chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: headaches; menstrual cycle has been extremely irregular; lost a lot of my hair; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Nov2021 at 12:00 as dose 2, single (Lot number: 32030BD) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: AUBAGIO. Vaccination history included: BNT162b2 (dose 1, lot number FE3590, on 22Oct2021,02:15 PM, vaccine location Right arm), administration date: 22Oct2021, when the patient was 41-year-old, for COVID-19 immunization.  The following information was reported: HEADACHE (non-serious) with onset 29Dec2021, outcome "not recovered", described as "headaches"; ALOPECIA (non-serious) with onset 29Dec2021, outcome "not recovered", described as "lost a lot of my hair"; MENSTRUATION IRREGULAR (non-serious) with onset 29Dec2021, outcome "not recovered", described as "menstrual cycle has been extremely irregular". Therapeutic measures were not taken as a result of headache, menstruation irregular, alopecia.  Additional information: The patient had received no other vaccine in four weeks and had no known allergies. Since getting second vaccine in Nov2021 her menstrual cycle has been extremely irregular, after decades of being the same day every month. She has also lost a lot of hair and developed weekly headaches where she never had headaches before. No Covid prior vaccination and tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Feb2022 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 16Sep2022, outcome "recovering" and all described as "tested positive for COVID". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Sep2022) Positive, notes: Tested positive for COVID. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. 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: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 70-year-old 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Vaccine lot unknown reason was noted as misplaced/discarded. COVID 19 Treatment with Paxlovid start date on 31Aug2022 and stop date on 05Sep2022. The patient had Paxlovid rebound COVID on 31Aug2022 and recovering- no treatment was received.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Have the Pfizer vaccine just tested positive for COVID-19 last night.; Have the Pfizer vaccine just tested positive for COVID-19 last night.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 9-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 1, single (Lot number: FK5127), in arm, on 01Dec2021 as dose 2, single (Lot number: FL0007), in arm and on 09Jun2022 as dose 3 (booster), single (Lot number: FL8094) at the age of 8 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Sep2022, outcome "unknown" and all described as "Have the Pfizer vaccine just tested positive for COVID-19 last night.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Sep2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The report was not related to a study or program. NDC number, expiry date of COVID-19 vaccine: Unknown. Caller reported that her two kids who have the Pfizer vaccine and just tested positive for covid-19 last night. Her children received two doses plus a booster. The patient received all 3 vaccines in morning. No additional vaccines administered on same date of the Pfizer suspect, no vaccines administered on same date with the Pfizer vaccine considered as suspect.
Age: 80.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 15:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 80 years, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 14Sep2022 as 0.7 ml (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Vascular issues with stents" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Thyroid issues" (unspecified if ongoing); "Known allergies: seafood" (unspecified if ongoing). Concomitant medication(s) included: TOPROL XL; SYNTHROID; LISINOPRIL; BABY ASPIRIN; Z-PAK. Past drug history included: Mycins, reaction(s): "Known allergies: Yes many meds(most mycins)". Vaccination history included: BNT162b2 (Dose number: 4,, Lot number: FJ9943, Dose administration time: 10:00 AM, Dose vaccine location: Left arm), administration date: 31Mar2022, when the patient was 79-year-old, for COVID-19 Immunization, reaction(s): "fever", "chills"; BNT162b2 (Dose number: 3, Lot number: FC3184, Dose vaccine location: Left arm), administration date: 25Aug2021, when the patient was 79-year-old, for COVID-19 Immunization, reaction(s): "fever", "chills"; BNT162b2 (Dose number: 2, Lot number: EL9267, Dose vaccine location: Left arm), administration date: 17Feb2021, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "sore arm"; BNT162b2 (Dose number: 1, Lot number: EL9263, Dose vaccine location: Left arm), administration date: 27Jan2021, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: CHILLS (non-serious) with onset 15Sep2022 at 02:00, outcome "recovered" (Sep2022); PYREXIA (non-serious) with onset 15Sep2022 at 02:00, outcome "recovered" (Sep2022), described as "fever". Therapeutic measures were taken as a result of pyrexia, chills.  Additional information: NDC for Fluzone HD was provided as 49281-0122-05. The patient did not have covid prior vaccination and did not take a covid test post vaccination. Around 10 hours after vaccination (dose 5) awoke with fever and chills which lasted around 10-12 hours and which responded to Tylenol. Exact same response for vaccination dose 4. Dose 3 was more intense and same symptoms lasted for 3 days. Oddly no after effect other than sore arm for dose 1 or dose 2.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna:dose 1-2/ Pfizer / BioNTech: dose 3; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: EW0173) at the age of 39 years, in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2020 as dose 1, single (Lot number: 011J20A), in left arm and on 25Jan2021 as dose 2, single (Lot number: 042L2OA), in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Nov2021, outcome "unknown", described as "Moderna:dose 1-2/ Pfizer / BioNTech: dose 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: The patient was not taking other medications within 2 weeks of starting COVID-19 treatment.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9263), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Vascular issues with stents" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Thyroid issues" (unspecified if ongoing); "seafood" (unspecified if ongoing). Concomitant medication(s) included: TOPROL; SYNTHROID; LISINOPRIL; BABY ASPIRIN; Z-PAK. Past drug history included: Known allergies: mycins, reaction(s): "Drug allergy". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Patient not been received any other vaccine in four weeks.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Injection site pain, Pain, Pain in extremity
Clinical narrative: Injection was painful (first 3 were not). Nine hours post injection, awoke with R arm pain and lightheaded.  R arm is painful when attempting to move out from side and raise above shoulder level.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pharmacist intended to administer bivalent vaccine, but regular pfizer (non-bivalent) was given by mistake as patient's 5th dose.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pharmacist intended to administer bivalent vaccine, but regular pfizer (non-bivalent) was given by mistake as patient's 5th dose. No physical or other adverse events reported by patient.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 2, single (Lot number: EL9267) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Vascular issues with stents" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Thyroid issues" (unspecified if ongoing); "Known allergies: Seafood" (unspecified if ongoing). Concomitant medication(s) included: TOPROL XL; SYNTHROID; LISINOPRIL; BABY ASPIRIN; Z-PAK. Past drug history included: Known allergies: mycins, reaction(s): "drug allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9263; Anatomical location: Left arm), administration date: 27Jan2021, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Patient not been received any other vaccine in four weeks. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Aug2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Vascular issues with stents, Hypertension, Thyroid issues" (unspecified if ongoing), notes: Vascular issues with stents, Hypertension, Thyroid issues; "Known allergies: many meds(most mycins)" (unspecified if ongoing); "Known allergies: Seafood" (unspecified if ongoing), notes: Known allergies: Seafood; "Vascular issues with stents" (unspecified if ongoing), notes: Vascular issues with stents; "Hypertension" (unspecified if ongoing); "Thyroid issues" (unspecified if ongoing), notes: Thyroid issues; "Known allergies: many meds(most mycins)" (unspecified if ongoing). Concomitant medication(s) included: TOPROL XL; SYNTHROID; LISINOPRIL; BABY ASPIRIN; Z-PAK. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EL9263; Anatomical location: Left arm), administration date: 27Jan2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "Sore arm"; BNT162b2 (DOSE 2, SINGLE; Lot Number: EL9267; Anatomical location: Left arm), administration date: 17Feb2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "Sore arm". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever"; CHILLS (non-serious), outcome "recovered".  Additional information: The patient experienced same symptoms (fever and chills) however dose 3, was more intense and same symptoms lasted for 3 days. The patient did not receive any other vaccines within four weeks prior to the vaccination. Oddly no after effect other than sore arm for dose 1 and dose 2.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 at 10:00 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid issues" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Vascular issues with stents" (unspecified if ongoing); "Seafood" (unspecified if ongoing), notes: Known allergies : Seafood. Concomitant medication(s) included: TOPROL XL; LISINOPRIL; BABY ASPIRIN; SYNTHROID; Z-PAK. Past drug history included: Mycins, reaction(s): "Drug allergy", notes: Known allergies : Yes many meds (most mycins). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9263, Anatomical location: Arm Left), administration date: 27Jan2021, when the patient was 78-year-old, for COVID-19 immunisation, reaction(s): "sore arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: EL9267, Anatomical location: Arm Left), administration date: 17Feb2021, when the patient was 78-year-old, for COVID-19 immunisation, reaction(s): "sore arm"; BNT162b2 (DOSE 3 (BOOSTER) SINGLE; Lot number: FC3184, Anatomical location: Arm Left), administration date: 25Aug2021, when the patient was 79-year-old, for COVID-19 immunisation, reaction(s): "Chills", "Fever". The following information was reported: CHILLS (non-serious) with onset 2022, outcome "recovered" (2022); PYREXIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "fever". Therapeutic measures were taken as a result of pyrexia, chills that included Tylenol.  Additional information: The patient did not receive any other vaccine within the four weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID -19. Around 10 hours after vaccination dose 5, the patient awoke with fever and chills which lasted around 10 to 12 hours and which responded to Tylenol. Exact same response for vaccination dose 4. With dose 3, was more intense and same symptoms lasted for 3 days. Oddly no after effect other than sore arm for dose 1 or dose 2. Since the vaccination, the patient had not been tested for COVID-19.
Age: 67.0
Sex: F
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 15Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Stage 2 kidney disease" (unspecified if ongoing), notes: Stage 2 kidney disease. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jun2021; PRAVASTATIN, start date: 06Apr2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, 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: Abdominal pain, Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder, Muscle spasms
Clinical narrative: her period was every four days and she would bleed for two days / bleeding; her period was every four days and she would bleed for two days; spotting; abdominal cramps; cramps; she is been having pain after she has intercourse; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 29-year-old female patient 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: Bnt162b2 (Dose number unknown - original Pfizer Covid-19 vaccine, ), administration date: Jul2021, when the patient was 29 years old, for COVID-19 Immunization, reaction(s): "after intercourse she hurts in the morning with abdominal cramps and bleeding", "after intercourse she hurts in the morning with abdominal cramps and bleeding", "spotting", "after intercourse she hurts in the morning with abdominal cramps and bleeding". The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant), outcome "not recovered", described as "her period was every four days and she would bleed for two days / bleeding"; MENSTRUAL DISORDER (medically significant), outcome "not recovered", described as "her period was every four days and she would bleed for two days"; INTERMENSTRUAL BLEEDING (medically significant), outcome "not recovered", described as "spotting"; ABDOMINAL PAIN (non-serious), outcome "not recovered", described as "abdominal cramps "; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "cramps"; PAIN (non-serious), outcome "not recovered", described as "she is been having pain after she has intercourse". Clinical course: reporter stated her 29-year-old daughter in law got the "original Pfizer COVID-19 vaccine" in Jul2021. She was trying to have a child. She was getting her period every 40 days until she got the vaccine. Now, after intercourse she hurts in the morning with abdominal cramps and bleeding. Reporter stated she thinks it was just spotting and stated her daughter in law was healthy. Reporter stated her daughter in law then got a booster in August (as reported). After that her period was every four days and she would bleed for two days. Now she was doing "fertility things every morning peeing on these sticks and stated she can't find out when she was ovulating now. Reporter was  asking if Pfizer has any information on menstrual changes after vaccination with Comirnaty. She has been having pain after she has intercourse and cramps.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: her period was every four days and she would bleed for two days / bleeding; her period was every four days and she would bleed for two days; spotting; abdominal cramps; cramps; she is been having pain after she has intercourse; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 29-year-old female patient 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: Bnt162b2 (Dose number unknown - original Pfizer Covid-19 vaccine, ), administration date: Jul2021, when the patient was 29 years old, for COVID-19 Immunization, reaction(s): "after intercourse she hurts in the morning with abdominal cramps and bleeding", "after intercourse she hurts in the morning with abdominal cramps and bleeding", "spotting", "after intercourse she hurts in the morning with abdominal cramps and bleeding". The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant), outcome "not recovered", described as "her period was every four days and she would bleed for two days / bleeding"; MENSTRUAL DISORDER (medically significant), outcome "not recovered", described as "her period was every four days and she would bleed for two days"; INTERMENSTRUAL BLEEDING (medically significant), outcome "not recovered", described as "spotting"; ABDOMINAL PAIN (non-serious), outcome "not recovered", described as "abdominal cramps "; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "cramps"; PAIN (non-serious), outcome "not recovered", described as "she is been having pain after she has intercourse". Clinical course: reporter stated her 29-year-old daughter in law got the "original Pfizer COVID-19 vaccine" in Jul2021. She was trying to have a child. She was getting her period every 40 days until she got the vaccine. Now, after intercourse she hurts in the morning with abdominal cramps and bleeding. Reporter stated she thinks it was just spotting and stated her daughter in law was healthy. Reporter stated her daughter in law then got a booster in August (as reported). After that her period was every four days and she would bleed for two days. Now she was doing "fertility things every morning peeing on these sticks and stated she can't find out when she was ovulating now. Reporter was  asking if Pfizer has any information on menstrual changes after vaccination with Comirnaty. She has been having pain after she has intercourse and cramps.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dysuria, Fatigue, Immunisation, Nephritis
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 55-year-old male patient received BNT162b2 (BNT162B2), on 14Sep2022 at 15:00 as dose 5 (booster), single (Lot number: 6J2524) at the age of 55 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "testicular cancer" (unspecified if ongoing), notes: (40 year survivor); "severe vertigo" (unspecified if ongoing); "VACTERL syndrome at birth" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE; AMLODIPINE; EZETIMIBE; SERTRALINE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose:03; Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose:04; Manufacturer unknown), for Covid-19 Immunization. There were no other vaccines received in four weeks. The patient did not have Covid prior vaccination. The following information was reported: OFF LABEL USE (hospitalization), IMMUNISATION (hospitalization) all with onset 14Sep2022 at 15:00, outcome "unknown" and all described as "dose number: 5"; NEPHRITIS (hospitalization), SEPSIS (hospitalization) all with onset 16Sep2022 at 05:00, outcome "unknown" and all described as "Sepsis/nephritis"; URINARY TRACT INFECTION (hospitalization) with onset 16Sep2022 at 05:00, outcome "unknown", described as "UTI"; DYSURIA (hospitalization), FATIGUE (hospitalization) all with onset 16Sep2022 at 05:00, outcome "unknown" and all described as "difficulty urinating and tiredness"; PYREXIA (hospitalization) with onset 16Sep2022 at 05:00, outcome "unknown", described as "fever of 103". The patient was hospitalized for off label use, immunisation, nephritis, sepsis, pyrexia, dysuria, fatigue, urinary tract infection (start date: Sep2022). It was reported that the patient experienced fever of 103, difficulty urinating and tiredness. Went to urgent care where UTI was diagnosed. Sent to emergency room for further evaluation where IV antibiotics were started. Sepsis/nephritis are suspected, and patient is being admitted. The events "dose number: 5", "sepsis/nephritis", "fever of 103", "difficulty urinating and tiredness" and "UTI" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (16Sep2022) 103; SARS-CoV-2 test: (17Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of nephritis, sepsis, pyrexia, dysuria, fatigue, urinary tract infection.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pyrexia, SARS-CoV-2 test, Sepsis, Urinary tract infection
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 55-year-old male patient received BNT162b2 (BNT162B2), on 14Sep2022 at 15:00 as dose 5 (booster), single (Lot number: 6J2524) at the age of 55 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "testicular cancer" (unspecified if ongoing), notes: (40 year survivor); "severe vertigo" (unspecified if ongoing); "VACTERL syndrome at birth" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE; AMLODIPINE; EZETIMIBE; SERTRALINE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose:03; Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose:04; Manufacturer unknown), for Covid-19 Immunization. There were no other vaccines received in four weeks. The patient did not have Covid prior vaccination. The following information was reported: OFF LABEL USE (hospitalization), IMMUNISATION (hospitalization) all with onset 14Sep2022 at 15:00, outcome "unknown" and all described as "dose number: 5"; NEPHRITIS (hospitalization), SEPSIS (hospitalization) all with onset 16Sep2022 at 05:00, outcome "unknown" and all described as "Sepsis/nephritis"; URINARY TRACT INFECTION (hospitalization) with onset 16Sep2022 at 05:00, outcome "unknown", described as "UTI"; DYSURIA (hospitalization), FATIGUE (hospitalization) all with onset 16Sep2022 at 05:00, outcome "unknown" and all described as "difficulty urinating and tiredness"; PYREXIA (hospitalization) with onset 16Sep2022 at 05:00, outcome "unknown", described as "fever of 103". The patient was hospitalized for off label use, immunisation, nephritis, sepsis, pyrexia, dysuria, fatigue, urinary tract infection (start date: Sep2022). It was reported that the patient experienced fever of 103, difficulty urinating and tiredness. Went to urgent care where UTI was diagnosed. Sent to emergency room for further evaluation where IV antibiotics were started. Sepsis/nephritis are suspected, and patient is being admitted. The events "dose number: 5", "sepsis/nephritis", "fever of 103", "difficulty urinating and tiredness" and "UTI" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (16Sep2022) 103; SARS-CoV-2 test: (17Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of nephritis, sepsis, pyrexia, dysuria, fatigue, urinary tract infection.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Headache, Lymphadenopathy
Clinical narrative: Headache; Muscle pain; Chills; Nausea; Swollen lymph nodes; Decreased appetite; Dizziness; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: elo142), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Known allergies: egg" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, single, lot number : EN5318, vaccine location: left arm), administration date: 10Jan2021, for Covid-19 immunization; Covid-19 vaccine (dose 2, single, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (dose 3 (booster), single, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); DECREASED APPETITE (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); DIZZINESS (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); HEADACHE (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); MYALGIA (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022), described as "Muscle pain"; NAUSEA (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); LYMPHADENOPATHY (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022), described as "Swollen lymph nodes". Therapeutic measures were taken as a result of headache, myalgia, chills, nausea, lymphadenopathy, decreased appetite, dizziness.  Additional information: The patient did not receive other vaccine in four weeks. Facility type vaccine was Public Health Clinic/ Administration facility. The patient received apap 1000 mg Q 6-8 hours, Pepcid treatment for AE. The patient did have covid prior to vaccination. The patient did have covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201170341 Same reporter/ patient/ vaccine, different dose numbers/ events;
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Headache; Muscle pain; Chills; Nausea; Swollen lymph nodes; Decreased appetite; Dizziness; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: elo142), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Known allergies: egg" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, single, lot number : EN5318, vaccine location: left arm), administration date: 10Jan2021, for Covid-19 immunization; Covid-19 vaccine (dose 2, single, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (dose 3 (booster), single, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); DECREASED APPETITE (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); DIZZINESS (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); HEADACHE (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); MYALGIA (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022), described as "Muscle pain"; NAUSEA (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); LYMPHADENOPATHY (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022), described as "Swollen lymph nodes". Therapeutic measures were taken as a result of headache, myalgia, chills, nausea, lymphadenopathy, decreased appetite, dizziness.  Additional information: The patient did not receive other vaccine in four weeks. Facility type vaccine was Public Health Clinic/ Administration facility. The patient received apap 1000 mg Q 6-8 hours, Pepcid treatment for AE. The patient did have covid prior to vaccination. The patient did have covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201170341 Same reporter/ patient/ vaccine, different dose numbers/ events;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever/The temp reached 100.9 on Friday and stayed around 99.5 since Saturday mid day; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 17:30 as dose 4 (booster), single (Lot number: GJ2524), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Macrobid, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED: UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 16Sep2022 at 12:00, outcome "not recovered", described as "body aches"; PYREXIA (non-serious) with onset 16Sep2022 at 12:00, outcome "not recovered", described as "fever/The temp reached 100.9 on Friday and stayed around 99.5 since Saturday mid day". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain.  Additional Information: It was reported that, the patient had a fever and body aches since Friday afternoon. The temperature reached 100.9 on Friday and stayed around 99.5 since Saturday mid-day. She had known allergies to Penicillin and Bactria and other medical history: Macrobid. She had no other vaccine in four weeks. She had other medications in two weeks. She did not have COVID-19 prior to vaccination and was tested negative for COVID-19 post the vaccination. No treatment was received for the adverse events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This is a spontaneous report received from a contactable reporter (Consumer (patient's husband)) from medical information team.  A female patient 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 complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Cancer". Therapeutic measures were taken as a result of neoplasm malignant. Clinical course: The reporter mentioned that he was scheduled to receive the bivalent vaccine next Tuesday. Caller states he and his wife were taking Keytruda for cancer. His doctor said because they had received booster doses of the Pfizer COVID-19 Vaccine before and done well this one should not cause a problem as it is similar and a combination of mRNA from the original vaccine. The reporter was asking if he can get this vaccine at the same time as his flu vaccine, and if it is true that this vaccine is a combination of the old vaccine and something new for Omicron.  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-202201169977 same vaccine and event, different patient;
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Worst headache; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 24Aug2022 at 09:30 as dose 1, single (Lot number: PF7140) at the age of 62 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 24Aug2022 at 21:30, outcome "recovered" (27Aug2022); HEADACHE (non-serious) with onset 24Aug2022 at 21:30, outcome "recovered" (27Aug2022), described as "Worst headache". Therapeutic measures were taken as a result of headache, chills. Additional information: No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination, COVID not tested post vaccination. 12 Hours after the shot the patient started having chills and "the worst headache he had ever had". They lasted for about 3 days. The patient was told to take Advil or Tylenol for treatment.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A little sore at the site" after receiving those previous doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 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, reaction(s): ""a little sore at the site" after receiving those previous doses". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "A little sore at the site" after receiving those previous doses". 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: Vaccination site pain
Clinical narrative: "a little sore at the site" after receiving those previous doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "suspected nickel allergy" (unspecified if ongoing), notes: sometimes the earrings that have nickel irritate my skin. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization, reaction(s): ""a little sore at the site" after receiving those previous doses"; Bnt162b2 (Dose 2, single), for Covid-19 immunization, reaction(s): ""a little sore at the site" after receiving those previous doses". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as ""a little sore at the site" after receiving those previous doses".  Additional information: The patient took the first 2 Pfizer shots at her hospital, and the 2 boosters at her pharmacy. Her pharmacist wasn't sure whether she could get the new booster when she "went 3 days ago".    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: Vaccination site pain
Clinical narrative: "a little sore at the site" after receiving those previous doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "nickel allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): ""a little sore at the site" after receiving those previous doses"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): ""a little sore at the site" after receiving those previous doses"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization, reaction(s): ""a little sore at the site" after receiving those previous doses". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as ""a little sore at the site" after receiving those previous doses".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Oct2021 as dose number unknown, single (Lot number: EN6206) at the age of 27 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir (PAXLOVID) from 13Sep2022 to 15Sep2022.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3247), in left arm and on 06Feb2021 as dose 2, single (Lot number: EM9810) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Nov2021 as dose 3 (booster), single (Lot number: 026D21A), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Positive, notes: Indication: Treatment of COVID-19; (17Sep2022) Positive, notes: Tested on 5th day after stopping paxolvid and tested very clear positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.