chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia on the right lung after booster shot) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 024M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PNEUMONIA (Pneumonia on the right lung after booster shot) (seriousness criteria hospitalization and medically significant). On 13-Dec-2021, PNEUMONIA (Pneumonia on the right lung after booster shot) had resolved.            No concomitant and treatment medication was reported by patient. It was reported that after booster vaccine at 12 midnight patient had the same symptoms that happened after the second shot. Patient was hospitalized again and had Pneumonia in the right lung again. The pulmonologist told patient to call Moderna and report it.  Company Comment: This case concerns an 87-year-old, male patient, with no relevant medical history reported, who experienced the unexpected event of pneumonia. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-428474 (Patient Link).; Sender's Comments: This case concerns an 87-year-old, male patient, with no relevant medical history reported, who experienced the unexpected event of pneumonia. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm 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 and no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative multiple times; (02Mar2023) Positive, notes: Began experiencing symptoms again and tested positive on 02Mar2023. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 18Feb2023 to 22Feb2023. The patient recovered from Covid after taking Paxlovid. The patient tested negative multiple times and all symptoms were gone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Under the arm was swollen the day following the vaccination, That evening swelling extended past the elbow, This now 36 hours after vaccination. Around 24 hours post vacc, the swelling decreased. Swelling increased again about 6 hrs later later.
Significant arm pain at site of injection starting at 5pm. Then developed vague aching throughout lower back, shoulder, and hips. Progressed to shooting pains (mild) into both legs and down both arms into fingers and toes. muscle aches and pains persisted until 4pm on 1/7. Also developed inflamed lymph node under left arm pit.
Information has been received from a nurse referring to 14 unspecified patients of unknown age and number. Information about patients' concurrent conditions and medical history was not reported. The nurse reported that on unspecified between 01-SEP-2015 and 18-MAR-2016, oral, ROTATEQ (lot: L004466; expiration: 02-AUG-2016 and lot: K015831; expiration: 18-APR-2016) was improperly exposed to <24F (exact temperature unspecified) for greater than 5 cycles into this range. On unspecified dates after 01-SEP-2015, these 14 patients each received a dose of the improperly exposed oral, ROTATEQ (dose not reported) listed above. It was unspecified which patients received which lot. No known adverse effects were reported. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine : symptoms started with rash and swelling at injection site.  Rash and itching progressed till it covers front and back of the trunk.  The rash appears and disappears but the itching is constant.  Treatment has been with over the counter antihistamine (Zrytec once daily, Claritin two times a day, Benadryl 50mg every 4-6 hours depending on how bad it itches).  We have also been applying OTC creams (Benadryl 2% and Hydrocortisone 1%).
Mild chills and not feeling great about 4am on 1/14/21 Tired feeling on 1/14/21 (no specific time) Nausea for about 30 mins on 1/14/21 around 3pm  Mild swelling around both eyes at 4am on 1/15/21, got slightly worse when I woke up at 8am.  I called employee health at work who told me to call my family doctor.  I called my family doctors office who told me to watch it closely and that I could take an antihistamine.  I took an antihistamine and the next day the swelling was essentially all gone.
Injection site feels hot to touch; Slight redness at injection site; Injection site is itchy; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site feels hot to touch), INJECTION SITE PRURITUS (Injection site is itchy), INJECTION SITE RASH (Rash at injection site) and INJECTION SITE ERYTHEMA (Slight redness at injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 036B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included POTASSIUM, METFORMIN and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced INJECTION SITE PRURITUS (Injection site is itchy) and INJECTION SITE RASH (Rash at injection site). On 14-May-2021, the patient experienced INJECTION SITE WARMTH (Injection site feels hot to touch) and INJECTION SITE ERYTHEMA (Slight redness at injection site). At the time of the report, INJECTION SITE WARMTH (Injection site feels hot to touch), INJECTION SITE PRURITUS (Injection site is itchy), INJECTION SITE RASH (Rash at injection site) and INJECTION SITE ERYTHEMA (Slight redness at injection site) outcome was unknown. Not Provided          Concomitant medication includes COPD Medications, Diabetes Medications, HBP Medications,Nerve Medication,Stomach Medication,Water Medication,Thyroid Medication, Blood Thinner Medication. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-132110 (Patient Link).
Vomited; Tired; Fever; arm is sore; Lightheaded; pre-filled syringe that had been at room temperature/improper storage of dose given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (pre-filled syringe that had been at room temperature/improper storage of dose given to patient), DIZZINESS (Lightheaded), VOMITING (Vomited), FATIGUE (Tired) and PYREXIA (Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-May-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced PRODUCT STORAGE ERROR (pre-filled syringe that had been at room temperature/improper storage of dose given to patient). On 22-May-2021, the patient experienced DIZZINESS (Lightheaded), FATIGUE (Tired), PYREXIA (Fever) and MYALGIA (arm is sore). On 22-May-2021 at 1:00 AM, the patient experienced VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) on 23-May-2021 for Adverse event, at an unspecified dose and frequency. On 21-May-2021, PRODUCT STORAGE ERROR (pre-filled syringe that had been at room temperature/improper storage of dose given to patient) had resolved. At the time of the report, DIZZINESS (Lightheaded), VOMITING (Vomited), FATIGUE (Tired), PYREXIA (Fever) and MYALGIA (arm is sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   On 23-May-2021, the patient's arm was sore and so they used a cold compress.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Newevents added.
localized pain on day of & day p/vax;redness & swelling 5 days p/vax;
gen rash & mild breathing difficulties;tx none;mom did not follow through to notify MD till 4 days later then mom brought in pt;
3 days p/vax pt devel red raised wheal like rash; rash lasted 3 days; no swelling of face or eyes; no elevated temp;
arm was a little sore where the needle went in; 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 male patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 28Jan2021, for COVID-19 immunisation, reaction(s): "shot was not administered correctly". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "arm was a little sore where the needle went in".  Additional information: Patient stated he had no other side effects other than his arm was a little sore where the needle went in. He wanted to know if it was safe if he receives a third dose of the vaccine because he thinks the first one does not count, so it would be like getting 2 doses.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 29-JUN-2012, a healthcare provider at a department of health administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 11-MAR-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Pt. developed fever/chills, aches 39.7 C with Rx of IV fluids, antipyretics & eventual recovery to normal after 2-3 days at home.
Runny nose; Slight cough; Tested positive for COVID-19; A spontaneous report was received from a nurse concerning a 91-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for COVID-19, and experienced runny nose and slight cough.   The patient's medical history was not provided. No concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.   On 03 Jan 2021, the patient tested positive for COVID-19 by PCR analysis and also experienced runny nose and slight cough.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, tested positive for COVID-19, runny nose and slight cough was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse via company representative refers to a 2 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 16-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # L042836 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
10APR95 non tender, non erythematous induration of mid lateral aspect lt arm; no streaking, no lymphadeno; 6APR95 sore arm;
Sore arm afternoon of first shot into next day and then went away.  Me week later area where shot administered was very hot and itchy which lasted about 3-4 days.
Pain, erythema, induration at injection site. Extensive erythema and induration appx 10 x 15 cm.
tinnitus ... periodically in my left ear.   Started after the booster.   Buzzing more than a ringing.    Not constant throughout the day - comes and goes....   It has gotten better - and less and less each day.
At 09:14 am, Client reported feeling dizzy immediately after getting vaccinated by second dose Pfizer. Vital signs were initiated within normal limits. Client complained of dizziness accompanied by headache. Co-worker was made aware and decided to call EMT on site and activated EMS. Client was further observed, vital signs, crackers and water was given. Oxygen was administered by Emergency medical tech. Emergency Medical Services arrived at 09:51 am. Client Stated " without oxygen I feel dizzy. Client voluntary agree to be taken to hospital. Client left ambulating with fellow officer, EMT, and EMS at 09:53 am.
(L) bicep developed erythema with swelling & warmth. Pt treated with KEFLEX for cellulitis.
I got the moderna vaccine on 02/23/2021 1st dose. My LMP was 02/03/2021. On 3/5/2021, I took a pregnancy test due to nausea and it was positive. I was super concerned due to getting the covid vaccine around the time of ovulation and so I contacted my FNP  and started getting serial Hcgs due to right side pelvic pain which was confirmed to be a hemorrhagic corpus luteal cyst.  A couple of weeks later, My 4th Pregnancy was confirmed via trans vaginal ultrasound  with a strong heart beat on 03/30/2021 and a gestational age of 7 weeks exactly and  a due date of 11/16/2021.   I decided not to get the 2nd dose of the vaccination due to concerns of miscarrying in the first trimester and limited studies on covid vaccine and it?s safety despite having 3 healthy children and zero miscarriages in the past.  On to my next appt on 04/19/2021, the fetus should alreayd measure at 10 weeks. Without having any abdominal pain, bleeding, or spotting, the baby stopped growing and measured at 7 weeks and 5 days with no heartbeat. Again, I had no symptoms of miscarrying at all.  We decided for a d&c and sent the fetal tissue for genetic testing. My d&c was performed on 04/22/2021 at 12pm.  We are currently waiting for genetic testing results at this time.
Redness on injection site getting bigger and wider, swollen and firm to touch, today, is day 3, warm, mist compress, ZYRTEC 5 mg every day.
fatigue; Fever; Chills; Malaise; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involved a 72 year old male patient who experienced fatigue, fever (Pyrexia), chills and malaise, while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23).  On 28-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number- UJ470AB and unknown expiration date) via unknown route at unknown administration site.  On an unknown date, the patient experienced fatigue, fever (Pyrexia), chills and malaise, unknown latency following administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  No relevant laboratory data was reporting.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for fatigue all the events at the time of reporting.
Bells Palsy due to facial swelling and jaw pain. Swollen lymph nodes.
This spontaneous report has been received from a registered nurse via Pfizer referring to a female patient of unknown age. The patient's current condition and medical history was not reported. Approximately in 2015, last year, the patient was vaccinated the first dose of PNEUMOVAX 23 (lot number, expiration date, dose and route unknown). Concomitant therapy was not reported. On 12-FEB-2016, the patient was vaccinated with the second dose of PNEUMOVAX 23 instead of the ordered PREVNAR 13. The patient would be scheduled to receive PREVNAR 13 at a later date. The patient did not have any adverse effects. It was also reported as that the patient had received PREVNAR last year. The patient was ordered to receive PNEUMOVAX 23 this year, but received PREVNAR on 12-FEB-2016. Additional information has been requested.
N17.9 - AKI (acute kidney injury) (CMS/HCC) N17.9 - Acute renal failure, unspecified acute renal failure type (CMS/HCC)" R79.9 - Elevated BUN R79.89 - Elevated serum creatinine
Vomiting, headache (felt like my brain was melting), high fever, chills I couldn?t control.
Complained of rash behind both ears, front, neck, left arm. Rash itches slightly, scattered patches with pink papules lasted 4 days. Pt had gone in hot tub that previous weekend and had similar rash after hot tub before.
Sore shoulder at injection site beginning evening of 4/1/21, which persists at this time. Severe chills on 4/2/21 from 2-3:30 AM, and subsequent chills (less severe) periodically later that day.  Body aches starting in the middle of the night on 4/2/21, which persist. Fatigue and headaches throughout the day on 4/2/21. Runny nose starting around 2:00 PM on 4/2/21.
diabetes; high blood pressure; This is a spontaneous report from a Pfizer Sponsored Program. A contactable male consumer reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) at single dose for COVID-19 immunisation on 16Jan2021. Relevant history and concomitant drugs were unknown. Relevant history and concomitant drugs were unknown.  The patient wanted to see his family doctor about his conditions like diabetes, high blood pressure and also about going to a urologist. Outcome of events was unknown.   Information about Lot/Batch has been requested.
Hives, itching started 11/7/04 in 5-6pm. No fever/chills/SOB, wheezing
Initial unsolicited report received from a physician on 31 October 2016. This case involves a 41-year-old female patient who was vaccinated with second dose of FLUZONE QIV (batch number: UI658AB; expiry date- 30 June 2017, dose, site of administration) in right deltoid on 12 October 2016. The patient had a medical history of seasonal allergies, migraines, GERD, anxiety and depression. Illness at the time of vaccination was none. The patient did not receive any other vaccinations within four weeks of above vaccination. No other information regarding concomitant medications was available. On 13 October 2016, one day following the vaccination, the patient developed low back pain non-radiating. It was reported that previously the patient had received first dose of FLUZONE QIV. The patient required ER/doctor visit. Laboratory data was reported as none. The patient received corrective treatment with anti-inflammatory, ice and heat with rest. The outcome of the event was recovering (reported as 'she is improving at this point but not recovered'). List of documents held by sender: none.
Double vision pain at base of neck / brainstem. Numbness in toes and legs, Esp. left leg.  11/06/09 Medical records recieved for DOS 11/06/09: Neuro consult visit. Facial numbness. Resolved in 2 days. Vertical diplopia and binocular vision persists. Tilting head to L helps. Parasthesia persist  bil feet and legs,  spread to hands and forearms bil. Limb pain and weakness, unsteadiness, bladder fx disturbance. Action tremor bil UE w/finger to nose testing.  All other neuro PE WNL.  10/28/09 Medical records received for dates 10/8/09 to 10/12/09. Pt seen by neurologist. DX: postvaccinal encephalomyelopathy, rt. 4th cranial nerve dysfunction, action tremor and myelopathy. Presenting sx: pt. states received flu vax 9/30, on 10/1 c/o vertical diplopia with binocular vision, 10/4 c/o tingling parethesia bilat legs and feet. Assessment: WNL, evidence of previous back surgery. Diagnostics ordered. ICD9 code 341.20      11/06/09 Medical records recieved for DOS 11/06/09: Neuro consult visit. Facial numbness. Resolved in 2 days. Vertical diplopia and binocular vision persists. Tilting head to L helps. Parasthesia persist  bil feet and legs,  spread to hands and forearms bil. Limb pain and weakness, unsteadiness, bladder fx disturbance. Action tremor bil UE w/finger to nose testing.  All other neuro PE WNL.   12/10/09 Hospital records received. Service date 10/19/09. Patient presents with c/o pressure in head and base of skull, vision diminished, double vision. Paraparesis.