chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is unable to fully lift arm and reports stiffness and discomfort in the shoulder area.
severe asthma; cough; This non-serious case was reported by a physician via sales rep and described the occurrence of asthma in a 68-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-SEP-2023, the patient received Arexvy. On 20-SEP-2023, 1 days after receiving Arexvy, the patient experienced cough (Verbatim: cough). On 26-SEP-2023, the patient experienced asthma (Verbatim: severe asthma). The outcome of the asthma and cough were unknown.   It was unknown if the reporter considered the asthma and cough to be related to Arexvy.     It was unknown if the company considered the asthma and cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 03-OCT-2023 The reporter stated after administration of Arexvy vaccine, following day he experienced a cough. One week later he was diagnosed with severe asthma. In structural field event onset date was reported as 18Sep2023 which was before vaccine administration date. According to narrative patient experienced event following day of vaccine administration that was on 20Sep2023. Hence according to narrative event onset date was captured (20Sep2023). The reporter consented to follow up.
This spontaneous report was received from a licensed practical nurse refers to a multiple unknown patients of unknown age and gender. No pertinent medical history, drug reactions/Allergies and concomitant medications were reported. On an multiple unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M004726 and expiry date 19-OCT-2017) (dosing regimen was unknown by the reporter). The vaccine was exposed to temperature of 0.2 degree Celsius for 4 hours and 51 minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Raised (bee sting like) swelling at injection site immediately. Next day 6in diameter red area around injection site that was warm to touch. Raised swelling at injection site and red area around with fever continued for 1 week with tenderness to touch. Raised bump at injection site still exists.
had pneumonia twice in the past few years; had pneumonia twice in the past few years; One of my arms swelled up so big; I was in the bed for a week for what I thought was the flu; This is a spontaneous report from a contactable consumer who reported for herself, an 85-year-old female patient who received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown) and influenza vaccine (FLU), both via an unspecified route of administration in the arm, on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient got the flu shot and the pneumonia shot the same day, one in each arm - several years ago. One of her arms swelled up so big and she was in the bed for a week for what she thought was the flu. She had pneumonia twice in the past few years. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Information has been received from a nurse concerning a female patient who "about 3 weeks ago" (on approximately 03-SEP-2009), was vaccinated intramuscularly with a 0.5mL dose of GARDASIL (dose, LOT# not reported). On 24-SEP-2009, the patient called the office and reported that she had felt fatigued ever since. No lab diagnostic study was performed. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Soon after, and constantly since, first dose of COVID-19 Vaccination I have had ringing in both ears  - at times (such as following 2nd dose) level has amplified for several hours, then returned to the more constant level.
In May of 2022, pt was given a dose of the Quadracel vaccine, which is not appropriate for this age. Pt had no immediate or long term reaction observed. This event was only discovered when pt transferred to another clinic and staff there noticed it while reviewing immunization records.
1st dose administered to 17 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 17 year old). On 06-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter who was a nurse reported regarding an administration error to a 17 year old patient. The patient received their 1st dose on 06-Dec-2021 and on 08-Dec-2021 they realized that the patient was 17 years old. No symptoms were reported, and the reporter have not contacted the patient yet.  No medical conditions were reported.  No Concomitant product use was reported. No treatment information was provided.
Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) in a 30-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 DIZZINESS (Lightheadedness). At the time of the report, DIZZINESS (Lightheadedness) outcome was unknown. Not Provided          Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-059278 (Patient Link).
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Moderna Vaccine on 4/15/21 and 5/13/21. Found on 2/16 w/AMS brought to ED. Worsening SOB, cough, AMS and COVID+. Admitted to ICU w/acute hypoxic respiratory failure requiring BIPAP. Resp failure cont to worsen requiring mechanical ventilation (2/26), c/b Afib w/RVR on heparin drip d/c'd 2/2 drop in Hgb, transfused w/PRBC, transferred to facility 2/27 for liver transplant f/u per family request. Admitted to ICU w/acute hypoxic resp failure 2/2 Covid PNA c/b AKI and metabolic acidosis. Cont'd to worsen, transitioned to  comfort care. Tx'd w/Vanc, zosyn, cefepime, flagyl, micafungin.  Expired 3/8/22. Pt continued to worsen with poor prognosis. Pt eventually decompensated and was transitioned to comfort care. Treated with Vancomycin, zosyn, cefepime, flagyl, micafungin.  Pt expired 3/8/22.
5 minutes after receiving vaccine, patient complained of feeling faint, dizzy, and lightheaded.  Pt reports h/o of vasovagal reaction when she receives a needle.
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    No relevant concomitant medications were reported. It was also reported that there was potentially a second lot number that was expired on 28 Feb 2023 and was administered to patients on 3 Mar 2023, but HCP did not have any details on this event at this time.  Vial size was reported as 10 dose vial. The vial haven't undergone any temperature excursions.  No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Rash to face, neck, chest, abdomen, and extremities with fever prompting patient to be brought into the ED. Was also having decreased appetite, vomiting, headache, and fatigue. She was admitted to the floor on 10/10 for this. A rapid response was called on the patient on 10/12 due to hypotension, tachycardia, tachypnea, nasal flaring, decreased peripheral pulses, and decreased urine output. She was subsequently admitted to the PICU and is still being managed for this decompensation. She has required intubation and vasopressors for her condition.
Within 24 hrs of receipt of the vaccine, he developed a diffuse, nonpruritic, erythematous rash on his bilateral upper extremities and front and back of his trunk. No mouth/airway involvement or difficulty breathing/wheezing. Pt had no known allergies or history of past drug reactions. He otherwise felt well. Pt was given Claritin to take twice daily for suspected urticarial and advised to return immediately if he developed any airway symptoms. The patient has not returned in the last 48 hours.
On 03/08/2023, she woke up irritable, congestion, head and throat hurt and a raised red lump at vaccination site. The doctor advised MOTRIN and TYLENOL and that resolved it.
Patient received the first Moderna vaccination at Publix pharmacy. He was instructed to remain in the area for 15 minutes for observation but he went to get something to drink with his wife. At checkout he fell and personnel was immediately called for assistance. When I arrived from the pharmacy to check on patient he was alert but clammy and covered in cold sweat. We removed his mask and called the EMS. Patient wanted to sit on the bench so he was escorted. He stated that he was feeling fine but he was very scared of needles which might have caused the incident. The EMTs arrived shortly after and took over the patient care. He was escorted out of the store by EMTs.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 28-JUN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10PK-0.5ml SD-PFS LLok w Tip" (lot # M005286, expiration date: 08-OCT-2017, dose and route were unspecified). No adverse effects were reported. This specified lot number was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 304 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Entire body feels like it's on fire; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Entire body feels like it's on fire) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to NSAIDS), Drug allergy (Methadone), Allergic reaction to analgesics (Tramadol), Allergic reaction to analgesics (Nucynta), Drug allergy (Buprenorphine) and Behcet's syndrome.    On 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced FEELING HOT (Entire body feels like it's on fire). At the time of the report, FEELING HOT (Entire body feels like it's on fire) had not resolved.            Concomitant product use was not provided by the reporter.  No treatment information was 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 of 104.4°F, severe headache, severe bodyaches, severe chills. Moderate fatigue and nausea
Vials were stored in refrigerator even after expiration date/vials were stored in the refrigerator and thawed on same day of administration; Vaccine was administered on 13 Apr 2022 and expired on 04 Apr 2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 13 Apr 2022 and expired on 04 Apr 2022.) and PRODUCT STORAGE ERROR (Vials were stored in refrigerator even after expiration date/vials were stored in the refrigerator and thawed on same day of administration) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 13 Apr 2022 and expired on 04 Apr 2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were stored in refrigerator even after expiration date/vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 13 Apr 2022 and expired on 04 Apr 2022.) and PRODUCT STORAGE ERROR (Vials were stored in refrigerator even after expiration date/vials were stored in the refrigerator and thawed on same day of administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The weight of patient was reported as 180.  Patient received second booster. Date the vial was initially stored in the refrigerator, was the same day vials were thawed. The vial did not undergo any temperature excursions. It was reported that patient did not experienced any known reactions.  No treatment medication were reported.
Patient was nervous prior to getting vaccines, patient was distracting herself by being on her phone while I was about to inject vaccines. Injected MenQuadfi and patient was ok and then I injected Bexsero, and patient was still doing ok. She did complain about the vaccines hurting as they were administered. Did a Tuberculosis testing on patient as well, as i removed needle after administrating it, patient started to slowly lean and collapsed to the floor.  Patient was picked up and sat down and was crying and was feeling pain in her face, since she collapsed face down. Nurse came in to see how patient was feeling, patient stated she was ok and that she only felt pain on her face. We asked her if she was feeling dizzy or nauseous or having an head pain. Patient stated no.  She was only confused on why she had collapsed she stated that all she remembered was hitting the floor. Patient was kept in the facility for a few more minutes to make sure she was ok to leave home.  Patient was advised to go to the ER if she experiences nausea, dizziness and headaches.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 26-JUL-2012, the patient was administered with a dose of VARIVAX (Lot # 670799/0975AA, expiry date 17-JUN-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
exceeded 35 day interval between doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (exceeded 35 day interval between doses) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (Patient was undergoing chemotherapy and therefore could not receive his second dose which was scheduled for 20Mar2021.) since an unknown date. Concurrent medical conditions included Lymphoma (Diffuse b-cell lymphoma).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (exceeded 35 day interval between doses). On 08-Apr-2021, PRODUCT DOSE OMISSION ISSUE (exceeded 35 day interval between doses) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication included chemotherapy  Treatment medication was not provided   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-MAY-2021: Email id, past medical history were updated On 10-May-2021: follow up received: No new information
COVID on March 18.  Slight sore throat at first, then fever and chills, sinus congestion, cough.  Covid test positive on March 19.  Paxlovid taken March 19 - 23.   Better on March 25 but fatigue lingered until April 1.
Information has been received from a nurse concerning a currently 6 year old male who in approximately 2004 (at 12 to 15 months old) was vaccinated with the first dose of VARIVAX (Merck) (lot#, route and site of administration not reported). About a month later (at approximately age 13 months) the patient had a breakthrough case of chickenpox with less than 50 lesions on his body. The outcome of the chickenpox was unknown. In approximately 2008 (at five and a half years old) the patient received the second dose of VARIVAX (Merck) (lot#, route and site of administration not reported). About three to four months after vaccination, the patient developed a rash all over his body, but he had no fever. The nurse reported the patient had seen another physician other than the primary care physician and no diagnosis had been made. At the time of reporting the patient still had the rash all over his body and may be going to see a dermatologist. Additional information has been requested.
(R) upper arm pain, headache and nausea, decreased appetite, fatigue. Mild erythema 2cm x 1 cm (R) deltoid without heat or drainage.
Severe congestion; swelling in feet arms legs and hands; headache; Extreme fatigue; Short of breath; Body soreness; Irritability; Soft stools; Loss of taste; Loss of smell; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (COMIRNATY; Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 at 15:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included congestive heart failure, hypertension, hypothyroidism, narcolepsy, musculoskeletal disorder, arthritis and sciatica. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol succinate (METOPROLOL), hydralazine hydrochloride (HYDRALAZINE), losartan (MANUFACTURER UNKNOWN) and levothyroxine sodium (LEVOTHYROXIN); all from an unknown date for unknown indication and unknown if ongoing. The patient previously received morphine sulfate (MORPHINE), codeine (MANUFACTURER UNKNOWN) and metronidazole (FLAGYL) and experienced drug allergy. On 06Apr2021, the patient experienced severe congestion, swelling in feet arms legs and hands, headache, extreme fatigue, short of breath, body soreness, and irritability, and soft stools, loss of taste and smell. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events congestion, swelling in feet arms legs and hands, headache, extreme fatigue, short of breath, body soreness, irritability, soft stools, loss of taste and smell was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.