chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in an 83-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
Breakthrough case admission after 3 doses Moderna 3/3/21 Lot# 01021A;  Moderna 3/31/21 Lot# 017B21A;  Moderna 11/9/21 Lot# 065F21A
After receiving flu shot, patient came in 2 days later complaining of numbness, pain and swelling of the hand. Patient went to hospital and was given a script for the pain.
mom reports pt shook all over x 3min/4PM 5JUN97 recv 2PM;no fever;no LOC;uneventful course thereafter;
Patients wife states he had covid vaccine end of July 2022 and was dead 8/3/2022. Patient's wife wanted us to file vaccine adverse event on her husbands behalf. She states he received covid booster in July 2022 and died sudden death August 3, 2022
Pfizer COVID vaccine stored in regular freezer for longer than 2 weeks and patient received.
Carditis; Palpitation; Sudden Heart Beat; This is a solicited report based on information received by Pfizer (Mfr. Control No.: 21K-163-4093548-000). A contactable consumer (patient) reported a 50-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), first dose, intramuscularly on 23Jun2021 at the age of 50 years old, as single dose, second dose, intramuscularly on 21Jul2021 as single dose for covid-19 vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date to an unspecified date, at unspecified dose for moderate to severe chronic plaque psoriasis. Medical history included moderate to severe chronic plaque psoriasis. The patient's concomitant medications were not reported. On an unknown date, the patient experienced slowed not as thick but persisting plaques with HUMIRA (adalimumab). The patient experienced carditis in 2021, palpitation in 2021, sudden heart beat in 2021. In 2021, the patient experienced noticed reaction to first dose and second dose was carditis, palpitation and sudden heart beat. The patient underwent lab tests and procedures which included heart monitor: unknown results in Aug2021. The action taken in response to the events for adalimumab was unknown. The outcome of the events was recovered in 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of noticed reaction to first dose and second dose was carditis, palpitation and sudden heart beat onset in 2021 with humira(adalimumab) was no reasonable possibility. The reporter's causality for the events of noticed reaction to first dose and second dose was carditis, palpitation and sudden heart beat onset in 2021 with BNT162b2 was possible.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available in narrative the reported  event of  carditis, palpitation, heart rate increased is assessed as related to suspected vaccine BNT162B2 The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Side effects awakened me from sleep with onset of chills, aches in muscles and joints and headache. Later developed nausea. Fatigue aches in  muscles and joints persisted until 1/31/21 am. Headache persisted from onset of symptom on 1/30/21 until approximately 10:30 am on Sunday 1/31/21. I did not seek medical attention, as I am a health care provider and was aware that these were common side effects of the vaccine.
Headaches, upset stomach, nausea, vomiting, vision problems, can't sleep. Went to her doc 02/18/2016 got sent to another Dr may have POTS. 03/31 back to primary doctor sent to Neuro and Cardio blood work negative has a stress test and brain MRI scheduled. Having heart palpitations and missing a lot of school and effecting her daily activities.
How important is it to get the vaccine at the 3 week mark? Should take a chance and get it tomorrow or not; Inflammation; pain; Headache; nasal burn; This is a spontaneous report from a contactable Consumer or other non HCP (patient). This 69-year-old female consumer reported that:   A 69 years old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Aug2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Active Drug substance names was reported as COVID 19 Vaccine, mRNA. She received the first Pfizer vaccine on 11Aug2021 and was scheduled to get the 2nd one tomorrow afternoon from the day of report. On an unspecified date, the patient experienced and enquired how important was it to get the vaccine at the 3-week mark and Should take a chance and get it tomorrow or not. She wanted to get protection. She felt bad after the first shot because of inflammation. She was holding a lot of fluid and it set up pain. She had headaches after the vaccination. She totally didn't get rid of the headaches. In August and September, she had headaches and nasal burn on an unspecified date in Aug2021. Initially came on with the shot but continued so was not sure if that was due to the shot or not. She started having problems from not taking the medications she needed to take. Outcome of events were reported as unknown.  Information on the lot batch number has been requested.
31MAR92 pt recvd 1st dose of Engerix-B & 1APR92 devel fine rash on bridge of nose; an ER or MD office visit was required to treat the event;
Patient received Pfizer Biotech vaccine as second covid19 vaccine.  She received Moderna vaccine as her first dose elsewhere at another facility. Patient was made aware of error. No adverse reactions in terms of patient's health. Patient made awre that vaccine series is complete although not as indicated by EUA
generalized maculopapular erythematous rash  given benadryl  Likely had 12mo wce immunizations - attempted to contact primary provider was unsuccessful
Pt sts she has not been feeling her normal self since receiving the MMR vaccine. Pt woke up today with a rash on her trunk, back, and arms. Also swollen glands on both sides of neck.  Dr. is diagnosing rash as Measles.
15 minutes after recieving the Moderna vaccine, the left since of my face went numb. The numbing lasted over three days and has left my face with a tingling sensation to this day (16 days later). An itching, irritating rash appeared on the site of injection 2 days after recieving the vaccine which lasted about 4 days after appearance. Lastly, joint pain that has lasted to this day and is on going (16 days after the vaccine). Prior to the vaccine I had no joint pain, Starting the day after injection, my knees, hips, shoulders, elbows, wrists, and even finger joints are abnormally stiff and aching. I have a difficult time doing day to day tasks.
My arm where the injection was is swollen, red, and slightly itchy.  It?s slightly larger than a quarter size in diameter.
Vaccine had expired on 10/21/2021. Contacted medical director, Dr. Educated patient vaccine had expired one day prior; however, not required to repeat dose.
Patient developed erythema to L Deltoid, warm to touch and soreness. Vaccine administered 10/16/06 (4pm). Local skin reaction occurred within 24 hours. Patient given antihistamine to aid with allergic reaction 10/18/06. Patient is to take Benadryl 25mg at bedtime 10/18/06. Patient was asked to report "no change" in status or if condition worsens. Follow-up by Employee Health Nurse twice daily.
Breakthrough case admission after 3 vaccines Pfizer 4/14/21 lot# EP6955;  Pfizer 5/5/21 lot# Ew0168;  Pfizer 11/19/21 lot# Ew0186
Tingling/feeling of numbness in upper lip.  Lip remains slightly swollen 1 day later.
This spontaneous report was received from a medical assistant referring to an unspecified amount of patients of unknown age and gender. On an unknown date, an unspecified amount of patients were vaccinated with improperly store doses of ROTATEQ orally, (dose was not reported) lot # M031650 with expiration date 16-MAR-2018, lot # M042169, with expiration date 22-JUN-2018, lot# M042822,with expiration date 19-JUN-2018, for prophylaxis. No adverse event was reported. The doses of ROTATEQ were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77°F (19 °F) during a time frame of 48 hours (previously reported as 96h). Digital data logger was not involved. No previous temperature excursion was reported. This is one of two cases from the same source (MARRS # 1708USA005357) Sender's Comments: US-009507513-1708USA005357.
Headache; Vomiting; Fatigue; Nasal congestion; Sinus congestion; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 55-years-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3247) via an unspecified route of administration on her left arm on 15Mar2021 at 12:45 PM (age at vaccination was 55-years-old) for COVID-19 immunisation. Medical history of the patient was not reported. The patient was not allergic to medications, food, or other products. Concomitant medications (received within 2 weeks of vaccination) included levothyroxine (LEVOXYL), alprazolam (XANAX) and fish oil, all used for an unknown indication started from an unreported date. Her past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration on the left arm on 22Feb2021 at 12:30 PM (age at vaccination was 55-years-old) for COVID-19 immunisation. She had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Also, prior to vaccination, she was not diagnosed with COVID-19 and since the vaccination, she had not tested for COVID-19. On 16Mar2021, at 04:00 AM, she experienced headache, vomiting, fatigue, nasal congestion, sinus congestion and muscle aches. No therapeutic measures were taken to resolve these events. The clinical outcome of the events headache, vomiting, fatigue, nasal congestion, sinus congestion and muscle aches was recovering. No follow-up attempts are needed. No further information is expected.
vertigo; dizziness; nausea; This is a spontaneous report from a contactable physician.  A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, on 21Dec2020 at 10:00 AM at single dose for COVID-19 immunisation. Vaccine location was left arm.  The patient was vaccinated at hospital, age at vaccination was 41-years-old. Medical history and concomitant medications were unknown. On 22Dec2020 at 12:30 PM, the patient experienced abrupt onset vertigo, dizziness nausea - self resolved but then second wave of similar symptoms also self resolved. Th events were reported as non-serious. No treatment was received for the events. Information on the lot/batch number has been requested.
He had COVID 2 weeks ago; He had COVID 2 weeks ago; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "He had COVID 2 weeks ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: He tested negative twice before no longer wearing a mask around other people; (Mar2023) Negative, notes: He tested negative twice before no longer wearing a mask around other people; (05Apr2023) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter reported that last dose was several months ago (I do not have access to his vaccination card to provide the exact date). Patient had COVID 2 weeks ago and took 5 days of paxlovid which patient finished on 30Mar2023. After 6 days of infection, patient tested negative twice before no longer wearing a mask around other people per CDC guidelines. On 03Apr2023 patient started sneezing. On 05Apr2023, patient developed a runny nose and increased sneezing and tested positive again that evening (appropriately 11pm).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
3 days post vax the pt developed a bright pink or red rash all over her torso. It spread onto her chest and back. The areas where the rash appeared are tender, sore and itchy. The pt has had the rash for 18 days. The pt was seen by a physician who treated her with Benadryl. When she stopped taking the Benadryl the rash became red and itchy again. Additional information has bee requested.
Headache; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 18:15 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021, the patient experienced headache. The event 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 the event. The clinical outcome of the event headache was resolving at the time of tis report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever, cold sweat, extreme lethargy, fainted after going to bathroom.  Ambulance responded middle of night.
This case was reported by a nurse via call center representative and described the occurrence of underdose in a 15-month-old female patient who received BOOSTRIX (batch number G932P, expiry date 30th November 2019). On an unknown date, the patient received BOOSTRIX. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration were unknown. Additional information was received as follows: The 15 months old patient inadvertently received a dose of BOOSTRIX (reduced antigen), instead of DTaP, which led to accidental underdose and inappropriate age at vaccine administration. No further information was reported. Follow up information received from nurse on 13th March 2018: The patient's demographic details were reported. The patient received 0.5 ml dose of BOOSTRIX intramuscularly as 4th dose in the DTaP series. Less than a month, after receiving BOOSTRIX, the patient experienced soreness at injection site. Error occurred in selecting the correct vaccine with unknown contributing factors. The person double checking the vaccine did not catch it. The VAERS information was updated. This case was medication error with adverse event.
I got the vaccine felt fine arm felt sore that night. I exp redness on left arm appeared to become larger. I contacted my PCP set up a Telehealth was told to come in the office. She wanted to give it few more days for observation and was prescribed a Prednisone dose pack 6 days,EpiPen. The symptoms started to slowly go away.My PCP took blood work (2)was concerned that vaccine might have triggered Hepatitis over 40 years ago.
Pancytopenia including platelet nadir of 50,000, Altered mental status, fever and chills.   Patient received 3rd dose of Pfizer on Friday September 24th and has since been feeling more so fatigued, decreased appetite, and having fevers and chills.  ED clinical summary: Vitals T 36.4 °C, P 74, RR 18, BP 167/83, SPO2 95%.  UA unremarkable.  CBC remarkable for hemoglobin 9.9, hematocrit 20.9, platelets 84.  CMP remarkable for potassium 3.3, glucose 105.  Pro-Cal 0.56.  CT head/brain showed no evidence of acute intracranial process.  CXR showed parenchymal clear and left lungs obscured by patient and and cardiac silhouette.  Patient given Rocephin/doxy and Tylenol in ED and admitted for further evaluation. Peripheral smear: Thrombocytopenia demonstrating, morphologically normal platelets. Hemolysis work up negative, folic acid and Vitamin B12 normal.  Does not drink alcohol.  TSH mildly elevated at 5.5 (patient has known history of hypothyroidism).  Ferritin 554. D-Dimer elevated at 798.  Last CBC was in 12/2020 Hb was 13.7 and PLT was 180 at that time.  Patient's platelets decreased to nadir of 50,000 on 4th day of hospitalization and then increased to 66,000 on day 6 without any treatment. patient's mentation improved to baseline on 2-3 day of hospitalization.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. The nurse reported that on 03-FEB-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported feeling weak, dizzy and nauseous. Patient indicated he hadn't eaten before coming when questioned. Patient advised to sit back, take slow, deep breaths and was given a snack and some juice. After 15 min pt reported feeling better and was able to ambulate alone left office with mother.
Sore arm second day Right armpit and right front shoulder pain including clavicular area pain starting the fifth day Bump on right area started day 7 Day 8 large rash, itching near injection side Increase sweating from right armpit starting day 7
Patient was requested to wait 30 minutes after receiving COVID19 Pfizer vaccine due to her hx of anaphylactic reaction to influenza vaccine. After 15 minutes after receiving her vaccine patient started to complain of itchy throat and bilateral itchy ears- no rash present. Patient in no acute distress. Denies shortness of breath, lightheadedness, wheezing, chest tightness, throat swelling. Patient states the throat itching started to get worse @1536 at which time vitals BP 136/87 HR 92 and SPO2:100%. Patient states she took 25 mg oral benadryl prior to coming to vaccine clinic today. 25 mg oral BENADRYL given at 1540. 20 mg of oral PEPSID given @1541. SOLUMEDROL 125 mg IM injection given @1543. Repeat vitals @ 1545 are as follows: BP 144/94 HR 80 SPO2:100%. Patient states symptoms of throat itching and bilateral ear itching resolved @1555.  Repeat vitals@1602 BP 134/94 HR 89 SPO2:100%. Patient was monitored for an additional 20 minutes and patient left facility symptoms free at 1625. Spoke with her husband in the parking lot to update on symptom management. Husband states he will drive her home and monitor. Recommended if symptoms of throat swelling, shortness or breath, wheeze occurs to utilize EPI pen and immediately follow up in ER. Patient and husband agreeable to plan.
Fever, chills, pain in injection site, redness on left arm, severe swelling of left eye with redness, discharge, color change of eyeball. Scheduled appointment with optometrist.
Pt received FLUZONE HD in pharmacy on 9/9/14. 3 1/2-4 hours later, pt started to feel wheezy, tight in chest and eyes started to swell. Pt took BENADRYL but reaction progressed so she went to ER where she received IV BENADRYL. We are unsure if the vaccine triggered some type of reaction 4 hours later, pt has never reacted to previous flu vaccine, but this was first HD dose.
PHN saw patient 24 hr after administration of vaccine. Upper (L) arm (deltoid) swollen and red - size of baseball. During 15 min. after vaccination - he did become pale, lightheaded, clammy skin. Legs elevated. Ice pack to head.
Coughing, red itchy eyes, shortness of breath, swollen throat, cold/hot flashes.
The next day severe pain at shot location on arm.   Constant Severe joint pain in shoulders, hips and knees.  This pain was continuous and no amount of pain reliever medicine would work.  My pain management doctor increased my dose of Tramadol to 2 every 4 to 6 hours with Tylenol or aspirin in-between and it did not help.    The pain finally stopped when I woke up on the 8th of October, 23 days later.  I took the 2nd dose today 10/12/21.
Site of injection red, warm to touch, Pt was put on course of antibiotics Keflex x 1 week.