chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received 2nd Pfizer Vaccine after only 11 days between doses. First dose given on 22Feb2021. Patient has thus far experienced no adverse reactions.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: clerk overlooked pts age when checking patient in for the vaccine, then the pharmacist overlooked the pts age before administering the vaccine
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Large red( 6?) warm , sore and itchy area  just below the injection site on the upper right arm. Presented itself about 45 minutes after Moderna COVID-19 Vaccine EUA . Today is 03/05/2021 and area is smaller in size ( about 3? ) but still red, sore, warm and itchy. Treatment with Benadryl topical cream
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Burning sensation, Headache, Pain, Pain in extremity
Clinical narrative: Burning in arm almost instantly. Mom said that she had a fever (100.5), body aches, headache, stomachache  and pain in the arm. Mom gave Motrin and Benadryl. Patient said Motrin did nothing and Benadryl just made her tried.  She has missed 2 days of school because the pain was so severe.  Doing better today but the arm pain is still an issue. Coming in tomorrow to let the Doctor take a look at the arm.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Burning in arm almost instantly. Mom said that she had a fever (100.5), body aches, headache, stomachache  and pain in the arm. Mom gave Motrin and Benadryl. Patient said Motrin did nothing and Benadryl just made her tried.  She has missed 2 days of school because the pain was so severe.  Doing better today but the arm pain is still an issue. Coming in tomorrow to let the Doctor take a look at the arm.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO adverse event; Expired dose; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 26-FEB-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally, lot # reported as "1660945", expiration date 13-FEB-2021, for prophylaxis.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: immune response / very strong / muscle aches; immune response / very strong / fever; it knocked me out for a day; This case was reported by a physician and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced muscle pain, fever and feeling unwell. On an unknown date, the outcome of the muscle pain, fever and feeling unwell were unknown.   The reporter considered the muscle pain, fever and feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced muscle aches and fever. The adverse event in the article and think that the closest side effects that seen it compared to be the shingles vaccine, which was a little bit of a rough vaccine to get in that the immune response was very strong.  The reporter had it the shingles vaccine personally and it knocked out for a day and then was fine.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Infection
Clinical narrative: He had the first shot......then got the shingles; He'll be able to get the second one in March / Has to be a year from when you had the shingles; This case was reported by a consumer and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The age at vaccination was not applicable for this report for 2nd dose. The patient received Shingrix and had shingles. The patient would able to get the second one in March but till the time of reporting did not receive, which led to incomplete course of vaccinations. The reporter stated it had to be a year from when had the shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: itching near injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovered/resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient experienced constant itching near injection site for 2 years. The follow-up would not possible, as no contact details were available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever; Headache; Flu l ke aches; Tiredness; This case was reported by a consumer via other manufacturer and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma and fibromyalgia.   On 4th January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced fever, headache, flu-like aching and tiredness. On an unknown date, the outcome of the fever, headache, flu-like aching and tiredness were unknown.   It was unknown if the reporter considered the fever, headache, flu-like aching and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received 1st dose on left arm. The patient experienced fever, headache, flu like aches and tiredness. The consent to follow-up was requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient received a dose of Moderna vaccine on 1/29/21 and came back for second vaccine at our vaccine site and was mistakenly given Pfizer for second dose.  Mom notified and she states no adverse reaction noted with patient.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram normal, Asthenia, Blood albumin increased, Blood cholesterol normal, Blood creatine phosphokinase normal
Clinical narrative: 2/23 - PT awoke at 0230 w/altered mental status, generalized weakness, severe headache, nausea and fever. T 101.2,  PERL, BP 120/82, HR 88 regular, RR 18.  Grips/Pushes equal/weak. A&O x2 (A&O x 4 baseline).  ABDM soft, non tender. Breath sounds clear bilaterally.  1100 IV NS 1L, 30 mg Toradol IV given.  Temp 99.2-102.0 variable throughout the day.  Severe HA.  Tylenol and Motrin alternated q 4hr. 2/24  Severe Headache, pt reports disturbances in her visual field. A&O x3. weakness/malaise continues. Motrin & Tylenol - LABS 2/25 Severe Headache, with altered visual fields.- CT HEAD 2/26 Same as above.  2/27 Same as above. Urgent Care for Flu & COVID Testing. Both Neg 2/28 Headache managed with Celebrex, 12 hrs relief, then 200mg Motrin 3/1 Same as above.  Retinal specialist for consult and Fluorescien Angiography - WNL 3/2-3/5 Headache and visual field changes continue.  Pt states "do not feel myself"
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Cerebral microangiopathy, Computerised tomogram head abnormal
Clinical narrative: 2/23 - PT awoke at 0230 w/altered mental status, generalized weakness, severe headache, nausea and fever. T 101.2,  PERL, BP 120/82, HR 88 regular, RR 18.  Grips/Pushes equal/weak. A&O x2 (A&O x 4 baseline).  ABDM soft, non tender. Breath sounds clear bilaterally.  1100 IV NS 1L, 30 mg Toradol IV given.  Temp 99.2-102.0 variable throughout the day.  Severe HA.  Tylenol and Motrin alternated q 4hr. 2/24  Severe Headache, pt reports disturbances in her visual field. A&O x3. weakness/malaise continues. Motrin & Tylenol - LABS 2/25 Severe Headache, with altered visual fields.- CT HEAD 2/26 Same as above.  2/27 Same as above. Urgent Care for Flu & COVID Testing. Both Neg 2/28 Headache managed with Celebrex, 12 hrs relief, then 200mg Motrin 3/1 Same as above.  Retinal specialist for consult and Fluorescien Angiography - WNL 3/2-3/5 Headache and visual field changes continue.  Pt states "do not feel myself"
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate decreased, Grip strength decreased, Haematocrit decreased, Haemoglobin decreased, Headache
Clinical narrative: 2/23 - PT awoke at 0230 w/altered mental status, generalized weakness, severe headache, nausea and fever. T 101.2,  PERL, BP 120/82, HR 88 regular, RR 18.  Grips/Pushes equal/weak. A&O x2 (A&O x 4 baseline).  ABDM soft, non tender. Breath sounds clear bilaterally.  1100 IV NS 1L, 30 mg Toradol IV given.  Temp 99.2-102.0 variable throughout the day.  Severe HA.  Tylenol and Motrin alternated q 4hr. 2/24  Severe Headache, pt reports disturbances in her visual field. A&O x3. weakness/malaise continues. Motrin & Tylenol - LABS 2/25 Severe Headache, with altered visual fields.- CT HEAD 2/26 Same as above.  2/27 Same as above. Urgent Care for Flu & COVID Testing. Both Neg 2/28 Headache managed with Celebrex, 12 hrs relief, then 200mg Motrin 3/1 Same as above.  Retinal specialist for consult and Fluorescien Angiography - WNL 3/2-3/5 Headache and visual field changes continue.  Pt states "do not feel myself"
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza A virus test negative, Mental status changes, N-terminal prohormone brain natriuretic peptide, Nausea, Platelet count normal
Clinical narrative: 2/23 - PT awoke at 0230 w/altered mental status, generalized weakness, severe headache, nausea and fever. T 101.2,  PERL, BP 120/82, HR 88 regular, RR 18.  Grips/Pushes equal/weak. A&O x2 (A&O x 4 baseline).  ABDM soft, non tender. Breath sounds clear bilaterally.  1100 IV NS 1L, 30 mg Toradol IV given.  Temp 99.2-102.0 variable throughout the day.  Severe HA.  Tylenol and Motrin alternated q 4hr. 2/24  Severe Headache, pt reports disturbances in her visual field. A&O x3. weakness/malaise continues. Motrin & Tylenol - LABS 2/25 Severe Headache, with altered visual fields.- CT HEAD 2/26 Same as above.  2/27 Same as above. Urgent Care for Flu & COVID Testing. Both Neg 2/28 Headache managed with Celebrex, 12 hrs relief, then 200mg Motrin 3/1 Same as above.  Retinal specialist for consult and Fluorescien Angiography - WNL 3/2-3/5 Headache and visual field changes continue.  Pt states "do not feel myself"
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate normal, SARS-CoV-2 test negative, Scan with contrast normal, Thyroid function test normal
Clinical narrative: 2/23 - PT awoke at 0230 w/altered mental status, generalized weakness, severe headache, nausea and fever. T 101.2,  PERL, BP 120/82, HR 88 regular, RR 18.  Grips/Pushes equal/weak. A&O x2 (A&O x 4 baseline).  ABDM soft, non tender. Breath sounds clear bilaterally.  1100 IV NS 1L, 30 mg Toradol IV given.  Temp 99.2-102.0 variable throughout the day.  Severe HA.  Tylenol and Motrin alternated q 4hr. 2/24  Severe Headache, pt reports disturbances in her visual field. A&O x3. weakness/malaise continues. Motrin & Tylenol - LABS 2/25 Severe Headache, with altered visual fields.- CT HEAD 2/26 Same as above.  2/27 Same as above. Urgent Care for Flu & COVID Testing. Both Neg 2/28 Headache managed with Celebrex, 12 hrs relief, then 200mg Motrin 3/1 Same as above.  Retinal specialist for consult and Fluorescien Angiography - WNL 3/2-3/5 Headache and visual field changes continue.  Pt states "do not feel myself"
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment, White blood cell count normal
Clinical narrative: 2/23 - PT awoke at 0230 w/altered mental status, generalized weakness, severe headache, nausea and fever. T 101.2,  PERL, BP 120/82, HR 88 regular, RR 18.  Grips/Pushes equal/weak. A&O x2 (A&O x 4 baseline).  ABDM soft, non tender. Breath sounds clear bilaterally.  1100 IV NS 1L, 30 mg Toradol IV given.  Temp 99.2-102.0 variable throughout the day.  Severe HA.  Tylenol and Motrin alternated q 4hr. 2/24  Severe Headache, pt reports disturbances in her visual field. A&O x3. weakness/malaise continues. Motrin & Tylenol - LABS 2/25 Severe Headache, with altered visual fields.- CT HEAD 2/26 Same as above.  2/27 Same as above. Urgent Care for Flu & COVID Testing. Both Neg 2/28 Headache managed with Celebrex, 12 hrs relief, then 200mg Motrin 3/1 Same as above.  Retinal specialist for consult and Fluorescien Angiography - WNL 3/2-3/5 Headache and visual field changes continue.  Pt states "do not feel myself"
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Injection site inflammation, Rash erythematous, Rash pruritic, Swelling
Clinical narrative: Feb 20, 2021 = 24 hours post-vaccine left deltoid presented 6 inch diameter slightly inflamed patchy area. Feb 27, 2021 = 8 days post-vaccine front of both thighs and back of both legs (mid-calf to mid-thigh) presented an inflamed red, itchy, swollen rash. Mar 01, 2021 = 10 days post-vaccine Primary Care Physician diagnosed the likelihood of the rash being a delayed reaction to the Moderna vaccine. PCP recommended and I'm following her advice to: 1) apply hydrocortisone 1% creme 3 times daily 2) take Xyzal 5mg daily 3) take Benadryl 25mg at bedtime
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine normal, Blood urea increased, Blood urea nitrogen/creatinine ratio increased, Death, Full blood count normal
Clinical narrative: 2/9/2021 Expired at facility.  Several weeks prior with several medical and mental health issues as noted prior. 2/4 began with increased lethargy and somnolence. Medications being held per MD. 2/5 CBC WNL, BUN/Cr 38/1.23 GFR 41 2/5 Admitted to Hospice services on 2/5.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate decreased, Lethargy, Somnolence
Clinical narrative: 2/9/2021 Expired at facility.  Several weeks prior with several medical and mental health issues as noted prior. 2/4 began with increased lethargy and somnolence. Medications being held per MD. 2/5 CBC WNL, BUN/Cr 38/1.23 GFR 41 2/5 Admitted to Hospice services on 2/5.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Body stiffness so much so I literally could only wiggle my toes. Another side effect was a  red swollen lump in a shape of an oval that a preschool may draw. The area is very tender  to touch  and formed next to injection site a day after and is still present two days after.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Myalgia
Clinical narrative: Muscle and joint pain , chills, and weakness
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Illness, Pain in extremity
Clinical narrative: Sore arm / feeling is not much different from / shingles vaccine in Nov2020; When she touches it, it still hurts some / feeling is not much different from / shingles vaccine in Nov2020; Had the COVID virus back in Nov2020; Sick for 2 full weeks / with the COVID virus felt really like she does right now; Had a headache / with the COVID virus felt really like she does right now; Doesn't feel good / with the COVID virus felt really like she does right now; Tired / with the COVID virus felt really like she does right now; This case was reported by a nurse via other manufacturer and described the occurrence of pain in arm in a 53-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included breast cancer (newly diagnosed with non-metastic triple negative breast cancer prior to getting the vaccine, patient was advised by the doctor to get the vaccine as soon as possible).   In November 2020, the patient received Shingles vaccine. In November 2020, less than a month after receiving Shingles vaccine, the patient experienced pain in arm, tenderness, covid-19, sickness, headache, feeling bad and tiredness. The patient was treated with excedrin (nos) (Excedrin), paracetamol (Tylenol) and sumatriptan. On an unknown date, the outcome of the pain in arm, tenderness, covid-19, sickness, headache and feeling bad were recovered/resolved and the outcome of the tiredness was unknown.   It was unknown if the reporter considered the pain in arm, tenderness, covid-19, sickness, headache, feeling bad and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for herself. The patient experienced sore arm and when she touch it, it was hurt. The patient had Covid virus back in November 2020, she did not feel good and was tired. The patient was sick for two full weeks with Covid and then on the third week she felt better but had a headache. On 29th January 2021, the patient received 1st dose of Pfizer Covid 19 vaccine on left deltoid with batch number EL9265 and expiration date 31st May 2021. On 30th January 2021, the patient's arm was very sore, really sore the first day after she puts a cold compresses and felt much better the next day. The patient mentioned that starting Friday she had headache on and off and felt like she was at the tail end of having the virus. The patient was not tested positive for Covid after having the first shot. The patient mentioned that, she was an active person but she had not done much since the shot. The reporter asked if was this normal and could the reaction had something to do with her already having Covid. The pharmacist told her it should only last a couple days. The consent to follow-up was granted.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative, Tenderness
Clinical narrative: Sore arm / feeling is not much different from / shingles vaccine in Nov2020; When she touches it, it still hurts some / feeling is not much different from / shingles vaccine in Nov2020; Had the COVID virus back in Nov2020; Sick for 2 full weeks / with the COVID virus felt really like she does right now; Had a headache / with the COVID virus felt really like she does right now; Doesn't feel good / with the COVID virus felt really like she does right now; Tired / with the COVID virus felt really like she does right now; This case was reported by a nurse via other manufacturer and described the occurrence of pain in arm in a 53-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included breast cancer (newly diagnosed with non-metastic triple negative breast cancer prior to getting the vaccine, patient was advised by the doctor to get the vaccine as soon as possible).   In November 2020, the patient received Shingles vaccine. In November 2020, less than a month after receiving Shingles vaccine, the patient experienced pain in arm, tenderness, covid-19, sickness, headache, feeling bad and tiredness. The patient was treated with excedrin (nos) (Excedrin), paracetamol (Tylenol) and sumatriptan. On an unknown date, the outcome of the pain in arm, tenderness, covid-19, sickness, headache and feeling bad were recovered/resolved and the outcome of the tiredness was unknown.   It was unknown if the reporter considered the pain in arm, tenderness, covid-19, sickness, headache, feeling bad and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for herself. The patient experienced sore arm and when she touch it, it was hurt. The patient had Covid virus back in November 2020, she did not feel good and was tired. The patient was sick for two full weeks with Covid and then on the third week she felt better but had a headache. On 29th January 2021, the patient received 1st dose of Pfizer Covid 19 vaccine on left deltoid with batch number EL9265 and expiration date 31st May 2021. On 30th January 2021, the patient's arm was very sore, really sore the first day after she puts a cold compresses and felt much better the next day. The patient mentioned that starting Friday she had headache on and off and felt like she was at the tail end of having the virus. The patient was not tested positive for Covid after having the first shot. The patient mentioned that, she was an active person but she had not done much since the shot. The reporter asked if was this normal and could the reaction had something to do with her already having Covid. The pharmacist told her it should only last a couple days. The consent to follow-up was granted.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered had been at room temperature for > 6 hours.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Fatigue, Lethargy
Clinical narrative: 102 degree fever, body aches, severe chills, lethargy, weakness, muscle aches, fatigue, swollen lymph nodes. Rested in bed for 4 days, felt better on the fifth. I feel an onset of similar symptoms today 03/05/2021, 17 days after 2nd vaccine dose.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mobility decreased, Myalgia, Pain
Clinical narrative: 102 degree fever, body aches, severe chills, lethargy, weakness, muscle aches, fatigue, swollen lymph nodes. Rested in bed for 4 days, felt better on the fifth. I feel an onset of similar symptoms today 03/05/2021, 17 days after 2nd vaccine dose.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt stood up and began to walk after injection and became light headed. Pt sat down on the floor. Pt was assisted to a  chair. VS were stable, pt felt recovered after a few minutes. Pt was monitored for 30 minutes.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: heavyness left arm
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a double dose of the Moderna vaccine, NO adverse reactions noted
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Anaemia, Faeces discoloured, Haemoglobin decreased, Occult blood positive
Clinical narrative: Patient presented to ED with black stool and anemia, hemoccult positive, Hgb 6.2. Patient received 1 unit packed blood and IV protonix. Pt admitted. AKI improving on floor. Patient currently still admitted. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Packed red blood cell transfusion
Clinical narrative: Patient presented to ED with black stool and anemia, hemoccult positive, Hgb 6.2. Patient received 1 unit packed blood and IV protonix. Pt admitted. AKI improving on floor. Patient currently still admitted. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 11:15 AM PT ARRIVED IN OBSERVATION STABLE. HE FELT DIZZY. SAT IN CAR FOR 15 MIN. PT REMAINS DIZZY. PT INSTRUCTED TO DRIVE TO TENT. DENIES SOB AND CHEST PAIN. 11:30 AM BP 155/101 HR 103 SPO2 98% 11:50 AM PT STATES HE IS FEELING BETTER. DENIES DIZZINESS @ THIS TIME. PT DENIES SOB AND CHEST PAIN AT TIME OF D/C. 11:57AM BP 153/85  HR 106 O2 96%
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received the Moderna Covid vaccine at the Mobile Covid vaccine clinic. Mom called the Nurseline on 03/04/2021 and stated that her daughter is 15 years old and according to the Moderna vaccine, she is not supposed to receive that vaccine if she is under 18 years old.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test normal, Electric shock sensation, Electrocardiogram normal, Flushing
Clinical narrative: After an adverse reaction to the Covid 19 Vaccine, the emergency room Doctor suggested I contact you for a follow-up visit.   Dateline and symptoms:  03/01 Received first Moderna Covid Vaccination at 3:45 p.m... 03/02 No symptoms until 6 p.m. When blood pressure started to go up from my normal level of 116/68 to 179/82 by 10 p.m..  During this time I had what felt like mild electric currents from the left side of my chest down my left arm and into my hand.  These systems subsided around 11 p.m. and by midnight my blood pressure was almost back to normal. 03/03 Felt sluggish all day but no blood pressure problems. 03/04 Felt great all day then around 6 p.m. my blood pressure started to rise, by 9:30 p.m. it was 190/90.  At this time I started to feel like my body was shutting down, my face felt flush, and experiencing long distant vision problems, so I had my wife take me to the emergency room. At 10:00 p.m. I went to the emergency room  EKG  showed no heart problems, the blood test showed no heart problems, and after 11:30 p.m. my blood pressure started going down and I was released at 1:30 a.m..  Blood test did show high levels of Blood Urea Nitrogen 26.0, Bun/Creatinine Ratio 33.0, Aspartate Amino Tranf (AST/SGOT) 43, Alanine Aminotransferase (ALT/SGPT) 59 and Alkaline Phosphatase 189, all of which are higher than my last blood test on 10/22/20. 03/05  As of 10:30 a.m. my blood pressure is 126/62.  I feel fine except I'm very tired from not much sleep last night.  1p.m. Starting to feel some more chest and arm symptoms as described before, blood pressure now 146/66. Events happened twice, 2 days apart.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Sluggishness, Visual impairment
Clinical narrative: After an adverse reaction to the Covid 19 Vaccine, the emergency room Doctor suggested I contact you for a follow-up visit.   Dateline and symptoms:  03/01 Received first Moderna Covid Vaccination at 3:45 p.m... 03/02 No symptoms until 6 p.m. When blood pressure started to go up from my normal level of 116/68 to 179/82 by 10 p.m..  During this time I had what felt like mild electric currents from the left side of my chest down my left arm and into my hand.  These systems subsided around 11 p.m. and by midnight my blood pressure was almost back to normal. 03/03 Felt sluggish all day but no blood pressure problems. 03/04 Felt great all day then around 6 p.m. my blood pressure started to rise, by 9:30 p.m. it was 190/90.  At this time I started to feel like my body was shutting down, my face felt flush, and experiencing long distant vision problems, so I had my wife take me to the emergency room. At 10:00 p.m. I went to the emergency room  EKG  showed no heart problems, the blood test showed no heart problems, and after 11:30 p.m. my blood pressure started going down and I was released at 1:30 a.m..  Blood test did show high levels of Blood Urea Nitrogen 26.0, Bun/Creatinine Ratio 33.0, Aspartate Amino Tranf (AST/SGOT) 43, Alanine Aminotransferase (ALT/SGPT) 59 and Alkaline Phosphatase 189, all of which are higher than my last blood test on 10/22/20. 03/05  As of 10:30 a.m. my blood pressure is 126/62.  I feel fine except I'm very tired from not much sleep last night.  1p.m. Starting to feel some more chest and arm symptoms as described before, blood pressure now 146/66. Events happened twice, 2 days apart.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram, Dizziness, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower lip
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging spinal, Paraesthesia, Paraesthesia oral, Scan with contrast
Clinical narrative: Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower lip
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: lightheaded, nauseous
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache
Clinical narrative: Chills, headache and diarrhea
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered had been at room temperature for > 6 hours.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Cancel her 2nd dose/scheduled for 2nd dose on Feb 27th; Diagnosed for COVID; A spontaneous report was received from a consumer concerning 55-years-old female consumer, who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed for COVID after 27 days of vaccination without any symptoms.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for the prophylaxis of COVID-19 infection.  The patient was diagnosed for COVID on 13 Feb 2021.  She was exposed on 06 Feb 2021 and had no symptoms. The patient was on a 10 day quarantine and canceled the second dose for 20 Feb 2021.   The patient was tested negative for the first rapid test. The first PCR test result was inconclusive and the second PCR test was positive.  The patient was scheduled for second dose on 27 Feb 2021, which is an inappropriate schedule of administration (greater than one month apart).  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event COVID-19 infection was unknown and outcome for event inappropriate schedule of product administration was considered as resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273. Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the event of COVID-19, is assessed as unlikely related.  Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: sharp pain at injection site, pain in arm
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: MEDICATION ERROR: Patient was vaccinated at 17 years old
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Palpitations, Sensation of foreign body
Clinical narrative: About an hour after the Covid vaccine was given I experienced heart racing very rapidly, wave of nausea, feeling faint, knot in throat, this last about 5-10 minutes then passed, had knot in throat x 2 days.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Minor rash after first dose, faded away. Rash came back after 2nd dose, has lasted a week and feels as though it is not getting better. Rash was located in 3 hot spots (left and right arms under arm/near armpit, and lower stomach). Rash has slowly spread and has not shown improvement with benedryl/loratadine and cortosone over last 4-5 days.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Minor rash after first dose, faded away. Rash came back after 2nd dose, has lasted a week and feels as though it is not getting better. Rash was located in 3 hot spots (left and right arms under arm/near armpit, and lower stomach). Rash has slowly spread and has not shown improvement with benedryl/loratadine and cortosone over last 4-5 days.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: minor pain in arm for first day only
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery bypass, Laboratory test, Myocardial infarction
Clinical narrative: Massive Heart Attack
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC13, VARCEL
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Lymphadenopathy, Peripheral swelling
Clinical narrative: Cellulitis of left thigh - Give Keflex twice a day for 7 days, may use warm compress for a few minutes at a time. Watch for increase in size of swelling. swollen glands      swelling on left legs and area between groin and thigh since 15mo vaccines  This is a new problem.   Started after the pt received DtaP in left leg 8 days ago. The problem has been gradually worsening (some swelling since day of vaccines, but has enlarged for past 3 days, but not getting any larger since). Associated symptoms include swollen glands (in right groin (not left where swelling is)). Pertinent negatives include no fever or vomiting. Nothing aggravates the symptoms. He has tried nothing for the symptoms.  Swelling of thigh at site of vaccine, tender to touch but not red, no fever
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Gait inability
Clinical narrative: could no longer walk and could only crawl, just drags his feet; gets tired very quickly; seemed drunk and his feet from the knee down weren't working; A spontaneous report was received from consumer concerning a 26-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and seemed drunk and his feet from the knee down, he could no longer walk and could only crawl,  just drags his feet and was also getting tired very quickly.    The patient's medical history included aphasia. Products known to have been used by the patient, within two weeks prior to the event, included diazepam, duwalpro and another, unspecified over-the-counter product.  On 15-FEB-2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot unknown) intramuscularly for prophylaxis of COVID-19 infection.   That same day, according to report, the patient seemed drunk and his feet from the knee down were not working.  On 16-FEB-2021, the patient was unable to walk and could only crawl; he was just dragging his feet. He was also getting tired very quickly.     Treatment for the event included paracetamol and ibuprofen.    The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable.    The outcome of the events, seemed drunk and his feet from the knee down, he could no longer walk and could only crawl,  just drags his feet and was also getting tired very quickly, was considered unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 cannot be excluded. Fatigue is consistent with the known safety profile of the vaccine.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient reported dizziness at 30 min post injection but admitted symptom had started soon after injection. She was given po fluids and allowed to rest in recumbent position until improved.  At time of discharge was ambulating without syncope but still had residual dizziness which family reported will typically persist for 1-2 days.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Peripheral swelling, Swelling
Clinical narrative: Swelling not at injection site.  One day after the shot, my right finger swelled up for about 12 hours followed by swelling on the right side of my top and bottom lip.  No treatment, just advised to keep an eye on it.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: 9 days after receiving 2nd vaccination, I began having extreme fatigue and muscle aches all over my body.  This lasted about 3 days, but the fatigue is lingering, although mild in comparison.  I had no fever, no respiratory issues, no digestive issues.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiplegia, Seizure
Clinical narrative: Loss of failing left side stroke like symptoms with seizures
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a double dose of the Moderna Vaccine, NO adverse reactions noted
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patch of red the size of a silver dollar on the left arm next to the injection site, which lasted 3 days and then went away. The rash returned about 4 days later, it was large (about 3 inches wide, 4 inches tall). The rash was very red and very very itchy. Treated with hydrocortisone cream, which calmed it down after about 4 or 5 days. The red mark is still there and itches slightly, but not severely any longer.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Hypoxia, Nausea, Palpitations
Clinical narrative: Patient presented today to ED with palpations, nausea/vomiting, SOB, dry cough. Patient hypoxemic and admitted to the hospital. Patient currently still admitted. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient presented today to ED with palpations, nausea/vomiting, SOB, dry cough. Patient hypoxemic and admitted to the hospital. Patient currently still admitted. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered had been at room temperature for > 6 hours.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: symptoms started 6 hours after vaccination Fever up to 103 body pain headache stomach pain fatigue
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram normal, Fall, Flank pain, Head injury
Clinical narrative: (3) syncopal episodes following vaccination, one of which resulted in a fall with direct injury to the base of neck, head, and right flank. Pt reported chest pain prior to syncope.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Laboratory test normal, Neck injury, Renal function test normal, Syncope
Clinical narrative: (3) syncopal episodes following vaccination, one of which resulted in a fall with direct injury to the base of neck, head, and right flank. Pt reported chest pain prior to syncope.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin I normal
Clinical narrative: (3) syncopal episodes following vaccination, one of which resulted in a fall with direct injury to the base of neck, head, and right flank. Pt reported chest pain prior to syncope.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dyspnoea, Pulmonary embolism, Sluggishness, Ultrasound Doppler
Clinical narrative: Deep vein thrombosis left calf; Difficulty breathing; Pulmonary Embolism; Felt doggy, sluggish, punky; Arm hurt; A spontaneous report was received from a nurse concerning a 54-year-old, male patient who experienced pulmonary embolism, deep vein thrombosis, vaccination site pain, sluggishness and dyspnoea.   The patient's medical history was not provided.    Concomitant product use was not provided by the reporter.   On 12-Feb-2021, approximately 2 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    The patient received his vaccine on 12-Feb-2021 and reported that his arm hurt a little for a few days. On 14-Feb2021, he reported that he started feeling sluggish and on 20-Feb-2021 he began to have difficulty breathing and pain in the right lower base of rib cage. He went to urgent care where he was diagnosed with a pulmonary embolism for which he received treatment. On the evening of the same day, he again started having difficulty breathing with pain upon inhalation. He returned to urgent care and was subsequently admitted at 12:30 AM on 21-Feb-2021. That  Monday, 22-Feb-2021, a doppler ultrasound revealed a deep vein thrombosis in the left calf. Patient was treated with heparin intravenously (IV). He was discharged 22-Feb-2021.    Treatment for the event included Xarelto 20mg twice per day for two weeks and Heparin IV.    Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events, pulmonary embolism, deep vein thrombosis and dyspnea, was considered recovering/resolving as of discharge on 22-Feb-2021.  The outcome of the events, vaccination site pain and sluggishness, were considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Deep vein thrombosis left calf; Difficulty breathing; Pulmonary Embolism; Felt doggy, sluggish, punky; Arm hurt; A spontaneous report was received from a nurse concerning a 54-year-old, male patient who experienced pulmonary embolism, deep vein thrombosis, vaccination site pain, sluggishness and dyspnoea.   The patient's medical history was not provided.    Concomitant product use was not provided by the reporter.   On 12-Feb-2021, approximately 2 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    The patient received his vaccine on 12-Feb-2021 and reported that his arm hurt a little for a few days. On 14-Feb2021, he reported that he started feeling sluggish and on 20-Feb-2021 he began to have difficulty breathing and pain in the right lower base of rib cage. He went to urgent care where he was diagnosed with a pulmonary embolism for which he received treatment. On the evening of the same day, he again started having difficulty breathing with pain upon inhalation. He returned to urgent care and was subsequently admitted at 12:30 AM on 21-Feb-2021. That  Monday, 22-Feb-2021, a doppler ultrasound revealed a deep vein thrombosis in the left calf. Patient was treated with heparin intravenously (IV). He was discharged 22-Feb-2021.    Treatment for the event included Xarelto 20mg twice per day for two weeks and Heparin IV.    Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events, pulmonary embolism, deep vein thrombosis and dyspnea, was considered recovering/resolving as of discharge on 22-Feb-2021.  The outcome of the events, vaccination site pain and sluggishness, were considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 62 year old female complained of a headache after receiving vaccine. Onsite EMS was called vritals  BP 166/98  100%O2 HR 98. She refused further eval and care.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Student had gotten a flu vaccine on 12/16/20. He came to the campus flu clinic on 1/26/21 and received another flu vaccine, his first dose being unbeknownst to the flu clinic staff.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Nausea
Clinical narrative: pt stated that he got chills the night after receiving the vax.  Early hours in the morning his temp was 98.7 and reached 101.7.  He was nauseated at this time.  Next morning he woke up 99.4 temp but all other symptoms were gone.  He contacted his PCP at the hospital and they instructed him to call us to file report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Gait disturbance, Headache, Nausea
Clinical narrative: Patient complained of dizziness and nausea.  She said she has a headache.  Responders saw her slowly walk to her seat ahd she tripped.  She looked faint when they helped her up.  Her blood pressure was 107/74.  She was given IV fluids and transported to medical center
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient complained of dizziness and nausea.  She said she has a headache.  Responders saw her slowly walk to her seat ahd she tripped.  She looked faint when they helped her up.  Her blood pressure was 107/74.  She was given IV fluids and transported to medical center
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Pruritus, Rash
Clinical narrative: Rash at maximum- 6mm x 8mm, inflamed area, itching, 4 days then faded away.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered had been at room temperature for > 6 hours.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Erythema, Feeling cold, Rash macular
Clinical narrative: Within 7 min. Of vaccine i began to feel like i was on a cold IV drip; the sensation started at vaccine site and traveled down my arm into my body.  I then went to pharmacy desk and said i thought i was having a reaction and went to the bathroom to see if i was red in the face.  Yes, my face and body were red splotchy which is my indicator of having an allergic reaction.   I also noticed that my chest was feeling tight like my bra was on too tight.  The pharmacist gave me a Benadryl and i waited 15 more minutes.    The Benadryl relieved most of the symptoms after an hour but my chest was tight the remainder of the day and fine the next day.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Nervousness, Pain
Clinical narrative: Next morning of shot, injection arm sore, minor muscle aches all over, legs shakey.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a double dose of the vaccine, NO adverse reaction was noted.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Patient developed a gout attack that took a week to resolve. Patient states that she has experienced gout in the past, but has not experienced a flare recently. This flare did not present the way her past flares have.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: No adverse effect from shot for 6 days. On 7th day, the shot site started itching, with a noticeable small swelling.  Itching is extreme and constant.  Using ice pack to relieve itching, but it comes back.  No other adverse symptoms from the shot.  Just concerned about the delay of these symptoms.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Night sweats, Pain
Clinical narrative: Fatigue, body aches, night sweats (like menopause), painful under armpits (even on second day), headaches
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: The above patient received a COVID-19 vaccine on 03MAR21 @ 1440.  He came to the EH&S office on the morning of 04MAR21 complaining of left arm pain, fatigue, headache, muscle pain, joint pain, chills, and nausea/vomiting.  He was evaluated by a healthcare provider who noted mild swelling and a small knot was felt in his left arm.  He is to follow-up with our onsite nurse or his medical provider if his condition worsens.