chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number: 4, Pfizer / BioNTech Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 26Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 26Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 18Sep2022 as dose 4 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DEXLANSOPRAZOLE; ESTRADIOL; CITALOPRAM; MONTELUKAST; XYZAL; LEVOTHYROXINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Sep2022, outcome "unknown", described as "Moderna Dose Number: 4, Pfizer / BioNTech Dose Number: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Negative tests 1 & 3 days after end of treatment; Negative, notes: Negative tests 1 & 3 days after end of treatment; Positive, notes: positive test morning of day 5 after end of treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details: Product COVID 19 Treatment, brand=Pfizer, Treatment start date on 21Dec2022, Treatment stop date on 25Dec2022, Indication on Treatment of COVID-19.
Age: 73.0
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 73-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (PFIZER BIONTECH COVID-19 VACCINE BIVALENT), on 08Sep2022 as dose 6 (booster), single (lot number GJ2524) at the age of 73 years, in right arm for covid-19 immunisation; BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 04Apr2022 as dose 5 (booster), single (lot number FK9893), in left arm for covid-19 immunisation; covid-19 vaccine as dose 1, single (lot number unknown), as dose 2, single (lot number unknown), as dose 3 (booster), single (lot number unknown) and as dose 4 (booster), single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing). The patient had no known allergies. Concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant) both with onset Dec2022, outcome "unknown" and described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective and covid-19 which included Paxlovid taken from 18Dec2022 to 22Dec2022.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: had 3 Pfizer shots, 2 Moderna boosters; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "bipolar" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "had 3 Pfizer shots, 2 Moderna boosters"; 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: (19Dec2022) Negative; (20Dec2022) Negative; (21Dec2022) Negative; (22Dec2022) Negative; (26Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 17Dec2022 to 21Dec2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. There were no concomitant medications. Patient did not receive the other vaccine in 2 weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid-began on day 3 after symptom start date. No other underlying conditions and takes no meds.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events drug ineffective, COVID 19  and the suspect drug BNT162B2 cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jul2022 at 13:00 as dose number unknown, single (Lot number: 077b22a) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Minor heart valve regurgitation" (unspecified if ongoing); "Known allergies" (unspecified if ongoing), notes: Known allergies: Yes. 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: (29Dec2022) Positive, notes: Tested positive 3 days after finishing the Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  Clinical Course: Patient had known allergies. The patient not received other medication in 2weeks. Received COVID 19 Treatment with Paxlovid (Lot number 1919256A) treatment start date on 21Dec2022 and stop date on 26Dec2022.
Sex: F
Vaccine: PNC13
Symptoms: Death
Clinical narrative: Vaccinated and died the same day; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), 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: DEATH (death), outcome "fatal", described as "Vaccinated and died the same day". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Additional information: The female nurse (patient) was vaccinated with Pneumonia Vaccine with Pfizer and was vaccinated and died that same day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Vaccinated and died the same day
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Arthritis, Back pain, Illness, Pain in extremity
Clinical narrative: Pfizer COVID 19 Vaccine: Sore arm for a day or two; sick badly for 3 weeks; sore back or shoulder and arthritis maybe".; sore back or shoulder and arthritis maybe".; sore back or shoulder and arthritis maybe".; 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 male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (Dose: 02, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (Dose: 03, Lot number: unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pfizer COVID 19 Vaccine: Sore arm for a day or two"; ILLNESS (non-serious), outcome "unknown", described as "sick badly for 3 weeks"; ARTHRALGIA (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "sore back or shoulder and arthritis maybe"."; ARTHRITIS (non-serious), outcome "unknown", described as "sore back or shoulder and arthritis maybe". ".   Additional information: He had a male patient who was also a veterinarian on the line and unable to get his age.  He did mention that he received 4 Pfizer COVID 19 vaccine shots and mentioned having sore arm for like a day or two and also the Pfizer Flu shot which afterwards he was sick badly for 3 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Dyspnoea, Gait inability, Pericardial effusion
Clinical narrative: pericardial effusion; short of breath; I cannot walk thru a grocery store; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: PERICARDIAL EFFUSION (medically significant), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath"; GAIT INABILITY (non-serious), outcome "unknown", described as "I cannot walk thru a grocery store". The patient underwent the following laboratory tests and procedures: Catheterisation cardiac: (19Dec2022) No results provided. Therapeutic measures were taken as a result of pericardial effusion.  Clinical course: A few weeks after the patient received the booster, the patient became short of breath. I cannot walk thru a grocery store patient had a heart cath on 19Dec2022 and patient have pericardial effusion trying to clear it with medication and patient pray it works. After the booster patient told my pulmonary doc and PCP that after patient had that booster patient can't breathe. Now the patient know why.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COVID; got COVID; 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 Nov2022 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 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 "got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: I now tested positive.  Clinical course: It was reported that, 6 weeks ago patient received the bivalent COVID booster vaccine and now tested positive. Patient thought he/she was supposed to have protection longer than 6 weeks and wear mask everywhere and continue to follow all recommendations. Patient also thought symptoms were supposed to be "mild" if vaccinated and still got COVID. Patient further stated that his/her symptoms were not mild and will not be recommending vaccine to anyone. Patient's Primary Immunization series completed but unknown manufacturer.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: Taken all five Pfizer shots for COVID, still got COVID; Taken all five Pfizer shots for COVID, still got COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Taken all five Pfizer shots for COVID, still got COVID". Additional information: The patient was in pain and disappointed.  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: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Influenza
Clinical narrative: tested positive; tested positive; influenza; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "moderately over weight" (unspecified if ongoing), notes: moderately over weight. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, in Sep2022 as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive"; INFLUENZA (medically significant), outcome "unknown". The events "tested positive" and "influenza" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: over 103, notes: fever as high as just over 103.  Clinical course: The patient just tested positive at the hospital with Both Covid 19 and influenza. He's a firefighter paramedic and was moderately over weight. He received flu vaccine in September, but had not yet received the most recent booster for Covid. He's running a fever as high as just over 103. The ER doctor didn't know if he could have both Paxlovid and Tamiflu, so prescribed Paxlovid. His wife was RN for a doctor group considering adding Tamiflu for him. Wanted to know if it was ok to take both.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid Testing 17Jan2022 result: Pos; Covid Testing 17Jan2022 result: Pos; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 21Apr2021 as dose 2, single (Lot number: EWO169), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: EWV183) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CSF Leak out left nostril", start date: 2017, stop date: 07Jul2020, notes: Surgery to patch hole, medication for headaches and pressure; "Headaches" (unspecified if ongoing), notes: Headaches; "anxiety/depression" (unspecified if ongoing), notes: anxiety/depression. The patient's family history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure (mom+dad); "obesity" (unspecified if ongoing), notes: (Mon and dad); "Diabetes" (unspecified if ongoing), notes: Grand parents. Concomitant medication(s) included: ACETAZOLAMIDE oral taken for headache, start date: Jul2020 (ongoing); LAMOTRIGINE oral taken for depression, start date: Apr2021 (ongoing); AMLODIPINE oral taken for hypertension, start date: Jul2020. The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 17Jan2022, outcome "unknown" and all described as "Covid Testing 17Jan2022 result: Pos". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jan2022) Positive.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: patient died after receiving Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female 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: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "patient died after receiving Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: On 10Dec2022, it was reported that a patient started treatment on an unspecified date with Pfizer 2-dose primary series. It was reported that the patient died after receiving Pfizer. No further follow-up was anticipated. On 13Dec2022, the caller stated her friend's husband already reported to Pfizer.  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: patient died after receiving Pfizer
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Fibromyalgia, Lyme disease
Clinical narrative: developed as a result of Lyme's disease; it exacerbated her fibromyalgia; experienced a wide range inflammatory response in all joints; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US253025.  A female patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lyme's disease" (unspecified if ongoing), notes: Caller said it exacerbated her fibromyalgia, which developed as a result of Lyme's disease. The patient's 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: LYME DISEASE (medically significant) with onset 2022, outcome "unknown", described as "developed as a result of Lyme's disease"; ARTHRITIS (non-serious) with onset 2022, outcome "unknown", described as "experienced a wide range inflammatory response in all joints"; FIBROMYALGIA (non-serious) with onset 2022, outcome "unknown", described as "it exacerbated her fibromyalgia".  Clinical Course: Reported as, Reporter received the Pfizer COVID booster in Jan2022 and experienced a wide range inflammatory response in all joints. reporter said it exacerbated her fibromyalgia, which developed as a result of Lyme's disease she contracted several years ago. Reporter mentioned spouse also received Pfizer COVID booster at the same time and experienced same side effects.  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-202201399995 same reporter/drug/event, different patients;
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID 19; Positive COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 21Dec2020 at 08:00 as dose 1, single (Lot number: EL9231), in left arm, on 12Jan2021 at 08:00 as dose 2, single (Lot number: EK9231), in left arm and on 25Oct2021 at 08:00 as dose 3 (booster), single (Lot number: EW0183) at the age of 66 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Positive COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: (positive Covid 19) Oct.  Clinical course: The patient had provide the information regarding the reported adverse event (s) with the use of the product. The Pfizer product had a casual effect to the adverse event: Yes. Vaccine was not administered at military facility. Prior vaccination (within 4 weeks) was none. Relevant test was none. Specific relevant test for thromboembolic events with thrombocytopenia was none.; Sender's Comments: Based on the available information in the case, an association between the reported events VACCINATION FAILURE & COVID-19 and The suspected drug cannot be ruled out.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID (I tested positive on 05Dec2022)/trouble breathing, muscular pain, head ache, cough (with pain in lungs), mucous, fever, lethargy, brain fog, sore throat; Came down with COVID (I tested positive on 05Dec2022)/trouble breathing, muscular pain, head ache, cough (with pain in lungs), mucous, fever, lethargy, brain fog, sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 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: DRUG INEFFECTIVE (medically significant) with onset 05Dec2022, outcome "unknown", described as "COVID (I tested positive on 05Dec2022)/trouble breathing, muscular pain, head ache, cough (with pain in lungs), mucous, fever, lethargy, brain fog, sore throat"; COVID-19 (medically significant) with onset 05Dec2022, outcome "unknown", described as "Came down with COVID (I tested positive on 05Dec2022)/trouble breathing, muscular pain, head ache, cough (with pain in lungs), mucous, fever, lethargy, brain fog, sore throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Dec2022) positive, notes: I came down with COVID at the beginning of December (I tested positive on 05Dec2022).  Clinical course: Patient received 5 Pfizer COVID-19 vaccines and/or boosters (including a bivalent shot on 17Sep2022.) Unfortunately, I came down with COVID at the beginning of December (I tested positive on 05Dec2022). My symptoms lasted long and were not sever but definitely not mild. I had trouble breathing, muscular pain, head ache, cough (with pain in lungs), mucous, fever, lethargy, brain fog, sore throat. I wanted to reach out since it was my understanding I had "protection" for 3-4 months and to provide feedback.  The lot number for [BNT162b2, BNT162b2 omi ba.4-5, BNT162b2], was not provided and will be requested during follow up.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; fever; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 25-year-old patient received BNT162b2 (BNT162B2), on 25May2021 as dose 1, single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; RHINORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "runny nose".  Additional information: Phlebotomist, described experiencing fever and a runny nose following both 1st and 2nd doses of the Pfizer COVID-19 vaccine on 25May2021 and 16Jun2021, respectively. 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: F
Vaccine: COVID19-2, UNK
Symptoms: Blood pressure measurement, Blood pressure systolic, Fatigue, Pain in extremity
Clinical narrative: arm pain; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):   A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; lenvatinib mesilate (LENVIMA), since 08Feb2022 (Batch/Lot number: unknown) at 10 mg daily for endometrial cancer. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lenvima, start date: 08Feb2022, for Endometrial Cancer, reaction(s): "fluctuating blood pressure", notes: since starting Lenvima (around 2/8/22) to a high of 144/73, 09 systolic is usually her baseline blood pressure per patient.; Lenvima, start date: 08Feb2022, for Endometrial Cancer, reaction(s): "increased urination"; Lenvima, start date: 08Feb2022, for Endometrial Cancer, reaction(s): "Abdominal pain", notes: described as a 2/10 pain scale, rating; Lenvima, start date: 08Feb2022, for Endometrial Cancer, reaction(s): "decreased weight". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate was unknown.  Additional information: The patient reported that her blood pressure has continued to fluctuate. The patient also voiced that she planned to take a trip with her daughter before she gets married in the spring and got a COVID booster shot on 30Nov2022, since getting the booster she reported getting "really sick" with arm pain and fatigue. The patient's relevant history included previously reported fluctuating blood pressure since starting Lenvima (around 08Feb2022) to a high of 144/73, 109 systolic was usually her baseline blood pressure per patient. The patient also reported increased urination, abdominal pain described as a 2/10 pain scale rating, and decreased weight since starting Lenvima (around 08Feb2022), The patient voiced that she was also a Vegan (prior to Lenvima) and was receiving dietician consults to help her to eat more Protein and fats in her diet. Unknown if caused by Lenvima. C54.1 Endometrial Cancer diagnosis, 10mg Lenvima daily, Started 08Feb2022, taking with Keytruda. Date the event description was reported was 02Dec2022  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; 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), 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: ALOPECIA (non-serious), outcome "unknown", described as "hair loss". Additional information: the patient reported he experienced hair loss since taking your COVID vaccine.  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: Amenorrhoea
Clinical narrative: Why haven't I gotten my period since I got dose 2 of covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female 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: AMENORRHOEA (non-serious), outcome "unknown", described as "Why haven't I gotten my period since I got dose 2 of covid vaccine".  Additional information: Patient asked that why haven't I gotten my period since I got dose 2 of covid vaccine? Please enlighten me. Pregnancy not possible.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got my shot and now have the flu; Initial information received on 29-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient who experienced got my shot and now have the flu after receiving  influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer [formulation, lot number and expiry date was not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed got my shot and now have the flu (influenza) (unknown latency)   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got my shot and now have the flu).  At time of reporting, the outcome was Unknown for the event got my shot and now have the flu.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19, Malaise
Clinical narrative: Covid; still was sick as a dog with Covid twice. Stinks; Initial information received on 01-Jan-2023 regarding an unsolicited valid social media non-serious case received from a consumer/non-HCP.  This case involves an unknown age and unknown gender patient who experienced covid; still was sick as a dog with covid twice. stinks after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor The patient's medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, dose expiry date: unknown).  On an unknown date the patient developed covid; still was sick as a dog with covid twice. stinks (covid-19) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Not Recovered / Not Resolved for the event covid; still was sick as a dog with covid twice. stinks.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19, Influenza
Clinical narrative: got covid n flu as a Christmas gift; got covid n flu as a Christmas gift; Initial information received on 31-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got covid n flu as a christmas gift after receiving vaccine Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On Nov, the patient received unknown dose of suspect Influenza Vaccine produced by unknown manufacturer lot (number, strength, formulation, expiry date not reported) via unknown route in unknown administration site for Influenza immunization.  On an unknown date the patient developed a non-serious event "got covid n flu as a christmas gift (covid-19) and (influenza)(unknown latency) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both the events.    Outcome: Unknown for both the events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 29-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-HCP.  This case involves a patient with unknown demographics who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and 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 flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Influenza
Clinical narrative: 2 weeks of bad cough; flu; Initial information received on 29-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (non-health care professional).  This case involves an unknown age and unknown gender patient who had 2 weeks of bad cough and flu after receiving  INFLUENZA VACCINE.  The patient's past medical history, concomitants, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown  dose of suspect INFLUENZA VACCINE ( with unknown strength, form, route, frequency, batch number and expiry date ) at  unknown administration site for prophylactic vaccination.  On an unknown date the patient had non-serious events 2 weeks of bad cough (cough) and flu (influenza) (unknown latency) .  It is unknown if the patient had any medical history, concomitant disease or risk factor.  No lab data included  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events (2 weeks of bad cough, flu).  Outcome : recovering/ resolving for both events.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: i have the flu never been so sick; I have the flu never been so sick; Initial information received on 30-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves an adult patient of unknown gender who have the flu never been so sick and i have the flu never been so sick after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient had non-serious events of  i have the flu never been so sick (influenza) (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (i have the flu never been so sick, I have the flu never been so sick).  Outcome was Unknown for both the events.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got sick; Initial information received on 01-Jan-2023 regarding an unsolicited valid Social Media non-serious case received via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got sick after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, batch number, expiry date: unknown) via unknown route in unknown administration site for Flu (immunization).  On an unknown date the patient diagnosed with a non-serious event of got sick (illness) (unknown latency) following the administration of influenza vaccine.  It was reported " I had the flu shot and still got sick. Today is 15 days. Feeling better but not great "  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Recovering / Resolving.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still got the flu; Initial information regarding an unsolicited valid social media non-serious case received via consumer/non-hcp on 30-Dec-2022.  This case involves patient of unknown demographics who still got the flu after getting vaccinated with INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in October 2022, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route, administration site) for prophylactic vaccination. Lot number and batch number was not provided. Drug expiry date was not reported. Information regarding batch number requested.   On an unknown date in Dec-2022, the patient developed a non-serious still got the flu (influenza) at few months latency following the administration of INFLUENZA VACCINE.  It was reported that "we got our flu shots on Oct, still got the flu this Christmas vacation. Maybe a little less complication, thankfully, but still got it, first time in 10 years." It was unknown if the company suspect product inappropriately used as per local Regulatory authorization.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event Influenza.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I has the flu shot and still got the flu; Initial information received on 30-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who stated i has the flu shot and still got the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) not reported via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient had a non-serious event of i has the flu shot and still got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: came down with the flu; Initial information received on 30-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who stated came down with the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date in Aug-2022, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for flu vaccination.  On an unknown date in Dec-2022, the patient had a non-serious event of came down with the flu (influenza) (approximately 4 months latency) following the administration of influenza vaccine.  It was reported: First of all nothing is guaranteed I took my flu shot in August I came down with the flu Christmas week end and still sick I been getting my flu shots for many many years   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 30-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown age and unknown gender patient who had flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history included Pneumonia. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumonia shot   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for prophylactic vaccination (Immunisation)  On an unknown date the patient had non-serious event flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was  reported "I got a flu and pneumonia shot - and still flu got to me but not as bad as when I had pneumonia in the summer- home recovering "  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: but now I have the flu; Initial information received on 31-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown age and unknown gender patient and reported but now i have the flu after receiving  INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient said but now i have the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (but now I have the flu).  At time of reporting, the outcome was Unknown for the event but now I have the flu.