chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 1st dose of Shingrix on 23Sep2020, 2nd dose on 19Nov2020, and a 3rd dose today (20May2021); This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on 23rd September 2020) and Shingrix with an associated reaction of no adverse event (2nd dose received on 19th November 2020). On 20th May 2021, the patient received the 3rd dose of Shingrix. On 20th May 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional details were provided as follows: The doctor reported that the patient received 3 doses of Shingrix, which led to extra dose administered. No symptoms was reported. No further information was reported. The reporter consented to follow up. The HCP  did not have lot number/expiry date.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: a child received an adult dose of Havrix; a child received an adult dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 5-year-old female patient who received HAV (Havrix adult) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th April 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 8th April 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an adult dose of Havrix, which led to overdose and adult product administered to child. No symptoms reported. The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: patient who received a dose of Menveo / was reconstituted on 14May2021   / stored in the refrigerator until 17May2021 when it was finally administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA549A, expiry date 28th February 2022) for prophylaxis.   On 14th May 2021, the patient received Menveo. On 14th May 2021, unknown after receiving Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: On 14th May 2021, a dose of Menveo was reconstituted and stored in the refrigerator which led to incorrect storage of drug. On 17th May 2021, the reconstituted vaccine was administered to the patient. The reporter consented to follow up via email.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: administered an pediatric dose of Havrix to a 20 year old patient; administered an pediatric dose of Havrix to a 20 year old patient; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 19-year-old female patient who received HAV (Havrix pediatric) (batch number K5FA5, expiry date 12th June 2021) for prophylaxis.   On 20th May 2021, the patient received Havrix pediatric. On 20th May 2021, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional information was provided as follows: The patient received vaccination in left deltoid region. The reporter called to inform that a pediatric dose of Havrix was administered to an adult which led to underdose and adult use of a child product. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the second dose of Shingrix/first dose 06Jun2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th June 2019, batch number 739K3).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received the 2nd dose of the Shingrix vaccine which led to incomplete course of vaccination. No expiration date was reported. The HCP (healthcare professional) consented to follow up via email.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: patient is coming in to get a second dose/first dose almost 2 years ago (7/17/2019).; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th July 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient had received 1st dose of Shingrix almost 2 years ago, till the time of reporting the patient did not receive 2nd dose which led to incomplete course of vaccination. Pharmacist was unable to provide vaccine details. The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Dizziness, Feeling abnormal, Nausea
Clinical narrative: DIZZINESS; NO APPETITE; WEIGHT LOSS; STOMACH PAIN; FEELING OFF; EXTREME NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-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 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced no appetite. On 01-APR-2021, the subject experienced weight loss. On 01-APR-2021, the subject experienced stomach pain. On 01-APR-2021, the subject experienced feeling off. On 01-APR-2021, the subject experienced extreme nausea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from dizziness, extreme nausea, no appetite, weight loss, stomach pain, and feeling off. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: DIZZINESS; NO APPETITE; WEIGHT LOSS; STOMACH PAIN; FEELING OFF; EXTREME NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-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 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced no appetite. On 01-APR-2021, the subject experienced weight loss. On 01-APR-2021, the subject experienced stomach pain. On 01-APR-2021, the subject experienced feeling off. On 01-APR-2021, the subject experienced extreme nausea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from dizziness, extreme nausea, no appetite, weight loss, stomach pain, and feeling off. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthropathy, Chest pain, Emotional distress, Headache, Hypoaesthesia
Clinical narrative: CHEST PAIN; TINGLING; SWELLING; NUMBNESS; MOBILITY ISSUE; SHOULDER ISSUE; STIFFNESS IN LEFT SIDE OF NECK/STIFFNESS; SWELLING IN LEFT LEG; EMOTIONAL DISTRESS/SUFFERING; PAIN; EXTREME HEADACHE; 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  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced chest pain, tingling, swelling, numbness, mobility issue, shoulder issue, stiffness in left side of neck/stiffness, swelling in left leg, emotional distress/suffering, pain, and extreme headache. The action taken with covid-19 vaccine was not applicable. The outcome of the tingling, stiffness in left side of neck/stiffness, swelling in left leg, extreme headache, chest pain, emotional distress/suffering, pain, numbness, swelling, mobility issue and shoulder issue 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: Mobility decreased, Musculoskeletal stiffness, Pain, Paraesthesia, Peripheral swelling
Clinical narrative: CHEST PAIN; TINGLING; SWELLING; NUMBNESS; MOBILITY ISSUE; SHOULDER ISSUE; STIFFNESS IN LEFT SIDE OF NECK/STIFFNESS; SWELLING IN LEFT LEG; EMOTIONAL DISTRESS/SUFFERING; PAIN; EXTREME HEADACHE; 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  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced chest pain, tingling, swelling, numbness, mobility issue, shoulder issue, stiffness in left side of neck/stiffness, swelling in left leg, emotional distress/suffering, pain, and extreme headache. The action taken with covid-19 vaccine was not applicable. The outcome of the tingling, stiffness in left side of neck/stiffness, swelling in left leg, extreme headache, chest pain, emotional distress/suffering, pain, numbness, swelling, mobility issue and shoulder issue 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: Swelling
Clinical narrative: CHEST PAIN; TINGLING; SWELLING; NUMBNESS; MOBILITY ISSUE; SHOULDER ISSUE; STIFFNESS IN LEFT SIDE OF NECK/STIFFNESS; SWELLING IN LEFT LEG; EMOTIONAL DISTRESS/SUFFERING; PAIN; EXTREME HEADACHE; 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  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced chest pain, tingling, swelling, numbness, mobility issue, shoulder issue, stiffness in left side of neck/stiffness, swelling in left leg, emotional distress/suffering, pain, and extreme headache. The action taken with covid-19 vaccine was not applicable. The outcome of the tingling, stiffness in left side of neck/stiffness, swelling in left leg, extreme headache, chest pain, emotional distress/suffering, pain, numbness, swelling, mobility issue and shoulder issue 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
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: FULL BODY FATIGUE; MILD HEADACHE; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 165 pounds, and height was 165 centimeters.  The patient's concurrent conditions included alcohol use, smoker, chronic pain, scoliosis of the 4 lower vertebrae, high anxiety, and marijuana addiction. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included fentanyl citrate for high anxiety, lorazepam for high anxiety, gabapentin for pain, and scoliosis, and cyanocobalamin for scoliosis, and back ache.  On 12-MAR-2021, the subject experienced mild headache. On 13-MAR-2021, the subject experienced full body fatigue. The action taken with covid-19 vaccine  was not applicable. The patient recovered from mild headache on 12-MAR-2021, and had not recovered from full body fatigue. 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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Pain, Pyrexia
Clinical narrative: SEVERE MIGRAINE; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a consumer/non healthcare professional (patient's mother) concerned a 22 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: Unknown) dose was not reported, frequency 1 total, administered on 07-APR-2021  Vaccination site was left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced body aches, chills, weakness. fever and severe headache with eye involvement. Patient was taken to the Emergency Room and was told that the vaccine caused a severe migraine. The reporter sought compensation of patient's medical bills. Patient was hospitalized and discharged on 30-APR-2021. Patient was hospitalized for 1 day. Patient was hospitalized on 30-APR-2021. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from body aches, chills, and fever on 2021, and the outcome of severe migraine was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210539285-COVID-19 VACCINE AD26.COV2.S- severe migraine, body aches. 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). 20210539285-COVID-19 VACCINE AD26.COV2.S- chills, fever. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Erythema, Hypoaesthesia, Magnetic resonance imaging head, Pain in extremity
Clinical narrative: BLOOD CLOTS IN BOTH ARMS; NUMBNESS IN BILATERAL ARMS; REDNESS ON BOTH LEGS; SWELLING OF BOTH LEGS; PAIN IN BOTH LEGS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer. The patient experienced drug allergy when treated with hydrocodone, and oxycodone 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: 1805029, and expiry: unknown) dose was not reported, 1 total administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in 2021, the patient felt numbness on both arms. Numbness got worse and patient went to emergency room. On an unspecified date in 2021, Laboratory data included: MRI brain results of which were pending. On an unspecified date in MAR-2021, a week after the vaccination patient went to emergency room due to redness, swelling, and pain on both legs. The doctor prescribed antibiotics which relieved those symptoms and was encouraged to get blood circulation assessed once patient returned to home. On 17-MAY-2021, patient got hospitalized, and on same day, ultrasound test showed a blood clot in each arm. Patient underwent chest X-ray and a test with and without contrast for the lungs. It was reported that patient was started on anticoagulants and physical therapy. On 18-MAY-2021, ultrasound of legs was negative for blood clots. On 19-MAY-2021, test in a machine with and without contrast to look at lungs (Lung scan) was within normal limits. On 19-MAY-2021, the patient got discharged from hospital. Patient stated that, consulted two doctors if it may have been the Janssen covid-19 vaccine that caused this and doctors said possibly and recommended that patient should report the information.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness on both legs, swelling of both legs, and numbness in bilateral arms, and had not recovered from pain in both legs, and blood clots in both arms. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540231-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOTS IN BOTH ARMS, NUMBNESS IN BILATERAL ARMS. 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
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis, Ultrasound scan, Ventilation/perfusion scan
Clinical narrative: BLOOD CLOTS IN BOTH ARMS; NUMBNESS IN BILATERAL ARMS; REDNESS ON BOTH LEGS; SWELLING OF BOTH LEGS; PAIN IN BOTH LEGS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer. The patient experienced drug allergy when treated with hydrocodone, and oxycodone 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: 1805029, and expiry: unknown) dose was not reported, 1 total administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in 2021, the patient felt numbness on both arms. Numbness got worse and patient went to emergency room. On an unspecified date in 2021, Laboratory data included: MRI brain results of which were pending. On an unspecified date in MAR-2021, a week after the vaccination patient went to emergency room due to redness, swelling, and pain on both legs. The doctor prescribed antibiotics which relieved those symptoms and was encouraged to get blood circulation assessed once patient returned to home. On 17-MAY-2021, patient got hospitalized, and on same day, ultrasound test showed a blood clot in each arm. Patient underwent chest X-ray and a test with and without contrast for the lungs. It was reported that patient was started on anticoagulants and physical therapy. On 18-MAY-2021, ultrasound of legs was negative for blood clots. On 19-MAY-2021, test in a machine with and without contrast to look at lungs (Lung scan) was within normal limits. On 19-MAY-2021, the patient got discharged from hospital. Patient stated that, consulted two doctors if it may have been the Janssen covid-19 vaccine that caused this and doctors said possibly and recommended that patient should report the information.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness on both legs, swelling of both legs, and numbness in bilateral arms, and had not recovered from pain in both legs, and blood clots in both arms. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540231-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOTS IN BOTH ARMS, NUMBNESS IN BILATERAL ARMS. 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
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE BEING AT ROOM TEMPERATURE FOR OVER 2 HOURS AFTER FIRST PUNCTURE; ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced administration of expired vaccine. On an unspecified date, the subject experienced vaccine being at room temperature for over 2 hours after first puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and vaccine being at room temperature for over 2 hours after first puncture was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POOR QUALITY VACCINE ADMINISTERED; VACCINE AFTER BEING AT ROOM TEMPERATURE FOR OVER 2 HOURS AFTER FIRST PUNCTURE; This spontaneous report received from a health care professional 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, intramuscular, batch number: 205A21A, and batch number: 205A21A expiry: 23/JUNE/2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced vaccine after being at room temperature for over 2 hours after first puncture. On an unspecified date, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality vaccine administered and vaccine after being at room temperature for over 2 hours after first puncture was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545147.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE; FEELING TIRED; 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: 1816022, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and feeling tired was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Chest X-ray, Computerised tomogram, Dizziness
Clinical narrative: LEFT SIDED WEAKNESS; HEART PALPITATIONS; DIZZINESS AND FEELING FAINT; UNABLE TO LIFT LEGS TO GO UPSTAIRS; FATIGUE; WEAKNESS; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAY-2021, the patient experienced dizziness, heart palpitations during weeding outside, had fatigue and was feeling faint. On 08-MAY-2021, the patient was also unable to lift legs to go upstairs. On 12-MAY-2021, the patient experienced left sided weakness. On 20-MAY-2021, the patient visited the emergency room or department for treatment of the events and this was the second time of weakness.  On 20-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not reported, computed tomography scan (NR: not provided) No stroke and no blood clot, Chest X-ray (NR: not provided) Not reported, electrocardiogram 12 lead (ECG) (NR: not provided) Not reported, Investigation (NR: not provided) Not reported, and Magnetic resonance imaging (NR: not provided) No stroke and no blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and had not recovered from left sided weakness, heart palpitations, dizziness and feeling faint, unable to lift legs to go upstairs, and weakness. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000180437.; Sender's Comments: V0:20210544480-Covid-19 vaccine ad26.cov2.s-Left sided weakness. This event is considered unassessable. The event 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Hemiparesis, Investigation, Magnetic resonance imaging
Clinical narrative: LEFT SIDED WEAKNESS; HEART PALPITATIONS; DIZZINESS AND FEELING FAINT; UNABLE TO LIFT LEGS TO GO UPSTAIRS; FATIGUE; WEAKNESS; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAY-2021, the patient experienced dizziness, heart palpitations during weeding outside, had fatigue and was feeling faint. On 08-MAY-2021, the patient was also unable to lift legs to go upstairs. On 12-MAY-2021, the patient experienced left sided weakness. On 20-MAY-2021, the patient visited the emergency room or department for treatment of the events and this was the second time of weakness.  On 20-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not reported, computed tomography scan (NR: not provided) No stroke and no blood clot, Chest X-ray (NR: not provided) Not reported, electrocardiogram 12 lead (ECG) (NR: not provided) Not reported, Investigation (NR: not provided) Not reported, and Magnetic resonance imaging (NR: not provided) No stroke and no blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and had not recovered from left sided weakness, heart palpitations, dizziness and feeling faint, unable to lift legs to go upstairs, and weakness. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000180437.; Sender's Comments: V0:20210544480-Covid-19 vaccine ad26.cov2.s-Left sided weakness. This event is considered unassessable. The event 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Palpitations
Clinical narrative: LEFT SIDED WEAKNESS; HEART PALPITATIONS; DIZZINESS AND FEELING FAINT; UNABLE TO LIFT LEGS TO GO UPSTAIRS; FATIGUE; WEAKNESS; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAY-2021, the patient experienced dizziness, heart palpitations during weeding outside, had fatigue and was feeling faint. On 08-MAY-2021, the patient was also unable to lift legs to go upstairs. On 12-MAY-2021, the patient experienced left sided weakness. On 20-MAY-2021, the patient visited the emergency room or department for treatment of the events and this was the second time of weakness.  On 20-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not reported, computed tomography scan (NR: not provided) No stroke and no blood clot, Chest X-ray (NR: not provided) Not reported, electrocardiogram 12 lead (ECG) (NR: not provided) Not reported, Investigation (NR: not provided) Not reported, and Magnetic resonance imaging (NR: not provided) No stroke and no blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and had not recovered from left sided weakness, heart palpitations, dizziness and feeling faint, unable to lift legs to go upstairs, and weakness. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000180437.; Sender's Comments: V0:20210544480-Covid-19 vaccine ad26.cov2.s-Left sided weakness. This event is considered unassessable. The event 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.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Rash
Clinical narrative: PAINFUL ARMPITS; REDNESS IN ARMPITS; RASH UNDER BOTH ARMPITS; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. patient took 180mg of otc allergy medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced painful armpits. On 21-MAY-2021, the subject experienced redness in armpits. On 21-MAY-2021, the subject experienced rash under both armpits. On 22-MAY-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from painful armpits, and had not recovered from rash under both armpits, and redness in armpits. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle tightness, Neck pain
Clinical narrative: TIGHTENING OF MUSCLES ABOVE EAR AND SHOULDERS; HURTS TO TURN NECK; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 65 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: 21/H21H, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced tightening of muscles above ear and shoulders, hurts to turn neck, and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tightening of muscles above ear and shoulders, hurts to turn neck and slight headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer by a other manufacturer company (Pfizer Inc.) received on14-MAY-2021 and concerned multiple (few) patients. 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: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Reporter stated that Johnson and Johnson vaccine caused blood clots and few people died. It was not reported whether autopsy was performed. On an unspecified date, the patients experienced blood clots. On an unspecified date, the patients died from blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0; 20210545044-covid-19 vaccine ad26.cov2. s Blood clots. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: BLOOD CLOTS
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Feeling abnormal, Injection site pain, Pruritus
Clinical narrative: FEELING SPACEY; PEA-SIZE LUMP UNDER LEFT ARM; ITCHY UNDER LEFT ARM; INJECTION SITE PAIN LEFT ARM; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included gout, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced injection site pain left arm. On 07-MAY-2021, the subject experienced pea-size lump under left arm. On 07-MAY-2021, the subject experienced itchy under left arm. On 16-MAY-2021, the subject experienced feeling spacey. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain left arm on 07-MAY-2021, and had not recovered from pea-size lump under left arm, itchy under left arm, and feeling spacey. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED VACCINE BEYOND EXPIRATION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 21-MAY-2021, the subject experienced administered vaccine beyond expiration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered vaccine beyond expiration was not reported. 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.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Diarrhoea, Fatigue
Clinical narrative: loss of sense of smell; fatigue; mild diarrhea; This is a spontaneous report from Pfizer sponsored program via a contactable consumer (patient). A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Jan2021 (Batch/Lot number was not reported; Reason for no lot number: Patient unwilling to complete the report) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got the COVID vaccine last Friday on 22Jan2021. The Patient had been having different side effects. Today on 29Jan2021 she had lost the sense of smell. She was not feeling bad. She wanted to know if she needs to take next steps. On 29Jan2021, experienced loss of sense of smell and on an unknown date in 2021 experienced fatigue, and mild diarrhea. The outcome of all events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Headache, Pyrexia, Sinusitis
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 24Jan2021 (Batch/Lot Number: EL3249) (at the age of 70-year-old) as 1st dose, single for covid-19 immunisation. Medical history and concomitant medications included none. The patient reported that on 27Jan2021 (Wednesday early evening) she developed a headache and a deep and persistent cough/nasty deep cough. On 28Jan2021 (Thursday) she was still coughing a little and her temperature was 100.5 and the patient reported that during the night, the cough absolutely stopped. It came back this morning (29Jan2021). The patient underwent lab test and procedure which included body temperature: 100.5 on 28Jan2021. The patient reported that it was hard to tell the status of her headache because she took Advil. At first, the patient thought that it was a sinus infection on an unknown date in Jan2021, but the cough was unusual and very bad. The outcome of the events temperature of 100.5 was recovered on 28Jan2021, persistent cough/nasty deep cough was not recovered and sinus infection was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity
Clinical narrative: nausea; chills; soreness of arm; This is a spontaneous report received from a contactable consumer reported for herself. A female patient of unspecified age received first dose bnt162b2 (batch/lot number: unknown, brand: Pfizer) via unspecified route of administration at unspecified location on an unknown date at single for covid-19 immunisation.The patient relevant medical history and concomitant medications were not reported. The patient got the first dose of her Covid vaccination about a week ago and she needs to get a TB test and wants to know if she needs to wait until she is finished with all the Covid vaccines, if it is okay to go ahead and get it, or how long will she have to wait after the second Covid vaccine dose to get the TB test. One week after vaccine administration, the patient experienced chills, soreness of arm, and nausea. Outcome of the events chills, soreness of arm, and nausea was unknown.  Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient conveys she had an earache that started five hours ago on an unknown date and wanted to know whether she could take Tylenol. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sneezing
Clinical narrative: Sneezing and itching; Sneezing and itching; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 08:00 (Lot Number: El9265, at the age of 67-years-old) as single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus, ongoing hypertension, non connective tissue disease from an unknown date and unknown if ongoing, allergies from an unknown date and unknown if ongoing. The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination, and did not tested positive post vaccination. The patient experienced sneezing and itching on 29Jan2021 14:00. It was unknown if treatment was received for adverse events. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: blistering rash to back and abdomen; blistering rash to back and abdomen; This is a spontaneous report from a contactable consumer or other non hcp. A 80-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3246), dose 1 via an unspecified route of administration, administered in Arm Right on 20Jan2021 14:00 as SINGLE DOSE for an unspecified indication. Medical history included hypertension, asthma and drug hypersensitivity from an unknown date. Concomitant medication(s) included benazepril, hctz (HCTZ), atorvastatin, montelukast for an unspecified indication. The patient experienced blistering rash to back and abdomen on 22Jan2021. Therapeutic measures were taken as a result of blistering rash to back and abdomen. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Condition aggravated, Dizziness, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3246, Expiration Date: Apr2021), intramuscular, administered in Arm Left on 25Jan2021 11:00 as 0.3 mL, single for covid-19 immunisation. Medical history included hypersensitivity, immunodeficiency, respiratory disorder, cytogenetic abnormality, endocrine disorder, diabetes mellitus, obesity, asthma from 1990 to an unknown date, Asthmatic diagnosed 1990. Patient's concomitant medication was not reported. The patient experienced caller experienced side effects including chills, dizziness, tiredness, weakness, generally feeling unwell on 28Jan2021 was reported as worsened on Jan2021. Reporter stated that "Did not think about it and could not explain why he was not feeling well until he looked at the side effect sheet. It has been going on a couple of days and he does not know when it started". NO ER or physician's office required Prior. Outcome of the event worsened was unknown and others were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3246, Expiration Date: Apr2021), intramuscular, administered in Arm Left on 25Jan2021 11:00 as 0.3 mL, single for covid-19 immunisation. Medical history included hypersensitivity, immunodeficiency, respiratory disorder, cytogenetic abnormality, endocrine disorder, diabetes mellitus, obesity, asthma from 1990 to an unknown date, Asthmatic diagnosed 1990. Patient's concomitant medication was not reported. The patient experienced caller experienced side effects including chills, dizziness, tiredness, weakness, generally feeling unwell on 28Jan2021 was reported as worsened on Jan2021. Reporter stated that "Did not think about it and could not explain why he was not feeling well until he looked at the side effect sheet. It has been going on a couple of days and he does not know when it started". NO ER or physician's office required Prior. Outcome of the event worsened was unknown and others were not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Heart rate increased
Clinical narrative: anxiety; experienced transient burning type sensation in the chest; a fast heartbeat; This is a spontaneous report from a contactable other hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 24Jan2021 as SINGLE DOSE for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced experienced transient burning type sensation in the chest and a fast heartbeat on 27Jan2021. Anxiety on 29Jan2021 at 15:30. The patient's lab tests included heart rate increased: a fast heartbeat on 27Jan2021. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.