chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6204), administration date: 11Mar2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "Sore arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: ER8733), administration date: 31Mar2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "Sore arm"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: EW0172), administration date: 15Nov2021, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "Sore arm"; flu shot (.), administration date: 26Oct2021, for Immunization, reaction(s): "Sore arm".  Additional information: It was reported that she had no problems with the first 4 doses, there was a bit of sore arm. No additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room and physician office. The patient did not receive other vaccines within four weeks prior to COVID vaccine . The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201241797 same reporter/patient/AE, different dose;
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: very very painful and sore; very very painful and sore; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 14:00 as dose 3 (booster), single (Lot number: GH9702) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart attack" (unspecified if ongoing), notes: Heart attack about 6 weeks ago; "Pacemaker" (unspecified if ongoing), notes: he got 5 weeks ago. Concomitant medication(s) included: ELIQUIS taken for anticoagulant therapy; METOPROLOL taken for anticoagulant therapy, stop date: 19Oct2022 at 00:09; FLU [INFLUENZA VACCINE] taken for immunisation. Vaccination history included: Bnt162b2 (DOSE 1; lot number: unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2; lot number unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 18Oct2022, outcome "not recovered" and all described as "very very painful and sore". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity. Clinical course was as follows: The reporter/patient stated that he received Pfizer covid-19 bivalent booster shot yesterday (18Oct2022) and his arm is "very very painful and sore". The patient had the Pfizer Covid Bivalent Booster at 2 in the afternoon (on 18Oct022). He is in a lot of pain and has soreness where they gave the needle in the left arm. The patient asked if this is common and how long his pain on his arm would last. He is still experiencing this now, that is why he is calling, has stayed the same without treatment. The patient has 2 medicines he is taking for blood thinners. Is that going to affect him? When clarifying that both Eliquis and Metoprolol were being taken as blood thinner, but he is not quite sure and believes it they are (taken) for blood thinners. The patient also asked if Eliquis (2x a day) and metoprolol tartrate (reported as a non-Pfizer product) has an interaction with Pfizer covid-19 bivalent booster shot? He was on a blood thinner and stopped taking it because he is afraid, because he took the booster. Prior Vaccinations (within 4 weeks): "2 or 3 weeks ago, had flu shot." The patient also stated that he got a heart device "pacemaker" 5 weeks ago, had heart back about 6 weeks ago. When he came out of hospital, they told him to take this (Eliquis). He also clarified that he stopped taking this medication and did not take it today because he is concerned; and that he stopped taking the Metoprolol today, as well. Since he has a pacemaker, he wanted to know if that is okay with the vaccine.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6207), on 02Apr2021 as dose 2, single (Lot number: ER8734), on 04Oct2021 as dose 3 (booster), single (Lot number: FF2587) and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "A-fib" (unspecified if ongoing); "HIV+ 30 years" (unspecified if ongoing), notes: HIV+ 30 years. Concomitant medication(s) included: METOPROLOL; SYMTUZA; TIVICAY; VALTREX. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Oct2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: After Paxlovid done, tested neg for 5 days; (unspecified date) Positive, notes: Started testing pos 2 days after that; (05Oct2022) Positive, notes: Started Paxlovid on 1st day of symptoms/testing pos. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information:  Started Paxlovid on 1st day of symptoms/testing pos. Symptoms went away after 3 days. After Paxlovid done, tested neg for 5 days. Symptoms came back on 6th day. Started testing pos 2 days after that. On 5th day of symptoms- feeling sick. Congestion, headache, lots of sneezing and runny nose. Much worse than before the Paxlovid. Still in the thick of it - hopefully better soon.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased
Clinical narrative: Developed an 102F for two days; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 72-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNISATION SERIES COMPLETE, UNKNOWN MANUFACTURER), for COVID-19 immunization, reaction(s): "Covid-19". The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Developed an 102F for two days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Physician is calling about a 72 year old female who received the gray cap formulation of the Pfizer BioNTech Covid 19 vaccine as a booster about six months ago and she developed an 102F for two days. Does this mean that she cannot receive the new bivalent gray cap formulation of the Pfizer BioNTech Covid 19 vaccine?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Body temperature increased, Fatigue, Heart rate increased
Clinical narrative: My Whoop showed very elevated respiratory rate and BPM; My Whoop showed very elevated respiratory rate and BPM; elevated skin temperature; Fatigue; Achiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 10:45 as dose 4 (booster), single (Lot number: 10046) at the age of 51 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: 7182, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular, is bivalent=False), administration date: 26Nov2021, when the patient was 50-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose:2, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (Dose:1, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 2022, outcome "recovering", described as "Achiness"; FATIGUE (non-serious) with onset 2022, outcome "recovering"; RESPIRATORY RATE INCREASED (non-serious), HEART RATE INCREASED (non-serious) all with onset 17Oct2022, outcome "recovering" and all described as "My Whoop showed very elevated respiratory rate and BPM"; BODY TEMPERATURE INCREASED (non-serious) with onset 17Oct2022, outcome "recovering", described as "elevated skin temperature". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pain, respiratory rate increased, heart rate increased, body temperature increased.  Additional information: Patient had no known allergies. The patient did not have covid prior vaccination nor tested post vaccination. Fatigue and achiness. Also the night of the injection his whoop showed very elevated respiratory rate and BPM and elevated skin temperature. He did not received other medications in two weeks. He received other vaccine i.e. flue vaccine in four weeks.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Respiratory rate, Respiratory rate increased
Clinical narrative: My Whoop showed very elevated respiratory rate and BPM; My Whoop showed very elevated respiratory rate and BPM; elevated skin temperature; Fatigue; Achiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 10:45 as dose 4 (booster), single (Lot number: 10046) at the age of 51 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: 7182, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular, is bivalent=False), administration date: 26Nov2021, when the patient was 50-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose:2, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (Dose:1, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 2022, outcome "recovering", described as "Achiness"; FATIGUE (non-serious) with onset 2022, outcome "recovering"; RESPIRATORY RATE INCREASED (non-serious), HEART RATE INCREASED (non-serious) all with onset 17Oct2022, outcome "recovering" and all described as "My Whoop showed very elevated respiratory rate and BPM"; BODY TEMPERATURE INCREASED (non-serious) with onset 17Oct2022, outcome "recovering", described as "elevated skin temperature". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pain, respiratory rate increased, heart rate increased, body temperature increased.  Additional information: Patient had no known allergies. The patient did not have covid prior vaccination nor tested post vaccination. Fatigue and achiness. Also the night of the injection his whoop showed very elevated respiratory rate and BPM and elevated skin temperature. He did not received other medications in two weeks. He received other vaccine i.e. flue vaccine in four weeks.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Loss of consciousness
Clinical narrative: passed out on the floor; uncontrollable chills (for which he could not get warm); too weak to get up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 14:30 as dose 5 (booster), single (Lot number: GJ5342) at the age of 75 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "prostrate cancer" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; JARDIANCE; ALPHA LIPOIC ACID; CETIRIZINE; ATORVASTATIN; VITAMIN D [COLECALCIFEROL]. Vaccination history included: BNT162b2 (DOSE 4; SINGLE, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 11May2022, for COVID-19 immunization; BNT162b2 (DOSE 3; SINGLE, Batch/Lot No: FC3184, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 17Sep2021, for COVID-19 immunization; BNT162b2 (DOSE 2; SINGLE, Batch/Lot No: EN6102, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Feb2021, for COVID-19 immunization; BNT162b2 (DOSE 1; SINGLE, Batch/Lot No: EN5318, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 08Feb2021, for COVID-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 05Oct2022 at 21:30, outcome "recovered with sequelae", described as "passed out on the floor"; ASTHENIA (non-serious) with onset 05Oct2022 at 21:30, outcome "recovered with sequelae", described as "too weak to get up"; CHILLS (non-serious) with onset 05Oct2022 at 21:30, outcome "recovered with sequelae", described as "uncontrollable chills (for which he could not get warm)". Therapeutic measures were not taken as a result of loss of consciousness, chills, asthenia.  Clinical course: After receiving the last vaccine on 05Oct2022, reporter father went home, experienced uncontrollable chills (for which he could not get warm), and passed out on the floor. He was too weak to get up and his wife was unable to assist with lifting him, so he remained on the floor and slept for 12 hours. Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks.Other medications in two weeks were Metformin, prebiotic/probiotic, Jardiance, r alpha lipoic acid, Cetirizine, Atorvastatin, Vitamin D. No covid prior vaccination. Covid tested post vaccination was unknown. No Known allergies.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Chills; fever; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 10:00 as dose 5 (booster), single (Lot number: gh9694) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE ; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer Unknown), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 19Oct2022, outcome "recovered" (Oct2022); FATIGUE (non-serious) with onset 19Oct2022, outcome "recovered" (Oct2022); PYREXIA (non-serious) with onset 19Oct2022, outcome "recovered" (Oct2022), described as "fever"; HEADACHE (non-serious) with onset 19Oct2022, outcome "recovered" (Oct2022). Therapeutic measures were not taken as a result of chills, pyrexia, fatigue, headache.  Additional Information: The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had COVID-19; had COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing), notes: has allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "had COVID-19".  Clinical course: Patient was asking if it is okay to get the Bivalent vaccine since she has had a sinus headache for about 3 months now and did home test twice but tested negative. Patient and her husband both had COVID-19 at the end Jun2022. Patient had both the Pfizer-BioNTech COVID-19 Vaccine, (monovalent) vaccines, have had the primary series and the booster doses x2. The patient and her husband both received their last booster dose in May2022. Patient and her husband both got COVID in Jun2022. She mentioned she has allergies so the cough is most likely associated with that but she just wanted to confirm.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Nausea, Vomiting
Clinical narrative: Nauseous; vomiting; dizzy; weak; no appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's" (unspecified if ongoing). Concomitant medication(s) included: CARBIDOPA/LEVODOPA, start date: 19May2022. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; manufacturer unknown), for covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 17Oct2022, outcome "not recovered", described as "Nauseous"; DIZZINESS (non-serious) with onset 17Oct2022, outcome "not recovered", described as "dizzy"; DECREASED APPETITE (non-serious) with onset 17Oct2022, outcome "not recovered", described as "no appetite"; VOMITING (non-serious) with onset 17Oct2022, outcome "not recovered"; ASTHENIA (non-serious) with onset 17Oct2022, outcome "not recovered", described as "weak". Therapeutic measures were not taken as a result of nausea, vomiting, dizziness, asthenia, decreased appetite.  Additional information: No Known allergies. Nauseous vomiting dizzy weak no appetite. If treatment ae: No.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 30Mar2021 as dose 2, single (Lot number: ER8733), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 25May2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient took paxlovid for treatment of adverse events, Device timestamp: 19Oct2022. The patient had no Known allergies.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had COVID-19; had COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 day, as dose 2, single (Batch/Lot number: unknown) for 1 day, as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "had COVID-19".  Clinical course: It was reported that caller and the patient (husband) both had COVID-19 at the end Jun2022. Caller stated they have both had the Pfizer-BioNTech COVID-19 Vaccine, (monovalent) vaccines, have had the primary series and the booster doses twice. The caller and patient (husband) both received their last booster dose in May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Multiple allergies, SARS-CoV-2 test, Sinus headache
Clinical narrative: Sinus headache; Cough; Allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "COVID-19"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "COVID-19"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: MULTIPLE ALLERGIES (non-serious) with onset 2022, outcome "unknown", described as "Allergies"; COUGH (non-serious) with onset 2022, outcome "unknown"; SINUS HEADACHE (non-serious) with onset 2022, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Product was Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Reporter was asking if it was okay to get the Bivalent vaccine since she has had a sinus headache for about 3 months now and did home test twice but tested negative. Reporter stated she and her husband both had COVID-19 at the end Jun2022. She stated they have both had the Pfizer-BioNTech COVID-19 Vaccine, (monovalent) vaccines, have had the primary series and the booster doses 2. The reporter and her husband both received their last booster dose in May2022. Referred her to her HCP for treatment recommendations. Other Condition, Investigations and other products were not provided. Patient and her husband both got COVID in Jun2022. NDC number and Expiry Date of COVID-19 vaccine was not provided. Reason for no lot number of COVID-19 vaccine was Complainant hung up abruptly/transfer incomplete. Packaging sealed and intact was not provided. Patient stated that she started with a cough but no fever. Patient mentioned she had allergies so the cough was most likely associated with that but she just wanted to confirm.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2022 at 10:45 as dose number unknown, single (Lot number: G149693) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Other medical history Rheumatoid arthritis; "Known allergies Sulfa" (unspecified if ongoing), notes: Known allergies Sulfa. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19; patient received anti viral treatment (Paxlovid) from 05Oct2022 to 10Oct2022 as COVID 19 Treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "MS" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive a week after completing  paxlovid; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 08Oct2022, the patient received Paxlovid treatment for covid 19.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blister infected, Condition aggravated, Eczema, Temporomandibular joint syndrome
Clinical narrative: caller's eczema and TMJ was exacerbated; caller's eczema and TMJ was exacerbated; caller's eczema and TMJ was exacerbated; he had blistering on his fingers; 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 57-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "chronic Lyme's disease", start date: 1999 (unspecified if ongoing), notes: chronic Lyme's disease since 1999 but was only diagnosed on 2013; "flu" (unspecified if ongoing); "eczema", start date: 1999 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ECZEMA (non-serious), TEMPOROMANDIBULAR JOINT SYNDROME (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "caller's eczema and TMJ was exacerbated"; BLISTER INFECTED (non-serious), outcome "unknown", described as "he had blistering on his fingers".  Additional information: Caller was asking about Paxlovid and explained that he had chronic Lyme's disease since 1999 but was only diagnosed on 2013 when he pulled a tick out of his leg which he actually got very sick with flu like symptoms for. He states that his lyme disease presents itself as eczema on his fingers that are brutal have not gone away since 1999. He mentions that his doctor put him on and off different antibiotics (such as Doxycycline) from 2013. Caller shares that the eczema on his fingers worsens as the seasons transition and that typically there is only little eczema on the months of Jun, Jul, Aug, Sep, and at the onset of Oct onwards it gets worse. Now, caller reports that after he got his Pfizer covid 19 shot on Mar and Apr2021, and eventually the booster dose on Nov2021, caller's eczema and TMJ was exacerbated. caller's eczema and TMJ was exacerbated he had blistering on his fingers He reports that his eczema got worse than before the vaccine and that he had blistering on his fingers. Then at around Jul this year, caller was prescribed Paxlovid for 5 days by his doctor to try it out for his Lyme disease. Caller then states that when he used Paxlovid with another antibiotic Ceftin, his eczema healed but when he had to use Paxlovid with Amoxicillin his eczema came back, because of the success of his treatment his doctor had prescribed him again and again to take Paxlovid and is now on Day 39. He mentions he got 2 5 day packs of Paxlovid from his insurance and that he got his other doses from another Pharmacy he will not be naming. Caller was calling because he no longer has doses for Paxlovid and would like to ask Pfizer for help with this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling and pain at injection site; Swelling and pain at injection site; headache for 2 days; malaise for 3-5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacture unknown), for COVID-19 Immunization; Covid-19 vaccine (First booster), for COVID-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Oct2022, outcome "unknown" and all described as "Swelling and pain at injection site"; HEADACHE (non-serious) with onset Oct2022, outcome "recovered" (Oct2022), described as "headache for 2 days"; MALAISE (non-serious) with onset Oct2022, outcome "recovered" (Oct2022), described as "malaise for 3-5 days". The events "swelling and pain at injection site", "headache for 2 days" and "malaise for 3-5 days" required physician office visit. It was unknown if therapeutic measures were taken as a result of vaccination site swelling, vaccination site pain, headache, malaise. Additional information: Ae resulted in: Doctor or other healthcare professional office/clinic visit. If covid prior vaccination: Unknown. If covid tested post vaccination: Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Hypersensitivity, Impaired quality of life, Lymphadenopathy
Clinical narrative: allergy; left arm pit lymph node was swollen like a grapefruit; All of my joints, except my elbows, are freaking killing me now/ shoulders were the worst; negatively impacting my life; 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), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergy"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "left arm pit lymph node was swollen like a grapefruit"; ARTHRALGIA (non-serious), outcome "unknown", described as "All of my joints, except my elbows, are freaking killing me now/ shoulders were the worst"; IMPAIRED QUALITY OF LIFE (non-serious), outcome "unknown", described as "negatively impacting my life". Therapeutic measures were taken as a result of hypersensitivity, lymphadenopathy.  Additional Information: After second shot of Pfizer vaccine, the patient left arm pit lymph node was swollen like a grapefruit for 3 days. It felt like crap for about a week. "No more "boosters" for this guy". The patient stated that all of my joints, except my elbows, are freaking killing me now; shoulders were the worst. The patient felt like decomposing after the shots. The patient never had an allergy in life, but now was having it. The patient stated "Oh, and I get to take Zyrtec now; thanks so much for negatively impacting my life".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 2, single (Lot number: EL9266) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, lot EN53190), administration date: 25Jan2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "a little soreness". The following information was reported: PAIN (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "a little soreness".  Additional Information: It was reported that, other conditions and investigations reported as no. prior vaccination (within 4 weeks) and AE(s) following prior vaccinations was none. Phone in 3:26 pm from reporter (consumer/patient) in response to phone out 10:16 am to clarify whether the statement, "initial shot part" that was reported in Initial (PRD/SRD 13Oct2022) was referring to the first dose of the Pfizer COVID-19 vaccine (Dose 1) or the primary series of vaccination (Dose 1 and Dose 2). Reporter stated that she was referring to Dose 1, Dose 2, Dose 3 and Dose 4 of the Pfizer COVID-19 Vaccine. Reporter stated that with Dose 1, Dose 2, Dose 3 and Dose 4, that she did not experience any adverse events, that she just experienced a little soreness when she initially received those 4 shots and added that it was nothing and the soreness went away right away and that she does not consider "a little soreness" an adverse event.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003703 (Novavax).  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine for an unspecified indication), for COVID-19 Immunization; Bnt162b2 (Dose 2, Patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine for an unspecified indication), for COVID-19 Immunization.  The following information was reported: HEADACHE (non-serious), outcome "not recovered".  Adverse Event Information: On 03Oct2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine for an unspecified indication. It was reported after the 3rd dose the patient developed a headache that has been on and off and has lasted a year. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Lost all my body strength; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series complete: unknown manufacturer), for COVID-19 immunization. The following information was reported: ASTHENIA (hospitalization) with onset 05Oct2022, outcome "unknown", described as "Lost all my body strength". The patient was hospitalized for asthenia (start date: 05Oct2022, discharge date: 07Oct2022, hospitalization duration: 2 day(s)). The event "lost all my body strength" required emergency room visit. Therapeutic measures were taken as a result of asthenia.  Clinical course: on Tuesday 04Oct, I received a Pfizer Bivalent inoculation from my local (vaccine facility name). The next day from the time I woke, I lost all my body strength and had to be taken to the emergency room of my local hospital. They admitted me and discharged me the following Friday at noon. They have no explanation for what happened to me on 05Oct.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I got breakthrough COVID despite having the COVID omicron bivalent booster. Tested positive 19Oct2022 after traveling for work; I got breakthrough COVID despite having the COVID omicron bivalent booster. Tested positive 19Oct2022 after traveling for work; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Oct2022, outcome "unknown" and all described as "I got breakthrough COVID despite having the COVID omicron bivalent booster. Tested positive 19Oct2022 after traveling for work". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2022) Positive, notes: Tested positive 19Oct2022 after traveling for work. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue
Clinical narrative: getting tired fast; Shortness of breath; Chills; achy joints; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious Courtesy case received from Pfizer via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was getting tired fast, shortness of breath, chills and achy joints after receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and Covid-19 vaccine Bivalent.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included NAPROXEN (NAPROXEN) and unspecified vitamins.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE  (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received an unknown dose of non-company suspect Covid-19 vaccine Bivalent strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  It was reported that patient had a INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE   and after 48 hrs later had the Pfizer BioNTech Bivalent and now patient had shortness of breath (dyspnoea), chills, no fever 98 degrees, achy joints(arthralgia) and was getting tired fast(fatigue) (onset and latency: unknown) . Patient injection was like 30 hours ago and he/she was feeling like 4 hours. Patient do not have fever.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: Unknown for all events
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Headache, Pain, Pyrexia
Clinical narrative: body aches; low grade fever; BP was elevated; began experiencing a headache. Headache got worse throughout the day; Initial information received on 15-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 74 years old female patient whose bp (blood pressure) was elevated,had body aches, began experiencing a headache,headache got worse throughout the day and low grade fever while receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On 15-Oct-2022, the patient received an unknown dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (formulation, strength: unknown) lot number not reported via intramuscular route in unknown administration site as Seasonal Flu Vaccination-recommended care.  On 15-OCT-2022 the patient developed a non-serious events bp was elevated (blood pressure increased), experiencing a headache, headache got worse throughout the day (headache) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On 16-OCT-2022 the patient developed a non-serious events body aches (pain) low grade fever (pyrexia) 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Headache got worse throughout the day prompting patient to check blood pressure using a home BP meter. BP was elevated. patient continued to monitor BP and rest. Late afternoon on 16Oct2022 the headache began to resolve and BP was slightly reduced. Began to develop a low grade fever and body aches which was expected as this is her usual reaction to annual flu shot. Patient did not experience any additional symptoms/events.  Relevant laboratory test results included: Blood pressure measurement - On 15-Oct-2022: [BP was elevated]  The company suspect product was not inappropriately used as per local Marketing authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (began experiencing a headache. Headache got worse throughout the day, low grade fever, body aches, BP was elevated).  At time of reporting, the outcome was Recovering / Resolving for the event began experiencing a headache. headache got worse throughout the day, bp was elevated and  was Unknown for others.