chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed confusion, weakness, and had multiple falls resulting in admission to the hospital for generalized weakness and loss of balance.
This social media spontaneous report was received from a physician, via a company representative through a post from the patient's mother, referring to an approximately 1 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown by reporter. Concurrently, the patient had a total anomalous pulmonary venous return. On 27-APR-2018, reported as "8 days ago", the patient was vaccinated with M-M-R II for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported). On 05-MAY-2018, the boy had a high fever of 103 (units not provided) (pyrexia) and his hands and mouth turned blueish (cyanosis). Medical attention was sought but the reporter did not know if the patient received any treatment or if any laboratory study was performed. At the reporting time, the outcome of cyanosis and pyrexia was unknown. The causality assessment between the aforementioned adverse events and M-M-R II was not provided.
Patient complained of painful, increased swelling noted on the back of the left arm from injection site down to left elbow with a purplish color to it.  No fever indicated.
almost killed me; threw up; fever 102.7/Fever (102.5F); constipation; chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 102.7/Fever (102.5F)), CONSTIPATION (constipation), CHILLS (chills), NAUSEA (Nausea) and FEELING ABNORMAL (almost killed me) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (fever 102.7/Fever (102.5F)), CONSTIPATION (constipation), CHILLS (chills) and NAUSEA (Nausea). On an unknown date, the patient experienced FEELING ABNORMAL (almost killed me) and VOMITING (threw up). At the time of the report, PYREXIA (fever 102.7/Fever (102.5F)), CONSTIPATION (constipation), CHILLS (chills), NAUSEA (Nausea), FEELING ABNORMAL (almost killed me) and VOMITING (threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: address, email, outcome of events updated
Tested positive for Covid. Symptoms were congestion, cough, headache and fatigue.  Suffered a heart attack on 7/16/2022.
Pt is 6 weeks gestation, taking prenatal vitamins, and has not yet had 1st OB appointment. Pt c/o upper lip swelling and itchiness in throat within 30 minutes of vaccination. Pt given Benadryl 25 mg PO and evaluated by MD.
Pain runs from pelvis to clavicle, dry cough, fatigued, aching(most noticeable), happens in 2-3 hour spurts, headache on front left lobe, happened once Thursday twice yesterday, through the night, and this morning. Not as strong as before but still going. Has tried to self medicate with extra Norco, and tylenol but did not help  For many people the headache, fatigue, and aches tend to happen after receiving the vaccine.  The pain radiating from your pelvis to your clavicle is not a symptom I have seen and can be something unrelated to the vaccine or COVID, if symptoms persist check with PCP or go to ED.
C/o wheezing, fever and body aches with chills on 6/26/15. Pt. evaluated by NP. Treated with azithromycin and prednisone and OTC ROBITUSSIN. Returned to office on 7/6/15 and was redosed with same meds for not feeling completely better. Pt also using SYMBICORT. 7/13/15 pt. follow up - better but not completely. Gave a nebulizer Rx.
doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior; vial stored post puncture vial was stored under refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) and PRODUCT STORAGE ERROR (vial stored post puncture vial was stored under refrigerator) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced PRODUCT STORAGE ERROR (vial stored post puncture vial was stored under refrigerator). On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) and PRODUCT STORAGE ERROR (vial stored post puncture vial was stored under refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  On 31-Mar-2022, The vial was initially stored in the refrigerator.  On 21-Apr-2022 at 10:20 am, The vial was first punctured.  On 22-Apr-2022 at 9:30 am - 1:15 pm, The vaccine was administered.  The patient has not reported any adverse reactions to the expired dose administered.   Post puncture vial was stored in refrigerator and the vial did not undergo any temperature excursions.  The vial was not exposed to room temperature for more than 24 hours.  No treatment drug was reported.
Information regarding PREVNAR 13 was received from a healthcare professional regarding an 18-month-old female patient who experienced cellulitis, redness, tenderness on palpitation at the injection site, warmth and swelling. The patient received a dose on an unspecified date. Additional suspect medication included Hepatitis A Vaccine. The patient experienced cellulitis, redness and tenderness on palpitation at the injection site in Jul-2010. The patient also experienced warmth and swelling. Treatment included ceftriaxone and cephalexin. At the time of the report, the outcome of the events was unknown. No additional information was available at the time of this report.
Post vax, the patient experienced a high fever, a 3" area of redness and swelling around the injection site, his face was red and swollen and he cried continuously.
Cold with symptoms of cough and runny nose; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, she began having a "cold" with symptoms of cough and runny nose on 23Apr2021. She states her cold was from going in and out of air conditioning. Her second dose of the vaccine was due tomorrow 28Apr2021. Enquired could she get the second dose as scheduled and if not, how long does she need to wait. Enquired what was COVID-19. Because her symptoms are also symptoms of COVID-19, referred caller to her healthcare professional to determine if she needs to be tested for COVID-19 and when she should get her second dose of the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
booster; was "very sick with flu like symptoms; was "very sick with flu like symptoms; Nausea; Diarrhea; Arm rash; Needed to stay in bed for 2 days; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a sponsored program (060820).  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 67 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), INFLUENZA LIKE ILLNESS (non-serious) all with onset Nov2021, outcome "recovered" (Nov2021) and all described as "was "very sick with flu like symptoms"; NAUSEA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Nausea"; DIARRHOEA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Diarrhea"; RASH (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Arm rash"; BEDRIDDEN (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Needed to stay in bed for 2 days"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: The patient reported delayed start of current cycle by 1 week per MD hold because of lowered white and red blood count/neutrophil count which improved last week and cycle started on 17Nov2021. The patient had covid booster 19Nov2021 and was very sick with flu like symptoms, nausea, diarrhea, arm rash and needed to stay in bed for 2 days but now much better. The events were reported to (Pharmacy name withheld) by Patient/Caregiver.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
stomach pain; stomach felt swollen; couldn't eat for 10 hours; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISTENSION (stomach felt swollen) and FEEDING DISORDER (couldn't eat for 10 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISTENSION (stomach felt swollen) and FEEDING DISORDER (couldn't eat for 10 hours). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISTENSION (stomach felt swollen) and FEEDING DISORDER (couldn't eat for 10 hours) had resolved.            Conversation was held in Spanish. Patient prefers not to fill the ADR form. After the events reported she went to the otolaryngologist and was diagnosed with pharyngeal candidiasis. She is feeling better now after being on candida treatment for almost 8 weeks. Had the second vaccine shot on 10-Mar-21, she took Benadryl immediately after the shot and had no allergic symptoms, but experience stomach pain, couldn't ate for 10 hours and stomach felt swollen. She is feeling well now with no symptoms.   This case was linked to MOD-2021-038066 (Patient Link).
administered an expired Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA264A, expiry date 31st March 2021) for prophylaxis.   On an unknown date, the patient received Menveo .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported that she just administered an expired Menveo vaccine to the patient's left deltoid with standard dosing of the 0.5 ml dose in error, which led to expired vaccine used. The reporter consented to follow up
Fever 101 for two days (checked at physician's office -- UTI and ear infection ruled out) no known cause for fever. Followed by rash onset 09/05/2010.
Eyelids first started feeling burned - woke up next morning face was burnt and peeling - started having diarrhea and stomach cramps - Have a rash that looks like it is under the skin -  Rash comes out at night when I get hot or during the day when I get hot - Eyes and ears itching  - very uncomfortable and starting to get concerned because it is staying with me - Concerned about follow up shot- Feels like I am being stuck with pins. - Anti itch pills seem not to be working.
So I reacted pretty severely to the vaccine. It's almost been 24 hours now, and my symptoms are almost gone. I had, in this order, compounded, with the peak happening about 12 hours afterwards: immediate dizziness about 10 minutes after the shot, nausea started about 30 min, at 4 hours a strong headache that didn?t go away until now, took Tylenol at 7pm, stiffness in the joints, hands, and feet started about 6 hours of shot, at 8 hours pain in the shoulders and neck, at 12 hours cramping all down my back and my hips and low fever. Fever continued until around 6am despite taking more tilt at 2am. Finally got to sleep at 6am. Woke with remaining stiffness and headache at 7:30am. Nausea continued for another 6 hours. Headache continued for another 6 hours. Muscles remained sore due to severe cramping last night.
A non-serious report of nosebleed has been received from a nurse concerning a 15-year-old female patient.  The patient had no prior medical history and no concomitant medications.  The patient received FluMist and Gardasil on 21-Feb-2008.  The patient developed a bloody nose for two-minutes on 22-Feb-2008 and 23-Feb-2008.  The above event was considered resolved on 23-Feb-2008.  Rechallenge is not applicable to this adverse event.  The reporter did not provide a statement of causality to FluMist.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Fever of 101.5 taken with a mercury thermometer under the tongue.  And chills, sweating, difficulty walking, some disorientation.
On Tuesday, October 7th I had an immunization clinic.  I had a 39 year old female that I immunized with the Pneumovax vaccine in the left arm and the Fluarix Quad in the right arm.  The Pneumovax vaccine was indicated because she had asthma and had never received the pneumococcal vaccine before.  She stated that her doctor recommended that she receive the vaccine.  Patient describes that she developed a reaction in her left arm where she received the Pneumovax vaccine on the morning of Tuesday October 7, 2014.  She began feeling "bad" that afternoon and started running fever.  She states that it became very red and warm to the touch and became swollen to the size of a grapefruit at the injection site.  On October 10, 2014, she decided to see a physician.  At that time the physician prescribed her an antibiotic and ibuprofen.  I spoke with her on the evening of October 10th and she stated that she felt "much better."
Vaccine was administered post expiration. Patient's provider Dr. contacted a parent/guardian on 02/20/23 and left a voicemail with no return call back.   Moderna reviewed the stability of the vaccine you received and determined that it likely did not maintain the activity necessary to protect against COVID-19 at time of administration. Moderna cannot guarantee the protection you may have received is equivalent to what was seen in studies and data is not available to support administering an additional dose of vaccine to you. However, if you wish to undergo revaccination, we will provide you access as outlined below.
A spontaneous report has been received from consumer concerning a Male patient of 20 years. Patient relevant history, concurrent diseases and concomitant drugs were not provided. Patient had been receiving FLUMIST quadrivalent (intranasal) 0.2 milliliters, started on an unknown date. The reporter stated that patient experienced influenza. The outcome of the event of influenza was unknown. The reporter assessed the event of influenza to be non serious.
The first thing I experienced was numbness and tingling on the left side of my face and excessive watering and irritation in my left eye as well as some pain on the top of my head n the left side. I also had very swollen lymph nodes in my neck on the left side. This lasted for a while. I saw a doctor about it about a week after it. I had dangerously high blood pressure. They sent me home with medication and told me to go to the ER if I had any chest pains. As for the tingling, they initially thought it was shingles. I had some bumps that were painful at the top of my hairline in the left side. I was given something to put on that. I was also sent to the ophthalmologist because my eye was still continuously watering, The tingling went away after another week or so. The swollen lymph nodes came and went for about a month. My eye still continues to have problems. Eventually the ophthalmologist guessed that I had shingles which was probably triggered by the vaccine. I am currently taking a steroid drops in my left eye.
Tingling running up the legs through the body to the mouth.  Pain and heat in mouth and tongue.  Dizziness and extreme headache.  This continues to the present time.
nausea, fever, myalgias, headache, syncope.  Patient is treated with normal saline fluids.
Pt recvd vax & w/in 24 hrs of the 3rd dose exp rash on back & itching;
1030AM recv vax & 10PM pain (constant in axilla radiating to breast (lt) red, warm to touch where immunization given;size of silver dollar, joint pain, nausea;13NOV97 temp 191, fever/chills, nausea;14NOV97 8AM seen by MD;
Tinnitus in both ears. Constant ringing in the ears. Chronic ongoing post vaccine
Pt filled out conflicting information on COVID-19 Registration Form.  Pt only listed Johnson &Johnson vaccine on 4/8/21.  RN administered the Pfizer booster on 4/27/22, but then noticed on the back of her card she had another entry for a COVID vaccine- it was for a Pfizer booster on 11/10/21.  Pt is a healthy 20 year old.  She received J&J on 4/8/21 and then her booster of Pfizer on 11/10/21.  She does not fit into any age or immunocompromised category to receive a 2nd booster.  Immune RN gave her a 2nd Pfizer booster on 4/27/22 in error.  1st Pfizer booster was not listed in database.  She got her Pfizer booster on 11/10/21 at a pharmacy.
Information has been received from a health professional concerning a 16 year old female with a history of madelung's deformity who, on 01-SEP-2006, was vaccinated with her first dose of GARDASIL, IM. On 10-NOV-2006, the patient was vaccinated with her second dose of GARDASIL, IM. On 28-SEP-2007, the patient was vaccinated with her third dose of GARDASIL, IM, and a urine test in the office was negative. On 11-OCT-2007, a home pregnancy test was positive, and 2 repeated home pregnancy tests on a later date were also positive. The patient sought unspecified medical attention in the office and her outcome is unknown. Follow-up information was received on 29-OCT-2008 via phone call from a nurse indicating that, on 14-JUN-2008, the patient spontaneously delivered a healthy and normal male baby. Weighing 7 pounds, 7 ounces, 52 cm long with a head circumference of 32 cm at 40 and 3/7 weeks estimated gestational age. Apgars were 8/9. The baby was being watched for mild jaundice due to his mother's blood type. The mother was O negative and the baby was RH positive. The baby was discharged home with his adaptive parents on 16-JUN-2008, bottlefeeding and with routine care instructions. The mother did return to the office and saw a certified nurse midwife for her postpartum visit and physiologically was recovering well. Additional information is not expected.
Headaches, fatigue, muscle weakness, numbness hands and feet, abnormally high blood pressure, Worsening flu like symptoms, loss of weight. Tightness in chest, lower back pain, upper back pain.
SHAKY; HEART RACING; STOMACH PAIN; DIARRHEA; BODY ACHES/BODY PAIN; NAUSEA; FEVER 101F; This spontaneous report received from a parent concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced body aches/body pain. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever 101f. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021, the subject experienced heart racing. On 12-APR-2021, the subject experienced shaky. Laboratory data included: Blood glucose (NR: not provided) 120, and Heart rate (NR: not provided) 145. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, stomach pain, diarrhea, body aches/body pain, fever 101f, heart racing and shaky was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Patient was administered with moderna covid-19 vaccine for 6-11yrs of age instead of the updated moderna bivalent booster.
Found Dead in Crib 2/27/2008 Autopsy Summary received with COD: Sudden Infant Death Syndrome (SIDS).  Contributing:  Acute Bilateral Otitis Media.
Swelling of face, itching, muscle pain (left extremity). Tx'd with Benadryl, as advised by ER when she called them, 1/9/00, early a.m. 1/9/00, Saw MD and he gave her Decadron, Clarion, Medrol dose pk prescription.
102.4 degree fever, swollen lymph at neck, sore throat, lungs, cough.
Severe nausea, threw up multiple times, fever, chills, muscle pain. Went to hospital on Saturday 4/24 for an iv to receive fluids.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).