chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Polymenorrhoea, Pyrexia, Vomiting
Clinical narrative: Having menstrual bleeding 5 days early; More than 35 days between 1st and 2nd dose; After 2nd dose-fuzzy brain; After 2nd dose-never been this sick in life; After 2nd dose-headaches; After 2nd dose-chills; After 2nd dose-12 hours of vomiting; Fever; After 2nd dose-no energy/couldn't get off bathroom floor; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Having menstrual bleeding 5 days early), ASTHENIA (After 2nd dose-no energy/couldn't get off bathroom floor), FEELING ABNORMAL (After 2nd dose-fuzzy brain), ILLNESS (After 2nd dose-never been this sick in life) and HEADACHE (After 2nd dose-headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026P21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced ASTHENIA (After 2nd dose-no energy/couldn't get off bathroom floor), ILLNESS (After 2nd dose-never been this sick in life), HEADACHE (After 2nd dose-headaches), CHILLS (After 2nd dose-chills), VOMITING (After 2nd dose-12 hours of vomiting) and PYREXIA (Fever). On 11-Oct-2021, the patient experienced FEELING ABNORMAL (After 2nd dose-fuzzy brain). On an unknown date, the patient experienced POLYMENORRHOEA (Having menstrual bleeding 5 days early) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between 1st and 2nd dose). On 10-Oct-2021, ILLNESS (After 2nd dose-never been this sick in life) and CHILLS (After 2nd dose-chills) had resolved. At the time of the report, POLYMENORRHOEA (Having menstrual bleeding 5 days early), ASTHENIA (After 2nd dose-no energy/couldn't get off bathroom floor), FEELING ABNORMAL (After 2nd dose-fuzzy brain) and HEADACHE (After 2nd dose-headaches) had not resolved and VOMITING (After 2nd dose-12 hours of vomiting), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between 1st and 2nd dose) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-348452 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever of 102.2 F; Chills; Body aches; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever of 102.2 F), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040D21A, 007M20A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (diabetes medication) and Blood pressure high (high blood pressure medication).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-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 experienced PYREXIA (Fever of 102.2 F), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, PYREXIA (Fever of 102.2 F), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.2 f (High) Fever of 102.2 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Injection site arm was sore; Terrible headache,Covid Headache; High Fever, Fever of 102 degrees Farenheight.; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site arm was sore), HEADACHE (Terrible headache,Covid Headache), PYREXIA (High Fever, Fever of 102 degrees Farenheight.) and MYALGIA (Body Aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site arm was sore), HEADACHE (Terrible headache,Covid Headache), PYREXIA (High Fever, Fever of 102 degrees Farenheight.) and MYALGIA (Body Aches). At the time of the report, INJECTION SITE PAIN (Injection site arm was sore) outcome was unknown and HEADACHE (Terrible headache,Covid Headache), PYREXIA (High Fever, Fever of 102 degrees Farenheight.) and MYALGIA (Body Aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever of 102 degrees Fahrenheit.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient received second dose on 11 Mar 2021, lot number was 013A21A and did not experience any events after second dose. Patient drank a lot of water before the second dose.  Treatment medication was not provided by the reporter.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; Vomiting and not able to retain anything; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting and not able to retain anything) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Oct-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) (Intramuscular) 1 dosage form. On 10-Oct-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 11-Oct-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting and not able to retain anything). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency and FRUCTOSE, GLUCOSE, PHOSPHORIC ACID (EMETROL [FRUCTOSE;GLUCOSE;PHOSPHORIC ACID]) for Nausea, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting and not able to retain anything) outcome was unknown.            No concomitant medications were provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms for 24 hours after the second shot), MYALGIA (very achy after the second shot), FATIGUE (tired after the second shot), PYREXIA (may have had a fever after the second shot) and CHILLS (shivering a little bit after the second shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE, GLYCOPYRRONIUM BROMIDE (BREZTRI AEROSPHERE) for an unknown indication.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms for 24 hours after the second shot), MYALGIA (very achy after the second shot), FATIGUE (tired after the second shot), PYREXIA (may have had a fever after the second shot) and CHILLS (shivering a little bit after the second shot). The patient was treated with ALBUTEROL [SALBUTAMOL] for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Fever, at an unspecified dose and frequency and AZITHROMYCIN (ZITHROMAX) ongoing since an unknown date for Adverse event, at a dose of 500 mg. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms for 24 hours after the second shot) had resolved and MYALGIA (very achy after the second shot), FATIGUE (tired after the second shot), PYREXIA (may have had a fever after the second shot) and CHILLS (shivering a little bit after the second shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had his COPD under control for some time, but now if he does not use his inhaler, he cannot breath.  On unknown date, the patient had an additional test performed that included a nostril (strip test), however, the result was that he had the flu and an infection in his lungs provided.  If he did not take advil/tylenol he experience a fever.   This case was linked to MOD-2021-348854, MOD-2021-348936 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Costochondritis, Musculoskeletal chest pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of musculoskeletal chest pain (pain in the ribs) and costochondritis (inflammation in the ribs) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 044A21A and 015M20A) for COVID-19 immunization. No medical history reported. On Feb 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 12, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had musculoskeletal chest pain (pain in the ribs) and costochondritis (inflammation in the ribs). At the time of the report, musculoskeletal chest pain (pain in the ribs) and costochondritis (inflammation in the ribs) outcome: unknown. Diagnostic results: On an unknown date, computerised tomogram: normal (could not find anything wrong). The pain did not start right away after the doses of vaccine. No concomitant medications or treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Scalp psoriasis that got worse; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Scalp psoriasis that got worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis of scalp.    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 PSORIASIS (Scalp psoriasis that got worse). At the time of the report, PSORIASIS (Scalp psoriasis that got worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient experienced event after either the Pfizer or Moderna Covid-19 Vaccine.  No concomitant medication details was provided.  No treatment medication details was provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus pain, Sinusitis
Clinical narrative: severe sinus swelling / sinus cavity around the bridge of nose "swole"; severe sinus pain/sinus cavity around the bridge of nose "swole and it caused really bad pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUSITIS (severe sinus swelling / sinus cavity around the bridge of nose "swole") and SINUS PAIN (severe sinus pain/sinus cavity around the bridge of nose "swole and it caused really bad pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, the patient experienced SINUSITIS (severe sinus swelling / sinus cavity around the bridge of nose "swole") and SINUS PAIN (severe sinus pain/sinus cavity around the bridge of nose "swole and it caused really bad pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and STEROIDS for Adverse event, at an unspecified dose and frequency. At the time of the report, SINUSITIS (severe sinus swelling / sinus cavity around the bridge of nose "swole") and SINUS PAIN (severe sinus pain/sinus cavity around the bridge of nose "swole and it caused really bad pain) had not 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 drug details were reported.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: 3rd dose administered instead of flu vaccine,Patient is not considered as immunocompromised per HCP's knowledge; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (3rd dose administered instead of flu vaccine,Patient is not considered as immunocompromised per HCP's knowledge) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (3rd dose administered instead of flu vaccine,Patient is not considered as immunocompromised per HCP's knowledge). At the time of the report, OFF LABEL USE (3rd dose administered instead of flu vaccine,Patient is not considered as immunocompromised per HCP's knowledge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that The patient got the 2nd dose less than 1 month ago. No concomitant product information was provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; Arm pain; shivering; Legs were very weak/Very weak in the legs; had some shaking/shaky/arms and legs started shaking/tremor/whole body Shook for 10 mins then stopped after that worsening of shaking occured; Dizziness; Jerky; Forgetting everything; Would lose her balance; shaking woke her up; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Legs were very weak/Very weak in the legs), TREMOR (had some shaking/shaky/arms and legs started shaking/tremor/whole body Shook for 10 mins then stopped after that worsening of shaking occured), URINARY TRACT INFECTION (Urinary tract infection), DIZZINESS (Dizziness) and DYSKINESIA (Jerky) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037R21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Post-traumatic stress disorder, Fibromyalgia, Peripheral neuropathy, Sciatica, Acid reflux (esophageal) and Pain in hip. Concomitant products included OMEPRAZOLE (ZEGERID [OMEPRAZOLE]) for Acid reflux (esophageal), GABAPENTIN, VALACYCLOVIR [VALACICLOVIR], ALPRAZOLAM, PRAVASTATIN, METOPROLOL, NALTREXONE, ALPRAZOLAM (XANAX) and VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced MUSCULAR WEAKNESS (Legs were very weak/Very weak in the legs), TREMOR (had some shaking/shaky/arms and legs started shaking/tremor/whole body Shook for 10 mins then stopped after that worsening of shaking occured), DIZZINESS (Dizziness), DYSKINESIA (Jerky), MEMORY IMPAIRMENT (Forgetting everything), BALANCE DISORDER (Would lose her balance), SLEEP DISORDER (shaking woke her up) and CHILLS (shivering). On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) and PAIN IN EXTREMITY (Arm pain). At the time of the report, MUSCULAR WEAKNESS (Legs were very weak/Very weak in the legs), URINARY TRACT INFECTION (Urinary tract infection), DIZZINESS (Dizziness), DYSKINESIA (Jerky), MEMORY IMPAIRMENT (Forgetting everything), BALANCE DISORDER (Would lose her balance), SLEEP DISORDER (shaking woke her up), PAIN IN EXTREMITY (Arm pain) and CHILLS (shivering) outcome was unknown and TREMOR (had some shaking/shaky/arms and legs started shaking/tremor/whole body Shook for 10 mins then stopped after that worsening of shaking occured) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging head: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were reported.   This case was linked to MOD-2021-348968 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood zinc abnormal, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid19 infection; lack of drug effect; Messed up her blood sugar; Messed up her zinc; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid19 infection), BLOOD GLUCOSE ABNORMAL (Messed up her blood sugar), BLOOD ZINC ABNORMAL (Messed up her zinc) and DRUG INEFFECTIVE (lack of drug effect) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Diabetes and Thyroid disorder. Concomitant products included METFORMIN for Diabetes.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced COVID-19 (Covid19 infection) and DRUG INEFFECTIVE (lack of drug effect). In September 2021, the patient experienced BLOOD GLUCOSE ABNORMAL (Messed up her blood sugar) and BLOOD ZINC ABNORMAL (Messed up her zinc). At the time of the report, COVID-19 (Covid19 infection), BLOOD GLUCOSE ABNORMAL (Messed up her blood sugar), BLOOD ZINC ABNORMAL (Messed up her zinc) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BLOOD GLUCOSE ABNORMAL (Messed up her blood sugar) and BLOOD ZINC ABNORMAL (Messed up her zinc) to be unlikely related. No further causality assessments were provided for COVID-19 (Covid19 infection) and DRUG INEFFECTIVE (lack of drug effect).    Patient received Moderna vaccine at Vaccine facility Kroger K426, GA, US  Other concomitant medications included unspecified statin, unspecified blood pressure medication and thyroid medication.   Treatment medication included unspecified steroid for COVID-19 which messed up patient's  blood sugar and zinc.; Sender's Comments: This case concerns a 70-year-old female patient with  history of Diabetes and Thyroid disorder, who experienced the non-serious  unexpected event COVID-19 (AESI). The event occurred approximately 7 months after second dose of mRNA-1273 Moderna vaccine.  Lack of drug effect  was also captured as an event. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Six months ago I had my second Pfizer/both received a half dose booster of your Moderna; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Six months ago I had my second Pfizer/both received a half dose booster of your Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (Six months ago I had my second Pfizer) in May 2021.    On 10-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Six months ago I had my second Pfizer/both received a half dose booster of your Moderna). On 10-Oct-2021, INCORRECT DOSE ADMINISTERED (Six months ago I had my second Pfizer/both received a half dose booster of your Moderna) had resolved.            No concomitants medications was reported.  No treatments medications was reported.   This case was linked to MOD-2021-348882 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Pyrexia
Clinical narrative: Bad migraines; fevers; chills; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (bad migraines), PYREXIA (fevers) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (bad migraines), PYREXIA (fevers) and CHILLS (chills). At the time of the report, MIGRAINE (bad migraines) outcome was unknown and PYREXIA (fevers) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had bad migraines, fevers, & chills to the point that her & her doctor decided to put the 2nd dose off for a couple of weeks. The fevers & chills lasted for a  week after the 1st dose. No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-349189 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (2 months after getting the shot, my right arm started to hurt) and VACCINATION SITE MOVEMENT IMPAIRMENT (it still hurts when I lift it) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M70A and 007M20A) for COVID-19 vaccination.     Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Product Used For Unknown Indication, PIOGLITAZONE, ATENOLOL, METFORMIN and LISINOPRIL 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 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced VACCINATION SITE PAIN (2 months after getting the shot, my right arm started to hurt). On 11-Oct-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (it still hurts when I lift it). The patient was treated with MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (2 months after getting the shot, my right arm started to hurt) and VACCINATION SITE MOVEMENT IMPAIRMENT (it still hurts when I lift it) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Monoplegia, Vaccination complication, Vaccination site pain
Clinical narrative: right leg  was getting paralyzed, this occurred after his first shot and second shot; affected lower back and left side going down left leg; soreness in left arm and tenderness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Oct-2021 and was forwarded to Moderna on 11-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (right leg  was getting paralyzed, this occurred after his first shot and second shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery in October 2020. Concomitant products included WARFARIN, ATORVASTATIN, OMEPRAZOLE, HYDROCODONE and TESTOSTERONE 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 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MONOPLEGIA (right leg  was getting paralyzed, this occurred after his first shot and second shot) (seriousness criterion medically significant), VACCINATION COMPLICATION (affected lower back and left side going down left leg) and VACCINATION SITE PAIN (soreness in left arm and tenderness). At the time of the report, MONOPLEGIA (right leg  was getting paralyzed, this occurred after his first shot and second shot), VACCINATION COMPLICATION (affected lower back and left side going down left leg) and VACCINATION SITE PAIN (soreness in left arm and tenderness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications Senclanide 150mg twice a day. Patient discontinued testosterone shots because of his right leg was getting paralyzed after 2 doses and after 1st dose patient stated that he used cane due to problem with legs.That affected his lower back and a little bit in the left side going down his left leg.The patient side effects went away in 4-5 days. No treatment medications were reported.   This case was linked to MOD-2021-349075 (Patient Link).; Sender's Comments: This case concerns a male patient of unknown age with medical history of back surgery, who experienced the unexpected serious event of Monoplegia. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The rechallenge is positive since this event occurred after the first and second doses. The history of back surgery for unspecified indication remains a confounder considering that the underlying pathology may have contributed to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: Shoulder pain and stiffness in my the joint.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Underneath my Left Arm swelling and redness, itchy, elevated area for approximately one week after vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Blood alkaline phosphatase normal, Body temperature increased
Clinical narrative: Left arm pain, including down the left arm, the armpit, the upper left back, and left shoulder. Temp 101F oral. Elevated heart rate into the 130s. BP 140/100. All over body aches. Chills. Ice pic headache to the left temple. I went to the ER around 2pm Friday, 24 hours post vaccine. My temp spiked around 8pm Friday night to 101F oral. I had labs done. 2am on Saturday my temperature broke. I still have a sore left arm, and dull headache to the back of my head, and it?s Tuesday morning.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Lymphocyte count increased, Pain
Clinical narrative: Left arm pain, including down the left arm, the armpit, the upper left back, and left shoulder. Temp 101F oral. Elevated heart rate into the 130s. BP 140/100. All over body aches. Chills. Ice pic headache to the left temple. I went to the ER around 2pm Friday, 24 hours post vaccine. My temp spiked around 8pm Friday night to 101F oral. I had labs done. 2am on Saturday my temperature broke. I still have a sore left arm, and dull headache to the back of my head, and it?s Tuesday morning.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Prothrombin time prolonged
Clinical narrative: Left arm pain, including down the left arm, the armpit, the upper left back, and left shoulder. Temp 101F oral. Elevated heart rate into the 130s. BP 140/100. All over body aches. Chills. Ice pic headache to the left temple. I went to the ER around 2pm Friday, 24 hours post vaccine. My temp spiked around 8pm Friday night to 101F oral. I had labs done. 2am on Saturday my temperature broke. I still have a sore left arm, and dull headache to the back of my head, and it?s Tuesday morning.
Sex: U
Vaccine: COVID19
Symptoms: Dysphonia, Pain in extremity
Clinical narrative: my voice suddenly drops and I sound like a man; fingers hurting; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (my voice suddenly drops and I sound like a man) and PAIN IN EXTREMITY (fingers hurting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPHONIA (my voice suddenly drops and I sound like a man) and PAIN IN EXTREMITY (fingers hurting). At the time of the report, DYSPHONIA (my voice suddenly drops and I sound like a man) and PAIN IN EXTREMITY (fingers hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID and was vaccinated,; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID and was vaccinated,) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced COVID-19 (tested positive for COVID and was vaccinated,). At the time of the report, COVID-19 (tested positive for COVID and was vaccinated,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Oct-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided..  Per reporter its was unknown if patient had taken Pfizer's or Moderna.   No treatment information were provided.; Sender's Comments: This spontaneous report concerns an adult male patient with no medical history who experienced an unexpected non-serious AESI COVID-19. The event occurred after an unknown duration following vaccination with mRNA-1273. Re-challenge is not known due to lack of information about the doses. The outcome of the event is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose administered beyond 35 days; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days). On 10-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Non significant follow up On 11-Oct-2021: Non significant follow up
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: First 2 doses gave side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (First 2 doses gave side effects) 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 VACCINATION COMPLICATION (First 2 doses gave side effects). At the time of the report, VACCINATION COMPLICATION (First 2 doses gave side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications was reported. Treatment information was not provided.   This case was linked to MOD-2021-350562 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (first 2 doses gave side effects) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (first 2 doses gave side effects). At the time of the report, vaccination complication (first 2 doses gave side effects) outcome: unknown. No concomitant medication or treatment information reported. This case linked to MOD-2021-350487 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 patients were given doses that expired on Saturday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday) 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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 patients were given doses that expired on Saturday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Pruritus, Rash, Rash pruritic
Clinical narrative: Still itchy, faint pink rash; Itching,burning rash back on both sides; faint pink patches, no itching(almost normal); Swollen nodes on left side,also red itchy; Swollen nodes on left side,also red itchy; Swollen nodes on left side,also red itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Swollen nodes on left side,also red itchy), ERYTHEMA (Swollen nodes on left side,also red itchy), RASH PRURITIC (Itching,burning rash back on both sides), RASH PRURITIC (Still itchy, faint pink rash) and RASH (faint pink patches, no itching(almost normal)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives. Concurrent medical conditions included Allergy, Drug allergy (Amoxicillin allergy-patient experienced rash on torso, loss of sense of smell, burning feeling on soles of feet.) since 10-Mar-2013 and Hypothyroidism post ablative since 31-May-2018. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 05-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PRURITUS (Swollen nodes on left side,also red itchy), ERYTHEMA (Swollen nodes on left side,also red itchy) and LYMPHADENOPATHY (Swollen nodes on left side,also red itchy). On 21-Aug-2021, the patient experienced RASH (faint pink patches, no itching(almost normal)). On 14-Sep-2021, the patient experienced RASH PRURITIC (Itching,burning rash back on both sides). On 28-Sep-2021, the patient experienced RASH PRURITIC (Still itchy, faint pink rash). The patient was treated with HYDROCORTISONE (PROCTOZONE HC) from 06-Sep-2021 to 17-Sep-2021 for Itching, at a dose of UNK, qd. On 19-Mar-2021, PRURITUS (Swollen nodes on left side,also red itchy) was resolving, ERYTHEMA (Swollen nodes on left side,also red itchy) and LYMPHADENOPATHY (Swollen nodes on left side,also red itchy) had resolved. At the time of the report, RASH PRURITIC (Itching,burning rash back on both sides), RASH PRURITIC (Still itchy, faint pink rash) and RASH (faint pink patches, no itching(almost normal)) had not resolved.            This case was linked to MOD-2021-314641 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Dysphagia, Lymphadenopathy
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of BREAST PAIN (pain in breast), DYSPHAGIA (difficulty swallowing) and LYMPHADENOPATHY (pain in gland neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0N520A) for COVID-19 vaccination.     The patient's past medical history included Stroke (Deep in Skull,found in CT Scan) and Fusion lumbar spine on 20-Aug-2020. Concurrent medical conditions included Hypothyroidism (Under control with medication and blood work), Hodgkin's lymphoma, Latex allergy, Allergy to antibiotic (Bacitracin), Allergy to antibiotic (Biaxin/Septra), Drug allergy (Codeine), Drug allergy (Vicodin), Drug allergy (Elavil), Drug allergy (Ultram), Drug allergy (Morphine), Drug allergy (Fentanyl/HCL), Drug allergy (dilantin), Drug allergy (Darvon), Penicillin allergy, Drug allergy (Sulfa), Allergy to antibiotic (Neosporin), Allergy to antibiotic (Polysporin), Drug allergy (Oxycodone), Allergy to antibiotic (Clarithromycin), Drug allergy (Omeprazole), Allergy to antibiotic (Oxdrocodine), Drug allergy (Meperidine), Drug allergy (Phenytoin), Drug allergy (Tramadol), Gluten sensitivity and Drug allergy (Levofloxacin 500). Concomitant products included ONDANSETRON for Nausea, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 29-Mar-2015 to an unknown date, CLOPIDOGREL, METFORMIN from 09-Jan-2021 to an unknown date, KETOROLAC TROMETHAMINE (TORADOL), TEMAZEPAM (RESTORIL [TEMAZEPAM]), LORAZEPAM (LORAZEPAN), LEVOFLOXACIN (LEVAQUIN), CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]), HYDROXYZINE, HYDROXYZINE HYDROCHLORIDE (VISTARIL [HYDROXYZINE HYDROCHLORIDE]), MIDAZOLAM HYDROCHLORIDE (VERSED), LEVOFLOXACIN, KETOROLAC, FAMOTIDINE, CLINDAMYCIN, DEXAMETHASONE, MUPIROCIN, CEFIXIME (FLEXERIL [CEFIXIME]), METHYLPREDNISOLONE and AZITHROMYCIN for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced BREAST PAIN (pain in breast), DYSPHAGIA (difficulty swallowing) and LYMPHADENOPATHY (pain in gland neck). At the time of the report, BREAST PAIN (pain in breast), DYSPHAGIA (difficulty swallowing) and LYMPHADENOPATHY (pain in gland neck) 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.   This case was linked to MOD-2021-329115 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow up contains No New Information On 08-Oct-2021: Additional Information received and medical history was updated
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death and medically significant). The reported cause of death was Stroke. It is unknown if an autopsy was performed.            No concomitant medications information was reported.  No treatment medications were provided.  Patient had a stroke mid air and died.  Company comment: This case concerns a death of a male patient, of unknown age, with no medical history reported, who experienced the unexpected fetal event of cerebrovascular accident. The event occurred on an unknown date after a dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as event was fatal. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a death of a male patient, of unknown age, with no medical history reported, who experienced the unexpected fetal event of cerebrovascular accident. The event occurred on an unknown date after a dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as event was fatal. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Reported Cause(s) of Death: stroke
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Malaise, Pain in extremity
Clinical narrative: immediate loss of energy; sore arm; shaking; feeling completely depleted/feel worse; complete loss of appetite; had a low temp of 99 for a day and a half; fatigue; lost 22 lbs; This is a spontaneous report from a contactable other hcp (the patient, reported for self).  A 68-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL0142) single dose via an unspecified route of administration, administered in arm left on 05Jan2021 14:00 as for COVID-19 immunisation. Medical history included asthma, diabetes (Diabetes mellitus). Concomitant medication included metformin 500 mg, empagliflozin (JARDIANCE) 10 mg both taken for unspecified indications from unspecified dates. The patient did not have COVID prior vaccination. On 08Jan2021 14:00 three days after the event patient felt an immediate loss of energy, combined with a sore arm, shaking and feeling completely depleted. I went home and continued to feel worse, shaking, complete loss of appetite, and fatigue had a low temp of 99 for a day and a half. Continued to feel bad, staying in touch. Also lost 22 lbs. The patient did not tested COVID post vaccination. The outcome for all the events was recovered.  Follow-up attempts are completed. No further information is expected.