chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; sore throat; felt weak; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), ASTHENIA (felt weak) and NAUSEA (nauseas) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Cipro, sulfa drugs.). Concomitant products included LISINOPRIL, CARVEDILOL, PRAVASTATIN, LEVOTHYROXINE, AMLODIPINE and TELMISARTAN for an unknown indication.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 06-Mar-2021, the patient experienced DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), ASTHENIA (felt weak) and NAUSEA (nauseas). At the time of the report, DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), ASTHENIA (felt weak) and NAUSEA (nauseas) outcome was unknown.            Treatment was not reported.
Large welts and extreme itching in skin from the waist down, which are the typical reaction that he receives when he eats eggs. The Welts and itching subsided after 30 minues following the administration of an antihistimine.
The patient received the vaccine at 12:20pm.  He was observed per protocol for 15min until 12:35.  At 12:35pm he denied feeling any response to the vaccine and ambulated away with a steady gait.  At 12:41pm the patient reported back to the nursing area c/o "dizziness" and feeling like he does when he "drinks too much caffeine" and his left arm felt "tingly." Pt was asked to lay down.  Vitals were checked at 12:45pm while patient was laying down.  BP 180/90, Spo2 96%, HR 69 and regular rhythm per palpation, Temp 97.7, RR 16.  Pt was AO x 4. At 12:50pm BP was reassessed 186/100. At 12:55pm pt reported still feeling "dizzy." His face was flushed.  His left arm still felt "tingly."  He reported feeling "nauseous" and described "heart palpitations."  Pt was asked to sit up and  given 50mg of Benadryl PO per policy and 911 was called at 12:56pm.  Patient laid back down.  At 1300  temp 98.5, pulse 63 and RN noted irregular rhythm by palpation, Spo2 97%, RR 16. The ambulance arrived at 1303 and the paramedics resumed care of the patient.  The paramedics  noted PVCs on their rhythm strip and BP 170/90. At 1311 patient started reporting "epigastric pain" 5/10 pain. At 1313 the paramedics transported the patient to a hospital (unknown which hospital).
have recently been diagnosed with anemia.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAEMIA (non-serious), outcome "unknown", described as "have recently been diagnosed with anemia.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient have recently been diagnosed with anemia. Patient never had this before and he was 69. Patient had many tests to find the cause, but so far nothing. Patient had question Could the vaccines/booster cause this?  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Onset of increased temp to 103 degrees 10 days prior to administration, with rash.
pt recv vax & 1 day p/vax pt exp one crossed eye;the following day both eyes were crossed;CT scan was nl;pt was referred to an ophthalmologist & was under observation @ the time of the report;pt had no hx of crossed eyes;
10 minutes after vaccination, site became itchy.  8 hours after, had diarrhea.  24 hours after, site became raised, continues to be itchy, and is warm to touch.
By mid-afternoon intense ache spreading down upper arm; becoming uncomfortable and difficult to raise arm. By evening upper arm severely ached and beginning to swell; felt arm, and I could not raise my arm up to my mouth. Also skin of upper arm extremely sensitive to touch. Sleeping was difficult due to pain and touch sensitivity; do not believe I had a fever. Following day pain and inability to comfortably move arm increased significantly; waves of intense pain would ebb and flow most of the day and into the night. By third day these symptoms began to subside in frequency and intensity and did so gradually over the following 5-6 days. By Day 8 or 9 most symptoms were gone with only very occasional episode of localized itching and minimal swelling. On Day 10 only remaining symptom was an occasional localized itching in the underarm, especially in the morning which resolved in the next day or two. Have had no symptoms or ill effects since that time.
Pt became weal, pale, diaphoretic, shallow breathing and dizzy- unable to converse, stand, or hold head up. BP 102/58 pulse- unable to feel at first Epinephrine given P58-64. Ambulance called- follow up at hospital.
passed out; light headed; This is a spontaneous report from a contactable consumer (patient's daughter).  An 82-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK4176), via an unspecified route of administration on 25Jan2021 09:50 at single dose for covid-19 immunization. Medical history included visual problem. The patient's concomitant medications were not reported. The patient experienced passed out on 02Feb2021 and light headed in 2021. Clinical course: Consumer was calling regarding her dad who got the Pfizer COVID-19 vaccine. She said her dad had an event and she took him to his cardiologist who checked him out and suggest they call about it. She said that her dad passed out a week and a day after getting the vaccine and had been light headed. She said she was concerned that the second dose of the vaccine was supposed to be worse for effects, and she knew he was supposed to get it, but she wasn't sure that he should.  She said her dad would say to call his daughter, because he had a visual problem, which he had since before the first dose of the COVID-19 vaccine. Caller said that NDC/EXP were not provided on the handwritten card. She said it said he got his first dose 25Jan2021. She said that the report she filed online asked what time he got the vaccine dose, and she put 09:45AM since it would not let her put 09:50AM, it was really at 09:50AM. Outcome of events were unknown.
Fever- 101.6 F High heart rate - 160bpm Nausea Chest pain
Pt reports developing pruritis and proximal edema below the injection site on the inner portion of her arm (facing closest to her body) the evening the vaccine was administered. Symptoms began improving the next morning; however, proximal edema remained and was confirmed by pharmacist examination. Pt denied pain or fever on January 5, 2019. Pt was advised to continue monitoring symptoms and seek medical care if symptoms did not improve or worsened. On January 7th, pt's husband reported her symptoms continued to improve. Only mild edema and a spot of erythema above the elbow remained.
Chills, low-grade fever, headache day after injection Night sweats 2nd night after injection
Breakthrough case admission after 5 doses Moderna 2/16/21 lot# 006MA20;  Moderna 3/6/21 lot# 001B21A;  Moderna 10/3/21 lot# 026D21A;  Moderna 4/9/22 lot# 002M21A;  Moderna 11/9/22 lot# 014H22A
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient's friend reported this case. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient experienced flu like symptoms that lasted a day or two. For tolerance of 2nd dose of SHINGRIX, refer case US2018GSK150388 for same patient. This reporter had not yet received the vaccine. The reporter denied permission to contact their physician. The reporter declined to provide any additional information and said she would tell her friends to call the global response center (GRC). The reporter declined follow up contact. This case has been linked to US2018GSK150389 and US2018GSK150390, reported by the same reporter.
pt recv vax 23AUG95 & on 6JAN97 pt exp shingles rash that follows the nerves from the bottom of the sternum & cont to back;
Case number PHEH2017US005279, is an initial spontaneous report received from a pharmacist on 16 Feb 2017. This report refers to a 44 years old female patient. Medical history was not reported. Concomitant medication was not reported. The pharmacist reported that, the temperature excursion was occurred in Jan for 10 hours, maximum temperature of 51.8 Fahrenheit and the patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186867, expiry date: May 2017) at a dose of 0.5 ml, intramuscularly on 05 Feb 2017, following the temperature excursion. No adverse event was reported following this medication error.
Cellulitis, redness at injection site, rash, hard, swollen, extremely  painful, rash, fever
Past 24hours after being vaccinated, I got home from work and realized I had a rash over my stomach and both arm. Felt achy and had a sore throat. The rash was tiny red spots all over.  I still have rash on me today, and same symptoms. It has not gotten any worse.
"wiped out" for 3 days following the second dose. He also described it as being "exhausted"; This is a spontaneous report from a contactable other hcp. This contactable consumer reported for 2nd Dose administered.   A 64-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for an COVID-19 immunization. The patient medical history was not reported. Concomitant medications included metformin and meloxicam taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (COMIRNATY) and had he headache for 1.5 days and sore arm for a week. The patient stated that he experienced "wiped out" for 3 days following the second dose and described it as being "exhausted" on an unspecified date. The patient expressed that they should make it a standard protocol not to take anti-inflammatory drugs prior to the COVID-19 vaccination series and were there any test to assess the immunity after the receipt of the COVID-19 vaccine. The patient asked could COVID-19 vaccination series be repeated? Has it been done? If so, what are the consequences. Caller stated he received both doses of the COVID-19 vaccine while being on Meloxicam and Metformin. He explained yesterday, he read on news that taking anti-inflammatory drugs interferes with the body's immune response to the COVID-19 vaccine. The patient asked was there a potential interaction between Meloxicam, being an non-steroidal anti-inflammatory drug and the COVID-19 vaccine and Would these anti-inflammatory drugs inhibit an optimal immune response to the vaccine and was there a potential interaction between Metformin and this vaccine and how many of the clinical trial participants were on anti-inflammatory drugs during the study, how does it correlate with the 95 percent effectiveness for the vaccine and what percentage of participants who responded to the vaccine were on anti-inflammatory drugs. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
flu-like symptoms; body aches; low grade fever; didn't have the energy; This is a spontaneous report from a contactable Nurse. This female Nurse reported for herself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 10:00 at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The patient woke up at midnight with flu-like symptoms and she was still having them in Jan2021. The body aches and low grade fever are the worst in Jan2021, enough that she called out of work. The patient just didn't have the energy in Jan2021. The outcome of didn't have the energy was unknown. The outcome of other events was not recovered.  Information on the Lot/Batch Number has been requested.
had COVID on 7/3; had COVID on 7/3; This is a spontaneous report received from a contactable consumer (patient's daughter/son) reported for the patient (reporter's mother) forwarded as an Adverse Event by the call center team. A 78-years-old female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Jul2021, the patient had COVID. The patient underwent lab tests which included Sars-cov-2 test: positive on 03Jul2021. The patient had emergency room visit due to the event. It was reported that the reporter's mother had the Pfizer vaccine in Jan/Feb2021 and had COVID on 03Jul2021. The reporter stated that they needed a third vaccine. The outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021885466 Same reporter/ drug/ event, different patients.
Presented 6 day post vax, with 6 cm diameter erythema slightly elevated indurated, central clearing local irritation.
Elevated liver enzymes. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "TMJ" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: NUVARING; FLONASE [FLUTICASONE PROPIONATE]. Past drug history included: Biaxin, reaction(s): "Allergies: Biaxin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2022) Positive, notes: First tested positive for Covid 16Jun2022; (22Jun2022) Negative, notes: Received negative test 22Jun2022; (01Jul2022) Positive, notes: Tested positive again on 01Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. The vaccine received reported as yes. Other medication in 2weeks was yes. Patient received Covid 19 Treatment (Paxlovid) from 15Jun2022 and 19Jun2022. Other medication in 2weeks product was Nuva ring. Other medication in 2weeks brand was Flonase.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I took the first shot on 08/09021, then two days later, in the night, when I was sleeping, my heart started pounding very heavy and fast. I never had this kind of feeling before. I had fast heart rate for recent years, but the pounding feeling and the heaviness are something I never experienced before. The heavy pounding lasted for a day, then gradually become lighter. But the un-comfortable feeling is still hanging with my heart. I rested for a few weeks, I still do not feel my heart recovered to the state before I took the shot.
She received a Pfizer for her first dose but then was given a Moderna bivalent for the second dose, patient received second primary dose to complete primary series; She received a Pfizer for her first dose but then was given a Moderna bivalent for the second dose, patient received second primary dose to complete primary series; No adverse reaction; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (She received a Pfizer for her first dose but then was given a Moderna bivalent for the second dose, patient received second primary dose to complete primary series), COVID-19 IMMUNISATION (She received a Pfizer for her first dose but then was given a Moderna bivalent for the second dose, patient received second primary dose to complete primary series) and NO ADVERSE EVENT (No adverse reaction) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First dose). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (She received a Pfizer for her first dose but then was given a Moderna bivalent for the second dose, patient received second primary dose to complete primary series), COVID-19 IMMUNISATION (She received a Pfizer for her first dose but then was given a Moderna bivalent for the second dose, patient received second primary dose to complete primary series) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (She received a Pfizer for her first dose but then was given a Moderna bivalent for the second dose, patient received second primary dose to complete primary series), COVID-19 IMMUNISATION (She received a Pfizer for her first dose but then was given a Moderna bivalent for the second dose, patient received second primary dose to complete primary series) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (She received a Pfizer for her first dose but then was given a Moderna bivalent for the second dose, patient received second primary dose to complete primary series) and COVID-19 IMMUNISATION (She received a Pfizer for her first dose but then was given a Moderna bivalent for the second dose, patient received second primary dose to complete primary series).    No concomitant medications were reported.  It was reported that the patient received second primary dose to complete primary series.  No adverse reactions were reported.  No treatment medications were reported.   This case was linked to MOD-2023-714821 (Patient Link).
12/28 developed shingles for the first time. Started antivirals 12/31when vesicles appeared and I realized it was shingles.
Pt vax w/ hepta B; 20 min after vax exp heat, redness, and raised area at inject site.  tx w/ Benadryl.  Reporter felt exp related to vax.
received dose 1 on an uspecified date and exerpienced body aches; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 69-year-old female patient who received Herpes zoster SHINGRIX for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the general body pain to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced body aches.   For tolerances of 2nd dose, refer case US2020AMR206781, reporter by same reporter. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR206781:same reporter
Shortly after receiving my vaccine in September of 2022. My arm was sore for a day and a half which is normal for me. A week later, I noticed that under my arm was quite sore. That kind of came and went. Some days very sore, some days not sore at all. In January, it really started to bother me. I talked to a couple of different doctors who said that it was not uncommon after a vaccine and told me not to worry. I got really sick and was diagnosed with C. diff in the beginning of February. I don't think that was associated with the vaccine or the swelling in my arm. I saw my primary doctor a few weeks ago and said it was really bothering me still. She did not see or feel any swelling, but she gave me a referral to receive mammogram and ultrasound later this month.
administered varicella vaccine intradermal, like a TB skin test on left forearm with 0.1 ml. Whelp appeared.  After error gave 0.5 ml varicella sub-Q left tricep per Nurse Practitioners verbal order.  Gave TB skin test right forearm.
Flat red splotches of various shapes and sizes on torso that first appeared 2 days following vaccine and grew in number for several days thereafter. They were spread throughout stomach/chest/back area and neither itched nor hurt.  Began to fade approximately 2.5 weeks later but are still somewhat visable
Hep #2 vaccine administered 5/13/08, employee tolerated well.  Reported at 0800 5/14/08 3 fluid filled blister-like areas at injection site.  Patient with no c10's, have monitored partial area 5/14/08 and 5/15/08, no voiced c10's, area unchanged.
Swelling, redness, pain, itching at site of injection with 3 small vesicles reported in general area within 24 hr of vacination.  Signs/symptoms relieved following benadryl 25 mg PO.
Day 1 after the shot: Bump around the area of shot. Light itching in the shot area. Warmer to the touch in the shot area. These symptoms lasted approx. 3 days.  Day  8 after the shot: Return of the bump around the shot area. Light itching in the area of the shot.  Since the original symptoms had gone away, my concern is the out-of-the-blues return.
0.1ML OF JANSSEN COVID 19 VACCINE LEFT IN SYRINGE AFTER ADMINISTRATION; This spontaneous report received from a patient concerned multiple patients. 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced 0.1ml of janssen covid 19 vaccine left in syringe after administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 0.1ml of janssen covid 19 vaccine left in syringe after administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420581.
The pt experienced non-stop crying for over 3 hours, won't eat, and experienced a low grade fever.