chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose on May 11th 2022 planning to receive second on Jun 29th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: The pharmacist asked how to proceed if the patient was late for Engerix-B second dose. The first dose was on 11th May 2022 but due internal issues, they were planning to received Engerix-B second dose on 29th June 2022. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. This is one of 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093620:Same reporter US-GLAXOSMITHKLINE-US2022AMR093988:Same reporter US-GLAXOSMITHKLINE-US2022AMR093989:Same reporter US-GLAXOSMITHKLINE-US2022AMR093990:Same reporter
Vomiting and diarrhea began approx 3 days after Rotateq given Lasted about 10 days.
didn't have immunity for HepB; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 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.   In March 2021, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, the patient received 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, less than 3 months after receiving Engerix B and Engerix B Pre-Filled Syringe Device and unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder 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 details were provided as follows:  The age at vaccination was not reported.  The patient got the 3 doses of Engerix-B, last dose was given in March 2021. This week patient went to doctor to make a check-up and doctor told her she did not have immunity for hepatitis B. The health care professional was not at work at the time of the call, no information from patient nor vaccines was available and she was calling on behalf of a colleague at the pharmacy. The HCP did not consent nor declined follow-up
DEHYDRATION; SEVERE HEADACHE; NAUSEA; MASSIVE CHILLS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 25-MAY-2021) dose was not reported, 1 total administered on 10-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. Right after Vaccine administration no side effects but the patient spent the next day at Emergency Room. On 11-MAR-2021, the patient was sicker than dog and had experienced dehydration, massive chills, severe headache, and nausea. On the same day PET scan was performed for headache and pain was 10/10. Patient was given cold medicine and 2 unspecified intravenous medication. After that patient was well enough to go home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydration, massive chills, severe headache, and nausea on 11-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210458937-COVID-19 VACCINE AD26.COV2.S-DEHYDRATION. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210458937-COVID-19 VACCINE AD26.COV2.S-20210458937-COVID-19 VACCINE AD26.COV2.S-SEVERE HEADACHE, NAUSEA, MASSIVE CHILLS. This event(s) is labeled per RSI and is therefore considered potentially related.
Numbness in Right foot, persistent headaches, eye pain, photophobia, triggered episode of Trigeminal Neuralgia with left sided facial pain, numbness and tingling, teeth pain, sensitivity to sounds and lights. Off balance sensations. Still ongoing.
My arm became so painful; I see that it has some kind of inflammation in front of it; inflammation in front of it and where the shot was inserted on the muscles; Where the shot was inserted on my muscles and the skin has turned red; This is a spontaneous report from a contactable consumer (patient).  This patient of unspecified age and gender received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) via an unspecified route of administration on 19Oct2020 at single dose for immunisation. Relevant medical history and concomitant medications were not reported. In Oct2020, the patient stated that his/her arm became so painful; he/she saw that it had some kind of inflammation in front of it and where the shot was inserted on the muscles and the skin had turned red. The patient specified that he/she got a pneumonia shot and his/her arm became so painful and he/she noticed that it had some kind of inflammation in front of it. Where the shot was inserted on his/her muscles and the skin had turned red. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conjugate vaccine (dipht crm197 protein) in the country of incidence. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conjugate vaccine (dipht crm197 protein) has submitted the same report to the regulatory authorities.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report from a contactable nurse received via a sales representative. A 67-year-old female patient received PREVNAR 13, via intramuscular in the arm on an unspecified date in 2017 at single dose for immunisation. The patient medical history was not reported. Concomitant medication included Lisinopril and atorvastatin (ATORVASTATIN). The patient received the pneumococcal 13-val conj vac (dipht crm197 protein) at her doctor's appointment last year (in 2017) and within a couple of hours of getting the vaccine, her mother had a 103 degrees Fahrenheit fever, had vomiting, nausea, and was weak. This lasted for 2 to 3 days and everything was fine after. The arm that had received the vaccine was swollen and her mother was immunocompromised. The outcome of the events, 103 degrees Fahrenheit fever, vomiting, nausea, and weak, was recovered in 2017. The outcome of the other events was unknown.; Sender's Comments: Being immunocompromised is the patient's underlying medical condition unrelated to the vaccination with PREVENAR 13.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
SEVERE PAIN IN HIS KNEE; SHARP PAIN EVENTS; PINS, NEEDLES FEELING AND TINGLING AND WEIRD SENSATION ALL OVER BODY; This spontaneous report received from a parent concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-SEP-2021, the patient experienced pins, needles feeling and tingling and weird sensation all over body. On 09-SEP-2021, the patient experienced sharp pain events. On an unspecified date, the patient experienced severe pain in his knee. Laboratory data (dates unspecified) included: X-ray (NR: not provided) no blood clots was reported. The action taken with covid-19 vaccine was not applicable. The patient recovered from severe pain in his knee, and the outcome of pins, needles feeling and tingling and weird sensation all over body and sharp pain events was not reported. This report was non-serious.
Patient passed out approximately 3-4 minutes after vaccines were administered. Patient convulsed for approximately 10 seconds while passed out. Was unresponsive for 30 seconds to 1 minute. Patient was pale once she woke up and was shaky. Stated that she was lightheaded. No pain or cognitive deficits noted. Vitals after patient came to were P 70 O2 99 BP 106/72. Patient was given some juice, crackers and sat with her head lowered and her legs propped up. She began to feel better after approximately 10 minutes, stating she no longer felt light headed.
Dept/Mgr: Imaging services Date of expected test: done 7/21/21, Positive Reason for test: pre surgery Scheduled re-swab 7/23/21 at 1800, EWA for confirmation Day called in sick ?day absent?: 0, working from home Date Tested/Results: 7/21/21 Covid-19 Vaccine Yes/No:   yes, 2 doses    Date of last dose: 4/26/21   Tested Presumptive Positive 7/22/21 at presurgery swab. She had a scheduled surgery on 7/26 to remove a mass on her R finger. Surgery has been cancelled. EE is asymptomatic. EE is fully vaccinated for covid. EE is not part of QUASAR study. Antibodies testing ordered to be done after quarantine. Per EE, she was notified by DOH for presumptive positive result and was told she will need to do a DOH confirmation test, but did not schedule yet or receive directions to complete this. EE works remotely since 8/2020, has not been on campus, nor contact with other employees. EE update manager and discuss with manger about working from home. Instructed she will need to quarantine x 10 days from date of positive viral test since she is asymptomatic, release likely around 7/31. EE will need to clear with EH clinic when cleared from DOH for RTW if she does need to come on campus and will need to be asymptomatic.
Numbness and tingling of left hand and arm after vaccination. Patient/employee  was assesses with 5/5 strength, cool, dry skin, color good, Denies any other S/E or complaints.
Patient had onset of body-wider diffuse urticaria with adolescent area and hives at site of PREVENAR but mostly all over body. 1 diarrheal stool 2 hrs later, no respiratory distress and no mucous membrane swelling.
Patient reported itchy arm, gave patient benadryl and cold pack and asked patient to remain in pharmacy. After  30 minutes patient reported feeling ok, no itch and no swelling or redness noted in arm. patient requested to leave.
pt devel burning, pain, & a sensation of edema in hands, lower arms, & feet & lower legs approx 3 wks p/flu vax; pt described some tingling assoc w/reaction; pt did not exp loss of muscle movement or muscle paralysis; PE nl;
After my second vaccine on  2/26/2021 , Friday, on Feb 28th my lymph nodes under my left arm  were extremely swollen and sore. My left underarm remained swollen quite noticeably for 3 days and sore for a total of 5 days.
diabetes; high blood pressure; kidney disease; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Feb2021 as dose 1, single and dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient was seeking information on the booster dose of the Pfizer COVID-19 vaccine. He stated that he received both doses of the Pfizer COVID-19 vaccine back in Feb2021. On an unspecified date 2021, the patient experienced high blood pressure, diabetes and kidney disease and stated that he really needs the booster dose. Referred to health care professional (HCP) for further guidance and medical recommendation. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient has a history of vasovagal syncope when getting vaccines. Patient received COVID vaccine and about 30 seconds later passed out. Patient did not fall. Nurse was able to stabilize him.  Within 15 seconds patient regained consciousness and was fine.  Patient with no injuries or issues after. Was able to ambulate with no issues.
Vaginal spotting; abd bloating; abd cramping; Tingling in body- fingers/toes, radiating up her body, felt like she could not breathe; This is a spontaneous report from a contactable physician. A 49-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an intramuscular route of administration on 26Mar2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an intramuscular route of administration on 26Mar2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 the patient experienced vaginal spotting, abd bloating, abd cramping and tingling. The clinical course was reported as follows: Vaginal spotting and abd bloating that started shortly after 2nd shot, now for 1 month, abd cramping more recently, Tingling in body- fingers/toes, radiating up patient's body, felt like she could not breathe. The events resulted in emergency room/department visits or urgent care and physician visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vaginal spotting, abd bloating, abd cramping, the tingling was resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
she had one day of fatigue with her experience with Spikevax; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (she had one day of fatigue with her experience with Spikevax) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (she had one day of fatigue with her experience with Spikevax). At the time of the report, FATIGUE (she had one day of fatigue with her experience with Spikevax) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-749162 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749162:Son's case
Undiagnosed of MRSA 08/2020; 10/2020 Accumulated prescriptions. After receiving Dose 1 Pfizer-BioNTech 04/5/2021, that evening I began to feel severe chills, severe fatigue, shortness of breath, stuffy nose, headache, nausea and vomiting, muscle body ache, intermittent sore throat, congestion diarrhea intermittent cough, mental fog or confusion on, lethargic could not stay awake and off for three weeks. Televisit with nurse practitioner with directive of care. Hospital Emergency trip 12/24/2021, 12/26/2021, 01/22/2022 was treatment and care not admitted.
Red itchy rash on neck and lower face. Subsided after 24 hours. Slight redness and itchy for a few days.
sinus infection; really bad cold; right side of the face was swollen; rash all over the entire body/pink rash all over me; arm is still red now/It didn't go beyond the red spot on the arm; it's a little bit itchy; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen), RASH (rash all over the entire body/pink rash all over me) and VACCINATION SITE ERYTHEMA (arm is still red now/It didn't go beyond the red spot on the arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 027A21A and 939905) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen), RASH (rash all over the entire body/pink rash all over me), VACCINATION SITE ERYTHEMA (arm is still red now/It didn't go beyond the red spot on the arm) and VACCINATION SITE PRURITUS (it's a little bit itchy). The patient was treated with AMOXICILLIN TRIHYDRATE (AMOXICILLIN E) for Sinus infection, at a dose of 1 dosage form. At the time of the report, SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen), RASH (rash all over the entire body/pink rash all over me), VACCINATION SITE ERYTHEMA (arm is still red now/It didn't go beyond the red spot on the arm) and VACCINATION SITE PRURITUS (it's a little bit itchy) outcome was unknown.            The patient had been using amoxicillin for a sinus infection but then said that have had a really bad cold, the right side of the face was swollen, the cold was just about done, went to HCP and couldn't realized if it was a sinus infection or something with the teeth. Went to an oral surgeon and was advised to continue with the antibiotics. They couldn't find anything wrong with the teeth.   This case was linked to MOD-2021-386031 (Patient Link).
Received vaccine 1/20/2021 Awoke 1/21/2021 with chills, temp of 100.5, arm is sore
Rash and itching. Fever of 101. Swelling in armpits and breasts. Severe Fatigue
Mon 10/14/2013 2:00 PM Td vaccine administered to right arm. Some soreness, but no other symptoms. Tues 10/14/2013 2:00 AM - Woke to urinate and was uncoordinated moving to bathroom. 8:00 AM - Very tired and had vertigo symptoms (bed spins, etc.) * When I walked around I was uncoordinated / off-balance and was very nauseous. * No other cognitive symptoms. I could think fine. * At Dr.'s advice, I rested and ate breakfast. 12:00 PM - after a 1 hr nap I felt better, but still nauseous. 9:00 PM - not nauseous, no vertigo, still very tired. Weds 10/14/2013 No nausea, no vertigo, still tired. Thurs 10/15/2013 Nearly all better. Fri 10/16/2013 All better!
Patient complained of numbness on her ring and pinky fingers of left hand.  Numbness resolved. Observation done.
concerns of vaccine induced myocarditis. Noted to be less energetic, poor appetite, pale and sweaty appearing starting 3 days PTA. SOB and chest pain started 1 day PTA.  For the last two days he has had fevers (~100F) with generalized abdominal pain and diarrhea. A rash developed on his hands, chest, and legs, about 24 hours ago while he was febrile. The rash has persisted especially while febrile. ROS was otherwise negative; no vomiting, cough, loss of smell, etc. He has noticed improvement of symptoms with Ibuprofen. He received his first COVID-19 vaccine on 08/25/2021 (Pfizer). A classmate tested positive this week for COVID-19.
Diarrhea, nausea, vomiting, chills. Gave him Ppto Bismol and Tylenol.
Black Tongue. Tongue looked black and had to brush off black with tooth brush. I have never had black tongue before. I have excellent oral hygrine. I do not smoke or use tobacco products. When I looked it up it said it could be caused by medication side effects, and the only thing that has changed with medication recently is having my 1st shot 10 days prior. I did not see it listed as a side effect of the vaccine, so I figured I should report it.
Patient was given the adult dose of pfizer covid-19 vaccine in error.  Patient has not experienced adverse effects at this time.
red area 4or 5 inches below the injection site; at the beginning hurt; kind of warm to the touch; then it was itchy; disorder visual field, with some spots and with some white flashes in the field; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (disorder visual field, with some spots and with some white flashes in the field), VACCINATION SITE WARMTH (kind of warm to the touch), VACCINATION SITE PRURITUS (then it was itchy), VACCINATION SITE ERYTHEMA (red area 4or 5 inches below the injection site) and VACCINATION SITE PAIN (at the beginning hurt) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 immunisation.     The patient's past medical history included Migraine headache (Migraine Headache Syndrome). Concomitant products included LOSARTAN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced EYE DISORDER (disorder visual field, with some spots and with some white flashes in the field). On 30-Jan-2021, the patient experienced VACCINATION SITE WARMTH (kind of warm to the touch), VACCINATION SITE PRURITUS (then it was itchy), VACCINATION SITE ERYTHEMA (red area 4or 5 inches below the injection site) and VACCINATION SITE PAIN (at the beginning hurt). The patient was treated with PARACETAMOL (TYLENOL) on 29-Jan-2021 at an unspecified dose and frequency. At the time of the report, EYE DISORDER (disorder visual field, with some spots and with some white flashes in the field), VACCINATION SITE WARMTH (kind of warm to the touch), VACCINATION SITE PRURITUS (then it was itchy), VACCINATION SITE ERYTHEMA (red area 4or 5 inches below the injection site) and VACCINATION SITE PAIN (at the beginning hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications include Cortisol cream on 30-Jan-2021. Concomitant medications include losartan.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Non-significant follow up appended.
skin burning, broke out with something that seemed like chicken pots , tired and nausea, upset stomach and fever