chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sunday Day 3 - Complain of severe pain - 1:00 pm shoulder to elbow bright red, hot to touch, very hard + swollen. 4:30p worse- now eyes are red - very frigitty. Called then patients doctor 10:30pm was told to give him Benadryl every 4 hours and Zyrtec  every 4 hours if any worse take to ER. Had clusters of red rash all over his back. Day 4 - 6:30am bright red slightly less - continued with Benadryl and Zyrtec stayed same. Day 5 - Redness fading - swelling not eyes still Red and dry. Day 6 - severe itching arm and eyes, leg pains, runny nose. Day 7 - just starting to sleep all night again. Shoulder has red streaks - nut hardness and hot to touch starting to lessen and yes still itch - but not red. Day 8 and Day 9 Benadryl and Zyrtec stopped to see if reaction would come back or still subside. Day 10 - much better layed around most of weekend.
Information has been received from a health professional concerning a one year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 04-Apr-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from the same source. Additional information is expected.
Reoccurrence of Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Reoccurrence of Covid) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteopetrosis and Allergy (Allergy to unspecified drug).    On 21-Apr-2022 at 2:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022 at 6:00 AM, the patient experienced COVID-19 (Reoccurrence of Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 at an unspecified dose and frequency. At the time of the report, COVID-19 (Reoccurrence of Covid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient not had any other medications/products within 2 weeks of starting COVID-19 treatment. Device date was reported as 20-May-2022 Treatment received reported as no.  Company Comment: This is a spontaneous case concerning a 73-year-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the fourth dose of mRNA-1273 Vaccine and 7 days after the treatment with non-company product Nirmatrelvir, Ritonavir (Paxlovid). As reported, there was COVID recurrence after treatment with Paxlovid, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 73-year-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the fourth dose of mRNA-1273 Vaccine and 7 days after the treatment with non-company product Nirmatrelvir, Ritonavir (Paxlovid). As reported, there was COVID recurrence after treatment with Paxlovid, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
injection site was red and swollen, and  painful. She had oral temp of 103degrees, her HR was 128.
Superficial Thrombophlebitis: Complete thrombosis of all four superficial basilic veins.
Febrile seizure, Fever to 40C, GTC sz for less than 5 min.
One hive just below the site of injection approximately 2" x 2", red, slightly swollen and tender.
14 year old, accompanied by parents, got his first Pfizer vaccine.  After 15 minute observation, the parents and child left the site.  The parents returned within minutes from leaving and requested the child be checked out by EMS.  The child was feeling numbness in the let arm, face, and neck.  EMS responded and his vital were normal, but parents insisted EMS transport him to the hospital.
Patient was given a expired covid shot due to storage procedure. She received her 2nd dose. She is not experiencing any adverse reaction but it was an error on our part. We have called both cdc and Pfizer and they said we can revaccinate. Patient is coming  back to get revaccinated.
Patient reported for 2nd vaccination of the Moderna vaccine. He did not present a card but was scheduled for vaccination. He reported having had the first vaccine on Dec. 28 2020. This was verified after receiving second dose and having left the site. However, the first vaccination was given on Jan 5, 2021 and not Dec. 28 2020 as reported by the patient.
p/vax pt had possible intussusception; seen at medical center; KUB was possibly pos; BE neg; had painful crying
flu shot while in the hospital with pneumonia. It made it worse.i almost died; This case was reported by a consumer via interactive digital media and described the occurrence of pneumonia aggravated in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included pneumonia.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pneumonia aggravated (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the pneumonia aggravated was unknown.   It was unknown if the reporter considered the pneumonia aggravated to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient was given the flu shot while in the hospital with pneumonia. It made it worse and the patient almost died. The patient would not get another one and had not been sick. The reporter consented to follow up.
31DEC98 mom stated temp elevated to 102 @ 8 or 9PM;pt gave APAP temp dec on 1JAN99 temp up to 102.0;2JAN99 between MN & 12:30 temp up to 103;BP 95/51;T102, P131;R26;mom reported pt also exp dec appetite & diminished activity;sneeze & cough
PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO CHEST PAINS. UPON EXAMINATION, PATIENT HAD SEVERAL BLOOD CLOTS IN BOTH LUNGS. PATIENT WAS TREATED AND RELEASE AND TOLD TO REPORT ADVERSE REATION TO THE PHARMACY. THE PATIENT STATED THAT THE BLOOD CLOTS OCCURRED 8 DAYS AFTER RECEIVING MODERNA BOOSTER.
2nd vaccine 02/10/2021.  Went to location late July/early August and wasn't feeling well. DIagnosed with pneumonia around 08/02/2021 and tested negative for COVID. Was about  to undergo a lung procedure and as part of pre-op, was re-tested for COVID and found to be (+) on 08/09/2021. Admitted on 08/9/2021 and still admitted as of 9/18/2021. NO ICU Stay.
Redness, swollen at site, hot, itchy, painful to touch. Took 2 Benadryl and ibuprofen.
I noticed a couple of months after I had received the vaccine, I had discomfort in my armpit and down my arm intermittently. I called my doctor and discussed what was going on, that that the discomfort goes from one arm to the next. We are not sure if it is muscular, lymph gland related I am scheduled to have a mammogram.
Pt presented today w/ scab on area where shot was given. Shot was given 2/19/15. Did not look infected, no redness, no swelling, no pus. Scab was approx size of pencil eraser. Would have expected complete healing by now. Told pt to have primary MD look at it.
Rash entire upper arm below injection site.  Arm swollen and painful.  Rash after first vacine 9 days after injection.  Rash more pronounced after second shot and arm swollen.  I was advised to get 2nd shot in spite of 1st rash.  I think should not have.
Blood in the urine - hematuria - I saw the Urologist 3/30/21 -  Had to determine what caused it; was put on Kephlex for a possible UTI initially. I passed a kidney stone as pain in the area was relieved. It appeared that it was caused by a kidney stone.
possible allergic reaction to Pneumovax 23. The patient complained of chest pain. The patient is Asthmatic and used 3 pumps of albuterol HFA. The EMS told me to give 1 tablet of Aspirin 81 mg chewable EMS told me Not to use Epipen
sick; Rough shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, rough shots and made him/her sick, refer case US2021AMR191925).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and injection site pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness and injection site pain were unknown.   It was unknown if the reporter considered the sickness and injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient got Shingles shot and they were rough shots and made him/her sick, but the patient would put up with the shots to not to get shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR191925:same reporter
Patient presented to the ED with chest pain on 1/15/22.  Patient found to be COVID + but denies SOB, palpitations, lightheadedness, dizziness, fever or chills.  Had upper respiratory symptoms several days before coming to hospital.  Chest x-ray without obvious pneumonia, patient did not experience any respiratory distress.  Discharged 1/20/22.    Pfizer vaccine 2/17/21,  3/11/21, & 10/26/21.
12 hours after receiving vaccination, became "delirious" temp rose to 103.+ with chills malaise, joint pain,  "head hurt worse than did during active Covid + HA lasted 2 days".    Temp gradually decreased to 100 over 2 days.   Injection site had "fever" for 3 days still sore 5 days later  PCP ordered prednisone and z-pak for symptoms
9/13/07 5:40 PM Patient returned to office a few hours after receiving Menactra. SOB, cough, chest pains. Vaccine was given 11:00 AM. Office visit 5:40 PM. Was given albuterol neb, seemed to improve then given Rx for nebs and prednisone. F/U 9/19/07 Ok, improved.
No patients experienced symptoms; unspecified patients may have been administered improperly stored doses of PEDVAX HIB, GARDASIL 9, RECOMBIVAX HB and ROTATEQ; This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On unknown dates, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # R036178 with expiration date on 09-OCT-2021, and lot # R027329 with expiration date on 12-JUL-2021; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # S026372 and expiration date on 01-APR-2022, and lot # R029507 with expiration date on 10-JUL-2021; Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot # R031056 with expiration date on 04-JUN-2021, and lot # R031055 with expiration date on 04-JUN-2021; and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1660685 with expiration date on 21-MAR-2021, and lot # S005875 with expiration date on 30-NOV-2020, (strength, dosing details were not reported) via unknown route, all vaccines for prophylaxis.  It was reported that the vaccines were exposed to a temperature of 47.6-degree Fahrenheit for 41 minutes and 31.9-degree Fahrenheit for 6 hours and 58 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No symptoms were reported.  This is a non-valid case due to the lack of patient's identifiers.  Follow-up information was received on 03-MAR-2020 from a nurse supervisor.  The nurse referred to a 4-weeks-old male patient (previously considered non-valid).  On 17-JAN-2020, the patient was vaccinated with improperly stored Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength not reported) lot # R031056 with expiration date on 04-JUN-2021 for prophylaxis (product storage error).  The reporter confirmed that there had been no reports of adverse event following the administration of the vaccinations. She also reported that no patients received the Merck vaccination Hemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB). Additional information has been requested.  This is one of the several reports by the same reporter.; Sender's Comments:  US-009507513-2003USA001374: US-009507513-2003USA001375: US-009507513-2003USA001379: US-009507513-2001USA006732: US-009507513-2003USA001377: US-009507513-2003USA001378:
Mild rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HX44, expiry date 15th November 2021) for prophylaxis.   On 6th September 2019, the patient received the 1st dose of Shingrix. In September 2019, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows:  Three days post vaccination the patient developed a mild rash in a site different than the injection site. The reporter did not consent to follow up.
Tdap given 5-4-07; onset 5-5-07 a.m. of armpit pain left side, on 5-6-07 noted pain continued in left armpit but spread across left breast, no swelling, hardness, redness noted. Today still sore across left upper breast and armpit.
I received the vaccine then had pain the next day which went away. one week later after the first dose I noticed redness increasing up towards my neck and swelling (no pain) - and then found a small lump on the left side of my neck (same side I got the vaccine on) - in February I had a episode of a bad headache and couldn't see (mimicking a TIA) so I went to my doctor. They ordered a MRI and found a Parotid gland lesion on the left side (same side as the lump on my neck and where I got the shot) I had a follow up ultrasound saying it was benign in May
Itchy red bumps on ankles, knees, fingers (mosty ankles). Look like measles or mosquito bites. They itch like mosquito bites.  One or 2 showed up on day 8, by Day 10 many were on my ankles.
Narrative:  Patient is a 74 y.o M, with significant history of CAD, admitted with concerns for weakness in setting of COVID positivity, also with volume depletion associated acute renal failure. HOSPITAL COURSE: Initially received in MICU, stable on presentation, and downgraded to Covid Ward. Has done well, no cardiopulmonary difficulties, with acute concerns resolved. Discharged to home on 8/22/2021.
Patient was given 0.25mL Moderna booster vaccine (NDC: 80777-0275-05), which at the time was not approved for <18 yo.
doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 47-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant products were not provided. Temperature excursion occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Patient did not report any adverse reaction. Treatment medication were not reported.
Rash on both hips for 4 weeks and spreading.  Fatigue and unwell feeling  during that time as well.  Bloodwork was normal.  Steroid cream was prescribed, but hasn?t worked to resolve the rash.  The rash appears viral in nature.  I?m thinking the vaccine  may be the cause?  I got shingles almost a month after receiving the first shot.  Wondering if they  are connected somehow and if others have experienced this as well?
On day 10 after first shot I developed a red rash; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8732) via an unspecified route of administration in the right arm on 01Apr2021 at 13:15 (at the age of 63-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0171) via an unspecified route of administration in the  right arm on 22Apr2021 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and adhesive tape allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN), alprazolam (MANUFACTURER UNKNOWN) and famotidine (PEPCID) all for unknown indications on unknown dates and unknown if ongoing. On 11Apr2021 at 14:00, on day 10 after first shot, the patient developed a red rash. The adverse events did not result in doctor or other health care professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of red rash and included treatment with BENADRYL. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event red rash was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
malaise; Sore arm; fever; chills; exhaustion; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills) and FATIGUE (exhaustion) in a 42-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031419) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 25-Oct-2023, the patient experienced MALAISE (malaise), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and ARTHRALGIA (joint aches). At the time of the report, MALAISE (malaise), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and ARTHRALGIA (joint aches) was resolving.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   Concomitant and treatment medications were not reported.
Information has been received from an office manager, for the GARDASIL a Pregnancy Registry concerning a 16 year old female patient with depression, allergy to penicillin, amoxicillin, BACTRIM, CECLOR, erythromycin and a history of cesarean section performed less than a year ago and kidney stones with her last pregnancy who was vaccinated with the first, second and third dose of GARDASIL, 0.5 mL, intramuscularly, on 20-MAY-2008 (lot # 655604/0052X), 22-JUL-2008 (lot# 0250X) and on 25-NOV-2008 (lot # 0947X) respectively. Concomitant therapy included oral birth control pills (unspecified) and probably ZOLOFT. It was reported that the patient is pregnant. LMP was 31-OCT-2008. EDD was 07-AUG-2009. The patient sought medical attention at the physician's office. Follow up information has been received from an office manager concerning the 16-year-old female patient and revealed that the patient had a termination of pregnancy on 10-JAN-2009 at 10 weeks of gestation. The reporter stated that the patient did not terminate the pregnancy due to the vaccine, rather she had multiple or other personal reasons. The reporter indicated the patient had no problems with the procedure and recovered well. Upon internal review, termination of pregnancy was determined to be an other important medical event. Additional information has been requested.
Booster dose received less than 28 days after 2nd dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose received less than 28 days after 2nd dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 30-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose received less than 28 days after 2nd dose). On 26-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose received less than 28 days after 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.
Fully vaccinated with COVID breakthrough and inpatient admit to an ICU unit.  Chronic underlying lung disease with home oxygen