chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 minutes after administration she reports that she felt like she was going to pass out.  Pt's skin tone became ashy and she slumped over.  PT continued to be able to answer questions but was unable to open eyes.  BP was 86/60, HR 54 and RR, O2 Sat was 98 on RA. EMS evaluated and no further treatment needed
Moderna COVID-19 Vaccine EUA Per EMT Chief Complaint:  Dizziness  10:23 AM B/P 128/82 Pulse 46 Respirations 18 10:33 AM B/P 126/80 Pulse 48 Respirations 16 Patient CAO X 4, complaining of dizziness, pupils dilated, fisting with hands, appears nervous, vitals stable, pulse rate low but patient states he is a runner/soccer player. BLS assessment conducted, no issues noted, had breakfast, denies diabetic or similar history.  Physician on site evaluated patient, appears to be anxiety, patient declined EMS, released when dizziness subsided. Instructed to monitor symptoms, seek medical attention for anaphylaxis or near syncope symptoms.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-DEC-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
ALLERGIC REACTION TO VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced allergic reaction to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction to vaccine was not reported. This report was non-serious.
left arm is Sore and Tender; Jaw Swollen; in itching Hives "from head to toe".; Itching hives from head to toe; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 28th January 2021, 8 hrs after receiving Shingrix, the patient experienced hives and pruritus. On 29th January 2021, the patient experienced facial swelling. On an unknown date, the patient experienced pain in arm. On 29th January 2021, the outcome of the hives and pruritus were recovered/resolved. On an unknown date, the outcome of the facial swelling was recovering/resolving and the outcome of the pain in arm was unknown.   The reporter considered the facial swelling, hives and pruritus to be related to Shingrix. It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient broke out in itching Hives from head to toe.  On 29th January, he woke up at 4:00 AM to find his Jaw Swollen, the swelling had decreased.  He also reported that his left arm was sore and tender.  The reporter did not consent to follow-up.
I had a sinus infection at some point - within the last couple of months - treated with antibiotic (1 course). About six weeks ago my blood pressure was a little elevated and I had chest discomfort. I took the medication OTC - Prevised - 14 day regiment - which I was told to do for when my blood pressure acts up and it seems to have helped. I am feeling a little better so I'm hoping it was just my Reflux that was acting up.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Concurrent conditions, pertinent medical history or concomitant therapies were not reported. On 03-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9 (lot# reported as L019286, expiration date: 17-SEP-2017) (dose, route of administration and frequency were not reported), post temperature excursion. No adverse effects were reported. It was stated that the patient did not sought for medical attention. This is one of several cases from the same reporter. Additional information has been requested.
BACK OF NECK WARM TO TOUCH; PAIN ON BACK OF NECK; HEADACHE; FEVER; This spontaneous report received from a parent concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, treatment medications included: acetylsalicylic acid, and ibuprofen. On 06-MAY-2021, the subject experienced back of neck warm to touch. On 06-MAY-2021, the subject experienced pain on back of neck. On 06-MAY-2021, the subject experienced headache. On 06-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from fever on MAY-2021, and had not recovered from headache, back of neck warm to touch, and pain on back of neck. This report was non-serious.
This spontaneous report was received from a medical assistant, referring to multiple unspecified patients, from unknown ages and genders. Medical history or concurrent conditions were not reported. On an unknown date, improperly stored doses of PNEUMOVAX 23 (lot # L003188, expiration date: 06-JUL-2016) (strength, dose and route were not reported), were administered to multiple unspecified patients. Concomitant medication was not provided. No adverse effects were reported. It was also reported that the temperature was 10.3 degrees C, time frame was 4 hours, it was no previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information is not expected because the reporter did not allow further contact.
Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a four years old patient (gender not reported) who was vaccinated with a dose of vaccine ADACEL (lot U6104AA and exp. Date 02-Nov-2020) via unknown route in the left thigh on an unknown date. The patient's medical history included vaccine DAPTACEL received 4 doses in series at 2, 4, 6, and 17 months and no other vaccines were given concomitantly. It was an actual medication error case due to inappropriate age at vaccine administration. No adverse effects reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Employee repots dizziness, lightheaded and nausea. The employee went home and reports vomiting
Circumstance or information capable of leading to medication error; administration of 2nd dose of Shingrix less than 2 months from 1st dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error (Verbatim: Circumstance or information capable of leading to medication error) and drug dose administration interval too short (Verbatim: administration of 2nd dose of Shingrix less than 2 months from 1st dose of Shingrix). The outcome of the circumstance or information capable of leading to medication error and drug dose administration interval too short were unknown.   Additional Information: GSK Receipt Date: 21-JUL-2023 The reporter reported that potential of administration of 2nd dose of Shingrix less than 2 months from 1st dose of Shingrix.  The patient received 1st Shingrix vaccine on 26th May 2023 and wanted to have 2nd Shingrix vaccine on 21st July 2023.  The reporter stated that patient wanted to come at the time of reporting for 2nd dose of Shingrix.  The second dose of Shingrix had not been administered at the time of the call. The reporter consented to follow up. The reporter reported that potential of administration of 2nd dose of Shingrix less than 2 months from 1st dose of Shingrix, which led to circumstance or information capable of leading to medication error and drug dose administration interval too short.
lost 15 pounds; real bad headache; severe diarrhea/even when he drinks water, it goes straight out/Everything he's taken in has come straight out; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea/even when he drinks water, it goes straight out/Everything he's taken in has come straight out), WEIGHT DECREASED (lost 15 pounds) and HEADACHE (real bad headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 048F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced DIARRHOEA (severe diarrhea/even when he drinks water, it goes straight out/Everything he's taken in has come straight out) and HEADACHE (real bad headache). On an unknown date, the patient experienced WEIGHT DECREASED (lost 15 pounds). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at a dose of UNK UNK, qid. At the time of the report, DIARRHOEA (severe diarrhea/even when he drinks water, it goes straight out/Everything he's taken in has come straight out) had not resolved and WEIGHT DECREASED (lost 15 pounds) and HEADACHE (real bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2021, Blood test: negative (Negative) blood test negative..         no concomitant medications are provided, The diarrhea is so severe even when he drinks water, it goes straight out. patient went ER on 14-Oct-2021 and had  urine tests the results were negative. Everything he's taken in has come straight out.
Narrative:  74 y.o. male patient who received dose #1 of the Moderna COVID vaccine (Lot #031L20A, expiration 7/22/21) on 2/8/21. Primary Care Provider was notified of patient's death, which occurred in the patient's home around 20:03 on 2/20/2021. The patient's wife stated that patient had been functionally declining and weak. He also had a few episodes of vomiting and diarrhea but no blood in stool or in vomit. Per patient's wife, they did not plan to do an autopsy. Per PCP, possible cause of death includes right renal cell cancer, COPD with other associated co-morbidities. Renal ultrasound on 1/6/21 found "solid-appearing 1.8 cm mass at the lower pole the right kidney, suspicious for a primary neoplasm such as RCC." Patient followed with urology but declined any further workup. Reaction classified as severe as death occurred following vaccination.
Inconsolability with jerking movements, SX at this time 4/6/06 11:55 am.
After getting shot on 10/29/13, pt developed active case of shingles on 11/3/13. Seen Dr and getting antiviral and pain medication.
Patient got painful rash on face and opposite hand. Patient was not seen at the time and rash was beginning to resolve by time reports about one month later.
When the vaccine was withdrawn from the thigh and plunger depressed to activate the self retracting needle, the medical assistant felt that 1/2 the vaccine squirted out. Another 0.1 mL was administered on the same visit.
Flu like symptoms; Sore injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Sore injection site left arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Sore injection site left arm). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Sore injection site left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-248055 (Patient Link).
Fainting for aprox. 30 sec. Treatment: lay teen down for 15 minutes and gave Apple juice.
severe nausea, headache, fever, sore throat, dry mouth-symptoms began 10-12 hours after vaccination and lasted 12 hours. Fine by the next afternoon. Had a flu shot at the same time so can't say for certain that it was due to the Covid shot but was very sick .
Uncontrollable muscle spasms all over body. Most of the activity was in the legs, stomach, chest and shoulder muscles. There was no pain associated with the spasms. Did have tenderness and redness at injection site. Also experienced Nausea, vomiting, burning sensation in the eyelids and a weakness and stiffness in the left arm. Also numbness/dissociated feeling in his toes and a fever that ranged from 100.9 to 103. Tremors lasted a little while then headaches to left side of head started. Was taken to the ER and diagnosed with Pneumonia and dehydration. Went home and recovered after sleeping off and on for the next 24 hours.
the day after the Shingrix shot, I woke up with chills and aches.  Spent the entire day in bed, taking acetaminophen.  Felt better the following day.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX  for prophylaxis. Concurrent medical conditions included lymphoma. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a month after receiving SHINGRIX, the patient experienced melanoma (serious criteria GSK medically significant and clinically significant/intervention required). On 26th September 2018, the patient experienced shingles (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the melanoma was unknown. It was unknown if the reporter considered the shingles and melanoma to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. Fifteen days after vaccination, the patient experienced shingles. The patient was diagnosed with melanoma around that same time. The reporter consented to follow up.
Severe muscle pain throughout body (8/10 on pain scale) lasting a whole day tenderness of injection site (still present at time of report) mental haze tiredness fever (no thermometer in house, so unsure of exact temp)  Result: fell asleep at 7PM, and slept for twelve hours, not remembering much of the two hours prior to the sleep or the hour I woke up at around midnight. Dayquill reduced the symptoms somewhat, and I woke up the next day feeling significantly better. (If I hadn't I would have gone to the ER) Fever seems to have subsided muscle pain has dropped significantly (down to a 3-4/10 on the pain scale) Mental haze has cleared up Awake and alert
1 week delay, severe swelling and itching, scaley skin, small puss nodule
Immediately after receiving the vaccine tongue felt fuzzy/a little swollen. Also lightheaded, dizzy, eyes not focusing very well. After 10-15 minutes, eyes focusing better but still lightheaded. ~1 hour later noted swelling of uvula, posterior palatal arches, tongue, neck, face, lips, intermittent wheezing. In addition the next day headache and rash started. Now day 9 with continued intermittent severe swelling, wheezing, rash and headache and some level of oral and facial swelling every day as noted above. Muscle aches started on day 8.  Consulted with angioedema specialist; he felt was allergic reaction due to onset of symptoms. Had telemedicine visit with NP on 12/23/20. Had to go to Emergency Department on 12/25/20  for severe uvula, posterior palatal arch, face, lip, neck swelling unresponsive to oral Benadryl and oral steroids.
Arthralgia, UrticariaPruritus, Diarrhea, Tachycardia, HIVES/SOME WITH PUSTULES, FATIGUE, PAIN/SWELLING INJ SITE, INCREASE IN SOB WITH DECREASED BREATH SOUNDS. 02/17/2021 rash recurred in both hands and RLE requiring additional treatment with steroids Narrative:  seen by her PCP for asthma exacerbation very pruritic rash  following second dose of vaccine. treated with systemic steroids with  improvement but rash recurred soon after completing steroid therapy requiring  additional treatment  Other Relevant History:
Patient had chills, fever up to 101, tender neck and found to have viral thyroiditis.
pt recv vax 7AUG95 & parents found pt unresponsive & blue in crib 22:30 on 10AUG95; pt was successfully resuscitated & was adm to hosp for apnea monitoring & further viral illness which may be responsible for this near SIDS event;
Tendon inflammation in right foot, right hand, nerve inflammation in right, tendon on tongue and face.
Pt recvd MMR/DTP/OPV vax 11OCT90; On 13OCT90 pt was very irritable intermittently; On 15OCT90 exp poss sz versus breath holding; Hospitalized to r/o paritally treated meningitis; LP revealed clear fluid;
brain swelling; I feel like I am dieing/Why is it killing me; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I feel like I am dieing/Why is it killing me) and BRAIN OEDEMA (brain swelling) 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 07-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I feel like I am dieing/Why is it killing me) (seriousness criteria hospitalization and life threatening) and BRAIN OEDEMA (brain swelling) (seriousness criteria hospitalization and medically significant). At the time of the report, FEELING ABNORMAL (I feel like I am dieing/Why is it killing me) and BRAIN OEDEMA (brain swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was mentioned  No treatment medication information was mentioned  no any additional information was mentioned patient had a feel like I am dieing and  brain swelling to Patient reported that he experienced a feeling like he was dieing and was informed about brain swelling. He was in hospital and visited several doctors.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been  requested.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 001C21A) for COVID-19 vaccination.     The patient's past medical history included Prolactinoma (Managed with Cabergoline.no changes recently reduced visits to monitor. Prolactin levels were maintain normal range pre-pregnancy) on 07-Jan-2004 and Alcohol use (2 drinks per month.) from 08-Mar-2005 to 22-Feb-2020. Concurrent medical conditions included Drug allergy (Hydrocodone) and Drug allergy (Bactrim). Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) from 01-Jan-2015 to 22-Dec-2020 for Migraine, CABERGOLINE from 01-Jul-2020 to 22-Dec-2020 for Prolactinoma, VITAMIN D [VITAMIN D NOS] from 01-Jan-2018 to an unknown date, VITAMINS NOS (DAILY VITAMINS) from 01-Jan-2016 to 22-Dec-2020 and PRENATAL + DHA from 23-Dec-2020 to an unknown date for Vitamin supplementation.   On 30-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 15-Aug-2020 and the estimated date of delivery was 18-Jul-2021. On 30-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 30-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2020, Pregnancy test: positive (Positive) Positive. On 05-Jan-2021, Ultrasound antenatal screen: abnormal (abnormal) Slightly abnormal nuchal spacing. On 14-Jan-2021, Blood test: normal (normal) No genetic abnormalities found. On 29-Mar-2021, Echocardiogram: normal (normal) no heart concerns or abnormalities.. On 22-Apr-2021, Blood glucose: normal (normal) normal test results or gestational diabetes and normal (normal) no gestational diabetes..         Lab test also include : Anatomy Scan:25-02-2021-No abnormalities. Estimated date of conception-25 Aug 2020  No Treatment medications were reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Initial pregnancy report form was received: Patient demography, Allergies, Medical history, Concomitant medications and Lab tests were added.
3/19 Friday,    Moderate soreness behind the left eye, and Facial Swelling on Lt. cheek predominately under the eyes and slight numbness and tenderness.  Saturday  3/20, headache is dissipating however swelling under left eye is the same