chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Immediate post-injection reaction, Mobility decreased, Pharyngeal swelling
Clinical narrative: In spite of taking a 5mg Claritin 2 hours before shot I felt immediately my tongue and throat swell. I took another Claritin and sensations subsided in an hour. The next day my arm was bruised right above injection site. I couldn't lift my arm. I also had a fever and felt very tired. Both of these resolved by the third day. A few days later the rash began. All over my mid-body. It is itchy and has progressively gotten worse over the last couple of weeks.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Swollen tongue
Clinical narrative: In spite of taking a 5mg Claritin 2 hours before shot I felt immediately my tongue and throat swell. I took another Claritin and sensations subsided in an hour. The next day my arm was bruised right above injection site. I couldn't lift my arm. I also had a fever and felt very tired. Both of these resolved by the third day. A few days later the rash began. All over my mid-body. It is itchy and has progressively gotten worse over the last couple of weeks.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hypomenorrhoea
Clinical narrative: Light period started on December 20. This was two weeks earlier than the normal start of my menstrual cycle. I have had light bleeding for 2+ weeks at this point.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary normal, Anion gap decreased, Blood urea increased, Brain natriuretic peptide normal, Chest X-ray normal
Clinical narrative: Left leg pain and swelling, very pronounced as compared with right leg which did not appear to be swollen.  Patient attempted to schedule with primary doctor, but was not able to set up an appointment.  Patient went instead to an urgent care where she was instructed to immediately proceed to local hospital ER.  Several tests were performed, but patient was not treated.  Instructed to follow-up with Primary Care Physician.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Differential white blood cell count, Fibrin D dimer increased, Full blood count, Globulins increased
Clinical narrative: Left leg pain and swelling, very pronounced as compared with right leg which did not appear to be swollen.  Patient attempted to schedule with primary doctor, but was not able to set up an appointment.  Patient went instead to an urgent care where she was instructed to immediately proceed to local hospital ER.  Several tests were performed, but patient was not treated.  Instructed to follow-up with Primary Care Physician.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lipase normal, Mean platelet volume decreased, Metabolic function test, Pain in extremity, Peripheral swelling
Clinical narrative: Left leg pain and swelling, very pronounced as compared with right leg which did not appear to be swollen.  Patient attempted to schedule with primary doctor, but was not able to set up an appointment.  Patient went instead to an urgent care where she was instructed to immediately proceed to local hospital ER.  Several tests were performed, but patient was not treated.  Instructed to follow-up with Primary Care Physician.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Scan with contrast normal, Troponin I, Ultrasound Doppler normal
Clinical narrative: Left leg pain and swelling, very pronounced as compared with right leg which did not appear to be swollen.  Patient attempted to schedule with primary doctor, but was not able to set up an appointment.  Patient went instead to an urgent care where she was instructed to immediately proceed to local hospital ER.  Several tests were performed, but patient was not treated.  Instructed to follow-up with Primary Care Physician.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fundoscopy, Headache, Idiopathic intracranial hypertension, Lumbar puncture abnormal, Papilloedema
Clinical narrative: Pt developed headaches several weeks after her vaccine.  She was working out and  developed severe Headache and was seen in the ER.  She was diagnosed with Idiopathic Intracranial Hypertension.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Haemorrhage, Insomnia, Muscle spasms, Vomiting
Clinical narrative: SEVERE menstrual bleeding!!  Cramping so painful that I have been throwing up non stop for 3 days. Haven't been able to sleep or eat because the pain is so severe. I've had my period for almost 30 years now and have never experienced anything like this.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; one dose of VARlVAX was administered; This spontaneous report has been received from a physician (also reported as customer), referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 13-DEC-2021, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T035400 with expiration date: 16-OCT-2022, 0.5 milliliter, strength and route were unknown) for prophylaxis following a temperature excursion (product storage error). No additional AE reported.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion below 25.9 Fahrenheit degrees (F) for 4 hours and 30 minutes. There was no previous temperature excursions reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details reported; Administered an expired dose of PROQUAD; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent (STERILE DILUENT). Patient's concurrent conditions and medical history were not provided.  On 22-DEC-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD), 0.5 milliliter (lot # T021639 and expiration date reported as 21-DEC-2021) for prophylaxis (expired product administered). No additional AE details or PQC.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No addtional adverse events; Administration of improperly stored ROTATEQ; This spontaneous report has been received from medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not provided.   On 21-DEC-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (lot number 1741817 has been verified to be a valid lot number, expiration date was reported and established as 30-JUL-2022; vaccination scheme, and anatomical site of vaccination were not reported), 2 milliliters for prophylaxis.   The vaccine was exposed to a temperature of 50.5 Fahrenheit (F), for a time frame of 57 minutes. There were no previous temperature excursions. No additional adverse events (no adverse event) and no product quality complaints were reported.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS FLARE UP; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (dose series 1, suspension for injection, intramuscular, batch number was not reported) dose, 1 total, start therapy date were not reported for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  On an unspecified date, the patient experienced Rheumatoid arthritis symptoms returned (Rheumatoid arthritis flare up) and received treatment medications included methotrexate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of rheumatoid arthritis flare up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20220100123-covid-19 vaccine ad26.cov2.s -Rheumatoid arthritis flare up . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure, Vaccine breakthrough infection
Clinical narrative: BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a parent via a company representative via social media concerned a male of unspecified age, race and ethnic origin. 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, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). 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 an unspecified date, the patient experienced breakthrough infection and had almost no symptoms and suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220100161-Covid-19 vaccine ad26.cov2.s- Breakthrough infection. This event(s) is considered unassessable. The event(s) has unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20220100161-covid-19 vaccine ad26.cov2.s- Suspected clinical Vaccination failure. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Nausea, Pyrexia
Clinical narrative: LIGHTHEADED/DIZZY; WEAK; NAUSEOUS; 102.7 FEVER; This spontaneous report received from a patient concerned a 37 year old male. 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: 211D21A, expiry: UNKNOWN) dose was not reported, administered on 30-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-DEC-2021, the patient experienced lightheaded/dizzy, weak, nauseous, and 102.7 fever. Laboratory data included: Body temperature (NR: not provided) 102.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 102.7 fever, lightheaded/dizzy, weak, and nauseous. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM; This spontaneous report received from a parent via a company representative via social media concerned a 58 year old female of unspecified race. 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 (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number was unknown and expiry date was unknown) dose was not reported, 1 total, administered on 21-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had acute pulmonary embolism. On 01-OCT-2021, the patient died due to acute pulmonary embolism. It was unspecified if an autopsy was performed. As per the reporter "My daughter received the J&J vaccine 21-Sep-2021. Died 01-Oct-2021 due to an acute pulmonary embolism. She was 13 days from celebrating her 59th birthday." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20220100225-COVID-19 VACCINE AD26.COV2.S-Acute pulmonary embolism. 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).; Reported Cause(s) of Death: ACUTE PULMONARY  EMBOLISM
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: BAD THROMBOSIS IN LUNGS; This spontaneous report received from a parent concerned a male of unspecified age, race and ethnic origin. 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 was not reported, and batch number: unknown expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 1 total was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, son (patient) developed a bad thrombosis in his lung after he received the Johnson and Johnson Covid-19 vaccine (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad thrombosis in lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20220100267-COVID-19 VACCINE AD26.COV2.S- Bad thrombosis in lung. 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).
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media 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 (dose number in series was 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, therapy start date were not reported, administered 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 31-DEC-2021, the patient experienced suspected covid-19 infection and thus had suspected clinical vaccination failure. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The reporter stated that "tested positive two days ago, but if not for a 30 minute fever I would have never suspected or gotten tested". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209770.; Sender's Comments: V0: 20220100917-covid-19 vaccine ad26.cov2.s- Suspected clinical Vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Patient restraint, Soliloquy
Clinical narrative: Was on restraints 2 days after vaccination; She was talking all over the place; This spontaneous case was reported by a consumer and describes the occurrence of SOLILOQUY (She was talking all over the place) and PATIENT RESTRAINT (Was on restraints 2 days after vaccination) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Behaviour disorder.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced SOLILOQUY (She was talking all over the place). On an unknown date, the patient experienced PATIENT RESTRAINT (Was on restraints 2 days after vaccination). At the time of the report, SOLILOQUY (She was talking all over the place) and PATIENT RESTRAINT (Was on restraints 2 days after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  Patient had mentioned about treatment medication as Zyprexa but she refused to take, however, she was given 2 injections in her legs, which she does not know what it was.  Patient had reported that 2 days after vaccination she was on restraints at a behavioral health facility, and already went to court. The facility made her to get the vaccine. She was calling today to say that the Facility violated her rights.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster given greater than 12 hours after vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus, Hypertension, Chronic kidney disease, Atrial fibrillation, Cardiac failure and Drug allergy (Vioxx, morphine, celebrax). Concomitant products included ATORVASTATIN, BACLOFEN, AMIODARONE, CIPROFLOXACIN HYDROCHLORIDE (CIPRO 1A PHARMA), BUMETANIDE (BUMEX) and DOCUSATE SODIUM (COLACE) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information was provided. No Concomitant medication was provided.   This case was linked to MOD-2021-416295 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headaches) 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 HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: felt tired the next day; left arm was hurting; The callers husband received the Pfizer vaccine for his Primary vaccination series.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired the next day), VACCINATION SITE PAIN (left arm was hurting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The callers husband received the Pfizer vaccine for his Primary vaccination series.) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced VACCINATION SITE PAIN (left arm was hurting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The callers husband received the Pfizer vaccine for his Primary vaccination series.). On 09-Dec-2021, the patient experienced FATIGUE (felt tired the next day). On 08-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The callers husband received the Pfizer vaccine for his Primary vaccination series.) had resolved. At the time of the report, FATIGUE (felt tired the next day) and VACCINATION SITE PAIN (left arm was hurting) outcome was unknown.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-436175 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site papule
Clinical narrative: A big red circle on the site of the injection, and is all swollen  and hard; Itchy bumps on the site of the injection; Big red circle swollen and hard; Started itching around the site of the injection; Big red circle swollen and hard; When press on it, it hurts; Only a little bit of arm  soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (A big red circle on the site of the injection, and is all swollen  and hard), VACCINATION SITE PAPULE (Itchy bumps on the site of the injection), VACCINATION SITE INDURATION (Big red circle swollen and hard), VACCINATION SITE PRURITUS (Started itching around the site of the injection) and MYALGIA (Only a little bit of arm  soreness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045j21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROPINIROLE, GABAPENTIN ENACARBIL (HORIZANT), METHOTREXATE, DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ), FOLIC ACID, BUPROPION HYDROCHLORIDE (WELLBUTRIN), LANSOPRAZOLE (PREVACID) and CRATAEGUS LAEVIGATA, MAGNESIUM CITRATE, PLECTRANTHUS HADIENSIS, THEANINE, THEOBROMA CACAO (HIGH BLOOD PRESSURURE) for an unknown indication.    On 22-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2021, the patient experienced MYALGIA (Only a little bit of arm  soreness). On 31-Dec-2021, the patient experienced VACCINATION SITE ERYTHEMA (A big red circle on the site of the injection, and is all swollen  and hard), VACCINATION SITE PAPULE (Itchy bumps on the site of the injection), VACCINATION SITE INDURATION (Big red circle swollen and hard), VACCINATION SITE PRURITUS (Started itching around the site of the injection), VACCINATION SITE SWELLING (Big red circle swollen and hard) and VACCINATION SITE PAIN (When press on it, it hurts). At the time of the report, VACCINATION SITE ERYTHEMA (A big red circle on the site of the injection, and is all swollen  and hard), VACCINATION SITE PAPULE (Itchy bumps on the site of the injection), VACCINATION SITE INDURATION (Big red circle swollen and hard), MYALGIA (Only a little bit of arm  soreness), VACCINATION SITE SWELLING (Big red circle swollen and hard) and VACCINATION SITE PAIN (When press on it, it hurts) outcome was unknown and VACCINATION SITE PRURITUS (Started itching around the site of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported she took  antihistamine and doesn't itchy anymore. She is using High blood pressure Concomitant medication.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: A big red circle on the site of the injection, and is all swollen  and hard; Itchy bumps on the site of the injection; Big red circle swollen and hard; Started itching around the site of the injection; Big red circle swollen and hard; When press on it, it hurts; Only a little bit of arm  soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (A big red circle on the site of the injection, and is all swollen  and hard), VACCINATION SITE PAPULE (Itchy bumps on the site of the injection), VACCINATION SITE INDURATION (Big red circle swollen and hard), VACCINATION SITE PRURITUS (Started itching around the site of the injection) and MYALGIA (Only a little bit of arm  soreness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045j21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROPINIROLE, GABAPENTIN ENACARBIL (HORIZANT), METHOTREXATE, DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ), FOLIC ACID, BUPROPION HYDROCHLORIDE (WELLBUTRIN), LANSOPRAZOLE (PREVACID) and CRATAEGUS LAEVIGATA, MAGNESIUM CITRATE, PLECTRANTHUS HADIENSIS, THEANINE, THEOBROMA CACAO (HIGH BLOOD PRESSURURE) for an unknown indication.    On 22-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2021, the patient experienced MYALGIA (Only a little bit of arm  soreness). On 31-Dec-2021, the patient experienced VACCINATION SITE ERYTHEMA (A big red circle on the site of the injection, and is all swollen  and hard), VACCINATION SITE PAPULE (Itchy bumps on the site of the injection), VACCINATION SITE INDURATION (Big red circle swollen and hard), VACCINATION SITE PRURITUS (Started itching around the site of the injection), VACCINATION SITE SWELLING (Big red circle swollen and hard) and VACCINATION SITE PAIN (When press on it, it hurts). At the time of the report, VACCINATION SITE ERYTHEMA (A big red circle on the site of the injection, and is all swollen  and hard), VACCINATION SITE PAPULE (Itchy bumps on the site of the injection), VACCINATION SITE INDURATION (Big red circle swollen and hard), MYALGIA (Only a little bit of arm  soreness), VACCINATION SITE SWELLING (Big red circle swollen and hard) and VACCINATION SITE PAIN (When press on it, it hurts) outcome was unknown and VACCINATION SITE PRURITUS (Started itching around the site of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported she took  antihistamine and doesn't itchy anymore. She is using High blood pressure Concomitant medication.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Impaired quality of life, Influenza like illness, Vaccination complication
Clinical narrative: Adverse reaction; Ruining quality of life; Feel like I have the flu for 7 weeks; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feel like I have the flu for 7 weeks), VACCINATION COMPLICATION (Adverse reaction) and IMPAIRED QUALITY OF LIFE (Ruining quality of life) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 004C21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced INFLUENZA LIKE ILLNESS (Feel like I have the flu for 7 weeks). On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction) and IMPAIRED QUALITY OF LIFE (Ruining quality of life). At the time of the report, INFLUENZA LIKE ILLNESS (Feel like I have the flu for 7 weeks), VACCINATION COMPLICATION (Adverse reaction) and IMPAIRED QUALITY OF LIFE (Ruining quality of life) had not resolved. Not provided.         It was reported that the patient was caused weeks and weeks of adverse reaction and felt like had the flu for 7 weeks. The patient had been to several doctors to find out what was wrong as it just went on and on and was ruining the quality of life.  No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jan-2022: Follow up document contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction to the Moderna booster COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Reaction to the Moderna booster COVID-19 vaccine) 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 VACCINATION COMPLICATION (Reaction to the Moderna booster COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (Reaction to the Moderna booster COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    No treatment information provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest pain, Cough, Dyspnoea, Pain
Clinical narrative: Throat closure, tongue swelling, body aches, chest pain, SOB, coughing, congestion, elevated bpm,
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Swollen tongue, Throat tightness
Clinical narrative: Throat closure, tongue swelling, body aches, chest pain, SOB, coughing, congestion, elevated bpm,
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after 2nd dose. Patient was diagnosed of COVID Ascorbic acid, Regen-Cov, Discharged home
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after 2nd dose. Patient was diagnosed of COVID Aspirin, Tylenol Discharged home
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram, Disorientation, Dizziness, Electrocardiogram
Clinical narrative: Passed out while crossing the street. Hit the concrete on the road when I lost consciousness. Had to be transported to the ER. Disoriented upon awakening. Continue to experience dizzy spells and back neck muscles ache.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness, Myalgia
Clinical narrative: Passed out while crossing the street. Hit the concrete on the road when I lost consciousness. Had to be transported to the ER. Disoriented upon awakening. Continue to experience dizzy spells and back neck muscles ache.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after 2nd dose. Patient was diagnosed with COVID-19. Casirivimab and Discharged home.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Palpitations
Clinical narrative: Heart Palpitations
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after 2nd Dose. Patient diagnosed of COVID Discharged home
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer via Glaxosmithkline, referring to a 67-year-old patient at the reporting time of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided. On an unknown date (at age of 62-year-old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (reported as older shingles shot) (strength, dose, dose number, route, lot# and expiration date were not provided) for prophylaxis. On an unknown date (at age around 65-year-old), the patient was vaccinated with varicella zoster vaccine rge (cho) (SHINGRIX) (reported as newer shot) but only 1 injection (strength, dose, route, indication, lot# and expiration date were not provided). On an unknown date, the patient had shingles (herpes zoster). The outcome of event and the causality assessment were not provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. No information was provided about the patient's concurrent conditions, pertinent medical history, drug and/or allergies reactions. The patient's concomitant therapy included sterile diluent (STERILE DILUENT). On 22-DEC-2021 the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (recombinant Human albumin) (PROQUAD) 0.5 milliliter (ml), lot # T021639, expiration date: 21-DEC-2021, subcutaneously for prophylaxis (expired product administered). No product quality complaint (PQC) and no additional adverse event (AEs) were reported
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; administration of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, drug reactions, allergies, and concomitant medications.   On 16-DEC-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliters (ml), route defaulted to oral, lot # 1741817, expiration date: 30-JUL-2022, (route of administration and anatomical location were not provided), for prophylaxis. (Product storage error). The administered dose of vaccine experienced temperature excursion of 50.5 degrees Fahrenheit for 57 minutes. There was no previous temperature excursion reported.     No product quality complaint (PQC) and no additional adverse event (AEs) were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Administration of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, drug reactions, allergies, and concomitant medications.   On 21-DEC-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliters (ml), route defaulted to oral, lot # 1741817, expiration date: 30-JUL-2022, (route of administration and anatomical location were not provided), for prophylaxis. (Product storage error). The administered dose of vaccine experienced temperature excursion of 50.5 degrees Fahrenheit for 57 minutes. There was no previous temperature excursion reported.     No product quality complaint (PQC) and no additional adverse event (AEs) were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever that won't stop; shivering that won't stop; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th December 2021 13:00, the patient received the 2nd dose of Shingrix. On 30th December 2021, less than a day after receiving Shingrix, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were not recovered/not resolved.   It was unknown if the reporter considered the fever and shivering to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received 2nd dose of Shingrix shot at 1 pm on the day of reporting and experienced fever and shivering which was not stopped until the time of reporting.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: on dialysis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-DEC-2021, the reporter reported that patient on dialysis, and went to the emergency room patient was not feeling right and had a bad cough. On the same date patient was diagnosed with positive COVID-19 polymerase chain reaction (PCR) test (confirmed covid-19 infection, and confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection, and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209586.; Sender's Comments: V0: 20211266620-Covid-19 vaccine ad26.cov2.s- Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: RIGHT ARM PAIN EVER SINCE GOT VACCINATED AND THAT PAIN EXACERBATED WHEN BUMPED INTO OR SLEPT ON; This spontaneous report received from a patient concerned a female 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 not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced right arm pain ever since got vaccinated and that pain exacerbated when bumped into or slept on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain ever since got vaccinated and that pain exacerbated when bumped into or slept on. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Patient is 29 weeks pregnant and received COVID-19 vaccine (booster dose); This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is 29 weeks pregnant and received COVID-19 vaccine (booster dose)) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is 29 weeks pregnant and received COVID-19 vaccine (booster dose)). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Patient is 29 weeks pregnant and received COVID-19 vaccine (booster dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Pain in extremity
Clinical narrative: It was also reported that with previous vaccines he had arm pain only; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (It was also reported that with previous vaccines he had arm pain only) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL tablet for Secondary pulmonary arterial hypertension and TREPROSTINIL DIOLAMIN (ORENITRAM) for Secondary pulmonary arterial hypertension.    Concurrent medical conditions included Secondary pulmonary arterial hypertension. Concomitant products included TADALAFIL and AMBRISENTAN (LETAIRIS) for an unknown indication.   On 12-Mar-2021, the patient started TREPROSTINIL (Oral) 4.75 mg. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) .25 mg. On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.5 mg, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 1 mg and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 4.75 mg. In 2021, the patient experienced PAIN IN EXTREMITY (It was also reported that with previous vaccines he had arm pain only). At the time of the report, PAIN IN EXTREMITY (It was also reported that with previous vaccines he had arm pain only) outcome was unknown.            Orenitram 0.25 mg, 2.5 mg and 1 mg and the current dose was reported as 4.75 mg  Orenitram (TREPROSTINIL DIETHANOLAMINE) Extende (Continued)-Lot number (2102022),Expiry date-20-APR-2023.  Orenitram (TREPROSTINIL DIETHANOLAMINE) Extended-Lot number (2102020),Expiry date-20-NOV-2022.  No treatment medicines were reported.   This case was linked to MOD-2021-436681, MOD-2021-436609 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspepsia, Feeling abnormal, Headache, Lip swelling
Clinical narrative: felt like theres a hole in stomach; Throat and lips swollen; Throat and lips swollen; Hives bilaterally on body, puffy, outside of elbow, front and back of knees then all over body; Fever of 102.7F; Dermatographia; headache; heartburn; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Dermatographia), PHARYNGEAL SWELLING (Throat and lips swollen), LIP SWELLING (Throat and lips swollen), URTICARIA (Hives bilaterally on body, puffy, outside of elbow, front and back of knees then all over body) and DYSPEPSIA (heartburn) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 026B21A and 001821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. In 2021, the patient experienced MECHANICAL URTICARIA (Dermatographia), DYSPEPSIA (heartburn) and HEADACHE (headache). On 02-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever of 102.7F). On 11-Dec-2021, the patient experienced URTICARIA (Hives bilaterally on body, puffy, outside of elbow, front and back of knees then all over body). On 13-Dec-2021, the patient experienced PHARYNGEAL SWELLING (Throat and lips swollen) and LIP SWELLING (Throat and lips swollen). On an unknown date, the patient experienced FEELING ABNORMAL (felt like theres a hole in stomach). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MECHANICAL URTICARIA (Dermatographia), PHARYNGEAL SWELLING (Throat and lips swollen), LIP SWELLING (Throat and lips swollen), URTICARIA (Hives bilaterally on body, puffy, outside of elbow, front and back of knees then all over body), DYSPEPSIA (heartburn), FEELING ABNORMAL (felt like theres a hole in stomach), HEADACHE (headache) and PYREXIA (Fever of 102.7F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, Body temperature: 102.7 (High) Fever of 102.7 F.         No concomitant drug details were reported.  Patient stated that the symptoms were ongoing but controlled by medications.   This case was linked to MOD-2021-437080 (Patient Link).