chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Coughing; This case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced cough. On an unknown date, the outcome of the cough was unknown.   It was unknown if the reporter considered the cough to be related to Flu vaccine.     Additional Information: GSK receipt date: 29-Sep-2022 Reporter's comment: This case was reported via interactive digital media. Reporter reported that the patient had coughing. Additional supportive information: The follow up would not possible as no contact details were available.
Information has been received from a 23 year old female consumer who on 10-SEP-2009 was vaccinated with the first dose GARDASIL (lot# not reported). Since the patient was vaccinated, the patient had been experiencing pain in upper left arm ever. Therapy with human papilloma virus vaccine was discontinued. At the time of the report the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
3 days Post Shot: Felt like swollen glands in my arms, Bilateral upper arms between bicep and humerus. Pain bilateral upper arms to fingers, Arms became red/purple. Pain/stiffness in all joints of fingers (will come and go). Feels like fingers were swollen. Flushing when touched or scratched. Fatigue. Randomly welt when scratched/pinched (chest/arms) . Cold/numbness bilateral 4 h/5th fingers. Bilateral cold/numbness 4th/5th toes. Severe muscle twitches in lower extremities. Bilateral burning in toes and pads of feet. Muscle stiffness/soreness. Bright red rash on left knee ~ 4" in diameter. 9 months post shot: Bilateral muscle weakness in hands/fingers. Bilateral pain and stiffness in hands/fingers unable to flex them completely. Developed bilateral trigger finger in pinky fingers. Pads of feet continued pain and stiffness. Continued burning sensation in toes/feet.
I got both shingle shots in Jan 2020 and April 2020. I have the shingles\ suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2020, the patient received the 2nd dose of Shingles vaccine. In January 2020, the patient received the 1st dose of Shingles vaccine. In September 2021, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got both Shingles shots. In September 2021, the patient had shingles. The patient stated his/her physician told the shot was 95 percent effective. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster were unknown at the time of reporting.
Pt. noted arm that had received vaccines approximately 1 month ago was still sore and he was unable to lift arm over head.
Patient received Pfizer bivalent booster vaccine before the due time. Patient reported he received his 2nd dose of the primary pfizer series in early august this year 2022. After patient was vaccinated, he found and showed his card which showed he was actually vaccinated 9/11/2022. Patient reported no adverse reactions. Patient was monitored for 15 mins and left in stable condition.
I was feeling cold like symptoms when I woke up and I was having worsening congestion. throughout the day with a stuffy nose my throat was clogged up. I reached out to my health care provider after taking a COVID-19 Home Test and it was positive. They did give me something for treatment, but I was bed ridden for two days. I was so tired and could only sleep. My body ached all over and my joints hurt, and I had no appetite.
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 03-FEB-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB "10 PK 0.5 mcg/0.5ml SDLLolCap Ped" and lot number K008986 with expiration date of 01-APR-2016 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 444 hours with a lowest recorded temperature of -3 Fahrenheit (F) (-3 Celsius (C)) and other one of 336 hours with highest recorded temperature of 59 F (15 C). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Per pt. discovered small lump lower right arm, felt warm to touch, not itchy, not painful. 3-4 inches below injection site, recommended to see MD to evaluate the area.
rash characterized by fluid filled blisters dispersed approx (1cm apart) in a circular/oval pattern (approx 2"X1" in diameter)  on upper interior left arm about 2"X1" with .  Talk ied to pharmacist at CVS who indicated that it appeared "shingle-like" based on observation of blisters that had begun to"scab" over.  Initially noticed symptoms approx 5-7 days after vaccination which started as a couple blisters eventually spreading to 12 spots in the circle pattern described above.  1 additional blister noted on inner forearm.  Area is slightly painful.
Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: follow up received and contains non significant information.
First symptom was itching, then hives on my lower left arm. Within a week, I had the rash on both arms. Small pustules and broad, raised red patches. It spread along my arms, left armpit, chest and left side of my neck. I also had swelling  & tenderness in my left breast. The left was about 30% larger than my right.
I got a cold about the 12th of January. By the 15th I was coughing and had pneumonia in both lungs. I had the Pneumococcal Virus and Strep and Sepsis Shock. I was in ICU for 3 days and the regular unit for 2 more. I was unable to function at home for three weeks and I was just cleared the other day from the Pneumonia and Sepsis. I am still quite fatigue and have issues with remembering.
Top lip swelled up; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Top lip swelled up) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced LIP SWELLING (Top lip swelled up). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Top lip swelled up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Covid
Patient admitted 7/9 for flu like symptoms to ED, dyspnea, vaccinated for COVID 2/2/2021, tested positive 7/7/2021 Discharged Home 7/12  Allergies: ASA/NSAIDS Admitted 7/9 COVID test positive on 7/7 Reason for admission: shortness of breath and productive cough.  Plan to monitor: receiving dexamethasone and remdesivir   1st Dose: 1/12/21 1st Dose Lot Number: EL3749 1st Dose Administered by: an LPN    2nd Dose: 2/2/21 2nd Dose Lot Number: EL9261 2nd Dose Administered by: an LPN   Patient is a 61 y.o. female with past medical history of hypertension, migraine, hyperlipidemia,  Anxiety and GERD.  On 07/07 patient developed flu-like symptoms including body ache, fever and chills.  She went urgent treatment center and was tested positive for COVID.  Patient is fully vaccinated.  Over the next few days, patient develops short of breath with nonproductive cough and loss of taste and smell. She continues to have fever and body ache.  She denies abdominal pain, diarrhea or urinary symptom.   On arrival patient's oxygen was 90% on room air.  Currently on 2 L per nasal cannula O2 sat around 93%.   Review of Systems  Constitutional: Positive for chills, fatigue and fever.  Respiratory: Positive for cough.   All other systems reviewed and are negative.  Acute hypoxic respiratory failure secondary to viral pneumonia from COVID-19 infection - patient received 8 mg IV dexamethasone in the emergency - start oral dexamethasone and remdesivir on 7/10 - albuterol inhaler and Tessalon as needed - Monitor CBC w/dif, absolute lymphocyte/neutrophil ratio, CMP, CRP, ferritin, D-dimer, PT and fibrinogen  - oxygen as needed to keep sat greater than 95%   Transaminitis - No abdominal pain.  Normal abdominal exam - check acute hepatitis panel - trend liver enzymes while on remdesivir - hold Lipitor   Hypertension - on chorthalidone and lisinopril   Migraine headache - on prophylactic propanolol   Anxiety - on Atarax   Hypokalemia - replace   Obesity - complicate all aspects of care
Information has been received from an office manager concerning a pt with no medical history and no allergies who on 03/02/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647272/0664N). There was no concomitant medication. Subsequently, the pt developed swelling, redness and hot to touch at the injection site. No medical attention was sought and no diagnostic studies were performed. No product quality complaint was involved. It was also reported that two other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647272/0664N) and developed swelling, redness and hot to touch at the injection site (WAES # 0403USA00640 & 0404USA02544).  Additional information has been requested.
LEFT ARM REALLY HOT AND RED STARTED TO SWELL AND ALOT ITCHING. NO TEMP, SIZE 6.0 X 4.5. DR GAVE BENADRYL 25MG 1 EVERY 6 HRS FOR 5 DAYS.
1st shot 2 years ago 2nd dose not given yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the patient received 1st Shingrix shot 2 years ago and now was back to receive 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional (HCP) declined to provide any patient´s details . The HCP declined to have her personal contact information on our database. The reporter did not consent to follow
Developed swelling of eyes, then lips; on way to hospital developed difficulty swallowing, breathing.  Per Mom arrived at ER approximately 4:45 p.m. received IV Steroids, other medications and sent home with P.O. steroids x 5 days.
Roughly 7 hours after shot (3/21), overcome by all over body aches, chills, and general malaise.  While resting, my resting pulse rate raced to 120 beats per minute (normal for me is btw 79-82).  Headache and sleeplessness followed.  Could not work the following day (3/22), same symptoms, all over muscle pain, chills, inability to focus, deeply fatigued.  Finally, morning of 3/23, awoke feeling fine.  Entire duration was abt 36 hours.
DULL HEADACHE; MUSCLE SORENESS AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a male 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: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced muscle soreness at injection site. On 29-MAR-2021, the subject experienced dull headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dull headache, and the outcome of muscle soreness at injection site was not reported. This report was non-serious.
The day of the injection     Numb Lips     Numb gums     Tender Teeth at the roots     Joint pain     Head ache  The next day     The first days events listed above     Fatigue      Soreness at the injection site  As of 11.26.2021     Numb Lips     Numb gums     Tender Teeth at the roots     Joint pain     Head ache has been persistent since the injection      Fatigue      Reduced soreness at the injection site. The location is still sore, but not as bad as the day after the injection.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 302580) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (lot number: ER8732, administration time 03:00 PM, vaccine location Left arm), administration date: 15Apr2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "Fluid removed each symptom Started about 1 month after each dose"; BNT162b2 (lot number EW0161, administration time 12:00 PM, vaccine location Left arm), administration date: 18Mar2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "Fluid removed each symptom Started about 1 month after each dose". The following information was reported: FLUID RETENTION (non-serious), outcome "unknown", described as "Fluid removed each symptom Started about 1 month after each dose". The event "fluid removed each symptom started about 1 month after each dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: No Covid prior vaccination, no known allergies, no other medical history. No other vaccine in four weeks.
Starting on November 20, 2021 PATIENT experienced a rash on arms, abdomen, chest and trunk area that was itchy.  This nurse did not visualize it.
Mom told Dr. at 6 mo. well check that child had a fever of 102 the night of his last shots and had x 2 febrile seizures. Was seen at Emergency room that night. Not reported by ER.
11/13/2021 early morning, Right side of face swollen, cheek, jaw, and throat. Mild face droop. Sore throat. Can?t open mouth enough to eat due to swelling.
Received already 3 doses of PCV 7. Red, circle, warm to touch extending in whole front thigh area not the back. Not in pain. Sunday redness spread further but lighter. Gone today.
Information has been received from a physician assistant concerning a 17 year old female with no drug reaction/allergies and no pertinent medical history, who was vaccinated with GARDASIL (route and lot # not reported). There was no concomitant medication. On approximately 19-SEP-2010, 1 month ago, the patient experienced burning with urination, vaginal itching and went to the emergency room. The emergency room did a sexually transmitted disease (STD) screening and diagnosed with HPV. The patient was seen at the office and the physician assistant had a repeat test for HPV for the patient. At the time of this report, there was no result. The patient sought medical attention by office visit. Additional information has been requested.
Reactivation of HSV2 with cold sores and positive HSV2 in the CSF
Lympadenopathy right above left clavicle.  Symptoms started on 1/2/21 and have continued.  Nothing has been used to treat the symptoms.
After receiving SHINGRIX injection on 4/3/18, patient experienced slight soreness and redness that appeared around the site of injection on her left deltoid on 4/4/18. As of 4/5/18, patient came to the pharmacy and reported that a 5 inch diameter area around the site of injection was red, hot to touch, swollen and tender. Patient was advised to put ice pack on it and take OTC ibuprofen for pain and monitor for any changes.
This spontaneous report as received from a pharmacist refers to a 7 patients of unkonwn age and gender. On an unknown date, since 27-FEB-2014, the 7 patients were vaccinated with ZOSTAVAX (route, lot number and expiration date not reported) (7 doses) that were previously exposed to 16 F for 13.5 hours. The pharmacist stated that she had not been informed of any adverse experiences for these 7 patients. On 12-MAY-2014, the pharmacist reported that four doses of ZOSTAVAX (route, lot number and expiration date not reported) that were exposed to 16F for 13.5 hours were exposed to an additional 12 hours at a highest temperature of 36F. At the time of the report, the four doses of ZOSTAVAX that were exposed to the additional time out of range have not been administered to any patients. Additional information has been requested.
Headache, Myalgia & Diarrhea Narrative:  Per nursing report: "took first Moderna vaccine yesterday [3/29]. C/o body aches, headache, diarrhea, states feels like nerve jumping in right arm near shoulder area where received injection."  Other Relevant History:
Patient had a very short seizure lasting a few seconds.  Then was aroused and didn't have a postictal phase.  Her skin color was pale, blood pressure was low at 106/70 sitting, and heart rate was slow at 60.  She was evaluated by fire department paramedics and transported to ED.
Immediate red and hot neck, red hot face, itchy. Given double dose of Zyrtec. 12 hours later, needed another double dose, 12 hours later a single dose taken. Tongue is also sore.
This spontaneous report as received via Publicist Field Representative from a non-pregnant female, pharmacist of unknown age refers to herself. In 2012 reported as (within the past year) when the reporting pharmacist administered the ZOSTAVAX injection for prevention of shingles she experienced a swelling of the eyes which later resolved on its own on an unknown date. The reporting pharmacist did not seek medical attention. The relatedness between ZOSTAVAX and a swelling of the eyes was not reported. Additional information has been requested.
Received first dose of Pfizer COVID-19 mRNA vaccine at a vaccination site on 4/22/21 at 10:45am. Intermittent globus sensation that began approximately 45 minutes after receiving the vaccine.  Admitted to the Emergency Department at 11:29am due to concern of an allergic reaction. No other reported symptoms. Given diphenhydramine and famotidine. Discharged after 2 and a half hours.
headache which started 3 days after and has increased in severity, associated with increase in blood pressure
Multiple somatic complaints. Anxiety and feeling of doom and gloom, crying spells, chest  pain, headaches, dizziness. Body aches soon after 1st RABIES vaccine given while in Philippines and continued at this facility in the United States.
6/1  31y.o. G4P3003 at 37w6d by early 8 w 4 d  ultrasound presents to Triage with c/o contractions. Fetal movement normal. Pt states she is positive for COVID. Pt delivered baby girl
Significant erythema, edema, warmth to injection site and 9cm surrounding area. Oral DECADRON in office given for inflammation.
COVID ARM.  About 8 days in a large red circle appeared on left arm at injection site.  It was quite large with small bumps and somewhat itchy.
I felt normal; however, I believe it caused my blood pressure to increase.  My husband received his , also, and monitors his BP multiple times daily.  His BP continued to rise a little each day and thought our machine was off,  Then I took mine about 3 days later and my BP was 158/83- higher than I ever remember it.  Usually it is about 118 over seventy something.    It was back to about 108 over seventy something 5 days after the vaccine.  I wasn't going to report it, but thought someone might want to know.
This spontaneous report was received from a back office lead and refers to a 47 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2016, the patient vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L042846, expiration date: 15-SEP-2017, 1 ml, intramuscularly, in left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Nausea, headache, body ache. HPI: 35yo patient presenting to ED 24h after receiving 2nd COVID-19 vaccine with above complaints. He has no URI symptoms, no cough or dyspnea. He is having generalized abdominal discomfort without focal pain, having N without V or D. He has no other complaints.
Administered vaccine on 10/29/07 at 1129 to right deltoid area. Employee states she was unable to sleep due to pain/swelling at site and she also had a fever. Site was tender and warm to touch. Employee returned to work the following day but was naseated and had a headache. She was taken to the E.R. for evaluation due to several cardiac surgeries she had had during this year.