chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: expired dose of ACT HIB had be administered with no reported adverse event; 68 year old patient administred ACT-HIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and pharmacist via Global Medical Information (Reference number- 00684494) and transmitted to Sanofi on 15-Jul-2021.  This case involved a 68 year old male patient who administered expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (product administered to patient of inappropriate age and expired product administered)   Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 15-Jul-2021, the patient received 0.5ml dose of suspect HIB (PRP/T) VACCINE (lot: UJ328AB and expiry date: 30-Jun-2021) (Frequency = once) (Strength = standard) via intramuscular route in the right deltoid for prophylactic vaccination (product administered to patient of inappropriate age and expired product administered)  It was reported that, "the caller stated that an expired dose of ACT HIB had be administered. What are our recommendations"?  This case was an actual medication error (expired vaccine used and Inappropriate age at vaccine administration) (latency same day)  At the time of reporting, no adverse event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: RV5
Symptoms: Product temperature excursion issue
Clinical narrative: No additional AE reported. No PQC reported.; ROTATEQ had been administered to a patient since the excursion occured; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant therapy was not provided.  On an unspecified date in 2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # T039454 has been verified to be a valid lot number, expiration date reported as 14-DEC-2021; strength, dose and route were not reported) for prophylaxis. The vaccine had been stored under 0.3 degree Celsius for 11 hours, 0.4 degree Celsius for 11 hours and 0.6 degree Celsius for 3 hours, recorded by digital data logger. The reporter was told that the vaccine was still viable. There was no previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; An expired dose of VARIVAX was administered; This spontaneous report was received from a health care professional concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 07-JUL-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 milliliters, lot S020465 expiration date 02-JUL-2021 (route of administration was not provided) as prophylaxis. Caller provided information from the post expiry memo. No additional adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE reported; adult patient located at an offsite facility received a pediatric dose of RECOMBIVAX HB.; adult patient located at an offsite facility received a pediatric dose of RECOMBIVAX HB.; This spontaneous report as received from a pharmacist refers to an adult patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 12-JUL-2021, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Intensive care, Near death experience, Vaccination failure
Clinical narrative: Suspected vaccination failure; GOT shingles / nearly died and was in ICU for weeks; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization, GSK medically significant and life threatening) and shingles (serious criteria hospitalization and life threatening). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles.  The reporter stated that, the patient nearly died and was in intensive care unit for weeks. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.    This case had been linked with case US2021AMR156171, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156171:same reporter
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Hemiplegia, Hypoaesthesia, Seborrhoea
Clinical narrative: RIGHT HAND FELT GREASY AND THEN FELT STICKY NEED TO CLEAN HAND  SEVERAL TIMES A DAY; INSECURE FEELING DUE TO MUSCLE WEAKNESS (DIFFICULT TO TAKE A DECISION TO WALK FROM THE DINING TABLE TO THE BATHROOM OR OTHER AREAS); WEAKNESS INVOLVING WHOLE BODY; HAD PROBLEMS WHILE SPEAKING; RIGHT HAND AND LEG NUMBNESS; PARALYSIS RIGHT HALF OF THE BODY; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included back injury, and pain due to back injury, and concurrent conditions included symptoms of covid-19 (runny nose). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: unknown) dose was not reported, 1 total administered on 03-JUN-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 15-JUN-2021, at 21: 30 the patient experienced paralysis right half of the body and paralysis of the right leg. Did not feel any pain of previous back injury once the paralysis happened. On 16-JUN-2021, at 05:30- 06 the patient had problems while speaking, right hand and leg numbness and at unspecified time patient had trouble walking, hesitate difficult to get up from the couch or bed, insecure feeling due to muscle weakness (difficult to take a decision to walk from the dining table to the bathroom or other areas), tongue numbness, right arm weakness and sometimes left arm weakness and weakness that started on the right side and then involving whole body. On 19-JUN-2021, the patient felt right hand greasy and then felt sticky need to clean hand several times a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paralysis right half of the body, and paralysis of the right leg on 15-JUN-2021 lasted about 15 minutes, and had not recovered from had problems while speaking, weakness that started on the right side and then involving whole body, trouble walking, right hand and leg numbness, right hand felt greasy and then felt sticky need to clean hand several times a day, hesitate difficult to get up from the couch or bed, insecure feeling due to muscle weakness (difficult to take a decision to walk from the dining table to the bathroom or other areas), right arm weakness and sometimes left arm weakness, and tongue numbness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210731397-covid-19 vaccine ad26.cov2.s-Hemiplegia. 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: RIGHT HAND FELT GREASY AND THEN FELT STICKY NEED TO CLEAN HAND  SEVERAL TIMES A DAY; INSECURE FEELING DUE TO MUSCLE WEAKNESS (DIFFICULT TO TAKE A DECISION TO WALK FROM THE DINING TABLE TO THE BATHROOM OR OTHER AREAS); WEAKNESS INVOLVING WHOLE BODY; HAD PROBLEMS WHILE SPEAKING; RIGHT HAND AND LEG NUMBNESS; PARALYSIS RIGHT HALF OF THE BODY; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included back injury, and pain due to back injury, and concurrent conditions included symptoms of covid-19 (runny nose). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: unknown) dose was not reported, 1 total administered on 03-JUN-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 15-JUN-2021, at 21: 30 the patient experienced paralysis right half of the body and paralysis of the right leg. Did not feel any pain of previous back injury once the paralysis happened. On 16-JUN-2021, at 05:30- 06 the patient had problems while speaking, right hand and leg numbness and at unspecified time patient had trouble walking, hesitate difficult to get up from the couch or bed, insecure feeling due to muscle weakness (difficult to take a decision to walk from the dining table to the bathroom or other areas), tongue numbness, right arm weakness and sometimes left arm weakness and weakness that started on the right side and then involving whole body. On 19-JUN-2021, the patient felt right hand greasy and then felt sticky need to clean hand several times a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paralysis right half of the body, and paralysis of the right leg on 15-JUN-2021 lasted about 15 minutes, and had not recovered from had problems while speaking, weakness that started on the right side and then involving whole body, trouble walking, right hand and leg numbness, right hand felt greasy and then felt sticky need to clean hand several times a day, hesitate difficult to get up from the couch or bed, insecure feeling due to muscle weakness (difficult to take a decision to walk from the dining table to the bathroom or other areas), right arm weakness and sometimes left arm weakness, and tongue numbness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210731397-covid-19 vaccine ad26.cov2.s-Hemiplegia. 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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Pain
Clinical narrative: OVERALL  ACHINESS IN UPPER BODY; LABORED BREATHING; EXTREME PAIN IN JOINTS/PAIN IN RIGHT WRIST/SHOULDER PAIN/ELBOW PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180869 and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced overall achiness in upper body. On 03-APR-2021, the subject experienced labored breathing. On 03-APR-2021, the subject experienced extreme pain in joints/pain in right wrist/shoulder pain/elbow pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from labored breathing, overall achiness in upper body, and extreme pain in joints/pain in right wrist/shoulder pain/elbow pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 40.0
Sex: F
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 concerned a 40 year old White and Not Hispanic or Latino 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: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-JUL-2021, the patient was tested positive for COVID-19 (suspected COVID-19 infection and suspected clinical vaccination failure). The patient was close to someone who had COVID-19 with mild symptoms of a runny nose and cough. The symptoms were mild and patient got tested because she had children at home.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected COVID-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738685-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: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: BODY ACHES; FELT BLAH; This spontaneous report received from a patient 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: Unk) 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 subject experienced body aches, and felt blah. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and felt blah. This report was non-serious. This case, from the same reporter is linked to 20210740692.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED TO 16 YEAR OLD PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no medical history. the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced vaccine administered to 16 year old subject. On 02-JUL-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to 16 year old patient was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNDER MINIMUM CONDITIONS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-JUL-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 JUL-2021, the subject experienced under minimum conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from under minimum conditions. This report was non-serious. This case, from the same reporter is linked to 20210743283.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Unfortunately your medicine caused a stroke to my brain; Drug dose omission; Headache (hasn't gone away); Vomiting; Running nose; Diarrhea; Ache; Running temperature; Chills; Developed fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Lasted for two weeks.) from 28-Mar-2021 to April 2021.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced RHINORRHOEA (Running nose), DIARRHOEA (Diarrhea), PAIN (Ache), PYREXIA (Running temperature), CHILLS (Chills), FATIGUE (Developed fatigue) and VOMITING (Vomiting). On 29-Apr-2021, the patient experienced HEADACHE (Headache (hasn't gone away)). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Drug dose omission). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) outcome was unknown, RHINORRHOEA (Running nose), DIARRHOEA (Diarrhea), PAIN (Ache), PYREXIA (Running temperature), CHILLS (Chills), FATIGUE (Developed fatigue), VOMITING (Vomiting) and PRODUCT DOSE OMISSION ISSUE (Drug dose omission) had resolved and HEADACHE (Headache (hasn't gone away)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. In April 2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow up received contains no new information. On 18-Jul-2021: Follow up received, new event cerebrovascular accident added.; 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Product dose omission issue, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Unfortunately your medicine caused a stroke to my brain; Drug dose omission; Headache (hasn't gone away); Vomiting; Running nose; Diarrhea; Ache; Running temperature; Chills; Developed fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Lasted for two weeks.) from 28-Mar-2021 to April 2021.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced RHINORRHOEA (Running nose), DIARRHOEA (Diarrhea), PAIN (Ache), PYREXIA (Running temperature), CHILLS (Chills), FATIGUE (Developed fatigue) and VOMITING (Vomiting). On 29-Apr-2021, the patient experienced HEADACHE (Headache (hasn't gone away)). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Drug dose omission). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) outcome was unknown, RHINORRHOEA (Running nose), DIARRHOEA (Diarrhea), PAIN (Ache), PYREXIA (Running temperature), CHILLS (Chills), FATIGUE (Developed fatigue), VOMITING (Vomiting) and PRODUCT DOSE OMISSION ISSUE (Drug dose omission) had resolved and HEADACHE (Headache (hasn't gone away)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. In April 2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow up received contains no new information. On 18-Jul-2021: Follow up received, new event cerebrovascular accident added.; 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Unfortunately your medicine caused a stroke to my brain; Drug dose omission; Headache (hasn't gone away); Vomiting; Running nose; Diarrhea; Ache; Running temperature; Chills; Developed fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Lasted for two weeks.) from 28-Mar-2021 to April 2021.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced RHINORRHOEA (Running nose), DIARRHOEA (Diarrhea), PAIN (Ache), PYREXIA (Running temperature), CHILLS (Chills), FATIGUE (Developed fatigue) and VOMITING (Vomiting). On 29-Apr-2021, the patient experienced HEADACHE (Headache (hasn't gone away)). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Drug dose omission). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) outcome was unknown, RHINORRHOEA (Running nose), DIARRHOEA (Diarrhea), PAIN (Ache), PYREXIA (Running temperature), CHILLS (Chills), FATIGUE (Developed fatigue), VOMITING (Vomiting) and PRODUCT DOSE OMISSION ISSUE (Drug dose omission) had resolved and HEADACHE (Headache (hasn't gone away)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. In April 2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow up received contains no new information. On 18-Jul-2021: Follow up received, new event cerebrovascular accident added.; 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.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Fall, Fatigue, Gait inability, Hypersomnia
Clinical narrative: Developed weakness in legs, needed help with walking, legs got weak like rubber, couldn't hold self up.  ambulance to  hospital, next day, could walk again.  Was sent home after 3 days with home PT, had return of weakness, slid off bed, couldn't stand up.  Was sent to Rehab- 2 weeks, 75% back to baseline and is extremely tired, sleeping easily
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Weight bearing difficulty
Clinical narrative: Developed weakness in legs, needed help with walking, legs got weak like rubber, couldn't hold self up.  ambulance to  hospital, next day, could walk again.  Was sent home after 3 days with home PT, had return of weakness, slid off bed, couldn't stand up.  Was sent to Rehab- 2 weeks, 75% back to baseline and is extremely tired, sleeping easily
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Muscle aches, headache, chills lasting from the morning of 7/20/2021 to morning of 7/21/2021.  I took Tylenol for pain, which seemed to help.  Slept at least 10 hours on the night of 7/20-7/21.  Feeling a little better the morning of 7/21.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Nasopharyngitis, Pyrexia, Respiratory tract congestion
Clinical narrative: Cough, congestion, head cold, fever methylprednisolone Monitor home O2 level
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Cough, congestion, head cold, fever methylprednisolone Monitor home O2 level
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Burning sensation  all over my body
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Fever or Chills  Fatigue  Muscle or body aches  Headache  Congestion or running nose
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Fever or Chills  Fatigue  Muscle or body aches  Headache  Congestion or running nose
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Vaccine positive rechallenge
Clinical narrative: Slight nausea and severe malaise.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chest X-ray, Condition aggravated, Dyspnoea, Productive cough
Clinical narrative: Acute respiratory failure with hypoxia wet cough Shortness of breath
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Blindness transient, Blood glucose normal, Cold sweat
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: temporary loss of vision-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: pt was given vaccine and approximately 5minutes or less later patient fell out of chair and onto floor. patient was pale,unresponsive for less than 30 seconds and clammy to touch. her lips were blue. 911 was called. came to almost immediately and did not remember what happened. vision went black but came back after a few minutes. tested her blood sugar is was 114. pulse was rapid. anbulance arrived pt walked out on her own power. refused treatment from emts and refused to go to er.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Cyanosis, Dizziness, Fall, Flushing
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: temporary loss of vision-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: pt was given vaccine and approximately 5minutes or less later patient fell out of chair and onto floor. patient was pale,unresponsive for less than 30 seconds and clammy to touch. her lips were blue. 911 was called. came to almost immediately and did not remember what happened. vision went black but came back after a few minutes. tested her blood sugar is was 114. pulse was rapid. anbulance arrived pt walked out on her own power. refused treatment from emts and refused to go to er.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: temporary loss of vision-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: pt was given vaccine and approximately 5minutes or less later patient fell out of chair and onto floor. patient was pale,unresponsive for less than 30 seconds and clammy to touch. her lips were blue. 911 was called. came to almost immediately and did not remember what happened. vision went black but came back after a few minutes. tested her blood sugar is was 114. pulse was rapid. anbulance arrived pt walked out on her own power. refused treatment from emts and refused to go to er.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: temporary loss of vision-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: pt was given vaccine and approximately 5minutes or less later patient fell out of chair and onto floor. patient was pale,unresponsive for less than 30 seconds and clammy to touch. her lips were blue. 911 was called. came to almost immediately and did not remember what happened. vision went black but came back after a few minutes. tested her blood sugar is was 114. pulse was rapid. anbulance arrived pt walked out on her own power. refused treatment from emts and refused to go to er.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypertension, Palpitations, Pruritus, Tachycardia
Clinical narrative: Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Additional Details: Pt felt a burning sensation right away and stated that their heart was racing. I checked BP several times and the range was between 130-158 / 70-90. Pt went to urgent care & MD monitored until BP & HR was normal. They are unsure if this was vaccine related or nerves.  Pt was instructed to rest at home today & is feeling better but noted that she felt itchy when she first woke up this AM but it has since passed.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site haemorrhage, Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Hematoma immediately formed at injection site-Mild, Additional Details: Small amount of bleeding at injection site, but immediate hematoma formation. Correct landmarks were used and vaccine was administered into left deltoid in correct location. Pt denies any use of blood thinners or any bleeding disorders.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Complex regional pain syndrome, Limb discomfort, Paraesthesia, Peripheral swelling
Clinical narrative: CRPS (Complex Regional Pain syndrome); Right middle finger and then all of her right fingers felt like she had a million ants in them and in her entire hand; Right hand felt very tight,was about to explode; Right hand was swollen; This spontaneous case was reported by a consumer and describes the occurrence of COMPLEX REGIONAL PAIN SYNDROME (CRPS (Complex Regional Pain syndrome)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced PARAESTHESIA (Right middle finger and then all of her right fingers felt like she had a million ants in them and in her entire hand), LIMB DISCOMFORT (Right hand felt very tight,was about to explode) and PERIPHERAL SWELLING (Right hand was swollen). On an unknown date, the patient experienced COMPLEX REGIONAL PAIN SYNDROME (CRPS (Complex Regional Pain syndrome)) (seriousness criterion medically significant). The patient was treated with RISPERIDONE (NERVE) at an unspecified dose and frequency. At the time of the report, COMPLEX REGIONAL PAIN SYNDROME (CRPS (Complex Regional Pain syndrome)), PARAESTHESIA (Right middle finger and then all of her right fingers felt like she had a million ants in them and in her entire hand), LIMB DISCOMFORT (Right hand felt very tight,was about to explode) and PERIPHERAL SWELLING (Right hand was swollen) outcome was unknown.            On 11-MAY-2021, the patient experienced  her right middle finger and then all of her right fingers felt like she had a million ants in them and in her entire hand. Her right hand felt very tight like it was about to explode and was also swollen. She saw three doctors and had no blood clots. Patient was diagnosed with CRPS (Complex Regional Pain syndrome).  Treatment information Antidepressant medicine was provided by the 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.    This case was linked to MOD-2021-258023 (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 events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Arthritis, Burning sensation, Localised infection, Mania
Clinical narrative: Burning sensation on both of her legs; Statis dermatitis; Agitated; Infection leg; arm soreness; Excruciating pain on both legs; Arm soreness at the injection site; Extreme edema in both legs; Triggered Manic episodes; Lupus flare up; Arthritis flare up; Swelling of both legs; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriasis, Cellulitis and Intra-cerebral aneurysm clipping since an unknown date. Concurrent medical conditions included Drug allergy (Allergy to Methothrexate.), Drug allergy (Allergy to Prednisone.), Drug allergy (Allergy to Peroxide  (topical).), Hepatitis B carrier and Bipolar disorder.    On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) (seriousness criterion medically significant), ARTHRITIS (Arthritis flare up), PERIPHERAL SWELLING (Swelling of both legs), OEDEMA PERIPHERAL (Extreme edema in both legs), MANIA (Triggered Manic episodes), PAIN IN EXTREMITY (Excruciating pain on both legs) and VACCINATION SITE PAIN (Arm soreness at the injection site). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation on both of her legs), STASIS DERMATITIS (Statis dermatitis), AGITATION (Agitated), LOCALISED INFECTION (Infection leg) and PAIN IN EXTREMITY (arm soreness). The patient was treated with AMOXICILLIN at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. On 09-Jul-2021, VACCINATION SITE PAIN (Arm soreness at the injection site) had resolved. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up), ARTHRITIS (Arthritis flare up), PERIPHERAL SWELLING (Swelling of both legs), BURNING SENSATION (Burning sensation on both of her legs), OEDEMA PERIPHERAL (Extreme edema in both legs), AGITATION (Agitated), LOCALISED INFECTION (Infection leg), PAIN IN EXTREMITY (Excruciating pain on both legs) and PAIN IN EXTREMITY (arm soreness) outcome was unknown and MANIA (Triggered Manic episodes) and STASIS DERMATITIS (Statis dermatitis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.; 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pain in extremity, Peripheral swelling, Stasis dermatitis, Systemic lupus erythematosus
Clinical narrative: Burning sensation on both of her legs; Statis dermatitis; Agitated; Infection leg; arm soreness; Excruciating pain on both legs; Arm soreness at the injection site; Extreme edema in both legs; Triggered Manic episodes; Lupus flare up; Arthritis flare up; Swelling of both legs; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriasis, Cellulitis and Intra-cerebral aneurysm clipping since an unknown date. Concurrent medical conditions included Drug allergy (Allergy to Methothrexate.), Drug allergy (Allergy to Prednisone.), Drug allergy (Allergy to Peroxide  (topical).), Hepatitis B carrier and Bipolar disorder.    On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) (seriousness criterion medically significant), ARTHRITIS (Arthritis flare up), PERIPHERAL SWELLING (Swelling of both legs), OEDEMA PERIPHERAL (Extreme edema in both legs), MANIA (Triggered Manic episodes), PAIN IN EXTREMITY (Excruciating pain on both legs) and VACCINATION SITE PAIN (Arm soreness at the injection site). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation on both of her legs), STASIS DERMATITIS (Statis dermatitis), AGITATION (Agitated), LOCALISED INFECTION (Infection leg) and PAIN IN EXTREMITY (arm soreness). The patient was treated with AMOXICILLIN at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. On 09-Jul-2021, VACCINATION SITE PAIN (Arm soreness at the injection site) had resolved. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up), ARTHRITIS (Arthritis flare up), PERIPHERAL SWELLING (Swelling of both legs), BURNING SENSATION (Burning sensation on both of her legs), OEDEMA PERIPHERAL (Extreme edema in both legs), AGITATION (Agitated), LOCALISED INFECTION (Infection leg), PAIN IN EXTREMITY (Excruciating pain on both legs) and PAIN IN EXTREMITY (arm soreness) outcome was unknown and MANIA (Triggered Manic episodes) and STASIS DERMATITIS (Statis dermatitis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.; 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Burning sensation on both of her legs; Statis dermatitis; Agitated; Infection leg; arm soreness; Excruciating pain on both legs; Arm soreness at the injection site; Extreme edema in both legs; Triggered Manic episodes; Lupus flare up; Arthritis flare up; Swelling of both legs; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriasis, Cellulitis and Intra-cerebral aneurysm clipping since an unknown date. Concurrent medical conditions included Drug allergy (Allergy to Methothrexate.), Drug allergy (Allergy to Prednisone.), Drug allergy (Allergy to Peroxide  (topical).), Hepatitis B carrier and Bipolar disorder.    On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) (seriousness criterion medically significant), ARTHRITIS (Arthritis flare up), PERIPHERAL SWELLING (Swelling of both legs), OEDEMA PERIPHERAL (Extreme edema in both legs), MANIA (Triggered Manic episodes), PAIN IN EXTREMITY (Excruciating pain on both legs) and VACCINATION SITE PAIN (Arm soreness at the injection site). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation on both of her legs), STASIS DERMATITIS (Statis dermatitis), AGITATION (Agitated), LOCALISED INFECTION (Infection leg) and PAIN IN EXTREMITY (arm soreness). The patient was treated with AMOXICILLIN at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. On 09-Jul-2021, VACCINATION SITE PAIN (Arm soreness at the injection site) had resolved. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up), ARTHRITIS (Arthritis flare up), PERIPHERAL SWELLING (Swelling of both legs), BURNING SENSATION (Burning sensation on both of her legs), OEDEMA PERIPHERAL (Extreme edema in both legs), AGITATION (Agitated), LOCALISED INFECTION (Infection leg), PAIN IN EXTREMITY (Excruciating pain on both legs) and PAIN IN EXTREMITY (arm soreness) outcome was unknown and MANIA (Triggered Manic episodes) and STASIS DERMATITIS (Statis dermatitis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis, Pneumonitis
Clinical narrative: Myocarditis/ swelling around my heart on my heart; Pericarditis; Swelling around left lung; My ribs and collar bones feel bruised; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis/ swelling around my heart on my heart) and PERICARDITIS (Pericarditis) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis/ swelling around my heart on my heart) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), PNEUMONITIS (Swelling around left lung) and CONTUSION (My ribs and collar bones feel bruised). At the time of the report, MYOCARDITIS (Myocarditis/ swelling around my heart on my heart), PERICARDITIS (Pericarditis), PNEUMONITIS (Swelling around left lung) and CONTUSION (My ribs and collar bones feel bruised) outcome was unknown. Not Provided          The concomitant medications were not reported. The treatment information was not provided.  Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.