chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased
Clinical narrative: ELEVATED HEART RATE; DIZZINESS; This spontaneous report received from a patient concerned a female 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: unknown) dose, 01 total was administered, start therapy dates were not reported for prophylactic vaccination. No concomitant medications were reported.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1) .  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company suspect vaccine included: MRNA 1273 (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose, start therapy date were not reported for prophylactic vaccination.  On an unspecified date, following vaccination with MRNA 1273, the patient experienced elevated heart rate, and dizziness (dose number in series 2). Laboratory data (dates unspecified) included: Heart rate (NR: not provided) Elevated. The outcome of the elevated heart rate and dizziness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Depressed mood, Fatigue, Headache, Hypertension
Clinical narrative: HIGH BLOOD PRESSURE; VERY DEPRESSED; FATIGUED; BAD HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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 high blood pressure, very depressed, fatigued, and bad headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigued, high blood pressure, very depressed, and bad headaches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was gravida 1, para 1. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in a live birth. The patient gave birth to a male baby. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure during pregnancy was not reported. This report was non-serious. This parent/child case is linked to 20220248513.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 4 decade old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, start therapy date was 01-Mar-2021 for prophylactic vaccination. The patient experienced arthritic pains/pain in elbows, back pain, pain in fingers and plaque psoriasis (Dose number in series 1) when treated with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1).The patient not recovered from arthritic pains/pain in elbows, recovering from plaque psoriasis and outcome of back pain and pain in fingers was not reported. Risankizumab (Skyrizi) (form of admin unknown, subcutaneous, batch number was not reported) dose and frequency were not reported on an unspecified date for an unspecified indication. The patient previously received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, 1 total, start therapy date was unknown date in 2021 for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with risankizumab was not reported. The outcome of off label use, inappropriate schedule of vaccine administered was not reported. The patient received additional dose of MRNA 1273 (Moderna) (Elasomeran) (dose number in series 3) (form of admin unknown, intramuscular, batch number and expiry was not reported) dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following administration of MRNA 1273 (Moderna) (dose number in series 3). This report was non-serious. This case, involving the same patient is linked to 20220246704 (Dose number in series 1).
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Inner ear disorder, Magnetic resonance imaging
Clinical narrative: INNER EAR DAMAGE; This spontaneous report received from a patient via a company representative 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: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered 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 experienced inner ear damage and was hospitalized (dates unspecified). The patient had a severe reaction to the J and J vaccine. She was hospitalized with repeat MRIs (Magnetic resonance imaging) and CTs (Computerized tomogram). They believed that the inner ear damage was an overreactive immune response to the J and J vaccine. It caused vestibular damage and severe swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inner ear damage was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220252273-COVID-19 VACCINE AD26.COV2.S-Inner ear damage. 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). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: INCREASING IN CONVULSION; This spontaneous report received from a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: Cerebral palsy since born and convulsions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2022, a week later of vaccination the patient developed convulsions that persisted until the day of reporting. The patient was under treatment for convulsions associated with his diagnosis. The patient's mother did not know if the increasing in convulsions was an adverse reaction from the vaccine or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increasing in convulsions. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220253459-COVID-19 VACCINE AD26.COV2.S- Increasing in convulsions. 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: UNDERLYING DISEASE. Therefore, this event is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Muscle discomfort, Myalgia
Clinical narrative: SOME UNSPECIFIED LOCALIZED DISCOMFORT/MUSCULAR DISCOMFORT ON LEFT LEG AND SPREAD ALL OVER BODY; MUSCULAR BURNING SENSATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: osteoarthritis on right leg. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced some unspecified localized discomfort/muscular discomfort on left leg and spread all over body, and muscular burning sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some unspecified localized discomfort/muscular discomfort on left leg and spread all over body, and had not recovered from muscular burning sensation. This report was non-serious. This case, involving the same patient is linked to 20220254096.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Gait inability, Hypergammaglobulinaemia benign monoclonal, Muscle twitching, Myalgia
Clinical narrative: MGUS (MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE); MUSCLE TWITCHING; WHEELCHAIR BOUND, WHEELCHAIR ALMOST PERMANENTLY DUE TO SIDE EFFECTS; INABILITY TO WALK; MUSCLE PAIN; WEAKNESS; This spontaneous report received from a physician concerned a 45 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: some mild arthritis of the spine. The patient was previously treated with ergocalciferol for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the patient experienced muscle pain, and weakness. On an unspecified date, the patient experienced mgus (monoclonal gammopathy of undetermined significance), muscle twitching, wheelchair bound, wheelchair almost permanently due to side effects, and inability to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, weakness, wheelchair bound, wheelchair almost permanently due to side effects, muscle twitching, and inability to walk, and the outcome of mgus (monoclonal gammopathy of undetermined significance) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Wheelchair user
Clinical narrative: MGUS (MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE); MUSCLE TWITCHING; WHEELCHAIR BOUND, WHEELCHAIR ALMOST PERMANENTLY DUE TO SIDE EFFECTS; INABILITY TO WALK; MUSCLE PAIN; WEAKNESS; This spontaneous report received from a physician concerned a 45 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: some mild arthritis of the spine. The patient was previously treated with ergocalciferol for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the patient experienced muscle pain, and weakness. On an unspecified date, the patient experienced mgus (monoclonal gammopathy of undetermined significance), muscle twitching, wheelchair bound, wheelchair almost permanently due to side effects, and inability to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, weakness, wheelchair bound, wheelchair almost permanently due to side effects, muscle twitching, and inability to walk, and the outcome of mgus (monoclonal gammopathy of undetermined significance) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Balance disorder, Blood immunoglobulin A increased, Diplopia
Clinical narrative: MGUS (MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE); MUSCLE TWITCHING; WHEELCHAIR BOUND, WHEELCHAIR ALMOST PERMANENTLY DUE TO SIDE EFFECTS; INABILITY TO WALK; MUSCLE PAIN; WEAKNESS; This spontaneous report received from a physician concerned a 45 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: some mild arthritis of the spine. The patient was previously treated with ergocalciferol for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the patient experienced muscle pain, and weakness. On an unspecified date, the patient experienced mgus (monoclonal gammopathy of undetermined significance), muscle twitching, wheelchair bound, wheelchair almost permanently due to side effects, and inability to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, weakness, wheelchair bound, wheelchair almost permanently due to side effects, muscle twitching, and inability to walk, and the outcome of mgus (monoclonal gammopathy of undetermined significance) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Gait inability, Gastrointestinal pain, Heart rate increased, Hypergammaglobulinaemia benign monoclonal
Clinical narrative: MGUS (MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE); MUSCLE TWITCHING; WHEELCHAIR BOUND, WHEELCHAIR ALMOST PERMANENTLY DUE TO SIDE EFFECTS; INABILITY TO WALK; MUSCLE PAIN; WEAKNESS; This spontaneous report received from a physician concerned a 45 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: some mild arthritis of the spine. The patient was previously treated with ergocalciferol for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the patient experienced muscle pain, and weakness. On an unspecified date, the patient experienced mgus (monoclonal gammopathy of undetermined significance), muscle twitching, wheelchair bound, wheelchair almost permanently due to side effects, and inability to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, weakness, wheelchair bound, wheelchair almost permanently due to side effects, muscle twitching, and inability to walk, and the outcome of mgus (monoclonal gammopathy of undetermined significance) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Joint noise, Laboratory test, Loss of personal independence in daily activities, Magnetic resonance imaging head
Clinical narrative: MGUS (MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE); MUSCLE TWITCHING; WHEELCHAIR BOUND, WHEELCHAIR ALMOST PERMANENTLY DUE TO SIDE EFFECTS; INABILITY TO WALK; MUSCLE PAIN; WEAKNESS; This spontaneous report received from a physician concerned a 45 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: some mild arthritis of the spine. The patient was previously treated with ergocalciferol for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the patient experienced muscle pain, and weakness. On an unspecified date, the patient experienced mgus (monoclonal gammopathy of undetermined significance), muscle twitching, wheelchair bound, wheelchair almost permanently due to side effects, and inability to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, weakness, wheelchair bound, wheelchair almost permanently due to side effects, muscle twitching, and inability to walk, and the outcome of mgus (monoclonal gammopathy of undetermined significance) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal, Monoclonal immunoglobulin present, Muscle tightness, Myalgia, Neck pain
Clinical narrative: MGUS (MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE); MUSCLE TWITCHING; WHEELCHAIR BOUND, WHEELCHAIR ALMOST PERMANENTLY DUE TO SIDE EFFECTS; INABILITY TO WALK; MUSCLE PAIN; WEAKNESS; This spontaneous report received from a physician concerned a 45 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: some mild arthritis of the spine. The patient was previously treated with ergocalciferol for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the patient experienced muscle pain, and weakness. On an unspecified date, the patient experienced mgus (monoclonal gammopathy of undetermined significance), muscle twitching, wheelchair bound, wheelchair almost permanently due to side effects, and inability to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, weakness, wheelchair bound, wheelchair almost permanently due to side effects, muscle twitching, and inability to walk, and the outcome of mgus (monoclonal gammopathy of undetermined significance) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Pain in extremity, Pelvic pain, Skin disorder, Spinal instability
Clinical narrative: MGUS (MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE); MUSCLE TWITCHING; WHEELCHAIR BOUND, WHEELCHAIR ALMOST PERMANENTLY DUE TO SIDE EFFECTS; INABILITY TO WALK; MUSCLE PAIN; WEAKNESS; This spontaneous report received from a physician concerned a 45 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: some mild arthritis of the spine. The patient was previously treated with ergocalciferol for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the patient experienced muscle pain, and weakness. On an unspecified date, the patient experienced mgus (monoclonal gammopathy of undetermined significance), muscle twitching, wheelchair bound, wheelchair almost permanently due to side effects, and inability to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, weakness, wheelchair bound, wheelchair almost permanently due to side effects, muscle twitching, and inability to walk, and the outcome of mgus (monoclonal gammopathy of undetermined significance) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Vision blurred, Walking aid user
Clinical narrative: MGUS (MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE); MUSCLE TWITCHING; WHEELCHAIR BOUND, WHEELCHAIR ALMOST PERMANENTLY DUE TO SIDE EFFECTS; INABILITY TO WALK; MUSCLE PAIN; WEAKNESS; This spontaneous report received from a physician concerned a 45 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: some mild arthritis of the spine. The patient was previously treated with ergocalciferol for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the patient experienced muscle pain, and weakness. On an unspecified date, the patient experienced mgus (monoclonal gammopathy of undetermined significance), muscle twitching, wheelchair bound, wheelchair almost permanently due to side effects, and inability to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, weakness, wheelchair bound, wheelchair almost permanently due to side effects, muscle twitching, and inability to walk, and the outcome of mgus (monoclonal gammopathy of undetermined significance) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Decreased appetite, Diarrhoea, Emotional distress
Clinical narrative: ANXIETY; NOT ABLE TO EAT; BAD REACTION; SUFFERED FOR WEEKS BEING LEFT; DEATHLY SICK; ACHES; CHILLS; SEVERE HEADACHE; FEVER; DIARRHEA; VOMITING; HIGH PITCH RINGING IN MY LEFT EAR; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and heart disease. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced deathly sick, anxiety, not able to eat, suffered for weeks being left, bad reaction, aches, chills, severe headache, fever, diarrhea, vomiting, and high pitch ringing in my left ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anxiety, not able to eat, bad reaction, suffered for weeks being left, deathly sick, aches, chills, severe headache, fever, diarrhea, vomiting, and high pitch ringing in my left ear. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nonspecific reaction, Pain, Pyrexia
Clinical narrative: ANXIETY; NOT ABLE TO EAT; BAD REACTION; SUFFERED FOR WEEKS BEING LEFT; DEATHLY SICK; ACHES; CHILLS; SEVERE HEADACHE; FEVER; DIARRHEA; VOMITING; HIGH PITCH RINGING IN MY LEFT EAR; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and heart disease. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced deathly sick, anxiety, not able to eat, suffered for weeks being left, bad reaction, aches, chills, severe headache, fever, diarrhea, vomiting, and high pitch ringing in my left ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anxiety, not able to eat, bad reaction, suffered for weeks being left, deathly sick, aches, chills, severe headache, fever, diarrhea, vomiting, and high pitch ringing in my left ear. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vomiting
Clinical narrative: ANXIETY; NOT ABLE TO EAT; BAD REACTION; SUFFERED FOR WEEKS BEING LEFT; DEATHLY SICK; ACHES; CHILLS; SEVERE HEADACHE; FEVER; DIARRHEA; VOMITING; HIGH PITCH RINGING IN MY LEFT EAR; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and heart disease. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced deathly sick, anxiety, not able to eat, suffered for weeks being left, bad reaction, aches, chills, severe headache, fever, diarrhea, vomiting, and high pitch ringing in my left ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anxiety, not able to eat, bad reaction, suffered for weeks being left, deathly sick, aches, chills, severe headache, fever, diarrhea, vomiting, and high pitch ringing in my left ear. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Seizure
Clinical narrative: SEIZURES; OTHER HEALTH PROBLEMS; This spontaneous report received from a consumer via a company representative 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) 1 total, dose, 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.  It was reporter that "my granddaughter had seizures and other health problems with the shots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures and other health problems was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220253674-covid-19 vaccine ad26.cov2.s-Seizure. 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). Therefore, this event(s) is considered unassessable.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 POSITIVE; This spontaneous report received from a patient concerned a 52 year old white male of unspecified 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: 211D21A, and expiry: 11-APR-2022) dose was not reported, 1 total administered to left arm on 04-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-FEB-2022, the patient mentioned having tested positive for Covid with a rapid test after receiving the vaccine. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 positive was not reported. This report was non-serious. This report was associated with product quality complaint (PQC): 90000218866.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity, Thrombosis, Visual impairment
Clinical narrative: BLOOD CLOTS IN LEGS; EYESIGHT TROUBLE; ARM SORENESS; TIREDNESS; WEAK; This spontaneous report received from a consumer concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cigarette smoker. The patient has no known drug allergies, has no history of drug abuse or illicit drug use and does not drink alcohol. 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 blood clots in legs, eyesight trouble, arm soreness, tiredness, and weak. the reporter stated that the patient recently had a "procedure" for this issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in legs, arm soreness, tiredness, weak, and eyesight trouble. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210800541.; Sender's Comments: V0: 20220254679- covid-19 vaccine ad26.cov2.s Blood clots in legs. 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: PSOO30539 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-FEB-2022, the patient experienced tested positive for covid. Laboratory data included: COVID-19 antigen test (NR: not provided) tested positive twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: KILLED; This spontaneous report received from a consumer via a company representative from social media concerned a male of unspecified age, 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, and batch number were not reported) 1 total, dose, 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, the reporter mentioned  to sue for killing the reporter's dad after vaccine. On an unspecified date, the patient died from unknown cause of death. It was unknown if 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: 20220254949-COVID-19 VACCINE AD26.COV2.S-Killed. The event(s) 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(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative via social media ( concerned a female of unspecified age, race and ethnic origin The patient's weight, height, and medical history 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 was not reported, start therapy date were not reported, 01 total was administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  On an unspecified date, the patient was died. The patient was died from unknown cause of death. It was reported as "My mom died 2 days after getting the vaccine." It was unspecified if an autopsy was performed or not.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20220254993-Covid-19 vaccine ad26.CoV-2.s-Died. The event(s) 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(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: EXPIRED VACCINE USED; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 66 year old of unspecified 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: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 17-FEB-2022 for prophylactic vaccination. No concomitant medications were reported. On 17-FEB-2022, the patient experienced expired vaccine used, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine used and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: TESTED POSITIVE AGAIN; This spontaneous report received from a consumer via a company representative concerned a 31 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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, the patient experienced tested positive again. 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 tested positive again was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000218982 This case, from the same reporter is linked to 20220256345.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain
Clinical narrative: SEVERE INCHES WIDE RED GIANT LUMP AT VACCINE ADMINISTRATION LOCATION ON ARM; PAIN AT VACCINE ADMINISTRATION LOCATION ON ARM; This spontaneous report received from a consumer concerned a 43 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, expiry: UNKNOWN) dose was not reported, administered on 19-FEB-2022 for prophylactic vaccination. No concomitant medications were reported.  On 19-FEB-2022, the patient experienced severe inches wide red giant lump at vaccine administration location on arm, and pain at vaccine administration location on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at vaccine administration location on arm, and severe inches wide red giant lump at vaccine administration location on arm. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Pain in extremity, Weight decreased
Clinical narrative: LOSING WEIGHT; LEFT ARM STARTED HURTING DOWN TO ELBOW; COLD SENSATION; MUSCLE NUMBNESS; This spontaneous report received from a patient concerned a 63-year-old male. The patient's height, and weight were not reported. The patient's past medical history included: pneumonia, and concurrent conditions included: copd, asthma, and smoker, and other pre-existing medical conditions included: The patient had no known allergies, did not had any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on NOV-2021 for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported. On DEC-2021, the patient experienced losing weight, left arm started hurting down to elbow, cold sensation, and muscle numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sensation, and had not recovered from left arm started hurting down to elbow, muscle numbness, and losing weight. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHINESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had not participated in a clinical trial. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced achiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: STOMACH PAIN; CRAMPING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had done every test. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 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. On an unspecified date, the patient experienced stomach pain, and cramping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach pain and cramping was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Hypertension
Clinical narrative: CHEST PAINS AFTER THE VACCINE; HIGH BLOOD PRESSURE; This spontaneous report received from a consumer via a company representative concerned a 31 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, and batch number were not reported) dose, 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, the patient experienced chest pains after the vaccine, and high blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high blood pressure and chest pains after the vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220248513, 20220251231 and 20220255979.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Feeling abnormal
Clinical narrative: Suffered arrhythmias after the Moderna vaccine; The patient is emotional and seems quite upset; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Suffered arrhythmias after the Moderna vaccine) in a female patient of an unknown age 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 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 ARRHYTHMIA (Suffered arrhythmias after the Moderna vaccine) (seriousness criteria hospitalization and medically significant) and FEELING ABNORMAL (The patient is emotional and seems quite upset). At the time of the report, ARRHYTHMIA (Suffered arrhythmias after the Moderna vaccine) and FEELING ABNORMAL (The patient is emotional and seems quite upset) outcome was unknown.            Concomitant medication and treatment medications were not reported.  This is a spontaneous case concerning  a female patient of unknown age with no reported medical history, who experienced the unexpected serious (AESI) event of Arrhythmia and non-serious event of feeling abnormal. The events occurred approximately on an unspecified day after the third dose of mRNA-1273 COVID 19 Vaccine. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2022: Follow up received includes: Event 'feeling bad' added; Sender's Comments: This is a spontaneous case concerning  a female patient of unknown age with no reported medical history, who experienced the unexpected serious (AESI) event of Arrhythmia and non-serious event of feeling abnormal. The events occurred approximately on an unspecified day after the third dose of mRNA-1273 COVID 19 Vaccine. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This is a spontaneous report (MOD-2020-001709) received from a non-healthcare professional,  concerning a 48-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273). She experienced pain in left arm when raised, soreness and muscle pain in the left arm. The patient's medical history, as provided by the reporter, included underactive thyroid and borderline diabetes. Concomitant medications reported included levothyroxine. Dec 28, 2020, patient received their first of two planned doses of mRNA-1273 (batch/lot# 039K20A), intramuscularly, in the left arm, for prophylaxis of COVID-19 infection. Dec 28, 2020, patient experienced pain in the left arm when raised, soreness and muscle pain in the left arm. She stated she feels the pain when she tries to raise her arm. Treatment for the events included Tylenol. The second dose of mRNA-1273 vaccine scheduled for Jan 25, 2021. The outcome of the events, and experienced pain in left arm when raised, soreness and muscle pain in the left arm considered not resolved. Reporter'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.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood disorder, Headache, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 039K202A) for COVID-19 immunization. The patient's medical history included hemodialysis since an unknown date. Concurrent medical conditions included diabetes. Concomitant medication included Plavix (clopidogrel bisulfate). On Dec 28, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): intramuscular: unknown. The reporter did not provide any causality assessments. 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. The patient's medical history of  being on hemodialysis and taking clopidogrel bisulfate remains a confounder for the event of blood thinning.