chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Gait inability, Hot flush, Loss of control of legs
Clinical narrative: Cannot control himself; Face feels hot; loss of control of legs/cannot control himself/gait inability; shaking with chills; A spontaneous report was received from a consumer concerning a 83-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of cannot control himself (loss of control of legs), hard to walk (gait inability), shaking with chills (chills), face feels hot (hot flush).  The patient's medical history and concomitant medications was not provided.   On 17Feb2021, the day before the onset of the events, the patient received first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 18Feb2021, the patient experienced not controlling himself. He reported it was hard to walk, he was shaking with chills, had three coats on and his face felt hot. Additionally he reported he was on the floor because he was nervous he was going to fall. The patient's granddaughter came to his house and he tried to call his physician but was unsuccessful as his physician was not available. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, were considered as unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary congestion, Vaccination site pain
Clinical narrative: chest congestion; sore arm; A spontaneous report  was received from a consumer concerning a 67- year old-male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest congestion and vaccination site pain.  The patient's medical history was not provided.No relevant concomitant medications were reported.   On 30-Jan-2021,prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch 007M20A) on left arm for prophylaxis of COVID-19 infection.  On an unknown date,the patient experienced chest congestion and sore arm. No laboratory data was provided.Treatment information was not provided.   Action taken with mRNA-1273 in response to the events  was unknown.   The outcome of the events chest congestion and pain in arm  was considered as unknown at the time of the report.; 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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Loss of consciousness
Clinical narrative: passed out on the highway while driving; A spontaneous report was received from a consumer concerning himself, a 73 years old male patient, who received Moderna's COVID-19 vaccine and he passed out on the high way while driving/loss of consciousness.  The patient's medical history was not provided. Concomitant product was not provided by the reporter.  On 2-Mar-2021, prior to the onset of event, the patient received their first dose of mRNA-1273(batch number unknown) intramuscularly on his left arm for prophylaxis of COVID-19 infection.  On2-Mar-2021, after vaccination he passed out on the high way while driving. The event passed out on the high way while driving was considered to be medically significant.  Relevant laboratory investigation included blood pressure test which revealed as normal.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event which he passed out on the high was while driving was resolved.; Reporter's Comments: This case concerns a 65-year-old female with a serious unexpected event of loss of consciousness. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events resolved. 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: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; A spontaneous report was received from a consumer concerning a patient of an unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, approximately 11 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: 026L20A) for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient was admitted to the hospital and diagnosed with Bell's palsy. On 06 Feb 2021, the patient was released from hospital. Treatment for the event included cortisone and antiviral medications.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event Bell's palsy was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Retinal detachment, SARS-CoV-2 test
Clinical narrative: Tested positive COVID-19; Detached retina; A spontaneous report was received from a consumer concerning a 66-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Detached retina (Retinal detachment) and Tested positive COVID-19 (SARS-CoV-2 test positive).  The patient's medical history was not reported. The patient's concomitant product was not reported.    On 14 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 012L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 21 Jan 2021, the patient's retina got detached. The event detached retina was assessed as medically significant.  On 24 Jan 2021, the patient tested positive for COVID-19. Treatment details included eye vitamins and surgery.   The action taken with mRNA-1273 in response to the events detached retina and tested positive COVID-19 was unknown.  The outcome of the events, detached retina and tested positive COVID-19 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Asthenia, Chills, Decreased appetite, Dyspnoea
Clinical narrative: Hallucinated a little bit; Soreness in arms; Sick; no appetite; no sense of smell; No energy; Shortness of breath; Itchy on back; Very winded, like coming up a flight of stairs; Chills; High fever; A spontaneous report was received from a customer concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sick/illness, high fever/pyrexia, chills, couldn't move, soreness in arms/pain in extremity, felt like she had Covid, no appetite/decreased appetite, no sense of smell/anosmia, no energy/asthenia, hallucinated a little bit/hallucination, shortness of breath/dyspnea, itchy on back/pruritus and very winded like coming up a flight of stairs.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 03 Mar 2021, approximately 2 days prior to the event, the patient received their dose of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   After receiving the vaccine the patient experienced sickness, high fever, chills, couldn't move, soreness in arms, felt like Covid, no appetite, no sense of smell, no energy, hallucination, shortness of breath, itching, and very winded like coming up a flight of stairs.  No other details were reported. Treatment information  was  not reported.   Action taken with the drug in response to the event is not applicable  The outcome of the events sick/illness, high fever/pyrexia, chills, couldn't move, soreness in arms/pain in extremity, felt like she had Covid, no appetite/decreased appetite, no sense of smell/anosmia, no energy/asthenia, hallucinated a little bit/hallucination, shortness of breath/dyspnea, itchy on back/pruritus and very winded like coming up a flight of stairs were  considered to be unknown at the time of this report.; 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Hallucination, Illness, Pain in extremity, Pruritus
Clinical narrative: Hallucinated a little bit; Soreness in arms; Sick; no appetite; no sense of smell; No energy; Shortness of breath; Itchy on back; Very winded, like coming up a flight of stairs; Chills; High fever; A spontaneous report was received from a customer concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sick/illness, high fever/pyrexia, chills, couldn't move, soreness in arms/pain in extremity, felt like she had Covid, no appetite/decreased appetite, no sense of smell/anosmia, no energy/asthenia, hallucinated a little bit/hallucination, shortness of breath/dyspnea, itchy on back/pruritus and very winded like coming up a flight of stairs.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 03 Mar 2021, approximately 2 days prior to the event, the patient received their dose of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   After receiving the vaccine the patient experienced sickness, high fever, chills, couldn't move, soreness in arms, felt like Covid, no appetite, no sense of smell, no energy, hallucination, shortness of breath, itching, and very winded like coming up a flight of stairs.  No other details were reported. Treatment information  was  not reported.   Action taken with the drug in response to the event is not applicable  The outcome of the events sick/illness, high fever/pyrexia, chills, couldn't move, soreness in arms/pain in extremity, felt like she had Covid, no appetite/decreased appetite, no sense of smell/anosmia, no energy/asthenia, hallucinated a little bit/hallucination, shortness of breath/dyspnea, itchy on back/pruritus and very winded like coming up a flight of stairs were  considered to be unknown at the time of this report.; 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Hallucinated a little bit; Soreness in arms; Sick; no appetite; no sense of smell; No energy; Shortness of breath; Itchy on back; Very winded, like coming up a flight of stairs; Chills; High fever; A spontaneous report was received from a customer concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sick/illness, high fever/pyrexia, chills, couldn't move, soreness in arms/pain in extremity, felt like she had Covid, no appetite/decreased appetite, no sense of smell/anosmia, no energy/asthenia, hallucinated a little bit/hallucination, shortness of breath/dyspnea, itchy on back/pruritus and very winded like coming up a flight of stairs.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 03 Mar 2021, approximately 2 days prior to the event, the patient received their dose of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   After receiving the vaccine the patient experienced sickness, high fever, chills, couldn't move, soreness in arms, felt like Covid, no appetite, no sense of smell, no energy, hallucination, shortness of breath, itching, and very winded like coming up a flight of stairs.  No other details were reported. Treatment information  was  not reported.   Action taken with the drug in response to the event is not applicable  The outcome of the events sick/illness, high fever/pyrexia, chills, couldn't move, soreness in arms/pain in extremity, felt like she had Covid, no appetite/decreased appetite, no sense of smell/anosmia, no energy/asthenia, hallucinated a little bit/hallucination, shortness of breath/dyspnea, itchy on back/pruritus and very winded like coming up a flight of stairs were  considered to be unknown at the time of this report.; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypercalcaemia, Product dose omission issue, Renal failure
Clinical narrative: Renal failure; Hypercalcemia; Missed Dose; A spontaneous report was received from a pharmacist concerning a 73-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypercalcemia (hypercalcaemia) and renal failure.  The patient's medical history was not reported. Concomitant medications taken by the patient were not provided.  On 13 Jan 2021, 20 days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient was hospitalized for hypercalcemia and renal failure. The reporter reported that these events were not related to the vaccine. The patient did not see her regular doctor for this. The patient did not receive her second dose since she was hospitalized at the time and was at day 61. Treatment for the events was not provided. The patient was discharged from the hospital on 21 Feb 2021.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, hypercalcemia and renal failure, was unknown.  Follow up: Follow-up received on 15 Mar 2021, included email id of reporter, the hospitalization details, cause of hospitalization.; 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Pain in extremity, Thrombosis
Clinical narrative: blood clot in lower leg; achy; Pain in the back of leg that would not go away; body ache/ache; headache; A spontaneous report was received from a consumer  concerning a patient age ,57 years old male patient who developed Blood clot in lower leg/Thrombosis, Body ache/Myalgia, Headache/Headache and pain in the back of the leg that would not go away/pain in extremity.   The patient's medical history included Central Retinal vein occlusion (CRVO).  Concomitant product use was not provided/unknown by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on unknown date.   The patient received their second of two planned doses of mRNA-1273 (Batch number not provided) on 03 Feb 2021, intramuscularly in the (unknown injection site) for prophylaxis of COVID-19 infection.    On the same day as receiving the vaccine 03 Feb 2021 patient reported as having pain in back of the leg that would not go away. Patient also had body aches, felt achy and had headache. Patient went to Emergency room on 03 Feb 2021 and was diagnosed a blood clot in lower leg. The event blood clot in lower leg was assessed as medically significant based on IME list.  Treatment information was not provided/unknown. Patient is following up with a hematologist.   The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the event(s), Blood clot in lower leg/Thrombosis, Body ache/Myalgia, Headache/Headache and pain the 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 (pain, myalgia, and headache) a causal relationship cannot be excluded. A very limited information regarding these event (Thrombosis) has been provided at this time. Noting the history of central retinal vein occlusion may remain as a risk factor for thrombosis. Further information has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Her leg started bothering her, the pain was quite heavy and consistent; pain under her left arm; blood cloth in her leg; a little nauseous; headache; tired; pins; A spontaneous report was received from a consumer concerning a female patient of 70-years-old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Pins/ Paraesthesia,nausea,tiredness,headache,pain in leg was quite heavy and consistent, blood cloth in leg, pain under left arm.  The patients medical history was not provided .Concomitant medications reported included Eliquis starter pack twice a day,Latanoprost for Glaucoma,Omeprazole for heart burn.  On 15 Jan 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 037K20A) vaccine via unknown route for prophylaxis of COVID-19 infection.  On 12 Feb 2021,prior to the onset of events, the Patient received their second of two planned dose of mRNA-1273(Lot number: 024M20A) vaccine via unknown route for prophylaxis of COVID-19 infection  On 12 feb 2021,That evening she got pins again.The next day she was a little nauseous, tired and had a headache. Her leg started bothering her 3 days to a week after the second dose.And the pain in her leg was quite heavy and consistent, she thought it might be her sciatica. She went to the doctor and ended up getting a doppler and they discovered a blood clott there. She had never had a blood clott before in her life.she was feeling pain under her left arm as well.  No Treatment for the event was provided.   Action taken with the mRNA-1273 in response to the event was not applicable.  the event pins were considered resolved on 13 Feb 2021.  The events nauseous,tiredness,headache were considered resolved on 14 Feb 2021.  The outcome of the events pain in leg was quite heavy and consistent, blood cloth in leg, pain under left arm 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 these events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Thrombosis
Clinical narrative: Her leg started bothering her, the pain was quite heavy and consistent; pain under her left arm; blood cloth in her leg; a little nauseous; headache; tired; pins; A spontaneous report was received from a consumer concerning a female patient of 70-years-old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Pins/ Paraesthesia,nausea,tiredness,headache,pain in leg was quite heavy and consistent, blood cloth in leg, pain under left arm.  The patients medical history was not provided .Concomitant medications reported included Eliquis starter pack twice a day,Latanoprost for Glaucoma,Omeprazole for heart burn.  On 15 Jan 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 037K20A) vaccine via unknown route for prophylaxis of COVID-19 infection.  On 12 Feb 2021,prior to the onset of events, the Patient received their second of two planned dose of mRNA-1273(Lot number: 024M20A) vaccine via unknown route for prophylaxis of COVID-19 infection  On 12 feb 2021,That evening she got pins again.The next day she was a little nauseous, tired and had a headache. Her leg started bothering her 3 days to a week after the second dose.And the pain in her leg was quite heavy and consistent, she thought it might be her sciatica. She went to the doctor and ended up getting a doppler and they discovered a blood clott there. She had never had a blood clott before in her life.she was feeling pain under her left arm as well.  No Treatment for the event was provided.   Action taken with the mRNA-1273 in response to the event was not applicable.  the event pins were considered resolved on 13 Feb 2021.  The events nauseous,tiredness,headache were considered resolved on 14 Feb 2021.  The outcome of the events pain in leg was quite heavy and consistent, blood cloth in leg, pain under left arm 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 these events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Postmenopausal haemorrhage
Clinical narrative: bleed heavily again; a feeling of pins and needles in their face/tingling sensation in face; A spontaneous report  was received from a consumer who was also a 64-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heavy bleeding/ postmenopausal bleeding, a feeling of pins and needles that began on the left side of the face and radiated down to the bottom of the chin with sensitivity on the nose and lips/ paraesthesia oral.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient were not provided.   The patient received the first of two planned doses of mRNA-1273 (Lot number: 031M20A) intramuscularly in the left arm on 14 Feb 2021.   On 13 Mar 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 026A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021 four days after the first dose of vaccination, patient began to bleed as if their menstrual cycle began. Patient reported that she was at a menopausal phase in life to typically do not bleed not or if they do there was a light pink blood excreted, the last time this had occurred was in November. Patient had a bleeding that was very heavy and contained large blood clots. The event heavy bleeding/ post menopausal bleeding was a medically significant event.  Patient stated that this bleeding lasted 7 consecutive days until 25 Feb 2021. The bleeding then stopped 26 Feb 2021 for 2 days, and then heavy bleeding episode came back again on 28 Feb 2021 for 2 days lasting until 02 March 2021.  On 03 March 2021, patient reported that she had a fever of 102F which lasted for 24 hours. Patient also reported that she had very sore gums and swelling inside of mouth. Patient reported that she was not sure if these evets were due to the vaccination.  On 13 Mar 2021, after the 2nd dose patient had begun to bleed heavily again. Patient also reported that after the first and second dose immediately afterwards there was a feeling of pins and needles in their face. This tingling sensation began on the left side of face down to the bottom of the chin with the most sensitivity on the nose and lips. This tingling sensation was far more pronounced after the second dose than the feeling of the first dose. Patient reported that the heavy bleeding and feeling pins and needles in face were present on 15 March 2021. Treatment activities for event was not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcome of events, heavy bleeding and tingling sensation that began on the left side of face down radiating to the bottom of the chin with the most sensitivity on the nose and lips were not recovered/not resolved.; 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: COVID-19, Condition aggravated, Cough, Dyspnoea, Oxygen saturation
Clinical narrative: COVID-19; Breathing had gotten worse; O2 levels were low; Cough; Fever; Difficulty breathing/ shortness of breath; A spontaneous report was received from a consumer concerning her husband, a male patient who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cough, fever, difficulty breathing, shortness of breath/dyspnoea, COVID-19, O2 levels were low/ oxygen saturation decreased and breathing had gotten worse/condition aggravated.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch: 001A21A) via unknown route for prophylaxis of COVID-19 infection.  After receiving the vaccine the patient experienced a cough, fever, shortness of breath, and difficulty breathing. He went to a clinic where he was not given a COVID test but was prescribed 5 days of pills and sent home. He then returned the next day because his breathing had gotten worse and was admitted to the hospital for COVID-19. Following admittance he was given oxygen because his O2 levels were very low. He was also given some other medications. The event shortness of breath was considered as medically significant. The events breathing had gotten worse and COVID-19 led to hospitalization. Treatment details included oxygen therapy and some medications.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events cough, fever, difficulty breathing, shortness of breath, COVID-19, low o2 levels and breathing had gotten worse was not provided.; Reporter's Comments: This case concerns a male of unknown age hospitalized with a serious unexpected event of COVID-19 along with dyspnea, oxygen saturation decreased, condition aggravated and NS unexpected cough and expected pyrexia.  Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19; Breathing had gotten worse; O2 levels were low; Cough; Fever; Difficulty breathing/ shortness of breath; A spontaneous report was received from a consumer concerning her husband, a male patient who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cough, fever, difficulty breathing, shortness of breath/dyspnoea, COVID-19, O2 levels were low/ oxygen saturation decreased and breathing had gotten worse/condition aggravated.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch: 001A21A) via unknown route for prophylaxis of COVID-19 infection.  After receiving the vaccine the patient experienced a cough, fever, shortness of breath, and difficulty breathing. He went to a clinic where he was not given a COVID test but was prescribed 5 days of pills and sent home. He then returned the next day because his breathing had gotten worse and was admitted to the hospital for COVID-19. Following admittance he was given oxygen because his O2 levels were very low. He was also given some other medications. The event shortness of breath was considered as medically significant. The events breathing had gotten worse and COVID-19 led to hospitalization. Treatment details included oxygen therapy and some medications.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events cough, fever, difficulty breathing, shortness of breath, COVID-19, low o2 levels and breathing had gotten worse was not provided.; Reporter's Comments: This case concerns a male of unknown age hospitalized with a serious unexpected event of COVID-19 along with dyspnea, oxygen saturation decreased, condition aggravated and NS unexpected cough and expected pyrexia.  Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Faeces discoloured, Pyrexia
Clinical narrative: Black stool; fever; A spontaneous report was received from a consumer (patient) concerning a 56-years-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed black stool and fever.  No medical history was provided. On 24 Feb 2021, the patient received fluphenazine. No concomitant medications were provided.  On 26 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided), intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced, black stool and fever.  The treatment medication included paliperidone.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events of black stool and fever was unknown.   The reporter did not provide assessment for the events of black stool and fever.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Infection, Pneumonia, Pyrexia, Sepsis
Clinical narrative: Pneumonia; Sepsis; Aggravated an infection; Fever (104 ° F); Chills very bad; A spontaneous report was received from a consumer concerning her husband, 44-year-old, male patient who developed pneumonia, sepsis, aggravated an infection/infection, fever (104°F)/pyrexia, chills very bad/chills.  The patient's medical history included diabetes type 2, lung infection and blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included Amlodipine.   On 13 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) at unknown injection site for prophylaxis of COVID-19 infection.    On 13 Mar 2021 the patient five minutes later after received second dose he started to had chills very bad and fever (104 ° F). The patient has pneumonia and sepsis. This aggravated an infection that he had in a lung 11 years ago (before receiving the vaccine they were thinking of amputating a leg, because he also has type 2 diabetes). The patient was under treatment, every week to avoid amputation but now they decided to amputate his leg as soon as possible due to the infection. Treatment information of the event was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) pneumonia, sepsis, aggravated an infection, fever (104°F), chills very bad was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: affected her rheumatoid arthritis she had a flare up- bad time with hip,ankle and a pain that went across her shoulder; A spontaneous report was received from a consumer concerning 74-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and it affected her rheumatoid arthritis she had a flare up/ rheumatoid arthritis, bad time with hip, ankle a pain that went across her shoulder/ arthralgia.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient were not provided.  On 15 Feb 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 029L2OA) through unknown route at unspecified site for prophylaxis of COVID-19 infection.  On 16 Mar 2021, prior to the onset of the event, the patient received second of their two planned doses of mRNA-1273 (Lot number: 001B21A) through unknown route at unspecified site for prophylaxis of COVID-19 infection.  On 15 Feb 2021, after vaccination it affected her rheumatoid arthritis and she had a flare up, she had a bad time with hip, ankle a pain that went across her shoulder. Since then her healthcare professional had recommended, her to go to physical therapy.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, it affected her rheumatoid arthritis she had a flare up was not recovered. Outcome of the event of she had a bad time with hip, ankle a pain that went across her shoulder 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; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048050:crosslink for second dose events
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage
Clinical narrative: Left eye was red/ Subconjunctival hemorrhage; A spontaneous report was received from a physician, concerning a 86-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Left eye was red/ Subconjunctival hemorrhage (Subconjunctival Hemorrhage).  The patient's medical history was not provided by the reporter. Concomitant medications reported included, baby aspirin every day, high blood pressure medication, amlodipine, tamsulosin, vitamin C, atorvastatin calcium, metoprolol, vitamin D, multivitamin, zinc, alendronate, and docusate sodium.  A spontaneous report was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left eye was red, subconjunctival hemorrhage.  The patient's medical history was not provided. Concomitant medications reported were baby aspirin every day, high blood pressure medication, amlodipine, Tamsulosin, Vitamin C, Lipitor, metoprolol, Vitamin D, multivitamin, zinc, alendronate, Colace for drug use for unknown indication.  On 12 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 15 Mar 2021, the patient experienced the event(s) left eye was red, subconjunctival hemorrhage.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.  On 18 Mar 2021 the outcome of event(s), left eye was red, subconjunctival hemorrhage was resolved.   On 12 Mar 2021, prior to the onset of the event the patient received first of two planned doses of mRNA-1273 (lot/batch: 032M20A) by unspecified route on her left arm for prophylaxis of COVID-19 infection.    On 15 Mar 2021, 3 days post vaccination, patient's left eye was red, later the healthcare professional diagnosed it as "Subconjunctival Hemorrhage". Subconjunctival hemorrhage, was the medically significant event. Treatment details were mot reported.  Action taken with mRNA-1273 in response to the event was not reported.   On 18 Mar 2021, the event, Subconjunctival Hemorrhage was resolved.; 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: Dizziness, Dry mouth, Hyperhidrosis, Influenza, Pain
Clinical narrative: light headed; fainted; cold hot sweats; dry mouth; felt thirsty; flu symptoms; unbearable body aches; A spontaneous report  was received from a Consumer, concerning a female patient of 31 years-old-age, who received Modena's COVID-19 vaccine and she fainted and experienced cold hot sweats, dry mouth and felt thirsty.  The patient's medical history was not provided. Advil was the Concomitant products that was  provided by the reporter.  On 16Mar2021 at 8am, the patient received their first of two planed doses of mRNA-1273 (Unknown lot number) intramuscularly in her right non-dominant arm for prophylaxis of COVID-19 infection. After getting the dose at 8am, she had a bad reaction where 5 min later she fainted and experienced cold hot sweats, dry mouth and felt thirsty. On Tuesday night (16Mar2021) she had flu like symptoms with unbearable body aches.  She stated on 18Mar 2021 she is felling better but tired and felt like fainting, light headed and dizzy. The patient stated that she took Advil for flu like symptoms.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, was recovering and resolving.; 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. No follow up is possible.
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Thirst
Clinical narrative: light headed; fainted; cold hot sweats; dry mouth; felt thirsty; flu symptoms; unbearable body aches; A spontaneous report  was received from a Consumer, concerning a female patient of 31 years-old-age, who received Modena's COVID-19 vaccine and she fainted and experienced cold hot sweats, dry mouth and felt thirsty.  The patient's medical history was not provided. Advil was the Concomitant products that was  provided by the reporter.  On 16Mar2021 at 8am, the patient received their first of two planed doses of mRNA-1273 (Unknown lot number) intramuscularly in her right non-dominant arm for prophylaxis of COVID-19 infection. After getting the dose at 8am, she had a bad reaction where 5 min later she fainted and experienced cold hot sweats, dry mouth and felt thirsty. On Tuesday night (16Mar2021) she had flu like symptoms with unbearable body aches.  She stated on 18Mar 2021 she is felling better but tired and felt like fainting, light headed and dizzy. The patient stated that she took Advil for flu like symptoms.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, was recovering and resolving.; 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. No follow up is possible.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Inappropriate schedule of product administration, Pruritus, Skin injury
Clinical narrative: Skin was dry and peeling; Serious Swelling of the face; Itching of the face; Redness of her face; Face was  hot; Swelling of eye; Her second shot was delayed. The second dose was supposed to be 25FEB2021. The first dose was received on 21JAN2021, and didn't receive the second dose until 09MAR2021.; A spontaneous report was received from a consumer concerning a 69-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling of eyelid, Serious Swelling of the face/swelling of face, itching/pruritus, erythema/redness of face, feeling hot/hot feeling generalized, inappropriate scheduling of vaccine, generalized, and skin damage/skin injury.   The patient's medical history was reported as she had facial fillers. Products known to have been used by the patient, within two weeks prior to the event, included metoprolol, lisinopril, celecoxib, losartan, citalopram and spironolactone.  On 21 Jan 2021,the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 09 Mar 2021 ,the patient received their second of two planned doses of mRNA (Lot number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  The first dose was received on 21 Jan 2021, and did not receive the second dose until 09 Mar 2021. The patient was delayed because of the weather, and also received a Tetanus shot, which all contributed to delay. On 10 Mar 2021, approximately after one day patient developed swelling around her eyes. On Thursday 18 Mar 2021 the patient's face was swollen, flushed, red,itchy and was hot. The patient also experienced dry and peeling skin. The event serious swelling of the face was considered as medically significant. The treatment medications used were diphenhydramine.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events swelling around eyes, flushed, red, itchy, hot were considered as resolved on 19 Mar 2021. The outcome of the events dry and peeling skin were considered as unknown.; Reporter's Comments: This report refers to a case of 69-year-old, female patient who experienced non-serious unexpected event of second dose delayed (inappropriate scheduling of vaccine,) for mRNA-1273, lot # unknown, and experienced swelling of the eyelid and face, redness of the face, feeling hot and skin injury after the second dose.  Based on a temporal association between the events and use of the mRNA-1273 , a causal relationship with the events cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swelling of eyelid
Clinical narrative: Skin was dry and peeling; Serious Swelling of the face; Itching of the face; Redness of her face; Face was  hot; Swelling of eye; Her second shot was delayed. The second dose was supposed to be 25FEB2021. The first dose was received on 21JAN2021, and didn't receive the second dose until 09MAR2021.; A spontaneous report was received from a consumer concerning a 69-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling of eyelid, Serious Swelling of the face/swelling of face, itching/pruritus, erythema/redness of face, feeling hot/hot feeling generalized, inappropriate scheduling of vaccine, generalized, and skin damage/skin injury.   The patient's medical history was reported as she had facial fillers. Products known to have been used by the patient, within two weeks prior to the event, included metoprolol, lisinopril, celecoxib, losartan, citalopram and spironolactone.  On 21 Jan 2021,the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 09 Mar 2021 ,the patient received their second of two planned doses of mRNA (Lot number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  The first dose was received on 21 Jan 2021, and did not receive the second dose until 09 Mar 2021. The patient was delayed because of the weather, and also received a Tetanus shot, which all contributed to delay. On 10 Mar 2021, approximately after one day patient developed swelling around her eyes. On Thursday 18 Mar 2021 the patient's face was swollen, flushed, red,itchy and was hot. The patient also experienced dry and peeling skin. The event serious swelling of the face was considered as medically significant. The treatment medications used were diphenhydramine.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events swelling around eyes, flushed, red, itchy, hot were considered as resolved on 19 Mar 2021. The outcome of the events dry and peeling skin were considered as unknown.; Reporter's Comments: This report refers to a case of 69-year-old, female patient who experienced non-serious unexpected event of second dose delayed (inappropriate scheduling of vaccine,) for mRNA-1273, lot # unknown, and experienced swelling of the eyelid and face, redness of the face, feeling hot and skin injury after the second dose.  Based on a temporal association between the events and use of the mRNA-1273 , a causal relationship with the events cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Concussion, Fall, Headache, Hyperhidrosis, Loss of consciousness
Clinical narrative: had a rough night as she was tossing and turning; On and OFF headaches; completely unconscious; sweaty; collapsed on the floor; heart beats really fast when she wakes up from sleep; ended up with a concussion; arm started aching; A spontaneous report was received from a consumer, concerning herself a 73-years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced her arm started aching/ pain in extremity, she had a rough night as she was tossing and turning/ sleep disorder, she was all sweaty/hyperhidrosis, collapsed on the floor/fall, completely unconscious/loss of consciousness, headaches, ended up with a concussion/concussion and her heart beats really fast when she wakes up from sleep/tachycardia.  The patient's medical history included hight blood pressure and AFib. Concomitant medications reported included diltiazem hydrochloride, apixaban, levothyroxine, montelukast, dicyclomine, alprazolam, nortriptyline.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection. On 24 Feb 2021, on same day prior to onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 0016MOA (?)) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 24 Feb 2021, after taking mRNA-1273, patient experienced arm started Aching, Tossing and Turning at night. Next morning on 25 Feb 2021, she went to the bathroom, she was all sweaty, collapsed on the Floor, completely unconscious, ended up with a concussion.  After a week CT scan done which said everything was alright. Currently she has On and off headaches and her heart beats was fast when she wakes up from sleep. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events Aching, Tossing and Turning at night, sweaty, collapsed on the Floor, completely unconscious, ended up with a concussion, headache was not reported.; Reporter's Comments: This case concerns a 73 Y/O F with serious unexpected loss of consciousness and nonserious unexpected fall, concussion, tachycardia, pain in extremity, sleep disorder, hyperhidrosis, and expected headache. Event onset on Day 2 after the first dose of mRNA-1273. Event outcome sunknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.