chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC20
Symptoms: Hypoaesthesia, Nerve injury, Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: nerve damage; numbness; itching; tingling when trying to pick up something feels like an electric shock.; nerve type pain; pain located in the hands, feet, lower arms, and legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVE INJURY (non-serious), outcome "unknown", described as "nerve damage"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness"; PRURITUS (non-serious), outcome "unknown", described as "itching"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling when trying to pick up something feels like an electric shock."; NEURALGIA (non-serious), outcome "unknown", described as "nerve type pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain located in the hands, feet, lower arms, and legs".  Additional information: Caller states his wife (age unknown, did not want to provide age but states she is a senior female) received prevnar20. After several days she started to have the following symptoms: numbness, itching or pain, in the hands, feet, skin on the lower arms and legs, tingling when trying to pick up something feels like an electric shock. The reporter want to know if Prevnar20 cause these symptoms and if it caused nerve damage. She received Prevnar 20, received date unknown, and several days after she started to develop symptoms of numbness, itching, and pain located in the hands, feet, lower arms, and legs. She has tingling. When she tried to pick up something it was like an electric shock, nerve type pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Pruritus
Clinical narrative: nerve damage; numbness; itching; tingling when trying to pick up something feels like an electric shock.; nerve type pain; pain located in the hands, feet, lower arms, and legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVE INJURY (non-serious), outcome "unknown", described as "nerve damage"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness"; PRURITUS (non-serious), outcome "unknown", described as "itching"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling when trying to pick up something feels like an electric shock."; NEURALGIA (non-serious), outcome "unknown", described as "nerve type pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain located in the hands, feet, lower arms, and legs".  Additional information: Caller states his wife (age unknown, did not want to provide age but states she is a senior female) received prevnar20. After several days she started to have the following symptoms: numbness, itching or pain, in the hands, feet, skin on the lower arms and legs, tingling when trying to pick up something feels like an electric shock. The reporter want to know if Prevnar20 cause these symptoms and if it caused nerve damage. She received Prevnar 20, received date unknown, and several days after she started to develop symptoms of numbness, itching, and pain located in the hands, feet, lower arms, and legs. She has tingling. When she tried to pick up something it was like an electric shock, nerve type pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Carpal tunnel syndrome, Hypertension, Pyrexia, Sluggishness
Clinical narrative: blood pressure 140/80,; fever day and a half; sluggish but fine; Caller has recently been diagnosed with "severe" carpal tunnel in right hand; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "blood pressure 140/80,"; PYREXIA (non-serious), outcome "unknown", described as "fever day and a half"; SLUGGISHNESS (non-serious), outcome "unknown", described as "sluggish but fine"; CARPAL TUNNEL SYNDROME (non-serious), outcome "unknown", described as "Caller has recently been diagnosed with "severe" carpal tunnel in right hand". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was also reported that the patient was basically in good health and stated he had taken two vaccines plus the booster, 3-4 months ago. Caller stated he had a little bit of a reaction, fever day and a half, sluggish but fine. Caller stated his most recent blood pressure 140/80, and six months ago after second shot, it was 150/85-88.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm, on 27Apr2022 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years, in left arm and on 16Dec2021 at 11:00 as dose 3 (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: "High blood pressure" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) or other medication in 2 weeks included: SYNTHROID; LOSARTAN; COZAAR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Treatment of COVID-19; (2022) Positive, notes: Recurrence of symptoms on day 10 with a positive COVID test. Therapeutic measures were taken as a result of vaccination failure, covid-19. For covid-19, the patient was given anti-viral Paxlovid from 23Jun2022 to 28Jun2022. Treatment also included Remdesivir.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
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) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN, stop date: 02Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details Product COVID 19 Treatment, brand Paxlovid, Treatment start date 03Jul2022, Lot number FW4118, Indication Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Treated high blood pressure" (unspecified if ongoing); "Bradycardia" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinal course: No Known allergies reported. Anti-viral details: product- COVID 19 Treatment, treatment start date-27Jun2022, treatment stop date-01Jul2022, indication-Treatment of COVID-19.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: EK5730), in right arm, on 10Jan2021 as dose 2, single (Lot number: EL1283), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: EW0186), in right arm and on 10Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Undifferentiated mixed connective tissue disease" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE MOFETIL, start date: 30Nov2020, stop date: 20Jun2022. Past drug history included: Clindamycin, reaction(s): "Drug Allergy".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound CoVID on day 9 from positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19. This Report about covid treatment. The patient has received vaccine. Patient had other medication in 2 weeks. Patient received treatment for COVID-19 as Paxlovid from 20Jun2022 to 25Jun2022.  The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/ Re-occurance of Covid- Rebound Covid; Treatment of COVID-19/ Re-occurance of Covid- Rebound Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2022 at 17:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 76 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: "lung cancer" (not ongoing), notes: Recovered lung cancer; "emphysema" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE, start date: Jan2020, stop date: 05Jul2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/ Re-occurance of Covid- Rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results.   Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive for COVID; positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0158), in left arm, on 05May2021 as dose 2, single (Lot number: EW0179), in left arm and on 11Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "born with 1 kidney" (unspecified if ongoing), notes: born with 1 kidney; "Acid stomach" (unspecified if ongoing), notes: Acid stomach; "outdoor allergies" (unspecified if ongoing), notes: outdoor allergies. Concomitant medication(s) included: OMEPRAZOLE; IBUPROFEN; MELOXICAM. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "not recovered" and all described as "positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: after testing negative a couple of days earlier; (05Jul2022) Positive, notes: positive for COVID (after testing negative a couple of days earlier). Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: The patent age group was Adult (18-64 Years). The patient was received Covid-19 treatment with Paxlovid from 26Jun2022 to 30Jun2022 (Lot number GA3594). The patient received other medications within 2 weeks to the Covid-19 vaccine. The patient had no known allergies. Adverse event Four days after completing treatment, began to feel congested in nose/ears. Experienced a sinus headache. Took a home test five days after completing treatment and it came back positive for COVID (after testing negative a couple of days earlier). The patient not received treatment and the outcome of the event was not recovered.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Leukaemia, Pain in extremity, Pyrexia
Clinical narrative: leukemia; Had fever in Dec and in Feb started fever; hand pain in right arm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 9-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 2, single (Lot number: FK5127) at the age of 9 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Juvenile arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. Vaccination history included: BNT162b2 (Dose 1 single, lot number: FK5127, vaccine location: Left arm), administration date: 12Nov2021, when the patient was 9-year-old, for Covid-19 immunization. The patient was not diagnosed with covid prior vaccination. The patient was not tested for covid post vaccination. No known allergies.  The following information was reported: PYREXIA (non-serious) with onset 24Dec2021, outcome "not recovered", described as "Had fever in Dec and in Feb started fever"; PAIN IN EXTREMITY (non-serious) with onset 24Dec2021, outcome "not recovered", described as "hand pain in right arm"; LEUKAEMIA (medically significant) with onset 24Dec2021, outcome "not recovered", described as "leukemia". The events "leukemia", "had fever in dec and in feb started fever" and "hand pain in right arm" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (24Dec2021) Unknown results, notes: Had fever in Dec and in Feb started fever and hand pain in right arm which was finally diagnosed as a pre be All leukemia. Therapeutic measures (included Chemotherapy) were taken as a result of leukaemia, pyrexia, pain in extremity. Adverse event resulted in: Emergency room/department or urgent care.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Person is reporting persistent "brain fog" post-vaccination; This is a spontaneous report received from contactable reporter(s) (Physician).  A 13-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 12 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Person is reporting persistent "brain fog" post-vaccination". It was unknown if therapeutic measures were taken as a result of feeling abnormal.  Additional information: The most recent COVID-19 vaccine was administered reported as unknown. The patient receives any other vaccines within 4 weeks prior to the COVID vaccine reported as unknown. Prior to vaccination, the patient was diagnosed with COVID-19 reported as unknown. Since the vaccination, the patient has been tested for COVID-19 reported as unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Dec2021 at 12:00 as DOSE 4 (booster), SINGLE (Lot number: FJ6369 and the expiry date was unknown) at the age of 66 years, in left arm for COVID-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as DOSE 1, SINGLE (Batch/Lot number and the expiry date were unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number and the expiry date were unknown) for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing); "Known allergies: Coconut" (unspecified if ongoing). Concomitant medication(s) included: EZETIMIBE; MONTELUKAST; FLUTICASONE PROPIONATE.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: It was reported that the patient received anti-viral Paxlovid for COVID 19 Treatment, (Lot number=GA7394). It was also reported that the patient received Android Elipta (start date 01Jun2018) other medication within 2 weeks product. It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that the patient previously receives a COVID-19 Vaccine. On 01Jul2022 at 06:00 PM the patient experienced very strong metallic taste in mouth and patient did not receive the treatment and the outcome for this event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient'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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (Jul2022) Positive, notes: tested positive 4 days after finishing the Paxlovid course; (2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: After getting better and testing negative for SARSCov2 virus, I started with symptoms and tested positive 4 days after finishing the Paxlovid course. Symptoms improved quickly but I am still testing positive on RAT 19 days after the first positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
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 52-year-old female patient received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 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: "Asthma" (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 Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Antiviral details: product=COVID 19 Treatment, Treatment start date 25Jun2022, Treatment stop date 30Jun2022, Indication treatment of COVID-19, Reported Event was Covid Rebound, Adverse event start date was 04Jul2022, If patient not recovered, If treatment ae was No. Known allergies was no. Device Date was 05Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, SARS-CoV-2 test
Clinical narrative: Tremendous high  blood pressure;  had to go to the ER.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 14:15 as dose 4 (booster), single (Lot number: fp4554) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: ff2587, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 07Oct2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: en5818, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 09Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: e61283, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 19Jan2021, when the patient was 71-year-old, for COVID-19 Immunization. The following information was reported: HYPERTENSION (medically significant) with onset 08Jun2022 at 11:00, outcome "recovering", described as "Tremendous high  blood pressure;  had to go to the ER.". The event "tremendous high  blood pressure;  had to go to the er." required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Hypertension: (08Jun2022) blood pressure high, notes: Tremendous high blood pressure; SAaS-CoV-2 test: (01Jun2022) Negative, notes: COVID test type post vaccination nasal.Therapeutic measures were taken as a result of hypertension.
Age: 84.0
Sex: F
Vaccine: 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 84 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Feb2021 as dose 1, single (Lot number: 043620A), in right arm and on 10Nov2021 as dose 2, single (Lot number: 046c2119), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lymphedema" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Other medication were taken in 2 weeks. Anti viral product used for COVID 19 treatment was Paxlovid. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device date: 05Jul2022.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment with Paxlovid; COVID 19 Treatment with Paxlovid; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: el3247), in left arm, on 24Feb2021 as dose 2, single (Lot number: el3247), in left arm, on 10Nov2021 as dose 3 (booster), single (Lot number: ff8841), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: fl3197) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Purfumes" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL oral. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment with Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: It only takes 2 second for them to turn positive.; It only takes 2 second for them to turn positive.; 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 26Mar2021 as dose 1, single (Lot number: EP6955), on 16Apr2021 as dose 2, single (Lot number: ER8731) and on 03Dec2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "pneumonia" (unspecified if ongoing), notes: He had previous exposure to pneumonia and has weak lungs.; "headache" (unspecified if ongoing), notes: Advil for the headache. Concomitant medication(s) included: ADVIL [IBUPROFEN] taken for headache. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "It only takes 2 second for them to turn positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: He had all the vaccines, but had not gotten COVID until now. He lights up the test. It only takes 2 second for them to turn positive. Dose described as: 3 tablets at a time and it says 150 mg of the Nirmatrelvir and Ritonavir 100mg. It comes in a series of 3; 1 Ritonavir 100mg and 2 of the Nirmatrelvir 150 mg each time twice daily by mouth. Other medications provided as only Advil for the headache and he took a antihistamine because he originally thought it was an allergy attack. No further details provided. They were just over the counter ones.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment/Tested positive of 16Jun2022; COVID 19 Treatment/Tested positive of 16Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), on 18Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 27Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: RESTASIS, start date: 10Mar2022, stop date: 16Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment/Tested positive of 16Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (16Jun2022) Positive; (29Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: the patient tested positive of 16Jun2021 Mild flu like symptoms. Began Paxlovid when T went to 102. Negative Ag home test for 3 days after completing Paxlovid 5-day course. Tested positive again on 29Jun2022. Mild symptoms. But extreme fatigue and still positive with fatigue to date. Adverse events start date reported as 29Jun2022 (as reported). Adverse events start time reported as 10:00 (as reported). Adverse was not resulted in emergency room or physician office visit.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19, 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 59-year-old male patient received BNT162b2 (BNT162B2), on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) 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) and as dose 2, 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 Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment drug as Paxlovid for COVID-19 from 22Jun2022 to 26Jun2022. Patient did not received any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Lot number: EL1284), in right arm, on 15Jan2021 as dose 2, single (Lot number: EL1283), in right arm and on 24Sep2021 as dose 3 (booster) single (Lot number: 30145BA) at the age of 54 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 027L21A), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) positive, notes: Tested positive for Covid; (28Jun2022) negative, notes: Tested negative for Covid; (01Jul2022) negative, notes: took home Covid tested which was negative; (04Jul2022) positive, notes: took home Covid test which was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: Start date of treatment for COVID-19 was 23Jun2022. Stop date of treatment for COVID-19 was 05Jul2022. The patient previously receive a COVID-19 Vaccine. Tested positive for COVID on 23Jun2022. Started Paxlovid 23Jun2022 evening and completed treatment as prescribed on 28Jun2022 morning. Tested negative for COVID 28Jun2022 and symptoms resolved. Congestion, headache on 01Jul2022 - took home COVID tested which was negative. Sore throat, congestion, fatigue, feverish on 04Jul2022 - took home Covid test which was positive. Symptoms continue on 05Jul2022. The patient received the fourth dose of BNT162B2 on 01Apr2022 (lot number: 027L21A) on right arm for COVID-19 immunization.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Loss of consciousness, SARS-CoV-2 test
Clinical narrative: After shot #1, my period cramps caused meto nearly pass out from the severity of the pain; After shot #1, my period cramps caused meto nearly pass out from the severity of the pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jun2021 as dose 1, single (Lot number: EW0196) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known Allergy: gluten" (unspecified if ongoing), notes: Known Allergy: gluten; "Known Allergy: sulfa-based antibiotics" (unspecified if ongoing), notes: Known Allergy: sulfa-based antibiotics. The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Known Allergy: Ibuprofen". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), DYSMENORRHOEA (non-serious) all with onset 25Jun2021 at 11:00, outcome "recovered" and all described as "After shot #1, my period cramps caused meto nearly pass out from the severity of the pain". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2021) Negative, notes: Nasal Swab; (23Jun2022) Negative, notes: Nasal Swab; (05Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of loss of consciousness, dysmenorrhoea.  Clinical course: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of other medications the patient received within 2 weeks of vaccination were Muro 128, elderberry, magnesium, vitamin d, Tylenol. Patient got the COVID vaccine shot #1 and shot #2 right before her period. Her cramps were so much more horrible than normal. After shot #1, her period cramps caused her to nearly pass out from the severity of the pain. After shot #2, her period cramps caused her to vomit from the severity of the pain. There were no other obvious changes in her medications, work, sicknesses, diet, exercise, stress, etc. that could have affected her cycle. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. At dose 3 with suspect vaccine Pfizer Bio N tech, lot# FJ5683 and expiration date 03Mar2022 in right arm, having active substance COVID-19 , no relevant medical history and concurrent conditions noted. At dose 2 with suspect vaccine Pfizer Bio N tech, lot# EW0198 and expiration date 15Jul2021 in right arm, having active substance COVID-19 , no relevant medical history and concurrent conditions noted.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200932052 same patient, same drug, different dose/event;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL1283), on 09Feb2021 as dose 2, single (Lot number: EM9810), on 10Sep2021 as dose 3 (booster), single (Lot number: EW0185) and on 02Mar2022 as dose 4 (booster), single (Lot number: FM9895) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple chronic conditions" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing); "Yes, multiple med allergies" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Unknown Result; (04Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other medication in 2 weeks. On 20Jun2022, she started oral treatment with Paxlovid for COVID-19 which was stopped on 24Jun2022. Rebound symptoms started on 28Jun2022 (finished course 26Jun2022) and had sinus congestion, headache, still testing positive for Covid on 04Jul2022 on the rapid home antigen tests. The patient had multiple med allergies. Other medical history included multiple chronic conditions, immunocompromised.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (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 Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Negative; (04Jul2022) Positive; (28Jun2022) Negative; (30Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient was previously received a COVID-19 Vaccine. Rebound of COVID-19 after completing Paxlovid treatment. Patient started Paxlovid on 24Jun2022, after testing positive for COVID-19 . She completed the 5 day treatment on 29Jun2022. She stopped having covid symptoms on 28Jun2022, and tested negative for COVID-19, on 28Jun2022, on both a PCR test and an at home antigen test. She tested negative for COVID-19 on 30Jun, on a PCR test. On 04Jul2022,she began having COVID symptoms again and tested positive on an at home antigen test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative 7 days after first positive test; (unspecified date) Positive, notes: first positive test; (Jun2022) Positive, notes: 4 days after completing Paxlovid/tested very positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. No treatment taken for Adverse event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and COVID 19  and the suspect drug BNT162b2.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Same symptoms but milder- sore throat, headache, brain fog, nasal congestion, and sinus pressure/severe myalgias and severe headache/COVID 19 Treatment; Same symptoms but milder- sore throat, headache, brain fog, nasal congestion, and sinus pressure/severe myalgias and severe headache/COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "sinus allergies" (unspecified if ongoing), notes: sinus allergies. No known allergies. Concomitant medication(s) included: OZEMPIC; BREO ELLIPTA; FLONASE [FLUTICASONE PROPIONATE].  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Same symptoms but milder- sore throat, headache, brain fog, nasal congestion, and sinus pressure/severe myalgias and severe headache/COVID 19 Treatment". Clinical course: Rebound symptoms (start date 03Jul2022, 09:00) started with same symptoms but milder- sore throat, headache, brain fog, nasal congestion, and sinus pressure. Tested PCR plus again (had previously tested negative 5 days after initial positive symptoms). The patient did not have severe myalgias and severe headache like the 1st time. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Jun2022) Positive; (Jun2022) Negative. Therapeutic measures were taken as a result of covid-19. Treatment of COVID-19 included antiviral PAXLOVID (treatment start date=20Jun2022, treatment stop date=25Jun2022) and treatment for symptoms included over the counter guaifenesin and pseudoephedrine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if, and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.