chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He woke up with severe pain in his neck; He woke up with severe pain in his knees and shoulder; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NECK PAIN (He woke up with severe pain in his neck) and ARTHRALGIA (He woke up with severe pain in his knees and shoulder) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced NECK PAIN (He woke up with severe pain in his neck) and ARTHRALGIA (He woke up with severe pain in his knees and shoulder). At the time of the report, NECK PAIN (He woke up with severe pain in his neck) and ARTHRALGIA (He woke up with severe pain in his knees and shoulder) outcome was unknown.    The concomitant medication was not reported by reporter.  On 10-Jan-2021, patient received Moderna Covid-19 Vaccine first dose lot number 012L20A. On 07-Feb-2021, patient received Moderna Covid-19 Vaccine second dose lot number 016M20A. On 05-Nov-2021, patient received Moderna Covid-19 Vaccine first booster lot number 058F21A.  On 23-Nov-2022, on Wednesday patient got the Moderna Covid-19 Vaccine, Bivalent. On 28-Nov-2022 patient woke up with severe pain in his neck, knees, and shoulder.  The treatment medication was not reported by reporter.
Patient came in at 11/21/16 at 11:30 AM with a question whether PREVNAR 13 vaccine she received could have caused "bone pain" in the hips since she saw on a TV ad. She stated the pain seems to be from bones rather than muscle, and though she always has this problem, but it seems to have slight increased pain since the shot.
Experienced same symptoms as someone diagnosed with covid toes.  Took 6 months for lesions to heal this time as well.
Treatment of COVID-19/positive covid test; Treatment of COVID-19/positive covid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), as dose 3, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19/positive covid test". The patient underwent the following laboratory tests and procedures: COVID TEST: (May2022) Positive; (May2022) Positive, notes: DAY 7; SARS-CoV-2 antibody test: (May2022) Negative; (May2022) Negative, notes: DAY 10; (May2022) Positive, notes: DAY 12 Tested highly positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Reported event, rebound covid day 11. Started Paxlovid on day 2 of the positive covid test. Rapid response to Paxlovid by end of day 1 of starting treatment, completed full 5 days and tested negative the following day (RAT), day 7 of the initial positive test. remained negative on RAT tests thru day 10, day 11 developed symptoms (mild, sore throat, congestion, slight headache) and day 12 tested highly (like instantly) positive on RAT.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Extreme tiredness, muscle and body aches, severe headache.  Felt like i was hit by an 18 wheeler
Pt got the first vaccine on 3/1/21 and she developed a heart flutter on 3/4/21 and a rash on 3/5/21.  The patient developed heart flutter at night on 3/4/21, which she thought was a heart attack.  She called EMS and they checked her out and all her vitals were normal.  She saw her MD on 3/5/21 who said it was not a heart attack and she was fine.  He did not think the symptoms were related to the vaccination and he thought the heart flutter was stress related.   The heart flutter went away on it's own.   She also developed a red rash all over her body the evening of 3/5/21 that is still present.  She has been treating that with Vaseline intensive care and Aloe.  Her skin is very dry and crepey
I started to fell whole body side effect from 8/20/2021 around noon time. Symptoms are: headache, body ache, extremely tired, short breath, cold hands, no appetite, uncomfortable stomach. The symptoms got worse in the night. I slept about 15 hours and immediately lost 3 lbs.  When I wake up at 10am on 8/21/2021, I had to take ibuprofen 2 pills and ionic zinc and forced myself to eat pasta + butter + fresh ginger to prevent further losing weight, and then I slept 3 hrs more. I gradually got better and better.   I took another ibuprofen at maybe 3pm, in addition to Nettles, gingers, ionic zinc, green tea pills, etc. In the evening I felt a lot better so I did not take ibuprofen, but then I got almost all the symptoms back on 8/22 morning after slept almost 13 hours. Now I realize that I likely have to keep taking ibuprofen or Tylenol regularly to keep my symptoms controlled.
Lost consciousness, couldn't breathe, Kidney GFR dropped.  Fluid in the lungs, Kidney damage.  Still in hospital.  No diagnosis at this time.
This case was reported by a nurse via call center representative and described the occurrence of injection site burning in a 34-year-old male patient who received TWINRIX adult (batch number 2JN4N, expiry date unknown). Co-suspect products included TWINRIX adult. On 22nd October 2013, the patient received the 1st dose of TWINRIX adult. On 4th December 2013, the patient received the 2nd dose of TWINRIX adult. On 22 October 2013, immediately after receiving TWINRIX adult and not applicable after receiving TWINRIX adult, the patient experienced injection site burning. On 4th December 2013, the patient experienced drug dose administration interval too long. On 22 October 2013, the outcome of the injection site burning was recovered/resolved. On an unknown date, the outcome of the dose administration interval too long was unknown. The reporter considered the injection site burning to be related to TWINRIX adult. Additional details were provided as follows: The reporter believed this report might have already reported to GlaxoSmithKline in 2013, but was not sure. The nurse reported that, no other vaccines were administered by the patient on the day in October and he did not have other medications listed. The gentleman patient received 1st dose of TWINRIX adult by injection and during the push of the vaccine, he reported burning. The patient was monitored for about 30 minutes after the vaccination and the issue was resolved. On 4th December 2013, the patient returned to complete the schedule and received 2nd dose of TWINRIX adult, which led to lengthening of the vaccination schedule. On 7th May 2014, the patient received 3rd dose of TWINRIX adult without any incident and complaint.
More than 36 days from first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days from first vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days from first vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days from first vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medications were provided.   Reporter did not allow further contact
Sore arm escalated to intense pain in arm, felt like being beaten w a baseball bat, then could not move. Rest of body had intense pain that it was hard to move. Extreme fatigue to the point of feeling like a sedative was taken and memory loss during fatigue.  Took ibuprofen after shot to prevent some of this pain, don? Think it helped much. Arm intense pain lasted 24 hours. Yes, I had covid 90 days ago. Fatigue ongoing for over almost 72 hours now.
Fever; severe headache; dizziness; sleepiness; red skin face; This is a spontaneous report from a contactable other healthcare professional (patient). A 58-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 18Mar2021 12:00 (at the age of 58-years-old), at dose 1, single for covid-19 immunization. Medical history included atrial fibrillation, supraventricular tachycardia, known allergies to garlic, lactose intolerant. Concomitant medications included metoprolol succinate; flecainide acetate (FLECAINIDE). Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient experienced fever, severe headache, dizziness, sleepiness, red skin face on 18Mar2021 20:00. No treatment was received for the events. The outcome of the events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
R09.02 HYPOXIA 4/14/2023 CKD STAGE 4 (GFR 15-29)
she has been experiencing palpitations, shortness of breath, chest tightness, dizziness, lightheadedness and headache since receiving her COVID booster on October 21, 2021.  She explains that with her first COVID shot she did not have any side effects however after her second COVID shot and then after the booster she experienced same constellation of side effects.  She does work in a cardiology department and after the second vaccine had an ECG performed which was normal.  Symptoms lasted approximately 1 month before gradually resolving.  She reports currently that she has been experiencing tightness, pressure in her chest, heart pounding, lightheadedness, heart palpitations and shortness of breath present with waxing and waning severity throughout the entire day.  She is able to function normally and nothing seems to be getting better or worse.  She has not identified any external factors which seem to make her symptoms better or worse.  She was able to exercise on the elliptical machine 3 days last week for 20 minutes per episode without improvement or worsening of her symptoms. Patient notes baseline lightheadedness and palpitations that have been worked up without significant findings (has had ECG, echo, labs). No family history of thyroid dysfunction, no other changes, there is some heart history in the family which we review. No alcohol use. Occasional cigarette smoker (maybe once per month), no other nicotine use. No drug use. Drinks 1-2 cups of coffee per day.
This spontaneous report as received from a physician via a company representative refers to a 81-year-old female patient. The patient's concurrent conditions included hypertension and heart murmur. On 26-APR-2016, the patient was vaccinated with PNEUMOVAX 23 0.5 ml via intramuscular route, lot # L014420 (dose number, expiration date and vaccination site were not reported). The patient's concomitant therapies included CARDIZEM. On 26-APR-2016, after vaccination with PNEUMOVAX 23, the patient developed redness and swelling down her arm and her breast. The patient visited the physician's office and was treated with MEDROL. The patient was going to visit the physician on the day of the report. The outcome of the events was not reported. The causality assessment between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
12 hours after the 2nd vaccine, I experienced severe dizziness, body aches and fever. 17 hours after the vaccine I experienced a heartrate in the 150's, fever, chills, sweating and shortness of breath. 24 hours after i still had a fever, hr was 110 at rest and oxygen 99% at rest. While walking HR increased to 120's and oxgen saturation decreased to 86%. This persisted throughout the day.
I THREW UP  4-5 TIMES AND HAD DIARRHEA AROUND 9PM, AND SLIGHT DIZZINESS PRIOR TO THAT
Pt received TDaP at 1155 left deltoid. Began experience itching symptoms to face, neck and left arm at 1205 nurses contacted at this time. EPI was given at 1216. Vitals taken and provider notified. Pt taken to primary care and monitored for 2 hours. No further medications given. Patient d/c ed by provider at 215 pm.
No muscle strength to stand or walk or even move her legs; High fever; Shivering from head to toe; Sore arm; This is a spontaneous report from a contactable consumer. A 78-years-old female patient (mother) received second dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller was calling in behalf of her mom who has been experiencing side effects after getting the second dose yesterday on 16Feb2021. The patient had no muscle strength to stand or walk or even move her legs, high fever, shivering from head to toe, sore arm. They have not reported the side effects yet. asking for guidance on what to do. The outcome of event was unknown.    Follow-up attempts are completed. No further information is expected.
Body aches, joint pain, headache, fever of 102, lethargy, disoriented, cranky. I went back to sleep, drank a lot of water and took Tylenol. Felt ill until March 6th.
head to toe body aches, chills, major fatigue, itchy watery eyes, trouble breathing, painful breathing, soreness in right arm, increased desire for drinking water (hard to quench thirst).
The mother states child starting breaking out on both cheeks of her face approx. 14:15 with welt-like rash. No complaints of shortness of breath or noted respiratory distress. Referred mother to Medical Center.
10-10-07 School teacher called mother this AM, said child scratching and saw whelps. Told mother come get child and thought reaction to Varicella. On 9-28-07 - observed - bug type whelp - no open area - very few around waist - mosquito bite. Mother using Caladryl.
Sudden Sensorineural Hearing Loss in left ear. Symptoms began Friday evening Jan. 8, 2021. Sounded like muffled sound in my ear, water running, ringing. Then on Saturday Jan.9, 2021 my left ear felt like it had to pop and I felt my hearing was impaired.  By Sunday evening Jan. 10, 2021, I could barely hear out of my left ear. I called MD immediately Monday morning, Jan. 11, 2021 and was seen that afternoon. I was examined and had a hearing test. I was diagnosed with SSHL and started treatment of a series of steroid injections directly into my eardrum to save my hearing immediately. I have had 2 injections and hearing test since then. The doctors feel this was a side effect of the COVID vaccine due to my compromised immune system, but not an allergic reaction, but a side effect. I had the same condition about 15 years ago from a virus.
Vaccine was given 4 days past expiration date of refrigerator storage (10 weeks)
Vaccine remained in the freezer past the recommended guidelines (14 days). Once discovered, Pfizer was contacted but did not have stability data to support acceptability of the product greater than 31 days in the freezer. All patients that were administered vaccine past 31 days were contacted and given an option to be re-vaccinated based on their doctor's recommendation or Regulatory Authority guidance.
Pt vaccinated with DTP/OPV cried two days straight. Didn't want to eat. Didn't want to sleep. Tylenol did nothing.
my arm was swollen; arm was swollen and it hurt; cough, it gets really deep, I could spit something out; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my arm was swollen), PAIN (arm was swollen and it hurt) and PRODUCTIVE COUGH (cough, it gets really deep, I could spit something out) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 immunisation.     No medical history was reported.  The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PERIPHERAL SWELLING (my arm was swollen) and PAIN (arm was swollen and it hurt). In March 2021, the patient experienced PRODUCTIVE COUGH (cough, it gets really deep, I could spit something out). On 07-Mar-2021, PERIPHERAL SWELLING (my arm was swollen) and PAIN (arm was swollen and it hurt) had resolved. At the time of the report, PRODUCTIVE COUGH (cough, it gets really deep, I could spit something out) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included unspecified water pill, gout pill and potassium pill.   Patient used ice packs for swollen arm.   This case was linked to MOD21-051121 (E2B Linked Report).; Sender's Comments:  MOD21-051121:
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Type 1) since 30-May-1999, Coronary artery disease, Hypertension since 30-Jan-2015 and Drug allergy (Opioids). Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for Diabetes, LISINOPRIL for Hypertension, TOPIRAMATE (TOPAMAX) for Migraine.    On 03-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 31-Mar-2021 for Fever and Ache, at an unspecified dose and frequency; TRAMADOL on 08-Apr-2021 for Spasms and Inflammation, at an unspecified dose and frequency; TIZANIDINE on 08-Apr-2021 for Spasms and Inflammation, at an unspecified dose and frequency; NABUMETONE on 15-Apr-2021 at an unspecified dose and frequency; GABAPENTIN on 22-Apr-2021 for Allergy to vaccine, at an unspecified dose and frequency and GABAPENTIN on 29-Apr-2021 for Allergy to vaccine, at a dose of 300 mg. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: high (High) 101. On 08-Apr-2021, Magnetic resonance imaging: inconclusive (Inconclusive) spasms with some inflammation due to the vaccine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       15-Apr-2021, Tizanidine dose increased. Other concomitant medications include Predisone (Lab work). 22-Apr-2021, Occupational Therapy was started immediately.   This case was linked to INC.-MOD-2021-072591 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-MAY-2021 Contains patient demographics.Concomitant medications.treatment medications updated.; Sender's Comments:  INC.-MOD-2021-072591:CROSSLINKED WITH DOSE 2
At 5:50 PM on day of receiving vax, pt's mother called office stating pt was having an allergic reaction. He had a red rash all over body, was very itchy, and was "breathing noisey." At 6 PM pt arrived in office alert/oriented with generalized urticaria and diffuse, mild wheezing. He was given Zyrtec 10mg po and Xopenex 0.63% via nebulizer. His chest cleared and rash was fading. He was sent home with Xopenex tid and Benadryl 25mg q6h 2 24 hrs.
Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, route and lot # not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
PROQUAD given left thigh subcutaneous has reddened, raised, warm touch area 6x5cm diameter to right of injection site.
Headache, fever (99.7-100), body aches (mostly in the torso and neck), chills, tiredness, easily worn out. Took Advil. Lasted about 24 hours.
administered an expired vaccine to patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received on 22-JUL-2021 from a Physician and other healthcare professional (Reference number- 00693284) and transmitted to Sanofi on 22-Jul-2021.  This case involves a 6-month-old female patient who was vaccinated with an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 09-Jul-2021, the patient received a 0.5ml of third dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (lot number: UJ327AA and expiry date: 28-Jun-2021 was reported) via intramuscular route at the left thigh for prophylactic vaccination.  It was also reported that "if there was a grace period if an expired product was administered".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   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.