chrisvoncsefalvay/vaers-outcomes huggingface dataset:
around her neck looks swollen; rash on neck is brown; itchy; worried; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on 23Jan2021 (at the age of 84-years-old) at single dose for COVID-19 immunisation. Patient's medical history included heart troubles. Patient's concomitant medication was heart medication. The patient experienced around her neck looks swollen, rash on neck is brown on 03Feb2021 and it was still ongoing and itchy, worried on an unspecified date. Patient stated she read information about a rash all over the body after the COVID vaccine. She has had none of the side effects. She read about severe allergic reactions. She does have a history or heart troubles. She was washing her hair on Wednesday, and she noticed around her neck it looked swollen. Like a little band around her neck. It could have been there before the vaccine. She called her doctor that same day and she said to call Pfizer, and that she thinks she should cancel the second one. She got her first COVID vaccine on 23Jan2021, and she is scheduled for the second 13Feb2021. She does take a heart medication. The place on her neck is not itchy. She knows the vaccine could cause a severe allergic reaction. She sees her dermatologist for Basal cells and other things that are itchy. This place on her neck, if it is a rash, is brown not red. She gets a lot of those places on her skin. Her doctor told her to call Pfizer and then cancel her second appointment. She just wants to speak to medical information first. She doesn't even know if it is a rash. She hasn't had any side effects. Her arm didn't even hurt. This little rash is only on her neck. She had worked as a dental assistant. She is just worried now about getting the second shot. The outcome of event for itchy and worried was unknown and for other events it was not recovered.  Information on the Lot/Batch number has been requested.
Sore arm; 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.  An 84-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergic to Polyethylene glycol (PEG)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information: Patient age was reported as almost 85 years old. Patient mentioned that she called like year and a half ago regarding the ingredients of the vaccine. She's allergic to Polyethylene glycol (PEG) and remembered that when she called, someone told her that it contains 53 mg. She said she's allergic to PEG on quantities greater than 1000mg. She stated that she never had an adverse event when she received her first doses of the Pfizer-BioNTech COVID-19 Vaccine. Later, she mentioned that she only had a sore arm but that's all. She waited between 4 to 5 months to receive her next dose of the Covid Vaccine, but in her area someone told her that the new formulation is only available. It was further reported that she took three shots of the COVID-19 vaccine and would like to know more regarding the new booster vaccine because she had an allergic reaction with one of the ingredients in it. She got information and found out it was safe for her to take the vaccines which she had. She didn't have any problem with the vaccines she took. Patient wanted to know if the new bivalent formulation contains the same amount of PEG (53 mg) as the monovalent formulation. Patient would like more information regarding the new vaccines and is there any side effects to look out for.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201304677 Same reporter/patient/vaccine/events, different dose;
Patient stated she started noticing swelling of upper arm during evening hours and some discomfort. She reached out to her PCP and was given ketorolac injection, followed by Ketorolac 10mg PO Q6h. swelling and pain went down a little bit from upper arm but swelling expanded to lower arm. Patient will call PCP and follow up tomorrow. Advised patient to take PO benadryl q6h .
Site: Pain at Injection Site-Mild, Systemic: Headache-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient reported Numbness in one of her legs. It started 2/20, the day after the vaccine. The numbness is temporary. She states that it comes on and her leg is numb for a period of time and then the feeling of numbness goes away. That has occurred multiple times on 02/20. Patient also has mild headache and mild soreness at the injection site. Patient plans to follow up with physician or go to the urgent care.
Slightly sore arm for a day. Starting ten hours and lasting maybe thirty hours was a series of intense chills and strong, flu=like weakness.  From about 24 hours for maybe the next 4 days, significant aggravation of legacy rashes from my chronic skin conditions.  After 4 days, they reverted to normal.
Chills; headache; joint pain; muscle pain; injection site sorness; dizziness; nausea; tierdness; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0150)via an unspecified route of administration administered in the right arm on 01Apr2021 at 11:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis c, arthritis, thyroid(hypothyroidism), essential tremor and the patient was allergic to sulfonamide and penicillin. Concomitant medications included bupropion hydrochloride (BUPROPION), escitalopram oxalate (LEXAPRO), levothyroxine sodium (LEVOXYL), gabapentin (MANUFACTURER UNKNOWN) and topiramate (TOPAMAX), all taken from unknown dates and for unknown indications. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6199) via an unspecified route of administration, administered in the right arm on 11Mar2021 at 10:45(at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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. On 01Apr2021 at 18:00, the patient experienced  chills, headache, dizziness, joint pain, muscle pain, injection site soreness(vaccination site pain), nausea and tiredness. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event chills, headache, dizziness, joint pain, muscle pain, injection site soreness, nausea and tiredness was recovering at the time of this report.  No follow-up attempts are needed; No further information is expected.
Patient was to receive his first dose of the COVID-19 Moderna vaccine; however, was given the booster dose - no adverse effects.  Note: The vaccine site was not documented (although it was likely the left arm, as subsequent doses were in the left arm).
I received the second shot on 4/3/2021 and the next day I broke out in a rash I had to go to hospital they gave me famotidine and Methyiprednisolone however it's not working I have a bad rash on my hands and my fingers are burning .
Patient developed firey red rash on both facial cheeks that feels hot to touch.  This occurred on may 20.  She received an intra-articular steroid injection on may 19 also.
PATIENT MONTIORED FOR 30 MINUTES DUE TO HISTORY OF REACTIONS, AND HAD MINOR INFLAMMATION OF VACCINE SITE. AFTER ELAVIGN OBSERVATION SHE REPORTED TO ER WITH SWELLIGN OF THE FACE, WORSE ON LEFT SIDE, AND PAIN IN HER NECK AND BACK. PATIENT DIAGNOSED WITH ANGIOEDEMA, TREATED IN ER AND RELEASED.
Client noted redness with hives on both sides of face, with redness. Same radiated to neck and side of left arm. Treated with Benadryl X 2 days, given by child's mother.
This spontaneous report was received from a 65 years old consumer reporting on herself who in 2009, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that she had just in approximately 2012 gotten a case of shingles. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The consumer sought medical attention by seeing an urologist. The relatedness for shingles was unknown for ZOSTAVAX. Additional information is not expected.
Throw up. High fever. Cough. Asthma flare up. Snotty nose.
Mom reports red, swollen bump "like mosquito bite" at site VARIVAX injection, started around bed time. Has fever this morning. Giving Tylenol every 6 hours - advised to alternate with Ibuprofen (dosages provided at appt) x2 days.
tested positive for COVID-19; tested positive for COVID-19; feeling sick; This is a spontaneous report from a consumer or other non hcp.    A male patient of an unspecified age received bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration on  22Dec2020 at single dose for covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  On 24Dec2020   the patient was sick and was  tested positive for covid-19, the outcome of the event was unknown.   Information about Lot/Batch number has been requested.
Myalgia, Fever stated had chills and sore arm at injection site Narrative: stated took OTC Tylenol, motrin for symptom relief
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47-year-old male patient received BNT162b2 (BNT162B2), on 15Nov2021 at 13:00 as dose 2 (booster), single (Lot number: EW0185-H) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 03Mar2021 at 13:00 as dose 1, single (Lot number: 041A21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient not received other medication in 2weeks. The patient had no known allergies. While taking Paxlovid patient immediately got the bitter taste in his mouth. Since he stopped taking it, the taste in his mouth had gone away. However, patient now had an extreme overreaction to any food or drink that was bitter, making it wholly inedible. Patient thought it was maybe from the Paxlovid still in my system. Yet now a week later patient still had the same reaction.
pt recv vax & devel redness, itching & swelling @ the site of vax;
rash at the injection site; fatigue; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE RASH (rash at the injection site) and FATIGUE (fatigue) 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 February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (rash at the injection site) and FATIGUE (fatigue). At the time of the report, INJECTION SITE RASH (rash at the injection site) and FATIGUE (fatigue) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  No treatment medications were reported.   This case was linked to MOD21-079609, MOD21-079683, MOD21-079685 (E2B Linked Report).; Sender's Comments:  MOD21-079609: MOD21-079683: MOD21-079685:
Began having fatigue in legs on Nov. 18, 2011. On Nov. 19 could only walk from bed to bathroom and other short distances before having to sit. On Nov. 20 could stand but not walk and weakness in hands. Admitted to hospital. Diagnosed 11/21 GBS - treated with IVIG. After 3 3/4 doses of IVIG went into kidney failure. Had to have 2 kidney dialysis treatments. Was released to rehabilitation hospital on Dec. 2, 2011. Received inpatient physical therapy until Dec 7, 2011. Was released on Dec 7, 2011. Continued outpatient physical therapy 2 days a week for 6 weeks.
Rash, fever, puffy face, localized pain, IV fluids, Benadryl.
Ear information, Condition aggravated. Information regarding Flumist 2003-4 formula influenza virus vaccne live intranasal 2003-4 formula nasal solution frozen was received from a consumer regarding a ten year old male patient who experienced more frequent ear infections. The patient received a dose on an unspecified date. The pt experienced more frequent ear infections and conditioned aggravated since receiving Flumist (date unspecified). No additional information was available at the time of this report.
weakness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and FATIGUE (Fatigue) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Pain.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ASTHENIA (weakness) and FATIGUE (Fatigue). At the time of the report, ASTHENIA (weakness) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were reported include blood thinners (unspecified), cholesterol medication (unspecified), pain medication (unspecified). Treatment details not provided  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
L deltoid area with red 8 x 9 cm tear drop shaped; blanches with pressures; cutaneous.
received 1st dose in 2019 and is there today for 2nd dose.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date in 2019).   On 18th June 2021, the patient received the 2nd dose of Shingrix. On 18th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose, more than the recommended interval, which led to lengthening of vaccination schedule.  The reporter was not aware of exact date of 1st Shingrix vaccine or Lot and Expiration date. The reporter consented to follow up. The case has been linked with the case US2021134502 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134502:same reporter
28OCT96 pt c/o high BP, lightheadedness, weakness, muscle twitching, dizziness;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (unknown if pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11May2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Pitted fruits" (unspecified if ongoing); "Known allergies: some statin drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 31Aug2023 to 04Sep2023.  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.
Case, reference number 2000015096-1, is a spontaneous report from a specialist in internal medicine referring to a 54 year old male. Allergies are not known. The patient's medical history is notable for hypothyroidism of 10 years duration, which was treated with Synthroid. He reportedly has been clinically euthroid for several years. The patient reportedly denied taking other medications and has no history of sarcoidosis, collagen vascular disease, or alcohol abuse. Approximately 6 weeks after receiving his third dose of Lymerix, the patient presented with symptoms of myopathy, including swallowing dysfunction. The patient attempted to treat his symptoms with acupuncture and herbal remedies without success. At an unspecified time, he was referred to the reporting physician. Two muscle biopsies were interpreted at consistent with toxic myopathy or adult-onset Fonpe disease (a glycogen storage disease). The patient was treated initially with prednisone, and subsequently with methylprednisolone. He was incapacitated and hospitalized. The event is currently ongoing. Additional information has been requested.
Patient stated she was feeling a little light headed. EMT  assessed patient. Patient was A&Ox3. Patient was warm to the touch. Took Base Line Vitals and found them to be within normal limits. O2 97% - Heart Rate 90 - BP 132/78 - RR 18. Patient stated she was feeling better and refused additional medical attention.  EMT instructed patient to wait an additional 10 mins. patient waited the recommended time and stated she was feeling better and was able to drive home. EOR.
Patient called this morning to report that she started to experience dull, numb, and tingling sensation last night at bedtime. She ignored it but sensation did not go away. Sensation has extended from top to bottom on the right side of her body. In addition, she started having heart palpitation this morning. She called MD but they referred her back to the pharmacy. She is currently taking amitriptyline and stated that in the past on September 2019, she experienced the same heart palpitation when her body was under great stress. She does not think this is serious enough to go to urgent care at this time and will continue to monitor. Rph educated patient that paraesthesia is listed as one of the side effects on CDC website for this vaccine and recommended patient to continue to monitor the side effects. If symptoms worsen, she will need to go to the emergency room. Also, Rph recommended patient to potentially avoid second dose since her body has a strong reaction against this vaccine.
Rashes started appearing on my fingers / Thought  may be allergy / rashes have spread to all fingers, hands, elbows, thighs,knees, shin, back, butt and now appearing in the chest and stomach area.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes started appearing on my fingers / Thought  may be allergy / rashes have spread to all fingers, hands, elbows, thighs,knees, shin, back, butt and now appearing in the chest and stomach area.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes started appearing on my fingers / Thought  may be allergy / rashes have spread to all fingers, hands, elbows, thighs,knees, shin, back, butt and now appearing in the chest and stomach area.). At the time of the report, RASH (Rashes started appearing on my fingers / Thought  may be allergy / rashes have spread to all fingers, hands, elbows, thighs,knees, shin, back, butt and now appearing in the chest and stomach area.) had not resolved.            No concomitant product was provided by the reporter.  The treatment provided was creams which did not help. Dermatalogist tried to get approved for ILUMYA. But was denied by the insurance company.
Initial report received on 27 August 2010 from a company representative who received the original report from a health care professional. A male patient had received a dose of MENACTRA vaccine (lot number not reported) on an unspecified date. Two to three days after receiving the vaccination the patient experienced bumps on his arm. Final diagnosis with treatments and outcome of events were not reported. Documents held by sender: None.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with and improperly stored dose of VARIVAX (strength, dose and route of administration were not provided) (lot # L025207 expiration date 07-JUL-2017). The registered nurse stated that VARIVAX was exposed to the following temperature conditions: 7 F degrees during defrosting cycling. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter.
16JUN98 febrile;12AM wide awake;3AM screaming Y thrashing uncontrollably-throwing things (T100.8);this behavior repeated itself about every 1-2hr for rest of noc & occasionally during day;febrile x 3 days;
This case was reported by a consumer via call center representative and described the occurrence of dry mouth in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced dry mouth and taste bitter. On an unknown date, the outcome of the dry mouth and taste bitter were unknown. It was unknown if the reporter considered the dry mouth and taste bitter to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she was experiencing mouth dryness and mouth bitterness after receiving the SHINGRIX vaccine. The caller did not want to provide any additional information, therefore limited information was available.
Pt. rcvd vacc. on 8/24/99, dvlped stiff neck,headaches,crying,low grade fevers.8/29/99:Eye began drooping.9/7/99:Face dropping,severe migraines,unconciousness.9/25/99:Massive seizures uncontrolled.Dx-Encephalopathy.
Headache, Myalgia, chills Narrative:  Per employee report: "I received my second dose of the COVID vaccine on yesterday [2/22]. OVernight, I developed a headache, chills, and body aches."