chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bone densitometry: Bone density loss, (Bone density decreased).         The patient had received Booster dose of Moderna vaccine.  The patient had experienced Bone density loss. The reporter's causality for events of Bone density loss and Sick with Humira was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment medications were not provided.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a physician via a company representative referring to a teenage female patient. The patient's pertinent medical history and drug reactions/allergies were unknown. In approximately July 2012 (reported as "about 4 years ago") the patient was vaccinated with GARDASIL (dose, route, lot# and expiration date not reported). It was unknown if the patient had any concomitant medication. On an unknown date the patient developed type I diabetes after administration of GARDASIL. The patient had not recovered from the event. The causality between GARDASIL and the event was not provided. Upon internal review, the event of type I diabetes was considered to be medically significant. Additional information is not expected as the reporter did not wish further contact.
Eye redness, pain - one eye (left) - it feels like a neurological pain !! This is the second time I report this side effect  I received the third dose (booster) June 15, 2022 and I have the same side effect ( that i reported previously) but less  severe ( red eye, moderate pain on the upper lid).   I had the same side effect (1 eye) after the 2nd dose (Sep 2021) and I went to an ophthalmologist (was not convinced it is a side effect  - although I'm a pharmacist and I can tell with confidence that was a side effect).  The pain was so severe that I couldn't even go out.
A healthcare professional reported that a pt received Prevnar and experienced an unspecified reaction. No further information was available at the date of this report. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying information is provided.
Information has been received from a physician concerning a 30 year old female with no allergies who was vaccinated with a first and second dose of Varivax on 02-FEB-2007 and 06-MAR-2007. Three days after vaccination with the second dose, on 09-MAR-2007 the patient began to experience tingling and numbness. The patient was referred to a neurologist. An MRI of her brain was done which showed "demylenating plaques on the brain". The neurologist stated that patient "may have multiple sclerosis". The patient was asymptomatic of multiple sclerosis prior to vaccination with Varivax. There was no product quality complaint involved. Additional information has been requested.
Per patient report to writer: On 5/18/18, patient awoke at 2 AM with muscle cramp; went away-back to sleep. At 4 AM she awoke with shortness of breath (SOB), pain across left shoulder and down left arm. She took 800 mg ibuprofen with little relief, but SOB went away. At about 7:30 AM she experienced back pain, pain with deep breath inspiration; this moved to substernal pain. She soaked in tub for a while, SOB and pain with inspiration worsened. She went to ER at this time. Cardiac protocol completed with labs, ECG and CT of chest; dx of MI by about 1:00 PM; transferred to advanced cardiac care about 6:00 PM. Received advance care, Diagnosis perimyocarditis; discharged home 5/21/18 with medications.
Shoulder pain similar to impingement that's worsened over time. Pain is now constant.
Vaccine was administered 2/28/20, patient noticed redness and swelling developing 3/5/20 with no further spreading overnight through 3/6/20. Patient was advised to use ice and NSAIDs as well as try diphenhydramine to help control symptoms.
Patient given Pfizer COVID vaccine #2 at 0920 and at 0927 began to c/o hives and redness. Given Benadryl 25 mg PO. Began to improve, however at 0940 began to say she was having a feelin as if she had razor blades in her throat and began coughing. Given another Benadryl 25 mg PO and evaluated in ER, treated and released.
This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 50-year-old male subject who was vaccinated with influenza (unspecified), manufacturer unspecified). In October 1997, the subject received unspecified dose of influenza (unspecified) (unknown route, site of injection and batch number). In October 1997, 2 days after vaccination with influenza (unspecified), the subject experienced fatigue, chills and low-grade fevers. Two weeks after vaccination with influenza (unspecified), the subject was noted to have microscopic hematuria. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. The subject was diagnosed as having ANCA associated vasculitis (AAV) (type: cytoplasmic/proteinase 3) and granulomatosis with polyangiitis. Over the next 4 weeks after vaccination with influenza (unspecified), he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his finger nails, but the rest of his exam was unremarkable. This case was assessed as medically serious by GSK. The subject was treated with prednisone and cyclophosphamide. After achievement of remission of his vasculitis, he was switched to azathioprine for maintenance of remission. In October 2012, his renal function was stable. The temporal association of AAV to influenza vaccination suggests that the vaccine might serve as a trigger for development of AAV in predisposed individuals.
pt recv vax 25JAN97;the next day devel a local rxn consisting of site redness, swelling, hot to touch & about 4x5in in size;most of the upper arm was affected on the lateral side;last immun was over 10 yr ago;
Developed severe itching and rash on the scalp, face and neck around 15:00; Developed severe itching and rash on the scalp, face and neck around 15:00; This is a spontaneous report from a contactable consumer (Patient).  A 44-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in left arm on 18May2021 09:45 (at the age of 44-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Patient had no known allergies. The patient concomitant medication was not reported. Patient was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration on 27Apr2021 (at the age of 44-years-old) as DOSE 1, SINGLE for COVID-19 immunization and experienced No reaction on previous exposure to Vaccine. Patient took Ibuprofen 400 mg x 2 around 12:30 to prevent any fever. On 18May2021 15:00 after the second dose of vaccination, the patient experienced developed severe itching and rash on the scalp, face and neck around 15:00. Patient never had any side effects from Ibuprofen, other vaccinations or any other drugs. The patient did not received treatment for the adverse events. The outcome of events was not recovered.  Follow-up attempts completed. No further information is expected.
Syncope morning after injection at 9am - treated with rest and fluids  Fever of 102 12 hours after injection, lasted total of about 20 hours
Fatigued; Bad headaches, 5/6; booster; Muscle aches; Joint pain; achy; Bad headaches/Fatigued/Muscle aches/ Joint pain, can't get out of bed/was reported as worsened; can't get out of bed; This is a spontaneous report from a contactable consumer (Patient) via a Pfizer sponsored program. A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration in 2021 (Age at vaccination: 66 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation . Medical history was reported as None. Patients Medical History (including any illness at time of vaccination)? No. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 and dose 2, 2 months ago for covid-19 immunisation. The patient reported booster in 2021, bad headaches, 5/6 (headache) in Oct2021, fatigued on 03Oct2021, severe muscle aches, severe joint pain, achy, bad headaches/fatigued/muscle aches/ joint pain, can't get out of bed/was reported as worsened (condition aggravated), can't get out of bed (hard time getting out of bed) in 2021. The patient underwent lab tests and procedures which included magnetic resonance imaging: negative in 2021 Caller states he had an MRI done and it was negative, magnetic resonance imaging: normal on 25Oct2021. He wants some guidance, the doctors dont listen to him. Patient had Muscle aches, can't get out of bed, a week later after booster. He took Ibuprofen and Tylenol for the achiness, and it did help a little bit with his effects. He went to the doctor's office 2 or 3 times, his regular doctor and the doctor. The outcome of achy was unknown. The outcome of the rest of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Reason for Call  DIFFICULTY BREATHING and COVID-19 Vaccine The wife called initially. However, she was able to speak with pt directly Trying to get a nebulizer machine since Monday, pt is covid positive since 3/19/21 Nebulizer Machine at home broke on Saturday wants another machine Airway oxygen prescription was sent, and wrong information was given and was sent to store and also to pharmacy when needs to go to Airway Oxygen in  per wife Needed a neb machine for chronic asthma Pt took Symbicort inhaler at 0200 am Ventolin inhaler used as rescue only and states have not used it today Pt had johnson and johnson covid vaccine yesterday 3/31/2021 pt had chills, body aches, and fever No fever today was 98 while on the phone triaging pt Pt wants work note for yesterday, today, and tomorrow Pt not wanting to be seen in office today states are just going to sleep and be home and is already feeling better as compared to yesterday and last night after receiving the covid vaccine spoke with wife about airway oxygen prescription for nebulizer machine and pt's work excuse notes for yesterday, today, and tomorrow instructed the wife to call the office back in 2 hours if has not heard from PCP office
I started to feel aches almost immediately after the shot, which was about 6 pm. I also felt like my heart was racing and I couldn't breathe. There was a pounding under my collarbone. Anyway, I thought it was all psychosomatic and didn't say anything to the nurses. I woke up the next morning around 12 hours after the shot (6 am) with right arm pain that extended all the way down to my wrists and made my hand go numb. It was uncomfortable to lift my arms to the height of my desk and if I did, my hand would go numb anyway, so I could not work. I had aches that did not improve much with OTC painkillers, but they helped a bit. The aches were most "severe" in my ears, arms (both), back, and right under my ribcage. I also kept having the weird pounding under my collarbone. I had a fever, could not sleep, could not get comfortable, and was hungry, but could barely eat without getting "full." I did not have pain in my stomach, but more to the left of it. The next day (today), I feel fine, except the arm pain continues in my right arm down to my wrist. I still have some numbness in my hand when I lift it. And the lymph nodes under my arm are very swollen.
Information has been received from a nurse concerning a 14 year old female who on 28-JUL-2009 was vaccinated subcutaneously with the second 0.5mL dose of VARIVAX (Merck) (LOT # 664620/0797Y). On an unspecified date, the patient experienced local reaction at the injection site. There was no lab diagnostics performed. The patient was not recovered at the time of this report. Follow-up information has been received from the nurse. The patient was 22 years old (previous reported as 14). She has recovered on an unspecified date. Follow-up information has been received from the registered nurse concerning the 22 year old female patient who on 28-JUL-2009 was vaccinated subcutaneously with the third (previous reported as second) 0.5mL dose of VARIVAX (Merck) (LOT # 664620/0797Y). On 29-JUL-2009, the patient experienced local injection site irritation described as itchy and swollen. On 30-JUL-2009, 24 hours later, the patient experienced a temperature of 100 and a larger area of swelling. The patient was treated with ice and symptomatic treatment. On an unknown date the patient recovered. A lot check has been initiated. This is one of several reports from the same source. Additional information has been requested.
Hives appeared the next morning 7/27/2022, responded to benadryl.  Hives recurred  7/28/2022 a little more intensely, responded to benadryl and famotidine.  No trouble breathing/ talking.
Patient's face became red and inflamed 4/30 in the AM. Symptoms have mostly resolved on 5/2.
suspected vaccination failure; Received the vaccine, both doses, in August and October 2019/ I had shingles on my face; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included immunosuppressive drugs. Concurrent medical conditions included lymphoproliferative disorder (had iatrogenic immunodeficiency-associated lymphoproliferative disorders (B-cell type) caused by immunosuppressive drugs).   In October 2019, the patient received the 2nd dose of Shingrix. In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, more than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 3-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient received the Shingrix vaccine, both doses, in August and October 2019. Recently, the patient had shingles on face. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles was not provided.
This spontaneous report as received from a medical assistant refers to two patients of unknown demographics. Information about patients' medical histories were not provided. On an unknown date, the patients were inadvertently vaccinated with doses of MMR II (lot # K000255, expiration date: 08-JAN-2016) (therapy type was not specified) which had been improperly stored. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Gillian Barre Syndrome, emergency room visit Sept 8th, sent home and then hospitalized Sept 10th  until Sept 22nd
he is in the hospital with Covid pneumonia; he is in the hospital with Covid pneumonia; time did faint, passed out cold the day after his 2nd vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 64- year-old male patient 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 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient received first dose of 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. The patient experienced covid pneumonia leading to hospitalization on an unspecified date, he is in the hospital with covid pneumonia causing drug ineffective on an unspecified date. The caller states that her step father who is the patient did faint, passed out cold the day after his 2nd dose of vaccine, he messed up his face and arm and busted his whole self up and now he is in the hospital with Covid pneumonia causing loss of consciousness on an unspecified date. Outcome of events covid-19 pneumonia and loss of consciousness was recovered on an unspecified date. Outcome of pneumonia causing drug ineffective was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Mom called and stated that pt's injection site is red and swollen about the size of an egg. Instructed to give children's Benadryl and apply ice. If symtoms not resolved or worsen, come in.
I received my second Pfizer booster for COVID-19 on 4/14/2022. About two weeks later, on or about 5/1/2022, I noticed that both of my wrists and both of my hands became swollen. My wrists were also quite sore. My fingers and my hands both became stiff and sore. After dealing with it for about a month or a month and a half, I went to my PCP. My PCP gave me a 7-day supply of prednisone. While I took the prednisone, the swelling went down dramatically, and the tenderness was reduced, though not completely eliminated (especially in the wrists). Within approximately about 10 days or so after I completed the round of prednisone, the swelling and tenderness returned. I went back to the PCP about a week or so afterwards, and I was given another 7-day supply of prednisone. Once again, the swelling was reduced, and though the tenderness subsided somewhat, it wasn't completely eliminated. Gradually, both hands became swollen and tender again after I finished this round, with my right hand and wrist being more swollen and tender than the left. I dealt with this for a while, plus increased swelling in my right knee, with which I had had issues prior to the injections. I finally went to an orthopedist to see if the swelling in my wrists and hands could possibly be related to the increased swelling in the right knee. He told me that I had pseudogout. The orthopedist prescribed a 2-milligram a day course of prednisone for 30 days. My PCP referred me to a rheumatologist, whom I am due to see on 8/24/2022. At the time of this writing, the swelling has gone down substantially in both hands. The tenderness in the left wrist has gone down about 75%, while the tenderness in the right wrist has only gone down about 50-60%. The swelling in the left wrist is almost completely gone, but the although the swelling in the right wrist has gone down, it is still noticeably present. The tenderness in the right wrist is still greater than that in the left wrist. I have been taking a couple of 500-mg Tylenol tablets a day, and I think that they probably help some.
Moderna COVID-19 Vaccine EUA  Persistent joint pain throughout entire body, started about 18 hours after vaccination and did not fully subside until about 60 hours after vaccination. Pain was fully managed with ibuprofen, 400 mg was taken every 8 hours.
Admitted with syncope, related to dizziness for one week prior. Prior COVID-19 testing was POSITIVE in February 2022
This spontaneous report was received from a pharmacist concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On 05-NOV-2015, the patient was inadvertently vaccinated with an expired dose of VARIVAX (Merck) (Lot # J012380; expiration date 03-OCT-2015) (dose and route not provided). This was supported. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a Registered Nurse concerning a female patient of unknown age who in August 2011 was vaccinated with a 0.5 ml dose of GARDASIL, IM (Lot # not reported) and on 05-OCT-2012 was vaccinated with a second 0.5 ml dose of GARDASIL, IM (Lot # not reported). No adverse effect was reported. Additional information has been requested.
This case was reported by a pharmacist via claims management company and described the occurrence of adverse event (s) in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 October 2013 the subject received a dose of FLULAVAL (unknown). On an unspecified date in 2013, within months of vaccination with FLULAVAL, the subject experienced adverse event (s). At the time of reporting the outcome of the event (s) was unspecified.
8am on 4/4 - extreme chills, muscle and joint aches, fatigue, fever, skin feels sensitive (small normal touches hurt), back area between shoulder blades burns and hurts but no rash  By 1pm on 4/4 - now hot, still muscle and joint aches, fatigue, and fever, back burning and skin sensitivity continue - took 2 aleeve  By 8pm on 4/4 - felt better, no chills or feeling hot, less joint aches, still muscle aches, back burning and skin sensitivity continue  7am on 4/5 - Felt much better, only slight muscle aches , back burning and skin sensitivity continued - took one aleeve before work  6pm on 4/5 - still feeling better, slight muscle and joint aches. Skin sensativity is much less. Back burning continues.  Injection Site: for the first shot, I had no injection site redness or swelling. After the second dose (1:30pm on 4/3), the morning of 4/4 I noticed my arm was extremely swollen, hard, and hot at the injection site. About the size of a fist in terms of the amount of area and raised enough to be visible. Felt much hotter than surrounding skin and extremely red. Hurts to the touch.  By 6am on 4/5 red area had grown slightly larger, than night before, still hot, hard/swollen, and painful to the touch. By 6pm on 4/5 red area has grown slightly again larger than this morning, still hot, hard/swollen, and painful to the touch. Waiting another 24 before seeking medical advice.
1120 injection. 1125extreme itching at injection site, 1127 itching down arm of injection site , 1136throat tightness, 'sticky tongue' , 1137difficulty speaking and mentally altered, difficulty breathing       1138 Benadry 50 mg IM  1139 Dexamethasone 10 mg IM  1140 EPI Pen 0.3 mg IM   1141 Oxygen 6 L via face mask added  responding to commands , assessed by PA  1145 Patient able to speak but speech slurred . Paramedics arrived transported patient to nearby Medical Center
Redness, Swelling at Injection Site. Was in ER 8/29/16 and dx with Cellulitis. Tx with Bactrim BID x 10 days.