chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Condition aggravated, Eczema, Erythema
Clinical narrative: A few days post vaccination, (10/17 or 10/18) my abdomen began to feel very itchy, I was scratching myself all day. My hyterectomy and laporoscopic scars began to inflame a few days later and I broke out into what looked like a heat rash above my pubic area and below my abdominal area. Rash developed on my lower abdomen and over the course of the week it spread to my underarms and under my breasts. My nipples, anus, eyes were also itchy. The rash became inflamed and severe itchiness and I created gouges and scratches all over my body, from my neck to on down to my ankles. My eczema on the lower, exterior of my legs, became incredibly inflamed and itchy. The rash was hot to touch, burned, was itchy and swollen. It hurt to wear a bra, underwear, and clothing. When I would have hot flashes, the rash became inflamed and ,blistered to the point of nausea. I thought I had an allergic reaction to millet in some bread but it was beyond any reaction I had ever had to food. My elbows were extremely itchy and I began to form lesions on my elbows and forearms and abdomen. I finally went to urgent care on 10/30/22 and was given an injection of dexthamethasone, a medrol dose pack, econozole cream, triamcinolone ointment.  It barely took the edge off for 12 hours. My eczema began to look like raw meat and fissures and gouges were deep. I had slight infections in the open wounds. I noticed redness on my lower right leg and then swelling in my left foot and ankle on November 17th around 9pm. I went to the ER because I feared cellulitis. After a full blood panel, the doctor felt I had a slight infection and prescribed 10 days of Cephalexin. On November 19, I noticed blistery rash spreading on my forearms and some tiny blisters on my right hand. I assumed it was a reaction to Keflex.  I had blistery rash on my abdomen and breasts. On November 22nd I saw the dermatologist, she was alarmed and gave me Kenalog injection and a medrol dose pack. My rash continued to spread and did not respond to steroids at all.  On November 28, I made the connection to the booster and my rash. Rash became hives all over arms and torso and thighs. crusty blistery rash. I saw my allergist and he diagnosed me with PLEVA (pityriasis lichenoides chronica). Dermatologist on 12/7/22 wrote rx for doxycycline and I will start tomorrow, 12/8/22.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Infection, Inflammation, Joint swelling, Loss of personal independence in daily activities
Clinical narrative: A few days post vaccination, (10/17 or 10/18) my abdomen began to feel very itchy, I was scratching myself all day. My hyterectomy and laporoscopic scars began to inflame a few days later and I broke out into what looked like a heat rash above my pubic area and below my abdominal area. Rash developed on my lower abdomen and over the course of the week it spread to my underarms and under my breasts. My nipples, anus, eyes were also itchy. The rash became inflamed and severe itchiness and I created gouges and scratches all over my body, from my neck to on down to my ankles. My eczema on the lower, exterior of my legs, became incredibly inflamed and itchy. The rash was hot to touch, burned, was itchy and swollen. It hurt to wear a bra, underwear, and clothing. When I would have hot flashes, the rash became inflamed and ,blistered to the point of nausea. I thought I had an allergic reaction to millet in some bread but it was beyond any reaction I had ever had to food. My elbows were extremely itchy and I began to form lesions on my elbows and forearms and abdomen. I finally went to urgent care on 10/30/22 and was given an injection of dexthamethasone, a medrol dose pack, econozole cream, triamcinolone ointment.  It barely took the edge off for 12 hours. My eczema began to look like raw meat and fissures and gouges were deep. I had slight infections in the open wounds. I noticed redness on my lower right leg and then swelling in my left foot and ankle on November 17th around 9pm. I went to the ER because I feared cellulitis. After a full blood panel, the doctor felt I had a slight infection and prescribed 10 days of Cephalexin. On November 19, I noticed blistery rash spreading on my forearms and some tiny blisters on my right hand. I assumed it was a reaction to Keflex.  I had blistery rash on my abdomen and breasts. On November 22nd I saw the dermatologist, she was alarmed and gave me Kenalog injection and a medrol dose pack. My rash continued to spread and did not respond to steroids at all.  On November 28, I made the connection to the booster and my rash. Rash became hives all over arms and torso and thighs. crusty blistery rash. I saw my allergist and he diagnosed me with PLEVA (pityriasis lichenoides chronica). Dermatologist on 12/7/22 wrote rx for doxycycline and I will start tomorrow, 12/8/22.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Miliaria, Nausea, Parapsoriasis, Peripheral swelling, Pruritus
Clinical narrative: A few days post vaccination, (10/17 or 10/18) my abdomen began to feel very itchy, I was scratching myself all day. My hyterectomy and laporoscopic scars began to inflame a few days later and I broke out into what looked like a heat rash above my pubic area and below my abdominal area. Rash developed on my lower abdomen and over the course of the week it spread to my underarms and under my breasts. My nipples, anus, eyes were also itchy. The rash became inflamed and severe itchiness and I created gouges and scratches all over my body, from my neck to on down to my ankles. My eczema on the lower, exterior of my legs, became incredibly inflamed and itchy. The rash was hot to touch, burned, was itchy and swollen. It hurt to wear a bra, underwear, and clothing. When I would have hot flashes, the rash became inflamed and ,blistered to the point of nausea. I thought I had an allergic reaction to millet in some bread but it was beyond any reaction I had ever had to food. My elbows were extremely itchy and I began to form lesions on my elbows and forearms and abdomen. I finally went to urgent care on 10/30/22 and was given an injection of dexthamethasone, a medrol dose pack, econozole cream, triamcinolone ointment.  It barely took the edge off for 12 hours. My eczema began to look like raw meat and fissures and gouges were deep. I had slight infections in the open wounds. I noticed redness on my lower right leg and then swelling in my left foot and ankle on November 17th around 9pm. I went to the ER because I feared cellulitis. After a full blood panel, the doctor felt I had a slight infection and prescribed 10 days of Cephalexin. On November 19, I noticed blistery rash spreading on my forearms and some tiny blisters on my right hand. I assumed it was a reaction to Keflex.  I had blistery rash on my abdomen and breasts. On November 22nd I saw the dermatologist, she was alarmed and gave me Kenalog injection and a medrol dose pack. My rash continued to spread and did not respond to steroids at all.  On November 28, I made the connection to the booster and my rash. Rash became hives all over arms and torso and thighs. crusty blistery rash. I saw my allergist and he diagnosed me with PLEVA (pityriasis lichenoides chronica). Dermatologist on 12/7/22 wrote rx for doxycycline and I will start tomorrow, 12/8/22.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic, Rash vesicular, Scab
Clinical narrative: A few days post vaccination, (10/17 or 10/18) my abdomen began to feel very itchy, I was scratching myself all day. My hyterectomy and laporoscopic scars began to inflame a few days later and I broke out into what looked like a heat rash above my pubic area and below my abdominal area. Rash developed on my lower abdomen and over the course of the week it spread to my underarms and under my breasts. My nipples, anus, eyes were also itchy. The rash became inflamed and severe itchiness and I created gouges and scratches all over my body, from my neck to on down to my ankles. My eczema on the lower, exterior of my legs, became incredibly inflamed and itchy. The rash was hot to touch, burned, was itchy and swollen. It hurt to wear a bra, underwear, and clothing. When I would have hot flashes, the rash became inflamed and ,blistered to the point of nausea. I thought I had an allergic reaction to millet in some bread but it was beyond any reaction I had ever had to food. My elbows were extremely itchy and I began to form lesions on my elbows and forearms and abdomen. I finally went to urgent care on 10/30/22 and was given an injection of dexthamethasone, a medrol dose pack, econozole cream, triamcinolone ointment.  It barely took the edge off for 12 hours. My eczema began to look like raw meat and fissures and gouges were deep. I had slight infections in the open wounds. I noticed redness on my lower right leg and then swelling in my left foot and ankle on November 17th around 9pm. I went to the ER because I feared cellulitis. After a full blood panel, the doctor felt I had a slight infection and prescribed 10 days of Cephalexin. On November 19, I noticed blistery rash spreading on my forearms and some tiny blisters on my right hand. I assumed it was a reaction to Keflex.  I had blistery rash on my abdomen and breasts. On November 22nd I saw the dermatologist, she was alarmed and gave me Kenalog injection and a medrol dose pack. My rash continued to spread and did not respond to steroids at all.  On November 28, I made the connection to the booster and my rash. Rash became hives all over arms and torso and thighs. crusty blistery rash. I saw my allergist and he diagnosed me with PLEVA (pityriasis lichenoides chronica). Dermatologist on 12/7/22 wrote rx for doxycycline and I will start tomorrow, 12/8/22.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Scar inflammation, Scratch, Skin fissures, Skin lesion, Skin warm
Clinical narrative: A few days post vaccination, (10/17 or 10/18) my abdomen began to feel very itchy, I was scratching myself all day. My hyterectomy and laporoscopic scars began to inflame a few days later and I broke out into what looked like a heat rash above my pubic area and below my abdominal area. Rash developed on my lower abdomen and over the course of the week it spread to my underarms and under my breasts. My nipples, anus, eyes were also itchy. The rash became inflamed and severe itchiness and I created gouges and scratches all over my body, from my neck to on down to my ankles. My eczema on the lower, exterior of my legs, became incredibly inflamed and itchy. The rash was hot to touch, burned, was itchy and swollen. It hurt to wear a bra, underwear, and clothing. When I would have hot flashes, the rash became inflamed and ,blistered to the point of nausea. I thought I had an allergic reaction to millet in some bread but it was beyond any reaction I had ever had to food. My elbows were extremely itchy and I began to form lesions on my elbows and forearms and abdomen. I finally went to urgent care on 10/30/22 and was given an injection of dexthamethasone, a medrol dose pack, econozole cream, triamcinolone ointment.  It barely took the edge off for 12 hours. My eczema began to look like raw meat and fissures and gouges were deep. I had slight infections in the open wounds. I noticed redness on my lower right leg and then swelling in my left foot and ankle on November 17th around 9pm. I went to the ER because I feared cellulitis. After a full blood panel, the doctor felt I had a slight infection and prescribed 10 days of Cephalexin. On November 19, I noticed blistery rash spreading on my forearms and some tiny blisters on my right hand. I assumed it was a reaction to Keflex.  I had blistery rash on my abdomen and breasts. On November 22nd I saw the dermatologist, she was alarmed and gave me Kenalog injection and a medrol dose pack. My rash continued to spread and did not respond to steroids at all.  On November 28, I made the connection to the booster and my rash. Rash became hives all over arms and torso and thighs. crusty blistery rash. I saw my allergist and he diagnosed me with PLEVA (pityriasis lichenoides chronica). Dermatologist on 12/7/22 wrote rx for doxycycline and I will start tomorrow, 12/8/22.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Wound infection
Clinical narrative: A few days post vaccination, (10/17 or 10/18) my abdomen began to feel very itchy, I was scratching myself all day. My hyterectomy and laporoscopic scars began to inflame a few days later and I broke out into what looked like a heat rash above my pubic area and below my abdominal area. Rash developed on my lower abdomen and over the course of the week it spread to my underarms and under my breasts. My nipples, anus, eyes were also itchy. The rash became inflamed and severe itchiness and I created gouges and scratches all over my body, from my neck to on down to my ankles. My eczema on the lower, exterior of my legs, became incredibly inflamed and itchy. The rash was hot to touch, burned, was itchy and swollen. It hurt to wear a bra, underwear, and clothing. When I would have hot flashes, the rash became inflamed and ,blistered to the point of nausea. I thought I had an allergic reaction to millet in some bread but it was beyond any reaction I had ever had to food. My elbows were extremely itchy and I began to form lesions on my elbows and forearms and abdomen. I finally went to urgent care on 10/30/22 and was given an injection of dexthamethasone, a medrol dose pack, econozole cream, triamcinolone ointment.  It barely took the edge off for 12 hours. My eczema began to look like raw meat and fissures and gouges were deep. I had slight infections in the open wounds. I noticed redness on my lower right leg and then swelling in my left foot and ankle on November 17th around 9pm. I went to the ER because I feared cellulitis. After a full blood panel, the doctor felt I had a slight infection and prescribed 10 days of Cephalexin. On November 19, I noticed blistery rash spreading on my forearms and some tiny blisters on my right hand. I assumed it was a reaction to Keflex.  I had blistery rash on my abdomen and breasts. On November 22nd I saw the dermatologist, she was alarmed and gave me Kenalog injection and a medrol dose pack. My rash continued to spread and did not respond to steroids at all.  On November 28, I made the connection to the booster and my rash. Rash became hives all over arms and torso and thighs. crusty blistery rash. I saw my allergist and he diagnosed me with PLEVA (pityriasis lichenoides chronica). Dermatologist on 12/7/22 wrote rx for doxycycline and I will start tomorrow, 12/8/22.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna; 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 16Feb2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Mar2021 at 11:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Sep2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 23Sep2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Jul2015. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin", notes: Known allergies: amoxicillin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Apr2022 at 10:00, outcome "not recovered", described as "vaccine brand other=Moderna"; 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: Positive, notes: Treatment of COVID-19; Negative, notes: after receiving a negative  home test on Day 10. Therapeutic measures were taken as a result of vaccination failure, covid-19, interchange of vaccine products.  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
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Comirnaty Dose Number 5 / Moderna Dose Number 4; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Batch/Lot number: unknown), on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 25Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Autoimmune small vessel vasculitis" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; XELJANZ; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN D [VITAMIN D NOS]; VITAMIN B12 NOS.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "unknown", described as "Comirnaty Dose Number 5 / Moderna Dose Number 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Nov2022) Positive, notes: Paxlovid started on day 1 of positive test; (29Nov2022) Negative, notes: Negative test with significant symptom improvement on day 8 after starting paxlovid; (03Dec2022) Positive, notes: Return of symptoms with positive test day 12 after starting paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies. Paxlovid rebound: Paxlovid started on day 1 of positive test. Negative test with significant symptom improvement on day 8 after starting paxlovid. Return of symptoms with positive test day 12 after starting paxlovid (7 days after completing 5-day course of paxlovid). Paxlovid treatment start from 21Nov2022 to 26Nov2022.  No follow-up attempts are possible. No further information is expected.; 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: 38.0
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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "General Anxiety disorder" (unspecified if ongoing), notes: other medical history: General Anxiety disorder. Concomitant medication(s) included: SERTRALINE. 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 course: Vaccine received and other medication in 2weeks reported as yes. Antiviral details included COVID 19 Treatment with Paxlovid from 20Nov2022 to 25Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
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 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 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: "Post Whipple surgery" (unspecified if ongoing), notes: Other medical history: Post Whipple surgery; "Chronic Lyme disease" (unspecified if ongoing), notes: Other medical history: Chronic Lyme disease; "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Thyroid" (unspecified if ongoing), notes: Other medication in 2weeks product = Thyroid meds. Concomitant medication(s) included: PANTOPRAZOLE, start date: 01Jul2018, stop date: 23Nov2022; GABAPENTIN, start date: 01Jul2018, stop date: 23Nov2022. Past drug history included: Ciproflaxin, reaction(s): "Known allergies: Ciproflaxin", notes: Known allergies: Ciproflaxin; Creon, reaction(s): "Known allergies: Creon", notes: Known allergies: Creon; Statins, reaction(s): "Known allergies: Statins", notes: Known allergies: Statins. 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received other medication in 2 weeks, vitamin (Still taking from 01Jul2018 to 23Nov2022). Anti-viral details: Product was COVID 19 Treatment, Brand was Paxlovid started on 25Nov2022 to 30Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 26 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9269), on 23Feb2021 as dose 2, single (Lot number: EN6200), on 16Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 18Mar2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Autism" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: 01Jan2022; HYDROXYZINE, start date: 01Sep2022; AMPHETAMINE SALTS, start date: 01Sep2022; PRAZOSIN, start date: 01Nov2022; VERAPAMIL, start date: 01Jan2021; TOPIRAMATE, start date: 01Jan2019; ADVAIR, start date: 01Mar2022. Past drug history included: Amoxicillin, reaction(s): "Known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: Still being positive for covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid treatment from 25Nov2022 to 30Nov2022.
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 24Jun2022 at 15:00 as dose 4 (booster), single (Lot number: FJ4991), 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: "Osteoporosis" (unspecified if ongoing); "slipped discs" (unspecified if ongoing); "kidney stones" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergy: Amoxicillin causes a severe stomach ache", notes: Amoxicillin causes a severe stomach ache. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient treated with Paxlovid (anti-viral) for COVID-19 treatment from 30Nov2022 to unknown date. She did not take other medication in 2 weeks.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pain
Clinical narrative: soreness the day of the vaccine but no other symptoms since; Received the Pfizer COVID-19 Vaccine Gray Cap Monovalent today, but the vaccine had an expiry date of 30Nov2022; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team, Program ID.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2022 as dose number unknown, single (Lot number: FP7140, Expiration Date: 30Nov2022) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 02Dec2022, outcome "unknown", described as "Received the Pfizer COVID-19 Vaccine Gray Cap Monovalent today, but the vaccine had an expiry date of 30Nov2022"; PAIN (non-serious) with onset 02Dec2022, outcome "unknown", described as "soreness the day of the vaccine but no other symptoms since".  Additional Information: Reporter said they normally go based on the 10 weeks time period but unfortunately since the manufacturer expired first, they were told by the guidelines to use that instead of being normal 10 week period which would have made 11Jan2023. The correct expiration date was 30Nov2022. The expiration was 12 months after the manufacturing date. It had been stored in a regular refrigerator within recommended range. Reporter confirmed the product is the monovalent gray cap formulation, primary series for the patient.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: Family noticed brain fog within a few weeks of getting the vaccine; DOSE 1: 11Sep2021 and DOSE 2: 23Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 23Oct2021 at 10:00 as dose 2, single (Lot number: 30135ba) at the age of 36 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Anatomical location: Left arm, Vaccine administration time: 11:30 AM), administration date: 11Sep2021, when the patient was 36-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 23Oct2021 at 10:00, outcome "unknown", described as "DOSE 1: 11Sep2021 and DOSE 2: 23Oct2021"; FEELING ABNORMAL (non-serious) with onset 01Nov2021, outcome "recovered with sequelae", described as "Family noticed brain fog within a few weeks of getting the vaccine". Therapeutic measures were not taken as a result of feeling abnormal.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Family noticed brain fog within a few weeks of getting the vaccine. The event recovered with lasting effects. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, 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: "Anxiety" (unspecified if ongoing); "asthma" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "HBP (High blood pressure)" (unspecified if ongoing), notes: HBP (High blood pressure); "known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 51.0
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) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0150), in left arm, on 30Apr2021 as dose 2, single (Lot number: EW0169), in left arm, on 21Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 17Jul2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bmi >40" (unspecified if ongoing), notes: Bmi >40; "Early arthritis" (unspecified if ongoing); "Cold/exercise induced asthma" (unspecified if ongoing); "Cold/exercise induced asthma" (unspecified if ongoing); "Minor heart murmur" (unspecified if ongoing); "Surgical plates/screws in left radius" (unspecified if ongoing), notes: surgical plates/screws in left radius; "Bivalves allergy" (unspecified if ongoing), notes: Bivalves allergy. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy"; Marijuana, reaction(s): "Allergy"; Gin, reaction(s): "Allergy"; Juniper, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures, Paxlovid from 02Dec2022, were taken as a result of vaccination failure, covid-19.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2022 at 14:30 as dose number unknown single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid on 20Nov2022 to 25Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
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) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 09:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Jan2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 21Feb2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 28Feb2022 at 08:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 20Jun2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid on 22Nov2022 to 27Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; 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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 01Jun2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for COVID-19 immunization; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), in left arm for COVID-19 immunization. The patient's relevant medical history included: "MS and history of breast cancer" (unspecified if ongoing), notes: MS and history of breast cancer; "MS and history of breast cancer" (unspecified if ongoing), notes: MS and history of breast cancer; "Known allergies: Sulfa and Copaxone" (unspecified if ongoing), notes: Known allergies: Sulfa and Copaxone. The patient's concomitant medications were not reported. Past drug history included: Known allergies: sulfa and copaxone, reaction(s): "Allergy_Copaxone", notes: Known allergies: Sulfa and Copaxone. The following information was reported: DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Tested positive six days after finishing Paxlovid; (Dec2022) Negative, notes: Tested positive six days after finishing Paxlovid and negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Seriousness criteria was reported as disabling/incapacitating. Antiviral details included brand: PAXLOVID, treatment start date was 22Nov2022 and treatment stop date was 26Nov2022. Treatment received for the adverse event included antibiotics and nasal spray.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 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: "Known allergies: Sulfa and penicillin family drugs" (unspecified if ongoing), notes: Known allergies: Sulfa and penicillin family drugs; "Known allergies: Sulfa and penicillin family drugs" (unspecified if ongoing), notes: Known allergies: Sulfa and penicillin family drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was treated with Paxlovid from 20Nov2022 to 25Nov2022.    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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound COVID after two negative tests; Rebound COVID after two negative tests; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CYTOMEL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound COVID after two negative tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid (oral) from 23Nov2022 to 27Nov2022, for the treatment of COVID-19.  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 the available information in the case, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Known allergy: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Fluconazole, reaction: "Known allergy: Fluconazole". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Consumer reports an 'awful taste' from the Paxlovid. She states that she's had her Pfizer COVID 19 vaccine and her booster.". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Retested positive for Covid within 5 days of testing negative (on day 7 since testing positive); Retested positive for Covid within 5 days of testing negative (on day 7 since testing positive); 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 22-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 3 (booster), single (Lot number: GH9694) at the age of 22 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Childhood asthma" (unspecified if ongoing), notes: other medical history: Childhood asthma and anemia; "Childhood anemia" (unspecified if ongoing), notes: other medical history: Childhood asthma and anemia; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "known allergies: shellfish" (unspecified if ongoing), notes: known allergies: shellfish; "known allergies: seafood almost" (unspecified if ongoing), notes: known allergies: seafood almost, severely. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Retested positive for Covid within 5 days of testing negative (on day 7 since testing positive)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: Covid within 5 days of testing negative; Positive, notes: Retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not pregnant at the time of vaccination. Patient did not receive other medication in 2 weeks. Anti-viral details: product COVID 19 Treatment, Brand: Paxlovid, treatment start date was on 22Nov2022 and stopped on 26Nov2022, Lot number: 1919257A, Indication: Treatment of COVID-19.
Age: 77.0
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 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 19:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 77 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), 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: "CAD" (unspecified if ongoing), notes: CISD/CAD/Lobectomy; "Lobectomy" (unspecified if ongoing), notes: CISD/CAD/Lobectomy; "allergy to antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 21Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient was hospitalized for drug ineffective, covid-19 (start date: 22Nov2022, discharge date: 23Nov2022, hospitalization duration: 2 day(s)). The event "covid 19 treatment" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Nov2022) Unknown result, notes: on 21Nov and was diagnosed with COVID in the ER; (24Nov2022) Negative; (25Nov2022) Positive; (26Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment for the events were Paxlovid/Albuterol/Ativan.  Clinical course: The patient had awful chills, headache, sneezing, fever etc. on 21Nov2022 and was diagnosed with COVID in the ER. The patient was given Paxlovid. On Tuesday (22Nov2022), the patient was admitted to the hospital with chest pressure and pain. The patient was released on Wednesday (23Nov2022) with a clean heart bill of heart health. The patient tested negative for COVID on Thursday (24Nov2022). On Friday and Saturday (25Nov2022 and 26Nov2022 respectively), the patient tested positive for COVID. The patient asked why had five vaccine shots and was still in quarantine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.