chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Blood iron decreased, Blood test, Overdose, Product preparation error
Clinical narrative: Iron was little low; her daughters got 3 times the recommended dose/not diluted properly; her daughters got 3 times the recommended dose/not diluted properly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 4-year-old female patient received bnt162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), as dose 1, single (Lot number: HH3252, Expiration Date: Jul2024) intramuscular, in left leg for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose numner unknown. single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history included: "Hip dysplasia" (unspecified if ongoing). Concomitant medication(s) included: FLINTSTONES MULTIVITAMINS WITH IRON. The following information was reported: BLOOD IRON DECREASED (non-serious), outcome "unknown", described as "Iron was little low"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "her daughters got 3 times the recommended dose/not diluted properly". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter wanted to know the long term effect of the covid vaccine that was not diluted properly that was administered to her daughters. Reporter mother of 2 female children ages 1 and 4 1/2 years old, (injected a non-diluted Pfizer Covid Vaccine Yellow cap). She said that the nurse told her that her daughters got 3 times the recommended dose. She then said she had to end the call and requested for a call back. She had reported that her daughters got the Pfizer COVID vaccine, 2023-2024 formula, the 6 months to 4 years old. The daughter got dose. However, the nurse did not dilute the vaccine and so they were told that their daughters got 3 times the recommended dose. Reporter reported that she was unsure if patient' height was 37 inches or 39 inches, falls in the middle. Reporter stated she had multi-vitamin but she had the same one today and yesterday. It was Flintstones Gummies Complete Multivitamin. It was taken over the counter. She actually had blood done yesterday after the shot. Reporter stated both of her children had Hip Dysplasia and they had been treated with it and that was not relevant with COVID.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300325031 same reproter/drug/event, different patient;
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 14-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 17:00 as dose 1, single (Lot number: 4628) at the age of 14 years for covid-19 immunisation. The patient had no relevant medical history. 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, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 12Oct2023, outcome "recovering", described as "severe headache". Therapeutic measures were taken as a result of headache.  Additional information: No other vaccines received in four weeks of COVID-19 vaccination. Prior vaccination, patient doesn't have COVID-19. Post vaccination, patient was not tested for COVID-19. Patient was treated with Advil and Tylenol.
Sex: F
Vaccine: UNK, UNK
Symptoms: Chills, Feeling hot, Malaise, Nausea
Clinical narrative: Not feeling well; Feels hot; Getting nauseated; Kind of chilling; 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), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA IX VACCINE), on 11Oct2023 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: FEELING HOT (non-serious) with onset Oct2023, outcome "unknown", described as "Feels hot"; NAUSEA (non-serious) with onset Oct2023, outcome "unknown", described as "Getting nauseated"; CHILLS (non-serious) with onset Oct2023, outcome "unknown", described as "Kind of chilling"; MALAISE (non-serious) with onset Oct2023, outcome "unknown", described as "Not feeling well". Therapeutic measures were taken as a result of malaise, feeling hot, nausea, chills.  Additional Information: Reporter reported about grand daughter. They all had flu and COVID shot yesterday at morning about, around 11:30, 12 O' clock. Patient was not feeling well, she feels hot, she was getting nauseated, she was kind of chilling and reporter gave her two Tylenol and asked what was the reporter supposed to do.  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: Pruritus
Clinical narrative: itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "latex allergy" (unspecified if ongoing); "Shingrix reaction" (unspecified if ongoing), notes: She said she had Shingrix reaction. The patient took concomitant medications. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching". Therapeutic measures were taken as a result of pruritus. Additional information: A female patient called about the new Pfizer Covid vaccine Comirnaty 2023-2024 formula. She has latex allergy. She set aside the next 2 weeks to have her flu and Covid vaccines for the rest of the year. She'll go to her HCP or might get the Covid vaccine from local pharmacy. She said she had Shingrix reaction. Her allergist is a teaching immunologist. Her local health department and pharmacist weren't willing to give the original Covid vaccine to her before. So, her allergist wrote an allergy action plan for her, and advised her to take cetirizine, Pepcid (H1N1 blocker) and oral steroid. Having prescribed that cocktail allowed the pharmacist to feel secure to give the very first Covid vaccine. She said she only did have itching. She was monitored and allowed to get the next 3. She said she had total of 4 Pfizer Covid vaccines, she did not have any bad reaction to any. She said that the last one (Bivalent), she had nothing, no reaction at all. And so, she doesn't need to take steroid needlessly she said. She added that she doesn't intend to turn herself into a DM2 and so, she won't be taking the steroid, but just the other 2 medications. Also mentioned that her doctor died of Covid. She also asked if she can take the last one (Bivalent) if it's still available and if Pfizer now have Comirnaty listed as being safe for those who have latex allergy.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Investigation, Pyrexia
Clinical narrative: Chills; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diabetic. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; GLIPIZIDE taken for diabetes mellitus. The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia.  Additional Information: Reporter stated that she is the wife of the patient and stated, "He takes the Comirnaty vaccine. He is presenting chills, fever and the most concern is the chills".It was reported that Tylenol was taken as treatment for the adverse events.  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: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Balance disorder, Dizziness, Vaccination site pain, Vertigo
Clinical narrative: she is feeling dizziness; vertigo; she felt a little unsteady on her feet; soreness at the injection site; 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 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 11Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose: 01, Lot: EL0140, Expiry date: Unknown, Site: Right arm), administration date: 10Jan2021, when the patient was 68-year-old, for COVID-19 Immunization; bnt162b2 (Dose: 02, Lot: EL9265, Expiry: May2021, Site: Right arm), administration date: 29Jan2021, when the patient was 68-year-old, for COVID-19 Immunization; bnt162b2 (Dose: 03, Lot: FE3590, Expiry: 30Nov2021, SIte: Right arm), administration date: 12Oct2021, when the patient was 69-year-old, for COVID-19 Immunization; covid-19 vaccine moderna (Dose: 04), administration date: 23May2022, when the patient was 69-year-old, for COVID-19 Immunization; covid-19 vaccine moderna (Dose: 05), administration date: 26Oct2022, when the patient was 70-year-old, for COVID-19 Immunization; Flu shot (She gets 1 every year. She gets the senior dose after she turned 65. Has gotten vaccinated with flu shots ever since she was 21 year old.), for Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Oct2023, outcome "not recovered", described as "soreness at the injection site"; BALANCE DISORDER (non-serious) with onset 12Oct2023, outcome "unknown", described as "she felt a little unsteady on her feet"; DIZZINESS (non-serious) with onset 12Oct2023, outcome "not recovered", described as "she is feeling dizziness"; VERTIGO (non-serious) with onset 12Oct2023, outcome "not recovered". Additional information: If she moves her head rapidly it increases her vertigo symptoms. She has to move slowly. She noticed the dizziness and vertigo 17-18 hours after receiving the immunization (as reported). She woke up early in the morning and noticed that she felt a little unsteady on her feet. She received the vaccine about 1230 yesterday 11Oct2023. Her symptoms are a little worse than from when she first noticed it. She does have some soreness at the injection site that is mild and is typical like other vaccines. Noticed the soreness started within probably 5-6 hours of getting the injection.   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: 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) (Physician). The reporter is the patient.  A 57-year-old female patient received bnt162b2 (BNT162B2 NOS), on 03Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Oct2023, 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 drug ineffective, covid-19 (paxlovid).  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Bouts of Dizziness; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  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: DIZZINESS (non-serious), outcome "unknown", described as "Bouts of Dizziness". It was unknown if therapeutic measures were taken as a result of dizziness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Bilateral eyelid swelling staring 12 hours after vaccine and lasting about 30 hours.; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "known allergies: ACE inhibitors" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; HYDROCHLOROTHIAZIDE; ATORVASTATIN; VIT D [VITAMIN D NOS]. Past drug history included: Macrobid, reaction(s): "known allergies: macrobid"; Inapsine, reaction(s): "known allergies: inapsine". 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; Covid-19 vaccine (DOSE 5 (BOOSTER), Manufacturer Unknown), for Covid-19 immunization. The following information was reported: SWELLING OF EYELID (non-serious) with onset 03Oct2023 at 02:30, outcome "recovered" (04Oct2023 at 08:30), described as "Bilateral eyelid swelling staring 12 hours after vaccine and lasting about 30 hours.". The events "bilateral eyelid swelling staring 12 hours after vaccine and lasting about 30 hours." required physician office visit. Therapeutic measures were not taken as a result of swelling of eyelid.  Additional information: The patient did not have COVID prior to vaccination and was not COVID 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.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Got Covid after receiving Covid vaccines; Got Covid after receiving Covid vaccines; 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 75-year-old male patient received bnt162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 07Apr2021 as dose 2, single (Lot number: EN6201) and on 11Oct2021 as dose 3 (booster), single (Lot number: BO155EA/30155EA) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Vertigo cervical vertigo, positional vertigo" (unspecified if ongoing), notes: Vertigo cervical vertigo, positional vertigo; "venous chronic insufficiency" (unspecified if ongoing), notes: venous chronic insufficiency; "lesion in brainstem", start date: 2009 (unspecified if ongoing), notes: lesion in brainstem; "obese" (unspecified if ongoing); "migraines" (unspecified if ongoing); "anxiety" (unspecified if ongoing), notes: taking Soma, a muscle relaxer and Xanax for anxiety. Used since 1985, to manage stress migraines; "muscle relaxer", start date: 1985 (unspecified if ongoing), notes: taking Soma, a muscle relaxer and Xanax for anxiety. Used since 1985, to manage stress migraines; "back surgery" (unspecified if ongoing). Concomitant medication(s) included: SOMA CMPD taken for muscle relaxant therapy, start date: 1985; XANAX taken for anxiety, start date: 1985. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Got Covid after receiving Covid vaccines". Patient noted that he had sore throat and headache when he had Covid; he got Covid after receiving the Covid vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300327645 same patient/product, different dose number, different event;
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills
Clinical narrative: chilling; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA 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: CHILLS (non-serious), outcome "unknown", described as "chilling".  Additional information: Product: Comirnaty and/or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula), patient had the shot and the flu shot and the COVID shot and the flu shot and she's chilling and.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: UNK
Symptoms: Ear discomfort, Head discomfort
Clinical narrative: affected my head and my ears; affected my head and my ears; 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 patient (no qualifiers provided) 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: EAR DISCOMFORT (non-serious), HEAD DISCOMFORT (non-serious), outcome "unknown" and all described as "affected my head and my ears".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: HIV infection, HIV test
Clinical narrative: HIV disease/ HIV positive; 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 79-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: HIV INFECTION (medically significant), outcome "unknown", described as "HIV disease/ HIV positive". The patient underwent the following laboratory tests and procedures: HIV test: Positive. Patient also received COMIRNATY 2023-2024 formula on an unknown date. Clinical course: A 79-year-old male patient just had a COVID vaccine from a (Pharmacy name withheld), he had asked for a Pfizer vaccine which was what he had been provided from his previous 6 shots. He was HIV positive. After he got home, he realized that they had given him Comirnaty vaccine. He was asking if this was appropriate or should he had gotten something different? He had gone online and said there's lots of information he found like the 6 months to 11 years, and 12 years old etc. He said his previous Covid vaccines were also Pfizer's. Advised that for his age, Comirnaty 2023-2024 formula was really the appropriate formulation/dose for him. Also told him that the 6 months to 11 years was called Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) which was only authorized for emergency use while the Comirnaty 12 years and up was the approved one which was what he's given. Further explained to him that the study or the clinical trials they had for the Primary Series COMIRNATY included participants with confirmed stable human immunodeficiency virus (HIV) infection. And so, reassured him that he was given the appropriate formulation based on the information he's provided about himself. He understood and said he felt better.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) 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: PAIN (non-serious), outcome "unknown".  Additional information: Patient Age Not Provided: Non-phone report; not provided in correspondence/communication. Patient Gender: Non-phone report; not provided in correspondence/communication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Diplopia, Ophthalmological examination, Vision blurred, Visual impairment
Clinical narrative: double vision; Severe blurred vision; shadows in words when viewed or read; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 11:00 as dose 1, 0.3 ml single (Lot number: HD9876) at the age of 70 years, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 09Oct2023 as dose 1, 0.7 ml single (Lot number: FLUHD-UT809CA), in left arm for immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "History of Afib" (unspecified if ongoing). Concomitant medication(s) included: SYNJARDY; ELIQUIS; DILTIAZEM; ATORVASTATIN. The following information was reported: VISION BLURRED (non-serious) with onset 10Oct2023 at 10:00, outcome "not recovered", described as "Severe blurred vision"; DIPLOPIA (non-serious) with onset 10Oct2023 at 10:00, outcome "not recovered", described as "double vision"; VISUAL IMPAIRMENT (non-serious) with onset 10Oct2023 at 10:00, outcome "not recovered", described as "shadows in words when viewed or read". The events "double vision", "severe blurred vision" and "shadows in words when viewed or read" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diplopia, vision blurred, visual impairment.  Additional information: lot number also reported as C-HD9876. No covid prior vaccination and not covid tested post vaccination. No known allergies. Adverse events treatment thorough eye exam with a steroid prescription.
Age: 74.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Cognitive disorder, Confusional state, Headache, Incoherent, Nausea
Clinical narrative: Severe aches; Pain; Nausea; vomiting; headache; cognitive impairment/difficulties-not answering questions; confusion; not making sense, blank stare on my face; not making sense, blank stare on my face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Oct2023 at 16:45 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in right arm for immunisation; for immunisation; bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 16:45 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering"; PAIN (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering"; PAIN (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering", described as "Severe aches"; COGNITIVE DISORDER (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering", described as "cognitive impairment/difficulties-not answering questions"; CONFUSIONAL STATE (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering", described as "confusion"; HEADACHE (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering"; INCOHERENT (non-serious), STARING (non-serious) all with onset 11Oct2023 at 13:00, outcome "recovering" and all described as "not making sense, blank stare on my face"; VOMITING (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering". Therapeutic measures were not taken as a result of pain, pain, nausea, vomiting, headache, cognitive disorder, confusional state, incoherent, staring.  Additional information: Severe aches, pain, nausea, vomiting and headache were noted. This wss noted as starting at approximately 1 pm on 13Oct. The patients daughter noticed that she had cognitive impairment/difficulties. She was not answering questions, confusion, not making sense, blank stare on the face were noted.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v , bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Pain, Staring, Vomiting
Clinical narrative: Severe aches; Pain; Nausea; vomiting; headache; cognitive impairment/difficulties-not answering questions; confusion; not making sense, blank stare on my face; not making sense, blank stare on my face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Oct2023 at 16:45 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in right arm for immunisation; for immunisation; bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 16:45 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering"; PAIN (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering"; PAIN (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering", described as "Severe aches"; COGNITIVE DISORDER (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering", described as "cognitive impairment/difficulties-not answering questions"; CONFUSIONAL STATE (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering", described as "confusion"; HEADACHE (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering"; INCOHERENT (non-serious), STARING (non-serious) all with onset 11Oct2023 at 13:00, outcome "recovering" and all described as "not making sense, blank stare on my face"; VOMITING (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering". Therapeutic measures were not taken as a result of pain, pain, nausea, vomiting, headache, cognitive disorder, confusional state, incoherent, staring.  Additional information: Severe aches, pain, nausea, vomiting and headache were noted. This wss noted as starting at approximately 1 pm on 13Oct. The patients daughter noticed that she had cognitive impairment/difficulties. She was not answering questions, confusion, not making sense, blank stare on the face were noted.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v , bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Inflammation
Clinical narrative: started treatment with Pfizer BioNTech COVID-19 vaccine dose 1 on 13MAR2021, and dose 2 on 16AUG2021; chest inflammation; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001244 (Novavax).  A 64-year-old female patient received bnt162b2 (BNT162B2), on 16Aug2021 as dose 2, single (Lot number: 033H21A) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2, administration date: 13Mar2021, for Covid-19 immunization, reaction(s): "chest pain", "tachycardia", "myocarditis". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "started treatment with Pfizer BioNTech COVID-19 vaccine dose 1 on 13MAR2021, and dose 2 on 16AUG2021"; INFLAMMATION (non-serious), outcome "unknown", described as "chest inflammation"; CHILLS (non-serious), outcome "unknown".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300170002 same patient, different dose/event;
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site was sore/Vaccination site pain; injection site was red/Vaccination site erythema; swelling size of tennis ball at injection site/Vaccination site swelling; injection site was warm/vaccination site warmth; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 40-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 40 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Iodine" (unspecified if ongoing). Concomitant medication(s) included: PHENTERMINE; SPIRONOLACTONE. 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: VACCINATION SITE PAIN (non-serious) with onset 09Oct2023 at 13:15, outcome "recovered" (Oct2023), described as "Injection site was sore/Vaccination site pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset 09Oct2023 at 13:15, outcome "recovered" (Oct2023), described as "injection site was red/Vaccination site erythema"; VACCINATION SITE WARMTH (non-serious) with onset 09Oct2023 at 13:15, outcome "recovered" (Oct2023), described as "injection site was warm/vaccination site warmth"; VACCINATION SITE SWELLING (non-serious) with onset 09Oct2023 at 13:15, outcome "recovered" (Oct2023), described as "swelling size of tennis ball at injection site/Vaccination site swelling". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site swelling, vaccination site warmth.  Additional information: Did not had covid prior to vaccination. Did not tested positive with covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Aug2023 at 10:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Feb2021 at 12:00 as dose 1, single (Lot number: 042L20AA), in left arm, on 04Mar2021 at 12:00 as dose 2, single (Lot number: 032M20A), in left arm, on 14Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 939906), in left arm, on 03May2022 at 12:00 as dose 4 (booster), single (Lot number: 004m21a), in left arm and on 19Oct2022 at 12:00 as dose 5 (booster), single (Lot number: 049D22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Onion" (unspecified if ongoing). Concomitant medication(s) included: LYSINE, start date: 01Nov2022; FAMOTIDINE, start date: 01May2020; ESTROGEN vaginal, start date: 01Mar2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Aug2023 at 10:00, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment included Paxlovid (Treatment start date: 28Sep2023, Treatment stop date: 03Oct2023). Other medication in 2weeks included HEB (start date: 01May2020). No other medical history.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Musculoskeletal discomfort
Clinical narrative: (after re- start of therapy) pre-existing fatty liver disease worsened and worsened liver function labs; from kidneys down to tail bone, whole back seized up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 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: MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 12Oct2023, outcome "unknown", described as "from kidneys down to tail bone, whole back seized up"; INFLUENZA (non-serious), outcome "unknown", described as "(after re- start of therapy) pre-existing fatty liver disease worsened and worsened liver function labs".  Additional information: It was reported that the patient received shot on 11Oct2023 and on 12Oct2023, has got this from kidneys down to tail bone, whole back seized up (as reported), she also wondered if any side effects were caused by the Covid vaccine. It was clarified that patient if this Covid vaccine causes flu symptoms similar to this, the back being seized up from kidneys down to tail bone.   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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Very sore in arm/near injection; Very sore in arm/near injection; overall body aches; slight fatigue; slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 16:45 as dose 1, single (Lot number: HG4677) at the age of 46 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; OMEGA [CONVALLARIA MAJALIS;CRATAEGUS LAEVIGATA;PROXYPHYLLINE]; TURMERIC [CURCUMA LONGA RHIZOME]; B12-VITAMIIN; RETINOL; IVERMECTIN; RESTASIS; IUD NOS; COLLAGEN. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (Dose Number: 4, Batch/Lot No: GH9694, Location of injection: Arm Right), administration date: 03Oct2022, when the patient was 45-year-old, for Covid-19 Immunization, reaction(s): "Very sore in arm/near injection", "Very sore in arm/near injection", "overall body aches", "slight fatigue", "slight headache"; bnt162b2 (Dose Number: 3, Batch/Lot No: FH8028, Location of injection: Arm Right), administration date: 15Dec2021, when the patient was 44-year-old, for Covid-19 Immunization, reaction(s): "Very sore in arm/near injection", "Very sore in arm/near injection", "overall body aches", "slight fatigue", "slight headache"; bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 30Apr2021, when the patient was 44-year-old, for Covid-19 Immunization, reaction(s): "Very sore in arm/near injection", "Very sore in arm/near injection", "overall body aches", "slight fatigue", "slight headache"; bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 09Apr2021, when the patient was 44-year-old, for Covid-19 Immunization, reaction(s): "Very sore in arm/near injection", "Very sore in arm/near injection", "overall body aches", "slight fatigue", "slight headache". The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 12Oct2023 at 09:00, outcome "recovering" and all described as "Very sore in arm/near injection"; PAIN (non-serious) with onset 12Oct2023 at 09:00, outcome "recovering", described as "overall body aches"; FATIGUE (non-serious) with onset 12Oct2023 at 09:00, outcome "recovering", described as "slight fatigue"; HEADACHE (non-serious) with onset 12Oct2023 at 09:00, outcome "recovering", described as "slight headache". Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain, pain, fatigue, headache.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: vaccine did not work for her because she contracted COVID-19 3-4 weeks after being fully vaccinated; vaccine did not work for her because she contracted COVID-19 3-4 weeks after being fully vaccinated; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  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. 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "vaccine did not work for her because she contracted COVID-19 3-4 weeks after being fully vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: If covid tested post vaccination: Yes.  Clinical course: It was unknown if treatment was received. Patient did not had covid prior vaccination.  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
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Vaccination site inflammation
Clinical narrative: Red bump; Red bump; 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 patient (no qualifiers provided) 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 INFLAMMATION (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "Red bump".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: EW0217, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 13Oct2021, when the patient was 29-year-old, for COVID-19 immunization, reaction(s): "Low-grade fever", "Chills", "total body aches", "brain fog", "headache", "swollen/painful axillary left lymph node", "swollen/painful axillary left lymph node", "fatigue"; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Feb2021, when the patient was 29-year-old, for COVID-19 immunization; bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 29-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 12Oct2023 at 10:00, outcome "recovered"; PAIN (non-serious) with onset 12Oct2023 at 10:00, outcome "recovered", described as "body aches". Therapeutic measures were not taken as a result of chills, pain. Additional information: Chills and body aches approx 18 hrs after administration.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Disease Recurrence; Vaccination failure; COVID-19; 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 68-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 27May2021 as dose 1, single (Lot number: EW0178), on 17Jun2021 as dose 2, single (Lot number: EW0181), on 14Mar2022 as dose 3 (booster), single (Lot number: FK9895) and on 30Jul2022 as dose 4 (booster), single (Lot number: FM0173) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "breast cancer", start date: 2017 (unspecified if ongoing); "bladder cancer", start date: 2017 (unspecified if ongoing); "COVID-19 infection", start date: Feb2021 (unspecified if ongoing); "asthma" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing); "chemo therapy" (unspecified if ongoing); "issues with her memory" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE oral taken for rheumatoid arthritis (ongoing); FOLIC ACID oral taken for rheumatoid arthritis (ongoing); VITAMIN D3. The following information was reported: COVID-19 (medically significant) with onset Dec2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Dec2022, outcome "unknown"; DISEASE RECURRENCE (medically significant) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: She tested positive for covid in Dec2022; (2023) Positive, notes: She also tested positive for covid in Feb2023 or Mar2023. Clinical course: Patient reports she developed severe covid 19 infection for the first time in Feb2021 prior to receipt of any covid 19 vaccines; states almost died, it was bad. Then she developed covid 19 infection again in Dec2022 and then either Feb or Mar2023 while she was in rehab. States she was in a car accident and was in rehab 04Jan2023 to Mar2023. Stated she was immunocompromised. She was diagnosed with breast and bladder cancer in 2017 and had to had chemo therapy. Stated she also developed rheumatoid arthritis at that time as well (prior to any receipt of covid 19 vaccines). Stated she was currently taking Methotrexate (started taking a year before getting covid, the bad covid. Clarifies she thought she started taking in 2020 or the end of 2019). Reports she had asthma (timeline unclear); also comments that she had issues with her memory. She was asking if she could get another Pfizer covid vaccine at the end of Oct. She was hyperactive.  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-2021738674 same patient, different drug/event;