chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lack of Response - Information has been received from a health care professional concerning a 21 year old female patient who was vaccinated with the second dose of varicella virus vaccine live.  The patient subsequently sought medical attention and a serum VEV antibody test revealed that she was soronegative.  No further information is available.
This spontaneous report as received from a medical assistant refers to a 7 month old female patient. The patient's medical history was not reported. On 25-SEP-2018, the 7 month old patient was vaccinated with a dose of VAQTA lot # R013858, expiration date 12-JUN-2019, intramuscular for prophylaxis. No adverse effect was reported.
7/10 Very inflamed right upper eyelid, Slight fever 99.9. 7/10 Televisit with doctor who prescribed Paxlovid. Symptoms remained the same. Symptoms seemed to be about the same and things didn't noticeably change.
A red rash about 2" in diameter showed up 7 days after the injection, located about 1-1/2" below the injection site.  Bumpy, itchy, a little warm to the touch.
received the 1st dose / May 2019 / has not received dose 2 as of yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose in May 2019).   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 information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. No adverse events reported. The reporter did not consented to follow up. The VAERS details pertains to 1st dose of Shingrix.
Pt was playing when she began to cry, when mom picked her up she noticed that the patient was pale and her lips had turned purple.  It was noted that the patients body went limp for 2-3 minutes and she had a loss of consciousness for 5 seconds.  The patient vomited x 1 but never stopped breathing.  Patient was brought into the ED for work up of syncope and cyanosis.
Temp 103 degrees Tues pm (10/21/08)--fluctuated 101-103 degrees until Thursday 10/23/08.  RA had 4 cm circular red area directly below injection site and medial stripes on arm 1 cm X 5 cm.  Resolving as of 10/24/08.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:16 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:16 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 74.07.  No concomitant medications were reported.  On 31-Mar-2021, excursion time was 8 AM, temperature was 32 and 10 AM, temperature was 32. Total doses given for the day was 199, condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 23-Mar-2021 and beyond use date was 22-Apr-2021. 4 vials were sent to clinic on 31-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  No treatment medications were reported.
Got an extremely heavy period two weeks following first vaccine. Significant pain, a 102 degree fever, bled for over a month. Bleeding was heavy and would saturate a super plus tampons before an hour duration. Period frequency increases from once or twice a year to every three months. Continuing extreme with pain, long durations of heavy bleeding, sore throat, general drowsiness making any form of physical exertion difficult, continued fever over course of period. Following second vaccination pain increased. When fever, sore throat, and other indicators of Covid symptoms were present I got tested for Covid and it came back negative.  Another adverse reaction was following the first vaccination which led to a hive/rash outbreak 4 hours after injection. Hives appeared all over my back, in a line up from my elbow to my armpit on the left side of the body, on my chest and knees. This went away 12 hours after on set. Was tear your own eyes out painful/itchy.
was down for a day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (was down for a day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Fibromyalgia.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (was down for a day). At the time of the report, MALAISE (was down for a day) had resolved.            No concomitant medications were reported.  Treatment information was not provided.  It was reported that patient was slightly immunocompromised with fibromyalgia. Patient received a full dose of Moderna booster in September 2021 and patient was down for a day. Patient stated that the third shot was strong but the side effects did not last.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2022: Follow up received contains no new information.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) lot # L035105 expiration date 14-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 9 Fahrenheit degree (also reported as Celsius degree). The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 8.7 Fahrenheit degree (also reported as Celsius degree). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Developed expressive aphasia TIA 15 hours post vaccination, requiring 48 hour hospitalization
Pain in right neck, shoulder, and back between shoulder blade and kidney area.  Pain was intense and intermittently sharp, burning, pulsating and pins and needles.  Seen in ER on 05/14/2019.  When pain didn't let up, followed up with primary on 05/24/2019.  Prescribed gabapentin with successful reduction of pain.
unusual wheezing; felt lousy; headache; unusual chills; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (unusual wheezing), FEELING ABNORMAL (felt lousy), HEADACHE (headache) and CHILLS (unusual chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Wheezing. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR HFA), METHYLPHENIDATE HYDROCHLORIDE (CONCERTA) and MONTELUKAST for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced FEELING ABNORMAL (felt lousy), HEADACHE (headache) and CHILLS (unusual chills). On an unknown date, the patient experienced WHEEZING (unusual wheezing). The patient was treated with PREDNISONE for Wheezing, at an unspecified dose and frequency. At the time of the report, WHEEZING (unusual wheezing), FEELING ABNORMAL (felt lousy), HEADACHE (headache) and CHILLS (unusual chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Event treatment included nebulizer.   This case was linked to MOD-2021-030553 (Patient Link).
Arm was swollen up; Chills; Fatigue/Tiredness; Developed a rush on his face; After he received the vaccine, his face was numbed for a minute and then went away; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (After he received the vaccine, his face was numbed for a minute and then went away), PERIPHERAL SWELLING (Arm was swollen up), RASH (Developed a rush on his face), CHILLS (Chills) and FATIGUE (Fatigue/Tiredness) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced HYPOAESTHESIA (After he received the vaccine, his face was numbed for a minute and then went away). On 31-Mar-2021, the patient experienced RASH (Developed a rush on his face). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm was swollen up), CHILLS (Chills) and FATIGUE (Fatigue/Tiredness). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 30-Mar-2021, HYPOAESTHESIA (After he received the vaccine, his face was numbed for a minute and then went away) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm was swollen up), RASH (Developed a rush on his face) and CHILLS (Chills) outcome was unknown and FATIGUE (Fatigue/Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.
Low grade fever ranging from 99.0 to 100.6 for one week so far.; Mild sore throat - still ongoing; Left arm pain; Ear ache in right ear; Fatigue that lasted 48 hours afterinjection; injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 23Jun2021 at 14:30 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, inflammatory bowel disease, known allergies to sulfa antibiotics, penicillin, contrast dye(iodine), latex, coconut oil, more. The patient did not receive any medications within two weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took clarithromycin (BIAXIN), clindamycin (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all for unspecified indication on unknown dates and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 23Jun2021, the patient experienced low grade fever ranging from 99.0 to 100.6 (units unspecified) for one week so far, mild sore throat still ongoing, ear ache in right ear, not constant but occasional and ongoing, left arm pain, injection site pain and fatigue that lasted 48 hours after injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever ranging from 99.0 to 100.6 for one week so far, mild sore throat still ongoing, ear ache in right ear, not constant but occasional and ongoing left arm pain, injection site pain was not recovered at the time of this report and of the event fatigue that lasted 48 hours after injection was recovered on 25Jun2021.
scrotum swollen; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: SCROTAL SWELLING (non-serious), outcome "unknown", described as "scrotum swollen". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She reports Wednesday evening left side of face becoming numb and painful to touch, severe HA left side of head (sharp pain) fever 102, rash on both legs, self medicated with Tylenol and ibuprofen rotating then Benadryl with only fever reduction occurring that night. Symptoms return Thursday evening including fever and rash. Left side of face remains numb and painful to touch. No rash or fever Friday, went to doctor. Instructed to wait 5 days for symptoms to resolve
Breakthrough case admission after 2 vaccines: Pfizer 4/27/21 Lot# EW0164;  Pfizer 5/18/21 Lot# EW0164.
Information has been received from a physician concerning a 14 year old female patient with allergy to "sculsa" who on 01-SEP-2010 was vaccinated intramuscularly with her first dose of GARDASIL (lot#666162/0565Z). The physician stated that the patient got her vaccine and 20 minutes later while in her mother's car the patient began feeling tingling, numbness, swelling of the face, drooling and difficulty breathing, so her mother called 911. The patient was rushed to emergency room (E.R.), but not was hospitalized. At the time of report, the patient's outcome was unknown. Feeling tingling, numbness, swelling of the face, drooling and difficulty breathing were considered to be other important medical events by the physician. Additional information has been requested.
This 67 year old male patient had a pneumonia vaccine on 10/03/2002. On 10/04/2002 he developed arm pain and on 10/05/2002 he developed cellulitis at the site of injection and from his shoulder to his elbow around the arm circumferential. He also felt sick like after a flu shot. The main point of cellulitis is on the inside closer to the inner aspect of his arm by his left elbow. The injection site was below the deltoid. He was treated with dicloxicillin. On 10/05/2002 he does not feel ill any more but the cellulitis continues.
I did fine until 5 days later when I had postmenopausal spotting on 4/3/21.  It was very light, but abnormal.  The next day, 4/4/21, I went to the ER, since it started being a little more than spotting.  I had an U/S.  The PA said I may have uterine and/or ovarian cancer.  I saw a gynecologist who didn't think I had cancer.  He was unable to do an in-office biopsy, so scheduled a D&C.  The biopsy was non diagnostic, since he was unable to get a sufficient tissue sample.  The spotting had stopped approx on 4/8/21.  The Dr can't say for sure whether it is related to the vaccine or not.  I had gone through menopause at 51.  I turned 66 on 4/3/21.  The Dr will repeat an U/S in a month.
Sore shoulder: This lasted about 4 days, with the pain lessening after each day
Pt was given KINRIX and PROQUAD for 4yr checkup. Redness - localized swelling, warm to touch - some drainage from where PROQUAD was given (RA).
Initial and follow up information has been received from an RN and a practice manager concerning a female patient between the ages of 35-50 who on 18-SEP-2007 was inadvertently vaccinated with a dose of pneumococcal 23v polysaccharide vaccine, lot #655765/0061U; instead of the flu vaccine. On 18-SEP-2007, the flu vaccine was to be given to elementary school teachers and their spouses. Due to human error (not product confusion), pneumococcal 23v polysaccharide vaccine, lot #655765/0061, was brought to the school and administered instead of the flu vaccine. The patient had pain down her entire arm (unspecified), which "settled in the wrist." Medical attention was sought. As of 21-SEP-2007, the patient "was ok." The nurse also reported on additional patients who received pneumococcal 23v polysaccharide vaccine, lot #655765/0061U, instead of flu vaccine; some of whom developed adverse reactions. The practice manager stated "is there anything wrong with this lot?" and a lot check was requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Initial report received from health care professional on 21 Jan 2010: This patient was vaccinated with FLUVIRIN (Lot number 104045P1) on 13 Jan 2010. During vaccination patient received retractable part of the syringe malfunctioned resulting in an undetermined amount of vaccine running down patient's arm. The seriousness criteria of the events were not reported.
6 hours after injection, I began feeling muscle pain and chills, 8 hours after, these symptoms worsened, 11.5 hours after I had a fever and more intense symptoms with a max recorded fever of 102°F and intense cold sweats. This lasted for about 12 hours and I woke up with a slight fever which then subsided. Later the following day I felt fine again.   Essentially, when the symptoms were most intense, I felt like I did when I contracted Covid in March of 2020
Patient reported within about an hour of receiving her flu vaccine she began to get hives behind her ears within about 15 minutes of hives developing she reported that her throat became scratchy, and began to experience a cough.  She indicated that she took Benadryl and began feeling "back to normal" within an hour or so.  This morning she indicates that she is completely fine with no hives, itching, or scratchy throat.
Never received the second dose; Diagnosed with COVID-19 7 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19 7 days after the first dose) and PRODUCT DOSE OMISSION ISSUE (Never received the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID-19 7 days after the first dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never received the second dose). At the time of the report, COVID-19 (Diagnosed with COVID-19 7 days after the first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Never received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were not provided.
Redness to Lt deltoid area 7 cm wide x 9 cm length - warm to touch - skin intact. Child c/o of itching and slight pain.
J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/30/2023 SEVERE PERSISTENT ASTHMA W ACUTE EXACERBATION J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/30/2023 ASTHMA, UNSPECIFIED J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/30/2023 TRACHEAL STENOSIS
3hrs post vax pt devel loss of muscle tone, pale, diff breathing, unresponsive, blue lips for approx 15mins;
10/14/03: Temperature started 6:30 PM of 101.7, gave Tylenol. 10/15/03: Temp 102.7, diarrhea. MD did X-ray, Rx Advil. 10/16/03: Temp 103, diarrhea, blood in stool, pt went to ER, checked WBC, Rx Trimox. 10/17/03: Temp 101.4, diarrhea, blood, checked WBC. 10/20/03: Stool culture normal.
Flu like symptoms, tingling in hand, feet and legs since Sunday. Mild feverish and chilled feeling, decreased energy, and achy all over. Feels pulsating nerves, hard to sleep.
Information has been received from a licensed practical nurse concerning a 4 year old female pt who on 01/28/1999 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy on 01/28/1999 included a dose of MMR. On 12/14/2001 the pt developed a varicella illness and presented to the physician's office. It was noted that she had 30-50 lesions. Subsequently, "in a few days" the pt recovered. No further info is available.
Patient states that after she received the Shingrix vaccine, the place on her arm where she received the vaccine became hot, red, and swollen and these symptoms have continued into the next day (2 days after receiving it). The pharmacist recommended taking ibuprofen and putting an ice pack on the arm. Planning to follow-up with patient in the next day to see if she is still experiencing these symptoms.
Headache, Fever, fatigue, body aches Narrative:  employee states: felt drained, feverish and had a headache on 1/28/21 awoke with body aches, headache, and fatigue
Rash that looks like measles. Given ZYRTEC. Rash began to diminish 5 days after initial outbreak.