chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; chills; burning in chest; diarrhea; Patient ID:    MH Investigator site: Case reference number MOD-2021-009875 is a clinical trial case report which refers to a 62 Years old Female patient.  The patient experienced headache after receiving.  The patients relevant medical history included: COVID-19 NOV-2020. Rlevant   The patients started Moderna COVID-19 Vaccine on 12 Jan 2021.  Some  9 days  later, the patient developed headache, chills, burning in chest, diarrhea. The eventual diagnosis made was Headache, chills, burning in chest, diarrhea.  The event(s) were:  diarrhea - Unknown,burning in chest - Unknown,chills - Unknown,headache - Unknown.  The investigator considered the headache  did not declare related to the study drug/placebo. There is no product complaint associated with this case.
Woke on the morning after the shot 2/27/21 with a low grade fever (100), fatigue, headache, joint and muscle pain and slightly swollen lymph nodes in my neck.  Within a few hours, my body was completely covered in large hives from head to toe.  I rested or slept most of the day and by the afternoon, the fever had subsided.  By the next day headache, joint/muscle pain and swollen lymph nodes diminished.  I still felt fatigue and the hives were awful.   Began taking Benadryl with no relief.  Called my primary care doctor to report; increased Benadryl dosage to 2 every 4 hours.  There was some relief during the day, but the large doses of benadryl were making me anxious/nervous, racing heart, shakes.   Decreased following another call to Doctor and began taking Antronex; decreaed side effects, but little affect on the hives during the evening/overnight hours.  At times I would be completely covered in them, other times they were localized (bottoms of my feet, face, neck, eyes).   Returned call to Doctor, again suggested Prednisone. (I typically have strong reactions to steriods and wanted to avoid if at all possible) Began first dose 3/18/2021.  Experiencing some relief already.
In early evening after 11/21 dose, patient reports body aches, erythema, urticaria, & swelling at site. She reports that she went to doctor office on 11/24 for evaluation and was given topical hydrocortisone cream.
dryness in both eyes; pain in right eye; This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (dryness in both eyes) and EYE PAIN (pain in right eye) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 032L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Uveitis and Blind right eye. Concomitant products included PREDNISONE, MOXIFLOXACIN HYDROCHLORIDE (VIGAMOX), METOPROLOL, ATORVASTATIN, AMLODIPINE and OMEPRAZOLE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Nov-2021, the patient experienced DRY EYE (dryness in both eyes) and EYE PAIN (pain in right eye). The patient was treated with PREDNISOLONE ongoing since an unknown date at an unspecified dose and frequency and CARMELLOSE SODIUM (REFRESH [CARMELLOSE SODIUM]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DRY EYE (dryness in both eyes) had not resolved and EYE PAIN (pain in right eye) was resolving.            Pain in the right eye had reduced down to around 30%.
Admitted for pna d/t COVID-19; tx w/IV dexamethasone, zinc, steroid and O2.
VAERS reporting as required by law, death occurred on 11/11/2021. Pfizer COVID 19 vaccine completed on 12/22/2020 and 1/12/2021.
Sore, red, swelling & itching at injection site 7-8 cm around, warm to touch. Rash on entire body & itchy, red macular. Redness around eyes, scalp itchy, fever.
Hospitalization for shortness of breath and hypoxia from COIVD-19  on dates 6/18/2022-6/19/2022.  Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
2nd Pfizer vaccine in left deltoid at clinic. About 30 mins later she developed tingling in left face, jaw and neck. This went away but 6 hours later she had bad pain in left axilla, clavicle, neck and jaw. Area became swollen. Lymph nodes also became swollen. She called clinic and told to monitor. EE was also getting nausea and HA that lasted 2 weeks. Arm continued to be heavy and painful. Swelling started to go away after about 2.5 weeks. Last week face and neck numb, and she was dx with bells palsy.
Breakout of multiple blisters in red spots on two areas of right thigh. It lasted three months with stabbing pains at the end of that time. The doctor saw me and concurred that I had a case of shingles. He was surprised since I had the shot to prevent six months prior.
With all three doses of HBV , child complained of sore throat, sinus infection and drainage, soreness to ear right, SOB about 1-2 weeks after injection. With 8/03 injection , child was given 2-3 different courses of abx therapy.
Developed Fever, headache, general fatigue which resulted in hospital admissions overnight with a diagnosis of prolonged immuno-response to the vaccines.
The second one gave him tightness in the back of the head behind his right ear.; It has affected his mobility with his knees and right hand feeling weak and his legs buckling; It has affected his mobility with his knees and right hand feeling weak and his legs buckling; lewd dreams, weird dreams; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 Immunization, reaction(s): "seizure". The following information was reported: TENSION HEADACHE (non-serious), outcome "unknown", described as "The second one gave him tightness in the back of the head behind his right ear."; MOBILITY DECREASED (non-serious), MUSCULAR WEAKNESS (non-serious), outcome "unknown" and all described as "It has affected his mobility with his knees and right hand feeling weak and his legs buckling"; ABNORMAL DREAMS (non-serious), outcome "unknown", described as "lewd dreams, weird dreams".  Additional information: A 38 years old male patient called and reported that he was hesitant to take the Pfizer BioNTech COVID 19 vaccine but after the first one he experienced diminished health.  He caught a seizure and he suffers from seizures. The second one gave him tightness in the back of the head behind his right ear. It had affected his mobility with his knees and right hand feeling weak and his legs buckling. He also had been having lewd dreams, weird dreams. He had to go to court with his family, he lost his job, he's lost friends since the vaccine. He knows people are recording him. He was assaulted two days ago. There were cameras in the street and watching him when he goes to the bathroom. He sees things in his peripherals and sees them recording from his eyes. He asked if Comirnaty (also known as Pfizer-BioNTech COVID-19 Vaccine) contain a microchip to allow tracking of individuals who received vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and CHILLS (Chills) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Aches) and CHILLS (Chills). At the time of the report, PAIN (Aches) and CHILLS (Chills) outcome was unknown.            No concomitant medications were provided  No treatment medications were provided   This case was linked to MOD-2021-236539, MOD-2021-236569, MOD-2021-236580, MOD-2021-236580, MOD-2021-236539, MOD-2021-239232 (Patient Link).
IM vaccine given in the deltoid muscle rather than vastus lateralis, which is the recommended site for a 7 month old. The next day, caregiver reported infant had tender right deltoid area that was slightly swollen. She required one dose of Tylenol since administration of vaccine. Otherwise, according to caregiver patient was acting normally. The patient was reaching, picking up items and moving arm per her usual activity.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium
8AUG91 5 min p/vax recvd pt exp seizure lasting 30 sec, became pale; Recovered spontaneously; Observed for 20 min & seated for 15 min; BP 120/60;
Red and hot rash on left arm, cheek and leg; spread to right cheek, treated with calamine lotion and two benadryl taken. Began day after vaccination.
Got extremely ill off the first shot; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Got extremely ill off the first shot) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     Family history included Colon cancer since an unknown date and Leukemia since an unknown date. Concurrent medical conditions included Drug allergy (Allergy to Codeine).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got extremely ill off the first shot). At the time of the report, ILLNESS (Got extremely ill off the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient Height: 5'4 No concomitant medications were reported. No treatment details were reported.
itching (6hrs after injection- onset within 15min)  pain at injection site (4 days)  nausea (on 2nd day)  headache (4 days)
covid-19; runny nose; congestion; loss of taste; loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
Patient developed erythema, pain, and fever after vaccine administration. Doctor triaged phone call from parent. Advised to come in following day for follow-up. Did not make an appointment for follow up.
No Adverse event; excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine; excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT PREPARATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine), PRODUCT ADMINISTRATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milligram. On 07-Oct-2022, the patient experienced PRODUCT PREPARATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine) and PRODUCT ADMINISTRATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT PREPARATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine), PRODUCT ADMINISTRATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT PREPARATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine) and PRODUCT ADMINISTRATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine).    Concomitant product use was not provided by the reporter.   The patient had 1st dose on 22-Oct-2021, Lot Number reported as 014F21A and Expired date reported as 23-Jan-2022. The patient had 2nd dose on 17-Dec-2021 Lot Number reported as 051F21A Expired date reported as 25-Mar-2022.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-658075 (E2B Linked Report). This case was linked to MOD-2022-658264 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2022: Live follow up received included patient identifiers updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658075:patient 2( bivalent)
She develop Red eye, lethergy and sleepy (06/17/12) that night has has Fever 103-104F for 8-12 hrs then dropped as Tylenol given, cough then runny nose start with rash from 19 Jun 2012.
arrived with her mom to get her pedi-Pfizer 5-11 dose of vaccine. RN administered the vaccine at 4:25 pm. She was nervous but held herself together. then went to give the girl a lollipop about 2 minutes later and she was sitting quietly with her mom. As soon as he returned to complete the paperwork fell off her chair to the floor and her mom then screamed for help. rushed to her side and provided support and aid. Consoled child and mom. Gave an ice pack and had her sit comfortably on the floor by their side. Mom said that this has never happened before. No fainting episodes  history of seizures.
Reaction was reported 7 days after immunization was given, was seen in clinic. Erythema, edema, edema of arm.
Pt states she started coughing up blood and her nose was bleeding. Occurred some time in the evening. States her chest does not feel "right." Advised pt to go to ED.
blistery red rash on both cheek neck & elbow; seen @ clinic given DPH & PVC;
This spontaneous report was received from nurse practitioner referring to patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 22-JUL-2014 patient received improperly stored MMR II, [lot# J010933/exp. date 09/06/2015) exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. Additional information has been requested.
Presented via EMS to Emergency Dept on the morning of 08/11/2006 00:57 actively seizing.  Symptoms began 30 minutes prior to arrival to ED.  No fever documented.  Child received Valium en route to ED followed by 3 doses of Ativan for seizure control.  Seizure resolved after 3rd dose of Ativan at 01:37. 7/15/09-records received for DOS 8/11/06-DC DX- Seizures-presented to ED after generalized seizure activity which continued in ED. Ran a fever during day-choking spells prior to seizure. Observed and discharged home.  Follow-up: Pt continues with seizures although controlled with meds (KEPPRA and Valproic acid). She also has developmental delays and attends the steps program. Testing revealed function at a 2yo level (2 yrs behind). It is difficult to determine if some of these problems could be related to premature birth (32 wks gestation), but there is no history of birth depression. Normal MRI.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 in 11/2022. I contacted my doctor via the patient portal and got a prescription for Paxlovid. I tolerated the medication without any complications. As of today, I am feeling better with not lingering symptoms.
I was like I had l ke passed out; I couldn't feel hungry anymore, I didn't have appetite; It was the first time I was feeling so unable to even; I would get like dizzy and just fall in my bed again; Fever; Muscle Pain; Horribly exhausted for 5 days, I was in bed; I couldn't even lift up my arm to get up and go and eat; This spontaneous case was reported by a non-health professional and describes the occurrence of LOSS OF CONSCIOUSNESS (I was like I had l ke passed out) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (I was like I had l ke passed out) (seriousness criterion medically significant), DECREASED APPETITE (I couldn't feel hungry anymore, I didn't have appetite), HYPOKINESIA (It was the first time I was feeling so unable to even), DIZZINESS (I would get like dizzy and just fall in my bed again), PYREXIA (Fever), MYALGIA (Muscle Pain), FATIGUE (Horribly exhausted for 5 days, I was in bed) and VACCINATION SITE PAIN (I couldn't even lift up my arm to get up and go and eat). At the time of the report, LOSS OF CONSCIOUSNESS (I was like I had l ke passed out), DECREASED APPETITE (I couldn't feel hungry anymore, I didn't have appetite), HYPOKINESIA (It was the first time I was feeling so unable to even), DIZZINESS (I would get like dizzy and just fall in my bed again), PYREXIA (Fever), MYALGIA (Muscle Pain), FATIGUE (Horribly exhausted for 5 days, I was in bed) and VACCINATION SITE PAIN (I couldn't even lift up my arm to get up and go and eat) outcome was unknown.            No concomitant medication reported.  The patient stated having similar symptoms following the first dose of the Moderna COVID-19 Vaccine.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
MA mistakingly gave a pregnant patient preservative free Flublok instead of preservative free Fluzone Quad/no AE; MA mistakingly gave a pregnant patient preservative free Flublok instead of preservative free Fluzone Quad/no AE; Initial pregnancy information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA266135, 2019SA266137 and 2019SA266136 (same reporter).  This case involves a 32 years old female patient who was mistakenly exposed to preservative free vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of preservative free INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while she was pregnant.  Patient's gestation period at onset and gestation period at exposure was unknown, the date of last menstrual period was 06-JAN-2019 and the estimated due date is 13-OCT-2019.  The patient's past medical history, previous pregnancy/ies, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was received.  On 20-Sep-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number 16-DEC-2019 via unknown route in the left deltoid.  It was a case of actual medication error due to wrong vaccine administered (Wrong product administered).  It was reported that patient did not experience any adverse event at the time of reporting.  Additionally, at time of reporting, the outcome of the pregnancy was unknown because patient's delivery due date is on 13-OCT-2019.  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 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.
About 24 hours after FLUZONE Vaccine was administered, a rash that was warm to the touch appeared below the injection site on the left deltoid, and the rash spanned all the way down to the patient's elbow. The rash did not itch and was not painful for the patient.
Initial unsolicited report received from a nurse on 28-Nov-2017. This case involves a female patient of unknown age, who was vaccinated with a dose of FLUZONE QIV (batch number: U589DA, expiry date, dose, dose in series, route, site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed large red rash. Laboratory tests and corrective treatment were not reported. The event outcome was not reported at the time of reporting. List of documents held by sender: none.
G45.9 TRANSIENT CEREBRAL ISCHEMIA 3/28/2023 TRANSIENT CEREBRAL ISCHEMIA
Information has been received from a consumer concerning her friend's son, a 4 year old male who on an unspecified date was vaccinated with MMR II. Subsequently the patient developed autism right after receiving the vaccine. The patient was not functioning as normal kid as per the reporter. The patient's autism persisted. Upon internal review, autism was considered to be an other important medical event. This is one of the several reports from the same source. No further information is available.
Crying, decreased appetite, vomit x2, diarrhea x 4.  Injection site red, raised, warm to touch, penny sized.  No fever.