chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Chills, Dyspnoea
Clinical narrative: Chills; aches; congestion; difficulty breathing; loss of smell and taste; loss of smell and taste; fever; weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 06:15 PM), administration date: 2021, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 28Nov2021, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 28Nov2021, outcome "recovering", described as "aches"; NASAL CONGESTION (non-serious) with onset 28Nov2021, outcome "recovering", described as "congestion"; DYSPNOEA (non-serious) with onset 28Nov2021, outcome "recovering", described as "difficulty breathing"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 28Nov2021, outcome "recovering" and all described as "loss of smell and taste"; PYREXIA (non-serious) with onset 28Nov2021, outcome "recovering", described as "fever"; ASTHENIA (non-serious) with onset 28Nov2021, outcome "recovering", described as "weak". The events "chills", "aches", "congestion", "difficulty breathing", "loss of smell and taste", "loss of smell and taste", "fever" and "weak" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pain, nasal congestion, dyspnoea, anosmia, ageusia, pyrexia, asthenia.  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 had been tested for COVID-19.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; aches; congestion; difficulty breathing; loss of smell and taste; loss of smell and taste; fever; weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 06:15 PM), administration date: 2021, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 28Nov2021, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 28Nov2021, outcome "recovering", described as "aches"; NASAL CONGESTION (non-serious) with onset 28Nov2021, outcome "recovering", described as "congestion"; DYSPNOEA (non-serious) with onset 28Nov2021, outcome "recovering", described as "difficulty breathing"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 28Nov2021, outcome "recovering" and all described as "loss of smell and taste"; PYREXIA (non-serious) with onset 28Nov2021, outcome "recovering", described as "fever"; ASTHENIA (non-serious) with onset 28Nov2021, outcome "recovering", described as "weak". The events "chills", "aches", "congestion", "difficulty breathing", "loss of smell and taste", "loss of smell and taste", "fever" and "weak" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pain, nasal congestion, dyspnoea, anosmia, ageusia, pyrexia, asthenia.  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 had been tested for COVID-19.  Follow-up attempts completed. No further information expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Fatigue, Nasal congestion
Clinical narrative: Congestion; Fatigue; Cough; Loss of taste and smell; Loss of taste and smell; Aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)via COVID-19 Adverse Event Self-Reporting. The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 11:15 (Lot number: ER8731) at the age of 27 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: 1, Lot number: EW0150, administration time: 06:15 AM, vaccine location: Left arm), administration date: 07Apr2021, when the patient was 27 years old, for COVID-19 Immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 01Nov2021, outcome "recovering", described as "Congestion"; FATIGUE (non-serious) with onset 01Nov2021, outcome "recovering", described as "Fatigue"; COUGH (non-serious) with onset 01Nov2021, outcome "recovering", described as "Cough"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 01Nov2021, outcome "recovering" and all described as "Loss of taste and smell"; PAIN (non-serious) with onset 01Nov2021, outcome "recovering", described as "Aches". The events "congestion", "fatigue", "cough", "loss of taste and smell", "loss of taste and smell" and "aches" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasal congestion, fatigue, cough, ageusia, anosmia, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: Congestion; Fatigue; Cough; Loss of taste and smell; Loss of taste and smell; Aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)via COVID-19 Adverse Event Self-Reporting. The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 11:15 (Lot number: ER8731) at the age of 27 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: 1, Lot number: EW0150, administration time: 06:15 AM, vaccine location: Left arm), administration date: 07Apr2021, when the patient was 27 years old, for COVID-19 Immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 01Nov2021, outcome "recovering", described as "Congestion"; FATIGUE (non-serious) with onset 01Nov2021, outcome "recovering", described as "Fatigue"; COUGH (non-serious) with onset 01Nov2021, outcome "recovering", described as "Cough"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 01Nov2021, outcome "recovering" and all described as "Loss of taste and smell"; PAIN (non-serious) with onset 01Nov2021, outcome "recovering", described as "Aches". The events "congestion", "fatigue", "cough", "loss of taste and smell", "loss of taste and smell" and "aches" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasal congestion, fatigue, cough, ageusia, anosmia, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Swollen eyelids; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 17:00 (Lot number: FK5127) at the age of 8 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Right, Vaccine Administration Time: 04:30 PM), administration date: 08Nov2021, when the patient was 8 years old, for COVID-19 immunization. The following information was reported: SWELLING OF EYELID (non-serious) with onset 01Dec2021 07:00, outcome "recovered" (Dec2021), described as "Swollen eyelids". Therapeutic measures were not taken as a result of swelling of eyelid.  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. No hospitalization Prolonged. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lichen planus, Rash
Clinical narrative: Diagnosed with Lichen Planus; Skin rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: LICHEN PLANUS (non-serious), outcome "unknown", described as "Diagnosed with Lichen Planus"; RASH (non-serious), outcome "unknown", described as "Skin rash".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Headache; significant muscle aches; joint pain; nausea; fatigue; pain at the injection site; dizziness; fever; vision changes; sleep disturbance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Feb2021 12:45 (Lot number: EN6203) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies: sulfa antibiotics" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "Known allergies: Sesame" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EM9810, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 06Feb2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 27Feb2021, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset 27Feb2021, outcome "unknown", described as "significant muscle aches"; ARTHRALGIA (non-serious) with onset 27Feb2021, outcome "unknown", described as "joint pain"; NAUSEA (non-serious) with onset 27Feb2021, outcome "unknown", described as "nausea"; FATIGUE (non-serious) with onset 27Feb2021, outcome "unknown", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 27Feb2021, outcome "unknown", described as "pain at the injection site"; DIZZINESS (non-serious) with onset 27Feb2021, outcome "unknown", described as "dizziness"; PYREXIA (non-serious) with onset 27Feb2021, outcome "unknown", described as "fever"; VISUAL IMPAIRMENT (non-serious) with onset 27Feb2021, outcome "unknown", described as "vision changes"; SLEEP DISORDER (non-serious) with onset 27Feb2021, outcome "unknown", described as "sleep disturbance".  Additional information: No other vaccine were received in four weeks. The patient received Other medications in two weeks were supplements (unspecified) and no Rx. The patient experienced Headache, significant muscle aches, joint pain, nausea, significant fatigue, significant pain at the injection site, dizziness, fever, vision changes, sleep disturbance. These events lasted for at least 48 hours, some longer. No Covid prior vaccination and not tested for covid post vaccination.  Follow-up attempts completed. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Sleep disorder, Vaccination site pain, Visual impairment
Clinical narrative: Headache; significant muscle aches; joint pain; nausea; fatigue; pain at the injection site; dizziness; fever; vision changes; sleep disturbance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Feb2021 12:45 (Lot number: EN6203) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies: sulfa antibiotics" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "Known allergies: Sesame" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EM9810, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 06Feb2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 27Feb2021, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset 27Feb2021, outcome "unknown", described as "significant muscle aches"; ARTHRALGIA (non-serious) with onset 27Feb2021, outcome "unknown", described as "joint pain"; NAUSEA (non-serious) with onset 27Feb2021, outcome "unknown", described as "nausea"; FATIGUE (non-serious) with onset 27Feb2021, outcome "unknown", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 27Feb2021, outcome "unknown", described as "pain at the injection site"; DIZZINESS (non-serious) with onset 27Feb2021, outcome "unknown", described as "dizziness"; PYREXIA (non-serious) with onset 27Feb2021, outcome "unknown", described as "fever"; VISUAL IMPAIRMENT (non-serious) with onset 27Feb2021, outcome "unknown", described as "vision changes"; SLEEP DISORDER (non-serious) with onset 27Feb2021, outcome "unknown", described as "sleep disturbance".  Additional information: No other vaccine were received in four weeks. The patient received Other medications in two weeks were supplements (unspecified) and no Rx. The patient experienced Headache, significant muscle aches, joint pain, nausea, significant fatigue, significant pain at the injection site, dizziness, fever, vision changes, sleep disturbance. These events lasted for at least 48 hours, some longer. No Covid prior vaccination and not tested for covid post vaccination.  Follow-up attempts completed. No further information expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Ear pain, Eye irritation
Clinical narrative: stomach pain; fever; chills; Also mentioned burning eyes; pain in ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 05Dec2021 15:30 (Lot number: FK5618) at the age of 11 years as dose 2 (tris), single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "allergic to dust and pets" (unspecified if ongoing); "allergic to dust and pets" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Time: 15:30, anatomical site: right arm, route of administration: intramuscular, batch/lot number: FK5127), administration date: 14Nov2021, when the patient was 11 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "stomach pain"; PYREXIA (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "fever"; CHILLS (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "chills"; EYE IRRITATION (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "Also mentioned burning eyes"; EAR PAIN (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "pain in ear". The patient underwent the following laboratory tests and procedures: body temperature: (06Dec2021) unknown results; sars-cov-2 test: (06Dec2021) negative, notes: home Covid test. Therapeutic measures were taken as a result of abdominal pain upper, pyrexia, chills, eye irritation, ear pain.  Additional Information: Patient medical history was reported as none. It was reported that, early next morning (3 am) post second dose patient experienced stomach pain, fever and chills. Also mentioned burning eyes and pain in ear. Lasted entire day. The patient was reported to be physically active11 year old female. No medications. The events reported as non-serious. The patient received Advil as treatment for events. Awareness date was reported as 06Dec2021.  Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: stomach pain; fever; chills; Also mentioned burning eyes; pain in ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 05Dec2021 15:30 (Lot number: FK5618) at the age of 11 years as dose 2 (tris), single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "allergic to dust and pets" (unspecified if ongoing); "allergic to dust and pets" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Time: 15:30, anatomical site: right arm, route of administration: intramuscular, batch/lot number: FK5127), administration date: 14Nov2021, when the patient was 11 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "stomach pain"; PYREXIA (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "fever"; CHILLS (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "chills"; EYE IRRITATION (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "Also mentioned burning eyes"; EAR PAIN (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "pain in ear". The patient underwent the following laboratory tests and procedures: body temperature: (06Dec2021) unknown results; sars-cov-2 test: (06Dec2021) negative, notes: home Covid test. Therapeutic measures were taken as a result of abdominal pain upper, pyrexia, chills, eye irritation, ear pain.  Additional Information: Patient medical history was reported as none. It was reported that, early next morning (3 am) post second dose patient experienced stomach pain, fever and chills. Also mentioned burning eyes and pain in ear. Lasted entire day. The patient was reported to be physically active11 year old female. No medications. The events reported as non-serious. The patient received Advil as treatment for events. Awareness date was reported as 06Dec2021.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: I felt feverish but had no fever; I couldn't sleep; I couldn't sleep, and had really bad brain fog for a day or two\ Felt rush up neck; The second, too salty/I felt it rush up my neck to my head and had a metallic taste in my mouth.; Things tasted more sour after 2nd dose\Food tasted saltier; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 42 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Apr2021 (Lot number: EW0158) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: Feb2020 (unspecified if ongoing), notes: When I had COVID, I lost my sense of taste for 5 months before it came back, Lost sense of taste for 5 months. Very mild case, No fever; "I felt low on oxygen", start date: 13Feb2020 (unspecified if ongoing), notes: I felt low on oxygen; "Dry cough", start date: 21Jan2020 (unspecified if ongoing); "I had brain fog", start date: 13Feb2020 (unspecified if ongoing); "felt a little sick to my stomach", start date: 13Feb2020 (unspecified if ongoing); "Lost my sense of taste", start date: 14Feb2020 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8727, With the first shot, food was more sour), administration date: 19Mar2021, for COVID-19 immunization, reaction(s): "food was more sour/Food also tasted sour for a few weeks"; Bnt162b2 (Dose Number:01, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8727), administration date: 19Mar2021, for Covid-19 Immunization, reaction(s): "Felt a little brain fog for the first day", "tired", "couldn't sleep for a few nights"; Bnt162b2 (Dose Number:01, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8727), administration date: 19Mar2021, for covid-19 immunization, reaction(s): "felt feverish". The following information was reported: DYSGEUSIA (non-serious) with onset 10Apr2021, outcome "unknown", described as "The second, too salty/I felt it rush up my neck to my head and had a metallic taste in my mouth."; PYREXIA (non-serious) with onset 11Apr2021, outcome "unknown", described as "I felt feverish but had no fever"; SLEEP DISORDER (non-serious) with onset 11Apr2021, outcome "unknown", described as "I couldn't sleep"; FEELING ABNORMAL (non-serious) with onset 11Apr2021, outcome "unknown", described as "I couldn't sleep, and had really bad brain fog for a day or two\ Felt rush up neck"; TASTE DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "Things tasted more sour after 2nd dose\Food tasted saltier". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Tired and sore muscles in general; Tired and sore muscles in general; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 11:00 (Lot number: EL3247) at the age of 53 years as dose 1, single and administered in arm right, administration date 31Mar2021 10:30 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing); "History of babesiosis" (unspecified if ongoing); "Hashimoto" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for autoimmune thyroiditis, start date: 1995 (ongoing). The following information was reported: FATIGUE (non-serious), MYALGIA (non-serious) all with onset 11Mar2021, outcome "not recovered" and all described as "Tired and sore muscles in general". Therapeutic measures were not taken as a result of fatigue, myalgia. Additional information: The patient became first became aware of feeling tired and having sore muscles on days 11Mar2021 (first dose was on 10Mar2021) and again on 01Apr2021 (second dose on 31Mar2021). The patient was tired and had sore muscles in general, these were also experienced after the 1st and 2nd doses in March but not as severe as after the booster in November. The events happened the next day, day after each dose - mild. Vaccine facility type was Pharmacy or Drug store. The patient did not have any prior vaccinations (within 4 weeks). The patient did not have any relevant test or specific relevant test for thromboembolic events with Thrombocytopenia.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Fatigue, Pyrexia, Rash
Clinical narrative: Rash on my body; blisters on my fingers in my feet; Fever; Chills; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 (Lot number: 320308) at the age of 27 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 03Dec2021, outcome "recovered" (Dec2021), described as "Fever"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "Chills"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "Fatigue"; RASH (non-serious) with onset 06Dec2021, outcome "unknown", described as "Rash on my body"; BLISTER (non-serious) with onset 06Dec2021, outcome "unknown", described as "blisters on my fingers in my feet". Therapeutic measures were taken as a result of pyrexia, chills.  Additional information: Reason for no lot number: of Covid 19 Vaccine: Other: LOT#: Consumer stated, "LOT# is 320308, I can't tell if that's a D or 0. No, its 320308 and then the Last symbol is either a D or 0. I think it's 0 at the end and not a D or 0. No, its 320308 and then the Last symbol is either a D or 0 (Not clarified). Patient was stated, "I was just calling to, I felt like I should tell you about my, sort of my reactions I had to COVID Vaccine." Consumer stated, "Well I had a fever, chills which I know it's one of the common one and fatigue. Now I have like a rash on my body and I have like a, just little like blister on my fingers in my feet." Patient was stated, "I had it on last Thursday, so that was on 02Dec2021(Confirmed as 02Dec2021)." Patient was stated, "I took a lot of Advil, I don't have a fever anymore, my fever started 24 hour after the vaccine (Further clarification unknown) and my 'fit' probably another, like there is fever and chills were on and off for about 36 hours I took an Advil and Tylenol (Further clarification unknown hence not captured) during that time. I now today, I started having the blisters and the rash." Dosage of Advil and Tylenol: Consumer stated, "I took probably 200 milligrams of the Advil every 8 hours and I took Tylenol, I took 2 capsules every 8 hours also. I am not sure the capsule were the Tylenol." Other Medical Condition and Medications: Consumer stated, "I am just taking birth control (Further not clarified hence not captured)." Patient was stated Anatomical site "My Left Shoulder."  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, SARS-CoV-2 test
Clinical narrative: After 2nd COVD19 Pfizer Vaccine, entire joints in my body in pain. Especially my right thumb; weak; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jan2021 17:45 (Lot number: EL8982) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Uncontrolled Severe Asthma" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR; VENTOLIN [SALBUTAMOL]; TRELEGY; FLONASE [FLUTICASONE PROPIONATE]; ZIRTEC; BENADRYL. Past drug history included: Penicillin, reaction(s): "Hives". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231, Location of injection: Arm Left, Vaccine Administration Time: 05:45 PM), administration date: 04Jan2021, when the patient was 56 years old, for COVID-19 Immunization; Gsk hep b vaccine, reaction(s): "Erythema Multiforme". The following information was reported: ARTHRALGIA (non-serious) with onset Oct2021, outcome "not recovered", described as "After 2nd COVD19 Pfizer Vaccine, entire joints in my body in pain. Especially my right thumb"; ASTHENIA (non-serious) with onset Oct2021, outcome "not recovered", described as "weak". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia, asthenia. Additional information: Reported Event: After 2nd COVD19 Pfizer Vaccine, entire joints in my body in pain &weak. Especially my right thumb, I could not even hold a light plastic cup without a handle. It gradually got better, but not completely.  I still can't hold a cup without a handle if filled with liquid. I must hold bottom of the cup while filling under a faucet. After 3rd shot, entire body was aching w Severe DEEP pain in most of joints & I could not sleep much.  Next morning, I notice following issues: (1) lateral part of Left Wrist (swollen & could not rotate at all), (2) Throat (1. Externally: left side of Thyroid area swollen & very tender to gentle touch,  2. Internally: felt a lump in my throat on the left, which resulted in difficulties in swallowing) & (3) Worsening Asthma symptom (Existing dx: uncontrolled severe asthma). Patient took Prednisone (Rx from my pulmonologist, for asthma, filled before moving), but left wrist is still in pain esp. during supination over 1 month after 3rd shot. 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. The patient has been tested for COVID-19, since vaccination.  Follow-Up (15Dec2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: he had asthma after getting both doses of the vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "he had asthma after getting both doses of the vaccine.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ear congestion, Sinusitis, Sneezing, Upper-airway cough syndrome
Clinical narrative: Sinus infection; Sneezing; Cough; Posterior nasal drip; Ear congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021SA369081 (Sanofi).  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation; dupilumab (DUPIXENT), subcutaneous since 16Sep2021 (Batch/Lot number: unknown) at 300 mg (300 mg, once in every two weeks) for asthma. Relevant medical history included: "Influenza" (ongoing); "Asthma" (ongoing); "seasonal allergy" (ongoing), notes: Allergic rhinitis due lo pollen.; "upper abdominal pain" (ongoing), notes: Epigastric Abdominal Pain; "Hypothyroidism" (ongoing); "Type V Hyperlipidaemia" (ongoing); "Obesity" (ongoing); "Hypersensitivity" (ongoing); "Sinus infection" (unspecified if ongoing); "allergy" (unspecified if ongoing), notes: Notes: allergies: perfume, propolis,; "propolis" (unspecified if ongoing), notes: Notes: allergies: perfume, propolis.; "Gastro-esophageal reflux disease" (unspecified if ongoing); "fatty change of liver" (unspecified if ongoing). Concomitant medication(s) included: FLUARIX; PREDNISONE [PREDNISONE ACETATE] taken for asthma; HALOBETASOL PROPIONATE; DOXYCYCLINE HYCLATE; AZELASTINE; SALBUTAMOL [SALBUTAMOL SULFATE] taken for asthma; IPRATROPIUM BROMIDE IVAX; CIPROFLOXACIN [CIPROFLOXACIN HYDROCHLORIDE] taken for sinusitis; LEVOTHYROXINE SODIUM; SYMBICORT taken for asthma; MONTELUKAST SODIUM taken for asthma. The following information was reported: SINUSITIS (non-serious) with onset 26Oct2021, outcome "unknown", described as "Sinus infection"; SNEEZING (non-serious) with onset 26Oct2021, outcome "unknown", described as "Sneezing"; COUGH (non-serious) with onset 26Oct2021, outcome "unknown", described as "Cough"; UPPER-AIRWAY COUGH SYNDROME (non-serious) with onset 26Oct2021, outcome "unknown", described as "Posterior nasal drip"; EAR CONGESTION (non-serious) with onset 26Oct2021, outcome "unknown", described as "Ear congestion".  Additional Information:The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event the patient had ongoing Flu, Allergic rhinitis due to pollen, Asthma, Epigastric ache, Hypothyroidism, Mixed hyperlipidemia, Obesity and Hypersensitivity,Notes: allergies: perfume, propolis, Allergic rhinitis due lo pollen, Asthma, Epigastric Abdominal Pain, Fatty (change of liver, Gastro-esophageal reflux disease, Hypothyroidism, Mixed hyperlipidemia, Obesity.Concomitant medications included:BUDESONIDE.Action taken with DUPILUMAB (DUPIXENT) was unknown.It was not reported if the patient received a corrective treatment for the events (sinus infection, sneezing, cough, post nasal drip).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperacusis, Rash
Clinical narrative: I had intense headaches; extreme sound sensitivity to all 3 vaccines; I had rashes on my face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 12:00 (Lot number: ER8732) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ITP (idiopathic thrombocytopenia)" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cioro, reaction(s): "known allergies: Cioro". Vaccination history included: Bnt162b2 (1st Dose , time : 12:00, Lot: ER8730, Location: Left arm), administration date: 29Mar2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "I had intense headaches"; HYPERACUSIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "extreme sound sensitivity to all 3 vaccines"; RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "I had rashes on my face". Therapeutic measures were not taken as a result of headache, hyperacusis, rash.  Additional information- It was reported that patient administer drug at Pharmacy or Drug Store.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not administer other medications the patient received within 2 weeks of vaccination.Prior to vaccination,  the patient was not diagnosed with COVID-19 and Since the vaccination,  the patient had not been tested for COVID-19.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased, Eye disorder, Ocular discomfort, Ocular hyperaemia
Clinical narrative: kidneys weren't working; erythematous; Thigh pain reaction; Slight sore throat; Fizzing at the site; had trouble with my eyes and stuff; elevated creatinine; ocular issues; rash,; very red; erythematous; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN B COMPLEX; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization. The following information was reported: RENAL DISORDER (non-serious), outcome "unknown", described as "kidneys weren't working"; RASH ERYTHEMATOUS (non-serious), RASH ERYTHEMATOUS (non-serious), outcome "unknown" and all described as "erythematous"; PAIN (non-serious), outcome "unknown", described as "Thigh pain reaction"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Slight sore throat"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Fizzing at the site"; EYE DISORDER (non-serious), outcome "unknown", described as "had trouble with my eyes and stuff"; BLOOD CREATININE INCREASED (non-serious), outcome "unknown", described as "elevated creatinine"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "ocular issues"; RASH (non-serious), outcome "unknown", described as "rash,"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "very red". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Adverse Event(S)/Product Complaint Details: PT experienced side effects after COVID vaccine. PT: I don't think so. I know I wanted to ask about the test strips and, um, I think that's probably, was there something else? Um, just with the, I think with the, with the COVID vaccine, I came in a couple three days afterwards, remember, and my kidneys weren't working. DR: Yeah. PT: And I had turned like this red afterwards and, um, then I had trouble with my eyes and stuff. And I've been taking some vitamins like the B complex which they told me when I had chemo that that helps with nerves and like that and so I've been taking that and so I'm feeling better. I, I'm you know, my kidneys have come back. They're great. DR: Yep. PT: I'm on the lisinopril but I'm hesitant about the booster. DR: Um, come on in. Cap, patient was [DEIDENTIFIED] reaction, period. Thigh pain reaction, period. Thigh pain, period. Fizzing at the site, period. Slight sore throat, period. So which vaccine was it that you got? PT: It was the Pfizer. DR: Cap, problems or concerns. New line, patient had a reaction to the Pfizer vaccine, period.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Rash, Rash erythematous, Renal disorder
Clinical narrative: kidneys weren't working; erythematous; Thigh pain reaction; Slight sore throat; Fizzing at the site; had trouble with my eyes and stuff; elevated creatinine; ocular issues; rash,; very red; erythematous; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN B COMPLEX; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization. The following information was reported: RENAL DISORDER (non-serious), outcome "unknown", described as "kidneys weren't working"; RASH ERYTHEMATOUS (non-serious), RASH ERYTHEMATOUS (non-serious), outcome "unknown" and all described as "erythematous"; PAIN (non-serious), outcome "unknown", described as "Thigh pain reaction"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Slight sore throat"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Fizzing at the site"; EYE DISORDER (non-serious), outcome "unknown", described as "had trouble with my eyes and stuff"; BLOOD CREATININE INCREASED (non-serious), outcome "unknown", described as "elevated creatinine"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "ocular issues"; RASH (non-serious), outcome "unknown", described as "rash,"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "very red". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Adverse Event(S)/Product Complaint Details: PT experienced side effects after COVID vaccine. PT: I don't think so. I know I wanted to ask about the test strips and, um, I think that's probably, was there something else? Um, just with the, I think with the, with the COVID vaccine, I came in a couple three days afterwards, remember, and my kidneys weren't working. DR: Yeah. PT: And I had turned like this red afterwards and, um, then I had trouble with my eyes and stuff. And I've been taking some vitamins like the B complex which they told me when I had chemo that that helps with nerves and like that and so I've been taking that and so I'm feeling better. I, I'm you know, my kidneys have come back. They're great. DR: Yep. PT: I'm on the lisinopril but I'm hesitant about the booster. DR: Um, come on in. Cap, patient was [DEIDENTIFIED] reaction, period. Thigh pain reaction, period. Thigh pain, period. Fizzing at the site, period. Slight sore throat, period. So which vaccine was it that you got? PT: It was the Pfizer. DR: Cap, problems or concerns. New line, patient had a reaction to the Pfizer vaccine, period.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: kidneys weren't working; erythematous; Thigh pain reaction; Slight sore throat; Fizzing at the site; had trouble with my eyes and stuff; elevated creatinine; ocular issues; rash,; very red; erythematous; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN B COMPLEX; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization. The following information was reported: RENAL DISORDER (non-serious), outcome "unknown", described as "kidneys weren't working"; RASH ERYTHEMATOUS (non-serious), RASH ERYTHEMATOUS (non-serious), outcome "unknown" and all described as "erythematous"; PAIN (non-serious), outcome "unknown", described as "Thigh pain reaction"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Slight sore throat"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Fizzing at the site"; EYE DISORDER (non-serious), outcome "unknown", described as "had trouble with my eyes and stuff"; BLOOD CREATININE INCREASED (non-serious), outcome "unknown", described as "elevated creatinine"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "ocular issues"; RASH (non-serious), outcome "unknown", described as "rash,"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "very red". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Adverse Event(S)/Product Complaint Details: PT experienced side effects after COVID vaccine. PT: I don't think so. I know I wanted to ask about the test strips and, um, I think that's probably, was there something else? Um, just with the, I think with the, with the COVID vaccine, I came in a couple three days afterwards, remember, and my kidneys weren't working. DR: Yeah. PT: And I had turned like this red afterwards and, um, then I had trouble with my eyes and stuff. And I've been taking some vitamins like the B complex which they told me when I had chemo that that helps with nerves and like that and so I've been taking that and so I'm feeling better. I, I'm you know, my kidneys have come back. They're great. DR: Yep. PT: I'm on the lisinopril but I'm hesitant about the booster. DR: Um, come on in. Cap, patient was [DEIDENTIFIED] reaction, period. Thigh pain reaction, period. Thigh pain, period. Fizzing at the site, period. Slight sore throat, period. So which vaccine was it that you got? PT: It was the Pfizer. DR: Cap, problems or concerns. New line, patient had a reaction to the Pfizer vaccine, period.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: I also feel arm soreness once in awhile at the site the injections were made.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Apr2021 10:00 (Lot number: EW0170) 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: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "I also feel arm soreness once in awhile at the site the injections were made.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive  any other medications within 2 weeks of vaccination. Family Medical History: None The patient had  no relevant test done. Patient did not had treatment for AE. Patient did not had Covid prior vaccination. Patient  Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101729613 similar report from same reporter