chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling horrible; couldn't move her left arm; whole body ached so bad; slight headache; nausea; fever; chills and stated she was "so cold" and "couldn't get warm"; slight body aches; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (chills and stated she was "so cold" and "couldn't get warm"), MYALGIA (slight body aches), FEELING ABNORMAL (feeling horrible), MOBILITY DECREASED (couldn't move her left arm) and MYALGIA (whole body ached so bad) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Drug allergy (cipro). Concomitant products included GLIPIZIDE, METFORMIN, SIMVASTATIN, LOSARTAN, VITAMIN D NOS, CALCIUM, ZINC and MAGNESIUM for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced CHILLS (chills and stated she was "so cold" and "couldn't get warm") and MYALGIA (slight body aches). On 04-May-2021, the patient experienced FEELING ABNORMAL (feeling horrible), MOBILITY DECREASED (couldn't move her left arm) and MYALGIA (whole body ached so bad). 04-May-2021, the patient experienced HEADACHE (slight headache), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (chills and stated she was "so cold" and "couldn't get warm"), MYALGIA (slight body aches), FEELING ABNORMAL (feeling horrible), MOBILITY DECREASED (couldn't move her left arm), MYALGIA (whole body ached so bad), HEADACHE (slight headache), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a malae patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: 3 patients vaccinated with vaccine that was stored at -2,56C.
I received the vaccine in the early afternoon. By approximately 9PM I began experiencing all the typical AEs (nausea, vomiting, muscle aches, etc.) and also lower back pain. I mostly recovered from the other typical AEs by the next and fully recovered in 3 days. However, my lower back pain (bilateral, soft tissue) did not go away. I have chronic midline low back pain without sciatica. Treatments include massage therapy, ice, heat, rest, movement, and ibuprofen. To date, I have not healed. This AE is persistent and causing substantial disruption of my ability to conduct normal life functions.
Patient came to clinic on 11/14/18, she reports the afternoon after receiving the PNEUMOVAX vaccine she reportedly had a lump on her inside of her left forearm she reports it was swollen, red and painful and there was a red streak down her arm below this lump. She showed RN on 11/14/18 this area, the area still had swelling about 1/2 cm high and 3 cm by 3 cm area, it was not red or painful. The RN received a call on 11/27/18 reporting that she now having pain in the same arm this time on the back of her arm from the elbow to the shoulder, there was no swelling or red area. Her physician was contacted.
Fever and fatigue Day 2-5 after 2nd  shot. Day seven extreme fatigue, brain fog, earache, sore throat, worsening through day ten. Day ten awoke and could not get breathe in. Contacted physician and started taking steroid and antibiotic. Symptoms remained for a few days longer. Prescribed an inhaler and asthma meds on approximately day  15. Felt weak, unable to focus, sickly, hard to breathe for a few months after the second shot.
2 inch circle rash round on arm near injection; itchiness; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash), PRURITUS (Itchy) and PAIN (Soreness) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash), PRURITUS (Itchy) and PAIN (Soreness). On 08-Apr-2021, VACCINATION SITE RASH (Vaccination site rash), PRURITUS (Itchy) and PAIN (Soreness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown by the reporter. Treatment medication include Diphenhydramine
Red rash; Raised rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) and RASH PAPULAR (Raised rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) and RASH PAPULAR (Raised rash). On 12-Feb-2021, RASH ERYTHEMATOUS (Red rash) and RASH PAPULAR (Raised rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  Patient was treated with an unspecified anti-itch cream.
High platelets; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for two patients. This is second of two reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician (through the healthcare professional) would like to know if the company had any reports of thrombocytosis post vaccination. The physician had seen two patients who had high platelets after the vaccine on an unspecified date. There is no reported platelet value for this patient. The healthcare professional has no information on the patient since the physician only asked her to call. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021017585 Same reporter, product, and event; different patient
pt recv vax 31DEC96 & pt felt faint, exp h/a & was pale & very dizzy;the nurse also reported pt two brothers who exp same type rxn p/3rd dose of vax;
This spontaneous report as received from a pharmacy student refers to an unspecified number of patients (gender and age unknown). On an unknown date the patients were vaccinated with a dose of RECOMBIVAX HB (lot number, route and dose were not reported). The pharmacy student reported that an unknown number of doses of RECOMBIVAX HB that were exposed to temperatures of -9 degrees Celsius for 72 hours, may have been administered. No adverse effect were reported. This case is related to case MARRS # 1212USA005526 (same reporter link). Additional information has been requested.
Hand and feet cramping, severe pain in knees, couldn't hardly walk, pain in calf in left leg, red and swollen on left calf. Had to walk with cane. Lasted several months. Symptoms are subsiding, but still experiencing knee pain.
shoulder pain; low grade fever; This is a spontaneous report received from a contactable consumer. A 43-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE, Solution injection), via an unspecified route of administration on 10Feb2021 (at the age of 43-year-old) as single dose for covid-19 immunisation. Patient previously took first dose of bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were unknown. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. On the same day, patient experienced shoulder pain for 24 hours and potential low grade fever. The patient underwent lab tests and procedures which included body temperature which showed low grade fever. Therapeutic measures were not taken due to the events. The outcome of the events was recovered on unspecified date.  This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
I received my 2nd. Moderna vaccine @ 9:24 am at Publix pharmacy, at midnight I developed a fever and chills, headache and pain in every joint in my body I felt like I had the flu,
I was standing in my home and had a sudden onset of heart palpitations, dizziness, hot flash, and vision began to go black.  I quickly got down on the floor. I started to feel better after a few seconds, but  I stayed sitting on the floor for 30 minutes.
Raised, red, itchy area around the injection site (~1? in total diameter) starting about 12-16 hours after administration
My partner tested positive earlier, in late January I contracted COVID-19 on 01/25/2023. I tested positive at home. I consulted with my doctor if I should be taking PAXLOVID. They checked my other prescriptions and recommended that I can take it. My symptoms were sore throat, soon after I had nasal congestion. It's possible I had a fever for half a day at 98.6, which is a little high for me. It was hard to say, I might have had body aches. I would say two to three days I started to feeling better. Until, the following weekend on 02/04/2023, my symptoms were returning mostly the sore throat and the nasal congestion. I called the doctor again and was told I could have rebound COVID-19 due to the PAXLOVID. The symptoms lasted another good week. I was blowing my nose for a week; I did start feeling better by the 14th and I was testing negative. I am feeling fine now. I never had to blow my nose that much in my life, I went through three or four boxes of KLEENEX.
Pt reports sore arm, fatigue, evening nausea, and possible mild fever (not confirmed) since given PNEUMOVAX on 08/17/16. Denies redness or swelling at injection site. Denies taking any fever suppressant medication. Denies vomiting/ diarrhea. Since then, pt has experienced migratory, intermittent and severe arthralgias. No history of chronic pain.
Cardiac arrest. On Sept. 30th after exercising moderately on an elliptical for 30 min, I felt intense chest pain. I drove home, took two ibuprofen, and sat down. Within 20 minutes I had vomited and the stopped breathing. My wife called 911. The EMTs performed CPR for 20 min and used the defibrillator  4 times. When my heart started I was taken to the local for stabilization and then rushed to Medical Center. No issues were found with my heart or coronaries. I exercise regularly. A doctor at the Medical Center asked when I received the COVID vaccination. I was advised to report the incident.  After 11 days in the hospital with no explanation,  an ICD was implanted.
The patient states the next morning her right upper eye lid became swollen.  She has a small elongated itchy patch on the inner eyelid corner.  She reports no pain.  Her biggest complaint is itching.   She plans to take an oral antihistamine (loratadine) to help with the itch.  She may follow up with her provider.
Dose 1 on 3/21/21: no adverse event Dose 2 on 4/14/21: no adverse event  Booster on 12/1/21: vision in right eye diminished by 80% on 12/21/21.
Patient presented to COVID vaccine line on 10 Feb 2021.  Notes history of COVID infection in Dec 2020 having received Bamlanivimab on 29 Dec 2020. Pt received COVID vaccine dose #1 on 1/19/21 (within 90 days of monoclonal Ab treatment).  Provider contacted DHA IHS clinical help line. Discussed case with Dr. He recommends waiting for 90 days from monoclonal Ab before patient receives second dose. Reasonable given natural infection in Dec 2020 and having already received dose#1 (which she tolerated). Next dose due after 29 Mar 2021. Pt updated on recommendation.
Swollen, erythymatous thigh (entire thigh swelled up and hot to touch), fever (101) and nodule at injection site, all symptoms lasting for 2 weeks. Hypersensitivity reaction
Vasovagal syncope while sitting upright in chair.  Leaned back, legs raised, cool cloth to neck/face.  Regained consciousness within ~15 seconds.  No injury, no sequelae.
still got shingles/ SUSPECTED VACCINATION FAILURE; shingles, light case; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Apr-2022 Reporter's Comments: This case was reported by the patient's bother/sister via interactive digital media. The reporter stated that one might be safe, but the patient still got shingles after vaccine, doctor said it was a lighter case. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
when presenting for updated bivalent covid booster patient was asked if she had an arm preference.  She replied "you might as well put in the left arm as I still havent recovered from the last one. Upon further questioning she did deny that she had suffered from covid arm but did have SIRVA. She then explained to the vaccinator that it was a condition known as shoulder injury related to vaccine administration
Pt recv vax on 11/11/93; post vax pt exp fever & cease of all developmental milestones
Reports red rashes to bilateral upper extremities within developing 3 minutes post vaccination. Felt lump to throat developing, dizziness, warm flashes, felt like fainting, and shortness of breath. She was taken immediately to ED and was provided medications in the ED- IV benadryl and sodium medrol. Lump to throat relieved after medication IV administration. Was prescribed diphenhydramine and prednisone on discharge.
expired doses administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered to patients) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered to patients). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported.
Patient experienced severe headache, fatigue, chills, fever, dizziness, body aches, and chest pains.  Patient also experienced high heart rate and panic. Caused patient to seek care with primary care provider.
Deceased; collapsed; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Deceased) and LOSS OF CONSCIOUSNESS (collapsed) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Deceased) (seriousness criteria death and medically significant) and LOSS OF CONSCIOUSNESS (collapsed) (seriousness criterion medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (collapsed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  Patient also reports that her Daughter In-law received the Moderna Covid-19 vaccine booster dose in 2021 and then passed away 10 days later. Patient collapsed and went to the hospital and was deceased. Her Daughter in laws husband, the callers son told his Mother the caller that the doctor who pronounced his wife deceased verbally told him that his wife died from the Moderna Covid-19 vaccine.  Company Comment: This spontaneous case concerns an adult female patient of unknown age, with no medical history reported, who experienced a serious (medically Significant) unexpected event of collapse and Serious (Death, Medically significant) unexpected event of death around 10 days after receiving a dose of mRNA-1273 vaccine. Patient collapsed and went to the hospital and was deceased. There was no information provided about the patient's age, underlying medical conditions, concomitant medications, onset date and clinical course of the events, associated symptoms, final diagnosis, diagnostic and treatment details autopsy details and cause of death. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Reporter did not allow further contact; Reported Cause(s) of Death: Deceased
No adverse reaction occured however this was a vaccine error due to the fact that the patient was immunocompromised on Humira and received a live vaccine. 3 weeks after vaccine administration patient still had no rash, fever, or other adverse symptoms.
A little soreness in the arm; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer report for husband. A 73-year-old male patient received bnt162b2 (BNT162B2) via an unspecified route of administration, dose 1 on 13Jan2021 (Batch/Lot Number: EL3249) as 1ST DOSE, SINGLE, and dose 2 on 02Feb2021 (Batch/Lot Number: EL9265) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid 19 on 06May2021. Patient had no issues after the shot but a little soreness in the arm. The event outcome was unknown.
No additional AE/PQC reported; VARlVAX had been administered via the IM route to a patient; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not reported.  On 28-JAN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (strength and dose were not reported, lot # S031494, expiration date was 07-OCT-2021) intramuscularly (IM) for prophylaxis and sterile diluent (strength and dose were not reported, lot # T006500, expiration date was 16-SEP-2022) intramuscularly for prophylaxis (incorrect route of product administration).
Approximately 12 days post vax, the pt developed a fever and then a rash appeared the following morning.
Was supposed to be given booster dose and was given 0.5 mL of the Moderna monovalent 6 months ? 5 years
63 y.o. man with hx of prediabetes, diverticulosis, and family hx of CAD who presented on 4/12/21 with chest pain.(Pt had first dose of Pfizer Covid Vaccine on 3/25/21, with no causative factors for Pericarditis). He developed sternal CP radiating to both shoulders while working in the garden on 4/11. The pain improved with acetaminophen and sleeping overnight, but still was present in the morning, prompting him to go to the ED. EKG showed diffuse 1-mm ST segment elevations, prompting emergent cardiac catheterization + coronary angiography --- > no obstructive CAD. cTnI and CK-MB were normal. He had WBC 14.1 & CRP 9.3, which raised suspicion for acute pericarditis, although his symptoms were not typical. Overnight 4/12-4/13, he developed new-onset rapid atrial fibrillation which was treated with IV diltiazem and metoprolol tartrate. He is discharged with colchicine and metoprolol tartrate. The CP resolved postprocedurally and did not recur.
10:16 Pt came up to me and said she worked downstairs. She had her vaccine earlier and was feeling very itchy, like hives all over. She stated she was shaky and felt anxious. I walked her over to the AMR team. 10:17 epinephrine given by AMR in Right Arm 10:20 VS:140/81, 137, 100% 1025 EKG leads applied  1025 IV L arm with flush  1028 Benadryl 50 mg IV given by AMR 1029 BS 156  Patient had a blank expression and when asked to respond she stated it felt like she couldn't take a breath. We asked if she wanted some water and she said yes. We gave her water but she didn't drink any. AMR transferred her to stretcher and transported to ED at 1035.  1034 VS HR128, 100%  She stated that she had a hx of anaphylaxis of unknown cause Pfizer vaccine dose #1 given 1/6/21 in right arm- only side effects were fever and chills
headache, shaky chills, body aches and nausea within 3 hours of vaccination; these symptoms continued overnight;  low-grade fever started the following morning;  within 30 hours of receiving the second Pfizer shot, all symptoms suddenly disappeared and didn't return
Tested positive for covid19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid19) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M26A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, MAGNESIUM, ATORVASTATIN CALCIUM (LIPITOR) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced COVID-19 (Tested positive for covid19). At the time of the report, COVID-19 (Tested positive for covid19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.