chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: CHILLS; HEADACHE; NAUSEA; 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 was not reported, administered on 10-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced headache. On AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hyperhidrosis, Pain
Clinical narrative: PERIOD HAS BEEN SO HEAVY SINCE/NEVER SOAKED THROUGH A TAMPON IN 2 HOURS/BLED SO MUCH; PAIN; SWEATING; 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, 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 period has been so heavy since/never soaked through a tampon in 2 hours/bled so much, pain, and sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the period has been so heavy since/never soaked through a tampon in 2 hours/bled so much, pain and sweating was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Ultrasound scan
Clinical narrative: PAIN ON LEFT LEG IN THE BACK  OF CALF INTO THE KNEE AND INTO THE LOWER THIGH; CHILLS; This spontaneous report received from a patient via a company representative concerned a 64 year old female. The patient's weight was 145 pounds, and height was 64 inches. The patient's concurrent conditions included: alcohol user occasionally, non smoker, and thyroid, and other pre-existing medical conditions included: The patient had no known allergy and no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 20-JUL-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for thyroid disorder.  On 01-APR-2021, the patient experienced chills. On 07-APR-2021, the patient experienced pain on left leg in the back of calf into the knee and into the lower thigh. On 13-APR-2021, Laboratory data included: Sonogram (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 02-APR-2021, and was recovering from pain on left leg in the back of calf into the knee and into the lower thigh. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: VACCINATED WITH THE JANSSEN COVID-19 VACCINE FOR THE 2ND TIME IN ABOUT 3 MONTHS; 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 was not reported, administered on 04-MAY-2021, and dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 11-AUG-2021, the patient experienced vaccinated with the janssen covid-19 vaccine for the 2nd time in about 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccinated with the janssen covid-19 vaccine for the 2nd time in about 3 months was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER FOR ABOUT 12 HOURS; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced fever for about 12 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever for about 12 hours. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site nodule, Vaccination site pain
Clinical narrative: VACCINATION SITE NODULE; VACCINATION SITE PAIN; This spontaneous report received from a patient concerned a 7 decade 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, intramuscular, 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. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccination site nodule, and vaccination site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination site pain and vaccination site nodule was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature fluctuation, Bone pain, Diarrhoea, Musculoskeletal stiffness
Clinical narrative: Body aches; Fluctuation in his  temperature; Extremely thirsty; Severe weakness; Diarrhea; Stiff neck; Bone pain feels worse than when he had covid; Fever; Nausea; Muscle pain feels worse than when he has covid; A spontaneous report was received from a nurse reporting on behalf of himself, a 50-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced body aches, fluctuation in his temperature, fever, extremely thirst, severe weakness, nausea, diarrhea, stiff neck, muscle pain and bone pain.   The patient's medical history included COVID-19 infection. Concomitant product use was not provided by the reporter.   On 22 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 left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, in the early morning, the patient experienced body aches, fluctuation in his temperature, fever, extreme thirst, severe weakness, nausea, diarrhea and a stiff neck. Additionally, the patient reported experiencing muscle and bone pain that felt worse than when he had COVID-19. Treatment for the event included ondansetron for nausea and acetaminophen for his stiff neck.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome for the events, body aches, fluctuation in his temperature, fever, extremely thirst, severe weakness, nausea, diarrhea, stiff neck, muscle pain and bone pain, was not reported.; Reporter's Comments: This case concerns a 50-year-old  male patient with a medical history of COVID-19, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the listed events of diarrhea, fever, nausea, and muscle pain, and the unlisted events of body aches, fluctuation in temperature, fever, thirst, weakness, stiff neck, and bone pain.  The events were considered possibly related to the vaccine due to the temporal relationship with onset of events the day after the first dose.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Body aches; Fluctuation in his  temperature; Extremely thirsty; Severe weakness; Diarrhea; Stiff neck; Bone pain feels worse than when he had covid; Fever; Nausea; Muscle pain feels worse than when he has covid; A spontaneous report was received from a nurse reporting on behalf of himself, a 50-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced body aches, fluctuation in his temperature, fever, extremely thirst, severe weakness, nausea, diarrhea, stiff neck, muscle pain and bone pain.   The patient's medical history included COVID-19 infection. Concomitant product use was not provided by the reporter.   On 22 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 left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, in the early morning, the patient experienced body aches, fluctuation in his temperature, fever, extreme thirst, severe weakness, nausea, diarrhea and a stiff neck. Additionally, the patient reported experiencing muscle and bone pain that felt worse than when he had COVID-19. Treatment for the event included ondansetron for nausea and acetaminophen for his stiff neck.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome for the events, body aches, fluctuation in his temperature, fever, extremely thirst, severe weakness, nausea, diarrhea, stiff neck, muscle pain and bone pain, was not reported.; Reporter's Comments: This case concerns a 50-year-old  male patient with a medical history of COVID-19, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the listed events of diarrhea, fever, nausea, and muscle pain, and the unlisted events of body aches, fluctuation in temperature, fever, thirst, weakness, stiff neck, and bone pain.  The events were considered possibly related to the vaccine due to the temporal relationship with onset of events the day after the first dose.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Body aches; Fluctuation in his  temperature; Extremely thirsty; Severe weakness; Diarrhea; Stiff neck; Bone pain feels worse than when he had covid; Fever; Nausea; Muscle pain feels worse than when he has covid; A spontaneous report was received from a nurse reporting on behalf of himself, a 50-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced body aches, fluctuation in his temperature, fever, extremely thirst, severe weakness, nausea, diarrhea, stiff neck, muscle pain and bone pain.   The patient's medical history included COVID-19 infection. Concomitant product use was not provided by the reporter.   On 22 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 left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, in the early morning, the patient experienced body aches, fluctuation in his temperature, fever, extreme thirst, severe weakness, nausea, diarrhea and a stiff neck. Additionally, the patient reported experiencing muscle and bone pain that felt worse than when he had COVID-19. Treatment for the event included ondansetron for nausea and acetaminophen for his stiff neck.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome for the events, body aches, fluctuation in his temperature, fever, extremely thirst, severe weakness, nausea, diarrhea, stiff neck, muscle pain and bone pain, was not reported.; Reporter's Comments: This case concerns a 50-year-old  male patient with a medical history of COVID-19, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the listed events of diarrhea, fever, nausea, and muscle pain, and the unlisted events of body aches, fluctuation in temperature, fever, thirst, weakness, stiff neck, and bone pain.  The events were considered possibly related to the vaccine due to the temporal relationship with onset of events the day after the first dose.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain
Clinical narrative: Very Hard raised red spot; Achiness in arm and shoulder; A spontaneous report was received from a healthcare facility staff member concerning a 51-year-old, female patient who received Moderna's COVID-19 vaccine and experienced a very hard raised red spot and achiness in arm and shoulder.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 22 Dec 2020, approximately 36 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT # 011JZ0A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. After 36 hours of receiving the vaccine, the patient noticed a very hard raised red spot at the injection site. Treatment provided for the events included naproxen for achiness in arm and shoulder.  On 24 Dec 2020, the patient reported the spot on her arm had grown.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, very hard raised red spot and achiness in arm and shoulder, were unknown; Reporter's Comments: This case concerns a  51 year old female patient. The patient's medical history is not provided. The patient experienced an expected event of injection site very hard red raised spot and achiness in arm and shoulder of injection. The event occurred on 36 hours after  receiving first dose of mRNA-1273 (LOT # 011JZ0A) on 22 Dec 2020. The reporter causality assessment for the event was not provided. The sponsor assessed the event as possibly related to the mRNA-1273 vaccine. Swelling and Pain at the site of injection is listed on the company's fact sheet for the healthcare providers.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Hyperhidrosis, Influenza like illness
Clinical narrative: sore arm at injection site; COVID-19; Fever; Chills; drenching sweats; general feeling "similar to the flu"; A spontaneous report was received from a physician concerning a 61-year old, male patient who experienced fever, chills, drenching sweats, sore arm at injection site, general feeling "similar to the flu", and COVID-19 swab test which was positive.   The patient's medical history included current conditions did not feel quite normal on 22 DEC 2020, myalgia on 22 DEC 2020, and temperature of 98-99 which is high. The patient's medical history included ongoing current conditions of occasional dry cough beginning on 22 DEC 2020 and fatigue beginning on 22 DEC 2020. Concomitant product use was not provided by the reporter.   On 22 DEC 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the Right Deltoid for prophylaxis of COVID-19 infection.   On 22 DEC 2020, the patient woke up and did "not feel quite normal." He experienced myalgia, occasional dry cough, fatigue, and a temperature of 98-99 which was high for him. At approximately 18:30 on 22 DEC 2020, the patient received the first dose of mRNA-1273. After receiving the vaccine, he experienced a temp of 99.9F, reaching a maximum of 101F, fever, chills, drenching sweats, sore arm at site of injection, and a general feeling similar to the flu.   He received a positive COVID-19 swab test on 23 DEC 2020. On 24 DEC 2020, the patient continued to feel much better. His temperature had been below 99F since the evening of 23 DEC 2020. He continued to experience a slight cough and slight fatigue. He continued to take ibuprofen occasionally, and he continued to monitor his O2 levels which remained normal. Treatment for the events included ibuprofen, paracetamol, aspirin, acetylsalicylic acid, risperidone, quercetin, and turmeric.   Action taken with mRNA-1273 in response to the events was not reported.   The events chills, drenching sweats, sore arm at injection site, general feeling "similar to the flu", and COVID-19 swab test which was positive were considered resolving on 24 DEC 2020.  The event fever was considered resolved on 23 DEC 2020.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of COVID-19 is assessed as unlikely related. The patient had cough, fever, fatigue and myalgia before the administration of vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: sore arm at injection site; COVID-19; Fever; Chills; drenching sweats; general feeling "similar to the flu"; A spontaneous report was received from a physician concerning a 61-year old, male patient who experienced fever, chills, drenching sweats, sore arm at injection site, general feeling "similar to the flu", and COVID-19 swab test which was positive.   The patient's medical history included current conditions did not feel quite normal on 22 DEC 2020, myalgia on 22 DEC 2020, and temperature of 98-99 which is high. The patient's medical history included ongoing current conditions of occasional dry cough beginning on 22 DEC 2020 and fatigue beginning on 22 DEC 2020. Concomitant product use was not provided by the reporter.   On 22 DEC 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the Right Deltoid for prophylaxis of COVID-19 infection.   On 22 DEC 2020, the patient woke up and did "not feel quite normal." He experienced myalgia, occasional dry cough, fatigue, and a temperature of 98-99 which was high for him. At approximately 18:30 on 22 DEC 2020, the patient received the first dose of mRNA-1273. After receiving the vaccine, he experienced a temp of 99.9F, reaching a maximum of 101F, fever, chills, drenching sweats, sore arm at site of injection, and a general feeling similar to the flu.   He received a positive COVID-19 swab test on 23 DEC 2020. On 24 DEC 2020, the patient continued to feel much better. His temperature had been below 99F since the evening of 23 DEC 2020. He continued to experience a slight cough and slight fatigue. He continued to take ibuprofen occasionally, and he continued to monitor his O2 levels which remained normal. Treatment for the events included ibuprofen, paracetamol, aspirin, acetylsalicylic acid, risperidone, quercetin, and turmeric.   Action taken with mRNA-1273 in response to the events was not reported.   The events chills, drenching sweats, sore arm at injection site, general feeling "similar to the flu", and COVID-19 swab test which was positive were considered resolving on 24 DEC 2020.  The event fever was considered resolved on 23 DEC 2020.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of COVID-19 is assessed as unlikely related. The patient had cough, fever, fatigue and myalgia before the administration of vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Lethargy, Nasal congestion, Nasal discomfort
Clinical narrative: arm soreness; cough; congestion in upper airway/upper chest; Fatigue; Nasal congestion; Runny nose; itchy nose; Lethargic; A spontaneous report was received from a nurse concerning herself, a 36 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced sore arm, nasal congestion, runny nose, itchy nose, a little fatigue, cough, congestion in upper airway/upper chest and feeling a little lethargic.  The patient's medical history included an unspecified allergy. Products known to have been used by the patient, within two weeks prior to the event, included loratadine.    On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient reported that she felt fine the first two days after receiving the vaccine but experienced a sore arm at the end of day 3-4 that resolved. On the sixth day, the patient reports that she had nasal congestion, runny nose, itchy nose, and a little fatigue. She reported that on 01 Jan 2021 experienced an intermittent productive cough and nasal congestion was improving. The patient also reported some congestion in her upper airway/upper chest and feeling lethargic. Treatment for the event included loratadine which the patient states she was already taking for the weather change and allergies.    Action taken with mRNA-1273 in response to the events was not provided/unknown.   The outcome of the event, sore arm, was considered resolved on 29 Dec 2020. The outcome of the events, nasal congestion, runny nose, itchy nose, a little fatigue, cough, congestion in upper airway/upper chest, and feeling a little lethargic was considered unknown.; 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Rhinorrhoea, Vaccination site pain
Clinical narrative: arm soreness; cough; congestion in upper airway/upper chest; Fatigue; Nasal congestion; Runny nose; itchy nose; Lethargic; A spontaneous report was received from a nurse concerning herself, a 36 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced sore arm, nasal congestion, runny nose, itchy nose, a little fatigue, cough, congestion in upper airway/upper chest and feeling a little lethargic.  The patient's medical history included an unspecified allergy. Products known to have been used by the patient, within two weeks prior to the event, included loratadine.    On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient reported that she felt fine the first two days after receiving the vaccine but experienced a sore arm at the end of day 3-4 that resolved. On the sixth day, the patient reports that she had nasal congestion, runny nose, itchy nose, and a little fatigue. She reported that on 01 Jan 2021 experienced an intermittent productive cough and nasal congestion was improving. The patient also reported some congestion in her upper airway/upper chest and feeling lethargic. Treatment for the event included loratadine which the patient states she was already taking for the weather change and allergies.    Action taken with mRNA-1273 in response to the events was not provided/unknown.   The outcome of the event, sore arm, was considered resolved on 29 Dec 2020. The outcome of the events, nasal congestion, runny nose, itchy nose, a little fatigue, cough, congestion in upper airway/upper chest, and feeling a little lethargic was considered unknown.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Feeling abnormal
Clinical narrative: Brain fog; Confused which bathroom was men's at a restaurant; A spontaneous report was received from a nurse concerning her husband, who was the patient. This case concerns a 66 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced brain fog and confused which bathroom was men's at a restaurant with the use of mRNA-1273.   The patient's medical history included left lower lumbar back surgery, left and right hip replacement, right arm elbow surgery, steel rod in left leg, arthritis, and drinks but not as much. He has had atleast five surgeries in the left hip and one in the right..   Concomitant medications included allopurinol sodium, losartan, metformin, hydrocodone, and gabapentin for unknown indications.   The patient received his first of two planned doses of mRNA-1273 (Lot # 025L20A) on 29 Dec 2020 intramuscularly, in his left arm, for prophylaxis of COVID-19 infection.   A couple hours after the after the administration, the patient experienced "brain fog" and "confused which bathroom was men's at a restaurant".   Additionally, the patient experience decreased stiffness including exceptional increased ability to move within 24 hours of administration. It was noted that it was not hard for him to get up from the sitting position. He could get up without the use of armchair and just with his two arms. The second day, he was able to bend his knees and get his shoes from the closet, which he had not been able to do for a year. Additionally, he got up and helped unload the dishwasher, which he had not been able to do before. The patient was feeling much younger and much better and was excited for the second dose. The arthritis changes were dramatic and happened within the first 48 hours. There was no treatment information provided for the reported events.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events brain fog and confused which bathroom was men's at a restaurant were considered resolved as reported.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Nasopharyngitis, Pyrexia, Rhinorrhoea
Clinical narrative: She was cold; Nose running; Diarrhea; Vomiting; Back ache; Fever; A spontaneous report was received from a reporter concerning a 71-year-old, female patient who received Moderna (mRNA-1273) and experienced a cold, her nose running, diarrhea, vomiting, back ache and a fever.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 07 Jan 2021, in the middle of the night, the patient experienced a cold, her nose running, diarrhea, vomiting, back ache and a fever.  No treatment was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events a cold, her nose running, diarrhea, vomiting, back ache and a fever, were considered unknown.; Reporter's Comments: Based on the current available information and a temporal association between the use of the product and the start date of the reported events, a causal relationship with the events cannot be excluded. Fever and vomiting are consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: She was cold; Nose running; Diarrhea; Vomiting; Back ache; Fever; A spontaneous report was received from a reporter concerning a 71-year-old, female patient who received Moderna (mRNA-1273) and experienced a cold, her nose running, diarrhea, vomiting, back ache and a fever.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 07 Jan 2021, in the middle of the night, the patient experienced a cold, her nose running, diarrhea, vomiting, back ache and a fever.  No treatment was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events a cold, her nose running, diarrhea, vomiting, back ache and a fever, were considered unknown.; Reporter's Comments: Based on the current available information and a temporal association between the use of the product and the start date of the reported events, a causal relationship with the events cannot be excluded. Fever and vomiting are consistent with the known safety profile of the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; A spontaneous report was received from a physician concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received his first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, it was reported that the patient experienced hives. The reporter inquired about second dosing for the patient. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, hives, was unknown.; Reporter'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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Lumbar/back pain; A spontaneous report was received from a non-health professional concerning a 34-year-old, female patient who received Moderna's COVID-19 vaccine and developed lumbar back pain.  The patient's medical history included allergies to dust, pollen, and soymilk. Concomitant product use was not provided by the reporter.  On 12 Jan 2021, approximately 07:15am prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039KZ04) intramuscularly in the left shoulder for prophylaxis of COVID-19 infection.    On 12 Jan 2021, four hours after receiving the vaccine, the patient developed lumbar/ back pain. The patient also reported having the flu vaccine, on 09 Dec 2020. Treatment for the event included ibuprofen.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the event, lumbar back pain, was unknown.; Reporter'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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeling hot, Headache
Clinical narrative: feeling hot; Sore left arm; Looked pale; Low grade fever; Severe headache; Joint pain; Felt bad chills; Felt ringing sound in her ears; Very hot sweaty; Felt very thirsty; Black spots in front of her eyes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), TINNITUS (Felt ringing sound in her ears), HYPERHIDROSIS (Very hot sweaty), THIRST (Felt very thirsty) and VISUAL IMPAIRMENT (Black spots in front of her eyes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced TINNITUS (Felt ringing sound in her ears), HYPERHIDROSIS (Very hot sweaty), THIRST (Felt very thirsty), VISUAL IMPAIRMENT (Black spots in front of her eyes) and CHILLS (Felt bad chills). On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore left arm), PALLOR (Looked pale), PYREXIA (Low grade fever), HEADACHE (Severe headache) and ARTHRALGIA (Joint pain). On an unknown date, the patient experienced FEELING HOT (feeling hot). On 01-Jan-2021, HEADACHE (Severe headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore left arm), TINNITUS (Felt ringing sound in her ears), HYPERHIDROSIS (Very hot sweaty), THIRST (Felt very thirsty), VISUAL IMPAIRMENT (Black spots in front of her eyes), PALLOR (Looked pale), CHILLS (Felt bad chills), PYREXIA (Low grade fever) and ARTHRALGIA (Joint pain) had resolved and FEELING HOT (feeling hot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Body temperature: 99.5 f (abnormal) Low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain in extremity, Pallor, Pyrexia, Thirst
Clinical narrative: feeling hot; Sore left arm; Looked pale; Low grade fever; Severe headache; Joint pain; Felt bad chills; Felt ringing sound in her ears; Very hot sweaty; Felt very thirsty; Black spots in front of her eyes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), TINNITUS (Felt ringing sound in her ears), HYPERHIDROSIS (Very hot sweaty), THIRST (Felt very thirsty) and VISUAL IMPAIRMENT (Black spots in front of her eyes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced TINNITUS (Felt ringing sound in her ears), HYPERHIDROSIS (Very hot sweaty), THIRST (Felt very thirsty), VISUAL IMPAIRMENT (Black spots in front of her eyes) and CHILLS (Felt bad chills). On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore left arm), PALLOR (Looked pale), PYREXIA (Low grade fever), HEADACHE (Severe headache) and ARTHRALGIA (Joint pain). On an unknown date, the patient experienced FEELING HOT (feeling hot). On 01-Jan-2021, HEADACHE (Severe headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore left arm), TINNITUS (Felt ringing sound in her ears), HYPERHIDROSIS (Very hot sweaty), THIRST (Felt very thirsty), VISUAL IMPAIRMENT (Black spots in front of her eyes), PALLOR (Looked pale), CHILLS (Felt bad chills), PYREXIA (Low grade fever) and ARTHRALGIA (Joint pain) had resolved and FEELING HOT (feeling hot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Body temperature: 99.5 f (abnormal) Low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Visual impairment
Clinical narrative: feeling hot; Sore left arm; Looked pale; Low grade fever; Severe headache; Joint pain; Felt bad chills; Felt ringing sound in her ears; Very hot sweaty; Felt very thirsty; Black spots in front of her eyes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), TINNITUS (Felt ringing sound in her ears), HYPERHIDROSIS (Very hot sweaty), THIRST (Felt very thirsty) and VISUAL IMPAIRMENT (Black spots in front of her eyes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced TINNITUS (Felt ringing sound in her ears), HYPERHIDROSIS (Very hot sweaty), THIRST (Felt very thirsty), VISUAL IMPAIRMENT (Black spots in front of her eyes) and CHILLS (Felt bad chills). On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore left arm), PALLOR (Looked pale), PYREXIA (Low grade fever), HEADACHE (Severe headache) and ARTHRALGIA (Joint pain). On an unknown date, the patient experienced FEELING HOT (feeling hot). On 01-Jan-2021, HEADACHE (Severe headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore left arm), TINNITUS (Felt ringing sound in her ears), HYPERHIDROSIS (Very hot sweaty), THIRST (Felt very thirsty), VISUAL IMPAIRMENT (Black spots in front of her eyes), PALLOR (Looked pale), CHILLS (Felt bad chills), PYREXIA (Low grade fever) and ARTHRALGIA (Joint pain) had resolved and FEELING HOT (feeling hot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Body temperature: 99.5 f (abnormal) Low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hypertension, Pain
Clinical narrative: High blood pressure; Rapid pulse; Body aches; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High blood pressure), HEART RATE INCREASED (Rapid pulse), PAIN (Body aches) and HEADACHE (Headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19.    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 HYPERTENSION (High blood pressure), HEART RATE INCREASED (Rapid pulse), PAIN (Body aches) and HEADACHE (Headache). At the time of the report, HYPERTENSION (High blood pressure), HEART RATE INCREASED (Rapid pulse), PAIN (Body aches) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   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.; 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Red patch on her arm; A report was received from a consumer concerning a 32 year old female patient who was participating in the mRNA-1273 trail and developed red patch on her arm.   The patient's medical history, as provided by the reporter, and relevant concomitant medications were not reported.   On an unknown date the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient developed a red patch on her arm beginning on an unknown date.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event red patch on her arm was not reported.  Reporter causality for the event was not provided.; Reporter'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.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Vomiting
Clinical narrative: severely dehydrated; threw up; A spontaneous report was received from a nurse concerning a 22-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) who experienced events threw up and severely dehydrated.  The patient's medical history, as provided by the reporter, included eczema. Concomitant medications reported included unspecified eczema medication.  On 28 Dec 2020, approximately 6-9 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 03 Jan 2021, the patient went to eat and threw up. She took Dramamine and Tylenol. On 06 Jan 2021, the subject went to the doctor and had an IV placed as she was severely dehydrated. Treatment for the event included Dramamine, paracetamol, and IV drip.   Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events were unknown.; 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Cough, Fatigue
Clinical narrative: deep pain in her chest which is worse with deep breaths; cough; fever; chills; joint pain; muscle pain; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (deep pain in her chest which is worse with deep breaths), COUGH (cough), PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigue) and HEADACHE (headache). On 12-Jan-2021, the patient experienced CHEST PAIN (deep pain in her chest which is worse with deep breaths) and COUGH (cough). On 13-Jan-2021, CHEST PAIN (deep pain in her chest which is worse with deep breaths) had resolved. At the time of the report, COUGH (cough), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigue) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided; 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: deep pain in her chest which is worse with deep breaths; cough; fever; chills; joint pain; muscle pain; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (deep pain in her chest which is worse with deep breaths), COUGH (cough), PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigue) and HEADACHE (headache). On 12-Jan-2021, the patient experienced CHEST PAIN (deep pain in her chest which is worse with deep breaths) and COUGH (cough). On 13-Jan-2021, CHEST PAIN (deep pain in her chest which is worse with deep breaths) had resolved. At the time of the report, COUGH (cough), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigue) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided; 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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Pharyngeal hypoaesthesia
Clinical narrative: Left sided facial numbness; Couldn't breathe right due to his throat feeling numb; couldn't breathe right due to his throat feeling numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left sided facial numbness), DYSPNOEA (Couldn't breathe right due to his throat feeling numb) and PHARYNGEAL HYPOAESTHESIA (couldn't breathe right due to his throat feeling numb) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history was not reported.     On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (Left sided facial numbness), DYSPNOEA (Couldn't breathe right due to his throat feeling numb) and PHARYNGEAL HYPOAESTHESIA (couldn't breathe right due to his throat feeling numb). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Numbness throat, Numbness in face and Breathing difficult, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Breathing difficult, Numbness in face and Numbness throat, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Left sided facial numbness) was resolving and DYSPNOEA (Couldn't breathe right due to his throat feeling numb) and PHARYNGEAL HYPOAESTHESIA (couldn't breathe right due to his throat feeling numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Reporter contact information updated and Pt Initials updated On 09-Aug-2021: Non-significant follow-up information included reporter address added.; Sender's Comments: This case concerns a male of unknown age who experienced nonserious unexpected events of facial hypoesthesia, shortness of breath and throat numbness.  Event onset the same day as the first dose of mRNA-1273. Treatment with ibuprofen and diphenhydramine. Facial hypoesthesia resolving, other outcomes unknown. 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.