chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lost power the next day in the middle of the day at 12:00 PM.; No adverse event; Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  Temperature excursion occurred due to lost power in the middle of the day at 12:00 PM. Had placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. On 02-Mar-2023 to 28-Mar-2023, vaccines were administered to 26 Patients at facility. No reported symptoms.  No treatment medications was reported.  This case was reported for Patient 02 out of 26 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:
almost immed felt pins & needles sensation rt arm including hand, fingers, felt weak & did not seem to respond well;had weak grasp;by 9hr later still felt achiness in joint areas & weakness of hand persisted;joint stiffness;
Second dose in COVID-19 Vaccination series administered too  soon. Patient did not have reaction as a result. Per CDC guidance, doses  inadvertently administered earlier than the grace period should not be repeated.
VOMIT; HEADACHE; This spontaneous report received from a health care professional concerned a 47 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced vomit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomit on 13-MAR-2021, and had not recovered from headache. This report was non-serious.
had a stroke behind his eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 Immunization. The following information was reported: OCULAR VASCULAR DISORDER (medically significant) with onset 31Aug2021, outcome "unknown", described as "had a stroke behind his eye". The event "had a stroke behind his eye" was evaluated at the physician office visit. Therapeutic measures were taken as a result of ocular vascular disorder. Follow-up attempts completed. No further information is expected.  Additional information: It was reported that inquiring about receiving the booster dose of the Pfizer Covid-19 vaccine and that her husband received his second dose of the Pfizer Covid-19 vaccine on 06Apr2021, and he had a stroke behind his eye on 31Aug2021 and was diagnosed with a stroke on 01Sep2021 and started treatment. She reported that he had a stroke behind his right eye, her husband had no health issues whatsoever, stating there were no precursors to this, he was not diabetic, he doesnt have high blood pressure, there was no warning signals or reasons for this and asks could it be related to this vaccine and is he okay to receive the booster dose. Her husband was not on any medication and got the 2 doses of the Pfizer Covid shots. The second dose was taken last 06Apr2021 and last 01Sep he had a stroke. She stated that he had all the symptoms on the 31Aug2021 and went to the doctor on 01Sep2021. Went to the ophthalmologist was diagnosed by 2 different doctors and the same day they both stated he had a stroke behind the right eye. Last seen by the eye doctor a little over a year ago and his eyes were so good that he did not have to even wear his glasses. She wants to make sure because the vaccine is the only thing different, and she wants to make sure there is no link to that and if its considered safe to get. Is scheduled in a week from today for the booster.
Nurse knows someone who got a blood clot from the vaccine.; little sore in arm; left leg was swollen; feels like his skin is going to rip open; leg is really tight; very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Nurse knows someone who got a blood clot from the vaccine.) in a patient of an unknown age and gender 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 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Nurse knows someone who got a blood clot from the vaccine.) (seriousness criterion medically significant), PAIN IN EXTREMITY (little sore in arm), PERIPHERAL SWELLING (left leg was swollen), FEELING ABNORMAL (feels like his skin is going to rip open), SKIN TIGHTNESS (leg is really tight) and DISCOMFORT (very uncomfortable). At the time of the report, THROMBOSIS (Nurse knows someone who got a blood clot from the vaccine.), PAIN IN EXTREMITY (little sore in arm), PERIPHERAL SWELLING (left leg was swollen), FEELING ABNORMAL (feels like his skin is going to rip open), SKIN TIGHTNESS (leg is really tight) and DISCOMFORT (very uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the patient experienced blood clots and was given with blood thinners. the concomitant history was not reported.  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-2021-114494 (Patient Link).; 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.
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-392935 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2021: Follow up received, updated reporter's details and dose number updated as booster dose.
Severe bruising from shoulder to elbow of left arm. Saw Dr on 11/19/04 and was told needle hit a blood vessel and would go away on its own. Reports no pain or swelling.
Started with a sore arm at vaccine site about 6 hours after the shot. Then chills  Started at noon the day after the shot  or about 24 hours after the shot. By 6 pm the child were causing uncontrollable shaking  By 9 pm I had a temp of 100.8. Extremely achy joints and muscle pain in the night.  Very fatigued. Didn?t wake up until 11:15 am on Saturday 1/23.   Residual achiness and joint pain. Fever and chills gone. I had Covid in October (4th)  2020. These side effects were much worse than Covid.
Wry neck pain 24 hours post vaccine administration. It lasted 3 (three) days, and was resolved.
Gotten covid on 21Jun2022; Gotten covid on 21Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "High Blood Pressure" (unspecified if ongoing); "copd" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 21Jun2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 21Jun2022, outcome "not recovered" and all described as "Gotten covid on 21Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) positive, notes: Gotten covid on 21Jun2022 was told to take Paxlovid; (07Jul2022) Unknown results, notes: Unknown results. Therapeutic measures were taken as a result of suspected covid-19.  Clinical information: Gotten covid on 21Jun2022 was told to take Paxlovid due to underline health Cond and rebound of covid started on 07Jul2022. Patient started treatment with Paxlovid on 22Jun2022 and stopped treatment on 27Jun2022. Patient did not received other vaccination with 2 weeks of vaccination. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient complained of feeling dizzy 10 minutes after receiving vaccine.  Elevated blood pressure.  Was seen in the Emergency Department related to her ongoing elevated blood pressure, headache, and dizziness.
REDNESS, SWELLING, PRURITUS AND RASH OVER ARM/FOREARM.  HE WAS TREATED WITH BENADRYL.
About 2AM after receiving the vaccine, starting throwing up and feeling nauseous, Vomited about 3 x 2:30AM, 3:30AM, 4:30AM .  The 15th was exhausted all day. The 16th was nauseous all day but no vomiting.
forgot to get the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of series received two to three years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported that a patient forgot to get the 2nd dose of Shingrix which led to incomplete course of vaccination.   Pharmacist was not the administering provider of the vaccine and did not had lot number or expiration date details for 1st dose. The reporter consented to follow up.
No reaction or pain after vaccine, but he is a 72 yo old gentleman with history of gout for about 12 years, but had resolved after eating foods like cherry's, gradefruit juice and would go away after about a week without medication.  He got the vaccine and about a month later the gout came back and was eating the foods that he ate before and it did not go away.  He went to the doctor and she prescribed medicine for him, and he took it and it went from the left leg and then it went into her right leg and it has not resolved completely and continues to have flares about every 2 weeks without drinking and eating a lot of foods that help with gout flares.  It seems to have affected his immune system and will not resolve the gout issues.   He is just concerned about why the symptoms will not go away using the remedies he has had used in the past.
Report A0364836A describes joint pain and swelling in a 53 year old male who received Lyme disease vaccine recombinant OspA. This report was received from the vaccine and has not been verified by a physician or other healthcare professional. There was no relevant medical history, known allergy, or concurrent medication. The vaccinee reported that he has had no history of Lyme disease and did not have gout, psoriasis, or Crohn's disease. His 90 year old father reportedly had arthritis NOS. There was no family historyof lupus. On 2/11/02, the vaccinee reportedly received his first injection of LYMErix. The vaccinee stated that "within hours" post-immunization, he experienced cold symptoms. He stated that on 2/13/02, he was unable to get out of bed due to "extreme" exhaustion. Within ten days he experienced swelling and pain in both hands; the knuckles of the right hand were "extremely" swollen and painful. He reported that for the first few weeks, he experienced the sensation of body temperature changing from very hot to very cold. He also reported increasing back discomfort. He stated that his feet, knees, and wrists "crack," and he noticed swelling of his right foot. He stated that no laboratory studies had been performed. The vaccinee refused any further injections of LYMErix. As of 4/3/02, the events had improved. The adverse events 'joint pain, 'joint swelling,' and "joint crepitation' do not meet serious criteria, but are being submitted as an expedited report by special FDA request per the 628/00 letter.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2016, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On an unknown date in 2016, the patient was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles (developed on an unknown date in approximately 2016). As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX.
Developed recurrent scleritis after vaccination that went on for years without explanation only to discover my body is now in a state of autoimmunity and have since been diagnosed with autoimmune hypothyroidism (Hashimoto's) and rheumatoid arthritis.
Received flu shot x6 days ago developed hives on upper neck, both arms started 4 days after flu shot.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter
10:33p started with flushed feeling, dizziness and nausea ,no sob,150/90,83,96 given H2O 10:45p symptoms improving still flushed and hot, more H2O 158/108, 79, 98%, 10:50p feeling better,not flushed or hot feeling,149/96 78,98% stayed 40m, called 01/08 vm patient called back feeling better just sore arm and minor swelling at injection site. told to call PCP or 911 if symptoms return and are worse.
This case was reported by a healthcare professional and described the occurrence of fever in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), PEDIARIX, ENGERIX B and (non-gsk) PREVNAR. On an unspecified date the subject received unspecified dose of ROTARIX (intramuscular, right thigh), unspecified dose of PEDIARIX (unknown), unspecified dose of ENGERIX B (unknown), unspecified dose of PREVNAR (unknown). At the time of vaccination with ROTARIX the subject experienced drug administered via inappropriate route. The nurse inadvertently administered ROTARIX intramuscularly in the right leg. At the time of vaccination with ENGERIX B the subject experienced overdose. Within hours of vaccination with ENGERIX B, PEDIARIX, PREVNAR and ROTARIX, the subject experienced fever that lasted for one night. At the time of reporting the fever was resolved.
Swelling in right armpit started about 12 hours after vaccination; dissipated over next 2 days with no medical intervention
No adverse patient condition. Patient under the age of 18 received Moderna vaccine booster 0.25mL.
On 5/16/00, the pt developed an injection site reaction which included redness, approximately the size of a quarter, with a welt. The pt also experienced a single muscular jerk before leaving the office. On 5/17/00, the pt developed coughing, congestion, and wheezing. On 5/21/00, the pt developed a rash on her cheek and wheezing. Later in the day, the rash was noted to be spreading and the office told the mother to bring the pt to the ER. On 5/25/00, the pt developed bronchitis. On 6/15/00, the pt developed a fever of 102 and seizures. The pt was again brought back to the ER.
shortness of breath; aches; chills; nausea; weakness; swelling at the injection site; This spontaneous report was received from a nurse referring to her sister, a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications.  On 06-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, dose number, route of administration, anatomical injection site, lot number and expiration date were not reported). On the same date, after the administration of the vaccine, the patient experienced chills, nausea, aches (pain), shortness of breath (dyspnea), weakness (asthenia) and swelling at the injection site (injection site swelling) on an unspecified arm..  At the time of the report, the outcome of the events and the causality assessment between the aforementioned event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were not reported.
pt made appt and received pfizer dose 1 on 6/30/21. However, following review  pt had already received j&J on 4/2/21 at facility outside of county . No side effects noted.
extreme fatigue; chills; This is a spontaneous report from a contactable other HCP (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3247) via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: ER9231) on 29Dec2020 for COVID-19 immunization. The patient experienced extreme fatigue and minor chills 24 hours after 2nd dose of vaccine. Took Tylenol, felt better after 8 hours or so. This is a non-serious report per reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovered in Jan2021.
Started abdominal pain and heavy vaginal bleeding at the night of the first vaccine shot on 2/12/2021. That day was my 5th day of my period and there were very few brown spot during the day time as normal.  After dinner, I started feel abdominal cramp and suddenly a lot of blood came out. The bleeding lasted about 1 hour and soaked 5-6 pads.  The next few days had small amount of blood. This situation never happened in my past 20 years period experience before. I had very normal period always lasted about 5-6 days.
This spontaneous report as received from a female patient of unknown age refers to herself. In 2002 the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot#, dose and route unspecified) and no adverse effects reported with the first dose. On 24-OCT-2014 the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot#, dose and route unspecified). The reporter stated that she had difficulty sleeping that night (on 24-OCT-2014). The outcome of the event was unknown. Additional information is not expected as lack of contact details for the partner.