chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain, fever, chills and headache. On an unknown date, the outcome of the pain, fever, chills and headache were recovered/resolved. It was unknown if the reporter considered the pain, fever, chills and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the healthcare professional (HCP) for her colleague. The age at vaccination was not reported. The patient experienced soreness, fevers, chills and headaches that lasted about 24 hours. This case has been linked with case US2019GSK030864 reported by the same reporter.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and drug reactions or allergies were not provided. On 18-SEP-2018, the patient inadvertently received an expired dose of PROQUAD injection, lot # M044719 with expiration date on 07-MAY-2018 (dose and route of administration were not reported). Concomitant therapies included sterile diluent (lot# and expiration date were unknown). No adverse effects were reported.
9/23/2019 left neck, shoulder. arm and hand pain and tingling 9/28/2019 seen at Urgent Care- xray done  DX with degererative arthritis C5-C6- treated w prednisone and flexeril x 2 weeks 10/10/2019  no releief of symptoms
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on an unknown date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, on 28-AUG-2021 the patient was ended up getting corona virus disease (COVID). She seemed to have mild symptoms (suspected covid-19 infection and suspected clinical vaccination failure). She was on day 6 of symptoms. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210912838. This report was associated with product quality complaint: 90000192453.; Sender's Comments: V0. 20210913172-COVID-19 VACCINE Suspected clinical vaccine failure. This event is considered not related. The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS
Slight sore arm for 3 days, but then on the 8th day intense itching and very hot.  It is now Jan 30, 2021 and the area is still itching, tho less, and is still hot.  There is a 1/4" wide reddish ring in a circle of about a 3" diameter around the shot site.  Today I put a cold compress on it and was surprised that as soon as I took it off after about 10 minutes it was still hot.  I am worried about having the 2nd shot in the same place.
severe itching on bottom of feet-hives on back, red circle & arm sore @ inj site 5hr post vax;
Patient received 2 moderna booster shots on same day (equal to full dose). along with flu vaccine.  There was miscommunication when patient decided they wanted to receive flu shot as well. Moderna booster had already been given and second person came out to give Flu and also gave another moderna booster as well not knowing she had already received it.
devel severe h/a 12hr p/vax which lasted 36hr;pt had vomiting;tried taking advil & excedrin but could not keep it down;
09/23 came back to clinic; developed rash on neck and arms. No other symptoms as per patient 9/23/03. Seen in hospital for mosquito bites, and was treated with hydrocortizone cream.
This case was reported by a consumer and described the occurrence of increased runny nose in a 9-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  The subject received no concurrent medications.  On 19 September 2007, no concurrent vaccines were administered.  On unspecified dates, the subject received the first two doses of Pediarix (unknown), and on 20 June 2007 she received the third dose of Pediarix (unknown).  At unspecified time(s) following one or more of the initial three Pediarix vaccinations, the subject experienced increased sleepiness and slept more.  On 19 September 2007 the subject was inadvertently administered a fourth dose of Pediarix (unknown).  On 19 September 2007, less than one day after vaccination with Pediarix, the subject experienced an "increased runny nose of clear discharge".  The subject also experienced increased "sleep habits" described as sleeping more, which the reporter noted "normally occurs".  At the time of reporting the outcome of the events was unspecified.
No additional AE reported; Expired vaccine administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 05-OCT-2021, the patient was vaccinated with expired dose of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # S029457, expiration date 19-SEP-2021, 0.5 milliliter (concentration, formulation, dose number, anatomical location, frequency and route of administration were not reported) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Vaccine was given at 9:30 am, at 1:30 PM the pt had emesis, at 2:20 PM mom heard gagging and found him with eyes rolling back, jerking both arms in exertion. Head extended rhythmically, lasted 10 - 15 seconds. The pt had emesis during the episode. The pt was difficult to arouse until 30-40 minutes later.   Treatment - admission to Pediatric floor, for observation.
Two days post vax, pt started with diarrhea and low-grade temp of 99.9 with sore throat. On 9/15/01 pt developed hives with the majority of them on her left arm (MMR site). She was seen by MD on 9/16/01 who stated it was from MMR. She was treated with Benadryl po. On 9/17/01 she had a temp of 99, a headache and complained of not feeling well. On 9/18/01 she vomited x 2 and had abdominal pain. On 9/19/01 her hives were disappearing.
Have many allergies; Felt some irritation (vaginal area); Swelling in my vaginal area; Continued to get much worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (have many allergies), VULVOVAGINAL DISCOMFORT (felt some irritation (vaginal area)), VULVOVAGINAL SWELLING (swelling in my vaginal area) and ADVERSE REACTION (continued to get much worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO MEDICAL HISTORY REPORTED.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (have many allergies), VULVOVAGINAL DISCOMFORT (felt some irritation (vaginal area)), VULVOVAGINAL SWELLING (swelling in my vaginal area) and ADVERSE REACTION (continued to get much worse). At the time of the report, VACCINATION COMPLICATION (have many allergies), VULVOVAGINAL DISCOMFORT (felt some irritation (vaginal area)), VULVOVAGINAL SWELLING (swelling in my vaginal area) and ADVERSE REACTION (continued to get much worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were available.
Patient began experiencing hot flashes and chills a few hours after receiving the vaccine. The next day she experienced chills, fatigue, left arm pain (same arm as vaccine administration). Advised to obtain COVID19 testing, and seek immediate medical attention if symptoms worsen or severe symptoms appear.
This spontaneous report as received from a certified medical assistant refers to 5 patients of unknown age and gender who on unknown date were vaccinated with a dose of GARDASIL (dose, lot number and route not reported) that was improperly stored. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 17-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
inadequate titer response; This literature marketed report was received from the authors of a published literature article, titled as stated below, and refers to a child patient of unknown age and gender (mean age of group of the patients in the article was 12 years old +/- 2.9). The patient's concurrent conditions included sickle cell disease (SCD) and immunodeficiency. The patient's medical history included chronic transfusion therapy. The patient was vaccinated with 7-valent pneumococcal conjugate vaccine (reported as PCV7) or 13-valent pneumococcal conjugate vaccine (reported as PCV13), or both.  On an unknown date, the patients was vaccinated with 2 doses of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as PPSV23), for prophylaxis (dose, route of administration, lot # and expiration date were not provided). The vaccinations were given at 2 and 5 years of age, or in 3 to 5 years interval if vaccination was initiated at a later age.  Five (+/- 1) years after completion of a 2-dose pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccination series (also reported as 5.42 +/- 1.19 years) , the patient had inadequate titers (also reported as inadequate response) which was defined as immunoglobin (Ig) G levels less than 1.3 mcg/mL. The patient did not have any serious pneumococcal infections. The outcome of the event was not provided. The data analysis did not demonstrate associations between disease characteristics with an inadequate immune response. It was considered that the event was related to the suspect vaccine, as the authors stated that the patient had inadequate titers despite vaccination.  A copy of the published article is attached as further documentation of the patient's experience.   This is one of two reports derived from the same literature article (cross-referenced with US-009507513-2106USA002866).; Sender's Comments:  US-009507513-2106USA002866:
Patient did not tell us she has a history of fainting because it happened so long ago, they felt it was unimportant, but patient was fine, received vaccine while mom was standing nearby, and fainted and fell off of the chair. she was  conscious shortly after (about 5 seconds) and didn't realize she even fainted she said. they waited in our waiting area and refused to call EMS.
Diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First dose, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Second dose, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Third dose, unknown manufacturer), for COVID-19 immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 25Dec2022, outcome "recovering", described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. Post the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Began with a rash about midnight. No significant pain at injection site. Throughout the night I had chills and nausea. At 6 am on 2/1 I started having nausea and vomiting. Also, the rash that started on my neck went down around armpit and onto torso area. Symptoms were bad days one and two. Day 3 was a bit better but didn?t fully feel normal until day 4 but rash is still slightly present.
2 hours after receiving 1st combo vax (DTap/IPV/Hib) baby became lethargic, eyes glazed and unfocused, vomited until bile and became limp. After approx 1 hour, during which we called ER# for advice, she fell asleep and slept until early morning hours when she woke to feed again (nursed).
I received the vaccine on Tuesday 4/20/21.   On Thursday 4/22/21 around 11:30 am, I noticed my lip was swollen. I took Benedryl and this side effect subsided Friday evening.   On Tuesday 4/27/21 around 11:00 pm, I noticed a huge hive that was itchy, red, and swollen on the site where my vaccine was given. I went to the er because I have a history of anaphylaxis shock. They directed me to take Benedryl, use cortizone cream, and if it worsens-to use my Epi-Pen and call 911.   Currently, on Saturday 5/1/21 around 6:30 am, I woke up with a small hive on my lower back and a hive on my abdomen. I called my dr.'s phone service to determine what steps need to be taken. The on-call nurse advised me to take 10mg/day of  Zyrtec or Claritin and use cool baths to relieve itchiness. She stated that it they spread-to call back. If they remained the same-to follow up with my dr. on Monday.
Patient was administered Zoster in left arm. Patient called the next day complaining of swelling of right side of her face and numbness of right arm and leg. Patient was evaluated by provider and given prednisone burst of 20 mg 3 times a day for 7 days. Patient was also given valacyclovir 1,000 mg 3 times a day for 7 days. 2 weeks later patient was evaluated again and referred to neurology due to no improvement. Still waiting an appointment.
Tachycardia; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) and PYREXIA (Fever) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Tachycardia) and PYREXIA (Fever). At the time of the report, TACHYCARDIA (Tachycardia) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up received and contains no new information
On January 6, the area around the injection site started itching. I then noticed it was more tender. The area is now red, raised, swollen, tight and warm. The area is about the size of a deck of cards. I have now taken 50mg of diphenhydramine PO and 1000mg of Tylenol PO.
Constipation which lasted for 3 days; Arm soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation which lasted for 3 days) and VACCINATION SITE PAIN (Arm soreness at the injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness at the injection site). On 09-Mar-2021, the patient experienced CONSTIPATION (Constipation which lasted for 3 days). On 12-Mar-2021, CONSTIPATION (Constipation which lasted for 3 days) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Patient had water, juice, took constipation medication and his bowel movement went back to normal.
No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced EYE PAIN (Pain behind eye), FEELING ABNORMAL (brain fog), PAIN (Sharp shooting pain in right side of brain), ARTHRALGIA (Pain in shoulder), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (vaccination site pain). At the time of the report, EYE PAIN (Pain behind eye), FEELING ABNORMAL (brain fog), PAIN (Sharp shooting pain in right side of brain), HEADACHE (Headache) and VACCINATION SITE PAIN (vaccination site pain) had not resolved and ARTHRALGIA (Pain in shoulder) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Feb-2021: Reporter, patient details and events added On 29-Apr-2021: five events are added
This is more a concern regarding the injection of the vaccine,: My right arm developed a red, hard, painful/tender area approximately 4 inches wide and 5 inches long where the injection was given.  The area of  injection was black and blue.  I did not notice this at the beginning as I figured what I was feeling was normal.  On the second day, my wife wondered if the injection may have been given subcutaneously versus in the muscle.  No treatment was done.  This lasted until today 4/10, where now this area of the arm is back to normal, and only the black and blue area is evident where the injection was given.  My wife and I would just like to ensure that I will get adequate coverage from the vaccine if it was not administered in the muscle. We would like to ask for next steps.  Do you think it was given in the muscle? Should I receive another vaccine  after this one, since this was my second one?  Or, is there a way to determine if I built up enough antibodies to get the coverage from the vaccine at 95%, which I believe is the coverage for 2 doses of the Moderna vaccine?  My wife stated she will also call her physician on Monday to ask the same questions.  Thank you.
Anemic; Urinary tract infection; Lethargic; Lost a lot of weight but has regained some of it back; Became weaker; Extreme fatigue; Dehydration; Lack of taste; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (Anemic), URINARY TRACT INFECTION (Urinary tract infection), LETHARGY (Lethargic), WEIGHT DECREASED (Lost a lot of weight but has regained some of it back) and ASTHENIA (Became weaker) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAEMIA (Anemic), URINARY TRACT INFECTION (Urinary tract infection), LETHARGY (Lethargic), WEIGHT DECREASED (Lost a lot of weight but has regained some of it back), ASTHENIA (Became weaker), FATIGUE (Extreme fatigue), DEHYDRATION (Dehydration) and AGEUSIA (Lack of taste). At the time of the report, ANAEMIA (Anemic), URINARY TRACT INFECTION (Urinary tract infection), LETHARGY (Lethargic), WEIGHT DECREASED (Lost a lot of weight but has regained some of it back), ASTHENIA (Became weaker), FATIGUE (Extreme fatigue), DEHYDRATION (Dehydration) and AGEUSIA (Lack of taste) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-084862 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-084862:Crosslinked case for patient's mother
07/07/2021 it began with a runny nose and felt bad; did not feel right. On 07/07/2021 I went to urgent care and I tested posted for Covid-19.
Spasms in right side ear and head for 3 days. Perhaps path of vagus nerve.
"not felt right"; Palpitations; hot and cold spells; intermittent headaches; general fatigue; Shortness of breath; Weakness; hearing is more sensitive; fever for 2.5 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever for 2.5 days), MALAISE ("not felt right"), PALPITATIONS (Palpitations), FEELING OF BODY TEMPERATURE CHANGE (hot and cold spells) and HEADACHE (intermittent headaches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PYREXIA (fever for 2.5 days), PALPITATIONS (Palpitations), FEELING OF BODY TEMPERATURE CHANGE (hot and cold spells), HEADACHE (intermittent headaches), FATIGUE (general fatigue), DYSPNOEA (Shortness of breath), ASTHENIA (Weakness) and HYPOACUSIS (hearing is more sensitive). On an unknown date, the patient experienced MALAISE ("not felt right"). At the time of the report, PYREXIA (fever for 2.5 days), PALPITATIONS (Palpitations), FEELING OF BODY TEMPERATURE CHANGE (hot and cold spells), HEADACHE (intermittent headaches), FATIGUE (general fatigue), DYSPNOEA (Shortness of breath), ASTHENIA (Weakness) and HYPOACUSIS (hearing is more sensitive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information not provided. Treatment information not provided
Muscle pain, weakness, headache, and fever x 4 weeks post vaccine. Unable to walk x 2 days post vaccine due to pain and weakness. This week patient is starting to feel "like himself" again.
RN reported markedly increased periodic breathing with frequent desaturations for 2 hours after 6 hours after 6 hours of immunizations. NNP and MD reviewed the histogram which showed 19% of the time her oxygen saturations were below 80% during that time period. Differential includes: reaction to immunizations, nasal congestion/obstruction, discontinuation of caffeine a week ago. and sepsis concerns.