chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shaking all over; sick on stomach; arm extremely sore; chills; headache; so tired; nausea; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking all over), ABDOMINAL DISCOMFORT (sick on stomach), PAIN IN EXTREMITY (arm extremely sore), CHILLS (chills) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high and COVID-19. Concomitant products included POTASSIUM, CARVEDILOL, FUROSEMIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), TELMISARTAN, DOXAZOSIN MESYLATE, CLONIDINE HCL, SIMVASTATIN, ASCORBIC ACID, ZINC SULFATE (VITAMIN C & ZINK) and VITAMIN D2 for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced TREMOR (shaking all over), ABDOMINAL DISCOMFORT (sick on stomach), PAIN IN EXTREMITY (arm extremely sore), CHILLS (chills), HEADACHE (headache), FATIGUE (so tired) and NAUSEA (nausea). At the time of the report, TREMOR (shaking all over), ABDOMINAL DISCOMFORT (sick on stomach), PAIN IN EXTREMITY (arm extremely sore), CHILLS (chills), HEADACHE (headache), FATIGUE (so tired) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Wrist, elbow, knee, joint pain and swelling x 2 weeks. Abdominal rash resolved.  Ibuprofen 400mg every 4 hours with relief.
Tingling in left arm; Soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in left arm) and PAIN IN EXTREMITY (Soreness in left arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A, 029L20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced PARAESTHESIA (Tingling in left arm) and PAIN IN EXTREMITY (Soreness in left arm). On 30-Dec-2021, PARAESTHESIA (Tingling in left arm) had resolved. On 31-Dec-2021, PAIN IN EXTREMITY (Soreness in left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. It was reported that the patient received the vaccine in her left arm shoulder deltoid muscle. It was reported that there was no product complaint associated with this case   This case was linked to MOD-2022-459082, MOD-2022-459098 (Patient Link).
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 22-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Body aches, Fatigue One day post small pox vaccination. Primary vaccinee. 3 jabs given.
Vaccine given on 4/24/12 had expired on 4/20/12. No adverse event occurred.
Shortly after receiving vaccine, the patient began to experience lightheadedness.  Vital signs taken and within normal limits except for slight increased blood pressure.  Cleared medically.
Itchiness which is spreading; Redness which is spreading; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness which is spreading) and VACCINATION SITE ERYTHEMA (Redness which is spreading) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness which is spreading) and VACCINATION SITE ERYTHEMA (Redness which is spreading). At the time of the report, VACCINATION SITE PRURITUS (Itchiness which is spreading) and VACCINATION SITE ERYTHEMA (Redness which is spreading) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a pharmacist, via company representative, refers to a female patient of unknown age. On 28-JUL-2013 the patient was vaccinated with ZOSTAVAX (dose, strength, route and anatomical site of vaccination not reported). In approximately 28-JUL-2013 the patient developed red, hot circular area with tiny rash at the injection site of ZOSTAVAX. None lab test were performed. No treatment was given. The outcome of red, hot circular area with tiny rash was reported as not recovered/not resolved. The relatedness between ZOSTAVAX and red hot circular area with tiny rash at the injection site of ZOSTAVAX was not reported. The patient sought medical attention via contact with pharmacist. Additional information has been requested.
Began having pain in left hip 25 hours after 2nd dose. Later that day pain in left knee, then right knee, then left ankle. I treated these pains with otc meds with little relief. This progressed to muscle pain and weakness with swelling of the joints. I went to orthopedic office in March and fluid was aspirated from knees, and steroids injected which gave some relief for approximately 1 month. I was having difficulty walking and unable to sleep well because of the pain. I saw NP in May and she gave me a Rx for Gabapentin after approximately 4-5 doses I had swollen so bad that my knees could barely bend. I saw a rheumatologist in May and another orthopedic Dr.
Extreme blinding headache and body wrought with pain commencing approximately 9 hours after dosing (03/05/2021) and lasting 30 hours before beginning to abate at all. Symptoms gone on 03/07/2021.
Vaccination administered too high on arm causing limited range of motion, pain in shoulder joint and upper arm x14 days and ongoing, treating with anti-inflammatory medication.
Patient had a localized reaction at the site of the pneumovax injection in her right arm. Patient's arm was red and warm at the site of injection and her arm was slightly swollen down to her wrist. Patient was advised to take Benadryl and Tylenol or ibuprofen to help with the pain. Patient followed up with MD and  they gave patient a prescription for an antibiotic.
pt developed facial redness, eyes feeling like fire, itching, burning and itching on her head.  Pt also reported a rash - came to clinic to be evaluated - was given loratadine 10 mg PO x 1.  45 min later reported that symptoms were better.  rash resolving and eyes felt better.
itchy rash started on neck; itchy rash started on neck and it had been itchy since. It still had red marks left; itchy rash started on neck and it had been itchy since. It still had red marks left. It felt dry.; This is a spontaneous report from a contactable consumer reported for herself that a 38-years-old female patient received bnt162b2 (BNT162B2; brand=Pfizer, Lot number=EK5730) first dose, via an unspecified route of administration on 21Dec2020 11:00 AM at SINGLE DOSE at left arm for covid-19 immunisation. The patient medical history was not reported.  Concomitant medication included calcium, vitamin d, estradiol, apoaequorin, colecalciferol (PREVAGEN [APOAEQUORIN;COLECALCIFEROL]), iron. The patient previously took codeine and experienced drug hypersensitivity. After receiving the first dose of Pfizer, a itchy rash started on her neck and it has been itchy since. It still has red marks left. When I feel it, it felt dry. The events reported as non-serious. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient then received second dose of Pfizer COVID 19 vaccine (Lot number=EJ1685) on 11Jan2021 10:00 AM at Left arm. Outcome of events was not recovered, no treatment received for the adverse event.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 71-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date January 2019). Concurrent medical conditions included conditions included diabetes and blood pressure abnormal. Concomitant products included atenolol, Atorvastatin, Aspirin, Metformin, ramipril, glimepiride, and esomeprazole. On 18th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 7 days after receiving SHINGRIX, the patient experienced muscle pain, fever, chills, charley horse and tiredness. The patient was treated with (NOS) EXCEDRIN. On an unknown date, the outcome of the muscle pain, fever, chills, charley horse and tiredness were not recovered/not resolved. The reporter considered the muscle pain, fever, chills, charley horse and tiredness to be related to SHINGRIX. Additional details were provided as follows: About a week after his injection, the patient experienced muscle pain, like Charley horses in all of his muscles, feeling really tired, shivering and chills. The patient's body temperature recorded not higher than 100 degree F. The most bothersome were the muscle pain in his thighs, arms and legs. The patient said that he had been in bed and could barely go out of bed or to the bathroom. The patient also said that he had put on new diabetes medicine about the same time ramipril and glimepiride. However, his endocrinologist did not believe these product had anything to do with the symptoms. The reported batch number 324KL does not exists and was updated to 3Z4KL, as per sales data sheet.
pt recvd vax; erythema & induration w/in 1-2 days p/ vax; about 6wks later had purulent drainage;
I had a rising fever, chills, headache, short term memory, sometimes felt nausea, joint pain, shakes, insomnia. These are the same symptoms that was similar when I had Covid on Thanksgiving day 2020. After Dose 2 and Dose 3 exp the same symptoms next day after vaccine. As of present still have shortness of breath, fatigue, lingering side effects and my short term memory  has decreased after all doses.
Shaking; Chills; headache; nausea; metallic tase; malaise; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (Shaking), CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea) and DYSGEUSIA (metallic tase) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ringing in ears on 03-Mar-2021, Paracentesis ears on 03-Mar-2021, Malaise from 04-Feb-2021 to 06-Feb-2021, Taste metallic from 04-Feb-2021 to 06-Feb-2021, Nausea from 04-Feb-2021 to 06-Feb-2021, Headache from 04-Feb-2021 to 06-Feb-2021, Chills from 04-Feb-2021 to 06-Feb-2021 and Shaking from 04-Feb-2021 to 06-Feb-2021. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Migraine, BISOPROLOL FUMARATE (ZEBETA), HCTZ, KCL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), AMLODIPINE BESILATE (NORVASC), LISINOPRIL DIHYDRATE (PRINIVIL), TRAVOPROST (TRAVATAN BAK FREE), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), COLECALCIFEROL (VITAMIN D 3), ASCORBIC ACID, ZINC SULFATE (VITAMIN C & ZINK), PROBIOTIC 10, CALCIUM and MULTIVITAMIN & MINERAL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (headache), NAUSEA (nausea), DYSGEUSIA (metallic tase) and MALAISE (malaise). On 05-Feb-2021, the patient experienced TREMOR (Shaking) and CHILLS (Chills). On 06-Feb-2021, TREMOR (Shaking), CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea), DYSGEUSIA (metallic tase) and MALAISE (malaise) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Noticed redness at injection site starting 2/5/21. Some swelling. Now spreading.. Will trial antibiotic on possibility this is cellulitis.
Tinnitus; Hives; raised red rash left chest, sporadic over body; raised red rash left chest, sporadic over body; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.    A 66-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 27Nov2021 at 10:15 (Lot number: 33030BD) at the age of 66 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hypertension (HTN)" (unspecified if ongoing); "Asthma" (unspecified if ongoing) and "COVID-19" (unspecified if ongoing). Concomitant medications included: VALSARTAN; ATENOLOL; NORVASC; PROTONIX; ASPIRIN and HTZ. Past drug history included: Naproxen, reaction: "Drug allergy", notes: known allergies: Naproxen and Codeine, reaction: "Drug allergy", notes: known allergies: codeine.  The following information was reported: TINNITUS (non-serious) with onset 03Dec2021, outcome "recovering", described as "Tinnitus"; URTICARIA (non-serious) with onset 03Dec2021, outcome "recovering", described as "Hives"; RASH ERYTHEMATOUS (non-serious), RASH PAPULAR (non-serious) both with onset 03Dec2021, outcome "recovering", and both described as "raised red rash left chest, sporadic over body". Therapeutic measures were not taken as a result of tinnitus, urticaria, rash erythematous and rash papular.  Additional Information: Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Pt was given Vaccine too early. Pt was not due for Vaccine until 18 month well child
7:20 pm c/o of numbness and tingling in left hand and wrist. Same side as vaccine. Buzzing feeling, no hives, no SOB, no swelling in throat, 110/60/77 100% given H2O and rest, 7:35 no change and no change on V/S,  7:40 c/o numbness and tingling moving into left leg. and feels like it is progressing, 110/70, 84, 100% given more H2O,  Ambulance called at 7:45pm due to progression of numbness and tingling. Transported via ambulance to hospital.  9:45p patient called staff wanting to be discharged as the medical center was not responding to her medical issue. Patient chose to self discharged. Returned to site 10:20pm with a ride and driver., Reviewed symptoms with patient. c/o mild headache and no further numbness and tingling. 01/08 called pt to check in c/o headache mild, fatigue, and nausea. told to check in with PCP or call 911 if symptoms worsen. Pt stated she was drinking and eating. She also had family available to her if needed.
itchiness; red spots on face/bumps all over the body; swollen face; Swollen legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), RASH MACULAR (red spots on face/bumps all over the body), FACE OEDEMA (swollen face) and OEDEMA PERIPHERAL (Swollen legs) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced PRURITUS (itchiness), RASH MACULAR (red spots on face/bumps all over the body), FACE OEDEMA (swollen face) and OEDEMA PERIPHERAL (Swollen legs). At the time of the report, PRURITUS (itchiness), RASH MACULAR (red spots on face/bumps all over the body), FACE OEDEMA (swollen face) and OEDEMA PERIPHERAL (Swollen legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Friday about 2 p.m. had some dizziness. Had redness and swelling at sight of injection. Also, itching. Had redness for about 1 week. Also, sharp pain on left side of head that continue and went.
heart palpitations, tachycardia, chest pain, shortness of breath, dizziness, muscle weakness, internal shaking,  blurry vision, tremors, ringing in ears, trouble swallowing, skin burning and turns red on face, neck and chest.
pt. recvd. vax & developed fever & pharyngitis.On 11FEB91 pt. developed rash which developed into urticaria.
Patient says she was tired, spacey next day. Pin prick sensation on 8/30, awakened 8/31 at 0330 with eyes swollen, chest heaviness. 8/31 0800 she went to urgent care. From there she saw PCP.
Choking sounds; Difficulty breathing; This is a spontaneous report from a contactable other healthcare professional. A 3-month-old female patient received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: CD0412, expiration date: 31Jan2022), intramuscularly on 28Jan2021 at single dose for immunisation, hib vaccine conj (crm197) (HIB TITER), via an unspecified route of administration on 28Jan2021 at unknown dose for immunisation. Medical history included eczema. There were no concomitant medications. Clinical course: the patient had difficulty breathing and had choking sounds; caller states the patient's father said when the patient went home from the HCP office on 28Jan2021, within give or take 15-30 minutes the patient had difficulty breathing and had the choking sounds that lasted a few hours. The baby was fine and on 25Feb2021 was smiling, laughing, had gained weight, the baby was happy and not crying; the baby gained a pound and grew not quite an inch on 25Feb2021, the baby was drinking 6 ounces every four hours and was rolling over. The patient was given the other vaccines of Rotavirus vaccine and the DTaP vaccine on 25Feb2021. The outcome of events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "difficulty breathing and had the choking sounds" with PREVNAR 13 use can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
evening 4/8 l tongue tingling; am 4/9 mild l eyelid droop; am 4/10 left sided facial droop.  went to ED 4/10 given antiviral and prednisone
Heart starting racing (sitting at the time) and could feel it in her neck. lasting less than a minute
Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
initial redness at injection site similar to what I get with a flu shot. That resolved in 3 days. Nine days after the vaccination my injection site became red agin and itchy, hot and swollen. Very itchy, hot and swollen. The irregular circle was about 3 inches by 4 inches. That lasted one week and is now very faintly red.
Fri 4/9/2021- Immediately upon receipt of vaccine, reported prickliness of soft palate and ?heaviness in throat?.  Was observed for ~ one hour due to these symptoms q 10 assessments of vital signs, all of which remained normal at each measurement (100/60, o2 sat 97-99%, RR 12/min, HR 66).  Provided with water to drink. Later that day (fri 4/9) ? c/o of headache, tiredness, chills, low gr temp (100.5).  No resp c/o.  no body aches. Sat- 4/10- slept most of day.  Drank fluids (water, soup), nml urine. Began advil 400 mg bid-tid.  When awake, c/o Persistent headache,  Sun 4/11- c/o persistent headache, now with pain behind his eyes, and photophobia.  No blurred vision.  Denied sinus pain, nasal d/c or any visual changes. Applied cold spoons to his eyes with minimal relief. No sinus, nasal, or visual c/o. Continued motrin 200 mg po bid-tid. Mon 4/12- vaccine symptoms abating, eating normally, still tired and with HA (unchanged) and eye pain (unchanged).  Noted eye worse when looking t upper and lower extreme corners of visual fields. No sinus, nasal, or visual c/o, EOM intact but w/ pain when looking at superior and lateral fields (r&L). (said this optic complaint was true all along, but only at this point was able to describe it). Tues 4/13- Because of the unusualness of complaint and the "J&J Pause", patient given given 1 adult aspirin & evaluated by (optometrist).  Exam (including dilation) Nml optometric exam ( normal visual fields, visual acuity, color vision, eye pressures (14 bilateral); normal range of extra ocular movements, though pain reproduced at the extreme corners of the visual field; normal vessels and discs;  NO evidence of optic neuritis)
Mother brought pt back into office (pt walking) because in parking lot which mother states pt twitched & did not answer her for 2 minutes. Spontaneously recovered & in office was behaving normally, VSS left in stable condition.