chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa in antibiotics" (unspecified if ongoing). Concomitant medication(s) included: JUNEL FE 1.5/30 taken for contraception. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: Patient received Paxlovid (lot number: GC0529) from 23Jun2022 for COVID-19 treatment and experienced nausea and vomiting and change of taste in mouth.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: U
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 52-year-old patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), on 02Apr2021 as dose 2, single (Lot number: Er8735) and on 04Oct2021 as dose 3 (booster), single (Lot number: Ff8841) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (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: unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient vaccine received and other medication in two weeks. The patient received COVID 19 treatment, from 13Jun2022 to 18Jun2022.  Follow-up attempts are completed. No further information is expected.  Follow-up (29Jun2022): Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Batch/Lot number: unknown), on 30Jan2021 as dose 2, single (Batch/Lot number: unknown), on 12Oct2021 as dose 3 (booster) single (Batch/Lot number: unknown) and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Dec1997; AMLODIPINE, start date: Dec2019. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Positive covid test; Negative, notes: negative test. Therapeutic measures were taken as a result of covid-19, vaccination failure.  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: Vaccination site pruritus
Clinical narrative: Itching at the shot site; 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 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: Covid-19 vaccine (Dose-1 (Manufactruer Unknown)), for Covid-19 immunization; Covid-19 vaccine (Dose-2 (Manufactruer Unknown)), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE (Manufactruer Unknown)), for Covid-19 immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "Itching at the shot site".  Additional information: Consumer stated, ''Yes, just had my second booster (Suspect clarified as Pfizer Covid 19 shot) today which was fourth shot and experienced itching at the shot site. Patient questioned, I don't need to go hospital for that, do I.'' Consumer further stated, "Yes it was just a shot site you know with a shot, that's the only place I itch.'' Further probing could not be done as the consumer hung up the call abruptly. Hence, product details (LOT#, NDC, UPC and expiration) were unknown and limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I was being vaccinated with the Pfizer booster; I was being vaccinated with the Pfizer booster; 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 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), outcome "unknown" and all described as "I was being vaccinated with the Pfizer booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I got positive to covid on Monday morning. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Consumer stated that the reason I am calling because I got positive to covid on Monday morning. And in the evening went to ER and they offered me the medication, I was being vaccinated with the Pfizer booster (further clarifications unknown hence, suspect captured as unspecified booster) one so I did accept to take the treatment called it Paxlovid. I was aware of the side effects, and I had a hoarseness in my voice, but I thought it was I was coughing so much. You can listen to my voice, it was hoarse. I do not have any more fever. I feel ok except of this cough I don't have any more productions. I was ok, my stool got a little soft yesterday, I did not go yesterday but I went today but they are very pale. And that was what I am here because of that. I am calling to ask you advice to see what should I do.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Gingival recession, Heart rate, Heart rate increased
Clinical narrative: Muscle reaction and spasms; Muscle reaction and spasms; chest pains; occasional shortness of breath; gums receeding; rapid heart beat while resting; Pains all over his body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), 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: MUSCLE DISORDER (non-serious), MUSCLE SPASMS (non-serious), outcome "unknown" and all described as "Muscle reaction and spasms"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pains"; DYSPNOEA (non-serious), outcome "unknown", described as "occasional shortness of breath"; GINGIVAL RECESSION (non-serious), outcome "unknown", described as "gums receeding"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart beat while resting"; PAIN (non-serious), outcome "unknown", described as "Pains all over his body". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200894392 Same reporter/diff patient; Report 2 of 2;
Sex: F
Vaccine: COVID19
Symptoms: Muscle disorder, Muscle spasms, Pain
Clinical narrative: Muscle reaction and spasms; Muscle reaction and spasms; chest pains; occasional shortness of breath; gums receeding; rapid heart beat while resting; Pains all over his body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), 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: MUSCLE DISORDER (non-serious), MUSCLE SPASMS (non-serious), outcome "unknown" and all described as "Muscle reaction and spasms"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pains"; DYSPNOEA (non-serious), outcome "unknown", described as "occasional shortness of breath"; GINGIVAL RECESSION (non-serious), outcome "unknown", described as "gums receeding"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart beat while resting"; PAIN (non-serious), outcome "unknown", described as "Pains all over his body". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200894392 Same reporter/diff patient; Report 2 of 2;
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Second Covid infection detetected 17Jun in pos. test.; Second Covid infection detetected 17Jun in pos. test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 18:00 as dose 1, single (Lot number: EL9264), on 25Feb2021 at 18:00 as dose 2, single (Lot number: EN6203), on 26Sep2021 at 14:00 as dose 3 (booster), single (Lot number: EW0187) and on 13Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 83 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 08Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 08Jun2022, outcome "recovered" (23Jun2022) and all described as "Second Covid infection detetected 17Jun in pos. test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive; (13Jun2022) Negative; (17Jun2022) Positive; (23Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course was reported as the COVID infection detected on 08Jun2022 - positive. She was treated with Paxlovid. The patient tested clear negative on 13Jun2022. The patient had second COVID infection rebound, detected on 17Jun2022 positive test. No treatment. The patient was cleared 23Jun2022, negative test with continued low-grade fever.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Dose Number: 4; Treatment of COVID-19; Dose Number: 4; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Asthma" (ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Dose Number: 4; Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (20Jun2022) Negative, notes: Tested negative on antigen test last day of treatment; (25Jun2022) worse COVID symptoms than with initial infection, notes: Antigen test 5 days after completing paxlovid with worse COVID symptoms than with initial infection. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, 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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 02May2021 as dose 2, single (Lot number: EW0182), in left arm, on 19Nov2021 as dose 3 (booster), single (Lot number: 330308D), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MELOXICAM, start date: Mar2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jun2022, 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) Unknown results; (25Jun2022) Unknown results, notes: Rebound Covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received other medication in 2 weeks. The patient reported known allergies was no. The patient received anti viral product COVID 19 Treatment brand Paxlovid from 13Jun2022 to 18Jun2022 for the indication of Treatment of COVID-19
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia
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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 02May2021 as dose 2, single (Lot number: EW0182), in left arm, on 19Nov2021 as dose 3 (booster), single (Lot number: 330308D), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MELOXICAM, start date: Mar2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jun2022, 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) Unknown results; (25Jun2022) Unknown results, notes: Rebound Covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received other medication in 2 weeks. The patient reported known allergies was no. The patient received anti viral product COVID 19 Treatment brand Paxlovid from 13Jun2022 to 18Jun2022 for the indication of Treatment of COVID-19
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: After fourth dose of vaccine, experienced fever and body aches for less than 24 hours.  No similar symptoms experiences with 3 prior doses.; After fourth dose of vaccine, experienced fever and body aches for less than 24 hours.  No similar symptoms experiences with 3 prior doses.; 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 female patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MELOXICAM. Vaccination history included: pfizer (Dose Number: 3, Batch/Lot No: 330308D, Location of injection: Arm Left), administration date: 19Nov2021, when the patient was 51-year-old, for Covid-19 immunization; pfizer (Dose Number: 2, Batch/Lot No: ew0182, Location of injection: Arm Left), administration date: 02May2021, when the patient was 50-year-old, for Covid-19 immunization; pfizer (Dose Number: 1, Batch/Lot No: er8737, Location of injection: Arm Left), administration date: 04Apr2021, when the patient was 50-year-old, for Covid-19 immunization.  The following information was reported: PYREXIA (non-serious), PAIN (non-serious) all with onset 20Apr2022, outcome "recovered" and all described as "After fourth dose of vaccine, experienced fever and body aches for less than 24 hours. No similar symptoms experiences with 3 prior doses.". Therapeutic measures were not taken as a result of pyrexia, pain.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: After fourth dose of vaccine, experienced fever and body aches for less than 24 hours.  No similar symptoms experiences with 3 prior doses.; After fourth dose of vaccine, experienced fever and body aches for less than 24 hours.  No similar symptoms experiences with 3 prior doses.; 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 female patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MELOXICAM. Vaccination history included: pfizer (Dose Number: 3, Batch/Lot No: 330308D, Location of injection: Arm Left), administration date: 19Nov2021, when the patient was 51-year-old, for Covid-19 immunization; pfizer (Dose Number: 2, Batch/Lot No: ew0182, Location of injection: Arm Left), administration date: 02May2021, when the patient was 50-year-old, for Covid-19 immunization; pfizer (Dose Number: 1, Batch/Lot No: er8737, Location of injection: Arm Left), administration date: 04Apr2021, when the patient was 50-year-old, for Covid-19 immunization.  The following information was reported: PYREXIA (non-serious), PAIN (non-serious) all with onset 20Apr2022, outcome "recovered" and all described as "After fourth dose of vaccine, experienced fever and body aches for less than 24 hours. No similar symptoms experiences with 3 prior doses.". Therapeutic measures were not taken as a result of pyrexia, pain.
Age: 78.0
Sex: F
Vaccine: 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) (Other HCP).  A 78-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunization. The patient's relevant medical history included: "Essential Hypertension" (unspecified if ongoing); "obesity class I" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "acquired hypothyroidism" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "cat hair" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Oxycodone, reaction(s): "Allergy:Oxycodone"; Amlodopine, reaction(s): "Allergy:amlodopine". The following information was reported: COVID-19 (medically significant) with onset 25Jun2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (23Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: patient tested negative for covid on 23Jun2022 after completion of paxlovid. On day 10 she presents in telemedicine clinic with a new positive test and increased symptoms of covid which had previous resolved. Runny nose, 25Jun2022, lethargy, sneezing and congestion 26Jun2022 and 27Jun2022 with significant fatigue, lethargy, cough andcold sx and positive covid test, at home antigen  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Discomfort, Headache, Myalgia, Pain
Clinical narrative: Headache; I am just kind of my achy feeling this morning; today I got achy bones; muscle achy feeling; I am just kind of my achy feeling this morning; today I got achy bones; muscle achy feeling; I am just kind of my achy feeling this morning; today I got achy bones; muscle achy feeling; I am like discomfort right now; I had a restless night.; 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 4 (booster), single (Batch/Lot number: unknown, Expiration Date: 28Jul2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE: MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE: MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE: MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown"; BONE PAIN (non-serious), MYALGIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "I am just kind of my achy feeling this morning; today I got achy bones; muscle achy feeling"; DISCOMFORT (non-serious), outcome "unknown", described as "I am like discomfort right now"; RESTLESSNESS (non-serious), outcome "unknown", described as "I had a restless night."  Additional Information: Consumer stated I had my booster, second booster (Clarified as Pfizer Covid 19 vaccine) yesterday and during the night I had a restless night and I am just kind of, I am achy feeling this morning and I got a headache. Can I take Aleve or something like that. Is that okay to take something. Consumer stated Yes I want to know because I had a headache and kind of achy feeling, you know muscle achy feeling. Okay, Well I am not. I need to know is that okay to take something for the headache. Can I take Just the Aleve, you know an aspirin is not aspirin but its something like Ibuprofen or something that kind of medication (Further clarification unknown hence captured as Unspecified medications). Can I take that for my headache and my discomfort today, I have got achy bones. .Consumer further stated Okay, Alright. I just, okay. I can be alright. I am like discomfort right now but anyways. Okay. I will let it go with that and hopefully I just go and take one if she can help." (Further not clarified). But they are closed right now, they are closed. If it is there. I will calling the pharmacist who gave me the shot before that I am thrilled, anyways thank you for trying. Will this be HT347 I mean that's something written over here.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Restlessness
Clinical narrative: Headache; I am just kind of my achy feeling this morning; today I got achy bones; muscle achy feeling; I am just kind of my achy feeling this morning; today I got achy bones; muscle achy feeling; I am just kind of my achy feeling this morning; today I got achy bones; muscle achy feeling; I am like discomfort right now; I had a restless night.; 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 4 (booster), single (Batch/Lot number: unknown, Expiration Date: 28Jul2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE: MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE: MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE: MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown"; BONE PAIN (non-serious), MYALGIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "I am just kind of my achy feeling this morning; today I got achy bones; muscle achy feeling"; DISCOMFORT (non-serious), outcome "unknown", described as "I am like discomfort right now"; RESTLESSNESS (non-serious), outcome "unknown", described as "I had a restless night."  Additional Information: Consumer stated I had my booster, second booster (Clarified as Pfizer Covid 19 vaccine) yesterday and during the night I had a restless night and I am just kind of, I am achy feeling this morning and I got a headache. Can I take Aleve or something like that. Is that okay to take something. Consumer stated Yes I want to know because I had a headache and kind of achy feeling, you know muscle achy feeling. Okay, Well I am not. I need to know is that okay to take something for the headache. Can I take Just the Aleve, you know an aspirin is not aspirin but its something like Ibuprofen or something that kind of medication (Further clarification unknown hence captured as Unspecified medications). Can I take that for my headache and my discomfort today, I have got achy bones. .Consumer further stated Okay, Alright. I just, okay. I can be alright. I am like discomfort right now but anyways. Okay. I will let it go with that and hopefully I just go and take one if she can help." (Further not clarified). But they are closed right now, they are closed. If it is there. I will calling the pharmacist who gave me the shot before that I am thrilled, anyways thank you for trying. Will this be HT347 I mean that's something written over here.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive Covid; positive Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2020 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 09Jun2020 at 09:00 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "positive Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: I got Covid symptoms; (24Jun2022) Positive, notes: Got positive Covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient did not receive any other medication in 2 weeks. After taking Paxlovid. The patient recovered from Covid. And one week later, she got Covid symptoms and got positive Covid again. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure  is : expected. The case will be reassessed further upon receipt of additional information.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 49-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "OCD (Obsessive-compulsive disorder)" (unspecified if ongoing); "high triglycerides" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient had no known allergies. Concomitant medications included: ATORVASTATIN, start date: 31May2022, stop date: 24Jun2022; FLOMAX [TAMSULOSIN HYDROCHLORIDE], start date: 31May2022, stop date: 24Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 for which included Pfizer PF-07321332, ritonavir (PAXLOVID) from 25Jun2022 to 26Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: this vaccine was administered to a 3-year old; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 3-year-old female patient received BNT162b2 (BNT162B2), on 22Jun2022 as dose 1, 0.2 ml single (Lot number: FL8095, Expiration Date: 31Aug2022) at the age of 3 years intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (medically significant) with onset 22Jun2022, described as "this vaccine was administered to a 3-year old".  Additional information: She mentioned that this vaccine was administered to a 3-year-old. She wants to know what they should do or should they wait longer before giving another dose. Agent has a pharmacist on hold, who reports that there was an administration error with the Covid-19 vaccine, orange cap. It was administered to a 3-year-old.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 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: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: KESIMPTA, start date: 30Apr2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative on antigen test; Unknown results, notes: Indication=Treatment of COVID-19; Positive, notes: tested positive through day 13. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The antiviral drug paxlovid was started on 13Jun2022 for the treatment of COVID-19 and stop on 17Jun2022. Paxlovid Rebound. Felt fine and tested negative on antigen test on days 6 - 9 from original positive test. Have felt mildly ill and tested positive through day 13 and showing no signs of letting up. The patient was on a B cell depleting drug - Kesimpta. The patient has no Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 at 16:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 65 years, in left arm, on 07Oct2021 at 16:30 as dose 3 (booster), single (Lot number: FF2588), in left arm, on 05Apr2021 at 11:30 as dose 2, single (Lot number: EP7533), in left arm, on 15Mar2021 at 11:30 as dose 1, single (Lot number: EN6208), in left arm and (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lobster" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Acetaminophen; Guaifenesin.   The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle disorder
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 at 16:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 65 years, in left arm, on 07Oct2021 at 16:30 as dose 3 (booster), single (Lot number: FF2588), in left arm, on 05Apr2021 at 11:30 as dose 2, single (Lot number: EP7533), in left arm, on 15Mar2021 at 11:30 as dose 1, single (Lot number: EN6208), in left arm and (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lobster" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Acetaminophen; Guaifenesin.   The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: her son is already 2 years old and they were exposed to someone who had the Covid 19 virus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the parent.  A 2-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 2 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "her son is already 2 years old and they were exposed to someone who had the Covid 19 virus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 02Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 03Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 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), outcome "unknown", 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: (unspecified date) Unknown Results; (15Jun2022) positive, notes: Symptoms reoccurred ten days after testing positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2021 as dose 3 (booster), single (Lot number: Fe3592), in left arm and on 30Mar2022 as dose 4 (booster), single (Lot number: Flc9895) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pre diabetic" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Hypersensitivity" (unspecified if ongoing); "pneumonitis" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: now positive AGAIN covid home rapid test checked twice; Positive, notes: now positive AGAIN. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Symptoms started again 27Jun2022 sore throat nasal drainage with a now positive again covid home rapid test checked twice. Adverse event start date & start time reported as  26Jun2022 04:00 AM. No AE treatment and no known allergies .; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 at 16:45 as dose 4 (booster), single (Lot number: FK9893) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 07Feb2021 as dose 1, single (Lot number: 011M20A), in right arm, on 09Mar2021 as dose 2, single (Lot number: 001B21A), in right arm and on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
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 67-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6202), in right arm and on 28Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Mar2022 as dose 4 (booster), single (Lot number: 065K21A7147), in left arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "chronic sinusitis" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Positive, notes: I tested positive again; (24Jun2022) negative, notes: I first tested negative on 24Jun and symptoms were gone; (26Jun2022) Positive, notes: on 26Jun I tested positive again; (27Jun2022) Positive, notes: I tested positive again on 27Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: No Known allergies were reported.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: Covid rebound after Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.