chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pericarditis; a-fib; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) via an unspecified route of administration in the left arm on 09Feb2021 as single dose for Covid-19 immunization. Medical history included chronic lymphocytic leukemia, thyroid cancer, right lobe was removed. Concomitant medications included ibrutinib (IMBRUVICA) for chronic lymphocytic leukaemia, levothyroxine sodium (LEVOXYL) for thyroid cancer, vitamins. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) in the left arm on 19Jan2021 for Covid-19 immunization, with 0.3mg on the card. On 08Jun2021, the patient developed atrial fibrillation and pericarditis. 4 months after the second  COVID 19 vaccine, she developed pericarditis. Like the male guys get from the vaccine. She was just curious. The patient had heard that these can be side effects for young boys. She wanted to know if there's a report on atrial fibrillation and pericarditis for people belonging to her age group. At first they thought she had A-fib from one of her other pills, but they also had to pull 16oz bloody fluid off of her heart. They put her on pills for the A-fib. They think the A-Fib could be related to her other pill, but they couldn't figure out the fluid. The biopsy didn't answer the question. She was not on the medication that caused the A-fib anymore. That medication was Imbruvica for her CLL, Chronic lymphocytic leukemia. On that medication 5% of people can get A-fib. She was on it 2.5 years. Her Imbruvica was 140mg. She was no longer on it. She wanted to donate the ones she didn't use, but they wouldn't let her. Outcome of the event pericarditis was recovered in 2021, of the event a-fib was unknown.    Follow-up attempts are completed. No further information is expected.
Nurses called to lobby; pt ashen color; skin cold and clammy; responsive to verbal stimuli; no radial pulse. To exam room; Trendelenburg; BP-92/50. At 09:20, BP-100/58; P-88 regular; pt pale, responsive and radial pulse and complaining of epigastric pain and dizziness. At 09:25, EMS to ER.
8/30/2+ i revecived the second dose of the vaccines at 2:30pm.  Jus like the first doae i thought i was gana have uh sore arm, fever, nasesua whwn i recieved the first dose of the vaccine two weeks prior. . After recieveing the shot waiting 15mins bfo returning bac to work, i felt dizzy at moments but thought it was normal.. after a few hours passes i started felling my face burning and itchy my neck started itchjng and hand.. lil by lil my face, neck and hand started gettn red like irritated.   I came home round 8:00pm that night and notice red swollen patches forming on my face,neck and hand.  Waking up at 8:00am on 8/31/21 my face with swellon and neck and hand were itching and burning badly..  rubbed uh cortizone cream on but it didnt help it at all..  haven to miss work on 8/31/21, 9/1/21 & 9/2/21 due to the rection tht accured. The itching and burning woudnt stop.  I went to employee health on 9/1/21 at 12:30-1:00pm and was told to take benydryl and buy a cream other then corizone..  its 9/2/21 today and i still have the itching on my face, neck, and hand.. the redness and swelling have slightly went away but the itching still accures..  skin feel dry and cracky now.
Severe itching and rash over legs, arms, hands, feet, buttocks.  Treating with Benadryl OTC. Continuing to itch.
got really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (got really sick). At the time of the report, ILLNESS (got really sick) outcome was unknown.            No concomitant medication were provided. No treatment  details were provided. Consent for fallow up declined.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: reporter Email address were added.
PATIENT CALLED ON 11/19/22 STATING SHE HAD 104.1 FEVER AND INJECTION SITE REACTION AREA BLISTERED
Mother of patient describes chills, fatigue, and kidney pain. Is being exclusively managed by PCP who has seen him multiple times.  Given Jannsen at mass vaccination clinic by student nurse under preceptor supervision. Error not brought to attention of until 4/2/2021.
Patient was to get Pfizer bivalent vaccine the Medical Assistant accidently gave Pfizer monovalent
1st day: lightheadedness, nauseam with fatigue and mild SOB.  2nd day: In addition to the above symptoms, she developed headache with pallor, continuous vomiting until she had dizziness. She went to the Emergency Room and told she had infection and she was given an cephalexin.  Stayed with nausea, low-grade fever, fatigue, chills and headache until today 04/17/2021.
This spontaneous report was received from a physician and refers to multiple unspecified patients of unknown age and gender. There was no concurrent condition, medical history or concomitant medication reported for the patients. On unknown dates, improperly stored doses of GARDASIL lot # K011562, expiration date 08-APR-2017, (dose, frequency and route were not reported) were administered to an unspecified number of patients. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Warm; Achiness; Rash an inch down from injection site and 4 inches long; Tender to the touch, not painful; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), PAIN (Achiness), VACCINATION SITE RASH (Rash an inch down from injection site and 4 inches long), VACCINATION SITE PAIN (Tender to the touch, not painful) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 013M20A) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included HYDROXYZINE for an unknown indication.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm), PAIN (Achiness), VACCINATION SITE RASH (Rash an inch down from injection site and 4 inches long), VACCINATION SITE PAIN (Tender to the touch, not painful) and HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (Warm), PAIN (Achiness), VACCINATION SITE RASH (Rash an inch down from injection site and 4 inches long), VACCINATION SITE PAIN (Tender to the touch, not painful) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported    Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-MAY-2021 contains non-significant information
Cold; Painful right arm; Sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful right arm), MYALGIA (Sore right arm) and NASOPHARYNGITIS (Cold) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included LITHIUM CARBONATE, INSULIN GLARGINE, BENZTROPINE [BENZATROPINE], VITAMIN C [ASCORBIC ACID], ZINC and MELATONIN for an unknown indication, DOCUSATE.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Painful right arm) (seriousness criterion medically significant) and MYALGIA (Sore right arm) (seriousness criterion medically significant). On 26-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold) (seriousness criterion medically significant). On 01-Mar-2021, NASOPHARYNGITIS (Cold) had resolved. At the time of the report, PAIN IN EXTREMITY (Painful right arm) and MYALGIA (Sore right arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Products known to have been used by the patient, within two weeks prior to the event, included Insulin Novolog and antibiotic.  Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-024406, MOD-2021-024406 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21-Jul-2021 included updated Adverse event and concomitant drugs.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initial information received on 28-Jun-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case involves 70 years female old patient who received who received 0.5 ml and ACTHIB (frequency once, batch number UI911AA, expiry date, route and site of administration reported "route and site: UTR") on 08 June 2018 as she was to receive a Tetanus Toxoid shot and is there enough to cover just the tetanus. It was actual medication error due to inappropriate age at vaccine administration and Wrong vaccine administered as 70 year was given ACTHIB in any contraindications or any side effects. She was to receive a tetanus shot and is there enough to cover (Tetanus shot and received ACTHIB Immunization or TB skin test). On 08 June 2018, patient had emergency room visit (ER/Dr). No adverse event symptom occurred to patient. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. Documents held by sender: none.
Patient developed severe cellulitis on Left arm. Left arm, pain, swelling and redness to the elbow. She also had chills and nausea. She denies fevers. She went to the ER on 1/7/18 and was started on antibiotics. I followed up with patient 1/10/18 and she is healing each day, but still has a few more days of antibiotics.
Injection site was red and a little swollen the next day and has become increasingly larger.  Today (3 days later) the injection site is red, warm, swollen, and about the size of a grapefruit.; Injection site was red and a little swollen the next day and has become increasingly larger.  Today (3 days later) the injection site is red, warm, swollen, and about the size of a grapefruit.; Injection site was red and a little swollen the next day and has become increasingly larger.  Today (3 days later) the injection site is red, warm, swollen, and about the size of a grapefruit.; This is a spontaneous report from a contactable other HCP. A 39-yearsold female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular in left arm on 04Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination. Concomitant medication included desvenlafaxine succinate (PRISTIQ), fluoxetine (FLUOXETINE), bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), etonogestrel (NEXPLANON) , ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), cyanocobalamin (VIT B12), and iron. On 05Jan2021, the patient experienced injection site was red and a little swollen and has become increasingly larger. 3 days later, on 08Jan2021, the injection site was red, warm, swollen, and about the size of a grapefruit. The outcome of the event was not recovered. Treatment included over the counter medications and ice. The patient was not tested for COVID-19 post vaccination.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported injection site reactions. 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.
Pt reported to clinic 4DEC91 that had a sz 3DEC91 taken to ER kept until 9PM;
Patient reported on the night of her flu shot (at about midnight) she woke up dizzy, nauseous, weak, and vomiting (a little bit).
Felt fine the first 24 hours other than the arm soreness, moderate pain at site of injection. After 24 hours, my right eye lid started to catch when I started to blink. I call it lid lag. It has persisted longer than 24 hours.  My eye lid does not blink the same as my left eye. It's like a brief before it returns to my regular eye lid. There has been no worsening,  and no improvement, it has remained the same.
Bivalent formulation was given instead of monovalent for 1st dose of primary series.
One week after the first dose of the vaccine I started to get hives that spread all over my legs. The next day the rash was on my stomach. Every day they went from the soles of my feet and worked their way up my body until it reaches the palms of my hands. After this point I have been experiencing facial swelling. After the second dose the hives started  again but it was much worse. It started the day after and I also had swelling in my face and lips.  I have been referred to an immunologist. I still have hives every day after five months. They are mostly on my legs and thighs. They are big raised splotches which cover large areas. I have never had them on my face since the day after the second dose. I have taken Steroids and I still take Zyrtec every day. It is extremely itchy which was not helped by a topical cream. I also take anxiety medication so that I can sleep.  Dose 2: 02/05/2021 LOT#012M20A
Beginning 9PM night of immunization with FLUZONE HD patient c/o diarrhea, stuffy & runny nose, and short-winded. Sx improved by AM of day after immunization of their own accord - no additional meds taken.
Intense tinnitus within 4 hours of vaccine; unable to sleep easily; moderate pain soft tissue/bursa; moderate pain tendons; Burning bilateral patellar; arm pain; pain milder in bilateral shoulders; mild typical headache; fatigue; muscle and arm pain; This is a spontaneous report from a contactable physician (patient). A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Feb2021 14:15 (Lot Number: EN6203) (at the age of 62-years-old) as dose 1, single for covid-19 immunisation. Medical history included mild hypertension diet controlled, euthyroid with mild TSH (thyroid stimulating hormone) elevation. The patient had no known allergies. The patient had no concomitant medications in two weeks of vaccination. Patient did not receive any other vaccine in four weeks of vaccination. Patient did not have covid prior vaccination and was not tested for covid post vaccination. On 26Feb2021 18:00, the patient experienced intense tinnitus within 4 hours of vaccine and was unable to sleep easily, burning bilateral patellar, moderate pain in soft tissue/bursa, tendons, milder pain in bilateral shoulders. In addition, patient also had mild typical headache, fatigue, muscle, and arm pain on 26Feb2021 18:00. The events required topical medications started within 24 hours of vaccine, and the events were present 84 hours later, abating. The doctor appointment was pending. The events required doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
pt listless in evening p/vax 13MAY92 shook, pulled legs up, head down, slow to respond, gagging; lasted 5-15sec per epiosde; @ least 2 episodes;
Onset 20 min following injection, although not reported to nurse or teacher.  Developed hives on inner thighs bilaterally.  Benadryl and hydrocortisone cream applied with resolution.  History of hives following Augmentin and possibly Ceclor. No allergy to eggs.  Physician notified by phone, no visit.
A rash on the arm in which the vaccination was given. The rash was itchy, hot to the touch, swollen. It spread over the course of the first 72 hours or so.  It resolved in about 7 days.
Fatigue; Chills; Joint pain; A spontaneous report was received from consumer, concerning herself, a 74-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, chills, and joint pain.  The patient's historical vaccine included flu shot on 16-DEC-2020. Concomitant medication use was not reported.  On 19-Jan-2021, prior to the onset of the event, the patient received their first dose of mRNA-1273 (Lot number: unknown) via intramuscular route on the left upper arm for prophylaxis of COVID-19 infection.   On 25-Jan-2021, 7 days after the administration of vaccine, the patient reported the onset of symptoms included fatigue, chills, and joint pain. Treatment information not provided.  Action taken with the mRNA-1273 in response to the events were not provided.  The outcome of events fatigue, chills, and joint pain were considered unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Puffy eyes, sore throat - scratchy, stuffed nose, pain at injection site.
Mother reported pin point red rash on back, arms and chest. Denies other symptoms. Client seen by MD on this date. Spoke with MD who stated rash as red with some blotchiness, not raised but spreading. Treated with Benadryl. Spoke with client mother on 7/6/00 who stated pt still had rash today but no other signs and symptoms and was acting fine.
Arrived at the fairgrounds to receive 2nd dose of Covid-19 vaccine. The phlebotomist stuck me in the left arm and announced there was no vaccine in the syringe and would need to stick me again. There were 2 other people with me. We all received the vaccine. The next day I became concerned that the needle with the empty syringe may have been previously used and has subjected me to an unknown disease or illness.
First sore arm and then fatigue, severe muscle aches, headaches, chills, and feverish flu-like symptoms began about 9 hours after vaccination and got severe about 12 to 14 hours after. They gradually improved over the next 24 hours. Please note that this vaccination was given to me at the same time as the 2020 influenza vaccine.
This spontaneous report as received from a pharmacist refers to a 14 year old male patient. Information regarding the patient's concurrent conditions were not provided. On 30-JUL-2015 and 15-OCT-2015 the patient was vaccinated with GARDASIL (reported as GARDASIL 4), dose 1 and dose 2 respectively. On 30-JAN-2016 the patient was then vaccinated with GARDASIL 9, final dose (interchange of vaccine products). No adverse events were reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
The patient received an expired dose of Menactra on 30Aug2019, No AE; 21-year-old male received a delayed dose of Menactra  intramuscularly on 30Aug2019 as dose number 2 out of 2. the patient received dose number 1 as a child, No AE; Initial information received on 30-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse in the United States.  This case involves a 21 years old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) in right deltoid via intramuscular route for immunisation, on 30-Aug-2019.  On 30-Aug-2019, the patient received a delayed (second dose) and expired dose 0.5 ml dose once of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot: U5984AB, expiry date: 14-Aug-2019) via intramuscular route in the left deltoid.  It was also reported that the patient received dose number 1 as a child.  It was an actual medication error due to inappropriate schedule of vaccine administration and expired vaccine used.  At the time of reporting no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  List of documents held by sender: none.
coughing; throat itching; chest pain/ a pain on her chest; This is a spontaneous report from a contactable consumer or other non hcp reported for herself. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration on 14Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced coughing, throat itching, chest pain/ a pain on her chest. The clinical outcome of the events was unknown.     Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
After receiving flu vaccine, pt felt deep ache and weakness down left arm. Injection given October 11, 2001 in left deltoid. Pt taking large amounts of Tylenol.
Patient received second dose of moderna vaccine, 20 min after vaccine patient started complaining of throat feeling numb. V/S- B/P 148/74 Pulse 78 Respirations 18 Oxygen Saturation. Provider assessed patient and  advised to give Benadryl 50 MG IM. Taken to clinic with provider for further evaluation and for family to come pick patient up.   3:20 Pm Vaccine administered  3:43 patient advised staff of symptoms called for provider took vitals  3:48 provider with patient assessed ordered Benadryl 50 Mg IM  3:50 Benadryl 50 mg IM administered  3:56 Provider took patient into clinic to monitor awhile longer.  4:10 Patient verbalized relief of symptoms after Benadryl 4:30 Patient left facility with no further symptoms family member here to pick up patient and take home