chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lymph nodes enlarged; This spontaneous report was received from a physician via company representative, referring to a 13 year old male patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 13-JUN-2020, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot# R030453 has been verified to be a valid lot number (expiration date not reported, but upon internal validation established as 23-JUL-2021), for prophylaxis (strength, dose, route and frequency date were not reported).  On 19-JUN-2020, the patient came back into the office with a complaint of enlarged lymph nodes (lymphadenopathy). The patient sought medical attention; however, it was unknown if received any treatment or if diagnostic laboratories were performed.  On 19-SEP-2020, the patient was seen again, and the report indicates that 2 nodes resolved and 1 node still palpable, but any medical issue had resolved.  At the time of reporting, the outcome of lymphadenopathy was reported as resolving. Additionally, the causality assessment between lymphadenopathy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was reported as not related. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R030453; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received its 30-days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022 at 4:15 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 4:15 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. ethnicity: (Privacy). No concomitant medications were reported. Vaccine administration time was reported as 16:15:46. No treatment medications were reported.
Patient says has had arm pain ever since she received the vaccine. Believes it was given too high in her arm
pt recv vax & 25SEP97 seen w/local erythema, induration 4x6cm resolving in 3 days;
Information has been received from a physician concerning a female who was vaccinated with her first and only dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. The following day, the patient developed pimples on her face. The vaccine was given at another physician's office. The patient sought unspecified medical attention. Additional information has been requested.
The main symptoms was nausea and vomiting. I also exp swollen lymph node (left arm). I had a Xray for the swelling will have a repeat in 3 months to see if the lymph node has went down in size.
Patient received first COVID-19 dose on Jan 14th, 2021 and then developed chest pain and diarrhea 1 day later. On Jan 17th, she presented to hospital and was found to have an non-ST elevated MI and apical ballooning syndrome.
Pt recv vax on 1/6/99; less than 1 min post vax pt exp erythema, swelling, hypothermia distal to vax site on lt leg & vax site on rt leg, high pitched crying x 15 min; legs then had petechia & purpura
Case completed primary Covid series and booster by December 2021, then was hospitalized for Covid in January 2022 Hospitalized. Weakness: Assessment & Plan. Non Focal.  Head CT and brain MRI negative.  Related to COVID and improved.  Now independent and steady on her feet.
After the vaccine, I had felt fuzzy and confused on the next days. This is when the headaches started, the day after the vaccine. I did feel woozy as well. It was a dull headache that was on the 21st and it lasted through to the 27th of April. At 12:45PM on April 27th I was sitting at my desk, and I felt like I had just woken up and I was staring at my desk. It was as if I had a blackout. I heard myself having issues talking. I had to ask my client 3 times for her DOB and could not understand what she was telling me. I ate something and was able to recover my language however my headache did not go away, and I felt dazed and confused. I do have migraine medication, and I took Acetaminophen for my headache. By Friday morning, I realized that I needed to go the ER to get checked out for a possible stroke or TIA. My headaches were persisting, I did receive a CT scan and bloodwork. I was diagnosed with a migraine as the cause and stated that I had confusion as well. The doctor also linked the diagnosis with the booster as well. The headache did not go away, and it continued until this last Tuesday, 05/3/2022. I am in contact with my primary care and will be seeing them on May 10th.
Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient experienced dizziness and sought unspecified medical attention. No further information was provided. Additional information has been requested.
pain at the injection site; edema at the injection site; fever; fatigue; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ibuprofen and paracetamol (Tylenol).   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site), injection site edema (Verbatim: edema at the injection site), fever (Verbatim: fever) and fatigue (Verbatim: fatigue).  The outcome of the injection site pain, injection site edema, fever and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, injection site edema, fever and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site edema, fever and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2023 The patient was in her 60's. The patient had a Shingrix vaccine and 8 days later came back to the pharmacy / clinic.  The patient complaint of pain and edema at the injection site.  Patient also complaint of fever and fatigue.   Field Representative did not have information on when the symptoms started or if they were resolved. The reporter consented to follow up via email. No further information available.
After inoculation patient felt lightheaded. I seated him on a chair. In 2-3 minutes he said he was feeling fine. After about 7-8 minutes of original lightheadedness patient fainted onto the floor. His face lost color. He was this way for 2-3 minutes while we straightened him and called 911. Then he abruptly sat up, was coherent but sweating. Gave him water. He drank approx. 1 pint. Waited till his BP was 120/74 (approximately 45 minutes). He left feeling fine. Called him twice for follow up. No response.
diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. She described that after she received her Shingrix vaccine.Within a week,she experienced diarrhea.She had not reported other symptoms. The limited information provided. She did not consent to follow-up.
Headaches/Migraines, Fatigue/Tired, Extended Pain at Shot Site (Left Deltoid), Shot Site (area around Left Deltoid) red, hot and swollen...also itching, Pain in armpit and tricep radiating down the under side of the shot arm.  I have been using muscle cream and Advil and ensuring hydrated.
Swelling left neck the day after vaccine with erythema in neck.  Two days later developed rash that increased.  Seen in my facility, noting lymph nodes left neck.  No fever, SOB, chest pain, no angioedema to face. No dizziness.  VSS.   Pt given vaccine in MD office.  Seen in my facility.
Received vaccine after temperature excursion; A spontaneous report (United States) was received from a consumer concerning a 56-year-old, of an unknown gender, who received Moderna's COVID-19 vaccine (mRNA-1273) after temperature excursion.   The patient's medical history, as provided by the reporter, was unknown. Concomitant medications reported was unknown.  On 18 Mar, the patient received the mRNA-1273 (Lot number: Unknown) via unknown route of administration in an unknown location for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the events was not reported.  No treatment information was provided.  The outcome of the event, received vaccine after temperature excursion was considered as resolved.; Reporter's Comments: This report refers to a case of product storage error for mNA-1273, lot # unknown with no associated AEs.
Second dose not applied after 36 days /first dose was applied in April.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not applied after 36 days /first dose was applied in April.) 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not applied after 36 days /first dose was applied in April.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not applied after 36 days /first dose was applied in April.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided.
First time, Swollen lymph nodes under the arm. Left first time and body aches , fever for 2 days first time.  Second time , RT arm swollen to the point I couldn?t put my arm down fully. 106 temp the next morning , Felt like dying. Body hurt all over. Slept 8 hours that day woke up and I was at 99.  Started having blot clots.  Found out it was Pulmonary Blood Clots.
Had 3 vaccines for shingles, had shingles 3 times/Suspected vaccination failure; Shingles 3 times; Excruciatingly painful condition; had 3 shingles vaccines; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, pain and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received three doses of Shingles vaccine. The patient stated that in last year he/she experienced shingles three times. The condition was excruciatingly painful. The patient reported that he/she was told that if he/she did not had the vaccines he/she would had it far worse. The patient can not even imagine worse than his/her shingles experience thus far. The patient stated it may never come back again. The patient reported that get the vaccine and do favor on yourself. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received extra dose of Shingles in error, which led to extra dose administered. Follow-up would not possible as no contact details were available.
her arm started to hurt and swell up; her arm started to hurt and swell up/ it looks like a bum wound that extends all the way to her elbow; accidently received the vaccine again; the injection site was swollen and red with bumps; redness with her arm; the injection site was swollen and red with bumps; the injection site was swollen and red with bumps; This spontaneous report was received from a pharmacist and a 63 years old female patient referring to the patient herself.  Concomitant therapies included blood pressure medication, lifitegrast (XIIDRA) and covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE). The patient had seasonal allergies. Information about medical history was not provided.   On an unknown date in September 2020 (also reported as about a year ago), the patient was initially vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (anatomical location: right arm, route reported as injection; strength, dose, lot# and expiration date were not reported) for prophylaxis, with no adverse effects to report. On 05-OCT-2021, the patient was accidently vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, anatomical location: right arm, route reported as injection, lot # U010533, expiration date 29-OCT-2022; strength and frequency were not reported) for prophylaxis again despite not needing the revaccination (incorrect dose administered), a few hours after she received the second dose that her arm started to hurt and swell up. The patient mentioned that over the next few days she was having lots of pain, swelling, and redness with her arm. She mentioned that it was swollen by an inch thick, almost goes 3 quarters around the circumference of her arm, and had a distinct line around it. She mentioned it looked like a bum wound that extended all the way to her elbow. The patient did not seek medical attention but received paracetamol (TYLENOL) and paracetamol (ADVIL) as treatment. The outcome of all events except the event of incorrect dose administered  was not resolved.  The causality between all events except the event of incorrect dose administered and  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
This spontaneous report as received from a licensed practitional nurse refers to one unspecified patient of unknown age and gender. The nurse reported that on 30-JUN-2014 the patient was vaccinated with improperly stored ZOSTAVAX (route and dose were not provided) lot # J014811, expiration date: 21-FEB-2015. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: blood clots in stool-currently under care of primary care physician for clot formation investigation-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium, Additional Details: patient reported blood clots in stool on 4/11/21 and 4/12/21.  Patient was flushed, dizzy and faint after clot was found.  Patient has no significant history of hemorriods or colorectal conditions.
Patient experienced an itchy arm. The patient did not have any signs of redness, swelling or trouble breathing. The patient stayed in the store to keep monitor. Counseled patient on true signs and symptoms of allergic reaction for when she goes home.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 56 year-old male patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (Lot number: FC3184) at the age of 56 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (First dose received on 05Aug2021 in the left arm, Lot#FA7485, NDC/Expiry not known), administration date: 05Aug2021, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 26Aug2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 26Aug2021, outcome "unknown", described as "he took his temperature and he learned he had a fever of 38° C"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a registered nurse referring to a patient of unknown age and fender. On 12-MAY-2014, the patient received the first dose of GARDASIL (0.5ml, once, intramuscular, lot # and expiration date were unknown) and then received the second dose of GARDASIL 9 (lot # K026246, expiration date:28-JAN-2017, intramuscular, 0.5ml, once) on 20-MAY-2015. No adverse effect was reported. Additional information has been requested.
Headache, Myalgia, Fever, INJECTION SITE PAIN, STIFFNESS, PAINFUL LN B/L, JOINT PAIN TEMP 99.3 Narrative: 12/25-mile injection site pain 12/26-increased injection site pain, stiffness, painful lymph nodes on both sides, headache, body aches, joint pain and 99.3 temp. Completely resolved by 12/27
I had inflammation in my right eye. Postery utris was active again and I had to take medication to heal my ear. This was important because if not treated it can cause blindness. This lasted for 3 days and the medication stopped the inflammation. This also happened with my 3rd and 4th dose and they were Pfizer vaccines as well.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 41-year-old female 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, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            No concomitant medications reported. No treatment reported.   This case was linked to MOD-2021-417058 (Patient Link).
Headache, Myalgia, Fever, NauseaVomiting,  CHILLS Narrative:
Case number PHEH2016US031991, is an initial spontaneous report received from a pharmacist on 05 Dec 2016. This report refers to a 55 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated FLUVIRIN (batch number: not reported) on 11 Nov 2016. On the same day while vaccination, the vaccine squirted on the husband of patient sitting beside her and ran down her arm. The pharmacist concerned that she did not receive enough vaccine to protect herself from the influenza. No adverse event was reported following this administration error. Follow up report received from a consumer on 15 Dec 2016: updated patient demographics (initials and age), suspect drug coding (changed from influenza vaccine to FLUVIRIN vaccine) and vaccination date.
Information has been received through the pregnancy registry from a nurse practitioner concerning a 15 year old female with no known drug allergies, and with depression who on 8/31/06 at 3:00pm was vaccinated IM in the right deltoid with the first dose of GARDASIL (lot 653937/0637F). Illnesses at the time of vaccination included flu symptoms and a breast lump. Concomitant therapy included Zoloft. Other vaccinations given on 9/6/06 included Tdap. On 9/6/06 the pt was seen at her physician with a complaint of continued viral illness. It was reported that the pt was aware that she was pregnant but did not disclose this information to her health care provider until after vaccination. A urine pregnancy test was performed and found to be positive. The pt was advised no to receive the second dose of HPV. At the time of this report, the outcome of the viral illness and vaccine exposure during pregnancy was not known. Follow-up information has been received from the patient's OB-GYN. A nurse reported that the patient was last seen at 28 weeks gestation on 12-JAN-2007. At that time, she was transfered to the department of maternal-fetal medicine at a local hospital. A nurse at the maternal-fetal medicine department reported that the patient delivered via vaginal delivery a "healthy baby boy but had gastroschisis". The baby was born on 07-APR-2007 and APGAR scores were 8 and 9 at one and five minutes, respectively. The nurse was unable to provide the infant's birhtweight and indicated that infants born with this congenital anomaly are generally hospitalized for 12 weks. The nurse could not confirm when and if thin infant had been discharged from the hospital. Additional information has been requested.
A large, red, itchy bump showed up on my arm. It looks like a giant hive like when I break out in hives sometimes. I don't know exactly when it showed up but it's become really itchy and my arm feels tight when i lift my arm in certain ways.
Fever to 103, tachycardia, flushing of face within 1 hour of vaccine administration.  No hives, wheezing, angioedema, vomiting, or hypotension.  Treated with benadryl, tylenol, ibuprofen.  No progression of symptoms. 08/12/2009 After I filed the report the child had a febrile seizure and was seen in the emergency department. On follow-up this morning he has oral ulcerations consistent with herpangina on exam.