chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm being sore for a couple of days/Arm mildly sore; arm got a little warm; Really small red spot to arm; tired/exhausted; fell asleep; fever; chills; headache; vomiting; lower GI issues; Sick to stomach; Quite sick for a day/weak; sore; This is a spontaneous report from a contactable consumer (patient). This 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER2613) in the right arm on 24Mar2021 at single dose for COVID-19 immunization. Medical history included ongoing Shellfish Allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot EN6203) on 03Mar2021 for COVID-19 Immunization, and experienced sore arm that was a little pink, and warm. The red arm after first shot was very small spot, slightly raised, sort of pink, and probably the size of a half dollar. She was tired for a couple of hours that day, but didn't experience anything big. The patient previously experienced very swollen and red arm on 2 occasions with 2 flu vaccines. The Flu Vaccine was vaccinated about 10 years ago (2010) for immunization, her doctor told her it was cellulitis twice from the flu vaccine and she stopped getting them for a while.  After the second dose of BNT162B2, patient reported her arm being sore for a couple of days, but less sore than experienced with the first dose. Really small red spot to arm after second vaccine. The red arm with her second shot was really small, her arm was mildly sore for 2 days. Her arm got a little warm as well. She reported being tired for the first day, fell asleep, and was okay.  A week after receiving the second dose on 31Mar2021, she started experiencing a fever that wasn't high, chills, headache, vomiting, lower GI issues for the entire day, and was exhausted, sick to her stomach, weak and sore. She was quite sick for one day, then it just went away. Stated her fever wasn't bad so she didn't take her temperature. Stated she never got headaches, she took two ibuprofen (ADVIL) one time for it. The symptoms she experienced on 31Mar2021 were all resolved on 01Apr2021.   Patient consulted with HCP in which they had her take a COVID test and that came back negative.  The outcome of fell asleep was unknown, outcome of other events was recovered.   No follow-up attempts are needed. No further information is expected.
Patient received the Pfizer covid vaccine, and had no symptoms but a sore arm; This is a spontaneous report from a contactable consumer. A contactable consumer reported different events for 5 patients. This is 3 of 5 reports. This consumer reported for a male patient (reporter's brother). A male patient of an unspecified age received an unknown dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Expiry Date: unknown, Lot number: unknown as caller was unwilling to complete the report), via an unspecified route of administration, on an unspecified date, as single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after receiving the Pfizer covid vaccine, the patient had no symptoms but a sore arm. The patient stated while reporting about himself, and his wife, reporter mentioned that his two brothers received the Pfizer covid vaccine and had no symptoms but a sore arm. Reporter's brother number one is the patient. The reporter only knew that the patient got the Pfizer covid vaccine within the last two months and did not have any information. The outcome of event was unknown.   Information related to batch/Lot no. was requested.
Heat flushing in face Tingling in mouth Dry mouth Dizziness Started in 15 minute observation period. Symptoms resolved within 10 minutes. Dizziness for 2 hours.  5 hours later - Left arm and hand weak and aching for 2 hours.  Next day to present - injection site swelling/lump,  red and hard. Quarter size.
Happened seconds after shot, metallic taste in mouth, high pulse, high blood pressure, hot feet and hot vaginal area, started to panic each episode lasted several mins 11 in total getting weaker as each one happened.
PATIENT HAD PAIN AND REDNESS AT ELBOW OF VACCINATION ARM, BEGINING IN AFTERNOON OF DAY AFTER VACCINATION. NO SIGNS/SYMPTOMS AT INJECTION SITE. EXPERIENCED FATIGUE AND NAUSEA AS WELL, NO HEADACHE REPORTED. 2 DAYS FOLLOWING VACCINATION, PAIN AND SWELLING INCREASED FROM SHOULDER TO HAND (GRADUAL INCREASE IN PAIN AS DAY PROGRESSED).  PATIENT WENT TO URGENT CARE BECAUSE PAIN CONTINUED (DID NOT DECREASE IN SEVERITY) AND SHE WAS UNABLE TO BEND OR USE VACCINATED ARM. HAD FEVER OF 100 DEGREES, DID NOT FEEL WELL ALL DAY.  URGENT CARE MD SAID IT MAY BE CELLULITIS, PRESCRIBED DOXYCYCLINE 100MG FOR 10 DAYS AND INSTRUCTED TO FOLLOW UP ON SATURDAY 11/2/19.  ON FRIDAY, AFTER 2 DOSES OF ANTIBIOTIC, PATIENT SAW NO CHANGE IN SYMPTOMS. PLANNED ON TAKING BENADRYL IN CASE SYMPTOMS WERE AN ALLERGIC REACTION. AGREED TO FOLLOW-UP WITH PHARMACY AFTER URGENT CARE APPOINTMENT ON SATURDAY.  SUNDAY 11/3/19: PHARMACIST ON DUTY FOLLOWED UP WITH PATIENT VIA PHONE.  PT STATES MD TOOK X-RAYS TO RULE OUT BROKEN BONE/ELBOW, BUT COULD NOT DETERMINE ANYTHING BECAUSE THERE WAS TOO MUCH SWELLING.  PT DID NOT HAVE ANY CHANGES IN SYMPTOMS.  URGENT CARE DOCTOR GAVE PATIENT AN ANTIBIOTIC SHOT (PT DOES NOT RECALL NAME OF ANTIBIOTIC) AND WAS TOLD TO FOLLOW UP AGAIN ON WEDNESDAY 11/6/19.  PT DOES STATE THAT SWELLING HAS IMPROVED BUT STILL CANNOT BEND OR MOVE RIGHT ELBOW.  STILL EXPERIENCING PAIN.
Skin discoloration on face and neck. Eye redness and eyelid puffiness. Itching.
Cough  Wheeze Shortness of Breath  Fatigue  Sore throat  Congestion or running nose  Diarrhea
Directly after the vaccine; I experienced the normal arm soreness and fatigue that was to be expected.  On the 7th evening after the vaccine I experienced what is being called "Covid Arm";  my arm started to itch before I went to sleep at the injection site. When I woke up the following morning (day 8) I had a red circle (about 2 inches in diameter) around the injection site, the injection site was itchy, warm, and hard to the touch and when I did touch it there was a little pain. After 2-3 days the redness faded as did the pain, warmness and hardness. Today (13 days post-vaccine) it is still a little red (faint) and sometimes is still itchy.
Patient said his eye swelled up within hours of the injections and later on that evening he had fever, chills and joint pain.  Symptoms were better the following morning and all eye swelling gone 10/3/22.
Swollen eyes; swollen lids and underneath.; Eyes were leaking in the corners; Eyes (a bit crusty); Eyes burning; Eyes itching; face was breaking out like crazy as if had acne.; This is a spontaneous report from a contactable consumer, the patient. A 57-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 in the left arm on 08Apr2021 at 13:30 hours (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, cholesterol high, type 2 diabetes mellitus, arthritis and allergy to nuts. The patient previously took hydromorphone hydrochloride(DILAUDID) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included 6 prescription and 2 OTC (Over the counter) (MANUFACTURER UNKNOWN) for unknown indication, from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM6207) via an unspecified route of administration in the left arm on 18Mar2021 at 13:30 hours (at the age of 57-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 the patient woke up with swollen eyes, lids and underneath. Eyes were leaking in the corners (a bit crusty), burning and itching. The rest of her face had broken out like crazy as if the patient had acne. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen eyes, lids and underneath, eyes were leaking in the corners (a bit crusty), burning and itching and the rest of her face had broken out like crazy as if the patient had acne was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
No trearment... Sore Throat  Body  Ache Flu like Symptoms Stuff lose Sneezing and coughing
Headache Localized pain, redness, swelling Narrative:  Other Relevant History:
Pain in wrist in the arm where the shot was administered. There is also weakness and loss of grip strength. This is ongoing
Diagnosis- serum sickness like response.   1 week after vaccination, he developed a fever. 3 days later (10 days post vaccine) he broke out in what appeared to be full body hives, ped diagnosed post viral hives to an unknown virus and told to take antihistamines. The next day, he couldn't bear weight on his legs and his knees were painful and swollen, rash had changed to red circles with clearings in the middle so he was seen again. Suspicion of serum sickness like response and prescribed prednisilone which eased the knee swelling. As of 10/20/23 he is still experiencing symptoms.
anxious; discomfort; afraid; hot arm, at the injection site; lot of headache, from the neck to the forehead; little of nausea sometimes; red arm, at the injection site; swollen arm, at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (anxious), DISCOMFORT (discomfort), FEAR (afraid), VACCINATION SITE WARMTH (hot arm, at the injection site) and HEADACHE (lot of headache, from the neck to the forehead) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) cream for an unknown indication.    No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure high (patient has hypertension), Thyroid disorder NOS and Anxiety. Concomitant products included METOPROLOL for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, ALPRAZOLAM (XANAX) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEPRESSION (anxious), DISCOMFORT (discomfort), FEAR (afraid), VACCINATION SITE WARMTH (hot arm, at the injection site), HEADACHE (lot of headache, from the neck to the forehead), NAUSEA (little of nausea sometimes), VACCINATION SITE ERYTHEMA (red arm, at the injection site) and VACCINATION SITE SWELLING (swollen arm, at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, DEPRESSION (anxious), DISCOMFORT (discomfort), FEAR (afraid), VACCINATION SITE WARMTH (hot arm, at the injection site), HEADACHE (lot of headache, from the neck to the forehead), NAUSEA (little of nausea sometimes), VACCINATION SITE ERYTHEMA (red arm, at the injection site) and VACCINATION SITE SWELLING (swollen arm, at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   other treatment include : Ice at the injection site Events Verbatim
Right arm pit is swollen. Lymph nodes are sore and puffed up. Big noticeable bubble where armpit is; Lymph nodes are sore and puffed up. Big noticeable bubble where armpit is; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9264), via an unspecified route of administration on Right arm on 08Feb2021 12:00 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included back disorder and Chronic back problems. Concomitant medications within 2 weeks of vaccination were not reported. No Allergies to medications, food, or other products was reported. The patient experienced right arm pit is swollen, lymph nodes are sore and puffed up and big noticeable bubble where armpit is on 09Feb2021 05:00. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The outcome of events were not recovered.
03/01/2006 appeared with lesions that were Dx varicella > 50 pox.
BLOOD CLOTS; HEART ATTACK; This spontaneous report received from a social media via a company representative concerned a patient of unspecified age and sex with unknown ethnicity. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry were unknown) 1 total 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 heart attack due to blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack and blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210522101-Covid-19 vaccine ad26.cov2.s-Blood clots, Heart attack. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
On 11/11/2021 I experienced Sudden sensorineural hearing loss in left ear with tinnitus.   A moderate to severe loss across all frequencies.   Was seen by ENT and diagnosed on 11/17/2021.  Treatment was a week of oral steroids (prednisone) - started on 11/17.  Then, three intratympanic injections of steroids, each administered a week apart from each other: 11/24, 12/1, and 12/8.  Saw small improvements each week and then after third injection my hearing dropped again.
Patient is reporting pain - unusual pain- in the arm.  It is reported that the arm continues to be sore after administration.  Patient reports sharp radiating pain down arm as well as swelling.  Initially thought it was due to pulling luggage around airport.
On same side as vaccination I experienced burning knuckles on middle finger and ring finger, warmth on side of neck, the cheek on the left side of my face was numb, my lips tingled, and my heart rate increased to 105 bpm. The facial numbness went away after a few hours and felt like I had received Novicane for dental work. The burning knuckles took 8 days to go away. I called my doctor's office and spoke to the on call nurse who said the reaction was likely due to the vaccine.
Developed fever, myalgias & asthenia, 1 wk after Flu shot. This progressed to proximal muscle weakness & severe lwr extremity weakness. Extensive w/u "autoimmune myalgias". Pt has limited exercise & walking; still have sx's after 3 mos.
This case was reported by a physician and described the occurrence of vaccine underdose in a adult patient who received ENGERIX B pediatric. On an unknown date, the patient received ENGERIX B pediatric at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. Additional information received: HCP reported ENGERIX vaccine for pediatrics was given to adults. It is unknown at this time how many adults received the pediatric dose and on what day. Patient information is also unknown at this point.
I received my vaccine on 12/18/2020. The side effects I experienced were initially as expected. Mild headache, muscle pain at the injection site.   However, the muscle issues have not subsided, and have actually gotten worse. Day 3 I began having a burning sensation in my underarm area radiating back towards my triceps. Muscle spasms continued to increase and spread to include deltoid, trapezius, and SCM muscles. Yesterday I developed a fever and began having a burning sensation down my triceps muscles and radiating into my forearm (radial side). No visible rash noted. Slight weakness in left arm.
Increase pain, redness, swelling to left arm without drainage. Pain and swelling has continued to worsen over time. Erythema is blanchable. Treated for possible cellulitis and reaction.
On 10/20/99, post vax, pt experienced chickenpox. Pt was treated with Benadryl and recovered.
a 13 month old patient inadvertently received 2 doses of FLUZONE QIV NP 13 days apart with no reported AE; Initial information received on 21-Feb-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 13 months old and unknown gender patient who had inadvertently received 2 doses of influenza quadrival A-B vaccine [Fluzone QIV] 13 days apart with no reported ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B vaccine, suspension for injection (strength unknown) (lot: UT7723LA; expiry date: 30-Jun-2023) via unknown route in unknown administration site for Immunization.  On an unknown date the patient had received 2 doses of influenza quadrival A-B vaccine 13 days apart with no reported ae (inappropriate schedule of product administration) (same day latency).  Action taken with quadrivalent influenza vaccine (Fluzone QIV) was not applicable.  At time of reporting, the outcome was Unknown for the event a 13 month old patient inadvertently received 2 doses of fluzone qiv np 13 days apart with no reported ae.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On 7/25/2018 clt received Tdap IM in left deltoid and IPV and Var in left upper arm; on 7/31/2018 clt woke up with left upper arm and muscle pain measuring 7-8 on the pain scale; clt denies any excursive or other activities which would cause muscle soreness; nurse observed no redness, swelling or warmth in either arm. Clt did admit to another nurse she had exercised day before and it was a new activity.
Patient said she noticed her arm itching the night of 7/14/16 and it started swelling and got bright red and hot to the touch about the side of her hand. When she came in on 7/19/16 it was still red about size of 2x3 inch area but swelling improved.
Atrial fibrillation; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included hyperlipidemia and cholelithiasis. Concurrent medical conditions included blood pressure high (HTN) and osteoarthritis. Additional patient notes included NKDA-patient had no known drug allergy. Concomitant products included amlodipine, atorvastatin and nortriptyline.   On an unknown date, the patient received Arexvy. On an unknown date, 7 days after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria GSK medically significant). The outcome of the atrial fibrillation was resolved.   It was unknown if the reporter considered the atrial fibrillation to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-NOV-2023 The patient self-reported this case. The patient received Arexvy shot and with 7 days interval he/she was found to be in new onset atrial fibrillation. The patient had no prior vaccinations for this reported event. The patient did not have any current illness. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a medical student refers to a 17 year old male patient. Patient's concurrent conditions, medical history, concomitant medications were not reported. On 20-JAN-2018 the patient was vaccinated with improperly stored GARDASIL 9 (dose and route unknown) lot # N021475 expiration date 31-JAN-2020 and RECOMBIVAX HB (dose and route unknown) lot # N002202 expiration date 04-NOV-2019 for prophylaxis (Product storage error). The temperature was 53.2 F, time frame was 5 hours and 57 minutes. It was reported that there was no previous temperature excursion. This case is linked to the case 1802USA001471 (same reporter link).
Headache; Fever; Nausea; Vomiting and Sweats.
Dry eyes; Small Migraine; Haziness; Soreness; This is a spontaneous report from a non-contactable pharmacist. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8131) via intramuscular route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no allergies to medications, food, or other products. Concomitant medications included amlodipine 10 with unspecified units (MANUFACTURER UNKNOWN), perindopril 8 with unspecified units (MANUFACTURER UNKNOWN) and finasteride 1 with unspecified units (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via intramuscular route of administration in the left arm on 09Mar2021 at 10:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 00:00, the patient experienced dry eyes, small migraine, haziness and soreness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events of dry eyes, migraine, hazy vision and pain was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.