chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer vaccine (Patient received the Pfizer vaccine for primary vaccination series) and Pfizer vaccine. Past adverse reactions to the above products included No adverse drug reaction with Pfizer vaccine and Pfizer vaccine.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced VACCINATION SITE PAIN (sore injection site left arm). At the time of the report, VACCINATION SITE PAIN (sore injection site left arm) outcome was unknown.            Concomitant medications and treatment information were not provided by reporter. The patient had a sore injection site left arm.
Patient's guardian informed staff of the incorrect birthday leading to the patient getting vaccinated a day before she turned 12. Guardian did not inform staff of the misinformation until after the vaccination. Patient sustained no adverse reactions and needed no further treatment.
fussy, t104 x 72hr not responsive to other s/s of illness or roseola;last two immun had temp 101 x 24 to 48hr & fussy;
2 hours after receiving the second vaccine, began itching on  lower left side back and buttock, then started seeing blisters and it became very painful the next morning spoke to primary doctor and he diagnosed it to be shingles.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 11:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included cancer, colon surgery, breast surgery and hernia surgery. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and paracetamol, hydrocodone bitartrate (HYDROCODONE/ACETAMINOPHEN) all started from unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206) via an unspecified route of administration in left arm on 10Mar2021 at 11:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. 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 COVID-19 vaccination. On 01Apr2021 at 13:00 (2 hours after receiving the second vaccine), the patient began itching on her lower left side back and buttock, then she started noticing blisters and it became very painful, the next morning the patient spoke to her primary doctor and he asked the patient to send a photo and he diagnosed it to be shingles. The patient received treatment for the event shingles which included treatment with Famciclovir. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event shingles was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
reactivation of varicella / the patient previously received VARIVAX; Ramsay Hunt syndrome / increased dry eyes/right sided facial weakness; This spontaneous report was received from a physician referring to a 16 year old female patient. The patient had no relevant medical history, drug reactions/allergies or concomitant medications.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).         Since an unknown date, the patient had "reactivation of varicella". The patient experienced a herpetic rash with right trigeminal distribution and rash in her right ear canal. No rash was noted on the patient's tympanic membrane. There was no involvement of the optic nerve however the patient experienced increased dry eyes and right sided facial weakness. The patient was diagnosed with Ramsay Hunt syndrome and was initially given oral acyclovir however, due to worsening symptoms, had to be hospitalized on 22-AUG-2021 and given intravenous acyclovir.   The physician reported that the patient was improving however still had right sided facial weakness. Causality assessment was not provided.   Upon internal review, Ramsay Hunt syndrome was considered a medically significant event.
pt. recvd 1st dose of hepatitis B vac & exp. pleurisy.
14x11cm red macular area on left thigh that is painful with palpation. No systems signs. Denies fever, vomiting, diarrhea.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 59-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 17-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Flushed, hot and sweating after Flu shot. Gave 10ml. (5 mg.) of Benadryl. Checked after 1 hour of when Benadryl given. Pt. ok.
This case was reported by a nurse and described a 55 year old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. On unspecified dates in 2004, the patient received three doses of Engerix-B (lot number not specified). Subsequently on 08 October 2004, a hepatitis B surface antibody titer was negative. The nurse considered the event to probably be related to the use of Engerix-B.
Malaise with some chills and low grade fever. Not sure if this is related but on Monday, morning, March 29  I woke up to burst blood vessel in left eye.
When I first received the Tetanus shot I had muscle aches-a feeling of pins in my stomach-and arm pain-IT HAS BEEN WELL OVER TWO YEARS AND THE ARM PAIN HAS NEVER WENT AWAY.
ADACEL given 12/6/10 - by 12/8 redness/warmth swelling noted. Seen 12/15/10 - with persistent swelling 0.5 x 1 cm no redness or warmth.
Myalgia, slight fever, chills, headache, lethargy, insomnia (which I never have otherwise), cough (first night, overnight)
I had injection site pain . I woke up the next day with chills, body aches and pain, chest pains, heart palpitations, shortness of breath, arm soreness and swelling, fatigue, nausea and I could not get out of bed.  I called the hospital and left a message.  The doctor called me back and advised me to go to the ER.  By the time the doctor called me back, my chest pains and heart palpitations had resolved.  The other symptoms still persisted- extreme fatigue and headache which lasted another 4 days.  I started to feel better and it took about 6  days  for all symptoms to resolve.  I did not go to the ER since the cardiac symptoms  have resolved. I am still having SOB.
Patient reports having a red rash on entire trunk, the left arm, and her cheeks. The rash is not itching. She reports she had the same reaction after her flu and pneumonia vaccines. Patient will take Benadryl to help treat the rash.
Before 15 minute observation was completed, pt started experiencing numbness and tingling bilaterally. Pt vomited and then bilateral contracture of upper extremities began. Rapid response was called pt was taken to ER.  During observation period pt had numbness and tingling in her hands and feet and contractures of her hands and was  sent here after rapid response. Per mother she reports after the vaccination she felt numbness in her hands and feet and then noticed her hands were contracting, she reported nausea, trouble breathing, and fast breathing.
extreme muscle rigidity, back muscle pain upon movement, inability to raise arms and legs without excrutiating pain
Patient inadvertently received vaccine after published expiration date. Moderna company analyzed vial and indicated that lot 007B21A maintained the activity necessary to protect against covid 19. Patient  did not call in to complain of adverse event.  This is administrative error without adverse event.
This case was reported by a physician via sales rep and described the occurrence of syncope in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced syncope. On an unknown date, the outcome of the syncope was unknown. It was unknown if the reporter considered the syncope to be related to BEXSERO. Additional details were provided as follows: The patient's age at vaccine administration was not reported. The reporter reported to a GSK sales representative that at least one patient experienced syncope after receiving BEXSERO. The Sales representative had limited information but reporter had additional information which could be obtained by follow up.
started getting sick before bed and is sick today; Initial information was received on 09-Nov-2021 regarding an unsolicited valid social media non-serious case received from a Consumer.  This case involves a five-year-old female patient who experienced started getting sick before bed and is sick today (Illness) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient experienced started getting sick before bed and is sick today (Illness) (on the same day) following the administration of INFLUENZA VACCINE.  It was reported "Next door neighbor's 5 yr old had a flu shot ystrdy afternoon. She started getting sick before bed and is sick today from the shot".  Her mother's a school teacher and had to take off work to take care of her ill daughter today.  It is unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
This spontaneous report as received from an officer manager referring to a currently 2 year old female patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 26-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1805USA000922: US-009507513-1805USA000923: US-009507513-1805USA000928: US-009507513-1805USA000925: US-009507513-1805USA000926: US-009507513-1805USA000927: US-009507513-1805USA000921: US-009507513-1805USA000924:
Within 5 days of receiving vaccines listed below child developed petechial rash, gingival, rectal bleeding multiple ecchymoses. Platelet count less than 1,000 on adm. to Intensive Care Unit at Hospital.
At 3:45 pm on Tuesday, March 9th 2021, I bent down and immediately felt vertigo symptoms and fell to the ground.  The vertigo symptoms have persisted, however have subsided.  There was vomiting and intense feelings of dizziness, usually got worse when I moved my head or eyes a certain way.   A week after symptoms began, these feelings are now much less.
Chief Complaint   Dyspnea  History of Present Illness     Patient is a 73 year old male with a history of HLD, BPH, colovesicular fistula s/p repair 10/2020, and migraines who presented to UH ED for dyspnea. He was positive for COVID on 7/27, his symptoms started the day before with fevers and loose stools.  He has not had a fever since 7/30 but has gotten progressively more short of breath.  He has a cough, but it has not been productive.  He has had no abdominal pain, chest pain, leg swelling, or dysuria. In the ED he was found to be profoundly hypoxic requiring 100% FiO2 to resaturate. He has recieved 2 COVID vaccinations one month apart ending in March.
Raw patch of skin on my stomach with a small rash, mostly painful; Slightly itchy; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm on 07Apr2021 at 17:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date. It was unknown whether the patient had known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm on 10Mar2021 at 17:15(at the age of 48-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 COVID vaccine. On 08Apr2021 at 15:00 the patient experienced raw patch of skin on stomach with a small rash. Slightly itchy but mostly painful. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events raw patch of skin on stomach with a small rash, slightly itchy but mostly painful was not resolved at the time of report.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.
The pt experienced redness, swelling and indurated area to the right thigh that covered a 3cm x 5cm area. Advised to apply cold compresses every 2 hours for 10 minutes. Call back if no improvement.
No adverse event; Pregnant patient was administered GARDASIL 9 in error .; Pregnant patient was administered GARDASIL 9 in error .; This spontaneous report was received from a nurse referring to a pregnant female patient of unknown age.   The patient concurrent conditions, medical history and concomitant medications were not provided. Last menstrual period (LMP) date,  pregnancy due date, and pregnancy outcome were not provided, nor infant details.   On 15-JUN-2022, the patient was vaccinated in error with  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Dose, administration route were not provided) (Lot number 1780879 is an invalid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) an expiration date was reported as 11-SEP-2023) as prophylaxis (Exposure during pregnancy).  It was reported that the patient and the fetus were doing good, therefore, no adverse events or additional information were reported. At the time of reporting, the outcome of the exposure during pregnancy was not provided.
Can't even sleep; Weak; Tired; Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), SLEEP DISORDER (Can't even sleep), ASTHENIA (Weak), HEADACHE (Headache) and FATIGUE (Tired) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). On an unknown date, the patient experienced SLEEP DISORDER (Can't even sleep), ASTHENIA (Weak) and FATIGUE (Tired). At the time of the report, DIZZINESS (Dizziness), SLEEP DISORDER (Can't even sleep), ASTHENIA (Weak) and FATIGUE (Tired) outcome was unknown and HEADACHE (Headache) had not resolved. Not Provided          Patient was taking diabetes medication.  No treatment information was provided.
Episodes of Syncope; This case was reported by a consumer via call center representative and described the occurrence of syncope in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Shingrix.     Linked case(s) involving the same patient:  US2022191325   Additional Information: GSK receipt date: 21-DEC-2022 Reporters comment: The reporter was the patient and he stated that he received his first dose of the shingrix vaccine in October of 2021 and the second dose in January of 2022,since received his first dose he had experienced episodes of syncope. No additional details were provided. The reporter consented to follow-up. Additional Supportive information: This case has been linked to the cases US2022191325 reported by the same reporter for second dose. .; Sender's Comments:  US-GSK-US2022191325:Same reporter
01/15/04, twin sisters with varicella vaccine failure.  Tired Sunday evening 01/12/04.  Father noticed a couple of spots on her upper back that night.  More on Monday, on back and abdomen.  Today blistery, none crusted as yet.  Has approximately 100 lesions.  More ill than sister.  Exposed to unvaccinated 8 year old brother who developed chickenpox on 12/31/03.
This is a spontaneous report from a contactable consumer (patient) or other non-HCP. A male patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Mar 31, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, he had a sore right arm/shoulder and a sore shoulder the next day. The skin on his forearm between his wrist and elbow went numb. He felt a spot on his hand, right above his thumb. He had another spot on his left arm and felt tingling there or like it was going to become numb. He felt something going on too where he wears his mask (cheek and an area of his jaw under his eyes). He reported he just got the Pfizer COVID-19 shot and his skin was numb on his arm, but he felt it on his other arm. He clarified it was not muscle pain, it is skin. He felt tingling on his face. The patient went to his doctor. Reportedly, it was not a stroke or a heart attack, but he didn't know what to think. He was offered an MRI and other tests. The patient reported the tingling started 4 or 5 days after the shot. He still felt the tingling after 3 or 4 days, and still has numbness on his arm where he got the shot. He added the feeling was down on the forearm and not at injection site. The outcome of the events: unknown. No follow-up attempts needed. No further information expected.
left upper shoulder, it was little sore; my face was itching; My eyes puffed up; This is a spontaneous report from a contactable consumer via the Medical Information Team. A 76-year-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 04Jan2021 to 04Jan2021 at a single dose for an unspecified indication. Medical history included allergy to sweat Bees. The patient's concomitant medications were not reported. It was reported by the patient that after administration on his left upper shoulder, it was a little sore. On the 2nd or 3rd day after that, his face was itching so he took a Benadryl to keep from scratching and itching. The outcome of the events was unknown. He also reported that his eyes puffed up. Information on the Lot/Batch number has been requested.
Chills; Headaches; Very tiredness; Body aches; This is a spontaneous report from a contactable consumer (patient).  A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 25Feb2021 (Lot Number: EL3247, at the age of 25-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on 05Feb2021 (Lot Number was not reported, at the age of 25-year-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 25Feb2021 at 22:00 (after about 10 hours following vaccination), the patient had experienced chills, headaches, very tiredness and body aches. The patient did not receive any treatment for the events. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events tiredness and body aches was recovered on the morning of 27Feb2021, and the other events was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Initially sick, malaise, nausea, anxiety, next day lymph glands on right swollen, injection site red, hot, raised, swollen size of grapefruit on 11/16/12 MD prescribed cephalexin 250 mg QID fluocinonide 0.15 BID.