chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage, Vulvovaginal discomfort
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 15:30 (Lot number: FC3184) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "fertility issues" (unspecified if ongoing), notes: Fertility issues prior to the vaccine which causes me to not ovulate and rarely bleeding. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product=COVID 19, lot number=FC3184, lot unknown=False, dose number=1), administration date: 30Aug2021, when the patient was 34 years old, for Covid-19 immunization, reaction(s): "spotting".The following information was reported: VULVOVAGINAL DISCOMFORT (non-serious) with onset 24Sep2021, outcome "unknown", described as "a lot of pressure in both of my ovaries but especially on my left side"; VAGINAL HAEMORRHAGE (non-serious) with onset 24Sep2021, outcome "unknown", described as "spotting"; ARTHRITIS (non-serious) with onset 24Sep2021, outcome "unknown", described as "joint pain in my wrist elbow's meals"; NAUSEA (non-serious) with onset 24Sep2021, outcome "unknown", described as "a little nauseous"; HEADACHE (non-serious) with onset 24Sep2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 24Sep2021, outcome "unknown", described as "fatigue"; BREAST TENDERNESS (non-serious) with onset 24Sep2021, outcome "unknown", described as "breast tenderness as well as being able  able to fill my blood pump through my body".No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: severe abdominal pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: 301358A) 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: ABDOMINAL PAIN (non-serious), outcome "unknown", described as "severe abdominal pain".  Addition information: The report was not related to a study or programme. Expiry Date of COVID-19 Vaccine was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: My finger is red and purple sore and swollen.; My finger is red and purple sore and swollen.; My finger is red and purple sore and swollen.; Is preganant-Yes,delivery date:05Mar2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Sep2021 16:00 (Lot number: 30130BA) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Date of last menstrual period: 01Jun2021. The patient was 15 weeks pregnant at the time of exposure to bnt162b2. The patient was 15 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05Mar2022. The patient took concomitant medications. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 15Sep2021 14:00, outcome "unknown", described as "Is preganant-Yes,delivery date:05Mar2022"; SKIN DISCOLOURATION (non-serious), PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 29Sep2021 17:00, outcome "not recovered" and all described as "My finger is red and purple sore and swollen.". It was unknown if therapeutic measures were taken as a result of skin discolouration, pain in extremity, peripheral swelling.  Additional information: The patient didn't  receive any other vaccines within 4 weeks prior to the COVID vaccine The patient received Multiple vitamin within 2 weeks of vaccination. The patient wasn't diagnosed with COVID-19, prior to vaccination The patient hasn't been tested for COVID-19, Since the vaccination  No follow-up attempts are possible. No further information is expected.  Follow-up (11Oct2021): This is a Follow up spontaneous report from contactable consumer. This consumer (receptionist) reported in response to HCP telephonic follow up activity which included that: Phone-Out 11:14 PM, 1st attempt by phone to HCP to obtain follow-up information contained on HCP questionnaire. Phone answered by receptionist (No name provided) who provided HCP mailing address.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Hypoacusis, Immunisation, Tinnitus
Clinical narrative: He had sounds in his left ear, like birds chirping, like tinnitus.; Hearing was muffled, after third dose/trouble hearing/issues with hearing; Booster; 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. Other Case identifier(s): US-PFIZER INC-202101317606 (Pfizer).  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) at the age of 73 years 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 (First dose), for covid-19 immunization; Bnt162b2 (Second dose), for covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Sep2021, outcome "unknown", described as "Booster"; HYPOACUSIS (non-serious) with onset 29Sep2021, outcome "unknown", described as "Hearing was muffled, after third dose/trouble hearing/issues with hearing"; TINNITUS (non-serious) with onset 30Sep2021, outcome "not recovered", described as "He had sounds in his left ear, like birds chirping, like tinnitus.". The events "hearing was muffled, after third dose/trouble hearing/issues with hearing" and "he had sounds in his left ear, like birds chirping, like tinnitus." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypoacusis, tinnitus.  Additional information: Caller states he was fine, after his first two vaccines. Caller states he went to the ENT doctor, and reclarified, he is scheduled for a CT Scan. Caller states his doctor prescribed him Prednisone but does not specify if he has started taking the Prednisone yet.  Follow-up (24Nov2021): 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: Hypersensitivity
Clinical narrative: A patient is allergic to the first dose of the Pfizer Covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) from medical information team. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "a patient is allergic to the first dose of the Pfizer Covid 19 vaccine".  Additional information: Caller stated they have a patient who received the first dose of the Pfizer Covid 19 vaccine and reported some side effects. She went to receive the second dose, but the vaccination site refused to administer it. The father-in-law called them and they want to have a meeting with someone regarding what they can do. Someone who is allergic to the Pfizer Covid 19 vaccine will also be allergic to the Moderna vaccine.  Follow-up (24Nov2021): 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaginal haemorrhage
Clinical narrative: spotted; joint pain in my wrist elbow's meals; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Aug2021 (Lot number: FC3184) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "fertility issues" (unspecified if ongoing), notes: fertility issues prior to the vaccine which causes me to not ovulate and rarely have any bleeding. The patient's concomitant medications were not reported. The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 31Aug2021, outcome "not recovered", described as "spotted"; ARTHRALGIA (non-serious) with onset 31Aug2021, outcome "not recovered", described as "joint pain in my wrist elbow's meals". Therapeutic measures were not taken as a result of vaginal haemorrhage, arthralgia. Additional information: Patient was not received any other vaccine within 4 weeks. Patient not had covid prior vaccination as well after vaccination. 10 out of 10 don't recommend.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Chills, Dizziness, Fatigue, Headache
Clinical narrative: dizzyness; aches; tenderness; swollen left breast; slept 19hrs/slept 16hrs; fever; chills; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gerd" (ongoing); "Asthma" (ongoing). Concomitant medication(s) included: DEXILANT taken for gastrooesophageal reflux disease (ongoing); ALBUTEROL [SALBUTAMOL] taken for asthma. Vaccination history included: Bnt162b2 (1st Dose, Date: 02-MMM-2021, Anatomical site of injection: left ram), administration date: 2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizzyness"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "aches"; TENDERNESS (non-serious) with onset 2021, outcome "unknown", described as "tenderness"; BREAST SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swollen left breast"; HYPERSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "slept 19hrs/slept 16hrs"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache".  Additional information: Dose 2: It knocked her out for 2.5 weeks. Day1- fever, slept 19hrs, chills, dizziness. Day 2-fever, Chills, aches, fatigue, headache, swollen left breast (2x size) slept 16hrs, tenderness, dizziness. Day 3 3-7 headache, ache, fatigue, dizziness. Day 8- 21 fatigue and random headaches. Prior vaccinations were reported as none. Date and time of second dose: 03-MMM-2021, time: 15:45.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Pain, Pyrexia, Tenderness
Clinical narrative: dizzyness; aches; tenderness; swollen left breast; slept 19hrs/slept 16hrs; fever; chills; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gerd" (ongoing); "Asthma" (ongoing). Concomitant medication(s) included: DEXILANT taken for gastrooesophageal reflux disease (ongoing); ALBUTEROL [SALBUTAMOL] taken for asthma. Vaccination history included: Bnt162b2 (1st Dose, Date: 02-MMM-2021, Anatomical site of injection: left ram), administration date: 2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizzyness"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "aches"; TENDERNESS (non-serious) with onset 2021, outcome "unknown", described as "tenderness"; BREAST SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swollen left breast"; HYPERSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "slept 19hrs/slept 16hrs"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache".  Additional information: Dose 2: It knocked her out for 2.5 weeks. Day1- fever, slept 19hrs, chills, dizziness. Day 2-fever, Chills, aches, fatigue, headache, swollen left breast (2x size) slept 16hrs, tenderness, dizziness. Day 3 3-7 headache, ache, fatigue, dizziness. Day 8- 21 fatigue and random headaches. Prior vaccinations were reported as none. Date and time of second dose: 03-MMM-2021, time: 15:45.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, PNC13
Symptoms: Headache, Immunisation, Vaccination site erythema, Vaccination site pain
Clinical narrative: Booster; pain at the site of injection plus redness; pain at the site of injection plus redness; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 09Oct2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), administered in deltoid right, administration date 09Oct2021 (Batch/Lot number: unknown) as dose 2, single. 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; Pcv13 (Dose number: 1, It was years ago). The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Oct2021, outcome "unknown" and all described as "pain at the site of injection plus redness"; HEADACHE (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Headache". Therapeutic measures were taken as a result of headache.  Additional information :She reported that on 09Oct2021 She had an appointment at withheld (store location: withheld at around 5pm. She went there to get her covid-19 booster (she turned 65 recently) and she was also looking to get pneumovax as she already had PCV13 (she didn't recall the exact year in which she was vaccinated with PCV13 but she mentioned that it was years ago at the withheld office as part of a health fair). The pharmacist instructed her to get PCV13 as she just turned 65 recently and not pneumovax despite that she mentioned to the pharmacists that she already had PCV13. She ended getting her third covid-19 dose (comirnaty) plus PCV13 (2nd dose for her). She get comirnaty in her left shoulder and pcv13 in the right shoulder. In regards to adverse events she mentioned that she had pain at the site of injection plus redness, she referred that she had headache that resolved after taking panadol bid the next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: experienced nausea; extreme fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient in her 40's received bnt162b2 (BNT162B2), administration date 18Oct2021 (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 (1st dose), when the patient was in their 40's, for COVID-19 immunization; Bnt162b2 (2nd dose), when the patient was in their 40's, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 19Oct2021 03:00, outcome "not recovered", described as "experienced nausea"; FATIGUE (non-serious) with onset 19Oct2021 03:00, outcome "not recovered", described as "extreme fatigue".  Follow-up (24Nov2021): 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: Body temperature, Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: with the first shot his wife developed a fever (100, 101); When she got the first 2 doses initially she got a fever, felt lousy and had malaise; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program (005570).  A 58 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) for 1 day as dose 1, single and (Batch/Lot number: unknown) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "with the first shot his wife developed a fever (100, 101)"; MALAISE (non-serious), outcome "unknown", described as "When she got the first 2 doses initially she got a fever, felt lousy and had malaise". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient recieved both of the Pfizer Covid 19 Vaccinations. She recieved the Pfizer Covid 19 Vaccine Booster about 1-2 weeks ago. Per caller with the first shot patient developed a fever (100, 101) and malaise. When she got the first 2 doses initially she got a fever, felt lousy and had malaise but this fever was higher than the previous fevers. With the first 2 she was just lousy the first 2 days then fine.   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: Immune system disorder
Clinical narrative: States she is a retired person with a compromised immune system who is getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 21Oct2021 (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) for COVID-19 immunisation, Bnt162b2 (Dose 2) for COVID-19 immunisation. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious) with onset 2021, outcome "unknown", described as "States she is a retired person with a compromised immune system who is getting the vaccine".  Additional information: Caller stated she received the Pfizer COVID booster vaccine today and was calling to get instructions and wanted to register on VSafe and did that before when she received the 1st and 2nd doses of the vaccine, caller asks if Vsafe is set up for the booster, stated she is already registered through Vsafe and just wanted to contact Pfizer.  Reporter details: Caller stated she is a retired person with a compromised immune system who is getting the vaccine and is not a HCP. Caller declined to provide email address.  Follow-up (24Nov2021): 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.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Feeling abnormal, Musculoskeletal stiffness, Myalgia
Clinical narrative: Diarrhea; Joint pain; Muscle pain; just like my body if someone beat me up; like you are stiff, like I am stiff; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 09:30 (Lot number: 30155BA) at the age of 74 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 (1st Dose , Lot number: FF2587, Anatomical site of injection: Left arm, Time: 09:30 AM), administration date: 21Sep2021, when the patient was 74 years old, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset Oct2021, outcome "not recovered", described as "Diarrhea"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Joint pain"; MYALGIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Muscle pain"; FEELING ABNORMAL (non-serious) with onset Oct2021, outcome "not recovered", described as "just like my body if someone beat me up"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Oct2021, outcome "not recovered", described as "like you are stiff, like I am stiff". Therapeutic measures were taken as a result of diarrhoea, arthralgia, myalgia, feeling abnormal, musculoskeletal stiffness.  Additional information: The patient did not have any other vaccine prior to 4 weeks of COVID vaccine and did not have any relevant test. Clinical course: It was reported that patient got the Pfizer COVID shot last Monday and he still have side effects. Patient felt just like his body if someone beat him, he got none and he was healthy. The patient also got joint pain, diarrhea, muscle pain like stiff and like he was stiff. Patient took Tylenol for event treatment. Patient stated got the Pfizer COVID shot last Monday and I still have side effects. How long can the side effects last. Follow-up attempts are completed. No further information is expected  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Cough, Dizziness, Immunisation, Malaise
Clinical narrative: Booster; Had this weird dizzy feeling in my head; Started getting a lot of pain in my you know like lower back and then the pain got worse at night; My back, my both legs were in severe pain; My back, my both legs were in severe pain; Have been running fever; Cough; Not feeling well at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Oct2021 11:00 (Lot number: FF2590) 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 no: 1), administration date: 2021 for COVID-19 immunisation, Bnt162b2 (Dose no: 2), administration date: 2021 for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 23Oct2021 11:00, outcome "unknown", described as "booster", DIZZINESS (non-serious) with onset Oct2021, outcome "unknown", described as "Had this weird dizzy feeling in my head", PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "Started getting a lot of pain in my you know like lower back and then the pain got worse at night", BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Oct2021, outcome "unknown" and all described as "My back, my both legs were in severe pain", PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "Have been running fever", COUGH (non-serious) with onset Oct2021, outcome "unknown", described as "Cough", MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "Not feeling well at all". Therapeutic measures were taken as a result of pyrexia.  Additional Context: Consumer stated, Patient had the Pfizer COVID Vaccine Booster yesterday and after the shot patient had this weird dizzy feeling in my head and later on patient started getting a lot of pain in my you know like lower back and then the pain got worse at night, like really bad, my both (incomplete sentence) my back, my both legs were in severe pain and also I have been running fever. Patient had the shot at 11 am yesterday. Patient still running with fever tonight and I also developed a cough, that was really concerning me, Patient was taking Tylenol (Treatment) but the fever is been going up and down (Further clarification was unknown) and patient started coughing and from what I have read, I do not see anything of that being a side effect to the COVID booster.  QR comment: Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default.  Follow-up (18Nov2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Booster; Had this weird dizzy feeling in my head; Started getting a lot of pain in my you know like lower back and then the pain got worse at night; My back, my both legs were in severe pain; My back, my both legs were in severe pain; Have been running fever; Cough; Not feeling well at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Oct2021 11:00 (Lot number: FF2590) 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 no: 1), administration date: 2021 for COVID-19 immunisation, Bnt162b2 (Dose no: 2), administration date: 2021 for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 23Oct2021 11:00, outcome "unknown", described as "booster", DIZZINESS (non-serious) with onset Oct2021, outcome "unknown", described as "Had this weird dizzy feeling in my head", PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "Started getting a lot of pain in my you know like lower back and then the pain got worse at night", BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Oct2021, outcome "unknown" and all described as "My back, my both legs were in severe pain", PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "Have been running fever", COUGH (non-serious) with onset Oct2021, outcome "unknown", described as "Cough", MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "Not feeling well at all". Therapeutic measures were taken as a result of pyrexia.  Additional Context: Consumer stated, Patient had the Pfizer COVID Vaccine Booster yesterday and after the shot patient had this weird dizzy feeling in my head and later on patient started getting a lot of pain in my you know like lower back and then the pain got worse at night, like really bad, my both (incomplete sentence) my back, my both legs were in severe pain and also I have been running fever. Patient had the shot at 11 am yesterday. Patient still running with fever tonight and I also developed a cough, that was really concerning me, Patient was taking Tylenol (Treatment) but the fever is been going up and down (Further clarification was unknown) and patient started coughing and from what I have read, I do not see anything of that being a side effect to the COVID booster.  QR comment: Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default.  Follow-up (18Nov2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: face broke out rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 2019SA116434.  A 13 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, administration date Jul2021 (Batch/Lot number: unknown) at the age of 13  as dose 1, single for covid-19 immunisation; dupilumab (DUPILUMAB), first regimen subcutaneous from Jan2021 (Batch/Lot number: unknown) to Jan2021 at 400 mg (400 mg once,200mg every other week), second regimen subcutaneous from Jan2021 (Batch/Lot number: unknown) to Jan2021 at 400 mg (400 mg 1x subcutaneous) and third regimen subcutaneous since 2021 (ongoing) (Batch/Lot number: unknown) at 200 mg (200 qow subcutaneous) for asthma; crisaborole (EUCRISA), since 2021 (Batch/Lot number: unknown) for rash erythematous. 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 "face broke out rash". Therapeutic measures were taken as a result of rash. Additional info-On an unknown date in Jul2021, patient received first dose of COVID-19 vaccine once (strength, formulation, dosage, route, batch number, expiry: unknown) used as COVID-19 vaccination. On her first COVID vaccine, on an unknown date in Jul2021, after unknown latency, the patient had her face broke out in a rash which did not go away. On an unknown date in Aug2021, patient received second dose of COVID-19 vaccine. On her her second COVID vaccine on an unknown date in Aug2021, after unknown latency, patient had her face rash got worse that was red and raw (rash erythematous and skin erosion). Patient was being told to make sure dupilumab should not be given one week before the vaccine and should be okay to give 48 hours after the vaccine per doctor's recommendation   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) at the age of 75 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches".  Additional Information: Caller questioned if there had been any gerontology studies about how this vaccine was affected by age. Stated medications tend to effect people over 75 more, maybe the gerontologic population effects were more severe. First dose: Got on as clarified 19Mar2021. Second dose: Got it the specified number of days later, probably like 90 days later. It was whatever they said it was supposed to be. Indication: Due to age, it was recommended. She is in perfect health otherwise. She added, she will never get the COVID-19 vaccine after again. She will never want to go through all this suffering again. Concomitant Medications: Does not take anything serious, takes a few medications, but does not take any cancer drugs or immune suppressants. No additional vaccines were administered on same date as of the PFIZER Suspect. The patient had no prior vaccinations within 4 weeks. Medical History (including any illness at time of vaccination): None, the patient was pretty healthy. No relevant tests were done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: 2nd dose: Got it the specified number of days later, probably like 90 days later; Headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose:1), administration date: 19Mar2021, when the patient was 75 years old, for Covid-19 immunization, reaction(s): "Headache". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "2nd dose: Got it the specified number of days later, probably like 90 days later"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Oct2021 08:00 (Lot number: EW0217) at the age of 49 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 Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular, Time: 08:30 AM), administration date: 16Mar2021, when the patient was 48 years old, for Covid-19 immunization, reaction(s): "Feverish (99-100F), felt feverish", "Body aches, achy", "felt tired", "Pain at injection site", "lethargy (Need to sleep)"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular, Time: 08:30 AM), administration date: 23Feb2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Oct2021 08:00, outcome "unknown", described as "Receiving the booster shot "; FATIGUE (non-serious) with onset 28Oct2021 07:00, outcome "recovered" (29Oct2021), described as "felt tired"; PYREXIA (non-serious) with onset 28Oct2021 07:00, outcome "recovered" (29Oct2021), described as "slight fever"; PAIN (non-serious) with onset 28Oct2021 07:00, outcome "recovered" (29Oct2021), described as "a little achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pyrexia, pain. Additional information: There was no other vaccine in four weeks. After receiving her 2nd vaccine shot, the next day she felt feverish and achy and tired, by the following day she felt fine. After receiving the booster shot, the patient had the same symptoms the following day and the day after that she felt fine. It was reported as non-serious. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021297739 same patient/reporter/drug in different doses with similar events.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Fatigue, Headache
Clinical narrative: dizzy; Headache; Fatigue; Nausea; blood pressure starts rising, it's very high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 23 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid issues" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "blood pressure starts rising, it's very high". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had to go up on a 2nd floor, she said she felt like a 90 year old climbing those steps, took a long time its very tiring on her body, sounds similar. Caller stated that the patient had thyroid issues prior getting the vaccine, upon clarification and taking levothyroxine as medication. Caller is asking if there is anybody reported anything like these after taking the second vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: dizzy; Headache; Fatigue; Nausea; blood pressure starts rising, it's very high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 23 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid issues" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "blood pressure starts rising, it's very high". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had to go up on a 2nd floor, she said she felt like a 90 year old climbing those steps, took a long time its very tiring on her body, sounds similar. Caller stated that the patient had thyroid issues prior getting the vaccine, upon clarification and taking levothyroxine as medication. Caller is asking if there is anybody reported anything like these after taking the second vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Inflammation, Pyrexia
Clinical narrative: Fever of 103; just had joint pain and inflammation in those areas; just had joint pain and inflammation in those areas; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever of 103"; ARTHRALGIA (non-serious), INFLAMMATION (non-serious), outcome "unknown" and all described as "just had joint pain and inflammation in those areas". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller speaks of someone who had a fever of 103 that resolved after 1 to 2 days. She just had joint pain and inflammation in those areas and concerned of what the second dose may do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Interchange of vaccine products, Pain in extremity
Clinical narrative: The pedestrian accidently gave them both adult vaccine dose instead the age appropriate dose; The pedestrian accidently gave them both adult vaccine dose instead the age appropriate dose; other than pain in their arm where the vaccine is administered so far; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A 7 year-old female patient received BNT162B2 (COMIRNATY), administration date 09Nov2021 (Batch/Lot number: unknown) at the age of 7 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: INTERCHANGE OF VACCINE PRODUCTS (non-serious), ACCIDENTAL OVERDOSE (non-serious) all with onset 09Nov2021, outcome "unknown" and all described as "The pedestrian accidently gave them both adult vaccine dose instead the age appropriate dose"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "other than pain in their arm where the vaccine is administered so far".  Additional information: Reporter stated that my twins daughters, 7 yr, got their first Pfizer vaccine on 9th. The pedestrian accidently gave them both adult vaccine dose instead the age appropriate dose. Both my girls have develop no negative symptoms other than pain in their arm where the vaccine is administered so far. One of my twins have nephrotic syndrome. I am definitely concern for her and want to know if they should receive second dose or not. If yes what amount of dose they should get and when should be they be getting it. The caller states the report was regarding twins that are 7 years old, both received the Pfizer Covid Vaccine last Tuesday, 09Nov2021. On Friday, 12Nov2021 the caller received a call from withheld stating both patients were administered the Pfizer Covid Vaccine for older kids instead of the Pfizer Covid Vaccine 5211.  Follow-up (24Dec2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Heart rate increased, Heart rate variability decreased
Clinical narrative: Chills; sore Arm; headache; sore throat; high resting heart rate 90bpm & low heart Rate variability 8ms; high resting heart rate 90bpm & low heart Rate variability 8ms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 09:45 (Lot number: ff8841) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 29Oct2021 20:00, outcome "recovered with sequelae", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 29Oct2021 20:00, outcome "recovered with sequelae", described as "sore Arm"; HEADACHE (non-serious) with onset 29Oct2021 20:00, outcome "recovered with sequelae", described as "headache"; OROPHARYNGEAL PAIN (non-serious) with onset 29Oct2021 20:00, outcome "recovered with sequelae", described as "sore throat"; HEART RATE INCREASED (non-serious), HEART RATE VARIABILITY DECREASED (non-serious) all with onset 29Oct2021 20:00, outcome "recovered with sequelae" and all described as "high resting heart rate 90bpm & low heart Rate variability 8ms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pain in extremity, headache, oropharyngeal pain, heart rate increased, heart rate variability decreased.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has tested for COVID-19. Patient recovered with lasting effects.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate variability test, Oropharyngeal pain, Pain in extremity
Clinical narrative: Chills; sore Arm; headache; sore throat; high resting heart rate 90bpm & low heart Rate variability 8ms; high resting heart rate 90bpm & low heart Rate variability 8ms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 09:45 (Lot number: ff8841) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 29Oct2021 20:00, outcome "recovered with sequelae", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 29Oct2021 20:00, outcome "recovered with sequelae", described as "sore Arm"; HEADACHE (non-serious) with onset 29Oct2021 20:00, outcome "recovered with sequelae", described as "headache"; OROPHARYNGEAL PAIN (non-serious) with onset 29Oct2021 20:00, outcome "recovered with sequelae", described as "sore throat"; HEART RATE INCREASED (non-serious), HEART RATE VARIABILITY DECREASED (non-serious) all with onset 29Oct2021 20:00, outcome "recovered with sequelae" and all described as "high resting heart rate 90bpm & low heart Rate variability 8ms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pain in extremity, headache, oropharyngeal pain, heart rate increased, heart rate variability decreased.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has tested for COVID-19. Patient recovered with lasting effects.   No follow-up attempts are possible. No further information is expected.