chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Dyspnoea, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: shortness of breath; sore arm; rapid heart beat; tightness of chest; Second dose scheduled 41 days after first dose; fever; Diagnosed with asthma; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Diagnosed with asthma), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (sore arm), TACHYCARDIA (rapid heart beat) and CHEST DISCOMFORT (tightness of chest) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced ASTHMA (Diagnosed with asthma). On an unknown date, the patient experienced DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (sore arm), TACHYCARDIA (rapid heart beat), CHEST DISCOMFORT (tightness of chest), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 41 days after first dose) and PYREXIA (fever). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHMA (Diagnosed with asthma), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (sore arm), TACHYCARDIA (rapid heart beat), CHEST DISCOMFORT (tightness of chest), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 41 days after first dose) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: shortness of breath; sore arm; rapid heart beat; tightness of chest; Second dose scheduled 41 days after first dose; fever; Diagnosed with asthma; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Diagnosed with asthma), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (sore arm), TACHYCARDIA (rapid heart beat) and CHEST DISCOMFORT (tightness of chest) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced ASTHMA (Diagnosed with asthma). On an unknown date, the patient experienced DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (sore arm), TACHYCARDIA (rapid heart beat), CHEST DISCOMFORT (tightness of chest), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 41 days after first dose) and PYREXIA (fever). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHMA (Diagnosed with asthma), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (sore arm), TACHYCARDIA (rapid heart beat), CHEST DISCOMFORT (tightness of chest), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 41 days after first dose) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received an additional secondary dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (received an additional secondary dose of the Moderna COVID-19 vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (received an additional secondary dose of the Moderna COVID-19 vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (received an additional secondary dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Neck pain
Clinical narrative: Swelling in her mouth; Sore neck periodically; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (Swelling in her mouth) and NECK PAIN (Sore neck periodically) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOUTH SWELLING (Swelling in her mouth) and NECK PAIN (Sore neck periodically). At the time of the report, MOUTH SWELLING (Swelling in her mouth) and NECK PAIN (Sore neck periodically) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Pain, Product dose omission issue
Clinical narrative: no second dose; reaction on my right arm; not feeling well; itch; sore all over; still experiencing joint pain; the rash is itchy; there is hardness; rash on her hand; redness; she is very tired; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (no second dose), VACCINATION SITE REACTION (reaction on my right arm), MALAISE (not feeling well), PRURITUS (itch) and PAIN (sore all over) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder and Hypertension (Hypertension).    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced RASH PRURITIC (the rash is itchy), VACCINATION SITE INDURATION (there is hardness), RASH (rash on her hand), VACCINATION SITE ERYTHEMA (redness) and FATIGUE (she is very tired). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (no second dose), VACCINATION SITE REACTION (reaction on my right arm), MALAISE (not feeling well), PRURITUS (itch), PAIN (sore all over) and ARTHRALGIA (still experiencing joint pain). At the time of the report, PRODUCT DOSE OMISSION ISSUE (no second dose) had resolved, VACCINATION SITE REACTION (reaction on my right arm), MALAISE (not feeling well), PRURITUS (itch), PAIN (sore all over), RASH PRURITIC (the rash is itchy), VACCINATION SITE INDURATION (there is hardness), RASH (rash on her hand), VACCINATION SITE ERYTHEMA (redness) and FATIGUE (she is very tired) outcome was unknown and ARTHRALGIA (still experiencing joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant medications included Thyroid medication and Blood pressure medication (both unspecified). Reportedly, the doctor recommended a cold pack. Patient was also prescribed an unspecified medication for itch.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Suspect product start date and Outcome of event Arthralgia were added. On 16-Jul-2021: Updated activities tab.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic, Vaccination site erythema, Vaccination site induration
Clinical narrative: no second dose; reaction on my right arm; not feeling well; itch; sore all over; still experiencing joint pain; the rash is itchy; there is hardness; rash on her hand; redness; she is very tired; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (no second dose), VACCINATION SITE REACTION (reaction on my right arm), MALAISE (not feeling well), PRURITUS (itch) and PAIN (sore all over) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder and Hypertension (Hypertension).    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced RASH PRURITIC (the rash is itchy), VACCINATION SITE INDURATION (there is hardness), RASH (rash on her hand), VACCINATION SITE ERYTHEMA (redness) and FATIGUE (she is very tired). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (no second dose), VACCINATION SITE REACTION (reaction on my right arm), MALAISE (not feeling well), PRURITUS (itch), PAIN (sore all over) and ARTHRALGIA (still experiencing joint pain). At the time of the report, PRODUCT DOSE OMISSION ISSUE (no second dose) had resolved, VACCINATION SITE REACTION (reaction on my right arm), MALAISE (not feeling well), PRURITUS (itch), PAIN (sore all over), RASH PRURITIC (the rash is itchy), VACCINATION SITE INDURATION (there is hardness), RASH (rash on her hand), VACCINATION SITE ERYTHEMA (redness) and FATIGUE (she is very tired) outcome was unknown and ARTHRALGIA (still experiencing joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant medications included Thyroid medication and Blood pressure medication (both unspecified). Reportedly, the doctor recommended a cold pack. Patient was also prescribed an unspecified medication for itch.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Suspect product start date and Outcome of event Arthralgia were added. On 16-Jul-2021: Updated activities tab.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: no second dose; reaction on my right arm; not feeling well; itch; sore all over; still experiencing joint pain; the rash is itchy; there is hardness; rash on her hand; redness; she is very tired; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (no second dose), VACCINATION SITE REACTION (reaction on my right arm), MALAISE (not feeling well), PRURITUS (itch) and PAIN (sore all over) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder and Hypertension (Hypertension).    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced RASH PRURITIC (the rash is itchy), VACCINATION SITE INDURATION (there is hardness), RASH (rash on her hand), VACCINATION SITE ERYTHEMA (redness) and FATIGUE (she is very tired). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (no second dose), VACCINATION SITE REACTION (reaction on my right arm), MALAISE (not feeling well), PRURITUS (itch), PAIN (sore all over) and ARTHRALGIA (still experiencing joint pain). At the time of the report, PRODUCT DOSE OMISSION ISSUE (no second dose) had resolved, VACCINATION SITE REACTION (reaction on my right arm), MALAISE (not feeling well), PRURITUS (itch), PAIN (sore all over), RASH PRURITIC (the rash is itchy), VACCINATION SITE INDURATION (there is hardness), RASH (rash on her hand), VACCINATION SITE ERYTHEMA (redness) and FATIGUE (she is very tired) outcome was unknown and ARTHRALGIA (still experiencing joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant medications included Thyroid medication and Blood pressure medication (both unspecified). Reportedly, the doctor recommended a cold pack. Patient was also prescribed an unspecified medication for itch.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Suspect product start date and Outcome of event Arthralgia were added. On 16-Jul-2021: Updated activities tab.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: hot to the touch; Body aches; injection area it is read; injection area it is Swollen; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot to the touch), PAIN (Body aches), INJECTION SITE ERYTHEMA (injection area it is read), INJECTION SITE SWELLING (injection area it is Swollen) and PYREXIA (fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (hot to the touch), PAIN (Body aches), INJECTION SITE ERYTHEMA (injection area it is read), INJECTION SITE SWELLING (injection area it is Swollen) and PYREXIA (fever). At the time of the report, FEELING HOT (hot to the touch), PAIN (Body aches), INJECTION SITE ERYTHEMA (injection area it is read), INJECTION SITE SWELLING (injection area it is Swollen) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Fatigue, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Fatigue; redness on the injection site; itchiness on the injection site; Blisters on her hands; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters on her hands), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (redness on the injection site) and VACCINATION SITE PRURITUS (itchiness on the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced BLISTER (Blisters on her hands) (seriousness criterion disability), VACCINATION SITE ERYTHEMA (redness on the injection site) (seriousness criterion disability) and VACCINATION SITE PRURITUS (itchiness on the injection site) (seriousness criterion disability). On an unknown date, the patient experienced FATIGUE (Fatigue) (seriousness criterion disability). At the time of the report, BLISTER (Blisters on her hands), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (redness on the injection site) and VACCINATION SITE PRURITUS (itchiness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.  Patient received  the 1st dose of the Moderna Covid-19 vaccine at a local pharmacy.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-273456 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Product dose omission issue, Upper limb fracture
Clinical narrative: Broke her arm; Fell; Missed her second dose; This spontaneous case was reported by a consumer and describes the occurrence of UPPER LIMB FRACTURE (Broke her arm) and FALL (Fell) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fall on 09-Aug-2021.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced UPPER LIMB FRACTURE (Broke her arm) (seriousness criterion hospitalization) and FALL (Fell) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her second dose). At the time of the report, UPPER LIMB FRACTURE (Broke her arm) and FALL (Fell) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed her second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was hospitalized for 3-4 days. Concomitant medication use information was not provided by reporter.  Treatment medication use information was not provided by reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded However, the causality for the event of dose omission assessed as not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded However, the causality for the event of dose omission assessed as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient concerned a female 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 (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medication included rivaroxaban for drug used for unknown indication.  On an unspecified date, the patient experienced blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210807458-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOTS. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. .
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: SHE HAS NOT GOTTEN HER PERIOD AT ALL; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's past medical history included: benign polyp endometrium, mild dysplasia uterine neck, and cryotherapy, and concurrent conditions included: non smoker, and drinks alcohol, and other pre-existing medical conditions included: No drug abuse or illicit drug usage. Three negative pregnancy tests. The patient had no known allergies. Not sexually active for the last few months. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 20-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUL-2021, the patient experienced she has not gotten her period at all. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from she has not gotten her period at all. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED FROM THE VACCINE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient was very healthy. 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. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, after vaccination patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20210818781-COVID-19 Vaccine AD26.COV2.S-Died From The Vaccine. This event(s) is considered un-assessable. 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: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID 19 INFECTION; This spontaneous report received from other health care professional 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid 19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid 19 infection was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
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 from social media concerned a 23 year old of unspecified sex of unknown race and ethnicity. 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 and expiry: Unknown) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  Patient was vaccinated on JUN-2021 (two months ago) but on 09-AUG-2021, the patient was found covid-19 positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the patient experienced suspected clinical vaccination failure and was having cough and headache. 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 associated with product quality complaint 90000189066. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210820072- covid-19 vaccine ad26.cov2.s - Suspected 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, UNK
Symptoms: Gastroenteritis viral
Clinical narrative: STOMACH BUG; 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 guselkumab (solution for injection in pre-filled pen, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced stomach bug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with guselkumab was not reported. The outcome of stomach bug was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a pharmacist 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 not reported, batch number: Unknown) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. Batch number was not reported and has been requested. Concomitant medications included mrna 1273 for prophylactic vaccination. On 09-AUG-2021, the patient experienced inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Hypoaesthesia, Neuropathy peripheral, Pain in extremity
Clinical narrative: POSSIBLE NEUROPATHY OR NERVE DAMAGE; ARTHRITIS TRIGGERED; SHOULDER PAIN; TINGLING; PAINFUL BASE OF THUMB; POSTMENOPAUSAL BLEEDING AND SPOTTING; NUMBNESS THAT WENT DIRECTLY TO ALL THE FINGERS OF HER RIGHT HAND; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, non-alcohol user, non-smoker, and chocolate nuts allergy. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 23-JUL-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 23-JUL-2021, within a minute or two after vaccination the patient experienced numbness that went directly to all the fingers of her right hand. The patient reported that she could feel the numbness and tingling now only in her finger tips except for her index finger that was still numb. On 30-JUL-2021, the patient experienced menopausal bleeding that went on for 3 days. She described it as bleeding, spotting and cramps as if was about to have a cycle. On unspecified date, the patient experienced shoulder pain for a little over a week or 10 days, which was resolved. The patient also reported that the base of her thumb was painful. On 10-AUG-2021, the patient reported her symptoms to a physician who told her that it maybe Neuropathy or nerve damage and referred her to a Neurologist. The patient was prescribed Prednisone that she started on the day of this report on 11-AUG-2021. The patient also stated that she thought that the vaccine might have triggered her arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from postmenopausal bleeding and spotting on 02-AUG-2021, and shoulder pain, had not recovered from numbness, and tingling, and the outcome of arthritis triggered, possible neuropathy or nerve damage and painful base of thumb was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210822953- covid-19 vaccine ad26.cov2.s-POSTMENOPAUSAL BLEEDING AND SPOTTING,POSSIBLE NEUROPATHY OR NERVE DAMAGE. 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: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Postmenopausal haemorrhage
Clinical narrative: POSSIBLE NEUROPATHY OR NERVE DAMAGE; ARTHRITIS TRIGGERED; SHOULDER PAIN; TINGLING; PAINFUL BASE OF THUMB; POSTMENOPAUSAL BLEEDING AND SPOTTING; NUMBNESS THAT WENT DIRECTLY TO ALL THE FINGERS OF HER RIGHT HAND; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, non-alcohol user, non-smoker, and chocolate nuts allergy. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 23-JUL-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 23-JUL-2021, within a minute or two after vaccination the patient experienced numbness that went directly to all the fingers of her right hand. The patient reported that she could feel the numbness and tingling now only in her finger tips except for her index finger that was still numb. On 30-JUL-2021, the patient experienced menopausal bleeding that went on for 3 days. She described it as bleeding, spotting and cramps as if was about to have a cycle. On unspecified date, the patient experienced shoulder pain for a little over a week or 10 days, which was resolved. The patient also reported that the base of her thumb was painful. On 10-AUG-2021, the patient reported her symptoms to a physician who told her that it maybe Neuropathy or nerve damage and referred her to a Neurologist. The patient was prescribed Prednisone that she started on the day of this report on 11-AUG-2021. The patient also stated that she thought that the vaccine might have triggered her arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from postmenopausal bleeding and spotting on 02-AUG-2021, and shoulder pain, had not recovered from numbness, and tingling, and the outcome of arthritis triggered, possible neuropathy or nerve damage and painful base of thumb was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210822953- covid-19 vaccine ad26.cov2.s-POSTMENOPAUSAL BLEEDING AND SPOTTING,POSSIBLE NEUROPATHY OR NERVE DAMAGE. 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: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site pain, Mononeuropathy, Muscle spasms, Pain in extremity
Clinical narrative: POSSIBLE NEUROPATHY OR NERVE DAMAGE; ARTHRITIS TRIGGERED; SHOULDER PAIN; TINGLING; PAINFUL BASE OF THUMB; POSTMENOPAUSAL BLEEDING AND SPOTTING; NUMBNESS THAT WENT DIRECTLY TO ALL THE FINGERS OF HER RIGHT HAND; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, non-alcohol user, non-smoker, and chocolate nuts allergy. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 23-JUL-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 23-JUL-2021, within a minute or two after vaccination the patient experienced numbness that went directly to all the fingers of her right hand. The patient reported that she could feel the numbness and tingling now only in her finger tips except for her index finger that was still numb. On 30-JUL-2021, the patient experienced menopausal bleeding that went on for 3 days. She described it as bleeding, spotting and cramps as if was about to have a cycle. On unspecified date, the patient experienced shoulder pain for a little over a week or 10 days, which was resolved. The patient also reported that the base of her thumb was painful. On 10-AUG-2021, the patient reported her symptoms to a physician who told her that it maybe Neuropathy or nerve damage and referred her to a Neurologist. The patient was prescribed Prednisone that she started on the day of this report on 11-AUG-2021. The patient also stated that she thought that the vaccine might have triggered her arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from postmenopausal bleeding and spotting on 02-AUG-2021, and shoulder pain, had not recovered from numbness, and tingling, and the outcome of arthritis triggered, possible neuropathy or nerve damage and painful base of thumb was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210822953- covid-19 vaccine ad26.cov2.s-POSTMENOPAUSAL BLEEDING AND SPOTTING,POSSIBLE NEUROPATHY OR NERVE DAMAGE. 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: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: POSSIBLE NEUROPATHY OR NERVE DAMAGE; ARTHRITIS TRIGGERED; SHOULDER PAIN; TINGLING; PAINFUL BASE OF THUMB; POSTMENOPAUSAL BLEEDING AND SPOTTING; NUMBNESS THAT WENT DIRECTLY TO ALL THE FINGERS OF HER RIGHT HAND; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, non-alcohol user, non-smoker, and chocolate nuts allergy. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 23-JUL-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 23-JUL-2021, within a minute or two after vaccination the patient experienced numbness that went directly to all the fingers of her right hand. The patient reported that she could feel the numbness and tingling now only in her finger tips except for her index finger that was still numb. On 30-JUL-2021, the patient experienced menopausal bleeding that went on for 3 days. She described it as bleeding, spotting and cramps as if was about to have a cycle. On unspecified date, the patient experienced shoulder pain for a little over a week or 10 days, which was resolved. The patient also reported that the base of her thumb was painful. On 10-AUG-2021, the patient reported her symptoms to a physician who told her that it maybe Neuropathy or nerve damage and referred her to a Neurologist. The patient was prescribed Prednisone that she started on the day of this report on 11-AUG-2021. The patient also stated that she thought that the vaccine might have triggered her arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from postmenopausal bleeding and spotting on 02-AUG-2021, and shoulder pain, had not recovered from numbness, and tingling, and the outcome of arthritis triggered, possible neuropathy or nerve damage and painful base of thumb was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210822953- covid-19 vaccine ad26.cov2.s-POSTMENOPAUSAL BLEEDING AND SPOTTING,POSSIBLE NEUROPATHY OR NERVE DAMAGE. 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: HIVES APPEARING ON UPPER TORSO/HIVES APPEARING ON NECK; FAINTED ON THE FLOOR; EPISODE OF NAUSEA; HEADACHE; FEVER; TIREDNESS; MUSCLE ACHES; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies, migraine (taking medicines as needed), sulfonamide allergy, penicillin allergy, alcohol user (rarely), and non smoker. The patient experienced drug allergy when treated with ciprofloxacin, levofloxacin, and nitrofurantoin for drug used for unknown indication. The patient had allergy to many medications and usually had side effects that happen to a few number of people. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, 1 total, administered on 04-AUG-2021 at 15:20 into left arm for prophylactic vaccination. Concomitant medications included montelukast for allergies.  On 04-AUG-2021 in the evening (8 to 9 hours after vaccination), the patient experienced headache, fever, tiredness, muscle aches and nausea. Within 24 hours of getting the vaccine, the patient had an episode of nausea. On 05-AUG-2021, the patient experienced dizziness and then fainted on the floor. Most of her general side effects went away within 24 to 48 hours. On 09-AUG-2021 (Monday evening), the patient experienced hives appearing on upper torso and neck and the patient thinks that it might be related to the vaccine but not sure if it could be something else. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from episode of nausea, headache, fever, tiredness, and muscle aches on AUG-2021, had not recovered from hives appearing on upper torso/hives appearing on neck, and the outcome of fainted on the floor was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210823298- covid-19 vaccine ad26.cov2.s -Fainted on the floor. 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Urticaria
Clinical narrative: HIVES APPEARING ON UPPER TORSO/HIVES APPEARING ON NECK; FAINTED ON THE FLOOR; EPISODE OF NAUSEA; HEADACHE; FEVER; TIREDNESS; MUSCLE ACHES; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies, migraine (taking medicines as needed), sulfonamide allergy, penicillin allergy, alcohol user (rarely), and non smoker. The patient experienced drug allergy when treated with ciprofloxacin, levofloxacin, and nitrofurantoin for drug used for unknown indication. The patient had allergy to many medications and usually had side effects that happen to a few number of people. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, 1 total, administered on 04-AUG-2021 at 15:20 into left arm for prophylactic vaccination. Concomitant medications included montelukast for allergies.  On 04-AUG-2021 in the evening (8 to 9 hours after vaccination), the patient experienced headache, fever, tiredness, muscle aches and nausea. Within 24 hours of getting the vaccine, the patient had an episode of nausea. On 05-AUG-2021, the patient experienced dizziness and then fainted on the floor. Most of her general side effects went away within 24 to 48 hours. On 09-AUG-2021 (Monday evening), the patient experienced hives appearing on upper torso and neck and the patient thinks that it might be related to the vaccine but not sure if it could be something else. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from episode of nausea, headache, fever, tiredness, and muscle aches on AUG-2021, had not recovered from hives appearing on upper torso/hives appearing on neck, and the outcome of fainted on the floor was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210823298- covid-19 vaccine ad26.cov2.s -Fainted on the floor. 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Brain neoplasm, Cerebrovascular accident, Computerised tomogram
Clinical narrative: STROKE WHICH PARALYZED RIGHT SIDE; TUMOR IN THE BACK OF THE BRAIN; COULD NOT GET OUT OF BED; RIGHT SHOULDER HURT; RIGHT LEG PAIN; NECK HURT; This spontaneous report received from a patient concerned a 62 year old female of other ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 23-MAR-2021, after vaccination, the patient experienced neck hurt, right shoulder hurt and right leg pain. The patient used Tylenol initially to treat her neck pain. On 24-MAR-2021, the patient could not get out of bed. On an unspecified date in JUL-2021, the patient then had a stroke which paralyzed her right side, affecting speech. The patient had slurred speech and was difficult to understand. The patient could not recall what happened but she woke up was in the hospital. On 14-JUL-2021, she had computerized tomography (CT) scan of the head which showed a tumor in the back of her brain. The patient was hospitalized for 1 week from the 14-JUL-2021 to 21-JUL-2021, and was currently doing physical therapy, and taking unspecified medication for the stroke. The patient was currently using a walker and was unable to walk on her own, receiving assistance from her daughter. The patient was hospitalized for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, and could not get out of bed, was recovering from right shoulder hurt, and had not recovered from right leg pain, tumor in the back of the brain, and stroke which paralyzed right side. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V.0: 20210823410-Covid-19 vaccine ad26.cov2.s-stroke which paralyzed right side, tumor in the back of the brain. 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: UNDERLYING DISEASE, NATURE OF EVENT
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: STROKE WHICH PARALYZED RIGHT SIDE; TUMOR IN THE BACK OF THE BRAIN; COULD NOT GET OUT OF BED; RIGHT SHOULDER HURT; RIGHT LEG PAIN; NECK HURT; This spontaneous report received from a patient concerned a 62 year old female of other ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 23-MAR-2021, after vaccination, the patient experienced neck hurt, right shoulder hurt and right leg pain. The patient used Tylenol initially to treat her neck pain. On 24-MAR-2021, the patient could not get out of bed. On an unspecified date in JUL-2021, the patient then had a stroke which paralyzed her right side, affecting speech. The patient had slurred speech and was difficult to understand. The patient could not recall what happened but she woke up was in the hospital. On 14-JUL-2021, she had computerized tomography (CT) scan of the head which showed a tumor in the back of her brain. The patient was hospitalized for 1 week from the 14-JUL-2021 to 21-JUL-2021, and was currently doing physical therapy, and taking unspecified medication for the stroke. The patient was currently using a walker and was unable to walk on her own, receiving assistance from her daughter. The patient was hospitalized for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, and could not get out of bed, was recovering from right shoulder hurt, and had not recovered from right leg pain, tumor in the back of the brain, and stroke which paralyzed right side. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V.0: 20210823410-Covid-19 vaccine ad26.cov2.s-stroke which paralyzed right side, tumor in the back of the brain. 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: UNDERLYING DISEASE, NATURE OF EVENT