chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wife stated that on 10/29/09 husband was very quiet and didn't say much, then as days went on, he began to think that they had millions of dollars and was fixated on receiving millions of dollars and buying property, was taken to hospital and admitted on 11/16/09 and continues to have mental problems and fixations.  Pt. was admitted to hospital on 11/16/09 and transferred to Geriatric Psychiatric unit on 11/18/09 for "Elderly Mania". 12/01/09 Hospital records received for DOS 11/15/09-11/18/09 Pt presented with acute mental status changes including delusions of grandeur, acute anxiety and rage x 1-2 weeks, increasing in severity last 2-3 days Assessment: Acute mental status changes; mild dehydration  12/14/09 Hospital Discharge Summary received for DOS 11/16-11/18/09. Pt transferred to geropsychiatric ward for further evaluation. DC DX: acute delusional state with delusions of grandeur paranoid behavior; chronic renal insufficiency; CAD s/p CABG; hypertension; hypokalemia; history of edema; history of constipation; hyperlipidemia; B12 deficiency; osteoarthritis; peripheral artery disease of bilateral lower extremities; insomnia; COPD
I track my menstrual cycle using  and typically experience a 32-day cycle; in the past year, the longest cycle I have experienced was 35 days. Received the 2nd shot of COVID19 (Pfizer-BioNTech) the day after estimated ovulation (estimated ovulation 2/3/2021; 2nd shot 2/4/2021). Experienced expected menstruation starting on 2/15/2021. During following cycle, no clear sign of ovulation per  tracking. Currently on day 43 of my cycle and have taken 3 negative pregnancy tests. Period was expected to start 3/19/2021.
Information has been received from a consumer concerning her daughter, a 12 year old female with no medical history reported, who on 17-JAN-2008 was vaccinated with the first 0.5 ml dose of Gardasil.  There was no concomitant medication.  On 18-JAN-2008 the patient experienced sickness, nausea, vomiting, and weight loss.  The patient missed ten days of school.  The patient sought unspecified medical attention.  Diagnostic laboratory tests included a blood test, upper GI and urinalysis but no results were reported.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick".  Additional information: A Caller is trying to get a hold of an office to make an appointment so they can give her a shot. She mentioned that she had to wait for 9 months to get a booster shot and now she got sick. Also, she wants to get a flu vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29May2022 at 12:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (20Jul2022) Positive, notes: After treatment was complete I rebounded with Covid 4 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: It was unknown whether patient received any other medications in 2 weeks.
Mother noted infant's arms were shaking if he went to grab or eat something. Lasted for about 24 to 48 hours, then lessened in severity.
Patient became slightly tachycardic (HR 145, BP 140/75) and light-headed.  Described as anxiety attack.  Patient laid down and feet were elevated and heart rate and blood pressure returned to normal.  Patient was observed for another 30 minutes and released
I have had secondary lymphadema in right leg for over 25 years.  I got severe pain in right groin going down front of leg, in hip joint, and going down side of leg to the point of being unable to walk without assistance of a cane.  Severe pains lasted approximately 24 hours, then gradually reduced.  Swelling of right leg increased suddenly beyond the normal swelling, and didn't start decreasing until approximately 12 hours.  Some swelling remained (over normal swelling) for four (4) days.  This report is being filed on day five (5) and some swelling remains, but with continued massage and elevation of leg, the swelling is still gradually reducing, so I expect the leg to be back to normal swelling  size by day six (6).
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 18-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000996, expiry date 07-JAN-2018), dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
soreness in arm a few days after taking the vaccine, arm became puffy, lymph nodes was swollen under arm and sore
The patient called 9/23/16 with complaints of swelling of the arm from the injection site to the elbow. She also mentioned her arm being warm to the touch.
felt a lot of pain from  COVID vaccination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (felt a lot of pain from  COVID vaccination) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TREPROSTINIL DIOLAMIN (ORENITRAM) from 17-Jan-2020 to an unknown date for Pulmonary arterial hypertension, MACITENTAN (OPSUMIT) and TADALAFIL (ADCIRCA) for an unknown indication.   On 25-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 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (felt a lot of pain from  COVID vaccination) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 04-Apr-2021 due to PAIN. At the time of the report, PAIN (felt a lot of pain from  COVID vaccination) outcome was unknown.            Treatment information not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fever, myalgia onset on same day as vaccination. Followed by headache, neck pain and few days later rash, conjunctivitis, abdominal pain/diarrhea.
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients. On 23-JUN-2014, the patients were vaccinated with PNEUMOVAX 23 (dose, route and lot # not provided) that was improperly stored. The product was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, since the reporter does not want to be contacted.
5. COVID 19 positive by PCR - she has been adequately immunized with Moderna vaccine on 3/18/21 with the 2nd dose on 4/16/21 - she is afebrile and hemodynamically stable.  Her oxygen saturation is 98% on room air.  She does not have any respiratory symptoms.  Her lungs are completely clear on examination - she has likely been exposed for this might be a false positive - given the lack of lung findings MD held off on a chest x-ray at current time Repeat Covid testing was completed, both a repeat of the Abbott test as well as a Cephaid test both were negative, showing initially this was likely a false positive, this patient is fully vaccinated for several months
The patient's reaction started immediately after the vaccination with a dry cough and tickle in her throat.  Eight days after the vaccine, patient was taking a shower when the area of the vaccine suddenly started to swell, the patient's face and throat started to swell and she complained of chest pressure and tongue swelling.  Came into the ED and was given corticosteroids, benadryl, famotidine, albuterol with final resolution of swelling.  She then came back 2 days later with similar reaction, despite cetirizine, famotidine, albuterol with facial swelling, erythema and full body swelling .  Treated with epinephrine and swelling in face and neck resolved.
Heart/chest pain, tightness of heart/chest and elevated heart rate. Symptoms occurred for approximately 10 days
Systemic: Joint Pain-Medium, Additional Details: Patient describes pain in heel and leg that is moderate in severity. 2 days later the pain is more mild but she was concerned so she notified us.
Erythema approximately 10 inches diameter with swelling and warmth at injection site on (R) arm.
Chills; Headache; Body aches (joints and muscle); Body aches (joints and muscle); This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Body aches (joints and muscle)) and MYALGIA (Body aches (joints and muscle)) 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Body aches (joints and muscle)) and MYALGIA (Body aches (joints and muscle)). At the time of the report, CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Body aches (joints and muscle)) and MYALGIA (Body aches (joints and muscle)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Immediately muscle cramp pain in arm on day of injection. This pain lasted about 45 minutes.  I had a sore arm at injection site for 1 day afterwards. On 3/30/21 developed severe chills , fever up to 102.3, headache, nausea and continuing 3/31/21. Fever broke 3/31/21 @ 4 pm.
Red hot swollen itchy rash at on both legs.  Got worse on Wednesday then on Thursday  right leg was better but the left leg got worse.  Afebrile.  Spoke to mom and patient is doing a little bit better today, Mom has been applying cold compress and giving  Benadryl.
Vaccine Landing On My Arm Instead of It Going Into The Patient's Deltoid; Initial Report Received on 28-Sep-2022, 03-Oct-2022, 04-Oct-2022 and 18-Nov-2022  This is a spontaneous report, received via a MedWatch 3500A from the FDA MedWatch Program.  The report was reported by a patient safety specialist regarding a patient who received HEPLISAV-B for hepatitis B immunization. This case captures the occupation exposure for the Medical Assistant who administered the vaccine.  There was no medical history reported for the patient.  Concomitant medications were not reported.  On 09-Sep-2022, a dose of HEPLISAV B (Lot #937783, expiration date Dec 2025, NDC #43528-003-01), route not specified, was administered in the left deltoid for hepatitis B immunization by the medical assistant.  During administration, when attempting to administer HEPLISAV-B into a patient's left deltoid, the liquid of the vaccine shot out of where the syringe's plain tip and the needle's hub meet, causing the vaccine to land on the medical assistant's arm instead of going into the patient's deltoid. The needle was inserted into the arm, and when medical assistant pressed the plunger to administer the vaccine, a large amount of clear fluid squirted out the side between the hub of the needle and pre-filled syringe. It was reported that it appeared to be the full 0.5 ml as it was dripping from the medical assistant's arm and on her scrubs. This was immediately reported to provider, who advised new vaccine be administered and this was done with no issues.  The outcome of the adverse event was not reported.  The lot was investigated. No lot impact was found.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Fever, Chills, Nausea, Vomiting, Fatigue and swelling at site of injection. Pt. took some motrin and put ice on injection site. Felt better by 12/02/2016.
hives on face, various areas on body; Rash; redness at the site of injection; hardness at injection site; swelliing at injection site; Redness at the injection site; tiredness; body aches; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), URTICARIA (hives on face, various areas on body), RASH (Rash), VACCINATION SITE INDURATION (hardness at injection site) and VACCINATION SITE SWELLING (swelliing at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), FATIGUE (tiredness) and MYALGIA (body aches). On 08-Apr-2021, the patient experienced VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE SWELLING (swelliing at injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 15-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the site of injection). On 03-May-2021, the patient experienced URTICARIA (hives on face, various areas on body) and RASH (Rash). On 20-Apr-2021, PAIN IN EXTREMITY (Arm sore), FATIGUE (tiredness) and MYALGIA (body aches) had resolved. On 11-May-2021, URTICARIA (hives on face, various areas on body) and RASH (Rash) had resolved. At the time of the report, VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE SWELLING (swelliing at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment included non-drug treatment- applied ice pack on the affected area.   This case was linked to MOD-2021-131952 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Updated patient demographics. Updated event outcomes for the reported events.
Joint aches; injection site soreness; This is a spontaneous report from a contactable 69-year-old non-pregnant female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 25Feb2021 12:00 PM on left arm (at 69-year-old), as dose 1, single for COVID-19 immunization and secukinumab (Cosentyx) injection taken for an unknown indication on the same day (25Feb2021). The medical history of the patient included Ankelosing spondylitis. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not diagnosed with covid-19 prior to vaccination and had not been tested for covid-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021 at 12:15 PM the patient experienced joint aches and injection site soreness. No treatment was received for the adverse event. On an unknown date in 2021 the patient recovered.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information was expected.
sweating; his stomach hurt if he ate or drank anything/Stomach hurting a bit; had a really high fever/Still has fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (his stomach hurt if he ate or drank anything/Stomach hurting a bit), HYPERHIDROSIS (sweating) and PYREXIA (had a really high fever/Still has fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced PYREXIA (had a really high fever/Still has fever). On 13-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (his stomach hurt if he ate or drank anything/Stomach hurting a bit). On 14-Jun-2021, the patient experienced HYPERHIDROSIS (sweating). At the time of the report, ABDOMINAL PAIN UPPER (his stomach hurt if he ate or drank anything/Stomach hurting a bit) and PYREXIA (had a really high fever/Still has fever) had not resolved and HYPERHIDROSIS (sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was included. No treatment drug details was provided.
Redness, swelling and bumps in the area where the vaccine was administered (chicken pox, varicella).
Patient felt light headed weak and mild sothness of breath. after lying down and a few sips of water. At 12:12 PM patient seen by EMS her Pulse 68, O2 - 91, B/P 130/70. tried to help her relax vital signs repeated at 12:22 PM ulse 70, O2 - 99.  Released to go home.
I'm a C5-6 quadriplegic. Had intense muscle spasms and twtiching, fever and chills. They started at 1 am and started to calm down around 6 am. Slept from 6am - 3pm and awoke to use restroom and drink some gatorade. Didnt really have any strength. Went back to bed and slept until 11 pm. Ate some crackers and granola bars late that night and drank more gatorade. Next day (saturday)  strength started to come around but was hot. Had no fever but just sweated. By sunday most symptoms were gone
It was reported that a 65 year old female patient received a TD Adult vaccination on 21 Feb 2001. Reportedly that same day the patient developed a local reaction of redness, swelling and pain at the injection site. Patient was evaluated by physician and treated with Motrin and compresses. From follow up received on 5/7/01, it was reported that the pt recovered from this experience. Additional pt, responsible physician, vaccine administrator and vaccine info was also provided. This case is closed.
Pt became dizzy, upper extremities shaking, non-responsive for 7 minute. Pt then intermittently would become less responsive to verbal demands - This occurring for about 1 1/2 hours in office. Pt then transferred to ER per ambulance.
Pt was administered Janssen vaccine 0:50 minutes after the open vial time expired. Vial was punctured at 8:55am and vaccine was given at 3:45pm. Was realized the morning after (7/14/21)  by another staff member.
Approximately 15-20 minutes after vaccine administered, patient became pale and vomited. Never loss consciousness.
She presents to the emergency department after receiving a COVID-19 vaccination today and having signs and symptoms of anaphylaxis.  She described having sensation of swelling in her throat as well as cutaneous rash.  On presentation she is also coughing very frequently.  She is treated with IM epi, IV Benadryl and IV Solu-Medrol.  This rapidly improved her overall symptoms.  Reported per: Moderna COVID - 19 Vaccine EUA requirements
Mother reports baby has rash on stomach, then traveled over entire body. Dr noticed erythematous rash on different part of body, no fever.
Not normal; leg pain; swelling in the arm; feeling unwell; headaches everyday; soreness in the arm and body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not normal), PAIN IN EXTREMITY (leg pain), PERIPHERAL SWELLING (swelling in the arm), MALAISE (feeling unwell) and HEADACHE (headaches everyday) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced FEELING ABNORMAL (Not normal), PAIN IN EXTREMITY (leg pain), PERIPHERAL SWELLING (swelling in the arm), MALAISE (feeling unwell), HEADACHE (headaches everyday), MYALGIA (soreness in the arm and body aches) and FATIGUE (fatigue). At the time of the report, FEELING ABNORMAL (Not normal), PAIN IN EXTREMITY (leg pain), PERIPHERAL SWELLING (swelling in the arm), MALAISE (feeling unwell), HEADACHE (headaches everyday), MYALGIA (soreness in the arm and body aches) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included vitamins.  No treatment medication reported by reporter.  Patient stated she never had headaches before.   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Translation Document received on 03-oct-2021. Added vitamins as concomitant product. Event outcome captured. Event onset date captured.
Skin surrounding injection site noted to become dark pink, warm and firm to touch. Patient denied any pain to the area
Swelling at injection site, itchy hives or similar looking rash surrounding injection site, roughly 2-3" diameter for about 4-5 days