chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on the back of neck; Itching on her lower right arm; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 24KZ7, expiry date 12th May 2022) for prophylaxis.   On 23rd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd January 2020, 2 hrs after receiving Shingrix, the patient experienced rash and itchy upper limbs. On an unknown date, the outcome of the rash and itchy upper limbs were unknown.   It was unknown if the reporter considered the rash and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at 11 AM and approximately 2 hours later, the patient reported a rash on the back of her neck and itching on her lower right arm. The reporter consented to follow up.
Severe pain right elbow and up to triceps . Lasting 1 1/2 months. Pain is now reduced.
SORE ARM; RASH ON BACK AND BODY; MORE ITCHY AT THE FRONT AND BACK; LITTLE PIMPLE SPOTS; SCRATCHING/SCRATCH CHEST AREA; SHOULDER AREA SCABBED; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included polymyalgia rheumatica, non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies, no drug abuse/illicit drug use. The patient was previously treated with ibuprofen for pain.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced little pimple spots. On 2021, the subject experienced scratching. On 2021, the subject experienced shoulder area scabbed. On JAN-2021, Laboratory data included: CT scan (NR: not provided) Spot on lung on CT scan, result not reported., and MRI (NR: not provided) Not reported. On MAR-2021, the subject experienced more itchy at the front and back. On MAR-2021, the subject experienced rash on back and body. On 24-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 26-MAR-2021, had not recovered from rash on back and body, more itchy at the front and back, and little pimple spots, and the outcome of scratching and shoulder area scabbed was not reported. This report was non-serious.
Rashes on ears, face, neck, body, legs and arms which started 5 days post 2nd dose of the vaccine, lasting several days
Information has been received from a physician concerning a 12 month old male patient who on 28-MAY-2009 was vaccinated with a 0.5ml dose of VARIVAX (Merck) (lot# 663814/0265Y). There was no concomitant medication. On 08-SEP-2009 the patient presented with chicken pox. The patient had 14 lesions on his trunk, 6 on his right arm, 5 on his left arm, 12 on his right leg and 25 on his left leg. On 22-SEP-2009, the patient's mother called the office saying that the patient was presenting with what looked like chicken pox again. Subsequently, the patient recovered on an unspecified date. Additional information has been requested.
Dizzy; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizzy) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
I was really tired and not hungry.  Went to bed and at 4am I woke up burning up hot and took off my shirt and threw up with diarrhea the rest of the night and half the next day...then it was just diarrhea, loss of appetite and I slept all day the next day missing work.  Feel better today Friday 1/15/21.
Bilateral DVTS, bilateral PE?s, TIA with no history of blood clots.
Patient received her Covid vaccine at 15:28 and at 15:50 started having prickly feelin gin her hands, legs and lips. EMS assessed and treated with Diphenhydramine 25mg orally. She had no change in her symptoms so was sent by personal vehicle with a driver to local ER up the street. Report called and given to ER @16:05
Patient received Pfizer as a second dose in series, their first dose was Moderna.  No adverse conditions noted on the 30 min observation time.
1/2/2021: redness/warmth/induration to right arm. CBC w/diff ordered for 1/4/2021. 1/3/2021: redness/inudration improved. no visible s/s of pain  resolved with no further action
Initial 12-24 hours: sore arm, tingling in arm; Initial 12-24 hours: sore arm, tingling in arm; Chills; Fatigue; Sore throat; Tight chest; Cough; Persistent headache; Joint pain; Foggy brain; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. On an unknown date in Apr2021, within initial 12-24 hours the patient experienced sore arm and tingling in arm. 3-5 days after vaccination the patient experienced chills, fatigue, sore throat, tight chest, cough, persistent headache, joint pain, foggy brain and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, tingling in arm, chills, fatigue, sore throat, tight chest, cough, persistent headache, joint pain, foggy brain and dizziness was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Dizziness, Headache, Arthralgia, CHEST PAINS Narrative: ER VISIT FOR C/O CHET PAIN; EKG AND CT SCAN PERFORMED; NOTHING FOUND; SENT HOME WITH HER OTC IBUPROFEN FOR PAIN; TODAY'S PHONE CALL MEMEBER HAS RETURNED TO WORK; STATES FEELING MUCH BETTER;
Pharmacist stated that a female adult was given two doses of Spikevax 2023-24 formula of 0.5ml 5 minutes apart on the same day; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist stated that a female adult was given two doses of Spikevax 2023-24 formula of 0.5ml 5 minutes apart on the same day) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist stated that a female adult was given two doses of Spikevax 2023-24 formula of 0.5ml 5 minutes apart on the same day) and NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Pharmacist stated that a female adult was given two doses of Spikevax 2023-24 formula of 0.5ml 5 minutes apart on the same day) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Pharmacist stated that a female adult was given two doses of Spikevax 2023-24 formula of 0.5ml 5 minutes apart on the same day).    Concomitant medications were not reported.   Treatment medications were not reported.
Headache; Body aches; Right arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 45-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 09:15 (Lot number: EL3248) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot number: EL3248, Vaccine location: Right arm, Administration time: 07:30 AM), administration date: 02Mar2021, when the patient was 45 years old for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 24Mar2021 02:00, outcome "recovering", described as "headache", PAIN (non-serious) with onset 24Mar2021 02:00, outcome "recovering", described as "body aches", PAIN IN EXTREMITY (non-serious) with onset 24Mar2021 02:00, outcome "recovering", described as "Right arm was sore". Therapeutic measures were not taken as a result of headache, pain, pain in extremity.  Additional information: Patient did not have other vaccine in four weeks and other medications in two weeks. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient had no known allergies. Patient received vaccine facility type in Workplace clinic. The night following the 2nd injection (about 16 hrs later), patient had a headache and body aches. Symptom persisted through the next day (36 hrs after injection). Right arm was sore, but not more than expected based on other shots.   No follow-up attempts are possible. No further information is expected.
pt recv vax 30APR96 & exp rash described as bug bites w/redness & swelling, a low grade fever, & was not feeling well;6MAY96 pt recovered from exp;
Post vax, the pt developed severe neck spasms, optic spasm, torticollis.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 59 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FL3197) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient did not take any other medication within 2 weeks. It was reported that the patient received treatment of Paxlovid from 21Dec2022 to 26Dec2022, for treatment of COVID-19.
pt recv vax 15DEC94; had several episodes of shaking arms keep staring, ? sz; no postictal state; occurred several times over few days following DTP; CT, EEG, LP all nl;
Injection site reaction; Nausea; Headache; Numbness in extremities; Tingling in extremities; Lower back pain; Sharp pains throughout body; Sweating; This is a spontaneous report from a contactable nurse. A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and had no known allergies to medications, food or other products. 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. The patient did not receive any concomitant medications within two weeks prior to the COVID-19 vaccine. The patient previously received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 17Feb2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 10Mar2021 at 19:00, the patient experienced injection site reaction, nausea, headache, numbness and tingling in extremities, lower back pain, sharp pains throughout body and sweating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site reaction, nausea, headache, numbness and tingling in extremities, lower back pain, sharp pains throughout body and sweating were resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient claims soreness in arm over one month since receiving injection. Unsure if related to fibromyalgia or arthritis, but claims could raise arm over and behind head prior to injection and can no longer do so. Has not seeked medical attention. Claims that shot was given midway from shoulder to elbow.
Patient administered with the diluent part of Vaccine; Patient administered with the diluent part of Vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA5708, expiry date 22nd October 2021) for prophylaxis.   On 17th August 2021, the patient received Menveo. On 17th August 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that a male patient was administered with the diluent part of Menveo Vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Syncope, sweats, no other complaint. Patient kept awake, alert, given water, vitals taken. Pt became hypotensive from initial vitals - O2 given. BS 90 check. 911 called. Pt transfer to hospital.
I have had three things my psoriasis worsened I had a severe flare up. I began to get a bad rash under both arms. My left nostril feels strange and still does
Pain in left arm immediately following the vaccination.  I felt like the injection shot was too high in the arm.  Pain persisted.  Made appointment with doctor.  Diagnosis - shoulder tendonitis.
Narrative: COVID infection following COVID vaccine series 04/06, MODERNA, dose #1 05/03, MODERNA, DOSE #2 08/18 pt cc: No symptoms exposure: unknown 08/17 COVID swab, result: detected 08/17 SARS-COV-2 Variant Sequencing result: pending 08/26 COVID swab, result: detected
Acute nystagmus lasting about one hour then disappearing. No other apparent cause. Her father had vaccine at the same time and the same lot and also had nystagmus several days before.
Chills 100.5 fever malaise headache and knee and elbow joint pain lasting approx 48 hours.
Patient was given a pediatric dose of Hepatitis A. This was discovered during the visit and the Adult dose was given.
She developed diarrhea fever 37 hours after the typhoid vaccine. Diarrhea was watery (8-10/24 hours) daily times 4 days. Seen in the emergency room at Homestead Hospital. Admitted on 10-27-07 until 11-1-07, treated with IV Flagyl and Ceftriaxone, IVFs, NPO. CAT. Post infection/Post vaccine Irritable Bowel Syndrome.  4/28/2008 MR received for DOS 10/27-11/01/2008 with D/C DX:  Acute Colitis. S/P Vaccination.  L Adnexal cyst. Gastritis. Pt presented to ER with nausea, abdominal pain, diarrhea, fever, chills and generalized weakness which began 2 days s/p typhoid vax. PE (+) for Mid epigastric tenderness.  Txd with IV abx and symptomatic tx.
No adverse effects reported; Expired dose of ZOSTAVAX administered to 12 month old patient; This spontaneous report was received from a physician, concerning a 12-month old female patient.  The patient's medical history, concurrent conditions, drug reactions or allergies were not provided.   On 30-MAY-2019, an expired dose of Zoster Vaccine Live (ZOSTAVAX) (19400 plaque-forming units (PFU) vial) lot # N025703with expiration date 16-DEC-2018 (dose, frequency and anatomical location were not provided; route of administration was unknown by the reporter) was administered to the patient for prophylaxis.  No adverse effects were reported.
Rash; Fever; Headache; Fatigue; Swollen sore arm; Swollen sore arm; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 18Mar2021 at 09:45 (at the age of 78-years-old), as single dose for COVID 19 immunisation. Medical history included acid reflux, coronary artery, pre-diabetic and bee venom allergy. Concomitant medication included omeprazole (MANUFACTURER UNKNOWN), levothyroxine (LEVOTHYROXIN), telmisartan (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), cefuroxime (FURO); all for unspecified indication from unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the left arm on 25Feb2021 at 09:30 (at the age of 78-years-old) as single dose for COVID 19 immunisation. The patient previously took ampicillin (MANUFACTURER UNKNOWN), azithromycin (MANUFACTURER UNKNOWN), levofloxacin (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN); all from unknown dates to unknown dates for unknown indications and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 17:00, the patient experienced fever, headache, overall fatigue and swollen sore arm that lasted for 4 days. On 23Mar2021, fifth day onwards, the patient experienced rash and patient still had it on 24Mar2021 (sixth day). The patient did not receive any treatment for the events. The clinical outcome of the events fever, headache, overall fatigue, swollen arm and pain in arm were recovered on 22Mar2021 and rash was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Tremors in hands & feet, numbness in all extremities, dizzy, blood sugar dropped to 42, blurry vision, unsteady gait, heart palpitations, nausea.
pt stated 1 day p/vax had swelling in eyelids & broke out in face & devel a lump on rt clavicle;PE VSS NAD micropapular, rash facial, dark eyelids;1cm mobile rt supraclavicular LN, mild inflammation rt deltoid inj site;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 9:33 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 71.37 years for dose administered on 28-Feb-2021.No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 and 26 degrees Fahrenheit at 09:00 AM and 01:00 PM respectively. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).