chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Influenza like illness, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Within approx 11 hours of vaccine woke with severe chills, fever of 103°. This soon progressed to severe body aches, neck & shoulder pain, overall muscle weakness, loss of appetite, zaps of pain at left base of head. Overall felt like a severe flu. Half doses of Ibuprofen & Excedrin had little effect easing symptoms. but reduced fever to 100-101°. iSlept 10.5 hours and stayed in bed 24 hours - too weak to assume activities.  After 48 hours took half of Tylenol (250mg). Fever and body aches immediately responded. Had incident of vertigo. Have foggy brain, feeling dusconnected. Began to smell metal (phantom).  By 72 hours most symptoms resolve except for general weakness, joint pain, feeling disconnected and groggy, fatigued.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Neck pain, Pain, Parosmia, Pyrexia
Clinical narrative: Within approx 11 hours of vaccine woke with severe chills, fever of 103°. This soon progressed to severe body aches, neck & shoulder pain, overall muscle weakness, loss of appetite, zaps of pain at left base of head. Overall felt like a severe flu. Half doses of Ibuprofen & Excedrin had little effect easing symptoms. but reduced fever to 100-101°. iSlept 10.5 hours and stayed in bed 24 hours - too weak to assume activities.  After 48 hours took half of Tylenol (250mg). Fever and body aches immediately responded. Had incident of vertigo. Have foggy brain, feeling dusconnected. Began to smell metal (phantom).  By 72 hours most symptoms resolve except for general weakness, joint pain, feeling disconnected and groggy, fatigued.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Somnolence, Vertigo
Clinical narrative: Within approx 11 hours of vaccine woke with severe chills, fever of 103°. This soon progressed to severe body aches, neck & shoulder pain, overall muscle weakness, loss of appetite, zaps of pain at left base of head. Overall felt like a severe flu. Half doses of Ibuprofen & Excedrin had little effect easing symptoms. but reduced fever to 100-101°. iSlept 10.5 hours and stayed in bed 24 hours - too weak to assume activities.  After 48 hours took half of Tylenol (250mg). Fever and body aches immediately responded. Had incident of vertigo. Have foggy brain, feeling dusconnected. Began to smell metal (phantom).  By 72 hours most symptoms resolve except for general weakness, joint pain, feeling disconnected and groggy, fatigued.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Chills, Cough, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, chills, runny nose, cough, loss of smell
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Bilevel positive airway pressure, Chest pain, Computerised tomogram thorax abnormal, Dyspnoea, Hypoxia
Clinical narrative: Acute onset chest pain, increased work of breathing and hypoxia requiring BiPAP. CT scan with bilateral ground glass opacities  of unclear etiology
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Lung opacity, Respiratory viral panel, SARS-CoV-2 test negative
Clinical narrative: Acute onset chest pain, increased work of breathing and hypoxia requiring BiPAP. CT scan with bilateral ground glass opacities  of unclear etiology
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood potassium decreased, Cough, Ear infection, Feeling abnormal
Clinical narrative: Vax fog, joint pain, nasal congestion,  ear infection  right ear, cough, fever, red itchy painful bumps, sore throat
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: Vax fog, joint pain, nasal congestion,  ear infection  right ear, cough, fever, red itchy painful bumps, sore throat
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Vax fog, joint pain, nasal congestion,  ear infection  right ear, cough, fever, red itchy painful bumps, sore throat
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Painful hard knot at injection site that has not dissipated after 21 weeks
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Patient developed a large, red splotch on at the injection side.  The red site is about the size of a deck of cards.  On researching it appears to be "Covid Arm".  It doesn't itch, but is warm to the touch and swollen and red.  His lymph nodes in his arm pit and neck are also swollen.  Redness came up on day 7 after 1st dose.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: shortly after receiving vaccine, pt had blurred vison,sweating,nausea,clammy feeling,dizzinesss, felt like about to throw up, felt like passing out, tingling in the arm where vaccine administered. gave pt bottle of water, wet paper towels on neck. after sitting for about 30 minutes, he felt better and was able to go home. he was not driving, had another person with him.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Nausea, Paraesthesia, Tremor, Vision blurred
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: shortly after receiving vaccine, pt had blurred vison,sweating,nausea,clammy feeling,dizzinesss, felt like about to throw up, felt like passing out, tingling in the arm where vaccine administered. gave pt bottle of water, wet paper towels on neck. after sitting for about 30 minutes, he felt better and was able to go home. he was not driving, had another person with him.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: shortly after receiving vaccine, pt had blurred vison,sweating,nausea,clammy feeling,dizzinesss, felt like about to throw up, felt like passing out, tingling in the arm where vaccine administered. gave pt bottle of water, wet paper towels on neck. after sitting for about 30 minutes, he felt better and was able to go home. he was not driving, had another person with him.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vaccination site reaction
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient said she is experiencing covid arm and it is very swollen
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient explained before vaccination that she normally faints after vaccines. shortly after shot patient felt very lightheaded and very breifly fainted though unconfirmed if she was fully unconcious. patient was advised to sit on floor in fetle position and given water where she recovered fully shortly afterwards with no further complications.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: cellulitis-Medium, Error: Infection / Cellulitis (diagnosed by MD)-, Additional Details: patient came into pharmacy,indicating she was getting an antibiotic for cellulitis in left arm where covid shot was given. she said alcohol pad must not have worked
Sex: U
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Therapy partial responder
Clinical narrative: IGM POSITIVE, IGG NEGATIVE; This spontaneous report received from a patient via a company representative via social media (Facebook) concerned a patient of unspecified age and sex, race and ethnic origin. Initial information was processed with additional information received from Central complaint vigilance on 29-JUL-2021. 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).5 ml,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, four months later the patient had IgM positive, IgG negative. Laboratory data (dates unspecified) included: IgG (NR: not provided) Negative, and IgM (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of IgM positive, IgG negative was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210761815  This report was associated with product quality complaint: 90000187621; Sender's Comments: V0: 20210760356-COVID-19 VACCINE AD26.COV2.S- IgM positive, IgG negative. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Foetal exposure during pregnancy
Clinical narrative: BABIES BEING BORN WITH ISSUES AFTER MOTHERS RECEIVE VACCINE; DRUG EXPOSURE IN UTERO; This spontaneous pregnancy report received from a consumer concerned multiple patients. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported.  The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced babies being born with issues after mothers receive vaccine, and drug exposure in utero. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drug exposure in utero, and the outcome of babies being born with issues after mothers receive vaccine was not reported. This report was non-serious. This parent/child case is linked to 20210760501.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Inflammation scan, Influenza like illness, Pyrexia
Clinical narrative: INTERMITTENT FEVER; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. 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 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced flu-like symptoms. On 03-JUL-2021, the subject experienced intermittent fever. Laboratory data included: Body temperature (NR: not provided) 101-102 F. On 11-JUL-2021, Laboratory data included: Blood test (NR: not provided) did not reveal any conditions, Inflammation scan (NR: not provided) tested negative for inflammation, and Urinalysis (NR: not provided) negative for infections. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 12-APR-2021, and was recovering from intermittent fever. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urine analysis
Clinical narrative: INTERMITTENT FEVER; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. 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 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced flu-like symptoms. On 03-JUL-2021, the subject experienced intermittent fever. Laboratory data included: Body temperature (NR: not provided) 101-102 F. On 11-JUL-2021, Laboratory data included: Blood test (NR: not provided) did not reveal any conditions, Inflammation scan (NR: not provided) tested negative for inflammation, and Urinalysis (NR: not provided) negative for infections. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 12-APR-2021, and was recovering from intermittent fever. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, SARS-CoV-2 test positive, Suspected COVID-19
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; LIGHT CHILLS; SLIGHT HEADACHE; This spontaneous report received from a 53-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user (a few time in month to none). The patient had no known drug allergies and no 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: 1805022, and expiry: UNKNOWN) dose was not reported, 1 in total administered on 13-MAR-2021 into left arm between 13:00 hours to 14:00 hours for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced light chills and slight headache and took ibuprofen to relieve symptoms. By 21:00 hours, of the same day, patient felt normal and symptoms resolved. She travelled from 27-JUN-2021 to 01-JUL-2021. On 05-JUL-2021, the patient experienced COVID-19 symptoms of cough, fever (highest at 101.4F), congestion, body aches (felt like sunburn on inside and outside of body; skin hurt to touch), sore throat, extreme fatigue, severe weakness, nausea, diarrhea) and suspected clinical vaccination failure. She was sick for 2 weeks. On 08-JUL-2021, she tested positive for COVID-19. She received letter from Health department on 12-JUL-2021 to be in isolation through (16-JUL-2021). She went to the emergency room (ER) on 13-JUL-2021 , prompted by pain in chest and shortness of breath were severe. She was given antibiotics (unspecified) and inhaler at the ER. She made her primary care physician (PCP) aware and had follow up appointment on 16-Jul-2021. During time of sickness, she had congestion, which did not end until 23-JUL-2021. She was off work for another week. Laboratory data included: Body temperature (NR: not provided) 101.4 F and COVID-19 virus test positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on JUL-2021, and light chills, and slight headache on 13-MAR-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210763118- 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
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; LIGHT CHILLS; SLIGHT HEADACHE; This spontaneous report received from a 53-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user (a few time in month to none). The patient had no known drug allergies and no 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: 1805022, and expiry: UNKNOWN) dose was not reported, 1 in total administered on 13-MAR-2021 into left arm between 13:00 hours to 14:00 hours for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced light chills and slight headache and took ibuprofen to relieve symptoms. By 21:00 hours, of the same day, patient felt normal and symptoms resolved. She travelled from 27-JUN-2021 to 01-JUL-2021. On 05-JUL-2021, the patient experienced COVID-19 symptoms of cough, fever (highest at 101.4F), congestion, body aches (felt like sunburn on inside and outside of body; skin hurt to touch), sore throat, extreme fatigue, severe weakness, nausea, diarrhea) and suspected clinical vaccination failure. She was sick for 2 weeks. On 08-JUL-2021, she tested positive for COVID-19. She received letter from Health department on 12-JUL-2021 to be in isolation through (16-JUL-2021). She went to the emergency room (ER) on 13-JUL-2021 , prompted by pain in chest and shortness of breath were severe. She was given antibiotics (unspecified) and inhaler at the ER. She made her primary care physician (PCP) aware and had follow up appointment on 16-Jul-2021. During time of sickness, she had congestion, which did not end until 23-JUL-2021. She was off work for another week. Laboratory data included: Body temperature (NR: not provided) 101.4 F and COVID-19 virus test positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on JUL-2021, and light chills, and slight headache on 13-MAR-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210763118- 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: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: BLEEDING NOSE; 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: Unknown) dose was not reported, administered on 26-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2021, the subject experienced bleeding nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding nose on JUL-2021. 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: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Heart rate, Pain
Clinical narrative: BODY ACHES; BODY CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 22 year old male. The patient's weight was 180 pounds, and height was 182 centimeters. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the subject experienced body aches. On 30-JUL-2021, the subject experienced body chills. On 30-JUL-2021, the subject experienced headache. On 30-JUL-2021, the subject experienced fever. Laboratory data included Body temperature (NR: not provided) 100.7, and Heart rate (NR: not provided) 101bpm. Treatment medications (dates unspecified) included naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body chills on 30-JUL-2021, and had not recovered from body aches, headache, and fever. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; BODY CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 22 year old male. The patient's weight was 180 pounds, and height was 182 centimeters. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the subject experienced body aches. On 30-JUL-2021, the subject experienced body chills. On 30-JUL-2021, the subject experienced headache. On 30-JUL-2021, the subject experienced fever. Laboratory data included Body temperature (NR: not provided) 100.7, and Heart rate (NR: not provided) 101bpm. Treatment medications (dates unspecified) included naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body chills on 30-JUL-2021, and had not recovered from body aches, headache, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hypersomnia
Clinical narrative: SLEPT FOR A DECENT 15 HOURS; CHILLS; 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 not reported, batch number: UNKNOWN) 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 slept for a decent 15 hours, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for a decent 15 hours, and chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain
Clinical narrative: GENERALLY FEELING AWFUL; BODY ACHES; SOME CHILLS; 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 not reported, batch number: UNKNOWN) 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 generally feeling awful, body aches, and some chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, some chills and generally feeling awful was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Decreased appetite, Dehydration, Functional gastrointestinal disorder, Headache
Clinical narrative: swollen lymph nodes in stomach; his spleen is swollen; Severe abdominal cramping; his bowels have stopped working all together; dehydration; numbness in hands and feet; loss of appetite; vomiting; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes in stomach) and SPLENOMEGALY (his spleen is swollen) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes in stomach) (seriousness criterion hospitalization), SPLENOMEGALY (his spleen is swollen) (seriousness criterion hospitalization), ABDOMINAL PAIN (Severe abdominal cramping), FUNCTIONAL GASTROINTESTINAL DISORDER (his bowels have stopped working all together), DEHYDRATION (dehydration), HYPOAESTHESIA (numbness in hands and feet), DECREASED APPETITE (loss of appetite), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with ONDANSETRON (ZOFRAN MELT) for Vomiting, at a dose of 1 dosage form; DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Pain, at a dose of 1 dosage form; MAGNESIUM for Constipation, at a dose of 1 dosage form and MACROGOL 3350 (MIRALAX) at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes in stomach), SPLENOMEGALY (his spleen is swollen), ABDOMINAL PAIN (Severe abdominal cramping), FUNCTIONAL GASTROINTESTINAL DISORDER (his bowels have stopped working all together), DEHYDRATION (dehydration), HYPOAESTHESIA (numbness in hands and feet), DECREASED APPETITE (loss of appetite), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            Concomitant medication was not provided.  Treatment also included antibiotics.  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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Nausea, Splenomegaly, Vomiting
Clinical narrative: swollen lymph nodes in stomach; his spleen is swollen; Severe abdominal cramping; his bowels have stopped working all together; dehydration; numbness in hands and feet; loss of appetite; vomiting; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes in stomach) and SPLENOMEGALY (his spleen is swollen) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes in stomach) (seriousness criterion hospitalization), SPLENOMEGALY (his spleen is swollen) (seriousness criterion hospitalization), ABDOMINAL PAIN (Severe abdominal cramping), FUNCTIONAL GASTROINTESTINAL DISORDER (his bowels have stopped working all together), DEHYDRATION (dehydration), HYPOAESTHESIA (numbness in hands and feet), DECREASED APPETITE (loss of appetite), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with ONDANSETRON (ZOFRAN MELT) for Vomiting, at a dose of 1 dosage form; DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Pain, at a dose of 1 dosage form; MAGNESIUM for Constipation, at a dose of 1 dosage form and MACROGOL 3350 (MIRALAX) at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes in stomach), SPLENOMEGALY (his spleen is swollen), ABDOMINAL PAIN (Severe abdominal cramping), FUNCTIONAL GASTROINTESTINAL DISORDER (his bowels have stopped working all together), DEHYDRATION (dehydration), HYPOAESTHESIA (numbness in hands and feet), DECREASED APPETITE (loss of appetite), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            Concomitant medication was not provided.  Treatment also included antibiotics.  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.   Reporter did not allow further contact; 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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Patient was administer an expired vaccine/ no AE; Initial information was received on 26-Jul-2021 regarding an unsolicited valid non-serious case received from an Other healthcare professional via Medical Information (MI) (Reference number- 00696834) and transmitted to Sanofi on 27-Jul-2021.  This case involves a patient (unknown age and unknown gender) reported that patient was administer an expired HIB (PRP/T) VACCINE [ACT-HIB] with no adverse event (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 21-Jul-2021, the patient received a dose of suspect HIB (PRP/T) VACCINE [lot number not reported, and expiry date 08-Jun-2021] via unknown route in unknown administration site for prophylactic vaccination.  It was reported that, "Caller stated that ACT-HIB was administered to a patient on 7/21/2021 and expired on 6/8/2021. Caller would like to know what to do next and what side effects may be associated. Product used: Used".  It was a case of actual medication error due to expired vaccine used (latency 6 days).  At the time of reporting, patient had 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 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.  There will be no information available on the batch number for this case.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired vaccine/ no AE; Initial information was received on 26-Jul-2021 regarding an unsolicited valid non-serious case received from an Other healthcare professional via Agency (Reference number- 00697308) and transmitted to Sanofi on 26-Jul-2021.  This case involves a two-year-old female patient reported that the patient was administered an expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine with no adverse event (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (VAQTA) for prophylactic vaccination and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination.  On 26-Jul-2021, the patient received 0.5 mL (once) fourth dose of suspect HIB (PRP/T) VACCINE [lot UJ356AAB and expiry date 25-Jul-2021] via intramuscular route in right thigh for prophylactic vaccination.  It was reported that, "Clinical Supervisor called to report that ACTHIB was administered to a patient on 26JUL2021, but it expired on 25JUL2021. Caller would like to know if this dose is considered valid and whether the dose should be repeated? Product used: Used".  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had 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 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.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Flushing, Haemorrhage, Head injury, Hyperhidrosis
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: patient fainted shortly after administering first dose of vaccine. he was seated in a chair for observation and fell sideways, hit his head on the floor. minor bleeding on face. continued to observe patient until he felt stable again. monitored blood pressure. patient insisted on not calling for additional help
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: patient fainted shortly after administering first dose of vaccine. he was seated in a chair for observation and fell sideways, hit his head on the floor. minor bleeding on face. continued to observe patient until he felt stable again. monitored blood pressure. patient insisted on not calling for additional help
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Pruritus, Swelling face, Swelling of eyelid, Swollen tongue
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: patient developed linear large welts immediately on neck and had systemic itching. given 25mg benadryl & 20mg famotidine oral. pt advised to follow up with pcp.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: patient developed linear large welts immediately on neck and had systemic itching. given 25mg benadryl & 20mg famotidine oral. pt advised to follow up with pcp.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Injected limb mobility decreased, Injection site pain, Nervous system disorder, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Additional Details: patient felt pain immediately at site of injection. 2-3 hours post vaccination felt like she was having electrical zaps going down entire arm. patient had limited mobility all over and at injection site. referred to pcp.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient had passed out after injection.  Blood pressure was 86/50 with HR 52.  After about 40 min vitals were retaken and were 94/55 with HR 71.  We had patient in pharmacy for a round an hour until his vitals were normal and he felt better.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Thrombosis
Clinical narrative: Experienced unusual heavy bleeding and heavy clotting that patient had never experienced before with menstrual flow
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Eye swelling, Mouth swelling, Swelling face
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient immediately experience throat feeling tight and tongue feeling thick/full. referred pt to ED.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient immediately experience throat feeling tight and tongue feeling thick/full. referred pt to ED.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Medium, Additional Details: Patient noticed uncomfortable feeling in right armpit area during the evening/night after receiving vaccine. In the morning, patient noticed a bump/swollen area under his right armpit. Patient reports that bump doesn't hurt, but is uncomfortable; reports that bump is soft to touch. Patient reports no other symptoms and has no other complaints. Pharmacist visually observed bump, looked like a swollen lymph node. Advised patient to seek care from PCP/ER if swelling doesn't resolve in 1-2 days.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient waited 15 minutes then checked out. She then walked to the water fountain/restroom area where she fainted. Patient woke up shortly afterwards and we had her remain laying down and elevated her legs. When she felt better we had her sit on the floor for a bit, then moved her to a chair when she felt comfortable. Patient drank 3 small bottles of water and felt better. Patient's husband came to the pharmacy to assist patient in getting home.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dizziness, Hypotension, Injection site paraesthesia, Injection site warmth
Clinical narrative: Systemic: Hypotension-Mild, Systemic: Seizure-Mild, Additional Details: after a few minutes of monitoring patient started convulsing it appears like. she was sitting in a chair and started shaking with her head back for about 10 seconds. she does not remember this happening and reported she bit her mouth or tongue in the process. she slightly felt dizzy but that resolved in a few seconds. she reported felt some hotness and tingling at injection site, gave her water monitored more and she felt normal again, no history of seizures she reports. not sick either
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth injury, Seizure, Tongue biting, Tremor
Clinical narrative: Systemic: Hypotension-Mild, Systemic: Seizure-Mild, Additional Details: after a few minutes of monitoring patient started convulsing it appears like. she was sitting in a chair and started shaking with her head back for about 10 seconds. she does not remember this happening and reported she bit her mouth or tongue in the process. she slightly felt dizzy but that resolved in a few seconds. she reported felt some hotness and tingling at injection site, gave her water monitored more and she felt normal again, no history of seizures she reports. not sick either
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Systemic: Pain and swelling at the left armpit-Mild, Additional Details: Patient stated swelling and pain at left armpit area since today morning (08/01/2021). The area is slowly migrated downward. She feels pain when pressing the area. Patient took Advil this morning, but no help on migration. Suggested to have a doctor visit tomorrow (08/02/21, Monday)
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Musculoskeletal chest pain, Rash, Tenderness
Clinical narrative: On 7/29/2021 at approximately 1900, I developed right lower rib pain that was very tender to touch; On 8/1/2021, upon waking I discovered a rash in that same area.  I went to Health Same Day Clinic at 1100.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong dosage formulation
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Mental status changes, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Presented to emergency department on 7/27/2021 with fever and altered mental status. She was exposed to COVID-19 by her daughter who lives with her. She was found to be positive for COVID-19 and admitted for further management. She was treated with remdesivir, dexamethasone, and supplemental oxygen during admission. She was discharged from hospital on 7/31/2021 with home hospice services.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: Case symptom onset was 7/21/2021 which included subjective fever, chills, runny nose, fatigue, dry cough and shortness of breath.  He was tested for Covid 19 on 7/26/2021 with a positive result with a positive result with Rapid-Quidel Nose Swab. As of 7/30/2021 case was still symptomatic.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Case symptom onset was 7/21/2021 which included subjective fever, chills, runny nose, fatigue, dry cough and shortness of breath.  He was tested for Covid 19 on 7/26/2021 with a positive result with a positive result with Rapid-Quidel Nose Swab. As of 7/30/2021 case was still symptomatic.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Pain, SARS-CoV-2 test positive
Clinical narrative: Patient presented to emergency department on 7/20/2021 with generalized body aches, fatigue, and cough. She was found to be COVID-19 positive. She was treated with remdesivir, dexamethasone, and supplemental oxygen. Patient was discharged home on 7/31/2021.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Cough, Diarrhoea, Dyspnoea, Exposure to SARS-CoV-2
Clinical narrative: Case symptom onset was 7/28/2021 which included runny nose, sore throat, headache, cough, wheezing, shortness of breath, nausea, abdominal pain and diarrhea.  As of 7/30/2021 case was still symptomatic.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Oropharyngeal pain, Rhinorrhoea, Wheezing
Clinical narrative: Case symptom onset was 7/28/2021 which included runny nose, sore throat, headache, cough, wheezing, shortness of breath, nausea, abdominal pain and diarrhea.  As of 7/30/2021 case was still symptomatic.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: On Friday, 7/30, the vaccination site was itchy and there was a large red swollen area which was warm to the touch. By Monday 8/2, the red swollen area had decreased but was still slightly warm to the touch a little bit itchy.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Laboratory test, Pericarditis, Pleural effusion
Clinical narrative: June 19 2021 diagnosed with Perycarditis, treatment antiinflammatory medicines and pain killers, lasted until week of July 2 when diagnosed with puerleffussion  As of this date still experienceing weak condition
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Malaise
Clinical narrative: Pt acquired COVID 19 with symptoms post vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia, Paraesthesia oral, Pruritus
Clinical narrative: With 4 hours of  the vax  my legs began to feel numb and tingly, ,got worse thru the afternoon and night,   headache, Called Drs office  Saturday, still felt like legs were numb,  Sunday same thing, then about 2 pm started to slightly itch all over,. Had a hive beak out on my right cheek, lips are tingling, have a scratchy throat.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Urticaria
Clinical narrative: With 4 hours of  the vax  my legs began to feel numb and tingly, ,got worse thru the afternoon and night,   headache, Called Drs office  Saturday, still felt like legs were numb,  Sunday same thing, then about 2 pm started to slightly itch all over,. Had a hive beak out on my right cheek, lips are tingling, have a scratchy throat.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Cough, Diarrhoea, Fatigue
Clinical narrative: Case symptom onset 7/22/2021 included chills, headache, fatigue, cough, abdominal pain and diarrhea. As of 7/30/2021 case was still symptomatic.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: Case symptom onset 7/22/2021 included chills, headache, fatigue, cough, abdominal pain and diarrhea. As of 7/30/2021 case was still symptomatic.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Nausea, Pain in extremity, Vertigo
Clinical narrative: The first few days, patient had exhaustion and arm pain, which was expected...it seemed to be subsiding a bit, but then Thursday morning he was hit with a wave of fatigue again. He then had severe nausea, was freezing cold, and vertigo. I took his temperature and it was 95.5 degrees. He stayed in bed most of Thursday. By about 4:00 I took his temp again and it was up to 97.1. The low body temp and vertigo was particularly concerning, so I called his Dr and was advised to make this report. He is still extremely fatigued. At this time he has not experienced vertigo or low body temp since Thursday's episode.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Cough
Clinical narrative: Case symptom onset 7/23/2021 which included fever, subjective fever, chills, rigors, muscle aches, loss of taste and smell, fatigue, cough, shortness of breath and loss of appetite. As of 7/30/2021 case was still symptomatic. Antibody Infusion Treatment was also scheduled for 7/30/2021.