chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral vascular disorder, Vasodilatation
Clinical narrative: VEIN BULGING; BILATERAL NUMBNESS ON LEGS; LEFT THIGH PAIN; LOST CIRCULATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lost circulation. On 13-APR-2021, the subject experienced vein bulging. On 13-APR-2021, the subject experienced bilateral numbness on legs. On 13-APR-2021, the subject experienced left thigh pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left thigh pain on 14-APR-2021, had not recovered from bilateral numbness on legs, and the outcome of vein bulging and lost circulation was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment is not required as per standard operating procedures, as case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: ENLARGED LYMPH NODE ON LEFT SIDE OF NECK NEAR CLAVICLE; SORE ARM; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced enlarged lymph node on left side of neck near clavicle. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from enlarged lymph node on left side of neck near clavicle, sore arm, and tiredness. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Feeling abnormal, Flatulence, Headache
Clinical narrative: EXTRA SALIVA PRODUCTION; LETHARGY; HOT AND COLD SWEATS; UPSET STOMACH; WASN'T FEELING HIS SELF; GAS PAIN; ARM PAIN AND TENDERNESS; NAUSEA; HEADACHE; FEELING VERY TIRED; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included kidney stones. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced extra saliva production. On 08-APR-2021, the subject experienced lethargy. On 08-APR-2021, the subject experienced hot and cold sweats. On 08-APR-2021, the subject experienced upset stomach. On 08-APR-2021, the subject experienced wasn't feeling his self. On 08-APR-2021, the subject experienced gas pain. On 08-APR-2021, the subject experienced arm pain and tenderness. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced feeling very tired. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extra saliva production, hot and cold sweats, upset stomach, gas pain, nausea, and headache on APR-2021, lethargy on 10-APR-2021, and arm pain and tenderness on 11-APR-2021, and the outcome of feeling very tired and wasn't feeling his self was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lethargy, Nausea, Pain in extremity, Salivary hypersecretion
Clinical narrative: EXTRA SALIVA PRODUCTION; LETHARGY; HOT AND COLD SWEATS; UPSET STOMACH; WASN'T FEELING HIS SELF; GAS PAIN; ARM PAIN AND TENDERNESS; NAUSEA; HEADACHE; FEELING VERY TIRED; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included kidney stones. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced extra saliva production. On 08-APR-2021, the subject experienced lethargy. On 08-APR-2021, the subject experienced hot and cold sweats. On 08-APR-2021, the subject experienced upset stomach. On 08-APR-2021, the subject experienced wasn't feeling his self. On 08-APR-2021, the subject experienced gas pain. On 08-APR-2021, the subject experienced arm pain and tenderness. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced feeling very tired. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extra saliva production, hot and cold sweats, upset stomach, gas pain, nausea, and headache on APR-2021, lethargy on 10-APR-2021, and arm pain and tenderness on 11-APR-2021, and the outcome of feeling very tired and wasn't feeling his self was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Illness, Pyrexia, Vomiting
Clinical narrative: VOMITING; DIARRHEA; SICKNESS; FEVER; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, frequency one total, administered at right arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced vomiting, diarrhea that would not stop hence she had to go to the emergency room where she received an IV. The patient also had severe headache that lasted for several days and fever. The patient said the diarrhea stopped after getting the IV and she was pretty sick until last Saturday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and diarrhea on 07-APR-2021, and severe headache, and fever on APR-2021, and the outcome of sickness was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: 20210432019-covid-19 vaccine ad26.cov2.s-vomiting, diarrhea. 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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Fatigue, Heart rate, Heart rate decreased
Clinical narrative: FAINTED; HEARTRATE SLOWED; LOW BP; SHORTNESS OF BREATH; SWEATING FROM HEAD TO TOE; FATIGUE/TIREDNESS; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included food allergy-poultry. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978 expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 13:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced dizziness, light headedness and fainted 10 minutes after at vaccination centre. It was not allergy reaction, he had low blood pressure (BP) and his heartrate slowed. The nurses elevated his legs, other nurse took vitals. He was covered in sweats from head to toe, they gave him Gatorade. He kept his head down and legs up and was monitored for his vitals. It was reported that he came around in 10 minutes, after fainting until BP and heart rate returned to normal. The nurses kept checking vital, at vaccination centre, then sent home, asked him to eat and drink. He also had shortness of breath on and off lasting for 3 hours at a time and also fatigue/tiredness. He had never fainted before so unusual behaviour. Laboratory data included: Blood pressure (NR: not provided) normal, Low, and Heart rate (NR: not provided) Normal, Slowed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, heartrate slowed, low BP, and sweating from head to toe on 07-APR-2021, and was recovering from shortness of breath, and fatigue/tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210432065-covid-19 vaccine ad26.cov2.s-Fainted. 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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Syncope
Clinical narrative: FAINTED; HEARTRATE SLOWED; LOW BP; SHORTNESS OF BREATH; SWEATING FROM HEAD TO TOE; FATIGUE/TIREDNESS; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included food allergy-poultry. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978 expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 13:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced dizziness, light headedness and fainted 10 minutes after at vaccination centre. It was not allergy reaction, he had low blood pressure (BP) and his heartrate slowed. The nurses elevated his legs, other nurse took vitals. He was covered in sweats from head to toe, they gave him Gatorade. He kept his head down and legs up and was monitored for his vitals. It was reported that he came around in 10 minutes, after fainting until BP and heart rate returned to normal. The nurses kept checking vital, at vaccination centre, then sent home, asked him to eat and drink. He also had shortness of breath on and off lasting for 3 hours at a time and also fatigue/tiredness. He had never fainted before so unusual behaviour. Laboratory data included: Blood pressure (NR: not provided) normal, Low, and Heart rate (NR: not provided) Normal, Slowed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, heartrate slowed, low BP, and sweating from head to toe on 07-APR-2021, and was recovering from shortness of breath, and fatigue/tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210432065-covid-19 vaccine ad26.cov2.s-Fainted. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Hypoacusis, Pain, Pain in extremity
Clinical narrative: RIGHT EAR FEELING DEAF; COUGH; BODY ACHES; JOINT PAIN; RIGHT LEG HURTING; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced right ear feeling deaf. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced right leg hurting. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cough, fever, joint pain, body aches, right leg hurting and right ear feeling deaf was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: RIGHT EAR FEELING DEAF; COUGH; BODY ACHES; JOINT PAIN; RIGHT LEG HURTING; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced right ear feeling deaf. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced right leg hurting. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cough, fever, joint pain, body aches, right leg hurting and right ear feeling deaf was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Adenoidal disorder, Body temperature, Computerised tomogram, Enlarged uvula, Headache
Clinical narrative: THROAT SWELLED UP; SWOLLEN UVULA; ACHINESS; SWOLLEN ADENOIDS; HEADACHE; TEMPERATURE OF 102; NUMB ON LEFT SIDE (THROAT); NUMB ON LEFT SIDE (ARM); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included COVID-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 in total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   The patient was hospitalized twice on 07-APR-2021 and on 09-APR-2021 from receiving the vaccine. The patient's throat swelled up and uvula and adenoids completely swelled as per computerised tomogram (CAT) scan. The patient had horrendous achiness and headache that was so much worse than when the patient had COVID a year prior to this report. The patient also had a temperature of 102 that the patient also never had during COVID. The patient was numb on left side (throat and arm) as of 14-APR-2021 which was eight days later. Laboratory data included: Body temperature (NR: not provided) 102 (units unspecified), and CAT scan (NR: not provided) uvula and adenoids completely swelled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numb on left side (arm), and numb on left side (throat), and the outcome of throat swelled up, swollen uvula, achiness, headache, temperature of 102 and swollen adenoids was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V.0: 20210432171-covid-19 vaccine ad26.cov2.s-throat swelled up, swollen uvula, achiness and swollen adenoid. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210432171-covid-19 vaccine ad26.cov2.s-headache, temperature of 102. These events are labeled per RSI and are therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pharyngeal hypoaesthesia, Pharyngeal swelling, Pyrexia
Clinical narrative: THROAT SWELLED UP; SWOLLEN UVULA; ACHINESS; SWOLLEN ADENOIDS; HEADACHE; TEMPERATURE OF 102; NUMB ON LEFT SIDE (THROAT); NUMB ON LEFT SIDE (ARM); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included COVID-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 in total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   The patient was hospitalized twice on 07-APR-2021 and on 09-APR-2021 from receiving the vaccine. The patient's throat swelled up and uvula and adenoids completely swelled as per computerised tomogram (CAT) scan. The patient had horrendous achiness and headache that was so much worse than when the patient had COVID a year prior to this report. The patient also had a temperature of 102 that the patient also never had during COVID. The patient was numb on left side (throat and arm) as of 14-APR-2021 which was eight days later. Laboratory data included: Body temperature (NR: not provided) 102 (units unspecified), and CAT scan (NR: not provided) uvula and adenoids completely swelled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numb on left side (arm), and numb on left side (throat), and the outcome of throat swelled up, swollen uvula, achiness, headache, temperature of 102 and swollen adenoids was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V.0: 20210432171-covid-19 vaccine ad26.cov2.s-throat swelled up, swollen uvula, achiness and swollen adenoid. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210432171-covid-19 vaccine ad26.cov2.s-headache, temperature of 102. These events are labeled per RSI and are therefore considered potentially related.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Chest pain, Decreased appetite, Diarrhoea
Clinical narrative: ARTHRITIS; PAIN IN HIP; COUGHING BLOOD; BLEEDING NOSE; CHEST PAIN; DIARRHEA; LOST APPETITE; WORSENED PERSPIRATION; LOST 100LBS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin. The patient was previously treated with sulfur for drug used for unknown indication, codeine for drug used for unknown indication, and morphine for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 08:00 for prophylactic vaccination. Concomitant medications included warfarin sodium for drug used for unknown indication. On APR-2021, the subject experienced lost appetite. On APR-2021, the subject experienced worsened perspiration. On APR-2021, the subject experienced lost 100lbs. On 07-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced chest pain. On 09-APR-2021, the subject experienced coughing blood. On 09-APR-2021, the subject experienced bleeding nose. On 10-APR-2021, the subject experienced pain in hip. On 11-APR-2021, the subject experienced arthritis.  Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) negative (units unspecified). Treatment medications (dates unspecified) included: ketorolac, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 08-APR-2021, chest pain on 09-APR-2021, coughing blood, and bleeding nose on 10-APR-2021, and pain in hip on 11-APR-2021, had not recovered from lost appetite, and worsened perspiration, and the outcome of arthritis and lost 100lbs was not reported. 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Haemoptysis, Hyperhidrosis, SARS-CoV-2 test negative, Weight decreased
Clinical narrative: ARTHRITIS; PAIN IN HIP; COUGHING BLOOD; BLEEDING NOSE; CHEST PAIN; DIARRHEA; LOST APPETITE; WORSENED PERSPIRATION; LOST 100LBS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin. The patient was previously treated with sulfur for drug used for unknown indication, codeine for drug used for unknown indication, and morphine for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 08:00 for prophylactic vaccination. Concomitant medications included warfarin sodium for drug used for unknown indication. On APR-2021, the subject experienced lost appetite. On APR-2021, the subject experienced worsened perspiration. On APR-2021, the subject experienced lost 100lbs. On 07-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced chest pain. On 09-APR-2021, the subject experienced coughing blood. On 09-APR-2021, the subject experienced bleeding nose. On 10-APR-2021, the subject experienced pain in hip. On 11-APR-2021, the subject experienced arthritis.  Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) negative (units unspecified). Treatment medications (dates unspecified) included: ketorolac, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 08-APR-2021, chest pain on 09-APR-2021, coughing blood, and bleeding nose on 10-APR-2021, and pain in hip on 11-APR-2021, had not recovered from lost appetite, and worsened perspiration, and the outcome of arthritis and lost 100lbs was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: This spontaneous report received from a patient concerned multiple patients. The patient's height, and weight were not reported. The patient's concurrent conditions included mthfr gene mutation, and other pre-existing medical conditions included the patient had family history of mthfr gene mutation. 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 09-MAR-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 09-MAR-2021, the subject experienced intense pain across neck. On 09-MAR-2021, the subject experienced intense pain in down arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intense pain across neck, and intense pain in down arm on 09-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210441759.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Nausea
Clinical narrative: SLIGHT SHORTNESS OF BREATH; TIREDNESS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced slight shortness of breath. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, nausea and slight shortness of breath was not reported. This report was non-serious. This case, from the same reporter is linked to 20210429237.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hyperhidrosis, Hypoaesthesia, Pain
Clinical narrative: FAINTING; NUMBNESS; SORENESS; FEELING EXTREMELY HOT; SOAKING WET; HEADACHE ON THE RIGHT SIDE; This spontaneous report received from a patient unspecified age. The patient's height, and weight were not reported. The patient's past medical history included miscarriage, and concurrent conditions included anxiety, fainting, hazelnut allergy, Ceftin allergy, Alcoholic (drinks once a week), and non-smoker. The patient has 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: 1808980, and expiry: UNKNOWN) dose was not reported, one total, administered on 08-APR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. She fainted on occasion per her history. She felt numbness and felt hot and fainted 5 minutes after she received the vaccine. She experienced headaches on the right side, soreness, and soaking wet. She took ibuprofen and switch to aspirin yesterday. She still has the headaches come and go. She spoke with her doctor and was advised to go to the emergency room (ER) if symptoms continued. On 14-APR-2021, treatment medications included: Acetylsalicylic acid (Aspirin). Additional treatment medications (dates unspecified) included: Ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fainting, numbness, soreness, feeling extremely hot, and soaking wet, and had not recovered from headache on the right side. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210432537-Covid-19 vaccine ad26.cov2.s -Fainting. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: FAINTING; NUMBNESS; SORENESS; FEELING EXTREMELY HOT; SOAKING WET; HEADACHE ON THE RIGHT SIDE; This spontaneous report received from a patient unspecified age. The patient's height, and weight were not reported. The patient's past medical history included miscarriage, and concurrent conditions included anxiety, fainting, hazelnut allergy, Ceftin allergy, Alcoholic (drinks once a week), and non-smoker. The patient has 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: 1808980, and expiry: UNKNOWN) dose was not reported, one total, administered on 08-APR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. She fainted on occasion per her history. She felt numbness and felt hot and fainted 5 minutes after she received the vaccine. She experienced headaches on the right side, soreness, and soaking wet. She took ibuprofen and switch to aspirin yesterday. She still has the headaches come and go. She spoke with her doctor and was advised to go to the emergency room (ER) if symptoms continued. On 14-APR-2021, treatment medications included: Acetylsalicylic acid (Aspirin). Additional treatment medications (dates unspecified) included: Ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fainting, numbness, soreness, feeling extremely hot, and soaking wet, and had not recovered from headache on the right side. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210432537-Covid-19 vaccine ad26.cov2.s -Fainting. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Blood calcium increased, Blood pressure abnormal, Blood pressure measurement
Clinical narrative: FELT LIGHTHEADED; TINGLING IN HER FACE AND EXTREMITIES; UNABLE TO WALK; CALCIUM LEVELS WERE HIGH; ANXIETY; HYPERVENTILATED DURING SLEEP; BLOOD PRESSURE (BP) WAS OFF; HAND CONTRACTED; CHEST PAIN; CHEST TIGHTNESS; NUMBNESS IN EXTREMITIES AND FACE; SHORTNESS OF BREATH; FATIGUE; PAIN IN EXTREMITY; WEAKNESS; CHILLS; FEVER; MUSCLE ACHES; DECREASED ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING; This spontaneous report received from a consumer concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of report. The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced decreased ability to perform activities of daily living. On 10-APR-2021, the subject experienced pain in extremity. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced muscle aches. On 11-APR-2021, the subject experienced numbness in extremities and face. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced chest pain. On 12-APR-2021, the subject experienced chest tightness. On 14-APR-2021, the subject experienced hand contracted. On 14-APR-2021, the subject experienced blood pressure (bp) was off. Laboratory data included: Blood pressure (NR: not provided) BP was off, and Chest X-ray (NR: not provided) CLEAR. On 15-APR-2021, the subject experienced hyperventilated during sleep. On 16-APR-2021, the subject experienced calcium levels were high. On 16-APR-2021, the subject experienced anxiety. On 16-APR-2021, the subject experienced tingling in her face and extremities. On 16-APR-2021, the subject experienced unable to walk. Laboratory data included: Calcium increased (NR: not provided) Very High. On 18-APR-2021, the subject experienced felt lightheaded. Laboratory data included: MRI (NR: not provided) No clots in her chest or legs. Treatment medications (dates unspecified) included: warfarin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand contracted, and chills on APR-2021, and fever on 11-APR-2021, was recovering from shortness of breath, chest pain, chest tightness, hyperventilated during sleep, and calcium levels were high, had not recovered from numbness in extremities and face, fatigue, pain in extremity, weakness, anxiety, muscle aches and unable to walk, and the outcome of decreased ability to perform activities of daily living, blood pressure was off, tingling in her face and extremities and felt lightheaded was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest discomfort, Chest pain, Chills, Dizziness
Clinical narrative: FELT LIGHTHEADED; TINGLING IN HER FACE AND EXTREMITIES; UNABLE TO WALK; CALCIUM LEVELS WERE HIGH; ANXIETY; HYPERVENTILATED DURING SLEEP; BLOOD PRESSURE (BP) WAS OFF; HAND CONTRACTED; CHEST PAIN; CHEST TIGHTNESS; NUMBNESS IN EXTREMITIES AND FACE; SHORTNESS OF BREATH; FATIGUE; PAIN IN EXTREMITY; WEAKNESS; CHILLS; FEVER; MUSCLE ACHES; DECREASED ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING; This spontaneous report received from a consumer concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of report. The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced decreased ability to perform activities of daily living. On 10-APR-2021, the subject experienced pain in extremity. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced muscle aches. On 11-APR-2021, the subject experienced numbness in extremities and face. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced chest pain. On 12-APR-2021, the subject experienced chest tightness. On 14-APR-2021, the subject experienced hand contracted. On 14-APR-2021, the subject experienced blood pressure (bp) was off. Laboratory data included: Blood pressure (NR: not provided) BP was off, and Chest X-ray (NR: not provided) CLEAR. On 15-APR-2021, the subject experienced hyperventilated during sleep. On 16-APR-2021, the subject experienced calcium levels were high. On 16-APR-2021, the subject experienced anxiety. On 16-APR-2021, the subject experienced tingling in her face and extremities. On 16-APR-2021, the subject experienced unable to walk. Laboratory data included: Calcium increased (NR: not provided) Very High. On 18-APR-2021, the subject experienced felt lightheaded. Laboratory data included: MRI (NR: not provided) No clots in her chest or legs. Treatment medications (dates unspecified) included: warfarin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand contracted, and chills on APR-2021, and fever on 11-APR-2021, was recovering from shortness of breath, chest pain, chest tightness, hyperventilated during sleep, and calcium levels were high, had not recovered from numbness in extremities and face, fatigue, pain in extremity, weakness, anxiety, muscle aches and unable to walk, and the outcome of decreased ability to perform activities of daily living, blood pressure was off, tingling in her face and extremities and felt lightheaded was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Gait inability, Hyperventilation, Hypoaesthesia
Clinical narrative: FELT LIGHTHEADED; TINGLING IN HER FACE AND EXTREMITIES; UNABLE TO WALK; CALCIUM LEVELS WERE HIGH; ANXIETY; HYPERVENTILATED DURING SLEEP; BLOOD PRESSURE (BP) WAS OFF; HAND CONTRACTED; CHEST PAIN; CHEST TIGHTNESS; NUMBNESS IN EXTREMITIES AND FACE; SHORTNESS OF BREATH; FATIGUE; PAIN IN EXTREMITY; WEAKNESS; CHILLS; FEVER; MUSCLE ACHES; DECREASED ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING; This spontaneous report received from a consumer concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of report. The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced decreased ability to perform activities of daily living. On 10-APR-2021, the subject experienced pain in extremity. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced muscle aches. On 11-APR-2021, the subject experienced numbness in extremities and face. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced chest pain. On 12-APR-2021, the subject experienced chest tightness. On 14-APR-2021, the subject experienced hand contracted. On 14-APR-2021, the subject experienced blood pressure (bp) was off. Laboratory data included: Blood pressure (NR: not provided) BP was off, and Chest X-ray (NR: not provided) CLEAR. On 15-APR-2021, the subject experienced hyperventilated during sleep. On 16-APR-2021, the subject experienced calcium levels were high. On 16-APR-2021, the subject experienced anxiety. On 16-APR-2021, the subject experienced tingling in her face and extremities. On 16-APR-2021, the subject experienced unable to walk. Laboratory data included: Calcium increased (NR: not provided) Very High. On 18-APR-2021, the subject experienced felt lightheaded. Laboratory data included: MRI (NR: not provided) No clots in her chest or legs. Treatment medications (dates unspecified) included: warfarin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand contracted, and chills on APR-2021, and fever on 11-APR-2021, was recovering from shortness of breath, chest pain, chest tightness, hyperventilated during sleep, and calcium levels were high, had not recovered from numbness in extremities and face, fatigue, pain in extremity, weakness, anxiety, muscle aches and unable to walk, and the outcome of decreased ability to perform activities of daily living, blood pressure was off, tingling in her face and extremities and felt lightheaded was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: FELT LIGHTHEADED; TINGLING IN HER FACE AND EXTREMITIES; UNABLE TO WALK; CALCIUM LEVELS WERE HIGH; ANXIETY; HYPERVENTILATED DURING SLEEP; BLOOD PRESSURE (BP) WAS OFF; HAND CONTRACTED; CHEST PAIN; CHEST TIGHTNESS; NUMBNESS IN EXTREMITIES AND FACE; SHORTNESS OF BREATH; FATIGUE; PAIN IN EXTREMITY; WEAKNESS; CHILLS; FEVER; MUSCLE ACHES; DECREASED ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING; This spontaneous report received from a consumer concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of report. The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced decreased ability to perform activities of daily living. On 10-APR-2021, the subject experienced pain in extremity. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced muscle aches. On 11-APR-2021, the subject experienced numbness in extremities and face. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced chest pain. On 12-APR-2021, the subject experienced chest tightness. On 14-APR-2021, the subject experienced hand contracted. On 14-APR-2021, the subject experienced blood pressure (bp) was off. Laboratory data included: Blood pressure (NR: not provided) BP was off, and Chest X-ray (NR: not provided) CLEAR. On 15-APR-2021, the subject experienced hyperventilated during sleep. On 16-APR-2021, the subject experienced calcium levels were high. On 16-APR-2021, the subject experienced anxiety. On 16-APR-2021, the subject experienced tingling in her face and extremities. On 16-APR-2021, the subject experienced unable to walk. Laboratory data included: Calcium increased (NR: not provided) Very High. On 18-APR-2021, the subject experienced felt lightheaded. Laboratory data included: MRI (NR: not provided) No clots in her chest or legs. Treatment medications (dates unspecified) included: warfarin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand contracted, and chills on APR-2021, and fever on 11-APR-2021, was recovering from shortness of breath, chest pain, chest tightness, hyperventilated during sleep, and calcium levels were high, had not recovered from numbness in extremities and face, fatigue, pain in extremity, weakness, anxiety, muscle aches and unable to walk, and the outcome of decreased ability to perform activities of daily living, blood pressure was off, tingling in her face and extremities and felt lightheaded was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: ADVERSE REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: VISION TURNED ALL WHITE; ARM SORENESS; CHILLS; PAIN IN HIP JOINTS; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, administered on 10-APR-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 APR-2021, the subject experienced vision turned all white. On APR-2021, the subject experienced arm soreness. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced pain in hip joints. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness, fever, chills, pain in hip joints and vision turned all white was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest pain, Cough, Dyspnoea, Fatigue
Clinical narrative: SHORTNESS OF BREATH; CHEST PINCHING; FAST HEART BEAT; RASHES HAD REDNESS; RASHES AS ITCHY; RASHES ON CHEST AND BACK AS PAINFUL; EASILY GOT TIRED; FELT HEART WAS CONGESTED; COUGH; LITTLE BIT OF HEADACHE; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 150 pounds, and height was 170 centimeters. The patient's past medical history included low platelet, and bypass surgery, and concurrent conditions included rashes allergy, non drinker, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for low platelet. On 31-MAR-2021, the subject experienced little bit of headache. On APR-2021, the subject experienced felt heart was congested. On APR-2021, the subject experienced cough. On 12-APR-2021, the subject experienced shortness of breath. On 12-APR-2021, the subject experienced chest pinching. On 12-APR-2021, the subject experienced fast heart beat. On 12-APR-2021, the subject experienced rashes had redness. On 12-APR-2021, the subject experienced rashes as itchy. On 12-APR-2021, the subject experienced rashes on chest and back as painful. On 12-APR-2021, the subject experienced easily got tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little bit of headache on 01-APR-2021, had not recovered from shortness of breath, chest pinching, fast heart beat, rashes on chest and back as painful, easily got tired, rashes as itchy, and rashes had redness, and the outcome of felt heart was congested and cough was not reported. 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.