chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: strong body aches; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 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: PAIN (non-serious) with onset 27Sep2023, outcome "recovered" (28Sep2023), described as "strong body aches". It was unknown if therapeutic measures were taken as a result of pain.  Additional information: It was unknown if the patient had any known allergies and other medical history. It was unknown if the patient received any other vaccine within four weeks. Prior vaccination, it was unknown if the patient had COVID-19 while post vaccination, it was unknown if patient was tested for COVID-19. Patient had strong body aches on the next day of vaccination that resolved the next day by around 15:00. Patient was not able to provide additional details about the administration or vaccination history and did not want to be contacted. Other information is not known.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Pyrexia
Clinical narrative: Temperature is now up to 103 degrees; This is a spontaneous report received from contactable reporter (Consumer (patient's husband)).  A 51-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose number unknown, single (Lot number: HG4680) at the age of 51 years intramuscular, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "cancer" (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Temperature is now up to 103 degrees". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: reporter clarified the expiration date as 28Aug2023 (unknown if expired vaccine was administered to the patient). Reporter stated there wass nothing specifically saying how much she (patient) got or anything like that. They have no idea because they did not tell them if they were getting one quarter milligram or anything like that. They did not write it down on their card. Reporter stated patient had some blood work done just two days ago.  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: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Influenza, Malaise
Clinical narrative: sick; tiredness; muscle pain; feeling unwell; headache; body aches; like flu; 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 34-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: PAIN (non-serious) with onset 30Sep2023, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 30Sep2023, outcome "recovering"; INFLUENZA (non-serious) with onset 30Sep2023, outcome "recovering", described as "like flu"; ILLNESS (non-serious), outcome "recovering", described as "sick"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; MALAISE (non-serious), outcome "unknown", described as "feeling unwell".  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: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: sick; tiredness; muscle pain; feeling unwell; headache; body aches; like flu; 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 34-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: PAIN (non-serious) with onset 30Sep2023, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 30Sep2023, outcome "recovering"; INFLUENZA (non-serious) with onset 30Sep2023, outcome "recovering", described as "like flu"; ILLNESS (non-serious), outcome "recovering", described as "sick"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; MALAISE (non-serious), outcome "unknown", described as "feeling unwell".  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: PNC20
Symptoms: Axillary pain, Lymphadenopathy, Malaise
Clinical narrative: I have a lymph node under my same armpit that I had the shot in; its sore under my arm pit; it's sore under my arm pit; I feel yucky all week; I haven't feel particularly well all week; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), 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 LYMPHADENOPATHY (non-serious), outcome "unknown", described as "I have a lymph node under my same armpit that I had the shot in; its sore under my arm pit"; AXILLARY PAIN (non-serious), outcome "unknown", described as "it's sore under my arm pit"; MALAISE (non-serious), outcome "unknown", described as "I feel yucky all week; I haven't feel particularly well all week".  Additional information: The patient stated, "I had the Prevnar 20 Vaccine on Tuesday and today I have a lymph node under my same armpit that I had the shot in and I didn't know is that was a reaction to the injection or something totally different?" Consumer stated, "I feel yucky all week not particular but I haven't feel particularly well all week put it in that way instead of yucky. The injection site is no longer sore, it's sore under my arm pit where the node is."  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: sweat all day; felt just really bad; just felt unwell; Headache; Diarrhea; Muscle pain; Chills; have been pretty tired too and do have fatigue, lack of energy; Fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Lot number: HH7595) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Manufacturer Unknown), for covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 30Sep2023, outcome "unknown"; DIARRHOEA (non-serious) with onset 30Sep2023, outcome "unknown", described as "Diarrhea"; PYREXIA (non-serious) with onset 30Sep2023, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset 30Sep2023, outcome "unknown"; MYALGIA (non-serious) with onset 30Sep2023, outcome "unknown", described as "Muscle pain"; FEELING ABNORMAL (non-serious) with onset 30Sep2023, outcome "unknown", described as "felt just really bad"; FATIGUE (non-serious) with onset 30Sep2023, outcome "unknown", described as "have been pretty tired too and do have fatigue, lack of energy"; MALAISE (non-serious) with onset 30Sep2023, outcome "unknown", described as "just felt unwell"; HYPERHIDROSIS (non-serious) with onset 30Sep2023, outcome "unknown", described as "sweat all day". Relevant laboratory tests and procedures are available in the appropriate section. Clinical course details: The patient that the patient received the updated booster Pfizer Covid vaccine on 18Sep2023 and was going really well. The patient didn't have any issues until this morning when the patient was sweating and felt just really bad. The patient also had headache, diarrhea and muscle pain, then it is when the patient finally got chills. The patient basically sweat all day and was in the rest room between the restroom then on the bed all day. The patient have been pretty tired too and do have fatigue, lack of energy. The patient also had fever. The patient inquired if is it normal for the symptoms to come almost two weeks after the injection of the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Malaise, Myalgia, Pyrexia
Clinical narrative: sweat all day; felt just really bad; just felt unwell; Headache; Diarrhea; Muscle pain; Chills; have been pretty tired too and do have fatigue, lack of energy; Fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Lot number: HH7595) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Manufacturer Unknown), for covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 30Sep2023, outcome "unknown"; DIARRHOEA (non-serious) with onset 30Sep2023, outcome "unknown", described as "Diarrhea"; PYREXIA (non-serious) with onset 30Sep2023, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset 30Sep2023, outcome "unknown"; MYALGIA (non-serious) with onset 30Sep2023, outcome "unknown", described as "Muscle pain"; FEELING ABNORMAL (non-serious) with onset 30Sep2023, outcome "unknown", described as "felt just really bad"; FATIGUE (non-serious) with onset 30Sep2023, outcome "unknown", described as "have been pretty tired too and do have fatigue, lack of energy"; MALAISE (non-serious) with onset 30Sep2023, outcome "unknown", described as "just felt unwell"; HYPERHIDROSIS (non-serious) with onset 30Sep2023, outcome "unknown", described as "sweat all day". Relevant laboratory tests and procedures are available in the appropriate section. Clinical course details: The patient that the patient received the updated booster Pfizer Covid vaccine on 18Sep2023 and was going really well. The patient didn't have any issues until this morning when the patient was sweating and felt just really bad. The patient also had headache, diarrhea and muscle pain, then it is when the patient finally got chills. The patient basically sweat all day and was in the rest room between the restroom then on the bed all day. The patient have been pretty tired too and do have fatigue, lack of energy. The patient also had fever. The patient inquired if is it normal for the symptoms to come almost two weeks after the injection of the vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: arms are still really sore on day four; Redness, swelling, itching at the injection site; Redness, swelling, itching at the injection site; Redness, swelling, itching at the injection site; severe muscle aches; chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 10:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "allergies; Lisinopril". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer unknown), for covid-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 27Sep2023 at 16:00, outcome "recovering" and all described as "Redness, swelling, itching at the injection site"; PAIN IN EXTREMITY (non-serious) with onset 27Sep2023 at 16:00, outcome "not recovered", described as "arms are still really sore on day four"; CHILLS (non-serious) with onset 27Sep2023 at 16:00, outcome "recovering", described as "chills "; MYALGIA (non-serious) with onset 27Sep2023 at 16:00, outcome "recovering", described as "severe muscle aches ". Therapeutic measures were not taken as a result of pain in extremity, vaccination site erythema, vaccination site swelling, vaccination site pruritus, myalgia, chills.  Additional information: Facility type vaccine: Pharmacy or Drug Store. The patient had no other vaccine in four weeks and no other medication in two weeks No. The patient reported that this is the worse reaction of the five shots she had. Redness, swelling, itching at the injection site, severe muscle aches and chills and her arms are still really sore on day four.  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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: arms are still really sore on day four; Redness, swelling, itching at the injection site; Redness, swelling, itching at the injection site; Redness, swelling, itching at the injection site; severe muscle aches; chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 10:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "allergies; Lisinopril". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer unknown), for covid-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 27Sep2023 at 16:00, outcome "recovering" and all described as "Redness, swelling, itching at the injection site"; PAIN IN EXTREMITY (non-serious) with onset 27Sep2023 at 16:00, outcome "not recovered", described as "arms are still really sore on day four"; CHILLS (non-serious) with onset 27Sep2023 at 16:00, outcome "recovering", described as "chills "; MYALGIA (non-serious) with onset 27Sep2023 at 16:00, outcome "recovering", described as "severe muscle aches ". Therapeutic measures were not taken as a result of pain in extremity, vaccination site erythema, vaccination site swelling, vaccination site pruritus, myalgia, chills.  Additional information: Facility type vaccine: Pharmacy or Drug Store. The patient had no other vaccine in four weeks and no other medication in two weeks No. The patient reported that this is the worse reaction of the five shots she had. Redness, swelling, itching at the injection site, severe muscle aches and chills and her arms are still really sore on day four.  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: F
Vaccine: COVID19, FLUC3, COVID19, FLUC3, VARZOS
Symptoms: Interchange of vaccine products, Pain, Urticaria
Clinical narrative: Other vaccine same date product: Pfizer; dose number: 3; Other vaccine same date product: Moderna; dose number: 4; Raised, hard, warm red welt about 2 inches in diameter. Painful when touched; Raised, hard, warm red welt about 2 inches in diameter. Painful when touched; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 12:30 as dose 6 (booster), single (Lot number: HD9876) intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 30Sep2023 as dose 1, single (Lot number: 944484), in right arm. The patient's relevant medical history included: "known allergies: Yes" (unspecified if ongoing), notes: Name of Drug as Reported: Yes, Reaction: Allergy. Concomitant medication(s) included: SHINGRIX, on 10Sep2023 as dose 1, single. Vaccination history included: Bnt162b2;bnt162b2 omi ba.4-5 (Proprietary medicinal product name: Pfizer, Dose: 05, Batch/lot number: GH9703, Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization; Moderna covid-19 vaccine (Proprietary medicinal product name: Moderna, Dose: 04, Batch/lot number: 066K21A   , Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization; Bnt162b2 (Proprietary medicinal product name: Pfizer, Dose: 03, Batch/lot number: FF8841, Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization; Bnt162b2 (Proprietary medicinal product name: Pfizer, Dose: 02, Batch/lot number: EW0102, Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization; Bnt162b2 (Proprietary medicinal product name: Pfizer, Dose: 01, Batch/lot number: EPP6955, Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious), PAIN (non-serious) all with onset 01Oct2023 at 10:00, outcome "recovering" and all described as "Raised, hard, warm red welt about 2 inches in diameter. Painful when touched"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Other vaccine same date product: Pfizer; dose number: 3; Other vaccine same date product: Moderna; dose number: 4". Therapeutic measures were not taken as a result of urticaria, pain.
Sex: F
Vaccine: COVID19, FLUC3, COVID19, FLUC3, VARZOS
Symptoms: Pain of skin, Urticaria
Clinical narrative: Other vaccine same date product: Pfizer; dose number: 3; Other vaccine same date product: Moderna; dose number: 4; Raised, hard, warm red welt about 2 inches in diameter. Painful when touched; Raised, hard, warm red welt about 2 inches in diameter. Painful when touched; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 12:30 as dose 6 (booster), single (Lot number: HD9876) intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 30Sep2023 as dose 1, single (Lot number: 944484), in right arm. The patient's relevant medical history included: "known allergies: Yes" (unspecified if ongoing), notes: Name of Drug as Reported: Yes, Reaction: Allergy. Concomitant medication(s) included: SHINGRIX, on 10Sep2023 as dose 1, single. Vaccination history included: Bnt162b2;bnt162b2 omi ba.4-5 (Proprietary medicinal product name: Pfizer, Dose: 05, Batch/lot number: GH9703, Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization; Moderna covid-19 vaccine (Proprietary medicinal product name: Moderna, Dose: 04, Batch/lot number: 066K21A   , Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization; Bnt162b2 (Proprietary medicinal product name: Pfizer, Dose: 03, Batch/lot number: FF8841, Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization; Bnt162b2 (Proprietary medicinal product name: Pfizer, Dose: 02, Batch/lot number: EW0102, Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization; Bnt162b2 (Proprietary medicinal product name: Pfizer, Dose: 01, Batch/lot number: EPP6955, Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious), PAIN (non-serious) all with onset 01Oct2023 at 10:00, outcome "recovering" and all described as "Raised, hard, warm red welt about 2 inches in diameter. Painful when touched"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Other vaccine same date product: Pfizer; dose number: 3; Other vaccine same date product: Moderna; dose number: 4". Therapeutic measures were not taken as a result of urticaria, pain.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Myalgia
Clinical narrative: muscle, joint pain; muscle, joint pain; weakness; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 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. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset Sep2023, outcome "not recovered" and all described as "muscle, joint pain"; ASTHENIA (non-serious) with onset Sep2023, outcome "not recovered", described as "weakness". Additional information: Patient was vaccinated with the Pfizer on Friday at 1:40 (as reported) and had reactions it was not very severe but it has been going on now since Friday and patient was wondering if it is normal and how will these reactions normally lasts. Patient stated, "I did not pain at all but you know muscle, joint pain and the general weakness and just weakness. Bad time, I get such a bad time because my nephew lives in (City name withheld) in (State name withheld) and I am not going to be able to go to (withheld) today so that is why and I appreciate your time and help and I just wanted to thank you for giving me that number and I will call tomorrow."   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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: Pfizer/ Dose 5: Pfizer/Dose 6: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EL1284), on 25Jan2021 as dose 2, single (Lot number: EL9262), on 08Oct2021 as dose 3 (booster), single (Lot number: FF2590) and on 03Apr2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05May2023 as dose 6 (booster), single (Lot number: AS7184B) for covid-19 immunisation. The patient's relevant medical history included: "Moderate Immunodeficiency Syndrome" (unspecified if ongoing); "known allergies/ allergy to Ceftin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05May2023, outcome "unknown", described as "Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: Pfizer/ Dose 5: Pfizer/Dose 6: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". 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. Clinical course: Patient received Paxlovid from  21Sep2023 to 25Sep2023 as Treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315889 same patient, different drug/event;
Age: 42.0
Sex: M
Vaccine: COVID19, 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 43-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 22Sep2023 to 27Sep2023.    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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315938 Same patient, different drug, different event;
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Fatigue, Pain in extremity
Clinical narrative: arm soreness; fatigue; back ache; upset stomach; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist). The reporter is the patient.  A 41-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "arm soreness"; FATIGUE (non-serious), outcome "recovering"; BACK PAIN (non-serious), outcome "recovering", described as "back ache"; ABDOMINAL DISCOMFORT (non-serious), outcome "recovering", described as "upset stomach". Therapeutic measures were not taken as a result of pain in extremity, fatigue, back pain, abdominal discomfort.  Additional Information: The patient have no other vaccine in four weeks. Unknown if patient had COVID prior vaccination and was not tested post vaccination.  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: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; 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 elderly male patient received bnt162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1, single), administration date: 19Jan2021, for COVID-19 immunization, reaction(s): "Atrial fibrillation"; bnt162b2 (Dose 2, single), administration date: 05Feb2021, for COVID-19 immunization, reaction(s): "Atrial fibrillation", "Inappropriate schedule of vaccine administered". The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown". Clinical course: Caller stated that he received 3 doses of the Pfizer BioNTech COVID-19 vaccines on 19Jan2021, 05Feb2021 and 06Oct2021 all from Pfizer. Caller mentioned that he had atrial fibrillation and would like to know if he could get another shot of the vaccine. Caller was over 75.  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-202300317384 Same patient/same product, different dose/event;US-PFIZER INC-202300317383 Same patient/same product, different dose/event;
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 at 15:30 as dose 5 (booster), single (Lot number: Gj5342) at the age of 76 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: COVID 19 Treatment. Therapeutic measures as Paxlovid were taken as a result of drug ineffective, covid-19 from 22Sep2023 to 26Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315968 Same reporter/patient, different drug, different event.;
Age: 39.0
Sex: M
Vaccine: COVID19, FLUC3
Symptoms: Chest pain
Clinical narrative: Pain in the chest, on the left side. For a few seconds, a few sensations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 14:45 as dose 1, single (Lot number: HO9835) at the age of 39 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Subclinical hypothyroidism" (unspecified if ongoing), notes: Over the last few years. I do not take any medications associated with it. Concomitant medication(s) included: B12 [CYANOCOBALAMIN]; D3. The following information was reported: CHEST PAIN (non-serious) with onset 29Sep2023 at 21:30, outcome "recovered" (Sep2023), described as "Pain in the chest, on the left side. For a few seconds, a few sensations". Therapeutic measures were not taken as a result of chest pain.  Additional information: Patient reported pain in the chest on the left side for a few seconds and a few sensations. It was unusual and unexpected. He had to stop other activities, sat on the sofa and waited till it went away and then he went to sleep. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. He had no known allergies.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: developed covid-19 virus in early Sep; developed covid-19 virus in early Sep; 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 83-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (2023) and all described as "developed covid-19 virus in early Sep". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: Treatment of Covid-19/ Caller had the covid virus in early Sep and took 5 days of therapy with Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller had the covid virus in early Sep and took 5 days of therapy with Paxlovid and now felt completely fine.  He wanted to know if it was okay to get the newly approved covid-19 vaccine given his past medical history. Caller stated that he previously had covid-19 initial series and "all boosters" with the Pfizer vaccine and recently developed covid-19 virus in early Sep.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness of the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness of the vaccine".  Additional Information: Caller is asking about the fall vaccine that just came out this afternoon, she had all the other vaccines before. She would like to know if she could take Tylenol before she takes the vaccine to eliminate the arm soreness. Created manual AE form as she gets soreness in her arm whenever getting the vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 4 (booster), single (Lot number: GH9697) at the age of 57 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 08Apr2022 as dose 3 (booster), single (Lot number: FP4554), 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 had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. The patient had rebound beginning with runny nose and mild sore throat on evening of Saturday, 30Sep2023 (was symptom-free the previous two days). Positive Binax antigen test on morning of Sunday, 01Oct2023 (this morning). Today, sore throat was gone, but runny nose persists, as does mild fatigue (a lot like a mild head cold). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 23Sep2023 to 27Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314846 Same reporter/patient, different drug/event;
Sex: U
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling at the injection site; Redness and swelling at the injection site; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  An elderly patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), 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 ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "recovered" and all described as "Redness and swelling at the injection site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling. Additional information: No Hospitalization Prolonged, No Treatment Received for Redness and swelling at the injection site. Serious was No. Seriousness criteria-Results in death was No; Seriousness criteria-Life threatening was No; Seriousness criteria-Caused/prolonged hospitalization was No; Seriousness criteria-Disabling/Incapacitating: No; Seriousness criteria-Congenital anomaly/birth defect: No.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Dry mouth, Insomnia
Clinical narrative: Insomnia; dry mouth sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 09:15 as dose 3 (booster), single (Lot number: HF9275) at the age of 42 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 26Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior to vaccination. 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. The following information was reported: INSOMNIA (non-serious) with onset 27Sep2023, outcome "not recovered"; DRY MOUTH (non-serious) with onset 27Sep2023, outcome "not recovered", described as "dry mouth sensation". Therapeutic measures were not taken as a result of insomnia, dry mouth.
Sex: M
Vaccine: UNK
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), in Sep2023 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: FATIGUE (non-serious) with onset 2023, outcome "not recovered". Additional information: Patient stated that he was wondering, he had Comirnaty 12 plus Covid 23-24 SDV two weeks ago. Has been two weeks and they still experience fatigue. Wanted to know is that normal. Was curious as to whether it is normal to be tired after two weeks for him. Wondering if other people were reporting fatigue after two weeks.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300316111 similar report from same reporter, different patients;
Sex: F
Vaccine: UNK
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: FATIGUE (non-serious), outcome "not recovered".  Additional information: Caller stated that he called about the Comirnaty 12 plus Covid 23-24 SDV. Is the Covid booster, a Pfizer product. Was wondering, his wife had Comirnaty 12 plus Covid 23-24 a week ago. His neighbors all had it. Has been two weeks and they still experience fatigue. Wanted to know is that normal. In casual conservation they talked to each other about it. Is curious as to whether it is normal to be tired after two weeks for him and probably a week for them. Wondering if other people were reporting fatigue after two weeks.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300316106 same report/drug/events, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: had a reaction to that one, I had hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), in Apr2022 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: URTICARIA (non-serious), outcome "unknown", described as "had a reaction to that one, I had hives".  Additional information: Caller already had the Pfizer Bivalent vaccine and wanted to know if the Pfizer booster contains Sucrose. Caller would like to know the function of TRIS and sucrose. Caller would also like to know if the new COVID-19 vaccine 2023-2024 and the previous formulations of the COVID-19 vaccine also contained TRIS-sucrose.  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, 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 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: ej11685), in right arm, on 12Jan2021 as dose 2, single (Lot number: ej1686), in left arm and on 19Aug2021 as dose 3 (booster), single (Lot number: fd8448) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "SLE Lupus" (unspecified if ongoing); "Afib" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Known allergies: some cheeses" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid treatment taken from 21Sep2023 to 25Sep2023. Very strong bitter metallic taste in mouth, feeling extremely weak, diarrhea multiple times, loss of appetite. On day 13 since start of symptoms, all COVID symptoms returned stronger than before.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315987 Same reporter/patient, different drug, different AE.;
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Interchange of vaccine products
Clinical narrative: All my shots had been Moderna, but now I had Pfizer; a little bit dizzy; 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 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose 1, Manufacturer: Moderna), for COVID-19 immunization; Moderna (Dose 2, Manufacturer: Moderna), for COVID-19 immunization; Moderna (Dose 3, Manufacturer: Moderna), for COVID-19 immunization; Moderna (Dose 4, Manufacturer: Moderna), for COVID-19 immunization; Moderna (Dose 5, Manufacturer: Moderna), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2023, outcome "unknown", described as "a little bit dizzy"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 29Sep2023, outcome "unknown", described as "All my shots had been Moderna, but now I had Pfizer". Additional information: The patient noticed a lot of dizziness and it's making patient's life worse.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.