chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Dose of Heplisav-B was Given; Initial Report Received on 13-Aug-2021  A certified medical assistant reported that a 60  year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 11-Aug-2021, the patient received a dose of HEPLISAV-B (Lot # 933624, expiration date 10-Aug-2021, serial number 178642652628 and NDC # not reported) in the left deltoid. No adverse effects were reported.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
From Patient:    I received my shot on 12/30/20. When I got to my car I was having some face numbness and tingling. I went back to work  I also had some weakness and being tired but that went away and weakness in my legs but that went away didn?t last long.  The numbness and tingling in my face and neck did not go away.  My arm is still sore.  I did go to the er last night cause my blood pressure was high at home and face still numb and tingling.  Just thought I better check things out.  Dr wasn?t sure if it was a reaction from the covid shot he was checking for stroke issues all tests he ran were good.
Hives, redness, & itching surrounding injection site on arm, all over back, and down both legs. Took 2 Benadryl.
I have had shortness of breath, with people thinking I have just run up the stairs when I was just sitting in the room.
"by 11am the next day i felt tired, nauseated, fever of 101F and chills, diarrhea, abdominal cramps.  i had to call into work. it lasted 24 hours"
Initial report received from healthcare professional on 21 Nov 2014. A 72-year-old male patient, whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE (lot number, dose, dose number, not reported) in the left arm on 20 Oct 2014. The patient had a medical history of allergy to codeine, leg restlessness, insomnia. It was reported that on 21 Oct 2014, the patient developed pain at injection site and he had difficulty raising left arm. The patient had been taking ALEVE as corrective treatment. Lab details were not reported. The outcome of the event was unknown. Documents held by sender: None.
Headache, mild pain at injection site, lymphadenopathy, fatigue, nausea, malaise
Tested positive for Covid after her 1st dose; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid after her 1st dose) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Jul-2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Tested positive for Covid after her 1st dose). At the time of the report, COVID-19 (Tested positive for Covid after her 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. It was reported that patient has not gotten her 2nd dose. Patient wanted to know how long after testing negative could she get her 2nd dose. No treatment medications were reported.  Company Comment: This spontaneous case concerns a 26 year old female patient with no medical history reported , who experienced non-serious , unexpected , AESI of Covid 19 which occurred one month post vaccination with the dose 1 of mRNA-1273 vaccine. This patient test positive for SARS-COV 2 test last July 30, 2022. Treatment information , results of other  laboratories/diagnostic procedures were not reported and there was no report if any medical consult was done. Outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 26 year old female patient with no medical history reported , who experienced non-serious , unexpected , AESI of Covid 19 which occurred one month post vaccination with the dose 1 of mRNA-1273 vaccine. This patient test positive for SARS-COV 2 test last July 30, 2022. Treatment information , results of other  laboratories/diagnostic procedures were not reported and there was no report if any medical consult was done. Outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Arm sore. Then right after started running fever cough diarrhea shortness of breath.
pt recv vax 2JAN97 & mom found rash on pt chest & stomach 3JAN97 in evening;pt had no c/o itching was afeb;rash did not spread to other areas;6JAN97 pt slept p/school hr & until 7AM 7JAN97;flush colored lumpy feeling to stomach & ches
Vaccine administered L deltoid on 11/19/09. Burning sensation in L forearm began 11/21/09 - now resolved. Currently complains of tenderness L deltoid and L shoulder. Exam eval.
Localized swelling, warmth, redness, pain at left anterolateral arm injection site.  Began day after vaccination and was reported to be persisting on day 5
No adverse event noted - MMRV and Varicella vaccine given at the same visit instead of MMR and Varicella.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 09:00 as dose 1, single (Lot number: EN6203), in left arm, on 25Mar2021 at 09:00 as dose 2, single (Lot number: ER8732), in left arm and on 09Nov2021 at 16:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure. Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement, start date: Jan2010. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) Normal, notes: blood pressure has been normal for the past 10 years; (unspecified date) Normal, notes: my blood pressure went back to normal in just 4 hours after first dosage; (2022) 180/110, notes: my blood pressure was very high 180/110; Body temperature: (2022) 100 Fahrenheit, notes: for 2 days; Heart rate: (2022) 100 bpm, notes: elevated heart rate (100 bpm resting heart rate, 30 BPM above regular) for about 10 days,; SARS-CoV-2 test: (unspecified date) Negative, notes: COVID home test turned negative for 2 days on Thursday and Friday; (2022) Negative, notes: COVID home test turned negative for 2 days on Thursday and Friday; (2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (16Jul2022) positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (17Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (18Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (19Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (20Jul2022) positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (21Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (22Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (23Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (24Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (25Jul2022) Negative, notes: On Monday, 25Jul, I did PCR test and the result was negative. Therapeutic measures were taken as a result of covid-19.  Clinical course information: Patient took other medication in 2weeks.
20 Patients received Spikevax past the 30 day expiration date; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medications were reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701001, US-MODERNATX, INC.-MOD-2023-701033, US-MODERNATX, INC.-MOD-2023-701057, US-MODERNATX, INC.-MOD-2023-701080, US-MODERNATX, INC.-MOD-2023-701104, US-MODERNATX, INC.-MOD-2023-701107, US-MODERNATX, INC.-MOD-2023-701147, US-MODERNATX, INC.-MOD-2023-701172, US-MODERNATX, INC.-MOD-2023-701191, US-MODERNATX, INC.-MOD-2023-701204 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701147:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701172:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701057:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701104:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701033:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701107:Master case US-MODERNATX, INC.-MOD-2023-701080:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701001:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701191:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701204:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701196:Master case
Patient felt like she was having a seizure.  She was laying down at the time.  Was extremely weak and called out to me that she was having a seizure.  I immediately responded to her and asked if I should call EMS.  She said no.  I checked her blood pressure and it was normal.  Within about 5 minutes she was coherent and able to talk to me.  She got up and went to the bathroom about 5 minutes later.  She felt kind of unsteady the rest of the day but didn't show any signs of seizure.  She appears to be okay today
Possible syncopal episode, fell twice. 2nd vaccine dose on 5/20/21 at approximately 2:30 pm. Woke up in the night on 5/21/21 approximately 2:00am, went to the restroom. Upon return, felt dizzy (blurry vision, unsteady) and nauseated, attempted to return to bedroom but fell to the floor twice. I remember falling the 1st time, but do not remember anything between when I fell the first time and when a family member found me on the floor (likely less than 1 minute) a short distance away from where I fell the 1st time.   For the rest of the day on 5/21/21, felt lightheaded but no more syncopal or near syncopal episodes. Experienced fatigue, brain fog on 5/21 and smaller degree on 5/22 and 5/23.
A company representative reported that a 12 month old received an injection of Prevnar and subsequently, developed erythema multiforme. No further information was available at the date of this report. This is 1 of 2 pts from the facility who experienced an adverse event following receipt of Prevnar.
pt recvd vax; w/in 6 hrs pt exp nausea & diarrhea; devel headache; pt complained about tiredness;
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of COVID-19 with Humira (Adalimumab) was no reasonable possibility.  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.  Company Comment:  This spontaneous case concerns a 55-year-old female patient with use of Adalimumab (Humira) for rheumatoid arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of event onset was not provided. SARS-CoV-2  test, and treatment were not reported.  Patient received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart.  Adalimumab (Humira) is an immunosuppressant that may lower the immune system of the body and affect immune response to mRNA-1273 vaccine predisposing to COVID-19 infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient with use of Adalimumab (Humira) for rheumatoid arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of event onset was not provided. SARS-CoV-2  test, and treatment were not reported.  Patient received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart.  Adalimumab (Humira) is an immunosuppressant that may lower the immune system of the body and affect immune response to mRNA-1273 vaccine predisposing to COVID-19 infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
welts all over (her) body; Itching; Red welts all over body; This is a spontaneous report from a contactable consumer.   An 80-year-old female consumer BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) on 13Jan2021 at 12:00 p:m at single dose for COVID-19 immunization. Relevant medical history included penicillin and bee stings allergies. Concomitant medications were not reported. On 13Jan2021, about 3 hours after vaccine patient experienced red welts were all over her body, face, arms, and under breasts. She was itching all over. Patient took three allergy pills and the reaction subsided. Patient didn't provide product name of allergy pills. Patient informed she had a reaction before to Penicillin and clarified her reaction with Penicillin was red welts and itching, but her tongue didn't get sick on an unspecified date. Patient was supposed to go back and get second COVID-19 Vaccine, but she was not going to take it unless there is a COVID-19 Vaccine without Penicillin in it (as reported). Provided date on patient card of 03Feb2021. At the time of the reporting event outcome was unknown.
Body aches, chills, fever (up to 100.5), hives on chest, itching, chest pain.
89-year-old gentleman with past medical history of stroke, hyperlipidemia,  and C. difficile colitis in 2020 presented to sick call with a rash on his left  shoulder at the site of his second Moderna COVID-19 vaccine which she received  on 3/5/2021. He noticed the rash soon after receiving the vaccine and it has  become progressively larger with increased redness. There is a great deal of  pruritus and mild pain. He denies any fevers/chills. No shortness of breath or  wheezing. No chest pain or palpitations. No dizziness, vertigo, weakness. No  pain on movement of the arm or shoulder. He denied any other side effects since  receiving the vaccine.  He visited the ED last evening and was prescribed  cephalexin 500 mg 4 times a day for a 7 day course. Thus far, he has taken 2  doses. The ED marked the borders of the rash. The affected area remains with and  the demarcated borders.   ROS:  A 10 point review of systems is negative except as noted in the history of  present illness.
I had already had a light ringing in my ears, but after receiving the most recent dose, the ringing in my ears became louder. I went to an ENT, and they noticed that I've started to have some hearing loss. I'm not necessarily blaming the vaccine, but this did occur the day after receiving the fourth dose. I am having to see an ENT regularly now and I have realized that I will always have a ringing in my ear.
Shot given on right thigh (swollen and warm to touch). Started on Keflex 250 mg 1 tsp three times a day x 10 days.
Patient is complaining of a rash. She was going to try BENADRYL. Told her to see her doctor.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Medium, Systemic: Lymph Node Swelling-Medium
Explosive diarrhea, short duration shock, weakness, lack of appetite, large inflamed area on arm at site lasted - 2 weeks. Digestion irregular 2 weeks. Excessive diarrhea repeated second week. Site still red, slight swelling.
Patient did not have any symptoms or adverse effects of receiving vaccine; Administration of vaccine following temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender whose medical history and concurrent conditions were not reported. The patient's concomitant medication included sterile diluent (MERCK STERILE DILUENT).  On 19-APR-2022, the patient was vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliters (ml), once (strength, route of administration, anatomical location, and vaccine scheme were not reported; lot number U028179 was determined to be a valid lot number, expiration date reported and established as 08-MAR-2023) for prophylaxis.  The administered dose of the suspect vaccine experienced a temperature excursion of -13 degrees Celsius (°C) for 1 hour (product storage error). There was no previous temperature excursion. No additional adverse events (AE) were reported (no adverse event).
Scattered areas of pink/red lesions on lower extremities with a few on upper extremities appeared like urticarial lesions. Given Benadryl. Seen on 2/3/00, except for rash, looked stable. Was playful, no swelling and no distress.
death.  12/17/07 Reviewed autopsy report which states COD as SIDS.  Patient found in crib lying on back & unresponsive. 12/17/07 Received vax record & medical records which confirm vax dose & lot #s as reported.  Patient had thrush & was constipated during office visit 10/29/07, otherwise, healthy.
Painful Axillary lymphendenopathy within 3 hours of receipt, followed by supraclavicular lymphendenopathy within 24 hours - both of which worsened and and are still present 72 hours later, and left sided breast pain. Paresthesias of left lower arm and hand 48 hours after receipt which improved by 72 hours.   Periorbital cellulitis and severe itching  (left) beginning 10/21@ 0300am   Symptomatic elevated  blood pressure 180/111 which was first noted 10/21 AM and evaluated 1400 on 10/21.
Pretty significant side effects for 4 or 5 days; Reaction to the first dose of the Moderna vaccine; Most severe side effects; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Pretty significant side effects for 4 or 5 days), ADVERSE REACTION (Reaction to the first dose of the Moderna vaccine) and ADVERSE EVENT (Most severe side effects) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Pretty significant side effects for 4 or 5 days), ADVERSE REACTION (Reaction to the first dose of the Moderna vaccine) and ADVERSE EVENT (Most severe side effects). At the time of the report, ADVERSE DRUG REACTION (Pretty significant side effects for 4 or 5 days), ADVERSE REACTION (Reaction to the first dose of the Moderna vaccine) and ADVERSE EVENT (Most severe side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication were reported.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 15-SEP-2016, the patient was vaccinated an expired dose of ZOSTAVAX (dose and route unknown, lot # L021609, expiration date 10-SEP-2016). No adverse effects were reported. Additional information has been requested.
initialy didnt suspect vaccine but woke up with sharp pain in right side in Lung area.  it eased in a while but had it checked out a series of tests found two clots, one in each lung  D-dimer10/04- positive for clots.  CT scan 10/06 found clot in each lung
Vaccine was administered 40 days past the "use by" date. No adverse reactions. Patient was contacted about the error and reports no adverse reactions. RN 10/3/23
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not reported, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 13-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.