chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 23 month old male. Vaccine record review of his foreign vacine card showed "INFANRIX" as his 2nd DTaP in the "DTaP-HIB" section of the card. I interpreted this as an insufficient HIB since INFANRIX is DTaP only. However on further research, a foreign country uses INFANRIX-HEP A with DTaP, IPV, Hep B and HIB. Therefore, he had an extra HIB booster.
On her way to the emergency room with ITP,in extreme danger.; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE THROMBOCYTOPENIA (On her way to the emergency room with ITP,in extreme danger.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (On her way to the emergency room with ITP,in extreme danger.) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (On her way to the emergency room with ITP,in extreme danger.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: zero (abnormal) Zero.         Concomitant medications were not provided.  Treatment information was not provided.  Patient received the vaccination in June, and she is on her way to the emergency room with ITP. Her platelet count is zero, she is basically in extreme danger. The doctor told her not to hit her head on the way to the emergency room because she is going to hemorrhage. She received her 1st dose at the end of June and her 2nd dose 28 days later.  Company Comment: This case concerns a  24-year-old, female patient with no relevant medical history, who experienced the unexpected event of Immune Thrombocytopenia. The event occurred on an unspecified date after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  24-year-old, female patient with no relevant medical history, who experienced the unexpected event of Immune Thrombocytopenia. The event occurred on an unspecified date after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
A report was received from a health care professional on 12/3/03 concerning a 53 year old female vaccinee who experienced muscle aches, pain, a dull, achy pain in her left arm and a twinge of pain in her left arm and is unable to sleep on her left side on 11/7/03 after receiving 0.5ml Fluvirin vaccine on the same day. On 11/7/03, the vaccinee experienced muscle aches and pain following administration of Fluvirin. Soon after administration the vaccinee experienced a dull, achy pain in her left arm. The vaccinee took 3 Advil and the pain and achiness subsided. The vaccinee continues to experience discomfort in the left deltoid muscle. However, she has not experienced fever and the injection has not become red or swollen. When the vaccinee is not moving, she experiences a dull ache in her left arm and when she moves she feels a twinge of pain in her arm. The vaccinee cannot sleep on her left side due to the pain in her left arm. The vaccinee is not taking any other medications and has received the flu vaccine in the past without any complications following vaccination. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
04/05/2021- Headaches and neck pain  04/08/2021- Bilateral vision issues with near complete blindness in R eye   Unbale to enter hospitalization days. Patient is planned to be admissted for 5 days total.
About a month post vaccination, spontaneous hives/rash/red blotches appeared all over the body and would come and go in short intervals of under 20 minutes. They would sometimes itch. After 2 days of this, throat swelling began to occur nightly, accompanied by lip swelling and the aforementioned hives. A corticosteroid (Medrol/methylprednisolone) dosepk was prescribed for 6 days and did not help the symptoms in any noticeable way. A daily 10 mg of loratidine (claritin) was prescribed and did not help the symptoms in any noticeable way. Once these first 2 treatments ended, a daily combined dose of 10 mg Zyrtec and 20 mg Pepcid was prescribed, along with a nasal Fluticasone Propionate twice a day. These 3 medications (Zyrtec, Pepcid, Fluticasone) immediately drastically reduced hives and almost completely eliminated nightly throat/lip swelling. It is currently the 3rd day of that treatment, and the only symptom that persists are a much milder form of the hives, which disappear within 30 minutes of taking the medications.
Information has been received from a registered nurse concerning a 5 year old male patient who on 19-JUL-2010 was vaccinated with a first dose or second dose of VARIVAX (Merck) (route unspecified and lot number:665967/0224Z). Concomitant vaccines included a dose of HAVRIX, a dose of KINRIX and dose of MMR II. The nurse advised that "between the dates of 19-JUL-2010 and 21-JUL-2010, the patient had a localized reaction after receiving the first or second dose (unknown whether dose the patient received) of VARIVAX (Merck). The physician believed could have been cellulitis". At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
102+ fever, vomiting, diarrhea, muscle aches and stomach pain continuing for more than 2 weeks after booster shot. Over-the-counter medicine has not relieved symptoms.
severe h/a, lumps in lymph nodes & neck, tingling in finger, hand & arm;
red/itchy rash at the injection; red/itchy rash at the injection; rash in the right arm; chills; Fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (red/itchy rash at the injection), CHILLS (chills), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007N2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced CHILLS (chills), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (red/itchy rash at the injection), VACCINATION SITE ERYTHEMA (red/itchy rash at the injection) and VACCINATION SITE RASH (rash in the right arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (red/itchy rash at the injection), CHILLS (chills), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (red/itchy rash at the injection) and VACCINATION SITE RASH (rash in the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.    Reporter did not allow further contact
Swollen shoulder, extreme pain in arm and shoulder, unable to lift arm for 10 days, bruise at site, temperature of 101.5, fatigued for 3-4 weeks, muscle pains.
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 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            Concomitant medications were not reported.  Treatment medications was not given.
Seizure; This spontaneous serious safety report with reference number 2022SA063571 was received by a partner on 23-FEB-2022 and forwarded to Agency on 24-FEB-2022 from a health care professional.  A 2 month and 22 days old patient, with unknown medical history, had been vaccinated with the 1st dose of Vaxelis on an unknown date for prophylaxis.  The following concomitant vaccinations were reported: Pneumococcal 13 valent vaccine.  On the same date as Vaxelis vaccination, within 4 hours after vaccination the patient developed seizures.  At time of this report, the outcome of the event was unknown.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of seizure.  Further information is expected.  For reference purposes only case is linked to MCM-003179 (same reporter).  COMPANY COMMENT: Seizure is assessed as serious due to the event being medically significant.   Seizure is listed for Vaxelis as per the Reference Safety Information (CCDS).    Considering the event appeared 4 hours following Vaxelis vaccination, and despite the concomitant vaccine as a confounding factor, the causal relationship between Vaxelis and Seizure cannot be excluded and is assessed as related.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Seizure is assessed as serious due to the event being medically significant.   Seizure is listed for Vaxelis as per the Reference Safety Information (CCDS).    Considering the event appeared 4 hours following Vaxelis vaccination, and despite the concomitant vaccine as a confounding factor, the causal relationship between Vaxelis and Seizure cannot be excluded and is assessed as related.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The agency is working with the public health on a compliance improvement plan and has been reinstated vaccination privileges.
Fever started approximately 3pm 9/26/07 - 9:30pm got a several minute tonic clonic generalized seizure. EMT check temp = 105. Treatment with antipyretics.
Red solid rash on same are I got the vaccine. About 1 inch by .5 inches. Does not appear to be in the same location as injection. Occured about 11 days
Patient received second dose of vaccine one day earlier than recommended.  The patient received the second dose on day 16, instead of the recommended 17 days or later.
Facial drooping; Slurred speech; A spontaneous report was received from a nurse concerning a 66-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed facial drooping/facial paralysis and slurred speech/dysarthria.   The patient's medical history included pulmonary fibrosis. No relevant concomitant medications were reported.   On 21 Jan 2021, prior to onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) in the arm for prophylaxis of COVID-19 infection.   On 21 Jan 2021, the patient developed facial drooping (medically significant) and slurred speech. The patient did not receive any treatment for the events.     Action taken with mRNA-1273 in response to the event was not reported.     The outcome of the events facial drooping and slurred speech was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient was given concentrated dose of Pfizer vaccine. The vial was not diluted prior to administration. No adverse reactions noted.
Pt passed out approx 5 min after vaccine administration, for about 1 minute. Felt well, returned to work at approx 30 mins after vaccine admin. didn't feel well and became disoriented. Had amnesia for next few hours until hospitalization. Was hospitalized x 24 hours and had w/u including MRI, Lab, Exam all neg. 12/8/06 Received medical records from hospital which reveal patient  had flu shot at work & became confused approx 2 hours s/p flu shot.  Patient had been ill & left work day before flu vax.  Was admitted to hospital 10/24/06 & remained overnight for observation.  Neuro consult done Final Dx: Acute mental status changes & increased bilirubin.  Allergy to flu shot.
11-11-15 - stated getting sore. 11-13-15 - rash developed. 11-16-15 - rash size of upper deltoid area - patient medicating w/OTC BENADRYL. 11-20-15 - redness and rash gone - patient.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE; LEVOTHYROXINE; FLUOXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment with Paxlovid for COVID-19 from 26Jul2022 to 30Jul2022. Patient had no known allergies or any other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
12:08pm post vaccination reports feeling dizzy w/chills, nausea; appears pale and flushed. Medical monitoring x 30min w/ vital assessment: BP 135/73 P92 RR22; responds to rest and controlled breathing.  Symptoms resolve w/no additional complaints. Released from facility w/accompanied friends
side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th May 2019, the patient received the 2nd dose of Shingles vaccine. In May 2019, less than a week after receiving Shingles vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient for himself. The age at vaccination was not reported. On 13th May 2019 yesterday from the reporting date, the patient had 2nd dose of Shingles vaccine. The patient was having a common side effects. The patient inquired, how long does the side effects last after the injection. This case has been linked with the case US2019GSK100392, reported for patient's wife.
ITCHY LEGS; LEG SHAKING; SWELLING OF LEGS/FEET; TOENAILS TURNING BLUE; TIRED; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced swelling of legs/feet. On 09-APR-2021, the subject experienced toenails turning blue. On 28-APR-2021, the subject experienced leg shaking. On an unspecified date, the subject experienced itchy legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, had not recovered from swelling of legs/feet, and the outcome of toenails turning blue, leg shaking and itchy legs was not reported. This report was non-serious.
Local swelling 8x10cm on left thigh, site of MMR #2 and DTaP #5. Child is active and tender but not painful. D localized allergic reaction suspect to pertussis.
Fever of 101.2 48 hours after injection, fever of 99.8 72 hours after injection, inflammation at injection site 3-4" wide and long with a hard red raised center.
Myalgia  first side effect was 10/5/2021 2am with chills and body aches x 24 hours Narrative:
This patient, despite being contacted after receiving the first Moderna vaccine in error under the age of 18, returned to a mass vaccination clinic site and was administered the second dose.
Cough; This spontaneous case from was received on 11-Nov-2020 from other non-health professional (reference number: NVSC2020US019771) and concerned 53-year-old female patient.  The patient's historical vaccines included influenza virus vaccines after which the patient always felt like she was coming down with a cold. The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, anatomical location, route of administration and indication: not reported). The batch number was not reported.   On an unspecified date, an unknown amount of time after receiving influenza virus vaccine, the patient developed cough.  The outcome of the event was not reported.   The reporter assessed the event as related to influenza virus vaccine. The reporter stated that the she developed cough and that it was from getting her flu shot.  The case was assessed as non-serious.   The case is linked to the case 202006190 (the same patient).  Company comment: A 53-year-old female patient was administered influenza virus vaccine polyvalent. An unknown amount of time after receiving influenza virus vaccine, the patient developed cough. The patient's historical vaccines included influenza virus vaccines after which the patient always felt like she was coming down with a cold. More information regarding temporal relationship, diagnostic findings and medical history is needed. With information available, causality cannot be excluded and is assessed as possibly related.; Reporter's Comments: Patient had a cough, states it is from getting her flu shot.; Sender's Comments: A 53-year-old female patient was administered influenza virus vaccine polyvalent. An unknown amount of time after receiving influenza virus vaccine, the patient developed cough. The patient's historical vaccines included influenza virus vaccines after which the patient always felt like she was coming down with a cold. More information regarding temporal relationship, diagnostic findings and medical history is needed. With information available, causality cannot be excluded and is assessed as possibly related.
11 days after 1st shot, I woke up not remembering anything or knowing were I was. An ambulance transported me to the hospital with stroke symptoms. At the hospital I was diagnosed with a mild stroke, TIA. My memory of the events never came back but my consciousness returned about 10-12 hours later. I was released from the hospital when stable to my Son's care, a medical doctor to watch me.  I also had a  fever for three days after the second shot which was 3 weeks after the first shot.
administered 2 days past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 2 days past the beyond use date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 2 days past the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 2 days past the beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Beyond Use date was reported as 25-May-2022. It was reported that the product did not experienced any other temperature excursions and no particulates or discoloration noted. Suspect product was transported and maintained between 36-46F.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-582105 (Patient Link).
Friday morning I woke up extremely fatigued. I saw stars in my vision and I had to lay in bed all day. I didn?t have energy to even eat. Saturday evening or Sunday morning I noticed red splotches along my torso. Sunday they began to itch and I still have them along my neck, back, upper and lower torso, and a few on my legs. I haven?t changed any environmental factors (no new lotions, creams, hair products, diet, or perfumes). Today I used Benadryl cream, but in the past I?ve been putting my regular, non-scented Aveno lotion and coconut oil.
Severe swelling at injection site with pain and subsequent overlying hives and axillary tenderness.
Found my son face down in bed with labored breathing. He usually moves his head. This has happened again on 10/17 and 10/18 and with the most recent event he gasped for air when I picked him up off his face at 3 am and had to rouse him.  He also has had restless sleep, very fussy since Monday, and he had exquisite pain at the injection site, which he has never had previously. 5 hours after he was given the vaccine, he cried inconsolably for 40 minutes straight. Also, He now has a runny/congested nose (as of 10/20/13).