chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Booster; Severe chills; Fever; Fatigue; Body ache; Even more rapid heartbeat (approx. 140-150 bpm when resting); Even more rapid heartbeat (approx. 140-150 bpm when resting); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing), notes: Other medical history: Bicuspid aortic valve. There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Drug allergy", notes: Known allergies: Bactrim. Vaccination history included: Bnt162b2 (Dose no: 1, Anatomical location: Left arm), administration date: 21Mar2021, when the patient was 40 years old, for COVID-19 immunization, reaction(s): "Severe chills", "Fever", "Fatigue", "Body ache"; Bnt162b2 (Dose no: 2, Anatomical location: Left arm), administration date: 11Apr2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "Severe chills", "Fever", "Fatigue", "Very rapid heartbeat (approx. 120-130 bpm when resting)", "Body ache". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Severe chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body ache"; HEART RATE INCREASED (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Even more rapid heartbeat (approx. 140-150 bpm when resting)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia, fatigue, pain, heart rate increased, condition aggravated.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Additional information:  The rapid heartbeat continued for 24 hours before it stopped. For female 3rd dose, patient took Propanalol to regulate it. If Covid prior vaccination: No, if Covid tested post vaccination: Yes. Covid test type post vaccination: Nasal Swab, Covid test name post vaccination: PCR, Covid test date: 03Nov2021, Covid test result: Negative. if other vaccine in four weeks: No, other medications in two weeks: No
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Asthenia, Body temperature, Dizziness, Fatigue
Clinical narrative: Booster; Long dizziness; weakness and I couldn't get out of bed without help and all because I was so weak; Injection site pain; Tiredness; Headache/ severe headache; Fever 100.4; feeling unwell; Disease appetite; All day I had muscle pain like you get when you have the flu / muscle pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FD0809) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal; POTASSIUM; BABY ASPIRIN; ROSUVASTATIN; VITAMIN D3. Vaccination history included: Bnt162b2 (Dose 1 (MANUFACTURER UNKNOWN)), for Covid-19 immunization; Bnt162b2 (Dose 2 (MANUFACTURER UNKNOWN)), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 11Nov2021, outcome "unknown", described as "Long dizziness"; ASTHENIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "weakness and I couldn't get out of bed without help and all because I was so weak"; VACCINATION SITE PAIN (non-serious) with onset 11Nov2021, outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious) with onset 11Nov2021, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset 11Nov2021, outcome "unknown", described as "Headache/ severe headache"; PYREXIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "Fever 100.4"; MALAISE (non-serious) with onset 11Nov2021, outcome "unknown", described as "feeling unwell"; APPETITE DISORDER (non-serious) with onset 11Nov2021, outcome "unknown", described as "Disease appetite"; MYALGIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "All day I had muscle pain like you get when you have the flu / muscle pain"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, asthenia, vaccination site pain, fatigue, headache, pyrexia, malaise, appetite disorder, myalgia.  Additional information: Patient also took Multi-Vitamin as concomitant medication. When probed if administered with any other vaccine, patient stated, "No, I didn't."  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Malaise, Myalgia, Pyrexia
Clinical narrative: Booster; Long dizziness; weakness and I couldn't get out of bed without help and all because I was so weak; Injection site pain; Tiredness; Headache/ severe headache; Fever 100.4; feeling unwell; Disease appetite; All day I had muscle pain like you get when you have the flu / muscle pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FD0809) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal; POTASSIUM; BABY ASPIRIN; ROSUVASTATIN; VITAMIN D3. Vaccination history included: Bnt162b2 (Dose 1 (MANUFACTURER UNKNOWN)), for Covid-19 immunization; Bnt162b2 (Dose 2 (MANUFACTURER UNKNOWN)), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 11Nov2021, outcome "unknown", described as "Long dizziness"; ASTHENIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "weakness and I couldn't get out of bed without help and all because I was so weak"; VACCINATION SITE PAIN (non-serious) with onset 11Nov2021, outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious) with onset 11Nov2021, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset 11Nov2021, outcome "unknown", described as "Headache/ severe headache"; PYREXIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "Fever 100.4"; MALAISE (non-serious) with onset 11Nov2021, outcome "unknown", described as "feeling unwell"; APPETITE DISORDER (non-serious) with onset 11Nov2021, outcome "unknown", described as "Disease appetite"; MYALGIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "All day I had muscle pain like you get when you have the flu / muscle pain"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, asthenia, vaccination site pain, fatigue, headache, pyrexia, malaise, appetite disorder, myalgia.  Additional information: Patient also took Multi-Vitamin as concomitant medication. When probed if administered with any other vaccine, patient stated, "No, I didn't."  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Booster; Long dizziness; weakness and I couldn't get out of bed without help and all because I was so weak; Injection site pain; Tiredness; Headache/ severe headache; Fever 100.4; feeling unwell; Disease appetite; All day I had muscle pain like you get when you have the flu / muscle pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FD0809) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal; POTASSIUM; BABY ASPIRIN; ROSUVASTATIN; VITAMIN D3. Vaccination history included: Bnt162b2 (Dose 1 (MANUFACTURER UNKNOWN)), for Covid-19 immunization; Bnt162b2 (Dose 2 (MANUFACTURER UNKNOWN)), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 11Nov2021, outcome "unknown", described as "Long dizziness"; ASTHENIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "weakness and I couldn't get out of bed without help and all because I was so weak"; VACCINATION SITE PAIN (non-serious) with onset 11Nov2021, outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious) with onset 11Nov2021, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset 11Nov2021, outcome "unknown", described as "Headache/ severe headache"; PYREXIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "Fever 100.4"; MALAISE (non-serious) with onset 11Nov2021, outcome "unknown", described as "feeling unwell"; APPETITE DISORDER (non-serious) with onset 11Nov2021, outcome "unknown", described as "Disease appetite"; MYALGIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "All day I had muscle pain like you get when you have the flu / muscle pain"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, asthenia, vaccination site pain, fatigue, headache, pyrexia, malaise, appetite disorder, myalgia.  Additional information: Patient also took Multi-Vitamin as concomitant medication. When probed if administered with any other vaccine, patient stated, "No, I didn't."  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Lymphadenopathy, Peripheral swelling, Vaccination site pain
Clinical narrative: I got my booster shot; it just a little bit of injection site soreness; My lymph nodes must be swollen but its quiet large my armpit is exceedingly swollen and it's painful; My lymph nodes must be swollen but its quiet large my armpit is exceedingly swollen and it's painful; My left armpit was completely swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021, outcome "unknown", described as "I got my booster shot"; VACCINATION SITE PAIN (non-serious) with onset Nov2021, outcome "recovering", described as "it just a little bit of injection site soreness"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "My lymph nodes must be swollen but its quiet large my armpit is exceedingly swollen and it's painful"; PERIPHERAL SWELLING (non-serious) with onset Nov2021, outcome "not recovered", described as "My left armpit was completely swollen".  Additional Information: Consumer stated, " I was going to assume that my immune system mount to the pretty deep response and my lymph nodes must be swollen but its quite large my armpit is exceedingly swollen and it's painful if you would imagine. I was a little bit concerned because I kind of like understand how long something like this could be expected to last and whether I should be on the lookout for if it was getting if it stays as it was manageable, if it got worse you know how do know when I should see a medical professional about it? In every other respect I feel fine but my armpit was quiet swollen and tender so do you have an opinion or some guidance that you can offer me to make sure that, I did not feel alarmed by it but then, I also did not wait too long to act if there was some signal that I should be looking for to indicate that, I actually might need to seek professional attention? ". Consumer was informed about Pfizer drug safety.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Immunisation, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever (over 101F); body ache; injection location soreness/pain; Administration date: 10Nov2021; Dose number: 3; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 (Lot number: FF8841) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Seafood" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose Product= Covid 19, Previous dose brand= Pfizer, Previous dose brand unknown: False, Previous dose Lot number= EL3247, Previous dose Lot unknown= False, Previous dose Administration date= 10Feb2021, Previous dose Dose number= 2, Previous dose vaccine location= left arm), administration date: 10Feb2021, for COVID-19 Immunization; Bnt162b2 (Previous dose Product= Covid 19, Previous dose brand= Pfizer, Previous dose brand unknown: False, Previous dose Lot number= EL3247, Previous dose Lot unknown= False, Previous dose Administration date= 20Jan2021, Previous dose Dose number= 1, Previous dose vaccine location= left arm), administration date: 20Jan2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021, outcome "unknown", described as "Administration date: 10Nov2021; Dose number: 3"; PYREXIA (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "Fever (over 101F)"; PAIN (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "body ache"; VACCINATION SITE PAIN (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "injection location soreness/pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Anxiety, Fear, Immunisation, Tinnitus
Clinical narrative: distraught after receiving the booster dose of the Pfizer Covid vaccine; Humming that won't go away, in her head or ears non stop; worried and frightened; Humming that won't go away, in her head or ears non stop; worried and frightened; Caller states that she needs to talk to someone about her side effect that she has from the Booster Covid Shot.; Humming in my ears after the booster dose of the Pfizer Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 30Oct2021 (Batch/Lot number: unknown) at the age of 80 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (2nd dose), for COVID-19 Immunization; Bnt162b2 (1st Dose), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Oct2021, outcome "unknown", described as "Caller states that she needs to talk to someone about her side effect that she has from the Booster Covid Shot."; TINNITUS (non-serious) with onset 30Oct2021, outcome "not recovered", described as "Humming in my ears after the booster dose of the Pfizer Covid vaccine"; AGITATION (non-serious), outcome "not recovered", described as "distraught after receiving the booster dose of the Pfizer Covid vaccine"; ANXIETY (non-serious), FEAR (non-serious), outcome "unknown" and all described as "Humming that won't go away, in her head or ears non stop; worried and frightened". The events "humming in my ears after the booster dose of the pfizer covid vaccine" and "distraught after receiving the booster dose of the pfizer covid vaccine" were evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus, agitation.  Additional information: On 30Oct2021 had the Pfizer booster, and since then have this humming in her head and ear, like a distant air conditioner, and it wont go away. she want to know if this a symptom of this because it started up after the Pfizer booster. It is constant, and it sounds like it is out in the distance. she went to the doctors when it started and, they saw wax in it and they cleaned her ears, but it did not help, it has gotten worse, she need help, it is like a hummin in the background. Also reported Humming that wont go away has been there for 2 weeks now, in her head or ears nonstop: worried and frightened.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Hypoaesthesia, Immunisation, Lymphadenopathy, Paraesthesia
Clinical narrative: Swelling in L axilla (L arm injection); numbness and tingling in L arm, including fingers; numbness and tingling in L arm, including fingers; Pain in L axilla; dose_received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: FH8028) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3302), administration date: 19Jan2021, when the patient was 38 years old, for Covid-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0142), administration date: 30Dec2020, when the patient was 38 years old, for Covid-19 Immunisation; Flu, administration date: 06Nov2021, for Immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021, outcome "unknown", described as "dose_received: 3"; LYMPHADENOPATHY (non-serious) with onset 14Nov2021, outcome "not recovered", described as "Swelling in L axilla (L arm injection)"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 14Nov2021, outcome "not recovered" and all described as "numbness and tingling in L arm, including fingers"; AXILLARY PAIN (non-serious) with onset 14Nov2021, outcome "not recovered", described as "Pain in L axilla". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, hypoaesthesia, paraesthesia, axillary pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No relevant past drug history. Device Date: 15Nov2021.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Swelling in L axilla (L arm injection); numbness and tingling in L arm, including fingers; numbness and tingling in L arm, including fingers; Pain in L axilla; dose_received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: FH8028) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3302), administration date: 19Jan2021, when the patient was 38 years old, for Covid-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0142), administration date: 30Dec2020, when the patient was 38 years old, for Covid-19 Immunisation; Flu, administration date: 06Nov2021, for Immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021, outcome "unknown", described as "dose_received: 3"; LYMPHADENOPATHY (non-serious) with onset 14Nov2021, outcome "not recovered", described as "Swelling in L axilla (L arm injection)"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 14Nov2021, outcome "not recovered" and all described as "numbness and tingling in L arm, including fingers"; AXILLARY PAIN (non-serious) with onset 14Nov2021, outcome "not recovered", described as "Pain in L axilla". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, hypoaesthesia, paraesthesia, axillary pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No relevant past drug history. Device Date: 15Nov2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Erythema, Feeling abnormal, Immunisation, Mammogram
Clinical narrative: Big pink area where the injection was and it is still there and it is itchy; Big pink area where the injection was and it is still there and it is itchy; She just had her booster on Friday; she has big patches; Anxious; She is freaking out; Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A 67-year-old female patient received bnt162b2 (COMIRNATY), administration date 12Nov2021 (Lot number: 3302680) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot Number: EL9269), administration date: 16Feb2021, when the patient was 67 years old, for Covid-19 Immunization; Bnt162b2 (2nd dose, bad flare up of her Psoriasis /psoriasis went nuts and it has never calmed down, NOT RECOVERED/NOT RESOLVED, Lot Number: EN6205), administration date: 09Mar2021, when the patient was 67 years old, for Covid-19 Immunization, reaction(s): "bad flare up of her Psoriasis", "feeling like you have the flu", "Breast Cancer". The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "she has big patches"; ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 13Nov2021, outcome "not recovered" and all described as "Big pink area where the injection was and it is still there and it is itchy"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "Anxious"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "She is freaking out"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Had a sore arm"; IMMUNISATION (non-serious) with onset 12Nov2021, outcome "unknown", described as "She just had her booster on Friday". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No product information was obtained or provided for the mentioned Advil.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Vaccination site pruritus
Clinical narrative: Big pink area where the injection was and it is still there and it is itchy; Big pink area where the injection was and it is still there and it is itchy; She just had her booster on Friday; she has big patches; Anxious; She is freaking out; Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A 67-year-old female patient received bnt162b2 (COMIRNATY), administration date 12Nov2021 (Lot number: 3302680) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot Number: EL9269), administration date: 16Feb2021, when the patient was 67 years old, for Covid-19 Immunization; Bnt162b2 (2nd dose, bad flare up of her Psoriasis /psoriasis went nuts and it has never calmed down, NOT RECOVERED/NOT RESOLVED, Lot Number: EN6205), administration date: 09Mar2021, when the patient was 67 years old, for Covid-19 Immunization, reaction(s): "bad flare up of her Psoriasis", "feeling like you have the flu", "Breast Cancer". The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "she has big patches"; ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 13Nov2021, outcome "not recovered" and all described as "Big pink area where the injection was and it is still there and it is itchy"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "Anxious"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "She is freaking out"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Had a sore arm"; IMMUNISATION (non-serious) with onset 12Nov2021, outcome "unknown", described as "She just had her booster on Friday". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No product information was obtained or provided for the mentioned Advil.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Tinnitus
Clinical narrative: Right sided, low pitched, non pulsatile tinnitus; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Oct2021 (Lot number: Ff2589) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillins" (unspecified if ongoing), notes: known allergies: Penicillins; "Known allergies: cephalosporins" (unspecified if ongoing), notes: known allergies: cephalosporins; "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: DULOXETINE; BUPROPION. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Eh9899), administration date: 15Dec2020, when the patient was 29 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Ek9231), administration date: 05Jan2021, when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 25Oct2021, outcome "unknown", described as "Dose Number: 3"; TINNITUS (non-serious) with onset 30Oct2021, outcome "not recovered", described as "Right sided, low pitched, non pulsatile tinnitus". The event "right sided, low pitched, non pulsatile tinnitus" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: It was reported that patient had not taken any other vaccine in four weeks. Prior to vaccination patient was diagnosed with COVID-19 and since the vaccination patient had not been tested for COVID-19. Non pulsatile tinnitus which started 5 days after the dose and has persisted.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Headache, Immunisation, Pyrexia, Rash
Clinical narrative: High Fever; every bone ached; headache; rash on my neck; Dose Number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Nov2021 (Lot number: FF2593) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date Nov2021; LETROZOLE; LEXAPRO; AMLODIPINE BESYLATE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Right), administration date: Mar2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Right), administration date: Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Dose Number: 3"; PYREXIA (non-serious) with onset 05Nov2021, outcome "recovering", described as "High Fever"; BONE PAIN (non-serious) with onset 05Nov2021, outcome "recovering", described as "every bone ached"; HEADACHE (non-serious) with onset 05Nov2021, outcome "recovering", described as "headache"; RASH (non-serious) with onset 05Nov2021, outcome "recovering", described as "rash on my neck". Therapeutic measures were not taken as a result of pyrexia, bone pain, headache, rash.  Additional information: Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Pain, Swelling
Clinical narrative: Booster; my hurts it did that last time; it has a 12 in red swollen spot; it has a 12 in red swollen spot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; PAIN (non-serious), outcome "unknown", described as "my hurts it did that last time"; ERYTHEMA (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "it has a 12 in red swollen spot".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, Pruritus, Rash, Rash erythematous, Rash macular
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Lot number: FK5127) at the age of 11 years as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Influenza (Lot number: 42M95, Route: Intramuscular, Body site: Left arm, Dose number in series: N/A), administration date 14Oct2021, when the patient was 11 years old. The following information was reported RASH (non-serious) with onset 10Nov2021 21:00, outcome unknown; PRURITUS (non-serious) with onset 10Nov2021 21:00, outcome unknown; RASH ERYTHEMATOUS (non-serious) with onset 10Nov2021 21:00, outcome unknown; RASH MACULAR (non-serious) with onset 10Nov2021 21:00, outcome unknown; DERMATITIS (non-serious), VIRAL INFECTION (non-serious) all with onset 10Nov2021 21:00, outcome unknown. The events rash, rash is itchy, erythematous papules on buttocks, bilateral arms, legs and trunk, faint erythematous macules bilateral on palms, dermatitis from horseback riding but most likely viral exanthum, and were evaluated at the physician office visit.  A rash that started about 36 hours after getting covid vaccine. Rash was itchy. No new soaps or detergents. Bilateral arms, legs, and trunk. Faint Erythematous macules bilateral on palms. All same stages. No lesions on webs of hands or on feet. It was reported that possible contact dermatitis from horseback riding but most likely viral exanthem. Possible relation to recent covid vaccine.  Follow-up attempts completed. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Lot number: FK5127) at the age of 11 years as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Influenza (Lot number: 42M95, Route: Intramuscular, Body site: Left arm, Dose number in series: N/A), administration date 14Oct2021, when the patient was 11 years old. The following information was reported RASH (non-serious) with onset 10Nov2021 21:00, outcome unknown; PRURITUS (non-serious) with onset 10Nov2021 21:00, outcome unknown; RASH ERYTHEMATOUS (non-serious) with onset 10Nov2021 21:00, outcome unknown; RASH MACULAR (non-serious) with onset 10Nov2021 21:00, outcome unknown; DERMATITIS (non-serious), VIRAL INFECTION (non-serious) all with onset 10Nov2021 21:00, outcome unknown. The events rash, rash is itchy, erythematous papules on buttocks, bilateral arms, legs and trunk, faint erythematous macules bilateral on palms, dermatitis from horseback riding but most likely viral exanthum, and were evaluated at the physician office visit.  A rash that started about 36 hours after getting covid vaccine. Rash was itchy. No new soaps or detergents. Bilateral arms, legs, and trunk. Faint Erythematous macules bilateral on palms. All same stages. No lesions on webs of hands or on feet. It was reported that possible contact dermatitis from horseback riding but most likely viral exanthem. Possible relation to recent covid vaccine.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Peripheral swelling
Clinical narrative: booster; redness; swelling in arm from shoulder to elbow; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. This is one of two reports. This report is for female patient:  An elderly female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Done: 1st), for COVID-19 immunization; Bnt162b2 (Done: 2nd), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; ERYTHEMA (non-serious), outcome "unknown", described as "redness "; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in arm from shoulder to elbow ".  Additional information: Reporter stated that "I have seen two women and one man over 65 years, who got redness and swelling in their arm from shoulder to elbow a few days after getting the Pfizer booster shot." Reporter was asking information about side effects for recipients 56 years and older for the booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Immunisation, Interchange of vaccine products, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: took my first shot the JJ; Sore arm; Felt bloated that evening but didn''t think much of it.  Started spotting Sunday. Received my period today. I keep track of my cycles; Felt bloated that evening but didn''t think much of it.  Started spotting Sunday. Received my period today. I keep track of my cycles; Started spotting Sunday; Received Pfizer booster shot on Saturday at noon; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 12:15 (Lot number: FF2588) at the age of 43 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "covid prior vaccination" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulphur, reaction(s): "Drug Allergy". Vaccination history included: J&j (Dose 1, I took my first shot w the JJ on 13Mar.), administration date: 13Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021 12:15, outcome "unknown", described as "Received Pfizer booster shot on Saturday at noon"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "took my first shot the JJ"; MENSTRUATION IRREGULAR (non-serious), ABDOMINAL DISTENSION (non-serious) all with onset 15Nov2021 14:00, outcome "unknown" and all described as "Felt bloated that evening but didn''t think much of it. Started spotting Sunday. Received my period today. I keep track of my cycles"; INTERMENSTRUAL BLEEDING (non-serious) with onset 15Nov2021 14:00, outcome "unknown", described as "Started spotting Sunday"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Therapeutic measures were not taken as a result of menstruation irregular, abdominal distension, intermenstrual bleeding.  Additional Information: No other vaccine in four weeks. Patient had covid prior vaccination. No covid tested post vaccination. Facility type vaccine was Pharmacy or Drug Store. It was reported that patient was not due for a period for another 11 days, thought maybe it was due to ovulation but this was much heavier than spotting. So much more that had to insert a menstrual cup. Patient was not stressed. Haven't changed physical activities, nor diet. It was reported that she could only chock it up to receiving the Pfizer booster shot. Patient did not have any symptoms or side effects when took first shot with JJ on 13Mar.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: took my first shot the JJ; Sore arm; Felt bloated that evening but didn''t think much of it.  Started spotting Sunday. Received my period today. I keep track of my cycles; Felt bloated that evening but didn''t think much of it.  Started spotting Sunday. Received my period today. I keep track of my cycles; Started spotting Sunday; Received Pfizer booster shot on Saturday at noon; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 12:15 (Lot number: FF2588) at the age of 43 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "covid prior vaccination" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulphur, reaction(s): "Drug Allergy". Vaccination history included: J&j (Dose 1, I took my first shot w the JJ on 13Mar.), administration date: 13Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021 12:15, outcome "unknown", described as "Received Pfizer booster shot on Saturday at noon"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "took my first shot the JJ"; MENSTRUATION IRREGULAR (non-serious), ABDOMINAL DISTENSION (non-serious) all with onset 15Nov2021 14:00, outcome "unknown" and all described as "Felt bloated that evening but didn''t think much of it. Started spotting Sunday. Received my period today. I keep track of my cycles"; INTERMENSTRUAL BLEEDING (non-serious) with onset 15Nov2021 14:00, outcome "unknown", described as "Started spotting Sunday"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Therapeutic measures were not taken as a result of menstruation irregular, abdominal distension, intermenstrual bleeding.  Additional Information: No other vaccine in four weeks. Patient had covid prior vaccination. No covid tested post vaccination. Facility type vaccine was Pharmacy or Drug Store. It was reported that patient was not due for a period for another 11 days, thought maybe it was due to ovulation but this was much heavier than spotting. So much more that had to insert a menstrual cup. Patient was not stressed. Haven't changed physical activities, nor diet. It was reported that she could only chock it up to receiving the Pfizer booster shot. Patient did not have any symptoms or side effects when took first shot with JJ on 13Mar.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature, Chills, Decreased appetite
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028, solution for injection) via an unspecified route of administration in the left arm on 11Nov2021 at 18:00 (at the age of 46-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included iron deficiency and had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications received within two weeks of vaccination included FOCUS FACTOR at 2x/week, VITAMIN D3, and NUTRILITE at 2x/week, all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 04Apr2021 at 17:00 (at the age of 46-years-old) as dose 1, single and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 25Apr2021 at 11:00 (at the age of 46-years-old) as a dose 2, single for COVID-19 immunisation. On 11Nov2021 at 18:00, immediately after injection, the patient had pain at injection site. On 12Nov2021 at 03:00, after 9 hours (all side effects started around the same time), the patient experienced chills, fever (38 centigrade), sweating, pain in lymph nodes (left arm pit), fatigue, nausea, muscles and joints pain, light headache, and loss of appetite. After about 80 hours almost all above side effects diminished except for sweating and lymph node pain in the left arm pit. On 14Nov2021 at 06:00, after about 60 hours, mild intermittent pain started in upper left abdomen area, which got worse about 15 minutes after each meal and improved, but did not go away after about 4 hours, which was still present at 78 hours post injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with TYLENOL 1 tablet only, which did not help at all. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, chills, fever (38C), fatigue, nausea, muscles and joints pain, light headache, and loss of appetite was recovering. The events sweating, pain in lymph nodes, and mild intermittent pain started in upper left abdomen area was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.