chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Joint pain; Fever actually its getting worse. Last time I checked it was 100.8 and now it's 103; Fever actually its getting worse. Last time I checked it was 100.8 and now it's 103; I am calling to report the side effects. I took the booster shot yesterday. Chills, joint pain and fever and fever actually its getting worse. Last time I checked it was 100.8 and now it's 103."; I am calling to report the side effects. I took the booster shot yesterday. Chills, joint pain and fever and fever actually its getting worse. Last time I checked it was 100.8 and now it's 103."; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FD8448, NDC number, UPC number and Expiry Date are unknown), via an unspecified route of administration on 21Aug2021 at the age of 50-years-old as dose 3, single (Booster dose) for covid-19 immunisation. The patient's relevant medical history and concurrent conditions included Immune disease  and fever from an unknown date. Concomitant medications included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; tizanidine (TIZANIDINE) taken for an unspecified indication, start and stop date were not reported; rituximab (RITUXIMAB) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7534) on 19Mar2021 at the age of 50-years-old as single dose and second dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW958) on 19Apr2021 at the age of 50-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccine prior to Covid-19 Vaccine in four weeks of vaccination. There was investigation Assessment. The reporter stated that she was calling to report the side effects. She took the booster shot the previous day. On an unspecified date, the patient experienced Chills, joint pain and fever and fever actually its getting worse. Last time she checked it was 100.8 and then it was 103. It was reported that morning, she had fever. she had chills last night. Treatment for adverse events included Tylenol. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date in 2021, body temperature: 100.8 on an unspecified date, body temperature: 103 on an unspecified date, investigation: unknown results on an unspecified date in 2021. She stated, "Yeah, well I had the toxin within past two weeks, its 'fusion of toxin or toxin map' (further not clarified) and in blood work we had within the past 3 weeks." (further not clarified). The outcome of events was unknown.
1st 0Covid 19 dose 9/8/21 ER, Hospital Admission 9/11 - 9/15/21 Body swelling/tachycardia treated IV steroids/Benadryl  -resolved Memorial Hospital
Frozen shoulder, nerve issues including numbness in pinky and right finger and middle two right toes which over weeks has progressed to sensitivity to touch and achy joint pain when used.
Pt. with syncope x 2 events.  Syncopal events separated by ~5 minutes.  Pt. complained of severe dizziness for ~40 minutes after immunizations.
1 hr p/vax pt devel inject site rxn of redness, pain & itching. Recovered within 24-48 hr Reporter indicates approx 60 patients exp same rxn, they are not presently identifiable.
72-year-old male, with a PMHx of cirrhosis, hepatic encephalopathy and pericarditis, presented with CC of SOB x 2.5 weeks. Patient stated he was diagnosed with COVID-19 on 7/22/2022 at hospital. He admits to productive cough, intermittent SOB, intermittent lightheadedness upon standing and chest pain after coughing. His breathing feels better when he leans forward. He has a history of pericarditis and he is worried he might have pericarditis again. He also has a history of bradycardia with HR in the 50-60's at baseline. Patient deemed medically stable for discharge to home per physician. Patient and family agreeable.
WEIRD FEELING IN ARM; SORE ARM; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 09:30 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021 14:30, the subject experienced weird feeling in arm. On 05-APR-2021 14:30, the subject experienced sore arm. On 05-APR-2021 14:30, the subject experienced fever. On 05-APR-2021 14:30, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, fatigue, sore arm and weird feeling in arm was not reported. This report was non-serious.
Soft tissue pain; Body pain in leg, arm, and back; back pain; Headaches; Fatigue; Body pain in leg, arm, and back; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Soft tissue pain), PAIN IN EXTREMITY (Body pain in leg, arm, and back), BACK PAIN (back pain), HEADACHE (Headaches) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), OMEPRAZOLE and LORAZEPAM for an unknown indication.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (Soft tissue pain), PAIN IN EXTREMITY (Body pain in leg, arm, and back), BACK PAIN (back pain), HEADACHE (Headaches), FATIGUE (Fatigue) and MYALGIA (Body pain in leg, arm, and back). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at an unspecified dose and frequency and GABAPENTIN at an unspecified dose and frequency. At the time of the report, PAIN (Soft tissue pain), PAIN IN EXTREMITY (Body pain in leg, arm, and back), BACK PAIN (back pain), HEADACHE (Headaches), FATIGUE (Fatigue) and MYALGIA (Body pain in leg, arm, and back) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events were not applicable.
Patient has been feeling lethargic and has diarrhea for the past 3 weeks
pt exp feeling faint, h/a; pulse taken 80 & weak, BP 110/76; pt given Epi & DPH; also exp nervousness & restlessness; some soreness next day;
Patient had a brief crying spell right after first immunization (PEDIARIX) administered. Patient then proceeded to have breath holding spell during second and third shots (S. Pneumo, then Hib). Patient was picked up by MOC and proceeded to intermittently shut eyes and nod off within seconds of shots being administered. Patient lost color in skin. After trying to stimulate patient for a few seconds, Dr. was called in, patient laid back down on table, and blood pressure obtained. BP was low at 58/42.  Patient administered 0.15 ml of Epinephrine and vitals became more stable. Patient's color still very pale. Patient alert and behaving within normal limits at time of transfer to hospital.
Patient felt increased heart rate, increased blood pressure, and flushing, a sense of doom and hyperventilating 5 minutes after receiving flu shot.  She was not at her place of work and was taken by stretcher to the ER.  They gave her the EPINEPHRINE, SOLUMEDROL, BENADRYL and PEPCID.  She was monitored for 3 1/2 hours and discharged in stable condition.  Her work place gave her the flu shot and she followed up in our office on 9-29-09.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided   This case was linked to MODERNATX, INC.-MOD-2021-078437 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-078437:second dose case
PT EXPERIENCED DIZZINESS, WAS TAKEN TO ER HAD CT SCAN. HAS BEEN HAVING HA POST VACC. FATIGUE.
On 05/26/2021 pt. presents to HCF w/ fatigue & chills; per note "presents with tremulousness for the past 3-4 days. Patient reports decreased oral intake and cessation of alcohol use. He reports he is usually a "3-4 finger" of 5, nightly drinker. Patient abruptly stopped this 4 days ago as he ran out of vodka. He reports no prior withdrawal symptoms. He reports no history of withdrawal seizures. He does drink this amount every day. He reports that he became increasingly tremulous since cessation of the alcohol use. Denies fevers or infectious symptoms. No nausea or vomiting. No abdominal pain."
Difficulty breathing, chills, cold sweat, hives, swelling of face, severe headache, sensitive skin, eyes burning.  Lasting a week. Swelling still occurring in face.
Patient is a 81 y.o. male patient of MD.   Patient states he hasn't been feeling well past few days. He was positive for covid on home test 11/8. Discussed with family member and she reports he has had several falls at home over the past 2 weeks. No known injuries occurred. Troponin elevated on admission, pt denies CP or anginal equivalent.    Hospital course as below.  Patient improved medical treatment.  Patient was discharged to SNF in stable condition.  1. COVID, +11/8, symptoms roughly 11/6: -CXR no PNA -on RA, no indication for remdesivir or decadron currently -heparin DVT prophylaxis -crp somewhat elevated   2. Generalized weakness, recurrent falls: -secondary to above -PT/OT -SW for dc needs   3. Elevated troponin: -cardio consulted, likely type II in setting of COVID and AKI -pt denies CP -troponin max 128 -EKG no acute ischemic changes, ACS ruled out -11/9 ECHO EF 46%, grade 1 diastolic dysfunction (no prior in chart to compare to) -consideration for stress test outpatient    4. Dementia: -cont home meds -delirium precautions   5. AKI on CKD: -neph following -renal US WNL -IVF -hold home ACE and HCTZ   6. Other chronic medical conditions: anxiety, T2DM, HTN, HLD, CKD
Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves 18 years old male patient who received 0.5 mL dose of vaccine MENACTRA lot U5839AA, expiry date- 05-Mar-2019 via unknown route in the left arm on 28-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapy were not provided. It was a case of actual medication error due to Expired vaccine used. No adverse event was occurred. (reported as none symptoms). 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. Documents held by sender: none.
Immediately p/receiving a dose of Td, pt exp sharp pain & tenderness; A large bruise appeared @ inject site the following day; 2 days post-inject, pt had a fever of 102, which dec to 101 the following day;
My arm was really sore after the vaccine and swollen glands which lasted a week. I took both Tylenol and Advil to help with my symptoms.  I tested positive for COVID-19 with a home test on 07/12/2022.  I had a sore throat with puss on the right side which I could remove with tissue.  I had a telehealth visit with my doctor which  she did not think I should take Paxlovid. I continued to feel bad , contacted asthma doctor and she agreed that I should not take Paxlovid.  I took Vitamin C, nose spray, Benadryl  for my symptoms.
Patient was given a pneumo 15 when she had already completed her series. patient did not have any adverse reactions. verified with director that patient would be okay. patient was informed of the mistake and was understanding.
first dose 3 years ago, never went back for second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The patient received the 1st dose and never went back for the second dose of Shingrix. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix which led to incomplete course of vaccination. No further details were provided at the time of the call. No vaccine information was provided at the time of the call because patient received the first shot at another facility. The reporter did not consent to follow up.
On 11/13/2022  I started feeling mild symptoms. I had a  sore throat and  fatigue for 2 days. On the 11/15 I had a telehealth visit and was prescribed a 5 day course of Paxlovid.  After 5 days I had no symptoms and tested negative after 7 days.
On 10/20/00, pt developed hives and mother gave Benadryl and reported by phone that it had resolved.
This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. Additional details were provided as follows: The patient was 19 year old at the time of reporting. The age at vaccination was not reported. The healthcare professional reported that patient had received complete Hepatitis B series and tested negative for hepatitis B antibody titer. Thus, leading the patient to be a therapy non-responder. The healthcare professional was not sure which Hepatitis B brand was used. No side effects were reported.
brain is fried; she's in a psych ward going insane/ psychotic break/ mental breakdown; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient's husband.  A female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN INJURY (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "brain is fried"; PSYCHOTIC DISORDER (hospitalization) with onset 2021, outcome "unknown", described as "she's in a psych ward going insane/ psychotic break/ mental breakdown".  Caller states that his wife had a psychotic break after receiving the both doses of the vaccine and that he has a written statement from a doctor confirming her mental breakdown was a direct result of receiving the Pfizer BioNTech Covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Member was administered Moderna 0.5 ml due to him being immunocompromised on September 22, 2022. On September 26th, 2022 we were informed by the pharmacy that this vial was defrosted on August 16th, 2022 and therefore had a use by date of September 11, 2022.
injection site pain (mild), runny nose (mild), headache (mild), generalized muscle aches (mild)
As per mom left upper arm with erythema, hot elevated rash 3"x 2 1/2 ".  2nd degree to vaccine area.
Whole body aches; chills; headache; extreme fatigue; lack of appetite; slight rash; feverish; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 18:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis and sleep apnea. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN), timolol maleate, brimonidine tartrate (COMBIGAN) and LATANAP, all taken for unknown indication from an unspecified date. The patient previously received VICODIN on unknown date for pain and experienced drug allergy. The patient also had allergy to related pain killers. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 16:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 03:30 the patient experienced whole body aches, chills, headache, fatigue extreme, lack of appetite, slight rash and feverish. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events whole body aches, chills, headache, fatigue extreme, lack of appetite, slight rash and feverish were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
client vaccinated with Pfizer vaccines in March and April 2021.  Symptoms of Covid developed 11/16/2021.  nasal congestion, cough , fatigue, headache, myalgia, sore throat, loss of taste and smell.  Received treatment of monoclonal antibodies on 11/19. Reported as a breakthrough case of Covid in a vaccinated person
Given IPV LA SQ, DTaP LA IM, 3-20-22, MMR SQ RA 2 days post 3-22-02 left arm (deltoid) appears red, swollen, hot to touch.
This is a spontaneous report from a non-contactable physician. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever, chills, blue fingers, back pain and muscle pain all on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about lot number cannot be obtained.
Shivers; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Shivers) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 2) and PFIZER BIONTECH COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Shivers). At the time of the report, CHILLS (Shivers) had resolved.            No concomitant medications were reported.  The patient had shivers for a whole day.  No treatment details were reported.  I-narrartive: 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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2022: Follow-up document included no new information.
pt recv vax; rash w/ low grade T; suspect vasculitis type rxn; reported to pub hlth p/ seen in clinic; mom reports rash until 30jul95;
1710 pt c/o itching (generalized (R) arm, vaccine administered (R) deltoid. Itching increased to both arms. HR 60 RR20 BP 128/94. Diphenhydramine 50mg po given. 1725-130/95, HR 85, 20. Itching to (R) arms and upper back, no difficulty breathing no change in LOC. 1740-120/90, 70, 20, pt claims itchiness has gone away. No change LOC. 1745- instructed parent to monitor for symptoms and notify emergency personnel if symptoms worsen.
3pm, day after vaccine, general malaise, fatigue, body aches, no fever. Slept for 2.5 hours and woke up feeling better. Went to bed early and feel fine.
Light headedness, weakness, queasiness, then nauseousness, severe shaking from from head to toe (lasting several hours) achiness all over, head pressure checked in emergency room, where they felt that as my husband & I both had vaccines & these strange symptoms w/in 20-30 mins following vaccination, it must be a reaction.