chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 3 minutes after vaccine administered noticed patient hand twitching, asked if they were okay and got a head nod, then patient went unresponsive and fainted. Called for help and called 911. Laid patient down and elevated her legs and in a few seconds after patient came too.  When the EMT got here checked her BP and it was low, observed her for about 5-10 minutes and her BP went up to normal.  Patient left after about 30 minutes feeling fine
Woke up with a low grade fever of 100.4 and with nausea. The fever was on and off all day and had the shivers and body aches
Information has been received from a physician concerning a male who on 21-MAR-1991 was vaccinated with the first dose of MMR II (route, site and lot number not reported). On an unknown date, the patient experienced mumps (the date diagnosed was reported as 04-JAN-2009). The patient also experienced left side parotitis, coughed 3 days and was afebrile. On 04-JAN-2009, the first blood work was done which revealed serum IgM 3.81, serum IgG 0.55 and serum amylase 68. The outcome for mumps was not reported. Follow up information has been received and indicated that the patient was a 19 year old male who on 07-JUN-1991 (previously reported as 21-MAR-1991) was vaccinated with his first dose of MMR II (HSA), on 14-OCT-1994 was vaccinated with his second dose of MMR II (HSA) and on 29-NOV-2009 was vaccinated with his third dose of MMR II (Lot # 664886/0776Y). The patient's first blood work performed on 15-DEC-2009 included: IgM: <1:10; IgG: 5.7 and serum amylase 67. This is one of several reports from the same source. No further information is available.
pt recv vax 16APR96 & & w/in 1hr p/vax pt exp lightheadedness;pt recv vax 10:45 & had not eaten lunch;pt had some juice, sat for a while & started to feel better;sx totally resolved by 15:30 the day of the vax;
Herpetiform rash on my left leg and foot 3 days after Pfizer vaccine
ERRATIC HYPOTENSIVE EPISODES IN A PATIENT WITH HYPERTENSION WHILE NOT ON ANTIHYPERTENSIVE MEDICATIONS.
Vial was initially stored on 11-May-2023 and vaccine was administered on 13-Jun-2023.; No adverse event; Nurse is calling to report that a 71-year-old patient received expired booster (5th dose) of Moderna Bivalent COVID-19 vaccine on 13JUN2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that a 71-year-old patient received expired booster (5th dose) of Moderna Bivalent COVID-19 vaccine on 13JUN2023), PRODUCT STORAGE ERROR (Vial was initially stored on 11-May-2023 and vaccine was administered on 13-Jun-2023.) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that a 71-year-old patient received expired booster (5th dose) of Moderna Bivalent COVID-19 vaccine on 13JUN2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored on 11-May-2023 and vaccine was administered on 13-Jun-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that a 71-year-old patient received expired booster (5th dose) of Moderna Bivalent COVID-19 vaccine on 13JUN2023), PRODUCT STORAGE ERROR (Vial was initially stored on 11-May-2023 and vaccine was administered on 13-Jun-2023.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that a 71-year-old patient received expired booster (5th dose) of Moderna Bivalent COVID-19 vaccine on 13JUN2023) and PRODUCT STORAGE ERROR (Vial was initially stored on 11-May-2023 and vaccine was administered on 13-Jun-2023.).    Concomitant product use was not provided by the reporter.  Expiry date of suspect vaccine was reported as26-Sep-2023. Individual vials or intact cartons were in open carton. Vial size was reported as 2.5 ml. Expired lot was 3 days after the 30 days beyond use date. Vial did not undergo any temperature excursions.  Treatment information was not provided.
Erythematous rash and swelling. Woke up and reaction was there the day after shot.
maculo-papular confluent rash to torso, back, neck, upper/lower extremities
Titers were low after 3 dose series; This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 14-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included dialysis.   On an unknown date, the patient received the 3rd dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 2nd dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-Feb-2023: Reporter comment: The pharmacist called to inquire how to proceed with Engerix dosing for this patient. The pharmacist stated they have a 14 years old patient on dialysis and they would like to give the patient a Engerix booster dose because Titers were low.  The pharmacist was asking for any guidance on dosing. The pharmacist stated that the patient completed Engerix primary 3 dose series be-fore but unable to provide any details on patient or dates.  The reporter did not consent to follow up. Additional supportive information:  The reporter would like to give the patient a Engerix booster dose because titers were low Shingrix, which led to therapeutic response decreased.
This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), at the age of 61, via an unspecified route of administration, in left arm, on Mar 28, 2021, at 12:45, single dose, for COVID-19 immunisation. Medical history included diabetes and high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient previously took Zithromax Z-pack and experienced drug hypersensitivity. Other medications in two weeks reported as yes. On Mar 30, 2021, at 12:00, patient experienced muscles weakness, frequent chest pain and left arm weak/weakness in her left arm. No treatment received for the events. The outcome of the events: not recovered. No follow-up attempts possible. No further information expected.
Uncontrolled shaking/shakes; pain in chest; stiffness everywhere; weak and tired; Pain an left arm, pain in neck; chills; muscle pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Uncontrolled shaking/shakes), CHEST PAIN (pain in chest), MUSCULOSKELETAL STIFFNESS (stiffness everywhere), ASTHENIA (weak and tired) and PAIN (Pain an left arm, pain in neck) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TREMOR (Uncontrolled shaking/shakes), CHEST PAIN (pain in chest), MUSCULOSKELETAL STIFFNESS (stiffness everywhere), ASTHENIA (weak and tired), PAIN (Pain an left arm, pain in neck), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (fatigue). At the time of the report, TREMOR (Uncontrolled shaking/shakes), CHEST PAIN (pain in chest), MUSCULOSKELETAL STIFFNESS (stiffness everywhere), ASTHENIA (weak and tired), PAIN (Pain an left arm, pain in neck), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment was reported for the events.
severe h/a w/in 18 hrs or nl physical & DT; nausea & vomit 36 hrs p/shot; fever 102;
Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Medium, Systemic: Vomiting-Mild, Additional Details: Patient got the vaccine and was fine sat down and after 5 minutes fainted. Then got back consciousness then had seizure and lost consciousness. Then was ok but went to hospital to be evaluated.
Flashes of self limiting hives. Lasting a few hours. Present in abdomen, arms, legs. Spares face, hands, feet.
Patient called the pharmacy to report that she has redness and swelling with pain and warmth surrounding the injection site. Directed patient to treat with ice and ibuprofen/acetaminophen and to call the doctor to rule out infection.
Full body aches and stomach issues/diarrhea for about half a day, pain at injection site for 2 days
Friday night same night of vaccine. Arm started aching and hurting. After my shower, my whole arm was in pain. Pain then moved all the way to my back. I took two tylenol, and it calmed it down. At 3 am, it started hurting really bad, I had to take a lortab - a stronger pain med at 5am that morning. Around 10am, my whole back started hurting, and that evening, it still was hurting.  I ended up taking 3 lortab that day. The pain went to my neck. On Sunday, I ended up taking  two lortab . All together, I took 5 lortab to ease pain from this vaccine. I was scared that I was getting another blood clot from the feeling of the pain. I am still just sore.  NOTE: I am on blood thinner
I got my first dose of the Moderna vaccine on 2/23/2021. On 3/3/2021, I began developing tingling in the fingers of both hands. It got worse over the next 2 days to the point that the fingers were both burning and tingling. I could only get relief by putting my hands on something really cold, such as a refrigerator shelf. Late on 3/6/2021, the burning and tingling began to improve, and they were almost gone by early 3/7/2021.  Later on 3/7/2021, I developed shortness of breath, weakness, and rapid heart rate. I sent a Kardia tracing to my PCP, who read it on 3/8/2021.  She detected ventricular tachycardia, atrial fibrillation, and atrial flutter, and she had me go to the ER immediately.  On 3/8/2021, I went to the ER. I underwent various blood tests, several EKGs, and various other tests. I was in intensive care for 3 days and was seen by various cardiologists. None of them understood why I developed atrial fibrillation, ventricular tachycardia, and atrial flutter all at the same time.   An ablation was performed to stop the atrial flutter. A pacemaker/ICD was also implanted to control the ventricular tachycardia and atrial fibrillation. I was released on 3/11/2021. I have had no recurring symptoms since then.  I received my second Moderna dose on 3/23/2021. The only side effect I experienced was tenderness at the injection site for a day.
about 26 hrs p/vax pt devel swollen lips & tongue; pt did not devel inspiratory stridor or wheezing; HR 130/min resp rate 30/imn 230PM urticaria noticed on trunk;
Hot flashes; numbness; feel tired; foggy; feeling cold; Nauseous; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HOT FLUSH (Hot flashes), HYPOAESTHESIA (numbness), VACCINATION COMPLICATION (feel tired), FEELING ABNORMAL (foggy) and FEELING COLD (feeling cold) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced HOT FLUSH (Hot flashes), HYPOAESTHESIA (numbness), VACCINATION COMPLICATION (feel tired), FEELING ABNORMAL (foggy), FEELING COLD (feeling cold) and NAUSEA (Nauseous). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, HOT FLUSH (Hot flashes), HYPOAESTHESIA (numbness), VACCINATION COMPLICATION (feel tired), FEELING ABNORMAL (foggy), FEELING COLD (feeling cold) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
High blood pressure, normally is 105/70, went up to 155/110.; Severe headaches for 3 days.; Sore mouth; burning sensation inside my mouth; swollen lips; herpes like rush on my lips, inside and outside of my nose but only on the left side; herpes like rush on my lips, inside and outside of my nose but only on the left side; This is a spontaneous report from a non-contactable consumer. This 55-year-old female consumer (patient) reported for self. A 55-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: ER8733) via an unspecified route of administration on 05Apr2021 10:00 as dose number unknown, single (age at vaccination: 55 years) for COVID-19 immunisation. Medical history included none relevant history. Concomitant medications were not reported. No other vaccine in four weeks and no other medications in two weeks. No COVID prior vaccination and did not test COVID post vaccination. No known allergies. On 05Apr2021 07:00 PM, the patient experienced high blood pressure, normally is 105/70, went up to 155/110. Severe headaches for 3 days. Sore mouth, burning sensation inside my mouth, swollen lips, herpes like rush on my lips, inside and outside of my nose but only on the left side. No treatment was received. The patient underwent lab tests and procedures which included blood pressure resulted as 105/70 high and 155/110 high both on 05Apr2021. The clinical outcome of the event was resolved.  No follow-up attempts are possible. No further information is expected.
1 day after vaccination, patient developed facial tingling, numbness, soreness to shoulders & arms.
This case was reported by a nurse via sales rep and described the occurrence of erythematous rash in a 66-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 15th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced erythematous rash, chickenpox and nodule. On an unknown date, the outcome of the erythematous rash, chickenpox and nodule were unknown. It was unknown if the reporter considered the erythematous rash, chickenpox and nodule to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had first dose of SHINGRIX on 15th June 2018 without any issue. After receiving vaccine the patient had red rash and went to pharmacy who thought it might be chicken pox. The patient came to provider who recorded 2 to 3 centimeter nodules of unknown cause. The report sent to dermatologist for follow up. The reporter did not agree to be contacted for follow up.
Flat Rash; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE RASH (Flat Rash) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J202A and 025J202A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 29-Jan-2021, the patient experienced VACCINATION SITE RASH (Flat Rash). On 14-Jan-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. On 02-Feb-2021, VACCINATION SITE RASH (Flat Rash) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Products known to have been used by the patient, within two weeks prior to the event were not provided.  The Treatment information was not provided.   This case was linked to MOD-2021-018000 (Patient Link).
Breakthrough case admission after 2 vaccines ; Moderna 1/19/21 lot# 011L20A;  Moderna 2/16/21 lot# 016M20A
When I got my first dose of Moderna on 4/8/2021, I experienced cognitive impairment, bleeding issues, and cardiovascular issues. On 5/6/2021, I got my second dose of Moderna. At around midnight that night, I experienced significant pain (about an 8 out of 10) in my right arm. It went from my thumb all the way to my neck and shoulder blade. It lasted for several hours, and I couldn't sleep. After that, I had significant fatigue for a few days. I had difficulty standing for more than 15 minutes or so at a time. In addition, I also had some of the typical side effects of the vaccine, such as body aches and malaise, but I felt that the arm pain and my level of fatigue were unusual. In addition, I continued to have the cardiovascular side effects that had resulted from my first dose of Moderna, and as of now, I still haven't returned to my previous level of activity.
Pt had inflammation at sight. Pt (retired Nurse) says ZOSTAVAX administered more IM than subq. She came in and showed me and injection site was more 2 side of arm than back.
Crying unconsolably w/refusal to eat x 4 hrs p/immun;
Same day as Vaccinaton  Mild Migraine  in Evening. @ days Later Fever  99, next day Fever 100. Symptoms resolved now.
Pain in my chest/slight chest pain on the left side; Experiencing side effects; night sweating; increase in feelings of arthritis in our arthritic areas; joint pain; aching everywhere; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in my chest/slight chest pain on the left side), VACCINATION COMPLICATION (Experiencing side effects), NIGHT SWEATS (night sweating), ARTHRITIS (increase in feelings of arthritis in our arthritic areas) and ARTHRALGIA (joint pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Pain in my chest/slight chest pain on the left side), VACCINATION COMPLICATION (Experiencing side effects), NIGHT SWEATS (night sweating), ARTHRITIS (increase in feelings of arthritis in our arthritic areas), ARTHRALGIA (joint pain), MYALGIA (aching everywhere), CHILLS (Chills) and PYREXIA (fever). At the time of the report, CHEST PAIN (Pain in my chest/slight chest pain on the left side) had resolved and VACCINATION COMPLICATION (Experiencing side effects), NIGHT SWEATS (night sweating), ARTHRITIS (increase in feelings of arthritis in our arthritic areas), ARTHRALGIA (joint pain), MYALGIA (aching everywhere), CHILLS (Chills) and PYREXIA (fever) outcome was unknown.            It was reported that patient received the Booster dose of Moderna and experienced  chest pain that came  for five seconds and then departed  for period as long as fifteen minutes.  Concomitant medications were not reported.  Treatment information was  not provided.   This case was linked to MOD-2021-316965, MOD-2021-317608 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow up document received contained: Updated reporter details- Phone number; Dose number; Additional events; Outcome of event- From unknown to recovered;
No adverse effect reported; a patient received improperly stored PROQUAD; This spontaneous report was received from a medical assistant regarding a 23 month old patient of unknown gender. Information on pertinent medical history and drug reactions/allergies was not reported. Concomitant medications included sterile diluent.  On 05-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # S002494, expiration date: 23-JUL-2020, albumin status: rha) (dose, dose number, route, location of administration and frequency were not reported) administered for prophylaxis.  The vaccine was exposed to temperature of 6 to 14 degree Fahrenheit (F) (10.2 F, multiple) for 50 minutes as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported.