chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received COVID19 (Pfizer-BioNTech) vaccine at 4.5 weeks' of gestation. Focused anatomical scan during prenatal testing on 7/27/21, revealed baby with left kidney hydronephrosis which was confirmed at birth of baby on 9/15/2021.
Diarrhea; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Vaccination site pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Coronary stent placement (Left descending artery) in 2005 and Defibrillator/pacemaker insertion (Pacemaker defibrillator) in 2010. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL SUCCINATE, ASPIRIN [ACETYLSALICYLIC ACID] and NITROGLYCERIN for Heart disease, unspecified, TAMSULOSIN HCL for Kidney stone, ONDANSETRON HCL for Kidney stone and Nausea, CETIRIZINE HYDROCHLORIDE (CETRIZINE) for Sinus disorder and Allergy, ACETAMINOPHEN;HYDROCODONE, CARMELLOSE SODIUM, GLYCEROL (REFRESH RELIEVA), VITAMIN D3 and ACETAMINOPHEN for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021 at 11:06 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            Concomitant medication include Hydrocodone-Acetaminophen 5-325 MG per tablet for dosage of 1tablet every 4 hours as needed for pain and Multivitamins 50+ (Compare to Centrum Silver) for dosage of 1PM.  Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication was informed.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Updated reporter information , patient demographics, medical history . Updated product start date  . Added concomitant medications . Updated outcome of the events from unknown to recovered.; 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.
Patient stated that she noticed redness, swelling, and patches of hives beginning to form around her arm. She said they were itchy, red, swollen, and painful. She only self-treated with rubbing alcohol which she said helped, and took some Tylenol for the pain which she said helped a little. She denied taking any allergy type medications.
1st COVID-19 vaccine given at outside location on 1/17/2022. 2nd COVID-19 vaccine given at outside location on 2/14/2022. Third dose given here on 2/22/2022. Pt obtained booster early due to confusion around vaccine mandate. Pt's vaccine card is up to date. Followed up with patient x 3 days. No reported ADEs due to early booster.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A 66-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on unknown date. The patient medical history and concomitant medications were not reported. On unknown date, the patient experienced a cellulitis in the left arm 6 inch approximately. The patient was treated for the cellulitis with rx antibiotic. The outcome of the event was unknown.
This spontaneous report was received from a nurse via a company representative regarding a currently 23-year-old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in 2010, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) or with HPV rL1 6 11 16 18 31 45 52 58 VLP vaccine (yeast) (manufacturer unknown) (lot#, expiration date, formulation, dose, route of administration were not reported) administered for prophylaxis. On 05-SEP-2018, the patient was vaccinated with the second dose in series of GARDASIL 9 (lot#, expiration date, exact dose, formulation and route of administration were not reported) administered for prophylaxis. No adverse events were reported. The outcome of the event of product origin unknown was not reported. The causality between the event and an unspecified HPV vaccine was not reported. The causality between the event and GARDASIL 9 was not related.
Presented with large (20cm) redness area @ vaccine site approx. 10 min after adm of vaccine: site MD notified. VSS with BP 118/72 P88 - no wheezing 50 mg BENADRYL administered for  - VSS remained stable throughout - Area remained large (20 cm) BENADRYL adm. - Mother given instructions to give more po BENADRYL in 6 hrs.
This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Post vax slumped from chair to floor, unconscious, unresponsive to venbal or painful stimuli. Unable to appreciate pulse or respiration. 911 called, child responded to lowering hend and elevating legs. Cool cloth to forehead, increased air flow in area, awake and alert when ambulance arrived. Able to walk to stretcher. Dx at hospital probable vasovagal reaction to needles.
about 3 hrs following administration of vax pt woke up screaming & cont for 3 hrs continuously;
39 y.o. firefighter, healthy without significant past medical history. He has a hx with cashew allergy in the past (required Epi pen use). He felt  light headed, flushing sensation, and mild itchiness on the arm. His light headed felt worse and laid on ground. He remained alert and without apparent distress. There was no respiratory or cardiac complains. Vital signs were normal, O2 sat 100% on RA, BP 119/77, pulse 65, EKG NSR. Paramedics and his colleagues were present and assisted. Benadryl 50 mg IM once was given around 1300 pm. An IV 18 G was placed by paramedics to his right AC and NS tko.  Patient left via ambulance.
Plaintiff suffered severe pain in shoulders, fingers, hips and weakness/stiffness in arm. Plaintiff was diagnosed with polymyalgia rheumatica; Information has been received from a lawyer referring to a female patient (pt) of unknown age regarding a case in litigation. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  On or about 17-JUN-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, on an unknown date, the pt suffered severe pain in shoulders, fingers, hips and weakness/stiffness in arm which was diagnosed as polymyalgia rheumatica. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using the product and additionally, also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Pt sustained severe and permanent personal injuries and suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. She also suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  At the reporting time, the pt was not recovered from polymyalgia rheumatica and it was considered to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, polymyalgia rheumatica was considered a medically significant event.
APPROX. 24 HOURS AFTER VACCINE BEGAN WITH MUSCULAR NECK,BACK,LEG AND ARM PAIN.
Lump developed and became harder on 10/17 broke out in rash spreading down from site felt like pins on back, muscle soreness and Temp >100.
Post vax, pt had an episode of syncope after running 3 miles. She was found to be bradycardic, dehydrated, wobbling gait and severe headache. She was admitted in the hospital for hydration and further evaluation. Over 4 days in the hospital her gait, headache and nausea improved.
PATIENT FAINTED. RECOVERED IMMEDIATELY. EMT WAS CALLED AND ALL VITALS WERE TAKEN. PATIENT'S MOTHER REFUSED ER VISIT. MOTHER AND PATIENT WALKED OUT OF STORE WITHOUT ANY FURTHER INCIDENT.
Normal injection site pain, flu-like symptoms (body aches, extreme fatigue), elevated but normal temperature.  Worse than first injection.
Pt recvd 3 doses of vax & was pos for anti-HBC antibody & inc ALT; pt said this became pos in 1991 p/finishing Hep B series;
little fatigued; simply sore from the aches; muscle aches; shivering chills; This is a spontaneous report from contactable Physician (pediatrician, patient) via Pfizer Sales Representative. This male physician received second dose of BNT162B2 (the COVID vaccine) on 08Jan2021 at 1:00 PM for COVID-19 immunization. Medical history was had Covid in Aug2020 and he had zero symptoms. He has Graves' disease and microscopic colitis. Concomitant drug was not reported. Past drug was first dose of BNT162B2. He received his second dose of the COVID vaccine Jan 8th at 1:00 PM. At 2:30 AM on 09Jan2021 he woke with massive muscle aches and shivering chills. As of 8:00 AM on 09Jan2021 he is simply sore from the aches and a little fatigued. Event took place after use of product. Outcome of the event was unknown.  Information about Lot/Batch has been requested.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2022 as dose 4 (booster), single (Lot number: fj9943) at the age of 35 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: "crohn's" (unspecified if ongoing). Concomitant medication(s) included: REMICADE. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 31Aug2022, outcome "not recovered", described as "Rebound of symptoms and positive test"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment: Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 treatment: Paxlovid; (31Aug2022) positive, notes: Rebound of symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical information: Antiviral details: COVID 19 treatment was Paxlovid, treatment started on 22Aug2022, and treatment stopped on 27Aug2022. Other medication in 2 weeks was Remicade. Adverse event was rebound of symptoms and positive test. Adverse event started on 31Aug2022. No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER7934), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW2245), in left arm and on 28Jan2022 as dose 3 (booster), single (Lot number: EK9896) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Oct2022 as dose 4 (booster), single (Lot number: 061F22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LEVOTIROXINA [LEVOTHYROXINE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (21Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; I was afraid I was having a heart attack; Initial hyperactivity; tiredness; chest pains; urge to vomit; body aches all over; This is a spontaneous report received from a contactable consumer (patient herself). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration in left arm on 01Apr2021 at 16:00 (at the age of 49-year-old) as a single dose for COVID-19 immunization. The patient's medical history included issues with anemia in the past and known allergies: Tree nuts was all that I am aware of (allergies to medications, food, or other products: Tree nuts was all that I am aware of). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccine within four weeks of vaccination. The patient did not receive other medications within two weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. No COVID prior vaccination. The patient was not tested for COVID post vaccination. It was reported that the, initial hyperactivity on 04Apr2021 (patient think it was the anticipation of the shot), followed by tiredness that evening on 04Apr2021, Friday, Saturday, and Sunday. With the exception of having lunch with a friend on Saturday and stopping by to check on her mom, patient stayed home all weekend because she was feeling very tired. Late Sunday night after going to bed she awoke with chest pains and the urge to vomit on 04Apr2021. Patient was up and down vomiting for several hours and began to experience body aches all over on 04Apr2021. At one point she was afraid she was having a heart attack on 04Apr2021. On Monday morning and throughout the day she was still experiencing body aches and stayed home from the office. Patient slept propped up on the living room sofa Monday night because lying down made her body aches worse. Today, Tuesday 06Apr2021, her right leg was still bothering her, it feels a little bloated, so she was walking slower than usual. Otherwise she feel normal. The events were considered as serious (life threatening, hospitalization) by the consumer. No treatment medications were received for the adverse events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Temporary paralysis in my right hand. Around 9am today, my hand began making these involuntary movements and suddenly got very tense, almost like a claw. I had no control over my hand and it remained in this distorted position for about 1 minute before my hand relaxed back to its normal state.
Not felt right since 1st shot; I started with really severe heart palpitations/ the heart palpitations seemed to have been getting a little better before the 2nd dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (shingles outbreak in the eye about 2 years ago from reporting) and gluten free diet (gluten-free diet for 20 years). Concurrent medical conditions included cataract (had for over 2 years and still there which was preventing the patient from having her cataracts repaired), mitral valve prolapse (had done an echocardiogram: which showed that the patient had a valve issue which patient knew and was diagnosed with Mitral Valve Prolapse quite a few years ago in 1995), autoimmune disorder (due to celiac sprue been on a gluten-free diet for 20 years) and heart valve disorders.   On 1st March 2022, the patient received the 1st dose of Shingrix. In March 2022, immediately after receiving Shingrix, the patient experienced palpitation. On an unknown date, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved and the outcome of the palpitation was recovering/resolving.   It was unknown if the reporter considered the feeling bad to be related to Shingrix. The reporter considered the palpitation to be related to Shingrix.     Linked case(s) involving the same patient:  US2022132678   Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comments: The reporter was the patient. She had received Shingrix shot and she did not have the lot number but had provide her pharmacy's name and phone number, from where that information should be on file. She stated, she knew that from the very 1st shot, she had told her husband, she did not feel right since then and she still did not feel right. She stated, ever since she had the 1st dose, shortly after that she got that, she started with really severe heart palpitations. She had been to her doctor about that and she had instructed her to had the bloodwork done, which was okay, an echocardiogram, which had shown us that she had a valve issue which she knew, since she it was diagnosed as Mitral Valve Prolapse quite a few years ago from reporting and she also had a stress test done in which she had passed with no problems. However, the heart palpitations seemed to have been getting a little better before the 2nd dose of Shingrix. The reporter had consented to follow-up. Additional supportive information: The time taken for onset for event - palpitations was captured as Immediately. For tolerance of 2nd dose refer case US2022132678, reported by same reporter.; Sender's Comments:  US-GSK-US2022132678:Same reporter
chest pain, dyspnea, tachycardia, tachypnea, bronchospasm, pharyngeal edma
Involuntary movement of head left to right continuous, days within getting the Covid-19 vaccine. Stroke like symptoms started on or around Sept. 23rd then on September 30th Trip to emergency room because of weakness and unable to walk,  Word Searching, confusion, extreme weakness,. Oct. 8, 2021 started soiling herself and not knowing it.  Unable to stand had to be put in diapers. Sent home from the Hospital and had to be lifted at home by Husband and Daughter to Change diaper. Paralysis went from legs to trunk to arms, trouble swallowing,  trouble opening eye lids, muscle spasms in throat extremely hard to communicate and then only a whisper. Died November 1st 2021
Mom states pt has been c/o bodyaches and low grade fever the day of vaccination. Two days later, pt was in bed with severe headaches, fever, and stiff neck. Mom states pt did not have an appetite as well.
a 44 yr old female pt received an injection of Flu Shield 2000-2001 on 12/13/2000. Subsequent to a blood drive on 02/19/2001, her blood tested positive for hepatitis C and HTLV 1 & 2. The Red Cross told the reporter that a false positive reaction laboratory test interference nos with influenza vaccine was possible. The abnormal laboratory results were received on 03/15/2001.
Arm infection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOCALISED INFECTION (Arm infection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOCALISED INFECTION (Arm infection). At the time of the report, LOCALISED INFECTION (Arm infection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received antibiotics as treatment medication. Concomitant medications were not reported.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 11-Feb-2022; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 11-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 11-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 11-Feb-2022) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022 at 3:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Feb-2022 at 3:03 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 11-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 11-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 11-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 11-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Concomitant medications were not reported by the reporter.  Patient received booster dose. Patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Treatment medications were not reported by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
24 to 48 hrs following vax, pt reported a red itchy raised rash (like hives( fr neck down;
Pt. "S/P CABG in April" and presented at another hospital for sternal wound infection; sent on 05/24/2021.
9/1/16-Swelling (L) upper arm. No pain vaccinated area hot to touch, Temp 100-parents gave MOTRIN yesterday but none today.