chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Pancreatitis acute, Restless legs syndrome
Clinical narrative: shingles; debilitating with extreme pain episodes; acute pancreatitis; fibromyalgia; chronic fatigue syndrome; restless leg syndrome; illnesses; Initial information was received on 28-Nov-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional under reference number US-SA-SAC20211201000141.  This case involves Adult female patient who experienced shingles (herpes zoster), debilitating with extreme pain episodes (pain), acute pancreatitis (pancreatitis acute), fibromyalgia, chronic fatigue syndrome, restless leg syndrome (restless legs syndrome) and illness, after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PREGABALIN (LYRICA) for Fibromyalgia.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious shingles (herpes zoster), debilitating with extreme pain episodes (pain), acute pancreatitis (pancreatitis acute), fibromyalgia, chronic fatigue syndrome, restless leg syndrome (restless legs syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  On an unknown date the patient developed a non-serious illness (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for event.  At the time of reporting, outcome of all the events were unknown.  There will be no information available on batch number for this case.; Sender's Comments: This case involves adult female patient who experienced herpes zoster, pain, pancreatitis acute, fibromyalgia, chronic fatigue syndrome, restless legs syndrome and illness after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is not known. However, patient's medical condition at time of vaccination, Lab data and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the individual vaccines cannot be assessed.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Accidental exposure to product, Headache, Syringe issue
Clinical narrative: This spontaneous case was received on 02-Oct-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-03185) and concerned a 68-year-old, female patient. The patient's medical history and concomitant medications were not reported. On 30-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; indication, dose, route of administration and anatomical location: not reported). It was reported that when the nurse pulled the syringe out of the patient's arm a good amount of the vaccine squirted out of the syringe onto the patient arm (explicitly coded as 'Accidental exposure to product'). The patient felt she received maybe half a dose (explicitly coded as 'Incomplete dose administered'). The patient was offered another vaccine, but she declined. The patient had no soreness. The batch number was not reported. On 02-Oct-2021, two days after receiving incomplete dose of Fluad Quadrivalent, the patient developed headache. The outcome of the event of headache was not reported. The reporter did not provide a causality assessment. The reporter assessed the case as non-serious. Company Comment: The event of headache is considered as related to Fluad Quadrivalent. Additionally, 'accidental exposure to product' and 'incomplete dose administered' are assessed as unrelated to Fluad Quadrivalent per company's conventions.; Sender's Comments: The event of headache is considered as related to Fluad Quadrivalent. Additionally, 'accidental exposure to product' and 'incomplete dose administered' are assessed as unrelated to Fluad Quadrivalent per company's conventions.
Sex: F
Vaccine: FLUX
Symptoms: Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: A large marble-sized knot with heat at the site, and soreness; A large marble-sized knot with heat at the site, and soreness; A large marble-sized knot with heat at the site, and soreness; Allergic reaction to flu vaccine; This spontaneous case was received on 04-Nov-2021 from other non-healthcare professional (consumer) via Agency (reference number: SEQW21-05080) and concerned a female patient of an unreported age.  The patient's concurrent condition included malignant neoplasm of unspecified kidney, except renal pelvis. The patient's concomitant medications were not reported. The patient never had a reaction to the vaccine before.  On an unspecified date in Sep-2021, the patient started with non-company co-suspect Lenvima (lenvatinib mesilate; dose: 18 mg, daily (qd), route of administration: oral and anatomical location: not reported) for malignant neoplasm of unspecified kidney, except renal pelvis. The batch number was not reported.  On an unspecified date in 2021, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; indication, dose, route of administration and anatomical location: not reported). The batch number was not reported.  On an unspecified date in 2021, reported as recent, an unknown amount of time after receiving influenza virus vaccine polyvalent and non-company co-suspect Lenvima, the patient experienced an allergic reaction to the vaccine, a large marble-sized knot with heat at the site and soreness lasted for two weeks. The patient had treatment with unspecified antibiotics that ended this week, as reported.  The outcome of the events was unknown.  The reporter assessed the events as related to influenza virus vaccine polyvalent as the patient experienced an allergic reaction to the vaccine.   The case was assessed as non-serious.  Company comment: A female patient of an unreported age developed a painful and warm mass at vaccination site (reported as an allergic reaction to the vaccine) after receiving influenza virus vaccine polyvalent. Besides, treatment with non-company co-suspect product Lenvima was initiated an unknown amount of time before vaccination. Due to the lack of information regarding chronology, causality for the reported events is unassessable.; Reporter's Comments: The patient experienced an allergic reaction to the vaccine.; Sender's Comments: A female patient of an unreported age developed a painful and warm mass at vaccination site (reported as an allergic reaction to the vaccine) after receiving influenza virus vaccine polyvalent. Besides, treatment with non-company co-suspect product Lenvima was initiated an unknown amount of time before vaccination. Due to the lack of information regarding chronology, causality for the reported events is unassessable.
Age: 61.0
Sex: F
Vaccine: FLUC3, TDAP
Symptoms: Chest X-ray abnormal, Dyspnoea, Laboratory test, Pulmonary embolism
Clinical narrative: Bilateral pulmonary embolism (PE); Shortness of breath (SOB); This spontaneous case  was retrieved on 25-Nov-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1857195-1), reported by other healthcare professional and concerned a 61-year-old, female patient.   The patient's concurrent conditions included alcoholism, hypertension, hyperlipidemia, asthma and allergy to ACE inhibitors, causing cough. The patient's concomitant medications included hydrochlorothiazide and citalopram, both used for an unreported indication.   On 20-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular, dose, anatomical location and indication: not reported). The batch number reported was 308481.  On the same day, the patient was vaccinated with non-company, co-suspect Boostrix (diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid; route of administration: intramuscular, dose, anatomical location and indication: not reported). The batch number reported was MR5RK.  On 27-Oct-2021, seven days after receiving Flucelvax Quadrivalent and Boostrix, the patient experienced shortness of breath (SOB).   On 28-Oct-2021, the patient was seen in the doctor's office for SOB, had unspecified testing (labs/imaging as reported) and was admitted for bilateral pulmonary embolism (PE). Ultrasound (U/S) and echocardiogram (echo) were planned.   At the time of initial reporting, the patient had not recovered from the events.   The reporter did not provide causality assessment.  Both events were assessed as serious due to seriousness criterion of hospitalization. Additionally, the event of 'pulmonary embolism' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 61-year-old female patient developed dyspnea and bilateral pulmonary embolism 8 days after receiving Flucelvax Quadrivalent and non-company co-suspect Boostrix vaccines. The patient's concurrent conditions included alcoholism, hypertension, hyperlipidemia and asthma. Causality for the reported events is assessed as not related due to biological implausibility.; Sender's Comments: A 61-year-old female patient developed dyspnea and bilateral pulmonary embolism 8 days after receiving Flucelvax Quadrivalent and non-company co-suspect Boostrix vaccines. The patient's concurrent conditions included alcoholism, hypertension, hyperlipidemia and asthma. Causality for the reported events is assessed as not related due to biological implausibility.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year old daughter took her shot today; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old daughter took her shot today) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old daughter took her shot today). On 01-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old daughter took her shot today) had resolved.        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 drugs were not reported. Treatment medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: HEART FAILURE; This spontaneous report received from a consumer via a company representative through social media concerned a male of an 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 (series 1) (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered and start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced heart failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211209612-covid-19 vaccine ad26.cov2.s- Heart failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Feeling abnormal, Formication, Heart rate
Clinical narrative: FELT REALLY FUNNY, SOMETHING DOES NOT FEEL RIGHT AND STRANGE FEELING; BLOOD PRESSURE WENT DOWN; SLEPT AND SAT UP IN NIGHT; HEART RATE WENT DOWN; COULD NOT LAY DOWN; TINGLY CRAWLING AND FELT LIKE SOMETHING CRAWLING IN HEAD; This spontaneous report received from a patient concerned a 72 year old female. 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 not reported, batch number: Unknown) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-MAR-2021, the patient experienced felt really funny, something does not feel right and strange feeling. On 28-MAR-2021, the patient experienced blood pressure went down. On 28-MAR-2021, the patient experienced slept and sat up in night. On 28-MAR-2021, the patient experienced heart rate went down. On 28-MAR-2021, the patient experienced could not lay down. On 28-MAR-2021, the patient experienced tingly crawling and felt like something crawling in head. Laboratory data included: Blood pressure (NR: not provided) Low in 50s, and Heart rate (NR: not provided) Went down in 30s, Up to 42 before sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt really funny, something does not feel right and strange feeling, blood pressure went down, slept and sat up in night, heart rate went down, could not lay down, and tingly crawling and felt like something crawling in head on 31-MAR-2021. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Movement disorder, Parasomnia
Clinical narrative: FELT REALLY FUNNY, SOMETHING DOES NOT FEEL RIGHT AND STRANGE FEELING; BLOOD PRESSURE WENT DOWN; SLEPT AND SAT UP IN NIGHT; HEART RATE WENT DOWN; COULD NOT LAY DOWN; TINGLY CRAWLING AND FELT LIKE SOMETHING CRAWLING IN HEAD; This spontaneous report received from a patient concerned a 72 year old female. 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 not reported, batch number: Unknown) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-MAR-2021, the patient experienced felt really funny, something does not feel right and strange feeling. On 28-MAR-2021, the patient experienced blood pressure went down. On 28-MAR-2021, the patient experienced slept and sat up in night. On 28-MAR-2021, the patient experienced heart rate went down. On 28-MAR-2021, the patient experienced could not lay down. On 28-MAR-2021, the patient experienced tingly crawling and felt like something crawling in head. Laboratory data included: Blood pressure (NR: not provided) Low in 50s, and Heart rate (NR: not provided) Went down in 30s, Up to 42 before sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt really funny, something does not feel right and strange feeling, blood pressure went down, slept and sat up in night, heart rate went down, could not lay down, and tingly crawling and felt like something crawling in head on 31-MAR-2021. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Fatigue, Migraine, Varicose vein
Clinical narrative: TENSION MIGRAINE; PROTRUDING VEIN ON RIGHT SHOULDER; DIZZY; TIRED; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight was 128 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1, suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced dizzy. On 15-SEP-2021, the patient experienced tired. On 19-SEP-2021, the patient experienced protruding vein on right shoulder. On 28-SEP-2021, the patient experienced tension migraine. Laboratory data included: CT scan (NR: not provided) normal. Treatment medications included: ibuprofen. Additional treatment medications (dates unspecified) included: ketorolac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tension migraine, protruding vein on right shoulder, dizzy, and tired. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On AUG-2021, the patient experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. This case is associated with product quality complaint: 90000205505.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Typical side effects, nothing extreme or noteworth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Typical side effects, nothing extreme or noteworth) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Typical side effects, nothing extreme or noteworth). At the time of the report, VACCINATION COMPLICATION (Typical side effects, nothing extreme or noteworth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided No treatment details were provided.   This case was linked to MOD-2021-400021, MOD-2021-400021 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Chronic fatigue syndrome, Lymphadenopathy
Clinical narrative: Chronic Fatigue Syndrome worsened; Had plenty of side effects; Pain in the back side, that lasted for three weeks; Muscles pain, that lasted for three weeks; Join pain, that lasted for three weeks; Swollen lymph nodes, under the armpit of the injection side; Chills and was round down that night; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome worsened), VACCINATION COMPLICATION (Had plenty of side effects), BACK PAIN (Pain in the back side, that lasted for three weeks), MYALGIA (Muscles pain, that lasted for three weeks) and ARTHRALGIA (Join pain, that lasted for three weeks) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic fatigue syndrome and Epstein-Barr virus infection. Concomitant products included OMEGA-3 [OMEGA-3 NOS] and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION COMPLICATION (Had plenty of side effects), BACK PAIN (Pain in the back side, that lasted for three weeks), MYALGIA (Muscles pain, that lasted for three weeks), ARTHRALGIA (Join pain, that lasted for three weeks), LYMPHADENOPATHY (Swollen lymph nodes, under the armpit of the injection side) and CHILLS (Chills and was round down that night). On an unknown date, the patient experienced CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome worsened). The patient was treated with CELECOXIB (CELEBREX) from 03-Nov-2021 to 04-Nov-2021 at a dose of 1 dosage form and TIZANIDINE on 03-Nov-2021 at a dose of 1 dosage form. At the time of the report, CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome worsened), VACCINATION COMPLICATION (Had plenty of side effects), MYALGIA (Muscles pain, that lasted for three weeks), ARTHRALGIA (Join pain, that lasted for three weeks) and LYMPHADENOPATHY (Swollen lymph nodes, under the armpit of the injection side) outcome was unknown and BACK PAIN (Pain in the back side, that lasted for three weeks) and CHILLS (Chills and was round down that night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that on 02-Nov-2021, she had an appointment with doctor because she was not feeling better with the joint pain, muscle pain and fatigue.   This case was linked to MOD-2021-398450 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Patient demographics, Medical history, Outcome of events Joint pain and Muscle pain, Additional event of Chronic fatigue syndrome, Treatment medications were updated. On 01-Dec-2021: Contains no new information.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination complication
Clinical narrative: Chronic Fatigue Syndrome worsened; Had plenty of side effects; Pain in the back side, that lasted for three weeks; Muscles pain, that lasted for three weeks; Join pain, that lasted for three weeks; Swollen lymph nodes, under the armpit of the injection side; Chills and was round down that night; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome worsened), VACCINATION COMPLICATION (Had plenty of side effects), BACK PAIN (Pain in the back side, that lasted for three weeks), MYALGIA (Muscles pain, that lasted for three weeks) and ARTHRALGIA (Join pain, that lasted for three weeks) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic fatigue syndrome and Epstein-Barr virus infection. Concomitant products included OMEGA-3 [OMEGA-3 NOS] and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION COMPLICATION (Had plenty of side effects), BACK PAIN (Pain in the back side, that lasted for three weeks), MYALGIA (Muscles pain, that lasted for three weeks), ARTHRALGIA (Join pain, that lasted for three weeks), LYMPHADENOPATHY (Swollen lymph nodes, under the armpit of the injection side) and CHILLS (Chills and was round down that night). On an unknown date, the patient experienced CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome worsened). The patient was treated with CELECOXIB (CELEBREX) from 03-Nov-2021 to 04-Nov-2021 at a dose of 1 dosage form and TIZANIDINE on 03-Nov-2021 at a dose of 1 dosage form. At the time of the report, CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome worsened), VACCINATION COMPLICATION (Had plenty of side effects), MYALGIA (Muscles pain, that lasted for three weeks), ARTHRALGIA (Join pain, that lasted for three weeks) and LYMPHADENOPATHY (Swollen lymph nodes, under the armpit of the injection side) outcome was unknown and BACK PAIN (Pain in the back side, that lasted for three weeks) and CHILLS (Chills and was round down that night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that on 02-Nov-2021, she had an appointment with doctor because she was not feeling better with the joint pain, muscle pain and fatigue.   This case was linked to MOD-2021-398450 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Patient demographics, Medical history, Outcome of events Joint pain and Muscle pain, Additional event of Chronic fatigue syndrome, Treatment medications were updated. On 01-Dec-2021: Contains no new information.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Tremor
Clinical narrative: tremor, kicks/aggressive body tremor and involuntary limb flinging and shaking and body and limbs were still so aggressively shaking; tremor, kicks, spasm/very aggressive body tremors and spasms and body and limbs were still so aggressively spasming; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (tremor, kicks/aggressive body tremor and involuntary limb flinging and shaking and body and limbs were still so aggressively shaking) and MUSCLE SPASMS (tremor, kicks, spasm/very aggressive body tremors and spasms and body and limbs were still so aggressively spasming) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 025C21A and 036B21A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Vitamin D deficiency.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced TREMOR (tremor, kicks/aggressive body tremor and involuntary limb flinging and shaking and body and limbs were still so aggressively shaking) and MUSCLE SPASMS (tremor, kicks, spasm/very aggressive body tremors and spasms and body and limbs were still so aggressively spasming). On 24-Nov-2021, TREMOR (tremor, kicks/aggressive body tremor and involuntary limb flinging and shaking and body and limbs were still so aggressively shaking) and MUSCLE SPASMS (tremor, kicks, spasm/very aggressive body tremors and spasms and body and limbs were still so aggressively spasming) had resolved.            No medical history was reported by reporter.  Reporter reported that after booster dose what she thought was chills or shivering turned out to be tremors, and she had normal body temperature. Initially the reaction lasted about 40 minutes without pauses and then stopped abruptly, about 20 minutes later it restarted somewhat milder. She reported the incident to doctor and no medical follow-up was required. No treatment medications were reported.   This case was linked to MOD-2021-404745 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Updated reporter, patient information, concomitant drug information and event details.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Hypertension
Clinical narrative: BP was elevated; feelings poorly with headache; fatigue; Heart rate >100 beats per min; chills; Giant spot on my arm; Serious pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Giant spot on my arm), PAIN IN EXTREMITY (Serious pain), HYPERTENSION (BP was elevated), HEADACHE (feelings poorly with headache) and CHILLS (chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Sulfonamide allergy (had rash in childhood) since 01-Jan-1987, Grass allergy (Rash and hives) since 01-Jan-2010, Endometriosis (Endometriosis W HRT) since 01-Jan-2006, Chronic UTI since 01-Jun-2021, Migraine since 01-Jan-2010 and Fragrance sensitivity (Jasmine, had itching) since 01-Jan-2015. Concomitant products included ESTROGEN NOS;TESTOSTERONE from 01-Jan-2013 to an unknown date for Hormone replacement therapy, ERENUMAB (AIMOVIG [ERENUMAB]) from 01-Jan-2019 to an unknown date for Migraine, TIZANIDINE from 01-Jan-2016 to an unknown date for Muscle spasms, BUPROPION HYDROCHLORIDE (WELLBUTRIN SR) from 01-Jan-2008 to an unknown date for Off label use, HYDROMORPHONE from 01-Jan-2010 to an unknown date and METHADONE HYDROCHLORIDE (METHADONE [METHADONE HYDROCHLORIDE]) from 01-Jan-2010 to an unknown date for an unknown indication.    On 23-Sep-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced RASH MACULAR (Giant spot on my arm) and PAIN IN EXTREMITY (Serious pain). On 22-Oct-2021, the patient experienced CHILLS (chills) and HEART RATE INCREASED (Heart rate >100 beats per min). On an unknown date, the patient experienced HYPERTENSION (BP was elevated), HEADACHE (feelings poorly with headache) and FATIGUE (fatigue). At the time of the report, RASH MACULAR (Giant spot on my arm), PAIN IN EXTREMITY (Serious pain), HEADACHE (feelings poorly with headache), CHILLS (chills) and HEART RATE INCREASED (Heart rate >100 beats per min) had resolved and HYPERTENSION (BP was elevated) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Hydromorphone and methadone indication was given as ENDO.  Patient is on OPIATE C2 (Multivitamin) takes orally for endometriosis pain since from 01-Jan-2010 (still taking) and FIORINOL takes orally for migraine since from 01-Jan-2013 (still taking).  No treatment medications were reported.   This case was linked to MOD-2021-382911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Follow up received and medical history updated, added concomitant medications and event  heart rate increased were updated.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular
Clinical narrative: BP was elevated; feelings poorly with headache; fatigue; Heart rate >100 beats per min; chills; Giant spot on my arm; Serious pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Giant spot on my arm), PAIN IN EXTREMITY (Serious pain), HYPERTENSION (BP was elevated), HEADACHE (feelings poorly with headache) and CHILLS (chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Sulfonamide allergy (had rash in childhood) since 01-Jan-1987, Grass allergy (Rash and hives) since 01-Jan-2010, Endometriosis (Endometriosis W HRT) since 01-Jan-2006, Chronic UTI since 01-Jun-2021, Migraine since 01-Jan-2010 and Fragrance sensitivity (Jasmine, had itching) since 01-Jan-2015. Concomitant products included ESTROGEN NOS;TESTOSTERONE from 01-Jan-2013 to an unknown date for Hormone replacement therapy, ERENUMAB (AIMOVIG [ERENUMAB]) from 01-Jan-2019 to an unknown date for Migraine, TIZANIDINE from 01-Jan-2016 to an unknown date for Muscle spasms, BUPROPION HYDROCHLORIDE (WELLBUTRIN SR) from 01-Jan-2008 to an unknown date for Off label use, HYDROMORPHONE from 01-Jan-2010 to an unknown date and METHADONE HYDROCHLORIDE (METHADONE [METHADONE HYDROCHLORIDE]) from 01-Jan-2010 to an unknown date for an unknown indication.    On 23-Sep-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced RASH MACULAR (Giant spot on my arm) and PAIN IN EXTREMITY (Serious pain). On 22-Oct-2021, the patient experienced CHILLS (chills) and HEART RATE INCREASED (Heart rate >100 beats per min). On an unknown date, the patient experienced HYPERTENSION (BP was elevated), HEADACHE (feelings poorly with headache) and FATIGUE (fatigue). At the time of the report, RASH MACULAR (Giant spot on my arm), PAIN IN EXTREMITY (Serious pain), HEADACHE (feelings poorly with headache), CHILLS (chills) and HEART RATE INCREASED (Heart rate >100 beats per min) had resolved and HYPERTENSION (BP was elevated) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Hydromorphone and methadone indication was given as ENDO.  Patient is on OPIATE C2 (Multivitamin) takes orally for endometriosis pain since from 01-Jan-2010 (still taking) and FIORINOL takes orally for migraine since from 01-Jan-2013 (still taking).  No treatment medications were reported.   This case was linked to MOD-2021-382911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Follow up received and medical history updated, added concomitant medications and event  heart rate increased were updated.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Irritability, Neck pain, Swelling
Clinical narrative: swollenness of their neck; pain in their neck near the lymph nodes on the left side; it is a little annoying/It bothers them every once in a while; numbness in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollenness of their neck), NECK PAIN (pain in their neck near the lymph nodes on the left side), IRRITABILITY (it is a little annoying/It bothers them every once in a while) and HYPOAESTHESIA (numbness in the arm of the injection) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 032M20A and 026B21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (numbness in the arm of the injection). On an unknown date, the patient experienced SWELLING (swollenness of their neck), NECK PAIN (pain in their neck near the lymph nodes on the left side) and IRRITABILITY (it is a little annoying/It bothers them every once in a while). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK, qhs. In November 2021, HYPOAESTHESIA (numbness in the arm of the injection) had resolved. At the time of the report, SWELLING (swollenness of their neck), NECK PAIN (pain in their neck near the lymph nodes on the left side) and IRRITABILITY (it is a little annoying/It bothers them every once in a while) had not resolved.            No medical history were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Non-significant follow-up received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Fatigue, Oral herpes, Pyrexia
Clinical narrative: Patient felt tired; Patient developed a cold sore; Fever of 99.0 degrees Farenheight; Patients received the 0.5ml dose; This spontaneous case was reported by a nurse and describes the occurrence of ORAL HERPES (Patient developed a cold sore), PYREXIA (Fever of 99.0 degrees Farenheight), FATIGUE (Patient felt tired) and ACCIDENTAL OVERDOSE (Patients received the 0.5ml dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Concurrent medical conditions included Cold sores.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Patients received the 0.5ml dose). On 20-Nov-2021, the patient experienced PYREXIA (Fever of 99.0 degrees Farenheight). On 21-Nov-2021, the patient experienced ORAL HERPES (Patient developed a cold sore). On an unknown date, the patient experienced FATIGUE (Patient felt tired). On 19-Nov-2021, ACCIDENTAL OVERDOSE (Patients received the 0.5ml dose) had resolved. At the time of the report, ORAL HERPES (Patient developed a cold sore), PYREXIA (Fever of 99.0 degrees Farenheight) and FATIGUE (Patient felt tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-403029 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Secondary reporter Information was added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No concomitant medications reported. No treatment reported.    This case was linked to MOD-2021-403355, MOD-2021-403376 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Pain went down to her elbow for 2 months or more; Excruciating pain on right arm after second dose for 2 months or more; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain went down to her elbow for 2 months or more) and VACCINATION SITE PAIN (Excruciating pain on right arm after second dose for 2 months or more) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00GB21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LOSARTAN for Blood pressure management, COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, 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 PAIN (Pain went down to her elbow for 2 months or more) and VACCINATION SITE PAIN (Excruciating pain on right arm after second dose for 2 months or more). At the time of the report, PAIN (Pain went down to her elbow for 2 months or more) and VACCINATION SITE PAIN (Excruciating pain on right arm after second dose for 2 months or more) outcome was unknown.            No treatment information was provided.  The patient after their second dose had excruciating pain on the right of their arm (site of injection) and the pain went down to their elbow for 2 months or more.   This case was linked to MOD-2021-403382 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: A little rash after first dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A little rash after first dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced RASH (A little rash after first dose). In November 2021, RASH (A little rash after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-403398 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash macular, Rash vesicular
Clinical narrative: Rash area burning after 2nd dose; Rash area starting to blister after 2nd dose; the rash is moving into her face; she started with a red blotching rash on her neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (she started with a red blotching rash on her neck), BURNING SENSATION (Rash area burning after 2nd dose), RASH VESICULAR (Rash area starting to blister after 2nd dose) and RASH (the rash is moving into her face) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced RASH MACULAR (she started with a red blotching rash on her neck). On 01-Dec-2021, the patient experienced BURNING SENSATION (Rash area burning after 2nd dose), RASH VESICULAR (Rash area starting to blister after 2nd dose) and RASH (the rash is moving into her face). The patient was treated with ALOE VERA (ALOE 99) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (she started with a red blotching rash on her neck) outcome was unknown and BURNING SENSATION (Rash area burning after 2nd dose), RASH VESICULAR (Rash area starting to blister after 2nd dose) and RASH (the rash is moving into her face) had not resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-403389 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Chills; Headache; Body aches; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body aches) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown. Not Provided          No concomitant and treatment medication reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscular pain on entire body for 10 days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscular pain on entire body for 10 days) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) for Allergy.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYALGIA (Muscular pain on entire body for 10 days). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In April 2021, MYALGIA (Muscular pain on entire body for 10 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-404125 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: Discomfort; This spontaneous case was reported by an other health care professional and describes the occurrence of DISCOMFORT (Discomfort) 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 an unknown date, the patient received third 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 and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Discomfort). At the time of the report, DISCOMFORT (Discomfort) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-404247 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy, Myalgia, Pain
Clinical narrative: feel bruised; pain for a good day; had horrible muscle aches; lymph nodes in my neck that are really swollen; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (feel bruised), PAIN (pain for a good day), MYALGIA (had horrible muscle aches) and LYMPHADENOPATHY (lymph nodes in my neck that are really swollen) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (feel bruised), PAIN (pain for a good day), MYALGIA (had horrible muscle aches) and LYMPHADENOPATHY (lymph nodes in my neck that are really swollen). At the time of the report, CONTUSION (feel bruised), PAIN (pain for a good day), MYALGIA (had horrible muscle aches) and LYMPHADENOPATHY (lymph nodes in my neck that are really swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.