chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Malaise, Nausea
Clinical narrative: Submandibular glands swelled to size of plums; Malaise; Fatigue; Nausea; body aches; persistent mild to moderate headache for one week for dose one; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Aug2021 (Lot number: FC3180) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "contracted the virus", start date: 2021 (unspecified if ongoing), notes: I was not formally diagnosed with COVID but certain I contracted the virus as two members of my household were formally diagnosed I lost my sense of taste and smell for greater than six months . I had the virus likely around Feb-Mar 2021; "lost my sense of taste", start date: 2021 (unspecified if ongoing); "lost my sense of taste and smell", start date: 2021 (unspecified if ongoing). There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Aug2021, outcome "recovering", described as "Submandibular glands swelled to size of plums"; MALAISE (non-serious) with onset 09Aug2021, outcome "recovering", described as "Malaise"; FATIGUE (non-serious) with onset 09Aug2021, outcome "recovering", described as "Fatigue"; NAUSEA (non-serious) with onset 09Aug2021, outcome "recovering", described as "Nausea"; PAIN (non-serious) with onset 09Aug2021, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 09Aug2021, outcome "recovering", described as "persistent mild to moderate headache for one week for dose one". Therapeutic measures were not taken as a result of lymphadenopathy, malaise, fatigue, nausea, pain, headache.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Submandibular glands swelled to size of plums within two days, slowly resolving over the course of 30 days. This occurred again with dose two, but not as severe. Malaise, fatigue, nausea, body aches, persistent mild to moderate headache for one week for dose one; mild headache, body aches, and swollen glands dose two. No Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date was 29Sep2021.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Submandibular glands swelled to size of plums; Malaise; Fatigue; Nausea; body aches; persistent mild to moderate headache for one week for dose one; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Aug2021 (Lot number: FC3180) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "contracted the virus", start date: 2021 (unspecified if ongoing), notes: I was not formally diagnosed with COVID but certain I contracted the virus as two members of my household were formally diagnosed I lost my sense of taste and smell for greater than six months . I had the virus likely around Feb-Mar 2021; "lost my sense of taste", start date: 2021 (unspecified if ongoing); "lost my sense of taste and smell", start date: 2021 (unspecified if ongoing). There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Aug2021, outcome "recovering", described as "Submandibular glands swelled to size of plums"; MALAISE (non-serious) with onset 09Aug2021, outcome "recovering", described as "Malaise"; FATIGUE (non-serious) with onset 09Aug2021, outcome "recovering", described as "Fatigue"; NAUSEA (non-serious) with onset 09Aug2021, outcome "recovering", described as "Nausea"; PAIN (non-serious) with onset 09Aug2021, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 09Aug2021, outcome "recovering", described as "persistent mild to moderate headache for one week for dose one". Therapeutic measures were not taken as a result of lymphadenopathy, malaise, fatigue, nausea, pain, headache.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Submandibular glands swelled to size of plums within two days, slowly resolving over the course of 30 days. This occurred again with dose two, but not as severe. Malaise, fatigue, nausea, body aches, persistent mild to moderate headache for one week for dose one; mild headache, body aches, and swollen glands dose two. No Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date was 29Sep2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). Other case identifier: 20210921000818. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced hypersensitivity (allergic reaction) and urticaria (broke-out in hives), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in arm, on Sep 25, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient developed vaccination site lymphadenopathy (collarbone to the shoulder where there is a gland is bubbled and swollen), onset Sep 2021, with outcome of unknown. Additional information: Patient got her booster shot on Saturday, Sep 25, 2021. The upper part above her collarbone to her shoulder glands on the left-side where she got the shot, bubbled/swollen-up. She wanted to know if this is normal. Informed patient swollen lymph nodes (lymphadenopathy), generally resolved within 10 days, was likely to have resulted from a robust vaccine-elicited immune response. Patient referred back to her HCP. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: other arm is hurting as well/ opposite arm of injection started hurting; injection arm hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 (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: VACCINATION SITE PAIN (non-serious) with onset 29Sep2021, outcome "unknown", described as "injection arm hurting"; PAIN IN EXTREMITY (non-serious) with onset 30Sep2021, outcome "not recovered", described as "other arm is hurting as well/ opposite arm of injection started hurting".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: feeling sick; cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Sep2021 (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: MALAISE (non-serious) with onset Sep2021, outcome "unknown", described as "feeling sick"; NASOPHARYNGITIS (non-serious) with onset Sep2021, outcome "unknown", described as "cold". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported as patient received the first dose of the Pfizer COVID-19 vaccine beginning September. She is due for the second dose. She was feeling sick and she have a cold. she tested negative for COVID. She spoke to a pharmacist who recommended she wait until she feel better before getting the second dose. Caller didnt agree to speak to safety as she think this was not related to the vaccine. Response stared as noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Phone answered by consumer who states she was doing fine, states it was just a question she had and got a nice response to it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in left arm, on Sep 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced vaccination site discomfort (his arm has progressively started getting harder and harder to lift), onset Sep 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram, Fall, Fatigue
Clinical narrative: weak/fatigued; weak/fatigued; He fell and could not get up; he couldn't keep his head up. He has no energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 85 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 13:00 (Lot number: 30130BA) at the age of 85 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Quadruple bypass 11 years ago" (unspecified if ongoing), notes: His heart and lungs were checked out in June and July 2021 and all related tests showed they were fine.; "Asthma" (unspecified if ongoing), notes: His heart and lungs were checked out in June and July 2021 and all related tests showed they were fine. Concomitant medication(s) included: LIPITOR. Past drug history included: Aspirin, reaction(s): "Drug allergy", notes: Known allergies: Aspirin. The following information was reported: ASTHENIA (non-serious), FATIGUE (non-serious) all with onset 27Sep2021, outcome "not recovered" and all described as "weak/fatigued"; FALL (non-serious) with onset 27Sep2021, outcome "not recovered", described as "He fell and could not get up"; ASTHENIA (non-serious) with onset 27Sep2021, outcome "not recovered", described as "he couldn't keep his head up. He has no energy". The events "weak/fatigued", "he fell and could not get up" and "he couldn't keep his head up. he has no energy" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This was the booster shot. The patient had received other medications in 2 weeks with lipitor and some supplements. The patient had not received other vaccine in 4 weeks. The adverse event resulted in emergency room (department/urgent care). Patient had not covid prior vaccination and had not covid tested post vaccination. Adverse event, fine the day of the shot. The next day patient was so weak/fatigued patient fell and could not get up. An ambulance took him to the ER. All vitals, CT scan, blood work and urine test was normal. He was released with a walker and he could not keep his head up. Patient is still very fatigued and needs the walker. He never used a walker before this. He has no energy.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation
Clinical narrative: weak/fatigued; weak/fatigued; He fell and could not get up; he couldn't keep his head up. He has no energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 85 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 13:00 (Lot number: 30130BA) at the age of 85 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Quadruple bypass 11 years ago" (unspecified if ongoing), notes: His heart and lungs were checked out in June and July 2021 and all related tests showed they were fine.; "Asthma" (unspecified if ongoing), notes: His heart and lungs were checked out in June and July 2021 and all related tests showed they were fine. Concomitant medication(s) included: LIPITOR. Past drug history included: Aspirin, reaction(s): "Drug allergy", notes: Known allergies: Aspirin. The following information was reported: ASTHENIA (non-serious), FATIGUE (non-serious) all with onset 27Sep2021, outcome "not recovered" and all described as "weak/fatigued"; FALL (non-serious) with onset 27Sep2021, outcome "not recovered", described as "He fell and could not get up"; ASTHENIA (non-serious) with onset 27Sep2021, outcome "not recovered", described as "he couldn't keep his head up. He has no energy". The events "weak/fatigued", "he fell and could not get up" and "he couldn't keep his head up. he has no energy" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This was the booster shot. The patient had received other medications in 2 weeks with lipitor and some supplements. The patient had not received other vaccine in 4 weeks. The adverse event resulted in emergency room (department/urgent care). Patient had not covid prior vaccination and had not covid tested post vaccination. Adverse event, fine the day of the shot. The next day patient was so weak/fatigued patient fell and could not get up. An ambulance took him to the ER. All vitals, CT scan, blood work and urine test was normal. He was released with a walker and he could not keep his head up. Patient is still very fatigued and needs the walker. He never used a walker before this. He has no energy.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Complex regional pain syndrome, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: reflexive sympathetic disorder; I have tremendous pain in my right arm where i was vaccinated and i have lost basic use of my right arm. I'm loosing the use of my arm since march I'm in terrible pain and I've given it plenty time.; i have lost basic use of my right arm. I'm loosing the use of my arm since Mar I'm in terrible pain and I've given it plenty time.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm right, administration date Mar2021 (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: COMPLEX REGIONAL PAIN SYNDROME (non-serious) with onset 2021, outcome "unknown", described as "reflexive sympathetic disorder"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "I have tremendous pain in my right arm where i was vaccinated and i have lost basic use of my right arm. I'm loosing the use of my arm since march I'm in terrible pain and I've given it plenty time."; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "not recovered", described as "i have lost basic use of my right arm. I'm loosing the use of my arm since Mar I'm in terrible pain and I've given it plenty time.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Ventricular extrasystoles
Clinical narrative: had episodes of pre-ventricular contraction; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 01), for Covid-19 Immunization. The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious), outcome "recovered", described as "had episodes of pre-ventricular contraction". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter have an inquiry from one of physicians who had received 2 doses of the BioNTech Covid vaccine, the physician reported that he had episodes of pre-ventricular contraction 1 day after receiving the second dose of Covid vaccine. He sought medical attention the next day but the EKG shows no abnormalities, and there were no symptoms of pericarditis or myocarditis. The pre-ventricular contraction went away after that, so he did not report it to VAERS system. receiving the booster dose. Since pharmacist's facility was following the CDC recommendation to give the booster dose to physicians.  The 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypokinesia, Somnolence
Clinical narrative: fell asleep; tired; Didn't roll over or even move; 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. The reporter is the patient. A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Lot number: ET7534) at the age of 69 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: EN6208, When I initially got your vaccine 1st shot I did not feel anything, my arm did not hurt, nothing hurt I felt great.), administration date: 29Mar2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 19Apr2021, outcome "recovered" (Apr2021), described as "fell asleep"; FATIGUE (non-serious) with onset 19Apr2021, outcome "recovered" (Apr2021), described as "tired"; HYPOKINESIA (non-serious) with onset 19Apr2021, outcome "recovered" (20Apr2021), described as "Didn't roll over or even move". Additional information: Reporter had received two doses of the Pfizer COVID vaccine and she reported that, it was almost a benefit, after her 2nd dose she slept through the night and then she slept for about 12 hours and that is unusual for her. The caller had a good night sleep which is unusual for her. She also mentioned her friend who is immunocompromised and a female had received two doses of the Pfizer COVID vaccine and ended up getting COVID. Reporter was clarifies and says that she actually does usually sleep good she had slept through the night which was the perfect scenario for her. She usually goes to sleep around 11:00 PM and usually wake up to her alarm around 7:00 AM to 7:30 AM. She was tired around 9:00 that night that she had her COVID vaccine and when her head hit the pillow she didn't roll over or even move until 9:30 AM. She guesses that if this would of been in the daytime her side effect would of been tiredness. When she woke up that morning her husband was installing windows and she helped him with that that morning and actually for her with the timeframe for the tiredness it was a terrific night's sleep. Now, if her tiredness had been at 9:00 AM then maybe she would of slept the whole day away. Her only side effect was being tired and then she slept. If that would of happened at a different timeframe then maybe she would of slept the day away but it happened through the night. She says she was usually not good at surveys. Her 2nd dose was 19Apr2021 and so this would of been on the night of 19Apr2021 and it was only for that one night. Caller declined to complete a report on her friend, she says she will just leave it with the information that she provided. All of it is a little personal and she will just leave the report he way it is. Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 17:45 (Lot number: 301308A) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "bipolar" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Allergy: Lutein" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL; CYMBALTA; SYNTHROID; TOPAMAX; PRENATAL.  The following information was reported: POLYMENORRHOEA (non-serious) with onset 30Sep2021 19:30, outcome "not recovered", described as "Sudden early onset of menstrual cycle (three weeks)". Therapeutic measures were not taken as a result of polymenorrhea.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient not affected with Covid and not tested for Covid prior vaccination. No treatment received.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Vaccination site pain
Clinical narrative: chills; pain where the shot was; Caller stated that she had complaints of tiredness and body ache with the second dose of the Pfizer Covid-19 vaccine.; Caller stated that she had complaints of tiredness and body ache with the second dose of the Pfizer Covid-19 vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 (Lot number: EN6200) at the age of 66 years 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 Number: 1, Lot Number / Expiry Date: EL9265 or EL9263,, Anatomical site of injection: Left arm), administration date: 28Jan2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "tiredness", "pain where the shot was", "Chills". The following information was reported: PAIN (non-serious), FATIGUE (non-serious) all with onset 24Feb2021, outcome "unknown" and all described as "Caller stated that she had complaints of tiredness and body ache with the second dose of the Pfizer Covid-19 vaccine."; CHILLS (non-serious) with onset 25Feb2021, outcome "unknown", described as "chills"; VACCINATION SITE PAIN (non-serious) with onset 24Feb2021, outcome "unknown", described as "pain where the shot was".  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: Not feeling well; Feels fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) at the age of 53 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 (DOSE1, SINGLE), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious) with onset Sep2021, outcome "unknown", described as "Not feeling well"; FATIGUE (non-serious) with onset Sep2021, outcome "unknown", described as "Feels fatigue". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Fatigue, Headache, Pain in extremity
Clinical narrative: Extreme exhaustion lasting for longer than one week. Headaches, joint inflammation and pain in hands feet and knees as well as up and down spine.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: Extreme exhaustion lasting for longer than one week. Headaches, joint inflammation and pain in hands feet and knees as well as up and down spine.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lethargy, Malaise
Clinical narrative: She feels weak; Lethargic; Went down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 77 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: history of migraines and woke up with a migraine; "Asthma" (unspecified if ongoing), notes: Caller stated his wife has asthma. The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "She feels weak"; LETHARGY (non-serious), outcome "unknown", described as "Lethargic"; MALAISE (non-serious), outcome "unknown", described as "Went down".  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (08Nov2021): 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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Really bad pain on both sides of my mid section of my back for 3 days; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient reporting for himself.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Sep2021 12:30 (Lot number: FC3182) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Pain" (unspecified if ongoing). Concomitant medication(s) included: OXYCODONE; GABAPENTIN; CELECOXIB. Past drug history included: Codeine, reaction(s): "allergies", notes: known allergies: Codeine. The following information was reported: BACK PAIN (non-serious) with onset 23Sep2021 13:00, outcome "recovered" (26Sep2021 13:00), described as "Really bad pain on both sides of my mid section of my back for 3 days". Therapeutic measures were not taken as a result of back pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Oxicodone 5mg, Gabapentin 300mg, Celecoxib 100mg. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 30Sep2021. The reporter assessed event as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Adverse event resulted in None of the above.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: swollen lymph nodes near neck; fatigue; Arm soreness; Arm stiffness; achiness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Sep2021 11:00 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: LOESTRIN FE taken for polycystic ovaries, start date: 1996 (ongoing); METFORMIN taken for polycystic ovaries, start date: 1996 (ongoing); SPIRONOLACTONE taken for polycystic ovaries, start date: 1996 (ongoing); GLUCOSAMINE; LEXAPRO taken for depression, start date: 2009 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 13:30, Lot no: EL3247, Route: Intramuscular), administration date: 26Jan2021, when the patient was 41 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Time: 13:30, Lot no: EL3247, Route: Intramuscular), administration date: 16Feb2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 29Sep2021 20:00, outcome "recovering", described as "Arm stiffness"; PAIN IN EXTREMITY (non-serious) with onset 30Sep2021 11:00, outcome "recovered" (2021), described as "Arm soreness"; LYMPHADENOPATHY (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (2021), described as "swollen lymph nodes near neck"; FATIGUE (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (2021), described as "fatigue"; PAIN (non-serious) with onset 29Sep2021 20:00, outcome "recovering", described as "achiness". Therapeutic measures were not taken as a result of musculoskeletal stiffness, pain in extremity, lymphadenopathy, fatigue, pain.  Additional information: It was reported that, the patient had no known allergies. The patient did not receive any other vaccines prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Intermenstrual bleeding, Menstruation delayed
Clinical narrative: Menstral cycle halted/delayed, however spotting black blood.; Menstral cycle halted/delayed, however spotting black blood.; Facial skin sensitivity; This is a spontaneous report from a contactable consumer (Patient).An 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 13:00 (Lot number: FF8879) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthmatic" (unspecified if ongoing); "PCOS" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ceclor, reaction(s): "allergies"; Vicodin, reaction(s): "allergies". The following information was reported: MENSTRUATION DELAYED (non-serious), INTERMENSTRUAL BLEEDING (non-serious) all with onset 29Sep2021 14:00, outcome "not recovered" and all described as "Menstral cycle halted/delayed, however spotting black blood."; HYPERAESTHESIA (non-serious) with onset 29Sep2021 14:00, outcome "not recovered", described as "Facial skin sensitivity". Therapeutic measures were not taken as a result of menstruation delayed, intermenstrual bleeding, hyperaesthesia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: None. Menstral cycle halted/delayed, however spotting black blood. I should have had my period on or even the day after the vaccine. Instead I'm spotting black and nothing else. Also have facial skin sensitivity. My normal moisturizer and lotion I use stings my face. Very sensitive. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.if covid tested post vaccination : No. Device Date : 30Sep2021  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "Heart palpitations".  Additional information: The reporter stated that her niece was also experienced heart palpations after the two doses of the Pfizer covid vaccines, she was a lot younger than her mom.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101294229 same reporter/product/event, different patient
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bile culture, Bile output increased, Dyspepsia, Gastrooesophageal reflux disease
Clinical narrative: too much bile; acid stomach/digestion sped up/food not Digesting; acid reflux; stomach pain; sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 13:15 (Lot number: EP7533) at the age of 60 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 (lot number=EW0169, administration time=01:15 PM, dose number=1, vaccine location=Right arm), administration date: 14Apr2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: BILE OUTPUT INCREASED (non-serious) with onset 05May2021, outcome "not recovered", described as "too much bile"; DYSPEPSIA (non-serious) with onset 05May2021, outcome "not recovered", described as "acid stomach/digestion sped up/food not Digesting"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 05May2021, outcome "not recovered", described as "acid reflux"; ABDOMINAL PAIN UPPER (non-serious) with onset 05May2021, outcome "not recovered", described as "stomach pain"; HYPERHIDROSIS (non-serious) with onset 05May2021, outcome "not recovered", described as "sweating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of bile output increased, dyspepsia, gastrooesophageal reflux disease, abdominal pain upper, hyperhidrosis.  Additional information: Adverse event: too much bile, acid stomach, acid Reflux, digestion sped up, food not Digesting, stomach pain, sweating. Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient did not had covid prior vaccination. Patient was not covid tested post vaccination. Patient did not had covid test post vaccination. Patient had no known allergies. Patient did not had other medical history.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: too much bile; acid stomach/digestion sped up/food not Digesting; acid reflux; stomach pain; sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 13:15 (Lot number: EP7533) at the age of 60 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 (lot number=EW0169, administration time=01:15 PM, dose number=1, vaccine location=Right arm), administration date: 14Apr2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: BILE OUTPUT INCREASED (non-serious) with onset 05May2021, outcome "not recovered", described as "too much bile"; DYSPEPSIA (non-serious) with onset 05May2021, outcome "not recovered", described as "acid stomach/digestion sped up/food not Digesting"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 05May2021, outcome "not recovered", described as "acid reflux"; ABDOMINAL PAIN UPPER (non-serious) with onset 05May2021, outcome "not recovered", described as "stomach pain"; HYPERHIDROSIS (non-serious) with onset 05May2021, outcome "not recovered", described as "sweating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of bile output increased, dyspepsia, gastrooesophageal reflux disease, abdominal pain upper, hyperhidrosis.  Additional information: Adverse event: too much bile, acid stomach, acid Reflux, digestion sped up, food not Digesting, stomach pain, sweating. Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient did not had covid prior vaccination. Patient was not covid tested post vaccination. Patient did not had covid test post vaccination. Patient had no known allergies. Patient did not had other medical history.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick with normal side effects; 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 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 (Lot number: EN6200) at the age of 69 years as dose 2, single and administered in arm left, administration date 17Feb2021 (Lot number: EM9809) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Feb2021, outcome "unknown", described as "sick with normal side effects".  Additional Information: Patient received her third dose of the Pfizer COVID-19 Vaccine (lot: 301308A), Anatomical location: upper left arm, on 27Sep2021. She was sick with normal side effects that she had before with the initial vaccine series, but her left arm at the site of the injection looks like a huge red spot. It's hard and hot and black and blue in the middle. She was not feeling well enough to go out to the Emergency room. She had no doctor at this time due to retirement or leaving the practice. She called to find out if her arm symptoms have been reported so she knows if she should go out tomorrow to the Emergency Department and be evaluated. The patient was very concerned about the side effects. The patient was advised to go see somebody and she told as it was difficult to go see somebody right now, she was weighing out rather to go to Urgent care or not. Patient reports slight swelling and itching after receiving the third dose Pfizer Covid Vaccine. Slight swelling, she did not actually look for a couple days, the swelling was there yesterday, 30Sep2021 but the patient forgot to mention when reporting to Pfizer previously. The caller has been itching for a couple of days. The way the caller feels this morning is everything improved. Caller states the itching, was persistent, the itching happening now and was not happening when the caller reported to Pfizer previously. Patient states she received the third dose Pfizer Covid Vaccine because of her age and wouldn't say compromised immune system but she has medical issues and is overweight.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity
Clinical narrative: Hot and painful red arm.; Hot and painful red arm.; Hot and painful red arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01,single), for COVID-19 immunization. The following information was reported: FEELING HOT (non-serious), PAIN IN EXTREMITY (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "Hot and painful red arm.".  Additional Information:Reporter seriousness for Hot and painful red arm.: Unspecified.Reason for no lot number: of COVID-19 Vaccine: Other: Consumer stated, "What? LOT# it is in my safe may I just call back to them and go through once I get it I just thought it is easy to call and ask a question, its really not.".Expiry Date of COVID-19 Vaccine: Unknown. Transferring agent stated, "I do have the caller on the other line and she would like to report an adverse event after the second dose there is a hot and painful red arm.". When paraphrased the concern and Product name as Pfizer COVID-19 Vaccine: Consumer stated, "Yes, the reason why I called was that's not consider as a bad reaction right its just a reaction right.Further probing could not be done as consumer was unwilling to provide further information hence, product details (Expiration date, NDC#, and UPC #), purchase details and other details were unknown and limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Influenza like illness
Clinical narrative: I just had symptom of flu, little ''type thing''; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "I just had symptom of flu, little ''type thing''". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter seriousness for I just had symptom of flu, little type thing: Unspecified.LOT#: Consumer stated, "I can give you the slash numbers whatever they are I dont know what that is 2/7X267LTW4S-CMQ." Expiry Date of COVID-19 Vaccine: Unknown.Consumer stated, "Yes correct my first and second I didnt have a problem, yeah I just had symptom of flu little type thing (further not clarified hence captured as per verbatim) and that is nothing but I never had this ever in my life." Consumer stated, "Yes, On Friday 24Sep I received my third my Pfizer booster which is third shot and after I got home three hours later my fingers, my thumb started to jerk and involuntary movements and its been that way for a week and I just wondered if this an adverse reactions of Pfizer and how long will it last.Other Products: No.Patient History: No.Investigation Assessment: Yes.Investigation: Consumer stated, "Any blood work:Yes. Yes I had a blood test yesterday. I guess they are checking electrolytes and my magnesium (further not clarified) was okay. So I am waiting to get some more results but that is just for the finger, for the finger you know because looking for electrolytes because my thumb is jerking after the 3 hours after the shot."Consumer was unwilling to complete the report. Further probing could not be done. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Polymerase chain reaction
Clinical narrative: Left arm was very sore; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ADVASTAT. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Left arm was very sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Facility where the most recent COVID-19 vaccine was administered:Pharmacy or Drug Store. Pfizer vaccine was administered on 28Sep2021 (Lot number: FF839) in left arm. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received hydrochloride 12.5 mcg within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was tested for COVID-19. Device Date: 30Sep2021.  Follow-up attempts completed. No further information is expected.