chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: shellfish" (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 Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken with Paxlovid as a result of vaccination failure, covid-19.  Clinical information: The patient has taken treatment for covid-19 with paxlovid the treatment start date was 11Jul2022 and the treatment stop date was 17Jul2022. The patient took other medication product in 2 weeks are Topiramate, Spironolactone, Zantac, Amlodipine and Lexipro.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 20Apr2021 as dose 2, single (Lot number: EW0164), in right arm, on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030), in right arm and on 07Jun2022 as dose 4 (booster), single (Lot number: FP4559) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Severe Sleep Apnea" (unspecified if ongoing), notes: Other medical history: Severe Sleep Apnea, SVT; "SVT" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: TRINTELLIX (Brand: Takeda), start date: 01Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient experienced shortness of breath and fever which were part of symptoms and was deciding factor to confer MD who prescribed Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EM9810), on 20Mar2021 as dose 2, single (Lot number: ER8727), on 10Sep2021 as dose 3 (booster), single (Lot number: FC3184) and on 05Apr2022 (forgot if it was in the morning or afternoon) as dose 4 (booster), single (Lot number: FK9893) at the age of 69 years, in right arm (cannot get in left arm due to breast cancer) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: Oct2020 (unspecified if ongoing), notes: Breast cancer. No family medical history relevant to event. Concomitant medication(s) included: LETROZOLE oral taken for breast cancer, start date: Feb2021. Vaccination history included: Flu vaccine (Took flu vaccine in fall and she is fine and takes them all the time), for immunization. No prior vaccinations (within 4 weeks). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Weight: 179-180 lbs. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient did not have any reactions to these covid vaccines. Her husband traveled and brought home with covid him. She always uses a mask. Patient diagnosed with covid after four doses of Pfizer covid vaccine, tested positive for covid and was prescribed Paxlovid. No Emergency Room or Physician Office required. No relevant tests.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2021 as dose 1, single (Lot number: EW0172), in left arm, on 14May2021 as dose 2, single (Lot number: EW0183), in right arm and on 12Jan2022 as dose 3 (booster), single (Lot number: 33030BD) at the age of 30 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "adhd" (unspecified if ongoing); "asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "iron deficiency anemia" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE, start date: 03Aug2016, stop date: 07Jul2022; BUPROPION, start date: 05Jan2022; IRON [FERROUS CITRATE], start date: 01Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Atrial fibrillation, Heart rate
Clinical narrative: She had to go to the Hospital because she went into afib and then had a cardiac ablation; This is a spontaneous report received from a contactable Nurse from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; dofetilide (TIKOSYN), at 250 ug 2x/day. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: atrial fibrillation (hospitalization), outcome "unknown", described as "She had to go to the Hospital because she went into afib and then had a cardiac ablation". The reporter wants to know if there is any information about increased risk of Afib wile taking Tikosyn and receiving the 4th shot (second booster) of the Pfizer COVID-19 vaccine, she already received three shots of the Pfizer COVID-19 vaccine. She had to go to the Hospital because she went into Afib and then had a cardiac ablation, she has been taking Tikosyn ever since and haven't had another episode since she started taking the medication, she is also taking Eliquis. Her heart rhythm is normal currently. She is taking Tikosyn 250 mcg twice a day. She has read in "several places" that patients taking Tikosyn who receive a booster dose of the COVID-19 vaccine could go into Afib. She was not taking Tikosyn when she received the first three doses of the COVID-19 vaccine. Her cardiovascular Doctor who made her ablation might go with the CDC's recommendations. She has been two months out from her cardiac ablation. The patient underwent the following laboratory tests and procedures: Heart rate: heart rhythm is normal. The action taken for dofetilide was unknown. Therapeutic measures were taken as a result of atrial fibrillation.  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 temporal association and the information currently available, a causal association between the reported event and BNT162b2 and dofetilide cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling
Clinical narrative: golf ball-sized swelling at the posterior base of her right ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (COMIRNATY), on 02Feb2021 as dose 2, single (Lot number: EL9264) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE), administration date: 12Jan2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "Behind my ear I feel like it's like the gland is swollen/golf ball size swelling behind her ear", "saw the swelling and it's painful, pain a little bit, painful", "golf ball-sized swelling at the posterior base of her right ear". The following information was reported: EAR SWELLING (non-serious) with onset 2021, outcome "unknown", described as "golf ball-sized swelling at the posterior base of her right ear".  Additional information: Caller was a 63 year old consumer who had 3 doses of Comirnaty. The first was on 12Jan2021, the second on 02Feb2021, and the third on 12Nov2021. After each dose, she went to bed feeling fine, but woke up with golf ball-sized swelling at the posterior base of her right ear. Throughout the day, it would resolve. She was asking if it is safe to get another dose. The patient want to get another dose but was afraid it will swell. The patient knows it was probably the gland and was active.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 at 15:00 as dose 1, single (Lot number: EN6202), in right arm, on 11Oct2021 at 12:00 as dose 2, single (Lot number: 330125BA), in left arm, on 05Mar2022 at 12:00 as dose 3 (booster), single (Lot number: EP7534), in right arm and on 14Jun2022 at 12:00 as dose 4 (booster), single (Lot number: Fp7135) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; JARDIANCE; METFORMIN HCL; METOPROLOL; MONTELUKAST SODIUM; OMEPRAZOLE; RAMIPRIL, stop date: 05Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient used Paxlovid as COVID-19 treatment; Patient used Paxlovid as COVID-19 treatment; This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 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 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 "Patient used Paxlovid as COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Paxlovid COVID 19 Treatment; (13Jul2022) Negative, notes: tested negative on rapid antigen; (18Jul2022) Positive, notes: 18Jul2022 retest due to new symptoms and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors. Severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 18Jan2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and on 16May2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "sleep apnea" (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 "recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
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 58-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 25Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: Other medical history: Hypertension; "Known allergies:molds" (unspecified if ongoing). The patient's concomitant medications were not reported. 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: Negative, notes: rebound covid symptoms with positive test after negative testing.  afebrile; Positive, notes: rebound covid symptoms with positive test after negative testing.  afebrile; Unknown results, notes: rebound covid symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19. It was unknown if patient had received any Other medication in 2 weeks. Patient received Paxlovid from 08Jul2022 to 13Jul2022 for the treatment of COVID-19. rebound covid symptoms with positive test after negative testing.  afebrile.  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, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: 301308A) 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: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "htn" (unspecified if ongoing); "kidney dz" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: LISINOPRIL; HCTZ; SYNTHROID. The following information was reported: DRUG INEFFECTIVE (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: Unknown result. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and covid 19 cannot be ruled out.
Age: 33.0
Sex: F
Vaccine: 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) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 08Jun2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "Previous history of long covid from Feb2020", start date: Feb2020, stop date: Feb2020, notes: likely covid, but unconfirmed as predated testing; "illness" (unspecified if ongoing). There were no concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient treated with Paxlovid. The patient experienced a rebound of COVID-19 symptoms with accompanying positive rapid antigen test on Day 11 of infection, after several days of improved/non-existent symptoms. The tested negative on Day 5 since positive covid test / day 5 of medication. The following days the patient had a faint positive test until Day 11 when symptoms returned, at which point the test was a clear positive. The patient had not received any other medication in two weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN6203), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known Allergies: latex, nickel alloys" (unspecified if ongoing), notes: known Allergies: latex, nickel alloys; "hypoglycemia" (unspecified if ongoing); "handful of autoimmune diseases" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "known Allergies: latex, nickel alloys" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL PM, start date: Jan2015, stop date: Jul2022; ACETAMINOPHEN, start date: Jan2015, stop date: Jul2022; D3, start date: Jan2019, stop date: Jul2022; PROGESTERONE, start date: 26Apr2022, stop date: 18Jul2022; LIOTHYRONINE, start date: 27May2022, stop date: 18Jul2022; LOSARTAN, start date: 18Jun2022, stop date: 18Jul2022; LEVOTHYROXINE, start date: 24Apr2022, stop date: 18Jul2022; AMLODIPINE, start date: 17Jun2022, stop date: 18Jul2022; ROSUVASTATIN, start date: 03Jun2022, stop date: 18Jul2022.The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient has been taken other medication within two weeks. The patient has been treated with Paxlovid, (batch no. 1917017A) from 07Jul2022 to 11Jul2022 for event COVID-19.Metallic taste/ awful/ more like hairspray. Complete relapse 2 days after getting well + negative test; started completely over again, this time worse symptoms, testing positive.  No follow up attempt possible: No further information expected.
Age: 68.0
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 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 29Jan2021 as dose 1, single (Lot number: EL9261), in right arm, on 19Feb2021 as dose 2, single (Lot number: EL9266), in right arm, on 24Sep2021 as dose 3 (booster), single (Lot number: EW0773), in right arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: METFORMIN; QTERN [DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE;SAXAGLIPTIN HYDROCHLORIDE]; LISINOPRIL; ZYRTEC DAIICHI. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: When the patient tested positive, her symptoms were severe head congestion & a low grade fever. After her first 2 doses of Paxloxid, the congestion was completely gone, fever was intermittent for the next 2 days. she had felt fine other than being a bit tired in the afternoons until last night, 17Jul around 8 pm. Today, 18Jul she had a runny nose, sneezing, and moments of fever. She was taking Tylenol & Mucinex DM.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 at 08:00 as dose 1, single (Lot number: EL9265), in right arm, on 25Feb2021 at 08:00 as dose 2, single (Lot number: EN6203), in left arm and on 10Dec2021 at 15:00 as dose 3 (booster), single (Lot number: FJ8762) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "HBP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish. The patient took concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Rebound Covid" starting 8 days after paxlovid treatment began (day 10 after initial Covid symptoms initially appeared). Tested positive again and symptoms recurred after having felt better, tested negative after completion of paxlovid treatment.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hyperhidrosis, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: arm numbness; tingling; sweats; fevers; left arm still hurts; concerns about a stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jan2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "concerns about a stroke"; HYPOAESTHESIA (hospitalization), outcome "unknown", described as "arm numbness"; PARAESTHESIA (hospitalization), outcome "unknown", described as "tingling"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweats"; PYREXIA (non-serious), outcome "unknown", described as "fevers"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "left arm still hurts". The patient was hospitalized for hypoaesthesia, paraesthesia (start date: Apr2022).  Clinical course: The patient complaints from the first two doses of the Pfizer Covid-19 vaccine (first dose time unknown, second dose in Jan2022 per Caller). She reported that she has complaints of sweats, fevers, left arm still hurts, arm numbness and tingling She reported that she was in the hospital back in Apr2022 due to the complaints with arm numbness and tingling due to concerns about a stroke but was told nothing was wrong with her.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: arm numbness; tingling; sweats; fevers; left arm still hurts; concerns about a stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jan2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "concerns about a stroke"; HYPOAESTHESIA (hospitalization), outcome "unknown", described as "arm numbness"; PARAESTHESIA (hospitalization), outcome "unknown", described as "tingling"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweats"; PYREXIA (non-serious), outcome "unknown", described as "fevers"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "left arm still hurts". The patient was hospitalized for hypoaesthesia, paraesthesia (start date: Apr2022).  Clinical course: The patient complaints from the first two doses of the Pfizer Covid-19 vaccine (first dose time unknown, second dose in Jan2022 per Caller). She reported that she has complaints of sweats, fevers, left arm still hurts, arm numbness and tingling She reported that she was in the hospital back in Apr2022 due to the complaints with arm numbness and tingling due to concerns about a stroke but was told nothing was wrong with her.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I ended up with Covid; had the first two vaccines and two booster from Pfizer (Unspecified Vaccine); I ended up with Covid; had the first two vaccines and two booster from Pfizer (Unspecified Vaccine); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had bowel surgery" (unspecified if ongoing), notes: my bowel and I had bowel surgery (Intent: History) like major, it's 9 years ago. Concomitant medication(s) included: LINZESS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I ended up with Covid; had the first two vaccines and two booster from Pfizer (Unspecified Vaccine)". 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.  Clinical course: Patient stated that, ended up with Covid last week despite precautions and had the first two vaccines and two booster from Pfizer with no reactions whatsoever, and managed to all this time. So, patient was taking the Paxlovid and patient did not had high blood pressure but it felt like it was raising blood pressure. Patient had been trying Linzess from past couple of months although have not taken it from the past probably past 3 or so weeks because patient had been travelling and did not want to take it while travelling. Then the doctor knew this in backwards right now it's just experimental for patient because it gives diarrhea for sure so, patient was on the lowest dose of it and in fact were going to half the dose but patient had not taken it probably since the end of Jun because was going to travelling did not want to have that problem. Patient also drink some 'Prenz'  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive after testing negative for a week.; Tested positive after testing negative for a week.; 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 male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3247), in right arm, on 10Feb2021 as dose 2, single (Lot number: EM9810), in right arm and on 25Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Mar2022 as dose 4 (booster), single (Lot number: Q7OH21A), in right arm for covid-19 immunisation. The patient had no relevant medical history (No known allergies). There were no concomitant medications (No other medication in 2weeks). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive after testing negative for a week.". Tested positive after testing negative for a week. Mild cold. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive after testing negative for a week; Negative, notes: Tested positive after testing negative for a week. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 61-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 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 was not reported. Concomitant medication(s) included: LIPITOR. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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, suspected covid-19. Additional information: The patient received Dose 1 and 2 of Covid-19 immunization (unknown manufacturer). The patient received BNT162B2 as Dose 3 on 28Apr2022. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has tested positive for COVID-19. No known allergies. The patient was given COVID 19 treatment, Paxlovid, from12Jul2022 to16Jul2022 for the 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: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 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: "Asthma" (unspecified if ongoing); "Allergy:sulfa" (unspecified if ongoing); "Allergy:Penicillin" (unspecified if ongoing); "Allergy:cyclosporines" (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 Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was used from 17Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Cystitis interstitial, Discomfort, Muscle spasms, Pain
Clinical narrative: interstitial cystitis; after this latest booster, it has been very uncomfortable/had to add other forms of therapy to try to control the pain & spasms; uncomfortable; spasms; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "interstitial cystitis" (unspecified if ongoing), notes: had been well under control for years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Primary Immunization series completed., I received all of the Pfizer COVID vaccines.), for COVID-19 Immunization, reaction(s): "I did not have with the previous doses"; Bnt162b2 (DOSE 2, Primary Immunization series completed., I received all of the Pfizer COVID vaccines.), for COVID-19 Immunization, reaction(s): "I did not have with the previous doses". The following information was reported: CYSTITIS INTERSTITIAL (non-serious), outcome "unknown", described as "interstitial cystitis"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "after this latest booster, it has been very uncomfortable/had to add other forms of therapy to try to control the pain & spasms"; DISCOMFORT (non-serious), outcome "unknown", described as "uncomfortable"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "spasms"; PAIN (non-serious), outcome "unknown". Therapeutic measures were taken as a result of cystitis interstitial, condition aggravated, discomfort, muscle spasms, pain. Additional information: Patient received all of the Pfizer COVID vaccines, including the most recent booster shot. Patient had a reaction to this booster that did not have with the previous doses. Patient has interstitial cystitis that had been well under control for years, but after this latest booster, it has been very uncomfortable. Patient had to add other forms of therapy to try to control the pain & spasms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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: "high cholesterol" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN. The patient received other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (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: Unknown results; (14Jul2022) Negative, notes: rebound Covid after a negative test 4 days later; (Jul2022) Unknown results, notes: rebound Covid after a negative test 4 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received anti-viral (Paxlovid) for the treatment of COVID-19 from 05Jul2022 to 10Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
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) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Lot number: fe3590) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Negative; (16Jul2022) Positive, notes: On 15Jul2022 started to have cold-like symptoms. Next day tested positive (with a much more distinct positive line on test strip than back on 7/5). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: No. Product=COVID 19 Treatment (start date=05Jul2022, stop date=10Jul2022) indication=Treatment of COVID-19. Adverse event: after testing negative on 10Jul2022 I stopped isolation and wore a mask when in proximity to others. On 15Jul2022 started to have cold-like symptoms. Next day tested positive (with a much more distinct positive line on test strip than back on 7/5). Original symptoms were headache, muscle ache and fatigue. Rebound symptoms are stuffy nose and headache. Note: Paxlovid made me nauseous and gave me a disgusting taste in my mouth during the entire 5 days. Treatment for AE: No. Known allergies: no. Other medical history: none, generally healthy. Device timestamp: 19Jul2022.
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP).  A 3-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, 0.5ml single (Lot number: EL0611, Expiration Date: 31Aug2023) for immunisation. The patient's relevant medical history included: "Food allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), 3 days after the suspect product(s) administration, outcome "recovering", described as "Hives". Therapeutic measures were taken as a result of urticaria.  Additional information: He had hives. Reporter stated, "Okay so the patient got the vaccine on the 7th and then he start getting hives on 10th, three days later." Still experiencing: Reporter stated, "No, he was given Benadryl." The reporter stated that the event was improving.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/return of Covid symptoms; Treatment of COVID-19/return of Covid symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 was not reported. Concomitant medication(s) included: LEVOTHYROXIN. Past drug history included: Celecoxib, reaction(s): "Allergy:Celecoxib". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19/return of Covid symptoms ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jul2022) Positive, notes: Tested positive 6 days after completing Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient experienced a return of Covid symptoms and tested positive 6 days after completing Paxlovid course.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Reaction to excipient
Clinical narrative: had a reaction to it about a year and a half ago and they advised her that it was probable the PEG content that caused her reaction; had a reaction to it about a year and a half ago and they advised her that it was probable the PEG content that caused her reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 98-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, (single) (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION REACTION (non-serious), REACTION TO EXCIPIENT (non-serious), outcome "unknown" and all described as "had a reaction to it about a year and a half ago and they advised her that it was probable the PEG content that caused her reaction".  Additional information: it was reported that the patient was  suggested not to take any more Pfizer Covid-19 Vaccine because she had a reaction to it about a year and a half ago and they advised her that it was probable the PEG (polyethylene glycol) content that caused her reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: Rash developed all over back 10-12 hours after receiving shot. Some spread to chest 1-2 days later; This is a spontaneous report received from a non-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 16Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FO7139) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: ESTROGEN; LEVOTHYROXINE; PROGESTERONE. Vaccination history included: Covid-19 vaccine (Dose: 03, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 02, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 01, manufacturer unknown), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 16Jul2022 at 23:45, outcome "not recovered", described as "Rash developed all over back 10-12 hours after receiving shot. Some spread to chest 1-2 days later". The event "rash developed all over back 10-12 hours after receiving shot. some spread to chest 1-2 days later" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: Consumer reported rash developed all over back 10 to 12 hours after receiving shot. Some spread to chest 1-2 days later. Adverse event treatment was Claritin, Benadryl. Patient had covid prior vaccination. Patient had not tested covid post vaccination. Known allergies was unknown. Patient visited Doctor or other healthcare professional office or clinic.  No follow-up attempts are possible. No further information is expected.