chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Low density lipoprotein
Clinical narrative: increased fatiguability; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP) for a Pfizer sponsored program (054550). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Jan2021 (Batch/Lot number: unknown) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Low Amount of Calcium in the Blood" (unspecified if ongoing); "Major Depressive Disorder" (unspecified if ongoing); "EDEMA" (unspecified if ongoing); "joint supplementation" (unspecified if ongoing); "vitamin supplementation" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL 8 HR ARTHRITIS PAIN; ASPIRIN [ACETYLSALICYLIC ACID]; LIPITOR [ATORVASTATIN]; B-COMPLEX [VITAMIN B COMPLEX]; BACITRACIN; CALCIUM CARBONATE AND VITAMIN D taken for blood calcium decreased; CALCIUM MAGNESIUM [CALCIUM;MAGNESIUM]; CHOLECALCIFEROL; PROLIA; CYMBALTA; LASIX [FUROSEMIDE] taken for oedema; NEURONTIN; GLUCOSAMINE & CHONDROITIN COMPLEX taken for supplementation therapy; LECITHIN taken for vitamin supplementation; SYNTHROID; ZESTRIL; MAGNESIUM CHLORIDE; MELATONIN; TOPROL XL; REMERON; LESCOL; CYMBALTA taken for major depression. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "increased fatiguability". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient got her Covid vaccine 16Jan2021 and due second dose on 24Feb2021. Vaccination Facility Type was unknown. Vaccination facility type was unknown. Vaccine Administered at military facility was not reported. No prior Vaccinations within 4 Weeks. It was reported that Increased fatiguability Trying to switch to CYP2C9 agent: Fluvastatin = Lescol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Fatigue, Magnetic resonance imaging, Pain in extremity
Clinical narrative: sore arm; fatigue; This case has been considered invalid as there is no indication that the patient experienced an event.   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 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Feb2021 08:00 (Lot number: EM9810) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2015 (unspecified if ongoing); "Lichen sclerosus" (ongoing); "Cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "high Blood pressure" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing), notes: Various times; "Vitamin D low" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Muscle relaxant" (unspecified if ongoing); "Hair loss" (unspecified if ongoing); "back pain", start date: 06Feb2021 (ongoing); "preseptal cellulitis eyelid", start date: 06Feb2021 (ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol (ongoing); JARDIANCE DUO taken for diabetes mellitus (ongoing); METFORMIN taken for diabetes mellitus, start date: 2020 (ongoing); VALSARTAN + HIDROCLOROTIAZIDA taken for blood pressure measurement (ongoing); UROCIT-K taken for nephrolithiasis (ongoing); VITAMIN D [COLECALCIFEROL] taken for vitamin d decreased (ongoing); ALLEGRA taken for hypersensitivity (ongoing); ARIMIDEX taken for depression (ongoing); CLOBETASOL PROPIONATE taken for lichen sclerosus (ongoing); CEPHALEXIN [CEFALEXIN] taken for periorbital cellulitis, start date: 06Feb2021, stop date: 11Feb2021; MELOXICAM taken for back pain, start date: 11Feb2021 (ongoing); CYCLOBENZAPRINE HCL taken for muscle relaxant therapy (ongoing); LIDOCAINE HCL taken for back pain, start date: 11Feb2021 (ongoing); TYLENOL taken for back pain, start date: 08Feb2021; ANASTROZOLE; CLOBETASOL PROPIONATE; UROCIT K; JARDIANCE; TRADJENTA. Vaccination history included: Bnt162b2 (1st dose Time: 14:00 in the right arm. Lot: EL9261, Anatomical location - Arm right, Time: Afternoon, Route of administration: Intramuscular), administration date: 20Jan2021, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:It was fine. Sore arm both times at a little fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: sore arm; fatigue; This case has been considered invalid as there is no indication that the patient experienced an event.   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 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Feb2021 08:00 (Lot number: EM9810) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2015 (unspecified if ongoing); "Lichen sclerosus" (ongoing); "Cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "high Blood pressure" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing), notes: Various times; "Vitamin D low" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Muscle relaxant" (unspecified if ongoing); "Hair loss" (unspecified if ongoing); "back pain", start date: 06Feb2021 (ongoing); "preseptal cellulitis eyelid", start date: 06Feb2021 (ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol (ongoing); JARDIANCE DUO taken for diabetes mellitus (ongoing); METFORMIN taken for diabetes mellitus, start date: 2020 (ongoing); VALSARTAN + HIDROCLOROTIAZIDA taken for blood pressure measurement (ongoing); UROCIT-K taken for nephrolithiasis (ongoing); VITAMIN D [COLECALCIFEROL] taken for vitamin d decreased (ongoing); ALLEGRA taken for hypersensitivity (ongoing); ARIMIDEX taken for depression (ongoing); CLOBETASOL PROPIONATE taken for lichen sclerosus (ongoing); CEPHALEXIN [CEFALEXIN] taken for periorbital cellulitis, start date: 06Feb2021, stop date: 11Feb2021; MELOXICAM taken for back pain, start date: 11Feb2021 (ongoing); CYCLOBENZAPRINE HCL taken for muscle relaxant therapy (ongoing); LIDOCAINE HCL taken for back pain, start date: 11Feb2021 (ongoing); TYLENOL taken for back pain, start date: 08Feb2021; ANASTROZOLE; CLOBETASOL PROPIONATE; UROCIT K; JARDIANCE; TRADJENTA. Vaccination history included: Bnt162b2 (1st dose Time: 14:00 in the right arm. Lot: EL9261, Anatomical location - Arm right, Time: Afternoon, Route of administration: Intramuscular), administration date: 20Jan2021, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:It was fine. Sore arm both times at a little fatigue.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The initial case was missing the following minimum criteria: Other-Info not qualifying for AE reporting. Upon receipt of follow-up information on 06Apr2021, this case now contains all required information to be considered valid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history not reported. Concomitant medication included ibuprofen. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization. The patient experienced pain in extremity/arm soreness, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Pain at the injection site; sore muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Feb2021 18:44 (Batch/Lot number: unknown) at the age of 78 years 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, SINGLE, Time of vaccination was Given: 18:56, Vaccine location: Upper right arm, Route of administration: Intramuscular, batch/Lot Number: Not available/ provided at time of report completion), administration date: 28Jan2021, when the patient was 78 years old, for Covid-19 immunization, reaction(s): "Pain at the injection site", "sore muscle". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Feb2021 20:00, outcome "recovered" (25Feb2021), described as "Pain at the injection site"; MYALGIA (non-serious) with onset 22Feb2021 20:00, outcome "recovered" (25Feb2021), described as "sore muscle". Therapeutic measures were taken as a result of vaccination site pain, myalgia and treated with Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Product preparation issue
Clinical narrative: sore arm; the nurse administered reconstituted covid vaccine 7 and half hours and it supposed to be 6/ Delayed administration kept cold at 6 degree C; This is a spontaneous report from a contactable Nurse other health care professional. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9266, intramuscular, administered in arm right, administration date 20Feb2021 19:00 (at age of 52-year-old) as dose 2, single for covid-19 immunisation. The patient medical history was none. There was no family medical history. Concomitant medications were not reported. Vaccination history included: Pfizer/biotech covid-19 (Dose:1, Batch/Lot: EL9264, Route:IM, Anatomical site of Injection: LA, No of previous Doses: 0), administration date: 28Jan2021, for COVID-19 immunization. On 20Feb2021, the nurse administered reconstituted covid vaccine 7 and half hours and it supposed to be 6/ Delayed administration kept cold at 6 degree C and on an unspecified date, patient had sore arm. Nurse kept COVID-19 vaccine refrigerated until patient arrived for her second dose. Patient had just been on vacation and flew in, arriving a little late. Call made to Pfizer medical department and received the authorization to administer the vaccine up to 18 hours after reconstitution if the product was kept cold. The patient received the vaccine 7.5 hours after reconstitution, well within time allowed. Because the CDC site states that any administration over 6 hours should be considered an adverse event, this was reported as such. There was no true adverse event. The patient reported a sore arm, but no other side effects. There was no relevant test. The clinical outcome of the event sore arm was unknown and for other event it was recovered.  Information on the lot/batch number has been requested.  Follow-up (20Apr2021): This is a follow up-spontaneous report from a contactable Nurse. Updated information: Age, gender, product information, start date, new event and narrative updated.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Fatigue, Headache, Laboratory test, Nausea
Clinical narrative: Headache; Fatigue / Tiredness; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558).  A 80 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Jan2021 10:00 (Lot number: EL9263, Expiration Date: 31May2021) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Short of breath", start date: 12Jan2021 (ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 28Jan2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 28Jan2021, outcome "unknown", described as "Fatigue / Tiredness"; NAUSEA (non-serious) with onset 28Jan2021, outcome "unknown", described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021762946 same patient, vaccine, events; different dose
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Headache; Fatigue / Tiredness; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558).  A 80 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Jan2021 10:00 (Lot number: EL9263, Expiration Date: 31May2021) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Short of breath", start date: 12Jan2021 (ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 28Jan2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 28Jan2021, outcome "unknown", described as "Fatigue / Tiredness"; NAUSEA (non-serious) with onset 28Jan2021, outcome "unknown", described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021762946 same patient, vaccine, events; different dose
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain in extremity, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Sore arms; Sore shoulders; Fatigue; Runny nose; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Feb2021 at 08:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included acromegaly. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On an unknown date in Dec2020, the patient underwent SARS-COV-2 test (saliva test) and the result was negative. On 24Feb2021, the patient experienced sore arms and shoulders, fatigue and runny nose. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arms, sore shoulders, fatigue and runny nose were recovered on an unknown date in 2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended Reporter first name and last name.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache
Clinical narrative: chills; mild HA; felt cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 67 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Mar2021 12:00 (Lot number: EN6199) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL taken for pain in extremity, headache, start date: 16Feb2021, stop date: 11Mar2021; POLYSPORIN COMPLETE taken for pain in extremity, start date: 09Mar2021, stop date: 15Mar2021. Vaccination history included: Bnt162b2 (Dose 1, Single; 12:15; Batch/Lot number: EL9267; Intramuscular, Anatomical site of injection: Right arm), administration date: 16Feb2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "Headache", "Dizziness", "Nausea", "Fatigue", "Photophobia", "Right arm pain".  The following information was reported: FEELING COLD (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "felt cold"; CHILLS (non-serious) with onset 09Mar2021 18:00, outcome "recovered" (09Mar2021), described as "chills"; HEADACHE (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "mild HA". Therapeutic measures were not taken as a result of feeling cold, chills.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Headache, Influenza like illness, Pain, Toothache
Clinical narrative: She was advised to take Antibiotics now; aches in body and teeth; flu like symptoms; headache; aches in body and teeth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A 74 year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), administered in arm left, administration date 10Feb2021 (Lot number: EK4176) at the age of 74 years as dose 1, single and administered in arm left, administration date 03Mar2021 (Lot number: EK4176) as dose 2, single for covid-19 immunisation. Relevant medical history included: "overactive bladder" (ongoing). Concomitant medication(s) included: OXYBUTYNIN taken for hypertonic bladder (ongoing).  It was reported that caller had her first dose 2 weeks ago and scheduled for a second dose on Wednesday (02Mar2021), but she was advised to take Antibiotics now. On 14Feb2021, the patient experienced aches in body and teeth, flu like symptoms, headache. On 04Mar2021, the patient experienced same events. Treatment received no. The outcome of events was resolved on an unknown date in 2021.  Follow-up (01Apr2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to Non-HCP letter sent via follow-up letter which included that: patient age, relevant medical history, suspect: BNT162B2 dosage details added, concomitant medication added, new non-serious events added. Narrative updated.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slightly sore arm- (3-4days); This is a spontaneous report from a contactable consumer (patient) received from a regulatory authority. A 72-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, lot number: EM9809), intramuscular on 25Feb2021 as dose 2, single and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, lot number: EN5318), via an intramuscular on 04Feb2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experience slightly sore arm- (3-4days). The outcome of event was unknown.  No follow up attempts are needed; information on Lot/batch cannot be requested.  Follow-up (09Apr2021): This is a follow-up spontaneous report received from a contactable consumer. Updated information included patient's age, second dose information, route of administration, new event added as slightly sore arm, missed dose event deleted, vaccine facility information, lot numbers for both doses,   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Multiple allergies
Clinical narrative: She is dealing with allergies, which is very common; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (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: MULTIPLE ALLERGIES (non-serious) with onset Feb2021, outcome "unknown", described as "She is dealing with allergies, which is very common".  Follow-up (01Apr2021/02Apr2021) This is a follow-up spontaneous report from a regulatory authority. A contactable female consumer (patient) reported for herself that: New Event allergies was added and case became valid in follow up.  Additional information: Caller (Name with held) was fully vaccinated in February and it made her very happy. She is dealing with allergies, which is very common. She mentioned that this pandemic has no ending and she hadn't seen anything like this before. She is thankful she's living at this time and we are absolutely blessed. She also mentioned that she decided to get the vaccine not just for herself but for everyone too and she's glad she chose Pfizer. (Name with held) is asking if Pfizer is a specific country company. She also saw on the news that people are praising Pfizer to the moon but they made a statement that people who are vaccinated will only last for 6 months and she wants to know if that's true and asking what will happen after that. She is also asking if that will depend on the age, she shared that for her age, she's in good shape and really had no side effects.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Hypertension, Malaise
Clinical narrative: She is dealing with allergies, which is very common; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (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: MULTIPLE ALLERGIES (non-serious) with onset Feb2021, outcome "unknown", described as "She is dealing with allergies, which is very common".  Follow-up (01Apr2021/02Apr2021) This is a follow-up spontaneous report from a regulatory authority. A contactable female consumer (patient) reported for herself that: New Event allergies was added and case became valid in follow up.  Additional information: Caller (Name with held) was fully vaccinated in February and it made her very happy. She is dealing with allergies, which is very common. She mentioned that this pandemic has no ending and she hadn't seen anything like this before. She is thankful she's living at this time and we are absolutely blessed. She also mentioned that she decided to get the vaccine not just for herself but for everyone too and she's glad she chose Pfizer. (Name with held) is asking if Pfizer is a specific country company. She also saw on the news that people are praising Pfizer to the moon but they made a statement that people who are vaccinated will only last for 6 months and she wants to know if that's true and asking what will happen after that. She is also asking if that will depend on the age, she shared that for her age, she's in good shape and really had no side effects.   Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: He is not feeling well. He has a cold; He is not feeling well. He has a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021422759 (Pfizer).  A male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (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: NASOPHARYNGITIS (non-serious), MALAISE (non-serious) all with onset 2021, outcome "unknown" and all described as "He is not feeling well. He has a cold".  Additional information: Patient was asking if it was okay to have tooth extraction day before his 2nd dose schedule (23Mar2021). He got his 1st dose on 03MAR2021 and his 2nd dose schedule 24MAR2021. Patient stated that he made his inquiry a long time ago and does not need this information at the time.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Somnolence
Clinical narrative: Felt groggy; unfocused after first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (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: SOMNOLENCE (non-serious) with onset 23Mar2021 22:00, outcome "recovered", described as "Felt groggy"; DISTURBANCE IN ATTENTION (non-serious) with onset 23Mar2021 22:00, outcome "recovered", described as "unfocused after first shot". Therapeutic measures were not taken as a result of somnolence, disturbance in attention.  Additional information:  It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine: and within 2 weeks of vaccination. It was unknown if  the patient diagnosed with COVID-19 Prior to vaccination. Since the vaccination, it was unknown if the patient been tested for COVID-19. Allergies to medications, food, or other products: Unknown. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines: I became aware of the event the evening of 23Mar2021  approximately 10:00PM. If it is convenient, could you kindly provide the contact info for the person who is reporting to you: Response: I do not have his contact information. this was a comment on social media. All I know is he lives in (With held).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: my tinnitus has at least doubled in intensity / constant and does not come and go; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 11:15 (Lot number: EN6202) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "minor tinnitus" (unspecified if ongoing), notes: since teenage years; usually at times when extremely tired or stressed; "extremely tired" (unspecified if ongoing); "stressed" (unspecified if ongoing); "pain" (unspecified if ongoing); "bothersome" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Niacin, reaction(s): "known allergies", notes: oral tablet. The following information was reported: TINNITUS (non-serious) with onset 18Mar2021 15:00, outcome "not recovered", described as "my tinnitus has at least doubled in intensity / constant and does not come and go". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Prior the vaccination, the patient's tinnitus (mild) and it symptoms would come and go. A pain, yes, bothersome, not usually. Its symptoms where annoying, but it was not very troublesome and was very manageable. It was usually at times when the patient was extremely tired or stressed. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was reported that since the patient got the first Pfizer injection, her tinnitus has at least doubled in intensity; and was constant and does not come and go. The patient's second Pfizer injection was scheduled on Friday (as reported) and he would like to know if he should go through with it or put it on the back-burner for a couple of more weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersomnia, Somnolence
Clinical narrative: very drowsy/ very drowsy, kind of a floating feeling; sleeps a lot, normally she doesn't sleep that much; Feeling a little bit cloudy, floating, weird/feels like her brain is over relaxed; 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 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 (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: SOMNOLENCE (non-serious) with onset Mar2021, outcome "unknown", described as "very drowsy/ very drowsy, kind of a floating feeling"; HYPERSOMNIA (non-serious) with onset Mar2021, outcome "unknown", described as "sleeps a lot, normally she doesn't sleep that much"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "Feeling a little bit cloudy, floating, weird/feels like her brain is over relaxed".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Poor quality sleep, Tinnitus
Clinical narrative: He didn't sleep good; Tinnitus was reported as worsened / sound was buzzing more; 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 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 09:00 (Lot number: EN6206) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu shot. The following information was reported: TINNITUS (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Tinnitus was reported as worsened / sound was buzzing more"; POOR QUALITY SLEEP (non-serious) with onset 28Mar2021, outcome "unknown", described as "He didn't sleep good". The event "tinnitus was reported as worsened / sound was buzzing more" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that he had it about four days in a row when he was listening to music, it sounded like the music was broke and crackling. The events did not result to ER visit. The patient had not received any other vaccines within 4 weeks prior vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: I still have pain in that arm where injection was given. Whole area is still hurting; I still have pain in that arm where injection was given. Whole area is still hurting; 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 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 13:30 (Lot number: EP7534) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heartburn" (ongoing); "Depression" (ongoing); "Cholesterol" (ongoing). Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM] taken for dyspepsia, start date: 2006 (ongoing); EFFEXOR taken for depression, start date: 2006 (ongoing); LIPITOR [ATORVASTATIN] taken for blood cholesterol abnormal, start date: 2006 (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 15Mar2021, outcome "recovering" and all described as "I still have pain in that arm where injection was given. Whole area is still hurting". Therapeutic measures were taken as a result of vaccination site pain, pain in extremity.  Additional information: There were no additional vaccines administered on the same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated pain in arm began probably within 30 minutes after the shot. She treated the pain with ibuprofen by mouth and has reported that it has improved but still hurts.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Burning sensation, Electric shock sensation, Feeling abnormal
Clinical narrative: mild headache; felt like they have pushed a ball through there, inside of me / she felt like there was a bow inside of her arm; it felt like an electric discharge; pain in my armpit; my breast, on the side that is close to my armpit, it hurts; I feel like a burning, on the same side the injection was applied; 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), administered in arm, administration date 24Mar2021 (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, single), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "mild headache"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "felt like they have pushed a ball through there, inside of me / she felt like there was a bow inside of her arm"; ELECTRIC SHOCK SENSATION (non-serious) with onset Mar2021, outcome "unknown", described as "it felt like an electric discharge"; AXILLARY PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain in my armpit"; BREAST PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "my breast, on the side that is close to my armpit, it hurts"; BURNING SENSATION (non-serious) with onset Mar2021, outcome "unknown", described as "I feel like a burning, on the same side the injection was applied". Therapeutic measures were taken as a result of headache.  Additional information: It was reported that when the patient touch where it hurts, the pain goes away. Those are the only symptoms the patient experienced as well as a mild headache that went away with unspecified medication (the same day the vaccine was received).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache; felt like they have pushed a ball through there, inside of me / she felt like there was a bow inside of her arm; it felt like an electric discharge; pain in my armpit; my breast, on the side that is close to my armpit, it hurts; I feel like a burning, on the same side the injection was applied; 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), administered in arm, administration date 24Mar2021 (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, single), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "mild headache"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "felt like they have pushed a ball through there, inside of me / she felt like there was a bow inside of her arm"; ELECTRIC SHOCK SENSATION (non-serious) with onset Mar2021, outcome "unknown", described as "it felt like an electric discharge"; AXILLARY PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain in my armpit"; BREAST PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "my breast, on the side that is close to my armpit, it hurts"; BURNING SENSATION (non-serious) with onset Mar2021, outcome "unknown", described as "I feel like a burning, on the same side the injection was applied". Therapeutic measures were taken as a result of headache.  Additional information: It was reported that when the patient touch where it hurts, the pain goes away. Those are the only symptoms the patient experienced as well as a mild headache that went away with unspecified medication (the same day the vaccine was received).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: bad pain in left arm (worsened); 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 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 16Mar2021 15:00 (Lot number: EN6205) at the age of 41 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: VACCINATION SITE PAIN (non-serious) with onset 16Mar2021, outcome "not recovered", described as "bad pain in left arm (worsened)". Therapeutic measures were taken as a result of vaccination site pain. Additional information: It was also reported that the patient was unable to dress herself due to the left arm pain. When she rests her arm, the pain goes away. But when she moves her arm, the pain comes back. Treatment included unspecified pain medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has no family medical history relevant to the event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Aphonia, Asthenia, Chills, Diarrhoea
Clinical narrative: lost her voice; feeling bad; bad headaches; weakness; pain in the ribs and stomach; pain in the ribs and stomach; chills; diarrhea for 3 days; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (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: FEELING ABNORMAL (non-serious) with onset 25Mar2021, outcome "unknown", described as "feeling bad"; HEADACHE (non-serious) with onset 25Mar2021, outcome "unknown", described as "bad headaches"; ASTHENIA (non-serious) with onset 25Mar2021, outcome "unknown", described as "weakness"; MUSCULOSKELETAL CHEST PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious) all with onset 25Mar2021, outcome "unknown" and all described as "pain in the ribs and stomach"; CHILLS (non-serious) with onset 25Mar2021, outcome "unknown", described as "chills"; DIARRHOEA (non-serious) with onset 25Mar2021, outcome "recovered" (28Mar2021), described as "diarrhea for 3 days"; OROPHARYNGEAL PAIN (non-serious) with onset 25Mar2021, outcome "unknown", described as "sore throat"; APHONIA (non-serious) with onset 27Mar2021, outcome "unknown", described as "lost her voice". Additional information: The patient was wondering if it was normal to have these adverse events a week later after getting vaccinated. The patient was also concerned about her second dose because she will have her Stelara injection on the date of her 2nd dose of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Musculoskeletal chest pain, Oropharyngeal pain
Clinical narrative: lost her voice; feeling bad; bad headaches; weakness; pain in the ribs and stomach; pain in the ribs and stomach; chills; diarrhea for 3 days; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (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: FEELING ABNORMAL (non-serious) with onset 25Mar2021, outcome "unknown", described as "feeling bad"; HEADACHE (non-serious) with onset 25Mar2021, outcome "unknown", described as "bad headaches"; ASTHENIA (non-serious) with onset 25Mar2021, outcome "unknown", described as "weakness"; MUSCULOSKELETAL CHEST PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious) all with onset 25Mar2021, outcome "unknown" and all described as "pain in the ribs and stomach"; CHILLS (non-serious) with onset 25Mar2021, outcome "unknown", described as "chills"; DIARRHOEA (non-serious) with onset 25Mar2021, outcome "recovered" (28Mar2021), described as "diarrhea for 3 days"; OROPHARYNGEAL PAIN (non-serious) with onset 25Mar2021, outcome "unknown", described as "sore throat"; APHONIA (non-serious) with onset 27Mar2021, outcome "unknown", described as "lost her voice". Additional information: The patient was wondering if it was normal to have these adverse events a week later after getting vaccinated. The patient was also concerned about her second dose because she will have her Stelara injection on the date of her 2nd dose of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Balance disorder, Blood pressure inadequately controlled, Fatigue
Clinical narrative: a little bit unbalanced; she noticed constant hypertension, has not been able to control it/high blood pressure; nausea; tiredness; anxiety attacks; she woke up feeling unwell; weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021354605.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 15:30 (Lot number: EN6208) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension" (ongoing); "cancer" (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL taken for hypertension (ongoing). The following information was reported: MALAISE (non-serious) with onset 24Mar2021, outcome "unknown", described as "she woke up feeling unwell"; BLOOD PRESSURE INADEQUATELY CONTROLLED (non-serious) with onset 25Mar2021, outcome "unknown", described as "she noticed constant hypertension, has not been able to control it/high blood pressure"; NAUSEA (non-serious) with onset 25Mar2021, outcome "unknown", described as "nausea"; FATIGUE (non-serious) with onset 25Mar2021, outcome "unknown", described as "tiredness"; ANXIETY (non-serious) with onset 25Mar2021, outcome "unknown", described as "anxiety attacks"; ASTHENIA (non-serious) with onset Mar2021, outcome "unknown", described as "weak"; BALANCE DISORDER (non-serious) with onset 31Mar2021, outcome "unknown", described as "a little bit unbalanced". Therapeutic measures were taken as a result of hypertension.  Additional information: There were no additional vaccines administered on the same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated she received Pfizer Vaccine was on Tuesday and her blood pressure increased, had constant hypertension, and has not been able to control it, on Thursday (25Mar2021) at night and then yesterday at night. So whenever the blood pressure went up she took her pill of Enalapril and whenever she takes the Enalapril the blood pressure goes down and after that the feeling of anxiety came and she was too weak and was tired; stated the Enalapril 10mg she takes and would not take it this way if she weren't feeling like this but has taken it once per day and since that feeling started she takes it twice per day and three times per day. Patient also stated today she was feeling better and her blood pressure went up last night and she had anxiety and then took her blood pressure pill Enalapril and today she was tired and a little bit unbalanced. Events did not result to emergency room and physician office visit.  No follow-up attempts are possible. No further information is expected.