chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We have a pediatric patient that we accidentally gave 2 Moderna bivalent shots. We just wanted to report it. 1. 17Dec2022 2. 30May2023; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (We have a pediatric patient that we accidentally gave 2 Moderna bivalent shots. We just wanted to report it. 1. 17Dec2022 2. 30May2023) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (We have a pediatric patient that we accidentally gave 2 Moderna bivalent shots. We just wanted to report it. 1. 17Dec2022 2. 30May2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (We have a pediatric patient that we accidentally gave 2 Moderna bivalent shots. We just wanted to report it. 1. 17Dec2022 2. 30May2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (We have a pediatric patient that we accidentally gave 2 Moderna bivalent shots. We just wanted to report it. 1. 17Dec2022 2. 30May2023).    Concomitant medication details not reported by the reporter. It was reported that a pediatric patient that accidentally received 2 Moderna bivalent shots. They just wanted to report it. First vaccine was administered on 17-Dec-2022 and second vaccine was administered on 30-May-2023. Treatment details was not reported by the reporter.
numbness in the foot; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Apr2021 (Batch/Lot Number: EW0161) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included cardiac disorder from an unknown date and unknown if ongoing. Concomitant medication included amiodarone (AMIODARONE) taken for cardiac disorder, start and stop date were not reported; metoprolol (METOPROLOL) taken for cardiac disorder, start and stop date were not reported.  The patient experienced numbness in the foot on 16May2021. The patient stated that he wanted to get the vaccine and be protected but don't know if Pfizer caused this or not. The patient received only one vaccine and then that lady asked about medicine he was taking and he just wondering if that Pfizer shot-would it matter what kind of medicine he was on.  the patient thought Could they have a side effect both of them together causing numbness in his foot. The patient states he experienced numbness after the first shot of the Covid vaccine and wanted to know is there anyone else who complained about this. got vaccine on 26Apr2021, only got the first vaccine. Has been to the doctor a couple of times because of it. The outcome of the event was reported as not recovered. No follow up attempts are possible. No further information is expected.
White papule; Scab; This is a spontaneous report from a contactable other hcp (patient's mother). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0162), dose 2 intramuscular, administered in right arm on 19Apr2021 09:15 as 2nd dose, single for covid-19 immunisation. Medical history included vaso vagal syncope. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733,) intramuscular administered in right arm on 29Mar2021 16:00 for COVID-19 Immunization. On 26Apr2021, the patient developed white papule which turned into a scab approximately 1 week following second injection, roughly three inches below injection site. Seriousness criteria-Congenital anomaly/birth defect: Yes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination, no known Allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the vents was resolved with sequel.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of events cannot be excluded.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Client presented to the vaccination site on 11/19/2021. The client notified PHN that she received a single dose of Moderna COVID vaccine on 3/18/2021. Patient reported that 12 hours after receiving dose 1 of Moderna COVID vaccine, she experienced swelling on her chin to her neck, difficulty breathing, extreme fatigue. The side effects resolved within 4 days post injection. The patient reported no allergies. Medical conditions include hypertension and hypotention. Medications include losartan, amlodipine, aspirin, and a statin drug. PHN submitted a medical consult via message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Janssen. Approval to proceed with COVID vaccine Janssen was obtained from medical consult team via message from another PHN, Vaccine Operations Lead. Client received COVID vaccine Janssen Lot 211D21A on 11/19/2021. The client did not report any symptoms during the 30 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 1530 walking with steady gait.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 06-SEP-2013, the patient of unknown age and gender vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is on of several reports received from the same reporter. Additional information is not expected, all available information has been received.
No adverse event; received both doses of the Moderna covid vaccine 21 days apart back in April; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received both doses of the Moderna covid vaccine 21 days apart back in April) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received both doses of the Moderna covid vaccine 21 days apart back in April). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received both doses of the Moderna covid vaccine 21 days apart back in April) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
2/28/2022 I had severe numbness in both hands. My 3 fingers felt like they were on fire and swollen on my right hand. This happened during the night 4-5 times a night lasting about 45 minutes each time. It lessened over time where it actually stopped. By mid-April it was down to 2-3 times a night. By the time I had carpal tunnel surgery 4/27/2022, it had stopped. In addition to the hand, I had severe soreness in my shoulders. It was very difficult to dress. It diminished at the time of my surgery, and it has come back. I talked to my PCP about this condition and our plan is to wait another week or so past my surgery then she will evaluate me for Rheumatoid Arthritis or PMR. Blood work has begun to get process started. I also have pain in the hips which remains. In the first few weeks of April, I had fatigue and had to take naps every afternoon, which I previously did not have to do.
Patient's arm became swollen and sore at administration site. Then she developed a very large bruise about 4"x6". The bruise resolved within 7-10 days.
sick every time; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (patient) via The Agency through social media.  This case is linked to cases 2020SA306301, 2020SA306300, 2020SA306303, 2020SA306304, 2020SA306305, 2020SA306276, 2020SA306292, 2020SA306293, 2020SA306294, 2020SA306295, 2020SA306296, 2020SA306297, 2020SA306298, 2020SA306299 and 2020SA306302 (same reporter).  This case involves a male patient of unknown age who got sick every time (malaise), while he was treated with Influenza Vaccine.  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got sick every time (malaise).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Fatigue, pain in the left groin area, nerve pain in arm and leg, chills, headaches.
Cold sweats, vomiting, tingling and numbness in arms and legs, inability to breathe, clouded vision, difficulty hearing (this lasted approximately 5-10 minutes and was roughly 10 minutes after receiving my first dose of the vaccine)
Thrombosed Hemorrhoids, first thrombosed hemorrhoid was resolved through opening of the vein and draining of the hemorrhoid  by the oatient  The 2nd will be resolved today by a colorectal surgeon to cut open and drain the hemorrhoid
Had COVID-19 positive test on 3/1/21. Isolated 10 days and was cleared to get vaccine due to mild symptoms (described earlier) and clearance of symptoms by first date of vaccine appointment on 3/19/21.  First vaccine 3/19/21. Noticed some discomfort in chest after this date such as tightness (left side only) that could be alleviated if I twisted my body a certain way and would almost make a "pop" like cracking  knuckle would. (I did not experience this at all during isolation period and do not recall if I noticed it at all in days between isolation ending and first vaccine since it was about 10 days apart).  Had second dose 4/16/21. Was in bed with side effects (tired, sore arm, fever) on 4/17/21. On 4/18/21 I noticed that I could not take full deep breaths easily and still noticed discomfort in my chest. I went to an urgent care and they referred me to an Emergency Room. I was there for several hours. Chest XRay/ultrasound/EKG all normal and sent home told it may be costochondritis and to take ibuprofen for discomfort/inflammation.  Symptoms did not improve with time and ibuprofen. Had an appointment with a Rheumatologist who confirmed suspicion based on symptoms of Costochondritis. Ordered bloodwork (all normal) and prescribed diclofenac topical gel when chest is tender and 7.5 mg meloxicam for inflammation. After 1 month, upped to 15mg meloxicam which helped alot. Been on this medication for several months. Back to 7.5mg as of 10/10/21 to try to wean off medication since symptoms have improved (but not ceased) since onset.
Patient requested and received a Fluzone High-Dose vaccination on 9-22-2023.  After administration, it was discovered patient had been administered a flu vaccine by a different provider the day prior, 9-21-2023.  No known medical issues resulted as of 9-22-2023.
Intermittent electric shock sensations and pricks all over; Pricks all over/a pricking sensation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Dec2021 18:40 (Lot number: FD7218) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "WPW: Wolf Parkinsons White Syndrome", start date: 2012 (ongoing), notes: Verbatim: WPW: Wolf Parkinsons White Syndrome. The patient's concomitant medications were not reported. The following information was reported: ELECTRIC SHOCK SENSATION (non-serious) with onset 27Dec2021, outcome "not recovered", described as "intermittent electric shock sensations and pricks all over"; PARAESTHESIA (non-serious) with onset 27Dec2021, outcome "unknown", described as "pricks all over/a pricking sensation".  Additional Information: Patient got her first Pfizer covid vaccine on 27Dec and about 3 to 4 hours later, started experiencing intermittent electric shock sensations and pricks all over. The first occurred in her stomach, then in other parts like her arms, legs, right shoulder and it is a singular electric shock sensation. Patient is frustrated that there is no information on the side effect she is having. Pfizer is pushing the vaccine and there are mandates all over so she is forced to get it. She sees people reporting it on the internet. She took the vaccine because the government is mandating the vaccine for all private workers. Patient described the sensation similar to a belt that is used in physical therapy to decompress muscles and provides electric shocks. Patient describes as random and intermittent. Patient asked if this effect been reported. She needs concrete assistance because this is a problem. She said here is no level of accountability because the vaccine is mandated. She feels like a guinea pig, taking this vaccine. Patient did not receive additional vaccines on the same day of suspect. The events did not require emergency room or physician office visit. Patient did not receive any vaccinations within four weeks and there were no adverse events following prior vaccinations. Patient did not underwent any relevant test.   No follow-up attempts are possible. No further information is expected.
Joint pain followed by serious fatigue lasting 60 plus hours.  Also roughly 12 hours after injection experienced severe itching as if bugs were crawling all over my body. That lasted about 36 hours.  Approximately 72 hours after injection back pain started and lasted over a week.
Pfizer / BioNTech: 27Sep2022 / Moderna: 09Nov2021; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Other medical history: Hypothyroidism. Concomitant medication(s) included: SERTRALINE; ARMOUR THYROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Sep2022, outcome "unknown", described as "Pfizer / BioNTech: 27Sep2022 / Moderna: 09Nov2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was taken as therapeutic measures for COVID-19 from 21Oct2022 to 26Oct2022. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient got bad chills, felt feverish, was nauseous , was sweating profusely. All of this happened Friday night.  Also, about 3 inches down from where the shots were given, got a good size hard lump which was black and blue in like a horseshoe type shape.. didn't bruise where the vaccines were given until Sunday.
Patient experienced vasovagal syncope within a minute of her vaccination. Helped patient lie down on the floor and explained situation to her. Assisted patient to cot, and provided apple juice. Encouraged patient to call her mom and continued to monitor patient's status.
After 1st vaccine, (1/18/21  the next day. Went to hospital 1/20/21. incoherent and loss of balance. Went to hospital for 3 days. After 2nd shot 2/15/21 he got a reaction 6 days later. Very incoherent, delusional and loss of balance, unable to walk.  Fever
Patient received vaccine at 16 years of age however EUA is indicated for 18 years of age and older.
Fever (103), chills, body/muscle aches, chills, headache. Felt like the worst flu ever with really bad body pain. My hair even hurt. Lasted until 1500 on 2/21/21 and  all symptoms left very suddenly.
patient suffered a stroke and was hospitalized on june 22 2021  week long stay in hospital facility
Client was found in restroom hovering over the sink by staff. Client stated she felt like throwing up  and did not feel well. Client had completed 15 minute observation room and went into restroom because she did not feel well. Client was then safely ambulated back by staff to the observation room to where the client was provided interventions. Client appeared pale, had blank stare, and was visibly trembling. Client also stated "I have a knot in my throat." Client transferred into gravity chair, provided water, snacks, and emesis bag. RN Co Lead at vaccination site administered benadryl 50 mg Oral once to the client which alleviated her symptoms within 10 minutes. Vitals stable throughout incident. Client educated on when to call 911, when to go to urgent care, and to enroll in program and follow up with PCP within 24 hours. Client left facility safely with steady gait and verbally stating "I feel well now."
she was hospitalized due to a stroke; This is a spontaneous report from a contactable nurse (patient herself). An 81-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in arm at age 81 years on 24Feb2021 (Batch/Lot Number: EN6201) as single dose for COVID-19 vaccination. Medical history was reported as none. Patient had not had any other recent vaccinations. The concomitant medication includes an unspecified medication since she started a new cancer drug that starts with a L.Registered nurse calling as patient says she was supposed to have her second Pfizer COVID-19 shot 17Mar2021, but she was in the hospital. She says she is trying to reschedule her second shot. She says the first dose was given at (Hospital Name), and it says BNOI on her vaccine card. Patient was admitted to the hospital this past Monday evening (15Mar2021) and it was (Hospital name). She says her admitting diagnosis was unknown. She says she was discharged from the hospital Thursday 18Mar2021. Hospitalization seriousness patient says it was not serious. Patient missed the 2nd dose (17Mar2021) because she was hospitalized due to a stroke on an unspecified date. The outcome of the event was unknown.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of stroke.  The reported event likely represent intercurrent medical condition in this elderly patient.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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.
At injection site, area is red, raised, swollen. Other symptoms, neck pain, chest pain, cough, husky voice. Reported symptoms 2/15/2010. Denied any fever or difficulty breathing.