chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Concussion
Clinical narrative: Recovering from concussion; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: Covid-19 vaccine (DOSE:2, Single, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE:1, Single, Unknown manufacturer), for COVID-19 immunization. The following information was reported: CONCUSSION (non-serious), outcome "unknown", described as "Recovering from concussion". Additional Information: Reaction / Event as Reported. Recovering from concussion. Outcome of reaction/event at the time of last observation was (UNKNOWN). Batch/lot number was Not Provided. System Reference was reported. Details mentioned as: 159558 Pfizer. NDC number of Pfizer COVID vaccine booster was Not Provided. Reason for no lot number of Pfizer COVID vaccine booster was provided as Caller unwilling to complete the report. Expiry Date of Pfizer COVID vaccine booster was Not Provided. Additional Context was reported as, She has a patient on the line who is already done with first booster dose of the Pfizer COVID 19 vaccine and is due to get 2nd booster dose, however, she is recovering from a concussion, and she also wanted to know if there are any side effects in her brain from getting the 2nd booster dose. Caller confirmed information above and stated she did not wish to create report.  She did not want to provide an email or date of birth and requested to be transferred to have her question answered. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Suicidal ideation
Clinical narrative: hair loss; she's suicidal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 31-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ALOPECIA (non-serious) with onset Jun2021, outcome "unknown", described as "hair loss"; SUICIDAL IDEATION (medically significant) with onset 2021, outcome "unknown", described as "she's suicidal". The events "she's suicidal" and "hair loss" required physician office visit. Therapeutic measures were taken as a result of suicidal ideation, alopecia.  Clinical Course: AE: hair loss: Caller said her daughter started to notice the hair loss approximately two months after her second vaccine, and noticed it increased about two months after the third vaccination. She said it got worse after the third vaccination, and did not seem to have slowed much, between that it had waxed and waned. AE Treatment: Caller said her daughter has been to an endocrinologist, a dermatologist who specializes in hair loss with a hair and scalp fellowship, and an immunological dermatologist, for the purpose of finding out what is going on with the hair loss. She says her daughter tried quite a few things but nothing seems be working. She said her daughter tried vitamins and nutritional supplements mainly, and she took some iron supplements and B12 supplements. NDC/LOT/EXP: Unknown for the B12 and iron supplements that the patient took. She said she took those only after the hair loss for the purpose of trying to help the hair loss. She says she lives in a different state, so she doesn't know the dosage her daughter took, only that it was within recommended dosing.   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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient had the Pfizer COVID-19 Vaccine/patient was diagnosed with COVID on Friday; patient had the Pfizer COVID-19 Vaccine/patient was diagnosed with COVID on Friday; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 64-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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "unknown" and all described as "patient had the Pfizer COVID-19 Vaccine/patient was diagnosed with COVID on Friday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: the patient was diagnosed with COVID on Friday last week. Therapeutic measures were taken as a result of covid-19 included with Paxlovid . Clinical course: Nurse Practitioner reported about a 64y/o female patient taking PAXLOVID. The patient was diagnosed with COVID on Friday last week. Patient's symptoms started on Monday and patient was given PAXLOVID. Reporter wanted to know if the patient needs to be retested and for further guidelines. Reporter stated that she had called CDC and was told to call Pfizer. Reporter thinks the patient had the Pfizer COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: vaccine brand=Pfizer / BioNTech, COVID 19 Treatment; vaccine brand=Pfizer / BioNTech, COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-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: GABAPENTIN. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "vaccine brand=Pfizer / BioNTech, COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: The patient have received other medications in two weeks. Anti viral details. Product: COVID 19 Treatment, treatment start date: 29Apr2022, treatment stop date: 04May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine janssen ("DOSE UNKNOWN Single; Vaccine location: Left arm.). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: COVID-19: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient wasn't taken any medication in past 2 weeks. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "mild asthla (sports/allergy induced)" (unspecified if ongoing), notes: other medical history: mild asthla (sports/allergy induced); "covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gluten, reaction(s): "Allergy to gluten". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Adverse event: Patient was starting at the end of the 5-day cycle into the weekend her COVID line was faint and she thought that the virus was going away. It remained faint until day 10. At that time, it became dark red again. We are now unclear if this was a relapse and if she was still contagious. Being that the drug was new, her doctor was also unclear. She just have what she have read in articles on the internet where this was a gray area. Her doctor's guidance it to start he 10-day count again until. She would like more guidance. She have mild cold like symptoms: stuffiness and cough. Patient was not received other medication in 2weeks of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 64 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: "RA" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Raynaud's" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing); "Atypical cranial neuralgia" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Clinical information: Treatment drug included Paxlovid (Lot number: Fx4466) from 03May2022.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 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 was not reported. Concomitant medication(s) included: PANTOPRAZOLE; VITAMIN D NOS; CALCIUM. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome " not recovered ", 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: COVID 19 Treatment; (unspecified date) Negative, notes: tested negative for a week; (01May2022) Positive, notes: I tested positive for Covid again today. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received other medications (Concomitant medications) in 2 weeks. Paxlovid was given for COVID 19 Treatment on 19Apr2022 and stopped on 24Apr2022. The patient stated that I finished Paxlovid and recovered and tested negative for a week. Then all of my symptoms returned, and I tested positive for Covid again today.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 03Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 03Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing), notes: Depression & anxiety. high blood, pressure and high cholesterol.; "Anxiety" (unspecified if ongoing), notes: Depression & anxiety. high blood, pressure and high cholesterol.; "High Cholesterol" (unspecified if ongoing), notes: Depression & anxiety. high blood, pressure and high cholesterol.; "High blood pressure" (unspecified if ongoing), notes: Depression & anxiety. high blood, pressure and high cholesterol. Concomitant medication(s) included: CYMBALTA; WELLBUTRIN; LISINOPRIL; ROSUVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant) with onset 12Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 12Apr2022, outcome "recovered" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive; (19Apr2022) Negative; (22Apr2022) Positive, notes: Had a positive home test on day 11 & day 13; (24Apr2022) Positive, notes: Had a positive home test on day 11 & day 13; (26Apr2022) Negative, notes: tested negative day 15, 16 & 17; (27Apr2022) Negative, notes: tested negative day 15, 16 & 17; (28Apr2022) Negative, notes: tested negative day 15, 16 & 17. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts were possible. No further information was expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: developed severe sweating; profuse sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 01May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 81 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (First Booster , Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: HYPERHIDROSIS (non-serious) with onset May2022, outcome "recovered" (May2022), described as "developed severe sweating"; HYPERHIDROSIS (non-serious) with onset May2022, outcome "recovered" (May2022), described as "profuse sweating". Therapeutic measures were not taken as a result of hyperhidrosis, hyperhidrosis.  Additional information: Reason for no lot number: of COVID-19 Vaccine: Other: Consumer stated, "The LOT number is PF, I can hardly read it the pharmacist did not write too well, it looks like 2 and I can't make out what next is and then it says FM88 no could be 9992 could be 8882 not sure which." Expiry Date of COVID-19 Vaccine: Unknown, Other Products: Yes. Additional Context: Consumer stated, "I had my second booster (Later clarified as Pfizer COVID-19 Vaccine) on Sunday of 01May2022 at (withheld) in (withheld) where I live and a day or two after that I developed severe sweating, profuse sweating and it lasted almost 2 days and I believe it was from shot because it is totally gone now." When paraphrased the concern: Consumer stated, "Yes, it's gone, I checked with my GP and he said very well it could be." Consumer was informed about the Pfizer drug safety department. In response: Consumer stated, "Absolutely I want to help as much as I can." Height and weight: Consumer stated, "My height is approximately 5'9 I would say roughly. "Time of Vaccination: Consumer stated, "Around 2pm in the afternoon."  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: Ankylosing spondylitis, Injection site extravasation, Therapeutic response shortened
Clinical narrative: Ankylosing spondylitis flare up; Did injection and used inner part of thigh and angle of needle caused spillage of medication at injection site; Returned ankylosing spondylitis symptoms before the Humira injection was due with Humira (Adalimumab); This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4378911-00 (Company).  A 31-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "recovered", described as "Ankylosing spondylitis flare up"; INJECTION SITE EXTRAVASATION  (non-serious), outcome "not recovered", described as "Did injection and used inner part of thigh and angle of needle caused spillage of medication at injection site"; THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "unknown", described as "Returned ankylosing spondylitis symptoms before the Humira injection was due with Humira (Adalimumab)". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "ankylosing spondylitis flare up", "did injection and used inner part of thigh and angle of needle caused spillage of medication at injection site" and "returned ankylosing spondylitis symptoms before the humira injection was due with humira (adalimumab)" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of DID INJECTION AND USED INNER PART OF THIGH AND ANGLE OF NEEDLE CAUSED SPILLAGE OF MEDICATION AT INJECTION SITE with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of ANKYLOSING SPONDYLITIS FLARE UP and RETURNED ANKYLOSING SPONDYLITIS SYMPTOMS BEFORE THE HUMIRA INJECTION WAS DUE was not provided.  Clinical information: PFIZER BIONTECH COVID-19 VACCINE (TOZPINAMERAN) was also considered suspect. It was unknown if patient has enrolled in a COVID-19 Vaccine Trail. Primary reporter does not had the lot number information, because the packaging was discarded. Drug: PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN),UNKNOWN: Daily Dose: (1 in 1 Once). Did event abate after stopping drug: NA  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and close temporal association , the event of  ankylosing spondylitis flare up, injection site extravasation , therapeutic response shortened is assessed as related to suspected vaccine
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My mom (82 year old female) tested positive for covid 19 today.; My mom (82 year old female) tested positive for covid 19 today.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 82-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 05May2022 at 19:00, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown" and all described as "My mom (82 year old female) tested positive for covid 19 today.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased
Clinical narrative: she continues to have high levels after the booster dose.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ARMOUR THYROID; PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 08Mar2021, when the patient was 53-year-old, for Covid-19 Immunization, reaction(s): "showing 1.06 high creatinine levels"; BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 09Apr2021, when the patient was 53-year-old, for Covid-19 Immunization, reaction(s): "on 28Apr2021 1.06, on 05May2021 1.03, on 19May2021 1.16 High, on 05Aug2021 1.10 High, on 16Aug2021 1.13 High, on 08Sep2021 1.29 High". The following information was reported: BLOOD CREATININE INCREASED (non-serious), outcome "not recovered", described as "she continues to have high levels after the booster dose.". The event "she continues to have high levels after the booster dose." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood creatinine increased.  Additional information: Elevated levels of Creatinine following dosing. I reported this previously, but she continues to have High levels after the booster dose. Hoping to find out if this is related to vaccination prior to receiving additional booster doses. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not 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: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2022 at 11:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 37 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: "High BP" (unspecified if ongoing); "Shellfish" (unspecified if ongoing); "Crab" (unspecified if ongoing), notes: Crab; ">30BMI" (unspecified if ongoing), notes: >30BMI. Concomitant medication(s) included: METOPROLOL, start date: 16Apr2022, stop date: 16Apr2022.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Negative; (05May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: . Re-infection after testing negative. I have maintained social distancing:Tested negative 02May 8AM (with lingering symptoms: loss of taste, thick/yellow runny nose, joint pain in right knee and hip), BP back to 125/85.Tested Positive 05May 8AM after original symptoms appeared: runny nose (thin and clear mucus), muscle aches, productive cough, fatigue, continued loss of taste and higher BP (136/92). (No more joint pains.). Dry mouth, bitter taste in the mouth, better after drinking water or Gatorade. (Started after the first evening dose).High BP (coinciding with fever or periods of feeling worse -potentially due to COVID rather than Paxlovid. Allergies reaction from Shellfish Crab.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Lot number: F58742) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 06Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "melanoma" (unspecified if ongoing); "interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: THERAFLU COLD AND FLU, start date: 16Apr2022, stop date: 25Apr2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: COVID 19 Treatment; (03May2022) positive, notes: Viral rebound detected on Day 18 starting Paxlovid on Day1; (27Apr2022) Negative, notes: negative via RAT on Day 8. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient had other medication in 2 weeks. Patient had no known allergies. Patient not receive any treatment.  No follow-up attempts are possible. No further information is expected.
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 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 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) (Other medication in 2weeks product) included NYQUIL. 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: (unspecified date) Positive; (05May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid, treatment start date: 26Apr2022, treatment stop date 30Apr2022. Clinical course: Resurgence of covid symptoms 5 days after finishing Paxlovid course. Covid symptoms: runny nose, nasal congestion, cough. Afebrile. Covid test strongly positive today, but never completed test of cure following completion of Paxlovid course.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: she was tired after her first booster to Pfizer.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 23Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 19Jan2021, when the patient was 79-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 09Feb2021, when the patient was 79-year-old, for Covid-19 Immunization, reaction(s): "Tired", "Chills", "Cold", "Felt drugged". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "she was tired after her first booster to Pfizer.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Drug interaction, Pain, Psoriatic arthropathy, Road traffic accident
Clinical narrative: Psoriatic arthritis flare; Psoriatic arthritis flare/symptoms were came back; pain; Humira did not work well; drug interaction; car accident; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4378855-00 (Agency).  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 08Apr2020 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 40 mg (40 mg, [citrate free (40 mg, 1 in 2 week)]), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ROAD TRAFFIC ACCIDENT (non-serious) with onset 2017, outcome "unknown", described as "car accident"; PSORIATIC ARTHROPATHY (medically significant), outcome "recovered", described as "Psoriatic arthritis flare"; PSORIATIC ARTHROPATHY (medically significant), outcome "recovered", described as "Psoriatic arthritis flare/symptoms were came back"; PAIN (non-serious), outcome "unknown"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious), outcome "unknown", described as "Humira did not work well"; DRUG INTERACTION (non-serious), outcome "unknown". Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of car accident, psoriatic arthritis flare, psoriatic arthritis flare/symptoms were came back, pain and humira did not work well was not provided.  The reporter's assessment of the causal relationship of "psoriatic arthritis flare", "psoriatic arthritis flare/symptoms were came back", "car accident", "pain" and "humira did not work well" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events psoriatic arthropathy, pain and therapeutic product effect incomplete and drug interaction and the suspect drug BNT162B2 cannot be excluded. Based on known disease pathophysiology, the event of road traffic accident is assessed as not related to BNT162B2 and more likely due to accidental cause. 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.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Therapeutic product effect incomplete
Clinical narrative: Psoriatic arthritis flare; Psoriatic arthritis flare/symptoms were came back; pain; Humira did not work well; drug interaction; car accident; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4378855-00 (Agency).  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 08Apr2020 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 40 mg (40 mg, [citrate free (40 mg, 1 in 2 week)]), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ROAD TRAFFIC ACCIDENT (non-serious) with onset 2017, outcome "unknown", described as "car accident"; PSORIATIC ARTHROPATHY (medically significant), outcome "recovered", described as "Psoriatic arthritis flare"; PSORIATIC ARTHROPATHY (medically significant), outcome "recovered", described as "Psoriatic arthritis flare/symptoms were came back"; PAIN (non-serious), outcome "unknown"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious), outcome "unknown", described as "Humira did not work well"; DRUG INTERACTION (non-serious), outcome "unknown". Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of car accident, psoriatic arthritis flare, psoriatic arthritis flare/symptoms were came back, pain and humira did not work well was not provided.  The reporter's assessment of the causal relationship of "psoriatic arthritis flare", "psoriatic arthritis flare/symptoms were came back", "car accident", "pain" and "humira did not work well" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events psoriatic arthropathy, pain and therapeutic product effect incomplete and drug interaction and the suspect drug BNT162B2 cannot be excluded. Based on known disease pathophysiology, the event of road traffic accident is assessed as not related to BNT162B2 and more likely due to accidental cause. 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.
Age: 43.0
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) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2022 at 19:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Seizure disorder" (unspecified if ongoing). Concomitant medication(s) included: NYQUIL; IBUPROFEN; TYLENOL; LAMOTRIGINE. Past drug history included: Metronidazole for known allergies Metronidazole. 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, notes: my rapid test turned back to positive; negative, notes: negative rapid test on Day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Lot#FY7067) from 26Apr2022 to 30Apr2022.  Clinical Course: Other medication in 2 weeks included Lamotrigine, Nyquil, Ibuprofen, Tylenol. The patient started Paxlovid on Day 1 of symptoms. The patient had a negative rapid test on Day 7. She had no symptoms from Day 4-8. She began to have symptoms again (sneezing, congestion) on Day 9 and my rapid test turned back to positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, Covid-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: infected even though she had been previously vaccinated against covid; infected even though she had been previously vaccinated against covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "infected even though she had been previously vaccinated against covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: POSITIVE.  Clinical course: Caller reported that the companion (female) got infected even though she had been previously vaccinated against covid, not knowing if the vaccine was Pfizer or Moderna.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfur" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that patient did not receive other medication in 2weeks. It was also reported that Plaxvoid was taken as treatment of COVID-19 from 18Apr2022 to 23Apr2022. Adverse event: Patient was feeling much better on day 7 after taking the medicine. However, on day 10 Patient developed a post nasal drip, congestion and cough. Patient was prescribed a steroid to treat it. A week later, Patient was put on an antibiotic to treat an infection.Sulfur was reported as Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19, 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 57-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Lot number: EN6294), in right arm and on 19Sep2021 as dose 3 (booster), single (Lot number: 30130BA) at the age of 56 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OLMESARTAN HCTZ; CLOPIDOGREL; ROSUVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19.  Clinical Information: It was reported that patient received other medication in 2weeks Adverse event: Patient have apnea and use a cpap. he average 1-2 apnea episodes per hour. After a day or so of Paxlovid his episodes increased to approximately 12 per hour and he was awaken constantly by gasping. No such issues while away. No treatment ae. No known allergies.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Palpitations
Clinical narrative: numbness and palpitations; palpitations; This is a solicited report received from a contactable reporter(s) (Physician).  A 31-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (hospitalization), outcome "unknown", described as "numbness and palpitations"; PALPITATIONS (hospitalization), outcome "unknown".  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Crying, Erythema, Peripheral swelling
Clinical narrative: leg swelling; crying; redness of the left leg; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 20220422000219.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 20Apr2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), on 20Apr2022 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CRYING (non-serious) with onset 20Apr2022, outcome "recovered"; PERIPHERAL SWELLING (non-serious) with onset 20Apr2022, outcome "recovered", described as "leg swelling"; ERYTHEMA (non-serious) with onset 20Apr2022, outcome "recovered", described as "redness of the left leg".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Urinary tract infection
Clinical narrative: Patient said that she observed changes in her menstrual cycle after receiving the vaccine and also had a bad urinary tract infection shortly after receiving the vaccine; Patient said that she observed changes in her menstrual cycle after receiving the vaccine and also had a bad urinary tract infection shortly after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: URINARY TRACT INFECTION (non-serious), MENSTRUAL DISORDER (non-serious), outcome "recovered" and all described as "Patient said that she observed changes in her menstrual cycle after receiving the vaccine and also had a bad urinary tract infection shortly after receiving the vaccine". The events "patient said that she observed changes in her menstrual cycle after receiving the vaccine and also had a bad urinary tract infection shortly after receiving the vaccine" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of urinary tract infection, menstrual disorder. It was if patient had  any other vaccine in four weeks. Patient said that she observed changes in her menstrual cycle after receiving the vaccine and also had a bad urinary tract infection shortly after receiving the vaccine. AE Treatment: Not sure - she just mentioned that she went to the doctor and the emergency room. The patient did not have covid prior vaccination. It was unknown if the patient was tested for covid post vaccination. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.