chrisvoncsefalvay/vaers-outcomes huggingface dataset:
can hardly walk; could hardly get out of bed; dizzy; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (can hardly walk), MOBILITY DECREASED (could hardly get out of bed), DIZZINESS (dizzy) and MYALGIA (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 054C21A and 006B21A) for COVID-19 vaccination.     Concomitant products included INSULIN DEGLUDEC, LIRAGLUTIDE (XULTOPHY), METFORMIN HYDROCHLORIDE, CARVEDILOL, FENOFIBRATE, DESVENLAFAXINE, ROSUVASTATIN, FLUOXETINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN, IRON, CYANOCOBALAMIN (B-12) and COLECALCIFEROL (D3) for an unknown indication.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2022, the patient experienced MYALGIA (sore arm). On 20-Jan-2022, the patient experienced MOBILITY DECREASED (could hardly get out of bed) and DIZZINESS (dizzy). On an unknown date, the patient experienced GAIT DISTURBANCE (can hardly walk). At the time of the report, GAIT DISTURBANCE (can hardly walk), MOBILITY DECREASED (could hardly get out of bed) and MYALGIA (sore arm) outcome was unknown and DIZZINESS (dizzy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient said that on Wednesday after the booster shot it was great, the arm was sore. On Thursday, patient was so dizzy she could hardly get out of bed. Patient stayed dizzy until 5 o'clock in the evening and then she was 50% better. On Friday morning, she was just as dizzy as she was on Thursday and on Saturday she woke up and was very dizzy, she can hardly walk. No treatment medications was provided.
The pt presented an early atypical varicella. It began on the evening of 05/01/2002 and no fever noted. Treated with Zovirax, and Benadryl.
Sore/scratchy throat, slight headache, fever 100.2 degrees , chills, sore arm. At site
Information has been received from a physician concerning a 28 year old male pt who on 9/13/99 was vaccinated IM in the right deltoid. 3 hours post vax, the pt developed flu-like symptoms consisting of diarrhea, nausea, fatigue, dizziness and low grade fever. It was noted that the physician had been contacted.  Follow up information from a registered nurse reported that on 9/14/99 the pt recovered.
High fever (103.8); headache; leg pain; mouth pain; burning eyes; left eye red and swollen; lack of appetite; nightmare.
Days post medication administered, baby exhibited moderate vomiting & diarrhea for 2 1/2 weeks; 1 episode in doctor's office.  12/15/2008 Office notes and vax rec received from PCP. Seen for 2 mon well visit and vax 4/29/08. Imp: Well infant ? GER.   Returned 5/7/08 with c/o projectile vomiting, diarrhea, decreased appetite, not resting well, rash on face and extremities. DX:  Viral GE. Seen 5/13/08 still projectile vomiting.  Stool cx sent and (-). 3 month checkup 5/23/08-noted to be well.
No additional AE reported; VARlVAX expired on 22 JUL 2021 and was administered on 27 JUL 2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.   On 27-JUL-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S022757, expiration date 22-JUL-2021, (exact dose and route of administration were not provided) for prophylaxis. No additional adverse event was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008314:
Vestibular migraine; Tinnitus; llness in ear; Mild vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VESTIBULAR MIGRAINE (Vestibular migraine), TINNITUS (Tinnitus), EAR DISCOMFORT (llness in ear) and VERTIGO (Mild vertigo) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032LZ0A) for COVID-19 vaccination.     The patient's past medical history included Meniere's disease (flare up on or around 01-MAR-2021) in 2006.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VESTIBULAR MIGRAINE (Vestibular migraine), TINNITUS (Tinnitus) and EAR DISCOMFORT (llness in ear). 01-Mar-2021, the patient experienced VERTIGO (Mild vertigo). At the time of the report, VESTIBULAR MIGRAINE (Vestibular migraine), TINNITUS (Tinnitus), EAR DISCOMFORT (llness in ear) and VERTIGO (Mild vertigo) had resolved.        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.   No concomitant and treatment medications were reported.
gen arthritis starting 2wks p/rubella vax;swelling & pain both hands, both shoulders, & both knees;given rx for naproxen
headache and pressure; dizziness; nausea followed by vomiting; intestinal discomfort; extreme tiredness followed by sleeping for about 11 hours straight.  These symptoms were almost completely gone by the following Monday (3/15/21) when I received the second vaccine.
droopy eye lids tiny bumps on upper and lower lips throat was tingling both hands petechia
A nurse reported that a 14 year old female patient experienced itching, redness, swelling, difficulty breathing, and throat swelling during treatment with RabAvert therapy. The patient's medical history included allergies to penicillin and bee stings. She began her post-exposure vaccination series of RabAvert 1ml IM on 9/7/01. The patient received her first and second shots without any reported problems. She received her third shot on 9/14/01. On 9/16/01 the patient developed severe itching and redness around the face and neck area as well as some swelling around the eyes. On 9/17/01 the patient was treated with a Medrol Dose Pack and Benadryl cream PRN and the symptoms subsided. On the evening of 9/17/01 the patient was hospitalized for difficulty breathing and throat swelling. She was treated with epinephrine and adrenaline and the symptoms subsided. She was discharged on 9/19/01. The patient was scheduled to receive her fourth dose of RabAvert on 9/21/01, instead she received HDVC (rabies vaccine) on 9/22/01. The patient again experienced throat swelling and difficulty breathing and was treated with epinephrine and adrenaline. As of 9/26/01 the subject had discontinued RabAvert and the symptoms had resolved. The patient is scheduled to visit an allergist and dermatologist. The physician assessed this event as possibly related to RabAvert.
Left side if head and face become numb for about 4 weeks.  Sore throat that lasted 5 weeks but doctor could not see redness in my throat.  Tested for strep and other issues and doctor couldn't find anything wrong.  Ears started ringing and still ring 8 or 9 times per day.
1/6/21 Vaccine.   1/7/21 fever, severe migraine, aches everywhere, chills, vomiting, sore throat, tightness in chest
I woke up unable to move my body without extreme pain; still had horrible body aches; headache; sharp shooting pains in my left breast.; very dizzy/light headed; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 16:30 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 18May2021 04:00, outcome "unknown", described as "I woke up unable to move my body without extreme pain"; PAIN (non-serious) with onset 18May2021 04:00, outcome "unknown", described as "still had horrible body aches"; HEADACHE (non-serious) with onset 18May2021 04:00, outcome "unknown", described as "headache"; BREAST PAIN (non-serious) with onset 18May2021 04:00, outcome "unknown", described as "sharp shooting pains in my left breast."; DIZZINESS (non-serious) with onset 18May2021 04:00, outcome "unknown", described as "very dizzy/light headed". The events "i woke up unable to move my body without extreme pain", "still had horrible body aches", "headache" and "sharp shooting pains in my left breast." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of movement disorder, pain, headache, breast pain, dizziness.  Additional information: Adverse event start date: 18May2021,Adverse event start time: 04:00 AM, If patient recovered: Unknown, If treatment AE: No, If covid prior vaccination: No, If covid tested post vaccination: No. Serious: No, Seriousness criteria-Results in death: No, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No, Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine:No, Reported Event: About 8 hours after my second Covid shot I woke up unable to move my body without extreme pain. The follow day about 16 hours after shot I still had horrible body aches, headache and sharp shooting pains in my left breast. Now almost 48 hours after the shot I'm still currently very dizzy, light headed, sore and still have very sharp pains in my left breast. Did the adverse event result in any of the following: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, was the patient diagnosed with COVID-19:No. Since the vaccination, has the patient been tested for COVID-19:No  Follow-up attempts completed. No further information expected.
Patient came in for second dose and upon asking how she did with the first dose she began to describe what appeared to be an allergic reaction.  She described her reaction as occuring the same day as the vaccine. She states her arm became visibly swollen, red, and broke out into a rash. She described the rash as appearing like large welts. She states this rash went away after a few days but then came back and repeated in this way for the next 3 weeks. The pharmacist recommended the patient reach out right away to her primary care provider to discuss her reaction and whether they felt she should receive a second dose.
Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history and no known drug allergies/drug reactions who on 16-FEB-2009 was vaccinated with the first dose of GARDASIL. Concomitant therapy included meningococcal vaccine (manufacturer unknown). It was reported that "2 hours after getting the vaccine" the patient started having trouble breathing and feeling chest pains. The patient was taken to the emergency room but was not admitted overnight. "A full work up was performed at the emergency room (results not provided), also a computed axial tomography scan, electroencephalography and magnetic resonance imaging were performed (results not provided). It was reported that she had couple more breathing episodes since. The patient also experienced seizure like activity starting on 11-MAR-2009. It was reported that the first seizure was pretty severe and the patient did not calm down until she was given ATIVAN. It was reported that the patient overall was experiencing tiredness, weakness, chest pains, dizziness and nausea. The patient was seen at the practice. It was reported that the patient had not recovered at the time of the report. Upon internal review, seizure-like activity was determined to be other important medical event. Additional information has been requested.
The vaccine was injected too high in my shoulder and there was a pop that I heard and felt as the needle was injected. Two hours after the shot I was experienced extreme shoulder pain (not typical arm muscle soreness). I have limited range of motion and I am unable to lift and move my arm/shoulder without pain. I am experiencing some radiation pain up my neck and down to my elbow. The pain in my shoulder joint is more on the inside and not at the injection site. I am still experiencing pain five days later and went to an orthopedic doctor who specializes in shoulder injuries. He diagnosed me with SIRVA and said that the inflammation and pain I am experiencing is caused by the improper administration of the vaccine into my bursa and not my deltoid muscle. He said that these types of injuries typically take between 6-8 weeks to heal fully.
This spontaneous report as received from a Registered Nurse refers to a multiple unspecified patients of unknown age and gender, who on an unspecified dates were vaccinated with doses of RECOMBIVAX HB (dose, indication, route, site of administration and lot # were not reported) that might have been subjected to significant light exposure. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Exhaustion; Pain in arm/Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhaustion) and PAIN IN EXTREMITY (Pain in arm/Sore arm) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced FATIGUE (Exhaustion) and PAIN IN EXTREMITY (Pain in arm/Sore arm). At the time of the report, FATIGUE (Exhaustion) and PAIN IN EXTREMITY (Pain in arm/Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that on unknown dates, the patient experienced Exhausted and Sore arm. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
nurse gave a patient just the diluent; nurse gave a patient just the diluent; uses another diluent to reconstitute and administer it; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number 2Z9N3, expiry date 26-SEP-2025) for prophylaxis.   On 11-OCT-2023, the patient received Shingrix. On 11-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: nurse gave a patient just the diluent), inappropriate dose of vaccine administered (Verbatim: nurse gave a patient just the diluent) and wrong solution used in drug reconstitution (Verbatim: uses another diluent to reconstitute and administer it).  The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were unknown.   Additional Information: GSK Receipt Date: 11-OCT-2023 The nurse requested data that can Shingrix be reconstituted with anything other than the diluent it comes with as she was short 1 diluent because another nurse gave a patient just the diluent then uses another diluent to reconstitute and administer it which led to Wrong solution used in drug reconstitution, inappropriate preparation of medication and inappropriate dose of vaccine administered. He got a correct dose as well. Patient received Shingrix adjuvant only followed by a complete Shingrix dose on the same day. The reporter consented to follow up.
delay in receiving their third dose with no reported adverse event; Initial information received on 11-Jan-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 55 years old female patient who experienced delay in receiving their third dose with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] delivered by unknown device.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Jan-2022, the patient received a  dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site. On 04-Jan-2022 she also received a  dose of the same vaccine  with an unknown batch number via unknown route in unknown administration site. In case batch and expiry date of suspect were requested.  On 08-JAN-2022 the patient developed a non-serious delay in receiving their third dose with no reported adverse event (product use issue) 7 days following the administration of RABIES (HDC) VACCINE. On 11-Jan-2022 she also received a  dose of the same vaccine  with an unknown batch number via unknown route in unknown administration site.  It was reported that "Pharmacist reporting a patient who has received their first two doses of IMOVAX for a post exposure has a delay in receiving their third dose. Caller reporting that the patient is scheduled to come in today for her third dose, although it was due on 08Jan2022. Caller reporting first dose was administered on 01Jan2022 and second dose on 04Jan2022. Caller with question on how to proceed with vaccination schedule after todays dose."  Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  It was not reported if the patient received a corrective treatment for the event (delay in receiving their third dose with no reported adverse event).  At time of reporting, the outcome was Unknown for the event delay in receiving their third dose with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initial report was received from a health care professional on 01 Dec 2009: This patient (09 month old infant) inadvertently received a dose of FLUVIRIN (batch no: 1013273P) intramuscular on 01 Dec 2009. The dose volume was not specified. No adverse events were reported.
After the shot - Right arm got sore and painful. Then got Red Patch around arm about 6 inch. Very Painful and hurt when touch. I Google it and Put steroid cream on it Mometasone Furoate VSP ointment 0.1. Use for 5 days. Now getting better.
101 degree temp 24 hours after vaccination. 48 hours after vaccination, red, warm, induration and swelling. 4"x5"with raised vesicles along border of band aide.
Headache, Myalgia, Fever, site pain- all resolved in 48 hrs Narrative:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 06-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). (incorrect product storage). No adverse effects were reported. No product quality complaint was involved. This is one of several reports reported by the same reporter. Additional information has been requested.
Reason for Visit on 3/30/2021: rash and itching x 2days.  Skin Comment: multiple excorations, erythem papules, few ecchymoses.  ? due to Janssen vaccine.  Take hydroxyzine 25mg bid.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of the following vaccines for prophylaxis: PROQUAD lot # N001490, expiration date (exp. date) 12-JUL-2018; M-M-R II lot # reported as "N048036", exp. date 08-DEC-2018,  or lot # M047302 exp. date 30-NOV-2018; VARIVAX lot # reported as "W001528" exp. date 13-JAN-2017, or lot # reported as "W002203" exp. date 19-JAN-2019; VAQTA lot # N014945, exp. date 31-AUG-2018, or lot # N005796, exp. date 26-MAY-2018; GARDASIL 9 lot # N017832, exp. date 16-NOV-2019, or lot # N014470, exp. date 17-JUN-2019; and ROTATEQ lot # N009948, exp. date 12-OCT-2018 orally (strength, route of administration, dose and dose # were not provided). The sterile diluent (MERCK) used for reconstitution of vaccines was properly stored. The vaccines were exposed to an unknown temperature excursion during a time frame of 72 hours which was detected by the data logger. There was no prior temperature excursion.
After being vaccinated and while waiting in the observation area, I began to feel hot and light headed. I fainted about 15 minutes after sitting down in the waiting area and upon fainting hit my head on the floor. I regained consciousness while laying on the floor getting my vitals taken by staff. Because of the minor head injury and proximity to getting the vaccine, I accepted being taken to the ER.
Pt recv vax on 3/16/99; 10 min post vax pt exp rash on face & difficulty breathing; tx=Epinephrine, Benadryl
This spontaneous report as received from a Nurse practitioner refers two patients of unknown genders and ages who on an unknown date, were vaccinated with VARIVAX (Merck) (dose, route and lot # not provided) and on unspecified date vaccinated with M-M-R II (dose, route and lot # not provided). Nurse Practitioner reports that 2 children received doses of VARIVAX (Merck) and M-M-R II  that were stored at an unknown temperature for an unknown period of time. Two children each received a dose of VARIVAX (Merck) and dose of M-M-R II. No adverse effect reported. No other information provided. This is one of several reports from same source. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 3rd August 2018 10:05, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX vaccine in right arm. The patient had denied permission to contact their physician.
I had a mild headache. Cold symptoms- stuffiness, runny nose which lasted for and 2-3 days. I was tired for about 3 weeks. My PCP at the time prescribed me Paxlovid.
Given Janssen vaccine at clinic, upon putting information into Database, patient found to have received one dose of Moderna.