chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 12 year old female who on 01/24/1997 was vaccinated with a dose of varicella virus vaccine live.  The RN reported that on 02/08/2005 the patient presented to the physician's office exhibiting 60 to 80 varicella lesions across her body.  The patient was noted to be afebrile.  The patient was treated with acyclovir and diphenhydramine and was scheduled to be observed at a follow up visit.  At the time of this report, the patient was recovering from the varicella lesions.  Additional information has been requested.
Information has been received from a physician concerning a female who on 23-JUN-2007 was vaccinated intramuscularly with the first dose of the Gardasil. Concomitant therapy included "other vaccines". On 23-JUN-2007, the patient fainted. The patient was "unconscious for about 15 minutes". Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information is not expected.
This was my second dose. I have experienced disequilibrium from day 3 and it continues, today is day 7.  No adverse effects from the first dose
Headache, Fever, INJECTION SITE ARM PAIN, SWELLING, THROBBING, FATIGUE Narrative:
This spontaneous report as received from a registered nurse referring to her daughter an approximately 17 year old female patient with allergic to cockroaches. On an unknown date, the patient was vaccinated with GARDASIL 3 doses for vaccination (dose, concentration and lot number were not reported). Concomitant therapies were not reported. In January 2013 (exact date unspecified), the patient experienced headaches that were diagnosed as a Chiari malformation (with 4 mm extension of the cerebral tonsils into the spinal column caused by cerebral edema). The reporter stated that her daughter had experienced horrible pain, headaches, tingling and numbness of the extremities, and incontinence since January 2013. The reporter stated that her daughter had trouble getting through a day of school, and has missed school due to the pain, headaches and incontinence. The patient sought medical attention, she contacted her physician. A magnetic resonance imaging (MRI) was performed, but results were not provided. Patient received treatment with unspecified medication for headaches. The outcome of the events was reported as not recovered. The reporter considered the events to be disability and compression of brain stem to be life threatening. Additional information has been requested.
Patient reports shortness of breath one day post vaccine administration. Son brought patient to ER 1/13/21 where he was admitted for 3 days where Oxygen was administered.
left arm soreness; Shoulder pain; left arm swelling; redness left arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 22nd April 2019, 3 days after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the swelling arm and erythema of extremities were recovered/resolved and the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, erythema of extremities and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist at calling to report adverse event for a customer who reported that the patient received Shingrix and reported swelling and redness three days after receiving of the vaccine in her left arm, which had resolved.  The patient reports left arm pain radiating to the shoulder which started couple of days after receiving the vaccine and continued to experience this pain.
This was the second follow up shot.....no reaction to first injection.  fatigue, headache, shivering, fever and vomiting all night.
6 x 4 cm area of induration, erythema and warmth, left deltoid. Possible subcutaneous infiltration.
Pateint started with symptoms on 8/15/2021. he reported loose stools, low grade temp, cough and a runny nose. he tested positive in the emergency room on 8/17/2021. He has needed as much as 10 liters of high flow oxygen. Currently he is on 8 liter of high flow nasal cannula. he has been given remdesivir, dexamethsone, biricitinib, budesonide neb, DouNeb tx and albuterol inhaloer as needed.
Pt rec'd Covid 19 vaccine. Reported to RN about 10 min post vaccine that she felt like she was "going to have a seizure". Pt has aunt accompanying patient and pt was A&Ox3. Pt reports hx of "pseudoseizures x 5 years". RN then noted pt eyes roll back in head. Pt unconscious and assisted to floor and turned on Left Side. Head protected by staff member. AED placed on patient. Seizure approx lasted about 1 min. Pt awoke and alert and arouseable to staff. Pt then began with another seizure lasting approx the same amount of time. Pt awoke non post ictal. She was alert & oriented. Refusing 911 call or go to ED as she reports "I've been checked out many times before, I do this". Bp 140/80's, HR stable and palpable. Pt then underwent 2 more seizures lasting approx same amt of time. 911 called at beginning of 2nd seizure. Upon arrival of EMS pt was still unarouseable and taken by EMS to ED.
This spontaneous case was received from a physician via company representative regarding a 6 month old (also reported as 1 year and 9 month old) male patient. The patient did not have any pertinent medical history, drug reactions/allergies and was not taking any concomitant medications. On 02-DEC-2016, the patient received the first dose of ROTATEQ (dose, unit not reported) (lot# M029252, expiration date: 14-MAR-2018) orally, on 10-FEB-2017, the patient received second dose of ROTATEQ (dose, unit not reported) (lot# M031650, expiration date: unknown) orally for vaccination (immunization). On 05-APR-2017, the patient received the third dose of ROTATEQ (dose, unit not reported) (lot# M031650, expiration date: unknown) orally for vaccination (immunization) (Drug administered to patient of inappropriate age). On 22-NOV-2017, the patient went to an unspecified hospital and was diagnosed with intussusception. The patient sought medical attention.The patient was treated with an unspecified enema and air treatment. No lab diagnostics/studies were performed. The outcome of the event was reported as recovered. The causality assessment of the event to the therapy with ROTATEQ was not reported. The event intussusception was considered to be life threatening. No product quality complaint (PQC) was reported. Upon internal review, the event intussusception was determined to be medically significant. This is one of the two reports from the same source. Sender's Comments:  US-009507513-1807USA006275.
Had GARDASIL shot on 11/27. On 11/29 started getting large, swollen, itchy hives that lasted 15 min. and left a sore spot (like a bruise) for 24-48 hours after. Hives have continued for past two weeks. Occur at random times but nearly every night after shower. The hives/welts are smaller and last a shorter length of time 4-5 min. and are less itchy. These occur all over the body, not just at the injection site.
Pt was sitting after her COVID vaccine and began to feel faint.  She reported feeling clammy.  She denied SOB, CP.  She had not eaten in ~5 hours.  She states she has fainted before.  Pt was provided juice and crackers.  Her feet were elevated.  BP on initial encounter 110/68,  Pulse 98  O2 sat 99%.   At 5:25 BP 117/73  Pulse 82.  O2 sat 99%.  At this point pt felt back to baseline.  She denied lightheadedness, feeling clammy, SOB.     5:50pm pt left facility with co worker with no concerns.  Aware to hydrate and eat prior to next vaccine.  Aware also to come with someone.
Case number PHEH2014US021511, is an initial spontaneous report received from a nurse on 23 Oct 2014. This report refers to a 21 years old female patient. Past medical history and concomitant medication were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X14031), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 23 Oct 2014. No adverse event was reported following this administration error (inappropriate preparation of medication).
3-4 hours after receiving immunization patient reported shaking, chills, 102F temp, and watery eyes. By next morning temperature was down to 100F.
See note (attached) 02/15/2007-record received and reviewed. Office visit of 02/08/07-Assessment. Allergic reaction on chest back and left arm. Patient thinks it is related to Gardasil. Received treatment in Mexico. Treated with Betamethasone. Diagnosed with erythema multiforme. Right arm at injection site is not irritated or edematous. Allergic reaction mostly in the contralateral side.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient felt lightheaded during observation period. He fainted and fell to the ground but was responsive. the Nurse at the clinic took his vital signs.  Pt stated that he did not eat nor drink prior to vaccine administration. We provided gatorade and monitered him for an additional 30 minutes
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route, lot # were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several report received from the same reporter. Additional information has been requested,
Stroke; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Mar2021 09:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure, bleeding ulcer and helicobacter pylori infection both from 15Feb2021, and ongoing tumor on his heart. Concomitant medication included lisinopril taken for high blood pressure. The patient previously took the first dose of bnt162b2 in the left arm on 26Feb2021 (lot number: EN6203) for COVID-19 immunisation. Right before he had his first shot, he was in the hospital on 15Feb2021 with a bleeding ulcer and a helicobacter pylori infection. He had been in the hospital and isn't sure what all they gave him then. The patient started lisinopril 4 or 5 years ago when he was diagnosed with high blood pressure. His blood pressure was under control with the lisinopril but the patient is no longer on it. The patient's father had a stroke when he was 42 but he had high blood pressure and didn't get it treated. The patient got up around 07:00 in the morning on 27Mar2021. The patient's wife got up at 08:30 when she realized something was wrong. The patient said when he got up around 07:00, he experienced his right side being numb. The patient went to the emergency room and was treated there. He had a stroke. The patient was hospitalized from 27Mar2021 to 30Mar2021. The patient's wife doesn't know if it has anything to do with the shot. After his stroke, they put him on "carvilo". When the patient was in the hospital for the stroke, they found other issues. He has a tumor in his heart that's a pretty good size and the doctor said it had been there for awhile. So, they put her husband on "carvilo" to help with his blood pressure and his heart. She doesn't think the tumor had anything to do with the shot because the doctor did say the size of the tumor was as big as it was because it had been there a while. They found the tumor while trying to find out why he had the stroke. They still haven't found a reason as to why he had the stroke. The tumor is on the right side of his heart and they said they didn't think that had anything to do with the stroke. The tumor was found on 28Mar2021. They did an MRI and a CT scan on his head when he was in the emergency room (ER) on 27Mar2021. They also did an ultrasound on his heart, chest, and abdomen. Since he's been out, they did an MRI on his heart. They also did X-rays on his lungs. He is getting ready to go back to the hospital for open heart surgery on 07May2021. Outcome of the event was unknown.
Within a couple hours I had strong back aches. By about 8p.m. started to get chills severe enough to make my whole body shake. Hot shower took 5 minutes to take the edge off. Hopped in bed about 9 p.m. and spent the whole night either sweating and feverish or chilled and shaking. Developed a headache in the middle of the night. About 4 times on Monday I got sharp pains shooting in my left temple. By Monday evening I had sinus sensitivity that made it hard to ear or drink because all my upper teeth felt hyper sensitive. Today, Tuesday 16th, teeth are slightly sensitive, but overall I feel better
Patient had red area around the injection site that also continues down into the arm - area size of baseball.  Patient states that it comes and goes and is better in the morning.  The area is also slightly warm to the touch.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. The medical assistant reported that an excursion of SF for up to 3 minutes each day over the past 30 days, totaling 90 minutes. The product affected was PROQUAD (Merck) (dose and route not reported), lot numbers of product involved in the excursion(s), and which may have been administered, are as follows: Lot reported as K004712 expiration date 02-AUG-2015; lot K005885 expiration date 24-OCT-2015. The product was also involved in a supported excursion on 13-JUN-2014 of 7F for up to 16 minutes. The reporter presumes that the vaccine had been administered post excursion but is not 100% sure. She states that no one has reported any adverse effects post receipt of any vaccination administered at her office. This is one of several reports from the same reporter. Additional information has been requested.
After receiving the vaccine, I did not have a reaction. On 12/10/2022, I began not feeling well with a scratchy throat. I tested negative for COVID-19 on 12/11/2022. On 12/12/2022, I had a PCR test and on 12/15/2022, I found out I was COVID-19 positive. I started taking an antibiotic on 12/13/2022 as the doctor thought I had a respiratory infection. For my current symptoms, my doctor has started me on another antibiotic and prednisone.
On 6/22/2022 tested positive for Covid and was given Paxlovid by doctor.
stomach pains; weakness; Stayed in bed all day; fever; chill; headache; achiness; Arm was sore/pain in arm; she felt worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore/pain in arm), FEELING ABNORMAL (she felt worse), ABDOMINAL PAIN UPPER (stomach pains), ASTHENIA (weakness) and SOMNOLENCE (Stayed in bed all day) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore/pain in arm) and FEELING ABNORMAL (she felt worse). On 31-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pains), ASTHENIA (weakness), SOMNOLENCE (Stayed in bed all day), PYREXIA (fever), CHILLS (chill), HEADACHE (headache) and MYALGIA (achiness). At the time of the report, PAIN IN EXTREMITY (Arm was sore/pain in arm), FEELING ABNORMAL (she felt worse), ABDOMINAL PAIN UPPER (stomach pains), ASTHENIA (weakness), SOMNOLENCE (Stayed in bed all day), PYREXIA (fever), CHILLS (chill), HEADACHE (headache) and MYALGIA (achiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
This spontaneous report as received from a Licensed Practical Nurse refers to a 75 years old female patient. On an unknown date, the patient was vaccinated with, .5 ml PNEUMOVAX 23, IM, with 25 gauge needle, 1 inch (site of administration not reported, lot # reported as H012650, exp 27-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch. No treatment was commenced. Pain subsided in 2-3 days. The events went away in 3 days. The patient sought unspecified medical attention. There was no lab diagnostic studies performed. It was reported that PNEUMOVAX 23 was not reintroduced. The relatedness for swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch is unknown for PNEUMOVAX 23. This is one of several reports from the same source. Additional information has been requested.
Fever(approx. 101); chills; fatigue; body aches; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 18 years old male received meningococcal group b rlp2086 (TRUMENBA) on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced fever (approx. 101), chills, fatigue and body aches. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
bone pain; anxiety climbed up; felt fatigue; redness at the site of injection; surgeon in my body; experienced bad; not well; arm pain at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of UNEVALUABLE EVENT (surgeon in my body), FEELING ABNORMAL (experienced bad), BONE PAIN (bone pain), ANXIETY (anxiety climbed up) and MALAISE (not well) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid function abnormal and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) and CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]) for Thyroid function abnormal.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced UNEVALUABLE EVENT (surgeon in my body), FEELING ABNORMAL (experienced bad), MALAISE (not well), INJECTION SITE PAIN (arm pain at the injection site) and INJECTION SITE ERYTHEMA (redness at the site of injection). On 06-Jun-2021, the patient experienced BONE PAIN (bone pain), ANXIETY (anxiety climbed up) and FATIGUE (felt fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 UNK, bid. At the time of the report, UNEVALUABLE EVENT (surgeon in my body), FEELING ABNORMAL (experienced bad), BONE PAIN (bone pain), ANXIETY (anxiety climbed up), MALAISE (not well), INJECTION SITE PAIN (arm pain at the injection site), FATIGUE (felt fatigue) and INJECTION SITE ERYTHEMA (redness at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Over a week after vaccine I developed a very large red knot around the vaccine site. That didn't happen immediately and was over a week later. It resolved within 3 days. I did report it to my doctor and I was told that that was a known issue and that at that time was being referred to as Moderna arm, and if it didn't resolve in 3 days to check back in, but it did resolve in 3 days.
Headache, Myalgia, Arthralgia, Fever, Angioedema, Diarrhea, NauseaVomiting, chills/ fatigue/ swollen tongue (did not seek treatment)/ swollen glands Narrative:
Mom came to the pharmacy to request Covid shot for her daughter. However, when pharmacist asked her if it would be the booster dose, Mom confirmed it was in another language. Patient returned after 3 weeks for her second dose. Pharmacist found out the patient had never had any primary dose before.   Mom reported the child did not have any adverse events after the booster dose..
Information has been received from a pharmacist referring to a male patient of unknown age. The patient had no pertinent medical history or drug reactions/allergies. On 03-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, 0.65 ml, lot# and expiry date were unspecified). Concomitant therapies included atorvastatin, valsartan and hydrochlorothiazide (HCTZ). On an unknown date the patient developed swelling and erythema at the injection site after receiving ZOSTAVAX. On an unspecified date, the patient informed the pharmacist in an unspecified way for medical attention and didn't receive any treatment for the adverse events. No lab diagnostics study was performed. The outcome of the events was not provided. This is one of several reports received from the same source. Additional information has been requested.
Appendicitis. Abdominal pain started the day after the vaccine. Progressively got worse throughout the week until I went into the ER the following Sunday.
Sore Throat; Muscle Pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), MYALGIA (Muscle Pain) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included MONTELUKAST and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), MYALGIA (Muscle Pain) and FATIGUE (Fatigue). On 18-Feb-2021, OROPHARYNGEAL PAIN (Sore Throat) and MYALGIA (Muscle Pain) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided          Concomitant medication list also included asthma medication.  No treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received
Pt noted to have dizziness, heart racing, and possible hyperventilating with in the 1st hour, resolved after 1.5 hours.
Itching on head, arms and back.  BP 160/100, feels warm. P 88. Due to anaphylaxsis in past called 911
hives, itching, swollen eyes, runny nose,headaches, watery eyes. improved with benadryl at home, will continue anti histamine treatment today