chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: Muscle Pain; Fever 101.4F after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle Pain) and PYREXIA (Fever 101.4F after 2nd booster) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient experienced MYALGIA (Muscle Pain) and PYREXIA (Fever 101.4F after 2nd booster). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 13-Apr-2022, MYALGIA (Muscle Pain) and PYREXIA (Fever 101.4F after 2nd booster) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2022, Body temperature: 101.4 (High) Fever (101.4 F).         The consumer confirmed that she did not had any side effects from previous 3 shots (2 primary and one booster). No concomitant medication reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; Expired dose administered to 14 patients; 0.25ml/3rd; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25ml/3rd) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25ml/3rd). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25ml/3rd) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 14-Mar-2022 The vial does not undergo any temperature excursions.  No concomitant medications was reported. No treatment medications was reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Product storage error; Vial was not shipped frozen/ temperature excursion; The dose was given beyound 30days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was not shipped frozen/ temperature excursion), EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) and PRODUCT STORAGE ERROR (Product storage error) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was not shipped frozen/ temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was not shipped frozen/ temperature excursion), EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was not shipped frozen/ temperature excursion) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication were provided.  The patient had NKDA (No Known Drug Allergy).  The office was not aware that vial was not shipped frozen; staff put vial back into freezer when arrived morning of 16-Jun-2021. Transport temperature was 2-8 degree Celsius for couple of hours.   Patient had no signs or symptoms of any adverse reaction to the injection site.  No treatment medication were provided.   This case was linked to MOD-2022-539787 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  Date the vial was initially stored in the refrigerator: 14-Mar-2022 the vial did not undergo any temperature excursions.  No treatment medications was reported.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; Expired dose administered to 14  patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14  patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14  patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14  patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 14-Mar-2022 The vial did not undergo any temperature excursions. No concomitant medication reported. No treatment medication details reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Dose received 0.3ml  instead of 0.25 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Dose received 0.3ml  instead of 0.25 ml) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FK9894, 939906 and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Nystatin).   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 18-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Dose received 0.3ml  instead of 0.25 ml). At the time of the report, ACCIDENTAL OVERDOSE (Dose received 0.3ml  instead of 0.25 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  On 16-Jun-2021, moderna vial (lot 032B21A) were delivered at refrigerator temperature.  The reporter stated that the office was unaware that vial was not shipped frozen and staff put vial back into freezer when arrived on morning of 16-Jun-2021.  Transport temperature was between 2 to 8 degrees Celsius for couple of hours. Vial was then set out on 27-Aug-2021 to thaw for one hour to room temperature.  Dose of 0.5 ml then given to patient on 27-Aug-2021.  Per moderna one re-freeze was ok, but can not be given beyond 30 days. This dose was beyond that time.  Patient had no signs or symptoms of any adverse reactions to the injection given.  No treatment medication were provided.  Patient did not seek medical care.   This case was linked to MOD-2022-539687 (Patient Link).
Age: 61.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Tuberculin test, Wrong product administered
Clinical narrative: ipol was inadvertently administered to a patient instead of the intended dose of tubersol with no reported adverse event; Initial information received on 12-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 61 years old female patient who experienced ipol was inadvertently administered to a patient instead of the intended dose of tubersol with no reported adverse event while receiving vaccine Ipv (Vero) [Ipol] and while treated with Tuberculin Test [Tubersol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Apr-2022, the patient received a dose of suspect Ipv (Vero) 0.5 m of frequency: once (1 day) lot T1E872M via intradermal route (form, strength, lot number, expiry date and administration site: unknown) for Immunization.  On an unknown date, the patient started taking Tuberculin Test Solution for injection (form, strength, dose, lot number, route, expiry date and administration site: unknown) for Tuberculosis immunization.  On 12-Apr-2022 the patient developed a non-serious ipol was inadvertently administered to a patient instead of the intended dose of tubersol with no reported adverse event (wrong product administered) following the administration of Ipv (Vero) and Tuberculin Test.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, No adverse event, Off label use
Clinical narrative: was given to a 16 month old, administration to patient younger than what it is indicated fo with no reported adverse event; Initial information received on 12-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health care professional.  This case involves a 16 months old female patient who experienced was given to a 16 month old, administration to patient younger than what it is indicated fo with no reported adverse event while receiving Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hib Vaccine Conj (Tet Tox)(Acthib)for Prophylactic vaccination.  On 12-Apr-2022, the patient received a dose of  0.5 ml, frequency: once (1 day)of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] suspect ion for injection (lot-C5970AA)(expiry date:02-02-2024)(strength : unknown) via intramuscular route in the right thigh.  On 12-APR-2022 the patient developed  non-serious event was given to a 16 month old, administration to patient younger than what it is indicated fo with no reported adverse event (off label use) following the administration of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (was given to a 16 month old, administration to patient younger than what it is indicated fo with no reported adverse event).  At time of reporting, the outcome was Unknown for the event was given to a 16 month old, administration to patient younger than what it is indicated fo with no reported adverse event.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Injection site discolouration, Lymph node pain
Clinical narrative: There was a circular line of black dots about an inch in circumference around the injection site - looked like a tattoo. (I took a picture today the 17th) and further down my arm I had two larger reddened and warm swollen painful areas. I have a swollen painful lymph node at my left clavicle. Haaedache and fatigue on the 15th. No fever. Today the 17th, the reddend areas have gone down. The "tattooing" is still surrounding the injection site, headache and fatigue are gone.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: There was a circular line of black dots about an inch in circumference around the injection site - looked like a tattoo. (I took a picture today the 17th) and further down my arm I had two larger reddened and warm swollen painful areas. I have a swollen painful lymph node at my left clavicle. Haaedache and fatigue on the 15th. No fever. Today the 17th, the reddend areas have gone down. The "tattooing" is still surrounding the injection site, headache and fatigue are gone.
Age: 36.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Anti-thyroid antibody increased, Antinuclear antibody positive, Biopsy skin abnormal, Condition aggravated, Inflammation
Clinical narrative: Had  Covid vaccine booster and flu shot in November of 2021. Had common cold in January 2022, then strep throat infection 2/7/22. Developed Psoriasis rash all over my body in February, something which I?ve never had before. Has been progressively worse, not better. Also had positive ANA in march and exacerbated thyroid problems. Increase in inflammation overall, chronic pain issues, etc. But this rash is very unusual and psoriasis does not run in my family and was not pre existing.
Age: 36.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Nasopharyngitis, Pain, Pharyngitis streptococcal, Psoriasis, Rash
Clinical narrative: Had  Covid vaccine booster and flu shot in November of 2021. Had common cold in January 2022, then strep throat infection 2/7/22. Developed Psoriasis rash all over my body in February, something which I?ve never had before. Has been progressively worse, not better. Also had positive ANA in march and exacerbated thyroid problems. Increase in inflammation overall, chronic pain issues, etc. But this rash is very unusual and psoriasis does not run in my family and was not pre existing.
Age: 36.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Thyroid disorder
Clinical narrative: Had  Covid vaccine booster and flu shot in November of 2021. Had common cold in January 2022, then strep throat infection 2/7/22. Developed Psoriasis rash all over my body in February, something which I?ve never had before. Has been progressively worse, not better. Also had positive ANA in march and exacerbated thyroid problems. Increase in inflammation overall, chronic pain issues, etc. But this rash is very unusual and psoriasis does not run in my family and was not pre existing.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Ear discomfort, Ear pain, Headache, Pruritus
Clinical narrative: Tinnitus began fifteen minutes after the 1st dose and has been constant ever since. Over the next week there was an increase in pain and itching in the ear canal. Over the next three months there was an increase in pressure in the middle ear and difficulty in ear equalization. Also, I had headaches in the back of the head and head rushes whenever I bent over or was bearing down. These side effects peaked around the fourth month and have been decreasing ever since. I did not take the 2nd dose.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus began fifteen minutes after the 1st dose and has been constant ever since. Over the next week there was an increase in pain and itching in the ear canal. Over the next three months there was an increase in pressure in the middle ear and difficulty in ear equalization. Also, I had headaches in the back of the head and head rushes whenever I bent over or was bearing down. These side effects peaked around the fourth month and have been decreasing ever since. I did not take the 2nd dose.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Laboratory test normal, Oral herpes
Clinical narrative: I have not had a menstrual cycle since the beginning of May 2021. I have also had multiple out brakes of cold sores on my lip since the vaccine. It was very rare for me to get them in the past maybe once a year if that. Now, since June 2021 I have had at least 1 outbreak every 3 months.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Influenza, Injected limb mobility decreased, Injection site pain
Clinical narrative: After receiving my second dose of Pfizer Covid Vaccine on 5/14/21 the next day I felt like I had the flu and my arm was sore at the injection site (same symptoms I experienced for a few days after receiving my initial dose on 4/20/21).  After a few days I began to feel better (flu symptoms went away, but my left arm began to feel weak and painful).  My left arm (which I received all three of my vaccine injections in) continued to feel painful and my range of motion was limited and I had no strength in that arm.  It has continued to get worse and to date I have extreme pain in this shoulder and upper arm.  I have limited range of motion on that side and the pain is constant and the weakness is getting worse.  I am going to have an xray this week per my doctor.  I reported this to facility and explained to my doctor I cannot hardly lift the left arm at times.  It also throbs with pain  from the elbow up to the shoulder.  The inability and loss of strength has me extremely concerned.  Prior to receiving the Covid 19 Vaccine, I had no issues whatsoever with the arm and now worried because the pain is not getting better, and I feel like it is my shoulder and upper left arm.  The pain comes and goes, but mostly is there all the time.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: After receiving my second dose of Pfizer Covid Vaccine on 5/14/21 the next day I felt like I had the flu and my arm was sore at the injection site (same symptoms I experienced for a few days after receiving my initial dose on 4/20/21).  After a few days I began to feel better (flu symptoms went away, but my left arm began to feel weak and painful).  My left arm (which I received all three of my vaccine injections in) continued to feel painful and my range of motion was limited and I had no strength in that arm.  It has continued to get worse and to date I have extreme pain in this shoulder and upper arm.  I have limited range of motion on that side and the pain is constant and the weakness is getting worse.  I am going to have an xray this week per my doctor.  I reported this to facility and explained to my doctor I cannot hardly lift the left arm at times.  It also throbs with pain  from the elbow up to the shoulder.  The inability and loss of strength has me extremely concerned.  Prior to receiving the Covid 19 Vaccine, I had no issues whatsoever with the arm and now worried because the pain is not getting better, and I feel like it is my shoulder and upper left arm.  The pain comes and goes, but mostly is there all the time.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-Apr-2022 Reporter's comments: This case was received from facebook page. This case was reported by the patient. The patient's doctor advised and the patient received Shingles vaccine. The patient experienced only a sore arm for a couple of days. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR064685:Same reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: fever; chills; rash; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingrix. On 10th April 2022, less than 2 weeks after receiving Shingrix, the patient experienced fever, chills and rash. On an unknown date, the outcome of the fever, chills and rash were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's comment: This case was reported by patient. The patient reported that she received her first dose of Shingrix last week and yesterday before the day of reporting she experienced fever, chills and rash. The reporter did not consented to follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 8 days after booster shot, patient broke out in a rash (Not Hives) on Torso, Neck, Arm, Legs/Rash disappears and comes back again in another place; This spontaneous case was reported by a consumer and describes the occurrence of RASH (8 days after booster shot, patient broke out in a rash (Not Hives) on Torso, Neck, Arm, Legs/Rash disappears and comes back again in another place) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, the patient experienced RASH (8 days after booster shot, patient broke out in a rash (Not Hives) on Torso, Neck, Arm, Legs/Rash disappears and comes back again in another place). At the time of the report, RASH (8 days after booster shot, patient broke out in a rash (Not Hives) on Torso, Neck, Arm, Legs/Rash disappears and comes back again in another place) had not resolved.            No concomitant medications were reported. Treatment medication included Montelukast. Patient reports that Rash disappears & comes back again in another place. It started 8 days after the booster shot.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Left side of left breast became red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Left side of left breast became red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Left side of left breast became red). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Left side of left breast became red) had resolved.            Concomitant products were not provided.  It was reported that 2 days after the first booster dose on her left arm patient experienced redness on her left breast, it was not warm or itchy. Patient went to a doctor. The redness went away after few days with medication. It was reported that patient got full "hundred ccs" dose with her booster dose.   This case was linked to MOD-2022-538686, MOD-2022-538684, MOD-2022-538687 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: Whole side was hurting, and he was hurting; His arm was sore, he was sore, and that everything started in his arm,felt in the side of his ribs/in the site of injection, and it went right up and then whole side was hurting; Started in his arm, and then swell up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (His arm was sore, he was sore, and that everything started in his arm,felt in the side of his ribs/in the site of injection, and it went right up and then whole side was hurting), VACCINATION SITE SWELLING (Started in his arm, and then swell up) and PAIN (Whole side was hurting, and he was hurting) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066k21a) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (First booster dose) on 15-Nov-2021, Pfizer vaccine (Second dose) and Pfizer vaccine (First dose). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 02-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (His arm was sore, he was sore, and that everything started in his arm,felt in the side of his ribs/in the site of injection, and it went right up and then whole side was hurting), VACCINATION SITE SWELLING (Started in his arm, and then swell up) and PAIN (Whole side was hurting, and he was hurting). At the time of the report, VACCINATION SITE PAIN (His arm was sore, he was sore, and that everything started in his arm,felt in the side of his ribs/in the site of injection, and it went right up and then whole side was hurting), VACCINATION SITE SWELLING (Started in his arm, and then swell up) and PAIN (Whole side was hurting, and he was hurting) had resolved.            No concomitant medication information was provided.  No treatment medication were provided.  Patient received second booster dose of Moderna vaccine.  It was reported that patient took previous 3 dose of Pfizer vaccine he did not had any reaction. Patient had not received other vaccines within or 1 month prior to Moderna COVID-19 vaccine.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Headache, Migraine, X-ray
Clinical narrative: Migraine; Had fallen so went to the ER; Severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), FALL (Had fallen so went to the ER) and HEADACHE (Severe headaches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A, 037A21B and 030H21B) for COVID-19 vaccination.     Patient don't have Allergies. It was reported that patient has never been diagnosed/tested Positive for COVID-19.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine), FALL (Had fallen so went to the ER) and HEADACHE (Severe headaches). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Migraine, at an unspecified dose and frequency; HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine), FALL (Had fallen so went to the ER) and HEADACHE (Severe headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: normal (normal) There was nothing wrong.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant products were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered an expired vaccines; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired vaccines) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  On 30-Mar-2022, the patient administered 2nd booster dose and HCP thaws out the vial. The vial did not undergo any temperature excursions. The patient did not experienced adverse events.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-539489 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: Follow-up document contains no new information.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 29 DEC 2020 and 2nd shot on 21 JAN 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 29 DEC 2020 and 2nd shot on 21 JAN 2021) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028C20A and 025J2019) for COVID-19 vaccination.     The patient's past medical history included Aortic valve replacement in 1993 and Pacemaker insertion (cardiac) in 2016. Concurrent medical conditions included Dust allergy and Pollen allergy. Concomitant products included ALOPURINOL, LOSARTAN, WARFARIN, LEVOCETIRIZINE and GLIPIZIDE for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 29 DEC 2020 and 2nd shot on 21 JAN 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 29 DEC 2020 and 2nd shot on 21 JAN 2021) outcome was unknown.            Patient did not had any reaction to the first and second dose. Treatment information was not provided.   This case was linked to MOD-2022-539494 (Patient Link).
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Disorientation, Illness, Pyrexia
Clinical narrative: Fever; chills; Disoriented; He got so weak; Really sick for 3 days/the third dose did havoc to his body; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (chills), DISORIENTATION (Disoriented), ASTHENIA (He got so weak) and ILLNESS (Really sick for 3 days/the third dose did havoc to his body) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 012M20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis (40 years ago, ongoing and stable), Idiopathic pulmonary fibrosis (Stable) since 2021, Cholesterol and Thyroid disorder. Concomitant products included GUSELKUMAB (TREMFYA) for Psoriatic arthritis.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Aug-2021, the patient experienced PYREXIA (Fever), CHILLS (chills), DISORIENTATION (Disoriented), ASTHENIA (He got so weak) and ILLNESS (Really sick for 3 days/the third dose did havoc to his body). On 18-Aug-2021, ILLNESS (Really sick for 3 days/the third dose did havoc to his body) had resolved. On 20-Aug-2021, PYREXIA (Fever), CHILLS (chills), DISORIENTATION (Disoriented) and ASTHENIA (He got so weak) had resolved.            It was reported that patient was really sick for 3 days, and symptoms lasted for a total of 5 days, after which patient started getting better.  It was also reported that patient took antacid and some medication for Cholesterol and Thyroid. Patient did not have any allergies from medications, food and other products  No treatment details were provided   This case was linked to MOD-2022-539507 (Patient Link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna booster dose was administered to a 16 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster dose was administered to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster dose was administered to a 16 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster dose was administered to a 16 year old) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that a Moderna booster dose was administered to a 16 year old.  Treatment information was not reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vial was initially stored in the refrigerator on 14 Mar 2022.  No treatment information was reported.   This case was linked to MOD-2022-539669 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Pain in extremity
Clinical narrative: Arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm tenderness) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 029A21A) for COVID-19 vaccination.     Patient has never been diagnosed/tested positive for Covid-19. Patient did not have acute illnesses at time of vaccination or up to 1 month before vaccination.  The patient's past medical history included Syncope (had two syncope events in 2020 after heart surgery related to low blood pressure medication) in 2020, Low blood pressure and Cardiac operation. Concurrent medical conditions included Allergy (poultry), Allergy to antibiotic, Pernicious anemia since 1970, Thyroid disorder NOS since 08-Oct-2020, Red blood cell count abnormal and Cholesterol since 10-Aug-2020. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, FOLIC ACID (FOLVITE [FOLIC ACID]) for Red blood cell count, DOCUSATE SODIUM for Stools hard, LEVOTHYROXINE SODIUM (SYNTHROID) from 08-Oct-2020 to an unknown date and LEVOTHYROXINE SODIUM (LEVOTHROID) from 08-Oct-2020 to an unknown date for Thyroid disorder, CYANOCOBALAMIN, LACTASE (LACTAID), CYANOCOBALAMIN (VITAMIN B-12), LORATADINE (CLARITIN [LORATADINE]), ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL (OMEGA-3 FISH OIL), VACCINIUM MACROCARPON FRUIT (CRANBERRY FRUIT), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]), VITAMIN D3 and CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMIN & CHONDROITIN) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm tenderness). At the time of the report, PAIN IN EXTREMITY (Arm tenderness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) in the normal range (for the past two years).         Patients blood type reported as A positive. No treatment medication were provided.   This case was linked to MOD-2022-539711, MOD-2022-539722, MOD-2022-536098 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Confusion regarding the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Confusion regarding the vaccination site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Confusion regarding the vaccination site). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Confusion regarding the vaccination site) outcome was unknown.            No concomitant products were reported. No treatment information was reported.   This case was linked to MOD-2022-539724 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: Follow-up received contains no new information.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm tenderness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 026B21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic and Pernicious anemia since 1970. Concomitant products included FOLIC ACID (FOLVITE [FOLIC ACID]) for Blood disorder, ATORVASTATIN CALCIUM (LIPITOR) from 10-Aug-2020 to an unknown date for High cholesterol, DOCUSATE SODIUM for Stools abnormal, LEVOTHYROXINE SODIUM (SYNTHROID) from 08-Oct-2020 to an unknown date and LEVOTHYROXINE SODIUM (LEVOTHROID) from 08-Oct-2020 to an unknown date for Thyroid disorder, ATORVASTATIN, CYANOCOBALAMIN, TILACTASE (LACTAID), LORATADINE (CLARITIN [LORATADINE]), ASPIRIN [ACETYLSALICYLIC ACID], FISH OIL (OMEGA-3 FISH OIL), VACCINIUM OXYCOCCOS FRUIT EXTRACT (CRANBERRY EXTRACT [VACCINIUM OXYCOCCOS FRUIT EXTRACT]), CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]), COLECALCIFEROL (VITAMIN D3 1000) and GLUCOSAMINE & CHONDORITIN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Arm tenderness). At the time of the report, PAIN IN EXTREMITY (Arm tenderness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information included multivitamin (Centrum Silver) as 1 tab daily - AM.  The patient was allergic to poultry.  Treatment medication use was not provided by the reporter.   This case was linked to MOD-2022-539717, MOD-2022-536098, MOD-2022-539711 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient had to receive the 1st dose twice; Patient received the 1st dose for the second time 45 days after the first time; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient had to receive the 1st dose twice) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose for the second time 45 days after the first time) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient had to receive the 1st dose twice) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose for the second time 45 days after the first time). At the time of the report, EXTRA DOSE ADMINISTERED (Patient had to receive the 1st dose twice) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose for the second time 45 days after the first time) outcome was unknown.            No concomitant medication was reported.  Caller stated he first received the first shot in Jan-2021, then due to some confusion regarding the vaccination site, 45 days after one nurse told him to do the first dose all over again, so he received the first shot again on 03-Mar-2021 and 30 days later he received the second shot, after that on 04-Nov-21, he received his first booster, so would like to know how long should he wait for the second booster.  No treatment information was provided.   This case was linked to MOD-2022-539720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: Follow up information was received contains no new information.