chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Myalgia
Clinical narrative: Slept longer than usual; Triceps pain; This is a spontaneous report from a contactable healthcare professional (patient himself, physical therapist) via Pfizer colleague. A 31-year-old male patient received first dose of bnt162b2 (PFIZERBIONTECH COVID-19 VACCINE, lot number: EL9264 and expiry date: 31May2021), intramuscular on 04Feb2021 at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. Medical history and concomitant medications were not reported. The patient previously received hepatitis B vaccine last 12Jan2021. On 04Feb2021, the patient reported that after the vaccination, he slept longer than usual during the night. The patient also reported that he experienced triceps pain (not at the injection site area). Clinical outcome of the event slept longer than usual was unknown, while for triceps pain was not recovered as of time of report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Urticaria
Clinical narrative: light headed; woke up with hives on my neck; This is a spontaneous report from a contactable Other Health Professional (patient).  A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number PAA15 6651), via an unspecified route of administration in left arm on 03Feb2021 09:00 at single dose for Covid-19 immunization.  Medical history included allergies to medications, food, or other products: Penicillin. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Prior to vaccination, was the patient diagnosed with COVID-19: No. There were no concomitant medications.  Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: None. The patient previously took erythromycin and experienced Allergies: erythromycin. The patient experienced light headed and woke up with hives on her neck on 04Feb2021 06:00 with outcome of recovered in Feb2021.  Since the vaccination, has the patient been tested for COVID-19: Yes. The patient underwent lab tests and procedures which included BinaxNOW Covid-19 Ag Nasal Swab: negative on 05Feb2021 and negative on 08Feb2021. No treatment received for the adverse event. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, White blood cell count, White blood cell count decreased
Clinical narrative: fatigued; anxiety; WBC was a little low; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A 77-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on unspecified date, at single dose, for COVID-19 immunisation and palbociclib (IBRANCE), via an unspecified route of administration, from 06Jan2021 to an unspecified date, at 125 mg cyclic, for an unspecified indication (patient was on her 7 day break from 1st cycle). The patient's medical history and concomitant medications were not reported. The patient experienced fatigued on an unspecified date with outcome of unknown, anxiety on an unspecified date with outcome of unknown, white blood cell (WBC) was a little low in Jan2021 with outcome of unknown.  The patient underwent lab tests and procedures which included white blood cell count: low in Jan2021. The action taken in response to the events for palbociclib was unknown. She stated that fatigue could maybe be a result of her poor sleep due to anxiety.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cystitis, Nephrolithiasis, Urinary retention
Clinical narrative: severe back pain; unable to urinate; may have passed a kidney stone; Bladder infection; This is a spontaneous report from a contactable consumer who reported for herself. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL3247; expiry date: May2021), via an unspecified route of administration on 26Jan2021 at 12:00 (at the age of 70-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were both reported as none. The patient did not receive any other vaccines on the same date as the COVID-19 vaccination or within four weeks prior to the vaccination. On 08Feb2021 the patient experienced bladder infection and may have passed a kidney stone; on unspecified dates the patient experienced severe back pain and unable to urinate. The clinical course was reported as follows: "The patient received the first dose of the COVID-19 vaccine two weeks ago. She reported no side effects from the first dose of the vaccine; however, she was currently on an antibiotic for a bladder infection. She was scheduled to get the second dose on 16Feb2021; however, this weekend she developed a bladder infection and was on an antibiotic. She had symptoms on Sunday, and she saw her doctor on Monday. She also may have passed a kidney stone, but she was not certain. She had severe back pain and was unable to urinate." The patient read to not take any shots while taking the antibiotic. She would be off of the shot (as reported) for four days when she would get the next dose of the vaccine. The patient wanted to know "how many days would she need to be off of the antibiotic before she could get the next dose?" She stated that she would stop taking the antibiotic if she had to. She took one dose of the antibiotic on Monday and two doses today. The patient also inquired whether the side effects were different after the 2nd dose of the vaccine and how long she had to be off her antibiotics before getting her second dose of the COVID vaccine. The patient was taking sulfamethazole-TMP DS as treatment for the bladder infection since 08Feb2021. The patient sought care at the physician's office for the event bladder infection. Relevant tests were reported as none. The clinical outcome of the event bladder infection was recovering/resolving; the clinical outcomes of the events may have passed a kidney stone, severe back pain and unable to urinate were all unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Skin lesion
Clinical narrative: I have an itchy rash all over my body; little white bumps; This is a spontaneous report received from a contactable consumer (patient herself). A 27-year-old female patient (not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number; E19269) via an unspecified route of administration on right arm on 03Feb2021 18:30, at single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications included unspecified birth control within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that she had an itchy rash all over her body, they were little white bumps on 04Feb2021. The patient was not received any treatment for the events. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Seriousness of the events was assessed as non-serious by the reporter. The outcome of the events was reported as not recovered.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Within a week after receiving the first round of vaccine I have developed two blood clots in my left leg.; This is a spontaneous report from a contactable consumer (patient)  A 53-year-old male patient received first dose  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) on 21Jan2021 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. The patient didn't have medical history or concomitant medications. On an unspecified date in Jan2021 within a week after receiving vaccine patient developed two blood clots in his left leg. As treatment patient was currently on blood thinners. At the time of the reporting event outcome was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menorrhagia, Metrorrhagia
Clinical narrative: After 15 months of amenorrhea I have spotting/ bleeding and cramps the day following my first COVID-19 vaccine; After 15 months of amenorrhea I have spotting/ bleeding and cramps the day following my first COVID-19 vaccine; After 15 months of amenorrhea I have spotting/ bleeding and cramps the day following my first COVID-19 vaccine; This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EN6201; expiry date: unknown) via an unspecified route of administration in the left arm, on 09Feb2021 at 16:15, at a single dose, for COVID-19 immunization. Medical history included asthma and amenorrhea. The patient had no known allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility where vaccine was administered was reported as other. Concomitant medication included ibuprofen (Advil PM). After 15 months of amenorrhea, the patient had spotting/ bleeding and cramps the day following her first COVID-19 vaccine. The events occurred on 10Feb2021, at 8:00 A.M. The patient did not receive therapy for the events. Outcome of the events was unknown. The patient has not been tested for COVID-19 since vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen and painful supra clavicular lymph node left side.; Swollen and painful supra clavicular lymph node left side.; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 04Feb2021 at a single dose for COVID-19 immunization. Medical history included lupus and allergies to latex. Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced Swollen and painful supra clavicular lymph node left side on 10Feb2021. The patient underwent lab tests and procedures which included nasal swab: negative on 04Nov2020. Outcome of the event was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; Brief period of pain in my right bicep; Headaches off and on; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN0201, expiry date: unknown), via an unspecified route of administration on the left arm, on 10Feb2021 09:30, at single dose, for covid-19 immunisation, at the hospital. Medical history included anxiety and bipolar II disorder (reported as bipolar2). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), quetiapine fumarate (SEROQUEL) and "OTC vit" (as reported). The patient previously took lamotrigine and experienced allergies (known allergies: Lamotrigine).  The patient did not receive any other vaccines prior to the COVID vaccine. On 10Feb2021 at 20:00, the patient experienced "brief period of pain in my right bicep, headaches off and on, tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes". Treatment for the event "headache off and on" included 2 doses of 2 pills of acetaminophen. No treatment was given for the events "brief period of pain in my right bicep" and "tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes". The patient recovered from the events on an unspecified date. The events were assessed as non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Stomatitis, Swollen tongue
Clinical narrative: mouth sores; Numbness of left arm,  shoulder and left side of face; some tongue swelling.; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 66 years, on 10Feb2021 09:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa drugs) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took tetracyclines and experienced drug hypersensitivity, pneumovax vaccin and experienced drug hypersensitivity. On 10Feb2021, the patient experienced numbness of left arm, shoulder and left side of face and some tongue swelling. The patient applied ice for several hours. After 5 hours or so, the face and tongue were back to normal. The following day (11Feb2021), they noticed mouth sores. The patient used salt water rinse to help. The patient asked if she should be avoiding the 2nd dose scheduled in 18 days as a result of this reaction. Therapeutic measures were taken as a result of numbness of left arm,  shoulder and left side of face (hypoaesthesia), some tongue swelling. (swollen tongue), mouth sores (stomatitis). The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: Tingling to hands and feet X 3 weeks; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 19Jan2021 13:00 at a single dose for covid-19 immunization. Medical history included palpitations. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 (first dose). The patient experienced tingling to hands and feet x 3 on 21Jan2021 14:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Feb2021. No treatment has been received for the events. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Neck pain, Pain
Clinical narrative: Headache; body aches; neck and shoulder pain; neck and shoulder pain; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9264), via an unspecified route of administration left arm single dose on 10Feb2021 15:00 for covid-19 immunisation. The patient received the first dose on 20Jan2021 lot#lEL9263. The patient medical history was not reported. No other vaccine was received in four weeks. The patient's concomitant medications were not reported. The patient experienced headache on 11Feb2021 12:00, body aches on 11Feb2021 12:00, neck and shoulder pain on 11Feb2021 12:00. No treatment received. The events recovered in Feb2021  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Soreness at the injection site/tenderness of arm; Soreness at the injection site/tenderness of arm; This is a spontaneous report from a contactable consumer (patient).  This 28 -year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration, on 11Feb2021 (at 15:45) at a single dose on right arm for COVID-19 immunisation, administered at Workplace clinic. No relevant medical history and concomitant medications were provided. No known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 before vaccine. On 11Feb2021 (at 22:00), the patient had soreness at the injection site/tenderness of arm. The events were reported as non-serious. Post vaccination COVID test was not performed. The patient was not treated for the events. The patient was recovering from the events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Eating disorder, Fatigue, Nausea, Weight decreased
Clinical narrative: persistant nausea/nausea become much worse on day 4; fatigue; slight appetite loss; unable to eat normally; lost much weight; This is a spontaneous report from a contactable consumer reported for herself.   A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EM980) , on 04Feb2021 at 16:00 (at 62 years) at single dose in left arm for covid-19 immunisation .  Medical history included glucose intolerance.  Patient was not pregnant.Concomitant medication included atenolol and calcium/ergocalciferol (CALCIUM/VITAMIN D).  The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and experienced allergy.  On 08Feb2021 at 08:00 (as reported) the patient experienced persistent nausea, fatigue, slight appetite loss, unable to eat normally and lost much weight, all non serious. Events were described as follows: patient had persistent nausea. The first few days she had the expected side effects of fatigue and slight appetite loss.  The fatigue resolved on the second day, but the nausea become much worse on day 4.  She had been unable to eat normally since then and had lost much weight that she cannot afford to lose. She kept hoping that it will go away, but it was 8 days after her shot and she still had nausea (as reported).  Anti nausea medicine was administered, no treatment given for the other events. Patient recovered from fatigue in Feb2021; outcome of the other events was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate, Heart rate increased, Lymphadenopathy
Clinical narrative: Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; elevated heart rate; rash on face, neck and chest; Enlarged lymph nodes; dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on right arm on 09Feb2021 at 15:45 at a single dose for COVID-19 immunisation in the hospital. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included furosemide (LASIX) and other blood pressure meds (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 09Feb2021, at 16:45 the patient had difficulty breathing, swelling in face, neck, throat and tongue, elevated heart rate, rash on face, neck and chest, enlarged lymph nodes and dizziness. The patient assessed the events as non-serious. Steroids, Benadryl, Pepcid, antibiotics were given as treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the events.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash, Swelling, Swelling face, Swollen tongue
Clinical narrative: Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; elevated heart rate; rash on face, neck and chest; Enlarged lymph nodes; dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on right arm on 09Feb2021 at 15:45 at a single dose for COVID-19 immunisation in the hospital. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included furosemide (LASIX) and other blood pressure meds (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 09Feb2021, at 16:45 the patient had difficulty breathing, swelling in face, neck, throat and tongue, elevated heart rate, rash on face, neck and chest, enlarged lymph nodes and dizziness. The patient assessed the events as non-serious. Steroids, Benadryl, Pepcid, antibiotics were given as treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the events.
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Covid; Patient who received the first dose of trumenba last year.  8-6 months after first dose for the second dose; This is a spontaneous report from a Pfizer sponsored program via a contactable Other Healthcare Professional reported for a patient. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA; Lot number unknown), via an unspecified route of administration on an unspecified date at SINGLE DOSE (first dose) for immunisation. The patient medical history and concomitant medications were not reported. The patient who received the first dose of trumenba a year before (2020). 8-6 months after first dose for the second dose, patient could not get second dose on time due to Covid (as reported). Reporter was inquiring if patient should get second dose or restart process again. Outcome of the event was unknown.  Information on the batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: running fever; This is a spontaneous report from a contactable consumer reporting for herself.   A 67-years-old female patient  received bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration in the right arm  on 06Feb2021 15:30 at single dose  for covid-19 immunisation .  Medical history included blood pressure abnormal and blood cholesterol increased.  The patient experienced running fever on 08Feb2021 20:00 with outcome of not recovered.  The patient was hospitalized on an unknown date for running fever .  The patient underwent lab tests and procedures which included body temperature: still running temp   on Feb2021, Sars-cov-2 test: negative on 12Feb2021. The patient has received antibiotics as a treatment for pyrexia.  At the time of the vaccination the patient was not pregnant and after being vaccinated she was tested negative to Sars-Cov-2  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy; Runny nose; swelling on site; Very little redness when I got the vaccine/ very red; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration on the left arm on 05Feb2021 at 09:30 at a single dose for COVID-19 immunization. Medical history included palpitations controlled by medicine. The patient has no allergies to medications, food, or other products. Concomitant medication included metoprolol (METOPROLOL). 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. The patient had a little swelling on the site and very little redness when she got the vaccine. However, on the 8th day it was a bigger area, itchy and very red. No pain or other symptoms. The patient did start with a runny nose the day after the vaccine and still have, but not sure it's related. No treatment administered for the events. The events had not resolved.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient had her test done on 29Jan2021 and it came back positive for COVID; patient had her test done on 29Jan2021 and it came back positive for COVID; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 12Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history included the patient had a handicap. Concomitant medications were not reported. The patient who lived in a group home had her first dose of the Pfizer COVID-19 Vaccine on 12Jan2021. She was then exposed to someone who was positive for COVID within the group home. The patient went to live with her mother (reporter). The patient had her test done on 29Jan2021 and it came back positive for COVID (also reported that the patient tested positive last 31Jan2021). Therefore, she could not go and get her second scheduled Pfizer COVID vaccine. The nurse who oversaw the group home house scheduled the second dose for 23Feb2021 which was six weeks since the first dose. The reporter was inquiring to find out if that was okay and if it would still work. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 29Jan2021. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient was positive of COVID 19 in between doses; Patient was positive of COVID 19 in between doses; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (parent).  A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history included T-cell lymphoblastic leukemia acute (in remission). Concomitant medications were unknown. On an unspecified date, after the first dose, the patient was tested positive for COVID 19. It was confirmed that patient was positive of COVID 19 in between doses. Clinical outcome was unknown at time of this report.  The information on the lot number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menorrhagia, Menstruation irregular
Clinical narrative: Irregular menstrual cycles (3 periods in 6 weeks); Irregular menstrual cycles (3 periods in 6 weeks) and extremely heavy bleeding; This is a spontaneous report from a contactable nurse reported for herself.  A 40 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) via an unspecified route of administration on 21Dec2020 02:45 PM at age of 40 years old in left arm at single dose for covid-19 immunisation. Medical history included there was no known allergies. No covid prior vaccination. And no other medical history. Patient was not pregnant. Concomitant medications were none. Previously there was no other vaccine in four weeks. No other medications in two weeks. Patient experienced irregular menstrual cycles (3 periods in 6 weeks) and extremely heavy bleeding with several clots starting one week after first vaccine. The adverse events started date was on 31Dec2020. Patient had the doctor or other healthcare professional office/clinic visit. There was no treatment. No covid tested post vaccination. Outcome of events were unknown. Patient received the second dose of BNT162B2 (lot number= EL1283) on 11Jan2021 09:15 AM in left arm for covid-19 immunisation.
Age: 19.0
Sex: U
Vaccine: TYP
Symptoms: Unevaluable event
Clinical narrative: Took third dose a day late; Spontaneous report received on 30JAN2020.  A nurse reported that a consumer "took third dose a day late" (PT: Inappropriate schedule of product administration) while being on Vivotif for immunisation. The consumer forgot to take third dose of Vivotif which was due on 29JAN2020 and instead took it on 30JAN2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took third dose of Vivotif a day late (Inappropriate schedule of product administration) as the consumer forgot to take the third dose on the scheduled date. Considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took third dose of Vivotif a day late (Inappropriate schedule of product administration) as the consumer forgot to take the third dose on the scheduled date. Considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took last dose 2 days late; Spontaneous report received on 14FEB2020.  A pharmacist reported that a 51-year-old male consumer "took last dose 2 days late" (PT: Inappropriate schedule of product administration) while being on Vivotif for immunisation. He took the first three doses of Vivotif as per schedule. He was scheduled to take the last dose of Vivotif on 12FEB2020 but he took it on 14FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first three doses of Vivotif as per schedule but he took the last dose two days later than it was scheduled for (Inappropriate schedule of product administration). Vivotif doses should be taken every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first three doses of Vivotif as per schedule but he took the last dose two days later than it was scheduled for (Inappropriate schedule of product administration). Vivotif doses should be taken every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed the second dose of Vivotif; Spontaneous report received on 20FEB2020.  A pharmacist reported that a female consumer "missed the second dose of Vivotif" (PT: Product dose omission) while being on Vivotif for immunisation. On 17FEB2020, the consumer took her first dose of Vivotif. It was reported that the consumer missed the second dose of Vivotif which was due on 19FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The clinical outcome of the reported event was unknown.  Company Comment: A consumer missed the second dose of Vivotif (missed dose). Vivotif should be taken every other day and the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer missed the second dose of Vivotif (missed dose). Vivotif should be taken every other day and the causality of missed dose is assessed as not applicable to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Forgot her last dose of Vivotif; Spontaneous report received on 20FEB2020.  A female consumer reported that she "forgot her last dose of Vivotif" (PT: Product dose omission). She was receiving Vivotif capsule for immunisation. It was reported that the consumer had completed 3 doses but forgot to take her last dose of Vivotif which was due on 17FEB2020. She stated that she did not have the access to the capsule on that day but would be having access tonight. She will be on a trip to Africa on 05MAR2020. Action taken with Vivotif with respect to the reported event was not applicable. The clinical outcome of the reported event was unknown.  Company Comment: A consumer forgot to take her last dose of Vivotif (missed dose) as she did not have access to Vivotif on the scheduled date. Vivotif should be taken every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer forgot to take her last dose of Vivotif (missed dose) as she did not have access to Vivotif on the scheduled date. Vivotif should be taken every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took unrefrigerated dose; Spontaneous report received on 20FEB2020.  A pharmacist reported that a consumer "took unrefrigerated Vivotif" (PT: Product storage error). The consumer was receiving Vivotif capsule for immunisation. The consumer took the first dose of Vivotif which was left out of the refrigerator for 15 hours. The reporter could not confirm the exact temperature of the excursion or a lot number of Vivotif. Additionally, it was reported that the consumer did not take the dose of Vivotif with any liquid. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first dose of Vivotif which was unrefrigerated (product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first dose of Vivotif which was unrefrigerated (product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif every day instead of every other day; Spontaneous report received on 21FEB2020.  A nurse reported that a consumer "took Vivotif every day instead of every other day" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. It was reported that the consumer had taken Vivotif every day instead of every other day. The consumer will be travelling on 05MAR2020 as a onetime visit. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif every day instead of every other day (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took Vivotif every day instead of every other day (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Completed the course of unrefrigerated Vivotif; Spontaneous report received on 24FEB2020.  A healthcare professional reported that a consumer who "completed the course of unrefrigerated Vivotif" (PT: Product storage error). The consumer was receiving Vivotif for immunisation. It was reported that the consumer failed to refrigerate the Vivotif after purchasing it and completed the course of unrefrigerated Vivotif. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer completed the course of unrefrigerated Vivotif (Product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer completed the course of unrefrigerated Vivotif (Product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
Age: 60.0
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif for 4 days in a row; Spontaneous report received on 24FEB2020.  Based on the information obtained from a consumer, two individual case safety reports PVX2020-401 (20000166SP; wife) and PVX2020-403 (20000167SP; husband) were created and cross-linked in the database.  This case described a male consumer who "took Vivotif 4 days in a row" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif capsule for prevention of typhoid. The consumer took four doses of Vivotif every day from 19FEB2020 to 22FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the event was unknown.  Company Comment: A consumer took Vivotif 4 days in a row (Inappropriate schedule of product administration) instead of taking every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took Vivotif 4 days in a row (Inappropriate schedule of product administration) instead of taking every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Age: 70.0
Sex: F
Vaccine: TYP
Symptoms: Candida infection, Oral candidiasis, Swollen tongue, Tongue discolouration
Clinical narrative: Swollen, greyish tongue and thrush on the back of the tongue; Spontaneous report received on 20FEB2020.  A nurse reported that a 70-year-old female consumer who developed swollen, greyish tongue and thrush on the back of the tongue (PT: Oral candidiasis) while being on Vivotif for immunisation and doxycycline for an unknown indication. The consumer took first and second dose of Vivotif on 15FEB2020 and 17FEB2020 respectively. It was reported that she had taken the doxycycline from 05FEB2020 to 12FEB2020. On 18FEB2020 after second dose of Vivotif, she developed swollen, greyish tongue and thrush. The nurse stated that he was not sure about the location of the thrush but assumed it was in the back of the tongue. Moreover, the consumer stated that thrush could have been caused by doxycycline. Action taken with Vivotif with respect to the reported event was unknown while action take with doxycycline with respect to the reported events was not applicable. The outcome of the reported event was unknown at the time of report. The consumer took treatment for thrush which included nystatin and was started on 19FEB2020.  Concurrent medical conditions included atrial fibrillation, thyroid cancer-remission and sleep apnoea.  Allergy history included allergy to Demerol (meperidine) which caused nausea.  Concomitant medication included rivaroxaban (20 mg daily), Crestor (rosuvastatin, 20 mg daily), metoprolol (25 mg daily), and levothyroxine (125 microgram daily).  Company Comment: A consumer developed swollen, greyish tongue and thrush on the back of the tongue (Oral candidiasis) after second dose of Vivotif. This consumer completed one week of doxycycline course a few days before starting Vivotif. The consumer was then started on Nystatin for treating thrush. The causality of oral candidiasis is unlikely with Vivotif (Doxycycline course could have caused oral candidiasis).; Sender's Comments: A consumer developed swollen, greyish tongue and thrush on the back of the tongue (Oral candidiasis) after second dose of Vivotif. This consumer completed one week of doxycycline course a few days before starting Vivotif. The consumer was then started on Nystatin for treating thrush. The causality of oral candidiasis is unlikely with Vivotif (Doxycycline course could have caused oral candidiasis).
Age: 27.0
Sex: U
Vaccine: TYP
Symptoms: Intentional dose omission, Product storage error
Clinical narrative: Took only one dose of Vivotif as the consumer forgot to refrigerate remaining doses; Spontaneous report received on 24FEB2020.  A pharmacist reported that a 27-year-old consumer who "took only one dose of Vivotif as the consumer forgot to refrigerate remaining doses" (PT: Intentional dose omission). The consumer was receiving Vivotif for immunization. The consumer took the first dose of Vivotif on 20FEB2020. Then, the consumer forgot to refrigerate the remaining doses thus, the consumer did not take any more doses. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the event was unknown.  Company Comment: A consumer took only one dose of Vivotif as the consumer forgot to refrigerate remaining doses (Intentional dose omission). Vivotif must be stored in the refrigerator at the recommended temperature and should be taken every other day. Considering the nature of event, the causality of intentional dose omission is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took only one dose of Vivotif as the consumer forgot to refrigerate remaining doses (Intentional dose omission). Vivotif must be stored in the refrigerator at the recommended temperature and should be taken every other day. Considering the nature of event, the causality of intentional dose omission is assessed as not applicable to Vivotif.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: mild to moderate arm soreness after injection at injection site; This case was reported by a physician and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   The reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingrix and experinced mild to moderate arm soreness at injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Impaired work ability, Loss of personal independence in daily activities, Myalgia
Clinical narrative: extreme fatigue; muscle pain; chills; fever; side effects made him cancel seeing patients; This case was reported by a consumer and described the occurrence of fatigue in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  with an associated reaction of no adverse event.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, muscle pain, chills, fever and activities of daily living impaired. On an unknown date, the outcome of the fatigue, muscle pain, chills, fever and activities of daily living impaired were unknown.   It was unknown if the reporter considered the fatigue, muscle pain, chills, fever and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced extreme fatigue, muscle pain, chills and fever. His side effects made him cancel seeing patients.   No additional details were available. Consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021013449:same reporter US-GLAXOSMITHKLINE-US2021AMR014070:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: extreme fatigue; muscle pain; chills; fever; side effects made him cancel seeing patients; This case was reported by a consumer and described the occurrence of fatigue in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  with an associated reaction of no adverse event.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, muscle pain, chills, fever and activities of daily living impaired. On an unknown date, the outcome of the fatigue, muscle pain, chills, fever and activities of daily living impaired were unknown.   It was unknown if the reporter considered the fatigue, muscle pain, chills, fever and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced extreme fatigue, muscle pain, chills and fever. His side effects made him cancel seeing patients.   No additional details were available. Consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021013449:same reporter US-GLAXOSMITHKLINE-US2021AMR014070:same reporter
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Received his first dose of the vaccine and later developed pneumonia.; A spontaneous report was received from a health care professional concerning a male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced received his first dose of the vaccine and later developed pneumonia  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, the patient developed pneumonia after receiving his first dose. No treatment was reported.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome for the event, received his first dose of the vaccine and later developed pneumonia was unknown.; Reporter's Comments: The event of pneumonia was more consistent with infectious process in pandemic set up.Very limited information regarding this event has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.