chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bedridden, Blood test, Emotional disorder, Fatigue
Clinical narrative: I was buzzing my nose started twitching & my eyes started twitching also then I had a shooting pain all the way down my body when I got home I was down for 3 weeks I was so fatigued & had no strength it messed with my blood work it messed with my sleep, it messed with my emotions & my nerves so I called my dr.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Insomnia, Muscle twitching, Pain, Pain in extremity
Clinical narrative: I was buzzing my nose started twitching & my eyes started twitching also then I had a shooting pain all the way down my body when I got home I was down for 3 weeks I was so fatigued & had no strength it messed with my blood work it messed with my sleep, it messed with my emotions & my nerves so I called my dr.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: I was buzzing my nose started twitching & my eyes started twitching also then I had a shooting pain all the way down my body when I got home I was down for 3 weeks I was so fatigued & had no strength it messed with my blood work it messed with my sleep, it messed with my emotions & my nerves so I called my dr.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blepharospasm, Blood test abnormal, Emotional distress, Euphoric mood
Clinical narrative: I was buzzing my nose started twitching & my eyes started twitching also then I had a shooting pain all the way down my body when I got home I was down for 3 weeks I was so fatigued & had no strength it messed with my blood work it messed with my sleep, it messed with my emotions & my nerves so I called my dr.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Muscle twitching, Nervousness, Pain
Clinical narrative: I was buzzing my nose started twitching & my eyes started twitching also then I had a shooting pain all the way down my body when I got home I was down for 3 weeks I was so fatigued & had no strength it messed with my blood work it messed with my sleep, it messed with my emotions & my nerves so I called my dr.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: I was buzzing my nose started twitching & my eyes started twitching also then I had a shooting pain all the way down my body when I got home I was down for 3 weeks I was so fatigued & had no strength it messed with my blood work it messed with my sleep, it messed with my emotions & my nerves so I called my dr.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: pt brought to ED (Medical Center) via EMS; less responsive and in respiratory distress; O2 sats with EMS were 75% on RA; O2 supplementation; productive cough; positive for COVID; ABX and steroids given; poor prognosis; pt suddenly became bradycardic and lost pulse; she passed away in the ED
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bradycardia, COVID-19, Death, Hyporesponsive to stimuli, Productive cough
Clinical narrative: pt brought to ED (Medical Center) via EMS; less responsive and in respiratory distress; O2 sats with EMS were 75% on RA; O2 supplementation; productive cough; positive for COVID; ABX and steroids given; poor prognosis; pt suddenly became bradycardic and lost pulse; she passed away in the ED
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulse absent, Respiratory distress, SARS-CoV-2 test positive
Clinical narrative: pt brought to ED (Medical Center) via EMS; less responsive and in respiratory distress; O2 sats with EMS were 75% on RA; O2 supplementation; productive cough; positive for COVID; ABX and steroids given; poor prognosis; pt suddenly became bradycardic and lost pulse; she passed away in the ED
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Patient presents for covid vaccination.  Vaccination administered, and patient was observed after 15 minutes for reaction.  After the 9 minutes patient reported feeling lightheaded and nauseous. Patient's BP was 118/60, pulse 76, PA-C evaluated patient. Patient drank some water and is feeling better. Patient monitored for a full 25 minutes in the office after the vaccine was given. Patient reports she is feeling OK now- 3:06 PM. Walked patient out to the lobby- patient again felt lightheaded. Patient sat and got another drink of water. evaluated patient. Patient sat for another couple minutes and left at 3:19pm.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Urticaria
Clinical narrative: they will be 46 at the time of the scheduled third dose; Consumer states they have spoke with their doctor and pharmacist that stated it is up to the consumer if they receive the third dose/The consumer reported they will be 46 at the time of the scheduled third dose.; within about 7-10 days after each dose they experienced a hive reaction starting on their back and spreading to their breast.; within about 7-10 days after each dose they experienced a hive reaction starting on their back and spreading to their breast.; This spontaneous report was received from a 45-year-old female patient. The patient's medical history included reported family history of cancer. Patient's concurrent medical conditions, drug reactions/allergies and concomitant medications were not reported.   On an unknown date in January 2022, the patient was vaccinated with the first dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, strength, route of administration, lot number and expiration date were not reported) for prophylaxis (indication also reported as Gardasil 9 Vaccine) .  On an unknown date in January 2022, reported as within about 7-10 days after the dose of the vaccine, the patient experienced a hive reaction (urticaria) starting on their back and spreading to their breast. The patient stated that the hives lasted about a week, on and off. On an unknown date in early March 2022, the patient was vaccinated with the second dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, lot number and expiration date were not reported) for prophylaxis (indication also reported as Gardasil 9 Vaccine). On an unknown date in March 2022, reported as within about 7-10 days after the dose of the vaccine, the patient experienced a hive reaction (urticaria) again, starting on their back and spreading to their breast. The patient stated that the hives lasted about a week, on and off. The patient sought a medical attention and in the case of both of the events, treatment was given to the patient; over the counter generic diphenhydramine (BENADRYL) provided relief for hives. It was reported that the patient did not experience any other side effects. The patient stated she has spoken with her doctor and pharmacist that stated it is up to the patient if she wants to receive the third dose. The patient reported she will be 46-years-old at the time of the scheduled third dose (product administered to patient of inappropriate age, circumstance or information capable of leading to medication error). She was also inquiring the efficacy rate after two doses, and if a third dose is necessary. The outcome of the events was reported as recovered (reported as roughly a week after hive appearance in both episodes).  The causal relationship between the events of hives and hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was related (reported as the hives were delayed reaction from the vaccine).
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test abnormal, Burning sensation, Chronic inflammatory demyelinating polyradiculoneuropathy, Endodontic procedure
Clinical narrative: Received Covid Vaccine 6/23/22.  Mid July had an 8mm kidney stone. Tooth abscess with root canal.  Saw Dentist - received Zithromax for abscess. Ibuprofen. Vision Diopters changed on vision prescription - Left eye 1/4 diopter change after he had recently received new glasses. Now right eye vision seems to be changing. Rash/Hives whole body - come and go in 20-30 seconds 11/11/2021 - spoke w/ doctor and sent photos of rash.  Pin Pricks of abdomen, feet, hands  Other times felt like a parasite trying to dig out from skin in various places. CIDP - Chronic Inflammatory Demyelinating Polyneuropathy -
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Formication, Hypoaesthesia, Lumbar puncture abnormal, Muscle spasms
Clinical narrative: Received Covid Vaccine 6/23/22.  Mid July had an 8mm kidney stone. Tooth abscess with root canal.  Saw Dentist - received Zithromax for abscess. Ibuprofen. Vision Diopters changed on vision prescription - Left eye 1/4 diopter change after he had recently received new glasses. Now right eye vision seems to be changing. Rash/Hives whole body - come and go in 20-30 seconds 11/11/2021 - spoke w/ doctor and sent photos of rash.  Pin Pricks of abdomen, feet, hands  Other times felt like a parasite trying to dig out from skin in various places. CIDP - Chronic Inflammatory Demyelinating Polyneuropathy -
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Nephrolithiasis, Nerve conduction studies, Neurological examination abnormal, Neuropathy peripheral
Clinical narrative: Received Covid Vaccine 6/23/22.  Mid July had an 8mm kidney stone. Tooth abscess with root canal.  Saw Dentist - received Zithromax for abscess. Ibuprofen. Vision Diopters changed on vision prescription - Left eye 1/4 diopter change after he had recently received new glasses. Now right eye vision seems to be changing. Rash/Hives whole body - come and go in 20-30 seconds 11/11/2021 - spoke w/ doctor and sent photos of rash.  Pin Pricks of abdomen, feet, hands  Other times felt like a parasite trying to dig out from skin in various places. CIDP - Chronic Inflammatory Demyelinating Polyneuropathy -
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Vitamin D decreased
Clinical narrative: Received Covid Vaccine 6/23/22.  Mid July had an 8mm kidney stone. Tooth abscess with root canal.  Saw Dentist - received Zithromax for abscess. Ibuprofen. Vision Diopters changed on vision prescription - Left eye 1/4 diopter change after he had recently received new glasses. Now right eye vision seems to be changing. Rash/Hives whole body - come and go in 20-30 seconds 11/11/2021 - spoke w/ doctor and sent photos of rash.  Pin Pricks of abdomen, feet, hands  Other times felt like a parasite trying to dig out from skin in various places. CIDP - Chronic Inflammatory Demyelinating Polyneuropathy -
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram head, Condition aggravated, Corrective lens user, Culture negative
Clinical narrative: Received Covid Vaccine 6/23/22.  Mid July had an 8mm kidney stone. Tooth abscess with root canal.  Saw Dentist - received Zithromax for abscess. Ibuprofen. Vision Diopters changed on vision prescription - Left eye 1/4 diopter change after he had recently received new glasses. Now right eye vision seems to be changing. Rash/Hives whole body - come and go in 20-30 seconds 11/11/2021 - spoke w/ doctor and sent photos of rash.  Pin Pricks of abdomen, feet, hands  Other times felt like a parasite trying to dig out from skin in various places. CIDP - Chronic Inflammatory Demyelinating Polyneuropathy -
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endodontic procedure, Formication, Gait disturbance, Headache, Immunoglobulin therapy
Clinical narrative: Received Covid Vaccine 6/23/22.  Mid July had an 8mm kidney stone. Tooth abscess with root canal.  Saw Dentist - received Zithromax for abscess. Ibuprofen. Vision Diopters changed on vision prescription - Left eye 1/4 diopter change after he had recently received new glasses. Now right eye vision seems to be changing. Rash/Hives whole body - come and go in 20-30 seconds 11/11/2021 - spoke w/ doctor and sent photos of rash.  Pin Pricks of abdomen, feet, hands  Other times felt like a parasite trying to dig out from skin in various places. CIDP - Chronic Inflammatory Demyelinating Polyneuropathy -
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Infusion, Lumbar puncture, Magnetic resonance imaging neck, Magnetic resonance imaging spinal, Nephrolithiasis
Clinical narrative: Received Covid Vaccine 6/23/22.  Mid July had an 8mm kidney stone. Tooth abscess with root canal.  Saw Dentist - received Zithromax for abscess. Ibuprofen. Vision Diopters changed on vision prescription - Left eye 1/4 diopter change after he had recently received new glasses. Now right eye vision seems to be changing. Rash/Hives whole body - come and go in 20-30 seconds 11/11/2021 - spoke w/ doctor and sent photos of rash.  Pin Pricks of abdomen, feet, hands  Other times felt like a parasite trying to dig out from skin in various places. CIDP - Chronic Inflammatory Demyelinating Polyneuropathy -
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pyrexia, Rash, Tooth abscess, Urticaria
Clinical narrative: Received Covid Vaccine 6/23/22.  Mid July had an 8mm kidney stone. Tooth abscess with root canal.  Saw Dentist - received Zithromax for abscess. Ibuprofen. Vision Diopters changed on vision prescription - Left eye 1/4 diopter change after he had recently received new glasses. Now right eye vision seems to be changing. Rash/Hives whole body - come and go in 20-30 seconds 11/11/2021 - spoke w/ doctor and sent photos of rash.  Pin Pricks of abdomen, feet, hands  Other times felt like a parasite trying to dig out from skin in various places. CIDP - Chronic Inflammatory Demyelinating Polyneuropathy -
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Received Covid Vaccine 6/23/22.  Mid July had an 8mm kidney stone. Tooth abscess with root canal.  Saw Dentist - received Zithromax for abscess. Ibuprofen. Vision Diopters changed on vision prescription - Left eye 1/4 diopter change after he had recently received new glasses. Now right eye vision seems to be changing. Rash/Hives whole body - come and go in 20-30 seconds 11/11/2021 - spoke w/ doctor and sent photos of rash.  Pin Pricks of abdomen, feet, hands  Other times felt like a parasite trying to dig out from skin in various places. CIDP - Chronic Inflammatory Demyelinating Polyneuropathy -
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breast pain, Chest discomfort, Electrocardiogram normal, Mobility decreased, Muscular weakness
Clinical narrative: Not able to use left arm fully as I once did, losing strength in arm, upper left side aches, vaccine location=left arm; Not able to use left arm fully as I once did, losing strength in arm, /vaccine location=left arm; Ongoing sore muscle; Not able to use left arm fully as I once did, losing strength in arm, /vaccine location=left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Nov2021 (Lot number: 320308D) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfur" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: IRON; WELLBUTRIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FE3590, Location of injection: Arm Left), administration date: 27Oct2021, when the patient was 42 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (disability) with onset 21Nov2021, outcome "not recovered", described as "Not able to use left arm fully as I once did, losing strength in arm, upper left side aches, vaccine location=left arm"; VACCINATION SITE MOVEMENT IMPAIRMENT (disability), INJECTION SITE MUSCLE WEAKNESS (disability) all with onset 21Nov2021, outcome "not recovered" and all described as "Not able to use left arm fully as I once did, losing strength in arm, /vaccine location=left arm"; MYALGIA (disability) with onset 21Nov2021, outcome "not recovered", described as "Ongoing sore muscle". The events "not able to use left arm fully as i once did, losing strength in arm, upper left side aches, vaccine location=left arm", "not able to use left arm fully as i once did, losing strength in arm, /vaccine location=left arm", "ongoing sore muscle" and "not able to use left arm fully as i once did, losing strength in arm, /vaccine location=left arm" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain, vaccination site movement impairment, myalgia, injection site muscle weakness. Treatment includes Upcoming physical therapy. No covid prior vaccination. Not covid tested post vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: Not able to use left arm fully as I once did, losing strength in arm, upper left side aches, vaccine location=left arm; Not able to use left arm fully as I once did, losing strength in arm, /vaccine location=left arm; Ongoing sore muscle; Not able to use left arm fully as I once did, losing strength in arm, /vaccine location=left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Nov2021 (Lot number: 320308D) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfur" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: IRON; WELLBUTRIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FE3590, Location of injection: Arm Left), administration date: 27Oct2021, when the patient was 42 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (disability) with onset 21Nov2021, outcome "not recovered", described as "Not able to use left arm fully as I once did, losing strength in arm, upper left side aches, vaccine location=left arm"; VACCINATION SITE MOVEMENT IMPAIRMENT (disability), INJECTION SITE MUSCLE WEAKNESS (disability) all with onset 21Nov2021, outcome "not recovered" and all described as "Not able to use left arm fully as I once did, losing strength in arm, /vaccine location=left arm"; MYALGIA (disability) with onset 21Nov2021, outcome "not recovered", described as "Ongoing sore muscle". The events "not able to use left arm fully as i once did, losing strength in arm, upper left side aches, vaccine location=left arm", "not able to use left arm fully as i once did, losing strength in arm, /vaccine location=left arm", "ongoing sore muscle" and "not able to use left arm fully as i once did, losing strength in arm, /vaccine location=left arm" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain, vaccination site movement impairment, myalgia, injection site muscle weakness. Treatment includes Upcoming physical therapy. No covid prior vaccination. Not covid tested post vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site muscle weakness, Myalgia, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Not able to use left arm fully as I once did, losing strength in arm, upper left side aches, vaccine location=left arm; Not able to use left arm fully as I once did, losing strength in arm, /vaccine location=left arm; Ongoing sore muscle; Not able to use left arm fully as I once did, losing strength in arm, /vaccine location=left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Nov2021 (Lot number: 320308D) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfur" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: IRON; WELLBUTRIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FE3590, Location of injection: Arm Left), administration date: 27Oct2021, when the patient was 42 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (disability) with onset 21Nov2021, outcome "not recovered", described as "Not able to use left arm fully as I once did, losing strength in arm, upper left side aches, vaccine location=left arm"; VACCINATION SITE MOVEMENT IMPAIRMENT (disability), INJECTION SITE MUSCLE WEAKNESS (disability) all with onset 21Nov2021, outcome "not recovered" and all described as "Not able to use left arm fully as I once did, losing strength in arm, /vaccine location=left arm"; MYALGIA (disability) with onset 21Nov2021, outcome "not recovered", described as "Ongoing sore muscle". The events "not able to use left arm fully as i once did, losing strength in arm, upper left side aches, vaccine location=left arm", "not able to use left arm fully as i once did, losing strength in arm, /vaccine location=left arm", "ongoing sore muscle" and "not able to use left arm fully as i once did, losing strength in arm, /vaccine location=left arm" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain, vaccination site movement impairment, myalgia, injection site muscle weakness. Treatment includes Upcoming physical therapy. No covid prior vaccination. Not covid tested post vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin discolouration, Urticaria
Clinical narrative: pink to reddish areas on face; pink to reddish areas on face; diagonised with Seborrheic dermatitis; hives like rash on my neck; hives like rash on neck; This spontaneous case was reported by a nurse and describes the occurrence of SKIN DISCOLOURATION (pink to reddish areas on face), ERYTHEMA (pink to reddish areas on face), SEBORRHOEIC DERMATITIS (diagonised with Seborrheic dermatitis), URTICARIA (hives like rash on my neck) and RASH (hives like rash on neck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L2DA) for COVID-19 vaccination.     Patient had no known allergies and had no history of allergic/hypersensitive reactions to vaccines, medications, foods and envoronment. Patient had no acute illness at the time of vaccination and up to one month before. Patient had no vaccine on the same day or within one month prior to Moderna vaccine.  The patient's past medical history included Acne (never had any type of skin issues other than very mild acne as a teen). Concurrent medical conditions included Hives (Hives/Urticaria), Perimenopause, Depression (No recent change) since 2003 and ADHD (No recent change) since 1970. Concomitant products included METHYLPHENIDATE for ADHD, BUPROPION for Depression.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SKIN DISCOLOURATION (pink to reddish areas on face), ERYTHEMA (pink to reddish areas on face), SEBORRHOEIC DERMATITIS (diagonised with Seborrheic dermatitis), URTICARIA (hives like rash on my neck) and RASH (hives like rash on neck). The patient was treated with KETOCONAZOL (topical) in 2021 for Seborrheic dermatitis, at a dose of 2 % percent. At the time of the report, SKIN DISCOLOURATION (pink to reddish areas on face), ERYTHEMA (pink to reddish areas on face), SEBORRHOEIC DERMATITIS (diagonised with Seborrheic dermatitis), URTICARIA (hives like rash on my neck) and RASH (hives like rash on neck) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that Psoriasis runs in their family with her sister developing in their mid-twenties. It was reported that the vaccine administration site was deltoid.  Patient symptoms include Itching/Pruritis localized and Hives/Urticaria localized.  Patient events worsening over time with vaccine.  Patient reported that as she is in perimenopause, attributed her new skin condition to hormones finally made an appointment with dermatologist on 04-Nov-2021 where skin scraping was performed.   This case was linked to MOD-2022-516211, MOD-2022-516171 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Rash, Seborrhoeic dermatitis, Skin discolouration, Urticaria
Clinical narrative: pink to reddish areas on face; pink to reddish areas on face; diagonised with Seborrheic dermatitis; hives like rash on my neck; hives like rash on neck; This spontaneous case was reported by a nurse and describes the occurrence of SKIN DISCOLOURATION (pink to reddish areas on face), ERYTHEMA (pink to reddish areas on face), SEBORRHOEIC DERMATITIS (diagonised with Seborrheic dermatitis), URTICARIA (hives like rash on my neck) and RASH (hives like rash on neck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L2DA) for COVID-19 vaccination.     Patient had no known allergies and had no history of allergic/hypersensitive reactions to vaccines, medications, foods and envoronment. Patient had no acute illness at the time of vaccination and up to one month before. Patient had no vaccine on the same day or within one month prior to Moderna vaccine.  The patient's past medical history included Acne (never had any type of skin issues other than very mild acne as a teen). Concurrent medical conditions included Hives (Hives/Urticaria), Perimenopause, Depression (No recent change) since 2003 and ADHD (No recent change) since 1970. Concomitant products included METHYLPHENIDATE for ADHD, BUPROPION for Depression.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SKIN DISCOLOURATION (pink to reddish areas on face), ERYTHEMA (pink to reddish areas on face), SEBORRHOEIC DERMATITIS (diagonised with Seborrheic dermatitis), URTICARIA (hives like rash on my neck) and RASH (hives like rash on neck). The patient was treated with KETOCONAZOL (topical) in 2021 for Seborrheic dermatitis, at a dose of 2 % percent. At the time of the report, SKIN DISCOLOURATION (pink to reddish areas on face), ERYTHEMA (pink to reddish areas on face), SEBORRHOEIC DERMATITIS (diagonised with Seborrheic dermatitis), URTICARIA (hives like rash on my neck) and RASH (hives like rash on neck) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that Psoriasis runs in their family with her sister developing in their mid-twenties. It was reported that the vaccine administration site was deltoid.  Patient symptoms include Itching/Pruritis localized and Hives/Urticaria localized.  Patient events worsening over time with vaccine.  Patient reported that as she is in perimenopause, attributed her new skin condition to hormones finally made an appointment with dermatologist on 04-Nov-2021 where skin scraping was performed.   This case was linked to MOD-2022-516211, MOD-2022-516171 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Seborrhoeic dermatitis, Skin discolouration, Urticaria
Clinical narrative: pink to reddish areas on face; pink to reddish areas on face; diagonised with Seborrheic dermatitis; hives like rash on my neck; hives like rash on neck; This spontaneous case was reported by a nurse and describes the occurrence of SKIN DISCOLOURATION (pink to reddish areas on face), ERYTHEMA (pink to reddish areas on face), SEBORRHOEIC DERMATITIS (diagonised with Seborrheic dermatitis), URTICARIA (hives like rash on my neck) and RASH (hives like rash on neck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L2DA) for COVID-19 vaccination.     Patient had no known allergies and had no history of allergic/hypersensitive reactions to vaccines, medications, foods and envoronment. Patient had no acute illness at the time of vaccination and up to one month before. Patient had no vaccine on the same day or within one month prior to Moderna vaccine.  The patient's past medical history included Acne (never had any type of skin issues other than very mild acne as a teen). Concurrent medical conditions included Hives (Hives/Urticaria), Perimenopause, Depression (No recent change) since 2003 and ADHD (No recent change) since 1970. Concomitant products included METHYLPHENIDATE for ADHD, BUPROPION for Depression.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SKIN DISCOLOURATION (pink to reddish areas on face), ERYTHEMA (pink to reddish areas on face), SEBORRHOEIC DERMATITIS (diagonised with Seborrheic dermatitis), URTICARIA (hives like rash on my neck) and RASH (hives like rash on neck). The patient was treated with KETOCONAZOL (topical) in 2021 for Seborrheic dermatitis, at a dose of 2 % percent. At the time of the report, SKIN DISCOLOURATION (pink to reddish areas on face), ERYTHEMA (pink to reddish areas on face), SEBORRHOEIC DERMATITIS (diagonised with Seborrheic dermatitis), URTICARIA (hives like rash on my neck) and RASH (hives like rash on neck) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that Psoriasis runs in their family with her sister developing in their mid-twenties. It was reported that the vaccine administration site was deltoid.  Patient symptoms include Itching/Pruritis localized and Hives/Urticaria localized.  Patient events worsening over time with vaccine.  Patient reported that as she is in perimenopause, attributed her new skin condition to hormones finally made an appointment with dermatologist on 04-Nov-2021 where skin scraping was performed.   This case was linked to MOD-2022-516211, MOD-2022-516171 (Patient Link).
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer was administered to the patient after the BUD of 3/24/2022
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer was administered to the patient after the BUD of 3/24/2022
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer was administered after the BUD of 3/24/2022
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer was administered after the BUD of 3/24/2022
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer was administered after the BUD of 3/24/2022
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer was administered after the BUD of 3/24/2022
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Hyperaesthesia, Migraine, Nausea, Tenderness
Clinical narrative: Nausea started before I left clinic.  at home migraine started.  I had premedicated with Zofran, Tylenol, Pepcid.  this time only lasted 3 Days.  though needed to con't with Sumatriptiline, and Zofran at time for 3 days after the original 3.  week later noticed lump tender in Left Axilla.  This is still present and after booster on 11/16/21 was consistently tender.  now only tender when touched.  size has decreased to about 2 cm.    Email sent to my physician for more Zofran as I was running low.-unsure of date.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Fatigue, Feeling abnormal, Interchange of vaccine products
Clinical narrative: Fatigue; dizziness; brain fog.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: On 3/22/22, patient received Moderna COVID vaccine booster dose (0.25mL) lot # 013H21B, but this lot # expired on 3/19/22 (per manufacturer's expiration date). Moderna was contacted and they confirmed that: "The vaccine administered on March 22, 2022 from lot number 013H21B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration." Thus, we did not need to repeat the booster dose.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Eye movement disorder, Eye pain, Eyelid function disorder, Headache, Malaise
Clinical narrative: Feel like my head is going ot explode.  Stiff neck, under ears and across left shoulder, cant look down, cant open eyes fully.  Headache across eyes and deep within temples.  Sicky feeling due to the intense pain.  Keeping them closed makes feel bit better.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal stiffness, Pain, Sensory disturbance
Clinical narrative: Feel like my head is going ot explode.  Stiff neck, under ears and across left shoulder, cant look down, cant open eyes fully.  Headache across eyes and deep within temples.  Sicky feeling due to the intense pain.  Keeping them closed makes feel bit better.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Computerised tomogram, Eye infection
Clinical narrative: Acute left eye infection and cellulitis.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchial wall thickening, Chest X-ray, Chest pain, Electrocardiogram, Myocarditis
Clinical narrative: About 25 minutes after receiving the injection I started to experience chest pain. It did not go away after several hours. I went to the ER and had several tests done including a ECG 12-LEAD and chest x-rays. I was later prescribed an anti-inflammatory for the inflammation of the heart (Myocarditis).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pleural thickening
Clinical narrative: About 25 minutes after receiving the injection I started to experience chest pain. It did not go away after several hours. I went to the ER and had several tests done including a ECG 12-LEAD and chest x-rays. I was later prescribed an anti-inflammatory for the inflammation of the heart (Myocarditis).
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Administration error - 11 yo was inadvertently administered a 3rd dose of Pfizer Pediatric COVID-19 vaccine.  Second dose was on December 3, 2021.  Mother was advised as to the error; she thought all people could get a booster regardless of age or timing.  Mother was advised to monitor the child for any adverse reaction and to call the local dept. of health if anything abnormal occurred.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 1 affected vaccine vial was used for 1 dose given to a patient/ their freezer went out of  temperature range on 03MAR2022 for 24 minutes.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (1 affected vaccine vial was used for 1 dose given to a patient/ their freezer went out of  temperature range on 03MAR2022 for 24 minutes.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (1 affected vaccine vial was used for 1 dose given to a patient/ their freezer went out of  temperature range on 03MAR2022 for 24 minutes.). At the time of the report, PRODUCT STORAGE ERROR (1 affected vaccine vial was used for 1 dose given to a patient/ their freezer went out of  temperature range on 03MAR2022 for 24 minutes.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. Maximum temp exposure was 11.8 degrees F Total time of excursion duration was 24 minutes Vaccine is remained in the freezer now. There was no Visual inspection noting any vaccine state changes Number of vials/doses impacted was 10 vials in which 1 was used, 9 vials remaining unused.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Live follow-up/Non-significant follow-up appended.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Erythema, Feeling abnormal, Injection site erythema, Injection site pain
Clinical narrative: sore at sight of injection. red swelling continues to extend past injection site down the arm over night, face feels like swelling. after injection about 30 minutes felt confused a little foggy. overall felt odd so took two acetaminophen, 100 mg and went to bed, next day felt better but redness at site had spread down my arm, took two Benadryl and felt better Had only one Benadryl so took it. pharmacy will deliver more tpday and will continue and call doctor today.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: sore at sight of injection. red swelling continues to extend past injection site down the arm over night, face feels like swelling. after injection about 30 minutes felt confused a little foggy. overall felt odd so took two acetaminophen, 100 mg and went to bed, next day felt better but redness at site had spread down my arm, took two Benadryl and felt better Had only one Benadryl so took it. pharmacy will deliver more tpday and will continue and call doctor today.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fear, Feeling cold, Tremor
Clinical narrative: Client received her COVID Pfizer Booster dose lot # FF8841 exp. 12.31.21 on her left arm on 12.09.21.  interpreter provided to client. At 1321, client reported to EMT that she was feeling a ?cold sensation on her face and hands? and dizzy (6/10 level) and he transported client to the anti-gravity chair in a semi-fowler position. PHN came to assist with the client. Client denied shortness of breath (SOB). EMT took client?s vitals: BP 110/66, HR 132, O2 Sat. 99%. At 1328, EMT took client?s vitals: BP 111/91, HR 123, O2 95% and she reported dizziness and ?coldness.? She denied SOB or any other anaphylactic signs and symptoms. She denied any history of allergy or taking any medications. She reported had tonsils infection and took ?Doxiciclina? for 10 days which she completed the antibiotic three days ago. She told she has a primary care doctor follow-up in three weeks for the tonsils infection. At 1331, she drank a juice and ate crackers provided without any issue. At 1336, client reported she still had dizziness, but she didn?t have the ?coldness.? At 1338, EMT took client?s vitals: BP 118/73, HR 111, O2 Sat. 99% and still had dizziness and feeling a ?chill in neck only.? At 1341, client reported she felt ?cold? on her face and throat and that she has a history of dizziness with blood drawn and vaccination. At 1343, client started ?shaking and scare.? At 1351, EMT took client?s vitals except BP: HR 100, O2 Sat. 99%, and client reported no more dizziness or coldness anywhere. At 1351, her ?shaking and scare? stopped. PHN educated client on adverse reactions and when to seek EMS. At 1358, client declined to have her last vitals taken and left the vaccination site with a steady gait with her parents.
Age: 47.0
Sex: U
Vaccine: HEPA
Symptoms: Heart transplant, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No addittional adverse events; Adult patient received a pediatric dose of VAQTA by mistake on 08-MAR-2022. HCP stated the reason patient is receiving VAQTA is because the patient is going to have a heart transplant; This spontaneous report has been received from a registered nurse, concerning an 47-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies.  On 08-MAR-2022, the patient was vaccinated by mistake with a pediatric hepatitis a vaccine, inactivated (VAQTA) syringe, administered once as the patient had to undergo a heart transplant (lot number reported and validated as U024504, expiration date reported and stablished as 15-OCT-2022) (strength, exact dose, vaccination scheme, route of administration and anatomical location were not provided) (product administered to patient of inappropriate age). No other adverse events (AE) reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No AE or PQC; second dose of VAQTA was administered 5 months after receiving the first dose; This spontaneous report has been received from a phlebotomist, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies.  On 10-MAR-2022, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) as prophylaxis (strength, exact dose, vaccination scheme, route of administration and anatomical location, lot number and expiration date were not provided). Moreover, on 01-SEP-2021, after 5 months the patient received the second dose of hepatitis a vaccine, inactivated (VAQTA) at a dose of 0.5 milliliters (mL) as prophylaxis (lot number reported and validated as T022333, expiration date reported and stablished as 11-DEC-2021) (strength, vaccination scheme, anatomical location was not provided). No other adverse events (AE) reported (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No addittional adverse events reported; EXPIRED RECOMBIVAX HB ADMINISTERED; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies.  On 10-MAR-2022, the patient was vaccinated with an expired Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) at a dose of 0.5 milliliters (mL) administered intramuscularly (IM) as prophylaxis (lot number reported and validated as S002769, expiration date reported and stablished as 04-NOV-2021) (strength, vaccination scheme, anatomical location was not provided). No other adverse events (AE) reported (no adverse event).
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; administration of improperly stored vaccine; This spontaneous report was received from a registered nurse and refers to a 4-month-old female patient. There was no information regarding the patient's medical history, concurrent conditions or concomitant medications.  On 18-MAR-2022, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter, frequency: once, route of administration defaulted to oral, lot# 1742465 was confirmed to be valid, expiration date: 21-SEP-2022 (also reported as lot# U006165 confirmed to be valid with expiration date: 18-OCT-2022, conflicting information) for prophylaxis. The aforementioned vaccine underwent a temperature excursion for 20 minutes (product storage error), Digital Data Logger (DDL) was involved. There was no additional adverse event reported (no adverse event). Per reporter DDL was out of range for 20 minutes or less before the vaccines were moved to a unit that was in range. Merck was notified (also reported as cleared by Merck), vaccine still viable and use, no harm was reached the patient.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2203USA006960:
Age: 56.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Headache, Vaccination site erythema, Vaccination site movement impairment, Vaccination site swelling
Clinical narrative: headache; current diagnosis psoriatic arthritis; difficulty moving her arms; She also received two vaccination/and the other arm for Pneumovax/Her arm was red; She also received two vaccination two days ago for Shingrix in one arm on 14 Mar 2022, noted swelling; Chills and shivers; This spontaneous report was received from a consumer referring to a 56 year old female patient. Information regarding the patient's medical history, and concomitant medications was not provided. The patient had migraine headaches treated with historical drug sumatriptan, vision blurred, and the patient wore glasses.   On 12-MAR-2022, the patient started therapy with risankizumab(SKYRIZI) 150 mg solution for injection in pre-filled pen at a total daily dose of 150 mg by subcutaneous route (lot number and expiration date were not reported) for psoriatic arthritis (off label use). On 13-MAR-2022, the patient experienced headache (not specified as migraine, and not reported if treatment with sumatriptan was restarted). On 14-MAR-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and  varicella zoster vaccine rge (cho)(SHINGRIX) for prophylaxis (doses, routes of administration, vaccination scheme frequency, lot numbers and expiration dates were not reported) in the arms (not specified which vaccine in which arm). On unspecified date in March 2022, the patient experienced chills and shivers, and physician was unaware. Besides, after the vaccinations, she noted swelling in the arm where she was vaccinated (vaccination site swelling), her arm was also red (vaccination site erythema ), and had difficulty moving both arms (vaccination site movement impairment). On 16-MAR-2020, she would have a physician appointment. The action taken with the suspect vaccines was not applicable; therapy with risankizumab (SKYRIZI) was continued. The outcome of the events was unknown.   Causality assessment with risankizumab(SKYRIZI), pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and  varicella zoster vaccine rge (cho)(SHINGRIX) and the events was not provided. However, the headache was considered to be not related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and  varicella zoster vaccine rge (cho)(SHINGRIX)as it happened before the start of these therapies.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported ROTATEQ administered after temperature excursion.; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies.  On an unknown date, the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number 1742431 underwent a temperature excursion of 9.2 C for a time frame of 36 minutes, no previous temperature excursion were experienced (product storage error).   On 22-MAR-2022, the patient was vaccinated with the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered at a dose of 2 milliliters (mL) per oral (PO)(lot number reported and validated as 1742431, expiration date reported and stablished as 31-JAN-2023) (strength and vaccination scheme were not provided) (product storage error). No other adverse events (AE) reported (no adverse event).