chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 8 year old female with no known drug allergies and no pertinent medical history, who on 10-AUG-2009 was vaccinated intramuscularly in the left arm with MMR II.  There was no concomitant medication.  The registered nurse reported that on 10-AUG-2009, the patient developed a 2 cm nonerythematous "mass" with induration at the injection site after administration of MMR II.  The site of injection was also tender.  The registered nurse also reported that the patient at 6 weeks of age had a reaction to an immunization.  The nurse did not know which vaccine or what type of reaction.  At the time of the report, the patient had not recovered.  The patient was seen for an office visit.  Follow up information has been received from a physician via medical records concerning the patient who was vaccinated with MMR II in the right deltoid (previously reported as left arm).  On 12-AUG-2009, brief normal exam in skin showed induration and mass present in the left arm of 2 cm, no erythema.  On 24-AUG-2009, the patient's mother consulted the physician because on 23-AUG-2009 the patient had splinter in foot from wood chip and wanted to check site of MMR II given two weeks ago.  Dermatology examination showed in the right arm a small patch overlying deltoid mild papules, mild erythema anterior shoulder at junction of axilla.  The assessment was dermatitis, irritation of arm from seat belt and mild eczemoid reaction deltoid.  The treatment for the dermatitis was CORTAID.  Additional information has been requested.
gastrointestinal issues mainly diarrhea and flatulence; gastrointestinal issues mainly diarrhea and flatulence; This is a spontaneous report from a contactable consumer (patient) reporting on herself.  A 18-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER8734, Expiration date was unknown), via an unspecified route of administration on 03Apr2021 as 2nd dose, single dose (at the age of 18-years-old) for covid-19 immunisation. Patient had no medical history. Patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7534, Expiration date was unknown), via an unspecified route of administration on 13Mar2021 as 1st dose, single dose (at the age of 18-years-old) for covid-19 immunisation. Concomitant medications included cetirizine hydrochloride (ALLERTEC) at a dose of 5 mg, orally taken for hypersensitivity; sarecycline hydrochloride (SEYSARA) at a dose of 60 mg, orally (taking as antibiotic). Patient was also taking antibiotics, route of administration, they were just over the counter. So, the antibiotic was unrelated to this that was for the different health related issues (further clarification unknown). On unspecified date of 2021, patient experienced gastrointestinal issues mainly diarrhea and flatulence for the two months following because of the vaccine. Patient had done like Pro-biotic (TruNature Digestive Probiotic) recommended by her doctor, patient was not sure, it just said there were 10 billion TPCSE (Not clear and not further clarified) in one, she was not sure. It just said one tablet. On May-2021 (recently, last week), patient had blood test and stated that she does not had access to them right now and she do know that her doctor said that everything was negative, and she had them specifically for stomach issues. Patient had got a blood test and flu test and they both were negative, so she was seeing a gastroenterologist like tomorrow (01Jun2021). The outcome of the event was not recovered (still persisting).  Information on the lot/batch number is available; further information is expected.
The only time  the patient ever had the flu was the only year that he/she had a flu shot; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient) via Social media.  This case involved a patient with unknown demographics who ever had the flu (Influenza) was the only year that he/she had a flu shot INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication 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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported that he/she ever had the flu (Influenza) was the only year that he/she had a flu shot (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
This spontaneous report as received from a other healthcare professional via other company refers to 4 patients of unknown age and unknown gender. The patients current conditions and medical history was not reported. On an unknown date the 4 patients were vaccinated with RECOMBIVAX HB (dose, frequency and route were not reported) (lot # J013394) that had been exposed to temperatures outside of the required temperature range and the efficacy of the product outside the temperature range has not been established. Additional information has been requested.
arm really sore; I could barley even use my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles at the age of 43 years) and pain.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter also stated that, the shingles were far worse and he/she had got shingles at 43 years old and it felt like he/she was being eaten alive (no joke).  It was the most unbearable pain for like 5 solid days and the pain literally consumed the reporter. He/she could not sleep, eat, wear a shirt or even sit still and tears would just stream down the face constantly. After 5 days it was bearable but still was very painful for 2 more full weeks.  The reporter stated that, the 1st shot makes arm really sore and he/she could barley even use the arm for three days. The reporter stated that, he/she would take the shot ten times over just to keep from getting shingles ever again. The follow-up would not possible as no contact details were available.
Mild right atrial enlargement; This is a spontaneous report from a contactable other hcp (patient). A 67-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose number unknown via an unspecified route of administration in the left arm on 17Feb2021 11:00 (at the age of 67 years old) as dose number unknown, single for COVID-19 immunisation. The facility in which vaccination administered was other. Medical history included nephrectomy, transurethral bladder resection from 2020 (prior EKGs (3) in 2020 required for pre-op exams for bladder scrapping (2) and for right nephrectomy did not show any abnormal findings), contrast media allergy, iodized contrast dye allergy, Penicillin allergy, ureteric cancer, bladder cancer. Concomitant medications included amlodipine at 2.5 mg daily, diazepam dose unknown as needed for an unspecified indication. No other vaccines were given 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested COVID-19. On May2021 the patient experienced mild right atrial enlargement. The patient underwent lab tests and procedures on an unspecified date of 2020 which included electrocardiogram resulted did not show any abnormal findings. On May2021 which included electrocardiogram resulted right atrial enlargement. The events did not result in doctor office, emergency room or urgent care. No therapeutic measures were taken for the reported event. No treatment was given. The clinical outcome of the events was unknown.   Information on lot/batch number has been requested.
Information has been received from a registered nurse concerning a male patient who on unspecified dates was vaccinated with three doses of RECOMBIVAX HB (dose, route, and lot # not reported). The registered nurse stated that later the patient did not have protective titer levels. No medical intervention was needed. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Patient reports to me today that she developed increased swelling of feet and ankle the next morning after receiving first vaccine dose. She does have a history of CHF and she did not seek treatment for condition at the time.
G62.9 NEUROPATHY 5/12/2021 SYSTOLIC HEART FAILURE, ACUTE I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 6/27/2022 SYSTOLIC HEART FAILURE, ACUTE I82.409 ACUTE DVT, UNSPECIFIED VEIN 6/29/2022 SYSTOLIC HEART FAILURE, ACUTE G62.9 NEUROPATHY 5/12/2021 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 6/27/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE I82.409 ACUTE DVT, UNSPECIFIED VEIN 6/29/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE
Parents noted fever 101-102 F 5/7/04-5/9/04. On 5/10/04 am noted rash over entire body, slight urticaria and temp 99 degrees, tylenol.
Redness & slight swelling at injection site, advised pt to take BENADRYL and apply ice to injection site. Patient OK.
So painful I physically could not move my arm - it was dead weight- had to have help or lift it with left arm. Pain during night prevented any sleep 2 days out I can raise hand to the elbow up chest high but still can't raise upper part of arm. Still throbbing and very sore if touched. I am having to lift my shot arm up to the computer and move it around with my left hand just to be able to type this. Going to a Dr 7/2 if not much improved.
Boostrix administration after temperature excursion/vaccines were exposed to freezing conditions; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received DTPa (Reduced antigen) (Boostrix) (batch number J7E93, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:17-May-2022 Reporter's comments: The pharmacist reported the Boostrix maladministration as Boostrix vaccines were exposed to freezing conditions The consent to follow up was given. Additional Supportive Information: The patient received Boostrix that was exposed to freezing conditions, which led to incorrect storage of drug.
pt recv vax 26JUN97 & devel fever T102 that noc;the following morning 27JUN97 had a febrile convuls & was adm to hosp for 24hr observation then released;
Rash starting on chest - by morning 17/03, all over the body. BENADRYL prescribed afternoon 17 Mar to relieve itching.
soreness at injeciton site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: In 2019, the patient received a flu shot product name unknown and she experienced pain at injection site that resolved. The reporter did not consent to follow up. This case has been linked with case US2019104323, reported by the same reporter for same patient.
That evening had headache and muscle ache, sore arm. In the middle of the night had sore throat.  The next day had a fever over 100.5 felt really sick.  Also had SOB. Did not see doctor.
LOW GRADE TEMP OF 99-101 DEGREES F, CURRENTLY LASTING 6-7 HRS.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 17-SEP-2018, the patient was vaccinated with a properly stored but expired dose of VAQTA lot # N023954 (expiration date: 31-AUG-2018) for prophylaxis (additional dosage regimen information was not provided). No adverse event was reported.
This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving vaccine 40 days after first dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving vaccine 40 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving vaccine 40 days after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
10 minutes post vax, the pt complained of stomach hurting then a couple of minutes later the child's eyes rolled back in head and the child passed out.
Fever - lasted about 5 hours chills, fatigue, body aches - lasted about 12+ hours
Left arm (injection arm) became itchy and spread across to other arm. A few days later, the skin began to flake off. Some itching down legs but not as bad as the arms.
Very large, reddened, tender area at injection site (like the size of an angry red egg), and fever of 103.2.
she experienced nausea; This is a spontaneous report received from a non-contactable reporter consumer or other non HCP for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "she experienced nausea".  Additional information:-Verbatim and event description that Caller's Concern: Caller (Name withheld) got the 1st dose of covid-19 vaccine 14Jul2021 and she experienced nausea. Caller asking what she can take for her nausea. Caller refused to provide address and phone number. While warm transfer talking to the agent both lines disconnected. Provide PMI number and HOO. Submitted AE form.Customer and/or medical inquiry forwarded or referred to MI.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
cutting the nurse; leaving glass scraps on her fingers; leaving glass scraps on her fingers; VAXNEUVANCE PFS appear super fragile and keep shattering; syringe found broken; This spontaneous report was received from a registered nurse via company representative concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-FEB-2023,  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, lot #W021510, expiration date: 08-OCT-2023, administered as prophylaxis (strength, and route of administration were not provided); appeared super fragile and they had three different lot numbers that kept shattering (product physical issue). One pre-filled syringe was found broken in tray and it was unknown where it was broken or which lot number was affected. Additionally, it was reported that on the same date, the sixth pre-filled syringe broke (syringe issue) as one of the nurses was screwing on the needle, cutting the nurse (Skin laceration) and leaving glass scraps on her fingers (limb injury) (injury associated with device). Furthermore, it was reported that they had multiple syringes break while screwing the needles and taking them out of the box. The first one broke while taking it out of the box on 13-JAN-2023 and it was the very first one that was going to be used (Lot#: W021510). Second broke on 15-JAN-2023 while screwing on the needle, (same lot number W021510). The third one broke on 27-JAN-2023, as it was placed on the counter (Lot #: W021510). Fourth one broke on 02-FEB-2023, when a nurse screwed on the needle (Lot#: W027250). Fifth one broke on 03-FEB-2023 and it rolled onto the floor (Lot # W021510).  The outcome of the events of skin laceration, limb injury, and injury associated with device was not reported.   The causal relationship between the events of skin laceration, limb injury, and injury associated with device and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not reported.
On 5/8/03 at 4:01 pm patients mother reported patient has small red knot o LAT.  Mother states not sore to touch, not hot.  Patient doing fine  with no fever.  Applied warm compresses and massage.
Information has been received from a physician concerning a 23 year old female who on 02-MAY-2011 was vaccinated with the first dose of GARDASIL. On 04-MAY-2011 the patient experienced flu like symptoms and felt like she had been hit by a truck. The patient called the physician. Upon the time of the report, the patient was not recovered. No further information is available.
a clotting issue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COAGULOPATHY (non-serious), outcome "unknown", described as "a clotting issue".  Additioanl information: The reporter stated most elements were relatable, however he developed a clotting issue a few months after receiving (bnt162b2), and considered the event as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of currently 68 years old. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On or about 23-AUG-2016, the pt was vaccinated at a pharmacy/drug store with a dose of zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dosage schedule, route, lot number and expiration date were not provided).  On an unknown date, the pt developed shingles and as a result was treated by a physician. The outcome of shingles was unknown and the reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).
Approx. 6 days after the firs dose I experienced POTS. It woke me up. I have subsequently had 3 episodes with the most recent this morning  05/12/2021
Swollen erythematous left cheek, no temp or other symptoms, no rashes reported. NSAIDS, warm compress only treatment rendered at this time.
Dizziness for 4 days Swollen face Increased Heart Rate and Blood Pressure
COPD is a whole lot better; COPD is a whole lot better; This is a spontaneous report from a contactable consumer reporting for himself and from another consumer. An 80-year-old male patient  received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK9231), via an unspecified route of administration in left arm, on 19Jan2021 at 11:30, at single dose, for COVID-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (from 10 to 15 years), ongoing diabetes mellitus (from 10 to 15 years), ongoing cardiac disorder, ongoing bone disorder, ongoing body height decreased (due to natural aging). Concomitant medications included lisinopril (unknown manufacturer, 20 mg) from 10/15 years and ongoing for cardiac disorder, calcium, colecalciferol (CALCIUM + VITAMIN D3, 400IU/600mg) from 2020 (from 1 year) and ongoing for bone disorder and to help immunisation. The patient reported that COPD was a whole lot better on 21Jan2021 at 10:30. He had no popping in the lungs and his lungs were clear.
macular papular rash on throat  in Bilat Axilla Mac. Pac erythma on Trunk + arms See copy of office note   Patient is a 73-year-old gentleman who is an established patient with Dr. He has been in his normal state of health. He had the 1st 5 her COVID vaccine on February 24, 2017. He had the 2nd COVID vaccine on March 17, 2021.   He noticed on Monday March 22, 2021 he developed a red rash under his arms. It is now spread to all of his arms and his abdomen and back and on the upper thighs. Slightly itchy. No blistered areas. He denies change with anything else. No change in medication no change in detergent soaps, etc.. No shortness of breath.  He had no local reaction in his arm on the left deltoid where he had the COVID vaccine on the 17th of March.   He took a Zyrtec 1 tablet the other day did noticed much difference. We did discuss taking Zyrtec daily for the next
Guillian Barre Syndrome; This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included chemotherapy, nos (Chemotherapy).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced Guillian Barre Syndrome a few days after receiving the Shingrix vaccine.  The physician did not believed that the vaccine was the related to the event and planed to gave the second dose. The reporter consented for follow up.