chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the flu shot, administered by an RN, on Thursday, September 20, 2018. Almost immediately my left arm began to hurt but I attributed that to the shot. Late Friday evening on the 21st into Saturday afternoon on the 22nd I began to feel greater pain and a decrease in the range of motion of my left shoulder joint. I was unable to sleep on Saturday night into Sunday morning. When I awoke on Sunday, September 23, 2018 I was unable to move my arm above chest high without pain. I went to an orthopedic urgent care where I was treated for an inflammation to the bursa sac in my left shoulder as the injection was administered too high. I was given a cortisone shot to help with the inflammation but the pain and range of motion have not gone away (as of Monday, September 24, 2018).
the patient unknowingly had COVID19 at the time of vaccination. on 4/13 the patient experienced non-lifethreatening facial swelling and sought medical care with facility on 4/15. the patient was prescribed a course of prednisone and she reports that worked to bring the swelling down. per the patient, the patient's allergist has recommended waiting 90 days to receive the second dose and has prescribed an epi-pen for when she does receive the second dose. She has been advised to receive the dose in a healthcare facility.
I felt quite decent subsequent to the shot. Approximately 5-6 hours post shot, I began to feel freezing cold. I had a burning sensation in my penis which was not fun for about 1 hour. Afterwards, I started feeling very, very warm. My temperature went up to ~ 103.2. My body felt as though I had been beaten with a bat. My head was tender to touch, and it was painful while taking a shower. I had a strange taste in my mouth, seemingly, metallic. I slept horribly all last evening. I sweat all night, and I could  not stay asleep for more than 2-3 hours at a time. I woke up with horrible chest pain (left side), and I thought that I was having a heart attack. I still have a fever, however, it has dissipated to ~ 100.4. I have never in my life felt like this, and I regret taking this vaccine 100%. This is the only thing in my life that I have ever regretted, so to say that I am happy would be a complete and utter falsification. I now have the worst headache that I have ever had, and quite honestly, feel like waking out into traffic? This was a disaster, and I?m very regretful.
Crohn's disease aggravated; Common cold; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4364187-00 (Agency).  A 24-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown), on 20May2021 as dose 2, single (Batch/Lot number: unknown) and on 20Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 years, all intramuscular for covid-19 immunization; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Feb2022, outcome "unknown", described as "Common cold"; CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohn's disease aggravated". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.   Causality for BNT162B2: The reporter's assessment of the causal relationship of "crohn's disease aggravated" with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "common cold" related to BNT162b2 (reported as Possible).  Causality for adalimumab (HUMIRA): The reporter's causality for the event(s) of Crohn's disease flare up  with adalimumab (HUMIRA) was a reasonable possibility (also reported as Probable). The reporter's causality for the event(s) of mild cold with Humira (Adalimumab) was no reasonable possibility (also reported as Not related).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported event: "Common cold" and the suspect drug BNT162B2 cannot be completely excluded. As per the company assessment the reported event: "Crohn's disease aggravated" was assessed as Unelated to the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
To date, 1-25-2020 from a day or two after receiving 9-16-2019, the Flu shot, I started having pain in my muscles in my right arm where I got the shot. From then on it got worse and moved to my other arm, my back and legs. During that time I took only one pill a day to relieve the muscle pain, either ALEVE or OBUPROFEN, did not want any side effects from taking too many of those pills. The worse time of the day with the pain is every morning when I wake up and get up, some days for a while two hands to lift a cup of coffee. Now seems to be getting better now after all of this time but I still feel the muscle pain. Went to my regular Dr., and he suggested it was my right rotor cup in my shoulder and suggested I go to Rehabilitation. I am going to go, but do not agree with his thoughts on my problem I think it is some side effect of the Flu shot.
Fever(sl.) (not taken), irritable, cranky, crying, dec appetite; curls up wants to be held, holds head when cries;
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 12-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 25-OCT-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Vaccine placed in freezer on 12/9/2021 and removed from freezer on 1/3/22, outside the recommended amount of time they are supposed to  be in the freezer.  No adverse effects
Exactly four days after the second dose of the Pfizer vaccine, I had SEVERE diarrhea for three days.; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 08Feb2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and medication received within two weeks of vaccination was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Feb2021, exactly four days after the second dose of the Pfizer vaccine, the patient had severe diarrhea for three days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event exactly four days after the second dose of the Pfizer vaccine, had severe diarrhea for three days was resolved on 14Feb2021.   No follow-up attempts are needed. No further information is expected.
soreness in left arm; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: EW0150) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PE" (unspecified if ongoing), notes: Other medical history: PE, Sarcoidosis; "Sarcoidosis" (unspecified if ongoing), notes: Other medical history: PE, Sarcoidosis. The patient took concomitant medications. Past drug history included: Codine, reaction(s): "Known allergies: codine", notes: Known allergies: codine. The following information was reported: HEADACHE (non-serious) with onset 14Apr2021 14:30, outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 15Apr2021, outcome "unknown", described as "soreness in left arm". Therapeutic measures were not taken as a result of headache, pain in extremity.  Additional Information: Facility type vaccine: Public Health Clinic/Veterans Administration facility. Other medication in two weeks as dietary supplements. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and had received dietary supplements within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
headache; red, slight swelling and hot to touch at vaccination site; vaccination site red; slight swelling at vaccination site; hot to touch at vaccination site; Itchy at vaccination site; vaccination site rash; Initial information was received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA241448 and 2020SA241537 (same reporter).  This case involves an adult patient (gender unspecified) who had headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash, when received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2008 via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.
pain and imflammation in right hand so bad cant move my fingers treating it with cold and hot packs and ibpofin
pt recvd vax; fever, intermittent & spiking up to 106; dec appetite p/ 7 days;
Patient was waiting for 15 minutes after the administration of the vaccine in our waiting area.  All of a sudden the patient turned red and began having trouble breathing and was very shaky. Pharmacist was made aware and immediately brought her into the restroom and administered an EpiPen into her right thigh.  The patient felt better right away.  She declined medical attention, but agreed to have a family member pick her up.  She was advised again to seek medical attention  after leaving drug store.
Fatigue began at 6pm. Fever, chills and headache began at 10pm.  Severe fatigue and headache for about 30 hours.
6 days after vaccine, developed a red, itchy bump on injection site arm. By day 7, the hive-like bumps spread to both arms, neck, stomach, and back. The hive-like bumps started to fade around day 8-9.
Fever of 102.9 a half hour after vaccine, dizzy when standing, rapid heart beat, nausea, cough, horrible headache to the point of tears
Patient with failure to thrive symptoms prior to 2nd dose, not eating, not taking medications.
Breakthrough covid-19 infection.  Fever, chills, cough, sneezing, shortness of breath, vomiting
Immediately after receiving varicella (VARIVAX) vaccine, child developed one hive (urticarial) surrounded by redness and swelling 1.5 cm x 3 cm. Cold pack applied. Waited in office 40 minutes. Hive resolved. No other symptoms. Heart and lungs asculated with stethoscope- within normal limits.
10/16/19: Patient received Influenza vaccine in left deltoid per IM injection (25G/ 1 " needle utilized) while in clinic 2 approx. 10:30am-later that evening patient reported to his local ER with increased arm pain-was provided 3 tabs Hydrocodone and released. Patient called and reported ER visit to clinic. PACT RN followed up with patient re: arm pain/triaged over phone, offered patient apt on 10/17-patient refused and stated he would wait until today (10/18) to come into clinic. Patient was seen in clinic on 10/18/19 assessed by PCP and Pact RN-distinct rash visible on arm, left arm appeared slightly bigger than right arm., patient cried out in pain when he tried to move arm. Pact provider sent patient to local ER for further evaluation of vaccine in the event patient required antibiotics .
fever; chills; This is a spontaneous report from a contactable consumer. This consumer (Caregiver) reported for a male patient (brother-in-law).  A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient he experienced fever and chills since Last night (28Jan2021) that lasted until today (29Jan2021). Reporter wanted to know whether it was normal to experience these side effects. The outcome of the events was unknown. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. No PQC involved.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This case was reported by a pharmacist and described the occurrence of a possible interferon alpha level increase in a subject of unspecified age and gender who was vaccinated with Hep B (manufacturer unspecified). Concurrent medical conditions included scleroderma, systemic sclerosis and Raynaud's Syndrome. On an unspecified date the subject received unspecified dose of Hep B (unknown). After vaccination with Hep B, the subject experienced an immediate and very severe worsening of Raynaud's Syndrome. This may have been attributed to an interferon alpha level increase. At the time of reporting the outcome of the events was unspecified. It was noted that this event occurred in two subjects. Demographics were not known. Linked case is A0902895A.
Information has been received from a physician concerning a 15 year old female who was vaccinated with her third dose of GARDASIL (route and site not reported).  In July 2008, the patient developed left arm pain and a depression of her skin at the injection after receiving her third dose of GARDASIL.  A skin biopsy was consistent with atrophoderma.  The patient's left arm pain and a depression of her skin at the injection site persisted.  Additional information has been requested.
Patient is experiencing Headache, Nausea, Hot and Cold chills. The first shot in the series caused Nausea and Vomiting, Hot and Cold chills. The second shot is all the same as the first except the headache is now added.
About 9hrs post immunization, I awoke with chills, muscle ache, headache, nausea. I had a large welt with redness in a diffuse area where the shot was given. It is still hot to the touch with redness three days post shot.
A report has been received from a health professional concerning a, subject of unknown gender, who received FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres. FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The nurse reported FLUMIST temp excursions over the course of several months (9 excursions in Sept 2015, 11 excursions in Oct 2015; both to 1 degree C. Admitted that FLUMIST had been administered to several patients during this time. The outcome of the event of FLUMIST stored below pi recc temp and administered to several patients was unknown. The report was considered to be non-serious by company physician.
Large erythematous rash just below injection site, approximately 5cmX5cm, area was raised and warm to the touch, treated with ice and ibuprofen.
Received Pfizer COVID vaccine on 1/13/2021 and 2/3/2021.  On 3/31 developed chills, body aches, headache, and sore throat.  Tested positive for COVID.
Multiple large bilateral kidney stones requiring surgical removal; pain began on date reported (on 2nd day after 2nd vaccine)
baby had high pitched shrill cry during the first 24 hours after vaccine administration.  consolable after tylenol but remained crying off and on with shrill cry.
Numbness in one of her legs/ I have numbness in one my leg; This is a spontaneous report from a contactable consumer (patient) through Medical Information.  A 46-year-old female patient received bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated she received her 1st dose of the Pfizer COVID 19 vaccine "3 weeks ago." She is scheduled to have her 2nd dose administered today, however states that she is unsure if the symptoms she is experiencing could be a side effect from the 1st dose. She states that the symptoms of numbness in one of her legs began shortly after the time she got her 1st vaccine. She is not sure if the two are related to one another or not but wanted to follow up and ask and see if numbness in the legs a potential side effect is and should she follow through with 2nd dose of COVID vaccination or be seen by HCP. She stated I got the first dose of the vaccine on 22May2021, this was Saturday. So, it's going to be 3 weeks in 2 days. So anyways I have this side effect and I am stepped in to see if this is a side effect of a vaccine because it started around the same time. The outcome of the event was reported as unknown.   Follow up attempts are needed; information about lot/batch number has been requested.
Information has been received from a health professional concerning a female with no past medical history and no known allergies who on 03/05/2001 was vaccinated with the first dose of variella vaccine. There was no illness at the time of vaccination. There was no concomitant medication. On 08/22/2001, the pt developed a rash with a cluster of blisters on the left thigh that spread down her left leg. The pt was afebrile. It was noted that on a scale of 1-10, the pt's pain was 1. There were no other systemic symptoms. On 08/24/2001, the pt was seen by a physician who examined the child and visually diagnosed herpes zoster. The pt was also seen on 08/29/2001. A culture was not taken and there was no direct fluorescent antibody done. The pt was on therapy with Zovirax. The pt did not have a history of chicken pox and had no known exposure to chicken pox. The pt did not developed a rash at the site of injection or elsewhere within 42 days of the vaccination. The pt recovered. Additional info has been requested.
Temp 101, lethargic, decreased appetite. Redness & swelling at injection site; pain Pt treated with AMOX (RA).
Student reports having slight fever 1 day after vaccine. Then redness, pain, and warmth at site of injection 3 days after injection.
Before receiving the vaccine, she was deteriorating, but relatives agreed to vaccinate her. Last week she began to have swallowing problems, she was not eating. They started with serum, supplements, and nasogastric.
mom reports that pt was fine day & evening of 14APR98-woke up @ 7AM 15APR;c/o stomach pains & by 8:15 was pale, lethargic w/watery diarrhea & vomiting;went to ER-cont w/ n/v, diarrhea x 1 1/2hr, temp low;
3.5cm indurated dark red. 6cm total - lighter pink surrounding area. Itchy.
Headache, chills, fever, congestion, cough, sore throat, loss of appetite, loss of taste and smell. Treated with acetaminophen and ibuprofen.
This spontaneous report as received from a company representative refers to a male patient HCP of unknown age.  ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced numbness and nerve pain on his hand, nerve pain on his hand and accidently got "needle stick". No treatment information was reported. The outcome of numbness and nerve pain on his hand, nerve pain on his hand and accidently got "needle stick" was reported as not recovered/not resolved. The relatedness for numbness and nerve pain on his hand, nerve pain on his hand and accidently got "needle stick" is unknown for ZOSTAVAX. No other information is available. Additional information has been requested.
I did have an elevated heart rate 10 hours after the vaccine and did have a breakthrough fever that went to 99.2 two days after. I did have body chills, a slight headache, and fatigue. As of now my symptoms have improved.  For the first dose, 10 Hours later I had experienced an increased heart rate, fever, and the day after Heart rate of 130, Fever of 101 and high fatigue. I did go to the emergency room the day after the vaccine, they did bloodwork that stated I did not have a heart attack. After leaving the ER I had a  Fever 99. 141/69 BP on 11/12/2021. Heart rate had gone back to 131 and a temperature of 102. 11/13/2021 Was instructed to take ibuprofen and Tylenol in 3 hour intervals. Temperature stabilized however I then had a severe headache. Felt fatigued and abnormal until Wednesday the following week.