chrisvoncsefalvay/vaers-outcomes huggingface dataset:
his whole entire body broke out with welts/They were like red welts all over his whole body; the dermatologist said it was psoriasis; all over itching; he was miserable; This is a spontaneous report received from a contactable consumer (patient's daughter). A 85-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6200, expiry date: unknown), via an unspecified route of administration on arm left on 18Feb2021 (age at vaccination: 84 years) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications included Levothyroxine taken for thyroid removed (Thyroidectomy) from an unknown date. The past drug event included Glucosamine taken for Joint stuff(He might take glucosamine for joint stuff but he is in better shape than her). Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as no. Adverse events following prior vaccinations was reported as none. Family Medical History Relevant to Adverse event was reported as none.  Patient's Medical History (including any illness at time of vaccination) was reported as none. Prior Vaccinations (within 4 weeks) was reported as no.The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9262), dose 1 via an unspecified route of administration on left arm on 28Jan2021 (at age of 84 years) as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date in Mar2021, the patient experienced his whole entire body broke out with welts/They were like red welts all over his whole body It was gradual, over the whole body, it was the chest, then to the legs, arms and back, the dermatologist said it was psoriasis, all over itching, to the point of torture he was miserable. It was reported that After the second dose, his whole entire body broke out with welts. They say it is psoriasis all over. It is all over itching, to the point of torture, he was miserable. They were like red welts all over his whole body and the dermatologist said it was psoriasis, and he has never has psoriasis in his life. It was gradual, over the whole body, it was the chest, then to the legs, arms and back. Because it happened back in Mar2021, she does not really remember how it all evolved. On Easter, when sitting out in the sun, all of a sudden, his legs got three times worse. That was in Apr2021 and she thinks it was the first week in Apr2021. It started in Mar2021, about a week or so after the second shot. He is still experiencing this all now but has made tremendous progress. It has taken months of treatment and research. At the beginning of Mar2021, the symptoms started then they progressed and got horrible by Apr2021. His primary care doctor did say it was the vaccine. The event broke out in welts and was itching resulted in physician office visit. The outcome of events was resolving.  Follow-up (09Sep2021): Follow-up attempts are completed. No further information is expected.
Discharge Provider: MD Primary Care Provider:  Admission Date: 2/25/2023 Discharge Date: Mar 2, 2023  PRESENTING PROBLEM: NSTEMI (non-ST elevated myocardial infarction) (HCC) [I21.4]   HOSPITAL COURSE: 89 y.o. female with h/o COPD on 2L at baseline, OSA, and HFpEF who presented 2/25/2023 to ED for malaise, fatigue, shortness of breath, and cough, no chest pain. Found to have elevated troponin and sepsis likely 2/2 to COVID Pneumonia.  Cardiology consulted, TTE obtained with WMA concerning for atypical stress CMP with akinesis of the mid to distal anteroseptal and inferoseptal segments with preserved Apex wall motion. EF 26% previously 60-65%. Patient completed 48hrs of heparin drip. Upon discussion with cardiology she elected for a more conservative approach and was started on GDMT including metoprolol, spironolactone and Entresto.  Plan was to proceed with a CMR and initiate dual anti-platelet therapy for year if there was  any evidence of subendocardial infarct on the CMR.  However repeat echocardiogram on the day of the planned CMR revealed left ventricular ejection fraction preserved at 59% with minor regional variation in the wall motion.  Cardiology then deferred CMR as recovery of patient's cardiac function further confirms diagnosis of mid cavity variant stress-induced cardiomyopathy.  Recommendations were made discontinue spironolactone and Entresto and continue your patient's beta blocker metoprolol. From a cardiology standpoint patient was safe for discharge and is to follow-up in the outpatient setting with Cardiology.  Furthermore the pertains to patient's COVID pneumonia she completed a course of remdesivir, azithromycin, is to finish complete course of Decadron in the outpatient setting for 4 more days.  Patient also received IV iron in the setting of iron deficiency anemia and ongoing cardiomyopathy.  An incidental finding of thyroid nodule was noted on patient's CTA and she is to follow-up in the outpatient setting with primary care provider.  Patient discharged in stable condition
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received a single dose of TRUMENBA in the left arm, a single dose of MCV4 (manufacturer unknown) in the left arm and a single dose of HPV9 (manufacturer unknown) in the right arm, all 06Nov2015. Medical history and concomitant medications were not reported. The patient complained later on 06Nov2015 (Friday) that she had a swelling at the base of her shoulder and she felt sick. Over the weekend on Saturday and Sunday (07Nov2015 and 08Nov2015), the patient had fevers on and off. She took ibuprofen (manufacturer unknown) and she was presented to the office on 07Nov2015 and her shoulder looked red and it was hot to touch, according to the nurse. The patient continued to complain of sharp pain and tenderness from the shoulder to the upper neck. The patient recovered from fevers. The outcome of all over events was unknown. The doctors did not know but they suspect that all these side effects were related to the vaccines. They did not know if it was the combination of the vaccines or a single vaccine. Follow-up (07JAN2016): Follow-up attempts are completed. No further information is expected.
Initial misuse report received from a pharmacist on 08 November 2013. The patient had received 2 doses of FLUZONE HD. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
2/4/05 t/c to mother of client, client was given Ibuprofen in ER and fever broke that night. Mother explained that Dr told her his body did not tolerate a shot (unk which one). Matter states client is fine now.
literally can't do any movement; Unable to sleep; Muscle spasm shoulder and left region of his back; sweating; bad neck stiffness; joint pain(left wrist, left elbow, sleft houlders,left  rotated cuff); Throbbing pain on his left arm; chills; very fatigue, when he stand to do something for 5-8 minutes, it's like he ran a marathon; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (literally can't do any movement), INSOMNIA (Unable to sleep), MUSCLE SPASMS (Muscle spasm shoulder and left region of his back), HYPERHIDROSIS (sweating) and MUSCULOSKELETAL STIFFNESS (bad neck stiffness) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced HYPOKINESIA (literally can't do any movement), INSOMNIA (Unable to sleep), MUSCLE SPASMS (Muscle spasm shoulder and left region of his back), HYPERHIDROSIS (sweating), MUSCULOSKELETAL STIFFNESS (bad neck stiffness), ARTHRALGIA (joint pain(left wrist, left elbow, sleft houlders,left  rotated cuff)), MYALGIA (Throbbing pain on his left arm), CHILLS (chills) and FATIGUE (very fatigue, when he stand to do something for 5-8 minutes, it's like he ran a marathon). The patient was treated with METAXALONE (FLEXURA) ongoing since an unknown date at an unspecified dose and frequency; NAPROXEN ongoing since an unknown date at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) ongoing since an unknown date at an unspecified dose and frequency and METHYLPREDNISOLONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (literally can't do any movement), INSOMNIA (Unable to sleep), MUSCLE SPASMS (Muscle spasm shoulder and left region of his back), HYPERHIDROSIS (sweating), MUSCULOSKELETAL STIFFNESS (bad neck stiffness), ARTHRALGIA (joint pain(left wrist, left elbow, sleft houlders,left  rotated cuff)), MYALGIA (Throbbing pain on his left arm), CHILLS (chills) and FATIGUE (very fatigue, when he stand to do something for 5-8 minutes, it's like he ran a marathon) outcome was unknown.            Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant Follow up; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Fever of 103 for 3-4 days. Patient received baby Motrin which helped ease fever but it would go back up if he didn't receive more Motrin every 6-8 hours. He also got red, hard lumps on both legs - redness went away within 1-2 weeks, but lumps lasted 5 weeks.
This case was reported by a physician via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 61 days after receiving SHINGRIX, the patient experienced shingles, rash, jaw pain, tongue pain, blister and ear pain. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles, rash, jaw pain, tongue pain, blister and ear pain were unknown. It was unknown if the reporter considered the shingles, rash, jaw pain, tongue pain, blister and ear pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The healthcare professional reported that, the patient developed shingles about 2 months after receiving the SHINGRIX vaccine. The patient developed rash on eyes, blisters, pain in the ear canal, jaw, and the lateral side of the tongue.  The patient was seen in the emergency room (ER) and was diagnosed with a mild case of shingles. The patient was prescribed with antiviral.
Patient experienced fever over 100.0, nausea, body aches, headache, joint aches - quite a lot of them.
Information has been received from a pharmacist, referring to one unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-JAN-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # L023594 with expiration date on 26-JUN-2017 (anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported.
Pt received a 2nd dose of Shingrix too early, he was supposed to get 2nd dose of Twinrix
Measles - Information has been received from a company representative concerning her niece, who was vaccinated with mealses virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second  generation at one year of age.  subsequently, the patient was later diagnosed with a mild case of measles and is doing fine.  Additional information has been requested.
SCIATICA PAIN (BACK AND LEG PAIN, CAN'T WALK AND STAND); CAN'T SLEEP WITHOUT PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sciatica pain (back and leg pain, can't walk and stand), and can't sleep without pain. Treatment medications (dates unspecified) included: tramadol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sciatica pain (back and leg pain, can't walk and stand), and can't sleep without pain. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Fever Muscle aches Chest pains Shortness of breath Cold sweats Heart palpitations Dizziness Shaking uncontrollably Left arm pain Nauseous
Sudden migraine leading to fatigue and all-over muscle soreness which became excruciating and combined with rapid felt temperature fluctuations despite no fever being recorded. Symptoms seemed to die out in a few hours, then came back full force through that night, keeping me awake and in agony for several hours
client complained of dizziness and headache after receiving 1st dose Moderna. Client had already completed 30 min observation, had walked outside to vehicle, felt dizzy and returned back to EMT station. EMT took vitals at 1635: blood pressure 148/104, pulse 74, oxygen 100%. RN and PHN joined EMTs. Blood pressure rechecked to confirm first value: 148/104. Per client had just had coffee,  lunch and no hydration(water) all day. Per client history of asthma 10years ago, no medications, no known allergies. Vitals 1645: blood pressure 141/91, pulse 66, oxygen 99%. Per client feeling nauseous and blurry vision. EMT gave emesis bag and water. Vitals 1650: blood pressure 138/87, pulse 62, oxygen 100%. Client stated nausea resolved. At 1653 client stated headache worsened. At 1700 client stated vision improving. Vitals: blood pressure 138/90, pulse 75, oxygen 100%. Per client all symptoms had resolved. Client left facility with steady gait at 1735 after completing 1hr observation. At 1746 client returned to EMT station, stated once he began to drive he felt nauseous again. Vitals at 1750: blood pressure 148/90, pulse 65, oxygen 98%. Vitals at 1756: blood pressure 129/92, pulse 70, oxygen 98%. Per client nausea about the same. Vitals 1800: blood pressure 133/95, pulse 64, oxygen 98%. Per client nausea slightly improved, light headed, and slight vision changes per client. RN Thong offered client paramedics for further assessment, client denied, would like to stay longer in observation. Vitals at 1809: blood pressure 140/92, oxygen 72, oxygen 99%. Per client feeling hungry, still nauseous. 1820 vitals: blood pressure 136/98, pulse 66, oxygen 96%. Nausea and vision improving. 1831 vitals: blood pressure 134/87, pulse 69, oxygen 98%. Per client vision same, nausea improving. Client had family member come and pick him up. RN  advised client to follow up with provider regarding reaction. ER precautions also given. Client left facility with steady gait at 1840.
Patient came to the Pharmacy for his second dose on 6-17-21. He said that about one week after getting his first dose on 5-20-21 he started feeling a tingling sensation on his two fingers. He operates some sort of machinery for work and he is not sure whether the tingling was due to the vaccine or due to his work. He said he didn't feel any pain but he wasn't sure he wanted the second dose.
Red bumps going across back and over the shoulders. The bumps are not itchy but patient can feel them if shirt rubs across them.
Eyes swelled. Throat swelled and sore. Jaw pain. Coughing. Watery eyes. Fever of 101.8.
On day of injection left arm was sore and had a rash about 4 in. around site of injection. Two days later severe hives began to appear over entire body. I went to the Medical Center (on the advice of Ask a Nurse -insurance company). I received a steroid injection and a prescription for prednisone. One week after discontinuing the prednisone I went to a walk-in clinic (Saturday) for a rash on leg and behind ear. The diagnosis was an allergic reaction (rash on leg) and shingles behind ear. A prescription for prednisone was given for the allergy (hives) and a prescription for Valacylovir HCL (1gram) and ointment (Clotrimazole and Betamethasone Dipropionate Cream (1 %).
Red ring around injection site one week after injection. Itching at injection site and all over body, particularly upper left arm and face 5 days after vaccine.
Arm little sore; Constipated; Stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm little sore), CONSTIPATION (Constipated) and ABDOMINAL PAIN UPPER (Stomach cramps) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMINS NOS and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.    On 16-Mar-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm little sore), CONSTIPATION (Constipated) and ABDOMINAL PAIN UPPER (Stomach cramps). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency and TILACTASE (LACTAID) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm little sore) outcome was unknown and CONSTIPATION (Constipated) and ABDOMINAL PAIN UPPER (Stomach cramps) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
TIA; Lips numb; Face numb; Eyes spinning; Right eye winking; Feeling Cloudy vision; Dizziness; CHILLS; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA), HYPOAESTHESIA ORAL (Lips numb), HYPOAESTHESIA (Face numb), EYE MOVEMENT DISORDER (Eyes spinning), EXCESSIVE EYE BLINKING (Right eye winking), VISION BLURRED (Feeling Cloudy vision) and DIZZINESS (Dizziness) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (CHILLS). On 19-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion hospitalization), HYPOAESTHESIA ORAL (Lips numb) (seriousness criterion hospitalization), HYPOAESTHESIA (Face numb) (seriousness criterion hospitalization), EYE MOVEMENT DISORDER (Eyes spinning) (seriousness criterion hospitalization), EXCESSIVE EYE BLINKING (Right eye winking) (seriousness criterion hospitalization), VISION BLURRED (Feeling Cloudy vision) (seriousness criterion hospitalization) and DIZZINESS (Dizziness) (seriousness criterion hospitalization). The patient was hospitalized from 19-Mar-2021 to 21-Mar-2021 due to DIZZINESS, EXCESSIVE EYE BLINKING, EYE MOVEMENT DISORDER, HYPOAESTHESIA, HYPOAESTHESIA ORAL, TRANSIENT ISCHAEMIC ATTACK and VISION BLURRED. On 21-Mar-2021, TRANSIENT ISCHAEMIC ATTACK (TIA), HYPOAESTHESIA ORAL (Lips numb), HYPOAESTHESIA (Face numb), EYE MOVEMENT DISORDER (Eyes spinning), EXCESSIVE EYE BLINKING (Right eye winking), VISION BLURRED (Feeling Cloudy vision) and DIZZINESS (Dizziness) had resolved. At the time of the report, CHILLS (CHILLS) had resolved.            CT scan of the head was done and MRI. Patient said he was discharged on Sunday, March-21st. He said his symptoms were gone after that and he was given baby aspirin.  The action taken of all the events with the suspect drug Moderna COVID-19 Vaccine was not applicable. The causality of all events was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's medical history and concomitant medications are necessary for assessment. Further information has been requested.
pt tested positive for COVID on 7/24/21; brought to ED from nursing home with c/o weakness, cough, SOB; chest x-ray showed COVID pneumonia; NRB mask; comfort measures; in respiratory distress and desaturates quickly; given remdesivir and dexamethasone; transferred to in-hospital hospice care where the pt passed away
Much like my experience of COVID in 3/2020 and after my first shot of vaccine in 1/2021:  extreme chills, extreme achiness, extreme weakness & fatigue, extreme dry mouth, extreme chapped lips.  Duration of side effects after first shot was 4 days; duration after second shot was 48 hours, with lingering fatigue & dry mouth until at least a week after the shot.  Symptoms, though severe, resolved themselves in the time frames described above.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (paxlovid)  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.