chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red rash at the injection site; red rash at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (red rash at the injection site) and VACCINATION SITE ERYTHEMA (red rash at the injection site) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE RASH (red rash at the injection site) and VACCINATION SITE ERYTHEMA (red rash at the injection site). At the time of the report, VACCINATION SITE RASH (red rash at the injection site) and VACCINATION SITE ERYTHEMA (red rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Red rash increased in size and appear like a triangle measuring about 3 inches long x 1.5 inches wide.  Concomitant medication information was not provided.  Treatment medication information was not reported.
major dizziness/felt light headed/felt like she might pass out; involuntarily shaking; she didn't think she could get out of bed to walk; a little itchy at injection site; rash at the injection site; injection site pain; full blown, intense headache; rash - redness at the injection site; was scared and cried; an electrical feeling that was spinning in her head really fast; heaviness over her head; diarrhea; minor asthma; throbbing; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (throbbing), ASTHMA (minor asthma), DIZZINESS (major dizziness/felt light headed/felt like she might pass out) and TREMOR (involuntarily shaking) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included fluticasone/salmeterol                                         inhaler BID and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (throbbing). On 28-Feb-2021, the patient experienced ASTHMA (minor asthma). On 01-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 02-Mar-2021, the patient experienced VERTIGO (an electrical feeling that was spinning in her head really fast), HEAD DISCOMFORT (heaviness over her head) and TENSION (was scared and cried). On an unknown date, the patient experienced DIZZINESS (major dizziness/felt light headed/felt like she might pass out), TREMOR (involuntarily shaking), ASTHENIA (she didn't think she could get out of bed to walk), VACCINATION SITE PRURITUS (a little itchy at injection site), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PAIN (injection site pain), HEADACHE (full blown, intense headache) and VACCINATION SITE ERYTHEMA (rash - redness at the injection site). The patient was treated with GUAIFENESIN (MUCINEX) at a dose of 600 mg and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), PAIN (throbbing), ASTHMA (minor asthma), VERTIGO (an electrical feeling that was spinning in her head really fast), HEAD DISCOMFORT (heaviness over her head) and TENSION (was scared and cried) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-063929 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-063929:crosslinked with second dose
received her first dose on April 23, 2021; Expired dose was administered to 1 patient; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received her first dose on April 23, 2021) and EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to 1 patient) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (received her first dose on April 23, 2021) and EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to 1 patient). On 10-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to 1 patient) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (received her first dose on April 23, 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Updated Contact number and an Event. On 03-Aug-2021: Non-significant follow up received.
Cough; Runny nose; Waking up last night every hour; Feeling restless; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 25Mar2021 (at the age of 67-year-old) as Dose 2, single for COVID-19 immunization. Patient medical history included COPD from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient historical vaccine included received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as Dose 1, single for COVID-19 immunization. On 25Mar2021 (at night), the patient woke up to use the bathroom and felt restless every hour and on 26Mar2021, (this morning) patient had cough and runny nose. Patient wanted to know if this would be something to be concerned about. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Runny nose; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
This spontaneous report was received from a physician refers to a patient of unknown demographics. Information regarding medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (unspecified dose, Lot number and expiry date). Other co-suspects had concomitant medication were not reported. On an unknown date, the patient developed a respiratory infection. No product quality complaint was reported. The outcome of respiratory tract infection was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 29-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
deltoid became painful described as goose egg;pain radiated down left arm & neck;returned to MD ofc feeling hot & dizzy headed;placed on floor-progressed to syncopal episode (lost consciousness 1-2sec);tx DPH;adm to hosp r/o MI;
Patient only experienced headache and nausea during 24 hours after 2nd shot; Patient only experienced headache and nausea during 24 hours after 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Patient only experienced headache and nausea during 24 hours after 2nd shot) and NAUSEA (Patient only experienced headache and nausea during 24 hours after 2nd shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 001A21A, 012521D and 0B6L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension and Overweight. Concomitant products included LOSARTAN, CHARCOAL, ACTIVATED (CARBOTURAL), HYDROCHLOROTHIAZIDE, AMLODIPINE and POTASSIUM for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (Patient only experienced headache and nausea during 24 hours after 2nd shot) and NAUSEA (Patient only experienced headache and nausea during 24 hours after 2nd shot). At the time of the report, HEADACHE (Patient only experienced headache and nausea during 24 hours after 2nd shot) and NAUSEA (Patient only experienced headache and nausea during 24 hours after 2nd shot) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient didn't received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-710993 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710993:Bivalent case
Patient received the vaccine around 12:30 pm. After administering the vaccine, patient was told to wait 15 min in the waiting/observation area. After 10 min waiting her husband waived at the pharmacist stating she was not feeling ok. When I approached to her ask how she was feeling, she stated she had shortness of breath and was feeling that she was fainting. I decided to lay patient on the floor and pull legs up and ask patient to start breathing. I then asked patient if she was feeling ok and she stated was out of breath and had numbness on the lips and the arms. I asked the other pharmacist to call 911 and decided to administer an Epipen after checking on patient again and stated that she was out of breath and lips were still numb. After 5 mins patient continued with the shortness of breath and numbness but emergency services arrived at that moment and checked her vitals, administered IV fluids, and she was taken to hospital. She left awake and apparently ok and she never lost consciousness.
01/15/2022:  Injection site reaction - rash around injection developed and became increasingly larger each day through 01/21/2022.    The area was about the surface size of an orange and was red,  hot, painful, circular, swollen, itchy, and heavy feeling.  I also developed swelling  and pain in my armpit area to the level that it made it hard to  rest my arm against my body.    This all continued, and my whole arm began to feel painful down to the tips of my fingers with a great feeling of heaviness.  As of today, 01/24/2022, the redness has somewhat faded, but it is still warm, swollen, itchy, and heavy feeling with a "fluttering" feeling in my arm. 01/15/2022:  General health - developed a fever (102 at highest point), chills, fatigue, nausea, loss of appetite, headache with symptoms progressively getting better each day after.
Patient got lightheaded/dizzy, BP dropped as low as 66/33 P50. Placed supine with legs elevated. Given oral fluids total of 4 bottles (240mL) and 1 bottle (500mL), BP improved to 107/81 P55. Only drank milk in AM and no breakfast. Felt chills, given ASA 650mg PO. Given additional 500mL bottle of water, discharged in stable condition
Swelling, redness, and heat at injection site; Redness, and heat at injection site; Heat at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced swelling, redness, and heat at injection site following a dose of Shingrix.  The reporter consented to follow up.  The events lasted for 4-5 days following administration. No additional information provided. The case has been linked with the case US2020AMR163530, reported as same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR163530:several other patients case US-GLAXOSMITHKLINE-US2020161260:same reporter
Syncope and diaphoresis after immunization.  Placed supine and given oral glucose.  Transported to ED via ambulance.
Patient has redness and swelling from his deltoid to elbow area. Started with just redness to deltoid area on 4/26/18 and spread to elbow area by 4/27/218. Patient to use warm and cold compress on and off and administer TYLENOL as needed for pain. Provider ordered antibiotics for patient. Patient to return on Monday 4/30/18.
Patient admitted to the hospital on 10/5/2021 for evaluation of cough and nasal congestion.  Patient also reports bilateral foot coldness.
Local inflammation and induration on day 2, post vax. Received keflex and Motrin.
Child had a generalized tonic-clonic seizure of 3 min. duration associated w/a temp of 104 RToccurring approx 12 hrs after 4th DTP. No treatment given.
severe constipation 02 days; inappropriate schedule of vaccine administered ( dose 1 on 01Mar2021/ dose 2 on 21Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Apr2021 13:00 (Lot number: ER8736) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure", start date: Jul2014 (ongoing); "Depression", start date: Aug2018 (ongoing); "Anxiety", start date: Aug2018 (ongoing); "Diverticulosis", start date: Jan2016 (ongoing); "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN HYDROCHLOROTHIAZIDE AKRIKHIN taken for blood pressure abnormal (ongoing); WELLBUTRIN taken for depression, anxiety (ongoing); PRISTIQ taken for depression, anxiety (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 4pm, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Batch/lot number: ER8737), administration date: 21Mar2021, when the patient was 50 years old, for Covid-19 immunization, reaction(s): "severe constipation". The following information was reported: CONSTIPATION (medically significant) with onset 23Apr2021, outcome "recovered", described as "severe constipation 02 days"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Apr2021, outcome "unknown", described as "inappropriate schedule of vaccine administered ( dose 1 on 01Mar2021/ dose 2 on 21Apr2021". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Jul2014) high; colonoscopy: (Jan2016) unknown result. Therapeutic measures were taken as a result of constipation. Follow-up attempts are completed. No further information is expected.
hot to touch; very high fever/cools off and then have high temperature/hot to touch; headaches; chills; nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING HOT (hot to touch), PYREXIA (very high fever/cools off and then have high temperature/hot to touch), HEADACHE (headaches), CHILLS (chills) and NAUSEA (nausea) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced FEELING HOT (hot to touch), PYREXIA (very high fever/cools off and then have high temperature/hot to touch), HEADACHE (headaches), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 27-Oct-2021 at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (TYLENOL COLD [DEXTROMETHORPHAN HYDROBROMIDE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) on 28-Oct-2021 at an unspecified dose and frequency. At the time of the report, FEELING HOT (hot to touch), PYREXIA (very high fever/cools off and then have high temperature/hot to touch), HEADACHE (headaches), CHILLS (chills) and NAUSEA (nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.  Patient received 1st and 2nd dose of the Pfizer vaccine.  Patient got the moderna vaccine as booster dose.
Vaccine was given to 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was given to 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was given to 17 year old). On 16-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was given to 17 year old) 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.
After employee took a hot shower 5 hours after receiving the vaccine, she experienced sensation of lump in throat and facial flushing. She also felt her tongue "had a heartbeat" but not swollen. She drove herself to our ED. Also after arrival to ED felt nauseous, but no vomiting.
mildly sore left arm; I have received 4 shots of the Moderna vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (mildly sore left arm) and ACCIDENTAL OVERDOSE (I have received 4 shots of the Moderna vaccine) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, MAGNESIUM OXIDE, FISH OIL, CENTRUM VITAMINTS, PANTOPRAZOLE, FINASTERIDE, TAMSULOSIN, AMLODIPINE, FERROUS SULFATE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced ACCIDENTAL OVERDOSE (I have received 4 shots of the Moderna vaccine). On 14-Jan-2021, the patient experienced MYALGIA (mildly sore left arm). On 15-Jan-2021, MYALGIA (mildly sore left arm) had resolved. On 10-May-2021, ACCIDENTAL OVERDOSE (I have received 4 shots of the Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test negative: Negative. In June 2021, SARS-CoV-2 antibody test negative: Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received 2 more shots of the Moderna COVID-19 vaccine, as he thought that the negative test he took to test for the spike protein antibody in Mar 2021 was due to his autoimmune condition, which he thought was why he was not responding to the first 2 doses of the vaccine. He received the 3rd dose of the COVID-19 vaccine (Lot #: 036B21A) on 13 Apr 2021 and the 4th dose (Lot #: 048B21A) on 10 May 2021. He then got tested again for the spike protein antibody in early Jun 2021, which came back negative again. He said that the only adverse reaction he experienced was a mildly sore arm for 24 hours, 2 days after receiving the vaccination shots.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-238058 (Patient Link).
I passed out as soon as I walked away and that lasted about 30 minutes. I felt nauseous all day.
p/vax started coughing; awakened & vomited phlegm x2; T101; tx: tylenol & tepid bath, but inc when rx wears off; MD admits to flu like symptoms x1wk; recovery cont
Pt recvd vax 3PM 4JUN91, temp inc by 5PM; Mom called ER who told sponge bath in tepid water; Temp cont to inc to 104 R; Mom took pt to ER approx 630PM w/fever, chills, h/a, shaking hard, fast respirations; MD states pt not to havePertussis;
1 hour after, experienced mild soreness around site of inject and elbow of injection arm Ramped up until 4 hours later it was very sore at the shoulder, especially when rotating the shoulder back or lifting it. Pain continued until 9pm day two, when I took a tylenol for relief, along with pain. Around 5pm day 2, fatigue, chills, sore throat, and mild 99 fever began and continued until the tylenol at 9 pm. Day 3, woke up with slight arm pain and very mild cold symptoms, including fatigue and head congestion.