chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My first shot resulted in what appeared to be cellulitis approx. 1 week (January 7th, 2021) after first injection and was treated with antibotics and benadryl; it improved slightly but 5 days later welts and hives were in the same place as the previously thought cellulitis was.  With the flare up on the 12 of January 2021, I was given another antibiotic and predisone while continuing to take benadryl and iburprofen.   Second shot was given 1/28/2021 with no immediate reaction,  @ approx 12 noon on 1/29/2021 through my shirt i felt a raised elongated bump on my arm approx. 3 inches above elbow and 3 inches below injection site; it measured about 1 inch wide and 4 inches long.  By the end of the day the welt had grown to 3 inches moving upwards towards injection site.  The welt is red, raised, itchy, burning and has a fever.  By morning the welt was approx 6 inches wide and 6 inches in length and encompassed the injection site.  Throughout all this I was taking ibuprofen and benadryl per the recommendation of doctor and clinic that gave the injection.  Spoke with the urgent care over the phone and they ordered another round of prednisone (40 mg for 3 days, same as previous dosage from 1/13/2021 called in flare up of first reaction).  Woke up this morning and the welt is now 8 inches wide and 7 inches long, past the injection site moving towards shoulder and wrapping around arm.
w/in a hr of administration pt leg began to swell & turn red; very irritable & cried until 2PM (administered @ 9AM); MD called who gave APAP & tepid bath; t103;
Patient was nervous after Moderna vaccine. He felt dizzy and his hands felt cold. Patient laid on his side on the floor and felt better. He stated his throat was not swollen and he can breath just fine. I checked his blood pressure and it was normal. We called for the ambulance but when the paramedics arrived, patient felt a lot better and after their evaluation, they believed the patient did not need a trip to the ER.
Redness and knot at site of injection.  Treatment included cold compress and BENADRYL.
Patient tested positive for COVID-19 by PCR on 4/17/21; >2 weeks after being fully vaccinated.
I received a Pfizer COVID-19 booster on 6/6/2022. On 7/20/2022, I woke up feeling really tired. I also had a scratchy, sore throat. I decided to test myself, and the result was positive. I tested again 7/21/2022 and got another positive result. I didn't have too many symptoms during my illness. The main symptoms were fatigue and sore throat. I just took TYLENOL to treat my symptoms and waited out the virus.
Since receiving the 2nd dose of the Shingrix vaccine, the patient has suffered from soreness and loss of flexibility in that arm. The soreness and tightness has remained constant, but has not improved or gotten worse  since the vaccination. The patient did not experience this adverse event with the first dose she received.
Seizure. His body was stretched out, arms along his side, eyes rolled back, whole body was twitching, foam from mouth, gurgling noise from his mouth, breathing through his nose, and he was not responsive. Called 911. By the time they arrived his seizure had stopped and he was coming back. Took him to the ER just in case and bloodwork levels were ok.
Rash on Chest & neck; Increased blood pressure; Fast Heartbeat/ Increased pulse; Right ear pain; Neck pain; Red Ears/ Red face; Itchiness through out the inside & outside of the body; hives on my left arm & hand; This is a spontaneous report from a contactable consumer (patient). A 55-year-old  non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: ER8727, Expiration Date: not reported) via an unspecified route of administration, administered in right arm on 27Mar2021 at 14:30 (at the age of 55 years old) as dose 1, single for COVID-19 immunisation. Medical history included hypertension, ginger allergy, soy allergy, peanut allergy, tree Nuts allergy, and wheat allergy - all from an unknown date. Concomitant medications included losartan and hydrochlorothiazide (HCTZ), both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took prednisone and azithromycin (ZITHROMAX Z-PAK) and experienced drug allergy. On 27Mar2021 at 15:00, the patient experienced rash on chest & neck, increased blood pressure, fast heartbeat/ increased pulse, right ear pain, neck pain, red face, red ears, itchiness throughout the inside & outside of the body and hives on left arm & hand. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which includes antihistamine and increased blood pressure medicine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of all events was not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 03-NOV-2014, an unknown number of patients have been vaccinated with VARIVAX (Merck) (injection, subcutaneous, lot#, dose and frequency were not provided), that had underwent a supported temperature excursion, (dates unspecified, in approximately 2014). No adverse effect was reported. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 20th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 3 days after receiving SHINGRIX, the patient experienced shingles, headache, influenza-like symptoms and weakness. On 9th July 2018, the patient experienced neck pain. The patient was treated with VALTREX. In May 2018, the outcome of the weakness was recovered/resolved. On an unknown date, the outcome of the shingles, neck pain, headache and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the shingles, neck pain, headache, influenza-like symptoms and weakness to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine on right arm and she experienced weakness, flu like symptoms and headache which lasted for 2 to 3 days. On 14th June 2018 the patient broke with Shingles on the stomach and headache. She visited her doctor on 15th June 2018, and her doctor prescribed VALTREX to be taken three times a day for a week. She then completely recovered. On 9th July 2018, she experienced sore neck, shooting pain in head and neck, headache and flu like symptoms. On 4th August 2018, vaccination she broke out with Shingles bump on inside of her thighs. On 6th August, 2018 she broke out with Shingles on her knees. She had an appointment scheduled with her doctor on 8th August 2018 but she was not able to make it. She spoke with her doctor on the phone and she was referred to an infectious disease doctor. The patient had denied permission to contact their physician. The patient was referred to her health care provider.
Myalgia, Arthralgia, Fever, Diarrhea & NauseaVomiting  Narrative:  02/17/21: Symptoms (fever, chills, continues diaphoresis, body aches, joint, neck, and ear pain, nausea, diarrhea and extreme fatigue). These symptoms made it impossible to work. Symptoms occurred on 2/17/21@ approx 2000, resolved approx 2100 2/19/21.
patient reported redness and swelling at the injection site, with pain running up to the shoulder starting 1/4/23
I received the vaccine on 10/29/2021. On 11/01/2021, I began to feel ill. Sore throat, sinus pressure, beginning cough. Had to leave work around 1:30 p.m.. That night I had a fever of 101.7, shivering, cough getting worse. Symptoms moved to my chest. Chest congestion, constant coughing. Had 2 virtual visits, received 1 antibiotic (Augmentin). I was out of work for 2 weeks, and still feel fatigued, very tired at times. Had office visit on 11/16/2021 to be cleared back to work.
6/9 - Rash on left arm, swollen lymph node under left arm, costochondritis - rash and lymph node resolved in a few days. Costochondritis remains 6/15 - Muscular pain in mid left back, sharp, stabbing pain in mid left back when taking a deep breath 6/16 - Rash on back in area of pain. Diagnosed as shingles. Prescribed famciclovir. After 4 or 5 days it caused heart palpitations so medication stopped. Rash Disappeared in 2 or 3 days, pain lingered for approximately one week
Information has been received from a physician concerning a 12 month old male who was vaccinated with his first single SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 65712/0594U). In July 2007, the patient developed an local injection site reaction that was hard, swollen, red and feverish to the touch. The reaction had been of "softball-size." Unspecified medical attention was sought. Physician suggested Benadryl (manufacturer unknown) for treatment of the injection site reaction. Recovery status unknown. No product quality complaint reported. Additional information has been requested.
A Moderna Covid-19 vaccine booster was dose given to a patient 20 hrs after 1st puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A Moderna Covid-19 vaccine booster was dose given to a patient 20 hrs after 1st puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A Moderna Covid-19 vaccine booster was dose given to a patient 20 hrs after 1st puncture). On 23-Dec-2021, EXPIRED PRODUCT ADMINISTERED (A Moderna Covid-19 vaccine booster was dose given to a patient 20 hrs after 1st puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Received second dose more than 35 days after the first; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 35 days after the first) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 35 days after the first). On 15-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 35 days after the first) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported by the reporter.
08/13/2021: Noticed red, hot to the touch spot approximately quarter size on upper left arm near Moderna vaccine injection site (received 1st dose on 08/05/2021). Red spot is not painful to touch but felt like a knot under the skin. Decided to see if it changed for worse or better overnight. Checked arm today (08/14/2021) and original spot is less inflamed and red, but have a new and much larger inflamed area just below original injection site. It is also hot to the touch and only slightly tender when touched. Called and spoke with pharmacist this afternoon 08/14/2021, @5:45pm at pharmacy where I received my vaccine. Explained symptoms and she stated it is unusual to have symptoms present after 7 days of receiving injection. She suggested I document/photograph area and report my symptoms to the Vaccine adverse reaction site, and take OTC pain meds and apply cortisone cream if it continues or worsens. She also said if the area continues to get larger and seems to be worsening, to go to an urgent care or ER for treatment. I have documented and photographed inflamed red spots in case review is needed. Received Moderna vaccine 1st dose at pharmacy.
Client lost consciousness and had seizures x2 after vaccinations. Mother states this has happened before.  Mother requested EMS be called. Client had very low bp (60/20), was lethargic, very pale and complained of an upset stomach.
Received Engerix B after a too cold temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 1-day-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric (intramuscular) and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The reporter was a physician.  The patient received Engerix B pediatric after a temperature excursion of too cold. This case was 1 of 5 cases for the patient reported by same reporter. Additional supportive information: The patients received Engerix B after a temperature excursion of too cold, which led to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023008733:same reporter - female case US-GSK-US2023AMR009449:same reporter - female case US-GSK-US2023AMR009387:same reporter - male case US-GSK-US2023008735:same reporter - male case
It started with runny nose. I thought it was my allergies. I was sneezing a lot and then I started coughing. I tested positive at home. I saw the doctor on Saturday. I did not get PAXLOVID because my symptoms were not too bad. I am feeling fine as of today. My nose is just a little stuffy. Last night I still tested positive.
Arm Soreness; Body aches; Chills; Fatigue; Maternal exposure during pregnancy, second trimester; Received third dose of vaccine; This is a spontaneous report from a contactable pharmacist. A 31-year-old pregnant female patient received third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an intramuscular route of administration in the left arm on 20Oct2021 at 16:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa. The patient was 29 weeks pregnant and the due date was 01Jan2022. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was reported at eluxadoline (VIBERZI) from an unknown date, for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6000), via an unspecified route of administration on 25Mar2021 (at the age of 30-years-old), as a single dose for COVID-19 immunisation and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN8730), via an unspecified route of administration on 16Apr2021 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. On 21Oct2021 at 02:00 the patient experienced arm soreness, body aches, chills, and fatigue for approximately 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with acetaminophen (MANUFACTURER UNKNOWN) on an unknown date and unknown if ongoing. The clinical outcome of the events arm soreness, body aches, chills, and fatigue was resolved on an unknown date in Oct2021.
head is full or pressured; hearing is distorted; pressure in my ears; feel weak; general malaise; upper body aches; dose 1 to dose 5: Moderna, dose 6: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Jul2023 at 14:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 73 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Food allergies" (unspecified if ongoing), notes: Food allergies, all of which I avoid; "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM; HCTZ; ELIQUIS; ATORVASTATIN. Vaccination history included: coviD-19 vaccine moderna (DOSE 5 (BOOSTER), SINGLE), administration date: 03Mar2022, when the patient was 71-year-old, for COVID-19 Immunization; Covid-19 vaccine moderna (DOSE 1, SINGLE), for COVID-19 Immunization; Covid-19 vaccine moderna (DOSE 2, SINGLE), for COVID-19 Immunization; Covid-19 vaccine moderna (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization; Covid-19 vaccine moderna (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 27Jul2023 at 14:30, outcome "not recovered", described as "dose 1 to dose 5: Moderna, dose 6: Pfizer"; ASTHENIA (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "feel weak"; MALAISE (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "general malaise"; HEAD DISCOMFORT (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "head is full or pressured"; HYPOACUSIS (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "hearing is distorted"; EAR DISCOMFORT (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "pressure in my ears"; PAIN (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "upper body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of head discomfort, hypoacusis, ear discomfort, asthenia, malaise, pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior vaccination. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination. The side effects of Moderna were short lived and minimal.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Nausea, Vomiting, Diarrhea, 99.5 Degree Fahrenheit Temperature
Discharge Provider: MD Primary Care Provider: DO Admission Date: 3/4/2023 Discharge Date: Mar 7, 2023  PRESENTING PROBLEM: Pulmonary embolism, bilateral [I26.99]   HOSPITAL COURSE: Patient is a 88 year old female with history of breast cancer s/p mastectomy, bilateral PE in 2013 and DVT in 2021 who was admitted 3/4 with bilateral pulmonary emboli and bilateral DVTs.    For several weeks leading up to admission the patient has not felt well and so has not been taking her home medications including Eliquis.  She did have a recent COVID infection at the same time.  She continued to feel ill with shortness of breath, cough, lightheadedness she presented to the emergency department on 03/04.  CT angiogram showed bilateral pulmonary emboli with moderate to large clot burden.  Initially she was at an outside hospital and transferred to Hospital for evaluation for thrombectomy.  Echo was obtained which showed right heart strain.  She underwent thrombectomy and 3/5 with large volume thrombus retrieved on the right and moderate volume retrieved on the left.  She tolerated the procedure well and she was transitioned from heparin drip to Eliquis on 03/06.  She did have bilateral DVTs in the right common femoral, right gastrocnemius, right popliteal and an occluded stent in the left femoral veins.  She was asymptomatic from this and she had duplicated femoral vein so did not need to treat the clock and the stent.  She was encouraged to wear compression stockings.   Patient continued to require supplemental oxygen of about 2 L at all times.  She was evaluated by Pulmonary Rehab who recommended the oxygen at all times of 2 L. she was discharged in stable condition on 03/07 to home with home nursing and physical therapy.    Patient to continue with Eliquis 5mg twice daily.  She will need to follow up with pulmonology in about 2-3 months for repeat echo and CT scan to assess clots.
Excruciating pain  - in my bottom part of my butt and thigh and sometimes it goes down to my ankles but not always - both thighs - today it seems to be the left side. Also, in my legs, I get Charlie Horses.  Physical therapy and they have ordered MRI - on the 23rd or 28th. The physical therapy seems to be helping. I have been there four times. Dr. gave me some Tramadol (Opioid - that one doesn't work at all) and another one which I have to pick up for the Charlie Horses - generic name - Solma - it's a refill; I'm taking more steroids than I normally. The pain is so bad that I scream, it's really excruciating and it does it whenever it feels like it.
Sore left arm even tho shot was in right.  Very foggy brain...lack of focus for a day after shot.
This spontaneous report has been received from a nurse referring to 6 unspecified patients of unknown age and gender. On multiple unspecified dates, the 6 unspecified patients were vaccinated with 6 doses of VARIVAX (lot # L038132, expiration date 01-OCT-2017, dose and route were not reported) which was improperly stored. There was no previous temperature excursion and data logger. The vaccine has been stored under temperature of -8.38 C, degree for 17 hours and 46 minutes. No adverse effects were reported. Additional information has been requested.
Fever over 101.5 and severe headache for 48hrs.  About 16hrs  after the vaccine my left eye began to twitch.  The twitch will come and go.  But occurs more than if is not occurring.  The twitch is still occurring at this time on 1/12/2022
Information has been received from a consumer concerning her 15 months old son with a history of ear infection and with no drug reactions or allergies who on 17-JUN-2010 was vaccinated subcutaneously with a dose of MMR II (lot number unknown). Secondary therapy included a dose of VARIVAX (Merck) (lot number unknown). Concomitant therapy also included TYLENOL. The patient's mother stated on 18-JUN-2010 "the next day", her son had a yellow rash on the neck under the chin. The physician was notified and the patient was diagnosed with a "farmer's tan". The patient's mother also stated that on 20-JUN-2010 "two days after finding the rash" her son began vomiting and had diarrhea. The physician was notified and the patient was diagnosed with a "stomach bug". No laboratory studies were performed. On 28-JUN-2010, the patient recovered from yellow rash on the neck under the chin "farmer's tan" and on approximately 30-JUN-2010 "about a week and a half" the patient recovered from "stomach bug". Additional information has been requested.
Notes itchy swollen R upper arm on R.  (site of HPV and Menactra vaccines) and smaller area on L upper arm (TDAP site).