chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: En6208), in left arm, on 02Apr2021 as dose 2, single (Lot number: Er8737), in right arm and on 10Nov2021 as dose 3 (booster), single (Lot number: Fj1611) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "migraine" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL XR; FAMOTIDINE; VITAMIN D3. Past drug history included: Azithromycin, reaction(s): "Known allergies: Azithromycin". The following information was reported: VACCINATION FAILURE (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; (21Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient started COVID 19 treatment with Paxlovid from 12Aug2022 to 17Aug2022. And had rebound since 20Aug2022, symptoms began again 3 days after last dose, tested positive again 4 days after last dose, during treatment, bad taste in mouth.
p/vax pt lt arm started hurting/in 30" swelling, redness, inc skin temp;unable to sleep last noc secondary to pain;
Patient developed fever within 24 hours of receiving vaccines, and continued daily until seen 3 days after in the ED. She'd received 2 vaccines in the right upper thigh and 2 in the left upper thigh (parent unsure which were given and where). On her left thigh, large area of redness covering most of the thigh that would increase and decrease in severity throughout the day.  Patient also noted pain, but ambulated normally, eating and drinking normally. Lesion was not raised. It was warm to touch. Mom tried tylenol, ibuprofen, and bathing in cool water at home, which only helped a little.  Discharged patient home with 5 day course of cephalexin 20 mg/kg TID.
The next day my arm was sore as instructed. The soreness eventually went away, but then there was a tenderness at the injection sight. That tenderness later included pain. The pain has been off and on since, but the tenderness is always there. More recently the pain has become more severe with loss of strength above the elbow. Sometimes the pain is debilitating. Unable to lift my arm to the steering wheel when driving. Also makes lifting very difficult. These episodes come and go, but are becoming more frequent.
Pt called to say she has a light pink rash over body. A little itchy. Says it's hard to see. I told her to take BENADRYL and use hydrocortisone. She was ok. Called MD to let office know.
DOCTOR ORDER MMR , MA ADMINISTER MMR/V DIDNT VERIFY HER 7 RIGHTS
Vaccines given 8/28/06 pt developed severe pain and some numbness 3 days later arm was non tender no local RX on exam I thought she may have brachial neuritis SX resolved over next 2 weeks.
Felt dizzy after receiving her vaccination, has a hx of this dizzyness for the past 20 years, never been diagnosed with a cause.
Soon after vaccination, pt developed generalized muscle aches and SOB along with low grade fevers.  Pt was admitted to hospital on 3/13/2021 for fever, diffuse myalgia, arthritis, rash, tachycardia, and dsyphagia  and got diagnosed with likely serum sickness like reaction after COVID-19 vaccination after all the work up for autoimmune etiology such as vasculitis or SLE came back negative.  she's currently getting  IV solumedrol 50mg BID since 3/17 (switched from prednisone 40mg daily) with a good response.
Red dots/slightly raised bumps lightly began on face, chest, back & legs on 1/21. By 7:00 AM 1/22/12 the rash was all over - hands, feet, earlobes, as well as other areas listed & was very pronounced.
4x7cm Redness, warmth and swelling of injection site 2days with vaccine. Flu-like symptoms - cough, chills, HA.
vomiting; nausea; super tired; dizzy; right arm itchy; terrible headache; fever; super high energy after the vaccination; foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird; arm hot to touch /feeling boiling hot; sleepy; right arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird), FEELING HOT (arm hot to touch /feeling boiling hot), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (right arm swollen) and DIZZINESS (dizzy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESCITALOPRAM OXALATE (LEXAPRO) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 29-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced FEELING ABNORMAL (foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird), FEELING HOT (arm hot to touch /feeling boiling hot), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (right arm swollen), PRURITUS (right arm itchy), HEADACHE (terrible headache), PYREXIA (fever) and THERAPEUTIC RESPONSE UNEXPECTED (super high energy after the vaccination). On 30-Sep-2021, the patient experienced DIZZINESS (dizzy) and FATIGUE (super tired). On 02-Oct-2021, the patient experienced VOMITING (vomiting) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird), FEELING HOT (arm hot to touch /feeling boiling hot), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (right arm swollen), DIZZINESS (dizzy), PRURITUS (right arm itchy), HEADACHE (terrible headache), VOMITING (vomiting), NAUSEA (nausea), FATIGUE (super tired), PYREXIA (fever) and THERAPEUTIC RESPONSE UNEXPECTED (super high energy after the vaccination) outcome was unknown.            This case was linked to MOD-2021-343986, MOD-2021-343765 .
I work as a nurse, I was at work when I started having palpitations and felt lightheaded. I was unable to complete my shift. I went to the ER. They were unable to bring my heart and blood pressure down. I was admitted. Hospital was unable to diagnosis me. I then went to Dr of cardiology.  I was diagnosed with POTS which has been debilitating for me. i missed several days of work and still continue to suffer from it. I was placed on steriods which then caused severe esophagitis.  I was told that was the only treatment option for me. I still have POTS and can now no longer be treated. I also suffer from tinnitus and abnormal periods now. I have not reported this sooner, because I was told several times by my PCP and cardiologist, that there was no link between the COVID vaccine and POTS.  I have since then  read the doccuments Pfizer was mandated to release, which now shows POTS as an adverse reaction.  It has not only impacted my physical well being but I am also at risk to lose my job. The state has mandated the booster for healthcare workers. Despite all of the research I have to support my claims, no physician will sign my exemption form. Overall I would say that it has impacted not only my physical health ,but my mental health. I am being forced to choose between risking my health further or keeping a job that I love.
Patient given expired vaccine. Vacccine expired 3 day earlier. Report made, parent notified.
Pt states day after noticed large red swollen area at site of injection - lasted 4 days. No systemic symptoms. Induration the size of medium tomato.
Not sure if this is due to the vaccine. Soon after I had arm pain. I felt like something was in my throat, like I couldn't  swallow.  I seen my Dr. and an ENT they believe its a reflux issue, but I did not have this issue before the vaccine. I had soars in my mouth and never had that before, my gingiva was inflamed.  I also got shingles about 43 days after the second dose.
Within 30 minutes the patient had numbness and tingling in the left arm down to her hand.  This feeling progressed to numbness and tingling up into the left side of her face.  No redness or swelling anywhere.  These paresthesias have persisted for 1 week so far.
My first on 03/19/2021 went smoothly, just sore area of shot. They had me wait 15 minutes after just in case adverse reaction. On 04/09/2021 came back for second round. The nurse gave me my 2nd shot and said they don?t make patients wait after injections, I left the facility and by the time I reached my car my tongue had swollen up, went home and later that night my husband and kids asked what was wrong with my eyes - both my eyes were bloodshot red and swollen. On 4/10, my left eye was better but not my right. I have had brain fog, not being able to remember short memories all weekend. I plan to call my doctor in the morning.  As a woman, I felt morally obligated to share my side effects.
Patient accidentally received adult dose of Pfizer covid vaccine. Patient is only 10 years old and only pediatric Pfizer is approved for her age. Followed up with patient for 3 days. Mother reported no adverse events other than sore arm. Pediatrician has been notified.
severe aches,high grade fever,chills,sweating  over the course of 48 hours after which symptoms subsided. Also pain and numbness in left arm deltoid where vaccine administered "DEAD ARM"...Symptoms subsided after @48hours when first noticed but a residual "grogginess"
Warm red swelling on arm appearing to be from Pneumo shot.  Swelling migrated to cheek on left side of face
her legs have broken out in hives that are "very, very itchy; her legs have broken out in hives that are "very, very itchy/ as soon as she touches her skin, it starts itching; "bruised up" from scratching; pimples on her legs are "very, very small" and "very itchy."; as if the rash is underneath her skin; This is a spontaneous report from a contactable consumer (patient) reported that. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration was not reported) via an unspecified route of administration on 16Apr2021 as a single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. Patient experience side effects that she calls very odd. Caller reports that her legs have broken out in hives that are very, very itchy. She states that this started about 5 hours after her first dose and has been ongoing for 9 days in total. She reports that she was bruised up from scratching. Caller states that the pimples on her legs are very, very small and very itchy. She states that it looks as if the rash was underneath her skin and states she cannot feel it but can see it, and states that as soon as she touches her skin, it starts itching. Caller would like to know if it was safe for her to get her second dose of the vaccine because of these side effects. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
At 50 hours post-vaccine, nausea began; vomited at 52 hours; weakness and nausea remained for an additional 2 hours following vomiting; then for the next 6 hours, experienced chills and coldness in extremities to the point of pain; vomited again at 70 hours post-vaccine, leading to the onset of a severe, excruciating migraine; migraine lasted for 45 hours, accompanied by 14 hours of tears continuously leaking from eyes & nasal congestion; by the end of 5 days post-vaccine, all symptoms had subsided. No treatments were administered outside of ibuprofen (which seemed to have no effect) and a heating pad.
arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (086396). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 80 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "thyroid medicine" (unspecified if ongoing). The patient took concomitant medications.The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a 58 year old female patient, who was reporting on herself. The patient's medical history included: celiac disease. The patient had a drug reactions or allergies to sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine (SULFA).  On 23-JAN-2017, the patient was vaccinated with one dose of ZOSTAVAX subcutaneously to prevent shingles (dose, site of administration, lot # and expiration date were not reported). Concomitant therapies included tetanus toxoid shot. On an unknown date in 2017 (reported as shortly after receiving ZOSTAVAX), the patient developed a big red dot on an unspecified arm. The red dot lasted on her arm for about a week. Approximately in the middle of February 2017, the patient lost her hearing. The patient sought medical attention by seeing an unspecified physician, who prescribed her an oral prednisone treat the event. The patient said that it helped but her hearing did not fully return. Then the unspecified physician injected two unspecified topical steroids into her ear drums. The patient stated that her hearing improved but she still could not hear as well as she did before she received ZOSTAVAX. Another physician stated to her that she had some form of hearing lost in both ears. On an unknown date in 2017, the patient had an unspecified hearing test performed, but the results were not reported. The outcome of hearing loss bilateral was reported as recovering. The outcome of big red dot on an unspecified arm was considered resolved, on an unknown date in 2017. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the event of hearing loss bilateral was considered to be medically significant. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of injection site injury in a 58-year-old male patient who received FLUARIX. Concomitant products included CRESTOR. In November 2014, the patient received FLUARIX (intramuscular). In November 2014, less than a month after receiving FLUARIX, the patient experienced injection site injury, injection site inflammation, muscle weakness upper limb and muscle pain. The patient was treated with NAPROSYN. On an unknown date, the outcome of the injection site injury, injection site inflammation, muscle weakness upper limb and muscle pain were recovering/resolving. The reporter considered the injection site injury, injection site inflammation, muscle weakness upper limb and muscle pain to be almost certainly related to FLUARIX. Additional details provided as follows: The patient reported that he now knows that since receiving FLUARIX he has developed a chronic problem with his left deltoid. He clarified this problem as an injury. He often lifts weights vigorously and the FLUARIX has caused him not to be able to lift like he normally can. The injured area was inflamed and it has been hurting. The patient in particular has problem lifting weights that involves overhead movements. He has been seeing a physical therapist at least three times a week, has been self-medicating with NAPROSYN, and has been stretching. It does now seem better since beginning physical therapy. They have told him that the injury was with the middle deltoid tendon and a little bit of the interior. The reporting physician was wondering if there was an alternative route of administration because he does not plan on receiving in the deltoid again.
Began experiencing some minor bleeding. Upon meeting with nurse-midwife the next week (11/12/2009) an ultrasound was conducted and a "missed" miscarriage was estimated to have occurred a week earlier around the time of vaccination.
FLUARIX vaccine 10/7. Presented to ER 10/9 with angioedema.
A few minutes after receiving the vaccine patient started shaking and appeared to have difficulty breathing. This happened just a few minutes after saying she wanted to drive her car in a tree.
Initial report was received on 18 November 2008 from a health care professional. A 67-year-old male patient with a history of grass, mold and shellfish allergies, had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009, lot number U2849AC on 14 November 2008 and 30 minutes later, he developed weakness, nausea and vomiting which persisted at the time of the report. The patient was scheduled to be evaluated by their physician on 18 November 2008. At the time of the report, the patient had not recovered from the event. Follow-up information received on 08 December 2008 from a nurse. Per the reporter, their staff spoke with the patient on 24 November 2008 and he was continuing to feel disoriented. The patient went to the emergency room (date not provided) and reported "no organ damage." The patient reported he had lost 25 pounds since 14 November 2008. He also reported a rash on his elbow below the injection site. The patient is currently on a bland diet and at home. The reporter stated "contact patient for additional information." Per this new information, this case was upgraded to serious. The reporter for this case is the same as case number 2008-03659. Documents held by sender: None.
tested positive for Covid-19 the morning of 5/23/22; tested positive for Covid-19 the morning of 5/23/22; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9264), in right arm, on 25Feb2021 as dose 2, single (Lot number: EN6203), in right arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A), in right arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BUPROPION HCL XL, start date: 01Jan2022; ROSUVASTATIN, start date: 01Jan2022, stop date: 23May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "recovering" and all described as "tested positive for Covid-19 the morning of 5/23/22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive; (29May2022) Negative; (02Jun2022) positive; (04Jun2022) Negative; (06Jun2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks. Pfizer Paxlovid for COVID 19 Treatment; Treatment start date: 23May2022; Treatment stop date: 28May2022. Bupropion HCL XL 300mg, started on 01Jan2022. Rosuvastatin brand from torrent started on 01Jan2022 stopped on 23May2022. I tested positive for Covid-19 the morning of 23May2022. I called my doctor and he prescribed Paxlovid. I started taking that medication the evening of 23May and finished the morning of 28May. Tested negative for Covid on 29May. Continued to wear mask per CDC through 02Jun2022. But, tested positive for Covid on 02Jun2022 and again on 23Jun. Tested negative for Covid on 04Jun2022 and again on 06Jun2022.
Presented the same as my salicylate reactions, headache, claminess, fatigue, upset stomach, somnolence. I fell asleep twice. I am wondering if it contains salicylate.
Patient is complaining of an injection site reaction.  She said her arm is warm to touch, red, and tender.  She said the redness was wrapping around her bicep.  I advised to watch and wait.  If it becomes larger than it is tonight or becomes painful, to seek medical attention.
Long arm left shoulder atrophy, had reaction on way home from receiving vax. Mother states the pt had polio vax. Partial sacralization of the right aspect of the L5 vertebral Body.  Mild facet sclerosis as well. Normal shoulder other than probable Hill-Sach's defect in the left humerus. The annual follow up states, "All symptoms described previously present."
itchy; Lost weight; Pain in feet, buttocks; Pain in feet, buttocks; Lose his balance when he stands up; Rash; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: 3014SA) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot Number / Expiry Date: 19EJ1686/ Mar2021), administration date: 15Jan2021, when the patient was 81-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Lot Number / Expiry Date: 19623/ unknown), administration date: 05Feb2021, when the patient was 81-year-old, for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset Dec2021, outcome "recovering"; BALANCE DISORDER (disability, medically significant) with onset Jan2022, outcome "not recovered", described as "Lose his balance when he stands up"; WEIGHT DECREASED (disability) with onset Jan2022, outcome "not recovered", described as "Lost weight"; PAIN IN EXTREMITY (disability), MUSCULOSKELETAL PAIN (disability) all with onset Jan2022, outcome "unknown" and all described as "Pain in feet, buttocks"; PRURITUS (non-serious), outcome "unknown", described as "itchy". The events "rash" and "itchy" required physician office visit. Therapeutic measures were taken as a result of rash.  Clinical course: Patient states he got his third dose, clarified as first booster and had issues. States in December, he got a rash: armpits, neck, shoulder, down his leg, it was streaky and itchy. States his dermatologist said it was due to the vaccine. Patient lost weight: fat off feet, buttocks, chest, lost 12 pounds, pain in feet, bone on bone. He loses his balance when he stands up. The patient will be having an MRI on 19Sep2022. Vaccination Facility Type was reported as pharmacy. Prior vaccinations within 4 weeks were reported as none. Additional vaccines administered on same date of the Pfizer Suspect was reported as none.  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 reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   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.
I developed scleritis/episcleritis of my eye. I needed topical steroid drops and oral ibuprofen.