chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose received on 3.13.2021. On 3.20.20. developed sleepiness and fatigue. Next day fever 103.1 and extreme weakness, fatigue, drowsiness and shortness of breath when going upstairs. Fever controlled with ibuprofen 800 mg. Next day (3.22.2021) same symptoms. Ibuprofen  800 mg again given . Taken to ER. Blood work and chest x ray normal. Next day fever 100.1 down with ibuprofen 400 mg.  Continues with extreme sleepiness . Wakes up only when stimulated and given water. Had bad vivid nightmare, but seems oriented.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with VARIVAX from lot # L028277 that had expired on 28-JUL-2017 (expired product administered) for prophylaxis (dose, and route unknown). The vaccine was reconstituted with a sterile water diluent (MSD) (Lot # and expiry date unknown) and it was verified to be not expired. No adverse effects were reported. Product quality complaint was not involved.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates in April 2017, the patient received two doses of M-M-R II injection (dose, site of administration, route of administration, lot # and expiration date were not reported) for prophylaxis, approximately 25 to 26 days apart. No adverse effects were reported.
Severe flu-like symptoms ( extreme fever and chills), states her heart felt like it was going to "beat out of her chest" was aware of possible side effects but did not contact overnight pharmacy or MD.
This spontaneous report was received from a medical assistant referring to a currently 19-year-old female patient. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On an unknown date (reported as when the patient was 1-year-old), the patient was vaccinated with the first dose of M-M-R II (dose detail, route, lot # and expiration date were not reported) for prophylaxis (reported as routine vaccination). On an unknown date (reported as prior to elementary school), the patient was vaccinated with the second dose of M-M-R I) (dose detail, route, lot # and expiration date were not reported) for prophylaxis (reported as routine vaccination). On an unknown date in 2018 (reported as recently), the patient had titers drawn for nursing school and the measles portion came back as negative. The outcome of event was not reported. The causality assessment between the event and the M-M-R II were also not reported.
The patient experienced no symptoms; A patient was administered a dose of PNEUMOVAX 23 after having been administered a dose of PREVENAR 13 on an unspecified date in July 2019; 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, previous drug reactions or allergies, and concomitant medications were not reported.      On 15-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular for prophylaxis (lot number S013489 had been verified to be a valid number; expiration date was reported as 14-SEP-2020 and upon internal validation established as 06-MAR-2021), after the patient had been administered a dose of pneumococcal 13v conj vaccine (crm197) (PREVENAR 13) in July 2019 (duplicate therapy error). The patient experienced no symptoms.
Severe headache and nausea lasted about 24 hours.  Injection of Toradol 60 mg given to patient.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Allergy. Concomitant products included SYNTHROID for Thyroid disorder, SINGULAIR, CLARITINE, FAMOTIDINE, and VITAMIN D3 for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA. The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-328256 (Patient Link).
swollen lymph node on his neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node on his neck) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node on his neck). At the time of the report, LYMPHADENOPATHY (swollen lymph node on his neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. No treatment information provided.
left lower leg & ankle redness, rashes with swollen, warm, itch and pain.
Dizziness, Headache, Myalgia, NauseaVomiting, Chills, Sore throat, Left arm Pain Narrative:
EAR INFECTION; This spontaneous case (PVX2019-1575) report was received from a pharmacist on 17-Jun-2019. It describes a male consumer who developed ear infection, after the administration of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif and his last dose was due on 18-Jun-2019. He developed ear infection on 16-Jun-2019.  Action taken with Vivotif was unknown.  The clinical outcome of the event was unknown.  The reporter considered the event unrelated to Vivotif.  Company's Comment: In this case, a male consumer developed ear infection, after the administration of oral Vivotif. Due to the fact that ear infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif.; Sender's Comments: Company's Comment: In this case, a male consumer developed ear infection, after the administration of oral Vivotif. Due to the fact that ear infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif.
Patient received vaccine on 4/10/22 which was after the 'beyond use' date of 4/6/22.   We are awaiting guidance from Pfizer if the patient needs to have the dose administered again.
Left arm flushed pink from shoulder to 1" proximal to elbow; moderate swelling, no streaking, afebrile.
This spontaneous report as received from a registered nurse refers to an patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-MAY-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (dose, route of administration were not provided) lot # K006960, expiration date 19-FEB-2017. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
sugar levels got high; shakiness in the body; HIves, welt at the right arm injection site, having welts on the arms, stomach, back, and shoulders; the face being flushed; feeling weak; got deftly ill; Initial information received on 01-Nov-2019 and additional information 04-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 69 years old female patient who experienced sugar levels got high (blood glucose increased), shakiness in the body (tremor), hives, welt at the right arm injection site, having welts on the arms, stomach, back, and shoulders (urticaria), the face being flushed (flushing), feeling weak (asthenia) and got deftly ill (malaise), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ221AB, expiry date-01-Apr-2020 via intramuscular route in the right arm.  On an unknown date, the patient developed a non-serious sugar levels got high (blood glucose increased), shakiness in the body (tremor), hives, welt at the right arm injection site, having welts on the arms, stomach, back, and shoulders (urticaria), the face being flushed (flushing), feeling weak (asthenia) and got deftly ill (malaise) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, relevant laboratory test results included Glycosylated haemoglobin: 6.2 [6.2].  Final diagnosis was got deftly ill, feeling weak, the face being flushed, hives, welt at the right arm injection site, having welts on the arms, stomach, back, and shoulders, shakiness in the body and sugar levels got high.  The patient received the vaccine on 22-Oct-2019; that on 23-Oct-2019 she went to the emergency room (ER) and was given intravenous steroids and sent home with steroids; that she still was experiencing the welts; that she thinks she went back to the ER on 25-Oct-2019; that she was given IV steroids and then placed on another steroid.  On an unknown date, the patient was recovered from urticarial and outcome of the all other events was unknown.
Tingling/aching through the arm, elbow, wrist, shoulder, neck, fingers. Symptoms lasted 7 days. Patient used ibuprofen, warm moist heat to site.
One day following vaccination, patient noted spreading erythema and worsening pruritus at the injection site. Examination two days following vaccination revealed 3in x 3.5in raised, reddened, warm to touch area noted to left deltoid. Patient reported some throat itching as well, denied shortness of breath, swelling of the throat, or chest tightness.
Patient called clinic this afternoon and reported to this nurse that she was having shortness of breath, excessive coughing and O2 Sat was in the "80's."  This nurse notified patient to go to nearest ER as soon as possible.  Patient reported to hospital and is currently being treated.  She reported sore throat, SOB, cough, runny nose that began Tuesday per hospital RN.
right arm with 6x6 erythematous area, +itching, not indurated, not tender, no limitations of arm movement, no fever
13 days post vaccine employee reported right shoulder pain, he states it started  a few days post vaccine. At time of reporting he was seen in the clinic no swelling or erythema  painful arm, some pain with  range of motion. No history of allergies or previous shoulder injury, new job required pushing and pulling as he is a transporter in the hospital. He was advised to use ice and Over the counter Ibuprofen as directed. He returned for a second visit 8/8/19 with continued complaints of right shoulder pain with no visible signs of swelling or erythema. No neurovascular symptoms noted.  Due to continued complaints of shoulder pain he was referred to Occupational Health for further evaluation and treatment. His diagnosis at this time is right shoulder tendonitis possible associated with the vaccine, although new job required pushing, pulling and transporting of patients
My sense of smell went crazy.  I constantly smell what seems to be a sharp chemical or rancid smell, that doesn't exist, because noone else in my home smells it.
This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age and gender. On unknown dates since 09-NOV-2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L024253 with exp. 01-JUL-2017, (dose and route were not provided). No adverse effects were reported. The temperature excursion was 13.89F, during 65 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Pfizer COVID19 Vaccine was administered; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID19 Vaccine was administered) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 Vaccine on 18-Sep-2021.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID19 Vaccine was administered). On 18-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID19 Vaccine was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Reporter information, contact details were Updated.
Narrative: Patient received her bivalent boost on 11/18/2022 and within 5 minutes  she reported that her throat was swelling, and she felt like she had a lump in her throat. Patient declined having an allergic reaction to vaccine prior to receiving  this. She was administered 25 mg IM diphenhydramine x2 doses. Patient declined  an epi-pen. Patient received the moderna monovalent booster on 6/15/22 and had  a similar reaction of a lump in her throat and feeling flushed. An allergy was not recorded at that time. Recorded allergy in patient's chart on 11/18/22.
polymyalgia rheumatica; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the vaccination (date not reported), the patient experienced polymyalgia rheumatica. On an unspecified date, the patient was treated by a physician for polymyalgia rheumatica. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event polymyalgia rheumatica was considered to be medically significant.
presumed myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (presumed myocarditis) in a 52-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (presumed myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (presumed myocarditis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (presumed myocarditis) to be related.    Concomitant information were not provided. Treatment information was not Reported.  Company comment: This case concerns a 52-year-old, male patient, with no reported medical history, who experienced the serious, expected, AESI event of myocarditis. The patient was presumed to have myocarditis 3 days after second dose of mRNA 1273 vaccine. No lab data or clinical course provided.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 52-year-old, male patient, with no reported medical history, who experienced the serious, expected, AESI event of myocarditis. The patient was presumed to have myocarditis 3 days after second dose of mRNA 1273 vaccine. No lab data or clinical course provided.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Pt recvd vax & devel pain @ the inject site which lasted about 7 to 8 mins a/resolving; pt also c/o sore & heavy arm all day;
possible first dose April 14 2022, May 9th second dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 9th May 2022, the patient received the 2nd dose of Shingrix. On 9th May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 13-JUL-2022 Reporter's comment: The pharmacist intern had reported that the patient received his first dose on 14th April 2022 and on 9th May 2022 the second dose. The Healthcare Professional (HCP) does not know if the patient was immunocompromised or not. They were evaluating to give a third dose because they were not sure about the first dose. At the moment of the call, patient had have only two Shingrix dose. The reporter consented to follow-up by email. Additional supportive information: The patient received the second dose earlier than the recommended interval, which led to shortening of vaccination schedule.
woke up felt faint; Patient woke up this morning throwing up/threw up; cold sweat; joint ache and body ache.; Patient was also very very weak and was unable to sleep well due to the join pain; Patient was also very very weak and was unable to sleep well due to the join pain; sweating profusely; joint ache and body ache.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 83-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: DIZZINESS (non-serious), outcome "unknown", described as "woke up felt faint"; VOMITING (non-serious), outcome "unknown", described as "Patient woke up this morning throwing up/threw up"; COLD SWEAT (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "joint ache and body ache."; ASTHENIA (non-serious), INSOMNIA (non-serious), outcome "unknown" and all described as "Patient was also very very weak and was unable to sleep well due to the join pain"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating profusely". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Wife of patient called stating that the patient received the Pfizer COVID Vaccine. Patient woke up this morning throwing up and sweating profusely and with joint ache and body ache. Patient had a blood pressure of 126/69mmHg. Patient was also very very weak and was unable to sleep well due to the joint pain. Reporter stated that the patient did not have reactions from the previous doses. Reporter wanted to know if these are side effects from the vaccine and how long they last. Reporter mentioned that his doctor recommended for him to get another dose of the Pfizer COVID Vaccine and asked if this was necessary. Reporter stated, "He received the new COVID Shot (Pfizer COVID-19 Shot) yesterday, that morning he woke up felt faint, he was soaken wet, he broke out in a cold sweat, he threw up. All his joints were hurting him. She was wondering if that's the side effect of the drug. They were aching, every joint in his body were aching." She was ready to take him to emergency room because he was soaken wet, he was sweating profusely."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient report that she has muscle pain on her left side all the way down to her feet... also reported that she had a fever and numbness in her leg.
was bad ("bien mala"); pain while trying to pee; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (was bad ("bien mala")) and DYSURIA (pain while trying to pee) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (was bad ("bien mala")) and DYSURIA (pain while trying to pee). At the time of the report, FEELING ABNORMAL (was bad ("bien mala")) and DYSURIA (pain while trying to pee) outcome was unknown.            Patient has lots of medical conditions which are pre-existing that affect her health, so she is used to this. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-440451 (Patient Link).
In October 2022, I started having rectal bleeding. I was finally able to get in to see a gastroenterologist in December 2022. He performed a rectal exam and diagnosed me with having proctitis. He prescribed mesalamine suppositories to use for 60 days, then come back to see. On January 6, 2023, I went to the emergency room it got worse I was still bleeding. I was given an antibiotic and something to help with the nausea. This did not help either. I went in to see my PCP on January 10, 2023, for a follow up for my foot. I went to the emergency room on January 15, 2023, CAT scan with dye came back positive for blood clots in both lungs and both legs. I was admitted to the hospital. On January 18, 2023, I had a colonoscopy that came back positive for pancolitis. I was in the hospital for ten days. I went back in February 19, 2023, two days after taking my last prednisone pill. This time my stay was only for three days. I am still not one hundred percent, I am on my way.
pt recv vax 24OCT97 & p/vax pt exp weakness, h/a, & was seeing black spots;pt went to an outpatient clinic 7 was treated w/epi & norepinephrine;sx resolved that same day 24OCT97;
Chill's started about 5:00 pm Thursday (or 4 hours after the shot) and increased over the next hours until temperature. Acke's and pain remained with temperature increasing to 102 degrees Thursday night and Friday but temperature broke by  Saturday Morning. I would describe it as typical flu-like systems.