chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Nausea, Vomiting
Clinical narrative: Asthma; I got sick to my stomach and was throwing up; I got sick to my stomach and was throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EL9264), administration date: 01Apr2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "First two shots, I fell and had hard time getting up"; BNT162b2 (DOSE 2, SINGLE; Lot Number: EW0171), administration date: 29Apr2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "First two shots, I fell and had hard time getting up"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: 0308D), administration date: 10Dec2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "asthma", "I got sick to my stomach and was throwing up", "I got sick to my stomach and was throwing up". The following information was reported: ASTHMA (non-serious) with onset 2022, outcome "unknown"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 2022, outcome "unknown" and all described as "I got sick to my stomach and was throwing up". Therapeutic measures were not taken as a result of asthma, nausea, vomiting.  Additional information: The patient was taking blood pressure medication and stopped after the second dose as it may drop the blood pressure. After receiving the vaccinations couple of hours later, the patient got sick to stomach and was throwing up. The patient was not taking any regular medications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201375592 same patient/reporter, different vaccine;
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthma, Vomiting
Clinical narrative: Asthma; I got sick to my stomach and was throwing; I got sick to my stomach and was throwing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Dec2022 as dose 5 (booster), single (Lot number: GH9697) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EL9264), administration date: 01Apr2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "First two shots, I fell and had hard time getting up Fall"; BNT162b2 (DOSE 2, SINGLE, Lot number: EW0171), administration date: 29Apr2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "I fell and had hard time getting up"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: 0308D), administration date: 10Dec2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "I got sick to my stomach and was throwing up", "I got sick to my stomach and was throwing up"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number: FJ4991), administration date: 12Apr2022, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "I got sick to my stomach and was throwing up", "I got sick to my stomach and was throwing up". The following information was reported: ABDOMINAL DISCOMFORT (non-serious), VOMITING (non-serious) all with onset 11Dec2022, outcome "unknown" and all described as "I got sick to my stomach and was throwing"; ASTHMA (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of asthma, abdominal discomfort, vomiting.  Additional information: The patient had adverse reaction to the first two shots and all three boosters. And then on the other ones, afterwards, couple of hours later, the patient got sick to stomach and was throwing up and those were not given as any of the side effects. The patient did not undergo any investigations. Sender's Comments: Linked Report(s): PFIZER INC-202201375592 same reporter/patient, different vaccine dose;
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received other medications. The patient also received products within 2 weeks of starting COVID-19 treatment. The patient was previously received a COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, 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) 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 18Oct2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Known allergies: Nickel" (unspecified if ongoing), notes: Known allergies: Nickel. Concomitant medication(s) included: WELLBUTRIN, start date: Mar2022; LEXAPRO, start date: Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 07Dec2022, Treatment stop date: 09Dec2022, Indication: Treatment of COVID-19.
Age: 46.0
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 (consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (batch/lot number: unknown) at the age of 46 years, in right arm for covid-19 immunization; BNT162b2 (BNT162B2), on 18Apr2021 as dose 1, single (batch/lot number: unknown), in left arm, on 09May2021 as dose 2, single (batch/lot number: unknown), in left arm and on 19Nov2021 as dose 3 (booster), single (batch/lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Dec2022, outcome "recovered" (09Dec2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: Covid-19 Test: (unspecified date) positive, notes: treatment of COVID-19; (11Dec2022) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient reported that he had anti-viral COVID 19 Treatment Paxlovid with treatment start date on 05Dec2022 and stop date on 09Dec2022.  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: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: 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, notes: COVID 19 Treatment; Positive, notes: I am still testing positive as well. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After taking paxlovid the patient felt back to normal after experiencing very very bad sore throat, fever, cough and significant aches and pains. 2 days later the infection attacked my sinuses with fever and more coughing. These symptoms have now persisted for 5 days and patient still have them. Patient was still testing positive as well. Other medication in 2 weeks product was Mucinex, start on 11Dec2022 and stop on 13Dec2022. Patient had not known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Got covid/covid rebound; Got covid/covid rebound; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP), Program ID: (Unknown).  A 45-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; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Latex" (unspecified if ongoing). Concomitant medication(s) included: VOLTAREN [DICLOFENAC]; TYLENOL; TRAMADOL; SULFASALAZINE; SERTRALINE; RESTASIS; OMEGA 3 FISH OIL [FISH OIL]; METOPROLOL; LEFLUNOMIDE; HYDROXYCHLOROQUINE; HYDROCORTISONE; GABAPENTIN; CLOBETASOL; CITRACAL [CALCIUM CITRATE]; BETAMETHASONE. Past drug history included: Allergies: amoxicillin, reaction(s): "Drug allergy"; Thiomersal for Drug allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Got covid/covid rebound".  Clinical course: Patient "had to come off xeljanz xr for a booster, then got covid, then had covid rebound. been very sick. its been complicated lately" pt has been off xeljanz xr for about a month. (COVID)   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness
Clinical narrative: she took a second booster and she passed out and hit her head; Sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization complete, unknown Manufacturer), for covid-19 immunization; Covid-19 vaccine (First Booster, Unknown Manufacturer), for covid-19 immunization; Flu shot (had the Flu shot first. When probed if received the Flu shot prior 4 weeks: Consumer stated, "Yes.), for Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "she took a second booster and she passed out and hit her head"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweating".  Clinical course: "This is in regards to medication called Premarin (Further clarification unknown. Hence, captured as suspect conservatively). And the patient made an adverse event statement to me. And the patient did mention, I have a broken ankle, walk with crutches, also mentioned, she takes medication for her stomach. She stated, I can't take any generic stuff (event captured conservatively for unspecified medication captured conservatively). At one time she was enrolled for medication called Protonix, Protonix she indicated (Further clarification unknown. Hence, not captured in tab.) And then she mentioned that she took a second booster and she passed out and hit her head and she stated sweating. She made it sweating and I didn't hear all what she stated sweating (event captured as per transferring agent's verbatim). Sweating, what I heard she said sweating."When paraphrased the concern: Consumer stated, "No. I passed out and hit both of my ankles but one foot is just swollen but the swelling has gone down. The other one, I broke my ankle and I hit my head but I didn't have a concussion so I am normally cast walking. This is my third cast. I took the Pfizer, second booster last, two weeks ago on Friday. Saturday I was ok. Because I am highly allergic to everything (Further clarification unknown). So, Saturday I was ok. But my stomach was bothering me so I took my upper stomach medicine (Intent: Treatment), and on Sunday morning (statement incomplete)."When probed for the name of stomach medicine: Consumer stated, "Dexilant. (Suspect captured as per verbatim conservatively) I have got to walk with crutches so I am not going to get the bottle, ok."  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: Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient 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: PERICARDITIS (medically significant), outcome "unknown".  Clinical Course: Father with Pericarditis after first Pfizer Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Renal disorder
Clinical narrative: hospitalized for 10 days with significant kidney issues following Pfizer covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old patient received BNT162b2 (BNT162B2), 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: RENAL DISORDER (hospitalization, medically significant), outcome "unknown", described as "hospitalized for 10 days with significant kidney issues following Pfizer covid vaccine". The patient was hospitalized for renal disorder (hospitalization duration: 10 day(s)). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 31-year-old patient 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown".  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Multiple organ dysfunction syndrome
Clinical narrative: Multiple organ failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) 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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for covid-19 immunisation.  The following information was reported: MULTIPLE ORGAN DYSFUNCTION SYNDROME (death, medically significant), outcome "fatal", described as "Multiple organ failure". The patient date of death was unknown. Reported cause of death: "Multiple organ failure". It was not reported if an autopsy was performed.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Multiple organ failure
Sex: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: PERICARDITIS (medically significant), outcome "unknown".  Clinical Couse: dancer develops Pericarditis after receiving Pfizer vaccine unable to dance for at least a year.  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: Wheelchair user
Clinical narrative: Nephew in a wheelchair right now from one of these shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), 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: WHEELCHAIR USER (disability), outcome "unknown", described as "Nephew in a wheelchair right now from one of these shots".  Clinical Course: Caller asked if there was anything harmful in the product. Caller elaborated he wanted to know the ingredients of the vaccine. Caller mentioned during the call he has a "nephew in a wheelchair right now from one of these shots". Caller also referenced that people have died or had adverse events from the vaccine. Caller asked about the recording when he first contacted Pfizer. Caller reported the recording was 15 minutes, said the recording explained things he didn't want to know about a COVID shot or about Pfizer, said he found it very disturbing and asked was the purpose to scare me. Caller reported that his heart was beating fast, but it is not related to any vaccine, it was related to the fact that he had to listen to the recording while waiting on the line for almost 15 minutes. The recording is almost 15 minutes long. You have to listen to the information about the vaccines. He was blown away. He has never heard an introduction that was that in detail in length. He is calling because he called a local# with a question and they said to call Pfizer about vaccines. When the caller was questioned about which vaccine he was calling about he said all of them. Caller said also the COVID-19 vaccine. Has questions and concerns about that. Calling about all of the vaccines. Wondering if Pfizer is getting a lot of reports from people who have had adverse events from the vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "von Willebrand type 1" (unspecified if ongoing); "known allergies: yes many antibiotics" (unspecified if ongoing). Concomitant medication(s) included: BUDESONIDE, start date: 01Jul2021; ARFORMOTEROL, start date: 01Jul2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Dec2022) diagnosed with COVID; (12Dec2022) Positive, notes: retested positive; (Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient diagnosed with COVID 01Dec2022 took Paxlovid, Zpac antibiotic, and Prednisone. Tested negative then retested positive on 12Dec2022. By 15Dec2022 serious symptoms. On 15Nov2022 patient was taking Resprimat as concomitant medication in 2 weeks.
Age: 46.0
Sex: F
Vaccine: COVID19, 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 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Guillain-Barre syndrome, Influenza virus test, SARS-CoV-2 test
Clinical narrative: flare up of her guillain-barre; flare up of her guillain-barre; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia Gravis" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "Guillain Barre syndrome" (ongoing); "over weight" (unspecified if ongoing); "COVID-19", start date: Mar2020 (unspecified if ongoing), notes: Had first symptoms of Covid Mar2020. Concomitant medication(s) included: METHYLPREDNISOLONE taken for guillain-barre syndrome, myasthenia gravis. Vaccination history included: Bnt162b2 (First Dose: Apr2021, she thinks, when they came out), administration date: Apr2021, when the patient was 52 years old, for COVID-19 immunization, reaction(s): "Has autonomic dysfunction and had an increase of that as well", "balance was off", "Her eyes, she had the miller fisher variant and her eyes got really wonky again", "areup of her guillain-barre", "after the first vaccine, her reflexes went away and that was it"; Bnt162b2 (First Dose: Apr2021), administration date: Apr2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "Covid", "Covid". The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), CONDITION AGGRAVATED (medically significant), outcome "recovered" and all described as "flare up of her guillain-barre". The event "flare up of her guillain-barre" required physician office visit. The patient underwent the following laboratory tests and procedures: Influenza virus test: (09Dec2022) Positive, notes: Result: positive for Flu B; Unit: Not Provided; SARS-CoV-2 test: (09Dec2022) Positive, notes: Result: positive for Covid; Unit: Not Provided. Therapeutic measures were taken as a result of guillain-barre syndrome, condition aggravated.  Clinical Course: Stated with this vaccine and all others (unclear if received all pfizer covid 19 vaccines), she experienced a flareup of her guillain-barre. States before this she didnt have any symptoms for 30 years.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 16:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details, Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=14Dec2022, Treatment stop date=15Dec2022, Lot number=GF3597, Indication=Treatment of COVID-19.  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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: The patient got vaccine dose 1 of primary series and started her period very heavy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 31Dec2020 as dose 1, single (Lot number: EJ1685) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: I was covid + (positive). Concomitant medication(s) included: CETIRIZINE; ATORVASTATIN.  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 2021, outcome "recovered", described as "The patient got vaccine dose 1 of primary series and started her period very heavy".  Additional information: The patient got vaccine dose 1 primary series while she was having COVID and without her knowing. Few days later, she started her period very heavy. Changing super abs tampons every 30mins same as in Dec2020. She have read case reports of heavy menstrual cycles post COVID infections and from vaccine. Next period was heavy but not as much then it went back to normal. Sender's Comments: Linked Report(s) : PFIZER INC-202201360950 Same reporter and drug, events separated in time;
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Fatigue, Heart rate increased, Muscle spasms, Pain
Clinical narrative: chronic fatigue; constant pain in left arm; makes my arm spasm; constant heart rate to go up; left breast pain; strong amount of pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Follow-up (12Dec2022): The initial case was missing the following minimum criteria: reason. Upon receipt of follow-up information on (12Dec2022), this case now contains all required information to be considered valid.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 at 11:00 as dose 1, single (Lot number: EW0153) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "auto immune disease", start date: 12Jan2012 (ongoing); "chronic fatigue", start date: 12Jan2012 (ongoing); "hysterectomy", start date: 2009 (unspecified if ongoing); "Breast implant", start date: 2004 (unspecified if ongoing); "shoulder repair on left shoulder" (unspecified if ongoing); "neck fused", start date: 2013 (unspecified if ongoing); "bladder sling procedure symptom", start date: 2018 (unspecified if ongoing); "L5 S1 Fused", start date: 2015 (unspecified if ongoing), notes: L5 S1 Fused. The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "constant heart rate to go up"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "constant pain in left arm"; BREAST PAIN (non-serious) with onset 2021, outcome "unknown", described as "left breast pain"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "unknown", described as "makes my arm spasm"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "strong amount of pain"; FATIGUE (non-serious), outcome "unknown", described as "chronic fatigue". Additional information: Patient concerned about the shot i received 2021 the biotech one which I never signed up to receive my husband did Withheld had me get this and I've had bad side effects and who is to be held responsible for this because I told my doctor how bad it's effecting me please respond back, Patient have been having constant pain in left arm when i lift up anything heavy i creates a lot of pain and makes my arm spasm and shake and this is known to connect to the heart muscle that it causes constant heart rate to go up. i have been in pain with this shot since 2021 and cause left breast pain to create a strong amount of pain and i did not sign up for this shot. my husband signed me up who is were who works at.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: chronic fatigue; constant pain in left arm; makes my arm spasm; constant heart rate to go up; left breast pain; strong amount of pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Follow-up (12Dec2022): The initial case was missing the following minimum criteria: reason. Upon receipt of follow-up information on (12Dec2022), this case now contains all required information to be considered valid.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 at 11:00 as dose 1, single (Lot number: EW0153) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "auto immune disease", start date: 12Jan2012 (ongoing); "chronic fatigue", start date: 12Jan2012 (ongoing); "hysterectomy", start date: 2009 (unspecified if ongoing); "Breast implant", start date: 2004 (unspecified if ongoing); "shoulder repair on left shoulder" (unspecified if ongoing); "neck fused", start date: 2013 (unspecified if ongoing); "bladder sling procedure symptom", start date: 2018 (unspecified if ongoing); "L5 S1 Fused", start date: 2015 (unspecified if ongoing), notes: L5 S1 Fused. The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "constant heart rate to go up"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "constant pain in left arm"; BREAST PAIN (non-serious) with onset 2021, outcome "unknown", described as "left breast pain"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "unknown", described as "makes my arm spasm"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "strong amount of pain"; FATIGUE (non-serious), outcome "unknown", described as "chronic fatigue". Additional information: Patient concerned about the shot i received 2021 the biotech one which I never signed up to receive my husband did Withheld had me get this and I've had bad side effects and who is to be held responsible for this because I told my doctor how bad it's effecting me please respond back, Patient have been having constant pain in left arm when i lift up anything heavy i creates a lot of pain and makes my arm spasm and shake and this is known to connect to the heart muscle that it causes constant heart rate to go up. i have been in pain with this shot since 2021 and cause left breast pain to create a strong amount of pain and i did not sign up for this shot. my husband signed me up who is were who works at.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pain in extremity
Clinical narrative: previously had Moderna covid vaccines and booster; pain in both lower legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 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: Moderna covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 Immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 Immunization; Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2022, outcome "not recovered", described as "pain in both lower legs"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Dec2022, outcome "unknown", described as "previously had Moderna covid vaccines and booster".  Additional information: Patient previously had Moderna covid vaccines and booster. On an unknown date in Dec2022 (reported as last week), patient received the newest Covid booster, it was Pfizer. Since then, the patient had experienced pain in both lower legs, mostly at night. The patient inquired if it was a side effect and if so, how long did it last. The patient did not experience it after the other vaccinations.  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: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Erythema, Facial paresis
Clinical narrative: A hot blood rush up to my head; A hot blood rush up to my head; Face was red; Lost the strength of facial movement; Lost the strength of facial movement; Muscles of face turned very weak; Mouth was shivering; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HOT FLUSH (non-serious), DIZZINESS (non-serious) all with onset 28Jan2021, outcome "recovered" (28Jan2021) and all described as "A hot blood rush up to my head"; ERYTHEMA (non-serious) with onset 28Jan2021, outcome "recovered" (28Jan2021), described as "Face was red"; FACIAL PARESIS (non-serious), ASTHENIA (non-serious) all with onset 28Jan2021, outcome "recovered" (28Jan2021) and all described as "Lost the strength of facial movement"; CHILLS (non-serious) with onset 28Jan2021, outcome "recovered" (28Jan2021), described as "Mouth was shivering"; MUSCULAR WEAKNESS (non-serious) with onset 28Jan2021, outcome "recovered" (28Jan2021), described as "Muscles of face turned very weak". Therapeutic measures were taken as a result of hot flush, dizziness, erythema, facial paresis, asthenia, muscular weakness, chills.  Additional information: The reported events occurred after use of the product. Treatment with lot of water & Gatorade. All symptoms were gone after 40 minutes. There were no other product(s) that were taken together with those indicated above.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Muscular weakness
Clinical narrative: A hot blood rush up to my head; A hot blood rush up to my head; Face was red; Lost the strength of facial movement; Lost the strength of facial movement; Muscles of face turned very weak; Mouth was shivering; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HOT FLUSH (non-serious), DIZZINESS (non-serious) all with onset 28Jan2021, outcome "recovered" (28Jan2021) and all described as "A hot blood rush up to my head"; ERYTHEMA (non-serious) with onset 28Jan2021, outcome "recovered" (28Jan2021), described as "Face was red"; FACIAL PARESIS (non-serious), ASTHENIA (non-serious) all with onset 28Jan2021, outcome "recovered" (28Jan2021) and all described as "Lost the strength of facial movement"; CHILLS (non-serious) with onset 28Jan2021, outcome "recovered" (28Jan2021), described as "Mouth was shivering"; MUSCULAR WEAKNESS (non-serious) with onset 28Jan2021, outcome "recovered" (28Jan2021), described as "Muscles of face turned very weak". Therapeutic measures were taken as a result of hot flush, dizziness, erythema, facial paresis, asthenia, muscular weakness, chills.  Additional information: The reported events occurred after use of the product. Treatment with lot of water & Gatorade. All symptoms were gone after 40 minutes. There were no other product(s) that were taken together with those indicated above.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: A hot blood rush up to my head; A hot blood rush up to my head; Face was red; Lost the strength of facial movement; Lost the strength of facial movement; Muscles of face turned very weak; Mouth was shivering; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HOT FLUSH (non-serious), DIZZINESS (non-serious) all with onset 28Jan2021, outcome "recovered" (28Jan2021) and all described as "A hot blood rush up to my head"; ERYTHEMA (non-serious) with onset 28Jan2021, outcome "recovered" (28Jan2021), described as "Face was red"; FACIAL PARESIS (non-serious), ASTHENIA (non-serious) all with onset 28Jan2021, outcome "recovered" (28Jan2021) and all described as "Lost the strength of facial movement"; CHILLS (non-serious) with onset 28Jan2021, outcome "recovered" (28Jan2021), described as "Mouth was shivering"; MUSCULAR WEAKNESS (non-serious) with onset 28Jan2021, outcome "recovered" (28Jan2021), described as "Muscles of face turned very weak". Therapeutic measures were taken as a result of hot flush, dizziness, erythema, facial paresis, asthenia, muscular weakness, chills.  Additional information: The reported events occurred after use of the product. Treatment with lot of water & Gatorade. All symptoms were gone after 40 minutes. There were no other product(s) that were taken together with those indicated above.  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: COVID-19, Drug ineffective
Clinical narrative: she needs this Paxlovid to deal with the COVID that she has; she needs this Paxlovid to deal with the COVID that she has; 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 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 "she needs this Paxlovid to deal with the COVID that she has". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She wants to take this medication because she does not respond to the Pfizer COVID Vaccine. Caller states that she wants to take it because she doesn't respond to the COVID Vaccines, so she has no protection from COVID, so she needs this Paxlovid to deal with the COVID that she has.  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, Lethargy
Clinical narrative: It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.; It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 54-year-old female patient received BNT162b2 (BNT162B2), in 2021 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: LETHARGY (non-serious), FATIGUE (non-serious) all with onset 2021, latency 1 day after the suspect product(s) administration, outcome "unknown" and all described as "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.".  Additional Information: On 28Nov2022, it was reported that a patient started treatment on an unspecified date in early 2021 with Pfizer Covid-19 Vaccine dose 1, on an unspecified date (reported as 2 months later) with Pfizer Covid-19 Vaccine dose 2, on an unspecified date in Sep2021 with Pfizer Covid-19 Vaccine dose 3 (reported as 1st booster) and on an unspecified date in Apr2022 with dose 4 (reported as 2nd booster) for Covid-19 immunization. It was reported the patient was tired the next day and lethargic after the first dose, second dose and first booster. No further follow-up was anticipated.  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-202201375580 same patient different dose number/ event;US-PFIZER INC-202201375581 same patient /event different dose number;US-PFIZER INC-202201375582 same patient different dose number/ event;
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: Ischemic Stroke; This is a literature report for the following literature source(s): "Stroke in Patient With Controlled Preexisting Hypercoagulability After COVID- 19 Vaccine Booster:   A 55-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "factor V Leiden" (unspecified if ongoing); "protein C deficiency" (unspecified if ongoing). Concomitant medication(s) included: ENOXAPARIN taken for anticoagulant therapy. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (Unknown Manufacturer )), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE (Unknown Manufacturer )), for COVID-19 immunization. The following information was reported: ISCHAEMIC STROKE (hospitalization, medically significant, life threatening), outcome "recovering", described as "Ischemic Stroke". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: revealed an acute left thalamic, left posterior, notes: internal capsule, and bilateral middle cerebellar infarcts. Therapeutic measures were taken as a result of ischaemic stroke.  Clinical course: On admission, she presented with acute-onset right-sided weakness and numbness. She received the BNT162b2 vaccine booster dose 27 days prior to admission. Prior to this incident, she was successfully maintained on the same dose of enoxaparin for 19 years without clotting event along with recent outpatient hematology monitoring. After medical stabilization, she was admitted to the acute inpatient rehabilitation facility where she regained full motor strength and gait, although numbness persisted. Following consultation with her outpatient hematologist, she was discharged at an independent level with unchanged enoxaparin dosing.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the  "Ischemic Stroke" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The same  was blamed as a possible trigger by the reporter, and it can possibly be explained by the mechanism as stated in the full article.  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 notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.