chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: CHILLS THAT WERE SHAKING HEAD AND COLD AND TEETH CHATTERING IN HEAD; FEELING VERY WEAK; POSSIBLE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-JUL-2021, the subject experienced chills that were shaking head and cold and teeth chattering in head. On 07-JUL-2021, the subject experienced feeling very weak. On 07-JUL-2021, the subject experienced possible fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills that were shaking head and cold and teeth chattering in head, feeling very weak, and possible fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: ARM PAIN; TINY HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced arm pain, and tiny headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiny headache and arm pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210717233.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Laboratory test, Pain, Pain in extremity
Clinical narrative: ACHY; CHILLS; FLU LIKE FEVERISH; MILD/SEVERE HEADACHE; SORE ARM; This spontaneous report received from a patient concerned a 90 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was in excellent health, exercises and eats vegetables.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, treatment medications included: acetylsalicylic acid, and naproxen sodium. On 05-MAY-2021, the subject experienced sore arm. On 05-MAY-2021, the subject experienced mild/severe headache. On 23-JUN-2021, the subject experienced achy. On 23-JUN-2021, the subject experienced chills. On 23-JUN-2021, the subject experienced flu like feverish. On 27-JUN-2021, Laboratory data included: Lab test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, chills, and flu like feverish, and sore arm on 12-MAY-2021, and had not recovered from mild/severe headache. This report was non-serious.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHY; CHILLS; FLU LIKE FEVERISH; MILD/SEVERE HEADACHE; SORE ARM; This spontaneous report received from a patient concerned a 90 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was in excellent health, exercises and eats vegetables.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, treatment medications included: acetylsalicylic acid, and naproxen sodium. On 05-MAY-2021, the subject experienced sore arm. On 05-MAY-2021, the subject experienced mild/severe headache. On 23-JUN-2021, the subject experienced achy. On 23-JUN-2021, the subject experienced chills. On 23-JUN-2021, the subject experienced flu like feverish. On 27-JUN-2021, Laboratory data included: Lab test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, chills, and flu like feverish, and sore arm on 12-MAY-2021, and had not recovered from mild/severe headache. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Rash
Clinical narrative: HYPERSENSITIVITY TO THE SUN; LIGHT RASHES ON ARM BILATERALLY; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient did not have pertinent medical history. The patient experienced hypersensitivity when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced hypersensitivity to the sun. On JUN-2021, the subject experienced light rashes on arm bilaterally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from light rashes on arm bilaterally, and hypersensitivity to the sun. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Discomfort
Clinical narrative: BRUISE ON FINGER; GENERAL DISCOMFORT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported.  On 06-JUL-2021, the subject experienced general discomfort. On an unspecified date, the subject experienced bruise on finger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general discomfort on 07-JUL-2021, and the outcome of bruise on finger was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ADMINISTERED AFTER THE SIX (6) HOUR EXPIRY WINDOW; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine administered after the six (6) hour expiry window. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after the six (6) hour expiry window was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Injection site bruising
Clinical narrative: STARTED TO FEEL LIKE SOMEONE IS STANDING ON MY STOMACH IN THE MORNING/HE THOUGHT HE WAS CONSTIPATED/ PAIN THEN STARTED TO MOVE FROM THE LEFT SIDE THEN IN HIS BACK; BLACK AND  BLUE AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's past medical history included liver transplant, and concurrent conditions included diabetes, and spider bite. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUL-2021, the subject experienced black and blue at the injection site. On 06-JUL-2021, the subject experienced started to feel like someone is standing on my stomach in the morning/he thought he was constipated/ pain then started to move from the left side then in his back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from black and blue at the injection site on JUL-2021, and had not recovered from started to feel like someone is standing on my stomach in the morning/he thought he was constipated/ pain then started to move from the left side then in his back. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA/ STOOLS MOSTLY  WATERY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cancer.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-JUL-2021, the subject experienced diarrhea/ stools mostly watery. Treatment medications included: loperamide hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diarrhea/ stools mostly watery was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: RED DOT ON ONE LEG AND BECAME LARGER OVER TWO DAYS; DOT WAS PAINFUL WHEN WATER HIT IT UPON SHOWERING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced red dot on one leg and became larger over two days, and dot was painful when water hit it upon showering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the red dot on one leg and became larger over two days and dot was painful when water hit it upon showering was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: PERSISTENT HEADACHES IN THE BACK OF THE HEAD, ON TOP OF THE NECK AND BEHIND THE EARS; PAIN AT THE SITE OF INJECTION FOR 2 DAYS; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 24A21A, expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced pain at the site of injection for 2 days. On JUN-2021, the subject experienced persistent headaches in the back of the head, on top of the neck and behind the ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at the site of injection for 2 days on 30-MAY-2021, and had not recovered from persistent headaches in the back of the head, on top of the neck and behind the ears. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain in extremity
Clinical narrative: LETHARGY; PAIN IN ARM; HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 02-JUL-2021 18:30 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced pain in arm. On 02-JUL-2021, the subject experienced headache. On 03-JUL-2021, the subject experienced lethargy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, lethargy, and pain in arm. This report was non-serious. This case, from the same reporter is linked to 20210710122.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Sars-CoV-2; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Sars-CoV-2) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Sars-CoV-2) (seriousness criterion medically significant). The patient was treated with BAMLANIVIMAB for COVID-19, at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Sars-CoV-2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     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 relevant concomitant medications were reported.   The patient was scheduled to receive his 2nd dose of vaccine on 16 Feb 2021.  Based on the mechanism of action of mRNA-1273 causal association between the event of SARS-CoV-2 positive test and mRNA-1273 is assessed as not applicable.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of SARS-CoV-2 positive test and mRNA-1273 is assessed as not applicable.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: advice to wait 90 days before receiving the second dose; came down with covid-19; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (came down with covid-19) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Knee pain (knee hurts after jogging). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Knee pain, VITAMINS NOS for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced COVID-19 (came down with covid-19). On 04-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (advice to wait 90 days before receiving the second dose). On 04-Mar-2021, PRODUCT DOSE OMISSION ISSUE (advice to wait 90 days before receiving the second dose) had resolved. At the time of the report, COVID-19 (came down with covid-19) outcome was unknown. Not Provided      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.   On 04MAR2021 the patient had taken monoclonal antibodies to treat COVID-19 infection and was told to wait 90 days before receiving the second planned dose.; Sender's Comments: An alternative explanation is that based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 and mRNA-1273 is assessed as not applicable.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Cough, Flushing, Nausea, Swelling face
Clinical narrative: Anaphylaxis; Swelling of the face; Facial flushing; Nausea; Facial flushing; Facial swelling; Cough; This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis (treated with Ocrevus has polysorbate as an ingredient.). Concomitant products included OCRELIZUMAB (OCREVUS) for Multiple sclerosis, AMITRIPTYLINE and BACLOFEN for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced the first episode of FLUSHING (Facial flushing), SWELLING FACE (Facial swelling), COUGH (Cough) and NAUSEA (Nausea). On 13-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant), SWELLING FACE (Swelling of the face) and the second episode of FLUSHING (Facial flushing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Facial flushing, Swelling, Cough and Nausea, at a dose of 1 dosage form and EPINEPHRINE for Anaphylaxis, at a dose of 1 dosage form. On 12-Mar-2021, SWELLING FACE (Facial swelling), COUGH (Cough) and NAUSEA (Nausea) had resolved. At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis), SWELLING FACE (Swelling of the face) and the last episode of FLUSHING (Facial flushing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated with for Multiple sclerosis that has polysorbate as an ingredient. She had a theory that there was some sort of cross-reactivity between the polysorbate in the Ocreubus and the PEG in the Moderna COVID-19 vaccine that caused this reaction.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non-Significant Follow-Up Appended; Sender's Comments: This case concerns a 37-year-old female with a serious expected event of anaphylactic reaction, and nonserious swelling face, cough, nausea, and flushing. Event onset 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Immobile, Pain
Clinical narrative: immobility; tremendous pain; This spontaneous case was reported by a consumer and describes the occurrence of IMMOBILE (immobility) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (The patient had a history of bodily operations(did not specify) over his lifetime and had to use his cane due to pain and immobility.).    On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced IMMOBILE (immobility) (seriousness criterion medically significant) and PAIN (tremendous pain). At the time of the report, IMMOBILE (immobility) and PAIN (tremendous pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The treatment medication were not provided..  Patient is on blood pressure and cholesterol medications but refused to name them.   This case was linked to MOD-2021-081489 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Syncope
Clinical narrative: syncope; blood pressures issues; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (syncope) and BLOOD PRESSURE ABNORMAL (blood pressures issues) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 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 SYNCOPE (syncope) (seriousness criteria hospitalization and medically significant) and BLOOD PRESSURE ABNORMAL (blood pressures issues) (seriousness criterion hospitalization). At the time of the report, SYNCOPE (syncope) and BLOOD PRESSURE ABNORMAL (blood pressures issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Patient did not get the 2nd dose of the Moderna vaccine because she experienced blood pressure issues that resulted in Hospitalization two separate occasions; once on the Sunday after the vaccine and then the following Wednesday after the vaccine. Caller states, "I feel very afraid of the 2nd shot. I was afraid to get the 2nd shot because of the bad experience with the 1st one. She passed out 2 times, son had to call 911."  Treatment information was not provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Case upgraded case to serious. Added event of syncope; hospitalization.; 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: hearing loss at high frequencies; developed ringing sensation in both ears/Tinnitus symptom is still persisting; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss at high frequencies) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included ALLOPURINOL from 01-Jan-2015 to an unknown date for Gout.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced TINNITUS (developed ringing sensation in both ears/Tinnitus symptom is still persisting). On an unknown date, the patient experienced DEAFNESS (hearing loss at high frequencies) (seriousness criterion medically significant). At the time of the report, DEAFNESS (hearing loss at high frequencies) and TINNITUS (developed ringing sensation in both ears/Tinnitus symptom is still persisting) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported.  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.       Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up received contains information about developed ringing sensation in both ears/Tinnitus symptom is still persisting, sore arm injection site :Case upgraded to Serious.; 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Pain in extremity, Thrombosis, X-ray
Clinical narrative: Blood clot on leg; lump on leg; Very painful lump; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clot on leg) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot on leg) (seriousness criterion medically significant), LIMB MASS (lump on leg) and PAIN IN EXTREMITY (Very painful lump). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clot on leg), LIMB MASS (lump on leg) and PAIN IN EXTREMITY (Very painful lump) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) a clot in her leg.     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. Patient was currently on a blood thinner medication.  This case concerns a 75-year-old female with a serious unexpected event of thrombosis, and nonserious limb mass and pain in extremity. Event onset with unknown latency after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up information received on 01-JUL-2021: Email address of primary reporter added, additional reporter added, vaccination facility updated. On 06-Jul-2021: Significant follow-up received - Case upgraded to serious; Sender's Comments: This case concerns a 75-year-old female with a serious unexpected event of thrombosis, and nonserious limb mass and pain in extremity. Event onset with unknown latency after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Headache, Major depression, Myalgia
Clinical narrative: Depression; Major depressive disorder; Felt painful and a little bit sour on the left arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of MAJOR DEPRESSION (Major depressive disorder), DEPRESSION (Depression) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was not reported.  Concurrent medical conditions included Penicillin allergy, Depression (major depressive disorder) and Psychosis. Concomitant products included ZOLPIDEM for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced DEPRESSION (Depression) (seriousness criterion hospitalization). On 28-Apr-2021, the patient experienced MAJOR DEPRESSION (Major depressive disorder) (seriousness criteria hospitalization and medically significant) and HEADACHE (headache) (seriousness criterion hospitalization). On an unknown date, the patient experienced MYALGIA (Felt painful and a little bit sour on the left arm). The patient was hospitalized from 28-Apr-2021 to 30-Apr-2021 due to DEPRESSION and HEADACHE, and then from 30-Apr-2021 to 14-May-2021 due to MAJOR DEPRESSION. The patient was treated with FLUOXETINE HCL at a dose of 20 mg; OLANZAPINE at a dose of 10 mg once a day; TRAZODONE ongoing since an unknown date at a dose of 50 mg once a day and PAROXETINE (oral) from 05-Apr-2021 to 28-Apr-2021 for Depression, at a dose of UNK, qd. At the time of the report, MAJOR DEPRESSION (Major depressive disorder) had not resolved and DEPRESSION (Depression), HEADACHE (headache) and MYALGIA (Felt painful and a little bit sour on the left arm) had resolved.            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   This case was linked to MOD-2021-221026 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received on 05 JUL 2021 and Contains was updated patient details, vaccine details, and additional narrative information.; 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: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Death, Myalgia
Clinical narrative: passed away; dry, persistent cough; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), UBIDECARENONE (COQ10 [UBIDECARENONE]), LISINOPRIL, METOPROLOL TARTRATE and OMEPRAZOLE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced COUGH (dry, persistent cough) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, COUGH (dry, persistent cough) and MYALGIA (Body aches) had not resolved.            This a case of death in 81-year-old male patient who received mRNA-1273. Very limited information regarding death (cause unknown) has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the events cough and myalgia, a causal relationship cannot be excluded.  The event myalgia is consistent with the safety profile of the product.   This case was linked to MOD-2021-060909 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Contains patient death information.  Case upgraded to serious.; Sender's Comments: This a case of death in 81-year-old male patient who received mRNA-1273. Very limited information regarding death (cause unknown) has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the events cough and myalgia, a causal relationship cannot be excluded.  The event myalgia is consistent with the safety profile of the product.; Reported Cause(s) of Death: unknown cause of death
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Dizziness, Gait disturbance, Myalgia, Vaccination site rash
Clinical narrative: I seem to have had allergic reaction or some type of reaction to the Moderno second vaccine; Vertigo; 80% loss of hearing in the left ear; walking to the right with a lean; Very dizzy; Small rash on the injection arm; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (80% loss of hearing in the left ear) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included AMMONIUM CHLORIDE, MENTHOL (ROMEX) and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE RASH (Small rash on the injection arm) and MYALGIA (Soreness). On 24-Apr-2021, the patient experienced DIZZINESS (Very dizzy). On 25-Apr-2021, the patient experienced DEAFNESS UNILATERAL (80% loss of hearing in the left ear) (seriousness criterion medically significant) and GAIT DISTURBANCE (walking to the right with a lean). On 27-Apr-2021, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced VACCINATION SITE REACTION (I seem to have had allergic reaction or some type of reaction to the Moderno second vaccine). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at an unspecified dose and frequency. At the time of the report, DEAFNESS UNILATERAL (80% loss of hearing in the left ear) had not resolved and VERTIGO (Vertigo), VACCINATION SITE REACTION (I seem to have had allergic reaction or some type of reaction to the Moderno second vaccine), DIZZINESS (Very dizzy), GAIT DISTURBANCE (walking to the right with a lean), VACCINATION SITE RASH (Small rash on the injection arm) and MYALGIA (Soreness) had resolved.            The treatment information include steroid pills.  It was reported that, 2 MRIs were scheduled for the patient.  Very limited information regarding this event has been provided at this time   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Reporter information, patient information, second dose information and events (vaccination site rash, myalgia, dizziness, deafness unilateral, gait disturbance) were added.; Sender's Comments: Very limited information regarding this event has been provided at this time
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vertigo
Clinical narrative: I seem to have had allergic reaction or some type of reaction to the Moderno second vaccine; Vertigo; 80% loss of hearing in the left ear; walking to the right with a lean; Very dizzy; Small rash on the injection arm; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (80% loss of hearing in the left ear) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included AMMONIUM CHLORIDE, MENTHOL (ROMEX) and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE RASH (Small rash on the injection arm) and MYALGIA (Soreness). On 24-Apr-2021, the patient experienced DIZZINESS (Very dizzy). On 25-Apr-2021, the patient experienced DEAFNESS UNILATERAL (80% loss of hearing in the left ear) (seriousness criterion medically significant) and GAIT DISTURBANCE (walking to the right with a lean). On 27-Apr-2021, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced VACCINATION SITE REACTION (I seem to have had allergic reaction or some type of reaction to the Moderno second vaccine). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at an unspecified dose and frequency. At the time of the report, DEAFNESS UNILATERAL (80% loss of hearing in the left ear) had not resolved and VERTIGO (Vertigo), VACCINATION SITE REACTION (I seem to have had allergic reaction or some type of reaction to the Moderno second vaccine), DIZZINESS (Very dizzy), GAIT DISTURBANCE (walking to the right with a lean), VACCINATION SITE RASH (Small rash on the injection arm) and MYALGIA (Soreness) had resolved.            The treatment information include steroid pills.  It was reported that, 2 MRIs were scheduled for the patient.  Very limited information regarding this event has been provided at this time   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Reporter information, patient information, second dose information and events (vaccination site rash, myalgia, dizziness, deafness unilateral, gait disturbance) were added.; Sender's Comments: Very limited information regarding this event has been provided at this time
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Afib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021M20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-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 ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Afib) outcome was unknown.            No concomitant medication information was mentioned.  The caller stated that her husband developed atrial fibrillation (AFib) on an unspecified date after he received the Moderna vaccine. He did not have Afib prior to the vaccine.  Additional information was mentioned patient had developed AFib after receiving the moderna vaccine and has never had that before.  No treatment medication information was mentioned.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-244769 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Haemorrhage, Peripheral swelling, Skin discolouration
Clinical narrative: It was an hemorrhage with broken veins; He had his right feet hot, swelling and purple; He had his right feet hot, swelling and purple; He had his right feet hot, swelling and purple; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (It was an hemorrhage with broken veins), FEELING HOT (He had his right feet hot, swelling and purple), PERIPHERAL SWELLING (He had his right feet hot, swelling and purple) and SKIN DISCOLOURATION (He had his right feet hot, swelling and purple) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    In April 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (It was an hemorrhage with broken veins) (seriousness criteria hospitalization and medically significant), FEELING HOT (He had his right feet hot, swelling and purple) (seriousness criterion hospitalization), PERIPHERAL SWELLING (He had his right feet hot, swelling and purple) (seriousness criterion hospitalization) and SKIN DISCOLOURATION (He had his right feet hot, swelling and purple) (seriousness criterion hospitalization). At the time of the report, HAEMORRHAGE (It was an hemorrhage with broken veins), FEELING HOT (He had his right feet hot, swelling and purple), PERIPHERAL SWELLING (He had his right feet hot, swelling and purple) and SKIN DISCOLOURATION (He had his right feet hot, swelling and purple) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient went to the hospital and was told that it was an hemorrhage due to broken veins and did not have clots.  Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and 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 events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (blood clots) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided Treatment for the event was not provided.  Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: lost vision in one eye after 1st dose; This spontaneous case was reported by a non-health professional and describes the occurrence of BLINDNESS (lost vision in one eye after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 BLINDNESS (lost vision in one eye after 1st dose) (seriousness criterion medically significant). At the time of the report, BLINDNESS (lost vision in one eye after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was provided.  No treatment information was provided.  Very limited information regarding the event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Feeling abnormal, Hypersensitivity, Pharyngeal swelling
Clinical narrative: Allergic Reaction; Tongue and throat swelled; Tongue and throat swelled; Feeling odd; Shortness of breath/not breathing as normal; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (Allergic Reaction), SWOLLEN TONGUE (Tongue and throat swelled) and PHARYNGEAL SWELLING (Tongue and throat swelled) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. B04021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history was reported by reporter.  Concomitant products included THIAMINE (VITAMIN B1 [THIAMINE]) for an unknown indication.    On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jul-2021, the patient experienced HYPERSENSITIVITY (Allergic Reaction) (seriousness criterion hospitalization), SWOLLEN TONGUE (Tongue and throat swelled) (seriousness criterion hospitalization) and PHARYNGEAL SWELLING (Tongue and throat swelled) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling odd) and DYSPNOEA (Shortness of breath/not breathing as normal). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic Reaction), SWOLLEN TONGUE (Tongue and throat swelled), PHARYNGEAL SWELLING (Tongue and throat swelled) and FEELING ABNORMAL (Feeling odd) outcome was unknown and DYSPNOEA (Shortness of breath/not breathing as normal) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2021, Blood pressure measurement: 147 (High) Blood pressure 147 high.     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.   Patient was suffered with Shortness of breath ,  feeling better. patient  doesn't have a main doctor but provides information of the hospital and Doctor that treat his allergic reaction after taking the vaccine, gives consent to safety follow up.  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.