chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tunnel vision
Clinical narrative: tunnel vision; little woosy; This is a spontaneous report from a contactable consumer reporting for himself.  A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982) in left arm on 19Jan2021 08:30 at single dose for COVID-19 immunization. Medical history included shellfish allergy, asthma and high cholesterol; all from an unknown date and unknown if ongoing. Concomitant medication included simvastatin. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced events as stated, "like I was seeing tunnel vision and a little woosy" on 19Jan2021 13:00. No treatment was given to the patient for the events. The outcome of  the events was recovered on unspecified date. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and were not a congenital anomaly/birth defect.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Hypoaesthesia oral, Paraesthesia oral, Pharyngeal swelling, SARS-CoV-2 test
Clinical narrative: Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 18Jan2021 17:15 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and asthma, both from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 28Dec2020 at 01:15 PM (lot number: EL1284) in the left arm for COVID-19 immunization given when the patient was 53 years old. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She had known allergies which were not specified. She was not pregnant. The patient experienced chest tightness, wheezing, throat swelling, tongue tingling and lip numbness, all on 18Jan2021 at 05:45 PM with outcome of recovering. The events resulted to Emergency room/department or urgent care. Treatment received for all events included DECADRON and Benadryl script for Epipen. The patient had no covid prior vaccination. She was tested for covid post vaccination through nasal swab on 20Jan2021 with pending result.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of chest tightness, wheezing, throat swelling, tongue tingling and lip numbness  due to temporal relationship.  However,  the chest tightness, wheezing may possibly be associated with the patient's history of asthma. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray and pulmonary function tests, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 18Jan2021 17:15 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and asthma, both from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 28Dec2020 at 01:15 PM (lot number: EL1284) in the left arm for COVID-19 immunization given when the patient was 53 years old. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She had known allergies which were not specified. She was not pregnant. The patient experienced chest tightness, wheezing, throat swelling, tongue tingling and lip numbness, all on 18Jan2021 at 05:45 PM with outcome of recovering. The events resulted to Emergency room/department or urgent care. Treatment received for all events included DECADRON and Benadryl script for Epipen. The patient had no covid prior vaccination. She was tested for covid post vaccination through nasal swab on 20Jan2021 with pending result.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of chest tightness, wheezing, throat swelling, tongue tingling and lip numbness  due to temporal relationship.  However,  the chest tightness, wheezing may possibly be associated with the patient's history of asthma. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray and pulmonary function tests, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Paraesthesia oral, Throat tightness, Wheezing
Clinical narrative: Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 18Jan2021 17:15 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and asthma, both from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 28Dec2020 at 01:15 PM (lot number: EL1284) in the left arm for COVID-19 immunization given when the patient was 53 years old. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She had known allergies which were not specified. She was not pregnant. The patient experienced chest tightness, wheezing, throat swelling, tongue tingling and lip numbness, all on 18Jan2021 at 05:45 PM with outcome of recovering. The events resulted to Emergency room/department or urgent care. Treatment received for all events included DECADRON and Benadryl script for Epipen. The patient had no covid prior vaccination. She was tested for covid post vaccination through nasal swab on 20Jan2021 with pending result.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of chest tightness, wheezing, throat swelling, tongue tingling and lip numbness  due to temporal relationship.  However,  the chest tightness, wheezing may possibly be associated with the patient's history of asthma. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray and pulmonary function tests, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Injection site pain, Nausea, Pain
Clinical narrative: Felt like having the actual flu, when its signs/symptoms are most severe. All-over body ache, very painful at injection site/arm. Constant chills, fever that lasted through the next day. Nausea.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Felt like having the actual flu, when its signs/symptoms are most severe. All-over body ache, very painful at injection site/arm. Constant chills, fever that lasted through the next day. Nausea.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: just had body aches at first but then became extremely nauseated by Friday and vomiting became very bad by Sunday.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Feeling abnormal, Hypoaesthesia, Livedo reticularis
Clinical narrative: tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles on face; numb face; Red spots on nose and legs; mottled leg color but looked like a flat rash; mottled leg color but looked like a flat rash; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 07:15 PM (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ1685 and Expiration Date unknown) via an unspecified route of administration on 31Dec2020 11:30 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included asthma, chronic migraines from neck injury, increased weight, known allergies to Reglan. No covid prior vaccination. The concomitant medications was reported as pregabalin (LYRICA), cefixime (FLEXERIL), sertraline hydrochloride (ZOLOFT), omeprazole (PROTONIX), sumatriptan succinate (IMITREX).On 19Jan2021 08:00 PM, patient experienced pins and needles on face. Then numb face. Red spots on nose and legs. Then mottled leg color but looked like a flat rash. Next day (20Jan2021) tip of nose still funny feeling. Spots remain. Slight dry cough, clearing throat, hoarse voice. Events resulted in Emergency room/department or urgent care. Treatment information included IV fluid, Benadryl, pepcid, steroids.The outcome of events was recovering after treatment given.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash macular, Throat clearing
Clinical narrative: tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles on face; numb face; Red spots on nose and legs; mottled leg color but looked like a flat rash; mottled leg color but looked like a flat rash; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 07:15 PM (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ1685 and Expiration Date unknown) via an unspecified route of administration on 31Dec2020 11:30 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included asthma, chronic migraines from neck injury, increased weight, known allergies to Reglan. No covid prior vaccination. The concomitant medications was reported as pregabalin (LYRICA), cefixime (FLEXERIL), sertraline hydrochloride (ZOLOFT), omeprazole (PROTONIX), sumatriptan succinate (IMITREX).On 19Jan2021 08:00 PM, patient experienced pins and needles on face. Then numb face. Red spots on nose and legs. Then mottled leg color but looked like a flat rash. Next day (20Jan2021) tip of nose still funny feeling. Spots remain. Slight dry cough, clearing throat, hoarse voice. Events resulted in Emergency room/department or urgent care. Treatment information included IV fluid, Benadryl, pepcid, steroids.The outcome of events was recovering after treatment given.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fasciitis, Injection site pain, Lymphadenopathy, Magnetic resonance imaging abnormal
Clinical narrative: Inflammatory fasciitis; cervical lymph nodes; This is a spontaneous report from a contactable physician reporting for another physician (Orthopedic surgeon).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not provided) on 12Jan2021 in left arm via an unspecified route of administration at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It's unknown if the patient had any known allergies. It's not provided if the patient had had COVID prior the vaccination or had every tested post the vaccination. The patient received the second dose of the vaccine on 12Jan2021 Tuesday and by Thursday 14Jan2021 he experienced severe left upper girdle pain in her shoulder and neck. Eventually he was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis. This was considered as an unusual post vaccine response. The patient was worried as he didn't know how transient or permanent this condition would be. Magnetic resonance imaging (MRI) on an unspecified date showed cervical lymph nodes and reports of lymphadenopathy from the clinical trial were discussed. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Fasciitis cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Neck pain
Clinical narrative: Inflammatory fasciitis; cervical lymph nodes; This is a spontaneous report from a contactable physician reporting for another physician (Orthopedic surgeon).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not provided) on 12Jan2021 in left arm via an unspecified route of administration at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It's unknown if the patient had any known allergies. It's not provided if the patient had had COVID prior the vaccination or had every tested post the vaccination. The patient received the second dose of the vaccine on 12Jan2021 Tuesday and by Thursday 14Jan2021 he experienced severe left upper girdle pain in her shoulder and neck. Eventually he was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis. This was considered as an unusual post vaccine response. The patient was worried as he didn't know how transient or permanent this condition would be. Magnetic resonance imaging (MRI) on an unspecified date showed cervical lymph nodes and reports of lymphadenopathy from the clinical trial were discussed. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Fasciitis cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fasciitis, Laboratory test, Lymphadenopathy, Magnetic resonance imaging abnormal, Neck pain
Clinical narrative: Inflammatory fasciitis; cervical lymph nodes; This is a spontaneous report from a contactable physician reporting for another physician (Orthopedic surgeon).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not provided) on 12Jan2021 in left arm via an unspecified route of administration at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It's unknown if the patient had any known allergies. It's not provided if the patient had had COVID prior the vaccination or had every tested post the vaccination. The patient received the second dose of the vaccine on 12Jan2021 Tuesday and by Thursday 14Jan2021 he experienced severe left upper girdle pain in her shoulder and neck. Eventually he was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis. This was considered as an unusual post vaccine response. The patient was worried as he didn't know how transient or permanent this condition would be. Magnetic resonance imaging (MRI) on an unspecified date showed cervical lymph nodes and reports of lymphadenopathy from the clinical trial were discussed. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Fasciitis cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Shoulder girdle pain
Clinical narrative: Inflammatory fasciitis; cervical lymph nodes; This is a spontaneous report from a contactable physician reporting for another physician (Orthopedic surgeon).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not provided) on 12Jan2021 in left arm via an unspecified route of administration at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It's unknown if the patient had any known allergies. It's not provided if the patient had had COVID prior the vaccination or had every tested post the vaccination. The patient received the second dose of the vaccine on 12Jan2021 Tuesday and by Thursday 14Jan2021 he experienced severe left upper girdle pain in her shoulder and neck. Eventually he was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis. This was considered as an unusual post vaccine response. The patient was worried as he didn't know how transient or permanent this condition would be. Magnetic resonance imaging (MRI) on an unspecified date showed cervical lymph nodes and reports of lymphadenopathy from the clinical trial were discussed. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Fasciitis cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Immediate post-injection reaction, Pain
Clinical narrative: Instant Headache and feeling of Light headiness after admin of Vaccine. Then on 1/27/2021 at 1:30am I work with my left arm throbbing, hot to touch,  and very swollen. My Headache and Light headiness had gotten worse. Developed body aches and chills. Took 1,000mg Tylenol Q6h and 800mg of Ibuprofen TID.  Symptoms last for a total of 30 hours.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Instant Headache and feeling of Light headiness after admin of Vaccine. Then on 1/27/2021 at 1:30am I work with my left arm throbbing, hot to touch,  and very swollen. My Headache and Light headiness had gotten worse. Developed body aches and chills. Took 1,000mg Tylenol Q6h and 800mg of Ibuprofen TID.  Symptoms last for a total of 30 hours.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Chills, Dyspnoea, Electrocardiogram normal
Clinical narrative: syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck throughout body; unable to turn head; generalized weakness; hypotension; shortness of breath; unable to speak; chills; diaphoresis; severe pain radiating from neck throughout body; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283), via an unspecified route of administration on 18Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, shellfish. Concomitant medication included celecoxib (CELEXA), levocetirizine dihydrochloride (XYZAL), acetaminophen, ibuprofen, naproxen sodium. There were no other vaccines received in four weeks. The patient did not have Covid tested post vaccination. Upon awakening early morning after injection on 19Jan2021 04:00, the patient had severe pain radiating from neck throughout body, unable to turn head, generalized weakness, syncopal event, hypotension, increased respiratory rate, shortness of breath, unable to speak, unable to move, chills, diaphoresis, emergent to emergency department, received Intravenous NS bolus as treatment. Electrocardiogram (EKG), BMP, complete blood count (CBC), labs were Within Normal Limit on 19Jan2021, discharged home, slept all day. Feeling much better second day after injection. The reported events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of unable to move, syncopal event, increased respiratory rate, severe pain radiating from neck throughout body, unable to turn head, generalized weakness, hypotension, shortness of breath, unable to speak, chills, diaphoresis. The outcome of the events was recovered in Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Hyperhidrosis, Hypotension, Metabolic function test normal, Movement disorder
Clinical narrative: syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck throughout body; unable to turn head; generalized weakness; hypotension; shortness of breath; unable to speak; chills; diaphoresis; severe pain radiating from neck throughout body; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283), via an unspecified route of administration on 18Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, shellfish. Concomitant medication included celecoxib (CELEXA), levocetirizine dihydrochloride (XYZAL), acetaminophen, ibuprofen, naproxen sodium. There were no other vaccines received in four weeks. The patient did not have Covid tested post vaccination. Upon awakening early morning after injection on 19Jan2021 04:00, the patient had severe pain radiating from neck throughout body, unable to turn head, generalized weakness, syncopal event, hypotension, increased respiratory rate, shortness of breath, unable to speak, unable to move, chills, diaphoresis, emergent to emergency department, received Intravenous NS bolus as treatment. Electrocardiogram (EKG), BMP, complete blood count (CBC), labs were Within Normal Limit on 19Jan2021, discharged home, slept all day. Feeling much better second day after injection. The reported events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of unable to move, syncopal event, increased respiratory rate, severe pain radiating from neck throughout body, unable to turn head, generalized weakness, hypotension, shortness of breath, unable to speak, chills, diaphoresis. The outcome of the events was recovered in Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Respiratory rate increased, Syncope
Clinical narrative: syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck throughout body; unable to turn head; generalized weakness; hypotension; shortness of breath; unable to speak; chills; diaphoresis; severe pain radiating from neck throughout body; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283), via an unspecified route of administration on 18Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, shellfish. Concomitant medication included celecoxib (CELEXA), levocetirizine dihydrochloride (XYZAL), acetaminophen, ibuprofen, naproxen sodium. There were no other vaccines received in four weeks. The patient did not have Covid tested post vaccination. Upon awakening early morning after injection on 19Jan2021 04:00, the patient had severe pain radiating from neck throughout body, unable to turn head, generalized weakness, syncopal event, hypotension, increased respiratory rate, shortness of breath, unable to speak, unable to move, chills, diaphoresis, emergent to emergency department, received Intravenous NS bolus as treatment. Electrocardiogram (EKG), BMP, complete blood count (CBC), labs were Within Normal Limit on 19Jan2021, discharged home, slept all day. Feeling much better second day after injection. The reported events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of unable to move, syncopal event, increased respiratory rate, severe pain radiating from neck throughout body, unable to turn head, generalized weakness, hypotension, shortness of breath, unable to speak, chills, diaphoresis. The outcome of the events was recovered in Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood potassium decreased, Full blood count, Injection site erythema, Injection site swelling
Clinical narrative: Patient had swelling, redness, skin warm to the touch at injection site.  Soreness in muscle/joint pain began day after vaccination (1/7). Injection site became very swollen and painful on 1/14/21.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Metabolic function test, Myalgia, White blood cell count increased
Clinical narrative: Patient had swelling, redness, skin warm to the touch at injection site.  Soreness in muscle/joint pain began day after vaccination (1/7). Injection site became very swollen and painful on 1/14/21.
Sex: U
Vaccine: FLUR4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: injection site was swollen and warm; injection site was swollen; injection site was warm; Initial information received on 14-Jan-2021 regarding an unsolicited valid non-serious case received from the other health care professional via phone via call center.  This case is linked to case 2020SA360527.  This case involves three patients of an unknown age and gender who experienced injection site was swollen and warm (vaccination site inflammation with symptoms of vaccination site swelling and vaccination site warmth), when they received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patients medical history, medical treatments, vaccinations and family history were not provided.   On an unknown date in beginning of Nov-2020, the patients received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number: QFAA2016, expiry date: 30-JUN-2021) via an unknown route in the deltoid not otherwise specified (NOS) for prophylactic vaccination.  On an unknown date in Nov-2020, the patient developed a non-serious injection site was swollen and warm (vaccination site inflammation with symptoms of vaccination site swelling and vaccination site warmth) after few days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Narrative Log: MA (medical assistant) states doctor ordered four boxes of FLUBLOK. Dr. used the first box on 10 patients. Seven out of the 10 patients had severe reactions to it. The patients usually get their flu vaccines and they never had a problem with it in the past. Dr. refused to use any more of the ones we purchased. I reached out for about returning the three unused boxes and caller said call you guys directly to see if the vaccines can go back to you. Caller states no patient demographics are currently available as Dr. is out of the office and he has the information. I believe he (Dr.) said 4 of the patients ended up with a rash near the injection site and down the arm. Those patients were treated with Hydrocortisone cream. The other 3 patients it almost felt like an infection. The injection site was swollen and warm for almost 2 weeks. This happened in the beginning of November and all the patients have recovered. They want to return the 3 unused boxes. Whether product is available for return: Yes, 3 boxes are available for return. Therapy Date: Beginning of November. Dr. usually gives it on the left unless the patient is a lefty (implied left handed patient). Strength: Standard. Indications: Immunization Event Information. All 4 boxes have the same lot number, expiration date, Caller states none of the patients were pregnant.   Sill Using Product: No.  No laboratories details reported.   The patients were treated with oral antibiotics (corrective treatment).  On an unknown date in 2020, the patient recovered from the events after almost 2 weeks.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Severe Tension-Type Headache, Malaise, Myalgia, Insomnia, Chills, Sweating, Fatigue, Fever of 100.8 F, Mild Non-suppurative Cough. All tolerated with 600mg ibuprofen.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Severe Tension-Type Headache, Malaise, Myalgia, Insomnia, Chills, Sweating, Fatigue, Fever of 100.8 F, Mild Non-suppurative Cough. All tolerated with 600mg ibuprofen.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Intensive care, Respiration abnormal
Clinical narrative: her respirations were affected; patient was in the pool and began to shiver/shivered uncontrollably; Initial information regarding an unsolicited valid serious case via Agency (Reference number- 00442513) was received from a consumer and transmitted to Sanofi on 22-Jan-2021.  This case involved a 78 year old female patient who was in the pool and began to shiver/shivered uncontrollably (Chills) and her respirations were affected (Respiratory disorder), while she received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included FLUZONE HIGH DOSE on an unknown date in 2016 for prophylactic vaccination and had a reaction to the Vaccine in 2016. Got the shot in the morning and in the afternoon her arms/ upper extremities were flailing uncontrollably. She could not control her arms. Took her to urgent care 2 days and they gave her fluids 2019 She got the regular dose vaccine in the morning. She was treated with rehydration for 2 days and recovered without sequelae.  The patient's medical history, medical treatment(s), concomitant medications and family history were not provided.  Caller would like to know what were the ingredients in the Sanofi Flu vaccines between 2015 to present. Caller stated his wife had a reaction to the Vaccine in 2016.   On an unknown date in 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination. She got the regular dose vaccine in the morning.  On an unknown date, the patient was in the pool and began to shiver/shivered uncontrollably (Chills) and her respirations were affected (Respiratory disorder) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient had to go to the hospital a couple of times and was in intensive care for 2.5 days, followed by a week in the hospital.  Seriousness criteria included hospitalization for all the events.  Details of laboratory data were not reported.  The patient was in a rehab facility for a few more weeks as a corrective treatment.  The event outcome was reported as unknown for both the events, at the time of reporting.  There would be no information available on the batch number for this case.; Sender's Comments: This case involves a 78 year old female patient who developed Chills and Respiratory disorder following the vaccination with FLUZONE QUADRIVALENT. The time to onset was unknown. The patient's past vaccination(s) included FLUZONE HIGH DOSE. Further information regarding concurrent condition during vaccination, concomitant medications, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Feeling abnormal, Heart rate increased, Sleep disorder
Clinical narrative: About 5 mins after the shot I received on Sunday, I got a cooling effect in my chest and began to feel a bit off with an elevated HR of 132. I raised my hand to talk to a nurse and she said I was probably just nervous, got me a water, and said to continue to monitor symptoms. Then, after 15 minutes were up with no other symptoms I left the facility where I got the vaccine. The rest of the day I began to get a burning and cooling effect all around my sternum. It persisted through the day despite Tylenol 500 mg and worsened at night, keeping me up along with a slight fever and chills. The next morning I awoke with slightly lowered symptoms but the sternum pain would flare up on and off through the day and again was worse at night on Monday. So, I took a Benadryl and a 500 mg Tylenol and slept great. I woke up Tuesday feeling great with no fever and minimal chills and no sternal pain. I thought since I hit the 48 hour mark everything was going fine and I was recovering. I ran some errands and even went to the gym to do a mild workout. Then at about 6pm all the symptoms of the sternal pain flared up and was just as bad as Monday night. I took another 500mg Tylenol and 1 Benadryl again and they did not seem to work or help nearly as much as the night before. I woke up this morning with some pain in my sternum again and did not sleep much last night due to the pain as well. I have not taken any further medications at this time and I am also experiencing the worst fatigue I have so far today.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm. No treatments. Resolved in 2 days
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: inflamation, redness,  pain, soreness, warmth to touch at injection site.  An oval shaped area about 3 inches high and 4 inches wide.  I have a photo.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: Increased heart rate / has not resolved; This case was reported by a pharmacist and described the occurrence of heart rate increased in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 4JE2L, expiry date 17th September 2022) for prophylaxis.   On 6th January 2021, the patient received Shingrix. On 7th January 2021, 1 days after receiving Shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was not recovered/not resolved.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not provide the patients exact date of birth or initials. The patient received Shingrix and experienced increased heart rate.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, aches, headache
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Loss of consciousness, Nausea
Clinical narrative: Had shot at 4:26pm Ate  a light dinner(lentil soup and omelette) Woke up around 2:30 am felling nauseas and had diarhea and chills which continued through the night and following day.  Very weak and passed out briefly when feeding my dogs.Ate a bland diet and drank plenty of water for the next few days. Felt better on Saturday January 30th
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: About 10 hours after receiving my second dose of moderna, I began experiencing intense chills and joint pain.  My joint and muscle pain was very severe even after taking ibuprofen.  I developed a fever of 102.1.  Symptoms lasted for about 15 hours, then I slowly started to feel better.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Moderna COVID-19 Vaccine EUA Red rash at injection site approximately 5 cm in diameter, increased soreness beginning day 7 or 8. Increasing through day 10 at the time of this report. Photographs available
Age: 22.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Rigors, extreme myalgia, headache, fatigue. Occurred  with both doses approx. 12 hours post injection. Only resolved with scheduled ibuprofen and several doses of diphenhydramine to aid with sleep.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Lethargy
Clinical narrative: Tired and lethargic for 2 days...no energy
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: pain in upper arm around vaccination site, acute enough to disrupt sleep that night onset after four hours resolved after 24 hours
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, body aches, headaches
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Aches in body similar to flu like symptoms. 2 day headache Tiredness.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: 0830 severe chills, severe body and joint aches, fever 102.3, fatigue - took 650mg Tylenol and 800mg ibuprofen with resolution of symptoms
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Fall, Visual impairment
Clinical narrative: Systemic: Other- 1/28 early morning visual disturbance, lost balance and fell,lasted until mid day wednesday 1/28
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Chromatopsia, Fatigue, Hypersomnia, Influenza like illness
Clinical narrative: Systemic: Other- 1/28 early morning visual disturbance, lost balance and fell,lasted until mid day wednesday 1/28
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Retching, Thyroid function test normal
Clinical narrative: Systemic: Other- 1/28 early morning visual disturbance, lost balance and fell,lasted until mid day wednesday 1/28
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Symptoms started 2 hours after injection, lasted approx. 8 hours
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast tenderness, Contusion, Haemorrhage
Clinical narrative: Moderna COVID-a9 Vaccine EUA - Woke from sleep about 15-16 hours after vaccination with continuous sharp cutting sensations in arm pit of arm which received the vaccination.   Upper  portion of breast also was just tender to touch.  The cutting sensation continued for about 24 hours with improvement continuing but  2.5 days later the upper portion of the breast presented bruising/bleeding signs.  Picture was taken.  Some tenderness.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pruritus
Clinical narrative: Woke around 4 am with severe body aches, headache, and itching to the site, and nausea and fatigue
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Bad muscle and joint pain. All over. Lasting 36-38 hours.  Feeling cold, freezing, shaking. Last about 30 hours.  At injection site-very painful, red, hot to touch, knot larger than a 50 cent piece. Still present but less pain and not so hot to touch.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Tremor
Clinical narrative: Bad muscle and joint pain. All over. Lasting 36-38 hours.  Feeling cold, freezing, shaking. Last about 30 hours.  At injection site-very painful, red, hot to touch, knot larger than a 50 cent piece. Still present but less pain and not so hot to touch.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Low grade fever, muscle aches, headache (lasting 12 hours after symptoms started)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: Developed fatigue, chills, muscle aches, injection site pain 16 hours post-vaccination. lasted for 12 hours,  symptoms resolved with one dose of Tylenol.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Fever/chills, shaking, muscle aches, abdominal pain. Severe chills and sweating, I couldn?t get warm even with all of my blankets and heat set to 77 and woke up multiple times drenched in sweat.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Fever/chills, shaking, muscle aches, abdominal pain. Severe chills and sweating, I couldn?t get warm even with all of my blankets and heat set to 77 and woke up multiple times drenched in sweat.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Systemic: Anaphylaxis-Severe