chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Face twitching on the right side of my face) 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 MUSCLE TWITCHING (Face twitching on the right side of my face). At the time of the report, MUSCLE TWITCHING (Face twitching on the right side of my face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Follow-up consent approved. No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (really bad headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 610M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (17 years ago but has not had any problems since then). Concurrent medical conditions included Myelodysplasia and Osteopenia.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced MIGRAINE (really bad headache). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 UNK. At the time of the report, MIGRAINE (really bad headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. The patient was talking to a friend who had been having neurological problems with double vision, and headaches after receiving the  vaccine. The patient also spoke to someone else, whose sister had very bad vertigo since receiving the vaccine, and had episodes of vertigo in the past but since receiving the vaccine, it had been serious.   This case was linked to MOD-2021-281277 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: had not been feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (had not been feeling well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (had not been feeling well). At the time of the report, MALAISE (had not been feeling well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Negative) the test have indicated antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided. Patient took the Moderna vaccine in February(unknown dose). The patient's Doctor ordered a Covid test, reporter asked if ' Should the test have indicated antibodies"
Sex: U
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: Got sick; More than 35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) and PRODUCT DOSE OMISSION ISSUE (More than 35 days since first 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 ILLNESS (Got sick) and PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose). At the time of the report, ILLNESS (Got sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Raise my diabetic blood sugar/My sugar was 161 on the day I got my shot/It has varied between 197 and 222 for eight days; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Raise my diabetic blood sugar/My sugar was 161 on the day I got my shot/It has varied between 197 and 222 for eight days) 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 BLOOD GLUCOSE INCREASED (Raise my diabetic blood sugar/My sugar was 161 on the day I got my shot/It has varied between 197 and 222 for eight days). At the time of the report, BLOOD GLUCOSE INCREASED (Raise my diabetic blood sugar/My sugar was 161 on the day I got my shot/It has varied between 197 and 222 for eight days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: 161 (High) Blood sugar was 161 on the day of vaccine received. and 222 (High) varied between 197 and 222 for eight days.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.  Patient's sugar was 161 on the day got the shot and it has varied between 197 and 222 for eight days   Reporter did not allow further contact
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered BUD (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32). No temperature excursion episodes occurred. Vial was kept between 36 and 45.9 degrees Fahrenheit.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32). No temperature excursion episodes occurred. Vial was kept between 36 and 45.9 degrees Fahrenheit.) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32). No temperature excursion episodes occurred. Vial was kept between 36 and 45.9 degrees Fahrenheit.). On 16-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32). No temperature excursion episodes occurred. Vial was kept between 36 and 45.9 degrees Fahrenheit.) 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 reported No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Follow-up information includes no new information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Interchange of vaccine products, Pain in extremity
Clinical narrative: Little sore arm; Felt tired; Was given 3rd dose of Moderna covid-19 vaccine accidentally instead of Shingrix vaccine; accidentally administered Moderna covid-19 vaccine as third dose instead of shingrix vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Little sore arm), FATIGUE (Felt tired), EXTRA DOSE ADMINISTERED (Was given 3rd dose of Moderna covid-19 vaccine accidentally instead of Shingrix vaccine) and INTERCHANGE OF VACCINE PRODUCTS (accidentally administered Moderna covid-19 vaccine as third dose instead of shingrix vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Aug-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) (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 07-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Was given 3rd dose of Moderna covid-19 vaccine accidentally instead of Shingrix vaccine) and INTERCHANGE OF VACCINE PRODUCTS (accidentally administered Moderna covid-19 vaccine as third dose instead of shingrix vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Little sore arm) and FATIGUE (Felt tired). On 07-Aug-2021, EXTRA DOSE ADMINISTERED (Was given 3rd dose of Moderna covid-19 vaccine accidentally instead of Shingrix vaccine) and INTERCHANGE OF VACCINE PRODUCTS (accidentally administered Moderna covid-19 vaccine as third dose instead of shingrix vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Little sore arm) and FATIGUE (Felt tired) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had completed her vaccination series in Feb-2021. Concomitant medication list was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Skin discolouration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Burning sensation in arm; Arm is sore at injection site; Arm is swollen at injection site; Arm is dark; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Arm is dark), BURNING SENSATION (Burning sensation in arm), VACCINATION SITE PAIN (Arm is sore at injection site) and VACCINATION SITE SWELLING (Arm is swollen at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E214) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced SKIN DISCOLOURATION (Arm is dark), VACCINATION SITE PAIN (Arm is sore at injection site) and VACCINATION SITE SWELLING (Arm is swollen at injection site). On 09-Aug-2021, the patient experienced BURNING SENSATION (Burning sensation in arm). At the time of the report, SKIN DISCOLOURATION (Arm is dark), VACCINATION SITE PAIN (Arm is sore at injection site) and VACCINATION SITE SWELLING (Arm is swollen at injection site) outcome was unknown and BURNING SENSATION (Burning sensation in arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug reported. No treatment drug reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Rash
Clinical narrative: little swollen; horrible rash underneath the arm; light head ache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (little swollen), RASH (horrible rash underneath the arm) and HEADACHE (light head ache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     Concomitant products included BUPROPION for an unknown indication.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced PERIPHERAL SWELLING (little swollen), RASH (horrible rash underneath the arm) and HEADACHE (light head ache). At the time of the report, PERIPHERAL SWELLING (little swollen), RASH (horrible rash underneath the arm) and HEADACHE (light head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication includes Ftmmtnessenct Mecapause  of unknown indication. Treatment information was not provided.      This case was linked to MOD-2021-281410.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot
Clinical narrative: Feeling  little hot; Shoulder is  hurting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling  little hot) and ARTHRALGIA (Shoulder is  hurting) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Feeling  little hot) and ARTHRALGIA (Shoulder is  hurting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, FEELING HOT (Feeling  little hot) and ARTHRALGIA (Shoulder is  hurting) outcome was unknown.            No concomitant medications were  reported Patient also used Ice for treatment
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Headache, Hot flush, Hyperhidrosis, Memory impairment
Clinical narrative: Trouble with memory; Depressed; Eyes do not feel right; Throat hurts; Sweats; hot flashes; nausea; headache; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Trouble with memory), DEPRESSION (Depressed), OCULAR DISCOMFORT (Eyes do not feel right), OROPHARYNGEAL PAIN (Throat hurts) and HYPERHIDROSIS (Sweats) in a 58-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.     Concurrent medical conditions included Blood pressure. Concomitant products included ATORVASTATIN for an unknown indication.   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, 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 experienced MEMORY IMPAIRMENT (Trouble with memory), DEPRESSION (Depressed), OCULAR DISCOMFORT (Eyes do not feel right), OROPHARYNGEAL PAIN (Throat hurts), HYPERHIDROSIS (Sweats), HOT FLUSH (hot flashes), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever). At the time of the report, MEMORY IMPAIRMENT (Trouble with memory), DEPRESSION (Depressed), OCULAR DISCOMFORT (Eyes do not feel right), OROPHARYNGEAL PAIN (Throat hurts), HYPERHIDROSIS (Sweats), HOT FLUSH (hot flashes), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.            It was reported that the adverse events lasted for about a month, even though dates were not provided  Concomitant medications also included: Blood pressure medications  Treatment information was not reported   This case was linked to MOD-2021-281438 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Ocular discomfort, Oropharyngeal pain, Pyrexia
Clinical narrative: Trouble with memory; Depressed; Eyes do not feel right; Throat hurts; Sweats; hot flashes; nausea; headache; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Trouble with memory), DEPRESSION (Depressed), OCULAR DISCOMFORT (Eyes do not feel right), OROPHARYNGEAL PAIN (Throat hurts) and HYPERHIDROSIS (Sweats) in a 58-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.     Concurrent medical conditions included Blood pressure. Concomitant products included ATORVASTATIN for an unknown indication.   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, 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 experienced MEMORY IMPAIRMENT (Trouble with memory), DEPRESSION (Depressed), OCULAR DISCOMFORT (Eyes do not feel right), OROPHARYNGEAL PAIN (Throat hurts), HYPERHIDROSIS (Sweats), HOT FLUSH (hot flashes), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever). At the time of the report, MEMORY IMPAIRMENT (Trouble with memory), DEPRESSION (Depressed), OCULAR DISCOMFORT (Eyes do not feel right), OROPHARYNGEAL PAIN (Throat hurts), HYPERHIDROSIS (Sweats), HOT FLUSH (hot flashes), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.            It was reported that the adverse events lasted for about a month, even though dates were not provided  Concomitant medications also included: Blood pressure medications  Treatment information was not reported   This case was linked to MOD-2021-281438 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), MYALGIA (Muscle pain), PYREXIA (Fever) and FATIGUE (Feeling tired) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pain), MYALGIA (Muscle pain), PYREXIA (Fever) and FATIGUE (Feeling tired). At the time of the report, PAIN (pain), MYALGIA (Muscle pain), PYREXIA (Fever) and FATIGUE (Feeling tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Still experiencing some side effects from the 2nd vaccine which got on 13-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Still experiencing some side effects from the 2nd vaccine which got on 13-May-2021) 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-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 (Still experiencing some side effects from the 2nd vaccine which got on 13-May-2021). At the time of the report, VACCINATION COMPLICATION (Still experiencing some side effects from the 2nd vaccine which got on 13-May-2021) had not resolved.            No concomitant medication was provided by the reporter.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: So much pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (So much pain in my arm) 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 PAIN IN EXTREMITY (So much pain in my arm). At the time of the report, PAIN IN EXTREMITY (So much pain in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported No treatment medication was reported
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Malaise, Muscle spasms, Muscular weakness, Pain
Clinical narrative: it hurts all from her waist down; Almost like a charley horse; wakes her up in the middle of the night; felt sick for a few days; felt like she couldn't walk, she started hobbling around/ first thing in the morning it's hard to walk; feeling weak in her legs and knees; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (felt like she couldn't walk, she started hobbling around/ first thing in the morning it's hard to walk), PAIN (it hurts all from her waist down), MUSCLE SPASMS (Almost like a charley horse), SLEEP DISORDER (wakes her up in the middle of the night) and MUSCULAR WEAKNESS (feeling weak in her legs and knees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MUSCULAR WEAKNESS (feeling weak in her legs and knees). In May 2021, the patient experienced GAIT DISTURBANCE (felt like she couldn't walk, she started hobbling around/ first thing in the morning it's hard to walk). On an unknown date, the patient experienced PAIN (it hurts all from her waist down), MUSCLE SPASMS (Almost like a charley horse), SLEEP DISORDER (wakes her up in the middle of the night) and MALAISE (felt sick for a few days). At the time of the report, GAIT DISTURBANCE (felt like she couldn't walk, she started hobbling around/ first thing in the morning it's hard to walk), PAIN (it hurts all from her waist down), MUSCLE SPASMS (Almost like a charley horse), SLEEP DISORDER (wakes her up in the middle of the night), MUSCULAR WEAKNESS (feeling weak in her legs and knees) and MALAISE (felt sick for a few days) outcome was unknown.            Patient was reported that after the second dose, the patient felt sick for a few days.  Then in April patient started feeling weak in legs and knees.  In mid-May patient really felt like couldn't walk, started hobbling around and never thought it could be from the vaccine until visited  a pharmacist.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: it hurts all from her waist down; Almost like a charley horse; wakes her up in the middle of the night; felt sick for a few days; felt like she couldn't walk, she started hobbling around/ first thing in the morning it's hard to walk; feeling weak in her legs and knees; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (felt like she couldn't walk, she started hobbling around/ first thing in the morning it's hard to walk), PAIN (it hurts all from her waist down), MUSCLE SPASMS (Almost like a charley horse), SLEEP DISORDER (wakes her up in the middle of the night) and MUSCULAR WEAKNESS (feeling weak in her legs and knees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MUSCULAR WEAKNESS (feeling weak in her legs and knees). In May 2021, the patient experienced GAIT DISTURBANCE (felt like she couldn't walk, she started hobbling around/ first thing in the morning it's hard to walk). On an unknown date, the patient experienced PAIN (it hurts all from her waist down), MUSCLE SPASMS (Almost like a charley horse), SLEEP DISORDER (wakes her up in the middle of the night) and MALAISE (felt sick for a few days). At the time of the report, GAIT DISTURBANCE (felt like she couldn't walk, she started hobbling around/ first thing in the morning it's hard to walk), PAIN (it hurts all from her waist down), MUSCLE SPASMS (Almost like a charley horse), SLEEP DISORDER (wakes her up in the middle of the night), MUSCULAR WEAKNESS (feeling weak in her legs and knees) and MALAISE (felt sick for a few days) outcome was unknown.            Patient was reported that after the second dose, the patient felt sick for a few days.  Then in April patient started feeling weak in legs and knees.  In mid-May patient really felt like couldn't walk, started hobbling around and never thought it could be from the vaccine until visited  a pharmacist.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Night sweats, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: started sneezing; my sinuses were draining down; kind of felt like I had a sore throat; night sweats; slight fever off and on; night sweats; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of NIGHT SWEATS (night sweats), SNEEZING (started sneezing), SINUSITIS (my sinuses were draining down), OROPHARYNGEAL PAIN (kind of felt like I had a sore throat) and the second episode of NIGHT SWEATS (night sweats) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shortness of breath on 15-Jul-2021, Weakness on 15-Jul-2021, Pain in extremity on 15-Jul-2021 and Nausea on 15-Jul-2021.    On 29-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 the first episode of NIGHT SWEATS (night sweats) and PYREXIA (slight fever off and on). On 06-Aug-2021, the patient experienced the second episode of NIGHT SWEATS (night sweats). On 07-Aug-2021, the patient experienced SNEEZING (started sneezing), SINUSITIS (my sinuses were draining down) and OROPHARYNGEAL PAIN (kind of felt like I had a sore throat). At the time of the report, SNEEZING (started sneezing), SINUSITIS (my sinuses were draining down), OROPHARYNGEAL PAIN (kind of felt like I had a sore throat), the last episode of NIGHT SWEATS (night sweats) and PYREXIA (slight fever off and on) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, Body temperature (Unknown-97.5): 98 (High) fever of 98 degree F. On 06-Aug-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Concomitant product use was not provided by the reporter.  Treatment medication was not provided by the reporter.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis, Sneezing
Clinical narrative: started sneezing; my sinuses were draining down; kind of felt like I had a sore throat; night sweats; slight fever off and on; night sweats; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of NIGHT SWEATS (night sweats), SNEEZING (started sneezing), SINUSITIS (my sinuses were draining down), OROPHARYNGEAL PAIN (kind of felt like I had a sore throat) and the second episode of NIGHT SWEATS (night sweats) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shortness of breath on 15-Jul-2021, Weakness on 15-Jul-2021, Pain in extremity on 15-Jul-2021 and Nausea on 15-Jul-2021.    On 29-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 the first episode of NIGHT SWEATS (night sweats) and PYREXIA (slight fever off and on). On 06-Aug-2021, the patient experienced the second episode of NIGHT SWEATS (night sweats). On 07-Aug-2021, the patient experienced SNEEZING (started sneezing), SINUSITIS (my sinuses were draining down) and OROPHARYNGEAL PAIN (kind of felt like I had a sore throat). At the time of the report, SNEEZING (started sneezing), SINUSITIS (my sinuses were draining down), OROPHARYNGEAL PAIN (kind of felt like I had a sore throat), the last episode of NIGHT SWEATS (night sweats) and PYREXIA (slight fever off and on) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, Body temperature (Unknown-97.5): 98 (High) fever of 98 degree F. On 06-Aug-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Concomitant product use was not provided by the reporter.  Treatment medication was not provided by the reporter.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Called to provide patient information (Administered improperly stored vaccine); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Called to provide patient information (Administered improperly stored vaccine)) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Called to provide patient information (Administered improperly stored vaccine)). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Called to provide patient information (Administered improperly stored 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 treatment and concomitant medications were provided.   This case was linked to MOD-2021-128210, MOD-2021-128181 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up document received contains No New Information. On 09-Aug-2021: Followup received  contains No New Information.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Huge,fatty bump in arm pit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Huge,fatty bump in arm pit) 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 AXILLARY MASS (Huge,fatty bump in arm pit). At the time of the report, AXILLARY MASS (Huge,fatty bump in arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Extra dose administered
Clinical narrative: 2 (TWO) doses of Moderna vaccine today/Double dosing; 2 (TWO) doses of Moderna vaccine today/Double dosing; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (2 (TWO) doses of Moderna vaccine today/Double dosing) and ACCIDENTAL OVERDOSE (2 (TWO) doses of Moderna vaccine today/Double dosing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third 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) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (2 (TWO) doses of Moderna vaccine today/Double dosing) and ACCIDENTAL OVERDOSE (2 (TWO) doses of Moderna vaccine today/Double dosing). At the time of the report, EXTRA DOSE ADMINISTERED (2 (TWO) doses of Moderna vaccine today/Double dosing) and ACCIDENTAL OVERDOSE (2 (TWO) doses of Moderna vaccine today/Double dosing) had resolved.            Concomitant product information was not provided.  The patient's mother reported that her son presented for his second dose of the Moderna vaccine and that the pharmacist administered two doses on the same day. The pharmacist stated that the earlier dose had been sitting out too long.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Felt achy; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy), PYREXIA (Fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2021, the patient experienced PAIN (Felt achy), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with IBUPROFEN for Ache NOS, Fever and Chills, at a dose of 1 UNK. At the time of the report, PAIN (Felt achy), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient felt better a few hours later.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Peripheral coldness, Urticaria
Clinical narrative: feet touching cold water or anything like air condition my hands; allergies to your hands and feet; feet get hives when they get cold from ice are air conditioners or cold water; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (feet touching cold water or anything like air condition my hands), HYPERSENSITIVITY (allergies to your hands and feet) and URTICARIA (feet get hives when they get cold from ice are air conditioners or cold water) 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 PERIPHERAL COLDNESS (feet touching cold water or anything like air condition my hands), HYPERSENSITIVITY (allergies to your hands and feet) and URTICARIA (feet get hives when they get cold from ice are air conditioners or cold water). At the time of the report, PERIPHERAL COLDNESS (feet touching cold water or anything like air condition my hands), HYPERSENSITIVITY (allergies to your hands and feet) and URTICARIA (feet get hives when they get cold from ice are air conditioners or cold water) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information provided.   This case was linked to MOD-2021-281485 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: after first dose, lump in arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (after first dose, lump in arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ATORVASTATIN 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 SKIN MASS (after first dose, lump in arm). At the time of the report, SKIN MASS (after first dose, lump in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took blood pressure medication (unspecified drug) as concomitant drug.  No treatment drug was provided by reporter.   This case was linked to MOD-2021-281363 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Headache, Lymphadenopathy
Clinical narrative: she hadn't felt good, can't stay awake for a few hours; weakness; nodules (in lung, lymph, thyroid, under arm on left side ); hurt everywhere, so much pain; exhausted; nausea; fever; fatigue, debilitating fatigue, exhausted; enlarged lymph nodes; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she hadn't felt good, can't stay awake for a few hours), ASTHENIA (weakness), NODULE (nodules (in lung, lymph, thyroid, under arm on left side )), PAIN (hurt everywhere, so much pain) and FATIGUE (exhausted) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (she hadn't felt good, can't stay awake for a few hours), ASTHENIA (weakness), NODULE (nodules (in lung, lymph, thyroid, under arm on left side )), PAIN (hurt everywhere, so much pain), FATIGUE (exhausted), NAUSEA (nausea), PYREXIA (fever), FATIGUE (fatigue, debilitating fatigue, exhausted), LYMPHADENOPATHY (enlarged lymph nodes) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (she hadn't felt good, can't stay awake for a few hours), ASTHENIA (weakness), NODULE (nodules (in lung, lymph, thyroid, under arm on left side )), PAIN (hurt everywhere, so much pain), FATIGUE (exhausted), NAUSEA (nausea), PYREXIA (fever), FATIGUE (fatigue, debilitating fatigue, exhausted), LYMPHADENOPATHY (enlarged lymph nodes) and HEADACHE (headache) outcome was unknown.            No concomitant medications were provided. Treatment medication included antibiotics  for patient's lymph nodes in case of possible infection but nothing changed. Patient's blood drawn for  blood test, Catscan and other test were done. It was reported that patient was actively experiencing symptoms and stated that they were getting worse.   This case was linked to MOD-2021-281144 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nodule, Pain, Pyrexia
Clinical narrative: she hadn't felt good, can't stay awake for a few hours; weakness; nodules (in lung, lymph, thyroid, under arm on left side ); hurt everywhere, so much pain; exhausted; nausea; fever; fatigue, debilitating fatigue, exhausted; enlarged lymph nodes; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she hadn't felt good, can't stay awake for a few hours), ASTHENIA (weakness), NODULE (nodules (in lung, lymph, thyroid, under arm on left side )), PAIN (hurt everywhere, so much pain) and FATIGUE (exhausted) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (she hadn't felt good, can't stay awake for a few hours), ASTHENIA (weakness), NODULE (nodules (in lung, lymph, thyroid, under arm on left side )), PAIN (hurt everywhere, so much pain), FATIGUE (exhausted), NAUSEA (nausea), PYREXIA (fever), FATIGUE (fatigue, debilitating fatigue, exhausted), LYMPHADENOPATHY (enlarged lymph nodes) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (she hadn't felt good, can't stay awake for a few hours), ASTHENIA (weakness), NODULE (nodules (in lung, lymph, thyroid, under arm on left side )), PAIN (hurt everywhere, so much pain), FATIGUE (exhausted), NAUSEA (nausea), PYREXIA (fever), FATIGUE (fatigue, debilitating fatigue, exhausted), LYMPHADENOPATHY (enlarged lymph nodes) and HEADACHE (headache) outcome was unknown.            No concomitant medications were provided. Treatment medication included antibiotics  for patient's lymph nodes in case of possible infection but nothing changed. Patient's blood drawn for  blood test, Catscan and other test were done. It was reported that patient was actively experiencing symptoms and stated that they were getting worse.   This case was linked to MOD-2021-281144 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Decreased appetite, Nausea
Clinical narrative: feels very shaky; has no appetite; is very thirsty; thrown up 8 times; cold sweats; restless leg syndrome; fever of 102.3; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), RESTLESS LEGS SYNDROME (restless leg syndrome), NERVOUSNESS (feels very shaky), DECREASED APPETITE (has no appetite) and THIRST (is very thirsty) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A  no ex) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Tested positive three months back).    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced COLD SWEAT (cold sweats), RESTLESS LEGS SYNDROME (restless leg syndrome), PYREXIA (fever of 102.3), CHILLS (chills) and NAUSEA (nausea). On 09-Aug-2021, the patient experienced VOMITING (thrown up 8 times). On an unknown date, the patient experienced NERVOUSNESS (feels very shaky), DECREASED APPETITE (has no appetite) and THIRST (is very thirsty). At the time of the report, COLD SWEAT (cold sweats), RESTLESS LEGS SYNDROME (restless leg syndrome), NERVOUSNESS (feels very shaky), DECREASED APPETITE (has no appetite), THIRST (is very thirsty), PYREXIA (fever of 102.3), CHILLS (chills), NAUSEA (nausea) and VOMITING (thrown up 8 times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) positive. On 08-Aug-2021, Body temperature: 102.3 f (High) 102.3 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes no concomitant medication. No treatment information was provided.