chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: feet swelling; feet swelling and pain; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Aug2021 10:30 (Lot number: FF2588) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vitamin D deficiency" (unspecified if ongoing); "penicillin" (unspecified if ongoing), notes: known allergies: penicillin. The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 28Aug2021 14:30, outcome "not recovered", described as "feet swelling"; PAIN IN EXTREMITY (non-serious) with onset 28Aug2021 14:30, outcome "not recovered", described as "feet swelling and pain". Therapeutic measures were not taken as a result of peripheral swelling, pain in extremity.  Additional information: Bilateral feet swelling and pain, Swelling is medial, just posterior to feet arches. No other vaccine in four weeks, no Covid prior vaccination and no Covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Speech disorder, Trance
Clinical narrative: Approximately 30 -45 minutes after receiving the vaccine patient had difficulty communicating; patient was in like a trance his arms were limp; patient was in like a trance his arms were limp; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 16:00 (Lot number: FC 3183) at the age of 14 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 (Dose number: 01, Lot number: EW0177, Vaccine location: Left arm, Administration time: 04:30 PM), administration date: 06Aug2021, when the patient was 14 years old, for Covid-19 immunization. The following information was reported: SPEECH DISORDER (non-serious) with onset 27Aug2021 16:45, outcome "recovered" (Aug2021), described as "Approximately 30 -45 minutes after receiving the vaccine patient had difficulty communicating"; TRANCE (non-serious), GAIT DISTURBANCE (non-serious) all with onset 27Aug2021 16:45, outcome "recovered" (Aug2021) and all described as "patient was in like a trance his arms were limp". The events "approximately 30 -45 minutes after receiving the vaccine patient had difficulty communicating", "patient was in like a trance his arms were limp" and "patient was in like a trance his arms were limp" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of speech disorder, trance, gait disturbance.  Additional information: Approximately 30 -45 minutes after receiving the vaccine patient had difficulty communicating, patient was in like a trance his arms were limp, reporter's older son took patient for the vaccine flagged down an EMT who couldn't get a response from him and patient was taken to the hospital. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Patient was not covid tested post vaccination. No known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Breast pain, Dizziness, Fatigue, Lymphadenopathy
Clinical narrative: Swollen Lymph nodes on her left arm; Left breast pain; Lung pain; Lightheaded; Muscle aches; Tiredness; Weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 16:00 (Batch/Lot number: unknown) at the age of 37 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "sulfa allergy" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Penicillin, reaction(s): "Penicillin allergy"; Cipro, reaction(s): "Cipro allergy". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Swollen Lymph nodes on her left arm"; BREAST PAIN (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Left breast pain"; PULMONARY PAIN (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Lung pain"; DIZZINESS (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Lightheaded"; MYALGIA (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Muscle aches"; FATIGUE (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Tiredness"; ASTHENIA (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Weakness". It was unknown if therapeutic measures were taken as a result of lymphadenopathy, breast pain, pulmonary pain, dizziness, myalgia, fatigue, asthenia.  Additional information: No other vaccine in four weeks. No other medications in two weeks. Covid prior vaccination was yes. Covid tested post vaccination was no.  Follow-up attempts completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pulmonary pain
Clinical narrative: Swollen Lymph nodes on her left arm; Left breast pain; Lung pain; Lightheaded; Muscle aches; Tiredness; Weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 16:00 (Batch/Lot number: unknown) at the age of 37 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "sulfa allergy" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Penicillin, reaction(s): "Penicillin allergy"; Cipro, reaction(s): "Cipro allergy". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Swollen Lymph nodes on her left arm"; BREAST PAIN (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Left breast pain"; PULMONARY PAIN (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Lung pain"; DIZZINESS (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Lightheaded"; MYALGIA (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Muscle aches"; FATIGUE (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Tiredness"; ASTHENIA (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Weakness". It was unknown if therapeutic measures were taken as a result of lymphadenopathy, breast pain, pulmonary pain, dizziness, myalgia, fatigue, asthenia.  Additional information: No other vaccine in four weeks. No other medications in two weeks. Covid prior vaccination was yes. Covid tested post vaccination was no.  Follow-up attempts completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Trichorrhexis
Clinical narrative: Loss of hair at the front in two separate  sections.  Additional to balding significant hair breakage throughout the front and middle of my hair; Loss of hair at the front in two separate  sections.  Additional to balding significant hair breakage throughout the front and middle of my hair; 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 19May2021 (Lot number: EW0169) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EW0175, administration date: 27Apr2021, vaccine location: Left arm), administration date: 27Apr2021, when the patient was 34 years old, for Covid-19 immunisation.  The following information was reported: ALOPECIA (non-serious), TRICHORRHEXIS (non-serious) all with onset 09Jun2021, outcome "not recovered" and all described as "Loss of hair at the front in two separate sections.  Additional to balding significant hair breakage throughout the front and middle of my hair". Therapeutic measures were not taken as a result of alopecia, trichorrhexis.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Loss of hair at the front in two separate sections. Additional to balding significant hair breakage throughout the front and middle of my hair.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; 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 patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: ER8732) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes" (ongoing), notes: Onset date: 8 or more years ago, Patient Details: fine with blood glucose and on low carb keto diet. The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "flu like symptoms".  Additional information: After the first dose patient was fine after 3 days of flu like symptoms. after the second dose, patient was waiting to recover from it but arms did not recover from pain. Patient can not move left arm upward and its now pain full to raise left arm or reach back patient can not tie hair and became so difficult to remove clothes or put them on  patient can not lean on it when patient sleeping and it wakes me up when accidentally turn to the left. its un comfortable even if not leaning on it that patient need extra pillow under it.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Episcleritis
Clinical narrative: Diagnosed with episcleritis following vaccine admission.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 12:30 (Lot number: EW0161) at the age of 32 years as dose 1, single and administered in arm left (Lot number: ER8736) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: EPISCLERITIS (non-serious) with onset 03May2021, outcome "recovered" (2021), described as "Diagnosed with episcleritis following vaccine admission.". The event "diagnosed with episcleritis following vaccine admission." was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of episcleritis.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since and post the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. The patient received medication within 2 weeks of vaccination was Prenatal vitamins and treatment for adverse event was CT Scan, steroid eye drops, anti inflammatory meds.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Injection site pain, Malaise, Myalgia
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received meningococcal group b rlp2086 (TRUMENBA), administration date 25Aug2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "sick". Additional information: The reporter stated that the patient received the vaccine the week of the report and that he is shortly exhibiting some symptoms (further not clarified) and the reporter was not sure if they are side effects that are common from meningococcal group b rlp2086 or if he is sick with something else. The reporter was looking for some information and read the pamphlet insert with meningococcal group b rlp2086 saying that there is the adverse reaction listed there pain at the injection site, fatigue, headache and muscle pain and wanted to know if there are any other common adverse reactions that are common for meningococcal group b rlp2086.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Muscle spasms, Muscle twitching
Clinical narrative: Roughly 10 days after 1st shot I began feeling painless muscle spasms/twitching all over my body (calves, back, side, hand, arms).; Roughly 10 days after 1st shot I began feeling painless muscle spasms/twitching all over my body (calves, back, side, hand, arms).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jul2021 10:00 (Batch/Lot number: unknown) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: MUSCLE TWITCHING (non-serious), MUSCLE SPASMS (non-serious) all with onset 10Aug2021 12:00, outcome "not recovered" and all described as "Roughly 10 days after 1st shot I began feeling painless muscle spasms/twitching all over my body (calves, back, side, hand, arms).". The event "roughly 10 days after 1st shot i began feeling painless muscle spasms/twitching all over my body (calves, back, side, hand, arms)." and "roughly 10 days after 1st shot i began feeling painless muscle spasms/twitching all over my body (calves, back, side, hand, arms)." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of muscle twitching, muscle spasms.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, has not been the patient been tested for COVID-19. Contacted my primary care physician, and did some blood tests today. Never experienced this before the shot. Unknown at this time if there's a link. Patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (07Oct2021)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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling in right arm to fingertips numbness on right cheek tingling in tongue; Tingling in right arm to fingertips numbness on right cheek tingling in tongue; Tingling in right arm to fingertips numbness on right cheek tingling in tongue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 16:00 (Batch/Lot number: unknown) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: METRONIDAZOLE; LEVONORGESTREL AND ETHINYL ESTRADIOL; CEPHALEXINE. The following information was reported: PARAESTHESIA ORAL (non-serious), PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 26Aug2021, outcome "unknown" and all described as "Tingling in right arm to fingertips numbness on right cheek tingling in tongue". The event "tingling in right arm to fingertips numbness on right cheek tingling in tongue", "tingling in right arm to fingertips numbness on right cheek tingling in tongue" and "tingling in right arm to fingertips numbness on right cheek tingling in tongue" was evaluated at the physician office visit.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm at site of injection; leg pain; 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 26Apr2021 13:30 (Lot number: EW0167) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose number=1, lot number=ER8733,, administration time=13:30 PM,, vaccine_location=Left arm}]), administration date: 01Apr2021, when the patient was 47 years old, for Covid-19 Immunization; Bnt162b2 (Covid vaccine details:, Product: COVID 19, Brand: Pfizer, Lot number: ER8733, Administration time: 01:30 PM, Dose number: 1, Vaccine location: Left arm), administration date: 01Apr2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Apr2021 13:30, outcome "not recovered", described as "Sore arm at site of injection"; PAIN IN EXTREMITY (non-serious) with onset 26Apr2021 13:30, outcome "not recovered", described as "leg pain". The events "sore arm at site of injection" and "leg pain" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity.  Additional Information: A 47-year-old non-pregnant female patient received second single dose of bnt162b2 (BNT162B2), on 26Apr2021 13:30 PM as dose 1, Single for covid -19 immunisation. The patient had no known allergies. Historical vaccine included the patient previously received first single dose of bnt162b2 (BNT162B2) on 01Apr2021 at 01:30 PM as dose 1, Single for covid -19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for Covid-19. The patient received within 2 weeks of vaccination. On 26Apr2021 at 01:30 PM, the patient had experienced adverse events. The patient was not received treatment with medication. The seriousness of the events was not provided.   No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Onychomadesis
Clinical narrative: Since having the vaccine she has lost 3 nails on her hand and 1 nail on one of her toes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2021 08:30 (Batch/Lot number: unknown) as dose 1, single and administered in arm left, administration date 11Feb2021 08:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Parkinson's" (unspecified if ongoing), notes: diagnosed almost 12 years ago; "aortic valve replaced", start date: Apr2019 (unspecified if ongoing). Concomitant medication(s) included: ENTRESTO taken for cardiac disorder, start date: Jun2021 (ongoing). The following information was reported: ONYCHOMADESIS (non-serious) with onset 2021, outcome "unknown", described as "Since having the vaccine she has lost 3 nails on her hand and 1 nail on one of her toes".  Additional information: Patient received both doses of the covid-19 vaccine and she said that the same time she started a new heart medication but she doesn't think that the heart medication is the problem but since having the vaccine she has lost 3 nails on her hand and 1 nail on one of her toes."if one were to have a reaction to the Covid 19 vaccine how soon after the vaccine would you get a reaction. states she had her 1st in Jan2021 and the 2nd in Feb2021 and since then she has lost 1 toenail and 3 fingernails. she lost her toenail probably in the spring on her foot and it had to have taken weeks to get to that point and it could have been a week after the vaccine. states then her hand started about 3 weeks after that and she lost 2 nails on her right hand and just lost 1 on her left hand. She is asking should she take the booster. If she had a reaction to Covid if she should take the 3rd. States what comes 1st the chicken or the egg. States she will take the 3rd and see if she has a reaction. States if she does have the 3rd and loses 3 more nails she has 4 left.   She thought it was Entresto caused the event she was put on and the doctor said no it probably was the Covid vaccine if anything and is doing research. States she takes 24-28mg 2 a day and thinks she started taking it in Jun2021 and is still taking it. Patient  reported Entresto is a Novartis product and she already talked to them and it has no side effects.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0186) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: On an unspecified date the patient received first dose of BNT162B2(COMIRNATY, Solution for injection; Expiration date: Unknown) Other Products detail, Patient History and Investigation Assessment reported as No. Consumer stated, I am Pfizer employee actually and I have been trying to report safety event from a COVID website, but it kicks me out every single time. Consumer stated, I need, myself and my daughter got vaccinated with the Pfizer vaccine and we have adverse event. Consumer mentioned after the first dose she had swollen was just a sore arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Chills, Dizziness
Clinical narrative: Palpitations; elevated Blood pressure; high pulse rate; light headed; chills causing body shakes; trouble clearing throat; weak; chills causing body shakes; This is a spontaneous report from a contactable consumer. This 42-year-old Female consumer (patient) reported for herself.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Aug2021 15:00 (Lot number: FD8448) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PALPITATIONS (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "Palpitations"; BLOOD PRESSURE INCREASED (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "elevated Blood pressure"; HEART RATE INCREASED (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "high pulse rate"; DIZZINESS (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "light headed"; TREMOR (non-serious), CHILLS (non-serious) all with onset 22Aug2021 15:10, outcome "recovering" and all described as "chills causing body shakes"; OROPHARYNGEAL DISCOMFORT (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "trouble clearing throat"; ASTHENIA (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "weak". The events "palpitations", "elevated blood pressure", "high pulse rate", "light headed", "chills causing body shakes", "trouble clearing throat", "weak" and "chills causing body shakes" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, blood pressure increased, heart rate increased, dizziness, tremor, oropharyngeal discomfort, asthenia, chills.  Additional information: Patient did not had covid prior vaccination. Patient did not had covid tested post vaccination. Patient did not had any known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient not been tested for COVID-19.  Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Oropharyngeal discomfort, Palpitations, Tremor
Clinical narrative: Palpitations; elevated Blood pressure; high pulse rate; light headed; chills causing body shakes; trouble clearing throat; weak; chills causing body shakes; This is a spontaneous report from a contactable consumer. This 42-year-old Female consumer (patient) reported for herself.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Aug2021 15:00 (Lot number: FD8448) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PALPITATIONS (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "Palpitations"; BLOOD PRESSURE INCREASED (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "elevated Blood pressure"; HEART RATE INCREASED (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "high pulse rate"; DIZZINESS (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "light headed"; TREMOR (non-serious), CHILLS (non-serious) all with onset 22Aug2021 15:10, outcome "recovering" and all described as "chills causing body shakes"; OROPHARYNGEAL DISCOMFORT (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "trouble clearing throat"; ASTHENIA (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "weak". The events "palpitations", "elevated blood pressure", "high pulse rate", "light headed", "chills causing body shakes", "trouble clearing throat", "weak" and "chills causing body shakes" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, blood pressure increased, heart rate increased, dizziness, tremor, oropharyngeal discomfort, asthenia, chills.  Additional information: Patient did not had covid prior vaccination. Patient did not had covid tested post vaccination. Patient did not had any known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient not been tested for COVID-19.  Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Menstrual disorder, Pain in extremity
Clinical narrative: I had sore arm; I had swollen lymph node on my neck; painful swollen on lymph nodes; perturb menstrual cycle/ perturb dysfunctional not regular not ok; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 50 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0191) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot: EW0186), when the patient was 50 years old, for Covid-19 Immunization, reaction(s): "Lymphadenopathy", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had sore arm"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "I had swollen lymph node on my neck; painful swollen on lymph nodes"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "perturb menstrual cycle/ perturb dysfunctional not regular not ok". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy, menstrual disorder.  Additional information: Consumer stated, "So I had three adverse event. So I had sore arm, I had swollen lymph node on my neck, painful swollen on lymph nodes this is after my second shot. Let me explain the first dose swollen was just a sore arm but the second one sore arm, lymph nodes that was swollen and really painful and the third one is that I experience a perturb menstrual cycle, perturb dysfunctional not regular not ok. I am going through very menopause and I the cycle I had was very unusual and so." (Incomplete sentence). The patient did not receive any vaccination, prior vaccine within Four weeks. Consumer further stated, did you capture those three adverse events, yes what is important is painful swollen lymph node. The seriousness for all the events was not reported.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Sore arm,; Weak body; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 20-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 09:00 (Lot number: Ew0175) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Aug2021 19:00, outcome "recovering", described as "Sore arm,"; ASTHENIA (non-serious) with onset 26Aug2021 19:00, outcome "recovering", described as "Weak body". Therapeutic measures were not taken as a result of pain in extremity, asthenia.  Additional information: patient has not received any other vaccine with in four weeks. Other medications in two weeks were yes. Prior to vaccine patient was not tested with covid-19 and not been tested since the vaccination. patient has no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: My neighbor and she told me they have another family member in the chair they experience the same problem from walking. She had only one vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).This consumer reported for a patient (caller neighbour family member).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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: GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "My neighbor and she told me they have another family member in the chair they experience the same problem from walking. She had only one vaccine".  Additional Information: caller neighbour and she told me they have another family member in the chair they experience the same problem from walking. She had only one vaccine. She was complaining about this. (Further information unknown)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Insomnia, Muscle twitching, Paraesthesia
Clinical narrative: insomnia; Global body muscle twitching 5 months and counting; dizziness; bright flashes in peripheral vision; pins and needles sensation; anxiety; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Feb2021 14:00 (Lot number: EL9264) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "known allergy: sulfa drug" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; SINGULAIR; FLONASE [FLUTICASONE PROPIONATE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ALBUTEROL [SALBUTAMOL]. Vaccination history included: Bnt162b2 (dose number=1), administration date: 30Jan2021, when the patient was 36 years old, for COVID-19 immunisation.  The following information was reported: INSOMNIA (non-serious) with onset 13Mar2021 13:00, outcome "not recovered", described as "insomnia"; MUSCLE TWITCHING (non-serious) with onset 13Mar2021 13:00, outcome "not recovered", described as "Global body muscle twitching 5 months and counting"; DIZZINESS (non-serious) with onset 13Mar2021 13:00, outcome "not recovered", described as "dizziness"; PHOTOPSIA (non-serious) with onset 13Mar2021 13:00, outcome "not recovered", described as "bright flashes in peripheral vision"; PARAESTHESIA (non-serious) with onset 13Mar2021 13:00, outcome "not recovered", described as "pins and needles sensation"; ANXIETY (non-serious) with onset 13Mar2021 13:00, outcome "not recovered", described as "anxiety". The events "insomnia", "global body muscle twitching 5 months and counting", "dizziness", "bright flashes in peripheral vision", "pins and needles sensation" and "anxiety" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of insomnia, muscle twitching, dizziness, photopsia, paraesthesia, anxiety.  Additional Information: No other vaccine in four weeks. Other medications in two weeks: Flonase, Zyrtec, Advair, Singulair, Albuterol. Adverse event: Global body muscle twitching 5 months and counting, dizziness, bright flashes in peripheral vision, pins and needles sensation, anxiety, insomnia. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Ae treatment: Medication for neuropathy and vitamin supplements. If covid prior vaccination: Yes. If covid tested post vaccination: Yes. Covid test post vaccination: covid test type post vaccination=Nasal Swab. Covid test date=20Aug2021. Covid test result=Negative  Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, SARS-CoV-2 test
Clinical narrative: insomnia; Global body muscle twitching 5 months and counting; dizziness; bright flashes in peripheral vision; pins and needles sensation; anxiety; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Feb2021 14:00 (Lot number: EL9264) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "known allergy: sulfa drug" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; SINGULAIR; FLONASE [FLUTICASONE PROPIONATE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ALBUTEROL [SALBUTAMOL]. Vaccination history included: Bnt162b2 (dose number=1), administration date: 30Jan2021, when the patient was 36 years old, for COVID-19 immunisation.  The following information was reported: INSOMNIA (non-serious) with onset 13Mar2021 13:00, outcome "not recovered", described as "insomnia"; MUSCLE TWITCHING (non-serious) with onset 13Mar2021 13:00, outcome "not recovered", described as "Global body muscle twitching 5 months and counting"; DIZZINESS (non-serious) with onset 13Mar2021 13:00, outcome "not recovered", described as "dizziness"; PHOTOPSIA (non-serious) with onset 13Mar2021 13:00, outcome "not recovered", described as "bright flashes in peripheral vision"; PARAESTHESIA (non-serious) with onset 13Mar2021 13:00, outcome "not recovered", described as "pins and needles sensation"; ANXIETY (non-serious) with onset 13Mar2021 13:00, outcome "not recovered", described as "anxiety". The events "insomnia", "global body muscle twitching 5 months and counting", "dizziness", "bright flashes in peripheral vision", "pins and needles sensation" and "anxiety" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of insomnia, muscle twitching, dizziness, photopsia, paraesthesia, anxiety.  Additional Information: No other vaccine in four weeks. Other medications in two weeks: Flonase, Zyrtec, Advair, Singulair, Albuterol. Adverse event: Global body muscle twitching 5 months and counting, dizziness, bright flashes in peripheral vision, pins and needles sensation, anxiety, insomnia. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Ae treatment: Medication for neuropathy and vitamin supplements. If covid prior vaccination: Yes. If covid tested post vaccination: Yes. Covid test post vaccination: covid test type post vaccination=Nasal Swab. Covid test date=20Aug2021. Covid test result=Negative  Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes in my right armpit became swollen the day after my shot. It's now 3 days after my shot and my lymph nodes are still swollen.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Aug2021 22:00 (Lot number: EW0191) at the age of 19 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, lot number= EW0191), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 28Aug2021, outcome "not recovered", described as "Lymph nodes in my right armpit became swollen the day after my shot. It's now 3 days after my shot and my lymph nodes are still swollen.". The event "lymph nodes in my right armpit became swollen the day after my shot. it's now 3 days after my shot and my lymph nodes are still swollen." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Patient had no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Polymenorrhoea
Clinical narrative: Irregular and frequent periods; Irregular and frequent periods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Jan2021 (Lot number: EL9261) at the age of 39 years as dose1, single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing); "Sinus issues" (unspecified if ongoing). There were no concomitant medications. The following information was reported: MENSTRUATION IRREGULAR (non-serious), POLYMENORRHOEA (non-serious) all with onset 25Jan2021, outcome "not recovered" and all described as "Irregular and frequent periods". The event "irregular and frequent periods" and "irregular and frequent periods" was evaluated at the physician office visit. Therapeutic measures were taken as a result of menstruation irregular, polymenorrhoea. Additional information: Patient did not receive other vaccine in four weeks. prior vaccination, patient did not diagnosed with covid and not tested covid post vaccination. Treatment included Ultrasound, OB/gyn exams. other vaccine same date details: other vaccine same date product: Pfizer, other vaccine same date lot number=EL9261, other vaccine same date vaccine date: 25Jan2021, other vaccine same date dose number: 2, other vaccine same date vaccine location: Left arm  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Normal pain at injection site; whole body pain; some mental fog over two days.; continuous pain in left arm radiating from the shoulder blade to the elbow; continuous pain in left arm radiating from the shoulder blade to the elbow; slight numbness of forearm into the fingers.; 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 27Aug2021 17:15 (Lot number: EW0172) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "familial adenomatous polyposis" (unspecified if ongoing), notes: familial adenomatous polyposis, Gardner syndrome, j-pouch surgeries (no colon).; "known allergies: Sulfa" (unspecified if ongoing), notes: Sulfa food intolerance that causes gut swelling; reactions have improved over the last 4 years.; "Gardner syndrome" (unspecified if ongoing), notes: familial adenomatous polyposis, Gardner syndrome, j-pouch surgeries (no colon).; "j-pouch surgeries (no colon)." (unspecified if ongoing). Concomitant medication(s) included: IMODIUM; COLESTID; VITAMIN D NOS; VITAMIN B12 [MECOBALAMIN]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Aug2021 20:00, outcome "not recovered", described as "Normal pain at injection site"; PAIN (non-serious) with onset 27Aug2021 20:00, outcome "not recovered", described as "whole body pain"; FEELING ABNORMAL (non-serious) with onset 27Aug2021 20:00, outcome "not recovered", described as "some mental fog over two days."; PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset 27Aug2021 20:00, outcome "not recovered" and all described as "continuous pain in left arm radiating from the shoulder blade to the elbow"; HYPOAESTHESIA (non-serious) with onset 27Aug2021 20:00, outcome "not recovered", described as "slight numbness of forearm into the fingers.". Therapeutic measures were not taken as a result of vaccination site pain, pain, feeling abnormal, pain in extremity, pain, hypoaesthesia.  Additional information: No other vaccine was given in four weeks. The patient reported normal pain at injection site, whole body pain, some mental fog over two days. So far the only lasting effect (as of today) is a continuous pain in left arm radiating from the shoulder blade to the elbow and slight numbness of forearm into the fingers. The patient did not had COVID prior vaccination and not tested for COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Feeling abnormal
Clinical narrative: developed brain fog; slurred speech; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. A 35 year-old 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: FEELING ABNORMAL (non-serious), outcome "recovered", described as "developed brain fog"; DYSARTHRIA (non-serious), outcome "recovered", described as "slurred speech". Therapeutic measures were taken as a result of feeling abnormal, dysarthria.  Additional information included: Verbatim Question: What is the feasibility of getting only half of the 2nd COVID vaccine? My patient of 35-year-old is a university professor who had no comorbidity but developed brain fog & slurred speech within a wk after getting the 1st shot. She tried salt pills and high-intensity exercises and her symptoms resolved within 6 wks. She is very concerned about having recurrent or worse symptoms, if she gets the full dose of the 2nd shot. Would love to seek your guidance. Can she just receive half of the 2nd shot?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.