chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Erythema, Feeling abnormal, Gastrointestinal pain, Menstrual disorder
Clinical narrative: This is a spontaneous report from a contactable Other-HCP (patient, self-reported). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK9231 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on an unspecified date (age at vaccination: 31 years), as a single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL1283 and expiry date was not reported), via an unspecified route of administration, Arm Left, on 30Dec2020 (age at vaccination: 31 years), as a single dose for COVID-19 immunization at workplace clinic. The patient was not pregnant at the time of vaccination. The patient's medical history was not reported. Past drug event included genetically tested to diazepam allergy. The patient had 4 children and last born in May2020. She was not nursing when vaccinated. Concomitant medications included L-methylfolate, vitamin B complex, cyanocobalamin (B12), and lamotrigine (LAMOT). 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 was not tested for COVID-19. The patient reported that she started with a few hives on her elbows at the end of Jan2021, then her entire body was covered in large hives (red, warm, raised, itchy) almost every day. She spoke with NP and tried oral steroids, and multiple antihistamines with no relief. She stopped all meds and supplements. She spoke with immunologist and started on multiple antihistamines daily. She had no relief and at times worsened and started on xolair injections. Xolair was the only medication that has helped. There were still hives but not every day and not head to toe like they were. She also has to take antihistamines. When she didn't, she break out in more hives. She has taken multiple pictures to document. Since Jan2021, she was struggled with abnormal menstrual cycles, gut issues, severe brain fog, edema, angioedema, along with the hives. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse events which included mult. meds, stopped all current meds, and Xolair. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of angioedema 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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report from a contactable Other-HCP (patient, self-reported). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK9231 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on an unspecified date (age at vaccination: 31 years), as a single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL1283 and expiry date was not reported), via an unspecified route of administration, Arm Left, on 30Dec2020 (age at vaccination: 31 years), as a single dose for COVID-19 immunization at workplace clinic. The patient was not pregnant at the time of vaccination. The patient's medical history was not reported. Past drug event included genetically tested to diazepam allergy. The patient had 4 children and last born in May2020. She was not nursing when vaccinated. Concomitant medications included L-methylfolate, vitamin B complex, cyanocobalamin (B12), and lamotrigine (LAMOT). 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 was not tested for COVID-19. The patient reported that she started with a few hives on her elbows at the end of Jan2021, then her entire body was covered in large hives (red, warm, raised, itchy) almost every day. She spoke with NP and tried oral steroids, and multiple antihistamines with no relief. She stopped all meds and supplements. She spoke with immunologist and started on multiple antihistamines daily. She had no relief and at times worsened and started on xolair injections. Xolair was the only medication that has helped. There were still hives but not every day and not head to toe like they were. She also has to take antihistamines. When she didn't, she break out in more hives. She has taken multiple pictures to document. Since Jan2021, she was struggled with abnormal menstrual cycles, gut issues, severe brain fog, edema, angioedema, along with the hives. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse events which included mult. meds, stopped all current meds, and Xolair. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of angioedema 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.
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, SARS-CoV-2 test, Sensory neuropathy hereditary, Vaginal infection
Clinical narrative: Infection in vagina area; yeast infection; HSN1; This is a spontaneous report from a contactable consumer (patient). A female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178), via an unspecified route of administration in arm left on an unspecified date as a dose 1, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0181), via an unspecified route of administration in arm left on an unspecified date as a dose 2, single for COVID-19 immunisation. The patient's medical history included diabetes. The patient had allergies to strawberries, pineapple, tomatoes, nuts. The patient's concomitant medications within 2 weeks of vaccination included levocetirizine dihydrochloride (XYZAL), ergocalciferol (VIT D), biotin, probiotic, dulaglutide (TRULICITY), metformin hydrochloride (METFOR). It was reported that, the patient was not pregnant at time of vaccination. 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, has the patient been tested for COVID-19 was reported as yes. On 07Jun2021, the patient experienced infection in vagina area, yeast infection, HSN1. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not had prolonged hospitalization. Treatment medications included ceohalexin, fluconazole and metformin. On 15Jun2021, the patient underwent lab tests and procedures which included nasal swab, resulted as negative. The outcome of the events was resolving.  Information about lot/batch number was provided. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Maternal exposure during pregnancy, Peripheral swelling, Vaccination site erythema
Clinical narrative: I still have swollen arm and i had 4 days of strong sweat. The application site still has a slight red spot.; I still have a swollen arm; I still have swollen arm and i had 4 days of strong sweat.; The application site still has a slight red spot; This is a spontaneous report from a contactable consumer (patient). A 34-years-old female pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: unspecified, Pfizer), via an unspecified route of administration in left arm on 08Jun2021 at 16:45 (at the age of 34-years-old) as unknown, single for covid-19 immunization. The patient medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. The patient did not receive any other medication in 2 weeks. The patient did not receive any other vaccines within 4 weeks. On 09Jun2021, the patient stated that she still had swollen arm and had 4 days of strong sweat. The application site still had a slight red spot. The mother reported she became pregnant while taking bnt162b2. The mother was 24 Weeks pregnant at the onset of the event. The mother was due to deliver on 29Sep2021. The patient did not receive ant treatment for the events. The clinical outcome for the event was not recovered for events except for event exposure during pregnancy which was unknown.  Information on the lot/batch number has been requested.  Amendment- This follow up is being submitted to amend previously reported information:To delete classification At Risk from general tab.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Joint noise, Pain, SARS-CoV-2 test
Clinical narrative: the patient experienced left knee joint pain and creeking; I wanted to die rather than endure the pain any longer; 6 hours of all joints pain and body aches; Worried I won't be able o walk or use my hands again; 6 hours of all joints pain and body aches/Left knee joint pain and creeking/Now right knee and all joints hurting all the time.; This is a spontaneous report from a contactable consumer (patient).   A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: En 6198 en 6207) via an unspecified route of administration, in left arm on 18Mar2021 (at the age of 63-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. On 27Mar2021 at 03:00, the patient experienced left knee joint pain and creeking. 6 hours of all joints pain and felt like he wanted to die rather than endure the pain any longer. He said that right knee and all joints was hurting all the time. Worried he won't be able to walk or use his hands again. Have read online of others the same. On 12May2021, the patient underwent lab tests and procedures which included negative sars-cov-2 test (nasal swab). The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Patient received steroids as treatment for the reported events. Outcome of all events was not recovered.  Information on the lot/batch was available, Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Suicidal ideation
Clinical narrative: the patient experienced left knee joint pain and creeking; I wanted to die rather than endure the pain any longer; 6 hours of all joints pain and body aches; Worried I won't be able o walk or use my hands again; 6 hours of all joints pain and body aches/Left knee joint pain and creeking/Now right knee and all joints hurting all the time.; This is a spontaneous report from a contactable consumer (patient).   A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: En 6198 en 6207) via an unspecified route of administration, in left arm on 18Mar2021 (at the age of 63-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. On 27Mar2021 at 03:00, the patient experienced left knee joint pain and creeking. 6 hours of all joints pain and felt like he wanted to die rather than endure the pain any longer. He said that right knee and all joints was hurting all the time. Worried he won't be able to walk or use his hands again. Have read online of others the same. On 12May2021, the patient underwent lab tests and procedures which included negative sars-cov-2 test (nasal swab). The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Patient received steroids as treatment for the reported events. Outcome of all events was not recovered.  Information on the lot/batch was available, Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hallucination, visual, Loss of personal independence in daily activities, Speech disorder
Clinical narrative: This is a spontaneous report from a contactable consumer (parent). A 35-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 25 May 2021 (at the age of 35-years) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced initially visual hallucination, struggling with brain fog and was unable to do her work. Reporter explained it was difficult for her daughter who an attorney and had to supervise people. She added her brain fog was worse yesterday where it "got the point she is having difficulty speaking fluently". Reporter stated that her daughter was crying and has been dealing with this for 3 days and she was unable to do her work because of the brain fog. Her daughter was unable to pronounce some words due to the brain fog. Her daughter doesn't want the second dose. Her daughter was scheduled to get the second dose on 10Jun2021. She didn't get the second dose because she was scared. The outcome of events was unknown. Information on the lot/batch number has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Dry throat, Fatigue, Headache
Clinical narrative: headache; threw up; shallow quick breathing; fever; Injection site sore arm 4 hours after vaccine given; very tire 10 hours after; chills; shallow quick breathing; heart racing; very uncomfortable; dry throat; arm extremely sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 12-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0187), via an unspecified route of administration, administered in Left arm on 06Jun2021 at 09:00 AM (at the age of 12-year-old), as single dose for covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EW0180), via an unspecified route of administration on 25May2021, 09:00 AM administered in left arm as single dose for COVID-19 immunization. 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 and since the vaccination the patient was not tested for COVID 19. On 15Jun2021 at 13:00, the patient experienced injection site sore arm four hours after vaccination/ arm extremely sore; she was very tire 10 hours after chills; had fever; experienced shallow quick breathing, heart racing, dry throat; and she was very uncomfortable. On the same day, she fell asleep about 11:30pm and threw up at 3:00 AM. On 16Jun2021 (on next day), she had headache and still on day 3. Therapeutic measures were taken with Tylenol, cool compress, hydration as a result of reported events. The outcome of event was resolving.  Follow-up attempts are needed. Further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Hypopnoea, Pain in extremity, Palpitations, Pyrexia, Tachypnoea
Clinical narrative: headache; threw up; shallow quick breathing; fever; Injection site sore arm 4 hours after vaccine given; very tire 10 hours after; chills; shallow quick breathing; heart racing; very uncomfortable; dry throat; arm extremely sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 12-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0187), via an unspecified route of administration, administered in Left arm on 06Jun2021 at 09:00 AM (at the age of 12-year-old), as single dose for covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EW0180), via an unspecified route of administration on 25May2021, 09:00 AM administered in left arm as single dose for COVID-19 immunization. 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 and since the vaccination the patient was not tested for COVID 19. On 15Jun2021 at 13:00, the patient experienced injection site sore arm four hours after vaccination/ arm extremely sore; she was very tire 10 hours after chills; had fever; experienced shallow quick breathing, heart racing, dry throat; and she was very uncomfortable. On the same day, she fell asleep about 11:30pm and threw up at 3:00 AM. On 16Jun2021 (on next day), she had headache and still on day 3. Therapeutic measures were taken with Tylenol, cool compress, hydration as a result of reported events. The outcome of event was resolving.  Follow-up attempts are needed. Further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: headache; threw up; shallow quick breathing; fever; Injection site sore arm 4 hours after vaccine given; very tire 10 hours after; chills; shallow quick breathing; heart racing; very uncomfortable; dry throat; arm extremely sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 12-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0187), via an unspecified route of administration, administered in Left arm on 06Jun2021 at 09:00 AM (at the age of 12-year-old), as single dose for covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EW0180), via an unspecified route of administration on 25May2021, 09:00 AM administered in left arm as single dose for COVID-19 immunization. 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 and since the vaccination the patient was not tested for COVID 19. On 15Jun2021 at 13:00, the patient experienced injection site sore arm four hours after vaccination/ arm extremely sore; she was very tire 10 hours after chills; had fever; experienced shallow quick breathing, heart racing, dry throat; and she was very uncomfortable. On the same day, she fell asleep about 11:30pm and threw up at 3:00 AM. On 16Jun2021 (on next day), she had headache and still on day 3. Therapeutic measures were taken with Tylenol, cool compress, hydration as a result of reported events. The outcome of event was resolving.  Follow-up attempts are needed. Further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac monitoring, Chest X-ray, Feeling hot, Heart rate
Clinical narrative: Pulse rate 150/min; I felt warm on my left arm and whole back; tremors; Blood pressure check 150/89; This is a spontaneous report from a contactable Nurse (patient herself). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0217; Expiration date: unknown) an unspecified route of administration, administered in Arm Left on 15Jun2021 13:15 (Batch/Lot Number: EW0217) as single dose for COVID-19 immunization. Medical history included drug hypersensitivity. Concomitant medication included vitamin NOS (MULTIVITAMINS ) taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. It was reported that within 20 minutes after the vaccination on 15Jun2021 13:30 she felt warm on left arm and whole back, tremors. blood pressure checked and it was 150/89 and pulse rate 150/min. The adverse event resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events as patient received treatment with pepcid, cardiac monitoring and chest x-ray. The patient underwent lab tests and procedures which included blood pressure measurement: 150/89 on 15Jun2021, on Jun2021 cardiac monitoring, chest x-ray results not reported and heart rate: 150/min on 15Jun2021. The outcome of events was recovering.   Further information has been requested.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the event "tachycardia" 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Tachycardia, Tremor
Clinical narrative: Pulse rate 150/min; I felt warm on my left arm and whole back; tremors; Blood pressure check 150/89; This is a spontaneous report from a contactable Nurse (patient herself). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0217; Expiration date: unknown) an unspecified route of administration, administered in Arm Left on 15Jun2021 13:15 (Batch/Lot Number: EW0217) as single dose for COVID-19 immunization. Medical history included drug hypersensitivity. Concomitant medication included vitamin NOS (MULTIVITAMINS ) taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. It was reported that within 20 minutes after the vaccination on 15Jun2021 13:30 she felt warm on left arm and whole back, tremors. blood pressure checked and it was 150/89 and pulse rate 150/min. The adverse event resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events as patient received treatment with pepcid, cardiac monitoring and chest x-ray. The patient underwent lab tests and procedures which included blood pressure measurement: 150/89 on 15Jun2021, on Jun2021 cardiac monitoring, chest x-ray results not reported and heart rate: 150/min on 15Jun2021. The outcome of events was recovering.   Further information has been requested.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the event "tachycardia" 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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: pt states she allergic reaction to the covid vaccine when she received the first dose; This is a spontaneous report from a contactable nurse. A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date as single dose for COVID-19 Immunisation. The patient's medical history and concomitant medications were not reported. Past medication history included tofacitinib citrate (XELJANZ XR, 11 mg, Tablet (30'S), Lot number: Unknown, Expiration date: 28Feb2023) orally, daily in the spring season 2019. The patient stated, she had allergic reaction to the Covid vaccine when she received the first dose. Outcome of the event was unknown. No additional information provided.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lip swelling, Lymphadenitis
Clinical narrative: Lips are swelling up; bottom lip; Lymph node are inflamed; Had a little bit of tiredness and stuff like that; This is a spontaneous report from a contactable consumer (patient wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 12Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had the Pfizer shot last Saturday (12Jun2021) and his lips were swelling up right now, his bottom lip, his lymph node were inflamed. The patient had a little bit of tiredness and stuff like that but today (16Jun2021) his lips swell up like just now about an hour. Reporter need the information as far as how to proceed, if patient took Benadryl but reporter trying to figure out to take him in or call a doctor or what. Reporter wanted to know, its after hour so what do they do. Reporter was advised to contact the Healthcare professional. Outcome of the events was unknown.  Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Deafness, Migraine, Neck pain, Pain in extremity
Clinical narrative: Muscle aches in legs, upper back, and neck; Muscle aches in legs, upper back, and neck; Muscle aches in legs, upper back, and neck; slight loss of hearing started approximately 2 hours 15 minutes after receiving vaccine; Ringing/hearing loss then accompanied by an oncoming migraine approximately 10 minutes after the start of the tinnitus; Migraine/headache; Drowsy after 1.5 hours of receiving vaccine; This is spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0185 Expiry date unknown) via an unspecified route of administration at right arm on 11Jun2021 08:30 as a single dose for COVID-19 immunization, dose 1 administered at right arm on 19May2021 11:45 (Lot number EW0183 Expiry date unknown) as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. No known allergies were reported. Since the vaccination, the patient had not been tested for COVID-19 and she did not receive any other vaccines within 4 weeks, and she received antibiotics within two weeks of vaccination. On 11Jun2021 10:00 patient felt drowsy after 1.5 hours of receiving vaccine and dissipated after approximately 40 minutes, ringing in right ear accompanied by slight loss of hearing started approximately 2 hours 15 minutes after receiving vaccine, ringing/hearing loss then accompanied by an oncoming migraine approximately 10 minutes after the start of the tinnitus, on 12Jun2021 muscle aches in legs, upper back, and neck. Muscles aches lasted around 3 hours. No further side effects after the muscle aches went away. No further side effects until approximately 20 hours later. Treatment received was Tylenol taken to alleviate the headache before it became worse. Headache and ringing in ear began to dissipate after 15 minutes of taking Tylenol. The outcome of the event slight loss of hearing was recovered on an unknown date in June2021, drowsy after 1.5 hours of receiving vaccine, ringing, migraine/headache was recovered on 11Jun2021 and muscle aches in legs, upper back, and neck recovered on 12Jun2021.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tinnitus
Clinical narrative: Muscle aches in legs, upper back, and neck; Muscle aches in legs, upper back, and neck; Muscle aches in legs, upper back, and neck; slight loss of hearing started approximately 2 hours 15 minutes after receiving vaccine; Ringing/hearing loss then accompanied by an oncoming migraine approximately 10 minutes after the start of the tinnitus; Migraine/headache; Drowsy after 1.5 hours of receiving vaccine; This is spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0185 Expiry date unknown) via an unspecified route of administration at right arm on 11Jun2021 08:30 as a single dose for COVID-19 immunization, dose 1 administered at right arm on 19May2021 11:45 (Lot number EW0183 Expiry date unknown) as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. No known allergies were reported. Since the vaccination, the patient had not been tested for COVID-19 and she did not receive any other vaccines within 4 weeks, and she received antibiotics within two weeks of vaccination. On 11Jun2021 10:00 patient felt drowsy after 1.5 hours of receiving vaccine and dissipated after approximately 40 minutes, ringing in right ear accompanied by slight loss of hearing started approximately 2 hours 15 minutes after receiving vaccine, ringing/hearing loss then accompanied by an oncoming migraine approximately 10 minutes after the start of the tinnitus, on 12Jun2021 muscle aches in legs, upper back, and neck. Muscles aches lasted around 3 hours. No further side effects after the muscle aches went away. No further side effects until approximately 20 hours later. Treatment received was Tylenol taken to alleviate the headache before it became worse. Headache and ringing in ear began to dissipate after 15 minutes of taking Tylenol. The outcome of the event slight loss of hearing was recovered on an unknown date in June2021, drowsy after 1.5 hours of receiving vaccine, ringing, migraine/headache was recovered on 11Jun2021 and muscle aches in legs, upper back, and neck recovered on 12Jun2021.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: not feeling well, cough, congested, achy and possible symptoms of covid 19; This is a spontaneous report received from a contactable consumer or other non health care professional (patient's mother). A 19-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on 13Mar2021 (at the age of 19-year-old), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not provided. On 14Mar2021 the patient started not feeling well, cough, congested, achy and possible symptoms of COVID-19. The patient underwent lab tests and procedures which included: SARS-CoV-2 test: positive on 16Mar2021. The reporter was concerned about whether the patient be able to get the second dose of vaccine. The outcome of events was not provided.  Product Complaint: There is no product complaint associated with this case.  Information about batch/Lot number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash pruritic
Clinical narrative: burning and itching rash on hand and wrist (same side as injection); burning and itching rash on hand and wrist (same side as injection); This is a spontaneous report from a contactable physician. A 14-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported, age at vaccination 14 years), via an unspecified route of administration on 15Jun2021 as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. Since the vaccination, the patient has not been tested for COVID-19. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. The patient experienced burning and itching rash on hand and wrist (same side as injection) on 16Jun2021. The patient was treated with topical steroid for events. The outcome of the events was not recovered.  Information regarding lot/batch number has been requested ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Itchy rash and the suspect drug BNT162B2. Also, as there is limited information in the case provided, the causal association between the events Burning sensation 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.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test
Clinical narrative: Two weeks after first dose pt developed diarrhea.; This is a spontaneous report from a contactable physician. A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included eczema. The patient had no known allergies. The patient had no covid prior vaccination. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient had other vaccine in four weeks. It was reported that in Apr2021, two weeks after first dose, the patient developed diarrhea. Given symptom improvement. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient received treatment with Steroids, Infliximab. The patient underwent covid test post vaccination (Nasal Swab) which was Negative on 26May2021 and 01Jun2021. Outcome of the event was recovering.  Information on the lot/batch number has been requested. ; Sender's Comments: As there is temporal relationship in the case provided, the causal association between the events and the suspect drug 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.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Colectomy, Colitis ulcerative, Condition aggravated, Cytomegalovirus colitis
Clinical narrative: Two weeks after first dose pt developed diarrhea.; This is a spontaneous report from a contactable physician. A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included eczema. The patient had no known allergies. The patient had no covid prior vaccination. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient had other vaccine in four weeks. It was reported that in Apr2021, two weeks after first dose, the patient developed diarrhea. Given symptom improvement. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient received treatment with Steroids, Infliximab. The patient underwent covid test post vaccination (Nasal Swab) which was Negative on 26May2021 and 01Jun2021. Outcome of the event was recovering.  Information on the lot/batch number has been requested. ; Sender's Comments: As there is temporal relationship in the case provided, the causal association between the events and the suspect drug 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.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pericarditis
Clinical narrative: Felt like I am having a heart attack, it was severe, my chest was tighten up so I had to rushed to the emergency room; Had pericarditis; This is a spontaneous report received from a contactable consumer or other non hcp.  A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch number: ER8736 and Expiration date was not reported), via an unspecified route of administration, on 07Jun2021, Monday (at the age of 46 years), as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications included warfarin taken for anticoagulant therapy, start and stop date were not reported. No other medical condition was reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch number: ER8736 and Expiration date was not reported), via an unspecified route of administration, on 17May2021, as a single dose for covid-19 immunisation. Prior to vaccination, the patient didn't receive any vaccines within 4 weeks. There was no family medical history related to AE. On 09Jun2021, early Wednesday morning, she woke up and was having chest pain and the muscle and stuff in left arm, all that was just radiating pain in her arm, and then in neck area she thought maybe it's just muscle spasm or some-thing like that so she gave it another day or 2.  And Friday night went to bed at 11 and when she woke up Saturday morning itself and felt like she was having a heart attack, it was severe, her chest was tighten up so she had to rushed to the emergency room on 12Jun2021. The end of that the tests and all that and came back and see that she had pericarditis. She was 46 years old and from what she had heard it effects all the younger generation, so she was just kind of, and she still, she trying to talk slow or not to because if she breathes to harder the breast it hurts all day but she still experiencing the pain in her chest like she can lean forward she get relieve but she lay back she can't sleep or anything.  And they gave inflammation medicine Naproxen that get the inflammation down, but she had been, like she said she had been taking it since Saturday and today Thursday and she still feeling bad (further clarification unknown). She doesn't know how long it is going to last and said she 'shall do a' research but she doesn't know. Treatment received included Naproxen 500mg and the pain medication included Tylenol with codeine #3. The lab tests and procedures included Blood work with unknown results. Outcome of the event was unknown. Reporter seriousness for Felt like I am having a heart attack, it was severe, my chest was tighten up so I had to rushed to the emergency room; Had pericarditis was unspecified.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Nasal dryness, Vertigo
Clinical narrative: Nose was so dry; Lot of vertigo; Very dizzy; Felt so weak; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration on 09Jun2021 as DOSE 1, SINGLE for covid-19 immunisation .Medical history and concomitant medications were not reported.The patient experienced lot of vertigo and very dizzy on Jun2021 with outcome of recovered ,felt weak on Jun2021 with outcome of unknown , nose dry on 17Jun2021 with outcome of unknown. Follow-up (18Jun2021):This female patient reported for herself that she felt dizziness for 3 days from a unspecified date after taking 1st dose of Pfizer covid19 vaccine. Caller was unsure if she can take the 2nd dose. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: feels dizzy and with nausea today; feels dizzy and with nausea today; This is a spontaneous report received from a contactable consumer (Patient). A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 17Jun2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 18Jun2021, Patient feels dizzy and with nausea today. The outcome of event was unknown.    Information about batch/Lot number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (reported for himself). A 73-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0170/Batch number was not reported), dose 2 via an unspecified route of administration on 17Jun2021 at 11:00 (at the age of 73-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, The Lot is either ER8737 or FR8737/Batch number was not reported), dose 1 on an unspecified date and via unspecified route of administration (at the age of 73-years-old) as dose 1, single for covid-19 immunization and no reaction exposure to vaccine. On 17Jun2021 at 20:00, the reporter stated that he felt something coming on and reports a fever of 100.6 Fahrenheit and feeling achy and sore. The reporter had paperwork that said he could take acetaminophen, but all he had in his house was aspirin and ibuprofen and enquired if that was ok to take aspirin. It was advised that reporter was unable to provide treatment recommendations. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 17Jun2021. The outcome of the events was unknown.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Pyrexia, Vomiting
Clinical narrative: Chills; Fever; Vomiting like "20 times"; Severe stomach ache like sharp pain; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 2, single for covid-19 immunization at the age of 13-year-old. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for covid-19 immunization.The reported stated that the patient got a worse side effect. On the night of vaccination, the patient experienced side effects of chills, fever and at 4:00, had started vomiting like 20 times and had severe stomach ache like sharp pain. The reporter went to the pediatrician of her son but that did not help and the pediatrician told this symptom is not a COVID vaccine (as reported). The reporter stated that the patient never got sick before and that her son was feeling better at the time of this report. The outcome of the events was recovered. Therapeutics measures were taken for events chills and fever and included acetaminophen (TYLENOL) and ibuprofen (ADVIL).  Information on lot/batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: A 39-years-old female consumer (patient) reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 09Jun2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated had a question about side effects from the COVID vaccine. Stated she received the first dose of the Pfizer COVID last week on Wednesday, 9Jun2021 and this week on Tuesday, 15Jun2021, she started throwing up and nauseous for 24 hours and "still doesn't feel right is it possible to have side effects a week after the dose". On 16Jun2021, 7 days later first dose of vaccine, the patient had diarrhoea. The patient wanted to know was it a normal side effect of vaccine. It was reported that, in clinical trials, reactogenicity symptoms (side effects that happen within 7 days of getting vaccinated) were common but were mostly mild to moderate. The patient declined to provide contact information, declined to file a report, she would like to be transferred for information on side effects. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.