chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: HEMATOMA BELOW INJECTION SITE; SORE ARM; VIAL WAS SHAKEN BY VACCINE PROVIDER; LOWER BACK PAIN; FATIGUE; MUSCULAR PAIN; This spontaneous report received from a patient concerned a 49 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced lower back pain. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced muscular pain. On 06-AUG-2021, the patient experienced vial was shaken by vaccine provider. On 06-AUG-2021, the patient experienced sore arm. On 10-AUG-2021, the patient experienced hematoma below injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial was shaken by vaccine provider, fatigue, lower back pain, muscular pain, hematoma below injection site and sore arm was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: VOMITING (VOMITED TWICE); NAUSEA; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to cipro, fibromyalgia, and trigeminal neuralgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-AUG-2021, the patient experienced vomiting (vomited twice). On 10-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and vomiting (vomited twice). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Drooling, Periarthritis
Clinical narrative: DEAD SHOULDER; SOME DROOLING IN FACE; This spontaneous report received from a patient via a company representative 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 patient experienced dead shoulder, and some drooling in face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dead shoulder and some drooling in face was not reported. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort
Clinical narrative: HEAVINESS IN ONE LEG; NUMBNESS IN HER TOES ON ONE SIDE; This spontaneous report received from a pharmacist concerned a 23 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: 205A21A, expiry: 18-SEP-2021) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced heaviness in one leg. On AUG-2021, the patient experienced numbness in her toes on one side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heaviness in one leg and numbness in her toes on one side was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Product leakage, Underdose
Clinical narrative: VACCINE LEAKED OUT DURING ADMINISTRATION; PARTIAL DOSE ADMINISTERED; 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 not reported, batch number: Unknown) 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 patient experienced vaccine leaked out during administration, and partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine leaked out during administration and partial dose administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: SORE GLAND IN ARMPIT, JUST AT THE TOP OF LEFT BREAST; SWOLLEN GLAND IN ARMPIT, JUST AT THE TOP OF LEFT BREAST; 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, intramuscular, batch number: unknown) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-AUG-2021, the patient experienced sore gland in armpit, just at the top of left breast. On 10-AUG-2021, the patient experienced swollen gland in armpit, just at the top of left breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore gland in armpit, just at the top of left breast and swollen gland in armpit, just at the top of left breast was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rash, Scar, Urticaria
Clinical narrative: COVID INFECTION AFTER VACCINATION(DELTA VARIANT); SLIGHT SCARRING UNDER ARMS AND CHEST; STINGING BURNING RASH OF ABOUT 1000 BUMPS LIKE A BABY'S HEAT RASH ON THE FRONT OF CHEST AND UNDER ARMS; ITCHING RASHES OF ABOUT 1000 BUMPS AND BIGGER HIVES ON BACK SHOULDERS AND BACK; This spontaneous report received from a patient via a company representative concerned an adult 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: Unknown) 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 patient experienced covid infection after vaccination (delta variant), slight scarring under arms and chest, stinging burning rash of about 1000 bumps like a baby's heat rash on the front of chest and under arms, and itching rashes of about 1000 bumps and bigger hives on back shoulders and back. Treatment medications (dates unspecified) included: calamine, and diphenhydramine citrate/pseudoephedrine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging burning rash of about 1000 bumps like a baby's heat rash on the front of chest and under arms, and itching rashes of about 1000 bumps and bigger hives on back shoulders and back, and the outcome of covid infection after vaccination(delta variant) and slight scarring under arms and chest was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: REDNESS (CIRCULAR, SIZE OF A NICKEL IN RADIUS) ON THE LEFT ARM JUST BELOW THE INJECTION SITE AND IT LOOKS LIKE A MOSQUITO BITE; ITCHY REDNESS ON THE LEFT ARM; This spontaneous report received from a patient concerned a 75 year old male. The patient's weight was 155 pounds, and height was 67 inches. 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-AUG-2021, the patient experienced redness (circular, size of a nickel in radius) on the left arm just below the injection site and it looks like a mosquito bite. On 03-AUG-2021, the patient experienced itchy redness on the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness (circular, size of a nickel in radius) on the left arm just below the injection site and it looks like a mosquito bite, and itchy redness on the left arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: BRUISING ON LEGS AND ARMS; This spontaneous report received from a consumer 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: unknown) 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 patient experienced bruising on legs and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruising on legs and arms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, SARS-CoV-2 test
Clinical narrative: FLU LIKE SYMPTOMS (COUGH AND CONGESTION); 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: kidney disease, and macular degeneration. 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 patient experienced flu like symptoms (cough and congestion). Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms (cough and congestion). This report was non-serious. This case, involving the same patient is linked to 20210648086.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Throat irritation
Clinical narrative: Felt faint; Throat itchiness; A report was received from a non-health care professional and experienced throat itchiness and felt faint.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 22 Dec 2020. On 22 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the patient felt faint and had throat itchiness. Treatment for the events included diphenhydramine hydrochloride and the events went away.   Action taken with mRNA-1273 in response to the events was not reported.   The events, felt faint and throat itchiness, were considered resolved on 22 Dec 2020.  The reporter did not provide an assessment for the events, felt faint and throat itchiness.; Reporter's Comments: This case concerns a subject, who experienced the unlisted events of dizziness and throat irritation. The events occurred on the same day after first dose of IP on 22 DEC 2020. The event was considered resolved on 22 DEC 2020. The events were considered related to IP due to temporal association. However, further details are requested to better assess the case.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness in arm of injection; A spontaneous report was received from a non-health care professional concerning a 27 year old, male patient who experienced, soreness in arm of injection.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    Prior to the onset of the symptom, on 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient reported the event, soreness in arm of injection, on 23 Dec 2020 at 9:30 am.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event, soreness in arm of injection, was not reported.   The outcome of the event, was not reported.   The reporter did not provide assessments for the event, soreness in arm of injection.; Reporter's Comments: This case concerns a  27 year old male patient. The patient's medical history is not provided. The patient experienced an expected event of soreness in arm of injection. The event occurred on 23 Dec 2020, 1 day after  the first dose of mRNA-1273. The sponsor assessed the event as possibly related to the mRNA-1273 vaccine. Pain at the site of injection is listed on the company's fact sheet for the healthcare providers.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Throat irritation
Clinical narrative: Scratchy throat; Swelling in the back of the throat; A spontaneous report was received from a healthcare professional concerning a 47-years-old, female patient and who experienced scratchy throat and swelling in the back of throat.   The patient's medical history was not provided. Concomitant medications were not provided.   On 21 Dec 2020,  the patient received their first of two planned doses of mRNA-1273 (lot# 011-J208) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The healthcare professional reported that 20 minutes after administering mRNA-1273 to the patient in the left arm on 21 Dec 2020, the patient experienced a scratchy throat and swelling in the back of the throat.  The patient was a health care professional herself and took diphenhydramine hydrochloride (Benadryl), which caused the symptoms to subside but not completely resolve.  Action taken with mRNA-1273 in response to the events was unknown.  The events, scratchy throat and swelling in the back of the throat, were considered resolving.  The reporter did not provide an assessment of causality for the events, scratchy throat and swelling in the back of the throat.; Reporter's Comments: This case concerns a 47 year old female subject, who experienced the unlisted events of throat irritation and pharyngeal swelling.  The events occurred on 21 DEC 2020,  20 minutes after first dose of IP. The events were treated with diphenhydramine hydrochloride (Benadryl) and was considered resolving. The events were considered related to IP due to temporal association. However, further clarifications are requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Fever; Chills; A spontaneous/solicited report was received from a consumer concerning a female patient and who experienced fever and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 21 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the shoulder for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the patient experienced fever and chills. Her temperature reached 101.7 degrees Fahrenheit. Treatment for the event included paracetamol; after taking paracetamol her temperature decreased to 100.6 degrees Fahrenheit, and her chills subsided.  Action taken with mRNA-1273 in response to the events was not reported.   The event, fever, was considered not resolved. The event, chills, was considered resolved on 22 Dec 2020.   The reporter did not provide a causality assessment for the events, fever and chills, to study drug.; Reporter's Comments: Company Comment: This case concerns a consumer report of a female patient who experienced a listed events of fever and chills per EUA fact sheet. The events occurred 2 days after the first dose of vaccine administration.. Company causality assessed as possibly related.
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypersensitivity, Joint stiffness, Migraine, Pain
Clinical narrative: Migraine; Joint stiffness; Skin feels hypersensitive especially at injection site; Body aches; A spontaneous report was received from a nurse concerning a 25-years-old, white, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced multiple events of migraine, body aches, joint stiffness and skin feels hypersensitive at injection site.  The patient's medical history as provided by the reporter, included COVID-19 and allergy to amoxicillin/ clavulanic acid. Concomitant medications reported included fish oil, colecalciferol, cetirizine hydrochloride and vitamins.   On 23 Dec 2020, approximately sixteen hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot number: 011J20A) intramuscularly in the left arm for COVID-19 prophylaxis.  On 24 Dec 2020, the patient experienced migraine, body aches, joint stiffness and injection site hypersensitivity. The treatment for the events included paracetamol, and the symptoms improved.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, migraine, body aches, joint stiffness and skin feels hypersensitive at injection site, were unknown.; Reporter's Comments: This case concerns a 25-years-old, white, female patient who received their first of two planned doses of mRNA-1273 (Lot-# 011J20A; expiration date- unknown), reporting an unexpected event of migraine, joint stiffness, injection site hypersensitivity and an expected event of pain (body aches).  The event occurred 15 hrs. 52 min after vaccine administration. Due to the temporal association between the onset of events and administration of vaccine, a causal relationship cannot be excluded.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Neck pain, Pain
Clinical narrative: Sore in neck and lower back; Sore in neck and lower back; Body aches; Lightheaded; Fatigue; A spontaneous report was received from a nurse concerning a 29  year old, male patient  was participating in the mRNA-1273 Emergency use  program and experienced sore in neck and lower back, body aches, lightheaded and fatigue.  The patients medical history included allergy to orange juice and COVID-19 positive. Concomitant medications included fluoxetine, trazodone and amphetamine/dextroamphetamine .  On 23 Dec 2020, 15-20 minutes prior to the onset of sore in neck and lower back pain, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. A few hours later he experienced body aches,lightheaded and fatigue . No treatment information was provided.   Action taken with mRNA-1273 in response to events, sore in neck and lower back, body aches,lightheaded, and fatigue was unknown.  The  events were considered not recovered as of 24DEC2020.; Reporter's Comments: This case concerns a 29 year old male patient who experienced non-serious unexpected events of Neck pain, Back pain, Pain, and Dizziness, and a non-serious expected event of Fatigue. The events of Neck pain and Back pain occurred 15-20 minutes after first dose of mRNA-1273 administration. The events of Pain, Dizziness, and Fatigue occurred a few hours after first dose of mRNA-1273 administration. Very limited information regarding this events has been provided at this time.  Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site pain, Pain, Pyrexia
Clinical narrative: body aches; low grade fever of 100.6 degrees Fahrenheit; sore injection site; A spontaneous report was received from a 45-year-old, female consumer who was a nurse. The patient was participating in the mRNA-1273 Emergency Use Program and experienced the events of sore injection site, body aches and low-grade fever of 100.6 degrees Fahrenheit.   The patient's medical history included COVID-19. No concomitant medications were reported.  Prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (lot #011J20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection on 22 Dec 2020.   On 22 Dec 2020, the patient experienced sore injection site.  On 23 Dec 2020, the patient experienced body aches and low-grade fever of 100.6 degrees Fahrenheit. No other side effects were reported. Treatment for the events included, paracetamol and naproxen.   The action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, sore injection site, body aches and low-grade fever of 100.6 degrees Fahrenheit were unknown.  The reporter did not provide any assessment for the events.; Reporter's Comments: This case concerns a 45-year-old female patient with a medical history of COVID-19, who experienced the events of Pain, Injection site pain, and Pyrexia. Injection site pain occurred on the same day when the first dose of mRNA-1273 vaccine was administered. Pain and Pyrexia occurred the day after the first dose of mRNA-1273 vaccine. Based on the temporal association, the events are assessed as possibly related to mRNA-1273 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Feeling of body temperature change, Heart rate increased, Hypersomnia
Clinical narrative: Hyper somnolent; Confused; Rapid heart rate; Hot and cold off and on; A spontaneous report was received from a physician concerning a female patient of unknown age, race who received Moderna's COVID-19 vaccine and experienced hyper somnolent, confused, rapid heart rate and hot and cold off and on.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 22 Dec 2020, approximately 30 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot # 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Dec 2020, within 30 minutes of receiving the vaccine, the patient began to experience feeling hot and cold intermittently, became hyper somnolent, confused, and had a rapid heart rate.  911 was called, but she did not go to the hospital. No treatment information was provided.  On 23 Dec 2020, she was better.   Action taken with mRNA-1273 in response to the events was not reported.   The events, hyper somnolent, confused, rapid heart rate and hot and cold off and on, were resolved on 23 Dec 2020.   The reporter assessed the events hyper somnolent, confused, rapid heart rate and hot and cold off and on as related to study drug.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot 025J20-2A), and who experienced the unlisted events of Hypersomnia, Confusional state, Heart rate increased, and  Feeling of body temperature change. The events were considered possibly related to the vaccine due to the temporal relationship and in agreement with the physician reporter.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Injection site rash
Clinical narrative: Feeling lousy; 3x3 rash on left arm right above injection site; Diarrhea; A report was received from a nurse, also a 59-year old female patient who was participating in the mRNA-1273 a Program and experienced feeling lousy, 3x3 rash on left arm right above injection site, and diarrhea.   The patient's medical history was not provided. Concomitant medications included acetylsalicylic acid, diltiazem, sitagliptin phosphate, escitalopram oxalate, esomeprazole sodium, simvastatin, ezetimibe and losartan potassium.   The patient received their first dose of two planned doses of mRNA-1273 on 22 Dec 2020. On 22 Dec 2020, one day prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot 011I-20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient woke up feeling lousy with diarrhea and a 3x3 rash on her left arm above the injection site that was not itchy, spreading, or getting bigger. No treatment was taken.    Action taken with mRNA-1273 in response to the event was unknown.   The outcomes for the events, feeling lousy, 3x3 rash on left arm right above injection site, and diarrhea, were not reported.   The reporter did not provide an assessment for the events, feeling lousy, 3x3 rash on left arm right above injection site, or diarrhea.; Reporter's Comments: This case concerns a 59 year old female patient with medical history not reported, who experienced the unlisted events of feeling abnormal, injection site rash, and diarrhea.  The events occurred 2 days after the first dose of mRNA-1273 vaccine.  The events were considered possibly related to the vaccine due to the plausible temporal relationship and known safety profile.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Rash
Clinical narrative: diarrhea; Feeling lousy; 3x3 rash on left arm right above the injection site; A spontaneous report was received from a consumer concerning a 59-year old, female patient who is a nurse and experienced feeling lousy, 3x3 rash on left arm right above injection site, and diarrhea.   The patient's medical history was not provided. Concomitant medications reported included acetylsalicylic acid, diltiazem, sitagliptin, escitalopram oxalate, esomeprazole magnesium, simvastatin, ezetimibe, and losartan potassium.   The patient received their first of two planned doses of mRNA-1273 (lot #011I-20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection on 22 Dec 2020.    On 23 Dec 2020, the patient reported waking up feeling lousy, with diarrhea, and a 3x3 rash on her left arm above the inject site that was not itchy, spreading or getting bigger. No treatment was given in response to the events.    Action taken with mRNA-1273 in response to the events was unknown.    The outcome for the events, feeling lousy, 3x3 rash on left arm right above injection site, and diarrhea, were unknown.   The reporter did not provide an assessment for the events, feeling lousy, 3x3 rash on left arm right above injection site, or diarrhea.; Reporter's Comments: This case concerns a 59 year old female patient , who experienced the unlisted event of  diarrhea and the listed events of feeling lousy and a 3x3 rash on her left arm above  The events occurred  one day after first dose of IP. No action was informed regarding the second dose of IP.  The reporter did not provide event´s outcome or causality assessment regarding the IP. The event was considered related to the event due to temporal association. Further details are requested to reporter.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling; Numbness; A spontaneous report was received from a 47-year-old female patient who is a nurse and received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, tingling and numbness.  The patient's medical history was not provided. Concomitant medications were not reported.  On 23 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number:039K20-2A) in her left deltoid muscle for prophylaxis of COVID-19 infection. She experienced tingling and numbness on left side of her face 30 minutes after the injection and was still experiencing the event at the time of reporting.  Treatment for the events was not reported.  Action taken with mRNA-1273 vaccine in response to the events was not provided.  The events, tingling and numbness, were considered not resolved.; Reporter's Comments: This case concerns a 47-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 039K20-2A), and who experienced the unlisted events of tingling and numbness.  The events were considered possibly related to the vaccine due to the temporal relationship.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Dysstasia, Fatigue, Feeding disorder, Feeling abnormal
Clinical narrative: Feeling bad; Out of it; Soreness of left arm; Drenched in sweat; Fatigue; Aches; Could not get out of bed; Could not eat; Could not stand up; A spontaneous report was received from a consumer of age 25-year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple event(s) of feeling bad, out of it, soreness of left arm, drenched in sweat, fatigue, aches, could not get out of bed, could not eat and could not stand up.  The patient's medical history included COVID-19. No concomitant medications were reported.  On 23 Dec 2020 at 17:19pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037R-20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020, the patient experienced feeling bad, out of it, soreness of left arm, drenched in sweat, fatigue, aches, could not get out of bed, could not eat and could not stand up. Treatment for the event(s) included, Tylenol and the symptoms were ongoing but seemed better.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event(s) feeling bad, out of it, soreness of left arm, drenched in sweat, fatigue, aches, could not get out of bed, could not eat and could not stand up were considered as resolving.; Reporter's Comments: This case concerns a 74-year-old female with PMH of COVID-19 who had NS unexpected events of pain, pain in extremity, feeling abnormal, hyperhidrosis, feeding disorder, dysstasia, and bedridden and NS expected fatigue.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment included Tylenol. Events resolving. 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: Feeling bad; Out of it; Soreness of left arm; Drenched in sweat; Fatigue; Aches; Could not get out of bed; Could not eat; Could not stand up; A spontaneous report was received from a consumer of age 25-year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple event(s) of feeling bad, out of it, soreness of left arm, drenched in sweat, fatigue, aches, could not get out of bed, could not eat and could not stand up.  The patient's medical history included COVID-19. No concomitant medications were reported.  On 23 Dec 2020 at 17:19pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037R-20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020, the patient experienced feeling bad, out of it, soreness of left arm, drenched in sweat, fatigue, aches, could not get out of bed, could not eat and could not stand up. Treatment for the event(s) included, Tylenol and the symptoms were ongoing but seemed better.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event(s) feeling bad, out of it, soreness of left arm, drenched in sweat, fatigue, aches, could not get out of bed, could not eat and could not stand up were considered as resolving.; Reporter's Comments: This case concerns a 74-year-old female with PMH of COVID-19 who had NS unexpected events of pain, pain in extremity, feeling abnormal, hyperhidrosis, feeding disorder, dysstasia, and bedridden and NS expected fatigue.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment included Tylenol. Events resolving. 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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Malaise, Pyrexia
Clinical narrative: I feel sick; Left arm injections site hurts a lot; Fever of 100.4F; headache; chills; A spontaneous report was received from a health care professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events of headache, chills, fever of 100.4 degrees fahrenheit, left arm injection site hurts a lot, and I feel sick.  The patient's medical history, as provided by the reporter, included COVID. No concomitant medications were reported.  On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22 Dec 2020, soon after vaccine administration, the patient experienced the events headache, chills, fever of 100.4 degrees fahrenheit, left arm injection site pain, and felt sick. Treatment for the events included, paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, headache, chills, fever of 100.4 degrees fahrenheit, left arm injection site hurts a lot and I feel sick were considered not resolved.  The reporter assessed events, headache, chills, fever of 100.4 degrees fahrenheit, left arm injection site hurts a lot and I feel sick as related to the study drug.; Reporter's Comments: This case concerns a female patient with a medical history of COVID-19 who received their first of two planned doses of mRNA-1273 (Lot 011J20A), and who experienced the listed events of Injection site pain, Pyrexia, Headache, and Chills, and the unlisted event of Malaise.  The events were considered possibly related to the vaccine due to the temporal relationship and the known safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Breastfeeding; A report was received from a consumer, who was a 37-year-old female patient and was breastfeeding.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on 22 Dec 2020, intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient received the vaccine and was currently breastfeeding. The subject did not experience symptoms.   Action taken with mRNA-1273 in response to the event was not reported  The outcome for the event, breastfeeding, was unknown.  The causality assessment for the event, breastfeeding, was not provided.; Reporter's Comments: This case concerns a 37-year-old female patient who received their first of two planned doses of mRNA-1273, reporting breastfeeding without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever; A spontaneous report was received from a nurse concerning a male nurse patient who received Moderna's COVID-19 Vaccine and experienced the non-serious event of low grade fever.  The patient's medical history included post COVID. No relevant concomitant medications were reported.   On 21 Dec 2020, prior to the onset of the event, the patient received their first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the patient developed a low-grade fever which resolved the next day. No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not reported.   The event, low grade fever, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a male patient who experienced a non-serious expected event of Pyrexia, which occurred the day after first dose of mRNA-1273 administration. Very limited information regarding the event has been provided at this time. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Malaise, Pain
Clinical narrative: Feel sick; Body Ache; Feeling lymph node was swollen; Feeling ache at the site of injection; A spontaneous report was received from a consumer concerning a 35-years-old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced multiple events of injection site ache, wide spread body ache, lymph node swollen and feel sick.  The patient's medical history was not provided. No concomitant medications were reported.  On 23 Dec 2020, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection. A few minutes later, she experienced the event injection site ache.  On 24 Dec 2020, the patient experienced wide spread body ache, lymph node swollen and feel sick. The treatment for the events included naproxen, and the symptoms were better.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, injection site ache, wide spread body ache, lymph node swollen and feel sick were considered as recovering/resolving.; Reporter's Comments: This case concerns a 35-years-old, female subject, who experienced a non-serious unexpected event of malaise and non-serious expected event of pain, injection site pain and lymphadenopathy. The event of injection site pain occurred one day after first dose of mRNA-1273 and the event of malaise, pain and lymphadenopathy occurred 2 days after first dose of mRNA-1273. The treatment medication included naproxen. 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Nausea, Pain assessment
Clinical narrative: vertigo; numbness on the left side of the face (cheek line but more on the lower lip side); Nausea; soreness on the injection site (L arm) including L shoulder blade; soreness on the injection site (left arm); A spontaneous report (United States) was received from a 48-year-old female patient who is also a healthcare professional. The patient is a participating in the mRNA-1273 a Program and experienced pain on the left shoulder blade, extreme vertigo, numbness on the left side of the face (cheek line but more on the lower lip side), soreness on the injection site (left arm); worsening, and nausea with the use of mRNA-1273.    There were no relevant medical history and concomitant medication included flu vaccine.  On 23 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient, experienced the non-serious events of soreness on the injection site (left arm); worsening, pain on the left shoulder blade. Additionally, on 24 Dec 2020 she experienced vertigo, nausea, and numbness on the left side of the face (cheek line but more on the lower lip side). It was noted the event of soreness on the injection site (left arm) worsened the day of this report, (pain was a 6 out of 10). The patient noted the pain was worse than the pain after the flu vaccine and the extreme vertigo was associated with nausea. Treatment included ondansetron for nausea. There was no consult as the patient stated the clinic she normally visits was closed for the holiday.  Action taken with mRNA-1273 in response to the event was not reported.   The reported events of pain on the left shoulder blade, extreme vertigo, numbness on the left side of the face (cheek line but more on the lower lip side), soreness on the injection site (left arm); worsening, and nausea were ongoing at the time of this report as reported by the patient.  There was no causality assessment provided for the events of pain on the left shoulder blade, extreme vertigo, numbness on the left side of the face (cheek line but more on the lower lip side), soreness on the injection site (left arm); worsening, and nausea.; Reporter'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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; numbness on the left side of the face (cheek line but more on the lower lip side); Nausea; soreness on the injection site (L arm) including L shoulder blade; soreness on the injection site (left arm); A spontaneous report (United States) was received from a 48-year-old female patient who is also a healthcare professional. The patient is a participating in the mRNA-1273 a Program and experienced pain on the left shoulder blade, extreme vertigo, numbness on the left side of the face (cheek line but more on the lower lip side), soreness on the injection site (left arm); worsening, and nausea with the use of mRNA-1273.    There were no relevant medical history and concomitant medication included flu vaccine.  On 23 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient, experienced the non-serious events of soreness on the injection site (left arm); worsening, pain on the left shoulder blade. Additionally, on 24 Dec 2020 she experienced vertigo, nausea, and numbness on the left side of the face (cheek line but more on the lower lip side). It was noted the event of soreness on the injection site (left arm) worsened the day of this report, (pain was a 6 out of 10). The patient noted the pain was worse than the pain after the flu vaccine and the extreme vertigo was associated with nausea. Treatment included ondansetron for nausea. There was no consult as the patient stated the clinic she normally visits was closed for the holiday.  Action taken with mRNA-1273 in response to the event was not reported.   The reported events of pain on the left shoulder blade, extreme vertigo, numbness on the left side of the face (cheek line but more on the lower lip side), soreness on the injection site (left arm); worsening, and nausea were ongoing at the time of this report as reported by the patient.  There was no causality assessment provided for the events of pain on the left shoulder blade, extreme vertigo, numbness on the left side of the face (cheek line but more on the lower lip side), soreness on the injection site (left arm); worsening, and nausea.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Body temperature, Diarrhoea, Headache
Clinical narrative: Really really bad Abdominal Cramping; Diarrhea; feels very weak; Nausea; Throwing up; Sore arm; Ranging Headache; A spontaneous report was received from a 23-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, ranging headache, sore arm, throwing up, diarrhea, nausea, really really bad abdominal cramping, and feels very weak.  The patients' medical history was not provided. Concomitant medications included escitalopram, buspirone and etonogestrel implant.  On 23 Dec 2020 at 13:30 approximately one hour prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 vaccine intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Dec 2020 after vaccination, the patient experienced ranging headache and soreness on her arm. She had severe abdominal cramping in middle of the night.   On the morning of 24 Dec 2020 she began having diarrhea, nausea, really, really bad abdominal cramping and took 2 naproxen and warm bath after which she felt little better, but threw up immediately after. She also reported having to get up and down to go to the bathroom, but all that was coming out was water. She denied a fever. The patient attempted to go to urgent care during morning hours, but because she was experiencing COVID symptoms, healthcare provider stated they could not help her until she provided a negative COVID test result. The patient reported to have self-treated for her symptoms but continued to feel weak. Treatment for the events included naproxen and bismuth subsalicylate.  The event, ranging headache was considered resolved on 24 Dec 2020. The outcome of events, really really bad abdominal cramping, diarrhea, throwing up, feels very weak, and nausea, were considered not resolved. The outcome of the event, sore arm, was unknown.  Action taken with mRNA-1273 in response to the events was not provided.; Reporter's Comments: This case concerns a 23-year-old, female subject, who experienced a non-serious unexpected event of abdominal pain, diarrhea, asthenia and expected event of nausea, vomiting, injection site pain and headache. The event of headache and injection site pain within few hours after the first dose of mRNA-1273 (Lot# unknown) administration. The events of nausea, vomiting, abdominal pain, diarrhea and asthenia occurred 1 day 10 hrs. after the first dose of mRNA-1273 administration. 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.