chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna; Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Lot number: EL 3247), in right arm, on 07Feb2021 as dose 2, single (Lot number: EL 9264), in right arm and on 27Sep2021 as dose 3 (booster), single (Lot number: BA30125) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Apr2022 as dose 4 (booster), single (Lot number: 046L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Colorectal Cancer", start date: 2019 (unspecified if ongoing), notes: Colorectal Cancer in 2019. Concomitant medication(s) included: ACETAMINOPHEN; LEVOTHYROXIN; TYLENOL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 18Apr2022, outcome "unknown", described as "Moderna; Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid given from 01Dec2022 to 05Dec2022 as Covid-19 treatment.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SLE" (unspecified if ongoing), notes: Other medical history: Yes - SLE; "normocalcemoc hyperparathyroidism" (unspecified if ongoing), notes: normocalcemoc hyperparathyroidism. Concomitant medication(s) included: MYCOPHENOLATE MOFETIL; PREDNISONE; PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]; ESCITALOPRAM; OMEPRAZOLE; METOPROLOL; ESTRADIOL. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin", notes: Known allergies: Yes - amoxicillin; Clarithromycin, reaction(s): "Known allergies:clarithromycin", notes: Known allergies: Yes - clarithromycin; Metronidazole, reaction(s): "Known allergies:metronidazole", notes: Known allergies: Yes-metronidazole; Ibuprofen, reaction(s): "Known allergies: ibuprofen", notes: Known allergies: Yes-ibuprofen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2weeks. The patient received Paxlovid for COVID 19 Treatment, Treatment start date was 26Nov2022, Treatment stop date was 30Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events Drug ineffective and COVID-19 cannot be ruled out.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: Shingles on left side of neck & left ear lobe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jun2022 as dose 3 (booster), single (Lot number: FP7135) at the age of 54 years, in left arm for covid-19 immunisation. Patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Sulfites Allergy" (unspecified if ongoing), notes: Known allergies: sulfites. Concomitant medication(s) included: FISH OIL [EICOSAPENTAENOIC ACID]; VITAMIN B12 [CYANOCOBALAMIN]. Other medication details reported as might have taken EPA/DHA fish oil, vitamin B12. DK. Vaccination history included: BNT162b2 (lot number: FT1614, dose number 2, vaccine location Left arm), administration date: 28Jan2022, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (lot number 33130BA, dose number 1, vaccine location Left arm), administration date: 07Jan2022, when the patient was 54-year-old, for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 22Oct2022, outcome "recovered" (2022), described as "Shingles on left side of neck & left ear lobe". The event "shingles on left side of neck & left ear lobe" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of herpes zoster.  Additional information: Treatment included antibiotics & then antivirals with antibiotics. If other vaccine in four weeks reported as no.
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Diabetes mellitus" (unspecified if ongoing), notes: other medical history: diabetes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovvid.  Addition al information: Anti-viral details: Paxlovvid: Treatment start date: 28Nov2022, Treatment stop date: 02Dec2022, Indication: Treatment of COVID-19. The 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: since getting my booster shot I have developed a cough starting 04Nov2022; product=COVID 19, brand=Pfizer, is bivalent=False, Administration date=06Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 2 (booster), single (Lot number: GJ6665) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: covid 19 janssen (Dose Number: 1, Batch/Lot No: 1855191, Location of injection: Arm Left), administration date: 15Dec2021, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Oct2022, outcome "unknown", described as "product=COVID 19, brand=Pfizer, is bivalent=False, Administration date=06Oct2022"; COUGH (medically significant) with onset 04Nov2022, outcome "not recovered", described as "since getting my booster shot I have developed a cough starting 04Nov2022". The event "since getting my booster shot i have developed a cough starting 04nov2022" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Dec2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of cough.  Clinical course: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. She have no other illnesses. Since getting her booster shot she had developed a cough starting 04Nov2022 and have been treated with antibiotics, advent inhaler, abuterol, and cough Medications and my cough will not go away. She had medications and her cough will not go away. She had never before prior to the vaccine had an issue getting over a cough. Patient treated with antibiotics, breathing treatments, cough suppress.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Moderna Dose 3, 4 & 5; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EP7534), in right arm and on 11Apr2021 as dose 2, single (Lot number: EL00151) at the age of 60 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Dec2021 as dose 3 (booster), single (Lot number: 027H21B), in right arm, on 31Aug2022 as dose 4 (booster), single (Lot number: 082B22A), in right arm and on 04Nov2022 at 14:30 as dose 5 (booster), single (Lot number: 010H22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "strep throat prior to Covid" (unspecified if ongoing), notes: other medical history: strep throat prior to Covid. Concomitant medication(s) included: QUETIAPINE FUMARATE; ZOLPIDEM TARTRATE; MONTELUKAST SODIUM; AZELASTINE HCL; CETIRIZINE HCL; DIPHENHYDRAMINE HCL; PHENYLEPHRINE HCL; DAYQUIL SEVERE COLD & FLU; NYQUIL SEVERE COLD & FLU; AMOXICILLIN, start date: 17Nov2022, stop date: 27Nov2022; GLUCOSAMINE & CHONDORITIN; AZO; CENTRUM SILVER [ASCORBIC ACID;BIOTIN;BORON;CALCIUM;CALCIUM PANTOTHENATE;CHLORINE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;MAGNESIUM;MANGANESE;MOLYBDENUM;NICKEL;NICOTINAMIDE;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCH; OMEGA 3 FISH OIL [FISH OIL]; TURMERIC [CURCUMA LONGA RHIZOME]; COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]; CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; VALERIN [VALPROATE SODIUM]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna Dose 3, 4 & 5". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Dec2022) Negative; (06Dec2022) Negative; (08Dec2022) Positive; (11Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid,treatment start date was 30Nov2022 and stop date was 05Dec2022.  Clinical course: Tested at home as negative on 04Dec and 06Dec. Tested at home as positive on 08Dec with mild cold-like symptoms. Today, 11Dec, I tested at home as positive still. Symptoms are subsiding, but not completely gone. I was diagnosed with strep throat before Covid which was why I was on amoxicillin. I contracted Covid about the same time that I finished the amoxicillin. The patient had No known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: lot of itching in her arm; lot of pain on the site of shot; she has like symptoms; Experienced pain in her arm and it would not go away; the pain goes to her back; A bump in her chest; feeling really hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "lot of itching in her arm"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "lot of pain on the site of shot; she has like symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Experienced pain in her arm and it would not go away"; BACK PAIN (non-serious), outcome "unknown", described as "the pain goes to her back"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "A bump in her chest"; FEELING HOT (non-serious), outcome "unknown", described as "feeling really hot".  Additional information: Patient had a lot of itching in her arm and she was feeling, Patient was having a lot of pain on the site of shot. Patient experienced pain in her arm and it would not go away, the pain goes to her back; A bump in her chest; feeling really hot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: lot of itching in her arm; lot of pain on the site of shot; she has like symptoms; Experienced pain in her arm and it would not go away; the pain goes to her back; A bump in her chest; feeling really hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "lot of itching in her arm"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "lot of pain on the site of shot; she has like symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Experienced pain in her arm and it would not go away"; BACK PAIN (non-serious), outcome "unknown", described as "the pain goes to her back"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "A bump in her chest"; FEELING HOT (non-serious), outcome "unknown", described as "feeling really hot".  Additional information: Patient had a lot of itching in her arm and she was feeling, Patient was having a lot of pain on the site of shot. Patient experienced pain in her arm and it would not go away, the pain goes to her back; A bump in her chest; feeling really hot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Magnetic resonance imaging, Tinnitus, Vaccination site bruising, Weight
Clinical narrative: tinnitus; It is about 140 (lbs.) and I know I am shrinking; bruising where the injection is done is ordinary; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose number unknown (booster), single (Lot number: GJ6739) at the age of 74 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose Number unknown (Booster), Manufacturer Unknown), for COVID-19 Immunization.  The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 10Dec2022, outcome "unknown", described as "bruising where the injection is done is ordinary"; TINNITUS (non-serious), outcome "unknown"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "It is about 140 (lbs.) and I know I am shrinking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site bruising, tinnitus.  Additional information: Caller was asking if "bruising where the injection is done is ordinary" for "Pfizer COVID vaccine booster dose". "it was the second dose he had in 30Nov". I got a bruise from it. There is no pain. It is just a bruise. It is like a combination of black and blue and green." Other Conditions: No. Other Products: No. No prior vaccinations (within 4 weeks), Consumer stated the last one before that was 25May. That was well past 4 weeks. Treatment in response to adverse event: Consumer stated as No. Consumer stated, "I did go to the ear, nose and throat doctor at the (name withheld). That was for, to check, I have a tinnitus (Further clarification unknown. Hence not captured in tab). That has something to do with the hearing. It is in the left ear and that was about that. I mean I ended up getting an MRI done because they wanted to see if the tinnitus was caused by my brain or was it caused by tumor but they haven't gone back to me yet. So, I am assuming it was caused by the brain because first of all, it was only a 3 percent chance that it was caused by a tumor and it if it was caused by a tumor, I think they would have told me about it by now whereas if it was caused by brain, I mean I think they wouldn't have bothered telling me. You know it is one of those things, no news is good news, you know what I mean. They had to do an IV for that and if you know how an MRI works. I mean, I never had one done on my skull before. Saturday noticed he has a bruise where it was done.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: tinnitus; It is about 140 (lbs.) and I know I am shrinking; bruising where the injection is done is ordinary; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose number unknown (booster), single (Lot number: GJ6739) at the age of 74 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose Number unknown (Booster), Manufacturer Unknown), for COVID-19 Immunization.  The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 10Dec2022, outcome "unknown", described as "bruising where the injection is done is ordinary"; TINNITUS (non-serious), outcome "unknown"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "It is about 140 (lbs.) and I know I am shrinking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site bruising, tinnitus.  Additional information: Caller was asking if "bruising where the injection is done is ordinary" for "Pfizer COVID vaccine booster dose". "it was the second dose he had in 30Nov". I got a bruise from it. There is no pain. It is just a bruise. It is like a combination of black and blue and green." Other Conditions: No. Other Products: No. No prior vaccinations (within 4 weeks), Consumer stated the last one before that was 25May. That was well past 4 weeks. Treatment in response to adverse event: Consumer stated as No. Consumer stated, "I did go to the ear, nose and throat doctor at the (name withheld). That was for, to check, I have a tinnitus (Further clarification unknown. Hence not captured in tab). That has something to do with the hearing. It is in the left ear and that was about that. I mean I ended up getting an MRI done because they wanted to see if the tinnitus was caused by my brain or was it caused by tumor but they haven't gone back to me yet. So, I am assuming it was caused by the brain because first of all, it was only a 3 percent chance that it was caused by a tumor and it if it was caused by a tumor, I think they would have told me about it by now whereas if it was caused by brain, I mean I think they wouldn't have bothered telling me. You know it is one of those things, no news is good news, you know what I mean. They had to do an IV for that and if you know how an MRI works. I mean, I never had one done on my skull before. Saturday noticed he has a bruise where it was done.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 16:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Feb2021 at 12:30 as dose 1, single (Lot number: EN6200), in left arm, on 13Mar2021 at 12:30 as dose 2, single (Lot number: EN6206), in left arm, on 16Aug2021 at 15:15 as dose 3 (booster), single (Lot number: FA7485), in left arm and on 17Jan2022 at 15:30 as dose 4 (booster), single (Lot number: FJ6369), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: Apr2012; ATORVASTATIN, start date: Apr2012. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Nov2022, outcome "recovered" (2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Antigen Test was NEGATIVE for three days; (20Nov2022) Positive, notes: Covid-19 Tested positive on 20Nov2022 by NAAT at [Facility name withheld]; (28Nov2022) Negative, notes: Felt feverish on 28Nov2022 and Home Antigen Test became NEGATIVE; (04Dec2022) Negative, notes: Home Antigen Test became NEGATIVE on 04Dec2022; (06Dec2022) Negative, notes: Lab NAAT test at [Facility name withheld] became NEGATIVE on 06Dec2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: First covid-19 symptoms appeared on 19Dec2022 (possibly discrepant information; pending clarification). Covid-19 Tested positive on 20Nov2022 by NAAT at [Facility name withheld]. Paxlovid started on 20Nov2022. Paxlovid 5-day course finished on 24Nov2022. Home Antigen Test was NEGATIVE for three days. Felt feverish on 28Nov2022 and Home Antigen Test became NEGATIVE. Started 2nd course of Paxlovid on 01Dec2022 evening. Home Antigen Test became NEGATIVE on 04Dec2022. Finished the 2nd course of Paxlovid (5-day) in the morning of 06Dec2022. Lab NAAT test at [Facility name withheld] became NEGATIVE on 06Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, the events VACCINATION FAILURE, COVID-19 are assessed as related to the suspect drug BNT162b2, BNT162b2 omi ba.4-5.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity
Clinical narrative: left arm got very painful/most painful around the bicep area/ pain has moved down to her fingers and wrist; pain has moved down to her fingers and wrist; she can barely move her arm; 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.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 16May2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2022, outcome "not recovered", described as "left arm got very painful/most painful around the bicep area/ pain has moved down to her fingers and wrist"; ARTHRALGIA (non-serious) with onset May2022, outcome "not recovered", described as "pain has moved down to her fingers and wrist"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset May2022, outcome "not recovered", described as "she can barely move her arm". Therapeutic measures were taken as a result of pain in extremity, arthralgia, joint range of motion decreased.  Additional information: It was reported that, after receiving second Pfizer covid booster dose, left arm got very painful to use ever since and most painful around the bicep area. Patient tried heating and doing rubs to try and make it go away and that it seems to help sometimes but she can barely move her arm. Patient's pain has moved down to her fingers and wrist and that it has been 7 months that she has been experiencing this. After consultation with doctor patient tried taking Tramadol, sometimes Tylenol, and even Lidocaine for the pain. Pain calms down for a while but that it is not lasting and that the pain comes back.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got Covid; Got Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right 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: "Obesity" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: testing positive again several days following finishing my course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies. Patient received other medication in 2 weeks. COVID 19 Treatment included paxlovid from 29Nov2022 to 04Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history was not reported. The patient took concomitant medications. 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: Positive, notes: Tested positive again 6 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient received COVID treatment: patient took the antiviral. Tested positive again 6 days after finishing Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201368703 Same patient, different product and event;
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2022 as dose 1, single (Lot number: GT2524) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing). Concomitant medication(s) included: CALQUENCE, start date: May2019, stop date: 29Nov2022; ELIQUIS, start date: Feb2018, stop date: 29Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: rebound tested positive 2 days after negative test; Positive, notes: rebound tested positive 2 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Known allergies was no. Paxlovid was taken on 29Nov2022 as Covid-19 treatment.
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 44-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxocilin, reaction(s): "known allergies: AMOXOCILIN", notes: known allergies: AMOXOCILIN. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Plaxovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201368713 Same patient, different product and event;
Age: 37.0
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 37-year-old male patient received BNT162b2 (BNT162B2), on 13Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Relapsing Polychondritis" (unspecified if ongoing); "Tracheomalacia" (unspecified if ongoing). Concomitant medication(s) included: ACTEMRA; IVABRADINE; PREDNISONE; RASUVO; ROSUVASTATIN; METHOTREXATE SODIUM. 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Brand: Paxlovid Treatment start date: 02Dec2022 Treatment stop date: 06Dec2022 Indication: Treatment of COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Dec2022) Positive, notes: Positive text and symptoms 2 days after completing Paxlovid medication. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID-19 rebound. Positive text and symptoms 2 days after completing Paxlovid medication. COVID 19 Treatment started on 02Dec2022 and stop date was 07Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: Gh9694), 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 and concomitant medications were not reported. Past drug history included: Illsone antibiotics, reaction(s): "Known allergies: Illsone antibiotics", notes: Known allergies: Illsone antibiotics. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound symptoms- positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine COVID 19 Treatment, Paxlovid from 30Nov2022 to 04Dec2022. Known allergies: Illsone antibiotics.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old patient received BNT162b2 (BNT162B2), on 21Jul2022 at 13:15 as dose 4 (booster), single (Lot number: FJ4991) at the age of 54 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Feb2021 at 14:30 as dose 1, single (Lot number: 038K20A), in left arm, on 22Mar2021 at 12:00 as dose 2, single (Lot number: 007B21A), in left arm and on 01Nov2021 at 15:45 as dose 3 (booster), single (Lot number: 939905), in left arm 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) all with onset 27Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Nov2022) Positive, notes: I tested positive on 27Nov2022; (10Dec2022) Positive, notes: tested positive again on 10Dec2022. Clinical details: It was reported, the patient tested positive on 27Nov2022 and started Paxclovid (Lot number: GF3197) on 28Nov2022 to 03Dec2022. Then tested positive again on 10Dec2022 07:00 AM. No other medication in 2 weeks. Patient was not recovered and No treatment received.   Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 15Apr2021 as dose 2, single (Lot number: ER8731), in left arm, on 11Oct2021 as dose 3 (booster), single (Lot number: FF2987), in left arm and on 30Aug2022 at 14:00 as dose 4 (booster), single (Lot number: FPT135) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). There were no concomitant medications. The patient was not received other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 30Nov2022 to 05Dec2022
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Hypoaesthesia, Oral pain, Pain in jaw
Clinical narrative: massive pain in the mouth area/ear, jaw pain as well; ear & jaw pain as well; ear & jaw pain as well; my right side of my face goes numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Jan2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ORAL PAIN (non-serious), outcome "unknown", described as "massive pain in the mouth area/ear, jaw pain as well"; EAR PAIN (non-serious), PAIN IN JAW (non-serious), outcome "unknown" and all described as "ear & jaw pain as well"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "my right side of my face goes numb".  Additional information: Since the patient got vaccine had massive pain in the mouth area, right side of face goes numb; there's ear and jaw pain as well. The patient didn't have this until took the Jab December of last year. It was highly annoying and now the patient had to see a neurologist. The patient asked if they had any idea why this happened. The patient had Covid in Jan2020, doctor has it in record. it's like it shot up what the patient fought without anything; brought it back in system. The patient was highly upset. Medical inquiry was forwarded to MI.  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: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 16:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Feb2021 at 13:00 as dose 1, single (Lot number: EN6200), in left arm, on 13Mar2021 at 13:00 as dose 2, single (Lot number: EM6206), in left arm, on 19Aug2021 at 16:00 as dose 3 (booster), single (Lot number: EW0217), in left arm and on 17Jan2022 at 16:00 as dose 4 (booster), single (Lot number: FJ6369), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Guaifenesin, reaction(s): "Known allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" (10Dec2022) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 19Nov2022 to 23Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 18:30 as dose 4 (booster), single (Lot number: Glt9702) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 at 14:00 as dose 1, single (Lot number: EN6208), in right arm, on 31Mar2021 at 13:45 as dose 2, single (Lot number: ER8734), in right arm and on 21Dec2021 at 17:30 as dose 3 (booster), single (Lot number: FE3594), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Chronic Fatigue Syndrome" (unspecified if ongoing), notes: Other medical history: Chronic Fatigue Syndrome; "POTS" (unspecified if ongoing), notes: Other medical history: POTS. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received paxlovid for COVID 19 treatment since 07Dec2022 till 11Dec2022. The patient reported that other medication in 2 weeks were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: soreness of left arm after each injection; they got the first 2 doses 2 weeks apart; 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 male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6199; Anatomical location: left arm), administration date: 06Mar2021, for COVID-19 immunization, reaction(s): "Soreness of arm after each injection". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "they got the first 2 doses 2 weeks apart"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness of left arm after each injection".  Additional information: Reporter stated that they had both had the series of Pfizer injections where they got the first 2 doses 2 weeks apart.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201369161 same patient and drug, different dose and event;US-PFIZER INC-202201369165 same reporter and drug, different patient and event;US-PFIZER INC-202201369162 same reporter and drug, different patient and event;US-PFIZER INC-202201369163 same reporter and drug, different patient and event;US-PFIZER INC-202201369164 same reporter and drug, different patient and event;US-PFIZER INC-202201375453 same reporter/patient/AE, different vaccine dose;US-PFIZER INC-202201375452 same reporter/patient/AE, different vaccine dose;US-PFIZER INC-202201375418 same reporter/patient/AE, different vaccine dose;