chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was sick, out of work for 4 days; Had difficulty breathing; Hit head at work, concussion; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick, out of work for 4 days), DYSPNOEA (Had difficulty breathing) and CONCUSSION (Hit head at work, concussion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CONCUSSION (Hit head at work, concussion). On an unknown date, the patient experienced ILLNESS (Was sick, out of work for 4 days) and DYSPNOEA (Had difficulty breathing). The patient was treated with GABAPENTIN for Concussion, at an unspecified dose and frequency; AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Concussion, at an unspecified dose and frequency; TRAZODONE for Concussion, at a dose of 50 mg at bedtime and METOPROLOL for Concussion, at a dose of 50 mg once a day. At the time of the report, ILLNESS (Was sick, out of work for 4 days), DYSPNOEA (Had difficulty breathing) and CONCUSSION (Hit head at work, concussion) outcome was unknown.            It was reported that the patient was on leave from work since the patient had concussion.  No concomitant medications were reported.   This case was linked to MOD-2021-407432, MOD-2021-407321, MOD-2021-407545 (Patient Link).
Patient reported that RN had inadvertently squired a small amount of vaccine in patient's eye.
got vaccine for shingles, had shingles/ suspected vaccination failure; shingles; COVID; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient stated that he/she got the vaccine for shingles and COVID and experienced shingles twice and also had COVID. The patient stated that he/she was not sure about these vaccines. It was unknown if the reporter considered the shingles and covid-19 to be related to covid-19 vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were not provided. Note: From the narrative it was not clear if the patient received covid vaccine before or after shingles vaccine hence covid vaccine considered as suspect and covid-19 added as event conservatively.
Continued itching, slight soreness and redness at sight after 3 weeks; slight radiating pain.
This spontaneous report as received from a medical assistant refers to an unspecified number patients of unknown age and gender. Medical assistant reported that, on an unknown date, multiple unspecified patients received a doses of GARDASIL (dose, route of administration, lot number and expiration date were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Per nurse, patient's mother called stating that she developed a rash on her face within 1 hour of receiving the vaccine.
Rash and hives over night. Relieves the next morning after taking diphenhydramine
Arm warm to the touch; Left ear pain; Arm red; tired; Fever101.8; headache/aches in the  left side of the head; body aches; strong flu like symptoms; big sweats that night; mucus on nose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (strong flu like symptoms), NIGHT SWEATS (big sweats that night), SECRETION DISCHARGE (mucus on nose), FEELING HOT (Arm warm to the touch) and EAR PAIN (Left ear pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (strong flu like symptoms), NIGHT SWEATS (big sweats that night), SECRETION DISCHARGE (mucus on nose), PAIN (body aches), PYREXIA (Fever101.8) and HEADACHE (headache/aches in the  left side of the head). On 28-Apr-2021, the patient experienced FATIGUE (tired). On 29-Apr-2021, the patient experienced FEELING HOT (Arm warm to the touch), EAR PAIN (Left ear pain) and ERYTHEMA (Arm red). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (strong flu like symptoms), NIGHT SWEATS (big sweats that night), SECRETION DISCHARGE (mucus on nose), FEELING HOT (Arm warm to the touch), EAR PAIN (Left ear pain), ERYTHEMA (Arm red), PYREXIA (Fever101.8), HEADACHE (headache/aches in the  left side of the head) and FATIGUE (tired) outcome was unknown and PAIN (body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Pyrexia: 101.8 (High) 101.8.         Concomitant product use was not provided by the reporter.   Reporter did not allow further contact
fever 101, gen aches, fatigue, nausea; sx sent employee to bed for several hrs-lasted approx 8-12 hrs w/no residual effects;
onset that afternoon/evening w/high fever 1044+ & short (1-3 seconds) uncontrollable shaking in pt;MD informed & pt placed on APAP & advil every 3hr for next 2+ days;under med fever averaged 99.5/100.0 x 3 days;uncontrollable shaking
100.2 F Fever - 30 hours after inj. for 16 hours.
This case was reported by a pharmacist via out of hour services and described the occurrence of injection site swelling in a female patient who received BOOSTRIX (batch number EY273, expiry date 18th March 2019). On 6th September 2017, the patient received BOOSTRIX. In September 2017, less than a week after receiving BOOSTRIX, the patient experienced injection site swelling, injection site erythema, injection site warmth, injected limb mobility decreased, pain in arm and muscle soreness. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth, injected limb mobility decreased, pain in arm and muscle soreness were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, injected limb mobility decreased, pain in arm and muscle soreness to be related to BOOSTRIX. Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported that the patient came back and injection site was swollen. The spots on which where the reporter grabbed the muscle to administer had prints because it was swollen from the reaction site. The injection site and the area below that was also reddened and warm. It was about 5:20pm the site was warm also. The patient's arm was extremely sore. It was really hard for the patient to lift her arm and it was very painful to her.
Patient complained of dizziness and fatigue during 20 minute post injection monitoring period. She had elevated BP 183/90 and HR 102. Paramedics were called and she was transferred to the hospital for further evaluation.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test positive (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint:90000193147
Arm pain; Muscle soreness; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle soreness) and PYREXIA (Slight fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle soreness) and PYREXIA (Slight fever). At the time of the report, PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle soreness) and PYREXIA (Slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Soreness / knot on arm, red, warm; also nausea, vomiting, diarrhea, fever up to 102.8 x36 hours.
I woke up and mid morning I had body aches and a headache. After lunch, I was lightheaded and dizzy. BP was high and heart rate was high.
Shortness of breath while climbing stairs; This is a spontaneous report from a contactable consumer (patient's mother).  A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) via an unspecified route of administration on 12Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced shortness of breath while climbing stairs. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
left arm became swollen; hand became numb for 6 hours; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm became swollen) and HYPOAESTHESIA (hand became numb for 6 hours) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 148A21A and 177A27A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Clot blood (blood clot in left arm 3 years ago) and Factor V Leiden thrombophilia. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PERIPHERAL SWELLING (left arm became swollen) and HYPOAESTHESIA (hand became numb for 6 hours). On 04-Mar-2021, PERIPHERAL SWELLING (left arm became swollen) and HYPOAESTHESIA (hand became numb for 6 hours) had resolved. Not Provided          This case was linked to MOD-2021-090687 (Patient Link).
Ringing in ears; This spontaneous case was reported by a pharmacist and describes the occurrence of TINNITUS (Ringing in ears) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypogonadism since 2008. Concomitant products included TESTOSTERONE CIPIONATE (TESTOSTERONE CYPIONATE) for Testosterone low.   On 06-Jan-2021 at 7:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 7:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced TINNITUS (Ringing in ears). At the time of the report, TINNITUS (Ringing in ears) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-Jun-2021 and included non significant information was added (Reporter occupation and Patient  information updated) On 03-Jul-2021: Follow-up information received on 03-Jul-2021 and included Concomitant information and Relevant Medical History added, Moderna vaccine anatomical location updated.
Information has been received from a consumer concerning her 14 year old daughter with no pertinent medical history and no known drug allergies who in "August/September 2006", was vaccinated with the first 0.5ml dose of GARDASIL (injection, lot# not reported). There was no concomitant medication. The consumer reported that in "mid January 2007", her daughter experienced diarrhea, vomiting and she was unable to keep food in her stomach after getting second dose of GARDASIL in November/December 2006. The patient was hospitalized end of February 2007 and was diagnosed with gastroparesis by physician at the hospital. The patient was discharged on 07-MAR-2007. She received the third dose of GARDASIL in April/May 2007. Lot# was not provided. The patient was recovered but she would get periodic gastroparesis it depended on what she ate. On unspecified day, a stomach emptying scan test and numerous other tests were performed, and the results were unknown. Follow up information has been received via telephone call from a physician indicating that the patient received the first dose of GARDASIL on 20-OCT-2006 (Lot number unavailable to the physician). The patient received the second dose of GARDASIL on 20-DEC-2006 (Lot number unavailable to the physician) and the third dose of GARDASIL on 01-MAY-2007 (Lot number unavailable to the physician). The physician stated that the lot number records for the GARDASIL vaccinations were accidentally discarded. The physician stated that she had changed her Physician Practice and had not seen the patient in over one year. The physician confirmed that the patient was hospitalized sometime at the end of February 2007 and was discharged from the hospital on 07-MAR-2007. The physician confirmed that the patient was diagnosed with Gastroparesis. The health care professional contacted during telephone follow-up could not supply the following information: lot number (if applicable). Additional information has been requested.   9/1/09  MR received for DOS 2/28-/06/2007 with D/C DX:  Gastroparesis.  Pt presented with c/o RUQ pain, diarrhea, vomiting, palpitations,sweating and H/A x 1 month.  Hypertensive with diarrhea and increased HR with abd pain. Worse after eating. PE (+) for abd tenderness, tearful. Referred to outpt GI. 11/12/09 Vaccination records received, same docs as prev. entry 10/19/09, no Lot number provided.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # N010105, expiration date: 15-NOV-2018, for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23.; Sender's Comments: US-009507513-1708USA004783:
arm where received shot feels hot; arm where I received my shot Begin to swel; arm where received shot is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm where received shot feels hot), VACCINATION SITE SWELLING (arm where I received my shot Begin to swel) and VACCINATION SITE ERYTHEMA (arm where received shot is red) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced VACCINATION SITE WARMTH (arm where received shot feels hot), VACCINATION SITE SWELLING (arm where I received my shot Begin to swel) and VACCINATION SITE ERYTHEMA (arm where received shot is red). At the time of the report, VACCINATION SITE WARMTH (arm where received shot feels hot), VACCINATION SITE SWELLING (arm where I received my shot Begin to swel) and VACCINATION SITE ERYTHEMA (arm where received shot is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication not provided.  Treatment information not provided.
PATIENT DID NOT EXPERIENCE ADVERSE SIDE EFFECTS. CHILD REGISTERED HIMSELF FOR THE APPOINTMENT. THE VICE PRINCIPAL WAS PRESENT AND CALLED THE PATIENT'S MOM TO GET CONSENT.   PATIENT RECEIVED THIRD DOSE (BOOSTER) WHEN IT WAS NOT DUE. HIS FIRST DOSE WAS 10/17/21 AND SECOND DOSE WAS 12/10/21.
Pt was resting the chair. About 5 min post vaccine pt slumped over in chair. responded to her immediately. upon assessment pt had lot of consciousness. Medical help called immediately. staffed and I immediately placed her flat on the floor. sternal rub was conducted to wake pt up. pt breathing but finally woke up in about 40 seconds. a&ox4. pt felt dizzy and nauseous. initial VS: 78/63, HR 82, O2 99% RA RR 16, VS post 5 mins BP: 69/42, HR 86, O2 sat 99% RR 16, pt was taken to the emergency room. son states mother has a hx of fainting.
A 42-year-old female here because she had some pins and needles, sharp pains in her left arm and left leg after receiving a Tdap vaccine on December 19. It was in the left upper arm. On Monday, she got it, the next day she felt arm pain and tingling on the lateral three fingers and up the forearm to the site where she got the vaccine and that area was very swollen and painful. Also, developed numbness in the bottom of the foot up the calf in the lateral aspect of the calf. That is continuing. The numbness in the arm has gotten much better since swelling from the vaccine site has gotten better. Came and saw Dr. who thought it was not from the vaccine. She has taken no new medications, except doxycycline for two days, which she stopped, but that was well after she had gotten this problem. No headache, neck pain, rash, back pain. Never had this problem before.
Subsequent to Plaintiff's ZOSTAVAX inoculation, Plaintiff was treated by M.D. at the Office of M.D. for shingles.; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. In 2008, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided), as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and zoster-related conditions. Alternatively, in 2008, the pt's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by physician, at the Office, for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization (date unspecified), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
A physician reported that a 13 month old male received a 3rd dose of Prevnar vaccine on 9/12/01, when he was 9 months old. On 1/12/02, the infant developed a fever that continued into 1/13/02. On 1/13/02, he developed diarrhea and then seizures. On 1/14/02, he was admitted to the hospital after biting his tongue during 1 of the seizures. While hospitalized, his temperature was 106F and his heart rate was in the 200's. At the hospital, they were unable to obtain IV access. An intraosseous line was started and he was given 50cc/kg of fluid total. The pt was placed on a ventilator and a central line was started. Additional fluids were given and he was transferred to the PICU. He was also noted to have dehydration and hypovolemic shock associated with the diarrhea. He was treated with ceftriaxone, cefepime, vancomycin, Decadron (dexamethasone), morphine and lorazepam. On 1/16/02, the pt died. No additional information was available as of the date of this report. Follow-up info received on 02/20/2002, stated "a spinal fluid isolate was analyzed as 19F." Serum antibody levels were also requested; however, lab analysis has not been completed. Follow up info recevied on 03/19/2002 from physician. On the day of admission, it was noted that the pt was not responding to pain. His pupils were becoming larger and more sluggish. A CT scan was performed that showed multiple areas of increased water density throughout his brain. later that evening he had ventricular tachycardia that did not respond to lignocaine. He still was able to maintain a blood pressure and was subsequently loaded with amiodarone, with a good response and control of his dysrythmia. He did require some dopamine, however, at that point to maintain a good perfusion pressure. He was seen on 01/15/2002 by a physician who performed an examnation that was consistent with brain death. On 01/16/2002, the reporting physican also examined the pt and the findings were consistent with brain death. An apnea study was performed, there was no respiratory effort despite a pCO2 rising from 36 to 76, and he was pronounced dead. The death diagnosis was "brain death secondary to pneumococcal meningitis.