chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician for GARDASIL, a pregnancy registry product, concerning an 18 year old female patient, with no pertinent medical history and no known drug reactions or allergies, who on approximately 12-OCT-2010, was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported), one month prior to conception. It was reported the patient became pregnant her last menstrual period was on 12-NOV-2010 and estimate delivery date is on 19-AUG-2011. A serum alpha-fetoprotein test (AFP) screening was performed and it was abnormal, and an ultrasound of fetus was performed and showed hypoplastic right heart and open neural tube encephalopathy (see WAES#: 1104USA02227B1). Follow up information has been received from a registered nurse via telephone call indicating that the patient was presently pregnant and not due until December 2012. The nurses also stated that the patient was presently being seen for a current pregnancy that was proceeding without any difficulties. However, she stated that the intake medical history form for their clinic mentioned a history of abnormal fetus (WAES 1104USA02227B2). The nurse reported that the patient probably aborted but could not confirm by record at that time. At the time of the report, the patient's outcome was unknown. Upon internal review, probably aborted was considered to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
administer a first dose of the Moderna covid19 vaccine to a  15 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administer a first dose of the Moderna covid19 vaccine to a  15 year old) in a 15-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 11-Apr-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administer a first dose of the Moderna covid19 vaccine to a  15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administer a first dose of the Moderna covid19 vaccine to a  15 year old) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Rash & UrticariaPruritus  Narrative:   Other Relevant History:
Starting 11/03/2022, I felt like I was getting the flu and I had a strange cough. I was tired but didn't have a fever. I stayed in bed for 48 hours and when I got up I did not have an appetite. I tested negative with a COVID-19 at home test on 11/05/2022 and I waited 48 hours before I tested myself again. On 11/07/2022, I tested myself again and was positive. I started coughing pretty severely but never at any point did I develop a fever. I would eventually test negative on 11/12/2022 with an at home COVID-19 test and ended up leaving the house on 11/14/2022 after testing negative again. I did call my doctor on 11/15/2022 to get some relief from the severe cough and was prescribed some cough medicine. I stayed in bed on 11/16/2022 and 11/17/2022 and I had a telehealth visit on 11/18/2022 for a follow up. At that time, I still had the nasal congestion, sinus drainage, severe fatigue and a cough. The symptoms slowly started to get better and by 11/24/2022 I felt well enough to have people over for the holiday but my cough was still quite persistent. It has slowly been improving since then and I have started back with some regular exercise at this point, and resumed more of my normal daily activities.
4.5 cm erythematic wheal at injection site. No system angioedema. Took BENADRYL po 50mg & wheal resolved. Allergic reaction.
Patient asked for 2rd dose of Covid-19 vaccine. We told patient that we had Moderna vaccine. Patient answered the pre-questionaire form and signed. We gave the patient the vaccine, then we saw on his CDC vaccination card, his first dose was Pfizer. Patient did not know that he had first dose Pfizer. We told the patient about the side affect of the Morderna vaccine and  asked him to call us if he had any questions
Got covid booster Pfizer vaccine at 1:30 PM Rt am yesterday.   Rt leg pain started yeterday. Also is sore all over. Feeling tired.   No fever No reactions with first 2 vaccines   Not taken any medications yet.
Chills; Fever; Her arm, not the injection site but lower down the arm, towards the elbow, clarified as right above the elbow (in the fleshy area) was totally swollen.; clarifies further that area above her elbow is very swollen and distorted; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date: was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Report was not related to a study or programme. The patient's medical history and concomitant medications were not reported. Other Products was not provided. It was reported that, patient had the COVID vaccine on Tuesday, 2 days ago. The patient experienced chills and fever, but that was all done now, her arm, not the injection site but lower down the arm, towards the elbow, clarified as right above the elbow (in the fleshy area) was totally swollen, clarifies further that area above her elbow is very swollen and distorted on an unspecified date. Patient wanted to know if she should go to the hospital and was that a side effect. No further information was provided or obtained. Investigation Assessment was not provided. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Soreness at injection site persisting 32 hours+ Awakened with chills/shaking approx. 20 hours after vaccination. Low grade fever (99.1) and fatigue day following vaccination.
11:00am- 1hr after vaccine- Headache. Noon- achy, tired, general malaise, went home. 1:00pm & after, fever no higher then 100F, vomiting x 1. Out of work.
Erythema and edema at left arm injection site. Treated with Tylenol and compress.
Toes became sore; Toes became itchy; Left hand broke out in itchy rash; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 13:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), paroxetine hydrochloride (PAXIL); both from an unknown date for unknown indication and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 02:00 the patient experienced toes became sore and itchy, left hand broke out in itchy rash.  The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with topical cream. On 30Mar2021, the patient underwent Nasal Swab, SARS CoV-2 test and the result was Negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events toes became sore, toes became itchy and left hand broke out in itchy rash were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Right after patient received vaccine, she experienced severe dizziness  that she had to sit down.  She also had shivering, warmth, nausea and vomiting
Seizure 4 hours after given and irritability for 24 hours after seizure. 3/9/06 Received medical records which revealed patient experienced an allergic reaction & laceration s/p seizure & hypokalemia/ss
High Fever rate. Parent called on the 2nd day after vaccination. Sometimes parents want to talk with provider.; This non-serious spontaneous safety report was received by a partner on 03-NOV-2021 and forwarded on 05-NOV-2021 from a health care professional.  The reporter did not provide as assessment of the causal relationship between Vaxelis and the reported event High fever rate, parent called on the 2nd day after vaccination.  Further information is expected.
pt recv vax 1AUG95 & 1OCT95 pt presented w/aplastic anemia;MD reported he planned to have pt undergo a bone marrow transplant;f/u from pt's MD indicated he saw no assoc between the use of vax & developing aplastic anemia;
I received my second Covid shot of the Moderno vaccine at the medical center. I was approached by a technician to follow him. There were three women dressed in what appeared to be nurses clothing sitting behind him, and an assistant next to him. I was told by one of the three women not to pay attention to them that they were observers. Technician prepped and administered the shot into my left arm upon delivering the shot a liquid was leaking down my arm which brought his assistant to be flapping her arms to get the attention of the three women sitting behind that was supposed to be observing him. One of them stood up and approached me grab some gauze and was wiping the area. Technician finished the injection applied a Band-Aid I was told by one of the observers that I didn?t need to worry about anything. To me it appeared that the shot was given too high on the  left arm. It was much closer to the top of my shoulder. By 7 o?clock the next morning I could not move my arm at all. It was the same sensation as having your arm dislocated it would just hang. There was no way to lift it up without pain. The pain continue to be excruciating at times, unable to use the arm painful to sleep. Called the medical center and was told that if I felt it an emergency  I should come in to the medical center. I was told that this is a typical reaction for some patients. I waited two days and went to emergency care. I didn?t get further than the waiting room when I was told by a doctor behind a plexiglass shield when I describe the problem that again this was a side effect. It?s been over 6 weeks now and the pain has subsided somewhat but there is still an issue with my shoulder and movement. I personally feel that the person who administered this injection was not trained properly  and follow up with the hospital that provided the vaccine was not responsible. I want it on record that I have sustained an injury that I feel was due to improper administering  of the vaccine.
8/5/2021 16:00 - Felt major pain (burning sensation)  thereafter, my left arm, chest and side began swelling.  8/5/2021 20:00 - Felt major throbbing in my chest area 8/6/2021 08:00 - Doctor informed that my systolic blood pressure was 154 8/9/2021 AM - Started taking Ibuprofen 2 times a day 8/12/2021 09:00 - I can still feel 10% swollen
~20 minutes after injection tongue began to swell and was hard to move and throat became tight. Did not subside for 4 hours. Took 1 Benadryl when the swelling and tightness began and another one an hour after when symptoms did not improve. No allergies known and no allergic reaction to first 2 Pfizer shots.
On the evening of her vaccination 1/8/21 she reports soreness at injection site. The following day 1/9/21 she reports  experiencing headache, chills, body ache and a temperature of 100.0. She reports taking OTC Tylenol but no other treatment. As of date of reporting (1/13/21) she reports a headache remains but this is the only ongoing symptom.
adjuvant portion administered / did not reconstitute; adjuvant portion administered / only gave the adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number L4LH5, expiry date 25th January 2023) and (batch number AP545, expiry date 25th January 2023) for prophylaxis.   On 9th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 9th April 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received adjuvant portion of Shingrix vaccination, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021216655, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021216655:same reporter US-GLAXOSMITHKLINE-US2021216677:same reporter, FU#1 Original case, deleted for being created in error
FLUSH FACE, TROUBLE BREATHING, NASAL CONGESTION, PALPITATION, PRICKLY SENSATION.
A report has been received from a Health Professional concerning a 2 year old, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. The reporter stated that we accidentally administered expired FLUMIST on 24-Feb-2015. The outcome of the event of ACCIDENTALLY ADMINISTERED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Approximately 2 months after receiving 2nd dose of vaccine, I went in for mammogram and that is when they located swollen lymph node going from under right arm to middle of left breast. Also, performed ultrasound. A second ultrasound was done in December and it was found to be growing. A needle core biopsy was performed February 2022. Results came back negative for cancer.
I've been having persistent fatigue in the arm where I got my vaccine (left arm). It gets tired faster than it used to when doing dishes, etc.
This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (eyesight is not clear as it used to be), DRY EYE (eyes is dry.), VISION BLURRED (slight blurred) and DRY MOUTH (mouth feels dry as well.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03LM20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure. Concomitant products included VENLAFAXINE HYDROCHLORIDE (FLAVIX) for an unknown indication. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced OCULAR DISCOMFORT (eyesight is not clear as it used to be), DRY EYE (eyes is dry.), VISION BLURRED (slight blurred) and DRY MOUTH (mouth feels dry as well.). At the time of the report, OCULAR DISCOMFORT (eyesight is not clear as it used to be), DRY EYE (eyes is dry.), VISION BLURRED (slight blurred) and DRY MOUTH (mouth feels dry as well.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product : Blood pressure medication. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: TCR.
Initial report received from a healthcare professional (pharmacist) on 31 October 2014. A 75-year-old female patient, with no reported past medical history and no known allergies, received on 22 September 2014 a left deltoid injection of FLUZONE HD (lot number U5017BA). The day of vaccination, she experienced an aching pain in her left arm which has since that time moved to the left side of her face. She reported that she was unable to move or use the arm at all. She had been seen in the emergency room, in an urgent care facility, by her family physician and by a specialist. She did not provide the reporter with any additional details about diagnostic testing or treatment. She did not receive prior dose of FLUZONE HD. At the time of the report, the events were ongoing. Documents held by sender: None.
Pain in both legs. Softball size bruising on both legs. Headache which would not go away with two doses of Motrin one dose of Tylenol.
soreness in the arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 013A21A) for COVID-19 vaccination. Concurrent medical conditions included Sjogren's (Sjogren's (kind of a lupus) unknown onset but caller confirmed it was prior to the vaccine.).On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in the arm). At the time of the report, PAIN IN EXTREMITY (soreness in the arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.The  concomitant medications on use were not provided.No treatment information was provided.This case was linked to MOD-2022-456733, MOD-2022-456752 (Patient Link).Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2022: Added reporter information.
Stress fracture at their back; This spontaneous case was reported by a consumer and describes the occurrence of STRESS FRACTURE (Stress fracture at their back) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced STRESS FRACTURE (Stress fracture at their back). At the time of the report, STRESS FRACTURE (Stress fracture at their back) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 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 an unknown date, 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 an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 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 ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml).    No concomitant medications were reported.   Physician reported that, the nurses had no standing order other than what they had for the second booster and assumed the same dose as the second booster (administered 0.25 milliliter instead of 0.5 ml to uncompromised adults). The patient did not experience any adverse events.  It was reported that, the national public health agency recommended to revaccinate the patient with full dose of 0.5 mL.  No treatment details were reported.
Lump, swelling, tender, redness all at injection site. Felt on first day, all have increased second and third day.
Several hours after first injection of Moderna I began to have a fever of 103 and my heart started to race as if I was having a heart attack. My body had extreme aches  and as well as a severe pain in my left arm that I cannot even describe. Following that I began to vomit and blacked out. The fever/vomiting/body aches lasted for 2 weeks. I am now  left with shortness of breath and grey mark where my injection site was. My hair has begun to fall out as I am assuming it is from this vaccine as well.
This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer. A 15-year-old patient of unspecified race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation and PNEUMOVAX, via an unspecified route of administration, on an unspecified date, at unspecified dose, for immunisation. Relevant medical history included immunodeficiency. Concomitant medications were not reported. The antibody titer increased after vaccinations. It was reported that the patient experienced thrombocytopenia and PREVNAR 13 and PNEUMOVAX was administered at the same time to a 15 years old with immune deficiency all on unspecified date with outcome of unknown.
Headache, Sedation, Myalgia, Diarrhea, Fatigue Narrative: Sude Effects:Fatigue 12/8, then awoke 12/9 with HA,myalgia,fatigue, and diarrhea. Side Effects with #1 and #2; however, worse with 3rd dose. She came to work today; however, she is going home due to illness.
Extreme elasticity so that I came very close to falling out of my wheelchair. several times. One spasm was so intense that I fell against the front edge of t h e seat and horribly bruised my back. I then returned to bed so I wouldn't get hurt further.  I also lost the use of my hands . My hand dexterity began to improve over the next week but my back continues to be quite painful even though the bruising looks better.  This a began when I awoke the morning after I had the vaccine.