chrisvoncsefalvay/vaers-outcomes huggingface dataset:
palpitations; severe chest pain; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Feb2021 as dose 2, single (Lot number: EM9810), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thalassemia Trait" (unspecified if ongoing), notes: other medical history: Thalassemia Trait; "Mitral Valve Prolapse" (unspecified if ongoing), notes: other medical history: Mitral Valve Prolapse. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, lot number: EL3247, vaccine location: Left arm), administration date: 15Jan2021, for Covid-19 Immunization. The following information was reported: PALPITATIONS (disability, medically significant) with onset 2021, outcome "unknown"; CHEST PAIN (disability, medically significant) with onset 2021, outcome "unknown", described as "severe chest pain". The events "palpitations" and "severe chest pain" required emergency room visit. Therapeutic measures were taken as a result of palpitations, chest pain.  Additional Information: No allergies were reported. 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. The patient did not receive any other medications within 2 weeks of vaccination. Adverse event: Developed tingling, burning and felt like shards of glass were being thrown inside the flesh in my lower extremities. Also had the most severe pain in my feet, felt like I was walking on my bones and there were no padding/flesh on the soles of my feet within a week of receiving the booster.Dose received: 3, Most recent dose details: product=COVID 19, brand=Pfizer, Brand unknown=False, Lot number=33036BD, Lot unknown=False, Administration date=16Feb2022, Dose number=3, Vaccine location=Left arm.
adult received the pediatric formulation; adult received the pediatric formulation; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 36-year-old female patient who received HAV (Havrix 720 Junior) for prophylaxis.   On 4th April 2022, the patient received Havrix 720 Junior. On 4th April 2022, unknown after receiving Havrix 720 Junior, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 04-Apr-2022 Reporter's comment: An adult patient received the pediatric formulation of Havrix, which led to underdose and adult use of a child product. The reporter consented to follow-up.
About 10 minutes after receiving the vaccine the client reported he developed tingling on his face. Client stated the tingling resolved after 5 minutes. No medications were administered on site. The client's mother reported that the client developed headache and tiredness about 4 hours after receiving the Pfizer COVID vaccine. The client's mother administered Motrin for the client's headache. Client denied having felt any shortness of breath, dizziness, or other symptoms of anaphylaxis. The client didn't follow up with any healthcare provider. No chronic conditions, medications, or known allergies.
Large area of erythema (10cm x 4cm) (elongated) and tenderness day after receiving vaccine - received KEFLEX from PMD on 10/26/12 for 5 days.
This was a second dose. With the first dose I experienced a VERY sore arm for a week. With this dose I vigorously exercised the arm. During the night following the vaccination I awoke with a very high fever and quaking chills - so much so that I could not even walk. I had someone bring me 2 TYLENOL which I took. Over the period of about an hour, the symptoms dissipated. The arm was sore for nearly a week and did itch.
Pt experienced an injection site reaction. On 2/10/00 mother states child had large red mark around injection site. Saw family MD who said it was a reaction.
No adverse event; Caller reports that doses of improperly stored vaccines were administered to patients.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent historical condition, concurrent condition, drug reactions/allergies or concomitant medication was not provided.    On 17-JUN-2022, the patient was vaccinated with improperly stored of  Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (1 dose, via oral, lot number 1742084, expiration date 05-OCT-2022) for prophylaxis (strength and frequency were not reported) that after temperature excursion to 47.17 Fahrenheit (F) for 15 minutes (product storage error). There was no previous temperature excursion. No other adverse events were reported (no adverse event).  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2206USA006116: US-009507513-2206USA006096: US-009507513-2206USA006061: US-009507513-2206USA006141: US-009507513-2206USA006019:
Chief Complaint: COVID-19 DIAGNOSIS CONFIRMED (+ COVID x4 days ago, c/o left sided abd pain started 1200. ) and ABDOMINAL PAIN Tested positive for COVID 4 days ago. Has scant cough. No SOB The patient has been screened for common infectious diseases and offered vaccinations as appropriate for the presenting medical condition. Follow-up for medical care and/or behavioral issues has been arranged as clinically appropriate
flu; tired; raised lesion exactly at the site of injection; itchy; arm felt warm; arm felt hard; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (arm felt warm), LIMB DISCOMFORT (arm felt hard), INJECTION SITE ABSCESS (raised lesion exactly at the site of injection), PRURITUS (itchy) and FATIGUE (tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026l20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE WARMTH (arm felt warm), LIMB DISCOMFORT (arm felt hard), INJECTION SITE ABSCESS (raised lesion exactly at the site of injection) and PRURITUS (itchy). On 05-Feb-2021, the patient experienced FATIGUE (tired) and INFLUENZA (flu). At the time of the report, INJECTION SITE WARMTH (arm felt warm), LIMB DISCOMFORT (arm felt hard), INJECTION SITE ABSCESS (raised lesion exactly at the site of injection), PRURITUS (itchy), FATIGUE (tired) and INFLUENZA (flu) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Patient used topical hydrocortisone on the rash and took zyrtec initially but then switched to benadryl   treatment information provided be reporter was  Patient used topical hydrocortisone on the rash and took zyrtec initially but then switched to benadryl   This case was linked to MODERNATX, INC.-MOD-2021-070135 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-070135:First dose case
My arm began to itch and swell.  It became red and inflamed at the injection and around the injection site, extending to my elbow and whole upper arm.  It was hot to the touch. I contacted the doctor's office on Wednesday, January 12, 2011 and was advised to to take Benadryl and apply cold compresses.  When I woke up the next morning, it was worse.  I contacted the doctor again and requested an appointment.  The doctor said that it looked infected and prescribed Cephalexin (500 mg), 30 tablets and MethylPREDIsolone (4mg), 21 tablets. I started taking the medications on January 13, 2011.
Case number PHEH2014US025058, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 59 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 23 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Pt has pain from shoulder to past elbow then numbness from wrist to fingers. There is also a small bruise the size of a quarter mid arm, towards the back of arm. Pt says this bruise has been there since 9-22-10 to present 11-4-10. After shot pt came back to pharmacy because of the pain. Pharmacist gave her TYLENOL/Ibuprofen. The OTC pain reliever did not help so after about 2 weeks (from shot) she called her Dr for some pain meds. She tried those but still had no relief. She then tried an orthopedic doctor to see if pain maybe due to 'something else' Dr recommended pt to see a neurologist (Pt not sure of how to spell Dr's name). She said she is still having tests done but so far Dr completed a 'nerve test', tested her neck & just had a MRI done this past Tuesday (11-2-10). Also pt has a painful bruise not in deltoid area - that is not going away. Pt feels this is where her shot was administered but it is far too low, below the deltoid.
This spontaneous report was received from a medical assistant concerning an unknown number of patients of unknown age. On an unkonwn date, unknown number of patients were inadvertently administered VARIVAX (Merck), 0.5milliliter (ml), subcutaneously, that had been improperly stored. No concomitant therapy was reported. However, no adverse effects were reported. No product quality complaint was filed. The action taken was assessed as not applicable. The outcome of events was not reported. The causality was assessed as not related to VARIVAX (Merck). Additional information has been requested.
low immunity after three doses of Moderna Vaccine/has no circulating antibodies against SARS-CoV-2; patient had low immunity and patient received Booster dose after two primary dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE INDUCED ANTIBODY ABSENT (low immunity after three doses of Moderna Vaccine/has no circulating antibodies against SARS-CoV-2) and ACCIDENTAL UNDERDOSE (patient had low immunity and patient received Booster dose after two primary dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included CYCLOPHOSPHAMIDE, DOXORUBICIN HYDROCHLORIDE, PREDNISONE, RITUXIMAB, VINCRISTINE SULFATE (R CHOP) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINE INDUCED ANTIBODY ABSENT (low immunity after three doses of Moderna Vaccine/has no circulating antibodies against SARS-CoV-2) and ACCIDENTAL UNDERDOSE (patient had low immunity and patient received Booster dose after two primary dose). At the time of the report, VACCINE INDUCED ANTIBODY ABSENT (low immunity after three doses of Moderna Vaccine/has no circulating antibodies against SARS-CoV-2) and ACCIDENTAL UNDERDOSE (patient had low immunity and patient received Booster dose after two primary dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: has no circulating antibodies against SARS-CoV-2, no antibodies and no antibodies.         No concomitant medication was reported. The patient had two doses of the Moderna COVID-19 vaccine and then was administered chemotherapy. After the chemotherapy ended, he got the booster dose of the Moderna vaccine and, according to an antbody test, he has no circulating antibodies against SARS-CoV-2. The oncologist recommends the patient to get a 4th dose, but that this time be from Pfizer-BioNtech. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I got 3 shots but never went for the booster. Made me sick each time. Don't feel like being sick.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got 3 shots but never went for the booster. Made me sick each time. Don't feel like being sick.".  Additional information: "I got 3 shots but never went for the booster. Made me sick each time. Don't feel like being sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 14-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
3 weeks after vaccine administration, patient developed fasciculations and atrophy of the right calf. He then about 1 month later subsequently developed weakness in the distal right foot (weakness in ankle dorsiflexion and toe extension with difficulty standing on his toes) and fasciculations spread over 2-3 months to involve the bilateral thighs and arms.  He has had an extensive work up with imaging, lab testing and electrodiagnostics with a diagnosis most concerning for either an idiopathic autoimmune axonal motor neuropathy or early onset ALS. He is being managed with 3-6 months of IVIG for possible autoimmune neuropathy.
RECEIVED HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 52 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (un specified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number was either 1822809 or 211A21A and expiry: UNKNOWN) 0.25 ml, 1 total administered on 27-NOV-2021 for prophylactic vaccination. (Dose number in series 2). No concomitant medications were reported. On 27-NOV-2021, the patient received half dose for their booster dose (coded as vaccine under dose and off label use) (both events dose number in series 2). The reporter stated that something was printed and was disseminated which said to administer 0.25ml. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported. This report was non-serious. . This case, from the same reporter is linked to 20211202250, 20211202469, 20211202515, 20211200675, 20211201168, 20211201179, 20211201228, 20211201286, 20211201304, 20211201351, 20211201362, 20211201392, 20211201443, 20211201450, 20211201963, 20211202161, 20211202199, 20211201046, 20211200752, 20211200994, 20211204104, 20211202379, 20211220146, 20211220262, 20211220250, 20211220145, 20211220619, 20211220129, 20211219871 and 20211219926.
Swelling, burning, itching , Body aches, headache, fatigue, chills, poss fever.
shingles; Late for a second dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was resolved with sequelae and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported.  After receiving 1st dose of Shingrix, the patient experienced shingles. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Low grade temperature late afternoon and evening for two days. Tylenol Itchy rash over body. Benadryl
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date in 2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M000761, expiration date: 06-JAN-2016, 0.5 ml, (route of administration was not provided), after a temperature excursion at 8 Fahrenheit degrees, for 12 hours on 18-MAY-2016. No previous temperature excursions were reported. Patient's concomitant medication was not reported. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Shingles developed within 4 hours of shot.   Went to doctor the next day and they confirmed shingles.  I had never had it before.
On early morning of 5-20-2021.  Shortness of breath, felt weird, coughing up blood.
This reaction 14 days after vaccinated. L arm site red, war and slightly swollen with some itching
Covid booster: chest pain; Covid booster: shoulder pain; Stated that he has pain when lying back and it is better when he leans forward; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 21Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Jan2021, for COVID-19 immunization, reaction(s): "No adverse event"; Bnt162b2 (DOSE 2, SINGLE), administration date: Jan2021, for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "Covid booster: chest pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Covid booster: shoulder pain"; PAIN (non-serious), outcome "unknown", described as "Stated that he has pain when lying back and it is better when he leans forward".  Additional information: Patient stated that yesterday he had stabbing chest pain and proceeding the chest that he had shoulder pain. Patient stated that he remembered seeing on the consent form about pericarditis and myocarditis. Patient stated that he was in medical school and knows about those sorts. Stated that it was intermittent in nature. Patient stated that this seems consistent with that. Patient stated that he looked on website about it and read a article about pericarditis for the second shot and it was like about 20 days which was what made him concerned. Patient stated that he had chest pain like he never had before.   Follow-up attempts completed. No further information is expected.
Woke up due to arm being very sore- went to get ibuprofen and got very light headed. Needed to sit down, ears began ringing and  felt like I was going to faint/pass out. Went into bathroom, felt some what nauseated and weak. Suddenly felt hot, sweating and ears still ringing. Had to keep my head below my knees due to still feeling like I was going to faint. Eventually sat on floor doing deep breaths, feeling weak and hot/sweaty. Then started to feel very cold/clammy. Took temp at this point- no temperature. More deep breaths and eventually after possibly 5 to 10 minutes felt like I could walk to my bed. Still felt very cold but no longer like I was going to faint and ear ringing had stopped. Slept through the remainder of the night until approximately 7am without incident.
Prior to these vaccines, patient had not been sick once. Patient had unusual cries, she developed a fever and we gave her children's tylenol per doctors instruction. We tried to cool her down the best we could. She suddenly began to stiffen her hand and legs and her eyes rolled back, her lips turned blue and she had a seizure for about 4 minutes. We called 911 and paramedics took us to ER. She was given fever medication at hospital to relieve fever. They ran tests and found nothing wrong and said it was a febrile seizure. I didn't see Hib 4 dose on the list but it is the one administered that resulted in the seizure.
Within two weeks post vax the pt experienced joint pain including ankle pain. No treatment was given. The most recent information reports the outcome of the event as resolved.
Chronic Diarrhea for five days, fever of 102 degrees, severe chills, sweats, severe abdominal pain, dizziness, horrible side effects like I experienced were  not listed on any other website. I am fearful now to schedule a 2nd shot. Please advise, thank you.
I had severe abdominal pains and nausea again following this booster dose of Moderna, very similar to the pains I experienced after my first dose. This time, however, they lasted for a full 72 hours before finally returning to normal. Along with the cramping pains and nausea I was also very gassy and kept belching.    I had originally thought the pains I experienced in April 2021 were unrelated to the vaccine, but after experiencing similar pains after all three doses of the Moderna COVID-19 vaccine I now suspect they are related.
Initial swelling, then 5 inch by 4 inch area near shot side became red, hot to touch and EXTREMELY sore. Later, I felt very ill (achy) and feverish.
8 - 12 hours post vax, the pt had a choking and cyanotic episode that was not associated with feeding. The pt was taken to the hospital.