chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) (by physician) at a healthcare facility/office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2014, the patient was treated by a physician at a healthcare facility/office for a blistering vesicular outbreak, which was diagnosed as a herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
MADE ME THINK I WAS DYING; This spontaneous report received from a patient via company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series1) (form of admin, route of admin not reported, batch number: unknown expiry: unknown) dose not reported, 01 total administered on an unspecified date for covid-19 prophylaxis.  The patient had no adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series1) The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose not reported, 01 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient thought patient was dying (dose number in series 2) and it was reported as " The only reason I got the shot was because I wanted to travel and the airports wanted proof that you had your shots. The first one did not affect me. The second one made me think that I was dying. It took months for me to begin to feel like myself. Still not able to travel." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from made me think i was dying. This report was non-serious.
itching; injection site seemed hot; 1 hive; red welt with hard top; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), VACCINATION SITE WARMTH (injection site seemed hot), ERYTHEMA (red welt with hard top) and URTICARIA (1 hive) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z3MZOA) for COVID-19 vaccination.     The patient's past medical history included Angioedema. Previously administered products included for an unreported indication: MMR. Concurrent medical conditions included Hypothyroidism and Anxiety. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, LEVOTHYROXINE for Hypothyroidism.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ERYTHEMA (red welt with hard top). On 04-Mar-2021, the patient experienced PRURITUS (itching), VACCINATION SITE WARMTH (injection site seemed hot) and URTICARIA (1 hive). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PRURITUS (itching), VACCINATION SITE WARMTH (injection site seemed hot), ERYTHEMA (red welt with hard top) and URTICARIA (1 hive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Levothyroxine, Buspar  Patient stated she usually puts hydrocortisone.
Developed a blood clot in his right leg, inner thigh, up toward groin area. ER diagnosis on 4/20/21 at healthcare facility.
It has been constantly ringing in both of my ears, High-pitched and it is constantly on both ears, I felt very tired when I came home around 8PM, that was very unusual for me, a couple days I was achy, and it lasted about 40 hours and since this has happen, I made an appointment with a doctor and we'll see if we can get some labs done.
Patient had shoulder and neck pain that progressed to bilateral arm weakness the next day. Within hours, patient had bilateral upper and lower extremity numbness and left arm and leg weakness. She felt the strength in the right upper and lower extremities was strong and normal. She was seen in the ED that day because she was dragging her left foot/leg and couldn't use her left hand. She was admitted into the hospital with an abnormal C spine MRI. Within 24 hours, she had complete left sided paralysis with bilateral upper and lower extremities numbness. She received 5 days of 1,000 mg solumedrol. She slowly saw improvement in movement to the arm and then leg during her 8 day hospital stay. She was discharged on day 8 with a wheel chair. She is learning to walk again with the help of home PT and OT. She has been out of work for 6 weeks now.
Injection site pain; Psoriasis flare-up; Flu like symptoms; COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4291897-00 (Company).  A 43 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01May2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single and intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown) at unk- disco for psoriasis; risankizumab rzaa (SKYRIZI [RISANKIZUMAB RZAA]), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", COVID-19 (medically significant) with onset 2021, outcome "recovered" (2021) and all described as "COVID-19"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Injection site pain"; PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis flare-up"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu like symptoms". The action taken for risankizumab and risankizumab rzaa was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of Skyrizi pen causes soreness, seasonal plaque psoriasis flair ups  in private areas where perspires, covid and flu like symptoms was not reported.  The reporter's causality for the event(s) of Skyrizi pen causes soreness, seasonal plaque psoriasis flair ups in private areas where perspires, covid and flu like symptoms was not reported. The reporter's causality for the event(s) of bnt162b2 (BNT162B2), causes soreness, seasonal plaque psoriasis flair ups in private areas where perspires was not reported, covid and flu like symptoms was reported as possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
This spontaneous report as received from a medical assistant C.M.A. refers to a patient of unknown age. The patient was vaccinated subcutaneously with a dose of 0.5 ml (M-M-R II) (lot # 667881/0661Z, expiration date 4-MAY-2012) on 14-AUG-2012. It was reported that it was an expired dose of M-M-R II. No adverse effect was reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. Additional information is not expected.
Received flu shot on September 17th. Pt concerned about SIRVA. Very sore shoulder by 6 hrs after shot progressed to shoulder pain that pt's dr. thinks may be tendonitis/bursitis. Soreness fluctuates, but is still ongoing. Pt. has been trying different NSAIDs for pain relief. Been to Dr. twice now on diclofenac -> feeling better. Seeing shoulder specialists in 2 weeks.
6 days after my 3rd Moderna dose, I started noticing intense itching at the side of my neck, extreme itching neck, palms of hands, burning itching. I took a Benadryl and it got worse and it spread to hives all over my body head to toe. My lips started to swell. The next day I went to the ER and from there I went to the local healthcare clinic in our county. There are still here today. They pop up and start itching still.
On 07/22/2000, the patient developed half dollar size redness, tenderness, swelling, induration and heat at the injection site. It was reported that the patient was afebrile. The patient sought unspecified medical attention. Additional information has been requested. Follow up information from the NP indicated that the rash developed on 07/21/2000. The patient was seen by the physician on 07/25/2000. Subsequently on 08/01/2000, it was reported that the patient recovered. No further information is expected.
A report has been received from a Pharmacist concerning, subject of unknown gender, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patient received EXPIRED FLUMIST on 12-Feb-2014. The outcome of the event of EXPIRED FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Pt vaccinated with Recombivax HB experienced Temp 98.6, Arthargias & mono articulas, arthritis rt elbow, paresthesias.
Fever (12 hours), Extreme Fatigue and tiredness (since onset of symptoms), muscle aches (5hours after vaccine and current), body pain (4 hours), joint pains(10-12 hours) migraine (24 hours) , swollen lymph nodes (armpit -visible to the eye- and neck area  over 24 hours), flare up of psoriasis on scalp, chills without fever (14 hours) , tingling on left side of face ( short on and off intervals lasting in total about 2 hours)
Started to itch on my neck 1 week after vaccination. It progressively got worst, and I realized it was hives as it traveled around my body. It manifested on my hands, back, stomach, chest, neck, ears, scalp, legs, groin, feet...everywhere. It is taking a road trip around my body.
Diarrhea; Dizzy; Feels weakness; feeling really weird; Feels hot and cold; Feeling very cold, an unusual cold; Muscle pain, it's an incredible pain; Headache; Blood pressure is 35 above normal and somedays lower (109 mm Hg); First dose on her "left hand"; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Blood pressure is 35 above normal and somedays lower (109 mm Hg)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First dose on her "left hand"). On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure is 35 above normal and somedays lower (109 mm Hg)) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), DIZZINESS (Dizzy), ASTHENIA (Feels weakness), FEELING ABNORMAL (feeling really weird), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), FEELING COLD (Feeling very cold, an unusual cold), MYALGIA (Muscle pain, it's an incredible pain) and HEADACHE (Headache). On 17-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First dose on her "left hand") had resolved. At the time of the report, BLOOD PRESSURE FLUCTUATION (Blood pressure is 35 above normal and somedays lower (109 mm Hg)), DIARRHOEA (Diarrhea), DIZZINESS (Dizzy), ASTHENIA (Feels weakness), FEELING ABNORMAL (feeling really weird), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), FEELING COLD (Feeling very cold, an unusual cold), MYALGIA (Muscle pain, it's an incredible pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. The patient reported that only with a hair dryer could they get warm. Each day is worse and wanted to know when it will end. The patient said they had a blood test, previous to the vaccination because they gained weight, and it was normal. Treatment for the events included paracetamol, ibuprofen and cold showers.  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.; Sender'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.
Pt had severe nausea for one day and chills and was not able to keep food down. The following day, pt was able to keep some food down and be more active.
Patient started having punch feeling in arms that traveled to her shoulders 3-4 hours after vaccination. She felt body aches, pains, and had low grade fever 99.0.Also had a Covid test results negative.
Today I brought my child to the pharmacy to get her COVID booster. The pharmacist checked her temperature before giving the vaccine. She said it was 100.0 so she could not give the vaccine. She said my child must be dehydrated and needed to drink some water and return. I told the pharmacist that 100 is not a fever and asked if that was pharmacy policy. She said no that was just her policy. I told her that I would like her to give the vaccine. She did give it but I am very concerned that she is turning away people for the vaccine based on her own made up policies and made up medical advice. This needs to be stopped immediately.
Chronic idiopathic urticaria with angioedema and itching post COVID VX.
seizure or mini stroke; hallucinations; seizure or mini stroke; pain; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (seizure or mini stroke), HALLUCINATION (hallucinations) and SEIZURE (seizure or mini stroke) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 030b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included no adverse event (NO Relevant medical information provided). Concomitant products included GALANTAMINE and LEVETIRACETAM (KEPPRA) for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (seizure or mini stroke) (seriousness criterion medically significant), HALLUCINATION (hallucinations) (seriousness criterion medically significant) and PAIN (pain). On an unknown date, the patient experienced SEIZURE (seizure or mini stroke) (seriousness criterion medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (seizure or mini stroke), HALLUCINATION (hallucinations), PAIN (pain) and SEIZURE (seizure or mini stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Aspirin. The drug history included "blood pressure medication"; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
low grade fever, muscle ache, lightheaded, skin sensitive to touch, shooting pain on right side of head, scalp sensitive when brushing hair, malaise, site red, swollen, hard to touch, palpitations at times.
Excessive, continuous crying for over 3 hrs within 4 hrs of receiving immunizations. Symptoms resolved 16 hours later.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information has been received from the registered nurse who provided patient details. This report refers to a 2 year old infant patient of unknown gender. On 11-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot # J015437, expiration date: 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
hives all over my body; Chronic Idiopathic Urticaria; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Lot number not provided ), for COVID-19 immunization. The following information was reported: CHRONIC SPONTANEOUS URTICARIA (non-serious) with onset May2021, outcome "unknown", described as "Chronic Idiopathic Urticaria"; URTICARIA (non-serious) with onset May2021, outcome "unknown", described as "hives all over my body". Therapeutic measures were taken as a result of urticaria.  Additional information: Patient received second covid-19 vaccine and within 1 hour patient began to have hives all over the body. These hives could not be controlled with allergy medications and ever since had been diagnosed with Chronic Idiopathic Urticaria.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-NOV-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). The temperature excursion of the administered dose of vaccine was 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Inconvenient heart beats, while laying on sofa a feeling of flicker beats but I thought it would be muscles and as there were no pain I did not called my doctor, for less than a minute But generally good state so no doctor or emergency call
Has improved but has not gone away after ten days A previous dose was had on March 11, sinovac
"sinus pressure" headache. Forehead, eyes. Ears ringing.; "sinus pressure" headache. Forehead, eyes. Ears ringing.; "sinus pressure" headache. Forehead, eyes. Ears ringing.; "sinus pressure" headache. Forehead, eyes. Ears ringing.; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 19Feb2021 at 11:30 (at the age of 69-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history included hashimotos, glaucoma and had known allergies to penicilliin, Levaquin and Cipro. The patient did not received any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Bimatoprost (LUMIGAN EYE DROP), Dorzolamide hydrochloride, timolol maleate (COSOPT EYE DROP), ciclosporin (RESTASIS) and Vit. On 19Feb2021 at 15:00, the patient experienced "sinus pressure" headache, forehead, eyes, ears ringing. The patient self-medicated with Motrin, Bufferin, Sudafed, Claritin and Tylenol. On 26Feb2021, the physician prescribed 6 day dose pack. The patient still had headache after 2 weeks. On 03Mar2021, she visited ear, nose and throat (ENT). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of all the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
BACK PAINS; CHILLS; HIGH TEMPERATURE; SWELLING AT THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure , no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced back pains, chills, high temperature, and swelling at the injection site. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) HIGH. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the back pains, chills, high temperature and swelling at the injection site was not reported. This report was non-serious.
Patient came to pharmacy 11/6/07 complaining of arm pain thought was from Flu shot. Patient recovered Fluzone 10/23/07 + no problems saving injection or injection site problems. Pharmacist called patient 11/7/07 and patient said he had normal soreness from Flu shot baton 11/4/07 got noticeably worse said had shoulder/arm pain from shoulders to elbow) hurt enough to cause trouble sleeping on arm. Saw his physician and physician prescribed Methylprednisolone pak
Administered covid Pfizer for 6months-4 yrs to child without diluting vaccine. Parent was notified per Dr. and parent stated there were no adverse events .
No known adverse reaction. Vaccine expired 8/31/2022 and erroneously administered on 9/1/2022. Parent being contacted and recommended to revaccinate as soon as possible. First dose given 6/23/2022.