chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 05-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
103.9 fever, aches, chills, sweating, back ache, headache
Was moderately sick for 4 days with hot and cold chills; Was moderately sick for 4 days with hot and cold chills; Was moderately sick for 4 days with hot and cold chills; mild dizziness; extreme fatigue; whole body aches and soreness; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; Had a fairly harsh headache about 3 hours; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA7484), via an unspecified route of administration in left arm on 27Jul2021 at 14:15 (at the age of 48-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/veteran's administration facility. Medical history included diabetes from an unknown date and unknown if ongoing, high blood pressure from an unknown date and unknown if ongoing, penicillin (drug hypersensitivity) from an unknown date and unknown if ongoing, broccoli, avocados, bananas (food allergy) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 27Jul2021 at 17:30, was moderately sick for 4 days with hot and cold chills, mild dizziness, extreme fatigue and whole-body aches and soreness. Had a fairly harsh headache about 3 hours after injection that lasted about 4 hours. Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness. Still have the knot after 5 days. The patient underwent lab tests and procedures which included blood pressure was high on an unknown date. The patient did not receive any treatment for the events. The outcome of the events was reported as resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
Pain in my left arm; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female 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 01Apr2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient received unspecified medication within two weeks of vaccination. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 15:00, the patient experienced pain in her left arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in her left arm was recovered on 01Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Tested positive for covid-19; Head cold; Congestion; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (Head cold), NASAL CONGESTION (Congestion) and COVID-19 (Tested positive for covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced NASOPHARYNGITIS (Head cold) and NASAL CONGESTION (Congestion). On 24-Mar-2021, the patient experienced COVID-19 (Tested positive for covid-19). At the time of the report, NASOPHARYNGITIS (Head cold) and NASAL CONGESTION (Congestion) had not resolved and COVID-19 (Tested positive for covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 test: positive (Positive) 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.   No relevant concomitant medications were reported. No treatment information was provided.
99 degree fever; This is a spontaneous report from a contactable consumer or other non-health care professional, the patient. A 43-year-old male patient received BNT162B2(PFIZER- BIONTECH COVID-19 mRNA Vaccine, lot number: En6204), Dose: 1 on the left arm via an unspecified route of administration on 16Mar2021 at 12:45 PM (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 at 3:15 PM, the patient experienced 99 degrees fever. As a therapeutic measure took Tylenol at home Prior to vaccination. The clinical outcome of 99-degree fever was recovering at time of reporting. No follow-up attempts are needed. No further information is expected
High fever of over 104, severe difficulty breathing, pain all over body, unable to move arm where vaccine was put in for 3 days.
Patient presented to emergency department on 9/10/2021 after falling at his home. He was found to be tachypneic and hypoxic at home and was transported to emergency department. He was admitted previously from 8/25/21 to 9/3/21 for COPD exacerbation. Patient was found to be COVID-19 positive and in a. fib. He was admitted for further management. He was treated with remdesivir and dexamethasone. He was discharged to an extended care facility on 9/21/2021.
Patient was shaving legs and cut herself, her bleeding was abnormal, she experienced bleeding for a longer period of time than she usually does if cut.  She wasn't thinking she needed medical attention, just curious if it was a adverse effect of the immunization.
Left deltoid blisters, swelling, redness and warmth. Tx Benadryl, Ice and antibiotic ointment PRN
Tender, red, and itchy at injection site. Mild headache and joint pain. Symptoms lasted 9-10 days.
Large (3inX2in) red welted area.  Evening of 4/27/17 excruciating pain began in joints, headache, fever. Morning of 4/28/17 welted area spread and became painful, nodules developed on L hand.  Paint in joints -both wrists. L shoulder, L back area, both ankles and in both knees that had joint replacements.
10 days after my booster, I started with severe hives and a rash. This started on the back of my neck and ears. The itching, burning and inflammation pain in unbearable. The rash and hives has moved to my entire body. Night and Mornings are the worst.  I am 3 weeks in and I am still experiencing this terrible reaction.
HCP REPORTED LACK OF EFFICACY IN PATIENT WITH RECURRENT BILATERAL PE ON ELIQUIS; RECURRENT BILATERAL PE ON ELIQUIS; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative and License Party (RA). Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2023-019213 (RA).  This case was received via {BP} Pfizer Inc (Reference number: 202300024515) on 07-Feb-2023.Information was received from a Health Professional concerning a patient, who received Suspect product APIXABAN for product used for unknown indication, lot number: Unknown; Suspect product COVID-19 VACCINE for COVID-19 immunization, lot number:  Unknown. On an unknown date, the patient had pulmonary embolism (recurrent bilateral PE on eliquis), which met the following seriousness criteria: medical significance. It is unknown if treatment was provided. The outcome of the pulmonary embolism was unknown. On an unknown date, the patient had drug ineffective (HCP reported lack of efficacy in patient with recurrent bilateral PE on eliquis), which was considered non-serious. It is unknown if treatment was provided. The outcome of the drug ineffective was unknown.  The action taken with APIXABAN medication was unknown. The action taken with COVID-19 VACCINE medication was unknown. Concomitant medications were not reported.  The reporter did not provide a causality assessment for events pulmonary embolism and drug ineffective to APIXABAN. The reporter considered events pulmonary embolism and drug ineffective related to COVID-19 VACCINE. HCP reported lack of efficacy in patient with recurrent bilateral PE on Eliquis within one month of treatment initiation. Patient had been vaccinated and boosted with Covid vaccine and provider believes there was a connection between the two events. Reporter does not wish to be contacted for follow-up.  Consent to contact health professional for follow-up information was denied.  Eliquis is under agreement with RA.; Sender's Comments:  Comments: This patient had pulmonary embolism after receiving apixaban therapy along with COVID- 19 vaccine. Based on the limited information available regarding the therapy details, event onset date, action taken with the suspects, treatment given and outcome of the event, it cannot be ascertained with the reasonable possibility that the apixaban/ COVID- 19 vaccine could have contributed to the event pulmonary embolism.
Pt given HIGH DOSE flu shot - By next day, extreme soreness at injection site. Now 4 weeks later has soreness still in that arm. Pt also complaining of generalized body ached. Wife has similar symptoms.
get more blisters in her mouth; progressed to two blisters, one on each arm; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported), at the age of 76-years-old as 1st dose, single; and dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Medical history included mucous membrane pemphigus. Historical vaccines included shingles vaccine and pneumonia vaccine on Nov2020 and flu shot on Dec2020; all taken at the age of 76-years-old. The patient's concomitant medications were not reported. The patient received her first shingles vaccine in November as well as pneumonia vaccine. She received Flu shot in December. She waited a month after second dose of product before receiving second dose of Shingrex. She knows vaccines can cause flare up of her historical condition of mucous membrane pemphigus and has been controlled with very low dose dapsone and under control for two years. She stated she started to get more blisters in her mouth and was prescribed dexamethasone wash. Then progressed to two blisters, one on each arm. Referred to her dermatologist who indicated she has seen the condition progress/ in those whose who are fully vaccinated. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Client was dizzy after couple of seconds of receiving janssen vaccine AT 11: 42 AM. Client had 1st seizure at 11:43 am . client layed on the ground,  Vitals  recorded at 11:46 am HR 56 R 16, BP 100/60 O2 sat 99.  client vomited 6-7 times. Client had 2nd episode of seizure @11:49 am for 6-7 seconds.  client's vitals were normal when checked again.  Client continued to vomit and  called 911.  911 arrived at 12:50 pm and client was taken to medical facility.
Left deltoid red, warm to the touch, swollen and feels tight. Employee complains of pain with touch or pressure to the area.
Rash, spots, burning on hip/stomach, side, took place 3 days after she got Zostavax shot.
Redness, warmth, and slight firmness in area of vaccination. Tx- Cephalexin 500 mg BID x 100, BENADRYL.
Patient c/o general weakness, dyspena, lightheadedness.  No increase in resp effort.  Vital signs: 92/62-52-14-96% O2 Sat.  Alert and orients.  Skin cool and clammy.  Breath sounds clear.  Cap refil 4 sec.  Laid supine. Monitored patient for 35 min.  Vital signs: 132/88-70-96% O2Sat.  Patient returned to basesline.  No dizziness or lightheadedness.  Patient discharge home.
Felt shaky and a warmth went from my feet to head causing a low grade headache. Shaking was internal but then became external. I felt light headed as if my BP was low. The next day I have a rash on my neck with bumps on the side I received the vaccine. I also have had a headache all day as well.
EDC: 25 APR 2021  AE1: Superficial Venous Thrombosis: On 10 Feb 2021, patient presents with RLL pain and swelling. Dopplers with non-occlusive Superficial Venous Thrombosis. Started on 40 Lovenox qd. On 23 Feb, had worsening pain and repeat doppler showed occlusive SVT. Her Lovenox was increased to 40 mg BID and referred to Hematology. Her hematologist increased her lovenox to 80 mg bid.   SAE: Pulmonary Embolism: On 3/9 patient developed Shortness of breath and chest pain and went to ED where she was diagnosed with Bilateral pulmonary emboli. She was admitted to the hospital and started on an heparin drip.   AE2: SVT: Patient developed a second SVT after discharge from hospital on 17 Mar 2021 that is located away from original SVT site.
Pt reported at 1800 - started with chills et general illness. Felt feverish. Became short of breath - couldn't catch her breath or take deep breath. Took ADVIL and BENADRYL. By 0100 was better and able to sleep. Next day felt lethargic et upset stomach. No appetite. Began feeling "normal" 1/2/13.
dT given 6/28/03 - redness and soreness started 6/29/03 - steadily worsening. Now very red, warm, fore. Swollen lump left neck noted 6/29 and increasing in size and is firm.
fever to 101.8, myalgias, headache, starting within 24 hours of 1st of series of Shingrix
Pfizer maroon monovalent vial was undiluted and a 0.2mL dose was given to patient. Patient monitored for 30 minutes before being released from clinic and no reaction noted.  Patient 's mother was informed and instructed on what to look for and when to call 911. Patient was checked on next day and mother states no side effects for patient at that time.
Approximately 15 minutes after the vaccine was administered, the patient reported feeling hot and lightheaded. They begin vomiting and sweating heavily within 30 minutes after the vaccine. They felt very dizzy and were unable to walk from the clinic to their car and had to find a ride home from the facility. They were unable to return to their shift that evening.
Information has been received from a RN concerning a 9 year old healthy white male pt with no allergies and not past medical history who on 09/04/96, was vaccinated IM in the right thigh with a first dose of varicella virus vaccine, live. Concomitant vaccination on 09/04/1996 included a fourth dose IM in LL of diphtheria toxoid + pertussis vaccine + tetanus toxoid. There was no illness at the time of vaccination and there were no adverse events following prior vaccination. On 04/22/04. the pt presented to the office with approximately ten widely scattered macules with clear vesicles on the right shoulder, left foot and lower abdomen. There were no other sx. An onset date of 04/02/04 was noted. The pt was treated with oral acyclovir and OTC diphenhydramine hydrochloride lotion (Benadryl). Lab tests were not performed. Subsequently the pt recovered. A product quality complaint was not involved. Additional information is expected.
Arm ached; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient reported for himself. About 2 months and 1 week before the reporting date, the patient got his 1st dose of Shingrix in an unknown arm. Afterwards his arm ached quite a bit for about 1 week before resolving.  The patient consented to follow up. This case has been linked to US2019162791, reported by the same reporter.
On 15-May-00, the vaccinee received his first dose of Engerix-B. Fifteen days later, on 30-May-00, and, in addition, on an unknown date, he experienced a total of two seizures. The seizures were not witnessed by medical personnel. The vaccinee's cell-mate described mild clonic seizures, post-ictal, with droolong. Outcome: unresolved. On 20-Jul-00, the vaccinee received his second dose of Engerix-B. On 03-AUG-00, 25-AUG-00, and 17-OCT-00, he experienced a total of three seizures. THe vaccinee was unresponsive and drooling. His cell-mate describes jerking movements while sleeping. Outcome: unresolved. Engerix-B was discontinued. This case is considered medically serious. As of 19-OCT-00, the outcome of the event is unresolved.
About 3 months after shot, I developed warts from lichen sclerosis that became a squamous cell carcinoma. I had a Condition for 10 hrs, never had a wart, but after the vaccine this occurred. I just had surgery to removed the carcinoma.
Sudden onset hearing loss, left ear 2 days after receiving vaccination.  Gradual recovery over 30 days to approximately 10% permanent hearing loss.
Fever, Redness and swelling in the left arm, approximately 36 hours after injection
First symptoms started on Friday Oct 1st, test on Sunday the 3rd at park given results today that he is positive. Symptoms are flu like- cough, sore throat and muscle aches, tired all the time. Rec'd 3rd Pfizer dose in September
No additional AE/ PQC reported; Temperature excursion; This spontaneous report was received from a medical assistant referring to a 17-month-old patient of unknown age. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 12-APR-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (albumin status recombinant Human albumin (rHA)) (lot #: T029099, expiration date was 23-FEB-2022, dose, strength, and route were not reported) for prophylaxis.  Temperature excursion of this vaccine was -58 degrees Fahrenheit and +5 degrees Fahrenheit (6.3 F) for 6 hours and 30 seconds, -58 degrees Fahrenheit and +5 degrees Fahrenheit (10.9 F) for 7 minutes and 30 seconds with previous temperature excursion. The digital data logger was involved in recording excursion details.; Sender's Comments:  US-009507513-2104USA008134: US-009507513-2104USA008302: US-009507513-2104USA008088:
Temp. greater than 102 rectally, fussy, irritability with no other focus of infection, approximately 2 hours after administration. patient had previous immunization @ 2 months of age with same symptoms patient was given pediatric dt with his hx. instead of dtap.
weak; nausea; diarrhea; severe pain in my abdomen feeling like a knife stabbing me mostly left side; chills; headache; mental clarity and can't think straight; This is spontaneous report from a contactable consumer (patient).A female  (age: 68 unit: unknown) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021, as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunisation and experienced fainted, fell down face forward, busted her lip, blurred vision, rash on arms, back and chest, Joint pain, muscle pain, weak and having to walk with a cane. On01Apr2021, the patient experienced weak, nausea, diarrhea, severe pain in abdomen feeling like a knife stabbing me mostly left side. It was excruciating. On 01Apr2021, the patient experienced chills, headache, mental clarity and couldn't think straight. Started last night of the day of reporting and the patient had some symptoms and needed to talk to someone about what to do about them. The reporter assessed the case as non serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. .
Woke at 11AM crying, pale twice gave TYLENOL. 4 PM act fine except nursing fair. 9 AM next day - baby fine.
Pt experienced HA, fatigue , vomiting and dizziness that have gradually improved within the last 48 hours.