chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Inappropriate schedule of product administration, Pyrexia, Vaccination site pain
Clinical narrative: He has a fever of 101° today, pain at the injection site and feels tired.; He has a fever of 101° today, pain at the injection site and feels tired.; He has a fever of 101° today, pain at the injection site and feels tired.; Patient took Moderna vaccine on 12SEP2023 and a dose on 8NOV2023, lot number 3030949.; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (He has a fever of 101° today, pain at the injection site and feels tired.), VACCINATION SITE PAIN (He has a fever of 101° today, pain at the injection site and feels tired.), FATIGUE (He has a fever of 101° today, pain at the injection site and feels tired.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Moderna vaccine on 12SEP2023 and a dose on 8NOV2023, lot number 3030949.) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030949) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 08-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Moderna vaccine on 12SEP2023 and a dose on 8NOV2023, lot number 3030949.). On an unknown date, the patient experienced PYREXIA (He has a fever of 101° today, pain at the injection site and feels tired.), VACCINATION SITE PAIN (He has a fever of 101° today, pain at the injection site and feels tired.) and FATIGUE (He has a fever of 101° today, pain at the injection site and feels tired.). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 700 milligram. At the time of the report, PYREXIA (He has a fever of 101° today, pain at the injection site and feels tired.), VACCINATION SITE PAIN (He has a fever of 101° today, pain at the injection site and feels tired.), FATIGUE (He has a fever of 101° today, pain at the injection site and feels tired.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Moderna vaccine on 12SEP2023 and a dose on 8NOV2023, lot number 3030949.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Fever of 101°.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  Patient gotten all the COVID-19 vaccines available to him including a Moderna vaccine on 12SEP2023 and a dose on 8NOV2023, lot number 3030949.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.
Age: 29.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Arthralgia
Clinical narrative: Pain in joints of hands, wrists, elbows, and knees bilaterally lasting 10 days so far; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in joints of hands, wrists, elbows, and knees bilaterally lasting 10 days so far) in a 29-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058856) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 30-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 02-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ARTHRALGIA (Pain in joints of hands, wrists, elbows, and knees bilaterally lasting 10 days so far). The patient was treated with PREDNISONE at a dose of 15 milligram once a day and MELOXICAM at a dose of 7.5 milligram twice a day. At the time of the report, ARTHRALGIA (Pain in joints of hands, wrists, elbows, and knees bilaterally lasting 10 days so far) had not resolved.            Concomitant medication was not reported. Patient had pain in joints of hands, wrists, elbows, and knees bilaterally lasting 10 days so far.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 12-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported. It was reported that patient received the vaccine on friday and 6 hours later experienced headache. She always feels like that after receiving a vaccine, so she didn´t worry about it. Then on sunday she felt achy, and with headaches, so she took a covid test which came out positive. She was feeling horrible. No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Caller states he had been fighting Covid for 2 years and 9 months now. He could not  get over Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Caller states he had been fighting Covid for 2 years and 9 months now. He could not  get over Covid) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In February 2021, the patient experienced COVID-19 (Caller states he had been fighting Covid for 2 years and 9 months now. He could not  get over Covid). At the time of the report, COVID-19 (Caller states he had been fighting Covid for 2 years and 9 months now. He could not  get over Covid) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that he had been fighting Covid for 2 years and 9 months now. He could not get over Covid. He received Moderna vaccines in the past. He had Covid right know but then explained that he actually had Covid before receiving his vaccinations. Not clear if caller had Covid also after the vaccination.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Injection site pain
Clinical narrative: The most recent one was slightly more intense; soreness at the injection site; fatigue; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (The most recent one was slightly more intense), INJECTION SITE PAIN (soreness at the injection site) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA. Past adverse reactions to the above products included No adverse event with INFLUENZA. Concurrent medical conditions included Chronic lung disease and Polyneuropathy.    In 2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (The most recent one was slightly more intense), INJECTION SITE PAIN (soreness at the injection site) and FATIGUE (fatigue). At the time of the report, CONDITION AGGRAVATED (The most recent one was slightly more intense), INJECTION SITE PAIN (soreness at the injection site) and FATIGUE (fatigue) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. Patient tolerated all shots well and has not gotten sick. Patient had a little bit of soreness at the injection site and fatigue with all of the doses. Events lasted about 1.5 days before resolving with each dose. The most recent one was slightly more intense, lasting 2 days. Patient had taken another 5 doses of the Moderna COVID-19 vaccine as on 24FEB2021 with lot number 006M20A, 26MAR2021with lot number 026A21A, 9NOV2021 with lot number 004F21N, 3JUN2022 with lot number 05A22A, 28NOV2022 with lot number 016H22A.   This case was linked to MOD-2023-749424, MOD-2023-749425, MOD-2023-749427.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient said 12 hours after Moderna shot in 2020 she got very itchy Even in throat and mouth; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Patient said 12 hours after Moderna shot in 2020 she got very itchy Even in throat and mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Heart disease, unspecified.    On 15-Jun-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2020, the patient experienced PRURITUS (Patient said 12 hours after Moderna shot in 2020 she got very itchy Even in throat and mouth). On 23-May-2020, PRURITUS (Patient said 12 hours after Moderna shot in 2020 she got very itchy Even in throat and mouth) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient said 12 hours after Moderna shot in2020 she got very itchy Even in throat and mouth. She never had a problem breathing. It subsided within 12 hours.  Treatment information was not provided.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue, No adverse event
Clinical narrative: When he was preparing Abrysvo vaccine about an hour ago, he inverted the plastic piece connected to the syringe. However, it got separated off from the syringe; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 09Nov2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group, Program ID.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), outcome "unknown", described as "When he was preparing Abrysvo vaccine about an hour ago, he inverted the plastic piece connected to the syringe. However, it got separated off from the syringe". Additional information: The pharmacist reported that when he was preparing Abrysvo vaccine, he inverted the plastic piece connected to the syringe. However, it got separated off from the syringe. So, he was asking if he could be refunded for this. The plastic piece connected to the syringe separated off and then he was not able to use the product anymore, so the vaccine spilled. He was asked if he tried to administer the same product, but he said that he used another vial, so no patient was involved. The vial little piece of plastic that attached to the vial, that you screw the thing into, popped off. It is a single dose.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Hyperaesthesia teeth, Toothache
Clinical narrative: tooth pain; tooth pain - sensitivity to hot and cold and pressure; 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 73-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTHACHE (non-serious), outcome "recovering", described as "tooth pain"; HYPERAESTHESIA TEETH (non-serious), outcome "recovering", described as "tooth pain - sensitivity to hot and cold and pressure". Additional information: Caller stated 2 weeks ago from tomorrow she received her RSV vaccine, Abrysvo. She had a reaction to it which was tooth pain - sensitivity to hot and cold and pressure. It is starting to resolve but next week she is supposed to get a Prevnar vaccine (she does not know which one) and she is concerned she may have the tooth pain again. She did not see anything about tooth pain with the Abrysvo but when she googled it she saw many people said the same thing about Pfizers covid vaccine giving them tooth pain and some rated it 8 out of 10.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: RSV, RVX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: experiencing swelling, redness and pain on the arm where she got the vaccine; experiencing swelling, redness and pain on the arm where she got the vaccine; experiencing swelling, redness and pain on the arm where she got the vaccine; 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 rsv vaccine prot.subunit pref 2v (ABRYSVO), on 31Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation; rsv vaccine (RSV VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 06Nov2023, outcome "unknown" and all described as "experiencing swelling, redness and pain on the arm where she got the vaccine". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pain.  Additional information: Caller got her dose of Abrysvo on 31Oct2023. On 06Nov2023, she started experiencing swelling, redness and pain on the arm where she got the vaccine. She mentioned she has a surgery next week, so she saw a nurse in a dermatologist and told her that it is in the same location of the muscle that starts with d where the vaccine is given. She wanted to know if this is related to the vaccine as she had none of this side effects when the vaccine was given, not even pain. Caller mentioned she was started in antibiotics just in case this was something related to getting staph infection during the shot. I am having surgery next week. If I knew this was a possible reaction, I would not be so worried because now I am worrying if it is unrelated but I cannot seem to find information from Pfizer on whether or not people can get a delayed reaction like this.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain
Clinical narrative: migraines got significantly worse/migraines to go loop crazy and the pain was a 7 to 8 out of 10; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "epilepsy" (unspecified if ongoing); "Migraine" (ongoing), notes: that never go away, they're usually at a 2 or 3 on a pain scale of 10. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious), outcome "not recovered", described as "migraines got significantly worse/migraines to go loop crazy and the pain was a 7 to 8 out of 10". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine. Additional information: after taking her second Pfizer Covid 19 vaccine in Apr2021, it caused her migraines to go loop crazy and the pain was a 7 to 8 out of 10.    The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient. A 68-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension controlled"; "hypothyroidism"; "Asthma"; "obesity"; "Sulfa drugs p allergy"; "Penicillin allergy". The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 3 (booster), single, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (primary immunization series completed, manufacturer unknown), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE(medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, including Paxlovid from 29Oct2023 to 03Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events vaccination failure, Covid 19 and suspect drug cannot be excluded completely
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Inappropriate schedule of product administration, Oral pain, Pain, Pain in extremity
Clinical narrative: horrific pain; pain in left leg, side, mouth, jaw; pain in left leg, side, mouth, jaw; pain in left leg, side, mouth, jaw; pain in left leg, side, mouth, jaw; pressure in head; 1 of your COVID booster shots occurring 21Nov2021; 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.  An 84-year-old female patient received bnt162b2 (BNT162B2), on 21Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 82 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 complete;  unknown manufacturer), for COVID-19 immunization.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "horrific pain"; PAIN IN JAW (non-serious), PAIN IN EXTREMITY (non-serious), PAIN (non-serious), ORAL PAIN (non-serious), outcome "unknown" and all described as "pain in left leg, side, mouth, jaw"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "pressure in head"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "1 of your COVID booster shots occurring 21Nov2021".  Clinical course: It was reported that patient requested some retribution for horrific pain and suffering and "run around" following 1 of the COVID booster shots occurring 21Nov2021. Patient reported that she received a government letter stating that she was too late, but patient didn't know. Pfizer sent forms from your (Safety Dept.) which patient documented, all 15+ pages of ER dates & findings, etc. Your forms were sent twice & documented twice, per Pfizer instructions. Nothing has helped, Pfizer never got back to me, (Clinic name withheld) and (Clinic name withheld) Clinics not studying side affects & my Primary Dr. has helped all she can. I'm now walking with a cane, have pain in left leg, side, mouth, jaw & pressure in head. Patient asked to be sent to a clinic doing research on COVID booster residuals, but have found no place, nobody accepting her request/doing such work. Patient mentioned she has been to ER several more times since filling out the forms.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: horrific pain; pain in left leg, side, mouth, jaw; pain in left leg, side, mouth, jaw; pain in left leg, side, mouth, jaw; pain in left leg, side, mouth, jaw; pressure in head; 1 of your COVID booster shots occurring 21Nov2021; 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.  An 84-year-old female patient received bnt162b2 (BNT162B2), on 21Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 82 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 complete;  unknown manufacturer), for COVID-19 immunization.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "horrific pain"; PAIN IN JAW (non-serious), PAIN IN EXTREMITY (non-serious), PAIN (non-serious), ORAL PAIN (non-serious), outcome "unknown" and all described as "pain in left leg, side, mouth, jaw"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "pressure in head"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "1 of your COVID booster shots occurring 21Nov2021".  Clinical course: It was reported that patient requested some retribution for horrific pain and suffering and "run around" following 1 of the COVID booster shots occurring 21Nov2021. Patient reported that she received a government letter stating that she was too late, but patient didn't know. Pfizer sent forms from your (Safety Dept.) which patient documented, all 15+ pages of ER dates & findings, etc. Your forms were sent twice & documented twice, per Pfizer instructions. Nothing has helped, Pfizer never got back to me, (Clinic name withheld) and (Clinic name withheld) Clinics not studying side affects & my Primary Dr. has helped all she can. I'm now walking with a cane, have pain in left leg, side, mouth, jaw & pressure in head. Patient asked to be sent to a clinic doing research on COVID booster residuals, but have found no place, nobody accepting her request/doing such work. Patient mentioned she has been to ER several more times since filling out the forms.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Heart rate, Heart rate increased, Lymphadenopathy
Clinical narrative: Joint inflammation; neck lymph nodes are enlarged; heart rate has been fast; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, 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: ARTHRITIS (non-serious), outcome "unknown", described as "Joint inflammation"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "neck lymph nodes are enlarged"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "heart rate has been fast". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Clarified had joint inflammation, like joints feel irritated as if has some sort of arthritis, seems to aggravate it, that's one thing. The other thing, which caller stated is probably already documented because when caller has mammogram as a female they ask if you have had a COVID vaccine within the last 6 months to let know, because sometimes lymph nodes will appear enlarged, and caller's neck lymph nodes are enlarged again, stated that is a common side effect. Felt important to mention that, but caller is looking at a form and sees the joint issue mentioned but doesn't seem lymph nodes mentioned, but caller stated that should be a well-known side effect, it is well known in radiology department, so that should be there. Caller does see fast heart rate listed, and stated caller's heart rate has been fast.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid 19 Treatment; Covid 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Sep2022. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim"; Macrobid, reaction(s): "known allergies: Macrobid"; Septra, reaction(s): "known allergies: Septra". Vaccination history included: bnt162b2, bnt162b2 omi ba.4-5 (Dose Number: 6, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 11Jul2023, when the patient was 72-year-old, for Covid-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Back pain, Influenza like illness, Myalgia
Clinical narrative: Intense back pain; muscle pain; more like a flu type achy pain; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 73-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 08Nov2023 as 0.5 ml, single (Lot number: HL9687, Expiration Date: Mar2025) at the age of 73 years intramuscular for immunisation; for immunisation. The patient's relevant medical history included: "Chronic respiratory disease" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; DULOXETINE; LEVOTHYROXINE; OMEPRAZOLE; PREMARIN; PRIMIDONE; SYMBICORT; TRAZODONE. The following information was reported: BACK PAIN (non-serious) with onset 08Nov2023, outcome "not recovered", described as "Intense back pain"; INFLUENZA LIKE ILLNESS (non-serious) with onset 08Nov2023, outcome "unknown", described as "more like a flu type achy pain"; MYALGIA (non-serious) with onset 08Nov2023, outcome "unknown", described as "muscle pain". Therapeutic measures were taken as a result of back pain, myalgia, influenza like illness. Additional information: patient called last night to state that about a half hour after the shot she started to experience back pain, midline, called this morning said that it was intense back pain. She said she have looked and saw about muscle pain, and the reporter said typically that's myalgia more like a flu type achy pain that you would see in the muscles, not a sharp pain in an area but she still said it happened after the shot. It's not something that she normally gets, and the reporter said that's not something that they would typically see, but the reporter can and will report it and let them know. The reporter thought that the treatment was just Tylenol.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: fatigue; Three patients have been seen in follow-up visits and have reported mild injection site pain; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An elderly patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Oct2023, outcome "unknown", described as "Three patients have been seen in follow-up visits and have reported mild injection site pain"; FATIGUE (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300362807 Same product and event, different patient;US-PFIZER INC-202300362808 Same product and event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Her arm hurts off and on since she received the vaccine/can pinpoint where the injection was given; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Her arm hurts off and on since she received the vaccine/can pinpoint where the injection was given". It was unknown if therapeutic measures were taken as a result of vaccination site pain.  Additional information: Her arm hurts off and on since she received the vaccine. She can pinpoint where the injection was given.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Migraine, Vertigo
Clinical narrative: Had an episode of almost like extreme vertigo; I could not stand and was using the wall to hold myself up; migraine that could not be controlled by medicine; I never have dizziness with my migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received bnt162b2 (BNT162B2), on 26Jan2021 as dose 2, single (Lot number: EL3248) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing), notes: Migraine. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (Starting with 05Jan2021. I have the Pfizer mRNA vaccine. The LOT# is EL0142. This was administered by the city of [withheld]. I think it was the state combination vaccine."), administration date: 05Jan2021, when the patient was 45-year-old, for Covid-19 immunization. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "Had an episode of almost like extreme vertigo"; DYSSTASIA (non-serious), outcome "unknown", described as "I could not stand and was using the wall to hold myself up"; MIGRAINE (non-serious), outcome "unknown", described as "migraine that could not be controlled by medicine; I never have dizziness with my migraine". Therapeutic measures were taken as a result of migraine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360561 Same product, patient, different AEs, different dose;
Age: 64.0
Sex: F
Vaccine: 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) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 64 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (03Nov2023 at 08:00) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) positive, notes: COVID 19 Treatment; (03Nov2023) Negative, notes: Tested negative no symptoms. Time: 08:00 AM. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Three patients have been seen in follow-up visits and have reported mild injection site pain; Fatigue; This is a spontaneous report received from contactable reporter(s) (Physician) from a Pfizer sales representative.  An elderly patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Oct2023, outcome "recovered"; VACCINATION SITE PAIN (non-serious) with onset Oct2023, outcome "recovered", described as "Three patients have been seen in follow-up visits and have reported mild injection site pain". Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Additional information: it was reported she had prescribed the RSV older adult vaccine to approximately 7 patients. Three patients have been seen in follow-up visits and have reported mild injection site pain and fatigue.  Adverse events start date was reported Oct2023, and the patients recovered. No treatment was received for the adverse events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300362628 Same product and event, different patient;
Age: 83.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history included: "gluten allergy" (unspecified if ongoing); "celiac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 01Jun2022, for Covid-19 Immunization; bnt162b2 nos (DOSE NUMBER UNKNOWN, SINGLE), administration date: 21Sep2022, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 30Oct2023 to 04Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300362775 same patient, different drug, different event;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had one and her arm hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 60-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "she had one and her arm hurt". Additional information: The caller is the mother of the patient. The caller was asked for the age of the patient at the time the pain began and asks when were the first shots, and states this occurred either for the first or 2nd year of the pandemic and that was when the pain in her arm began and it was in 2020 or 2021. She does not know when the patient's dose of the Pfizer covid vaccine was but she had one and her arm hurt for a while but that went away and then she got the 2nd one and had the pain in her arm and the migraine headache and it would not go away.  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-202300354214 same patient, different vaccine dose number/event;
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Vasculitis, Wagner's disease
Clinical narrative: vasculitis; Wagner disease; 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 59-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "She is a controlled diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: VASCULITIS (non-serious), outcome "unknown"; WAGNER'S DISEASE (non-serious), outcome "unknown", described as "Wagner disease". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated she was previously talking with a safety agent. Reporter was not provided a reportum. The Reporter stated she was diagnosed with vasculitis and Wagner disease. She was a controlled diabetic, stated her Hemoglobin A1c levels were on 5.9%. She was concerned that the vasculitis was caused by the Pfizer COVID-19 vaccine. She has had five doses of the Pfizer Biontech COVID-19 vaccine the last one was on 08Sep2022. Reporter stated that what she was experiencing was very painful. Asked if there was any information or clinical trials reporting vasculitis as a side effect of the Pfizer COVID-19 vaccine.  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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient developed moderate-Covid-19 48 hours after receiving the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An 80-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COVID-19 (non-serious) with onset 01Nov2023, outcome "unknown", described as "Patient developed moderate-Covid-19 48 hours after receiving the vaccine". The event "patient developed moderate-covid-19 48 hours after receiving the vaccine" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Patient did not received other vaccine in four weeks. No covid prior vaccination and covid was tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 31Oct2023 to 05Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300362883 Same patient, different product, different dose/event;
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 69-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. He would be 70 on Monday. The patient's relevant medical history included: "tongue swell" (unspecified if ongoing); "have trouble breathing" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer covid 19 vaccine (DOSE 1, SINGLE), administration date: Feb2021, for Covid-19 immunisation; Pfizer covid 19 vaccine (DOSE 2, SINGLE), administration date: 2021, for Covid-19 immunisation; Pfizer covid 19 vaccine (DOSE 3 (BOOSTER), SINGLE), administration date: 2021, for Covid-19 immunisation; Pfizer covid 19 vaccine (DOSE 4 (BOOSTER), SINGLE), administration date: 2022, for Covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Nov2023, outcome "not recovered" and all described as "positive for Covid". The event "positive for covid" required physician office visit. Clinical course: In Feb2021 the patient got their first shot and got 2 boosters in 2021, for a total of 3 doses in 2021. They got another dose in 2022. They just received a another booster on 24Oct2023. All Pfizer Covid-19 vaccines. The patient had some underlying conditions and had been isolating from anything outside. After they got the 5th booster on 30Oct2023 they went to concert went out without a mask on 30Oct2023. By Thursday 02Nov2023 the patient had a sore throat and was not feeling good. He had a sore throat, headache, and fatigue. The patient came up positive for covid. Friday (03Nov2023) the patient called their physician and he put in for Paxlovid. The patient did not take the Paxlovid because he read the instructions and reported that he had a reaction from a different medication previously a few years ago that made his tongue swell and have trouble breathing. Some of the side effects showed swollen mouth and breathing issues and he already had a sore throat. He did another test the next day and he was positive still. He couldn't go anywhere since he was still testing positive. He could start Paxlovid because he was beyond 5 days of the positive test.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.