chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling extremely weak; Can't stay awake; Fatigued,extramly tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling extremely weak), SOMNOLENCE (Can't stay awake) and FATIGUE (Fatigued,extramly tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced ASTHENIA (Feeling extremely weak), SOMNOLENCE (Can't stay awake) and FATIGUE (Fatigued,extramly tired). At the time of the report, ASTHENIA (Feeling extremely weak), SOMNOLENCE (Can't stay awake) and FATIGUE (Fatigued,extramly tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reportedly, the patient was on concomitant medications but denied providing further information stating she did not think those medications had anything to do with the symptoms.  No treatment information was provided.
they tried to administer it to the patient, they were unable to discharge the vaccine into the patient's arm.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Lot number: HG4664, Expiration Date: Dec2023) at the age of 70 years intramuscular, in arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE OCCLUSION (non-serious) with onset 11Oct2023, outcome "unknown", described as "they tried to administer it to the patient, they were unable to discharge the vaccine into the patient's arm.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller is a pharmacist reporting that they took two syringes of the Pfizer covid-19 vaccine for 12 years and older that they took from the same box and when they tried to administer it to the patient, they were unable to discharge the vaccine into the patient's arm. Caller stated that they called to report these two faulty syringes from the same box and are hoping to have the faulty syringes replaced. He mentioned that he pulled out 2 syringes from the same box and both syringes were unable to discharge the vaccine in to patient's arm but when they took a syringe from a different box, it worked well. They are suspecting that the two syringes are faulty, and they are hoping for a replacement. Site of administration was originally on the left arm and then they also tried her right arm. No prior vaccination (4 weeks prior).  The reporter considered "they tried to administer it to the patient, they were unable to discharge the vaccine into the patient's arm." not related to bnt162b2 omi xbb.1.5. Causality for "they tried to administer it to the patient, they were unable to discharge the vaccine into the patient's arm." was determined associated to device constituent of bnt162b2 omi xbb.1.5.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Day 1-3 headache swollen neck lymph nodes Day 4-10 (and currently) sore throat, congestion, cough, headache  Possible activation of latent adenovirus???
Within fifteen seconds after injection, patient became very diaphoretic and stated he was very hot. Full body sweating, along with chills, mild body ache, and abdominal pain. Patient given water to drink and vital signs measured. Pt moved to a cooler environment and was given relaxation techniques.. After five minutes of deep breathing sweating stopped, abdominal pain resolved, and patient was able to walk to the observation section of the clinic. D/C'd home to self care. Given further instructions in the event symptoms returned.
I left the office immediately after getting the injection., so this happened within 5 min.   As I walked out the door, I had a fleeting sensation of disorientation.  Within another couple minutes, all my muscles seized up  (especially severe in lower back).  I could barely walk or talk & moaned slightly, leaning up against the outside of the building, until passing person helped me back inside to lie down on bench.  No fall, no LOC, no pain except muscular.   Within 5-10 min, it eased completely with deep breaths & drinking some cold water -- with just some residual achiness.  I waited another 1/2 hr in the doctor's office & then returned home.  I rested there the remainder of the afternoon until ~5 PM.  After standing for ~15 min, I had a fairly severe attack of chilling.   With warm clothing & compresses & 2 Tylenol, that receded.  I've felt completely normal since then (now 3 days later.)
Swollen lymph node in right armpit - still persisting chills and joint aches day after vaccine only
This spontaneous report has been received from a physician via a company representative referring to a male patient of unknown age. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication were unknown. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route, batch/lot # and expiration date were unknown) for prophylaxis. On an unknown date, the patient stated the injection site and the shoulder was painful. It was also reported that the patient experienced injection site reaction on unspecified date. Information about treatment given for the events and lab diagnostics/studies was unknown by reporter. The patient visited the physician and sought medical attention. The outcome of the events was reported as recovering (reported as the patient was getting better but it was not completely resolved). The causality between PNEUMOVAX 23 and the events was unknown.
July 22 morning had intense chest pain/burning that seemed like heart attack, went to covenant ER. ekg was fine, cardiac enzymes very high indicative of heart attack, was put on heparin, nitro patch, aspirin. had a cath scan/angioplasty the next morning, no signs of blockages, no stent needed. also had x ray, cat scan, echo, which i was told all looked normal too. multiple blood draws where cardiac enzymes remained elevated, but on the downtrend. i was discharged the 24th and prescribed aspirin, colchicine, famotidine, atorvastatin. Still notice some slight chest discomfort, no where close to on ER admission though.
Swollen injection site and 3 other places within about 4 inches area below the injection site; Raised places itch; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Pfizer ER6207), via an unspecified route of administration in the right arm on 23Mar2021 at 09:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient had no known allergies to medications, food or other products. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN), and ergocalciferol (VITAMIN D); all from unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), via an unspecified route of administration in the right arm on 19Feb2021 at 17:15 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, the patient developed swollen injection site and three other places within about 4 inches area below the injection site. The raised places were itchy and had the same appearance as a mosquito bite. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events vaccination site swelling and vaccination site pruritus was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
1PM shot given 2PM t101 R started shaking lasted around 5 mins; Brought to pvt ER around  4PM; temp 103 given APAP supp & Amoxicillin has OM; CBC, UA, CXR done; discharged from ER @ 7PM in fair condition;
I26.99 ACUTE PULMONARY EMBOLISM 7/20/2022 RECTAL CANCER J96.00 ACUTE RESPIRATORY FAILURE 7/20/2022 RECTAL CANCER J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/18/2022 RECTAL CANCER I26.99 ACUTE PULMONARY EMBOLISM 7/20/2022 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 7/20/2022 ACUTE RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/18/2022 ACUTE RESPIRATORY FAILURE I26.99 ACUTE PULMONARY EMBOLISM 7/20/2022 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 7/20/2022 ACUTE RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/18/2022 ACUTE RESPIRATORY FAILURE I26.99 ACUTE PULMONARY EMBOLISM 7/20/2022 INTRAABDOMINAL ABSCESS J96.00 ACUTE RESPIRATORY FAILURE 7/20/2022 INTRAABDOMINAL ABSCESS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/18/2022 INTRAABDOMINAL ABSCESS I26.99 ACUTE PULMONARY EMBOLISM 7/20/2022 RECTAL CANCER J96.00 ACUTE RESPIRATORY FAILURE 7/20/2022 RECTAL CANCER J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/18/2022 RECTAL CANCER I26.99 ACUTE PULMONARY EMBOLISM 7/20/2022 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 7/20/2022 ACUTE RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/18/2022 ACUTE RESPIRATORY FAILURE I26.99 ACUTE PULMONARY EMBOLISM 7/20/2022 SEPTIC SHOCK J96.00 ACUTE RESPIRATORY FAILURE 7/20/2022 SEPTIC SHOCK J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/18/2022 SEPTIC SHOCK
No adverse event; Expired M-M-R II dose was administered; This spontaneous report was received from a certified medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 16-JAN-2020, the patient was vaccinated with one expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), therapy type: recombinant human albumin (rHA), lot # N025894 (expired date: 19-SEP-2019), for prophylaxis (strength, anatomical location and route were not reported). The patient did not experience any adverse events. No product quality complaint (PQC) was involved.
Information has been received from a nurse concerning her 21 year old daughter, who, on an unspecified date, was vaccinated with a second dose of GARDASIL vaccine (yeast). Subsequently, one day post vaccination the patient experienced flu like symptoms and a headache. The patient fully recovered the next day. It was reported that the patient will go on to receive the third dose. The patient did not seek medical attention. No product quality complaint was involved. Additional information has been requested.
Intussusception, admit to Hosp, 11/6/15 - 11/7/15.
Moderna COVID 19 Vaccine EUA Injection site red, warm, tender at touch, measures about 2" x 2". Minor flu-like symptoms.
no other AE occurred; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 1 dose, lot #u039948, expiration date: 16-DEC-2023 (route of administration was not provided). The administered dose of vaccine experienced the temperature excursion of -2.5 degrees Celsius for 5 hours and 6 minutes. There was no previous temperature excursion. No other adverse event (AE) occurred.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005588: US-009507513-2206USA005697: US-009507513-2206USA005817: US-009507513-2206USA005711:
EDD 7/11/2021, no issues with pregnancy Patient with fever to 101.5 day after the vaccination, as well as myalgias, fatigue, dizziness, left arm soreness, etc. No concerns about patient. Appx 4 hours after vaccine, patient breastfed 2 year old child - child developed fever with no associated symptoms, first noted at 8AM (101.7F), responded to ibuprofen. No known sick contacts for child who was swabbed for Covid (NP PCR) and tested negative. Fever resolved within 12 hours and did not recur.
Information has been received from a physician who has heard of a couple of female patient's who were vaccinated with dose of GARDASIL. The patient's developed arthritis after getting the dose of GARDASIL. Attempts are being made to obtain and verify additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one two reports from the same source. Additional information has been requested.
I asked the nurse when I had the shot for information and she said she didn't know. I asked my doctor today when I went to be seen what it was called and she said Flulaval Quad.
Mom concerned that vision concerns - double vision, blurry vision due to getting MMR vaccine. Dx with vision conversion per optometry. MMR given 4/11/14 and sx started several days after vaccine.
Patient is a 45 y.o. female patient of System, Provider Not In with history of iron deficiency anemia, possible COPD presented to Hospital with Acute hypoxemic respiratory failure requiring BIPAP and found to be COVID 19 Positive. Transitioned to 2L NC and finally to RA. She was admitted for further eval and treatment.      Acute hypoxemic respiratory failure Sepsis due to COVID Acute COVID pneumonia Presents via EMS with shortness of breath x1 week. Initially required bipap, transitioned to 2L NC after DuoNeb treatment. On admission, tachycardic and tachypnic. Febrile at 100.7 COVID+, no leukocytosis -CTPA: bilateral small ground glass infiltrates -Started Remdesivir and dexamethasone and duonebs -Pt is off O2, stable for discharge -Discharge on prednisone and antitussives     Chronic iron deficiency anemia Hgb 11.4 on admission, Fe 11, Fe Sat 3, ferritin 30 Start oral Fe   Hyperglycemia BG on admission 189, A1c 5.7 Most likely will increase due to corticosteroids   Obesity BMI 37.76 -Encourage dietary and lifestyle modifications Recheck A1c in 3 mn
Pt recvd measles vax 22AUG89 & was found to be immune to rubella & had moderate antibodies of 2.55 for mumps; On 3AUG91 rubeola antibody IgG was 0.11 which indicated lack of seroconversion; Therefore pt was given addtl dose of measles vax;
the vials was being used past the recommended 12 hour post puncture time; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the vials was being used past the recommended 12 hour post puncture time) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (the vials was being used past the recommended 12 hour post puncture time). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (the vials was being used past the recommended 12 hour post puncture time) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-418964 (Patient Link).
At 11:40AM the patient experienced visual distortions in the left eye. She saw pulsing flashes of light whether her eyes were open or closed. The left side of whatever she looked at was obscured. The patient felt lightheaded and unsteady. The patient's blood pressure was elevated. Her vision cleared after 20 minutes. At 12:30PM the patient experienced tingling and numbness in her left hand, lips and nose. This subsided in 10 minutes. At 2:00PM the patient experienced chills, a slight fever, extreme malaise, slept 15 hours, had a sore arm and a headache.
death Narrative:  Patient received Moderna COVID #1 vaccine on 1/28/21. On 2/3/21, he was admitted to a facility for fever, weakness, chills and rigor. Noted history of B cell lymphoma not on chemotherapy at the time. He also had reports of productive cough with thick brown/green sputum. He was admitted to the hospital and given 1 round of methotrexate and Rituxan. Hospital course was complicated with bacteremia (given vancomycin and cefepime), A fib, AKI, HTN, neutropenia (received Neupogen), acute popliteal VT (unable to anticoagulated due to thrombocytopenia - platelets as low as 20). No bleeding issues noted. On 2/18/21, family opted to change his status to DNR with hospice/comfort care and he passed on 2/19/21. No autopsy results available. 22 days from date of vaccine to date of death.
The patient called on 2/26/2021  9:15 AM, reporting that he experienced redness and hives all over his body and he has tightness of chest.  He started that morning.
Severe hair loss after second vaccination dose 12Apr2021; This is a spontaneous report from a contactable consumer. This 54-year-old female consumer (Patient) reported for herself.  A 54-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown) on 12Apr2021 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, GERD, eczema and seasonal allergies. Concomitant medication included symbicort inhaler. Patient previously took received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), in left arm on 22Mar2021 at 11:15 am (at the age of 54-year-old) as a single dose for COVID-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. Tested covid post vaccination. No known allergies. On Apr2021, the patient experienced Severe hair loss after second vaccination dose. Event resulted in Physician Office Visit. No treatment was given. Patient underwent laboratory test which included Nasal Swab/PCR resulted negative on 21May2021. Outcome of the event was recovering.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Itchy rash all over his body 2 days after varicella vaccine. Started on his chest, spread to his back, arms, face, and very itchy. No fever. Lesions on trunk. No crust or vesicular lesions. Upper extremities and face. Treatment: BENADRYL 25 mg TID PRN x 3 days; Calamine lotion QID x 3 days.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old male patient who received SHINGRIX for prophylaxis. On 27th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced fever, weird feeling, tremor, chills and pain in arm. On an unknown date, the patient experienced pharmaceutical product complaint. On 31st May 2018, the outcome of the fever, weird feeling, tremor, chills and pain in arm were recovered/resolved. On an unknown date, the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the fever, weird feeling, tremor, chills and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The patient experienced side effects after receiving his first dose of SHINGRIX.
Pt received a dpt immunization on 10/30/03 with subsequent swelling and erythema to right thigh injection site 7 x 8cm induration and erythema at site. Given Keflex and Ibuprofen. Dr recommends no more tetanus immunizations.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 70-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received 5 years ago. On 28th March 2018, the patient received the 1st dose of SHINGRIX. On 28th march 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, pain, bone pain and sleeplessness. The patient was treated with ibuprofen and non-drug therapy (Hot Compresses). On an unknown date, the outcome of the pain and bone pain were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, pain and bone pain to be related to SHINGRIX. It was unknown if the reporter considered the sleeplessness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right arm and in evening of the injection, the patient experienced extensive swelling of vaccinated limb (swelling down her right arm from her shoulder to her hand), redness down her right arm. She had body and bones hurt and could not sleep for 2 nights due to the pain. She received ibuprofen and that seemed to help. The pain was gone and hot compresses helped the redness and swelling. The patient does not plan to get the 2nd dose. She states she got the shot at her local pharmacy in her right shoulder area. When she was asked about the dose given she noted 50mcg or 50 cc. The reporter was not sure of the dose or lot number of the product. The reporter's husband was a physician and she had only consulted him for care. The patient has denied permission to contact their physician. The caller had requested reimbursement for out of pocket cost for the product of $160.23. She was provided the reimbursement address and process.