chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed vomiting (x4 episode with the last possibly bilious) and diarrhea with fever to 102.7 within 24 hr of receiving vaccines. Afebrile in office, with normal mental status and abdominal exam on 11/9/12.
Update: 1st day 5/27/2021 afterwards I had to leave work early bc I was dizzy, nauseous, body aches, very weak. Day 2 was better in the morning but as the day went more body aches and headaches. Towards the end of day 2 I can?t taste anything. Day 3 sinus is all the getting on my last nerves. Nose running, head congestion, body aches, and still can?t taste anything. Now I don?t know if it?s just my allergies bc I was in pollen a little bit yesterday. PLEASE understand that I am sensitive to foreign things and have had reactions to other vaccines.
VR reported chest tightness and coughing. EMS was called to site. VR rec. epi, albuterol, and benedryl in the ambulance and was transported.
Five minutes after receipt of vaccine, patient c/o dizziness, hot, flush, shaking, nausea.   Gave Benadryl 25 mg PO @ 1214.  1215 Shaking and other s/s resolved.  1220  All symptoms resolved and decline ambulance nor visit to the hospital.   1237 All s/s resolved and left site.
Extreme sickness; felt really bad/felt crummy; Arm hurt really bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt really bad/felt crummy), PAIN IN EXTREMITY (Arm hurt really bad) and ILLNESS (Extreme sickness) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. LSAD02B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING ABNORMAL (felt really bad/felt crummy) and PAIN IN EXTREMITY (Arm hurt really bad). On 10-Mar-2021, the patient experienced ILLNESS (Extreme sickness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Mar-2021, FEELING ABNORMAL (felt really bad/felt crummy), PAIN IN EXTREMITY (Arm hurt really bad) and ILLNESS (Extreme sickness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 15:00 as dose 1, single (Lot number: EL9267), in right arm and on 03Mar2021 at 13:00 as dose 2, single (Lot number: EN6204) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bleeding peptic ulcer" (unspecified if ongoing); "Lactose intolerant" (unspecified if ongoing); "C-Diff" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "known allergies: Ceclor"; Nsaids, reaction(s): "known allergies: NSAIDS". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Anti-viral details treatment start date was on 14Jul2022, treatment stop date was on 15Jul2022, Lot number= 2815213 for indication of treatment of COVID-19.
Active Period. Second time a vaccine triggered a period. I have only had periods in the past year that were triggered within a week of receiving a COVID Vaccine.
From faxed correspondence received at manufact.  on March 27, 2002, it was reported that a 27 year old male received 2nd dose of JE-Vax vaccine, lot number ENJ2001 on  March 14, 2002. Pt experienced chest discomfort, anxiety, and jaw tightness on the date of vaccination. Pt seen in ER and all test reported to be negative. Pt also experienced dizziness after first dose with unspecified vaccination date. Pt recovered.
12/23 patient transferred out to acute care hospital for treatment/evaluation of gi bleed. patient does have h/o PPI use that was d/c 5/2020 and no recent gerd symptoms requiring intervention >60 days. NauseaVomiting, GastricBleeding & heartburn
After an hour the left foot was numb. Arm is sore at the injection site. Then it went away. Today having body aches, back pain. Temp is 99.7. Had COVID in April.
Information has been received from a pharmacist referring to a newborn. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 14-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Immediately after getting the shot- arm was sore and I was extremely  exhausted.  The day after getting the shot - I couldn?t lift my arm, had nausea, diarrhea that was golden in color, massive migraine, left kidney was in pain Day 3 - massive migraine, golden diarrhea, nausea, vomiting, left kidney pain
This spontaneous report was received from a pharmacist refers to a 65 year old male patient with diabetes, high cholesterol, chronic obstructive pulmonary disease (COPD) and gastroesophageal reflux disease (GERD). The patient's medical history included coronary artery disease, back pain and crestor which caused elevated liver enzymes. On 24-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001003, expiry : 24-APR-2014). Concomitant therapies included acetaminophen with codeine, albuterol nebulizer (manufacturer unknown), aspirin 81 mg, glyburide, metformin, methocarbamol, omeprazole, simvastatin (manufacturer unknown), tiotropium bromide, gabapentin, dutasteride and tamsulosin hydrochloride. On 25-JUL-2013, the patient experienced shingles rash two days after vaccination with ZOSTAVAX. The pharmacist reported that the patient described the shingles rash as a rash on the front of his chest from his armpit to his chest that is red, itchy and painful (like mosquito bites). Patient sought medical attention-contacted pharmacist. No treatment was given. No laboratory tests were performed. The outcome of shingles rash was reported as not recovered. Additional information is not expected.
REDNESS; SWELLING AT SITE; CHILLS; HIGH TEMPERATURE; NAUSEA; HEADACHE; COUGHING; SNEEZING; PRESSURE IN EARS; SORE THROAT; RUNNY NOSE; This spontaneous report received from a patient concerned a 72 year old female. 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 not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced sneezing. On MAY-2021, the subject experienced coughing. On MAY-2021, the subject experienced pressure in ears. On MAY-2021, the subject experienced sore throat. On MAY-2021, the subject experienced runny nose. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced high temperature. On MAY-2021, the subject experienced nausea. On MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced redness. On 15-MAY-2021, the subject experienced swelling at site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure in ears on 23-JUN-2021, redness on 16-MAY-2021, and swelling at site, chills, nausea, and headache, was recovering from sneezing, and runny nose, had not recovered from coughing, and the outcome of sore throat and high temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210643478.
Pt recvd 2 doses of Engerix-B & exp no reaction following 1st inject but 6 hrs p/2nd dose pt devel itchy rash; seen by MD for tx;
Pink eye in both eyes; painful in the left eye; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVITIS (Pink eye in both eyes) and EYE PAIN (painful in the left eye) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONJUNCTIVITIS (Pink eye in both eyes) and EYE PAIN (painful in the left eye). At the time of the report, CONJUNCTIVITIS (Pink eye in both eyes) and EYE PAIN (painful in the left eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
pt recv vax; 21mar96 @ 5:00 am pt exp very high fever. mother did not have thermometer but stated the pt whole body was hot.  pt was lethargic, pt body shook, & vomited. APAP was given & fever went down; 3 days later pt devel chicken
tingling her left side of her abdomen; arm pain; myalgia; fever; malaise; HA; chills; fatigue; sweating; trouble lifting her arm; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling her left side of her abdomen), PAIN IN EXTREMITY (arm pain), MYALGIA (myalgia), PYREXIA (fever) and MALAISE (malaise) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-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 PARAESTHESIA (tingling her left side of her abdomen), PAIN IN EXTREMITY (arm pain), MYALGIA (myalgia), PYREXIA (fever), MALAISE (malaise), HEADACHE (HA), CHILLS (chills), FATIGUE (fatigue), HYPERHIDROSIS (sweating), MOBILITY DECREASED (trouble lifting her arm) and NAUSEA (nausea). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]) for Shingles, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling her left side of her abdomen), PAIN IN EXTREMITY (arm pain), PYREXIA (fever), MALAISE (malaise), CHILLS (chills), FATIGUE (fatigue), HYPERHIDROSIS (sweating), MOBILITY DECREASED (trouble lifting her arm) and NAUSEA (nausea) had resolved and MYALGIA (myalgia) and HEADACHE (HA) outcome was unknown.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: New events and their respective outcomes added.
Patient stated about 4 hours after receiving her Covid vaccine she starting throwing up and had a headache. She stated she threw up several times and felt really tired. With in 24 hours the nausea and vomiting passed. However she still felt tired.
Mother reported adverse reaction  on 11/16/2020  x telephone visit and Vaccine Concern.  Per: Mother Sx's began 10 days ago. Mother states she noticed vomiting after injection administration 11/06/2020. Mother states " we couldn't give him any food because he would throw up." Mother did not take patient to urgent care and patient is feeling better. Patient reported soreness in area of injection. Denies rash, site reaction, diarrhea, cough or cold sx's.  Provider will keep in observation. Patient has an appointment in 1 month.
SLIGHTLY TIRED; NAUSEA; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included: reaction to the shingles shot, and concurrent conditions included: colitis, hashimotos, blood pressure, and anxiety, and other pre-existing medical conditions included: Got unspecified shingles shot 3 years ago and was not on Xelganz at the time and she did have a reaction to the shingles shot. She was B+ blood type. Took unspecified medications for high blood pressure and anxiety. The patient experienced drug allergy when treated with benzoyl peroxide, and ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 002A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included tofacitinib citrate for colitis. On an unspecified date, the patient experienced slightly tired, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and the outcome of slightly tired was not reported. This report was non-serious.
a month and a half after receiving the vaccine, I developed blood clots in legs; I was diagnosed with DVT; it travelled to the lungs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (a month and a half after receiving the vaccine, I developed blood clots in legs), DEEP VEIN THROMBOSIS (I was diagnosed with DVT) and PULMONARY EMBOLISM (it travelled to the lungs) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced THROMBOSIS (a month and a half after receiving the vaccine, I developed blood clots in legs) (seriousness criteria hospitalization and medically significant), DEEP VEIN THROMBOSIS (I was diagnosed with DVT) (seriousness criteria hospitalization and medically significant) and PULMONARY EMBOLISM (it travelled to the lungs) (seriousness criteria hospitalization and medically significant). The patient was treated with APIXABAN (ELIQUIS) in March 2021 for Deep vein thrombosis, at a dose of UNK dosage form. At the time of the report, THROMBOSIS (a month and a half after receiving the vaccine, I developed blood clots in legs), DEEP VEIN THROMBOSIS (I was diagnosed with DVT) and PULMONARY EMBOLISM (it travelled to the lungs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: he was diagnosed as having deep vein thrombosis (abnormal) CT scan of his lungs. He was diagnosed as having Deep Vein Thrombosis (DVT). In 2021, Ultrasound Doppler: he was diagnosed as having deep vein thrombosis (abnormal) An ultrasound of his heart and legs. He was diagnosed as having Deep Vein Thrombosis (DVT).         Patient reports having to be hospitalized overnight, one month after vaccination. He stated that he was previously a healthy male with no underlying health conditions.   Concomitant medications were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Part 1 of the Zoster Vaccine given in May 2019. About 12 hours after receiving vaccine felt weak, fatigued, nauseous. Arm was very sore. Could not eat all day. Slept for full day thereafter. The next day was fine.  Part 2 of the Zoster Vaccine given in August 2019. Again, 12 hours after receiving vaccine overcome by weakness, fatigue, nausea at a level twice of the previous experience, including arm soreness. This time recorded a fever of 101ºF. Also nausea so severe it caused one episode of vomiting. Lasted throughout the day. The next day was fine.  The good news is that in the one year since, I have not had a shingles break through since. With the previous one dose Zostavax vaccination received in October 2017, I continued to have small shingles outbreaks every few months for which I would take Valacyclovir.   Apologies for the delay in reporting.  At my 2020 physical, I told this to my doctor, who said to report it to the CDC.
Patient diagnosed with varicella in 2003; Patient diagnosed with herpes zoster 4/08
10 minutes post vaccination during observation, patient fainted and did not rouse immediately.  I administered ammonia inhalant was used within 1-2 minutes of her LOC, and patient gained consciousness but was diaphoretic and pale.  Within 2 minutes of the ammonia inhalant, she began convulsing (full body convulsions, eyes rolled)  For 30-45 seconds.  She had continued LOC for 1-2 minutes, 15L O2 mask was administered, and patient slowly came in and out of consciousness for the next 5-10 minutes, bradycardic 35-45 bpm, BP 72/50, HR irregular, RR 16 BS clear.  At the time of observed convulsions, 911 was called and arrived within 10-12 minutes.  When EMS arrived, she remained pale but with some improved pallor, HR 45 bpm, and more alert.  Transported by EMS to hospital for eval.
Broke out with 15 pox unilateral face and arm.  Developed 1-2 more pox each day for next two days.  Total 18 pox per mom.  No fever no coryza- (+) cranky/grumpy.  Resolved without incident-some scars per mom.  Fine now. (Pox developed bilateralley after first day).
Pain right deltoid and shoulder, more prominent in shoulder region. Denies fever. Full movement of arm. No redness. Slight edema noted. Pt's return to clinic was 2 days, post vax. Pt's mother could not wait and went to own MD on Monday, after injection, then to ER for admitting.  Diagnosis: septic shoulder
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 1:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 1:14 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was reported as 49.57.  No concomitant medications were reported.  On 13-Jan-2021, 30 vials were moved to clinic. The vial was initially moved to the fridge on 09-Feb-2021 and proposed beyond use date was 10-Mar-2021.  On the date of administration, at 09:00 A.M to 11:00 AM., the temperature recorded was 32 degree Fahrenheit and at 02:00 PM to 03:00 PM., the temperature recorded was 35 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 13-Jan-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.  The occupation of reporter was reported as clinic manager.   This case was linked to MOD-2022-566976 (Patient Link).
No adverse event; Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 27-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Feb-2023, after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date).    No concomitant medications were reported.  No treatment information was provided.
This spontaneous report as received from a pharmacist refers to a patient of unknown age with HIV infection. On an unknown date the patient was vaccinated with a higher than normal dose of RECOMBIVAX HB (lot number unspecified). No adverse symptoms reported. The outcome of the patient was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
None known at this time - Moderna not approved for use of patient under 18 years of age
Patient reports  start feeling shooting  through her chest once they inject her with needle, start feeling little dizziness, it was her second COVID vaccine, Moderna, denies chest pain, SOB, palpitations, blurred vision, lightheadedness, swelling of the face, throat or tongue. denies weakness.