chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "SI joint dysfunction hence methocarbam" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: METHOCARBAMOL taken for arthropathy, start date: 04Apr2022; HYDROCHLOROTHIAZIDE, start date: 01Aug2020; GABAPENTIN, start date: 25Jan2021; LOSARTAN, start date: 01Aug2021. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 12May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of suspected covid-19 which included Paxlovid from 10May2022 to 15May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I have excruciating pain in joints and back, that has not gone away,  by Friday 3//5/201 I was doubled over in pain on 3/5/2021 I had had to go to the ER where they diagnosed kidney stones, the left kidney stone passed, and still have a small kidney stone in right kidney.  I still over a month after the shot, I am in a lot of pain and  I have loss of energy. The pain is in my lower back, my joints radiating to my abdomen and upper legs. I find it difficult to do any activity.  This all happened after the second Moderna shot. I contracted Covid-19 March 7 2020 and had the same pain for months.
pt recvd vax;had episode of high pitched crying,lasted for hrs;pt still very fussy;crying thru next day according to mom;saw MD,stated, was a rxn to DTP & advised ped DT;
Outside of the "normal" side effects I was physically ill with what seemed like a severe case of food poisoning.  I got sick every 30 - 45 minutes from 9pm until 8am the next morning.
Around the beginning of November, I started experiencing a low roaring sound in my ears (like a lawnmower), especially at night when it's very quiet. I initially thought that there was something running in my house i.e. roof wind turbines, heating system, plumbing, appliances, etc. However, I couldn't find anything making the same noise that I was hearing. I asked my wife many times if she heard anything, but she did not. I ordered some earplugs and started using them around the first week of November, but they didn't really help. So, I started wearing my Bluetooth earpiece to bed and playing music of ?midnight rain and thunderstorms?. That?s the only thing that really helped and I continue doing that to this day. On December 5, I requested an evaluation by my doctor. I am waiting for an appointment date.
Approximately 10 minutes after receiving 1st covid Pfizer shot, patient reported feeling light headed and dizziness.  He reported blurry vision,ringing in ears and was looking very pale.  He was evaluated and monitored any other symptoms until paramedics came.  Water and ice was given to patient while he waited.  paramedics came and monitored patient and left
Patient is a 78  years old female patient of PRIVATE, MD with history of CAD, afib, HTN, Renal artery stenosis, CKD 3 presented to local General Hospital with general weakness.   Paroxysmal atrial fibrillation with RVR, likely due to COVID CAD  Hypertension Heart rate controlled Continue amiodarone Increased metoprolol to 50 mg twice daily Continue Imdur, aspirin, statins Continue Coumadin and monitor INR Continue clonidine and Norvasc for BP control Monitor BP and heart rate and follow-up with PCP for medication adjustment   Weakness Deconditioning Fall due to weakness COVID infection Viral sepsis, POA; due to above; resolved Acute hypoxic respiratory failure, resolved Presented with dry nonproductive cough associated with shortness of breath  Respiratory status is stable Currently on room air Supportive care Supplemental oxygen as needed. Incentive spirometry Tessalon for cough PT OT Discharge to short-term rehab   AKI Due to p.o. poor p.o. Creatinine 1.4=> 1.2=> 1.1 S/p IVF Encourage oral hydration
A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Oct-2021 and was forwarded to Moderna on 29-Oct-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     The patient's past medical history included Painful ankle and Drug use disorder (History of Drug Use). Concurrent medical conditions included Drug allergy (Tylenol) and Obesity (on 15-02-2020 the weight was 102.4kg on 04-08-2021 the weight was 133.4kg).    On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use). On 02-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: elevated (High) ELEVATED BLOOD PRESSURE.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications was not reported.   This case was linked to MOD-2021-303426 (Patient Link).
no adverse event; Patient was inadvertently and concomitantly administered PROQUAD and VARIVAX on 09/28/2022.; This spontaneous report was received from a healthcare business professional referring to a patient of unknown age and unknown gender. The patient's concurrent conditions, medical histories, concomitant therapies and drug reactions or allergies were not reported.  On 28-SEP-2022, the patient was inadvertently and concomitantly administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) orsubcutaneous injection, lot #U022729, expiration date: 16-JAN-2023, therapy type: recombinant human albumin (rHA); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U016062, expiration date: 20-MAY-2023. both administered for prophylaxis (strength, dose, route of administration and anatomical site of administration were not provided regarding both of vaccines) (overdose). No additional adverse event reported.
I had hives show up on my wrists about a day and a half after receiving the vaccine. There have been no other life changes.
Extreme general body aches Fever Chills Nausea Headache Exhaustion
Joint pain-hips,knees, shoulders, neck, fingers, toes; flu-like symptoms, fatique, muscle pain-esp biceps, forearms, legs, eye pain, pressure, facial numbness, headaches, random sharp pain and twitching, chest pressure and pain with radiating numbness
The patient was vaccinated with RabAvert in right outer thigh; RabAvert and HRIG were administered on the same leg; Case reference number US-BN-2022-002010 is a spontaneous case report initially received on 22-Aug-2022 from pharmacist (reference number: USBAV22-1110) and concerns a 12-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with RabAvert (rabies virus (inactivated, strain flury LEP); batch number: unknown) vaccine at dose reported as 1.0 ml, intramuscularly, in right outer high, for post-exposure immunisation (post-exposure rabies treatment) and with co-suspect HRIG (immunoglobulin human anti-rabies) at an unknown dose, reported also as half, route at the same leg, for unknown indication (explicitly coded as 'vaccine administered at inappropriate site' and 'product administration error').  At the time of this report, it was unknown which dose this was or if patient experienced adverse events.  Additional information received on 22-Aug-2022 included local case ID.; Reporter's Comments: A 12-year-old female patient was vaccinated with RabAvert, 1 ml, intramuscularly, in the right outer thigh (which is considered product administered at inappropriate site), for post-exposure rabies treatment. It was unknown if it was first dose or successive dose. Co-suspect medication was HRIG (human anti-rabies immunoglobulin), and it was administered as a half dose via unknown route at the same leg as RabAvert (which is considered product administration error due to the requirement to administer the two products at distant injection sites). No associated adverse events have been reported with the reported medication errors. Product administered at inappropriate site and product administration error are considered listed per company convention. The patient's medical history and concomitant medications were not reported. Product administered at inappropriate site and product administration error are assessed as not related to RabAvert, but to human factor. The case is non-serious.; Sender's Comments: A 12-year-old female patient was vaccinated with RabAvert, 1 ml, intramuscularly, in the right outer thigh (which is considered product administered at inappropriate site), for post-exposure rabies treatment. It was unknown if it was first dose or successive dose. Co-suspect medication was HRIG (human anti-rabies immunoglobulin), and it was administered as a half dose via unknown route at the same leg as RabAvert (which is considered product administration error due to the requirement to administer the two products at distant injection sites). No associated adverse events have been reported with the reported medication errors. Product administered at inappropriate site and product administration error are considered listed per company convention. The patient's medical history and concomitant medications were not reported. Product administered at inappropriate site and product administration error are assessed as not related to RabAvert, but to human factor. The case is non-serious.
received 2nd dose on 2/11/2021.  Woke around 4AM on 2/15/2021.  Noted blurry vision in left eye.  By 8am had progressed to blackness  starting at inner visual field and spread to total blindness by 9:30am.  Went to urgent visit with optometrist.  Appt was made for urgent work in with a Retinal Specialists on 4/16/2021.  Diagnosed with left retinal vein thrombosis.  Ordered further testing.  MRI of brain and orbits, TEE, carotid ultrasound and sent to hematology/oncology for evaluation.  Only finding on bloodwork was elevated homocysteine.   Being treated for HTN now with  Metoprolol, Amlodipine, Losarten/HCTZ, Crestor and BASA, MVI.  Vision is unchanged.  Blindness remains in left eye.  Right eye at this point is unaffected.
Information has been received from a office manager, for GARDASIL, a Pregnancy Registry Product, concerning a 23 year old female who on 11-SEP-2008 was vaccinated with the first dose of GARDASIL (0.5ml, IM). On 31-OCT-2008 the patient received the second dose of GARDASIL (0.5ml, IM, lot# 659653/1448U). Concomitant therapy included omeprazole and DIFLUCAN. Subsequently the patient got pregnant on an unspecified date. In April 2009, the baby girl was born prematurely and was on an incubator. The patient had a 2 month postpartum visit on 30-JUN-2009. A physician had a note in a chart saying the third dose of GARDASIL would hold off since the patient was breastfeeding. At the reporting time the outcome was unknown. Additional information has been requested.
The afternoon following her injection, she became extremely fatigued/ had body aches/ and sore, swollen arm at injection site. This lasted 3 days per her report. Redness/swelling and pain is still evident.
Shivering/Teeth chattering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EW0176) 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: CHILLS (non-serious), outcome "unknown", described as "Shivering/Teeth chattering".  Additional information: Patient got the vaccine (Covid-19 Vaccine) earlier today patient was received first shot and it was around 4 O'clock and now it was 2:30 in the morning but like 30 minutes ago patient started like patient don't know patient just had a bunch of shivering but patient wasn't patient not had cold or hot, it was weird it just like patient teeth was chattering. Patient don't know if it was normal but it was a lot.  No follow-up attempts are possible. No further information is expected.
Allergic reaction to Afluria Quadrivalent; This is a non-serious spontaneous case from, initially received from other health professional (nurse) on 22-Oct-2018, concerning a female patient of an unspecified age.  On an unspecified date in 2018 (reported as a couple of weeks ago), the patient was administered Afluria quadrivalent [influenza vaccine, batch number: YF37506 (reported as YF35706), expiry date: 06-Jul-2019, dose, route of administration and anatomical location: not reported] for active immunization against influenza.  On an unspecified date after vaccination, the patient experienced an allergic reaction to the vaccine.  The outcome of the event was not reported at the time of this report.  The reporter assessed this case as related to the suspect product.  Non-significant case amendment (22-Oct-2018): Code (+1) was added for fax number in the general tab. No changes were made in the narrative.  Non-significant follow up received on 26-Dec-2018: This case was considered as lost to follow up as the reporter could not be contacted to gather further information Added reference number (Med Info Number: SEQ18-06870) in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A female patient of an unspecified age experienced an allergic reaction to the vaccine, on an unspecified date after vaccination with Afluria quadrivalent. The causality of the event was taken as unassessable due to the lack of information regarding the onset latency of the event.
This spontaneous report as received from a Licensed Practical Nurse refers to two unspecified patient of unknown age and gender. Information on patients pertinent medical history and concurrent condition was not reported. On 22-APR-2016, two patients were vaccinated with improperly stored (Oka-Merck) PROQUAD lot # M003435, expiry 19-JUL-2017 (dose and route not reported). No adverse effects were reported. The data loggers were used. On unspecified date, the temperature was 6.5 Fahrenheit (F) for a time frame of 13 minutes and was back in range. A previous temperature excursion on unspecified date was reported to the same lot number, previously exposed to 6.7 F for 13 minutes. The total cumulative time out of range was 26 minutes. No additional information was provided. This case is one of the two reports received from the same reporter. Additional information has been requested.
Redness; Flu-like Symptoms; Low-grade Fever; Wrong Route of Administration; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis.   On 4th June 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 4th June 2019, less than a day after receiving Shingrix, the patient experienced erythema, influenza-like symptoms, low grade fever and intramuscular formulation administered by other route. On 5th June 2019, the outcome of the influenza-like symptoms and low grade fever were recovered/resolved. On an unknown date, the outcome of the erythema was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the erythema, influenza-like symptoms and low grade fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix subcutaneously rather than intramuscularly on the right arm, which led to intramuscular formulation administered by other route. Flu-like symptoms and low-grade fever were lasted for approximately 1 day. This case has been linked with US2019103301 and US2019102443, reported by the same reporter.
2 days following 2nd set of immun awakened from nap @ 1130AM limp, colorless & lethargic lasted approx 30 to 60 min;
Left arm itchy; left arm hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Left arm itchy) and VACCINATION SITE PAIN (left arm hurting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Cholesterol and Depression.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Left arm itchy) and VACCINATION SITE PAIN (left arm hurting). At the time of the report, VACCINATION SITE PRURITUS (Left arm itchy) and VACCINATION SITE PAIN (left arm hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pain; Feel feverish; Nausea; Extreme dizziness; Cold sweats; Burning inflammation throughout their body; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning inflammation throughout their body), DIZZINESS (Extreme dizziness), COLD SWEAT (Cold sweats), PAIN (Pain) and PYREXIA (Feel feverish) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced BURNING SENSATION (Burning inflammation throughout their body). On 11-Mar-2021, the patient experienced DIZZINESS (Extreme dizziness), COLD SWEAT (Cold sweats), PYREXIA (Feel feverish) and NAUSEA (Nausea). On an unknown date, the patient experienced PAIN (Pain). On 11-Mar-2021, BURNING SENSATION (Burning inflammation throughout their body) and PAIN (Pain) had resolved. At the time of the report, DIZZINESS (Extreme dizziness), COLD SWEAT (Cold sweats), PYREXIA (Feel feverish) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2017, the patient's healthcare provider at health care facility administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2017, the patient was treated by his healthcare provider at the same facility for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, 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, 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; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
No adverse event; 11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    It was unknown if the patient receives any other vaccine in the 4 weeks prior to Moderna Pink Cap COVID-19 vaccine. These patients were never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and Expiry Date was unknown), (Lot number 216K22A and Expiry Date was unknown).  Treatment information was not provided.  This case contains information about patient 3 out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Master case
Dizziness, Myalgia, Arthralgia, vertigo and LUE pain Narrative:
Injection site red , swollen, hard, painful. Swollen and painful glands R upper arm to R underarm and along R side of chest. Throbbing headache , using gloves, extra layers of clothing and blankets for episodes of chills and weakness, loss of appetite.
PATIENT CALLED TO SAY HE HAD A SWOLLEN TONGUE AFTER THE VACCINATION.