chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Positron emission tomogram
Clinical narrative: I don't feel good today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): EC-2021-101205.  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral since 06Aug2021 (Lot number: 1562116) at 10 mg daily for endometrial cancer. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I don't feel good today". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate was unknown.  Additional information: Patient stated that she don't feel good today. She had a PET scan today and had covid vaccine. She will have blood work and see the oncologist 13 Oct 2021. Patient stated her next infusion was 15 Oct 2021. Instructed patient to call for any questions and concerns. Patient stated that she was okay and had no questions today. There was no drug interaction between the suspect drugs. Dose of LENVIMA was not reduced due to event. LENVIMA was not discontinued due to the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Culture urine, SARS-CoV-2 test, Swelling
Clinical narrative: swollen armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Feb2021 (Lot number: EN6201) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TAMSULIN taken for transurethral prostatectomy, start date: 28Sep2021, stop date: 28Oct2021. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer BioNTech Covid Vaccine, prev dose brand unknown=False, prev dose lot number=EL3302 30mcg/0.3ml, prev dose lot unknown=False, prev dose administration date=21Jan2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 21Jan2021, when the patient was 69 years old, for COVID-19 Immunization, reaction(s): "No adverse effect". The following information was reported: SWELLING (non-serious) with onset 2021, outcome "recovered" (2021), described as "swollen armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling. Additional information: The first shot had no adverse effects. The second shot he had a swollen armpit for several days which went away. The third booster shot he received recently, he had a swollen armpit which was quite large and also the pain radiated to the front and back of his shoulder. It was quite painful and limited the use of his right arm in that he could not extend it without pain. This lasted for about a week and gradually decreased in severity. However, after more than two weeks he still had some shoulder pain and not full use of his right arm. The patient had no known allergies. Prior vaccination, the patient was not diagnosed with Covid-19. Post vaccination, the patient had not been tested for Covid-19. Patient not received other vaccine and medications in four weeks   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Axillary lymph node enlargement in the vaccination arm.; Rash over abdomen and lower back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Oct2021 13:30 (Lot number: 1358A) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Factor 5 Leiden" (unspecified if ongoing), notes: Other medical history:Factor 5 Leiden. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: ER8733, Administration date: 12Apr2021,10:00AM, Dose number: 2, Vaccine location: Left arm), administration date: 12Apr2021, when the patient was 63 years old, for COVID-19 immunization; Bnt162b2 (Lot number: EN6200, Administration date: 2Mar2021,01:00 PM, Dose number: 1, Vaccine location: Left arm), administration date: 22Mar2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 13Oct2021 07:00, outcome "unknown", described as "Axillary lymph node enlargement in the vaccination arm."; RASH (non-serious) with onset 13Oct2021 07:00, outcome "unknown", described as "Rash over abdomen and lower back". Therapeutic measures were not taken as a result of lymphadenopathy, rash.  Additional information: The patient took vaccine at a Pharmacy or Drug Store. The patient had not received any other vaccine in four weeks and no other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient had not been tested for COVID-19 and not having any Known allergies.  No follow-up attempts are possible. No further information is expected.  Follow-up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Lacrimation increased, Sneezing
Clinical narrative: she started with Sneezing, watery and itchy eyes; she started with Sneezing, watery and itchy eyes; she started with Sneezing, watery and itchy eyes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 89 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 29Sep2021 10:00 (Lot number: 301458A) at the age of 89 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetic" (ongoing), notes: Verbatim: Diabetic, Diagnosed: between 15-20 years ago. Family history included: "Allergies" (unspecified if ongoing), notes: Family Medical History Relevant to AE(s): her daughter has allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, LOT: EL9263, Route: Right arm, Manufacturer: Pfizer), administration date: 27Jan2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Route: Right arm), administration date: 16Feb2021, for Covid-19 Immunization. The following information was reported: EYE PRURITUS (non-serious), LACRIMATION INCREASED (non-serious) all with onset 03Oct2021, outcome "recovering" and all described as "she started with Sneezing, watery and itchy eyes"; SNEEZING (non-serious) with onset Oct2021, outcome "recovering".  Additional information: Caller states she received the Pfizer COIVD-19 booster dose and about a week later she started with Sneezing, watery and itchy eyes, feels fines otherwise.  She states she never had allergies before in her life and she did not start any new medications or change anything else. She is wondering if these symptoms could be from the vaccine. She does not feel like she has a cold and has no other symptoms. Additional vaccines administered on same date of the pfizer suspect reported as none. Event does not require to visit emergency room or physicians office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Swelling
Clinical narrative: her entire neck and ears are swollen after taking the covid-19 vaccine; her entire neck and ears are swollen after taking the covid-19 vaccine; This is a spontaneous report received from a non-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 number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), EAR SWELLING (non-serious), outcome "unknown" and all described as "her entire neck and ears are swollen after taking the covid-19 vaccine".  Additional information: reporter said that she was advised to call to report if she experienced any side effects. Reporter mentioned that her entire neck and ears are swollen after taking the covid-19 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: Dehydration, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: extreme fatigue; low grade fever and body aches.; body aches; Experienced a headache; Stated that she feels the headache was due to dehydration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization; Bnt162b2 (Dose 2, Single), for COVID-19 Immunization.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever and body aches."; PAIN (non-serious), outcome "unknown", described as "body aches"; HEADACHE (non-serious), outcome "unknown", described as "Experienced a headache"; DEHYDRATION (non-serious), outcome "unknown", described as "Stated that she feels the headache was due to dehydration". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder
Clinical narrative: I had light flow; I had continual spotting ranging in color; Abnormal Menstrual cycle; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Jul2021 (Lot number: EW0181) at the age of 22 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ehlers-Danlos Syndrome", start date: 26Jan1999 (ongoing), notes: Illness/AE: Ehlers-Danlos Syndrome, Onset Date: Birth, Stop Date (check box if ongoing): ongoing; "Idiopathic Urticaria" (ongoing), notes: Reason for Use: Idiopathic Urticaria, Route: Oral, Start Date: 2018, Check box if ongoing: (Checked); "Pain" (ongoing), notes: Reason for Use: Pain, Route: Oral, Start Date: 2021, Check box if ongoing: (Checked); "GERD" (ongoing), notes: Reason for Use: GERD, Route: Oral, Start Date: 2020, Check box if ongoing: (Checked). Concomitant medication(s) included: SINGULAIR taken for idiopathic urticaria, start date: 2018 (ongoing); MELOXICAM taken for pain, start date: 2021 (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease, start date: 2020 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Anatomical Site of injection : Right Deltoid, Batch/Lot number - FA6780, Route of administration: Intramuscular, Date: 02Jul2021, Site and Route of injection, Anatomical Site of injection: Right deltoid, Route of administration: Intramuscular, Batch/Lot number: FA6780), administration date: 02Jul2021, for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 20Aug2021, outcome "not recovered", described as "Abnormal Menstrual cycle"; INTERMENSTRUAL BLEEDING (non-serious) with onset 28Aug2021, outcome "recovered" (2021), described as "I had continual spotting ranging in color"; MENSTRUAL DISORDER (non-serious) with onset 06Sep2021, outcome "recovered" (09Sep2021), described as "I had light flow". The event "abnormal menstrual cycle" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: From 20Aug - 23Aug Patient had an abnormal period where she was only shedding the lining without much blood. 28Aug - 05Sep she had continual spotting ranging in color. From 06Sep - 09Sep she had light flow. From 10Sep - 22Sep she had continual spotting ranging in color from bright red to black. she had not had a normal period since 02Oct2021. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. Prior Vaccination was reported None. VACCINATION FACILITY TYPE reported as Pharmacy or Drug Store. FAMILY MEDICAL HISTORY RELEVANT TO AE(S) reported as None  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chest discomfort, Dizziness, Headache
Clinical narrative: I felt awful; I just felt weak; Nauseous; Arm hurt really bad; I felt awful; I just felt weak; Headache; My chest felt really heavy, not super short of breath, just a heavy feeling; It could be the anxiety of not being sure; 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 29 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 12Oct2021 07:00 (Lot number: FE3590) at the age of 29 years 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: DIZZINESS (non-serious) with onset 13Oct2021, outcome "recovering", NAUSEA (non-serious) with onset 13Oct2021, outcome "recovering" and all described as "Nauseous"; PAIN IN EXTREMITY (non-serious) with onset 13Oct2021, outcome "recovering", described as "Arm hurt really bad"; CHEST DISCOMFORT (non-serious) with onset Oct2021, outcome "unknown", described as "My chest felt really heavy, not super short of breath, just a heavy feeling"; ANXIETY (non-serious) with onset Oct2021, outcome "unknown", described as "It could be the anxiety of not being sure"; ASTHENIA (non-serious) with onset 13Oct2021, outcome "unknown", described as "I felt awful; I just felt weak"; HEADACHE (non-serious) with onset 13Oct2021, outcome "unknown", described as "Headache". Therapeutic measures were taken as a result of dizziness, nausea, pain in extremity, chest discomfort, anxiety, asthenia, headache.  Additional information: Regarding treatment medication, Consumer stated, No, just like Ibuprofen kind of stuff. (Further Clarification Unknown). Prior vaccination (within 4 weeks): Consumer stated, No. There was no lab test done. Patient asked since she had side effects, should she get the second dose, she was answered when scheduling, that if she had the second one the side effects could be worse. As noted in the Fact Sheet for Recipients, patient should not get the Pfizer-BioNTech COVID-19 Vaccine if had a severe allergic reaction after a previous dose of the vaccine or if had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. Pfizer refer patients to speak to their healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider knows the health situation.  Follow-up (14Oct2021): This is a follow up spontaneous report from a contactable consumer. Updated information included Reporter Information. Patient Characteristics. New Events added.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: I felt awful; I just felt weak; Nauseous; Arm hurt really bad; I felt awful; I just felt weak; Headache; My chest felt really heavy, not super short of breath, just a heavy feeling; It could be the anxiety of not being sure; 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 29 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 12Oct2021 07:00 (Lot number: FE3590) at the age of 29 years 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: DIZZINESS (non-serious) with onset 13Oct2021, outcome "recovering", NAUSEA (non-serious) with onset 13Oct2021, outcome "recovering" and all described as "Nauseous"; PAIN IN EXTREMITY (non-serious) with onset 13Oct2021, outcome "recovering", described as "Arm hurt really bad"; CHEST DISCOMFORT (non-serious) with onset Oct2021, outcome "unknown", described as "My chest felt really heavy, not super short of breath, just a heavy feeling"; ANXIETY (non-serious) with onset Oct2021, outcome "unknown", described as "It could be the anxiety of not being sure"; ASTHENIA (non-serious) with onset 13Oct2021, outcome "unknown", described as "I felt awful; I just felt weak"; HEADACHE (non-serious) with onset 13Oct2021, outcome "unknown", described as "Headache". Therapeutic measures were taken as a result of dizziness, nausea, pain in extremity, chest discomfort, anxiety, asthenia, headache.  Additional information: Regarding treatment medication, Consumer stated, No, just like Ibuprofen kind of stuff. (Further Clarification Unknown). Prior vaccination (within 4 weeks): Consumer stated, No. There was no lab test done. Patient asked since she had side effects, should she get the second dose, she was answered when scheduling, that if she had the second one the side effects could be worse. As noted in the Fact Sheet for Recipients, patient should not get the Pfizer-BioNTech COVID-19 Vaccine if had a severe allergic reaction after a previous dose of the vaccine or if had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. Pfizer refer patients to speak to their healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider knows the health situation.  Follow-up (14Oct2021): This is a follow up spontaneous report from a contactable consumer. Updated information included Reporter Information. Patient Characteristics. New Events added.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Feeling hot, Rash, Swelling
Clinical narrative: Rash; a bit of swelling; Heat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Oct2021 15:00 (Batch/Lot number: unknown) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 11Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. Concomitant medication(s) included: CHOLESTYRAMINE. Vaccination history included: Bnt162b2 (dose number: 1), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (dose number: 2), administration date: Feb2021, when the patient was 78 years old, for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 12Oct2021 10:00, outcome "recovering", described as "Rash"; SWELLING (non-serious) with onset 12Oct2021 10:00, outcome "recovering", described as "a bit of swelling"; FEELING HOT (non-serious) with onset 12Oct2021 10:00, outcome "recovering", described as "Heat". Therapeutic measures were not taken as a result of rash, swelling, feeling hot.  Additional information: Facility type vaccine was Pharmacy or Drug Store. There was no vaccine in four weeks. Adverse event: Appprox 20 hrs after vaccine I developed a rash with a bit of swelling and heat. The same exact reaction occurred after my second dose in Feb2021. There was no covid prior vaccination. There was no covid tested post vaccination. There was no known allergies. There was no other medical history. Device timestamp: 14Oct2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: icky feeling; fever; headache; chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EK9231) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Caller states her first dose of the vaccine had lot EJ1685 and was not involved in the temperature excursion), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "recovered" (2021), described as "icky feeling"; PYREXIA (non-serious), outcome "recovered" (2021), described as "fever"; CHILLS (non-serious), outcome "recovered" (2021), described as "chills"; HEADACHE (non-serious), outcome "recovered" (2021), described as "headache".  Additional information: She is calling about the Pfizer COVID Vaccine and is not sure how to pronounce the name of Comirnaty and asked if anyone can pronounce the name. She is calling because she works at a local public health agency and had a temperature excursion for the Pfizer COVID Vaccine and it has been ongoing and they realized the freezer was set a little too low for the last couple of months and were keeping it at negative 28 degrees Celsius and had raised the temperature to negative 25 to negative 15 degrees Celsius about a day ago; the freezer never went below negative 30 degrees Celsius and kept it the standard frozen temperature between negative 30 to negative 15 degrees Celsius and the vaccine was administered to patients for their 1st, 2nd and booster doses. She is seeking stability information. She does not know the number of patients that received the vaccine after the temperature excursion and has no patient information to provide. She also received her booster dose of the Pfizer COVID Vaccine and that was involved in the temperature excursion; states for herself and the other patients involved the lot number involved in the temperature excursion is FF8841 and it has expiry date 31Mar2022 and she does not have the NDC to provide. She has no HCP information to provide. Her first dose of the vaccine had lot EJ1685 and was not involved in the temperature excursion, her 2nd dose has lot EK9231 and was not involved in the temperature excursion and her 3rd booster dose was administered on 06Oct2021. States for seriousness criteria for the temperature excursion she would say it is a near miss potential and medically significant and she also had the same reaction for the booster dose as she had for her 2nd dose of the vaccine and that was fever, chills for a day, icky feeling and headache and those symptoms have resolved but began on 07Oct2021 and resolved that evening.  Verbatim event relatedness: Pfizer COVID Vaccine: icky feeling - Related   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Cough, Headache, Malaise
Clinical narrative: Stomach pain; Coughing; Left arm pain at injection site; Headache; Low grade temperature 100.9 degrees Fahrenheit; Malaise; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single and administration date 17Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2010 (unspecified if ongoing), notes: Asthma, Autoimmune, all her life for Asthma, 2010. The patient's concomitant medications were not reported. Vaccination history included: Pneumonia vaccine. (Eight weeks prior had pneumonia vaccine.), for Immunization. The following information was reported: HEADACHE (non-serious) with onset 24Feb2021 20:00, outcome "recovered" (26Feb2021), described as "Headache"; PYREXIA (non-serious) with onset 24Feb2021 20:00, outcome "recovered" (26Feb2021), described as "Low grade temperature 100.9 degrees Fahrenheit"; MALAISE (non-serious) with onset 24Feb2021 20:00, outcome "recovered" (26Feb2021), described as "Malaise"; COUGH (non-serious) with onset 25Feb2021 10:00, outcome "recovered" (26Feb2021), described as "Coughing"; ABDOMINAL PAIN UPPER (non-serious) with onset 25Feb2021 13:00, outcome "recovered" (26Feb2021), described as "Stomach pain"; VACCINATION SITE PAIN (non-serious) with onset 24Feb2021 20:00, outcome "recovered" (25Feb2021), described as "Left arm pain at injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Aadditional Information: Patient confirmed information above. It has been a while since patient received it. First dose was back in 24Feb2021. She lost both her husband and hers cards. When they got second one, they said to call Pfizer to see if Pfizer can provide the lot number for the first dose. On the card for the second dose, they just listed the date and that it was Pfizer, but did not include the lot number for the first dose. She was a nurse practitioner but she is retired now. She did not have an address or email for primary care provider. Headache lasted 48 hours and it improved. Low grade temp improved within 24 hours. Malaise improved within 48 hours. Coughing for 24 hours then improved. Stomach pain resolved 26Feb2021. Everything resolved within 2 days. Arm pain lasted 24 hours. She cannot find it, so when they had second shot, they wrote the date and Pfizer, but no lot number. Second dose was given on 17Mar2021, Lot EN6205, Expiration unknown. Injected in left arm in the muscle. Causality not provided for events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Stomach pain; Coughing; Left arm pain at injection site; Headache; Low grade temperature 100.9 degrees Fahrenheit; Malaise; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single and administration date 17Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2010 (unspecified if ongoing), notes: Asthma, Autoimmune, all her life for Asthma, 2010. The patient's concomitant medications were not reported. Vaccination history included: Pneumonia vaccine. (Eight weeks prior had pneumonia vaccine.), for Immunization. The following information was reported: HEADACHE (non-serious) with onset 24Feb2021 20:00, outcome "recovered" (26Feb2021), described as "Headache"; PYREXIA (non-serious) with onset 24Feb2021 20:00, outcome "recovered" (26Feb2021), described as "Low grade temperature 100.9 degrees Fahrenheit"; MALAISE (non-serious) with onset 24Feb2021 20:00, outcome "recovered" (26Feb2021), described as "Malaise"; COUGH (non-serious) with onset 25Feb2021 10:00, outcome "recovered" (26Feb2021), described as "Coughing"; ABDOMINAL PAIN UPPER (non-serious) with onset 25Feb2021 13:00, outcome "recovered" (26Feb2021), described as "Stomach pain"; VACCINATION SITE PAIN (non-serious) with onset 24Feb2021 20:00, outcome "recovered" (25Feb2021), described as "Left arm pain at injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Aadditional Information: Patient confirmed information above. It has been a while since patient received it. First dose was back in 24Feb2021. She lost both her husband and hers cards. When they got second one, they said to call Pfizer to see if Pfizer can provide the lot number for the first dose. On the card for the second dose, they just listed the date and that it was Pfizer, but did not include the lot number for the first dose. She was a nurse practitioner but she is retired now. She did not have an address or email for primary care provider. Headache lasted 48 hours and it improved. Low grade temp improved within 24 hours. Malaise improved within 48 hours. Coughing for 24 hours then improved. Stomach pain resolved 26Feb2021. Everything resolved within 2 days. Arm pain lasted 24 hours. She cannot find it, so when they had second shot, they wrote the date and Pfizer, but no lot number. Second dose was given on 17Mar2021, Lot EN6205, Expiration unknown. Injected in left arm in the muscle. Causality not provided for events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival pain, Heavy menstrual bleeding, Night sweats
Clinical narrative: gum sensitivity upper teeth front; night sweats; prolonged heavy flow period; prolonged heavy flow period; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 12:15 (Lot number: ff2589) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: latex" (unspecified if ongoing), notes: Allergy. The patient took concomitant medications. The following information was reported: GINGIVAL PAIN (non-serious) with onset 06Oct2021, outcome "recovering", described as "gum sensitivity upper teeth front"; NIGHT SWEATS (non-serious) with onset 06Oct2021, outcome "recovering", described as "night sweats"; HEAVY MENSTRUAL BLEEDING (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 06Oct2021, outcome "recovering" and all described as "prolonged heavy flow period". The events "gum sensitivity upper teeth front", "night sweats", "prolonged heavy flow period" and "prolonged heavy flow period" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of gingival pain, night sweats, heavy menstrual bleeding, heavy menstrual bleeding.  Additional information: facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. other medications in two weeks: multivitamin. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information was expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Dizziness, Dyspnoea
Clinical narrative: Fever; extreme body aches/pain; headache; Severe cough; chest pain; exhausted; dizziness; blurred, slow response vision; sweats; chills; swollen gland; shortness of breath; sore arm; unable to work at 100%.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 12:30 (Lot number: 30145BA, Expiration Date: 30Nov2021) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing). Concomitant medication(s) included: LARIN 24 FE taken for contraception, start date: 1997 (ongoing); IBUPROFEN taken for adverse reaction. The following information was reported: PYREXIA (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "extreme body aches/pain"; HEADACHE (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "headache"; COUGH (non-serious) with onset 12Oct2021 13:30, outcome "recovered" (2021), described as "Severe cough"; CHEST PAIN (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "chest pain"; FATIGUE (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "exhausted"; DIZZINESS (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "dizziness"; VISION BLURRED (non-serious) with onset Oct2021, outcome "unknown", described as "blurred, slow response vision"; HYPERHIDROSIS (non-serious) with onset Oct2021, outcome "unknown", described as "sweats"; CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "chills"; LYMPHADENOPATHY (non-serious) with onset Oct2021, outcome "unknown", described as "swollen gland"; DYSPNOEA (non-serious) with onset Oct2021, outcome "unknown", described as "shortness of breath"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "sore arm"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Oct2021, outcome "unknown", described as "unable to work at 100%.". Therapeutic measures were not taken as a result of pyrexia, pain, headache, cough, chest pain, fatigue, dizziness.  Additional information: Patient had no known allergies. Patient had adverse reaction (unspecified) to ibuprofen. Patient did not have any long term medical history. 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 had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Loss of personal independence in daily activities, Lymphadenopathy
Clinical narrative: Fever; extreme body aches/pain; headache; Severe cough; chest pain; exhausted; dizziness; blurred, slow response vision; sweats; chills; swollen gland; shortness of breath; sore arm; unable to work at 100%.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 12:30 (Lot number: 30145BA, Expiration Date: 30Nov2021) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing). Concomitant medication(s) included: LARIN 24 FE taken for contraception, start date: 1997 (ongoing); IBUPROFEN taken for adverse reaction. The following information was reported: PYREXIA (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "extreme body aches/pain"; HEADACHE (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "headache"; COUGH (non-serious) with onset 12Oct2021 13:30, outcome "recovered" (2021), described as "Severe cough"; CHEST PAIN (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "chest pain"; FATIGUE (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "exhausted"; DIZZINESS (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "dizziness"; VISION BLURRED (non-serious) with onset Oct2021, outcome "unknown", described as "blurred, slow response vision"; HYPERHIDROSIS (non-serious) with onset Oct2021, outcome "unknown", described as "sweats"; CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "chills"; LYMPHADENOPATHY (non-serious) with onset Oct2021, outcome "unknown", described as "swollen gland"; DYSPNOEA (non-serious) with onset Oct2021, outcome "unknown", described as "shortness of breath"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "sore arm"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Oct2021, outcome "unknown", described as "unable to work at 100%.". Therapeutic measures were not taken as a result of pyrexia, pain, headache, cough, chest pain, fatigue, dizziness.  Additional information: Patient had no known allergies. Patient had adverse reaction (unspecified) to ibuprofen. Patient did not have any long term medical history. 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 had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: Fever; extreme body aches/pain; headache; Severe cough; chest pain; exhausted; dizziness; blurred, slow response vision; sweats; chills; swollen gland; shortness of breath; sore arm; unable to work at 100%.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 12:30 (Lot number: 30145BA, Expiration Date: 30Nov2021) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing). Concomitant medication(s) included: LARIN 24 FE taken for contraception, start date: 1997 (ongoing); IBUPROFEN taken for adverse reaction. The following information was reported: PYREXIA (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "extreme body aches/pain"; HEADACHE (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "headache"; COUGH (non-serious) with onset 12Oct2021 13:30, outcome "recovered" (2021), described as "Severe cough"; CHEST PAIN (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "chest pain"; FATIGUE (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "exhausted"; DIZZINESS (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "dizziness"; VISION BLURRED (non-serious) with onset Oct2021, outcome "unknown", described as "blurred, slow response vision"; HYPERHIDROSIS (non-serious) with onset Oct2021, outcome "unknown", described as "sweats"; CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "chills"; LYMPHADENOPATHY (non-serious) with onset Oct2021, outcome "unknown", described as "swollen gland"; DYSPNOEA (non-serious) with onset Oct2021, outcome "unknown", described as "shortness of breath"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "sore arm"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Oct2021, outcome "unknown", described as "unable to work at 100%.". Therapeutic measures were not taken as a result of pyrexia, pain, headache, cough, chest pain, fatigue, dizziness.  Additional information: Patient had no known allergies. Patient had adverse reaction (unspecified) to ibuprofen. Patient did not have any long term medical history. 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 had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen. Lymph nodes under left arm.; fever/Low grade fever the following day; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 15:30 (Lot number: Ff2590) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXAPRO. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 01Apr2021, when the patient was 51 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 11Mar2021, when the patient was 51 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 13Oct2021, outcome "recovering", described as "Swollen. Lymph nodes under left arm."; PYREXIA (non-serious) with onset 13Oct2021, outcome "recovering", described as "fever/Low grade fever the following day"; CHILLS (non-serious) with onset 13Oct2021, outcome "recovering", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, pyrexia, chills.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Other medications in two weeks:Regular lexapro. High fever and chills that same night of the vaccine. Swollen. Lymph nodes under left arm. Low grade fever the following day. Adverse event start date: 13Oct2021, adverse event start time: 12:00 AM Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies reported  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gingival pain, Headache, Hyperaesthesia teeth, Nausea
Clinical narrative: Possible light fever; Soreness at site of administration; Mild headache; nausea; Tiredness; Sensitive teeth/gums to cold; Sensitive teeth/gums to cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Oct2021 12:15 (Lot number: EW0217) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing). Concomitant medication(s) included: ADVAIR HFA taken for asthma (ongoing). Vaccination history included: Bnt162b2 (Dose: 2, Lot number: EP6955, Administrator route: Intramuscular, Vaccine location: Left arm), administration date: 24Mar2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose: 1, Lot number: EL3247, Administrator route: Intramuscular, Vaccine location: Left arm), administration date: 02Mar2021, when the patient was 43 years old, for COVID-19 immunization; Flu (Other vaccine 4 weeks vaccine location: left arm), administration date: 22Sep2021.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Oct2021 01:00, outcome "recovering", described as "Soreness at site of administration"; HEADACHE (non-serious) with onset 13Oct2021 01:00, outcome "recovered" (Oct2021), described as "Mild headache"; NAUSEA (non-serious) with onset 13Oct2021 01:00, outcome "recovered" (Oct2021), described as "nausea"; PYREXIA (non-serious) with onset 14Oct2021 01:00, outcome "recovering", described as "Possible light fever"; FATIGUE (non-serious) with onset 13Oct2021, outcome "recovered" (Oct2021), described as "Tiredness"; GINGIVAL PAIN (non-serious), HYPERAESTHESIA TEETH (non-serious) all with onset 2021, outcome "recovering" and all described as "Sensitive teeth/gums to cold". Therapeutic measures were not taken as a result of vaccination site pain, headache, nausea, pyrexia, gingival pain, hyperaesthesia teeth.  Additional information: Patient received COMINARTY vaccine at Workplace clinic. Patient had no known allergy. other medications the patient received within 2 weeks of vaccination: Asthma inhaler. Patient received Flu vaccine within 4 weeks PRIOR. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. No Relevant Tests and Specific relevant test for thromboembolic events with thrombocytopenia were reported. The events were reported as non-serious.  Follow-up attempts are completed. No further information is expected.