chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: product - COVID 19 Treatment; product - COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "product - COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (17May2022) Positive, notes: positive antigen tests. 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: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Incorrect dose administered, Rash, SARS-CoV-2 test
Clinical narrative: Plenty rashes from the left knee down to the ankle , front part and also the back side .same for the right knee not as bad as the left .; Energy levels have decrease since the injection for no reason; Dose number=4; Administration date=31Mar2022 and Other Vaccine same date dose number=3; Other Vaccine same date vaccine date=31Mar2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) and on 31Mar2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete but unknown manufacturer.), for Covid-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 31Mar2022, outcome "unknown", described as "Dose number=4; Administration date=31Mar2022 and Other Vaccine same date dose number=3; Other Vaccine same date vaccine date=31Mar2022"; ASTHENIA (non-serious) with onset 02Apr2022 at 07:00, outcome "not recovered", described as "Energy levels have decrease since the injection for no reason"; RASH (non-serious) with onset 02Apr2022 at 07:00, outcome "not recovered", described as "Plenty rashes from the left knee down to the ankle , front part and also the back side .same for the right knee not as bad as the left .". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash, asthenia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 03Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Dec2021 as dose 3 (booster), single (Lot number: 068H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications or other medications in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (04May2022) Positive; (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 08May2022 to 12May2022. The patient tested positive for COVID-19 and took Paxlovid after four days of testing positive unpacked of it she tested negative for COVID-19 on an antigen test on day five. She tested negative again on day six. She felt good and thought she was in the clear. Four days after the first negative test she had all symptoms back and tested positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient received BNT162b2 (BNT162B2), on 27Oct2021 as dose 1, single (Lot number: FE3590) at the age of 22 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 12Nov2021, outcome "not recovered", described as "Rash all over body". The event "rash all over body" required physician office visit.  Additional information: Rash was kind of still going on a little bit. The rash began about two weeks after receiving the first dose Adult Pfizer Covid 19 Vaccine. Caller clarifies the rash began on 12Nov2021. Patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Prior to receiving the booster shot, she was menopause for 13 months, Since she has had her period each month and the past month the flow was heavier; 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 55-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose:2, Caller received 2 doses of Moderna COVID vaccine as the primary series), for COVID-19 Immunization; Moderna covid-19 vaccine (Dose:1, Caller received 2 doses of Moderna COVID vaccine as the primary series), for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Jan2022, outcome "not recovered", described as "Prior to receiving the booster shot, she was menopause for 13 months, Since Jan she has had her period each month and the past month the flow was heavier".  Additional information: Patient received 2 doses of Moderna COVID vaccine as the primary series and received her booster dose with Pfizer COVID vaccine on 12Jan2022. Prior to receiving the booster shot, she was menopause for 13 months, Since she has had her period each month and the past month the flow was heavier.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Severe stomach pain; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; AMLODIPINE; VENLAFAXINE; PROGESTERON. Past drug history included: Augmentin, reaction(s): "Allergy"; Hctz, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 19May2022 at 21:00, outcome "not recovered", described as "Severe stomach pain". Therapeutic measures were not taken as a result of abdominal pain upper.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she got COVID; she got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EM9809), on 01Mar2021 as dose 2, single (Lot number: EN6203), on 05Oct2021 as dose 3 (booster), single (Lot number: FF8839) and on 28Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years 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) with onset 07May2022, outcome "unknown", described as "she got COVID"; COVID-19 (medically significant) with onset 07May2022, outcome "unknown", described as "she got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive, notes: she used an at home test as well as went to Urgent care and did a Rapid Test and both tests were positive on the same day; (14May2022) Negative; (16May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Caller states that she is calling about Paxlovid. She tested positive for COVID on 07May2022, after testing positive she started taking Paxlovid on the same day as well 07May2022. On the 14May2022 she tested negative, and then she felt okay. Then 2 days later on Monday 16May2022 she tested positive, at first she thought she had allergies but it got worse and worse feeling like a head cold with cough. Then last week she had horrible cough with a very sore throat, and slight fever. This week she really has a bad head cold. She's never heard of a relapse of COVID after taking Paxlovid and wants to know is it possible to have COVID after. She knows that she hasn't been anywhere and she still wears a mask. On some days she went to the market and still had a mask on. She would like to know if its possible to get a relapse infection after completion of paxlovid, or how do you get a relapse once you have completed paxlovid. Agent mentioned that she was filling an AE/PQC as the patient was fully vaccinated with COVID vaccine. Caller would like to know if she can take cough syrup with Codeine in it given that she has finished paxlovid few days ago. Caller also mentioned hat she did have the Pfizer COVID vaccine booster 6 days before she got COVID. She lost weight, she might be below 100lbs, she is maybe 99lbs.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Vaccine brand: Pfizer/BioNTech/product: COVID 19 Treatment, brand: Paxlovid; Vaccine brand: Pfizer/BioNTech/product: COVID 19 Treatment, brand: Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 28Feb2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: THYROID, start date: 01Jan1991. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Vaccine brand: Pfizer/BioNTech/product: COVID 19 Treatment, brand: Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (15May2022) negative, notes: was negative after 5 days of paxlovid; (19May2022) positive, notes: I tested today and I am positive again. 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.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: She received one dose of the Pfizer COVID-19 vaccine and died ten days later; This is a literature report.  A 90-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "major neurocognitive disorder" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "home hospice" (unspecified if ongoing); "significantly deteriorated" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), 10 days after the suspect product(s) administration, outcome "fatal", described as "She received one dose of the Pfizer COVID-19 vaccine and died ten days later". The patient date of death was unknown. Reported cause of death: "She received one dose of the Pfizer COVID-19 vaccine and died ten days later". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, Death cannot be completely ruled out. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: She received one dose of the Pfizer COVID-19 vaccine and died ten days later
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): RA4593476 .  A 57-year-old female patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57  for covid-19 immunization. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Fever" (ongoing); "Urinary tract infection" (ongoing). Concomitant medication(s) included: FLUOXETINE; OCREVUS; CALCIUM; VITAMIN D 2000; LIPITOR; EVISTA; MELATONIN; CRANBERRY; AMINOPYRIDINE; BACLOFEN. The following information was reported: ILLNESS (non-serious) with onset 02Dec2021, outcome "recovered", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary mass, Lymphadenopathy
Clinical narrative: Swollen lymph node; Big lump under armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Relapsing remitting multiple sclerosis" (ongoing), notes: Relapsing remitting multiple sclerosis; "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "Complex ptsd" (unspecified if ongoing), notes: Complex ptsd; "Lactose intolerant" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Disk bulging" (unspecified if ongoing), notes: Disk bulging; "Disk degeneration" (unspecified if ongoing); "Dysphagia" (unspecified if ongoing); "Flare up" (unspecified if ongoing), notes: Flare up; "Swollen lymph node" (unspecified if ongoing), notes: Swollen lymph node; "Marijuana usage" (unspecified if ongoing), notes: Marijuana usage; "Paxlovid" (unspecified if ongoing), notes: Paxlovid. Concomitant medication(s) included: WELLBUTRIN XL; PAXLOVID taken for covid-19 treatment; VITAMIN B COMPLEX; VITAMIN D3; CALCIUM MAGNESIUM WITH VITAMIN D3; TYLENOL; IBUPROFEN. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "Swollen lymph node"; AXILLARY MASS (non-serious), outcome "recovered", described as "Big lump under armpit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Swollen lymph node; Big lump under armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Relapsing remitting multiple sclerosis" (ongoing), notes: Relapsing remitting multiple sclerosis; "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "Complex ptsd" (unspecified if ongoing), notes: Complex ptsd; "Lactose intolerant" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Disk bulging" (unspecified if ongoing), notes: Disk bulging; "Disk degeneration" (unspecified if ongoing); "Dysphagia" (unspecified if ongoing); "Flare up" (unspecified if ongoing), notes: Flare up; "Swollen lymph node" (unspecified if ongoing), notes: Swollen lymph node; "Marijuana usage" (unspecified if ongoing), notes: Marijuana usage; "Paxlovid" (unspecified if ongoing), notes: Paxlovid. Concomitant medication(s) included: WELLBUTRIN XL; PAXLOVID taken for covid-19 treatment; VITAMIN B COMPLEX; VITAMIN D3; CALCIUM MAGNESIUM WITH VITAMIN D3; TYLENOL; IBUPROFEN. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "Swollen lymph node"; AXILLARY MASS (non-serious), outcome "recovered", described as "Big lump under armpit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: indication: COVID 19 Treatment; indication: 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 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 at 13:00 as dose 1, single (Lot number: EN6198), in left arm, on 20Mar2021 at 13:00 as dose 2, single (Lot number: EP7534), in left arm and on 05Nov2021 at 12:00 as dose 3 (booster), single (Lot number: EW0183) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Degenerative disc disease" (unspecified if ongoing); "bulging disc" (unspecified if ongoing), notes: history of severe lung problems from COVID19 in 2020; "history of severe lung problems from COVID19 in 2020", start date: 2020 (unspecified if ongoing), notes: history of severe lung problems; "history of severe lung problems from COVID19 in 2020", start date: 2020 (unspecified if ongoing), notes: history of severe lung problems from COVID19 in 2020. Concomitant medication(s) included: DICLOFENAC SODIUM, start date: 17Jan2022; LORYNA, start date: 23Jun2017, stop date: 19May2022; METHOCARBAMOL, start date: 17Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "indication: COVID 19 Treatment". 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, 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) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "herpes in another quadrant of my mouth that has not flared up in a decade" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Autoimmune" (unspecified if ongoing); "oral mouth sores/ulcers." (unspecified if ongoing), notes: oral mouth sores/ulcers for 2 years; "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: 01Nov2021. 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: Biopsy: inflammation; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had taken Pfizer Paxlovid as a treatment. Patient have had oral mouth sores/ulcers for 2 years. Patient was told it was oral Lechin planus. The Biopsy did not confirm, and only concluded it was inflammation. After taking Paxlovid, the ulcer healed. Patient had Known allergies Penicillin. Patient had taken other medication Gabapentin in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: EW0150), in left arm, on 01May2021 as dose 2, single (Lot number: EW0173), in left arm, on 16Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing). Concomitant medication(s) included: TIVICAY, start date: Jan2017; DESCOVY, start date: Jan2017; MONTELUKAST, start date: Jan2016. 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) Positive, notes: Treatment of COVID-19; (14May2022) Negative, notes: 2 negative at-home tests (Days 7 & 8); (15May2022) Negative, notes: 2 negative at-home tests (Days 7 & 8); (16May2022) Positive, notes: viral rebound occurred on Day 9 (after initiating treatment). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No vaccine received and no other medication with in in 2weeks. Adverse event: After completing 5-day treatment course and symptoms (soar throat, fatigue, congestion, cough, headache and brain fog) surged back later the same day of viral rebound and were greater in severity than during initial infection. No known allergies, Other medical history: HIV  No follow-up attempts are possible. No further information is expected.
Age: 46.0
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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 03Oct2013; WELLBUTRIN, start date: 10Sep2015. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Patient received treatment with Paxovid (Lot: Ga5120) on 18May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, COVID-19, Drug ineffective, Lipase
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 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: "spondylitis" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: anti inflammatories, reaction(s): "Known allergies: anti inflammatories"; Known allergies: levaquin, reaction(s): "Known allergies: Levaquin"; Known allergies: codeine, reaction(s): "Known allergies: codeine". 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: Alanine aminotransferase: 379 U/L, notes: My Alt levels got to 379 U/L; Aspartate aminotransferase: 119 U/L, notes: my AST level got up to 119 U/L; Lipase: 584, notes: my Lypase was 584; SARS-CoV-2 test: 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.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 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: "spondylitis" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: anti inflammatories, reaction(s): "Known allergies: anti inflammatories"; Known allergies: levaquin, reaction(s): "Known allergies: Levaquin"; Known allergies: codeine, reaction(s): "Known allergies: codeine". 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: Alanine aminotransferase: 379 U/L, notes: My Alt levels got to 379 U/L; Aspartate aminotransferase: 119 U/L, notes: my AST level got up to 119 U/L; Lipase: 584, notes: my Lypase was 584; SARS-CoV-2 test: 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.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 21Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Eosinophilic esophagitis" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: eggplant" (unspecified if ongoing); "Known allergies: Onions" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient receive Paxlovid to treated drug ineffective, covid-19. Date of start of drug: 17May2022.
Age: 21.0
Sex: M
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 reporte (Consumer or other non HCP). The reporter is the parent.  A 22-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 21 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: "known allergies-Pollen" (unspecified if ongoing), notes: known allergies-Pollen; "Anxiety" (unspecified if ongoing), notes: other medical history-Anxiety/Depression; "Depression" (unspecified if ongoing), notes: other medical history-Anxiety/Depression. Concomitant medication(s) included: ESCITALOPRAM, also reported as other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) negative, notes: Tested negative on antigen test; (19May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 05May2022 ended 5 days later on 09May2022.   Clinical course was reported as, a few days after completing a course of Paxlovid, the patient was tested positive for COVID again. Symptoms of chills, headache, running nose, and dry throat appeared on the night of 18May2022. No therapeutic measures were taken as a result of symptoms. Reported that, Primary reporter did not had the lot number information, because lot number was not provided to the reporter at the time of report completion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): RA2021US186601_NC (Regulatory Authority).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "hives".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 12Mar2021 at 15:30 as dose 1, single (Lot number: EN6302) at the age of 20 years, in left arm, on 02Apr2021 at 17:15 as dose 2, single (Lot number: ep6955) at the age of 20 years, in left arm and on 29Oct2021 at 11:30 as dose 3 (booster), single (Lot number: FF2590) at the age of 21 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; LEVOTHYROXINE; VITAMIN D3; FAMOTIDINE; KLONOPIN; PREDNISONE, start date: 15May2022, stop date: 19May2022; ADVAIR, start date: 14May2022. The following information was reported: VACCINATION FAILURE (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: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid to treat vaccination failure, covid-19, treatment start date: 14May2022, treatment stop date: 19May2022.
Age: 37.0
Sex: M
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 37-year-old male patient received BNT162b2 (BNT162B2), on 17Oct2021 at 15:00 as dose 1, single (Lot number: PF2590) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Kidney stone" (unspecified if ongoing); "Seborrheic dermatitis" (unspecified if ongoing); "Benign heart murmur" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin base, reaction(s): "known allergies: Erythromycin base"; Tamsulosin, reaction(s): "known allergies: Tamsulosin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Apr2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive; (12May2022) Negative, notes: First negative antigen test (Cue) after starting paxlovid; (18May2022) Negative, notes: Still testing negative with antigen test (Cue) at this point; (19May2022) Positive, notes: Started testing positive again (antigen, Cue). 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 09May2022 Treatment stop date 14May2022, Lot Number: GA8200, Indication Treatment of Covid-19 About 12 hours after starting Paxlovid (9May2022 7:38 PM), noticed bad taste in mouth (metallic) even toothpaste tasted awful. This was persistent while on Paxlovid. 09May2022 7:38 PM Started (antigen testing positive, Cue). 12May2022 7:47 AM - First negative antigen test (Cue) after starting Paxlovid 18May2022 8:48 AM - Still testing negative with antigen test (Cue) at this point. 19May2022 7:53 AM - Started testing positive again (antigen, Cue).19May2022 9:30 AM - Met with PCP to discuss rebound: my symptoms, very small headache, no fever, postnasal drip / nasal congestion, fatigue
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: prescribed paxlovid; prescribed paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 61-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 manufacturer unknown (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), outcome "unknown" and all described as "prescribed paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive by PCR test 1 day prior to starting paxlovid treatment; Tested positive by PCR test 1 day prior to starting paxlovid treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-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 included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN, start date: 07May2022, stop date: 11May2022; ADVIL [IBUPROFEN], start date: 07May2022, stop date: 11May2022. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin"; Ceclor, reaction(s): "Known allergies: ceclor". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08May2022, outcome "unknown" and all described as "Tested positive by PCR test 1 day prior to starting paxlovid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: Tested positive by PCR test; (16May2022) Negative, notes: Tested negative on antigen test; (20May2022) Positive, notes: Cough symptoms developed on day 13 with strong positive antigen test. Clinical course: Symptoms included fever, bad body aches and chills, sore throat. Patient received Paxlovid from 09May2022, to 13May2022 for the treatment of Covid-19. Symptoms disappeared over course of treatment. Tested negative on antigen test day 7 after initial positive test, for several days was fine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Weight
Clinical narrative: She says she had itching after the first dose; 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 50-year-old female patient received BNT162b2 (BNT162B2), on 09Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing); "Retinopathy of prematurity" (unspecified if ongoing), notes: Was born two months early, and has been blind since birth, she has retinopathy of prematurity.; "COVID" (unspecified if ongoing), notes: had COVID twice and was in the hospital in the ICU the first time; "autoimmune issues" (unspecified if ongoing); "health issues" (unspecified if ongoing); "fluid retention problems" (unspecified if ongoing); "blind" (unspecified if ongoing), notes: she can not read her vaccine card, she is blind and can not read print to provide. There were no concomitant medications. Past drug history included: Gentamicin, reaction(s): "gentamicin allergy", notes: allergic to Gentamicin sometime between 1989-2000. The following information was reported: PRURITUS (non-serious) with onset Nov2021, outcome "recovered", described as "She says she had itching after the first dose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus.  Additional information: Patient had itching after the dose 1 and took Benadryl as a treatment and then it went away after taking Benadryl, she thinks she took two 25 mg tablets at a time, and she also took some Aller-Tec, which was like a version of Zyrtec, she took that two to three times a day as well for about a week or two maybe.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200742828 similar report from same reporter
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (Pfizer-BioNTech COVID-19), in 2021 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: HYPERSENSITIVITY (hospitalization) with onset 2021, outcome "unknown", described as "allergic reaction". The patient was hospitalized for hypersensitivity (start date: 2021). Additional information: Reporter stated:"I received the Pfizer vaccine 2021 I think I was hospitalized the same day for an allergic reaction."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: I was diagnosed with Covid on April 29; I was diagnosed with Covid on April 29; J&J Drug Start date 16Mar2021/ Pfizer / BioNTech Drug Start date 01Dec2021;  Drug Start date 16Mar2021/ Pfizer / BioNTech Drug Start date 01Dec2021; 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 01Dec2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; Janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 01Dec2021, outcome "unknown" and all described as "J&J Drug Start date 16Mar2021/ Pfizer / BioNTech Drug Start date 01Dec2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "not recovered" and all described as "I was diagnosed with Covid on April 29". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: diagnosed with Covid on 29Apr; (20May2022) Positive, notes: Today is day 21 and I am still testing positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was diagnosed with Covid on 29Apr. The doctor prescribed Paxlovid which patient took for 5 days. Today was day 21 and still testing positive for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.