chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, SARS-CoV-2 antibody test, Serum ferritin, Sleep disorder
Clinical narrative: Within 4-5 hours post-IM he developed severe upper posterior torso muscle aches/pains that were worse with movement.  Pain initially was about 5/10 (0=nothing/10=worst), increased to 9/10 by 9am the following morning, interfering with sleep entire interval.  Several hours later pain diminished to about 6-7/10.   IV EGCG and Methylprednisolone treatment initiated ~3pm, which will take a few hours to see notable response.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Vitamin D
Clinical narrative: Within 4-5 hours post-IM he developed severe upper posterior torso muscle aches/pains that were worse with movement.  Pain initially was about 5/10 (0=nothing/10=worst), increased to 9/10 by 9am the following morning, interfering with sleep entire interval.  Several hours later pain diminished to about 6-7/10.   IV EGCG and Methylprednisolone treatment initiated ~3pm, which will take a few hours to see notable response.
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient has had right arm pain for the 6 weeks post-vaccine. Cannot raise arm above a certain level without pain
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: no reactions, symptoms.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was given higher dose that appropriate for age group
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: shoulder is painful; shoulder is painful/cannot use it except maybe like 20 or 30 percent of the power of his hand; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 75-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), in Jun2023 as dose number unknown, single (lot number unknown) for immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing). Concomitant medications included: METFORMIN oral taken for diabetes mellitus; METOPROLOL; ATORVASTATIN; AMLODIPINE. The following information was reported: ARTHRALGIA (non-serious) with onset Jun2023, outcome "not recovered", described as "shoulder is painful"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset Jun2023, outcome "not recovered", described as "shoulder is painful/cannot use it except maybe like 20 or 30 percent of the power of his hand". The events "shoulder is painful" and "shoulder is painful/cannot use it except maybe like 20 or 30 percent of the power of his hand" required physician office visit. Therapeutic measures were not taken as a result of arthralgia, joint range of motion decreased.  Additional Information: The patient informed that 4 months ago, a nurse gave him a shot for pneumonia, it's Prevnar 20 which is made by Pfizer. Since that time from that day till now his shoulder is painful, he cannot use it except maybe like 20 or 30 percent of the power of his hand. He does not know what's going on. The doctor did not give him an answer, so he called a pharmacy "that makes the vaccination" and maybe they have an idea what's going on. The patient stated that it's painful until today and every day; maybe tomorrow it will get better, but nothing gets better and it's 4 months now. It's not getting better. He wanted to know exactly what the problem was. He asked for help and asked if the same problem was identified with other people. The patient did not know the lot, expiry, UPC and NDC as the nurse gave him the shot and she went home so she did not give him anything to keep. The patient had lab work done earlier than 4 weeks. The patient was still experiencing the event and stated, "It's persisting maybe getting worse." There was no treatment. He was given a slip to get an X-ray. The patient informed that he talked to a lawyer about the situation, and he was told that they are not sure of anything. The patient needs an MRI, so he is going to take an MRI to see what is going on. The patient added that he had been taking vaccination all his life and he has never had any problem, except this time.  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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=JnJ; vaccine dose number=2 and vaccine brand=Pfizer / BioNTech; vaccine dose number unknown=true; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 25May2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 03Nov2021 as dose 2 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25May2022, outcome "unknown", described as "vaccine brand other=JnJ; vaccine dose number=2 and vaccine brand=Pfizer / BioNTech; vaccine dose number unknown=true"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 04Oct2023 to 08Oct2023.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300330249 same patient, different drug/AE;US-PFIZER INC-202300329734 Same patient/product, different dose/events;
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Familial hyperlipidemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: ZOLPIDEM; CLONAZEPAM; ATENOLOL; REPATHA. Vaccination history included: janssen covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE ), administration date: 17Mar2021, when the patient was 52-year-old, for COVID-19 immunisation; bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE ), administration date: 18Jan2022, when the patient was 53-year-old, for COVID-19 immunisation; bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE ), administration date: 27May2022, when the patient was 54-year-old, for COVID-19 immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE ), administration date: 25Sep2022, when the patient was 54-year-old, for COVID-19 immunisation; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE ), administration date: Jul2022, when the patient was 54 years old, for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE ), administration date: Jun2023, when the patient was 55 years old, for covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with nirmatrelvir; ritonavir (PAXLOVID) from 02Oct2023 to 06Oct2023.   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-202300330644 Same patient and product, Different dose and events (LOE);
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, Interchange of vaccine products, Investigation
Clinical narrative: covid symptoms 10Oct2023/Pfizer Covid Vaccine- Tested positive for covid again; Drug ineffective/Pfizer Covid Vaccine- Tested positive for covid; COVID-19/Pfizer Covid Vaccine- Tested positive for covid; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient received bnt162b2 (BNT162B2), on 01Jul2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 66 years intramuscular, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Jan2021 as dose 1, single (Batch/Lot number: unknown), on 03Feb2021 as dose 2, single (Lot number: 032L20H) and on 10Nov2021 as dose 3 (booster), single (Lot number: 022C21A) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (ongoing); "asthma", start date: Aug2022 (ongoing), notes: controlled asthma rarely need any medical intervention for this; "smoked" (unspecified if ongoing), notes: Many years ago, she smoked for 4 years when she was in early 20s. Concomitant medication(s) included: CALCIUM; ROSUVASTATIN taken for blood cholesterol increased; TYLENOL; VITAMIN C [ASCORBIC ACID]; VITAMINS NOS. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Jul2022, outcome "unknown"; COVID-19 (medically significant) with onset Aug2022, outcome "recovered", described as "COVID-19/Pfizer Covid Vaccine- Tested positive for covid"; DRUG INEFFECTIVE (medically significant) with onset Aug2022, outcome "recovered", described as "Drug ineffective/Pfizer Covid Vaccine- Tested positive for covid"; DISEASE RECURRENCE (medically significant) with onset 10Oct2023, outcome "unknown", described as "covid symptoms 10Oct2023/Pfizer Covid Vaccine- Tested positive for covid again". The patient underwent the following laboratory tests and procedures: oxygen: (unspecified date) 93-95 %; SARS-CoV-2 test: (Jan2021) Positive; (Aug2022) Positive; (10Oct2023) Positive. Therapeutic measures were taken as a result of disease recurrence. Clinical course: Patient received Paxlovid treatment from 11Oct2023 to 12Oct2023.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness, COVID-19 and disease recurrence cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300330660 same patient, different drug/events;
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: covid symptoms 10Oct2023/Pfizer Covid Vaccine- Tested positive for covid again; Drug ineffective/Pfizer Covid Vaccine- Tested positive for covid; COVID-19/Pfizer Covid Vaccine- Tested positive for covid; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient received bnt162b2 (BNT162B2), on 01Jul2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 66 years intramuscular, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Jan2021 as dose 1, single (Batch/Lot number: unknown), on 03Feb2021 as dose 2, single (Lot number: 032L20H) and on 10Nov2021 as dose 3 (booster), single (Lot number: 022C21A) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (ongoing); "asthma", start date: Aug2022 (ongoing), notes: controlled asthma rarely need any medical intervention for this; "smoked" (unspecified if ongoing), notes: Many years ago, she smoked for 4 years when she was in early 20s. Concomitant medication(s) included: CALCIUM; ROSUVASTATIN taken for blood cholesterol increased; TYLENOL; VITAMIN C [ASCORBIC ACID]; VITAMINS NOS. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Jul2022, outcome "unknown"; COVID-19 (medically significant) with onset Aug2022, outcome "recovered", described as "COVID-19/Pfizer Covid Vaccine- Tested positive for covid"; DRUG INEFFECTIVE (medically significant) with onset Aug2022, outcome "recovered", described as "Drug ineffective/Pfizer Covid Vaccine- Tested positive for covid"; DISEASE RECURRENCE (medically significant) with onset 10Oct2023, outcome "unknown", described as "covid symptoms 10Oct2023/Pfizer Covid Vaccine- Tested positive for covid again". The patient underwent the following laboratory tests and procedures: oxygen: (unspecified date) 93-95 %; SARS-CoV-2 test: (Jan2021) Positive; (Aug2022) Positive; (10Oct2023) Positive. Therapeutic measures were taken as a result of disease recurrence. Clinical course: Patient received Paxlovid treatment from 11Oct2023 to 12Oct2023.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness, COVID-19 and disease recurrence cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300330660 same patient, different drug/events;
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 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: HEADACHE (non-serious), outcome "unknown". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 1, single (Lot number: GH9697) at the age of 37 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 04Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Oct2023) Positive; (12Oct2023) Negative; (14Oct2023) Negative; (15Oct2023) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: No known allergies. Patient tested positive on Wednesday evening 04Oct2023, visited telemedicine doctor immediately and was prescribed Paxlovid. Began 5 day course evening 04Oct2023, ending Monday morning 09Oct2023. Treatment helped, symptoms improved steadily, eventually testing negative on Thursday 12Oct2023 and again on Saturday 14Oct2023. Symptoms began returning morning Sunday 15Oct2023 and test came back positive. Currently, symptoms are not severe and include runny nose and cough. Patient received COVID 19 Antiviral treatment orally with Paxlovid from 04Oct2023 to 09Oct2023.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Moderna spikevaxDose number 4; Felt chills, mild fever, extreme fatigue and tested positive for covid; Felt chills, mild fever, extreme fatigue and tested positive for covid; 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 69-year-old male patient received bnt162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6200), on 23Mar2021 as dose 2, single (Lot number: EP7534) and on 31Mar2022 as dose 3 (booster), single (Lot number: FF2587) at the age of 68 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Sep2023 at 11:30 as dose 4 (booster), single (Lot number: 3030342), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "BPH" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "Long covid", start date: 2022 (unspecified if ongoing), notes: with figure and brain fog; "Brain fog", start date: 2022 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Felt chills, mild fever, extreme fatigue and tested positive for covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2023 at 11:30, outcome "not recovered", described as "Moderna spikevaxDose number 4". 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 with Paxlovid from 05Oct2023 to 10Oct2023. Clinical Course: Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331257 same patient, different drug, different event;
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain fog, Post-acute COVID-19 syndrome
Clinical narrative: Moderna spikevaxDose number 4; Felt chills, mild fever, extreme fatigue and tested positive for covid; Felt chills, mild fever, extreme fatigue and tested positive for covid; 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 69-year-old male patient received bnt162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6200), on 23Mar2021 as dose 2, single (Lot number: EP7534) and on 31Mar2022 as dose 3 (booster), single (Lot number: FF2587) at the age of 68 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Sep2023 at 11:30 as dose 4 (booster), single (Lot number: 3030342), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "BPH" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "Long covid", start date: 2022 (unspecified if ongoing), notes: with figure and brain fog; "Brain fog", start date: 2022 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Felt chills, mild fever, extreme fatigue and tested positive for covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2023 at 11:30, outcome "not recovered", described as "Moderna spikevaxDose number 4". 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 with Paxlovid from 05Oct2023 to 10Oct2023. Clinical Course: Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331257 same patient, different drug, different event;
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: diabetic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female 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. 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 nos (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetic". Clinical course: Reporter said that they got their Pfizer vaccine at (withheld), but they only had the Moderna for this year. So her mother and she were trying to find out where they can get the Pfizer vaccine this year, and they both had several vaccines. She mentioned her mother was diabetic, and she had sarcoidosis. They had several vaccines, their cards full front and back, because they both had the extra boosters, they wanted to continue with Pfizer and didn't want to get a different brand, and they wanted to stay consistent. Provided the website for vaccine appointments.  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-PV202300171511 Same reporter/product, different patient/event;
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Nasal congestion; Fatigue; a little bit of headache; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 50-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 17:15 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for influenza immunisation, on 03Oct2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: COVID-19 (non-serious) with onset 14Oct2023, outcome "not recovered"; FATIGUE (non-serious) with onset 14Oct2023, outcome "not recovered"; NASAL CONGESTION (non-serious) with onset 14Oct2023, outcome "not recovered"; HEADACHE (non-serious) with onset 14Oct2023, outcome "not recovered", described as "a little bit of headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller was a 74-year-old male patient. Consumer calling about himself and his wife. Transferring agent stated the caller stated his wife and he both received the Comirnaty 2023-2024 vaccine on Monday 09Oct2023 at about 05:15pm within minutes of each other. This report was for the caller's wife. On Saturday she started developing symptoms and tested positive for a home test on Saturday 14Oct2023 for COVID; she had not had anymore testing done since then and the caller just assumed she caught it from him. She not had a regular clinic test yet. Caller was not an HCP but does worked in the medical community and had a company that supplied surgical and emergency care products. The caller declined full report on his wife as she was not there to consent and stated he had no lots, expiry dates, NDC numbers for her Comirnaty vaccine or for her prior COVID vaccines and had no names of her prior COVID vaccines or dated administered to provide but she had similar vaccine dates as the caller does. The caller's wife had nasal congestion, fatigue and a little bit of headache but no fever and those symptoms are ongoing and just persisting and her symptoms did not seem to be getting 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331348 same reporter/drug, different patient/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, in Mar2021 as dose 2, single (Lot number: EX10175), in right arm, in Oct2021 as dose 3 (booster), single (Lot number: ER8730), in right arm and in Jul2022 as dose 4 (booster), single (Lot number: EN6198), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patent had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 05Oct2023 to 09Oct2023. Clinical course: Vaccine administration time was 10:00 AM for all suspect doses.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331711 same reporter/patient, different drug/AE;
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms for 7 days following 1st dose but not 2nd dose; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), 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: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptoms for 7 days following 1st dose but not 2nd dose".  Additional information: Patient also received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. Reportedly, it was unknown if patient had COVID prior to vaccination and it was also unknown if patient was tested post vaccination.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller got the Pfizer Covid 19 vaccine and 2 booster shots. Caller mentioned that she experienced small strokes after taking Paxlovid and could not speak; Caller got the Pfizer Covid 19 vaccine and 2 booster shots. Caller mentioned that she experienced small strokes after taking Paxlovid and could not speak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A 77-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller got the Pfizer Covid 19 vaccine and 2 booster shots. Caller mentioned that she experienced small strokes after taking Paxlovid and could not speak". 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.  Clinical course: The caller caller got the Pfizer Covid 19 vaccine and 2 booster shots. The caller mentioned that she experienced small strokes after taking Paxlovid and could not speak. The caller was calling about Paxlovid. She last took it back on 08Aug2022. She was 77 years old at the time. She experienced small strokes after taking Paxlovid. She was now 78 years old. She also said the virus wasn't the only monster. the drug Pfizer was calling people and naming them, it was hurting them. The patient had Pfizer Covid 19 vaccine and 2 booster last Nov2022 and got tested positive for covid. Caller mentioned that she got covid again and was prescribed for Paxlovid but when she took the pill she experience small stoke and could not speak. Created Manual AE form because after taking Paxlovid she experience small stoke and could not speak.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 22Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunization. The patient's relevant medical history included: "Unspecified/intermittent joint inflammation" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bacitracin, reaction(s): "Allergies"; Amoxicillin, reaction(s): "Allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 06Oct2023 and stopped on 11Oct2023.  Clinical course: It was reported that, patient experienced Paxlovid rebound. Two days after completed paxlovid, she started feeling sick again which developed into severe cold and flu like symptoms. Not received any treatment for these symptoms and was not recovered from symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye disorder, Illness
Clinical narrative: I became sick with it; problem in my eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 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: ILLNESS (non-serious) with onset Oct2023, outcome "unknown", described as "I became sick with it"; EYE DISORDER (non-serious) with onset Oct2023, outcome "unknown", described as "problem in my eyes". Therapeutic measures were taken as a result of eye disorder.  Additional information: Patient got a shot of vaccine, last not this past Friday, the Friday before patient became sick with it, patient figured it was just a reaction but patient's two friends got the same thing (no details and information available). So, patient's brother didn't get it and was told not to get it. Patient had some problem in eyes and had to use magnifying glass.  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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: aches; mild fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 10:15 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 16Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 17Oct2023 at 06:00, outcome "recovering", described as "aches"; PYREXIA (non-serious) with onset 17Oct2023 at 06:00, outcome "recovering", described as "mild fever". Therapeutic measures were not taken as a result of pain, pyrexia.  Addiitional information: Pfizer suspect drug dose number: 4. There was no covid prior vaccination, no covid tested post vaccination. There was no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Sep2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in left arm 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; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid treatment from 03Oct2023 to 07Oct2023.  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-202300331394 same reporter/patient, different product/AE;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 66-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 1, single (lot number HG4677) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "overweight" (unspecified if ongoing); "elevated blood pressure" (unspecified if ongoing); "allergies bee venom" (unspecified if ongoing). Concomitant medication included: ROSUVASTATIN, start date: 08Jun2022, stop date: 06Oct2023. Vaccination history included: Janssen covid-19 vaccine (dose 1 (primary immunization series), lot 180S01, left arm), administration date: 16Mar2021, when the patient was 63-year-old, for covid-19 immunisation; Moderna covid-19 vaccine (dose 2 (booster), lot 93990S, left arm), administration date: 01Nov2021, when the patient was 64-year-old, for covid-19 immunisation; Moderna covid-19 vaccine (dose 3 (booster), lot 001M21A, left arm), administration date: 13Apr2022, when the patient was 64-year-old, for covid-19 immunisation; Pfizer/Biontech covid-19 vaccine (dose 4 (booster), lot GH9694, left arm), administration date: 08Sep2022, when the patient was 65-year-old, for covid-19 immunisation; Pfizer/Biontech covid-19 vaccine (dose 5 (booster), lot GJ3268, left arm), administration date: 12May2023, when the patient was 65-year-old, for covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  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: COVID19
Symptoms: Infection
Clinical narrative: An infection. Three days later; 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)), on 09Oct2023 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 (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: INFECTION (non-serious) with onset Oct2023, 3 days after the suspect product(s) administration, outcome "unknown", described as "An infection. Three days later".  Additional information: Caller stated "Patient received 2324 Quadrivalent Booster on Monday, 09Oct. An infection. Three days later."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19/she started feeling bad and took a home covid test which came back positive; COVID-19/she started feeling bad and took a home covid test which came back positive; This is a spontaneous report received from a contactable reporter (consumer) from Medical Information Team. The reporter is the patient. A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (dose 1, lot number unknown), for covid-19 immunisation; Pfizer covid-19 vaccine (dose 2, lot number unknown), for covid-19 immunisation; Pfizer covid-19 vaccine (dose 3 (booster), lot number unknown), for covid-19 immunisation; Pfizer covid-19 vaccine (dose 4 (booster), lot number unknown), for covid-19 immunisation; Pfizer covid-19 vaccine (dose 5 (booster), lot number unknown), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Oct2023, outcome "not recovered" and all described as "COVID-19/she started feeling bad and took a home covid test which came back positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Oct2023) positive; (Oct2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient went on to say that Pfizer saved her life since she had 4 to 5 covid vaccinations, which she thinks were all Pfizer vaccines, but is not completely sure, and she then got the covid virus. She has recently returned from a trip where people on the ship were coughing, but she was wearing a mask. She got her most recent Pfizer covid 2023-2024 vaccine on Thursday (12Oct2023), then about 3 days later (14Oct2023) she started feeling bad and took a home covid test which came back positive. She took another home test and it was also positive. She was prescribed Paxlovid.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient had hives ever since the day after the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnoea syndrome" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM; FLEXERIL [CEFIXIME]. The following information was reported: URTICARIA (non-serious) with onset 09Oct2023 at 08:00, outcome "not recovered", described as "Patient had hives ever since the day after the shot". The event "patient had hives ever since the day after the shot" required physician office visit. Therapeutic measures were not taken as a result of urticaria.  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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure medication" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm".  Additional Information: Reporter states she got the booster shot and it has a different name from Pfizer, as it is called Comirnaty and the last 2 booster shots said just Pfizer and not this other new name. she always went with Pfizer for the Covid virus and never had any side effects. she just had a sore arm from the needle when being injected that goes away in 3 days, had this after all the injections. She states it is the same like when she gets the flu shot where she has a sore arm for a few days.  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-202300332935 Same reporter, patient, product, events and different dose;US-PFIZER INC-202300332933 Same reporter, patient, product, events and different dose;US-PFIZER INC-202300332934 Same reporter, patient, product, events and different dose;
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation delayed
Clinical narrative: Period late by 3 days with more intense cramps than usual; Period late by 3 days with more intense cramps than usual; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-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 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious), DYSMENORRHOEA (non-serious) all with onset Oct2023, outcome "unknown" and all described as "Period late by 3 days with more intense cramps than usual".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Exhaustion; 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 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 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 NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 17Oct2023, outcome "not recovered", described as "Exhaustion".  Additional information: Reporter stated he got Pfizer booster Covid shot yesterday (16Oct2023). Patient was having exhaustion on the day of report. Reporter wanted to know what 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.