chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: First day after receiving my second vaccination at 12:30, I became very puky and threw up the rest of the day along with my arm that the vaccination was received went dead. The following day I regained feeling in my left arm off and on throughout the day and had body aches, chills, and had shortness of breath. Day three I began to feel better with occasional shortness of breath and I had feeling in my arm again.  I was completely back to normal by day four.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Injection site discomfort, Injection site swelling
Clinical narrative: Initial not concerning:  Bad headache the next morning which passed by the end on the day. Injection site swelling and discomfort for a few days.   The reason I am submitting this form is fatigue, mild diarrhea, moderate nausea, and vomiting starting 8 days after the vaccine. So far it's nothing serious. I haven't been out to catch anything so it seems related. I thought you may want the data because of the strang delay in gastrointestinal symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Initial not concerning:  Bad headache the next morning which passed by the end on the day. Injection site swelling and discomfort for a few days.   The reason I am submitting this form is fatigue, mild diarrhea, moderate nausea, and vomiting starting 8 days after the vaccine. So far it's nothing serious. I haven't been out to catch anything so it seems related. I thought you may want the data because of the strang delay in gastrointestinal symptoms.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Muscle aches, severe chills,  dizziness, fatigue, temperature of 101.7 and severe injection site pain all resolved 24 hours from onset. Treated with Ibuprofen and Naproxen Sodium
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure systolic increased, Extremity contracture, Hypoaesthesia, Injection site pain
Clinical narrative: After my 2nd dose administration, I sat in an observation tent with 4 resident doctors. This is protocol at my hospital to assess for any adverse reactios. About 10 minutes later, I started to feel both of my arms (from should all the way to tips of my fingers) start to get tingly with an intense vibrating sensation. I tried to calm myself down, however numbness began to occur to both BUE seconds after. Next thing that happened, bilateral fingers became visually contracted however numb and I could not move my fingers. I also got a tingly/prickly sensation to my cheeks all the way down to my chin after the hand numbess. The resident doctors quickly took me by wheelchair to a private room where they checked my vital signs. BP was elevated with systolic in 190's, HR around 120s, and my limbs were all cold. By this time it was around 6pm and they were trying to calm me down as I started to have a panic attack. My parents came to pick me up at 7pm when my vitals were stable. I rested at home, and the contraction to my fingers/numbess did not subside until 8:30pm.  The following day, my left arm (injection site) had a soreness level of 9/10. Tylenol was used to relieve pain.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Panic attack, Paraesthesia, Peripheral coldness, Vibratory sense increased
Clinical narrative: After my 2nd dose administration, I sat in an observation tent with 4 resident doctors. This is protocol at my hospital to assess for any adverse reactios. About 10 minutes later, I started to feel both of my arms (from should all the way to tips of my fingers) start to get tingly with an intense vibrating sensation. I tried to calm myself down, however numbness began to occur to both BUE seconds after. Next thing that happened, bilateral fingers became visually contracted however numb and I could not move my fingers. I also got a tingly/prickly sensation to my cheeks all the way down to my chin after the hand numbess. The resident doctors quickly took me by wheelchair to a private room where they checked my vital signs. BP was elevated with systolic in 190's, HR around 120s, and my limbs were all cold. By this time it was around 6pm and they were trying to calm me down as I started to have a panic attack. My parents came to pick me up at 7pm when my vitals were stable. I rested at home, and the contraction to my fingers/numbess did not subside until 8:30pm.  The following day, my left arm (injection site) had a soreness level of 9/10. Tylenol was used to relieve pain.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: At the time of injection, experienced light headedness and chest pain on the right side.  One week after injection, the injection site became itchy, red and warm to the touch.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Peripheral swelling
Clinical narrative: COVID ARM Inflammation, itching of vaccine site beginning on the 8th day after vaccine was administered. Used Anti-itch cream Still in progress
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Malaise
Clinical narrative: general malaise, headache, body ache, shivering, joint pain, pain at injection site
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: general malaise, headache, body ache, shivering, joint pain, pain at injection site
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: lump just above injection site, one inch diameter
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: 101 fever, chills, body aches, fatigue, arm soreness, sore throat last 8 hours
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 101 fever, chills, body aches, fatigue, arm soreness, sore throat last 8 hours
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 8 days after the vaccine, I?ve developed a red itchy spot at the injection site
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Dizziness, Fatigue
Clinical narrative: FEVER (103.5F peak) AND CHILLS = 02/05/21 7pm-02/06/21 9am SLIGHT DIZZINESS = 02/05/21 10pm-02/05/21 11pm HEARING FADING IN AND OUT = 02/05/21 10pm-02/05/21 11pm DIARRHEA = 02/06/21 7pm-02/07/21 1pm OVERALL BODY ACHES = 02/05/21 7pm-02/09/21 9am  HEADACHE (Intermittent) = 02/05/21 7pm-Present INJECTION SITE PAIN = 02/05/21 7pm-Present NO APPETITE = 02/05/21 7pm-Present FATIGUE (Extreme to Medium) = 02/05/21 7pm-Present  TREATMENT: Stayed at home and rested, drank lots of water, took Ibuprofen as needed for fever and body aches/headaches. Did not go to the doctor.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoacusis, Injection site pain, Pain, Pyrexia
Clinical narrative: FEVER (103.5F peak) AND CHILLS = 02/05/21 7pm-02/06/21 9am SLIGHT DIZZINESS = 02/05/21 10pm-02/05/21 11pm HEARING FADING IN AND OUT = 02/05/21 10pm-02/05/21 11pm DIARRHEA = 02/06/21 7pm-02/07/21 1pm OVERALL BODY ACHES = 02/05/21 7pm-02/09/21 9am  HEADACHE (Intermittent) = 02/05/21 7pm-Present INJECTION SITE PAIN = 02/05/21 7pm-Present NO APPETITE = 02/05/21 7pm-Present FATIGUE (Extreme to Medium) = 02/05/21 7pm-Present  TREATMENT: Stayed at home and rested, drank lots of water, took Ibuprofen as needed for fever and body aches/headaches. Did not go to the doctor.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lip swelling, Lymphadenopathy, Myalgia
Clinical narrative: Swollen lips where filler has been  Swollen lymph nodes Headache fatigue muscle pain
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Skin discolouration
Clinical narrative: COVID ARM. Huge red area below the injection site of the Deltoid muscle darkening all the way down to the elbow and pooling there as a huge red arc. Painless with no itching.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Injection site inflammation, Injection site pain, Rash
Clinical narrative: On day seven after receiving the vaccination, a rash appeared on the back of the neck that progressed around the entire neck by day eight.  On day nine rash appeared on the back of both arms and significant left arm pain distal to the injection site accompanied by inflammation.  The inflammation appears to be present all over.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia
Clinical narrative: headache, lightheadedness, and muscle soreness
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Tremor
Clinical narrative: Client reported being anxious prior to vaccination, but did some deep breathing which she felt helped calm her down.  After the injection, she felt dizzy, "the room was spinning" and she was not able to focus on what the vaccinator was saying.  She reported feeling dizzy to the vaccinator who kept her seated and provided bottled water.  Clinic Manager and Vaccine Group Supervisor took initial vital signs.  Client also appeared to be shaking.  10:20am: BP: 130/96, HR: 90.  At about 10:25am, client reported feeling better.  VGS moved client to a seat near the clinic staff area to complete her 30 minute waiting period.  VGS took vital signs.  10:30am: BP: 120/90, HR: 88.  Client was no longer visibly shaking.  She reported that her husband was waiting in the car to take her home.  Client's condition improved and was released from the clinic to return to her home.  Client was escorted to her car by the Deputy Safety Officer.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Hard, itchy bump at injection site. Cannot see if discolored due to tattoo. Bump is approximately 1cm wide.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Severe right arm pain, chills, low grade fever, body aches, nausea. Most severe symptoms lasting 24 hours
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Night sweats
Clinical narrative: Nausea, Night sweats, Joint Pain in legs and lower back, Headache,  fever (99.3 to 100.9), fatigue. Treated with Tylenol , Naproxen ,  Lidocaine patch, fluids, heating pad and rest. Reduced fever, reduced joint pain, headache persisted. Time course: 24 hour period
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea, Night sweats, Joint Pain in legs and lower back, Headache,  fever (99.3 to 100.9), fatigue. Treated with Tylenol , Naproxen ,  Lidocaine patch, fluids, heating pad and rest. Reduced fever, reduced joint pain, headache persisted. Time course: 24 hour period
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, swelling (hardness) at injection site
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site rash, Muscle tightness, Pain
Clinical narrative: Rash and bruised appearance around injection site, one week after vaccine was administered.  Experiencing tight muscles and soreness.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Terrible headache that lasted 3 days
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pruritus
Clinical narrative: Red and itches
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Bone pain, Chills, Exercise tolerance decreased
Clinical narrative: Days 1-3: Headache, nausea, weakness, low-grade fever, chills, limited neck movement, limited left arm movement, bone pain in both legs and hips, full back pain Days 4-6: Headache, nausea, fatigue and poor activity tolerance Days 7-9: Hives/rash first appeared on upper arms, then progressed to lower arms and neck. Hives increased to mid and upper back, and both legs. Leg rash not raised, look like petechiae. Pruritus most severe in shoulders, neck, back.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Joint range of motion decreased, Nausea, Pruritus
Clinical narrative: Days 1-3: Headache, nausea, weakness, low-grade fever, chills, limited neck movement, limited left arm movement, bone pain in both legs and hips, full back pain Days 4-6: Headache, nausea, fatigue and poor activity tolerance Days 7-9: Hives/rash first appeared on upper arms, then progressed to lower arms and neck. Hives increased to mid and upper back, and both legs. Leg rash not raised, look like petechiae. Pruritus most severe in shoulders, neck, back.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Days 1-3: Headache, nausea, weakness, low-grade fever, chills, limited neck movement, limited left arm movement, bone pain in both legs and hips, full back pain Days 4-6: Headache, nausea, fatigue and poor activity tolerance Days 7-9: Hives/rash first appeared on upper arms, then progressed to lower arms and neck. Hives increased to mid and upper back, and both legs. Leg rash not raised, look like petechiae. Pruritus most severe in shoulders, neck, back.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Flushing
Clinical narrative: Client in post vaccination waiting area. Approximately 6 minutes after arriving, a felt flushed, anxious feeling. Reports dizziness and lightheadedness. Patient requests to use nearby cot.  Staff escorted patient to cot to lie down. BP on palpation 100. At 10:20am, BP 108/76 HR68 R18.  Requests to stay lying down. At 10:38am, patient is ready to sit up. BP120/76 HR72 R 72. Patient reports "feeling normal." Continues to sit and drink offered water.  Reports did not eat breakfast this AM. Ready to depart at 1050. Final BP 110/76 HR 76, R18. No complaints
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Fatigue, Headache, Injection site pain
Clinical narrative: Exhaustion onset about 8:00 PM 1/26/21 lasting over 36 hours before starting to feel better.  I literally slept all of the next day only getting up occasionally and most of the day after that.  I started to become more normal feeling the late afternoon of 1/28/21. I also felt very stiff and uncomfortable.  Sore neck and joint pain and a slight headache.  I had a sore area across my arm (felt like a bruise although there was no discoloration) about 1 inch inch below the injection sight which was on my upper left arm.  That persisted for several days. I slept and took 1 800 mg Ibuprofen (on   1/27/2021). Am feeling better but still not feeling 100 %.  That may be due to increased allergies due to time of year of etc a
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness, Somnolence
Clinical narrative: Exhaustion onset about 8:00 PM 1/26/21 lasting over 36 hours before starting to feel better.  I literally slept all of the next day only getting up occasionally and most of the day after that.  I started to become more normal feeling the late afternoon of 1/28/21. I also felt very stiff and uncomfortable.  Sore neck and joint pain and a slight headache.  I had a sore area across my arm (felt like a bruise although there was no discoloration) about 1 inch inch below the injection sight which was on my upper left arm.  That persisted for several days. I slept and took 1 800 mg Ibuprofen (on   1/27/2021). Am feeling better but still not feeling 100 %.  That may be due to increased allergies due to time of year of etc a
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain
Clinical narrative: chills, aches, and nausea.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Caller reports administration of ROTATEQ after temperature excursion; This spontaneous report was received from a reporter and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 11-JAN-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter oral route, lot # 1742457 and expiration date 06-JAN-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 1.3 degree Celsius (°C) for 19 minutes on an unknown date; no previous temperature excursion were reported.  The call was made due to a digital data logger.   Lot No. 1742457 has been verified to be a valid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), expiration date reported as 16-FEB-2022, but upon internal validation established as 06-JAN-2022.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: administration of rotateq after temperature excursion; This spontaneous report was received from an other reporter (unspecified) and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.  On 15-JAN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml, po (orally), lot # 1691141 (valid lot #), expiration date reported and also validated as 01-NOV-2021, for prophylaxis. It was detected by the data logger, that the vaccine had temperature excursion (product storage error). It was stored at the temperature of 1.3 degree Celsius (C) for 19 minutes. No previous temperature excursion reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EVENT; product storage error; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On 05-FEB-2021, the patient received improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T031820 with expiration date of 10-MAY-2022, 0.5 milliliter for prophylaxis.   The vaccines experienced temperature excursión of 47.7 degrees F for 30 minutes. No previous temperature of excursion. Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T031820; expirationdate: 10-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 79.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Arthropathy, Joint swelling, Pain
Clinical narrative: having trouble bending his right elbow; swollen right elbow; very painful; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-010782), license party for apixaban (ELIQUIS).  This case was received via Pfizer Inc (Reference number: 2021102713) on 26-Jan-2021 and was forwarded to BMS on 02-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of arthropathy (having trouble bending his right elbow), joint swelling (swollen right elbow) and pain (very painful) in 79-year-old male patient who received apixaban (ELIQUIS) tablet for cerebrovascular accident prophylaxis. Co-suspect products included COVID-19 vaccine injection for prevention. Concurrent medical conditions included congestive heart failure, type II diabetes mellitus and hypertension. On an unknown date, the patient started ELIQUIS (oral), 1 tab twice a day. On 21-Jan-2021, the patient started COVID-19 vaccine (intramuscular). On 22-Jan-2021, an unknown time after starting ELIQUIS, the patient experienced arthropathy (having trouble bending his right elbow), joint swelling (swollen right elbow) and pain (very painful). The dose of ELIQUIS (oral) was not changed. At the time of the report, arthropathy outcome was unknown, joint swelling did not resolve and pain was resolving. For ELIQUIS (oral), the reporter did not provide any causality assessments.
Age: 79.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity, Peripheral swelling
Clinical narrative: having trouble bending his right elbow; swollen right elbow; very painful; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-010782), license party for apixaban (ELIQUIS).  This case was received via Pfizer Inc (Reference number: 2021102713) on 26-Jan-2021 and was forwarded to BMS on 02-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of arthropathy (having trouble bending his right elbow), joint swelling (swollen right elbow) and pain (very painful) in 79-year-old male patient who received apixaban (ELIQUIS) tablet for cerebrovascular accident prophylaxis. Co-suspect products included COVID-19 vaccine injection for prevention. Concurrent medical conditions included congestive heart failure, type II diabetes mellitus and hypertension. On an unknown date, the patient started ELIQUIS (oral), 1 tab twice a day. On 21-Jan-2021, the patient started COVID-19 vaccine (intramuscular). On 22-Jan-2021, an unknown time after starting ELIQUIS, the patient experienced arthropathy (having trouble bending his right elbow), joint swelling (swollen right elbow) and pain (very painful). The dose of ELIQUIS (oral) was not changed. At the time of the report, arthropathy outcome was unknown, joint swelling did not resolve and pain was resolving. For ELIQUIS (oral), the reporter did not provide any causality assessments.
Sex: U
Vaccine: FLUX, MENB, MNQ
Symptoms: Dizziness, Viral infection
Clinical narrative: felt dizzy; VIRAL INFECTION FOLLOWING; This case was reported by a physician via sales rep and described the occurrence of dizziness in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and MENACTRA for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Influenza vaccine Quadrivalent unspecified season and MENACTRA. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Influenza vaccine Quadrivalent unspecified season, the patient experienced dizziness and viral infection. On an unknown date, the outcome of the dizziness and viral infection were unknown.   The reporter considered the dizziness and viral infection to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the reporter considered the dizziness and viral infection to be related to Influenza vaccine Quadrivalent unspecified season.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by the mother. The age at vaccination was not reported. The patient felt dizzy, followed by viral infection. The mother of the patient looked up Meningococcal B and was convinced that it was pulled up adverse reaction. She did not want to report it because it was 3 vaccines. It was unknown if the reporter considered the dizziness and viral infection to be related to Menectra. This case had been linked with US2020AMR261157 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR261157:Same reporter
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Gastrointestinal haemorrhage, SARS-CoV-2 test positive
Clinical narrative: Stomach bleed from blood thinners; Tested positive for COVID-19; A spontaneous report was received from a consumer concerning a 91-year-old, White, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a positive Covid-19 test and the serious adverse event of stomach bleed from blood thinners.    The patient's medical history, as provided by the reporter, included dialysis three times a week with a port in his left arm, broken hip, and stomach bleed. No medication allergies reported. Concomitant medications reported included acetylsalicylic acid and multiple medications not otherwise specified.    On an unknown date prior to receiving the vaccine, the patient began to experience stomach bleed. He was hospitalized and discharged before the vaccination.  On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot number 025J20A, expiration date 29 Jun 2021) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, after the injection, the patient was tested for Covid-19, and the results were positive.   On an undisclosed date purported to be two weeks after vaccination, the patient was hospitalized due to a stomach bleed from blood thinners, and an unknown blood vessel procedure was performed.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, tested positive for Covid-19 and stomach bleed from blood thinners, was not reported.; Reporter's Comments: A spontaneous report concerns a 91-year-old, White, male, patient, with medical history of dialysis three times a week with a port in his left arm, broken hip, and stomach bleed, who experienced a positive Covid-19 test and the serious event of stomach bleed from blood thinners. The event of positive Covid-19 test occurred on the same day after the administration of the first dose of mRNA-1273 (Lot number 025J20A, expiration date 29 Jun 2021) and stomach bleed occurred on an unknown date after the vaccine administration. Treatment for stomach bleed included blood vessel procedure. Based on the information provided, there is not a definite association between the vaccine administration and the reported events. Use of blood thinners could have contributed to the event of Stomach bleed, also confounded by the patient's medical history of stomach bleed and concomitant use of acetylsalicylic acid. COVID positive test was obtained on the same day as vaccination and unlikely to have resulted from mRNA-1273 administration.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Syncope, Tremor
Clinical narrative: Syncope; Shaking; Struggling to breathe; A spontaneous report was received from a consumer concerning a 90-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed syncope, shaking, and struggling to breathe.  The patient's medical history was not provided. Concomitant medications reported included warfarin, ezetimibe, bupropion, finasteride, tamsulosin, furosemide, potassium chloride, rosuvastatin, and nitrofurantoin.    On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Jan 2021, after vaccine administration, the patient stayed at the vaccination site for fifteen minutes to watch for any reaction, he had none, so he left. Later that night the patient began shaking and struggling to breathe, so 911 was called. At the hospital, the patient was diagnosed with syncope. He spent overnight in the hospital and had an echocardiogram the following day. No results were provided for the echo, but the patient was cleared to go home after a sixteen-hour hospital stay. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, syncope, shaking, and struggling to breathe, was resolved.; Reporter's Comments: This case concerns a 90 year-old, male patient, who experienced events of syncope, shaking, and struggling to breathe.  The events occurred the same night after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Clumsiness, Diarrhoea, Dizziness, Dysstasia, Fall
Clinical narrative: Flushed; Body aches; Red rashy spot; Fatigued; The site on my left arm got to a baseball size; Headaches; Felt like I would throw up; Ended up fainting/ went down for a second time; Diarrhea; Light headed; Discombobulated; A spontaneous report was received from a 58 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea, felt that she would throw up, light headed, fainted, discombobulated, site on her left arm got to a baseball size, and in the middle was a red rashy spot, flushed, fatigued, had body aches and headaches.   The patient's medical history included high blood pressure. Relevant concomitant medications included unknown blood pressure medication.    On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, around three, the patient experienced diarrhea, she thought it was food poisoning. While on the "pot" with diarrhea she felt that she would throw up. She mentioned that she became lightheaded but did not throw up and ended up fainting. She fell off the pot and decided to lay down in her bed. She got lightheaded again and went down for a second time. She stated she had a difficult time getting up; she crawled to the bed. When she attempted to stand up, she could feel she was lightheaded again. The patient mentioned that maybe she was down 45 minutes before getting to lay on her bed. She felt discombobulated. She felt very clumsy when trying to dial her sister's number; she left a message on the machine and was struggling to get her words together. The site on her left arm got to a baseball size, and in the middle was a red rashy spot.  On Friday evening, 26 Jan 2021, the patient stated she started feeling better. She mentioned that she was flushed, fatigued and had body aches. The patient stated she hasn't tried any treatments but took paracetamol for headaches and tried to rest.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, diarrhea, felt that she would throw up, light headed, fainted, discombobulated, site on her left arm got to a baseball size, and in the middle was a red rashy spot, were resolving. The outcome of the events, headaches, flushed, fatigued and body aches, were unknown.; Reporter's Comments: This case concerns a 58 year old female patient with medical history of high blood pressure, who experienced a serious unexpected event of Syncope and NS unexpected events of diarrhea, nausea, dizziness, confusional state, injection site swelling, rash erythematous, flushing , fatigue, pain and headache. The events occurred approximately 8 days after first dose of the study medication administration. she only took paracetamol for headaches and tried to rest without any other treatment.  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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Flushing, Headache, Injection site swelling
Clinical narrative: Flushed; Body aches; Red rashy spot; Fatigued; The site on my left arm got to a baseball size; Headaches; Felt like I would throw up; Ended up fainting/ went down for a second time; Diarrhea; Light headed; Discombobulated; A spontaneous report was received from a 58 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea, felt that she would throw up, light headed, fainted, discombobulated, site on her left arm got to a baseball size, and in the middle was a red rashy spot, flushed, fatigued, had body aches and headaches.   The patient's medical history included high blood pressure. Relevant concomitant medications included unknown blood pressure medication.    On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, around three, the patient experienced diarrhea, she thought it was food poisoning. While on the "pot" with diarrhea she felt that she would throw up. She mentioned that she became lightheaded but did not throw up and ended up fainting. She fell off the pot and decided to lay down in her bed. She got lightheaded again and went down for a second time. She stated she had a difficult time getting up; she crawled to the bed. When she attempted to stand up, she could feel she was lightheaded again. The patient mentioned that maybe she was down 45 minutes before getting to lay on her bed. She felt discombobulated. She felt very clumsy when trying to dial her sister's number; she left a message on the machine and was struggling to get her words together. The site on her left arm got to a baseball size, and in the middle was a red rashy spot.  On Friday evening, 26 Jan 2021, the patient stated she started feeling better. She mentioned that she was flushed, fatigued and had body aches. The patient stated she hasn't tried any treatments but took paracetamol for headaches and tried to rest.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, diarrhea, felt that she would throw up, light headed, fainted, discombobulated, site on her left arm got to a baseball size, and in the middle was a red rashy spot, were resolving. The outcome of the events, headaches, flushed, fatigued and body aches, were unknown.; Reporter's Comments: This case concerns a 58 year old female patient with medical history of high blood pressure, who experienced a serious unexpected event of Syncope and NS unexpected events of diarrhea, nausea, dizziness, confusional state, injection site swelling, rash erythematous, flushing , fatigue, pain and headache. The events occurred approximately 8 days after first dose of the study medication administration. she only took paracetamol for headaches and tried to rest without any other treatment.  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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Nausea, Pain, Rash erythematous, Syncope
Clinical narrative: Flushed; Body aches; Red rashy spot; Fatigued; The site on my left arm got to a baseball size; Headaches; Felt like I would throw up; Ended up fainting/ went down for a second time; Diarrhea; Light headed; Discombobulated; A spontaneous report was received from a 58 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea, felt that she would throw up, light headed, fainted, discombobulated, site on her left arm got to a baseball size, and in the middle was a red rashy spot, flushed, fatigued, had body aches and headaches.   The patient's medical history included high blood pressure. Relevant concomitant medications included unknown blood pressure medication.    On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, around three, the patient experienced diarrhea, she thought it was food poisoning. While on the "pot" with diarrhea she felt that she would throw up. She mentioned that she became lightheaded but did not throw up and ended up fainting. She fell off the pot and decided to lay down in her bed. She got lightheaded again and went down for a second time. She stated she had a difficult time getting up; she crawled to the bed. When she attempted to stand up, she could feel she was lightheaded again. The patient mentioned that maybe she was down 45 minutes before getting to lay on her bed. She felt discombobulated. She felt very clumsy when trying to dial her sister's number; she left a message on the machine and was struggling to get her words together. The site on her left arm got to a baseball size, and in the middle was a red rashy spot.  On Friday evening, 26 Jan 2021, the patient stated she started feeling better. She mentioned that she was flushed, fatigued and had body aches. The patient stated she hasn't tried any treatments but took paracetamol for headaches and tried to rest.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, diarrhea, felt that she would throw up, light headed, fainted, discombobulated, site on her left arm got to a baseball size, and in the middle was a red rashy spot, were resolving. The outcome of the events, headaches, flushed, fatigued and body aches, were unknown.; Reporter's Comments: This case concerns a 58 year old female patient with medical history of high blood pressure, who experienced a serious unexpected event of Syncope and NS unexpected events of diarrhea, nausea, dizziness, confusional state, injection site swelling, rash erythematous, flushing , fatigue, pain and headache. The events occurred approximately 8 days after first dose of the study medication administration. she only took paracetamol for headaches and tried to rest without any other treatment.  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: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Oxygen therapy, Renal failure, Urinary retention
Clinical narrative: Death; kidney failure (unable to urinate); shortness of breath; required oxygen; A spontaneous report was received from consumer concerning an 87-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, kidney failure and death.     The patient's medical history included advanced kidney and heart disease. 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 17 Jan 2021, the husband reported that the patient experienced adverse events. Symptoms included shortness of breath and kidney failure (unable to urinate). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath.  Action taken with mRNA-1273 in response to the events was not applicable.  On 20 Jan 2021, the patient died. The cause of death was unknown. Autopsy details were unknown.; Reporter's Comments: This case concerns a 87-year-old, female patient with the medical history of advanced kidney and heart disease, who experienced fatal unexpected event of dyspnea, renal failure and death. The events of dyspnea and renal failure occurred 12 days and the event of death occurred 15 days after the first dose of mRNA-1273 (Lot: unknown). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. The cause of death was unknown. Autopsy details were unknown.  Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However, the history of advanced kidney and heart disease may remain as confounder. Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Cellulitis, Headache, Retching
Clinical narrative: Also gagged a couple of times, but not really a stomachache; little bit of a headache; temperature of 101 with first shot; Cellulitis really bad right now; A spontaneous report was received from a consumer who was also a 66-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis really bad right now, gagged a couple times, but not really a stomachache, temperature of 101 degrees Fahrenheit and a little bit of a headache.  The patient's medical history included what she described as having reactions to things sometimes, and has an Epi-Pen, however has never ever used it.   On 26 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 31 Jan 2021, the patient increase in body temperature to 101 degrees Fahrenheit. On 01 Feb 2021, approximately one week after receiving the mRNA-1273 vaccine, the patient reported a visit to her physician. She has cellulitis really bad right now. She also reports a little bit of a headache and that she had gagged a couple times but not really a stomachache.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, cellulitis really bad right now, gagged a couple times, but not really a stomachache, temperature of 101 degrees Fahrenheit and a little bit of a headache were not reported.; Reporter's Comments: This case concerns a 66 year-old, female patient, who experienced events of a temperature of 101 degrees Fahrenheit,  cellulitis really bad right now, a little bit of a headache, and also gagged a couple times. The events occurred approximately 1 week after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate decreased
Clinical narrative: Heart rate dropped to 30; A spontaneous report was received from consumer concerning a 56 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient's heart rate had dropped to 30.  The patient's medical history was organ transplant. Concomitant product use was not provided.  On 22-Jan-2021, the patient received the first of two planned doses of mRNA-1273, Batch number 011J20A, intramuscularly for prophylaxis of Covid-19 infection.  On an unknown date, the patient's "heart rate was dropped to 30". He was hospitalized for 6 days.   Treatment medication was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was unknown.; Reporter's Comments: This case concerns a 56 year old male patient with relevant medical history of organ transplant who received the first of two planned doses of mRNA-1273 (Batch number 011J20A) intramuscularly for prophylaxis of Covid-19 infection and experienced a serious unlisted event of decreased heart to 30 and was hospitalized for six days. Treatment details not provided. Very limited information regarding this event has been provided at this time which precludes a proper medical assessment and in addition, patient's history of organ transplant may provide an alternative explanation and the event is unlikely related to the vaccine. Further follow has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac normal, Chest pain, Myocarditis, Pyrexia
Clinical narrative: Chest pain; Acute Myocarditis; Fever; A spontaneous report was received from a healthcare professional concerning a 35-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed chest pain, myocarditis, and fever.   The patient's medical history included COVID-19 in Oct of 2020.  No relevant concomitant medications were reported.   On 29 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (lot number or batch number not provided) intramuscularly (in the left arm) for prophylaxis of COVID-19 infection.   On an unknown date after receiving vaccine the patient developed a fever and chest pain.  On 31 Dec 2020 the patient was admitted to the hospital where a heart catheterization was done-negative results.  The patient was diagnosed with myocarditis.  He was scheduled to receive his second dose of vaccine on 03 Feb 2021.    No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events chest pain, myocarditis, and fever were not reported.; Reporter's Comments: This case concerns a 35-year-old, male patient with a medical history of COVID-19, who experienced a serious unexpected event of chest pain, myocarditis and an expected event of pyrexia. The events of chest pain and pyrexia occurred on an unspecified date and the event of myocarditis occurred 3 days after the first dose of mRNA-1273. A heart catheterization was done-negative results.Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Pyrexia, X-ray abnormal
Clinical narrative: Pneumonia; 104 Fever; A spontaneous report was received from a consumer who was also a 71-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 104 fever and pneumonia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 19 Jan 2021, after receiving the vaccination, the patient reported a 104 degrees Fahrenheit fever. The patient went to his health care provider (HCP). X-ray was taken. Pneumonia was diagnosed. Treatment included prednisone, antibiotic and nebulizer. The patient was also prescribed albuterol but did not use.  On 21 Jan 2021, the fever had resolved.  On 29 Jan 2021, the subject returned to the doctor. On the same day, pneumonia was gone.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the event was reported 104 fever was resolved on 21 Jan 2021. The outcome for the event pneumonia was reported resolved on 29 Jan 2021.; Reporter's Comments: This case concerns a 71-year-old male subject, who experienced a serious unexpected event of Pneumonia, and non-serious expected event of Pyrexia. The events occurred same day after the first dose of the mRNA-1273 administration. Treatment included prednisone, antibiotic and nebulizer. Pyrexia resolved 2 day after, and Pneumonia resolved 10 days after first dose of vaccination. Since Pneumonia has insidious onset rather than acute onset, the event was possibly caused by underlying condition confounded by elderly age of patient. Very limited information regarding these events have been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event of Pneumonia and Pyrexia, a causal relationship cannot be excluded.