chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 08-SEP-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at an outpatient clinic for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to inoculation with zoster vaccine live (ZOSTAVAX), the pt was treated by a healthcare provider at an outpatient clinic for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Shingles vaccine #1 (November 26 @ 3pm) gave me flu like symptoms, pain/bruising feeling at site of injection. I just felt awful but was able to go to work, the next day I felt 100% better. Shingles vaccine #2 gave me feelings of fever/chills, nausea, lightheaded and dizzy, extreme thirst, severe headache, achy all over, pain/bruising feeling at sight of injection I couldn't get out of bed without almost passing out.   by 9:30 am I took tylenol and drank water and was able to get out of bed, but still felt very achy and had no energy, still had the headache even after tylenol but lightheadednes and dizziness was better. By 2 I was feeling much better and was able to function, by evening I was feeling much better.
reports that she developed a sore throat and tested positive for covid on home antigen test 9/20/22- has had 1 dose of Janssen and 1 pfizer booster- due now for bivalent booster
1100: Pt received vaccine; waiting in 15 minute area; started feeling flush, lightheaded,. Observer asked pt to move to the 30minute observation area.  Feelings and signs and symptoms persisted. 1115: Medical assistants called for medical ad patient taken to first aid area. Provider on duty present at bedside.  Pt last ate 15 minutes prior to arrival and feels fully hydrated. Pt denies any SOB, Itchy throat or skin, nausea or vomiting, or hives.   Medications: Methotrexate for RA, Lamotrigine for mood stabilization Allergies: Adverse effects to codeine but denies any allergies.   Pt offered water and observation continued for 45 minutes. 1130: VS: 130/70-b/p, 16-rr, 67 HR, 98% on RA, lying down. 1151: VS: 128/80-b/p, 16-RR, 78-HR, 97% on RA, Sitting 1203: VS: 132/84-b/p, 16-rr, 82-HR, 99% on RA, Standing Pt cleared for discharge at 1206.
sore throat, itching eyes, very sore muscle ache at injection site. Some difficulty breathing, body aches and pains Took an anti histimine
pt recv vax 1OCT97 & devel 4" in diameter round red hot hard, very swollen area;given ATB;3OCT97 now 2" in diameter very swollen remains hard & warm;7OCT97 still 2", sl swollen, red not as warm or hard;
Fever 105.7 & sz; woke up during noc having difficulty breathing, eyes rolled back, body went limp 2", was irritable, temp 105.7; pt seen by MD in ER & blood test & CXR done; blood test-neg, CXR showed sl asthma, unrelated to rxn;
experiencing intense stomach pains and cramps 4 days post my second vaccine.; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (experiencing intense stomach pains and cramps 4 days post my second vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN UPPER (experiencing intense stomach pains and cramps 4 days post my second vaccine.). At the time of the report, ABDOMINAL PAIN UPPER (experiencing intense stomach pains and cramps 4 days post my second vaccine.) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication not provided.  Treatment information not provided.
NEAR IMMEDIATE SWELLING AT THE SITE OF INJECTION.  GAVE 50MG OF DIPHENHYDRAMINE ORALLY IMMEDIATELY FOLLOWING OBSERVATION OF SWELLING AT SITE OF INJECTION. BEGAN MONITORING BLOOD PRESSURE AND ASKED PATIENT A SERIES OF QUESTIONS REGARDING SYMPTOMS.  PATIENT WAS MONITORED UNTIL 3:05PM AND DEMONSTRATED ELEVATED BLOOD PRESSURE (HOWEVER WE DON'T KNOW WHAT HIS BASELINE BP IS).  HE NEVER HAD ANY ITCHING, TACHYCARDIA, FACIAL SWELLING OR TINGLING, RASH, OR ANY ABNORMAL FEELING OTHER THAN THE LOCAL SWELLING AT THE INJECTION SITE. CONTACTED THE PATIENT AGAIN AT 4:45 PM AT HIS HOME AND HE SAID HE WAS DOING FINE.  I INSTRUCTED HIM TO CONTACT 911 OR GO TO THE ER IF ANY OF THE ABOVE STATED SYMPTOMS AROSE.  ALSO INSTRUCTED HIM TO CONTINUE BENADRYL 50MG EVERY 6 HOURS FOR AT LEAST THE NEXT 24 HOURS.
As soon as patient got the MMR, she started feeling dizzy. We had to call 911. Patient then said that when she had her ear piercing, she felt dizzy just like she did today. The ambulance team came to the pharmacy & at this point patient said she was feeling well. They took the patient aside from the pharmacy & checked her out. Patient came back to the pharmacy with her boyfriend and said that was fine & wanted to complete her shot; she took her other shot. She said the team took some blood sample for her glucose levels & checked her BP. She said she was fine. She later left the pharmacy with her boyfriend.
Positive COVID test; Positive COVID test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202200071639 (Pfizer).  An adolescent patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Post first vax no untoward effects. Post second dose flu-like illness, which lasted a few days and resolved. Post third dose left sided numbness, swelling of hands, wrist, and shoulder, flu-like illness, and could not walk. Treatment included an over the counter non-steroidal. Information received on 4/13/00 reported the patient is now walking and was 80% better. Gets better each day.
This spontaneous report was received from a female patient of unknown age without pertinent medical history, drug reactions and allergies. Patient was not pregnant at the time of the report. On unknown date in 2007 the patient was vaccinated with the first dose of GARDASIL, intramuscular (dose and lot # were not reported). Patient completed doses of GARDASIL intramuscular on unknown date in 2008. There were not concomitant medications. In February 2009 a pap smear showed that the patient's cells were abnormal. It was reported that the patient had been testing positive for human papilloma virus (HPV) from unknown date. Patient stated that she did not contract this through sexual contact. Patient sought medical attention on unknown date. She did not receive any treatment for the adverse events. The outcome of the events was reported as not recovered/not resolved. Follow-up information had been received via a letter on 04-NOV-2014 sent by the patient. Patient noted that she had become HPV positive since receiving GARDASIL vaccination. Patient received the first vaccination on 16-AUG-2007. Since receiving the vaccination, patient noted she was diagnosed with pelvic inflammatory disease (date not reported). With medication, she was able to get rid of that. However, in January 2009, patient went to her family doctor for routine Pap smear and was found out to have an abnormal Pap smear. Patient was referred to a gynecologist and was only given the vinegar base solution due to the fact that she was pregnant. On 05-MAY-2009, patient had a miscarriage and went for a colposcopy shortly after that. Since then, patient had been having routine Pap smear to check the levels of HPV. However, January 2014, patient went in for her six-week checkup after giving birth to her son (MARRS# 1411USA004788) and physician informed her that she needed to have a colposcopy done again as she was HPV positive. Patient had to repeat Pap smear done on 18-SEP-2014 and had to have another one redone again in March 2015. Patient noted that she had not had any problems before receiving this vaccination and being that she was HPV positive her chances for cervical cancer had increased tremendously. Patient noted that she was only 24 years old and just beginning her life and it was very devastating going through Pap smear after Pap smear. Patient noted that being HPV positive was really causing great emotional distress. She was constantly worried about this and if her everyday life routine would contribute to anything such as eating habits, daily activities, etc. Upon internal review, miscarriage was considered to be medically significant. Additional information has been requested.
Onset of tinnitus, sought diagnoses from primary care physician, referred to an ENT office, administered several tests and checks, no other hearing related issues besides the perception of ringing in the years, no actual loss in hearing
She said the patient had not experienced any adverse reactions; an expired ZOSTAVAX vaccine was administered to a patient; This spontaneous report was received from a health care professional (HCP) and refers to a 62 years old female patient of unknown ethnic.  The patient pertinent medical history, concurrent conditions, drug allergies and concomitant therapies were not provided.   On 11-SEP-2020, the patient was vaccinated with 0.65 ml of an expired vaccine live (ZOSTAVAX) lot # S016663 and expiration date 27-AUG-2020 (national drug code (NDC) 00006-4963-41) (route of administration not provided) for prophylaxis. The HCP said that the patient had not experienced any adverse reaction.
Pt received FLUZONE on 9/15/09 at 15:00. She began to feel ill by 21:00 that same day. She c/o chills, body aches x 24 hours. On 9/18/09 she awoke feeling itchy and had welts over her arms, legs and torso. She has had a rash every evening afterward x 3. All sx's have currently cleared.
I developed a mild headache on 7/27 as well as a runny nose and body aches. I tested positive that night. I developed a high fever and sore throat and intermittent coughing. I called my PCP the night of 7/27 and was prescribed PAXLOVID which I'm currently taking.
Information had been received on 18-JAN-2017 from a nurse who reported that a patient (age and gender not reported) received M-M-R II (lot# M032157, expiration 01-JUL-2018) on 18-JAN-2017 which was reconstituted with RECOMBIVAX HB 2.5/0.5 (lot# M036153, expiration 31-MAY-2018) as the diluent. No side effects reported. No further information available. Additional information has been requested.
After administering the Gardasil vaccine, the plunger/back end of the shaft broke while still in the patient's arm. The broken piece cut the MA's finger administering the vaccine but did not cause harm/injury to the patient.
TC from pt's mother on 8/19/03. She reports child starting having a quarter size lump to left arm with a red ring around and some itching at injection site.
The day after receiving my third dose of the Pfizer vaccine, I started to feel sick. I know that I always feel like I have flu symptoms when I get a vaccine, so I waited a while to visit the doctor. I was feeling achy all over my body, fatigued, bad headaches, throbbing/shooting pains, nausea, body stiffness, shooting pain in my legs and had trouble with being mobile. It felt like the pain was traveling through my body. One week it would be in my left arm and the next week in my right leg. I was admitted to the ER on 11/07/2022 because I still wasn't feeling well. I was released with no diagnosis. I saw my doctor on 11/18/2022 and she sent me back to the ER to see a neurologist. My doctor was worried that I may have had Guillain barre syndrome.  I went on 11/22/2022 to the neurologist for a follow up and they did bloodwork to verify that I did not have myasthenia gravis. My bloodwork came back that I did not have that. I had a spinal tap, an MRI and a nerve construction study performed. The only problem that was found is that I have some nerve damage.
On tuesday, 5/23/23, Administered 1ml dose instead of 0.5ml dose, to right thigh.
Two days after the shot, my right armpit is swollen and sore.; Two days after the shot, my right armpit is swollen and sore.; This is a spontaneous report from a contactable Consumer. This 65-year-old female consumer (patient) reported that: A 65-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0151) via an unspecified route of administration in arm right on 14Apr2021 08:45 (age at the time of the vaccination 65 years) as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included controlled blood pressure. The patient was not pregnant at the time of the vaccination. No other vaccine in four weeks, and no other medication within two weeks. No COVID prior vaccination and no known allergies. Concomitant medications unspecified. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8730) via an unspecified route of administration in arm left on 24Mar2021 10:00 (age at the time of the vaccination 65 years) as DOSE 1, SINGLE for COVID-19 immunization. On 16Apr2021 07:00, two days after the shot, the patient right armpit was swollen and sore. No treatment received. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had reaction to her left arm from the knuckles to her arm. She has really small red spots. It is warm. She is taking benydryl for the reaction. It hasn't gotten worse.
Headache, Sedation, Myalgia, Arthralgia, Intermittent hot flashes and chills Noted significant fatigue 5- 6 hours post vaccination. Developed headache and myalgia/arthralgia day after injection. No fever, but complained of intermittent hot flashes and chills.
Patient complained of itching around area of injection. Around 8:00 PM on 12/3/2009, noticed a red rash starting. By 7:00am the next morning, the rash area was larger and felt warm to the touch. Severely itching. Current treatment is a topical anti-itch salve.
10 hrs. After shot-Body aches-duration 4days, vomit 1x, chills-12 hours, headache-5 days, 24 hrs. After shot-swollen lymph under left arm- 4 days, 30 hours after shot-swollen teeth and gums on right side of face-5days. NEVER HAD A FEVER
Severe pain in upper arm, unable to lift arm overhead or out to the side requiring medical attention but I have no health insurance.
moderate symptoms of myocarditis; heart palpitations/strong heart beat,  chest pressure and discomfort, shortness of breath when lying down, moderate fatigue, cough, nausea. Could not walk or conduct regular daily activities at normal pace without feeling increased chest discomfort, heart rate, fatigue and weakness, cough, and nausea. Contacted PCP on 8/27 who advised likely myocarditis. Advsied to take it easy and rest. On 8/28 experienced concerning palpitations and chest pain which spurred visit to ER. Referred to cardiologist for following up on 9/14.
I slept for 12 hours a day for the first 3 days on June 27th. I thought it was related to the drive since we were on vacation.  I started having breathing issues on July 3rd. By Tuesday the 5th, it started to feel like it was a sinus infection. I took Tylenol. I felt real nasally and I started using my inhaler. Later on the 28th I developed a fever of around 100.2 which lasted about 24 hours. I contacted my provider since I had bronchitis like symptoms and could tell I was getting gunky in my right lung. The doctor advised me to take the prednisone that I was prescribed previously and gave me a Z-Pack. I took a COVID-19 Home Test on Wednesday July 6th. I started the Z-Pack that night. The next day I started the prednisone. My symptoms improved. I have been fever free since July 6. I still have nasal discharge and coughing. I am still tired but I am in the process of recovery.
Breakthrough case of COVID-19 on June 22, 2022.  Symptoms include high levels of mucus and congestion, fever, sinus pressure, sore throat and lack of energy.  Just treating this at home, and I have improved.  Still diagnosed as COVID positive today.
Swelling of bottom lip; Swelling of hands and fingers; This is a spontaneous report from contactable consumer (patient's father). A 12-year-old female patient received first shot of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration, administered to her left arm on 24May201 (Batch/lot number: EW0179, NDC/Expiry date: Unknown) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. She had no prior vaccinations (within 4 weeks). On an unspecified date in May2021 (reported as a couple weeks ago), the patient experienced swelling of hands and fingers, and swelling of bottom lip on 10Jun2021 (noticed this morning). It was reported that, the patient took BNT162B2 so she would not contract COVID-19 virus. Began a couple weeks ago. Had no swelling in hands or fingers as of today. Stopped might be a week ago. Clarified both hands and all of her fingers were swollen. Recovered completely; was a volleyball player and had not complained of pain or anything. The reported wanted to know, what he can do, does patient need to go see a doctor or the emergency room, will it go away and how should it be treated. The patient did not go to emergency room and physician office. Outcome of the event morning swelling in her bottom lip was unknown, whereas swelling of hands and fingers was recovered on an unspecified date in Jun2021.  Information on Lot/Batch number was available. Additional information has been requested.
I became dizzy and I am still experiencing it.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I became dizzy and I am still experiencing it.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event and No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (I became dizzy and I am still experiencing it.). At the time of the report, DIZZINESS (I became dizzy and I am still experiencing it.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.
arm was swollen; arm was tender; hot to touch; she have a rash but not sure if it's because of the vaccine or due to the cold weather; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Mar-2021 and was forwarded to Moderna on 07-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen), TENDERNESS (arm was tender), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE RASH (she have a rash but not sure if it's because of the vaccine or due to the cold weather) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included PAROXETINE, ETHINYLESTRADIOL, NORGESTREL (ELINEST), VITAMIN D3, CALCIUM, MAGNESIUM and ZINC for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen), TENDERNESS (arm was tender), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE RASH (she have a rash but not sure if it's because of the vaccine or due to the cold weather). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm was swollen), TENDERNESS (arm was tender), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE RASH (she have a rash but not sure if it's because of the vaccine or due to the cold weather) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included Birth control pills and Multi vitamins.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-DEC-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L025738, expiry date: 14-AUG-2017 (dose-0.5ml, strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Superficial, tender erythema, lateral right thigh, no abscess suspected, fever, but also having URI and otitis media.
Should pain: The patient came into the pharmacy on 10/06/20. He said that he received a shot on 09/28/20. He said that his shoulder started to have pain, and the pain slowly increased over a weeks time span.  The patient claimed he couldn't move his arm on 10/06/20. The patient had a provider appointment on 10/07/20. We are going to follow up with pt on 10/15/20 for more information.
11/17/2022 Sore arm  ~ 12 -24 hours in vaccine spot on left arm  Developed COVID on 12/16/22 Symptoms- mild cold, runny nose, headache, slight cough fatigue Took Paxlovid for 5 days  Symptoms resolved though tired for a week or two after
Rash at injection site: a swollen, red mark 4 inches in diameter around the site of injection, painful and hot to the touch and itchy. Appeared 7 days after receiving the vaccine.