chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was in office on 6/15 for their 9 month physical exam. They still needed their 6 month vaccines. Provider ordered 6 month vaccines to be given. Both provider and the nurse administering the injections did not realize that RotaTeq vaccine had an 8 month cut off age and should have not been given to this patient. Practice manager and Nurse Manager was notified of event, and incident report was filed. We contacted the manufacturer, Merck, who stated there is no follow up and only adverse effect could be a fever. Patient's parents were notified on 6/23 and they stated he has been fine with no adverse effects since the event.
Pt c/o feeling like her heart rate is fast 13 mins after receiving vaccine. She was assessed and monitored by NP and EMT. Pt had mild anxiety. BP - 130/84, HR  - 68, O2 sat- 98% on RA. She was kept at site until she reported that she felt better.
This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 19) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported an event that happened on 04Jul2021 with 400 people about 60% of those who were vaccinated got infected with the covid-19 virus but only 2 of those people had to go to the hospital. A PCR test confirmed their covid-19 infection. Consumer reported he is 19 received first doses of Pfizer covid-19 vaccine. On an unspecified date, he got symptoms and was tested positive for covid-19 with a PCR test on an unspecified date. The reporter asked what their effectiveness after just one shot was. The reporter was seeking information about the 3rd dose of Comirnaty vaccine being offered for immunocompromised patients and if this was the same dose as the first and second. Consumer stated that recent studies showed that you can still inquire infection after the vaccine and was asking regarding the efficacy rate. Outcome of event was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Fever; very bad pain in his body; This is a spontaneous report from a contactable consumer (patient wife). A 50-years-old male patient (husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6204), via intramuscular route of administration in the left arm on 11Mar2021 at 15:00 (at the age of 50-years-old) as dose 1, single for COVID-19 immunization. Medical history included covid-19 from 18Jan2021 to an unknown date, her husband was pretty healthy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Reporter stated that, that day (12Mar2021) her husband woke up at 7 am and was having fever of 99.7 and he took Ibuprofen, 200mg, Lot: OME2332A, Expire date: Jul2021 and was fine. Then, at 10 am, his temperature got to 101.9 and she gave him Acetaminophen, 500mg, Lot: P121876, Expiry date: Sep2023 and he had very bad pain in his body (Mar2021). When reporter checked her husband's temperature during the call and confirmed her husband's current temperature was 100.6 The reporter doesn't know if her husband needs to go to the doctor. They were told the side effects will be for maybe a couple of days, so she doesn't know if her husband needs to go or not. The events did not result in physician and emergency room visit. He had an appointment before the vaccination where the doctor did blood tests and urine test. The patient underwent lab tests and procedures which included blood test: everything is okay on an unspecified date in 2021, body temperature: 99.7, 101.9 and 100.6 on 12Mar2021 and urine analysis: everything was okay on an unspecified date in 2021. Therapeutic measures were taken as a result of events. The clinical outcome for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient in for booster dose 2/19/2022, patient received booster dose Pfizer dose 33025BD in observation area and stated she felt like heart was racing and high anxiety noted.  Vitals taken P87, O2 100%, BP 120/82, R 20 patient given sips of H20 and visited w patient.  States increased anxiety was because days after 1st dose Pfizer her right eye became irritated and red,  Went to eye dr. and he stated she has had a reaction to something.  No treatment needed.  After 20 minutes she was calmer and states feeling better.  4:50 pm vitals were BP 116/60 , R 18, P 84, 02 98% Recommended if any issues contact physician or go to ER.
Eight days after injection, she developed COVID arm, and muscle turned red and itchy. Continued to itch for 4 days and continued redness for about 6 or 7 days. Then it all went away.
pt fainted after having 2nd dose covid vaccine.  came back around quickly. mom said patient was overly stressed about getting the vaccine.
chest pain; lymph nodes on the left side by her armpit swelled up; pain from her neck to the fingertips of her left arm; Aches everywhere; body hurt; Felt like arm was on fire; Diarrhea; Bruising; Fever; Pounding headache; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain), SWELLING (lymph nodes on the left side by her armpit swelled up), PAIN (pain from her neck to the fingertips of her left arm), PAIN (Aches everywhere) and PAIN (body hurt) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain), SWELLING (lymph nodes on the left side by her armpit swelled up), PAIN (pain from her neck to the fingertips of her left arm), PAIN (Aches everywhere), PAIN (body hurt), BURNING SENSATION (Felt like arm was on fire), DIARRHOEA (Diarrhea), CONTUSION (Bruising), PYREXIA (Fever), HEADACHE (Pounding headache) and CHILLS (Chills). At the time of the report, CHEST PAIN (chest pain), SWELLING (lymph nodes on the left side by her armpit swelled up), PAIN (Aches everywhere), PAIN (body hurt), BURNING SENSATION (Felt like arm was on fire), CONTUSION (Bruising), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown, PAIN (pain from her neck to the fingertips of her left arm) had resolved and DIARRHOEA (Diarrhea) and HEADACHE (Pounding headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided
TIGHTNESS IN HAMSTRINGS; BUTT PAIN; PAIN IN THIGHS AND CALVES AND ARM; GREAT DIFFICULTY IN MOVING; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included polio, and concurrent conditions included arthritis in the arms, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with abaloparatide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced great difficulty in moving. On 15-MAR-2021, the subject experienced tightness in hamstrings. On 15-MAR-2021, the subject experienced butt pain. On 15-MAR-2021, the subject experienced pain in thighs and calves and arm. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) no blood clots, not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tightness in hamstrings, pain in thighs and calves and arm, and butt pain, and the outcome of great difficulty in moving was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509287.
Pt received the dose 7 hours from the time the diluent added to vial. According to Pfizer , once diluent added dose must be administered within 6 hours. Pfizer contacted. Per Pfizer stability data , data supports an excursion up to 18 hours in addition to the allowed 6 hrs if doses remain in vial and not syringe.
Redness, soreness and swelling at site of injection. Also some itching. Later that day and next some slight headache and dizziness. Symptoms lasted 5-6 days
Arm swelling; warm; red hives; itching approximately 2x2 inches in size; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), FEELING HOT (warm), URTICARIA (red hives) and PRURITUS (itching approximately 2x2 inches in size) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Anticoagulant therapy, CALCIUM for Calcium supplementation, FISH OIL for Nutritional supplementation, MONASCUS PURPUREUS (RED YEAST RICE) for Supplementation therapy, VITAMIN C [ASCORBIC ACID] for Vitamin C supplementation, VITAMIN D [VITAMIN D NOS] for Vitamin D supplementation, ZINC for Zinc supplementation.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), FEELING HOT (warm), URTICARIA (red hives) and PRURITUS (itching approximately 2x2 inches in size). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Arm swelling), FEELING HOT (warm), URTICARIA (red hives) and PRURITUS (itching approximately 2x2 inches in size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications also included ice.
headache/migraine; shoulder and neck pain; shoulder and neck pain; feeling tired; her stomach was not in the best shape; Digestive distress; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: unknown, via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history Guillain-Barre syndrome. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for COVID-19 immunization and experienced 3 "rough days." The patient wanted information on some "residual" side effects that she is experiencing after receiving the COVID-19 vaccine, she received the second dose of the vaccine and presented the following side effects: headache/migraine that is diminishing, feeling tired, shoulder and neck pain or headache-type of reaction, her stomach was not in the best shape but she was tolerating food. She had been checked by two doctors and they can't find anything that could be causing this, she does not have a fever. The reporter is a patient with Guillain-Barre syndrome. She tried taking paracetamol (TYLENOL) but it did not make too much except for making blisters. She was a little concerned about her situation and stated that she wanted to make sure that she will be alright. During the call, she mentioned that one nurse told her that after receiving the vaccine she was on bed for 3 days and that other colleague of her was "not right" 6 days after receiving the vaccine she also knows that there are people who have some digestive distress after receiving the vaccine and she believes that her migraine/headache was causing her to have a digestive distress. She mentioned that after receiving the first shot of the vaccine she had 3 "rough days." The patient was recovering from the headache/migraine; while unknown for the rest of the events.   Information about lot/batch number has been requested.
Pt states she developed itching all over her body right after receiving the vaccine on her right deltoid. Symptoms of itching subsided within few hours. Also c/o numbness, tingling in both hands & right foot which still continues also chest tightness that comes and  goes since the vaccination. Chest tightness feel like lightning through her Chest lasting few seconds & Intermittent up to now. Pt c/o right foot leg as well
Facial redness and flushing, Swelling of the feet and ankles, Eyes are swelling, No issue of breathing or shortness of breath  Has been taking Benadryl 50 mg q 6 hours prn, Famotidine 40 mg bid, Hydrocortisone 20 mg bid symptoms persisting.
Headache; Episode of stiffness, going pale; Episode of stiffness, going pale; 15 seconds of memory loss; This is a spontaneous report from a non-contactable female other HCP reported for herself. A 19-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via intramuscular route of administration on 19May2021 16:45 (at the age of 19-year-old) as single dose for COVID-19 immunization. Medical history was none, and no allergies were reported. Concomitant medication included sarecycline(SARECYCLINE) contraceptive pill via oral route of administration. On 20May2021 11:00 AM, the patient experienced headache, episode of stiffness, going pale, 15 seconds of memory loss. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment medications for events. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine, diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination. The events were reported as non-serious. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
swelling at the injection site; Redness at the injection site; Redness at the injection site; at the same spot of the vaccine and is red a little hot; sore arm; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (at the same spot of the vaccine and is red a little hot), VACCINATION SITE PAIN (sore arm), the first episode of VACCINATION SITE SWELLING (swelling at the injection site), the second episode of VACCINATION SITE SWELLING (swelling at the injection site) and the first episode of VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE WARMTH (at the same spot of the vaccine and is red a little hot), VACCINATION SITE PAIN (sore arm), the first episode of VACCINATION SITE SWELLING (swelling at the injection site) and the first episode of VACCINATION SITE ERYTHEMA (Redness at the injection site). On 16-Mar-2021, the patient experienced the second episode of VACCINATION SITE SWELLING (swelling at the injection site) and the second episode of VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (at the same spot of the vaccine and is red a little hot), the last episode of VACCINATION SITE SWELLING (swelling at the injection site) and the last episode of VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown and VACCINATION SITE PAIN (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taking concomitant medications (no names mentioned).  The patient's husband stated that the patient had received the vaccine 05-MAR-2021 and experienced redness and swelling at the injection site which subsided then reappeared again on 16-Mar-2021. The he added that it is at the same spot of the vaccine and was red a little hot. It had been about 10-15 days since the patient first experienced the side effects.  No treatment details provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Additional information included new reporter's information, dose 1 administration date was provided as 05-Mar-2021 (earlier patient provided as 06-Mar-2021), reoccurrence of the events and new event.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-JUN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 0.5 ml (lot # K011492, expiration date 22-JUN-2016. No adverse effects were reported. This specified lot number was exposed to temperature excursion three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 24, 34, and R. The total cumulative excursion time (hour), the  highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 176, 48, and R; 48, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Itching, redness at vaccine site with 3.5 inch by 3.5 inch swelling and rash. Reports warmth at site. Redness resolved in 48 days. Continued itching on and off for two weeks. No itching on date of second dose.
Face paralysis; Ramsay Hunt Disease; got single dose years ago; This case was reported by a consumer via  media and described the occurrence of facial paralysis in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced facial paralysis (serious criteria GSK medically significant), ramsay-hunt syndrome (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the facial paralysis and ramsay-hunt syndrome were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the facial paralysis and ramsay-hunt syndrome to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's child. The age at vaccination was not reported. The patient received single dose of shingles vaccine years ago and experienced facial paralysis. Within days, the patient experienced Ramsay-Hunt disease. Till the time of reporting, patient did not receive 2nd dose of shingles vaccine, which led to incomplete course of vaccination. This case has been linked with the case US2021AMR176023, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176023:Dad's wife case
Information has been received on 31-DEC-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around January 2015, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving the ZOSTAVAX, the patient suffered optic nerve damage. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. The patient has paid and has become liable to pay for medical aid, treatment, monitoring, medications and other expenditures and will necessarily incur further expenses of a similar nature in the future as a proximate result of ZOSTAVAX. The outcome of the event is not recovered. The causality of the event is related. Optic nerve damage was considered to be disabling. Upon internal review, optic nerve damage was considered to be medically significant. Additional information has been requested.
Patient C/O pain immediately when shot given. Since then the redness and warmth has increased. The area is 12x17cm of erythematous irregularly boarded mild swelling, warm to touch. Central area 8x6cm w/faint violaceous discoloration. No drainage.
12 mo F w fever Tmax 101 F wo episodes, skin rash papular-erythematous on the left upper thigh round 2x2 cm in the same location she got immunizations, started 12 days after vaccines were given on 1/19/18. TYLENOL was given PRN for fever, w f/u appt on 2/6/18.
My mother suffered a massive stroke 40 days after receiving the 2nd dose of the cover 19 vaccine. She fell sick the day after the injection and suffered with brain fog, memory issues, lethargy from that day forward. On day 36 after the 2nd dose she developed a debilitating stomach issue that cause explosive diarrhea that lasted 4 days/nights. This bout with stomach issues left her extremely weak and exhausted. On the 4th night of the diarrhea she got up in the middle of the night to go to the bathroom and couldn't lift herself off of the commode. It took two hours for her to call for help. Once admitted to the ER the stroke was confirmed. Because they could not pinpoint the first stroke symptom she was not eligible for the life saving blood thinning meds and suffered complete paralysis of her right side.
worser cough than I had the day before I got the modrna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (worser cough than I had the day before I got the modrna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cough.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (worser cough than I had the day before I got the modrna vaccine). At the time of the report, COUGH (worser cough than I had the day before I got the modrna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided by the reporter.