chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: chills; fever; headache; muscle pain; joint pain; arm hurts; nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of unknown age reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 13Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history included Covid19 last September and she received a plasma. The patient's concomitant medications were not reported. After receiving the first dose on 14Mar2021 the caller experienced chills, fever, headache, muscle pain, joint pain, arm hurts and she had nausea. She experienced this in two days. She was schedule for second dose on 10Apr which was more than 21 days, she wanted to know if she could still get the vaccine after those experiences. The event outcome was unknown.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: chills; fever; headache; muscle pain; joint pain; arm hurts; nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of unknown age reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 13Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history included Covid19 last September and she received a plasma. The patient's concomitant medications were not reported. After receiving the first dose on 14Mar2021 the caller experienced chills, fever, headache, muscle pain, joint pain, arm hurts and she had nausea. She experienced this in two days. She was schedule for second dose on 10Apr which was more than 21 days, she wanted to know if she could still get the vaccine after those experiences. The event outcome was unknown.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Culture wound, Debridement, Erythema, Induration, Injection site vesicles
Clinical narrative: Swelling,  infection,  oozing
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Ultrasound scan, Wound
Clinical narrative: Swelling,  infection,  oozing
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Infection, Skin weeping, Swelling
Clinical narrative: Swelling,  infection,  oozing
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Computerised tomogram abnormal, Computerised tomogram thorax, Dyspnoea, Muscle spasms
Clinical narrative: 59 yo m HTN, obesity directed to emergency department on 9/28/21 after CTA ordered by Primary Doctor secondary to shortness of breath x4 days revealed diffuse bilateral multifocal main segmental and subsegmental PE to all lobes with a slightly dilated pulmonary artery concerning for right heart strain.  Patient states his symptoms started abruptly 4 days ago, just prior to that he noticed a cramp in his left lower extremity.  He denies any significant swelling redness or pain to this leg.  He states he has had several outpatient eye surgeries over the last 2 months.  He denies any recent travel, active cancer, history of DVT or PE.  Patient does state he received a Johnson & Johnson Covid 19 vaccine on 9/9/2021.  He denies any fevers chills or flulike symptoms. CTA obtained 9/28/21 demonstrating Submassive PE with acute cor pulmonale  Echo demonstrates pulmonary hypertension with right heart strain 9/29/21 and follow up 9/30/21 with continued elevated PAP, although improved. Lower extremity venous duplex ultrasound demonstrates left leg femoral, popliteal, tibial, and peroneal vein DVT. Pt treated with heparin gtt and transitioned to DOAC
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary artery dilatation
Clinical narrative: 59 yo m HTN, obesity directed to emergency department on 9/28/21 after CTA ordered by Primary Doctor secondary to shortness of breath x4 days revealed diffuse bilateral multifocal main segmental and subsegmental PE to all lobes with a slightly dilated pulmonary artery concerning for right heart strain.  Patient states his symptoms started abruptly 4 days ago, just prior to that he noticed a cramp in his left lower extremity.  He denies any significant swelling redness or pain to this leg.  He states he has had several outpatient eye surgeries over the last 2 months.  He denies any recent travel, active cancer, history of DVT or PE.  Patient does state he received a Johnson & Johnson Covid 19 vaccine on 9/9/2021.  He denies any fevers chills or flulike symptoms. CTA obtained 9/28/21 demonstrating Submassive PE with acute cor pulmonale  Echo demonstrates pulmonary hypertension with right heart strain 9/29/21 and follow up 9/30/21 with continued elevated PAP, although improved. Lower extremity venous duplex ultrasound demonstrates left leg femoral, popliteal, tibial, and peroneal vein DVT. Pt treated with heparin gtt and transitioned to DOAC
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time shortened, Angiogram pulmonary abnormal, Anticoagulant therapy, Blood creatinine normal, Brain natriuretic peptide increased
Clinical narrative: 59 yo m HTN, obesity directed to emergency department on 9/28/21 after CTA ordered by Primary Doctor secondary to shortness of breath x4 days revealed diffuse bilateral multifocal main segmental and subsegmental PE to all lobes with a slightly dilated pulmonary artery concerning for right heart strain.  Patient states his symptoms started abruptly 4 days ago, just prior to that he noticed a cramp in his left lower extremity.  He denies any significant swelling redness or pain to this leg.  He states he has had several outpatient eye surgeries over the last 2 months.  He denies any recent travel, active cancer, history of DVT or PE.  Patient does state he received a Johnson & Johnson Covid 19 vaccine on 9/9/2021.  He denies any fevers chills or flulike symptoms. CTA obtained 9/28/21 demonstrating Submassive PE with acute cor pulmonale  Echo demonstrates pulmonary hypertension with right heart strain 9/29/21 and follow up 9/30/21 with continued elevated PAP, although improved. Lower extremity venous duplex ultrasound demonstrates left leg femoral, popliteal, tibial, and peroneal vein DVT. Pt treated with heparin gtt and transitioned to DOAC
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Cor pulmonale acute, Deep vein thrombosis, Dyspnoea, Echocardiogram abnormal
Clinical narrative: 59 yo m HTN, obesity directed to emergency department on 9/28/21 after CTA ordered by Primary Doctor secondary to shortness of breath x4 days revealed diffuse bilateral multifocal main segmental and subsegmental PE to all lobes with a slightly dilated pulmonary artery concerning for right heart strain.  Patient states his symptoms started abruptly 4 days ago, just prior to that he noticed a cramp in his left lower extremity.  He denies any significant swelling redness or pain to this leg.  He states he has had several outpatient eye surgeries over the last 2 months.  He denies any recent travel, active cancer, history of DVT or PE.  Patient does state he received a Johnson & Johnson Covid 19 vaccine on 9/9/2021.  He denies any fevers chills or flulike symptoms. CTA obtained 9/28/21 demonstrating Submassive PE with acute cor pulmonale  Echo demonstrates pulmonary hypertension with right heart strain 9/29/21 and follow up 9/30/21 with continued elevated PAP, although improved. Lower extremity venous duplex ultrasound demonstrates left leg femoral, popliteal, tibial, and peroneal vein DVT. Pt treated with heparin gtt and transitioned to DOAC
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin normal, International normalised ratio normal, Muscle spasms, Platelet count decreased, Prothrombin time shortened
Clinical narrative: 59 yo m HTN, obesity directed to emergency department on 9/28/21 after CTA ordered by Primary Doctor secondary to shortness of breath x4 days revealed diffuse bilateral multifocal main segmental and subsegmental PE to all lobes with a slightly dilated pulmonary artery concerning for right heart strain.  Patient states his symptoms started abruptly 4 days ago, just prior to that he noticed a cramp in his left lower extremity.  He denies any significant swelling redness or pain to this leg.  He states he has had several outpatient eye surgeries over the last 2 months.  He denies any recent travel, active cancer, history of DVT or PE.  Patient does state he received a Johnson & Johnson Covid 19 vaccine on 9/9/2021.  He denies any fevers chills or flulike symptoms. CTA obtained 9/28/21 demonstrating Submassive PE with acute cor pulmonale  Echo demonstrates pulmonary hypertension with right heart strain 9/29/21 and follow up 9/30/21 with continued elevated PAP, although improved. Lower extremity venous duplex ultrasound demonstrates left leg femoral, popliteal, tibial, and peroneal vein DVT. Pt treated with heparin gtt and transitioned to DOAC
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary arterial pressure increased, Pulmonary artery dilatation, Pulmonary embolism, Pulmonary hypertension, SARS-CoV-2 antibody test negative
Clinical narrative: 59 yo m HTN, obesity directed to emergency department on 9/28/21 after CTA ordered by Primary Doctor secondary to shortness of breath x4 days revealed diffuse bilateral multifocal main segmental and subsegmental PE to all lobes with a slightly dilated pulmonary artery concerning for right heart strain.  Patient states his symptoms started abruptly 4 days ago, just prior to that he noticed a cramp in his left lower extremity.  He denies any significant swelling redness or pain to this leg.  He states he has had several outpatient eye surgeries over the last 2 months.  He denies any recent travel, active cancer, history of DVT or PE.  Patient does state he received a Johnson & Johnson Covid 19 vaccine on 9/9/2021.  He denies any fevers chills or flulike symptoms. CTA obtained 9/28/21 demonstrating Submassive PE with acute cor pulmonale  Echo demonstrates pulmonary hypertension with right heart strain 9/29/21 and follow up 9/30/21 with continued elevated PAP, although improved. Lower extremity venous duplex ultrasound demonstrates left leg femoral, popliteal, tibial, and peroneal vein DVT. Pt treated with heparin gtt and transitioned to DOAC
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin, Ultrasound Doppler abnormal
Clinical narrative: 59 yo m HTN, obesity directed to emergency department on 9/28/21 after CTA ordered by Primary Doctor secondary to shortness of breath x4 days revealed diffuse bilateral multifocal main segmental and subsegmental PE to all lobes with a slightly dilated pulmonary artery concerning for right heart strain.  Patient states his symptoms started abruptly 4 days ago, just prior to that he noticed a cramp in his left lower extremity.  He denies any significant swelling redness or pain to this leg.  He states he has had several outpatient eye surgeries over the last 2 months.  He denies any recent travel, active cancer, history of DVT or PE.  Patient does state he received a Johnson & Johnson Covid 19 vaccine on 9/9/2021.  He denies any fevers chills or flulike symptoms. CTA obtained 9/28/21 demonstrating Submassive PE with acute cor pulmonale  Echo demonstrates pulmonary hypertension with right heart strain 9/29/21 and follow up 9/30/21 with continued elevated PAP, although improved. Lower extremity venous duplex ultrasound demonstrates left leg femoral, popliteal, tibial, and peroneal vein DVT. Pt treated with heparin gtt and transitioned to DOAC
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Angina pectoris, Chest pain, Dysstasia
Clinical narrative: FACIAL SWELLING; LEG SWELLING; SEVERE VERTIGO; IRREGULAR HEART RHYTHM; CHEST PAIN; STOMACH PAIN; SEVERE ABDOMINAL PAIN; BLURRED VISION; COULDN'T STAND ON FEET; NUMBNESS IN LEFT SHOULDER/NUMBNESS BEHIND NECK/COULDN'T FEEL THE RIGHT HALF OF HEAD; SEVERE AND PERSISTENT HEADACHE; SHARP AND STEADY HEART PAIN; GENERAL NORMAL SIDE EFFECTS; This spontaneous report received from a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no allergies to medication or food at the time of vaccination. The patient had taken no medication or supplements before, at the time or after vaccination. The patient had no other illnesses at the time of vaccination. The patient had no chronic or long-standing health condition at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 25-SEP-2021:13:35 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021 after receiving the vaccination, patient experienced general normal side effects for two days. On 27-SEP-2021 at 08:00 AM, the patient started to have severe reaction including facial swelling, leg swelling, severe vertigo, irregular heart rhythm problem with sharp and steady heart pain, severe and persistent headache, chest pain, stomach pain, severe abdominal pain, blurred vision, numbness in left shoulder, numbness behind neck and she couldn't feel the right half of her head, and also the patient couldn't stand on her feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general normal side effects on 27-SEP-2021, and the outcome of facial swelling, leg swelling, severe vertigo, irregular heart rhythm, sharp and steady heart pain, numbness in left shoulder/numbness behind neck/couldn't feel the right half of head, severe and persistent headache, chest pain, stomach pain, severe abdominal pain, blurred vision and couldn't stand on feet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210958258-covid-19 vaccine ad26.cov2.s - sharp and steady heart pain. 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: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate irregular, Hypoaesthesia, Peripheral swelling, Swelling face
Clinical narrative: FACIAL SWELLING; LEG SWELLING; SEVERE VERTIGO; IRREGULAR HEART RHYTHM; CHEST PAIN; STOMACH PAIN; SEVERE ABDOMINAL PAIN; BLURRED VISION; COULDN'T STAND ON FEET; NUMBNESS IN LEFT SHOULDER/NUMBNESS BEHIND NECK/COULDN'T FEEL THE RIGHT HALF OF HEAD; SEVERE AND PERSISTENT HEADACHE; SHARP AND STEADY HEART PAIN; GENERAL NORMAL SIDE EFFECTS; This spontaneous report received from a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no allergies to medication or food at the time of vaccination. The patient had taken no medication or supplements before, at the time or after vaccination. The patient had no other illnesses at the time of vaccination. The patient had no chronic or long-standing health condition at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 25-SEP-2021:13:35 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021 after receiving the vaccination, patient experienced general normal side effects for two days. On 27-SEP-2021 at 08:00 AM, the patient started to have severe reaction including facial swelling, leg swelling, severe vertigo, irregular heart rhythm problem with sharp and steady heart pain, severe and persistent headache, chest pain, stomach pain, severe abdominal pain, blurred vision, numbness in left shoulder, numbness behind neck and she couldn't feel the right half of her head, and also the patient couldn't stand on her feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general normal side effects on 27-SEP-2021, and the outcome of facial swelling, leg swelling, severe vertigo, irregular heart rhythm, sharp and steady heart pain, numbness in left shoulder/numbness behind neck/couldn't feel the right half of head, severe and persistent headache, chest pain, stomach pain, severe abdominal pain, blurred vision and couldn't stand on feet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210958258-covid-19 vaccine ad26.cov2.s - sharp and steady heart pain. 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: U
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vision blurred
Clinical narrative: FACIAL SWELLING; LEG SWELLING; SEVERE VERTIGO; IRREGULAR HEART RHYTHM; CHEST PAIN; STOMACH PAIN; SEVERE ABDOMINAL PAIN; BLURRED VISION; COULDN'T STAND ON FEET; NUMBNESS IN LEFT SHOULDER/NUMBNESS BEHIND NECK/COULDN'T FEEL THE RIGHT HALF OF HEAD; SEVERE AND PERSISTENT HEADACHE; SHARP AND STEADY HEART PAIN; GENERAL NORMAL SIDE EFFECTS; This spontaneous report received from a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no allergies to medication or food at the time of vaccination. The patient had taken no medication or supplements before, at the time or after vaccination. The patient had no other illnesses at the time of vaccination. The patient had no chronic or long-standing health condition at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 25-SEP-2021:13:35 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021 after receiving the vaccination, patient experienced general normal side effects for two days. On 27-SEP-2021 at 08:00 AM, the patient started to have severe reaction including facial swelling, leg swelling, severe vertigo, irregular heart rhythm problem with sharp and steady heart pain, severe and persistent headache, chest pain, stomach pain, severe abdominal pain, blurred vision, numbness in left shoulder, numbness behind neck and she couldn't feel the right half of her head, and also the patient couldn't stand on her feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general normal side effects on 27-SEP-2021, and the outcome of facial swelling, leg swelling, severe vertigo, irregular heart rhythm, sharp and steady heart pain, numbness in left shoulder/numbness behind neck/couldn't feel the right half of head, severe and persistent headache, chest pain, stomach pain, severe abdominal pain, blurred vision and couldn't stand on feet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210958258-covid-19 vaccine ad26.cov2.s - sharp and steady heart pain. 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: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Adverse drug reaction, Angina pectoris, Chest pain
Clinical narrative: FACIAL SWELLING; LEG SWELLING; SEVERE VERTIGO; IRREGULAR HEART RHYTHM; CHEST PAIN; STOMACH PAIN; SEVERE ABDOMINAL PAIN; BLURRED VISION; COULDN'T STAND ON FEET; NUMBNESS IN LEFT SHOULDER/NUMBNESS BEHIND NECK/COULDN'T FEEL THE RIGHT HALF OF HEAD; SEVERE AND PERSISTENT HEADACHE; SHARP AND STEADY HEART PAIN; GENERAL NORMAL SIDE EFFECTS; This spontaneous report received from a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no allergies to medication or food at the time of vaccination. The patient had taken no medication or supplements before, at the time or after vaccination. The patient had no other illnesses at the time of vaccination. The patient had no chronic or long-standing health condition at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 25-SEP-2021:13:35 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021 after receiving the vaccination, patient experienced general normal side effects for two days. On 27-SEP-2021 at 08:00 AM, the patient started to have severe reaction including facial swelling, leg swelling, severe vertigo, irregular heart rhythm problem with sharp and steady heart pain, severe and persistent headache, chest pain, stomach pain, severe abdominal pain, blurred vision, numbness in left shoulder, numbness behind neck and she couldn't feel the right half of her head, and also the patient couldn't stand on her feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general normal side effects on 27-SEP-2021, and the outcome of facial swelling, leg swelling, severe vertigo, irregular heart rhythm, sharp and steady heart pain, numbness in left shoulder/numbness behind neck/couldn't feel the right half of head, severe and persistent headache, chest pain, stomach pain, severe abdominal pain, blurred vision and couldn't stand on feet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210958258-covid-19 vaccine ad26.cov2.s - sharp and steady heart pain. 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: U
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Headache, Heart rate irregular, Hypoaesthesia, Peripheral swelling
Clinical narrative: FACIAL SWELLING; LEG SWELLING; SEVERE VERTIGO; IRREGULAR HEART RHYTHM; CHEST PAIN; STOMACH PAIN; SEVERE ABDOMINAL PAIN; BLURRED VISION; COULDN'T STAND ON FEET; NUMBNESS IN LEFT SHOULDER/NUMBNESS BEHIND NECK/COULDN'T FEEL THE RIGHT HALF OF HEAD; SEVERE AND PERSISTENT HEADACHE; SHARP AND STEADY HEART PAIN; GENERAL NORMAL SIDE EFFECTS; This spontaneous report received from a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no allergies to medication or food at the time of vaccination. The patient had taken no medication or supplements before, at the time or after vaccination. The patient had no other illnesses at the time of vaccination. The patient had no chronic or long-standing health condition at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 25-SEP-2021:13:35 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021 after receiving the vaccination, patient experienced general normal side effects for two days. On 27-SEP-2021 at 08:00 AM, the patient started to have severe reaction including facial swelling, leg swelling, severe vertigo, irregular heart rhythm problem with sharp and steady heart pain, severe and persistent headache, chest pain, stomach pain, severe abdominal pain, blurred vision, numbness in left shoulder, numbness behind neck and she couldn't feel the right half of her head, and also the patient couldn't stand on her feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general normal side effects on 27-SEP-2021, and the outcome of facial swelling, leg swelling, severe vertigo, irregular heart rhythm, sharp and steady heart pain, numbness in left shoulder/numbness behind neck/couldn't feel the right half of head, severe and persistent headache, chest pain, stomach pain, severe abdominal pain, blurred vision and couldn't stand on feet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210958258-covid-19 vaccine ad26.cov2.s - sharp and steady heart pain. 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: U
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Vertigo, Vision blurred
Clinical narrative: FACIAL SWELLING; LEG SWELLING; SEVERE VERTIGO; IRREGULAR HEART RHYTHM; CHEST PAIN; STOMACH PAIN; SEVERE ABDOMINAL PAIN; BLURRED VISION; COULDN'T STAND ON FEET; NUMBNESS IN LEFT SHOULDER/NUMBNESS BEHIND NECK/COULDN'T FEEL THE RIGHT HALF OF HEAD; SEVERE AND PERSISTENT HEADACHE; SHARP AND STEADY HEART PAIN; GENERAL NORMAL SIDE EFFECTS; This spontaneous report received from a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no allergies to medication or food at the time of vaccination. The patient had taken no medication or supplements before, at the time or after vaccination. The patient had no other illnesses at the time of vaccination. The patient had no chronic or long-standing health condition at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 25-SEP-2021:13:35 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021 after receiving the vaccination, patient experienced general normal side effects for two days. On 27-SEP-2021 at 08:00 AM, the patient started to have severe reaction including facial swelling, leg swelling, severe vertigo, irregular heart rhythm problem with sharp and steady heart pain, severe and persistent headache, chest pain, stomach pain, severe abdominal pain, blurred vision, numbness in left shoulder, numbness behind neck and she couldn't feel the right half of her head, and also the patient couldn't stand on her feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general normal side effects on 27-SEP-2021, and the outcome of facial swelling, leg swelling, severe vertigo, irregular heart rhythm, sharp and steady heart pain, numbness in left shoulder/numbness behind neck/couldn't feel the right half of head, severe and persistent headache, chest pain, stomach pain, severe abdominal pain, blurred vision and couldn't stand on feet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210958258-covid-19 vaccine ad26.cov2.s - sharp and steady heart pain. 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: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Fever 102.1, Headache, Body Ache, Nausea and vomiting, Took Benadryl 25mg, Tylenol 500mg 3 times 6 hrs apart. Fever broke Oct 1st, 08:00
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever 102.1, Headache, Body Ache, Nausea and vomiting, Took Benadryl 25mg, Tylenol 500mg 3 times 6 hrs apart. Fever broke Oct 1st, 08:00
Age: 51.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; Caller stated a 51 year old female patient received the first dose of the vaccine on 08-APR-2021; This spontaneous report was received from a Nurse Prescriber concerning a 51-year-old female patient. Her concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported.  On 08-APR-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter (mL) as prophylaxis (route of administration, lot number, expiration date and site of administration were not provided) (inappropriate age at vaccine administration). It was reported that the patient did not receive the second dose within the two month period. No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Depression, Fatigue, Hemiparesis, Hypoaesthesia
Clinical narrative: multiple sclerosis; serious neurological issues; issues with left leg; numbness on left side; depression; constant pain; fatigue; anxiety; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or about 30-OCT-2015, the patient was administered zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions by a healthcare provider. Subsequently, on an unknown date, the pt was treated by unspecified providers, for the following injuries resulting from the pt's use of zoster vaccine live (ZOSTAVAX): serious neurological issues, issues with left leg, fatigue, constant pain and numbness on left side, depression, anxiety and multiple sclerosis. The outcome of the events was not reported. The reporter considered all events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of multiple sclerosis was determined to be medically significant. The event of nervous system disorder was considered serious by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort, Multiple sclerosis, Neurological symptom, Pain
Clinical narrative: multiple sclerosis; serious neurological issues; issues with left leg; numbness on left side; depression; constant pain; fatigue; anxiety; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or about 30-OCT-2015, the patient was administered zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions by a healthcare provider. Subsequently, on an unknown date, the pt was treated by unspecified providers, for the following injuries resulting from the pt's use of zoster vaccine live (ZOSTAVAX): serious neurological issues, issues with left leg, fatigue, constant pain and numbness on left side, depression, anxiety and multiple sclerosis. The outcome of the events was not reported. The reporter considered all events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of multiple sclerosis was determined to be medically significant. The event of nervous system disorder was considered serious by the reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AEs reported; dose of expired M-M-R II was administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions, or allergies was reported.  On 21-SEP-2021, an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) (lot number S028916 has been verified to be valid, expiration date reported and validated as 16-SEP-2021) was administered to the patient, at a dose of 0.5 milliliter (ml), subcutaneously (dose number, vaccination scheme, and anatomical location of vaccination were not reported) as prophylaxis (expired product administered). No additional adverse events (AEs) were reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; products experienced an excursion/have been administered to patients; This spontaneous report was received from a nurse referring to an 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose (Lot# U015682 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX), expiration date reported as 18-MAY-2023) (strength, dose, route, frequency, were not provided) for prophylaxis.  The nurse reported that the vaccine experienced an excursion of 4 Celsius degrees (C) from -10 C to 8 C for 20 minutes on 07-SEP-2021 during the transport; and of 4C from -10 C to 8 C for 20 minutes on 09-SEP-2021, again during transport. Previous temperature excursion included from -10°C to 8°C (4C) for 7 hours and 30 minutes. And no adverse events were reported.  This is one of 26 reports received from the same source.; Sender's Comments:  US-009507513-2109USA005628:
Age: 0.5
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's reported; temperature excursion for VARlVAX / have been administered to the patients; This spontaneous report was received from a registered nurse and refers to a 6-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 17-SEP-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot# U015682 verified as valid, with expiration date:18-MAY-2023) in dose: 1 (units not provided) for prophylaxis (exact dose, dose number, route of administration and anatomical location were not reported).  The temperature to which the vaccine was exposed was -10C to 8C (4 degrees of Celsius (C)) for 20 minutes on 07-SEP-2021 during the transport, and -10C to 8C (4 degrees of Celsius (C)) for 20 minutes on 09-SEP-2021 also during the transport. The vaccine underwent previous temperature excursion of temperature -10C to 8C ( 4C) for 7 hours and 30 minutes.   It was unknown if a digital data logger was involved. No adverse symptoms were reported. The outcome of product storage error was unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA005628:
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient is fine with no issues at all; Patient was inadvertently and concomitantly administered PROQUAD in combination with the intended subcutaneously administered VARIVAX on 09/09/2021; This spontaneous report was received from a nurse referring to a 14-year-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 09-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), subcutaneous (dose, lot number and expiration date not reported) and inadvertently was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, reoute of administration, lot number and expiration date were not provided) both for prophylaxis (accidental overdose). The patient was fine with no issues at all (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; MMRII Expired / Administered; inappropriate age at vaccination; This spontaneous report was received from a registered nurse and refers to potentially 6-day-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 24-SEP-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) lot # S029455, expiration date 19-SEP-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (inappropriate age at vaccine administration). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported; VARlVAX was administered to four patient; This spontaneous report was received from a medical assitant refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 13-AUG-2021, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number T010314, expiration date 24-MAR-2022 (dose and route of administration not provided) for prophylaxis. No adverse event was reported.  The vaccine underwent a temperature excursion of -13 dregrees Celsius for 1 hour and 30 minutes. There were no previous temperature excursions.  This is one of four cases reported by the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported; VARlVAX was administered to four patient; This spontaneous report was received from a medical assitant refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 26-AUG-2021, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number T010314, expiration date 24-MAR-2022 (dose and route of administration not provided) for prophylaxis. No adverse event was reported.  The vaccine underwent a temperature excursion of -13 dregrees Celsius for 1 hour and 30 minutes. There were no previous temperature excursions.  This is one of four cases reported by the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported; VARlVAX was administered to four patient; This spontaneous report was received from a medical assitant refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 01-SEP-2021, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number U002400, expiration date 22-JAN-2023 (dose and route of administration not provided) for prophylaxis. No adverse event was reported.  The vaccine underwent a temperature excursion of -13 dregrees Celsius for 1 hour and 30 minutes. There were no previous temperature excursions.  This is one of four cases reported by the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported; VARlVAX was administered to four patient; This spontaneous report was received from a medical assitant refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 20-AUG-2021, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number U002400, expiration date 22-JAN-2023 (dose and route of administration not provided) for prophylaxis. No adverse event was reported.  The vaccine underwent a temperature excursion of -13 dregrees Celsius for 1 hour and 30 minutes. There were no previous temperature excursions.  This is one of four cases reported by the same reporter.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a Licensed Practical Nurse (LPN) concerning a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies or reactions, and concomitant medications were not reported.   On 10-SEP-2021, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) had a temperature excursion with a temperature of 48.7 Fahrenheit degrees during a timeframe of 10 minutes, then both vaccines were improperly stored. On 13-SEP-2021, the patient was vaccinated with the improperly stored vaccines (product storage error) which included: rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number 1707460 with expiration date on 14-MAR-2022 and also with Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot number T026961 with expiration date on 02-APR-2023 both as prophylaxis; strength, dose, and route of administration were not reported for the vaccines. Previous temperature excursions were not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 21-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U015689 had been verified to be a valid number; expiration date 18-MAY-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007192: US-009507513-2109USA007193: US-009507513-2109USA007194: US-009507513-2109USA007195: US-009507513-2109USA007196: US-009507513-2109USA007197: US-009507513-2109USA007198: US-009507513-2109USA007199:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 22-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U015689 had been verified to be a valid number; expiration date 18-MAY-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007144:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 23-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U015689 had been verified to be a valid number; expiration date 18-MAY-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007144:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 23-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U015689 had been verified to be a valid number; expiration date 18-MAY-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007144:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 24-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U015689 had been verified to be a valid number; expiration date 18-MAY-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007144: