chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; Patient was inadvertently administered an expired dose of M-M-R II; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medications.  On 17-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rha(M-M-R II) lot # N014483 with expiration date of 10-MAY-2019, subcutaneously for prophylaxis (dose, frequency and anatomical location were not provided). No adverse effects were reported.
Vaccines given on 9/19/17 at approximately 4pm. Patient developed sore throat, profuse sweating with weakness/dizziness within 6-12 hours after receiving both vaccines. Had elevated WBC 20.7 and lactic acid 2.64 on admission to hospital. There is some redness at injection site of pneumococcal vaccine that patient says is getting worse (this is first encounter with patient- 9/21).
2 hours after the vaccine I got a  rash on my left arm & towards the night I was very tired. On Sunday a lot of soreness in my arm . Monday I had headaches. Tuesday I had chills I went to urgent care and they told me it was just a reaction to the vaccine .  On the Dec 29th I got tested for covid and I tasted positive and on the Dec 28th I got diagnosed with pneumonia.
Fatigue started day after, but felt better by evening. Extreme fatigue started 2/8 in the morning upon rising. Continued through 2/9 when 102.4 fever and chills set in.
One hour after injection: blurry vision, funny taste in mouth, weak, dizzy. Two hours later: had to go to bed so weak. Chills, achy especially in knees and ankles, severe headache  Evening felt itchy all over and a fever blister erupted.  Soak with sweat thru the night. Nauseated. Today(4th) day ringing in my ears, headache, still very weak.
The first day I was fine until about 11:30p.m. I started to have  fever and body aches. Then the next morning I started vomiting about 11:30am and again at 1:30pm. I became very weak and couldn't hold anything down. My wife took me to the ER and I was given iv fluids and nausea medicine, ibuprofen, Benadryl, and Toradol for my headache.  I was then released after a bag of fluids . The following day my injection site had a red circle the size of a large grapefruit and was warm to touch and I still have a light red circle around injection site.
Two hours after vaccine administered, pt experienced severe left lower quadrant pain/cramping a 7 on a scale of 1-10 with 10 being the worst pain. Pain lasted 1 hour, pt laid down, fell asleep.
INFLAMMATION OF OROPHARYNX; INFLAMMATION OF OROPHARYNX; DYSPHAGIA; DYSPHASIA; DOWN-TRENDING BLOOD PRESSURE; ABDOMEN TENDERNESS; TACHYCARDIA; CHILLS; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a health care professional concerned a 19 year old Hispanic or latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included glucose-6-phosphate dehydrogenase deficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021; 15:30 for prophylactic vaccination. Concomitant medications included ibuprofen.  On 15-MAR-2021 11:30, the patient experienced inflammation of oropharynx, inflammation of oropharynx, dysphagia, dysphasia, down-trending blood pressure, abdomen tenderness, tachycardia, chills, nausea, headache, and fever. Laboratory data included: Body temperature >102 F, Blood pressure (NR: not provided) Increased, and Tachycardia (NR: not provided) >115.  Treatment medications included: fluid resuscitation IV, Epinephrine, steroids, Antipyretic and diphenhydramine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflammation of oropharynx, inflammation of oropharynx, dysphagia, dysphasia, down-trending blood pressure, abdomen tenderness, tachycardia, chills, nausea, headache, and fever. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210330272-ovid-19 vaccine ad26.cov2.s- inflammation of oropharynx, abdomen tenderness, down-trending blood pressure, tachycardia, dysphagia, dysphasia. 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). 20210330272-ovid-19 vaccine ad26.cov2.s-chills, nausea, headache and fever. This event(s) is labeled and is therefore considered potentially related.
Caller reports no additional AE; expired dose of MMRlI was inadvertently administered to a patient; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-FEB-2021, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 mL, lot # S005249, expiration date 20-FEB-2021 (route of administration and anatomical location were not provided) for prophylaxis. The vaccine did not experience any temperature excursions. No additional adverse event was reported.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022).    No concomitant product use was reported.  Patient had received half dose.  Vial did not undergo any temperature excursions.  No treatment information was provided.
His wife and him were not feeling so good, due to allergies; This is a spontaneous report from a contactable consumer or other non hcp. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on an unspecified date (at the age of 49-Year-old) as dose 1, single for COVID-19 immunization. The second dose was rescheduled to be given after 5 weeks instead of 3. The patient medical history and concomitant medications were not reported. The patient experienced not feeling so good, due to allergies on an unspecified date. Patient husband would like to know if the vaccine would be as effective if it was not given at 3 weeks. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021535334 same reporter/drug/event, different patient
The patient received an expired covid vaccine at an outpatient clinic, The vial expired on 7/31/22 per extended shelf-life. The current process is covid vaccines are shipped to main hospital campus and stored in freezer. The Clinic Manager or designated leader from Urgent Care was picking up covid vaccines weekly or as needed to distribute to Urgent Care clinics. The Clinic Manager would store the vials in the refrigerator at Urgent Care to be ready to use. The nurse would pull vial from refrigerator to administer to patient.
This 66 year old woman was admitted with covid and copd exacerbation.  She was treated with steroids and remdesivir and is improved.  Today her lungs have no wheezing and she is off oxygen.  She will be assessed for home oxygen need before discharge.   She has history of PAF and did have a fib during this stay.  She was seen by cardiology.  Echo showed LVEF 35-40% She is on eliquis Further cardiac evaluation is planned as she recovers from covid
HIGH BLOOD SUGAR READING; BLACK SPOTS ON BACK AND RIGHT LEG; BODY ACHES; THROAT TIGHTNESS; THROAT PAIN; SLIGHT HEADACHE; FATIGUE, TIREDNESS; This spontaneous report received from a consumer concerned a 57 year old Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, high cholesterol, and she was a non-smoker, and non-alcoholic. The patient had no known drug or non-drug allergies and had no drug abuse or illicit use. The patient's normal fasting blood sugar was around 120. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 06-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced body aches, felt very fatigued, tired, throat pain/tightness, and slight headache after vaccination. On 08-APR-2021, the patient experienced high blood sugar with reading of 290 and 340. On 08-APR-2021, the patient noticed black spots on back and right leg (4 black dime-sized spots on her back and it spread to her right leg). The lowest blood sugar reading she had since post vaccination was on 13- APR-2021 morning which was 190 fasting.  On unspecified date, Laboratory data included: Blood test (NR: not provided) normal, cholesterol was getting better, blood sugar was under control. She was advised to continue with her dietary restrictions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 10-APR-2021, was recovering from throat tightness, and throat pain, and had not recovered from high blood sugar reading, black spots on back and right leg, fatigue, tiredness, and body aches. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood sugar increased. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
This is a spontaneous report from a 56 year old male who, received his 1st Lymerix on 3/28/1999 and subsequently, for 3-4 days he had discomfort at the injection site which resolved. On 4/28/99, the pt received his 2nd Lymerix and subsequently, he had pain at the injection site radiating to the chest for "several" months. The pt stated that his doctor recommended that the pt receive corticosteroid injection or physical therapy. The pt has used Advil for 1 month to treat discomfort. The most recent information, received on 8/18/1999, reports the condition of the pt as ongoing. On 3/10/00, the pt's wife reported that the pt had experienced lack of mobility again in shoulder and has completed four months of physical therapy. His symptoms are much improved, but are below his baseline. Additionally, the pt experienced pain in knucles.
Found a swelling under the left arm pit, no lumps in the breast. denies redness, streaks or warmth to the touch. had vaccine in that arm on 6/5/2021
itching at the lower extremities; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching at the lower extremities) in a female patient of an unknown age who received mRNA-1273 (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history Provided.).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching at the lower extremities). At the time of the report, PRURITUS (itching at the lower extremities) outcome was unknown.       No treatment information was reported. The action taken with mRNA-1273 (Unknown) was unknown.
patient passed out approximately 9 minutes after receiving his 1st dose of Pfizer vaccine.  he left his 15 minute observation period and became light headed as he passed out while on his walk to the bathroom in the facility he received his vaccine in.  he did not hit his head or otherwise injure himself during the fall. patient stated that he has a history of passing out after receiving dental work novocaine injections but did not tell this to the vaccine administrator when prompted to detail his "unsure" response to the question, "have you ever had an allergic reaction or fainted after receiving a vaccine or an injectable medication" on the vaccine consent questionnaire.  This information was provided to me by the patient after he passed out and we were asking him questions.  He felt fine and was taken back to the pharmacy for an additional 20 minutes of observation and provided him with a bottle of water.  he felt fine and left without incident after this observation period.
Pain, Redness, Swelling, Heat at the injection site. Chills, Body aches, Tiredness, nausea, for 2 days after the injection. Difficulty raising arm up above 90 degrees. Firm knot about the size of a plum, soreness, heat, and redness at the injection site still after 5 days.
This spontaneous report was received from a 66 year old female consumer reporting on herself, with irregular heartbeat, depression and no drug reactions or allergies. The patient was vaccinated in the right arm with a dose of ZOSTAVAX (lot #, dose and route not reported) on 23-JUL-2012, No other co-suspects were reported. Concomitant medications included TOPROL XL tablets, AMBIEN and LEXAPRO. The consumer reported that shortly after having the vaccine she noticed bumps on the right side of her face that went up into hairline and in the right ear on 03-AUG-2012. The right ear was where she experiencing pain down to her chin. The consumer was seen by her healthcare professional in 06-AUG-2012 and diagnosed with a case of shingles. The patient was given a prescription of antiviral medication as treatment. No lab diagnostic tests were performed. The outcome of shingles was unknown. The relatedness for shingles was not reported for ZOSTAVAX. Additional information has been requested.
Nodes around the ear, like insect bites; Pain around the ear in the same side of injection; This spontaneous case was reported by a consumer and describes the occurrence of EXTERNAL EAR PAIN (Pain around the ear in the same side of injection) and LYMPH NODE PAIN (Nodes around the ear, like insect bites) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced EXTERNAL EAR PAIN (Pain around the ear in the same side of injection). On 18-Jan-2021, the patient experienced LYMPH NODE PAIN (Nodes around the ear, like insect bites). At the time of the report, EXTERNAL EAR PAIN (Pain around the ear in the same side of injection) and LYMPH NODE PAIN (Nodes around the ear, like insect bites) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications were reported. Treatment for the events was not provided by the reporter
Injection site swelled up to size of golf ball, had severe arm pain and swelling would not go down for 5 days.
Nausea, dizziness, fatigue and a severe headache for the duration of 3-4 weeks after first vaccination.Pfizer booster reaction: leaking of lymph nodes beneath arm pit and below this on left side of upper torso.  Feels and looks like water balloons.  Soreness.  Inflammation & swelling still.
It was reported that a pt (3 of 13) received a Fluzone SV '01-'02 vaccination on 10/17/00. Reportedly, sometime after the vaccination, the pt developed a local reaction. No specifics were provided. Further information is requested.
it was irritated where I got the shot; red 2" long x 1" across; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (it was irritated where I got the shot) and VACCINATION SITE ERYTHEMA (red 2" long x 1" across) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE IRRITATION (it was irritated where I got the shot) and VACCINATION SITE ERYTHEMA (red 2" long x 1" across). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE IRRITATION (it was irritated where I got the shot) and VACCINATION SITE ERYTHEMA (red 2" long x 1" across) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included cold pack.
Warm to the touch injection site; 2" Rash on the injection site is back 6-7 days after the injection, gets worst at night; A spontaneous report was received from a consumer concerning a 32-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, two inches rash on the injection site/injection site rash and injection site was warm to the touch/injection site warmth.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 06 Jan 2021, approximately a day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly in the deltoid muscle of the left arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient received the vaccine and on 07 Jan 2021, she experienced two inches rash on the injection site. The rash lasted two to three days and the rash disappeared, but now it is coming back six to seven days later on 11 Jan 2021 and she felt the injection site was warm to touch. Treatment for the events included steroids.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event 2" rash on the injection site was not resolved. The event outcome injection site was warm to the touch was unknown.; 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.
Pt recvd 1 dose of Engerix-B & following dose exp severe rash head to toe;
08/24/2022 At approximately 02:05 PM child was given approximately 1/3 of dose and within 2 minutes and after child had been crying occurred emesis occurred with mucous and light green bile also mixed within mucous. Did not proceed with the rest of the dose and documented in system.
Day 1  Rapid heart rate, Fatigue, chills, slight temp,    Slept off and on 24 hrs thru Day 2 Day   3  Red rash over both arm pitts, below breasts, upper thighs,  Rapid heart pulse, irregular pulse, called and visited  Cardiology Clinic for Ekg confirmed PVCs Day 4    Light headed, dizziness affecting gait, forced  lying down , general brain fog, rash continued, shortness of breath, rapid heart rate, went to ER, saw nurse for Ekg, blood work, blood pressure, Tylenol 100mg 3x a day Day 5
Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:  Other Relevant History:
I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a large room that was busy with my mask, jacket and glasses on, I calmed down but did not feel well. I walked to my car, my fingers were a little tingly, then when I took my mask off the left side of my face was swelling, tingly, red (I have rosacea- but this was different) I did not panic, but I knew something was wrong. I decided to drive to the hospital instead of driving home, the valet said my face was swelling. I went to the ER - was given Pepic and Benadryl via an IV - I was there for observation - as I was waiting for my medication, I began to feel itchy at the base of my neck and on my chest
Information has been received from a healthcare worker concerning a 24 year old female who on 12-MAR-2007 was vaccinated IM 0.5ml first dose of Gardasil (lot# 655617/1447F). Concomitant therapy included DEPO-PROVERA lasted administered 12-Feb-2007. On 12-MAR-2007 the patient experienced induced period 2 hours after receiving Gardasil. Her previous period was 12-Feb-2007 so the nurse believes Depo is not working properly. The patient had the following lab diagnostics studies performed: Pap smear was normal and pregnancy test was negative. The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a healthcare worker concerning a 24 year old female with no medical history or allergies, who on 12-MAR-2007 was vaccinated IM with a first 0.5ml dose of GARDASIL (lot# 655617/1447F). Concomitant therapy given the same day included DEPO-PROVERA last administered 12-Feb-2007. There was no illness at the time of vaccination. On 12-MAR-2007 the patient developed an induced period 2 hours after receiving GARDASIL. Her previous period was 12-Feb-2007 so the nurse believes DEPO was not working properly. The patient had the following lab diagnostics studies performed: Pap smear was normal and pregnancy test was negative. The patient sought unspecified medical attention. At the time of this report, the patient recovered. Additional information is not expected.
Noted a few red spots on my arms; maybe 3-4 on each. The red spots increased in number: head, trunk, and to legs, neck and face. They only itched right when the spot appeared. Monday 3/13/06. Bumps flattened, no increase in numbers, no itchiness.
This spontaneous report as received from a register nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, strength, frequency and route were not reported) lot # J014406, expiration date 13-NOV-2015; lot # L013063, expiration date 14-APR-2017; lot # L001324, expiration date 13-JAN-2017; lot # L004655, expiration date 11-FEB-2017. No adverse effect reported. Additional information has been requested.