chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness as day went on. Noticed arm was swollen and black and blue. Prior to that, patient had difficulty swallowing, breathing all night. Pt used MDI, saline nasal.
Pt reported that he had light headedness. Pt reports that he gets Vagal response. Pt passed out and was pale and sweaty. Pt came to and BP 114/71, sats of 94% and HR 62.  Assoc redid Vital signs 130/73 and 3rd BP at 5 minutes after 119/73, SAO2 96%, HR 56. Patient was then escorted to ER.
About 5 minutes after the injection,  got a flushed feeling for a couple of minutes.; This is a spontaneous report from a contactable Other Health Professional. A 43-year-old female patient received bnt162b2 (BNT162B2) lot number: EK5730, intramuscular (left arm), first dose on 16Dec2020 19:00 at a single dose for immunization. Medical history included high blood pressure and known allergies to penicillin and sulfa. Concomitant medication included escitalopram oxalate (LEXAPRO), lisinopril and omeprazole (PRILOSEC [OMEPRAZOLE]). It was reported that about 5 minutes after the injection on 16Dec2020 at  07:15 PM (as reported), the patient got a flushed feeling for a couple of minutes. The patient recovered from flushed feeling for a couple of minutes (16Dec2020). The event was reported as non-serious with no treatment received. The patient had no covid prior vaccination. She had covid tested post vaccination on 18Dec2020 through nasal swab with negative result.
11/14/14 Developed scattered discrete blanching erythematous macular, papular rash on neck, face, stomach, (no petechiae, no hives) developed. Also has croupy cough, congestion, viral URI sx. Rash could be viral exanthem or rlt vaccines.
Patient got covid vaccine yesterday and called us today. Patient told us that she felt things were blurry and was not able to see the objects very well. She also experienced couple episodes of diarrhea yesterday. Patient also experienced sore left arm today and could not move one of her arms.
Patient stated that she experienced right shoulder & neck pain. Went to emergency room. Received pain medication. Followed up with PCP & received more pain medication & steroids.
fever; chills; headache; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle aches) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle aches). The patient was treated with IBUPROFEN for Fever and Headache, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) had resolved, CHILLS (chills) and MYALGIA (muscle aches) had not resolved and HEADACHE (headache) 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 shingles vaccine (ZOSTAVAX) given left arm SQ (under skin). Next day it swelled & got red. Pt took BENADRYL and hydrocortisone cream. Went away. 1 wk later it returned. Feels like something bit her she said.
SEVERE VOMITING ABOUT EVERY 30 MIN FOR 10 HOURS, CHILLS, COLD, CLAMMY, VERY TIRED, DIARRHEA,
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 3:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 3:49 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 18.48.  Concomitant medication of the patient was not reported.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature of 34 degrees Fahrenheit at 09:00 AM and 37 degrees Fahrenheit at 10:00 AM. These vials were moved to fridge on 09-Mar-2021 and beyond use date for the vials was reported as 08-Apr-2021. The vaccines moved to clinic on 20-Mar-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
He works at two LTCF and intentionally received two vaccine doses knowing that they would be given without the proper time passing that is required by the manufacturer
I21.9 ACUTE MI 12/23/2021 DM 2 W MIXED HYPERLIPIDEMIA J96.00 ACUTE RESPIRATORY FAILURE 12/23/2021 DM 2 W MIXED HYPERLIPIDEMIA
First shot 12/27/21. It has been more than 6 months; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose of Shingles vaccine received on 27th December 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 11-Aug-2022. Reporter's Comments: This case was reported by the patient via interactive digital media. The patient received 1st dose more than 6 months ago. The patient asked he/she should get a 2nd dose. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Lethargy; Chills; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 19-Feb-2021 to 28-Feb-2021.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced LETHARGY (Lethargy), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle pain). On 25-Mar-2021, LETHARGY (Lethargy), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified eye drops and supplements. No treatment information was provided.
10 weeks following vaccine, I developed a mild case of shingles. I am unusually young to experience the condition. I do not have an autoimmune disorder. I was treated with Valtrex twice a day for 1 week. I  have responded well to treatment. Symptoms have decreased but remain present.
Shot was given abnormally high in the right  arm, at top of shoulder.  Lymph nodes in collar bone,  neck, jaw, ear on right side all swollen and painful
Sores started to develop around my mouth and in my mouth and 2 days later I went to the doctor and was diagnosed with shingles
Right deltoid, itching at injection site 1 hour after administration, then swelling, redness and pain increasing next 12 hours.
Unexplained diarrhea that has been ongoing for 3 weeks/strange diarrhea; Digestive stomach problems; sore arm; felt malaise; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Unexplained diarrhea that has been ongoing for 3 weeks/strange diarrhea) and ABDOMINAL DISCOMFORT (Digestive stomach problems) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 038K7CA and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced DIARRHOEA (Unexplained diarrhea that has been ongoing for 3 weeks/strange diarrhea) (seriousness criteria hospitalization and medically significant) and ABDOMINAL DISCOMFORT (Digestive stomach problems) (seriousness criteria hospitalization and medically significant). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm) and MALAISE (felt malaise). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE (LOMOTIL [ATROPINE SULFATE;DIPHENOXYLATE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Unexplained diarrhea that has been ongoing for 3 weeks/strange diarrhea), ABDOMINAL DISCOMFORT (Digestive stomach problems) and PAIN IN EXTREMITY (sore arm) outcome was unknown and MALAISE (felt malaise) had resolved.            No concomitant medications were provided by the reporter.  This case concerns an 80-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected events of diarrhoea and abdominal discomfort. The events occurred the same day after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-331295, MOD-2021-331192 (Patient Link).; Sender's Comments: This case concerns an 80-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected events of diarrhoea and abdominal discomfort. The events occurred the same day after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ?  9/27/2021 Is this your first or second dose- 3rd (booster) Date of symptom onset - ? 9/27/2021 Symptoms - ? headache, chills, body aches, and fever (101.9, 99.1) Last day of work and shift - ? NA Home remedies- employee stated she took Advil for the headache this morning Any improvement- employee stated the Advil is relieving the headache and the fever Recommendation- Advised employee to continue taking advil or Tylenol per pack instructions as needed for pain and fever. Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
ELEVATED BLOOD PRESSURE; ELEVATED HEART RATE; CHEST TIGHTNESS; COATING OVER EYES; VERTIGO; BLURRY VISION; SEEING DOUBLE; HEADACHE; NAUSEA; SLEEPY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) High Blood pressure. On 12-MAR-2021, the patient experienced elevated blood pressure. On the same day, the patient experienced coating over her eyes, vertigo, elevated blood pressure and heart rate 5 minutes within receiving the vaccine, headache, nausea, and sleepy. The patient felt heart racing fast. Ambulance was called and on the same day, the patient was hospitalized for 8-9 hours until blood pressure stabilized. Laboratory data included: Heart rate (NR: not provided) elevated Heart rate. It was not known if patient was discharged or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, and seeing double on MAR-2021, was recovering from coating over eyes, chest tightness, and elevated heart rate, and had not recovered from elevated blood pressure, vertigo, headache, nausea, and sleepy. The reporter and company causality considered between covid-19 vaccine ad26.cov2.s and blurry vision, seeing double, coating over eyes, chest tightness, elevated heart rate, blood pressure, vertigo, headache, nausea, and sleepy as possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210332091-Covid-19 vaccine ad26.cov2.s-Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Beginning the evening of 04/10/2021 i had developed a migraine, chills, and body aches. This continued throughout the day on 04/11/2021 as well as extreme fatigue. The morning of 04/12/2021, i was feeling fine for the most part outside of having the chills. Around 2:00 p.m. on 04/12/2021, i began to get bodyaches again as well as an accompanying migraine and was now experiencing some nausea and had begun to develop a yeast infection. On 04/13/2021, most symptoms had resolved outside of the continuing yeast infection. No symptoms were present on the morning of 04/14/2021, other than the yeast infection. The evening of 04/14/2021 i began to develop symptoms again in the form of a migraine, body aches, and nausea. The morning of 04/15/2021, i woke up with these same symptoms, but also had the chills again and was very fatigued.
Fatigue; Muscle pain; Breathing problem; A spontaneous report, was received from a consumer (patient), concerning herself, a 78 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced breathing problem (dyspnea), fatigue, and muscle pain (myalgia).    The patient's medical history included asthma, high blood pressure, atrial fibrillation, and colitis. Concomitant medications include budesonide/formoterol fumarate, albuterol, an unknown medication for atrial fibrillation, an unknown medication for hypertension, an unknown medication for colitis, and a statin medication.  On 31 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown), intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient had a breathing problem. Despite her asthma, the patient states that she usually doesn't get this out of breath. She checked her airflow and it was in the yellow zone. She increased her asthma medication and started prednisone the next day in response to airflow being in a lower zone. The patient has some fatigue, however she related that to her asthma. She also reported muscle pain, but she said this was caused by her statin medication.  Treatment for the events included prednisone. 30 mg daily for 5 days.   Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of the events, breathing problem, fatigue, and muscle pain were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events of dyspnea, fatigue, and myalgia, a causal relationship cannot be excluded. However, patient's medical history of asthma may have been contributory for dyspnea.
Child was given FLUMIST prior to 2 years of age. Parent has been contacted and provided with information on assessing for wheezing and/or signs of asthma.
Ringing on his ears; Tingling like pins and needles all over his body; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing on his ears) and PARAESTHESIA (Tingling like pins and needles all over his body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced TINNITUS (Ringing on his ears) and PARAESTHESIA (Tingling like pins and needles all over his body). At the time of the report, TINNITUS (Ringing on his ears) and PARAESTHESIA (Tingling like pins and needles all over his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 30-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing on his ears) and PARAESTHESIA (Tingling like pins and needles all over his body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced TINNITUS (Ringing on his ears) and PARAESTHESIA (Tingling like pins and needles all over his body). At the time of the report, TINNITUS (Ringing on his ears) and PARAESTHESIA (Tingling like pins and needles all over his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.; Sender'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.
Hives broke out around an hour and a half after vaccine. Only on abdomen and lower back. When woke up the next morning, they were gone.
Extreme swelling and redness down the left arm, which actually lasted two weeks.  Extreme fatigue, flu-like symptoms, and light-headless.   Saw my cardiologist the morning after the injection (on 10-30) and they discovered that my blood pressure was too low.  86/60.  It was taken several times there and wasn?t coming back up.  I had to monitor my blood pressure for two weeks and it did come back up the next day (10-31) to normal levels.
2 days after Booster shot, severe diarrhea occurred. 8-15 times a day all liquid.  1st doctor visit recommended Imodium. No improvement . 2nd visit  took blood and stool sample  and got prescription for Prevolite. no change.  I went to specialist , had more blood tests and another stool sample. All tests were normal. Colonoscopy  ordered and performed in February . Still severe diarrhea after 2 1/2 months.
Widespread hives 8/6/07 and continues 8/7/07. Knee/joint pain about 8/4/07 through 8/7/07
Injection site pain - resolved by day 3 post vaccination. Headache - onset on March 25, 2021, continues 7 days post vaccine.  light-headedness - onset March 25, 2021, continues 7 days post vaccine. Diarrhea - March 26 (multiple bouts) Nausea - occasional - continues 7 days post vaccine
4-16-10 @ 02:00 pt. awakened with itchy left hip; again @ 04:00 bilateral hands swollen, pink; scattered raised pink itchy arms @ left injection site as well as left upper arm inner aspect, Left hip; groin area. Left posterior knee throughout morning hours; at approx. 10:30 am noted Right upper lip swelling; presented to clinic at 1330; 1335 assessed by Dr.; pt. denies any SOB, or difficulty breathing; BENADRYL 50 mg IM given; 1405 symptoms resolving.
Patient was hospitalized from 12/10/14-12/13/14 for thyrotoxicosis. Upon discharge on 12/13 she received three vaccinations: MCV4 in the right deltoid, PPSV23 in the left arm sq, and influenza quadrivalent in the right deltoid. Her mother brought her to the ED on 12/15/14 as the patient developed a fever to 102, chills, pain and swelling in the left shoulder. The patient was admitted to the hospital with a diagnosis of cellulitis. She was subsequently taken to the OR to I&D the site. Necrotic tissue was excised and is being cultured. She was initially admitted to the med/surg floor but transferred to ICU post-surgery due to her previous medical condition, where she currently remains. During her previous hospitalization she was initiated on methimazole and propranolol to treat the hyperthyroidism.
No additional adverse event or product quality complaint.; ROTATEQ administered on 24-MAR-2021 and expired on 22-MAR-2021; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's concomitant medication, pertinent medical history and drug reactions or allergies was provided.  On 24-MAR-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml, orally, lot # 1660666, expiry date 22-MAR-2021 for prophylaxis. The vaccine had never undergone a temperature excursion. No additional adverse event or product quality complaint was reported.