chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Vaccination site pain
Clinical narrative: chills; body ache; headache; Soreness at injection site started approx 2000hrs on 13Oct2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Oct2021 14:15 (Lot number: EW0217) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; SINGULAIR; LOSARTAN. Past drug history included: Theophylline, reaction(s): "Known allergies: Theophylline", notes: Known allergies: Theophylline. Vaccination history included: Bnt162b2 (lot number: EL3247, dose administration route: Intramuscular, dose number: 2, dose vaccine location: Left arm), administration date: 17Feb2021, when the patient was 44 years old, for Covid-19 Immunization; Bnt162b2 (lot number: EL3247, dose administration route: Intramuscular, dose number: 1, dose vaccine location: Left arm.), administration date: 27Jan2021, when the patient was 44 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Oct2021 20:00, outcome "recovering", described as "Soreness at injection site started approx 2000hrs on 13Oct2021"; CHILLS (non-serious) with onset 14Oct2021 17:30, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 14Oct2021 17:30, outcome "recovering", described as "body ache"; HEADACHE (non-serious) with onset 14Oct2021 17:30, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of vaccination site pain, chills, pain, headache.  Additional information: No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.    No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: hard of hearing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) at the age of 74 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), administration date: 02Feb2021, when the patient was 74 years old, for COVID-19 Immunization. The following information was reported: HYPOACUSIS (non-serious) with onset 2021, outcome "unknown", described as "hard of hearing". Therapeutic measures were taken as a result of hypoacusis.  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 have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization; Bnt162b2 (Dose Number: 2), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Severe arm pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood test, Syncope, White blood cell count decreased
Clinical narrative: 27 days after my second vaccine, my blood pressure dropped to 70/40 and I fainted. I called my doctor at 2:45 am. He told me to drink extra water/have salt/ and take 40mg prednisone and see him at 7am. My BP was higher. He took me off both blood pressure medications and took blood. My WBC count was 1.7 which rose to normal 5 days later. I stayed off the BP medication until Sept 17th (after my booster) and continued to consume a high salt diet and monitor my BP several times a day. My blood pressure was normally 100/70 often dropping to 90/60. If it got too low, I added more salt and fluids to my diet.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Dysphagia, Electromyogram, Erythema
Clinical narrative: developed multiple tendonitis issues withing1-3 months after 2nd Moderna. Muscle aches, joint pain.  Multiple type of steroids tried both oral and joint injections to treat.  After steroid stopped developed severe neurological issues, peripheral neurpathy- bilateral feet to knees and hands to elbows.  Face numbness, back numb.  Feels like red hot pokers in legs and had to use walker.  Struggling with ongoing neurological symptoms for5 months.  I don't walk normal, can't type/keyboard normal, etc.  Sometimes i feel like I can't swallow.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Inflammatory marker test, Lumbar puncture, Magnetic resonance imaging head
Clinical narrative: developed multiple tendonitis issues withing1-3 months after 2nd Moderna. Muscle aches, joint pain.  Multiple type of steroids tried both oral and joint injections to treat.  After steroid stopped developed severe neurological issues, peripheral neurpathy- bilateral feet to knees and hands to elbows.  Face numbness, back numb.  Feels like red hot pokers in legs and had to use walker.  Struggling with ongoing neurological symptoms for5 months.  I don't walk normal, can't type/keyboard normal, etc.  Sometimes i feel like I can't swallow.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal, Myalgia, Neurological symptom, Neuropathy peripheral, Skin warm
Clinical narrative: developed multiple tendonitis issues withing1-3 months after 2nd Moderna. Muscle aches, joint pain.  Multiple type of steroids tried both oral and joint injections to treat.  After steroid stopped developed severe neurological issues, peripheral neurpathy- bilateral feet to knees and hands to elbows.  Face numbness, back numb.  Feels like red hot pokers in legs and had to use walker.  Struggling with ongoing neurological symptoms for5 months.  I don't walk normal, can't type/keyboard normal, etc.  Sometimes i feel like I can't swallow.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tendonitis, Walking aid user
Clinical narrative: developed multiple tendonitis issues withing1-3 months after 2nd Moderna. Muscle aches, joint pain.  Multiple type of steroids tried both oral and joint injections to treat.  After steroid stopped developed severe neurological issues, peripheral neurpathy- bilateral feet to knees and hands to elbows.  Face numbness, back numb.  Feels like red hot pokers in legs and had to use walker.  Struggling with ongoing neurological symptoms for5 months.  I don't walk normal, can't type/keyboard normal, etc.  Sometimes i feel like I can't swallow.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Pain in extremity
Clinical narrative: soreness of the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22 year-old male patient received bnt162b2 (BNT162B2), administration date 17Sep2021 (Lot number: 30130BA) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing), notes: He is overweight, he weighs she thinks 230lbs, caller states that they are working on his weight. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "soreness of the arm". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash, Swelling
Clinical narrative: Appprox 20 hrs after vaccine I developed a rash; I developed a rash with a bit of swelling; heat/The same exact reaction occurred after my second dose in February; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 78 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CHOLESTYRAMINE. Vaccination history included: Bnt162b2 (1st dose, No events Reported), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset Feb2021, outcome "unknown", described as "Appprox 20 hrs after vaccine I developed a rash"; SWELLING (non-serious) with onset Feb2021, outcome "unknown", described as "I developed a rash with a bit of swelling"; FEELING HOT (non-serious) with onset Feb2021, outcome "unknown", described as "heat/The same exact reaction occurred after my second dose in February".  Additional information:  No known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   Follow-up attempts completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, SARS-CoV-2 test
Clinical narrative: she felt like she had the flu; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 (Lot number: EP7534) at the age of 49 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: diagnosed 8 or 9 years ago; "chronic pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "she felt like she had the flu". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: NDC number and Expiry Date of Pfizer Covid 19 Vaccine was Unknown. She took Pfizer Covid 19 Vaccine because she didn't want to die from COVID. Investigation Assessment was yes. Relatedness of first dose for event felt like she had the flu was related. Caller stated she had the Pfizer Covid vaccine back in the spring and then the second dose 08Apr2021, she had the booster Pfizer vaccine Monday afternoon, 11Oct2021, of this week, the first two times she had the  vaccine, the first week after the first one, she felt like she had the flu, she was sick for about 3 days after the second one. The other thing she should say, she takes a number of medications, she has chronic pain, she has fibromyalgia that they are treating, she doesn't know, they may think it may be some of the medications she takes and the vaccine, they didn't seem to know. She thinks she went to the doctor and they of course gave her a Covid test which was negative, they just said she would have to ride it out, in Mar2021. She has had Covid tests ongoing on and off throughout the pandemic and they all have  been negative.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: sick for about 3 days; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 (Lot number: ER8731) at the age of 49 years as dose 2, 0.3ml single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: diagnosed 8 or 9 years ago; "chronic pain" (ongoing), notes: she has chronic pain. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, LOT: EP7534, NDC: Unknown, Expiry Date: Unknown, Dosage text: Injection, right arm, 0.3 ML, She felt like she had the flu), administration date: 18Mar2021, when the patient was 49 years old, for COVID-19 Immunization, reaction(s): "She felt like she had the flu". The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "sick for about 3 days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient takes a number of medications, she has chronic pain, she has fibromyalgia that they are treating,she went to the doctor and they of course gave her a Covid test which was negative, they just said she would have to ride it out, in Mar2021. She has had Covid tests ongoing on and off throughout the pandemic and they all have  been negative.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pain in extremity
Clinical narrative: Arm soreness; chills; body ache; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Oct2021 (Lot number: FH8020) at the age of 45 years as dose 3 (booster) , single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 IMMUNIZATION; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 IMMUNIZATION. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "Arm soreness"; CHILLS (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "chills"; PAIN (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "body ache"; NAUSEA (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "nausea". Therapeutic measures were not taken as a result of pain in extremity, chills, pain, nausea.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any medications within 42weeks prior to the COVID vaccine. Patient did not received treatment for AE.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Fatigue; Injection site soreness; I had my 1st shot in Jan and 2nd today.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 14Oct2021 18:00 (Lot number: FF8839) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, time: 3:00pm, route of administration: intramuscular, Batch/ lot number: EN5318; the 5 might be an S, unsure, anatomical site of injection: L deltoid), administration date: 26Jan2021, for Covid-19 Immunization, reaction(s): "fatigue", "Inj. site soreness". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Oct2021, outcome "unknown", described as "I had my 1st shot in Jan and 2nd today."; FATIGUE (non-serious) with onset 15Oct2021, outcome "recovered" (2021), described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 15Oct2021, outcome "recovered" (2021), described as "Injection site soreness". Therapeutic measures were not taken as a result of fatigue, vaccination site pain.  Additional Information: Patient did not have any Prior Vaccination (within 4 weeks). No specific relevant test for thromboemobolic events with thrombocytopenia. There was no error, only that he received 2nd dose approx. 10 months after his first shot, thats all.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Lymphadenopathy
Clinical narrative: lips are still swollen; tongue is still numb; she has no feeling in her mouth and cheeks; lymph nodes in her neck got swollen; 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 (002191).  A female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 1, single and administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Cardura has been able to regulate her blood pressure. The patient's concomitant medications were not reported. The following information was reported: LIP SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "lips are still swollen"; HYPOAESTHESIA ORAL (non-serious) with onset 2021, outcome "not recovered", described as "tongue is still numb"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "she has no feeling in her mouth and cheeks"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "lymph nodes in her neck got swollen".  Additional information: It was reported that brand Cardura has been able to regulate her blood pressure as she has reactions to the generic because of fillers. She's never had pain in her arm like other people. Her lymph nodes in her neck got swollen, but it's now dissipated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: He also had fatigue with this shot; He has developed a Swollen lymph node in the axilla of the arm he received the vaccine of the size of a small key lime, specifically, 1 and a half inches long and 3/4 inch deep; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 40 year-old male patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for covid 19 immunization; Bnt162b2 (Dose 2), for covid 19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "He also had fatigue with this shot"; LYMPHADENOPATHY (non-serious) with onset 13Oct2021, outcome "not recovered", described as "He has developed a Swollen lymph node in the axilla of the arm he received the vaccine of the size of a small key lime, specifically, 1 and a half inches long and 3/4 inch deep". Additional information: Relevant Tests: None. Family Medical History Relevant to AE(s): No. Caller did not believe that the patient had prior Vaccinations (within 4 weeks). AE did not result in Emergency Room and Physician Office visit. Causality of swollen lymph nodes and fatigue: Yes, Clearly.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Feeling hot, Hyperhidrosis
Clinical narrative: she is very hot and sweaty; She is having hot sweats; she is very hot and sweaty; She is having hot sweats; her blood pressure is dropping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (COMIRNATY), administration date 14Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "factor VIII blood disorder" (unspecified if ongoing), notes: she had factor VIII blood disorder. The patient's concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), FEELING HOT (non-serious) all with onset 14Oct2021, outcome "unknown" and all described as "she is very hot and sweaty; She is having hot sweats"; BLOOD PRESSURE DECREASED (non-serious) with onset 14Oct2021, outcome "unknown", described as "her blood pressure is dropping". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that his wife had her first shot today and she spoke to her doctors before getting it because she had factor VIII blood disorder and she was very hot and sweaty and her blood pressure at the moment was 98/54. The blood pressure was normally 126/76 and when they took few moments later it was 104/64 and 10 minutes after previous measurement, was now 98/54. The reporter was concerned about his wife whose blood pressure was dropping and was having hot sweats  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: extreme pain; in the arm that I got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Oct2021 02:47, outcome "unknown", described as "extreme pain; in the arm that I got the shot".  Additional information: It was reported that, I am having some extreme 'pain'. In general city time it is 02:47 in the morning and I woke up with extreme pain in my, in the arm that I got the shot within and is it ok for me to use the ice pack. My arm is killing me.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Vaccination site pain
Clinical narrative: injection site pain; pain underneath the arm; lymph node; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 (Batch/Lot number: unknown) at the age of 19 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "had Covid", start date: 08Mar2021 (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Aug2021, outcome "recovered" (2021), described as "injection site pain"; PAIN IN EXTREMITY (non-serious) with onset 18Aug2021, outcome "recovered" (2021), described as "pain underneath the arm"; LYMPHADENOPATHY (non-serious) with onset 18Aug2021, outcome "recovered" (2021), described as "lymph node". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, lymphadenopathy.  Additional Information: 08Mar2021: Patient sick with COVID-19 virus. Patient is on birth control pill. Wants to know if there's any increased risk? Caller did not specify product name. Caller is thinking patient is better protected because of natural immunity and one vaccine than someone with just two vaccines. Small injection site reaction: States following day after the vaccination. Clarified it was pain at the injection site, the day of vaccination. Pain under the arm. The following day after the vaccination. Caller then states she is not sure if patient's reactions were a day after the vaccine.   Follow-up (19Nov2021): 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.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold
Clinical narrative: He is feeling, his bone inside the body cold.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 14Oct2021 (Lot number: 301358A) at the age of 12 years 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: FEELING COLD (non-serious), outcome "unknown", described as "He is feeling, his bone inside the body cold.". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "not recovered", described as "rash".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood triglycerides, Blood triglycerides abnormal, Computerised tomogram, Hepatic steatosis
Clinical narrative: her son is worried; his triglycerides were 700; had a fatty liver; developed lymph nodes on the supraclavicular & axillary region; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 35 year-old male patient received bnt162b2 (COMIRNATY), administration date 11Oct2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hodgkin's lymphoma" (unspecified if ongoing), notes: Per caller her son was treated and cleared of Hodgkin's Lymphoma 7 years ago.; "GERD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "allergic to Penicillin and Erythromycin" (unspecified if ongoing); "cancer" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: XANAX; PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE] taken for anxiety. Past drug history included: Erythromycin, reaction(s): "allergic to Penicillin and Erythromycin". Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunization; Comirnaty (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 14Oct2021, outcome "not recovered", described as "developed lymph nodes on the supraclavicular & axillary region"; ANXIETY (non-serious), outcome "unknown", described as "her son is worried"; BLOOD TRIGLYCERIDES ABNORMAL (non-serious), outcome "unknown", described as "his triglycerides were 700"; HEPATIC STEATOSIS (non-serious), outcome "unknown", described as "had a fatty liver". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient has a history of Hodgkin's Lymphoma, he was diagnosed when he was 28, so that was 7 years ago. He has had treatment and was cured. He was schedule for a Cat scan for an unrelated issue, and when cat scan results came, it showed that he has enlarged lymph nodes on the supraclavicular and ancillary region. Caller does not know the exact date, but her son got the first and second dose when it first came out because he worked in the hospital it was sometime in 2021. The Enlarged Lymph nodes were first observed from the CAT scan results last night; he did not know before the test. Patient  struggled with it since he had the cancer  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: her son is worried; his triglycerides were 700; had a fatty liver; developed lymph nodes on the supraclavicular & axillary region; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 35 year-old male patient received bnt162b2 (COMIRNATY), administration date 11Oct2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hodgkin's lymphoma" (unspecified if ongoing), notes: Per caller her son was treated and cleared of Hodgkin's Lymphoma 7 years ago.; "GERD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "allergic to Penicillin and Erythromycin" (unspecified if ongoing); "cancer" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: XANAX; PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE] taken for anxiety. Past drug history included: Erythromycin, reaction(s): "allergic to Penicillin and Erythromycin". Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunization; Comirnaty (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 14Oct2021, outcome "not recovered", described as "developed lymph nodes on the supraclavicular & axillary region"; ANXIETY (non-serious), outcome "unknown", described as "her son is worried"; BLOOD TRIGLYCERIDES ABNORMAL (non-serious), outcome "unknown", described as "his triglycerides were 700"; HEPATIC STEATOSIS (non-serious), outcome "unknown", described as "had a fatty liver". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient has a history of Hodgkin's Lymphoma, he was diagnosed when he was 28, so that was 7 years ago. He has had treatment and was cured. He was schedule for a Cat scan for an unrelated issue, and when cat scan results came, it showed that he has enlarged lymph nodes on the supraclavicular and ancillary region. Caller does not know the exact date, but her son got the first and second dose when it first came out because he worked in the hospital it was sometime in 2021. The Enlarged Lymph nodes were first observed from the CAT scan results last night; he did not know before the test. Patient  struggled with it since he had the cancer  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Head discomfort, Headache, Migraine
Clinical narrative: pain migraine, throbbing, pressure, headache; excruciating pulsating headache/ hurting headache; pulsating migraine, with pressure; pulsating migraine, with pressure; 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 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 (Lot number: FC3181) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: 26Aug2021, injection in left arm, between 1000am to 1100am, Lot: FC3180, First dose was good.), administration date: 26Aug2021, when the patient was 64 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 16Sep2021, outcome "not recovered", described as "excruciating pulsating headache/ hurting headache"; HEAD DISCOMFORT (non-serious), MIGRAINE (non-serious) all with onset 16Sep2021, outcome "not recovered" and all described as "pulsating migraine, with pressure"; HEADACHE (non-serious) with onset 09Oct2021, outcome "not recovered", described as "pain migraine, throbbing, pressure, headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, head discomfort, migraine, headache.  Additional information: Caller states to me that she knows that headache is a common side effect but she is wondering if the shot has the effect of giving you a pulsating migraine, with pressure, hurting headache in your whole head, excruciating migraine as being a side effect that she is experiencing three weeks after her second dose? . She is upset and nervous and hurting. The day of the second shot about two and a half hours later she started experiencing an excruciating headache, pulsing pressure in head like the shot went to her head and it lasted the whole day, it was an excruciating migraine pain and pressure. Last Saturday she started experiencing the same excruciating pain migraine, throbbing, pressure, headache. She is being told that she can get a headache. The severity of her headache is more than a headache. Asking if high blood pressure would have anything to do with pulsating migraine/headache. Thinks she had too much when talking about the dose and it was not pretty. First dose was good but the second dose caught her. she called the doctor and is taking ibuprofen for her headaches. No vaccination within 4 weeks prior vaccinations. No AE following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus began after the first series of two shots and worsened after the booster third dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus began after the first series of two shots and worsened after the booster third dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Skin burning sensation
Clinical narrative: 22 hours after injection- burning sensation on back of shoulders, neck area to top of scalp.; Burning sensation on right side of neck; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-years-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Sep2021 14:00 (Lot number: EW0185) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Congenital heart defect" (unspecified if ongoing); "Ankylosis Spondylitis" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN]. Past drug history included: Gabapentin, reaction(s): "Known allergies: Gabapentin". The following information was reported: BURNING SENSATION (non-serious) with onset 16Sep2021 20:00, outcome "not recovered", described as "Burning sensation on right side of neck"; SKIN BURNING SENSATION (non-serious) with onset 17Sep2021 12:00, outcome "not recovered", described as "22 hours after injection- burning sensation on back of shoulders, neck area to top of scalp.". The events "burning sensation on right side of neck" and "22 hours after injection- burning sensation on back of shoulders, neck area to top of scalp." were evaluated at the physician office visit. Therapeutic measures were taken as a result of burning sensation, skin burning sensation.  Additional Information: The patient had Burning sensation on right side of neck, 5 hours after infection. 22 hours after injection, had burning sensation on back of shoulders, neck area to top of scalp. Known allergies: Gabapentin. Other medical history: Congenital heart defect, Ankylosis spondylitis. She had no other vaccine in 4 weeks. Other medications in two weeks: Multivitamins and CLARITIN. She was reported to take MOTRIN and TYLENOL as treatment medication for adverse events. She did not have COVID-19 prior to vaccination and was not tested for COVID-19 post the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Investigation, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: no period since receiving first vaccination; no period since receiving first vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 18May2021 18:30 (Lot number: EW0162) at the age of 15 years as dose 1, single and administration date 08Jun2021 16:00 (Lot number: EW0180) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID19 positive in Feb2019- asymptomatic", start date: Feb2019 (unspecified if ongoing), notes: COVID19 positive in Feb2019- asymptomatic. Date of last menstrual period: 18May2021. There were no concomitant medications. The following information was reported: AMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious) all with onset Jun2021, outcome "not recovered" and all described as "no period since receiving first vaccination". The event "no period since receiving first vaccination" and "no period since receiving first vaccination" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of amenorrhoea, menstrual disorder. First day of last menstrual cycle was on 18May2021. No period since receiving first vaccination. Periods prior had been fairly regular. First menses at age 12. It had now been 5 months with no period. Full blood work completed on 08Oct. No abnormalities or pregnancy in lab results.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my husband and my friends it was no big deal, just a little sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my husband and my friends it was no big deal, just a little sore arm".  Additional information: She also reports that "my husband and my friends it was no big deal, just a little sore arm"   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Visual brightness
Clinical narrative: So bright I couldn't see anything because it was so bright/ brightness bothering patients eyes; 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 78 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 12Oct2021 (Lot number: EN6198) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical location: Left arm), administration date: 29Jan2021, when the patient was 78 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Anatomical location: Left arm, lot number EL1284), administration date: 26Feb2021, when the patient was 78 years old, for COVID-19 Immunization. The following information was reported: VISUAL BRIGHTNESS (non-serious) with onset 13Oct2021 10:30, outcome "recovered" (13Oct2021 11:30), described as "So bright I couldn't see anything because it was so bright/ brightness bothering patients eyes".  Additional information: The patient received her Pfizer BT Covid Booster dose on 12Oct2021. She came home and was fine and then the next day,13Oct2021, she had an appt with her PCP and when she went to the appt it was dark out and then she left at 10:30 and it was so bright she couldn't see anything because it was so bright. The patient stated it went away in about 60 min. The patient wanted to know had there been any other reports of brightness bothering patients eyes so it is hard for them to see after the vaccine. Response: Spoke to patient from the attached document: 20Apr2021 No information found regarding product medical question. The NDC number and expiry dates were unknown. There were no other products or investigation assessment. The patient would like to know if there was any information about what she experienced after the Pfizer COVID booster. She took the COVID booster on Tuesday. On Wednesday morning she was feeling good, and slept good. When she left her house at 730-8am it was still dark. She came out of her appointment at 1030am, and it was so bright she could not see. She literally could not see. It only happened just one time. She was glad she didn't drive because she couldn't have drove. Her appointment was at 830 am. She was just curious if this had been reported. She got the two prior vaccines with no problem. She had no side effects. Her height is 5'8"-5'9". She didn't have a prescribing doctor.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation delayed
Clinical narrative: her menstruation never came back; menstrual disturbances; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (COMIRNATY), administration date 10Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "tubal ligation" (unspecified if ongoing); "lot of stress" (ongoing), notes: lot of stress. Date of last menstrual period: 09Sep2021. Concomitant medication(s) included: APPLE CIDER VINEGAR.The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 2021, outcome "unknown", described as "her menstruation never came back"; MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "menstrual disturbances".  Additional information: Caller stated that she got the first dose of the Pfizer Biontech Covid-19 Vaccine on 10Sep2021 and a day before the vaccination was the last time that she had her menstruation and her menstruation never came back after. Caller also stated that her menstruation was regular before the shot and the only thing that she is taking in is apple cider vinegar and some other Vitamins. Caller also stated that she is not pregnant as she had ligations done. she is also under a lot of stress and has been under stress most of her life and has not missed a period and had a tubal ligation, so she is not pregnant; no further information provided by the caller. there is no information on dizziness and palpitation as an AE after getting the Pfizer BioNtech Covid-19 Vaccine. Spoke from reports of menstrual irregularities (US) Although not specific to Comirnaty or Pfizer-BioNTech COVID-19 Vaccine, withheld COVID-19 Vaccination Considerations for withheld that there have been anecdotal reports of temporary changes in menstruation patterns (e.g., heavier menses, early or late onset, and dysmenorrhea) in individuals who have recently been vaccinated for COVID-19. While environmental stresses can temporarily impact menses, vaccines have not been previously associated with menstrual disturbances. withheld will continue to monitor and evaluate available evidence on this issue. withheld has placed a special call for research focused on this issue. Also, an open survey to gather qualitative data on post-vaccination menstrual patterns has been initiated. Additionally, there is no reason for individuals to schedule their vaccinations based on their menstrual cycles; vaccines can be given to those currently menstruating. Yes is Pfizer COVID Vaccine a Pfizer product. Age was 43 Years Old. Patient medical history was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Feeling abnormal, Ventricular extrasystoles
Clinical narrative: his numbers were steady until 3 months after the vaccine and they bumped up; he felt bad after his second dose; his second dose was 15Apr2021 and two days later he had PVCs like crazy; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (COMIRNATY), administration date 15Apr2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MAGNESIUM; CELEBREX. Vaccination history included: Bnt162b2 (First dose), administration date: 15Mar2021, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "his numbers were steady until 3 months after the vaccine and they bumped up"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "he felt bad after his second dose"; VENTRICULAR EXTRASYSTOLES (non-serious), outcome "unknown", described as "his second dose was 15Apr2021 and two days later he had PVCs like crazy". Relevant laboratory tests and procedures are available in the appropriate section.  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.