chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Investigation, Pain in extremity, SARS-CoV-2 test
Clinical narrative: my left arm where I received the vaccine very sore all the way his into my hand; painful wrist, fingers/hand pains on both as well as left shoulder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Survived Uterus Cancer 2021", start date: 2021 (unspecified if ongoing); "Known allergies: Statin" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number=1, product=COVID 19, brand= Pfizer , lot number= FC3182, administration date=24Aug2021, administration time=02:00 PM,, vaccine location=Left arm), administration date: 24Aug2021, when the patient was 80-year-old, for COVID-19 Immunization; Covid-19 vaccine (Dose number 2; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose number 3; Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Apr2022 at 16:00, outcome "not recovered", described as "my left arm where I received the vaccine very sore all the way his into my hand"; ARTHRALGIA (non-serious) with onset 25Apr2022 at 16:00, outcome "not recovered", described as "painful wrist, fingers/hand pains on both as well as left shoulder". The events "my left arm where i received the vaccine very sore all the way his into my hand" and "painful wrist, fingers/hand pains on both as well as left shoulder" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, arthralgia.  Additional information: After the second Booster on 25Apr2022 I experienced my left arm where I received the vaccine very sore oll the way his into my hand. That we for over two months now for the past month I am also experiencing very painful wrist, fingers and hand pains on both as well as left shoulder. Very painful. Arthritis pain meds do not work have had different test no results so far. The only relief is from Tylenol which takes around 6 to make it tolerable. I am as lost as my doctors as to what to do. Please advise. Miserable. Adverse events start date: 25Apr2022, Ae treatment: Celebrex and Arthritis creams
Age: 53.0
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 reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jul2022) positive, notes: tested positive with symptom 4 days after finishing plaxovid. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient reported that received vaccine. Reported anti viral details regarding product COVID 19 Treatment, brand name was reported as plaxovid, treatment started on 08Jul2022, and treatment stopped on 12Jul2022. The treatment received for the indication COVID-19. The adverse event reported that patient tested positive with symptom 4 days after finishing plaxovid on 16Jul2022. The event was recovering. Therapeutic measures was not taken for the event.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Bananas" (unspecified if ongoing), notes: Known allergies: Bananas, Other medical history: None. Concomitant medication(s) included: PROGESTERONE; ESTROGEN; ESTRADIOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19 Includes Paxlovid from 07Jul2022 to 11Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive via Rapid PCR; tested positive via Rapid PCR; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 46-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 at 09:00 as dose 1, single (Lot number: EN6198), in left arm, on 16Mar2021 at 09:30 as dose 2, single (Lot number: EN6206), in left arm, on 25Sep2021 as dose 3 (booster) , single (Lot number: BA30135), in left arm and on 28Apr2022 as dose 4 (booster) , single (Lot number: FM7553) at the age of 46 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, outcome "not recovered" and all described as "tested positive via Rapid PCR". The event "tested positive via rapid pcr" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical Course: Age group reported was Adult (18-64 Years). Patient received more than 3 doses. No other vaccine in four weeks. No other medications in two weeks. Course of the event: onset headache in the evening of 15Jul2022. Sinus pressure pushing on his teeth started in the morning on 16Jul2022 and post-nasal drip along with nasal congestion started on17Jul2022, tested positive via Rapid PCR on 18Jul2022. Not Known Drug Allergy. No covid prior vaccination. Covid tested post vaccination. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment were given for symptoms headache, sinus disorder, upper-airway cough syndrome, nasal congestion. Patient was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Pain, Rash
Clinical narrative: arthritis in hands; ongoing pain; rash on face and chest; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Sep2021 at 18:30 as dose 1, single (Lot number: fc3182) at the age of 43 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ARTHRITIS (non-serious) with onset 17Sep2021, outcome "not recovered", described as "arthritis in hands"; PAIN (non-serious) with onset 17Sep2021, outcome "not recovered", described as "ongoing pain"; RASH (non-serious) with onset 17Sep2021, outcome "not recovered", described as "rash on face and chest". The events "arthritis in hands", "ongoing pain" and "rash on face and chest" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of arthritis, pain, rash.  Additional information: Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. Device Date: 18Jul2022.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL8982), in right arm, on 08Feb2021 as dose 2, single (Lot number: EL9262), in right arm, on 27Sep2021 as dose 3 (booster), single (Lot number: EW4918), in right arm and on 14Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CETIRIZINE HYDROCHLORIDE, start date: Jun2020; NATURE MADE VITAMIN C. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: On day 10 of originally testing positive; positive, notes: After testing -2 days before I tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that the patient had no known allergies. Treatment was taken with Paxlovid and it was reported that the treatment start date was 07Jul2022 and treatment stop date was 12Jul2022. Other medication in 2weeks product was Complete multivitamin. Other medication in 2weeks brand was Equate. On day 10 of originally testing positive patient's nose started running, he had a slight headache and felt slightly feverish. After testing -2 days before he tested positive.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: took two of the vaccine (Unspecified Vaccine); I have COVID; I did not trust the vaccine; took two of the vaccine (Unspecified Vaccine); I have COVID; I did not trust the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blind in one eye" (unspecified if ongoing), notes: I am feeling sorrow and I am blind in one eye (History), I do not want to lose my other eyesight.". The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "took two of the vaccine (Unspecified Vaccine); I have COVID; I did not trust the vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I only took it last night because I started feeling bad again because I have COVID and the side effect is worse then the COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  No follow-up attempts are possible. No further information is expected.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200974112 same patient, different product and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Anti viral details for COVID 19 Treatment included PAXLOVID (brand), treatment start date was on 15Jul2022 and treatment stop date on 18Jul2022. Patient got very nauseated and vomited after 5th dose of PAXLOVID and the taste was extremely bitter, which made patient vomit more. Patient stated that, "I would estimate that I vomited at least a half gallon of fluid." Adverse event start date/time reported as 17Jul2022 at 10:00 PM.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: little bit of soreness in her arm; Dose 1 on 02Mar2021 and Dose 2 on 20Mar2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 2, single (Lot number: ER8732) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "for bone density" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder, start date: 1980; FOSAMAX taken for bone density abnormal; FISH OIL; VITAMIN D3; MULTIVITAMINS [VITAMINS NOS]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EN6199), administration date: 02Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Mar2021, outcome "unknown", described as "Dose 1 on 02Mar2021 and Dose 2 on 20Mar2021"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little bit of soreness in her arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200974944 same reporter/patient/product, different dose/AE;US-PFIZER INC-202200975336 same reporter/patient/product, different dose/AE;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little bit of soreness in her arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Lot number: 331708A) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "for bone density" (ongoing), notes: Additional Information for Other medicines Fosomax: She has been taking this 3 or 4 years.; "Thyroid", start date: 1980 (ongoing), notes: Additional Information for Other medicines Levothyroxine: She has been taking this since the 1980s. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder, start date: 1980; FOSAMAX taken for bone density abnormal; FISH OIL; VITAMIN D3. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EN6199), administration date: 02Mar2021, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot Number: EK8732 or ER8732), administration date: 20Mar2021, when the patient was 64-year-old, for COVID-19 immunization, reaction(s): "little bit of soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little bit of soreness in her arm".  Additional information: The patient also received Multivitamin. The patient did not receive any other vaccines administered on same date of the Pfizer vaccine. The patient did not receive any other vaccines within four weeks prior to the first administration date of the suspect vaccine and no adverse events following them. The patient did not have any family medical history relevant to AE(s). Relevant laboratory history was none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200974944 same reporter/patient/product, different dose/AE;US-PFIZER INC-202200975335 same reporter/patient/product, different dose/AE;
Age: 67.0
Sex: M
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 67-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 at 09:00 as dose 3 (booster), single (Lot number: 31130BA) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31May2022 at 15:00 as dose 4 (booster), single (Lot number: 037A22B), 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: AMLODIPINE; ATORVASTATIN; HYDROCHLOROTHIAZIDE; CHOLESTYRAMINE LIGHT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (10Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, 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 50-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 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). The patient's relevant medical history included: "Sleep Apnea" (unspecified if ongoing), notes: Sleep Apnea - Treated. Concomitant medication(s) included: OLMESARTAN, start date: 05Jul2022, stop date: 07Jul2022; IBUPROFAN, start date: 05Jul2022, stop date: 07Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: 100 Fahrenheit; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 05Jul2022, Treatment stop date: 10Jul2022, Indication: Treatment of COVID-19. Adverse event: Rebound Covid approximately ten days after initial symptoms. Including positive at home test, slight fever (~100F), congestion, cough, and exhaustion. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jan2021 as dose 1, single (Lot number: 037K201), on 31Jan2021 as dose 2, single (Lot number: 043L20A), on 19Aug2021 as dose 3 (booster), single (Lot number: 059E21A) and on 23Feb2022 as dose 4 (booster), single (Lot number: 037K20A) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Essential thrombocytosis" (unspecified if ongoing). Concomitant medication(s) included: AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANIC ACID], start date: 05Jul2022. Past drug history included: Known allergies: levaquin for Drug allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound 4 days after completing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid from 05Jul2022 to 09Jul2022 for Covid-19 treatment.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Nov2021 at 11:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing). The patient's 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2weeks. Treatment product Paxlovid treatment started on 06Jul2022 to treatment stopped on 11Jul2022 for indication treatment of COVID-19. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling
Clinical narrative: golf ball-sized swelling at the posterior base of her right ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (COMIRNATY), on 12Nov2021 as dose 3 (booster), single (Lot number: FO3527, Expiration Date: 31May2022) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot EF3246), administration date: 12Jan2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "golf ball-sized swelling at the posterior base of her right ear"; BNT162b2 (2nd dose-, Lot EL9264, expiration is unknown.), administration date: 02Feb2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "golf ball-sized swelling at the posterior base of her right ear". The following information was reported: EAR SWELLING (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "golf ball-sized swelling at the posterior base of her right ear".  Additional information: Patient also had it with the prior COVID vaccines. It started with one of the first ones and also with last booster in Oct2021. She was nervous of getting another booster. She wants to get another one but is afraid it will swell. She knows it is probably the gland and is active. She wants to make sure there is no risk if she gets another booster.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 12Mar2021 as dose 1, single (Lot number: 010A21A) and on 16Apr2021 as dose 2, single (Lot number: 016B21A) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Mar2022, stop date: Jul2022. 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: Body temperature: (15Jul2022) 99.4; (16Jul2022) 100, notes: The next day fever was up to 100; SARS-CoV-2 test: (13Jul2022) Negative, notes: tested negative and went back to work on Wednesday the 13th; (15Jul2022) Positive, notes: I immediately went home that afternoon and tested and was positive; (18Jul2022) Positive, notes: Today, Monday, I am still positive with symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient had no known allergies.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 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: "Hypothyroidism" (unspecified if ongoing); "Allergies: sulfa" (unspecified if ongoing); "Allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Mar2020, stop date: 18Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive, notes: Reoccurance of symptoms and positive test on 18Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received paxlovid as Treatment of COVID-19 from 02Jul2022 to 06Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "IIH" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Covid symptoms ended on Day 10; Positive, notes: On Day 14, new symptoms began again, and new positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID-19 treatment from 05Jul2022 to 09Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: ew0158) and on 02May2021 as dose 2, single (Lot number: ew0173) at the age of 38 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Nov2021 as dose 3 (booster), single (Lot number: 039fzia), in right arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). There were no concomitant medications. The patient had no known allergies.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (17Jul2022) Positive, notes: Rebound with symptoms and positive testing. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had taken Paxlovid, from 08Jul2022 to 13Jul2022 for the treatment of Covid-19.  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 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Negative, notes: testing negative for 2 days following Paxlovid course; Negative, notes: testing negative for 2 days following Paxlovid course; Positive, notes: The test came back with the FAINTEST positive one day after finishing course; Positive, notes: a STRONG positive line two days following; Positive, notes: a STRONG positive line two days following. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Patient did not receive and other medication in 2 weeks. Anti-viral details: Product was COVID 19 Treatment, Brand was Paxlovid. Treatment start date was 07Jul2022 and treatment Stop date was11Jul2022, indication was treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
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 49-year-old male patient received BNT162b2 (BNT162B2), on 30Jan2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DILTIAZEM; CRESTOR; ZETIA; OLMESARTAN; PRILOSEC [OMEPRAZOLE]; FINASTERIDE; XYZAL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: started testing positive again; Positive, notes: Symptoms fully returned 5 days after completing Paxlovid treatment, started testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient received anti viral treatment (Paxlovid) from 08Jul2022 to 12Jul2022 for COVID 19 Treatment. The symptoms fully returned 5 days after completing Paxlovid treatment, started testing positive again.  No follow-up attempts are required. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 05Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 05Apr2022 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: "Asthma" (unspecified if ongoing), notes: other medical history: asthma; "Allergies" (unspecified if ongoing), notes: other medical history: allergies; "high cholesterol" (unspecified if ongoing), notes: other medical history: high cholesterol; "chronic pain (degenerative disc)" (unspecified if ongoing), notes: other medical history: chronic pain (degenerative disc); "chronic pain (degenerative disc)" (unspecified if ongoing), notes: other medical history: chronic pain (degenerative disc); "known allergies: latex" (unspecified if ongoing), notes: known allergies: latex; "known allergies: avocado" (unspecified if ongoing), notes: known allergies: avocado. Concomitant medication(s) included: VITAMIN D [ERGOCALCIFEROL], start date: 01Jul2022, stop date: 18Jul2022. Past drug history included: Aspirin, reaction(s): "known allergies: aspirin", notes: known allergies: aspirin; Ibuprofen (nsaids), reaction(s): "known allergies: ibuprofen (nsaids)", notes: known allergies: ibuprofen (nsaids). 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: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient received vaccine and had other medication in 2 weeks. Anti viral details: product: paxlovid, treatment start date: 06Jul2022, treatment stop date: 11Jul2022, indication: Treatment of COVID-19. Had sore throat, headache, stuffy nose, (reinfection of covid, or rebound) on 15Jul2022, and was recovering.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 71.0
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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), on 29Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Polio" (unspecified if ongoing), notes: Polio at age 1; "Psoriatic arthritis" (unspecified if ongoing); "HBP" (unspecified if ongoing); "osteomyelitis in left arm" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE, start date: 01Dec2021, stop date: 01Dec2021; OTEZLA, start date: 01Mar2022, stop date: 01Mar2022; SULFASALAZINE, start date: 01Mar2022, stop date: 01Mar2022; HYDRALAZINE, start date: 01Oct2021, stop date: 01Oct2021; METOPROLOL; AVAPRO; PROLIA, start date: 01Jul2019, stop date: 01Jul2019; PRAVASTATIN; AMLODIPINE; CLARID [LORATADINE]; FISH OIL; FENOFIBRATE. Past drug history included: Daptomycin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid from 09Jul2022 to 14Jul2022, lot number: GC8123 for treatment of COVID-19. Completed taking Paxlovid on (Wednesday) 16Jul2022 morning. Tested negative Saturday. Woke up Monday (today) with symptoms (sneezing, chills, headache, congestion) again. Tested positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 10Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 15Nov2021 as dose 3 (booster), single (Lot number: 939903), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: CONCERTA oral; PROPRANOLOL oral; MIRENA. The patient had no known allergies.  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: Unknown Result. Therapeutic measures were taken as a result of vaccination failure, covid-19. It was reported the treatment was received with Paxlovid, oral route of administration, treatment start date was given as 28Apr2022 and stop date was given as 28Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19/positive COVID-19 infection; Treatment of COVID-19/positive COVID-19 infection; 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 01Apr2021 as dose 1, single (Lot number: ER8732) and on 23Apr2021 as dose 2, single (Lot number: EW0170) at the age of 44 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 23Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 23Apr2022 as dose 4 (booster), single (Lot number: 001M21A) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) in two weeks included: LEVALBUTEROL HCL; SINGULAIR; SYMBICORT; XYZAL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19/positive COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: Rebound - return of positive COVID-19 infection; (Jul2022) negative, notes: repeat negative testing following completion of paxlovid course. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details for COVID-19 Treatment included Brand-PAXLOVID, with treatment start date on 07Jul2022 and treatment stop date on 12Jul2022. Rebound-return of positive COVID-19 infection after repeat negative testing following completion of paxlovid course. Adverse event start date was reported as 16Jul2022.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Loss of personal independence in daily activities, Macular degeneration, Visual impairment
Clinical narrative: macular degeneration; an allergic reaction; unable to read tiny print; unable to read tiny print; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 98-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 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: MACULAR DEGENERATION (medically significant), outcome "unknown"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "an allergic reaction"; VISUAL IMPAIRMENT (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown" and all described as "unable to read tiny print".  Clinical course: Caller was asking for a list of Paxlovid ingredients compared to the ingredients of the Pfizer covid 19 vaccine. Caller reported that she experienced an allergic reaction about 1.5 years ago after her first dose of the vaccine and wants to know if any ingredients of the vaccine are present in Paxlovid, in case she were to ever catch covid. Caller noted she also had macular degeneration and was unable to read tiny print. Caller said she received an email from Pfizer listing three ingredients in the vaccine that might have caused her allergic reaction. Caller explained she was able to access emails but was not able to look things up well or read tiny print.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm still hurts; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "left arm still hurts". The patient had complaints from the first two doses of the Pfizer Covid-19 vaccine (first dose time unknown, second dose in Jan2022 per Caller). Caller reported that she had complaints of sweats, fevers, left arm still hurts, arm numbness and tingling Caller reports that she was in the hospital back in Apr2022 due to the complaints with arm numbness and tingling due to concerns about a stroke but was told nothing is wrong with her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.