chrisvoncsefalvay/vaers-outcomes huggingface dataset:
traumatic brain injury; received blood transfusion from the vaccinated individual; Initial information received on 11-May-2022 regarding an unsolicited valid serious case received from a other health professional.   This case involves Adult and unknown gender patient who experienced traumatic brain injury and received blood transfusion from the vaccinated individual who received vaccine yellow fever vaccine - us [YF-VAX].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received blood transfusion from the vaccinated individual (exposure via blood) who received a dose of suspect yellow fever vaccine unknown formulation and strength lot number not reported via unknown route in unknown administration site for prophylactic vaccination and donated blood 6 days later.  On an unknown date, post blood transfusion, the patient died of traumatic brain injury (craniocerebral injury) (unknown latency). This event was assessed as medically significant and was leading to death.  Action taken: Not applicable for both  It was not reported if the patient received a corrective treatment for the event (traumatic brain injury).  At time of reporting, the outcome was Fatal for the event traumatic brain injury and unknown for the other.  It is unknown if an autopsy was done. The cause of death was reported as Traumatic brain injury.  Reporter causality: Not related for traumatic brain injury; Sender's Comments: Sanofi company comment dated 17-May-2022: This case involves an adult patient who died of traumatic brain injury. An unspecified time prior, the patient had received a blood transfusion from a vaccinated individual who received vaccine yellow fever vaccine - us [YF-VAX]. The traumatic brain injury was considered unrelated to the transfusion. There is limited information in the case. Further information regarding medical history, concurrent condition of patient, previous vaccination, concomitant medications and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed. SanofiPVPortal20220513000727: SanofiPVPortal20220513000741: SanofiPVPortal20220513000748: SanofiPVPortal20220513000757:; Reported Cause(s) of Death: traumatic brain injury
Red, hot, hard, itchy blotch 2" in diameter developed 1 week post shot administration.
About 45 minutes after first Pfizer shot I experienced a feeling like a warm starburst in the center of my head... and got very dizzy. It started in the center of my head and spread in all directions to fill my head. I was driving and had to pull over. It passed after about five  minutes. After that I felt a bit weak and slept that afternoon and most of next day.
Moderate fatigue - required rest all day; This is a spontaneous report from a non-contactable healthcare professional, the patient.  A 35-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration on 07Mar2021 at 19:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic bronchitis. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 07Mar2021, the patient experienced moderate fatigue. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event fatigue and included rest all the day. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event moderate fatigue was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
lower limb swelling; I can't walk; pain; 1st dose on 18Mar2021and the 2nd dose on 29Apr2021; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (lower limb swelling), GAIT INABILITY (I can't walk), PAIN (pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 18Mar2021and the 2nd dose on 29Apr2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (lower limb swelling), GAIT INABILITY (I can't walk), PAIN (pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 18Mar2021and the 2nd dose on 29Apr2021). At the time of the report, PERIPHERAL SWELLING (lower limb swelling), GAIT INABILITY (I can't walk) and PAIN (pain) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 18Mar2021and the 2nd dose on 29Apr2021) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
Patient had sore arm shortly after she received vaccine. Patient stated she was not getting full range of motion so went to chiropractor on 11/10/23 and some relief occurred. Followed up with primary on 11/20/23 and said range of motion was due to administration technique. Patient will be following up with physical therapy.
on 10/3/2019 patient was vaccinated at around 9am.  Later in the evening when the patient went home pt experienced chills, sweats and fever of 103 degrees.  On Friday night he noticed a red spot away from the injections site and irregular shape.  By Sunday he noticed new spots on his arm and this is when he became concerned and went to the urgent care.  He states he could not lift his arm and needed help putting on his shirt.  The urgent care prescribed him a prednisone pack and he took about a week on the medication and is feeling better and the swelling and red spots have gone away.
pt recvd vax; listless, fussy; T 104 since few hrs post vax;26feb dx: B AOM
While vaccinated for bivalent boosters at a care facility - this patient was vaccinated without having a primary series for COVID-19 completed
Fever 100.4 F for 12 hours. Swelling and pain at injection site for 2 days. Muscle pain and fatigue for 1 day. No treatment was given and the patient recovered naturally in 2 days.
Patient describes feeling "low energy" or fatigue, tenderness under the armpit and diarrhea.
Potential administration error: patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series; Patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Potential administration error: patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series), WRONG PRODUCT ADMINISTERED (Patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series) 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 vaccination.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Potential administration error: patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series), WRONG PRODUCT ADMINISTERED (Patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Potential administration error: patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series), WRONG PRODUCT ADMINISTERED (Patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series) 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 assessments were provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Potential administration error: patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series) and WRONG PRODUCT ADMINISTERED (Patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series).    No concomitant medication was reported.  No treatment medication was reported.
injection site pain; This is a spontaneous report from a non-contactable pharmacist (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730, expiry: unknown), via an unspecified route of administration on 17Dec2020 12:00 at single dose (Left Arm) for COVID-19 immunization. Medical history reported as none. Patient had no known allergies. Patient is not pregnant. The patient's concomitant medications were not reported. Other medications within 2 weeks of vaccination was reported as oral contraceptives. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Only adverse event related to first dose was injection site pain from an unspecified date. The outcome of the event was unknown. The events were reported as non-serious.   No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 13-NOV-2018, the patient was vaccinated with improperly stored rotavirus ROTATEQ (lot # R002805, expiration date: 23-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Sudden complete hearing loss in left ear on May 15.  Being treated by Dr., ENT with steroids and MRI follow-up.
I received my first Pfizer shot on 4/13/21 at 1:30pm.  I and some tenderness to injection site for 3 days but otherwise ok.  I have a baseline hx of migraines and have been treated since 1/2020 for bilateral ankle tendonitits treated w/ NSAIDS (prn) and steroid injections to ankles. On 1/2021, I first experience BPPV vertigo and was treated with vestibular PT. After I received my second covid vaccine on 5/4 1:30pm,  my arm felt sore but not as bad as the first time. However, on 5/5, I started to notice more pronounced tinnitus on my right ear. I still have the tinnitus and it's been constant. I am seeing my ENT on 5/20/21. I just wanted to report as I've never had the ringing for this long before and I am unsure it it's related to the vaccine. However, I haven't  dont anything differently and there hasnt been any changes to my health regimen.
Is hard for her to get around (more than usual); Feeling achy; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Is hard for her to get around (more than usual)) and MYALGIA (Feeling achy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced GAIT DISTURBANCE (Is hard for her to get around (more than usual)) and MYALGIA (Feeling achy). At the time of the report, GAIT DISTURBANCE (Is hard for her to get around (more than usual)) and MYALGIA (Feeling achy) outcome was unknown.     No relevant concomitant medications were reported.  Treatment information for the events was not provided.
Extreme pain and stiffness in left shoulder, per appointment with Dr. it was found the injection was too high in the shoulder. Pain started the evening of shot and has now resolved thanks to steroid treatment.  Patient had confirmed with xray that this was the cause of her pain. Has follow-up with Dr. on Friday and will update me with status.
Itchy throat 15min after receiving 2nd dose, notified vaccine employees and kept 15min extra,  and then 24hrs after 2nd dose left neck supraclavicular  lymph node swelling and tenderness. Left arm vaccine site tenderness next morning after 2nd dose as well.
feel sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient received 2nd Shingrix shot and had all the side effects listed how much longer will  the patient feel sick.
Injection site soreness (beginning within 6 hrs of injection, lasting 24 hrs) Headache (beginning within 12 hrs of injection, managed with ibuprofen, ceasing within 24 hrs) Fever (beginning within 12 hrs of injection, managed with ibuprofen and acetaminophen, lasting 24 hrs) Muscle soreness (beginning within 12 hrs of injection, managed with pain meds, lasting 24 hrs)  All symptoms resolved 36 hrs after injection
Headache, severe body aches, feverish, sore axilla nodes , fatigue
Patient started feeling dizziness and headache 10 min later vaccination at observation area. She complained of burning sensation on her abdomen but had breakfast at home. Fruit juice and water given to drink. Blood sugar checked : 129mg/dl at 11:45 with v/s: 18, 98%, 82, 132/85.  V/s monitored frequently on lying, sitting and standing position at triage and were stable. No dizziness at standing, Pt able to walk couples of steps comfortably. No any allergic reactions noted at vaccination site/arm. patient was monitored until she walks to parking lot and to her vehicle.
Incorrect dose of 0.2mg  Pink cap/yellow label administered for dose 1.
Racing heart. Elevated resting heart rate (up to 100 bpm). Sharp chest pain. Shortness of breath. Feels like unable to get enough oxygen & heart hurts.
states 8 hours after the shot she developed chills, body aches and a sore arm. 24 hours after the shot she developed itching and hives in hands, face and eyes which is what caused her to come to ED.
He had 3 grandma seizures , he was seizures free for 2 years prior to that it was well under control.
1hr p/vax pt exp face flushing & heart racing lasting for 3hr;took a nap & woke up feeling fine;
patient received an expired dose of Fluzone HD; Initial information received on 13-May-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Pharmacy-Other).   This case involves patient (age and gender unknown) who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and expiry date not reported via unknown route in unknown administration site.  It was an actual medication error due to expired vaccine used.  It was reported that patient received an expired dose of Fluzone HD.  It was unknown if patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested  List of documents held by sender- none.
extreme itchiness on the inner portion of arm from elbow to wrist; extreme redness on the inner portion of arm from elbow to wrist; burning on both hands; itchiness on both hands; top of left hand slightly swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (extreme itchiness on the inner portion of arm from elbow to wrist), ERYTHEMA (extreme redness on the inner portion of arm from elbow to wrist), FEELING HOT (burning on both hands), PRURITUS (itchiness on both hands) and PERIPHERAL SWELLING (top of left hand slightly swollen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (extreme itchiness on the inner portion of arm from elbow to wrist), ERYTHEMA (extreme redness on the inner portion of arm from elbow to wrist), FEELING HOT (burning on both hands), PRURITUS (itchiness on both hands) and PERIPHERAL SWELLING (top of left hand slightly swollen). At the time of the report, PRURITUS (extreme itchiness on the inner portion of arm from elbow to wrist), ERYTHEMA (extreme redness on the inner portion of arm from elbow to wrist), FEELING HOT (burning on both hands), PRURITUS (itchiness on both hands) and PERIPHERAL SWELLING (top of left hand slightly swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Local reaction 1"x2" circular warm, red, and indurated. No fever; only slight fussiness relieved with OTC pain reliever.
Fever 102.4. Very warm to touch. Lump beneath skin per pt. Reddened area per pt 11cm x 6.5cm. No oozing. No abscess. Pain at injection site. Upon visit today pt reports no fever, pain better. Given AUGMENTIN XR x 8 days and xray.
Information has been received from a physician assistant concerning a female patient who was vaccinated with a dose of GARDASIL vaccine (yeast) (lot # not provided). Subsequently the patient developed a small lump on the arm of the injection site. The patient sought unspecified medical attention. The patient recovered on an unspecified date. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician assistant concerning a female patient who was vaccinated with a dose of GARDASIL (lot # not provided). Subsequently, the patient developed swelling at injection site and a small lump on the arm of the injection site, 1 cm round, hard nodule that cleared spontaneously within 1-2 weeks. This was considered to be a local vaccine reaction. No fever and no erythema were experienced. The patient sought unspecified medical attention. The patient recovered. No further information was available.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PEDVAXHIB (injection) that went through an unsupported temperature excursion from 29-OCT-2013 to 06-NOV-2013 (dose, route and lot number were not provided). No concomitant medications were reported. No adverse effect reported. This is one of several reports received from the same source (MARRS# 1311USA003162, MARRS# 1311USA004587 and MARRS# 1311USA004588). Additional information has been requested.
Pfizer vaccine was not diluted properly- not enough diluent was used patient was called and informed, patient is not currently experiencing any side effects
Initial: fever up to 103.7 that lasted 24 hours.  Myalgia.  Numbness in right arm. Altered taste Progressive:  Liver enzymes  and A1C continue to be elevated, getting progressively worse.  Continuation of severe myalgia and altered taste.
heat from site to face; heat from site to face; stiffness in site hand; pain at shot site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat from site to face), FEELING HOT (heat from site to face), MUSCULOSKELETAL STIFFNESS (stiffness in site hand) and VACCINATION SITE PAIN (pain at shot site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE WARMTH (heat from site to face), FEELING HOT (heat from site to face), MUSCULOSKELETAL STIFFNESS (stiffness in site hand) and VACCINATION SITE PAIN (pain at shot site). At the time of the report, VACCINATION SITE WARMTH (heat from site to face), FEELING HOT (heat from site to face), MUSCULOSKELETAL STIFFNESS (stiffness in site hand) and VACCINATION SITE PAIN (pain at shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.
Pt initially reported facial pruritus and the mild sensation of her throat closing.  Discussed giving epi but pt requested delaying as she reports her throat feeling better.  Benadryl provided to help with pruritus since throat tightening improved.  Tightening of her throat later worsed and was associated with dysphagia.  Epi was administered and EMS contacted.  Pt's symptoms completely resolved before transport to the hospital.