chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started feeling fatigued on Sunday Feb 14. I started feeling this way in the afternoon. Next I felt like I had indigestion so I took some tums. At about 1:00am on Monday morning I woke up and felt really bad and thought I had indigestion so I tried to take some more tums and vomited. I was really weak and short of breath. I laid back down and tried to go to sleep but my heart felt like it was racing. Within an hour I was back up vomiting again with shortness of breath, weakness, heart racing. I tried to lay back down but within another hour I vomited again. This went on until 8:30am Monday morning. My pulse was everywhere. 97 to 112bpm. I was having chills all day and weak. I slept a lot Monday and also had diarrhea on Monday morning. I couldn't eat all of Monday and finally ate some soup on Tuesday. I am feeling much better today but still a little fatigued.
TEMPERATURE EXCURSION OCCURRED DUE TO THE PLACEMENT OF HAND WARMERS IN THE INSULATED BAG USED TO TRANSPORT VACCINE. ALL 81 PERSONS RECEIVING VACCINE IN LANES 5 AND 6 ON 02/15/2021 BETWEEN 14:00 and 16:45 WERE NOTIFIED THEY RECEIVED VACCINE THAT WAS OUTSIDE OF THE APPROPRIATE TEMPERATURE RANGE AND WERE RECOMMENDED TO BE REVACCINATED.
Initial case was received on 17 September 2010 from a consumer who is the grandmother of the patient. The reporter stated the patient was delayed receiving immunizations until 13 months of age. In 2009 (specific dates not reported), the patient received the following vaccines: DAPTACEL lot number C3081AA; DAPTACEL lot number C3139AA; DAPTACEL lot number C3192AA; ACTHIB lot number UF578AA (sanofi pasteur SA lot number B0295-1); ACTHIB lot number UF578AB (sanofi pasteur SA lot number B0295-1); ACTHIB lot number UF707AA (sanofi pasteur SA lot number D0556-1); IPOL lot number B0475-2; IPOL lot number A1229-2; IPOL lot number D0408; FLUZONE SV 2009-2010 lot number U3189AA and FLUZONE SV 2009-2010 lot number U3377AA. It was noted that only sanofi pasteur vaccines were reported, not other manufacturer's vaccines that were administered. The patient "developed Autism." The reporter stated an unspecified specialist claimed the cause of the Autism "was not separating the vaccines but administering concomitantly." No pre-existing medical conditions and no concomitant medications were reported. The outcome was not reported. Documents held by sender: None.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 011F21A, 010A21A and 042L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported.   The vial was initially stored in the refrigerator on 20-Apr-2022. Freezer expiration date was reported as 20-May-2022. On 24-May-2022, patient was given expired (4 days expired) Moderna vaccine lot 033K212A manufacturer expiration date 20-May-2022, Other vaccines were given on the same day of Moderna COVID-19 vaccine were reported as none. The vial did not undergo any temperature excursions.   Treatment information was not reported.
Itchy red spotty rash scattered over back and trunk. Started as small area on forearm. Gradually faded over one week with gradually decreasing itching
had 2 mild cases since double shingle shot/ Suspected vaccination failure; had 2 mild cases; 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, Flu unspecified (Flu vaccine) for prophylaxis, COVID-19 VACCINE for prophylaxis, COVID-19 VACCINE for prophylaxis and COVID-19 VACCINE for prophylaxis.   Concurrent medical conditions included thyroid disorder.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine, Flu vaccine, COVID-19 VACCINE, the 2nd dose of COVID-19 VACCINE and the 1st dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, not applicable after receiving Flu vaccine and an unknown time after receiving COVID-19 VACCINE, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the shingles to be related to Flu vaccine.     Additional Information: RA Receipt Date: 6-Aug-2022 Reporter's comment: The patient self reported the case via RA page. The patient had 2 mild cases of shingles since the double shingle shots. The patient had always gotten their flu shot and had 2 Covid dose and one booster dose. The patient stated that he/she would not get another covid booster dose. The patient stated that that it messed up his/her thyroid meds and doctor/pharmacist said that they thought covid booster had caused all the problems. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible as no contact details were available.
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced a mild case of shingles. Medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
11/09/21 - Injection site was a little red and swollen.  11/12/2021 - Started in 7:30am I felt intense stabbing pain in hip joints with reactive arthritis sacroiliac pain hip pelvic and small of my back, ankle and foot all on the left side, increased urination and dry, itchy burning eyes. Virtual health on 11/15/2021.
pt recv vax & devel flu sx of fever, aches & pains p/vax in 1995;sx lasted 3 days & pt recovered;
Received second vaccine outside dosing interval day 43; Redness and swelling at injection site (left) arm; Redness and swelling at injection site (left) arm; A spontaneous report was received from a consumer (patient's husband), concerning a 67-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and received second vaccine outside dosing interval day 43 (Inappropriate schedule of vaccine administered), experienced redness and swelling at injection site (left) arm (Vaccination site erythema), redness and swelling at injection site (left) arm (Vaccination site swelling).  The patient's medical history included liver transplant. Current condition included autoimmune disorder. No concomitant medications were reported.  On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) and on 24 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 012A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced redness and swelling at injection site (left) arm. The patient received second vaccine outside dosing interval day 43. The patient also had possible polyethylene glycol (PEG) reaction from Moderna vaccine ingredient.  Treatment information for the events was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the event(s) is not applicable.   The events of redness and swelling at injection site (left) arm (Vaccination site erythema), redness and swelling at injection site (left) arm (Vaccination site swelling) resolved on 19 Jan 2021 while the event of received second vaccine outside dosing interval day 43 (Inappropriate schedule of vaccine administered) was considered resolved on an unknown date.  The reporter did not provide an assessment for the events redness and swelling at injection site (left) arm (Vaccination site erythema), redness and swelling at injection site (left) arm (Vaccination site swelling) and received second vaccine outside dosing interval day 43 (Inappropriate schedule of vaccine administered).; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 (Lot #: 041L20A). Based on the current available information and temporal association between the use of the product and the start date of the events other events (Vaccination site erythema and Vaccination site swelling), a causal relationship cannot be excluded.
A non-serious spontaneous report of administration of expired product was received from a nurse practitioner concerning a 41-month-old female, who received FLUMIST.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with agency's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow up information was received on 06-Mar-2009 and incorporated into the narrative, confirmed thate there were no adverse events associated with the medication error.
Site: Bruising at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Mild
Developed 104 fever 2 hrs p/HBOC; No other source of fever identified afebrile by next AM (16 hrs later).
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-OCT-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot #, dose, route of administration and anatomical location were not provided). No adverse effect was reported. Additional information has been requested.
Dizziness, Headache, NauseaVomiting, Pain at injection site, fatigue, nasal congestion, tinnitus Narrative:
PATIENT STARTED TO FEEL DIZZY/LIGHT HEADED ABOUT 5 MINUTES AFTER HER VACCINATION. WE LAID HER DOWN AND RAISED HER FEET AND SHE STARTED TO FEEL BETTER. PATIENT RECOVERED. SHE DID STATE SHE HAS HAD REACTIONS TO VACCINE (FAINTING) IN THE PAST PRIOR TO RECEIVING HER COVID SHOT.
O2 level went down to 88; Feels like she is out of body; Achy feeling; Fever of 103F; Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), OXYGEN SATURATION DECREASED (O2 level went down to 88), FEELING ABNORMAL (Feels like she is out of body), MYALGIA (Achy feeling) and PYREXIA (Fever of 103F) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (Lightheadedness), MYALGIA (Achy feeling) and PYREXIA (Fever of 103F). On 29-Mar-2021, the patient experienced FEELING ABNORMAL (Feels like she is out of body). On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (O2 level went down to 88). On 26-Mar-2021, DIZZINESS (Lightheadedness) had resolved. On 28-Mar-2021, PYREXIA (Fever of 103F) had resolved. At the time of the report, OXYGEN SATURATION DECREASED (O2 level went down to 88), FEELING ABNORMAL (Feels like she is out of body) and MYALGIA (Achy feeling) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment for the event included acetaminophen and ibuprofen.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Severe migraine, fever, redness and pain at injection site for over 48 hours.
No adverse events. However, this was the patient's third dose of the vaccine and the booster has only been approved for patients >18 years old.
This child received 3rd Hepatitis B vaccine on 10/30/00 ( previous doses given 10/29/96 and 08/05/98). She developed a knot at the site of injection (left deltoid) which persisted but not reported until 02/06/01 when she developed redness and multiple small sq papules within the area of erythema. She was treated with Augmentin for 10 days for possible cellulitis. She returned 03/14/01 with 2 1/2 by 1/1/2 inch area of persistent induration, violaceous with central tenderness. Treated with 10- day course of Duricef. On 03/29/01, the lesion was essentially the same and she was referred to dermatology. They diagnosed a morphea-like reaction which they felt was due to a localized hypersensitivity response to Hep B vaccine, which might arrest with time, or continue to smolder. The lesion measured 6.5 cm by 4.5 cm. Dovonex Ointment was prescribed, and in one month if the lesion still expanding, will receive intralesional injection of triamcinolone.
lt arm below deltoid extending to biceps induration & warmth & inflammation 13 1/2 x 17 1/2 cm reactive to td; cellulitis;
Received MMR  12/04/2019. Minimum interval between live vaccines not met. Varicella to be repeated 1 month.
Patient stated that a moveable swollen little ball appeared on her collarbone the next day after her injection. She said that it isn't hot or red or painful. The swelling has gone down she said and is now flat.
Information has been received from a registered nurse concerning a female patient with a history of chickenpox who in approximately 2003 was vaccinated with a dose of varicella virus vaccine live (lot # not provided). The patient subsequently developed shingles. It was not known what treatment was provided or if the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter indicated a similar experience with another patient. No further information is available.
Patient stated they had not yet had a Bivalent Covid19 Booster, and is not immunocompromised.Initial review of CDC card showed monovalent booster given, but there was confusion based on recordings on back of same card. They actually DID get a bilvalent booster, here, on 10/25/22.
Information has been received from a physician concerning a 4 year old female child who on an unspecified date was vaccinated with a second dose of hepatitis B virus vaccine. The reporter indicated that two weeks after the vaccination, the child developed a butterfly rash. It was also noted that the child a positive ANA with a high titer at 1:160. It was also noted that the child's mother has lupus. It was also indicated that the child's ultimate diagnosis may have been juvenile dermatomyositis. Unspecified medical attention was sought. Upon internal review, juvenile dermatomyositis was determined to be an other important medical event (OMIC). Additional information has been requested. A 15-day follow up report received 12/12/2003 adds: Follow-up info received from a registered nurse reported that this experience had previously been reported to VAERS and provided the following VAERS # for the pt's case: 094649. No further info is expected.
About 19 hours later,  fever 102.6. Took 2 Tylenol arthritis strength,  after several hours temp went to 100, throughout next 24 hours fever continued between 102 and 103, used Tylenol by 1/26 temp was normal. Beginning 1/25 to present fatigue, weakness, dizziness, intermittent diarrhea, chilss with shivering to sweating with drenched clothes.
felt bad until 11 pm; vomiting; chills; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad until 11 pm), VACCINATION SITE PAIN (sore arm), VOMITING (vomiting), CHILLS (chills) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided b the reporter.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 15-Mar-2021, the patient experienced FEELING ABNORMAL (felt bad until 11 pm), VOMITING (vomiting), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. On 15-Mar-2021, FEELING ABNORMAL (felt bad until 11 pm), VOMITING (vomiting), CHILLS (chills) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.
Received flu shot on 11/11, noticed small measle like bumps on 11/12. Measle like bumps spread all over my trunk and arms (not on my face). Have 10 days of prednisone and used creams. It is now 12/8 and still have rash which is now also appearing on my forearms. It still itches.
Patient called in to request provider visit to discuss persistent left arm pain since receiving vaccination. Patient reported pain during activities of daily living.
Patient given adult Pfizer dose (grey cap) instead of pediatric Pfizer dose (maroon cap).
That day, a week after I had a headache starting midday. I took some Ibuprofen. Later that afternoon, about 04:30P I felt incredibly nauseous and had to lay down and leave the work I was doing. I called my doctor because symptoms came on pretty strong and quickly. I requested a COVID test. The headache lasted from about noon to 06:00 PM. The nausea came on at 04:30 and lasted until 06:00 or 07:00. (Of that same day of onset). Missed two days of work.
Anaphylaxis: extreme fatigue, chest tightness/ pain, shortness of breath, cough, skin redness/ rash on both arms and face, itchiness, confusion/disorientation 45 minutes post injection
3/2/99 mom called clinic approx 9:30 to reports child had fever >102 was crying inconsolably for over 3hr, reports child becalmed, shaky & unable to walk;to take child for immed eval;dx per MD severe OM, dizziness secondary to fever;
Loss of hearing to last less than 5 min.  followed by ringing ears through the following day.  Uncontrolled palsy for head and neck intermittently through the injection day.  I lost my voice and had spasms in my larynx.  For several hours I had a hard time choosing my words and speaking which was the scariest.  I could not focus enough to even wash my hands on injection day and had to be driven home from work.   I got dehydrated because water tasted horrible.  The next morning I am better on all fronts except the ringing in my ears wont stop
severe diarrhea; tachycardia; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (severe diarrhea), TACHYCARDIA (tachycardia) and CHEST PAIN (chest pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (severe diarrhea) (seriousness criterion hospitalization), TACHYCARDIA (tachycardia) (seriousness criterion hospitalization prolonged) and CHEST PAIN (chest pain) (seriousness criterion hospitalization). The patient was hospitalized on 28-Mar-2021 due to DIARRHOEA. At the time of the report, DIARRHOEA (severe diarrhea) was resolving, TACHYCARDIA (tachycardia) had not resolved and CHEST PAIN (chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 antibody test: positive (Positive) Had no symptoms from Covid 19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided to the patient. Treatment information was not provided.   Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Onset date for events was provided as 28-Apr-2021, which is after the report was submitted.  As vaccine was administered on 17-apr-2021 it is likely the onset date of events was 18-apr-2021 rather than the 28th, but this will need to be clarified on FU; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Onset date for events was provided as 28-Apr-2021, which is after the report was submitted.  As vaccine was administered on 17-apr-2021 it is likely the onset date of events was 18-apr-2021 rather than the 28th, but this will need to be clarified on FU.
Headache, Myalgia, Arthralgia, Fever,  CHILLS Narrative:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 04-MAR-2016, the patient was vaccinated with expired dose of RECOMBIVAX HB injection, lot # J006245, expiration date 03-FEB-2016 (dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
The patient received her 2nd dose of Moderna on 6/26/2021. The patient states that she felt fine immediately after the shot on Saturday around 2 PM. On Sunday afternoon, the patient reports feeling muscle stiffness and soreness all over. The patient tried to use ibuprofen, fish oil, and turmeric to help with her muscle stiffness with little success. Patient states that she also experienced loss of appetite, and mostly slept and remained inactive. The patient's stiffness/soreness gradually improved through the week and until she called on 6/30/2021. She reports still continuing to feel the muscle stiffness/soreness as of the time she called the pharmacy. The patient has not sought out any additional medical care at this time and says that she feels fine otherwise.