chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One day following the vaccine, patient begun experiencing bruising all over the body. the sizes range from about 2mm to 12 mm. Patient states that the spots are itchy from the inside and feel very uncomfortable. The largest bruised area was underneath the breasts, but those ones have reduced in size as of the 2nd of October. There some bruised spots on the trunk and one on the fore head and the nose and well as a little one close to the corner of the left eye. Patient had not taken any medication to try and mitigate the situation-Suggested an antihistamine until she's able to see  her physician.  Patient has an appointment to see her primary doctor on the 3rd of October.
Information has been received from a healthcare worker concerning a female (age unk), with unk medical history and unk drug reactions/allergies, who on an unspecified date was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot651321/1036P). Subsequently, on an unspecified date, the pt experienced pain at the injection site, fever, chills and fatigue, after receiving the vaccination. The pt's status was not reported. Additional information has been requested.
Given Moderna COVID-19 vaccine to 16-year-old boy; 2 doses of Pfizer vaccine previously and this was the 1st dose of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Given Moderna COVID-19 vaccine to 16-year-old boy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 doses of Pfizer vaccine previously and this was the 1st dose of Moderna) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Got 2 doses of Pfizer vaccine previously). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Given Moderna COVID-19 vaccine to 16-year-old boy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 doses of Pfizer vaccine previously and this was the 1st dose of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Given Moderna COVID-19 vaccine to 16-year-old boy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 doses of Pfizer vaccine previously and this was the 1st dose of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  On an unknown date, a 16 year-old boy was inadvertently given Moderna dose. The patient and his parents requested for Moderna vaccine. The patient did not experience AE.   Reporter did not allow further contact
First dose a little over a year ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year ago, from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter was not sure what the recommendations were for dosing now. No additional details were provided on voicemail. The reporter consented to follow up. Due to to time difference, specialist was unable to make callback and hence, no additional information was available.
Improperly stored administered Rotateq and Vaqta; This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.     On unknown dates, the patients were vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA), lot number T014836 with expiration date 17-JUL-2021 (dose, strength, anatomical location and route of administration were not provided) and improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot number 1691141 with expiration date 01-NOV-2021 (dose, strength and anatomical location were not provided); both administered for prophylaxis.  The temperature and timeframes were: below 36ºF (33.8F) for 0 hours 28 minutes and 0 seconds, below 36ºF (33.8F) for 7 hours 9 minutes and 0 seconds,  below 36ºF (33.4F) for 23 hours 59 minutes and 0 seconds and below 36ºF (33.8F) for 24 hours 0 minutes and 0 seconds.  All excursions were detected through data logger and was confirmed that were previous temperature excursions. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014836; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
atrial fibrillation, emergency room visit, overnight hospital stay.  Condition normalized and has not returned.  I have no history of AF, other heart conditions or other health issues.  I am a runner and exercise regularly.  I have returned to my normal routines.
no adverse event; temperature excursion; This spontaneous report was received from an office manager referring to a 12-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 17-OCT-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis by a physician at private doctor's office/hospital (lot# 1775811 (expiration date: 07-DEC-2023), 1775827 (expiration date: 27-JUN-2024), U032681 (expiration date: 26-OCT-2023), 1780876 (expiration date: 09-NOV-2023), or W009829 (expiration date: 19-OCT-2024); strength, dose, and route of administration were not provided). Temperature excursion occurred as a result of a reading from a digital data logger, on 09-SEP-2022 for 8 mins and on 16-SEP-2022 for 5 mins. Excursions were not noted until after the fact due to employee error of cleaning data logger more than once a day (product storage error). The patient had not adverse event.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Information has been received from a licensed practical nurse concerning an approximately 16 week old ("4 month old") male patient who received his first, second and third doses of ROTATEQ (lot # 669830/0078AA, EXP 31-OCT-2012) on 06-JUN-2011, 23-AUG-2011 and 31-AUG-2011, respectively. No adverse symptoms reported. It was unknown if the patient sought medical attention. Additional information has been requested.
pt recvd vax & & exp lt ear pain, fever & swollen lt lymph gland; upon visit to MD pt was found to have an ear infect;
pt recv vax; tested & failed to show IgG antibodies; 3rd dose administered, at time of report, had not yet been retested for antibodies;
Patient said that her arm was black and blue. Also red and swollen. Said that swelling is going down, but it hurts when she touches her arm.
injection site swollen, red, hot to touch, approx size of silver dollar, no knot per rn
Patient arrived at Center, where public health clinic hosts the COVID-19 Vaccination POD on 2/3/21 at approximately 4:20pm. Patient received her 1st dose of COVID-19 vaccine-Pfizer Lot #EM9810. Patient reported having myasthenia gravis and having a history of allergies and carrying an EpiPen. Patient was advised by medic administering vaccine and RN administering questionnaire to wait for 30 mins in parking lot near medic vehicle and to honk her horn if she felt any sort of reaction.   While waiting in her car, patient began to have trouble breathing and honked her horn. Medics identified her vehicle. Patient reported having trouble breathing, chest pain, tongue swelling, and a scratchy throat. Medics administered Epinephrine and Benadryl to patient and transported patient to  Medical Center.
Per the doctor's office, patient reported hearing loss in both ears the same day as he received the vaccination. The doctor reported severe sensorineural hearing loss in both right and left ears.
Intussception; reduced radiologicaly.  12/28/07 Reviewed hospital medical records which reveal patient experienced bloody stool, reduced oral intake & vomiting.  Admitted 12/25-12/26/2007.   FINAL DX: Ileocecal intussusception, enema reduced. 1/22/08 Reviewed vax record which confirms RO dose & lot as reported.
She is feeling like she is anorexic; when she eats something, she becomes ill and feels sick; any food she is eating is not sitting well; worried about developing an eating disorder from the vaccine; she just started throwing; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (She is feeling like she is anorexic), ILLNESS (when she eats something, she becomes ill and feels sick), DYSPEPSIA (any food she is eating is not sitting well), EATING DISORDER (worried about developing an eating disorder from the vaccine) and VOMITING (she just started throwing) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced DECREASED APPETITE (She is feeling like she is anorexic), ILLNESS (when she eats something, she becomes ill and feels sick), DYSPEPSIA (any food she is eating is not sitting well), EATING DISORDER (worried about developing an eating disorder from the vaccine) and VOMITING (she just started throwing). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (She is feeling like she is anorexic), ILLNESS (when she eats something, she becomes ill and feels sick), DYSPEPSIA (any food she is eating is not sitting well), EATING DISORDER (worried about developing an eating disorder from the vaccine) and VOMITING (she just started throwing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-137946 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up received contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-137946:Male patient
Severe chest pain on left side, relieved when leaning forward, diagnosed with pericarditis, unspecified chronicity, unspecified type.  Relieved with Toradol and Colchicine. Currently on 90 day treatment of Colchicine, 1 tablet per day.
Vaccines administered to patient sitting on the exam table. Almost immediately after completing the immunizations, patient lost consciousness and became incontinent (per patient- needed to urinate prior to vaccination). Patient was lowered to a supine position and regained consciousness within approximately 20 seconds. Was given apple juice which patient drank approximately 1/2 of prior to losing consciousness a second time. Patient was placed in a recovery position on his side and vitals obtained. BP was 100/56. The physician listed to heart and lung sounds while another nurse obtained an ammonia inhalant. Once inhalant was used patient regained consciousness immediately. The second syncopal episode lasted approximately 1 minute. Patient was monitored for another 30 mins post recovery until stable and able to ambulate on his own with BP stable at 110/58.
Red, itchy , hot upper arm on day 7  Red rash on chest day 13
administered with an expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A.) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.  Consent for follow up obtained. Preferred method of contact: email.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received on 28-oct-2021 contains no new information.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 22nd October 2018, the patient received the 2nd dose of SHINGRIX. On 22nd October 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The batch number and expiry date was not obtained from patient. The patient received SHINGRIX on left arm. The patient reported that after receiving SHINGRIX, the patient at the time of reporting had a deep aching pain in her arm.
Pt. came in to show us her arm which appeared red and tender to the touch. Pt. stated it was very swollen the previous day. We followed up 9/12/14 pt was much better.
Left deltoid with cellulitis, induratin at site of immunization. Given Td booster and Hep A #1 injection.
Pt recvd 3 doses of engerix-B vax 23JAN91 & on 20FEB92 & 10JUL91 & 22OCT01 pos HBSAB was 1.2 RU which is interpreted as neg (no immunity);
PM on Friday 28MAy93 devel fever which ranged from 101-104 through Sunday 30MAy; pt c/o stiff neck & sore throat also; devel a rash on legs; pt not seen by MD;
HPV vaccine was received in April and June, and she was seen in our office on June 16th for frequent urination. Tests performed in the office indicate new onset Type 1 Diabetes.
Information has been received from a health professional concerning a 23 year old female who on 09-MAR-2007 at 1:00 PM was vaccinated with a first dose of Gardasil (Lot # 656049/0187U). There was no concomitant medication. On 10-MAR-2007 at 7:00 PM the patient developed body aches, fever, chills, nausea and vomiting. It was reported the patient could not work. There was no rash or diarrhea. Unspecified medical attention was sought. There were no laboratory or diagnostic testing performed. On 13-MAR-2007, the patient recovered. Additional information has been requested.
Itch at site; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3247) via an unspecified route of administration in the right arm on 20Jan2021 10:45 AM at a single dose as COVID-19 vaccine. Medical history included allergies to maybe penicillin. Concomitant medications (received within 2 weeks of vaccination) included trazodone, fluticasone propionate (FLONASE), and cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced itch at site on 22Jan2021 12:00 PM. Treatment was not received for the event. The event was non-serious in which did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. She has not been tested for COVID-19 since the vaccination. The outcome of the event was not recovered.
4OCT95 pt recvd vax & came into clinic w/ c/o redness below site, no swelling, no c/o pain, no fever according to RN
pt recv vax & devel localized rxn @ inj site, which was red & warm to touch; vax as wheal, not sc; No further details were provided;
Full body muscle spasms, nausea, vomiting, back pain, migraine, fever.
Narrative:  Pt reported to PCP MD had bad reaction of nausea and vomiting to influenza vaccine 40 years ago. Md flagged pt's chart with ADR to influenza vaccine. No info available to report as this is a historical report.
pt c/o nausea, vomiting, diarrhea & cramping w/severe back pain p/1st inj lasting between 3-4 days;
Transient (2 days) ataxia 15 days p/recvd MMR;
I was tested with Covid; I was tested positive; I was tested with Covid; I was tested positive; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Feb2021 as single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. It was reported that the patient was tested with COVID and that it tested positive on 23Mar2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 23Mar2021. Outcome of events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
flu; Initial information was received on 16-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-healthcare professional.  This case is linked to cases 2021SA345659 and 2021SA349459(CLUSTER).  This case involves Adult female patient who experienced flu (influenza) while received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  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 developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "My ex wife got the flu shot twice in her life. Both times she got the flu. My co worker got the flu shot twice. Both times she got the flu. My daughter got the flu shot, and she got the flu. I Haven't had a vaccine in over 50 years, not going to start taking one now. Haven't had the flu in over 20 years until a vaccinated family member gave it to me."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Client stated had fever diarrhea, elevated BP and went to her doctor and was told had hyponatremia. Her and her doctor concurred it must have been caused by the flu shot. she is being followed by her private doctor.
Burning, itching, swelling and mild rash up and down arm  Disoriented  Pulsing cramps  Very uncomfortable feeling Sore throat /Dry throat  Gitters
My heart rate is racing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (My heart rate is racing) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (My heart rate is racing). At the time of the report, HEART RATE INCREASED (My heart rate is racing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant treatment medications were reported.   Reporter did not allow further contact
His eyelids have been swollen, and are showing swelling on both upper and lower lids of both eyes.; had a fever of 101-102; was not able to sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 10-year-old male patient received BNT162b2 (BNT162B2), on 05Jul2022 at 18:00 as dose 3 (booster), single (Lot number: FL8096) at the age of 10 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Lot number: FK5127), administration date: 20Nov2021, when the patient was 9-year-old, for Covid-19 immunization; BNT162b2 (Dose: 2, Lot number: FK5127), administration date: 01Dec2021, when the patient was 9-year-old, for Covid-19 immunization, reaction(s): "First dose given on 20Nov2021, FK5127/Second dose given on 01Dec2021, FK5127". The following information was reported: SWELLING OF EYELID (non-serious) with onset 06Jul2022, outcome "recovering", described as "His eyelids have been swollen, and are showing swelling on both upper and lower lids of both eyes."; PYREXIA (non-serious) with onset 06Jul2022, outcome "recovered" (07Jul2022), described as "had a fever of 101-102"; INSOMNIA (non-serious) with onset 06Jul2022, outcome "recovered" (Jul2022), described as "was not able to sleep". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: A couple doses of Tylenol and one dose of Motrin was given for fever. The fevers are gone. Reporter informed that the patient's swelling started on night of 06Jul2022. He also had a fever of 101-102. He was trying to sleep around 9-10pm but not able to sleep. He went to the kitchen when the reporter noticed he was swollen in the face all around his eye. It started in one eye, and then the second eye started to swell. He was able to sleep. Next morning, the swelling was not completely gone, but it has improved. Patient took no other vaccinations prior (within 4 weeks) of Covid-19 vaccine. Follow-up attempts are completed. No further information is expected.