chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pregnancy test was positive; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure before pregnancy in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number abxc06aa, expiry date 30-MAR-2023) for prophylaxis.   In DEC-2022, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced vaccine exposure before pregnancy (Verbatim: pregnancy test was positive). The outcome of the vaccine exposure before pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Bexsero): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-May-2023 No additional adverse event information available per health care professional. The reporter declined to follow-up. The patient received a dose of Bexsero and few days later was tested positive for pregnancy, which led to vaccine exposure before pregnancy.
Child broke out with chicken pox rash 1-2 weeks post exposure to another infected child, 30 - 50 poxs, no fever, mild itching. Treated with oral Benadryl and calimine on itchy spots.
Varicella vaccine given at 11:50AM. Child had onset of paleness, dizziness, nausea, increased heart rate at 12:15PM. He was placed on exam table with feet elevated. HR=80bpm, BP 90/60, A + 0x3 lungs LTA B. Recovered after 10-15 mins rest.
Pt fainted after receiving vaccines - came to within 20 seconds - was sweaty & denied dizziness. Left office fine.
Febrile seizure on 4/11/2000 about 18:00. Taken to hospital ER and had a normal exam.
Patient broken out in open sore lesions on his face and head that turned into scabs for 2-3 days following administration of the vaccine. He also reported having itchy lower extremities for 2-3 days following administration of the vaccine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-JUL-2016, the patient was treated at a hospital for a vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
no adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about patient 11th out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Master case  (Elderly Patient no 1)
Headache, Myalgia, Diarrhea, NauseaVomiting, arm pain Narrative:
Extreme fatigue,sever muscle and joint pain,nausea,vomiting (x1), dizziness ,fevers greater than 100.1 for 36 hours
Face is swollen after getting my second shot; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face is swollen after getting my second shot) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Face is swollen after getting my second shot). At the time of the report, SWELLING FACE (Face is swollen after getting my second shot) outcome was unknown.            No concomitant medications was provided by the reporter.  No treatment drug details was provided.
Started to have blurry vision with my eyeglasses on then got worst in the afternoon, which I took my glasses off to avoid straining my eye to focus on my computer screen and paperwork.  Vision was more blurry without my glasses but could not wear my glasses which made the blurriness worst.  Had pressure behind my eyes with a mild headache along with sensitivity to light.  The next day 11/05/2021, had my eyes checked by the eye doctor who indicated that everything was normal, eye pressure and response to light.  He did put a numbing eye drop in my eye that made the eye pressure relieve for a couple hours but when that wore off, I could feel the pressure behind my eyes.  On 11/06/2021, my eye and vision were back to normal
The initial case was missing the following minimum criteria: ICH-unspecified AE. Upon receipt of follow-up #1 information on 04Oct2016, this case now contains all required information to be considered valid.  This is a follow-up spontaneous report form a contactable consumer.  A 71-year-old female patient received PREVNAR 13 at single dose on 04Oct2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient previously took tetanus toxoid shot received as a kid and she had just a swollen arm. She has had the Tetanus shot since then with no reaction. On 04Oct2016 she experienced nausea with outcome recovered. She is not having nausea at time of reporting  now but does not feel 100% or good. On an unspecified date the patient experienced pain in her right side and left shoulder with outcome unknown, but not in the center over her heart, she thought she was having heart attack. She also had gastritis-like symptoms with outcome unknown, felts bad, like she just got over the flu with outcome unknown. Consumer stated there was no prescribing physician for the shot. Her family physician told her she should get one. Her family physician does not know she is having a problem. No product complaint was filed.
Extensive redness and swelling in arm of injection site. Diagnosed as cellulitis at subsequent medical visit on 09/12/2010.
pt recv vax in 1983 & devel a fever, double ear infect & measles;
shooting pain down the arm, the pain spread to the; pain  "all over" the consumer's body; pain is so severe in the buttocks; cannot tolerate sitting; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) (batch number 2437H, expiry date 28th March 2022) for prophylaxis.   Concurrent medical conditions included arthritis and carpal tunnel syndrome.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, general body pain, buttock pain and sitting disability. On an unknown date, the outcome of the pain in arm, general body pain, buttock pain and sitting disability were unknown.   It was unknown if the reporter considered the pain in arm, general body pain, buttock pain and sitting disability to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had tested for COVID and COVID antibodies which were negative. The patient received Shingrix at a pharmacy in the left arm and within one week of receiving had shooting pain down the arm that received the injection.  The pain spread to the other arm and was all over to the body.  The pain was so severe in the buttocks, the patient cannot tolerate sitting.  The patient has been to several doctors regarding these symptoms without success. The reporter consented to follow up.
Patient received COVID-19 vaccine on 5/5/2021 and 5/27/2021, unknown lot number. Seen in ED on 7/2/2022 for weakness, cough, shortness of breath, and decreased appetite. Tested COVID-19 PCR positive in the ED. He was admitted from 7/2-7/13; during admission had new diagnosis of invasive squamous cell carcinoma of the lung. This meets criteria for vaccine breakthrough case review.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 23Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient took Paxlovid, from 04Jan2023 to 08Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Symptoms started 6-10 hours after receiving my second vaccine dose. Symptoms included, malaise, headache,  body aches and fatique. Symptoms resolved after approximately 30-36 hours.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 04-JUN-2015, the patient was vaccinated with one dose of improperly stored GARDASIL (dose, route and site of administration were not reported, lot # K008931, expiration date 04-MAR-2017). No adverse symptoms were provided. This is one of several reports from the same reporter. Additional information has been requested.
Fluad (seqirus) influenza Pres Free vaccine given.  No adverse symptoms noted by patient at this time.
PT REPORTED 3-3.5 HOURS OF SEVERE CHILLS TO THE POINT THAT SHE FELT SHE COULDN'T STOP TREMORING. TEMP OF 101.4 FOR 12 HOURS, SEVEVE HEADACHE BEHIND THE EYES. OVERALL BODY ACHES AND FATIGUE FOR MORE THAN 24 HOURS
Patient's arm started hurting immediately after injection but thought that was normal. As the night went on, it started hurting a lot more and she felt she was getting a fever. She went to bed and woke up around 3 am and her head was feeling like it was spinning and fuzzy and she was chilling and sweating. She took her blood sugar and it was fine. She went in to go to the bathroom and next thing she knew she was waking up on the floor and had passed out. She did not know how long she was out but had hit her head near her eye and had a bump. She stayed up for a little bit trying to figure out what had happened, but eventually went back to bed. She really felt it had something to do with getting the SHINGRIX vaccination. Other than a sore head from hitting it, she has had no other side effects and is feeling fine now.
Pt called three days after administration (L) arm delt blistered up and turned red from delt to elbow, put homeopathic cream on it symptoms disappear.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age who was a nurse. There was no information about patient's concomitant medications and pertinent medical history reported. On 28-MAR-2017, while nurse was administering a PROQUAD recombinant human albumin (rHA) (lot # M021427; expiry date 29-OCT-2017, dose was not provided) the needle blew off of the syringe and PROQUAD sprayed into the nurse's eye. The vaccinated patient did not receive any of that dose and received another dose of PROQUAD (lot # M021427; expiry date 29-OCT-2017) and did not experience any adverse symptoms. The nurse experienced some burning in her eye but they flushed it with water and saline and the burning resolved on the same day. Causality assessment was not provided. Additional information has been requested.
but this time coldness came along with extreme fatigue; brain fog this time as well; uncomfortable; it was similar to bones in hands and feet; muscle hurt, and heavy-duty body ache, across the shoulders, spine and hips; Hurt, Pain, hurt only if she put her arm up and touched the shot area; extreme fatigue; heavy-duty body ache like as if she was hit by a truck which was across the shoulders, spine and was also affecting her joints; with headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (but this time coldness came along with extreme fatigue), FEELING ABNORMAL (brain fog this time as well), DISCOMFORT (uncomfortable), BONE PAIN (it was similar to bones in hands and feet) and MYALGIA (muscle hurt, and heavy-duty body ache, across the shoulders, spine and hips) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 031M20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vision abnormal NOS (bad vision even before the first dose of moderna vaccine).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (but this time coldness came along with extreme fatigue), FEELING ABNORMAL (brain fog this time as well), DISCOMFORT (uncomfortable), BONE PAIN (it was similar to bones in hands and feet), MYALGIA (muscle hurt, and heavy-duty body ache, across the shoulders, spine and hips), VACCINATION SITE PAIN (Hurt, Pain, hurt only if she put her arm up and touched the shot area), FATIGUE (extreme fatigue), ARTHRALGIA (heavy-duty body ache like as if she was hit by a truck which was across the shoulders, spine and was also affecting her joints) and HEADACHE (with headaches). At the time of the report, FEELING COLD (but this time coldness came along with extreme fatigue), FEELING ABNORMAL (brain fog this time as well), DISCOMFORT (uncomfortable), BONE PAIN (it was similar to bones in hands and feet), MYALGIA (muscle hurt, and heavy-duty body ache, across the shoulders, spine and hips), VACCINATION SITE PAIN (Hurt, Pain, hurt only if she put her arm up and touched the shot area), FATIGUE (extreme fatigue), ARTHRALGIA (heavy-duty body ache like as if she was hit by a truck which was across the shoulders, spine and was also affecting her joints) and HEADACHE (with headaches) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported. Patient had visited dentist to have her teeth cleaned.   This case was linked to MOD-2021-404868 (Patient Link).
PATIENT WAS SITTING IN CHAIR WATCHING HER SON. SHE THEN FELT DIZZY, LIGHTHEADED, SEEING BIGHT LIGHTS, AND NAUSEA. I APPLIED AN ICE PACK TO THE BACK OF HER HEAD AND NOTICED SHE WAS CLAMMY. I TURNED ON THE FAN FOR AIR CIRCULATION. I ALSO GAVE HER SOME FRUIT SNACKS AND COLD WATER TO DRINK. WITHIN I0 MINUTES SHE FELT BETTER, WAS MORE ALERT AND HAD NO COMPLAINTS OF BRIGHT LIGHTS, DIZZINESS, NAUSEA OR SPOTTY VISION. SHE ALSO STATED FEELING WELL ENOUGH TO LEAVE. I ESCORTED BOTH HER AND HER SON TO THE FAMILY VEHICLE. THE FATHER WAS WAITING THERE AND TOOK OVER TO DRIVE THEM HOME.
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates the unspecified patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot # L001316, expiration date 10-NOV-2016) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID vaccine breakthrough case. Pfizer 2/23/21 EN6198, 3/16/21 EN6205, and boosted 10/18/21 FF2590.
A few minutes after vaccine administration, patient fainted in her chair. Her mother was standing directly in front of her and was able to hold her upright. She came to immediately but felt warm to the touch. We provided an ice pack and her mother spoke to her as she seemed confused as to what happened. In the next few minutes she became nauseated  and vomited one time. Immediately afterwards she expressed that she felt better. She sat for a while sipping on water and was fully recovered. Per mom they have a family history of fainting after vaccination so she wasn't surprised at this event.
I was administered the first dose of the Moderna Covid-19 Vaccination at pharmacy on 9/25/2021. The Pharmacist who administered the vaccination via my left shoulder took a total of three attempts in order to successfully administer the vaccine due to the needle, "not being able to get through the muscle." Approximately three days after the vaccine was administered, my left ring finger and pinky finger have had a numb feeling that has yet to subside.
It was reported that a 17 month old female was vaccinated with Typhim VI and Havrix on 11/1/02. No lot numbers were reported. Three hours later, the pt developed a fever of 106 F degrees and had a seizure, which lasted for 3 minutes. She also became cyanotic and experienced loss of consciousness. Pt was admitted to hospital on 11/1/02. She was treated with IV fluids and antibiotics. She was discharged in satisfactory condition on 11/3/02. The infant was administered these vaccines because the family is going to Vietnam. It was not reported whether the pt recovered from the events. A 15-day follow up report received 10/22/2003 adds: Frmo additional info received on 10/09/2003 from the responsible physician's office, it was reported that the VAERS form was reviewed and there is no new info for this case. No further info is anticipated, this case is considered closed.
Left deltoid pain and swelling around injection site. Erythema of 5 cm around injection site. Fever of 38.5. Chills.
No additional adverse effects were reported in the patient; a patient received an expired dose of PROQUAD; The spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 01-APR-2020, the patient received an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (lot # R026719 and expiration date: 17-MAR-2020; dose, strength, frequency and route were unknown) for prophylaxis (expired vaccine used). No additional adverse effects were reported in the patient. No product quality complaint (PQC) reported. The outcome of the events was unknown.
Information has been received from a healthcare worker (certified medical Assistant C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 23-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Immediately after receiving Hep B injection - employee stated he had bitter then metallic taste in mouth. He then states he felt short of breath, face flushed, and he had some nausea. BP 124/71 - 75 - R=20. Monitored employee for 1/2 hour. Five minutes after injection employee states he feels "fine".  By 10 minutes all symptoms were gone. BP 106-67 - 79-16.
Symptoms started 7:30pm 10/11/2021 (fatigue,fever over 100 degrees, body chills, and mild headache). Symptoms worsened around 1:30am 10/12/2021 with (Fever 102.2 degrees, severe pounding headache and burning eye sensation, whole body aches especially low back pain and leg aches)  All symptoms were treated with Ibuprofen 800mg every 4-6hours and alternating Tylenol 500mg every 4-6 hours. Cold compress was placed on my forehead and room temperature was turned down to a cooler degree. Later result: Fever and bodyaches decreased by 11:00am 10/12/2021. Mild headache stayed persistent through the whole 24hours of 10/12/2021. I'm still fatigued with mild headaches as of today.
Case number PHEH2014US022757, is an initial spontaneous report from a nurse received on 11 Nov 2014 and with a follow-up from a nurse received on 23 Dec 2014. This report refers to a 9 years old male patient. Past medical history and concomitant medications were not provided. On 04 Nov 2014, the patient received an intramuscular dose of expired MENVEO (batch number: M12002, expiry date: 14 Oct 2014) at a dose of 0.5 ml into right arm in error. No adverse event was reported following this administration error. The patient was revaccination on 13 Nov 2014. Follow-up from a nurse received on 23 Dec 2014: Vaccine details (dose, site and expiry date), patient's demographics (weight and height) and revaccination details were updated.