chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash after 1 week to 10 days after receiving the vaccine; Hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset May2022, outcome "not recovered", described as "Hives"; RASH (non-serious) with onset May2022, outcome "not recovered", described as "rash after 1 week to 10 days after receiving the vaccine". The events "rash after 1 week to 10 days after receiving the vaccine" and "hives" required physician office visit. Therapeutic measures were taken as a result of rash, urticaria. Additional information: the patient had the second regular booster dose, not the bivalent. After 1 week to 10 days after receiving the vaccine, she had rash. She wanted to know if there was more information on this case. She received the COVID-19 vaccine and had a severe delayed reaction from it, she stated that she was fine after the first three shots, it was after the first and second booster that she had this reaction. She clarified that she experienced the reaction after her second booster dose of the vaccine. She went to three dermatologists and they all agreed clinically that it was from the COVID vaccine. She did not know what to do at this point. Antihistamines were no longer working. Normally she can take antihistamines and it will go away, but in this instance, it did not go away at all. She stated that it was weird. This seemed different, it was bilateral, if she got the rash/hives on one side, it will be in the same spot on the other side simultaneously. She stated that sometimes it was rash and sometimes it was welts, which were hives. She had no prior vaccinations within four weeks. She had no medical history nor relevant tests.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Entire body began itching for hours; large red welts appeared on right foot and wrist area of both hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 at 16:00 as dose 4 (booster), single (Lot number: GJ3277) at the age of 80 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "Allergies" (unspecified if ongoing), notes: known allergies: Yes. The patient took concomitant medications. 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: PRURITUS (non-serious) with onset 29Oct2022 at 01:30, outcome "recovering", described as "Entire body began itching for hours"; URTICARIA (non-serious) with onset 29Oct2022 at 01:30, outcome "recovering", described as "large red welts appeared on right foot and wrist area of both hands". Therapeutic measures were not taken as a result of pruritus, urticaria. Additional information: Clinical course: Entire body began itching for hours, large red welts appeared on right foot and wrist area of both hands. Itching continued for 36 hours. The patient was not tested for covid post vaccination. Stated that she was healthy.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood test
Clinical narrative: Caused her blood sugars to go sky high; 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 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Covid-19 shots before; dose number unknown; manufacturer unknown), for Covid-19 immunisation. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Caused her blood sugars to go sky high". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Had her blood work done and doctor said she has no antibodies, so she got another shot today and caused her blood sugars to go sky high. She was asking if vaccine caused blood sugar to go up like that.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "after 5 covid Pfizer vaccines and my last vaccine was a bivalent, 2 months ago, and I'm covid positive now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, 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) (Pharmacist). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 include Paxlovid from 12Oct2022 to 16Oct2022, orally. Patient did not take other medication in 2 weeks. No Known allergies. The below information to Safety on 31Oct2022 with the first Pfizer Awareness Date of 15Oct2022. Since the information was reporting outside of the 24hour compliance period for AE reporting, agency is actioned to follow-up on the delayed report.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Nausea, Product use issue, Pyrexia, Somnolence
Clinical narrative: got the Pfizer vaccine and the flu shot (Unspecified Flu shot); she got the 2 vaccines; she woke up today felling sick to her stomach; she has been sleeping all day; She has a fever of 102; every time she get up to go to the bathroom she throws up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "got the Pfizer vaccine and the flu shot (Unspecified Flu shot); she got the 2 vaccines"; NAUSEA (non-serious), outcome "unknown", described as "she woke up today felling sick to her stomach"; SOMNOLENCE (non-serious), outcome "unknown", described as "she has been sleeping all day"; PYREXIA (non-serious), outcome "unknown", described as "She has a fever of 102"; VOMITING (non-serious), outcome "unknown", described as "every time she get up to go to the bathroom she throws up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Yesterday my daughter got the Pfizer vaccine and the flu shot (As name of vaccine could not be clarified hence captured as Unspecified Flu Shot) (withheld) at our pharmacy and she woke up today felling sick to her stomach and she has been sleeping all day. She has a fever of 102 and every time she get up to go to the bathroom she throws up. I just wanted to know if its normal or may be she had a virus yesterday we didn't know about before she got the two vaccines. When probed to clarify if patient got the Pfizer COVID-19 Vaccine and Flu Shot on the same day, Reporter stated, Yes.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vomiting
Clinical narrative: got the Pfizer vaccine and the flu shot (Unspecified Flu shot); she got the 2 vaccines; she woke up today felling sick to her stomach; she has been sleeping all day; She has a fever of 102; every time she get up to go to the bathroom she throws up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "got the Pfizer vaccine and the flu shot (Unspecified Flu shot); she got the 2 vaccines"; NAUSEA (non-serious), outcome "unknown", described as "she woke up today felling sick to her stomach"; SOMNOLENCE (non-serious), outcome "unknown", described as "she has been sleeping all day"; PYREXIA (non-serious), outcome "unknown", described as "She has a fever of 102"; VOMITING (non-serious), outcome "unknown", described as "every time she get up to go to the bathroom she throws up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Yesterday my daughter got the Pfizer vaccine and the flu shot (As name of vaccine could not be clarified hence captured as Unspecified Flu Shot) (withheld) at our pharmacy and she woke up today felling sick to her stomach and she has been sleeping all day. She has a fever of 102 and every time she get up to go to the bathroom she throws up. I just wanted to know if its normal or may be she had a virus yesterday we didn't know about before she got the two vaccines. When probed to clarify if patient got the Pfizer COVID-19 Vaccine and Flu Shot on the same day, Reporter stated, Yes.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Limb discomfort, Magnetic resonance imaging
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FE3592) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "after the first one, I started noticing just very sporadically some pulling in my right side". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It has been about 8 months ago and initially the patient felt good but after the first one, the patient started noticing just very sporadically some pulling in her right side and she didn't like relate it to the vaccine initially. Prior vaccinations within 4 weeks were reported as none.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dystonia, Electroencephalogram, Magnetic resonance imaging
Clinical narrative: Focal dystonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 2, single (Lot number: FE3590) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, Lot number: FE3592), for Covid-19 immunization, reaction(s): "very sporadically some pulling in the right side/ focal dystonia". The following information was reported: DYSTONIA (medically significant), outcome "unknown", described as "Focal dystonia". The clinical course was as follows: Patient had the vaccines. It has been about 8 months prior and initially, she felt good but after the first one, she started noticing just very sporadically some pulling in her right side. She didn't relate it to the vaccine initially and then she got the second dose and the pulling started to happen more and more significantly to the point where her entire right side, like she was having pulling in her arm. It was going down her leg and she was having muscle spasms in her right leg, in her right foot where she has actually been to a neurologist. She has gotten 2 MRIs, 2 EEGs. There was nothing there that would indicate why it would be happening. The neurologist basically was diagnosing her with focal dystonia. When she asked him if he think this could be from the vaccine, the neurologist answered he didn't know, as there is no way to know. Since the patient has been to him, the neurologist reached out to her multiple times and he said at least 6 other women, right around her age have been there to see him with identical symptoms, all on one side of their body and all blaming the vaccines. Initially when she first went to the doctor, the doctor thought she was having focal seizures. She did take something for a very short time because it didn't work. The medicine was oxcarbazepine (TRILEPTAL).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201269543 same patient/event, different dose number;
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 60 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jun2022 as dose 3 (booster), single (Lot number: GH9693), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PSEUDOEPHEDRINE, start date: 21Oct2022, stop date: 27Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness". It was unknown if therapeutic measures were taken as a result of pain in extremity.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort
Clinical narrative: had a pain in the shoulder/ shoulder pain off and on; some discomfort; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; 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. The following information was reported: DISCOMFORT (non-serious) with onset Oct2022, outcome "unknown", described as "some discomfort"; ARTHRALGIA (non-serious) with onset 30Oct2022, outcome "unknown", described as "had a pain in the shoulder/ shoulder pain off and on".  Additional information: the patient had her second booster and on 30Oct2022, she had a pain in her shoulder. She wanted to know if it was from the combination of the vaccine. She  stated that he had 4 previous COVID shots with no issues. However, she had discomfort and wanted to know if it was normal to have a week later, and if it could be from the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little achiness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete: , Unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "a little achiness".  Additional information: Caller's husband, the patient, had the Pfizer BioNTech COVID-19 vaccine bivalent too, but didn't feel bad and didn't get arm thing like the caller did. Patient did have a little achiness.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 10:30 as dose 5 (booster), single (Lot number: GH9703) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 22Apr2022 at 16:00 as dose 4 (booster), single (Lot number: 057M21A), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: GABAPENTIN, start date: 01May2018. Past drug history included: Keflex, reaction(s): "Drug hypersensitivity". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID treatment).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: Ew0168), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROZAC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Oct2022) Positive, notes: took test and it was positive morning of 29Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19. Course of events: Rebound covid after completing treatment. Symptoms started Friday 28Oct2022, took test and it was positive morning of 29Oct2022; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2 vaccine,  cannot be excluded for suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment for COVID-19; Treatment for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 15:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 82 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLONIDINE; SERTRALINE; METFORMIN; PANTOPRAZOLE; BISOPROLOL; AMLODIPINE; HCTZ; ALLOPURINOL; ATORVASTATIN; LEVOTHYROXINE; LORAZEPAM; D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Oct2022, outcome "not recovered" and all described as "Treatment for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Oct2022) Positive; (22Oct2022) Positive,  (22Oct2022) Positive; (22Oct2022) Positive; (31Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19: Paxlovid.  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.
Age: 14.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Irritability, Product use issue, Pyrexia
Clinical narrative: irritability fever 100.1; irritability fever 100.1; Pfizer: 31Oct2022/Flu shot: 31Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 3 (booster), single (Lot number: GH9697) at the age of 14 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 31Oct2022 as dose 3, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Cerebral Palsy" (unspecified if ongoing); "rhizotomy shunt" (unspecified if ongoing); "spinal fusion" (unspecified if ongoing); "bilateral hip surgery" (unspecified if ongoing). Concomitant medication(s) included: IRON. Past drug history included: Vancomycin, reaction(s): "known allergies: Vancomycin". Vaccination history included: BNT162b2 (Dose 1, Lot number FC3182, Vaccine location: Left arm), administration date: 14Sep2021, for COVID-19 Immunization; BNT162b2 (Dose 2, Lot number FF2588, Vaccine location: Left arm), administration date: 04Sep2021, for COVID-19 immunization, reaction(s): "14Sep2021: Dose Number: 1/04Sep2021: Dose Number: 2". The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 31Oct2022, outcome "unknown", described as "Pfizer: 31Oct2022/Flu shot: 31Oct2022"; PYREXIA (non-serious), IRRITABILITY (non-serious) all with onset 31Oct2022 at 12:00, outcome "not recovered" and all described as "irritability fever 100.1". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, irritability.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201270012 same patient/product, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Arm soreness; Severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown.), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm soreness"; HEADACHE (non-serious), outcome "recovered", described as "Severe headache". Therapeutic measures were taken as a result of pain in extremity, headache.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fever; fatigue; headache; body aches; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old 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: Covid-19 vaccine (primary immunization series complete: unknown manufacturer), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches".  Additional Information: Patient reported one week of fever, fatigue, headache, and body aches after receiving COVID-19 booster vaccine (first booster). Awareness Date: 30Oct2022. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: The patient ready got the boosters,but the doctor says she didn't have the immune and to restart the 4 dose; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID: (159558).  A patient (no qualifiers provided) 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: Covid-19 vaccine (Primary immunization series completed, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "The patient ready got the boosters, but the doctor says she didn't have the immune and to restart the 4 dose".  Additional information: Caller was a pharmacist who mentioned that a patient called her saying that her oncology doctor wants to restart her series of Covid 19 vaccines and she was not sure if it was okay, she was wondering for some advice.   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: Muscle spasms, Muscle twitching
Clinical narrative: Is there a possibility that the vaccines cause muscular spasms and twitching as I have experienced after the last vaccine.; Is there a possibility that the vaccines cause muscular spasms and twitching as I have experienced after the last vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, 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.  The following information was reported: MUSCLE SPASMS (non-serious), MUSCLE TWITCHING (non-serious), outcome "unknown" and all described as "Is there a possibility that the vaccines cause muscular spasms and twitching as I have experienced after the last vaccine.".  Additional Information: The patient had taken 2-vaccines and 2-boosters and about to take 3rd of the bivariant against omicron. The patient was questioning that whether there is a possibility that the vaccines cause muscular spasms and twitching as the patient had experienced after the last vaccine and also questioned can these symptom get worse with continued use of Pfizer boosters.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Haematuria, Laboratory test, Urine analysis
Clinical narrative: husband just had the Covid booster and within 8 hours having hematuria; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete , unknown manufacturer), for COVID-19 Immunization. The following information was reported: HAEMATURIA (non-serious), outcome "unknown", described as "husband just had the Covid booster and within 8 hours having hematuria". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient just had the COVID booster and within 8 hours having hematuria. All his labs, urinalysis and a CT were clear, but the reporter had read that this was a very rare potential side effect.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4147796.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for suspected covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1164825), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "SUSPECTED COVID-19". The action taken for adalimumab was unknown.  The reporter considered "suspected covid-19" related to BNT162b2.  The reporter's causality for the event of COVID with Adalimumab Solution for Injection was reasonable possibility. The reporter's causality for the event of COVID with Pfizer BioNTech SUSPECTED COVID-19 vaccine (Tozinameran) was Reasonable Possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: hearing loss; tinnitus; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). Other Case identifier: 2022NVX-US-000003868.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 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: DEAFNESS (medically significant), outcome "unknown", described as "hearing loss"; TINNITUS (non-serious), outcome "unknown". Clinical course: On 14Oct2022, it was reported that a patient started treatment on 11Oct2021 with Pfizer BioNTech COVID-19 vaccine for COVID-19 immunization. It was reported that the patient had tinnitus and hearing loss.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: her arm was a little sore; Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2022SA436139(CLUSTER).  This case involves a 67 years old female patient who experienced her arm was a little sore while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination(immunisation).  On an unknown date the patient developed a non-serious her arm was a little sore (pain in extremity) (unknown latency) following the administration of influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event her arm was a little sore.; Sender's Comments:  SAD20221020002754:
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: received fluzone high-dose quadrivalent at her local drug store and was told later by the drug store that her dose had been in a warm temperature excursion with no adverse event; received fluzone high-dose quadrivalent at her local drug store and was told later by the drug store that her dose had been in a warm temperature excursion with no adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (healthcare professional).  This case involves an unknown age female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] at her local drug store and was told later by the drug store that her dose had been in a warm temperature excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Oct-2022 , the patient received a 0.7 ml total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength, and lot number: unknown) via unknown route in unknown administration site for immunization.  On 25-Oct-2022 the patient received Fluzone high-dose quadrivalent at her local drug store and was told later by the drug store that her dose had been in a warm temperature excursion with no adverse event (product storage error) (poor quality product administered) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired ADACEL (31Jul2022) was accidentally given to a patient today with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 35 years old male patient who received an expired adacel (31jul2022) with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Oct-2022, the patient received 0.5 mL total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE once (lot U6767AA and expiry date: 310Jul-2022) via intramuscular route in the deltoid nos for prophylactic vaccination.  On 25-Oct-2022, (latency: same day) an expired adacel (31jul2022) was accidentally given to a patient today with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Atrial fibrillation, Cardioversion, Condition aggravated
Clinical narrative: atrial fibrillation with Rapid Ventricular Response; Initial information received on 25-Oct-2022 regarding an unsolicited valid  serious case received from a other health professional.  This case involves a 69 years old female patient who experienced atrial fibrillation with rapid ventricular response after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history included Atrial fibrillation with previous event of A-Fib, that was 3 years ago, she underwent a cardiac ablation, which successfully resolved the condition. The patient's past vaccination(s) included INFLUENZA VACCINE. The patient's past medical treatment(s) and family history were not provided.   On 19-Oct-2022, the patient received 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE once (formulation, strength, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 19-Oct-2022, (latency: same day) the patient developed a serious event of atrial fibrillation with rapid ventricular response (atrial fibrillation) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   It was reported, patient received a FLUZONE HIGH-DOSE QUADRIVALENT vaccine on 19-Oct-2022. She states that she has had many flu vaccines, but this is the first time that she has gotten the High-Dose. Later that day, she went into Atrial Fibrillation with Rapid Ventricular Response. She is a retired ICU nurse and recognized what was happening, so she presented at the Emergency Department. She states that with the RVR, her rate reached 170. Treatment with Amiodarone was initiated but was unsuccessful at controlling the atrial fibrillation. She underwent synchronized cardioversion, which was effective. She spent about 5 hours at the hospital but did not require an overnight admit.   Action taken was not applicable.  The patient was treated with AMIODARONE (AMIODARONE) for Atrial fibrillation with rapid ventricular response.  At time of reporting, the outcome was Unknown for the event.  Seriousness criteria: This event of atrial fibrillation was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 01-Nov-2022: This case involves a 69 years old female patient who experienced atrial fibrillation with rapid ventricular response same day after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The time of event onset was compatible with the time of vaccination. The patient had history of Atrial fibrillation which could be a confounding factor in the event occurrence. Additional information regarding condition at the time of vaccination, concomitant disease or risk factor excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 0.33
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: was to get pentacel and inadvertently got just the hib component mixed with sterile water , instead of the dtap/IPV component to dilute it with no reported adverse event; was to get pentacel and inadvertently got just the hib component mixed with sterile water , instead of the dtap/IPV component to dilute it with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 months old and unknown gender patient who was to get diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and inadvertently got just the hib component mixed with sterile water , instead of the dtap/ipv component to dilute it with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination(immunisation).  On an unknown date the patient was to get pentacel and inadvertently got just the hib component mixed with sterile water, instead of the dtap/ipv component to dilute it with no reported adverse event (single component of a two-component product administered, product preparation error) (same day latency).  Action taken: Not applicable.  Outcome: Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error