chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose administered to patient after improper storage and handling; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling). On 26-Aug-2021, PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No Treatment medication was reported.   This case was linked to MOD-2021-299914 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up contains changed patient initials, gender, route of administration and dose details.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma chronic (Respiratory asthma Inhalation of toxic chemicals at work, burned eyes, nose & throat, ongoing) since 08-Jan-2016, Sleep apnea since 2014, Cancer (on 05-04-2020  Range of motion from proton radiation therapy - neck & spine.      14-09-2020 Neuropathy of hands and feet, toes from chemotherapy       26-01-2021 Lymphodemia - both arms and hands, lymph node removal,Double   mastectomy - range of motion, loss of upper body strength) since 14-Sep-2020 and Drug allergy (Zantac, Side Efftects to Anastrozole). Concomitant products included SALBUTAMOL (ALBUTEROL) and FLUTICASONE for Asthma chronic, EXEMESTANE from 23-May-2021 to an unknown date for Cancer, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Nasal discharge.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VISION BLURRED (Blurred vision). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In April 2021, VISION BLURRED (Blurred vision) had resolved.            patient  have metal expanders in his chest.   This case was linked to MOD-2021-308096 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: added patient address,patient demographics, medical conditions, vaccine facility information,     concomitant treatment and event outcome updated and narrative was generated accordingly.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blood urine present, Haematuria, Joint swelling, Pain in extremity
Clinical narrative: pain in  hand; Right elbowis swollen; Blood in urine; Right elbow hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in  hand), JOINT SWELLING (Right elbowis swollen), HAEMATURIA (Blood in urine) and ARTHRALGIA (Right elbow hurts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in  hand), JOINT SWELLING (Right elbowis swollen), HAEMATURIA (Blood in urine) and ARTHRALGIA (Right elbow hurts). At the time of the report, PAIN IN EXTREMITY (pain in  hand), JOINT SWELLING (Right elbowis swollen), HAEMATURIA (Blood in urine) and ARTHRALGIA (Right elbow hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood urine present: abnormal (abnormal) blood in urine.         Patient went to the hospital, they run some blood and urine tests and some x-rays and found they were fine.  No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.   This case was linked to MOD-2021-309210 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site swelling
Clinical narrative: a round about the size of a half a dollar on my arm right above my injection sight; feel a little soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING ("a round about the size of a half a dollar on my arm right above my injection sight") and MYALGIA ("feel a little soreness") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING ("a round about the size of a half a dollar on my arm right above my injection sight") and MYALGIA ("feel a little soreness"). At the time of the report, VACCINATION SITE SWELLING ("a round about the size of a half a dollar on my arm right above my injection sight") and MYALGIA ("feel a little soreness") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported No treatment Drug was reported
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site movement impairment, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itch on her left arm; sore/severe pain; Covid arm; Could not lift her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her left arm), VACCINATION SITE PRURITUS (Itch on her left arm) and VACCINATION SITE PAIN (sore/severe pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 78C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced VACCINATION COMPLICATION (Covid arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her left arm) and VACCINATION SITE PAIN (sore/severe pain). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itch on her left arm). At the time of the report, VACCINATION COMPLICATION (Covid arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her left arm), VACCINATION SITE PRURITUS (Itch on her left arm) and VACCINATION SITE PAIN (sore/severe pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medication information was reported. No treatment medications were provided.  Patient stated that she was experiencing pain and itching alternatively.   This case was linked to MOD-2021-310868 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow-up received contains non significant information
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Vaccination site pain
Clinical narrative: Lethargic; Pain at the injection site; Tired for a day; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Tired for a day) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargic), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Tired for a day). At the time of the report, LETHARGY (Lethargic), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Tired for a day) outcome was unknown.            Patient reported that the Patient took inhalers for COPD. Concomitant medications were not provided.    This case was linked to MOD-2021-311057, MOD-2021-311064 (Patient Link).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave Moderna COVID 19 vaccine to a 17-year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave Moderna COVID 19 vaccine to a 17-year old) in a 17-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 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 (gave Moderna COVID 19 vaccine to a 17-year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave Moderna COVID 19 vaccine to a 17-year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medicine information not provided. Treatment medicine information not provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: 2 patients got COVID19 10 days following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (2 patients got COVID19 10 days following vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (2 patients got COVID19 10 days following vaccination). At the time of the report, COVID-19 (2 patients got COVID19 10 days following vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Bit sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Bit sick) in a 51-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ILLNESS (Bit sick). At the time of the report, ILLNESS (Bit sick) 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.  No treatment information was provided.   This case was linked to MOD-2021-311010 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-Up received. Serious Disability is changed to No as per SD and case is downgraded to Non-Serious
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Moderna COVID-19 vaccine administered after temperature excursion; Moderna COVID-19 vaccine administered after temperature excursion; Moderna COVID-19 vaccine administered after temperature excursion; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Sep-2021. The most recent information was received on 13-Sep-2021 and was forwarded to Moderna on 14-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered after temperature excursion), PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered after temperature excursion) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C1A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered after temperature excursion). On 20-Jul-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that they went by the acceptable limits of Janssen Temperature Excursion, as they forgot they had one vial of the Moderna (10-dose vial) with Lot number-026C1A.  The reporter stated that maximum or minimum temperatures reached are as follows 08-July- greater than 12.23 C max-37 minutes 11-July-greater than 9.42 C max-33 minutes 11-July-2021- 11:26- 9.06°C max-32 minutes 11-July-2021- 21:28- 9.42°C max- 1 hour 5 min. 12-July- 10.6 C max- 51 minutes.  The reporter stated that the excursion duration greater than 8 degree C (46 degree F)-3 hours and 38 minutes at the absolute most and all at different times.  No concomitant product use was provided by the reporter.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: ADR Received on 13 Sep 2021,contain Patient Information (Initial, Gender,Age,Race and Ethinicity)
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Dyskinesia
Clinical narrative: My dad has been acting abnormal since he got the 2nd shot; Involuntary movement; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL BEHAVIOUR (My dad has been acting abnormal since he got the 2nd shot) and DYSKINESIA (Involuntary movement) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABNORMAL BEHAVIOUR (My dad has been acting abnormal since he got the 2nd shot) and DYSKINESIA (Involuntary movement). At the time of the report, ABNORMAL BEHAVIOUR (My dad has been acting abnormal since he got the 2nd shot) and DYSKINESIA (Involuntary movement) outcome was unknown.            No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: itches a lot; bad rash from head to toe including her hair; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itches a lot) and RASH (bad rash from head to toe including her hair) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Fungal foot infection.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced RASH PRURITIC (itches a lot) and RASH (bad rash from head to toe including her hair). At the time of the report, RASH PRURITIC (itches a lot) and RASH (bad rash from head to toe including her hair) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.  The patient had bad rash from head to toe including her hair a month after receiving her second dose of Moderna Covid-19 Vaccine and still continued to keep getting it back which she cannot handle since it itches a lot. Patient went to a allergy specialist and a skin doctor, but they cannot figure it out how to get rid of the rash. She has history of getting fungus on her toes and doctor gave her medication for it.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: vaginally blood spotting; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginally blood spotting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced VAGINAL HAEMORRHAGE (vaginally blood spotting). On 04-Sep-2021, VAGINAL HAEMORRHAGE (vaginally blood spotting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received second dose of Moderna on 09-SEP-2019 in her right arm. (LOT # 020F21A) No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-317480 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2021: Significant Follow-up on 11-sep-2021: reporter details, route of administration for dose 1, and dose 2 details
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Heavy menstrual bleeding, Nasal discomfort, Vaccination site pain
Clinical narrative: She had burning in nose.; She could taste chemical in her mouth.; Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily; She had mild fatigue on same day and following day after 1st dose and 2nd dose.; She started with immediate burning and pain at injection site.; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (She had burning in nose.), DYSGEUSIA (She could taste chemical in her mouth.), HEAVY MENSTRUAL BLEEDING (Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily), FATIGUE (She had mild fatigue on same day and following day after 1st dose and 2nd dose.) and VACCINATION SITE PAIN (She started with immediate burning and pain at injection site.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9399021A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and IRON for an unknown indication.    On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL DISCOMFORT (She had burning in nose.), DYSGEUSIA (She could taste chemical in her mouth.), HEAVY MENSTRUAL BLEEDING (Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily), FATIGUE (She had mild fatigue on same day and following day after 1st dose and 2nd dose.) and VACCINATION SITE PAIN (She started with immediate burning and pain at injection site.). At the time of the report, NASAL DISCOMFORT (She had burning in nose.), DYSGEUSIA (She could taste chemical in her mouth.), HEAVY MENSTRUAL BLEEDING (Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily), FATIGUE (She had mild fatigue on same day and following day after 1st dose and 2nd dose.) and VACCINATION SITE PAIN (She started with immediate burning and pain at injection site.) outcome was unknown.            Treatment information was included birth control.   This case was linked to MOD-2021-313046.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dry mouth, Dysphagia, Headache, Neck pain
Clinical narrative: hard for her to swallow food; discomfort in her thyroid; when bending her neck it gives pain in her neck; her vision has gotten worst; mouth is dry; needs to drink more water.; Has headaches that she has never had before; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (hard for her to swallow food), THYROID DISORDER (discomfort in her thyroid), NECK PAIN (when bending her neck it gives pain in her neck), VISUAL IMPAIRMENT (her vision has gotten worst) and DRY MOUTH (mouth is dry) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, PARACETAMOL (TYLENOL) for Pain, PRAVASTATIN for Triglycerides high, LANSOPRAZOLE (PREVACID) and LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPHAGIA (hard for her to swallow food), THYROID DISORDER (discomfort in her thyroid), NECK PAIN (when bending her neck it gives pain in her neck), VISUAL IMPAIRMENT (her vision has gotten worst), DRY MOUTH (mouth is dry), DEHYDRATION (needs to drink more water.) and HEADACHE (Has headaches that she has never had before). At the time of the report, DYSPHAGIA (hard for her to swallow food), THYROID DISORDER (discomfort in her thyroid), NECK PAIN (when bending her neck it gives pain in her neck), VISUAL IMPAIRMENT (her vision has gotten worst), DRY MOUTH (mouth is dry), DEHYDRATION (needs to drink more water.) and HEADACHE (Has headaches that she has never had before) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Past medical history includes past medical problem with esophagus, Gerd issues, that seems to getting worst from what was before with unknown date.  Events include has some fracture disk and vertebrae problem that has gotten worst with unknown date and unknown outcome.    Concomitant medications includes 2 other medicine for depression with unknown date.  No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder, Visual impairment
Clinical narrative: hard for her to swallow food; discomfort in her thyroid; when bending her neck it gives pain in her neck; her vision has gotten worst; mouth is dry; needs to drink more water.; Has headaches that she has never had before; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (hard for her to swallow food), THYROID DISORDER (discomfort in her thyroid), NECK PAIN (when bending her neck it gives pain in her neck), VISUAL IMPAIRMENT (her vision has gotten worst) and DRY MOUTH (mouth is dry) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, PARACETAMOL (TYLENOL) for Pain, PRAVASTATIN for Triglycerides high, LANSOPRAZOLE (PREVACID) and LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPHAGIA (hard for her to swallow food), THYROID DISORDER (discomfort in her thyroid), NECK PAIN (when bending her neck it gives pain in her neck), VISUAL IMPAIRMENT (her vision has gotten worst), DRY MOUTH (mouth is dry), DEHYDRATION (needs to drink more water.) and HEADACHE (Has headaches that she has never had before). At the time of the report, DYSPHAGIA (hard for her to swallow food), THYROID DISORDER (discomfort in her thyroid), NECK PAIN (when bending her neck it gives pain in her neck), VISUAL IMPAIRMENT (her vision has gotten worst), DRY MOUTH (mouth is dry), DEHYDRATION (needs to drink more water.) and HEADACHE (Has headaches that she has never had before) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Past medical history includes past medical problem with esophagus, Gerd issues, that seems to getting worst from what was before with unknown date.  Events include has some fracture disk and vertebrae problem that has gotten worst with unknown date and unknown outcome.    Concomitant medications includes 2 other medicine for depression with unknown date.  No treatment information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache) in a 71-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (severe headache). At the time of the report, HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious. Further information has been requested   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious. Further information has been requested
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site swelling
Clinical narrative: Arm swelled up a little in the injection area; Arm was a little sore; Arm was really itchy; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Arm swelled up a little in the injection area), PAIN IN EXTREMITY (Arm was a little sore) and PRURITUS (Arm was really itchy) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031C21A) for COVID-19 vaccination.     The patient's past medical history included Limb reconstructive surgery (Ankle and Knee).    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced VACCINATION SITE SWELLING (Arm swelled up a little in the injection area), PAIN IN EXTREMITY (Arm was a little sore) and PRURITUS (Arm was really itchy). The patient was treated with TRAMADOL for Adverse event, at an unspecified dose and frequency. On 21-Aug-2021, VACCINATION SITE SWELLING (Arm swelled up a little in the injection area), PAIN IN EXTREMITY (Arm was a little sore) and PRURITUS (Arm was really itchy) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Relevant concomitant medication included Thyroid medication  Treatment medication included half of a marihuana brownie.   This case was linked to MOD-2021-313252 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reactions to third dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reactions to third dose) in a  patient of an unknown age and gender 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 VACCINATION COMPLICATION (Reactions to third dose). At the time of the report, VACCINATION COMPLICATION (Reactions to third dose) outcome was unknown.            No Concomitant drugs were reported.  No Treatment information  were reported.    Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose administered on day after the manufacturer expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered on day after the manufacturer expiration date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered on day after the manufacturer expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose administered on day after the manufacturer expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drugs were reported.  No Treatment information  were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: New side effects keep coming. Should I be concerned about an allergic reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (New side effects keep coming. Should I be concerned about an allergic reaction) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (New side effects keep coming. Should I be concerned about an allergic reaction). At the time of the report, VACCINATION COMPLICATION (New side effects keep coming. Should I be concerned about an allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information is not given.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: It was given 2 weeks after the 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It was given 2 weeks after the 1st dose) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It was given 2 weeks after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It was given 2 weeks after the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Possible NNI F/U Received: No new information
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: had the first dose  on 25Feb2021, did not get second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (had the first dose  on 25Feb2021, did not get second dose yet) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included ENOXAPARIN SODIUM (ALEXA [ENOXAPARIN SODIUM]) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (had the first dose  on 25Feb2021, did not get second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (had the first dose  on 25Feb2021, did not get second dose yet) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Chromaturia, Dyspepsia, Haematoma, Vaccination site erythema
Clinical narrative: blood clots; Colored urine for 2-3 days; few tiny red spots on the lower arm that was injected/ red dots; mild heartburn for 8 days; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOMA (blood clots), CHROMATURIA (Colored urine for 2-3 days), DYSPEPSIA (mild heartburn for 8 days) and VACCINATION SITE ERYTHEMA (few tiny red spots on the lower arm that was injected/ red dots) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMATOMA (blood clots), CHROMATURIA (Colored urine for 2-3 days), DYSPEPSIA (mild heartburn for 8 days) and VACCINATION SITE ERYTHEMA (few tiny red spots on the lower arm that was injected/ red dots). At the time of the report, HAEMATOMA (blood clots), CHROMATURIA (Colored urine for 2-3 days), DYSPEPSIA (mild heartburn for 8 days) and VACCINATION SITE ERYTHEMA (few tiny red spots on the lower arm that was injected/ red dots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered invalid dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered invalid dose) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered invalid dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered invalid dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  As  reported drew up Moderna yesterday morning at 9:35,  clinical staff forgot to discard the extra doses  yesterday and another nurse just gave one of those doses.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: soreness in left arm; tiredness and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in left arm) and FATIGUE (tiredness and fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included METOPROLOL for Blood pressure, ROSUVASTATIN for Cholesterol, METFORMIN for Diabetes, LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in left arm) and FATIGUE (tiredness and fatigue). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in left arm) and FATIGUE (tiredness and fatigue) outcome was unknown.            Patient's Current Medical history includes Cholesterol.   This case was linked to MOD-2021-313910 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up received on 14-Sep-2021 with no new infomation On 15-Sep-2021: Includes no new information.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product usage were not provided. Treatment details were not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Having bad symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having bad symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Having bad symptoms). At the time of the report, VACCINATION COMPLICATION (Having bad symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed her  second dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed her  second dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her  second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed her  second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-313839 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pfizer vaccine for his first dose and the second dose was Moderna; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer vaccine for his first dose and the second dose was Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer vaccine for his first dose and the second dose was Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer vaccine for his first dose and the second dose was Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bed rest, Chills, Interchange of vaccine products
Clinical narrative: Had to stay in bed for two days; Chills; Mixed Pfizer's and Moderna's vaccines; This spontaneous case was reported by a consumer and describes the occurrence of BED REST (Had to stay in bed for two days), CHILLS (Chills) and INTERCHANGE OF VACCINE PRODUCTS (Mixed Pfizer's and Moderna's vaccines) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced BED REST (Had to stay in bed for two days), CHILLS (Chills) and INTERCHANGE OF VACCINE PRODUCTS (Mixed Pfizer's and Moderna's vaccines). At the time of the report, BED REST (Had to stay in bed for two days), CHILLS (Chills) and INTERCHANGE OF VACCINE PRODUCTS (Mixed Pfizer's and Moderna's vaccines) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Shot was a little achy next day but he says more achy today; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Shot was a little achy next day but he says more achy today) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Shot was a little achy next day but he says more achy today). At the time of the report, PAIN (Shot was a little achy next day but he says more achy today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Insomnia, Pyrexia
Clinical narrative: trouble sleeping; tiny fever/fever; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (trouble sleeping), PYREXIA (tiny fever/fever), ARTHRALGIA (joint pain) and HEADACHE (headache) 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 08-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 INSOMNIA (trouble sleeping), PYREXIA (tiny fever/fever), ARTHRALGIA (joint pain) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (trouble sleeping), PYREXIA (tiny fever/fever), ARTHRALGIA (joint pain) and HEADACHE (headache) outcome was unknown.            Patient received third dose of COVID-19 vaccine Moderna on 08Sep2021. Patient experienced joint pain, a tiny fever, trouble sleeping and possibly headache. Patient stated it wasnot serious. Patient took aspirin and it was not clear if also took Excedrin to treat symptoms. No concomitant medications reported.