chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fall, Immunisation, Ligament sprain
Clinical narrative: gained a few pounds; Passed out/ she was trying to get to the bathroom. She woke up on the floor/passed out again; fell; Everyday her knee reminds her of her adverse reaction/ She must have twisted her knee; Shakes; Got up feeling sick; Felt nauseous; Fever of 102/ really high fever; Chills; Booster; sore arm /couldn't touch her left arm or anything; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on [04Jan2022], this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A 52-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Dec2021 12:30 (Lot number: FE3594) at the age of 52 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1(lot number: EP6955)), administration date: 20Mar2021, when the patient was 51 years old for COVID-19 immunization. The patient was diagnosed with COVID 01Apr2021 (between the first and second dose). Then, had the 2nd dose (lot number: ER8735), administration date: 24Apr2021, when the patient was 52 years old.  She did not have any type of side effects on the 2nd one. Then, received the booster dose on 15Dec2021 12:30. She passed out at 3 o'clock in the morning (16Dec2021) after getting the booster dose. She woke up nauseous and got up feeling sick. She felt nauseous, when she was trying to get to the bathroom. Then, she woke up on the floor. She was calling her husband and carried her to the toilet, but she passed out again. She must have twisted her knee when she fell so her knee reminds her every day of the adverse reaction. She also had a high fever of 102. She also had shakes and chills on 16Dec2021. She just decided to call because she was sitting there, and her knee almost gave out on her. She thought she was going to end up having to go to the doctor for it. She also had a very sore arm in Dec2021 for 3 days. She couldn't touch her left arm or anything for 3 days. She has gained a few pounds also noted on unknown date. The patient recovered from the events nauseous, got up feeling sick, high fever, shakes and chills on 18Dec2021; recovered from sore arm on unknown date and passed out on 16Dec201 while unknown for the remaining events.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise, Nausea, Pain in extremity, Pyrexia
Clinical narrative: gained a few pounds; Passed out/ she was trying to get to the bathroom. She woke up on the floor/passed out again; fell; Everyday her knee reminds her of her adverse reaction/ She must have twisted her knee; Shakes; Got up feeling sick; Felt nauseous; Fever of 102/ really high fever; Chills; Booster; sore arm /couldn't touch her left arm or anything; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on [04Jan2022], this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A 52-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Dec2021 12:30 (Lot number: FE3594) at the age of 52 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1(lot number: EP6955)), administration date: 20Mar2021, when the patient was 51 years old for COVID-19 immunization. The patient was diagnosed with COVID 01Apr2021 (between the first and second dose). Then, had the 2nd dose (lot number: ER8735), administration date: 24Apr2021, when the patient was 52 years old.  She did not have any type of side effects on the 2nd one. Then, received the booster dose on 15Dec2021 12:30. She passed out at 3 o'clock in the morning (16Dec2021) after getting the booster dose. She woke up nauseous and got up feeling sick. She felt nauseous, when she was trying to get to the bathroom. Then, she woke up on the floor. She was calling her husband and carried her to the toilet, but she passed out again. She must have twisted her knee when she fell so her knee reminds her every day of the adverse reaction. She also had a high fever of 102. She also had shakes and chills on 16Dec2021. She just decided to call because she was sitting there, and her knee almost gave out on her. She thought she was going to end up having to go to the doctor for it. She also had a very sore arm in Dec2021 for 3 days. She couldn't touch her left arm or anything for 3 days. She has gained a few pounds also noted on unknown date. The patient recovered from the events nauseous, got up feeling sick, high fever, shakes and chills on 18Dec2021; recovered from sore arm on unknown date and passed out on 16Dec201 while unknown for the remaining events.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Weight, Weight increased
Clinical narrative: gained a few pounds; Passed out/ she was trying to get to the bathroom. She woke up on the floor/passed out again; fell; Everyday her knee reminds her of her adverse reaction/ She must have twisted her knee; Shakes; Got up feeling sick; Felt nauseous; Fever of 102/ really high fever; Chills; Booster; sore arm /couldn't touch her left arm or anything; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on [04Jan2022], this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A 52-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Dec2021 12:30 (Lot number: FE3594) at the age of 52 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1(lot number: EP6955)), administration date: 20Mar2021, when the patient was 51 years old for COVID-19 immunization. The patient was diagnosed with COVID 01Apr2021 (between the first and second dose). Then, had the 2nd dose (lot number: ER8735), administration date: 24Apr2021, when the patient was 52 years old.  She did not have any type of side effects on the 2nd one. Then, received the booster dose on 15Dec2021 12:30. She passed out at 3 o'clock in the morning (16Dec2021) after getting the booster dose. She woke up nauseous and got up feeling sick. She felt nauseous, when she was trying to get to the bathroom. Then, she woke up on the floor. She was calling her husband and carried her to the toilet, but she passed out again. She must have twisted her knee when she fell so her knee reminds her every day of the adverse reaction. She also had a high fever of 102. She also had shakes and chills on 16Dec2021. She just decided to call because she was sitting there, and her knee almost gave out on her. She thought she was going to end up having to go to the doctor for it. She also had a very sore arm in Dec2021 for 3 days. She couldn't touch her left arm or anything for 3 days. She has gained a few pounds also noted on unknown date. The patient recovered from the events nauseous, got up feeling sick, high fever, shakes and chills on 18Dec2021; recovered from sore arm on unknown date and passed out on 16Dec201 while unknown for the remaining events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Petechiae, Platelet count, Thrombocytopenia
Clinical narrative: thrombocytopenia/low platelet; Patches on both legs, like little red dots/looks like i'm bleeding under my skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOCYTOPENIA (medically significant) with onset 05Jan2022, outcome "not recovered", described as "thrombocytopenia/low platelet"; PETECHIAE (non-serious) with onset 05Jan2022, outcome "not recovered", described as "Patches on both legs, like little red dots/looks like i'm bleeding under my skin". The patient underwent the following laboratory tests and procedures: platelet count: (05Jan2022) low. Patient was asking She got her 1st dose (Pfizer covid vaccine) on 21Dec2021 and this morning she had patches on both legs, like little red dots (they were not itchy as per caller) and they were not going away. It looks like she was bleeding under her skin. she think it could be thrombocytopenia/low platelet, She read that it can cause this. She want to know what to, she was scared to get the second dose. Response received included No specific information found on patches or red dots or thrombocytopenia. They explained to caller that if she feels or believes she has thrombocytopenia then she should seek medical attention. Caller stated she would go to ER.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Booster; Cold symptoms; Sore throat; nasal congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FH2082) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (dose 1, Manufacturer Unknown.), for Covid-19 Immunization; Bnt162b2 (dose 2,), for Covid-19 immunization, reaction(s): "nausea", "fever 99.9", "vomiting". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold symptoms"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; NASAL CONGESTION (non-serious), outcome "unknown", described as "nasal congestion". Additional information Description of Event: Cold symptoms- Sore throat and nasal congestion.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Haemorrhage, Menstruation irregular, Thrombosis
Clinical narrative: blood clots; expelled hemorrhagically; abdominal pain/cramping; resembled menstruation, but 2 weeks ahead of my cycle; skipped menstrual period following the hemorrhage event; irregular menstrual periods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: Jul2021, when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: THROMBOSIS (medically significant) with onset 01Aug2021, outcome "not recovered", described as "blood clots"; HAEMORRHAGE (medically significant) with onset 01Aug2021, outcome "not recovered", described as "expelled hemorrhagically"; ABDOMINAL PAIN (non-serious) with onset 01Aug2021, outcome "not recovered", described as "abdominal pain/cramping"; MENSTRUATION IRREGULAR (non-serious) with onset 01Aug2021, outcome "not recovered", described as "resembled menstruation, but 2 weeks ahead of my cycle; skipped menstrual period following the hemorrhage event; irregular menstrual periods". The events "blood clots", "expelled hemorrhagically", "abdominal pain/cramping" and "resembled menstruation, but 2 weeks ahead of my cycle; skipped menstrual period following the hemorrhage event; irregular menstrual periods" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of thrombosis, haemorrhage, abdominal pain, menstruation irregular.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Sarcoidosis
Clinical narrative: 3 people that have been diagnosed with Sarcoidosis after having the Pfizer Covid-19 vaccine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown", described as "3 people that have been diagnosed with Sarcoidosis after having the Pfizer Covid-19 vaccine". The reporter knew 3 people that have been diagnosed with Sarcoidosis after having the Pfizer Covid-19 vaccine. The reporter wanted to know have there been any other such reports of these side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Pulmonary sarcoidosis
Clinical narrative: pulmonary sarcoidosis; This is a spontaneous report from a contactable consumer from medical information team for a Pfizer sponsored program (005570). A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), administration date May2021 as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COMIRNATY (first dose), administration date: Apr2021, for covid-19 immunisation. The following information was reported: pulmonary sarcoidosis (medically significant) with onset Sep2021, outcome "unknown", described as "pulmonary sarcoidosis". Patient had the Pfizer 2 dose Covid-19 vaccine in Apr2021 and May2021. By September, patient noticed trouble swallowing, talking, and breathing. After several CT scans, doctors had determined that patient had pulmonary sarcoidosis. It's patient belief that this diagnosis was directly related to the vaccine. Patient asked if there had been any other such reports of these side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Sarcoidosis
Clinical narrative: 3 people that have been diagnosed with Sarcoidosis after having the Pfizer Covid-19 vaccine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown", described as "3 people that have been diagnosed with Sarcoidosis after having the Pfizer Covid-19 vaccine". The reporter knew 3 people that have been diagnosed with Sarcoidosis after having the Pfizer Covid-19 vaccine. The reporter wanted to know have there been any other such reports of these side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Immunisation
Clinical narrative: Developed a large DVT in my left knee; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 11:30 (Batch/Lot number: unknown) at the age of 64 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 22Dec2021 11:30, outcome "unknown", described as "Booster"; DEEP VEIN THROMBOSIS (medically significant) with onset 25Dec2021 07:00, outcome "recovering", described as "Developed a large DVT in my left knee". The event "developed a large dvt in my left knee" was evaluated at the physician office visit. Therapeutic measures were taken as a result of deep vein thrombosis and included treatment with Prescription blood thinner. Clinical course: 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 did not have been tested for COVID-19. Known allergies were reported as No. Hospitalization Prolonged was reported as No.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Immunisation, SARS-CoV-2 test, Vertebral artery dissection
Clinical narrative: Vertebral artery dissection on V3 resulting in stroke; Vertebral artery dissection on V3 resulting in stroke; Booster; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 44-year-old male patient received BNT162B2 (COMIRNATY), administered in arm left, administration date 08Nov2021 (Lot number: FG3527) at the age of 44 years as dose 3 (booster), single for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medication included: FLU taken for immunisation, administration date 23Oct2021. Vaccination history included: Comirnaty (DOSE 1; Lot Number: ER8734; left arm), administration date: 10Apr2021; Comirnaty (DOSE 2; Lot Number: EW0167; left arm), administration date: 02May2021; both when the patient was 43 years old for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. The patient was administered with another vaccine in four weeks. The Pfizer vaccine was administered in a hospital facility. The following information was reported: IMMUNISATION (hospitalization) with onset 08Nov2021, outcome "unknown", described as "Booster"; VERTEBRAL ARTERY DISSECTION (hospitalization), CEREBROVASCULAR ACCIDENT (hospitalization) all with onset 11Nov2021, outcome "recovering" and all described as "Vertebral artery dissection on V3 resulting in stroke". The patient was hospitalized for all events (hospitalization duration: 4 days). The event "Vertebral artery dissection on v3 resulting in stroke" was evaluated at the physician office visit and emergency room visit. The patient has been tested for COVID-19 post vaccination. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Nov2021) negative. Therapeutic measures were taken as a result of vertebral artery dissection and cerebrovascular accident which included acetylsalicylic acid (ASPIRIN) and atorvastatin medications.  No follow-up attempts are possible. No further information is expected.  Follow-up (10Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: On 4Jan2022 patient tested positive for COVID-19; On 4Jan2022 patient tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 14May2021 (Lot number: EW0175) as dose 1, single and administration date 04Jun2021 (Lot number: EW0168) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 04Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 04Jan2022, outcome "recovering" and all described as "On 4Jan2022 patient tested positive for COVID-19"; OROPHARYNGEAL PAIN (non-serious) with onset 04Jan2022, outcome "recovering", described as "Sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. Therapeutic measures were not taken as a result of covid-19, oropharyngeal pain.  Additional information: 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 been tested for COVID-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure and Covid-19  and the suspect drug BNT162B2 cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Immunisation, Pain, SARS-CoV-2 test, Urticaria
Clinical narrative: Hives on arms and legs; Sever Shortness of Breath; Body aches; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 24 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jan2022 05:15 (Lot number: FE3594) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Right, Vaccine Administration Time: 09:15 AM), administration date: 29Apr2021, when the patient was 23 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Right, Vaccine Administration Time: 09:45 AM), administration date: 06Apr2021, when the patient was 23 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Jan2022 05:15, outcome "unknown", described as "booster"; DYSPNOEA (non-serious) with onset 02Jan2022 17:15, outcome "recovered" (03Jan2022 17:15), described as "Sever Shortness of Breath"; PAIN (non-serious) with onset 02Jan2022 17:15, outcome "recovered" (03Jan2022 17:15), described as "Body aches"; URTICARIA (non-serious) with onset 03Jan2022 05:15, outcome "recovering", described as "Hives on arms and legs". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, pain. Therapeutic measures were taken as a result of urticaria.  Additional information: Patient did not received any other vaccine in four weeks and no other medications in two weeks. Sever shortness of breath and body aches 12 hours after booster lasting 24 hours. Hives on arms and legs 24 hours after booster, only relieved with benydryl. No covid prior vaccination. No known allergies.
Sex: M
Vaccine: COVID19
Symptoms: Anti-aquaporin-4 antibody, Gait disturbance, Hyperreflexia, Investigation, Magnetic resonance imaging head
Clinical narrative: A diagnosis of MS was established; right sided internuclear ophthalmoplegia; left hand paresthesia; urinary urgency; gait imbalance; isolated left arm hyperreflexia; This is a literature report for the following literature source(s): "New diagnosis of multiple sclerosis in the setting of mRNA COVID-19 vaccine exposure". A 37 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "A diagnosis of MS was established"; OPHTHALMOPLEGIA (medically significant), outcome "unknown", described as "right sided internuclear ophthalmoplegia"; PARAESTHESIA (non-serious), outcome "unknown", described as "left hand paresthesia"; MICTURITION URGENCY (non-serious), outcome "unknown", described as "urinary urgency"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "gait imbalance"; HYPERREFLEXIA (non-serious), outcome "unknown", described as "isolated left arm hyperreflexia". The patient underwent the following laboratory tests and procedures: anti-aquaporin-4 antibody: negative; investigation: notable for right sided internuclear, notes: ophthalmoplegia and isolated left arm hyperreflexia (3+); negative; negative; magnetic resonance imaging head: multiple periventricular nonenhancing t2/flair, notes: hyperintensities and a C3-C4 cord T2 and STIR hyperintense lesion, compatible with demyelination; magnetic resonance imaging neck: multiple periventricular nonenhancing t2/flair, notes: hyperintensities and a C3-C4 cord T2 and STIR hyperintense lesion, compatible with demyelination. Therapeutic measures were taken as a result of multiple sclerosis, paraesthesia, micturition urgency, gait disturbance, hyperreflexia.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events Multiple Sclerosis, Ophthalmoplegia, Paraesthesia, Micturition urgency, gait disturbance, hyperreflexia  and the suspect drug BNT162B2 cannot be excluded.    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.,Linked Report(s) : US-PFIZER INC-202200012186 Same article/drug/event and different patient
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging neck, Micturition urgency, Multiple sclerosis, Ophthalmoplegia, Paraesthesia
Clinical narrative: A diagnosis of MS was established; right sided internuclear ophthalmoplegia; left hand paresthesia; urinary urgency; gait imbalance; isolated left arm hyperreflexia; This is a literature report for the following literature source(s): "New diagnosis of multiple sclerosis in the setting of mRNA COVID-19 vaccine exposure". A 37 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "A diagnosis of MS was established"; OPHTHALMOPLEGIA (medically significant), outcome "unknown", described as "right sided internuclear ophthalmoplegia"; PARAESTHESIA (non-serious), outcome "unknown", described as "left hand paresthesia"; MICTURITION URGENCY (non-serious), outcome "unknown", described as "urinary urgency"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "gait imbalance"; HYPERREFLEXIA (non-serious), outcome "unknown", described as "isolated left arm hyperreflexia". The patient underwent the following laboratory tests and procedures: anti-aquaporin-4 antibody: negative; investigation: notable for right sided internuclear, notes: ophthalmoplegia and isolated left arm hyperreflexia (3+); negative; negative; magnetic resonance imaging head: multiple periventricular nonenhancing t2/flair, notes: hyperintensities and a C3-C4 cord T2 and STIR hyperintense lesion, compatible with demyelination; magnetic resonance imaging neck: multiple periventricular nonenhancing t2/flair, notes: hyperintensities and a C3-C4 cord T2 and STIR hyperintense lesion, compatible with demyelination. Therapeutic measures were taken as a result of multiple sclerosis, paraesthesia, micturition urgency, gait disturbance, hyperreflexia.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events Multiple Sclerosis, Ophthalmoplegia, Paraesthesia, Micturition urgency, gait disturbance, hyperreflexia  and the suspect drug BNT162B2 cannot be excluded.    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.,Linked Report(s) : US-PFIZER INC-202200012186 Same article/drug/event and different patient
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhage, Rash macular
Clinical narrative: may be I am bleeding; have like a patches, like a little dots on my legs all over and they are so many; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 25Dec2021 (Lot number: FJ1620) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMORRHAGE (medically significant), outcome "unknown", described as "may be I am bleeding"; RASH MACULAR (non-serious), outcome "not recovered", described as "have like a patches, like a little dots on my legs all over and they are so many".  Clinical course details: Patient took the Pfizer vaccine on 25Dec2021, first dose and today (date unspecified) from the morning, patient started having like patches, like little dots on legs all over and they were so many, and not disappearing.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Incorrect dose administered, Interchange of vaccine products, Off label use
Clinical narrative: I have had 4 Pfizer vaccines and today I just got my 5th via Moderna.; I have had 4 Pfizer vaccines and today I just got my 5th via Moderna.; I have had 4 Pfizer vaccines and today I just got my 5th via Moderna.; I have had 4 Pfizer vaccines and today I just got my 5th via Moderna.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 5 (initial moderna dose), single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious), OFF LABEL USE (non-serious), INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown" and all described as "I have had 4 Pfizer vaccines and today I just got my 5th via Moderna."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Eosinophilic granulomatosis with polyangiitis
Clinical narrative: severe case of egpa; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A 59 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 Immunization. The following information was reported: EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS (medically significant), outcome "unknown", described as "severe case of egpa". The event "severe case of egpa" was evaluated at the physician office visit. Therapeutic measures were taken as a result of eosinophilic granulomatosis with polyangiitis. Additional information: The patient is presently being treated with Rituxan and prednisone. Prior to the vaccine, the patient had no asthma, no muscle problems and was a very health 59-year-old man. No weight issues, no diabetes, exercised daily, and was exceptionally healthy.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, SARS-CoV-2 test, Vaccination site erythema, Vaccination site induration
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Apr2021 12:15 (Lot number: EW0171) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE PRURITUS (non-serious) all with onset 29Apr2021, outcome "recovering" and all described as "raised, round, reddish, itchy spot at injection site of right arm"; INJECTION SITE INDURATION (non-serious) with onset 29Apr2021, outcome "recovering", described as "injection site of right arm continued to be hardened"; DIZZINESS (non-serious) with onset 28Apr2021, outcome "recovering", described as "Light-headed"; NAUSEA (non-serious) with onset 28Apr2021, outcome "recovering", described as "nauseas feeling". The events "raised, round, reddish, itchy spot at injection site of right arm", "injection site of right arm continued to be hardened", "light-headed" and "nauseas feeling" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of injection site erythema, injection site pruritus, injection site induration, dizziness, nausea. Additional information: This report was received via COVEAS. The patient received vaccine in pharmacy/drug store and she was not pregnant when administration and had no known allergies. Patient didn't receive other vaccine in four weeks and didn't take other medications in two weeks. The patient had no COVID-19 prior vaccination and she tested COVID-19 post vaccination. It was reported that shot 1 - 3 days later, patient found raised, round, reddish, itchy spot at injection site of right arm. The injection site continued to be hardened, raised and itchy for next 3-4 weeks. Additionally, patient had light-headed & nauseas feeling - come and go 4-5 times a day lasting approximately 2-3 months post 1st dose. Patient visited doctor but no treatment available. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Apr2021 12:15 (Lot number: EW0171) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE PRURITUS (non-serious) all with onset 29Apr2021, outcome "recovering" and all described as "raised, round, reddish, itchy spot at injection site of right arm"; INJECTION SITE INDURATION (non-serious) with onset 29Apr2021, outcome "recovering", described as "injection site of right arm continued to be hardened"; DIZZINESS (non-serious) with onset 28Apr2021, outcome "recovering", described as "Light-headed"; NAUSEA (non-serious) with onset 28Apr2021, outcome "recovering", described as "nauseas feeling". The events "raised, round, reddish, itchy spot at injection site of right arm", "injection site of right arm continued to be hardened", "light-headed" and "nauseas feeling" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of injection site erythema, injection site pruritus, injection site induration, dizziness, nausea. Additional information: This report was received via COVEAS. The patient received vaccine in pharmacy/drug store and she was not pregnant when administration and had no known allergies. Patient didn't receive other vaccine in four weeks and didn't take other medications in two weeks. The patient had no COVID-19 prior vaccination and she tested COVID-19 post vaccination. It was reported that shot 1 - 3 days later, patient found raised, round, reddish, itchy spot at injection site of right arm. The injection site continued to be hardened, raised and itchy for next 3-4 weeks. Additionally, patient had light-headed & nauseas feeling - come and go 4-5 times a day lasting approximately 2-3 months post 1st dose. Patient visited doctor but no treatment available. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, SARS-CoV-2 test
Clinical narrative: Numbness in upper lip - began 3.5 weeks following second shot, lasted continuously for 4 months on upper right; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 12:15 (Lot number: EW0177) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0171, Location of injection: Arm Right, Vaccine Administration Time: 12:15 PM), administration date: 26Apr2021, for COVID-19 immunization, reaction(s): "reddish, itchy spot at injection site of right arm", "reddish, itchy spot at injection site of right arm", "injection site of right arm  Continued to be hardened", "Light-headed", "nauseas". The following information was reported: HYPOAESTHESIA ORAL (disability) with onset Jun2021, outcome "recovering", described as "Numbness in upper lip - began 3.5 weeks following second shot, lasted continuously for 4 months on upper right". The event "numbness in upper lip - began 3.5 weeks following second shot, lasted continuously for 4 months on upper right" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Dec2021) negative, notes: Nasal Swab; (20Dec2021) negative, notes: Nasal Swab; (01Nov2021) negative, notes: Nasal Swab; (15Nov2021) negative, notes: Nasal Swab; (23Nov2021) negative, notes: Nasal Swab; (20Aug2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of hypoaesthesia oral. Clinical course: Numbness in upper lip - began 3.5 weeks following second shot, lasted continuously for 4 months on upper right spot on upper lip being 85-90% total numbness. At 5 months it began coming and going, but also spread to the upper left side of the upper lip and now at 7.5 months later is still flaring. Will go down to 10-20% numb for a few days to a week and then flare back to 80-90% numb for a few weeks.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus; I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result, notes: contracted the virus. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200015111 Same reporter/event/drug; different patient.;US-PFIZER INC-202200015112 Same reporter/event/drug; different patient.;US-PFIZER INC-202200015110 Same reporter/event/drug; different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted Covid-19; contracted Covid-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "contracted Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: they have contracted Covid-19. Caller was a pharmacist inquiring about two kids that were vaccinated with the pediatric formulation orange cap Pfizer BioNTech Covid-19 vaccine 3 weeks ago. Caller stated they have contracted Covid-19 and have now fully recovered. Caller would like to know if the second dose of the pediatric formulation Covid-19 vaccine should be administered on schedule or if the second dose should be delayed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Sex: M
Vaccine: COVID19
Symptoms: Ear disorder, Immunisation, Loss of personal independence in daily activities, Migraine
Clinical narrative: ear splitting; Pfizer covid booster shot, the third dose; experienced their 6th day of a Migraine headache; life changing; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE-1, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE-2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: EAR DISORDER (medically significant), outcome "unknown", described as "ear splitting"; IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer covid booster shot, the third dose"; MIGRAINE (non-serious), outcome "unknown", described as "experienced their 6th day of a Migraine headache"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "life changing". Clinical course: The patient called about the Pfizer covid booster shot, the third dose and reported that he received his Pfizer Covid-19 Booster Vaccine with his 60-year-old mother and they both have experienced their 6th day of a migraine headache. The patient asked had this been reported, how long will it last, missing work, was Pfizer going to shoot him a check from their big deal with country, did not get the Booster, it did not work against Omicron. The patient asked was it normal for people to experience ear splitting, life changing, migraines 4-5 days after getting the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient already got the first and second dose of the vaccine and that tested positive to Covid-19 weeks ago; patient already got the first and second dose of the vaccine and that tested positive to Covid-19 weeks ago; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 14 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) at the age of 14 years (as reported) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient already got the first and second dose of the vaccine and that tested positive to Covid-19 weeks ago". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The reporter wanted to know if the patient could receive the booster dose of the vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.