid basilar artery, moderate to severe stenosis of the short segments of both intracranial internal carotid  arteries and moderate to severe short-segment stenosis of the intracranial left vertebral artery, felt to be chronic and unrelated to current symptoms. She was started on dual antiplatelet therapy: clopidogrel  75 mg PO DAILY and   aspirin 81 mg Tablet, Delayed Release (Dr/Ec)  81 mg PO DAILY.  It should be noted that lab work reveals Thrombocytopenia chronically from 2011 forward.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DESVENLAFAXINE; TRAZODONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: received COVID 19 Treatment; (Oct2022) Positive, notes: positive test 5 days after treatment with paxlovid ended. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Anti-viral for Covid-19 from 11Oct2022 to 16Oct2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A spontaneous non-serious report of pregnancy was received from a nurse practitioner concerning a 34 year old female patient.  The mother of one of their patients was in the office and indicated that she, the mother, had received FLUMIST two weeks earlier and just found out the she was pregnant.  The mother experienced no difficulty at the time of the report.  There was no adverse event associated with this pregnancy.  Treatment and reporter/sponsor causality assessments are not applicable.  The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during this pregnancy.
Pt recv vax on 10/20/97; on 10/21/97 pt exp ecchymosis around vax site, Rt arm muscle twitching, vax site hives & itching, shooting pain in neck
Achy all over, fever maxed at 101. Started at about 4:30 pm on 2/1 and continued until approx 7 am 2/2. Currently no symptoms.
1. Injection site pain: started soon after injection continued to get worse until 1 day after injection then progressively got better 2. Fever: t-max 38.2 orally noted at 0430 1/6/21. Fevers associated with chills and rigors at times.  3. Extreme joint and body aches: started early morning 1/6/21 and progressively got worse until 1/7/21 then got better with subsiding around  1/8/21. Pain preventing/limiting normal movements such as walking, turning, and weight baring.  4. Extreme fatigue: sleeping for 18-20 hours a day with hard to stay awake 1/6/21-1/8/21. Resolved by 1/9/21.
Fever of 100.5 before bed, Motrin given. Patient woke up with a 103.0 fever at 7am. Very fussy night before and fatigued night prior and morning of high fever onset.
This spontaneous report was received from a licensed practical nurse regarding a 12 months old patient of an unknown gender. On 25-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # N013270, expiry date: 25-OCT-2018, lot # N014947 expiry date: 11-NOV-2018) (dose, route and anatomical location not reported) for prophylaxis, that was reconstituted with sterile diluent (MRK INJ) (lot#, expiration, route, dose and anatomical location not reported). The vaccine was stored at a temperature of 32 degree Fahrenheit (F) for unknown period of time (reported as "ongoing excursion"). The previous temperature excursion included multiple 6 degree Fahrenheit (F) to 14 degree Fahrenheit (F) for a total of 6.5 hours. The call was because of the data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000128: US-009507513-1710USA011203: US-009507513-1710USA011202: US-009507513-1710USA011201: US-009507513-1708USA010196.
PATIENT CAME TO PHARMACY TO SHOW SIGNICANT SWELLING UNDER HER LEFT ARMPIT THAT SHE WOKE  UP WITH 2 DAYS AFTER SHOT WAS ADMINISTERED.
Subsequently developed a low grade fever and an injection site reaction characterized by redness and swelling. The pt recovered. This is 1 of 4 pts from this facility who experienced this event following receipt of Pnu-Imune.
felt extreme weakness; neck soreness; bones with achiness; muscle tightness; Popping in her bones; This case was reported by a consumer via call center representative and described the occurrence of feelings of weakness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 28th December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced feelings of weakness, neck pain, bone pain, muscle tightness and joint clicking. The patient was treated with non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the feelings of weakness, neck pain, bone pain, muscle tightness and joint clicking were recovering/resolving.   It was unknown if the reporter considered the feelings of weakness, neck pain, bone pain, muscle tightness and joint clicking to be related to Shingrix.   Additional details were provided as follows: The patient reported that she received Shingrix in the left arm and she felt extreme weakness during the winter. The patient was not certain when the weakness started. The patient had neck soreness with popping of her bones with achiness which she had been experiencing in the past 5 months.  The patient had been seeing a physical therapist and her therapist said that she was having a tight muscle which was causing her symptoms. The bone popping was occurring on the upper part of her body in her muscles but mostly in her trunk.  The patient's symptoms were getting worse but were better at the time of reporting.  At the time of this reporting the extreme weakness was resolved. The patient claims that she was in good physical shape otherwise for her age and she works half days (1/2) during the week.  The reporter consented to follow up. This case has been linked to the US2019AMR118249, reported for the dose 2 of the same patient.
Egg sizes lump.  Warm to touch.  Ache in my arm from my armpit to my elbow.  Bumpy skin at the site. For about a week.  Two weeks later developed neuralgia in my face on the same side as the shot.  Diagnosed by a neurologist as A typical face pain.  On going.
After DPT high pitched screaming and swollen injection site, slow development became autistic approx 1 1/2 year old. There is no specific date of injury. His vaccine indured autism was due to cumulative vaccinations with mercury in them. A marked impairment in the use of multiple nonverbal behaviors, such as eye-to-eye gaze, facial expression, body postures, and gestures, to regulate social interaction. Failure to develop peer relationships appropriate to developmental level. Lack of social or emotional reciprocity. Delay in, or total lack of, the development of spoken language. Lack of spontaneous make-believe, or social imitative play appropriate to developmental level. Stereotyped and repetitive motor mannerisms. Persistent preoccupation with parts of objects. Slow onset. Happened right after first DPT, then went away. Then sometime after age 12 months gradually lost eye contact around 18 months lost ? 2 years lost social. 60 day follow up states pt has not recovered. Autism, immune disorder.
headache, body aches, chills, fatigue, lasting for approximately 2 days. Took acetominophen (1000mg) with no relief. Ibuprofen (400mg) alleviated the achiness temporarily. Also had pain at the injection site for about 3 days. Injection site still hurts when I lift my arm.
Fatigue, dizziness, lightheadedness, soreness,  slept for 34 hours  so dizzy i couldn't take my kid to school, felt so bad I thought I was going to die. Never again.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL, 120 Y(DF), injection. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. Additional information has been requested.
Extrême fever and unaware of surroundings for 1 day.  Then chemical odd smell of urine and pain /burning upon urination, then urination became very infrequent and so did bowel movements.  Extreme abdominal swelling which has continued for over 1 week.  Slight dry cough.
From initial information received on 08/14/03 from a physician regarding an adverse event occurring in the USA, it was reported that a 34 year old female pt received TD ADS ADULT, Lot # U0836AA, administered at 14:00 on 07/08/03.  The route and site were not reported. Two days later, the pt experienced stiffness, fatigue, joint pain, and shakiness. Treatment included unspecified pain medication. The pt was still experiencing symptoms at the time of this report. From additional information received through a telephone call on 10/29/03 from a health care professional, the reporter's full address was provided. No additional information was provided at this time.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-FEB-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 88, 32 and R; 208, 31 and R; 112, 30 and R; 104, 33, and R; 72, 29 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
severe spinal pain 5 days, blood spots on the trunk of the body as well as arms and legs.
Breakthrough case of Covid - 05/19/2022 Sx started on 05/19/2022, I was coughing, runny nose and very very tired all that day.  The next day I took a test, I was not nearly as tired but coughed a lot, it felt like a sinus infection.  I did a telehealth visit with my APRN and was asked to come in to the office, were they did another test and they gave me some medicine. I was prescribed Paxlovid and an antibiotic amoxicillin. Today is the first day I've felt pretty good, I am not coughing as much, I have the same type of sx only less. I have a metallic taste from the medicine, but I can taste my food, my bowels are not really normal. I have not had any trouble breathing, my SPO2 at it's lowest was 95 so my O2 is good. I tend to run a low temp in low 97's and my temp only went up slightly.
~ 12-24 hours after vaccine, patient started to experience weakness, myalgias, nausea/vomiting
Tested positive for COVID19 on 5/3/2021; Tested positive for COVID19 on 5/3/2021; This is a spontaneous report from a contactable consumer (patient).   A 58-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported ), via an unspecified route of administration, administered in Arm Left on 03Feb2021 (at the age of 58-year-old) as single dose, and first dose via an unspecified route of administration, administered in Arm Left on 13Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, allergy to chemicals (Nickel) from an unknown date and unknown if ongoing. Concomitant medication included irbesartan (IRBESARTAN) taken for an unspecified indication, start and stop date were not reported.   The patient experienced cold-like symptoms (nasopharyngitis) on 28Apr2021 with outcome of recovering, loss of smell (anosmia) on 02May2021 with outcome of recovering.  The patient tested positive for Covid-19 on 03May2021. The patient underwent lab tests and procedures which included Sars-Cov-2 antibody test: positive on 03May2021 (Nasal Swab).  Adverse events result in Emergency room/department or urgent care.   Information on the lot/batch number has been requested