chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted COVID-19.; Contracted COVID-19.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 23Mar2021 as dose 2, single (Lot number: EP6955) and on 25Nov2021 as dose 3 (booster) single (Lot number: FF8839) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history was not reported. Other vaccine in four weeks reported as no and other medications in two weeks reported as none. The patient did not have covid prior vaccination and covid tested after vaccination. There were no concomitant medications.    The following information was reported: VACCINATION FAILURE (medically significant) with onset 13Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 13Jun2022, outcome "recovering" and all described as "Contracted COVID-19.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive, notes: BinaxNow. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy
Clinical narrative: lymph nodes under her left arm were swollen and black and blue; lymph nodes under her left arm were swollen and black and blue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: CONTUSION (non-serious), LYMPHADENOPATHY (non-serious) all with onset 2022, outcome "unknown" and all described as "lymph nodes under her left arm were swollen and black and blue".  Additional information: The caller, also had a rough time with the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CHF" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result; Negative; Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not receive other medication in 2 weeks. Patient had no known allergies. COVID-19 Rebound - positive home tests following 2 days of negative ones. Patient received Paxlovid (anti viral product, Lot number: GC4035) from 13Jun2022 to 17Jun2022 for 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 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 05May2021 as dose 2, single (Lot number: EW0179) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diarrhoea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Advil, reaction(s): "Known allergies: Yes, advil family and related RX".  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient received other medication in 2weeks product: colestipol, start date: 03Apr2022.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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.  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Antiviral COVID 19 Treatment include Paxlovid, treatment start date was 08Jun2022 and treatment stop date was 11Jun2022. Adverse event was rebound covid after seven days. Patient had no allergies. No other medication in 2 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Cheilitis, Flushing, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Bell's Palsy; Vertigo; face numbness; I also have episodes of excessive sweating and flushing; I also have episodes of excessive sweating and flushing; developed red sores on the edge of my lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 3 (booster), single (Lot number: F35682) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (prev dose lot number=ER8732,, prev dose number=2), administration date: 07Apr2021, when the patient was 40-year-old, for COVID-19 Immunization, reaction(s): "COVID-19", "Bell's Palsy", "Vertigo", "face numbness", "episodes of excessive sweating", "flushing"; BNT162b2 (prev dose lot number=EN6199,, prev dose number=1), administration date: 18Mar2021, when the patient was 40-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: BELL'S PALSY (disability, medically significant) with onset 28Apr2022, outcome "not recovered"; HYPERHIDROSIS (disability), FLUSHING (disability) all with onset 2022, outcome "not recovered" and all described as "I also have episodes of excessive sweating and flushing"; VERTIGO (disability) with onset 2022, outcome "not recovered"; CHEILITIS (disability) with onset 2022, outcome "not recovered", described as "developed red sores on the edge of my lips"; HYPOAESTHESIA (disability) with onset 2022, outcome "not recovered", described as "face numbness".  It was reported that, again 40-50 days after booster shot on 28Apr2022. Patient also developed red sores on the edge of his lips. Patient had never had either of these things before in his life. Until after the vaccine. He also had a breakthrough Covid infection in Aug2021. The events "bell's palsy", "vertigo", "face numbness", "i also have episodes of excessive sweating and flushing" and "developed red sores on the edge of my lips" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If covid tested post vaccination: Yes. Therapeutic measures were taken as a result of bell's palsy, vertigo, hypoaesthesia, hyperhidrosis, flushing, cheilitis.  Follow-Up (23Jun2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200866994 Same patient, different dose and event;US-PFIZER INC-202200867634 Same patient and event, different dose;
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: Bell's Palsy; Vertigo; face numbness; I also have episodes of excessive sweating and flushing; I also have episodes of excessive sweating and flushing; developed red sores on the edge of my lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 3 (booster), single (Lot number: F35682) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (prev dose lot number=ER8732,, prev dose number=2), administration date: 07Apr2021, when the patient was 40-year-old, for COVID-19 Immunization, reaction(s): "COVID-19", "Bell's Palsy", "Vertigo", "face numbness", "episodes of excessive sweating", "flushing"; BNT162b2 (prev dose lot number=EN6199,, prev dose number=1), administration date: 18Mar2021, when the patient was 40-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: BELL'S PALSY (disability, medically significant) with onset 28Apr2022, outcome "not recovered"; HYPERHIDROSIS (disability), FLUSHING (disability) all with onset 2022, outcome "not recovered" and all described as "I also have episodes of excessive sweating and flushing"; VERTIGO (disability) with onset 2022, outcome "not recovered"; CHEILITIS (disability) with onset 2022, outcome "not recovered", described as "developed red sores on the edge of my lips"; HYPOAESTHESIA (disability) with onset 2022, outcome "not recovered", described as "face numbness".  It was reported that, again 40-50 days after booster shot on 28Apr2022. Patient also developed red sores on the edge of his lips. Patient had never had either of these things before in his life. Until after the vaccine. He also had a breakthrough Covid infection in Aug2021. The events "bell's palsy", "vertigo", "face numbness", "i also have episodes of excessive sweating and flushing" and "developed red sores on the edge of my lips" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If covid tested post vaccination: Yes. Therapeutic measures were taken as a result of bell's palsy, vertigo, hypoaesthesia, hyperhidrosis, flushing, cheilitis.  Follow-Up (23Jun2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200866994 Same patient, different dose and event;US-PFIZER INC-202200867634 Same patient and event, different dose;
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Bell's Palsy; Vertigo; face numbness; I also have episodes of excessive sweating and flushing; I also have episodes of excessive sweating and flushing; developed red sores on the edge of my lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 3 (booster), single (Lot number: F35682) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (prev dose lot number=ER8732,, prev dose number=2), administration date: 07Apr2021, when the patient was 40-year-old, for COVID-19 Immunization, reaction(s): "COVID-19", "Bell's Palsy", "Vertigo", "face numbness", "episodes of excessive sweating", "flushing"; BNT162b2 (prev dose lot number=EN6199,, prev dose number=1), administration date: 18Mar2021, when the patient was 40-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: BELL'S PALSY (disability, medically significant) with onset 28Apr2022, outcome "not recovered"; HYPERHIDROSIS (disability), FLUSHING (disability) all with onset 2022, outcome "not recovered" and all described as "I also have episodes of excessive sweating and flushing"; VERTIGO (disability) with onset 2022, outcome "not recovered"; CHEILITIS (disability) with onset 2022, outcome "not recovered", described as "developed red sores on the edge of my lips"; HYPOAESTHESIA (disability) with onset 2022, outcome "not recovered", described as "face numbness".  It was reported that, again 40-50 days after booster shot on 28Apr2022. Patient also developed red sores on the edge of his lips. Patient had never had either of these things before in his life. Until after the vaccine. He also had a breakthrough Covid infection in Aug2021. The events "bell's palsy", "vertigo", "face numbness", "i also have episodes of excessive sweating and flushing" and "developed red sores on the edge of my lips" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If covid tested post vaccination: Yes. Therapeutic measures were taken as a result of bell's palsy, vertigo, hypoaesthesia, hyperhidrosis, flushing, cheilitis.  Follow-Up (23Jun2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200866994 Same patient, different dose and event;US-PFIZER INC-202200867634 Same patient and event, different dose;
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Cheilitis, Flushing, Hyperhidrosis, Hypoaesthesia
Clinical narrative: I also had a breakthrough COVID infection in August 2021; I also had a breakthrough COVID infection in August 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6199), on 07Apr2021 as dose 2, single (Lot number: ER8732) and on 27Apr2022 as dose 3 (booster), single (Lot number: F35682) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2021, outcome "unknown" and all described as "I also had a breakthrough COVID infection in August 2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If covid tested post vaccination: Yes. Facility type vaccine was Doctor's office/urgent care, No other vaccine in four weeks. The patient experienced Bell's Palsy. Vertigo and face numbness. Stated that I also have episodes of excessive sweating and flushing. 1st episode started between 40-60 days after 2nd vaccine in 08Apr2021. It was getting better then boom Bell's Palsy is back. Again 40-50 days after booster shot on 28Apr2022. I've also developed red sores on the edge of my lips. I've never had either of these things before in my life. Until after the vaccine. I also had a breakthrough COVID infection in Aug2021.Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Patient was not recovered, Ae treatment included Prednisone and Valtrex. Patient was not tested for covid prior vaccination and was covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200864099 Same patient, different dose and event;US-PFIZER INC-202200867634 Same patient, different dose and event;
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: I also had a breakthrough COVID infection in August 2021; I also had a breakthrough COVID infection in August 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6199), on 07Apr2021 as dose 2, single (Lot number: ER8732) and on 27Apr2022 as dose 3 (booster), single (Lot number: F35682) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2021, outcome "unknown" and all described as "I also had a breakthrough COVID infection in August 2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If covid tested post vaccination: Yes. Facility type vaccine was Doctor's office/urgent care, No other vaccine in four weeks. The patient experienced Bell's Palsy. Vertigo and face numbness. Stated that I also have episodes of excessive sweating and flushing. 1st episode started between 40-60 days after 2nd vaccine in 08Apr2021. It was getting better then boom Bell's Palsy is back. Again 40-50 days after booster shot on 28Apr2022. I've also developed red sores on the edge of my lips. I've never had either of these things before in my life. Until after the vaccine. I also had a breakthrough COVID infection in Aug2021.Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Patient was not recovered, Ae treatment included Prednisone and Valtrex. Patient was not tested for covid prior vaccination and was covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200864099 Same patient, different dose and event;US-PFIZER INC-202200867634 Same patient, different dose and event;
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I also had a breakthrough COVID infection in August 2021; I also had a breakthrough COVID infection in August 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6199), on 07Apr2021 as dose 2, single (Lot number: ER8732) and on 27Apr2022 as dose 3 (booster), single (Lot number: F35682) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2021, outcome "unknown" and all described as "I also had a breakthrough COVID infection in August 2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If covid tested post vaccination: Yes. Facility type vaccine was Doctor's office/urgent care, No other vaccine in four weeks. The patient experienced Bell's Palsy. Vertigo and face numbness. Stated that I also have episodes of excessive sweating and flushing. 1st episode started between 40-60 days after 2nd vaccine in 08Apr2021. It was getting better then boom Bell's Palsy is back. Again 40-50 days after booster shot on 28Apr2022. I've also developed red sores on the edge of my lips. I've never had either of these things before in my life. Until after the vaccine. I also had a breakthrough COVID infection in Aug2021.Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Patient was not recovered, Ae treatment included Prednisone and Valtrex. Patient was not tested for covid prior vaccination and was covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200864099 Same patient, different dose and event;US-PFIZER INC-202200867634 Same patient, different dose and event;
Age: 69.0
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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EM6206), in left arm, on 21Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: EW0187), in left arm and on 16Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Discoid lupus" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Covid rebound., notes: Return of symptoms 2 days after testing negative after 5 day course of Paxlovid; negative, notes: Covid rebound. Return of symptoms 2 days after testing negative after 5 day course of Paxlovid. Therapeutic measures were taken with Paxlovid as a result of vaccination failure, covid-19.  Clinical information: Patient did not received other medication in 2 weeks. Patient treated with Paxlovid from 07Jun2022 to 11Jun2022. Covid rebound. Return of symptoms 2 days after testing negative after 5 day course of Paxlovid (from 16Jun2022 02:00 PM) and outcome was Recovering. Ae treatment: Penicillin  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid symptoms 20Jun2022 and testing positive again; Covid symptoms 20Jun2022 and testing positive again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1 , single (Batch/Lot number: unknown), in left arm and in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022, outcome "unknown" and all described as "Covid symptoms 20Jun2022 and testing positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: still testing positive; (16Jun2022) Negative, notes: Tested again 16Jun2022 and was negative; (20Jun2022) Positive, notes: started having Covid symptoms 20Jun2022 and testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. patient received paxlovid as covid-19 treatment.  Clinical course: No other medication in 2 weeks. Took Paxlovid on day 1 of Covid 06Jun2022. Was told by Dr could return to work 12Jun2022, but work required negative test and still testing positive. Tested again 16Jun2022 and was negative. Scheduled to return to work 21Jun2022 but started having Covid symptoms 20Jun2022 and testing positive again.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: 330268D), in right arm and on 05May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Mar2021 as dose 1, single (Lot number: 038A21A), in right arm and on 20Apr2021 as dose 2, single (Lot number: 006B21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE], start date: 07Jun2022, stop date: 09Jun2022; SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE], start date: 07Jun2022, stop date: 10Jun2022; BENADRYL, start date: 08Jun2022, stop date: 10Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid starting from 07Jun2022 to 11Jun2022. Clinical course: Vaccine and Other medication in two weeks were received. The patient had no known allergies.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "CKD stage 3" (unspecified if ongoing); "obstructive sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; HYDROCHLOROTHIAZIDE. Past drug history included: Penicillin for Hives, notes: Known allergies: Penicillin (hives). The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 21Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 21Jun2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (14Jun2022) Negative, notes: She previously tested negative on 14Jun; (21Jun2022) Positive, notes: She retested today 21Jun2022 and tested positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received vaccine. The patient received other medication Levothyroxine, hydrochlorothiazide in 2 weeks. Anti-viral details: The patient received Paxlovid via oral route from 06Jun2022 to 10Jun2022 for COVID 19 treatment of COVID-19.  Adverse event start date: 18Jun2022. Patient experienced rebound covid symptoms on Sunday 19Jun2022. She retested today 21Jun2022 and tested positive. She previously tested negative on 14Jun after finishing course of Paxlovid on 11Jan. The patient was recovering without treatment for AE.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 31May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "muscular dystrophy" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "skin cancer" (unspecified if ongoing); "allergy: Avocado" (unspecified if ongoing); "allergy: tree nuts" (unspecified if ongoing); "allergy: nickel" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Additional information: It was unknown if patient received other medication in 2weeks. Anti-viral details: product=COVID 19 Treatment, brand: Paxlovid, treatment start date=09Jun2022, treatment stop date: 13Jun2022, indication: Treatment of COVID-19. Return of symptoms 5 days after my last dose of paxlovid.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: ongoing headache everyday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 28May2021 as dose 1, single (Lot number: FC3182) at the age of 55 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "ongoing headache everyday". The event "ongoing headache everyday" required physician office visit. Therapeutic measures were taken as a result of headache. Additional information: Caller is calling about the Pfizer COVID-19 vaccine. Caller got both shots at (pharmacy name), confirmed 2 total doses of the Pfizer COVID-19 vaccine, and caller has been having an ongoing headache everyday, been to the neurologist and is still having headache. Calling to report headache. Start date of adverse event: Caller has his vaccine card. Caller is going to look on some medications that HCP prescribed for caller's headache to see a date. 03Sep2021 is when caller received the medication, Etodolac, for headache. Unknown exact date for when the headache started, but that is why caller got the medication, for headache. Vaccination Facility Type: Pharmacy/ Drug Store. Vaccine Administered at Facility: No. Got the flu shot the same day as the 2nd dose of the Pfizer COVID-19 vaccine. Vaccine Name: Unknown of the specific name of flu shot. AE Headache require a visit to Physician Office, no emergency room. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No. AE(s) following prior vaccinations: None. Family Medical History Relevant to AE(s): No. Caller is just reporting headache today, not sure, has been to HCP about headache and HCP also prescribed Sumatriptan medication, 50mg, for caller's headache. Sumatriptan:NDC number: 65862, Lot number: SQ5021020-A, Expiration date: Apr2025, Formulation, dose: 50mg, tablets, count size 9 tablets. Indication: For headache, for migraine headaches. Is a sample of the product available to be returned, if requested (Y/N): Yes for both. Packaging sealed and intact? Yes for both.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200867377 same patient/reporter, different dose/vaccine licensing;
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Nausea, Pain
Clinical narrative: About 18 hours after the injection, rash over upper arm developed/The associated skin broke out; High fever; severe body aches; headache; nausea; fatigue; weakness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 17Jun2022 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 12Jun2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 08Oct2021, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering", described as "About 18 hours after the injection, rash over upper arm developed/The associated skin broke out"; PYREXIA (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering", described as "High fever"; FATIGUE (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering"; HEADACHE (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering"; NAUSEA (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering"; PAIN (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering", described as "severe body aches"; ASTHENIA (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering", described as "weakness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that about 18 hours after the injection, rash over upper arm developed. The associated skin broke out. High fever, severe body aches and headache, nausea. Persisted for 48 hours. Then fatigue and weakness. No other vaccine in four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: About 18 hours after the injection, rash over upper arm developed/The associated skin broke out; High fever; severe body aches; headache; nausea; fatigue; weakness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 17Jun2022 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 12Jun2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 08Oct2021, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering", described as "About 18 hours after the injection, rash over upper arm developed/The associated skin broke out"; PYREXIA (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering", described as "High fever"; FATIGUE (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering"; HEADACHE (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering"; NAUSEA (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering"; PAIN (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering", described as "severe body aches"; ASTHENIA (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering", described as "weakness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that about 18 hours after the injection, rash over upper arm developed. The associated skin broke out. High fever, severe body aches and headache, nausea. Persisted for 48 hours. Then fatigue and weakness. No other vaccine in four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: He has been vaccinated for a year and even with the booster he must of had a break threw case. He was swabbed Saturday and has Covid; Bad sinus stuff and they did a PCR test and it came back positive for covid/he had a bad sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6206), on 03Apr2021 as dose 2, single (Lot number: ER8727), on 12Nov2021 as dose 3 (booster), single (Lot number: FM8020) and on 21Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). The patient's family history included: "Diabetes" (unspecified if ongoing), notes: Mother passed away years ago, she was a diabetic. Concomitant medication(s) included: OLMESARTAN table once a day taken for blood pressure abnormal; AMLODIPINE 5mg once a day in the evening taken for blood pressure abnormal; CARVEDILOL 6.25mg twice a day taken for blood pressure abnormal; VITAMIN D [COLECALCIFEROL]; FISH OIL. Vaccination history included: Flu shot (got a flu shot last year, no further details provided). The following information was reported: COVID-19 (medically significant) with onset 18Jun2022, outcome "unknown", described as "Bad sinus stuff and they did a PCR (Polymerase chain reaction) test and it came back positive for covid/he had a bad sore throat"; VACCINATION FAILURE (medically significant) with onset 18Jun2022, outcome "unknown", described as "He has been vaccinated for a year and even with the booster he must of had a break threw case. He was swabbed Saturday and has Covid". The events "he has been vaccinated for a year and even with the booster he must of had a break threw case. he was swabbed Saturday and has covid" and "bad sinus stuff and they did a PCR test and it came back positive for covid/he had a bad sore throat" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: He tested positive (nasal swab) on Saturday, he had a bad sore throat. He went to PRIVACY for bad sinus stuff, and they did a PCR test and it came back positive for covid. Patient confirmed that he did not seek medical attention for worsening symptoms. His doctor called him on Monday and suggested to take Paxlovid. His doctor had a discussion about side effects and all this other stuff and told him to read all the materials before taking it. He started treatment with Paxlovid (Batch/lot number: GA9816), for a total of 3 tablets by mouth for COVID-19. He only took the one dose last night (1 tablet) on 20Jun2022 and that was it, stated he was stopping it now. His doctor told him he should start feeling better within a couple of days. Discontinued Paxlovid due to adverse events.
Age: 55.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old male patient received BNT162b2 (BNT162B2), on 27Aug2021 as dose 2, single (Lot number: FC3182) at the age of 55 years, in right arm for covid-19 immunization; influenza vaccine (INFLUENZA VACCINE), on 27Aug2021 as dose number unknown, single (Batch/Lot number: unknown) for influenza. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Pfizer COVID-19 vaccine 1st dose, Lot Number / Expiry Date: Unknown, Route, Anatomical Location: In arm, unknown which arm.), administration date: 28May2021, when the patient was 55-year-old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "1st dose: 28May2021/2nd dose: 27Aug2021"; HEADACHE (non-serious), outcome "not recovered", described as "ongoing headache everyday". Therapeutic measures were taken as a result of headache. Additional information: Caller is calling about the Pfizer COVID-19 vaccine. Caller got both shots at #, confirmed 2 total doses of the Pfizer COVID-19 vaccine, and caller has been having an ongoing headache everyday, been to the neurologist and is still having headache. Calling to report headache. Caller has his vaccine card. Caller is going to look on some medications that HCP prescribed for caller's headache to see a date. 03Sep2021 is when caller received the medication, Etodolac,(400mg, quantity of 60,take 1 tablet by mouth twice) for headache. Unknown exact date for when the headache started, but that is why caller got the medication, for headache. Caller is just reporting headache today, not sure, has been to HCP about headache and HCP also prescribed Sumatriptan medication, 50mg, for caller's headache.  Vaccination Facility Type: Pharmacy/ Drug Store. Vaccine not Administered at Military Facility. List all vaccines administered on same date with the Pfizer vaccine considered as suspect: Got the flu shot the same day as the 2nd dose of the Pfizer COVID-19 vaccine. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No. Family Medical History Relevant to AE(s): No. Relevant Tests: Unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202200866909 same patient/reporter, different dose/vaccine licensing;
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Flushing, Hyperhidrosis, Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: Bell's Palsy; Vertigo; face numbness; I also have episodes of excessive sweating and flushing; I also have episodes of excessive sweating and flushing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: ER8732) at the age of 40 years for covid-19 immunization. The patient's relevant medical history included: "Allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (prev dose lot number=EN6199, prev dose dose number=1), administration date: 18Mar2021, for COVID-19 Immunization. The following information was reported: BELL'S PALSY (disability, medically significant) with onset 2021, outcome "not recovered"; HYPERHIDROSIS (disability), FLUSHING (disability) all with onset 2021, outcome "not recovered" and all described as "I also have episodes of excessive sweating and flushing"; VERTIGO (disability) with onset 2021, outcome "not recovered"; HYPOAESTHESIA (disability) with onset 2021, outcome "not recovered", described as "face numbness". The events "bell's palsy", "vertigo", "face numbness" and "i also have episodes of excessive sweating and flushing" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If covid tested post vaccination: Yes. Therapeutic measures were taken as a result of bell's palsy, vertigo, hypoaesthesia, hyperhidrosis, flushing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200866994 Same patient, different dose and event;US-PFIZER INC-202200864099 Same patient, different dose and event;US-PFIZER INC-202200866994 Same patient, different dose and event;
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Bell's Palsy; Vertigo; face numbness; I also have episodes of excessive sweating and flushing; I also have episodes of excessive sweating and flushing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: ER8732) at the age of 40 years for covid-19 immunization. The patient's relevant medical history included: "Allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (prev dose lot number=EN6199, prev dose dose number=1), administration date: 18Mar2021, for COVID-19 Immunization. The following information was reported: BELL'S PALSY (disability, medically significant) with onset 2021, outcome "not recovered"; HYPERHIDROSIS (disability), FLUSHING (disability) all with onset 2021, outcome "not recovered" and all described as "I also have episodes of excessive sweating and flushing"; VERTIGO (disability) with onset 2021, outcome "not recovered"; HYPOAESTHESIA (disability) with onset 2021, outcome "not recovered", described as "face numbness". The events "bell's palsy", "vertigo", "face numbness" and "i also have episodes of excessive sweating and flushing" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If covid tested post vaccination: Yes. Therapeutic measures were taken as a result of bell's palsy, vertigo, hypoaesthesia, hyperhidrosis, flushing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200866994 Same patient, different dose and event;US-PFIZER INC-202200864099 Same patient, different dose and event;US-PFIZER INC-202200866994 Same patient, different dose and event;