chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headaches; low-grade fever; chills; Body aches; low-grade fever; chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PYREXIA (low-grade fever), the first episode of CHILLS (chills), the first episode of MYALGIA (Body aches), HEADACHE (headaches) and the second episode of PYREXIA (low-grade fever) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 024MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (No longer taking medicine, but something fluctuates with weight) since 01-Aug-2017.   On 02-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced the first episode of PYREXIA (low-grade fever), the first episode of CHILLS (chills) and the first episode of MYALGIA (Body aches). On 08-Apr-2021, the patient experienced the second episode of PYREXIA (low-grade fever), the second episode of CHILLS (chills) and the second episode of MYALGIA (Body aches). On 20-Apr-2021, the patient experienced HEADACHE (headaches). On 09-Apr-2021, last episode of PYREXIA (low-grade fever), the last episode of CHILLS (chills) and the last episode of MYALGIA (Body aches) had resolved. On 23-Apr-2021, HEADACHE (headaches) had resolved.            Following the second dose, He had symptoms that have been described as "typical" reactions to the Moderna second dose. While very unpleasant, he recovered in about 12 hours and felt great for a week. About 8 days (08-APR-2021) following that 2nd vaccine shot, he had very similar symptoms at about 70% of the intensity of the initial sickness. The symptoms were the exact same (aches, chills, low-grade fever). He reported the adverse reaction because he had not heard of recurring symptoms after a patient recovered after the 2nd shot. He rarely had headaches, but there was severe weather coupled with high allergy events, so it is possible that was the cause of the headaches.   Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patient demographics (height,weight,race) was added, additional adverse events were updated, reporter causality was updated
My arm that I got the shot is has went numb and lost mobility. when I use it I get tired faster than I ever have. Sometimes I cant open a bottle or pick my son up without it hurting. Now the pain has started going towards my middle back. The only thing new is the vaccination. I have been taking tramadol now muscle relaxers.
This spontaneous report was received from a Registered Nurse, referring to an unknown number of patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were vaccinated on unspecified dates  with improperly stored doses of PNEUMOVAX 23, (lot # L019836; expiration date: 24-MAR-2017, lot # M033086; expiration date: 05-MAY-2018). No adverse effect reported. No further information was received. Temperature excursion: 35.2 degrees F for 1 hour and 6 minutes. This is one of two reports received from same reporter. Additional information has been requested.
Myocarditis; chest pain with elevated troponin, delayed myocardial enhancement on cardiac MRI
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 20-FEB-2013, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
No adverse event; Patient received monovalent booster instead of bivalent booster of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received monovalent booster instead of bivalent booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received monovalent booster instead of bivalent booster of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received monovalent booster instead of bivalent booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received monovalent booster instead of bivalent booster of Moderna COVID-19 vaccine).    No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  This case contains information for the 1st of four adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-647563, US-MODERNATX, INC.-MOD-2022-647564, US-MODERNATX, INC.-MOD-2022-647562 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-647563:Patient-3 US-MODERNATX, INC.-MOD-2022-647564:Patient-4 US-MODERNATX, INC.-MOD-2022-647562:Patient-2
Patient presented to clinic for 1st booster dose of a Covid-19 vaccine. He received a 0.25 dose of Moderna on 11/03/2021. Later it was discovered that patient had received a booster dose of Pfizer on 10/20/21. Making the dose intervals too close together.
Tylenol given at 3 pm day of shot 2/9/2006. On 2/10/2006 child woke up and his arm felt funny. Black and blue at site of injection, Red hot to touch from shoulder to elbow and child was itching just posterior to site of top injection. Child was afebrile. No treatment done B/C mom stated child refused. On 2/13/2006 area child was itching developed scabs and arm from shoulder to elbow slight red but not warm. Cool dry to touch.
27OCT95 itching follow by raised rash on arm thigh & waist 13NOV95 rash spread to chest, breast & back;used cortisone cream 9NOV95;started on Saldane BID on 13NOV95; still has rash
scratched at rash that came back; itchiness inside of hands, leg, arm and thigh; A Spontaneous report was received from consumer concerning a 82-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced itching on right leg, right arm, right thigh and scratched at rash.  The patient's medical history and concomitant medications are unknown.  On 18 JAN 2021, the patient received their first dose of the two planned doses of COVID-19 Vaccine (mRNA-1273) intramuscularly in the left arm for prophylaxis of COVID-19 infection and on 20 JAN 2021 and started to feel symptoms the night like felt itchiness inside of hands for 45mins and on 21 JAN 2021 itching on right leg, right arm, right thigh and symptoms went away at the afternoon of 21JAN2021. At night of 21JAN2021 consumer scratched at rash that came back After 15 mins rash went away  No laboratory tests were provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events are Resolved/Recovered.
I passed a blood clot and was hospitalized for 3 days. I had extreme vertigo and vomiting.  I had the vaccines on 12/28 and the stroke on 12/30.  I had a CT and then a MRI and was diagnosed with a stroke.  I was in the hospital for three days.
Patient failed to inform his first booster prior the 4th dose. The clerk tried to doubled check in the system the vaccine records  via online prior administering the vaccine ; she said "patient is clear and okay to give the 1st BOOSTER shot". The RN clarified to her (clerk) again and said "ok to give the booster shot, he does  not have a booster shot yet". After administering the dose the clerk, checked the online records again and told the RN that he has 1st booster shot already and she admitted that she overlooked it. Monitored the patient for 15-30 minutes for any adverse reaction. No adverse reaction presented after observation.
pt recv vax 1AUG95 & 16APR97 pt devel a large, dark, red rash w/pus head on face, arms, neck, back & groin;pt was seen by MD on 17APR07 & dx w/varicella zoster;
This spontaneous report as received from a registered nurse refers to a 5 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (Merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source3. No further information is available.
Rebound COVID-19 test positivity; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound COVID-19 test positivity) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia, Degenerative joint disease and Drug allergy. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced COVID-19 (Rebound COVID-19 test positivity). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound COVID-19 test positivity) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient received COVID 19 vaccine previously. Device Date : 22May2022  Company commnet: This spontaneous case concerns a 67-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 11-May-2022 to 15-may-2022.She was tested positive 4 days after the treatment with Paxlovid. SARS-CoV-2 test positive on 19-may-2022. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: Company comment: This spontaneous case concerns a 67-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 11-May-2022 to 15-may-2022.She was tested positive 4 days after the treatment with Paxlovid. SARS-CoV-2 test positive on 19-may-2022. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Child cried much of the time from the afternoon of 4/15/16 until the eve of 4/17/16. Mom stated child would seem fine and then just start crying.
Bell's Palsy on the right side of my face.  ear ache, head ache all on the right side. droopiness of the right eye and right side of  lips. inability to fully  shut my eye., difficulty eating and drinking.  Attempted to go to an urgent care on 1/02/2021, but they sent me to the ER. ER evaluated me and sent me home with antivirals and steroids. I was sent home with Prednisone and Acyclovir
Within minutes patient reported pressure around throat- it felt like it was closing and she was having trouble breathing; there were white bumps on her arms which she recognized as hives.   Pharmacist administered Epinephrine 0.3mg in right thigh, with patient consent- patient reported throat no longer closing, ease breathing, and increased heart rate.  Pharmacist offered second dose of epinephrine- patient reported feeling better; offered to call 911- patient declined and wanted to call husband (who was a firefighter and right outside).  Husband called 911 and paramedics arrived on scene (in less than a half hour).
SM STATED SHE IS EXPERIENCING PAIN AND BURNING IN RIGHT ARM RADIATING UP SHOULDER AND NECK. ALSO HAS LIMITED ROM AND SKIN IS WARM TO TOUCH, REDNESS AND SWELLING NOTED. SM WAS SEEN BY URGENT CARE AT MEDICAL CENTER. DISCHARGED WITH ALLERIC REACTION, MILD TO MODERATE. PRESCRIPTIONS GIVEN WERE: KEFLEX, ULTRAM, AND MEDROL (PAK).
No additional AE/PQC was reported; improperly stored VARlVAX was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 30-AUG-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T006347, expiration date 20-FEB-2022) for prophylaxis (product storage error).Temperature excursion was 18.1 Fahrenheit degree for 408 hours 0 minutes and 0 seconds. Previous temperature excursions were - 7.0 Fahrenheit degree for 0 hours 20 minutes and 0 seconds; 7.7 Fahrenheit degree for 0 hours 15 minutes and 0 seconds; 5.4 Fahrenheit degree for 0 hours 5 minutes and 0 seconds. No additional AE/PQC was reported.  This is one of four reports received from the same reporter.
Narrative:  85yo patient with Chronic right heart failure- in setting of severe pulmonary HTN and PMH: OSA-not on CPAP, COPD on 4 liters continuously, HTN, DM type 2, PAH, RLS died outside of facility (place of death not mentioned in system) with no information given to facility about this pt's death. Pt had received 3 covid vaccines on 2/4/21, 3/4/21, & 8/31/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
It started with a cough that just wouldn't go away I took over the counter medication and it did help some. Then I took a COVID-19 test and once it came back positive, I was prescribed Paxlovid it did help but left a bad taste in my mouth and within 10 days I tested negative.
Headache, Myalgia, SkinRash, chills, stuffy nose, severe backpain Narrative:  Other Relevant History:
I had theSpikevax on 09.20.23.  On 09.25.23, I woke up with severe pain around my left eye.  The pain subsided, but the eye became red.  On 10.02.23, I went to my eye doctor, who said she could see irritation and prescribed abx eyedrops with steroids(Tobradex).  Finished the eyedrops on 10.06.23.  Redness had subsided.  Went on vacation.  Woke up on 10.09.23 with tenderness/pain on left side of head, face and around eye.  Went to urgent care on 10.11. 23.  Diagnosed with shingles.    Prescribed Prednisone Dosepak - 10 mg, valacyclovir, 1 gm, 3x/day and robramycin eyedrops. Came home, went to eye doctor on 10.13.23.  Shingles have involved the eye. Prescribed eyedrops-tobradex.  Will see eye doctor again on 10.19.23
Information has been received from a registered nurse concerning a now 15 month old patient who was vaccinated with the first, second and third dose of ROTATEQ (lot# unspecified) by oral on 28-DEC-2010, 14-MAR-2011 and 27-APR-2011 (approximately at 6 month old). Additional information has been requested.
Muscle and joint pain; Muscle and joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset May2023, outcome "not recovered" and all described as "Muscle and joint pain".  Additional information: Received a Pfizer covid booster shot on 08May at primary doc. Muscle and joint pain started about 10 days later, and continues today, 30Sep2023. Patient wanted to know if there could be a connection.  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.
developed a fever of 103.9° FAHRENHEIT; weakness; FLUZONE HIGH-DOSE QUADRIVALENT was inadvertently given to a patient who was under the age of 65; Initial information was received on 14-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 54 years old female patient who developed fever of 103.9° fahrenheit, weakness and Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] was inadvertently given to a patient who was under the age of 65.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included: Bivalent COVID booster for Immunization.  On 09-Nov-2022, the suspect Influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml (lot UJ926AC, expiration date: 30-Jun-2023) via intramuscular route in the left deltoid for Immunization was inadvertently given to a patient who was under the age of 65 (product administered to patient of inappropriate age) (latency: same day).  On 09-Nov-2022 the patient developed fever of 103.9° fahrenheit (pyrexia) and weakness (asthenia) on the same day following the administration of Influenza quadrival A-B high dose HV vaccine.  Relevant laboratory test results included: Pyrexia - On 09-Nov-2022: 109 ° Fahrenheit.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for all the events.   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 guidelines. 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.
headache got a little worse, severely dizzy, then I fainted.  I laid on the ground for about 10 minutes, then I was okay.
I had the third shot yesterday afternoon at my Doctor's office.  I sat around and read magazines for over an hour after the shot.  I had the shot at around 2 PM.  Outside of a dry, clay taste I didn't have an immediate reaction.  At around 6:30 PM my body started to ache all over.  All my joints hurt.  My hips, knees, and ankles were really painful.  I got cramps in my feet and tingling in both hands.  I couldn't concentrate and was very restless.  Every five minutes or so I felt like I should get off the couch and do somethingvery vague.  Standing up caused the aching in my legs to worsen.  At around 9 PM it occurred to me that I had reached a plateau and things weren't getting any worse.  I went to bed at around 9:30 PM and around 3 AM the aching stopped.  Up to that point I kept tossing and turning.  The aching kept me from finding a comfortable position.  Today my legs and joints are sore.  The kind of "I just ran a mile" sore.  Typing has caused my fingers to ache.  I have not had any cramps in my feet.  I have had some tingling in my hands.  Oddly enough, I feel sort of relaxed and somewhat spacey minded.  NOTE:  1st 2 shots given and similar reactions were reported on 11-03-2003 on paper report to VAERS by doctor who is writing this now. Please contact pt. and discuss reaction and advise if he needs testing for antiHBs to assure immunity.
01/07/10 Pc from client, reports after immunization 01/05/10 with seasonal flu vaccine - burning, ability to "taste" med, feeling light-headed. Once home c/o throbbing pain - asked family member to assess - area approx 3" diameter "red, swollen, hot". "Bothered her all night." 01/7/10 reports cont with redness, warmth and there is a knot." Reported h/o cellulitis and is afraid this feels the same.
Chronic Diarreah started early Friday morning, March 5, eased by Saturday evening, and started again early Monday morning, March 8. This is accompanied by feeling very cold, and chills,  but no fever.
This spontaneous report as received from a nurse refers to a patient of unknown age. The nurse reported the patient might have received improperly stored ROTATEQ (lot # reported as J010985, exp 24-APR-2015) on an unknown date that was exposed to 52.1F for 188 hours. No adverse symptoms were reported. Additional information has been requested.
This case was reported by the mother of a consumer and described the occurrence of nausea in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. Following vaccination with PEDIARIX in April 2004, the subject experienced nausea, vomiting, abnormal stools, digestive problems, inability to gain weight and food allergies including diary and wheat sensitivities. On 05 August 2008 at 15:45, the subject received 1st dose of INFANRIX at 0.5 ml in the left arm. In the morning of the day following vaccination with INFANRIX, on 06 August 2008, the subject experienced nausea and began vomiting. This was a systemic reaction. The event were unresolved at the time of reporting. The subject has a history of a similar reaction following vaccination with PEDIARIX in April 2004. For information surrounding this report, refer to case number A0742470A.
Child with c/o severe pain to upper (L) thigh, limping & not wanting to walk, no redness.
Vaccine was reconstituted with 0.8mL of diluent instead of 1.8mL.  Error was found approximately 30 minutes after dose was given.  Patient was called and notified of error.
Approx. 9-10 hours after vaccination I began to experience nausea, severe chills/shakes, general body flu-like aches. It has now been 24 hours and I am experiencing extreme fatigue and malaise. I am able to control the chills with TYLENOL. My arm is quite sore but that's no big deal. The nausea and fatigue are annoying.
This case was reported by a other health professional via sales rep and described the occurrence of passed out in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced passed out (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a clinic for one of the physicians at the practice. The age at vaccination was not reported. The age group was not reported, but was captured adult as per the patient's profession. Recently from the reporting date, the patient received a SHINGRIX shot and the next day he experienced passing out and has been hospitalized. No further details were available.