chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Paraesthesia oral
Clinical narrative: Lips began tingling (similar to when administered novocaine at the dentist) and tightness along jawline to left ear after I left the site, approximately 40 minutes after injection. After about 1 1/2  hour the sensation lessened.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Hives, SOB, itching
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Hyperhidrosis, Oral pruritus, Palpitations, Pruritus
Clinical narrative: Hives, SOB, itching
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Throat tightness
Clinical narrative: Hives, SOB, itching
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient may have inadvertently been given 1cc of Moderna CVID vaccine instead of 0.5cc. Patient was notified. State was notified
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia, Night sweats, Pyrexia
Clinical narrative: headache, muscle aches and pains, night sweats, fever, arm very sore at site of injection 3 days later
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine at room temperature > 6 hours at time of administration.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Bronchitis, Chest X-ray normal, Chest pain, Cough
Clinical narrative: On 02/24/21 & 02/25/21,  I had body aches, fever, nasal drainage, and fatigue. On 02/25/21 I visited the pt care and was swabbed for covid - negative.  On 02/26/21 I began to cough and  felt fatigue. I visited an pt care - tested negative for covid again, & was diagnosed with bronchitis - given a Rocephin & steroid shot + oral antibiotics & an inhaler. On 02/28/21 my left eye broke out in hives. I took benadryl. On 03/01/21 I attempted to go back to work and became over heated, short of breath, and coughed, felt extreme fatigue. I left early and slept from 3pm - the next day. On 03/02/21 I visited my primary care dr and was diagnosed with an adverse reaction to the vaccine and lung inflammation. I was given oxygen in office due to it being low and me being short of breath. Still experiencing coughing, shortness of breath, pain in chest, nasal congestion, fatigue - I was given another steroid shot and a 7 day steroid pack. Chest xray was normal. On 03/09/21 I visited a pulmonologist and was started on breathing treatments, high dose steroid pack, antibiotics, and a different inhaler. Today, 03/11/21 I am experiencing chest pain, fatigue, shortness of breath at rest and on exertion, and extreme brain fog, I have been out of work since 02/24/21.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Hyperhidrosis, Impaired work ability
Clinical narrative: On 02/24/21 & 02/25/21,  I had body aches, fever, nasal drainage, and fatigue. On 02/25/21 I visited the pt care and was swabbed for covid - negative.  On 02/26/21 I began to cough and  felt fatigue. I visited an pt care - tested negative for covid again, & was diagnosed with bronchitis - given a Rocephin & steroid shot + oral antibiotics & an inhaler. On 02/28/21 my left eye broke out in hives. I took benadryl. On 03/01/21 I attempted to go back to work and became over heated, short of breath, and coughed, felt extreme fatigue. I left early and slept from 3pm - the next day. On 03/02/21 I visited my primary care dr and was diagnosed with an adverse reaction to the vaccine and lung inflammation. I was given oxygen in office due to it being low and me being short of breath. Still experiencing coughing, shortness of breath, pain in chest, nasal congestion, fatigue - I was given another steroid shot and a 7 day steroid pack. Chest xray was normal. On 03/09/21 I visited a pulmonologist and was started on breathing treatments, high dose steroid pack, antibiotics, and a different inhaler. Today, 03/11/21 I am experiencing chest pain, fatigue, shortness of breath at rest and on exertion, and extreme brain fog, I have been out of work since 02/24/21.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Pneumonitis, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: On 02/24/21 & 02/25/21,  I had body aches, fever, nasal drainage, and fatigue. On 02/25/21 I visited the pt care and was swabbed for covid - negative.  On 02/26/21 I began to cough and  felt fatigue. I visited an pt care - tested negative for covid again, & was diagnosed with bronchitis - given a Rocephin & steroid shot + oral antibiotics & an inhaler. On 02/28/21 my left eye broke out in hives. I took benadryl. On 03/01/21 I attempted to go back to work and became over heated, short of breath, and coughed, felt extreme fatigue. I left early and slept from 3pm - the next day. On 03/02/21 I visited my primary care dr and was diagnosed with an adverse reaction to the vaccine and lung inflammation. I was given oxygen in office due to it being low and me being short of breath. Still experiencing coughing, shortness of breath, pain in chest, nasal congestion, fatigue - I was given another steroid shot and a 7 day steroid pack. Chest xray was normal. On 03/09/21 I visited a pulmonologist and was started on breathing treatments, high dose steroid pack, antibiotics, and a different inhaler. Today, 03/11/21 I am experiencing chest pain, fatigue, shortness of breath at rest and on exertion, and extreme brain fog, I have been out of work since 02/24/21.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus operation, Urticaria
Clinical narrative: On 02/24/21 & 02/25/21,  I had body aches, fever, nasal drainage, and fatigue. On 02/25/21 I visited the pt care and was swabbed for covid - negative.  On 02/26/21 I began to cough and  felt fatigue. I visited an pt care - tested negative for covid again, & was diagnosed with bronchitis - given a Rocephin & steroid shot + oral antibiotics & an inhaler. On 02/28/21 my left eye broke out in hives. I took benadryl. On 03/01/21 I attempted to go back to work and became over heated, short of breath, and coughed, felt extreme fatigue. I left early and slept from 3pm - the next day. On 03/02/21 I visited my primary care dr and was diagnosed with an adverse reaction to the vaccine and lung inflammation. I was given oxygen in office due to it being low and me being short of breath. Still experiencing coughing, shortness of breath, pain in chest, nasal congestion, fatigue - I was given another steroid shot and a 7 day steroid pack. Chest xray was normal. On 03/09/21 I visited a pulmonologist and was started on breathing treatments, high dose steroid pack, antibiotics, and a different inhaler. Today, 03/11/21 I am experiencing chest pain, fatigue, shortness of breath at rest and on exertion, and extreme brain fog, I have been out of work since 02/24/21.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Eye swelling
Clinical narrative: Right eye is swollen and heavy feeling.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Myalgia, Pyrexia, Tinnitus
Clinical narrative: first night high fever 103, bad chills, muscle pain.  Next night tinnitus.  I have existing tinnitus that is not that noticable.  This increased the volume 3 times.  lost weight, 3 pounds not since injection.  stomach pain 3rd night.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Urticaria
Clinical narrative: Add:Hx of anaphylaxis. Reported hives and nausea after first shot. Did not receive 2nd shot. Unknown referral plan.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Balance disorder, Eye pain, Headache, Lethargy
Clinical narrative: Off balance in am; headache; weak/lethargic; eyes ache;
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Laboratory test normal, Syncope
Clinical narrative: PMH dementia, HTN & syncope who experienced a syncopal episode during the post vaccine observation. Episode like historical syncopal event s with feeling overheated when over tired or worried. Transferred to ED, Labs, EKG within pt's norm's. Given IV Fluid and discharged to home.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Large size of  a  Orange,  reddish in color, warm to touch.  Went to local Urgent Care last night my husband noticed it had gotten larger with more color than the day before, they gave me 7 days of  Cephalexin 500mg, 3 times a day for 7 days.  They told me to take Benadryl when needed and Claritan   daily.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular
Clinical narrative: scattered erythematous papules scattered over upper extremity and trunk
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Dysstasia, Epistaxis, Injection site pain
Clinical narrative: 3/3 to 3/6 sore arm at injection site   3/5 in the morning high pressure in my right sinus (bloody nose) it subsided.  3/6  Pain in my right breast tissue that lasted a couple of days.  3/8 started getting a sore right hip in the afternoon and could barely lay down. The pain lasted all night and in the morning I could barely get out of bed.  I was able to slide out of bed with considerable pain.  Once up I struggled to bend at all. My husband had to put my socks and shoes on.  I had to take him to get a medical procedure that morning and I could barely get in the car.  I took an Alieve before we left because   sitting down was excruciating.  I had everything I could do to get up and down from chairs while waiting.  When we got back about 10:30 I took another Alieve.  It was starting to calm down.  I took another Alieve later in the evening and today it still hurts but not as bad.  Now it includes my right Knee.   I have never had these pains before.   I am concerned about my second shot.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Paranasal sinus discomfort
Clinical narrative: 3/3 to 3/6 sore arm at injection site   3/5 in the morning high pressure in my right sinus (bloody nose) it subsided.  3/6  Pain in my right breast tissue that lasted a couple of days.  3/8 started getting a sore right hip in the afternoon and could barely lay down. The pain lasted all night and in the morning I could barely get out of bed.  I was able to slide out of bed with considerable pain.  Once up I struggled to bend at all. My husband had to put my socks and shoes on.  I had to take him to get a medical procedure that morning and I could barely get in the car.  I took an Alieve before we left because   sitting down was excruciating.  I had everything I could do to get up and down from chairs while waiting.  When we got back about 10:30 I took another Alieve.  It was starting to calm down.  I took another Alieve later in the evening and today it still hurts but not as bad.  Now it includes my right Knee.   I have never had these pains before.   I am concerned about my second shot.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine at room temperature > 6 hours at time of administration.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Co-located at Vaccine Clinic, who is administering COVID vaccine. Our Health Center is administering Covid Vaccine. Agency is administering vaccines on Health Center behalf. Patient who was supposed to be vaccinated for second dose of one vaccine, received first other vaccine. Patient made aware. Followed guidance and will not give patient another vaccine. Family made aware.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient was given the vaccine at age 16 when minimum age for vaccine is recommended to be age 18. she had no adverse effects
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Corneal epithelium defect, Eye pain, Neurotrophic keratopathy, Visual acuity reduced
Clinical narrative: central epithelial defect; neurotrophic keratopathy; Information has been received from a lawyer referring to a male patient of unknown age regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 11-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered severely painful impaired vision, redness in left eye and decreased visual acuity. The patient was diagnosed with neurotrophic keratopathy and central epithelial defect. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events neurotrophic keratopathy and central epithelial defect was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events neurotrophic keratopathy and central epithelial defect to be disability.   Upon internal review, central epithelial defect was determined to be medically significant.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Bell's palsy, Herpes zoster, Hypoacusis, Post herpetic neuralgia
Clinical narrative: Bell's palsy; postherpetic neuralgia; vision problems; hearing problems; balance problems; Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 67-year-old patient of an unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-OCT-2012, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiration date were not specified), at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster, postherpetic neuralgia, vision problems, hearing problems, balance problems and Bell's palsy. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of Bell's palsy was determined to be medically significant.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Bell's palsy; postherpetic neuralgia; vision problems; hearing problems; balance problems; Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 67-year-old patient of an unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-OCT-2012, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiration date were not specified), at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster, postherpetic neuralgia, vision problems, hearing problems, balance problems and Bell's palsy. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of Bell's palsy was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: I made my arm sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received shingles shot 8 years ago).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as per vaccine indication. The patient had the shot 8 years ago. The physician advised the patient get the new one.  The patient had the 1st dose and the patient experienced  arm sore for a few days. The patient had time till end of February to get the last part.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Coordination abnormal, Dizziness, Erythema, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; tingling extended over his entire body; lightheaded; malaise; flu syndrome; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 7th January 2019, the patient received Shingrix (intramuscular). On 8th January 2019, 1 days after receiving Shingrix, the patient experienced malaise and flu syndrome. On 11th January 2019, the patient experienced light headedness. On 14th January 2019, the patient experienced tingling. On an unknown date, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome, malaise, flu syndrome, light headedness and tingling were unknown.   It was unknown if the reporter considered the guillain barre syndrome, malaise, flu syndrome, light headedness and tingling to be related to Shingrix.  additional details: The initial information was received on 24 February 2021 via medical record (case is medically confirmed). The patient ingested shingrix vaccine on 07 January 2019. January 7, he had the SHINGRIX vaccine. January 8, he had malaise and a flu syndrome. January 11, he felt lightheaded and faint with tingling beginning in his toes, extending up his leg to knees. January 14, the tingling extended over his entire body. His body was red, He felt lethargic. He had no actual muscle weakness but noted decreased functional ability at the gym. The diagnosis of Guillain-Barre was made. He received IVIG in the hospital. The tingling decreased and has receded such that it is present from the knee down through his shins into his feet. He notes the occasional tingling in his hands since the onset of symptoms. His walking and balance are 80% improved. His balance and coordination are improved, and he is not dropping objects.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Immunoglobulin therapy, Influenza, Lethargy, Malaise, Muscle strength abnormal
Clinical narrative: Guillain-Barre syndrome; tingling extended over his entire body; lightheaded; malaise; flu syndrome; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 7th January 2019, the patient received Shingrix (intramuscular). On 8th January 2019, 1 days after receiving Shingrix, the patient experienced malaise and flu syndrome. On 11th January 2019, the patient experienced light headedness. On 14th January 2019, the patient experienced tingling. On an unknown date, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome, malaise, flu syndrome, light headedness and tingling were unknown.   It was unknown if the reporter considered the guillain barre syndrome, malaise, flu syndrome, light headedness and tingling to be related to Shingrix.  additional details: The initial information was received on 24 February 2021 via medical record (case is medically confirmed). The patient ingested shingrix vaccine on 07 January 2019. January 7, he had the SHINGRIX vaccine. January 8, he had malaise and a flu syndrome. January 11, he felt lightheaded and faint with tingling beginning in his toes, extending up his leg to knees. January 14, the tingling extended over his entire body. His body was red, He felt lethargic. He had no actual muscle weakness but noted decreased functional ability at the gym. The diagnosis of Guillain-Barre was made. He received IVIG in the hospital. The tingling decreased and has receded such that it is present from the knee down through his shins into his feet. He notes the occasional tingling in his hands since the onset of symptoms. His walking and balance are 80% improved. His balance and coordination are improved, and he is not dropping objects.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Guillain-Barre syndrome; tingling extended over his entire body; lightheaded; malaise; flu syndrome; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 7th January 2019, the patient received Shingrix (intramuscular). On 8th January 2019, 1 days after receiving Shingrix, the patient experienced malaise and flu syndrome. On 11th January 2019, the patient experienced light headedness. On 14th January 2019, the patient experienced tingling. On an unknown date, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome, malaise, flu syndrome, light headedness and tingling were unknown.   It was unknown if the reporter considered the guillain barre syndrome, malaise, flu syndrome, light headedness and tingling to be related to Shingrix.  additional details: The initial information was received on 24 February 2021 via medical record (case is medically confirmed). The patient ingested shingrix vaccine on 07 January 2019. January 7, he had the SHINGRIX vaccine. January 8, he had malaise and a flu syndrome. January 11, he felt lightheaded and faint with tingling beginning in his toes, extending up his leg to knees. January 14, the tingling extended over his entire body. His body was red, He felt lethargic. He had no actual muscle weakness but noted decreased functional ability at the gym. The diagnosis of Guillain-Barre was made. He received IVIG in the hospital. The tingling decreased and has receded such that it is present from the knee down through his shins into his feet. He notes the occasional tingling in his hands since the onset of symptoms. His walking and balance are 80% improved. His balance and coordination are improved, and he is not dropping objects.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: shigles outbreak; generalized pain; rash on groin and lower back; This case was reported by a lawyer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced shingles, generalized aching and rash. The action taken with Shingrix was unknown. On an unknown date, the outcome of the shingles, generalized aching and rash were unknown.   It was unknown if the reporter considered the shingles, generalized aching and rash to be related to Shingrix.  The initial information was received on 24 February 2021 via medical record (case is medically confirmed). The patient ingested shingrix vaccine. As per pharmacy record, on 24 September 2020 patient dispensed shingrix vaccine. The patient  generalized pain after getting shingles vaccine at pharmacy. Began night of vaccine left arm pain which generalized to whole body ache Subsequently develped rash on groin and lower back. The diagnosis was Shingles outbreak.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Oedema peripheral, Pain, Swelling
Clinical narrative: swelling in her right armpit; tiredness; achiness; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer (history of cancer). Previously administered products included Shingrix (received first dose of Shingrix an unknown date).   On 26th February 2021, the patient received the 2nd dose of Shingrix. In February 2021, 24 hrs after receiving Shingrix, the patient experienced local swelling, tiredness and pain. The action taken with Shingrix was unknown. On an unknown date, the outcome of the local swelling was not recovered/not resolved and the outcome of the tiredness and pain were recovered/resolved.   It was unknown if the reporter considered the local swelling, tiredness and pain to be related to Shingrix.  Additional details were provided as follows: The reporter does not know lot or expiration date of vaccine.  The reporter reported that she received dose of Shingrix on her right arm at pharmacy. On 27th February 2021, the patient noticed swelling in her right armpit, tiredness, and achiness. The reporter stated she was concerned as she had a history of cancer. The reporter consented to follow up. The reporter had called her health care professional and had given GlaxoSmithKline permission to follow up with her HCP.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; A spontaneous report was received form a physician concerning a male patient who received Modern's COVID-19 Vaccine and who developed Covid-19.   The patient's medical history was not provided nor was concomitant product us. Patient was reportedly recovering from Covid-19.  Prior to the onset of events, (date not provided) the patient received the first of two planned doses of mRNA-1273 (Batch number unknown) intramuscularly for prophylaxis of Covid-19 infection.  The patient was diagnosed with Covid-19 after receiving the first dose of mRNA-1273 on an unknown date. The patient was hospitalized (admission date not provided). Treatment for the illness included mechanical ventilation. No other treatment information nor relevant laboratory/diagnostic tests were provided.  Planned discharge date from the hospital was reported as 27-Feb-2021. The reporting physician asked whether the patient could have the second dose of vaccine which was due on 27-Feb-2021.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, Covid-19, was considered recovering/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.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Petechiae
Clinical narrative: Bleeds under her skin from knees to ankles; Left ankle is swollen; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bleeds under her skin from knees to ankles, left ankle is swollen.  The patient's medical history, as provided by the reporter, included, 21 years ago the patient had a virus that attacked her spleen, she does not have her spleen. She stated that two weeks before the Moderna shot she got two hips injections. Additional suspected medications included: on 29-Jan-021, two knee injections.  On 26-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13-Feb -021, the patient experienced bleeds under her skin in both legs from knees to ankles, her left ankle was swollen. She stated that the bleed spots started like little dots. She would get blood work done.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, bleeds under her skin from knees to ankles, left ankle is swollen was unknown.; Reporter's Comments: This patients petechial rash is likely due to the knee injections and unlikely to be due to Moderna Covid 19 vaccine. However, 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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Aphthous ulcer, Dry mouth, Dysgeusia, Lymphadenopathy
Clinical narrative: angioedema; swollen glands below the jaw; dry mouth; canker sores; thrush; a metal taste in his mouth; swelling of lips, tongue and gums; Rash; A spontaneous report was received from a consumer concerning a 51-year-old, male patient, who received Moderna's COVID-19 vaccine and experienced angioedema, swollen glands below jaw, dry mouth, canker sores, thrush, metal taste in mouth, swelling of lips, tongue and gums.   The patient's medical history was not provided. Concomitant product use was not provided  by the reporter.  0n 06 Jan 2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: unknown)  for prophylaxis of COVID-19 infection.   The patient developed symptoms after the first dose like dry mouth, canker sores, swollen glands below the jaw, swollen tongue, thrush, a metal taste in his mouth, and swollen lips.   On 05 Feb 2021, the patient received the second dose of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. Nothing new happened after the second dose.  On 29 Feb 2021 (the date will be confirmed) he went to ER received steroids, Benadryl and Pepcid. They treated him for angioedema. Most of the symptoms went away except for the swelling of the gums, rash and metallic taste.  The outcome of the events, angioedema, swollen glands below jaw, swollen tongue and lip, dry mouth, canker sores, thrush, swelling of lips, tongue and were resolved. The outcome of the events metal taste in mouth, gums and rash 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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema mouth, Oral candidiasis, Rash
Clinical narrative: angioedema; swollen glands below the jaw; dry mouth; canker sores; thrush; a metal taste in his mouth; swelling of lips, tongue and gums; Rash; A spontaneous report was received from a consumer concerning a 51-year-old, male patient, who received Moderna's COVID-19 vaccine and experienced angioedema, swollen glands below jaw, dry mouth, canker sores, thrush, metal taste in mouth, swelling of lips, tongue and gums.   The patient's medical history was not provided. Concomitant product use was not provided  by the reporter.  0n 06 Jan 2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: unknown)  for prophylaxis of COVID-19 infection.   The patient developed symptoms after the first dose like dry mouth, canker sores, swollen glands below the jaw, swollen tongue, thrush, a metal taste in his mouth, and swollen lips.   On 05 Feb 2021, the patient received the second dose of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. Nothing new happened after the second dose.  On 29 Feb 2021 (the date will be confirmed) he went to ER received steroids, Benadryl and Pepcid. They treated him for angioedema. Most of the symptoms went away except for the swelling of the gums, rash and metallic taste.  The outcome of the events, angioedema, swollen glands below jaw, swollen tongue and lip, dry mouth, canker sores, thrush, swelling of lips, tongue and were resolved. The outcome of the events metal taste in mouth, gums and rash 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Syncope
Clinical narrative: She states it felt like she may faint; she has been feeling unwell and not her normal self for 4 days now; she had 1 dizzy spell; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer reported for self. This 84-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Feb2021 at single dose for covid-19 immunisation. Yesterday, 23Feb2021, she had 1 dizzy spell; she sat down and the dizziness went away within seconds. She states it felt like she may faint. She states she has been feeling unwell and not her normal self for 4 days now. She's wondering if this is a serious side effect, if she should still get the second dose, and how long do the symptoms last. Outcome of the event 1 dizzy spell was recovered on 23Feb2021. Outcome of the event feeling unwell was not recovered. Outcome of another event was unknown.  Information on Lot/Batch has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dysarthria, Exophthalmos, Eye disorder, Eye movement disorder
Clinical narrative: optical neuritis; inability to move, chew, eat, etc.; inability to move, chew, eat, etc.; neurological damage; unable to speak; changes in her eyes; Her right eye was bulging; Neither eye looked in the same direction, or able to track objects; known allergies: Apparently the Covid Vaccine by Pfizer; This is a spontaneous report from a contactable consumer. The consumer reported two reports for two separate vaccine doses for the same patient. This is the first of two reports. A 74-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included advanced stages of Multiple Sclerosis, Diabetes, depressant, covid prior vaccination. The patient's concomitant medications included diabetic meds (pills), anti-depressants, etc. The patient previously received the first dose of BNT162B2 in Dec2020 at age of 74 years old for COVID-19 immunization and experienced neurological setback and it wasn't terribly obvious at that time. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. The patient (mother of the reporter) suffered a neurological setback following the first injection, although it wasn't terribly obvious at that time, in comparison to what occurred after she received the second vaccine. The patient suffered major neurological damage after the second vaccine; unable to speak, followed by an inability to move, chew, eat, etc. The reporter also noticed optical neuritis or changes in her eyes. Her right eye was bulging. Neither eye looked in the same direction, or able to track objects. The patient was currently in a long term acute hospital (pending clarification) with a tracheostomy and a food peg. She had advanced stages of Multiple Sclerosis. Reporter had since learned she had been advised by her MS doctors NOT to receive flu shots. The reporter had known this and would not have listened to the doctors at the nursing home, who recommended she receive the Covid Vaccine. This was serious. The reporter was awaiting medical records, which would provide exact dates, times, etc of the administration of the vaccines. Adverse events resulted in Disability or permanent damage. Known allergies: Apparently the Covid Vaccine by Pfizer. If treatment adverse events: unknown. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included unknown covid test: negative in Jan2021 (post vaccination). The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Mastication disorder, Nervous system disorder, Optic neuritis, Paralysis, SARS-CoV-2 test
Clinical narrative: optical neuritis; inability to move, chew, eat, etc.; inability to move, chew, eat, etc.; neurological damage; unable to speak; changes in her eyes; Her right eye was bulging; Neither eye looked in the same direction, or able to track objects; known allergies: Apparently the Covid Vaccine by Pfizer; This is a spontaneous report from a contactable consumer. The consumer reported two reports for two separate vaccine doses for the same patient. This is the first of two reports. A 74-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included advanced stages of Multiple Sclerosis, Diabetes, depressant, covid prior vaccination. The patient's concomitant medications included diabetic meds (pills), anti-depressants, etc. The patient previously received the first dose of BNT162B2 in Dec2020 at age of 74 years old for COVID-19 immunization and experienced neurological setback and it wasn't terribly obvious at that time. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. The patient (mother of the reporter) suffered a neurological setback following the first injection, although it wasn't terribly obvious at that time, in comparison to what occurred after she received the second vaccine. The patient suffered major neurological damage after the second vaccine; unable to speak, followed by an inability to move, chew, eat, etc. The reporter also noticed optical neuritis or changes in her eyes. Her right eye was bulging. Neither eye looked in the same direction, or able to track objects. The patient was currently in a long term acute hospital (pending clarification) with a tracheostomy and a food peg. She had advanced stages of Multiple Sclerosis. Reporter had since learned she had been advised by her MS doctors NOT to receive flu shots. The reporter had known this and would not have listened to the doctors at the nursing home, who recommended she receive the Covid Vaccine. This was serious. The reporter was awaiting medical records, which would provide exact dates, times, etc of the administration of the vaccines. Adverse events resulted in Disability or permanent damage. Known allergies: Apparently the Covid Vaccine by Pfizer. If treatment adverse events: unknown. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included unknown covid test: negative in Jan2021 (post vaccination). The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: PATIENT RECEIVED SHOT ON 2/25/2021 AND ON 3/7/2020 PT STARTED SHOWING SIGNS OF BELL'S PALSEY
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal sensation in eye, Corneal reflex decreased, Lacrimation increased, Mastication disorder, Mobility decreased
Clinical narrative: PATIENT RECEIVED SHOT ON 2/25/2021 AND ON 3/7/2020 PT STARTED SHOWING SIGNS OF BELL'S PALSEY
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Sensory disturbance
Clinical narrative: PATIENT RECEIVED SHOT ON 2/25/2021 AND ON 3/7/2020 PT STARTED SHOWING SIGNS OF BELL'S PALSEY
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: My arm was swollen with fever. The redness continued to get bigger and farther around my arm. It was very sore.
Age: 1.08
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given adult dose of Hep A instead of pediatric dose. No adverse symptoms.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine at room temperature > 6 hours at time of administration.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity, Paraesthesia
Clinical narrative: arm pain, shortness of breath, arm tingling bilaterally
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling cold, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: COLD TO TOUCH AND SWEATING, DIFFICULTY HEARING-Mild, Systemic: Flushed / Sweating-Medium
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Lethargy, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: COLD TO TOUCH AND SWEATING, DIFFICULTY HEARING-Mild, Systemic: Flushed / Sweating-Medium
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: chills, fever, body aches, headache, loss of appetite and no energy/tired
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: chills, fever, body aches, headache, loss of appetite and no energy/tired
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient may have inadvertently been given 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notified. State of MD was notified.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms. Aches and fatigue, possible low grade fever.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Muscle twitching, Pain, Pain in extremity
Clinical narrative: Fever up to 101, body aches primarily targeted at 6 chronic pain sites but substantially more significant than usual, headache, injection site pain, thumb muscle twitches, "electrical" momentary pains in a variety of places, including head and arms
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever up to 101, body aches primarily targeted at 6 chronic pain sites but substantially more significant than usual, headache, injection site pain, thumb muscle twitches, "electrical" momentary pains in a variety of places, including head and arms
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Lip swelling, Swelling face
Clinical narrative: dizziness described as spinning while in bed on Tuesday morning associated with episodes of diaphoresis, and chills.    This morning she awakened and noted left facial swelling and left lip swelling
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: dizziness described as spinning while in bed on Tuesday morning associated with episodes of diaphoresis, and chills.    This morning she awakened and noted left facial swelling and left lip swelling
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives mainly at night diffusely which started 2-3 days after vaccine
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Injection site pruritus, Pruritus, Rash
Clinical narrative: Hives mainly at night diffusely which started 2-3 days after vaccine
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in left upper arm developed the day after 2nd COVID  vaccine on 1/22/21.  Persistent upper left arm pain, especially with internal rotation and abduction of shoulder. No redness, swelling, weakness, numbness or tingling.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Dyspnoea, Headache, Nausea, Pain in extremity
Clinical narrative: pt states that she woke up w/ headache, nauseated, SOB, and  pain in left arm.  she says these symptoms come and goes in waves.  pt went to urgent Care   on 3/8/2021.  Pt was ordered Chest X-Ray that came back normal.  Rapid Covid Test w/ negative results.  All vitals were good.  Pt was prescribed an inhaler.  Pt also went to her local pharmacy and took another Covid test on 3/10/2021 w/ pending results and then FU w/ PCP.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test negative
Clinical narrative: pt states that she woke up w/ headache, nauseated, SOB, and  pain in left arm.  she says these symptoms come and goes in waves.  pt went to urgent Care   on 3/8/2021.  Pt was ordered Chest X-Ray that came back normal.  Rapid Covid Test w/ negative results.  All vitals were good.  Pt was prescribed an inhaler.  Pt also went to her local pharmacy and took another Covid test on 3/10/2021 w/ pending results and then FU w/ PCP.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: 1.   Moderate headache starting an hour after receiving first dose; resolved after 24 hours 2.   Mild nausea starting an hour after receiving first dose; resolved after 4 hours 3.   Moderate fatigue starting an hour after receiving first dose and became mild after 24 hours. Mild fatigue still unresolved as of 11Mar2021. 4.   Mild brain fog that started on 10 March 2021 after receiving first dose on 07 March 2021. Still unresolved as of 11Mar2021.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Arm pain at injection site with 1st injection.  Headache, chills, fatigue, low grade fever and arm pain with 2he injection.  Treated with acetaminophen with good results.  Symptoms lasted approximately 24 hours.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Injection site pain, Pain
Clinical narrative: FEVER, CHILLS, HEADACHE, SHIVERING, BODY ACHES, GENERAL WEAKNESS, PAIN AT INJECTION SITE
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER, CHILLS, HEADACHE, SHIVERING, BODY ACHES, GENERAL WEAKNESS, PAIN AT INJECTION SITE
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: patient expired 2/10/2021.  Unknown whether the death was even related to the vaccine. Pt did not have any problems during 15 min observation period and no issues reported to HD after vaccination.  reported because the person expired within 7 days of vaccination.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Feeling hot, Headache, Influenza like illness
Clinical narrative: Flu like symptoms 8 hours after injection, bad headache, body chills and shaking, felt both cold and hot, couldn't untense legs or relax, body aches. Lasted around 4 hours until falling asleep. Mild headache the next day.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tension, Tremor
Clinical narrative: Flu like symptoms 8 hours after injection, bad headache, body chills and shaking, felt both cold and hot, couldn't untense legs or relax, body aches. Lasted around 4 hours until falling asleep. Mild headache the next day.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Cardioversion
Clinical narrative: patient states his pacemaker defibrillated twice 03/09/21, and went to ER. not sure if its a side effect of the vaccine, but we decided to report.