chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Burning feet syndrome, Dizziness, Eye inflammation
Clinical narrative: pain in the groing ("female area she said") area just inmediately after the shot; "tea bag" under her left eye; "legs discomfort" (below the knees); feets burning during the nigth and frozen during daylight.; pain on both knees "my knees ick"; lower back pain; left eye pain like"zzuuu"; dizziness at times ready to vertigo; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), EYE PAIN (left eye pain like"zzuuu"), DIZZINESS (dizziness at times ready to vertigo), GROIN PAIN (pain in the groing ("female area she said") area just inmediately after the shot) and EYE INFLAMMATION ("tea bag" under her left eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Groin hernia.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced BACK PAIN (lower back pain), EYE PAIN (left eye pain like"zzuuu"), DIZZINESS (dizziness at times ready to vertigo), EYE INFLAMMATION ("tea bag" under her left eye), LIMB DISCOMFORT ("legs discomfort" (below the knees)), BURNING FEET SYNDROME (feets burning during the nigth and frozen during daylight.) and ARTHRALGIA (pain on both knees "my knees ick"). On 20-Aug-2021, the patient experienced GROIN PAIN (pain in the groing ("female area she said") area just inmediately after the shot). At the time of the report, BACK PAIN (lower back pain), EYE PAIN (left eye pain like"zzuuu"), DIZZINESS (dizziness at times ready to vertigo), GROIN PAIN (pain in the groing ("female area she said") area just inmediately after the shot), LIMB DISCOMFORT ("legs discomfort" (below the knees)), BURNING FEET SYNDROME (feets burning during the nigth and frozen during daylight.) and ARTHRALGIA (pain on both knees "my knees ick") had not resolved and EYE INFLAMMATION ("tea bag" under her left eye) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Significant Follow up received on 15-SEP-2021: Batch# updated and patient name spelling corrected. On 19-Sep-2021: Significant follow up: Patient History Information added. Newevents added. Events missed from the initial version added. Outcome updated to not recovered/not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Groin pain, Limb discomfort
Clinical narrative: pain in the groing ("female area she said") area just inmediately after the shot; "tea bag" under her left eye; "legs discomfort" (below the knees); feets burning during the nigth and frozen during daylight.; pain on both knees "my knees ick"; lower back pain; left eye pain like"zzuuu"; dizziness at times ready to vertigo; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), EYE PAIN (left eye pain like"zzuuu"), DIZZINESS (dizziness at times ready to vertigo), GROIN PAIN (pain in the groing ("female area she said") area just inmediately after the shot) and EYE INFLAMMATION ("tea bag" under her left eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Groin hernia.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced BACK PAIN (lower back pain), EYE PAIN (left eye pain like"zzuuu"), DIZZINESS (dizziness at times ready to vertigo), EYE INFLAMMATION ("tea bag" under her left eye), LIMB DISCOMFORT ("legs discomfort" (below the knees)), BURNING FEET SYNDROME (feets burning during the nigth and frozen during daylight.) and ARTHRALGIA (pain on both knees "my knees ick"). On 20-Aug-2021, the patient experienced GROIN PAIN (pain in the groing ("female area she said") area just inmediately after the shot). At the time of the report, BACK PAIN (lower back pain), EYE PAIN (left eye pain like"zzuuu"), DIZZINESS (dizziness at times ready to vertigo), GROIN PAIN (pain in the groing ("female area she said") area just inmediately after the shot), LIMB DISCOMFORT ("legs discomfort" (below the knees)), BURNING FEET SYNDROME (feets burning during the nigth and frozen during daylight.) and ARTHRALGIA (pain on both knees "my knees ick") had not resolved and EYE INFLAMMATION ("tea bag" under her left eye) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Significant Follow up received on 15-SEP-2021: Batch# updated and patient name spelling corrected. On 19-Sep-2021: Significant follow up: Patient History Information added. Newevents added. Events missed from the initial version added. Outcome updated to not recovered/not resolved.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Insomnia, Pain in extremity
Clinical narrative: Problems sleeping caused by pain; Could barely walk/preventing from walking right; Pain at the lower back; Severe pain in the right leg/Pain in right thigh/It hurts all the time (referring  to the leg); This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain at the lower back), PAIN IN EXTREMITY (Severe pain in the right leg/Pain in right thigh/It hurts all the time (referring  to the leg)), INSOMNIA (Problems sleeping caused by pain) and GAIT DISTURBANCE (Could barely walk/preventing from walking right) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced BACK PAIN (Pain at the lower back) and PAIN IN EXTREMITY (Severe pain in the right leg/Pain in right thigh/It hurts all the time (referring  to the leg)). On 06-Sep-2021, the patient experienced INSOMNIA (Problems sleeping caused by pain) and GAIT DISTURBANCE (Could barely walk/preventing from walking right). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, BACK PAIN (Pain at the lower back), PAIN IN EXTREMITY (Severe pain in the right leg/Pain in right thigh/It hurts all the time (referring  to the leg)), INSOMNIA (Problems sleeping caused by pain) and GAIT DISTURBANCE (Could barely walk/preventing from walking right) outcome was unknown.        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.   No concomitant medications provided.  Patient went to the emergency room in two instances and no cause of the pain could be found.   Patient prescribed Norco, Vicodin and Prednisone but she has not used the Vicodin yet.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: little pain in right foot's toes/ pain in toes, pain has been going up through the calf; does not feel good; 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 PAIN IN EXTREMITY (little pain in right foot's toes/ pain in toes, pain has been going up through the calf) and FEELING ABNORMAL (does not feel good) 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 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced PAIN IN EXTREMITY (little pain in right foot's toes/ pain in toes, pain has been going up through the calf) and FEELING ABNORMAL (does not feel good). At the time of the report, PAIN IN EXTREMITY (little pain in right foot's toes/ pain in toes, pain has been going up through the calf) and FEELING ABNORMAL (does not feel good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was reported. Patient called asking for recommendation and did not have any intentions on reporting the AE. Patient received first dose of Moderna COVID-19 vaccine on 10Sep2021. Next day patient started to experience a little pain in right foot's toes. The pain has been going up through the calf. Patient felt that the symptom was related to blood circulation because when patient puts leg up, pain stops and when places foot down again, pain continues hence the patient was afraid called to ask what medication should the patient take and how long should the patient wait to start taking it and also stated that the patient does not feel good.   Reporter did not allow further contact
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Pyrexia, Tremor
Clinical narrative: sweating (1st dose); shakes (1st dose); arm soreness (1st dose); fever (1st dose); This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (sweating (1st dose)), TREMOR (shakes (1st dose)), MYALGIA (arm soreness (1st dose)) and PYREXIA (fever (1st dose)) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced HYPERHIDROSIS (sweating (1st dose)) (seriousness criterion hospitalization), TREMOR (shakes (1st dose)) (seriousness criterion hospitalization), MYALGIA (arm soreness (1st dose)) (seriousness criterion hospitalization) and PYREXIA (fever (1st dose)) (seriousness criterion hospitalization). At the time of the report, HYPERHIDROSIS (sweating (1st dose)), TREMOR (shakes (1st dose)), MYALGIA (arm soreness (1st dose)) and PYREXIA (fever (1st dose)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment medication provided.  Company comment: This case concerns a 34-year-old male subject who experienced the serious, unexpected events of hyperhidrosis, tremor, myalgia, and pyrexia. The events occurred approximately 1 month after the first dose of Spikevax. Patient's medical history was not provided. The rechallenge was not applicable as the patient was yet to receive the second dose of the vaccine.Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.   This case was linked to MOD-2021-319719 (Patient Link).; Sender's Comments: This case concerns a 34-year-old male subject who experienced the serious, unexpected events of hyperhidrosis, tremor, myalgia, and pyrexia. The events occurred approximately 1 month after the first dose of Spikevax. Patient's medical history was not provided. The rechallenge was not applicable as the patient was yet to receive the second dose of the vaccine.Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Muscle spasms, Pain in extremity
Clinical narrative: Really bad, painful muscle spasms; Right big toe is still sore; Had a bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Really bad, painful muscle spasms), PAIN IN EXTREMITY (Right big toe is still sore) and ADVERSE REACTION (Had a bad reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, the patient experienced MUSCLE SPASMS (Really bad, painful muscle spasms), PAIN IN EXTREMITY (Right big toe is still sore) and ADVERSE REACTION (Had a bad reaction). The patient was treated with Physical therapy (massaged) for Muscle spasms. At the time of the report, MUSCLE SPASMS (Really bad, painful muscle spasms) and ADVERSE REACTION (Had a bad reaction) outcome was unknown and PAIN IN EXTREMITY (Right big toe is still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment information was reported.  Patient stated that she had a bad reaction to the initial vaccination. On 11-Sep-2021, she developed really bad, painful muscle spasms in her right leg and stated that she massaged it to try and get it to reduce.   Patient stated she has never had this happen before and was afraid she will have more of a reaction with the second shot and patient doesn't think she will get a second shot.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia
Clinical narrative: Can't lift it up parallel without shooting pain; Shoulder just hurts/can't lift it up parallel without shooting pain/ My left shoulder is still in pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Can't lift it up parallel without shooting pain) and ARTHRALGIA (Shoulder just hurts/can't lift it up parallel without shooting pain/ My left shoulder is still in pain) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-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 HYPOKINESIA (Can't lift it up parallel without shooting pain) and ARTHRALGIA (Shoulder just hurts/can't lift it up parallel without shooting pain/ My left shoulder is still in pain). At the time of the report, HYPOKINESIA (Can't lift it up parallel without shooting pain) and ARTHRALGIA (Shoulder just hurts/can't lift it up parallel without shooting pain/ My left shoulder is still in pain) had not resolved.      No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-318973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow up received: Outcome of the event updated.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia
Clinical narrative: Heart pain; Joint pain is all over my body; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heart pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced ARTHRALGIA (Joint pain is all over my body). On an unknown date, the patient experienced ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant). At the time of the report, ANGINA PECTORIS (Heart pain) had not resolved and ARTHRALGIA (Joint pain is all over my body) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provider by the reporter.  Treatment information was not provided.   After vaccination on March, patient's had joint pain all over body on April and for heart pain patient went to doctor 2 weeks after first shot.  Company Comment: This case concerns a patient of unknown age and gender who experienced serious event angina pectoris and non-serious event of arthalgia after the first dose of the vaccine. Dechallenge is unknown and rechallge as not applicable. The benefit-risk relationship is not affected by this report   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender who experienced serious event angina pectoris and non-serious event of arthalgia after the first dose of the vaccine. Dechallenge is unknown and rechallge as not applicable. The benefit-risk relationship is not affected by this report
Sex: U
Vaccine: COVID19
Symptoms: Injection site swelling, Vaccination site discomfort, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Warmth; Discomfort at the injection site; Injection site swelling; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth), VACCINATION SITE DISCOMFORT (Discomfort at the injection site), INJECTION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Redness) 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 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE WARMTH (Warmth), VACCINATION SITE DISCOMFORT (Discomfort at the injection site), INJECTION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE WARMTH (Warmth), VACCINATION SITE DISCOMFORT (Discomfort at the injection site), INJECTION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Diarrhoea, Muscle spasms, Pain in extremity
Clinical narrative: inability to control diarrhea; arm pain in left arm; severe painful cramps; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ANAL INCONTINENCE (inability to control diarrhea), PAIN IN EXTREMITY (arm pain in left arm), MUSCLE SPASMS (severe painful cramps) and DIARRHOEA (diarrhea) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included TESTOSTERONE CIPIONATE (TESTOSTERONE CYPIONATE), VENLAFAXINE HYDROCHLORIDE (EFFEXOR), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and CLONAZEPAM for an unknown indication.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced ANAL INCONTINENCE (inability to control diarrhea), PAIN IN EXTREMITY (arm pain in left arm), MUSCLE SPASMS (severe painful cramps) and DIARRHOEA (diarrhea). The patient was treated with PARACETAMOL (TYLENOL) in September 2021 for Pain in arm, at a dose of 1 UNK. At the time of the report, ANAL INCONTINENCE (inability to control diarrhea), PAIN IN EXTREMITY (arm pain in left arm), MUSCLE SPASMS (severe painful cramps) and DIARRHOEA (diarrhea) outcome was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: kinda sick (after first dose); This spontaneous case was reported by a patient and describes the occurrence of MALAISE (kinda sick (after first dose)) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Congestive heart failure. Concomitant products included LISINOPRIL, NAPROXEN and METOPROLOL (CORVITOL [METOPROLOL]) for an unknown indication.    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 MALAISE (kinda sick (after first dose)). At the time of the report, MALAISE (kinda sick (after first dose)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Blood thinners, 2 diuretics and six pills a day were also reported as concomitant medications. No treatment medications were reported.   This case was linked to MOD-2021-319932 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Muscle spasms, Nausea, Pain
Clinical narrative: dizzy; I feel achy; leg cramps; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PAIN (I feel achy), MUSCLE SPASMS (leg cramps) and NAUSEA (nauseous) 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 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced DIZZINESS (dizzy), PAIN (I feel achy), MUSCLE SPASMS (leg cramps) and NAUSEA (nauseous). At the time of the report, DIZZINESS (dizzy), PAIN (I feel achy), MUSCLE SPASMS (leg cramps) and NAUSEA (nauseous) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site erythema, Vaccination site pain, Vaccination site reaction, Vaccination site warmth
Clinical narrative: hot feeling; heat was there again; adverse reaction/She had an adverse reaction apparently to the first dose of Moderna/expected reaction on the left arm; sore arm; red spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot feeling), FEELING HOT (heat was there again), VACCINATION SITE REACTION (adverse reaction/She had an adverse reaction apparently to the first dose of Moderna/expected reaction on the left arm), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (red spot) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot feeling), FEELING HOT (heat was there again), VACCINATION SITE REACTION (adverse reaction/She had an adverse reaction apparently to the first dose of Moderna/expected reaction on the left arm), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (red spot). At the time of the report, VACCINATION SITE WARMTH (hot feeling), FEELING HOT (heat was there again), VACCINATION SITE REACTION (adverse reaction/She had an adverse reaction apparently to the first dose of Moderna/expected reaction on the left arm), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (red spot) outcome was unknown.        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 concomitants drugs were reported. No treatment drugs were reported.  She had the expected reaction on the left arm - the hot feeling, red spot, and sore arm. That lasted maybe 3 days, then went away completely. Two days ago, it was back again. The spot was bigger, and the pain was there again.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore) 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 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced PAIN IN EXTREMITY (Arm is very sore). At the time of the report, PAIN IN EXTREMITY (Arm is very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: non-immunocompromised patient received 3 doses of MOderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (non-immunocompromised patient received 3 doses of MOderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (non-immunocompromised patient received 3 doses of MOderna vaccine). At the time of the report, OFF LABEL USE (non-immunocompromised patient received 3 doses of MOderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. Patient was not immunocompromised. HCP did not have info on first 2 doses.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Trigeminal neuralgia
Clinical narrative: Trigeminal neuralgia flare up; Extremely Bad pain; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extremely Bad pain), TRIGEMINAL NEURALGIA (Trigeminal neuralgia flare up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 051C21A) for COVID-19 vaccination.     The patient's past medical history included Chronic kidney disease stage 3 in 2008, Microvascular decompression (05/2019 and 12/2020:  first and second failed microvascular decompression surgeries.) in May 2019 and Microvascular decompression in December 2020. Concurrent medical conditions included Trigeminal neuralgia (Became bilateral on 07/19/2021) since 2019. Concomitant products included CARBAMAZEPINE (TEGRETOL) from 09-Jan-2019 to an unknown date for Trigeminal neuralgia.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 12-Aug-2021, the patient experienced PAIN (Extremely Bad pain). On 20-Aug-2021, the patient experienced TRIGEMINAL NEURALGIA (Trigeminal neuralgia flare up). On 22-Aug-2021, TRIGEMINAL NEURALGIA (Trigeminal neuralgia flare up) had resolved. At the time of the report, PAIN (Extremely Bad pain) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No treatment medication reported. patient also added that extremely bad pain,on 08/12, 14, 15, 18, 19 but not quite "flare up level,"   This case was linked to MOD-2021-277719 (Patient Link).   Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness around the shot area/soreness of arm more after the 1st dose then the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness around the shot area/soreness of arm more after the 1st dose then the 2nd dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LEVOTHYROXINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness around the shot area/soreness of arm more after the 1st dose then the 2nd dose). At the time of the report, VACCINATION SITE PAIN (soreness around the shot area/soreness of arm more after the 1st dose then the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has asked doctors about getting 3rd dose and patient have scheduled for 3rd dose. He was not immunocompromised and was asking for recommendation.  No treatment medications were reported.   This case was linked to MOD-2021-319641.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered after expiration date) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Nasal congestion
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergies and stuffy nose) and NASAL CONGESTION (allergies and stuffy nose) 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 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergies and stuffy nose) and NASAL CONGESTION (allergies and stuffy nose). At the time of the report, HYPERSENSITIVITY (allergies and stuffy nose) and NASAL CONGESTION (allergies and stuffy nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment information was provided.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Medical Assistant inadvertently gave a patient 1 ml instead of 0.5 ml of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Medical Assistant inadvertently gave a patient 1 ml instead of 0.5 ml of the vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (Medical Assistant inadvertently gave a patient 1 ml instead of 0.5 ml of the vaccine). At the time of the report, ACCIDENTAL OVERDOSE (Medical Assistant inadvertently gave a patient 1 ml instead of 0.5 ml of the vaccine) 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 medication was reported.  No treatment medication was reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Sexual dysfunction
Clinical narrative: Patient can't perform sexually since he got the shot; This spontaneous case was reported by a consumer and describes the occurrence of SEXUAL DYSFUNCTION (Patient can't perform sexually since he got the shot) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced SEXUAL DYSFUNCTION (Patient can't perform sexually since he got the shot). At the time of the report, SEXUAL DYSFUNCTION (Patient can't perform sexually since he got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 101F after first dose; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever of 101F after first dose) 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.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PYREXIA (Fever of 101F after first dose). In 2021, PYREXIA (Fever of 101F after first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101 (High) Fever of 101 Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported  Treatment information was not reported   This case was linked to MOD-2021-319554, MOD-2021-319555 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever reaching up to 101F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever reaching up to 101F) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery. Concurrent medical conditions included Lupus erythematosus.    On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (fever reaching up to 101F). At the time of the report, PYREXIA (fever reaching up to 101F) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and no treatment were provided .   This case was linked to US-MODERNATX, INC.-MOD-2021-025550 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-025550:Dose 2
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose >12 hours after puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose >12 hours after puncture) 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 (Administration of an expired dose >12 hours after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose >12 hours after puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was provided. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow up received is non significant.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema, Vaccination site inflammation
Clinical narrative: Inflamed  Injection Site; Red Injection Site 7" below the shoulder bone; Injected 7" below the shoulder bone/ vaccine was not given in the deltoid muscle; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflamed  Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site 7" below the shoulder bone) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected 7" below the shoulder bone/ vaccine was not given in the deltoid muscle) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflamed  Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site 7" below the shoulder bone) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected 7" below the shoulder bone/ vaccine was not given in the deltoid muscle). In September 2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected 7" below the shoulder bone/ vaccine was not given in the deltoid muscle) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (Inflamed  Injection Site) and VACCINATION SITE ERYTHEMA (Red Injection Site 7" below the shoulder bone) outcome was unknown.        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.   No concomitant medication was reported. No treatment information was provided. The patient was a nurse and she was sure that the vaccine was not given in the deltoid muscle.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: If it has been 2 months since my first dose, can I get 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 (If it has been 2 months since my first dose, can I get the second 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 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 (If it has been 2 months since my first dose, can I get the second dose?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (If it has been 2 months since my first dose, can I get the second dose?) had resolved.            No concomitant medications and no treatment medications were provided .   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose administered after improper storage and handling; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered after improper storage and handling) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered after improper storage and handling). At the time of the report, PRODUCT STORAGE ERROR (Dose administered after improper storage and handling) 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.   No Concomitant medications were provided  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Oxygen saturation decreased
Clinical narrative: Low oxygen level/low oxygen saturation level; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN SATURATION DECREASED (Low oxygen level/low oxygen saturation level) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Interstitial lung disease.    On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (Low oxygen level/low oxygen saturation level) (seriousness criterion medically significant). At the time of the report, OXYGEN SATURATION DECREASED (Low oxygen level/low oxygen saturation level) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: low (Low) Low.         The patient had experienced the event after the booster dose. No relevant concomitant medications were reported. No treatment information was reported.  Company comment: This case concerns a patient of an unknown age, unknown gender with a relevant medical history of rheumatoid arthritis and interstitial lung disease, who experienced the unexpected serious event of oxygen concentration decreased. The latency for the event is unknown (date of onset of the event was not reported) after receiving the third dose of mRNA-1273 vaccine. The rechallenge is not applicable. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine in not affected by this report. Further information has been requested.; Sender's Comments: This case concerns a patient of an unknown age, unknown gender with a relevant medical history of rheumatoid arthritis and interstitial lung disease, who experienced the unexpected serious event of oxygen concentration decreased. The latency for the event is unknown (date of onset of the event was not reported) after receiving the third dose of mRNA-1273 vaccine. The rechallenge is not applicable. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine in not affected by this report. Further information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Rash papular, Vaccination site discomfort, Vaccination site pain
Clinical narrative: bumps around the place of the vaccine, like mosquito bites; warm to the touch; was itchy - ongoing; it hurt if she moved or touched it; The site of injection got swollen; chills; a little bit of a headache; general discomfort in the area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (general discomfort in the area), RASH PAPULAR (bumps around the place of the vaccine, like mosquito bites), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (was itchy - ongoing) and VACCINATION SITE PAIN (it hurt if she moved or touched it) in a 48-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.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE DISCOMFORT (general discomfort in the area), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (was itchy - ongoing), VACCINATION SITE PAIN (it hurt if she moved or touched it), VACCINATION SITE SWELLING (The site of injection got swollen), CHILLS (chills) and HEADACHE (a little bit of a headache). On 12-Sep-2021, the patient experienced RASH PAPULAR (bumps around the place of the vaccine, like mosquito bites). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at a dose of Cream. On 11-Sep-2021, HEADACHE (a little bit of a headache) had resolved. On 14-Sep-2021, CHILLS (chills) outcome was unknown. At the time of the report, VACCINATION SITE DISCOMFORT (general discomfort in the area), RASH PAPULAR (bumps around the place of the vaccine, like mosquito bites), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (was itchy - ongoing), VACCINATION SITE PAIN (it hurt if she moved or touched it) and VACCINATION SITE SWELLING (The site of injection got swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included Heart burn medications