chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Anaphylactic reaction, Hypersensitivity, Internal haemorrhage, Migraine
Clinical narrative: Internal Bleeding; Anaphylactic reaction; bad allergies; sinus migraine; acne on face/ back; nausea; vomiting; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INTERNAL HAEMORRHAGE (Internal Bleeding) and ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis.    Concurrent medical conditions included Latex allergy (latex allergy), Gluten intolerance (Gluten allergy) and Drug allergy (Tylenol). Concomitant products included MAGNESIUM CITRATE, MOMETASONE FUROATE (NASONEX), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ASCORBIC ACID (VITAMIN C ACID), VITAMIN D3, MULTIVITAMIN AND MINERAL and FISH OIL for an unknown indication.   On 10-Sep-2020, the patient started TOFACITINIB CITRATE (XELJANZ XR) (unknown route) 11 mg once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERNAL HAEMORRHAGE (Internal Bleeding) (seriousness criterion medically significant), ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), HYPERSENSITIVITY (bad allergies), MIGRAINE (sinus migraine), ACNE (acne on face/ back), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, INTERNAL HAEMORRHAGE (Internal Bleeding), ANAPHYLACTIC REACTION (Anaphylactic reaction), HYPERSENSITIVITY (bad allergies), MIGRAINE (sinus migraine), ACNE (acne on face/ back), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment medications were reported.  Company comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product known safety profile.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product known safety profile.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Internal Bleeding; Anaphylactic reaction; bad allergies; sinus migraine; acne on face/ back; nausea; vomiting; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INTERNAL HAEMORRHAGE (Internal Bleeding) and ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis.    Concurrent medical conditions included Latex allergy (latex allergy), Gluten intolerance (Gluten allergy) and Drug allergy (Tylenol). Concomitant products included MAGNESIUM CITRATE, MOMETASONE FUROATE (NASONEX), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ASCORBIC ACID (VITAMIN C ACID), VITAMIN D3, MULTIVITAMIN AND MINERAL and FISH OIL for an unknown indication.   On 10-Sep-2020, the patient started TOFACITINIB CITRATE (XELJANZ XR) (unknown route) 11 mg once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERNAL HAEMORRHAGE (Internal Bleeding) (seriousness criterion medically significant), ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), HYPERSENSITIVITY (bad allergies), MIGRAINE (sinus migraine), ACNE (acne on face/ back), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, INTERNAL HAEMORRHAGE (Internal Bleeding), ANAPHYLACTIC REACTION (Anaphylactic reaction), HYPERSENSITIVITY (bad allergies), MIGRAINE (sinus migraine), ACNE (acne on face/ back), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment medications were reported.  Company comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product known safety profile.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product known safety profile.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TIA; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078B20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included DICLOFENAC and FINASTERIDE for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion medically significant). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of Low dose and CLOPIDOGREL BISULFATE (PLAVIX) at an unspecified dose and frequency. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided were unknown blood thinner medication.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender'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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: diagnosed with pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (diagnosed with pneumonia) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced PNEUMONIA (diagnosed with pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (diagnosed with pneumonia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported. No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. No further information is expected at this time.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. No further information is expected at this time.
Sex: U
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: broken blood vessels in my eye; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (broken blood vessels in my eye) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE HAEMORRHAGE (broken blood vessels in my eye) (seriousness criterion medically significant). At the time of the report, EYE HAEMORRHAGE (broken blood vessels in my eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported. No treatment information was provided.; Sender's Comments: Very limited information regarding the event, Eye haemorrhage, has been provided at this time. There is no patient information, no onset date and outcome of the event. No patient information to further follow-up.  This case was submitted via adverse event chatbot Text.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia, Pain, Paraesthesia, X-ray
Clinical narrative: Extreme pain numbness tingling
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria in axilla
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: Pt. experiencing anxiety, light headedness and dizziness. B/P 89/54, B/P 101/65
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, UNK
Symptoms: Aphasia, Crying, Head banging, Hypersomnia
Clinical narrative: Patient received all the vaccines due at the four month visit. As soon as we got home he slept a lot, when he woke up he cried a lot, kept banging his head and we noticed that from a very chatty baby he was completely silent. I inquired about the type of vaccines he received and all I received was the name but not the manufacturer or other information. His doctor knows about the side effects and we stopped vaccinating since we don?t know what or which vaccine affected him.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Pt. complains of dizziness and weakness.  She has a hx of hypertension and diabetes and advised she had not really eaten before vaccine.  Pt. went home w/ son.  Vitals spO2 99%, BP 167/85, HR 65.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: 4/14/21 - 1st CoVid shot 11:30 a.m.- arm pain over the next 2 days, few days later noticed a ringing in my ears that didn't go away. Not certain exactly when it started as it wasn't very loud and other sounds would mask it.  5/12/21 - 2nd CoVid shot 11:00 a.m.- arm pain, felt like my equilibrium was off that afternoon (a little dizzy, etc), constant ringing in the ears became louder. Next day after the shot had arm pain, fairly bad headache, light nausea, low fever 100.2 in the morning but was gone later in the day. (Felt like a really bad hangover) Took a few days to feel normal, however the constant ringing in the ears has not subsided as of this writing (6/3/21) and can be quite annoying.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: 4/14/21 - 1st CoVid shot 11:30 a.m.- arm pain over the next 2 days, few days later noticed a ringing in my ears that didn't go away. Not certain exactly when it started as it wasn't very loud and other sounds would mask it.  5/12/21 - 2nd CoVid shot 11:00 a.m.- arm pain, felt like my equilibrium was off that afternoon (a little dizzy, etc), constant ringing in the ears became louder. Next day after the shot had arm pain, fairly bad headache, light nausea, low fever 100.2 in the morning but was gone later in the day. (Felt like a really bad hangover) Took a few days to feel normal, however the constant ringing in the ears has not subsided as of this writing (6/3/21) and can be quite annoying.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Rash, Swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient had itchiness at the injection site within 5 min of administration. Patient had redness and slight swelling. He was given 25mg of benadryl and checked up on 15 min after. Patient said the itching went down and the redness decreased. He went home with his partner and confirmed no further issues.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: Diagnosed with AFib on 04/21/2021
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Starting around 2:00pm June 2, 2021 approximately 9 days after first dose I had terrible stomach cramps and my arm had a small itchy raised spot I took for a bug bite because I actually forgot about the vaccine at the time. It itched badly. After going to bed, all night it got worse and upon waking today there?s a large red itchy rash right below the injection site and a red spot AT the site. I also have had a headache nearly nonstop for 36 hours.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: Starting around 2:00pm June 2, 2021 approximately 9 days after first dose I had terrible stomach cramps and my arm had a small itchy raised spot I took for a bug bite because I actually forgot about the vaccine at the time. It itched badly. After going to bed, all night it got worse and upon waking today there?s a large red itchy rash right below the injection site and a red spot AT the site. I also have had a headache nearly nonstop for 36 hours.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Nervousness, Pallor
Clinical narrative: At 6:25pm after patient received vaccine EMT observed patient appeared pale with her eyes closed.  Medic walked over to patient in which patient informed that, "I don't feel good, I feel nervous and dizzy."  Medic took patient to medic area where vital signs were done and water was given.  After 15 mins. patient recovered.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hypotension
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Mild, Additional Details: 1st Dose given at 6:05 PM, lightheaded within 5 minutes. also developed chills. BP read 115/60, 5 mins later 108/67 and sat for 30 minutes. patient had improved since then and was able to leave.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Dizziness; loss of balance resulting in falling; Chills; fatigue; sleepiness; diarrhea; Loss of strength; loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received a first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number = unknown) via an unspecified route of administration in the left arm on 05Feb2021 at 01:00pm (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma, shingles (15 years ago) and anemia. The patient was allergic to codeine. Concomitant medications included vitamin b12, c, d3, iron and Tylenol (MANUFACTURER UNKNOWN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccination. On 05Mar2021 at 1:00 PM, the patient experienced dizziness, loss of balance resulting in falling, chills, fatigue, sleepiness, diarrhoea, loss of strength and loss of appetite. On 06Mar2021, the patient underwent COVID-19 virus test (nasal swab type) and the result reported as negative. Adverse events resulted in emergency room/department or urgent care. Clinical outcome of the events dizziness, loss of balance resulting in falling, chills, fatigue, sleepiness, diarrhoea, loss of strength and loss of appetite was reported as not recovered.  Information about lot number cannot be obtained and no further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, SARS-CoV-2 test, Somnolence
Clinical narrative: Dizziness; loss of balance resulting in falling; Chills; fatigue; sleepiness; diarrhea; Loss of strength; loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received a first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number = unknown) via an unspecified route of administration in the left arm on 05Feb2021 at 01:00pm (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma, shingles (15 years ago) and anemia. The patient was allergic to codeine. Concomitant medications included vitamin b12, c, d3, iron and Tylenol (MANUFACTURER UNKNOWN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccination. On 05Mar2021 at 1:00 PM, the patient experienced dizziness, loss of balance resulting in falling, chills, fatigue, sleepiness, diarrhoea, loss of strength and loss of appetite. On 06Mar2021, the patient underwent COVID-19 virus test (nasal swab type) and the result reported as negative. Adverse events resulted in emergency room/department or urgent care. Clinical outcome of the events dizziness, loss of balance resulting in falling, chills, fatigue, sleepiness, diarrhoea, loss of strength and loss of appetite was reported as not recovered.  Information about lot number cannot be obtained and no further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Flu like symptoms. Extreme fatigue, body aches, back pain, joint pain, chills and fever.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Burning sensation, Dysmenorrhoea, Feeling hot, Pruritus
Clinical narrative: After 2nd dose body felt like it was on fire/itchy/hot for about 24 hrs after. Was relieved by Benadryl. Continue to have breast tenderness that was never a symptom before as well as odd menstral cramping
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Discomfort, Dizziness, Dysphagia, Erythema
Clinical narrative: - Dizziness / feeling of dis-ease within 15-30 mins following shot  - Some  face swelling and redness, hot to touch within first hour with itchiness - swelling and redness similar to a bad sunburn  - itchiness spread down neck and eventually to whole body and lasted for around 5-6 days - Nausea / general discomfort within first hour  - swelling feeling in my calves and feet like I was retaining water the first night after the shot, lasted a few days  - what felt like swelling / tightness in throat - felt like the back of my tongue was swelling a bit / harder to swallow  - extremely swollen lymph node at left collar bone  - noticeably swollen lymph node under left arm area
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: - Dizziness / feeling of dis-ease within 15-30 mins following shot  - Some  face swelling and redness, hot to touch within first hour with itchiness - swelling and redness similar to a bad sunburn  - itchiness spread down neck and eventually to whole body and lasted for around 5-6 days - Nausea / general discomfort within first hour  - swelling feeling in my calves and feet like I was retaining water the first night after the shot, lasted a few days  - what felt like swelling / tightness in throat - felt like the back of my tongue was swelling a bit / harder to swallow  - extremely swollen lymph node at left collar bone  - noticeably swollen lymph node under left arm area
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Throat tightness
Clinical narrative: - Dizziness / feeling of dis-ease within 15-30 mins following shot  - Some  face swelling and redness, hot to touch within first hour with itchiness - swelling and redness similar to a bad sunburn  - itchiness spread down neck and eventually to whole body and lasted for around 5-6 days - Nausea / general discomfort within first hour  - swelling feeling in my calves and feet like I was retaining water the first night after the shot, lasted a few days  - what felt like swelling / tightness in throat - felt like the back of my tongue was swelling a bit / harder to swallow  - extremely swollen lymph node at left collar bone  - noticeably swollen lymph node under left arm area
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Malaise, Pain
Clinical narrative: Skin began to ache and became sensitive about 11 hours after vaccine was received.  Began having chills, lethargy, body aches (it felt like both inside of body and outside of skin), nausea, and high fever. Took Tylenol and Advil to attempt to alleviate symptoms. Could not get to sleep until about 12:30 a.m. and woke up at 2:30 a.m. with headache, extreme chilling, and intense body aches. I didn't know if I could walk. I put a sweatshirt and a coat on, and my teeth were chattering uncontrollably. I can't remember the last time that I was that sick. I contemplated going to the ER but didn't think I could drive. The entire day was a headache, nausea and lethargy. When at the clinic, I stated that I had heard that there could be some minor side effects with the 2nd shot and was told, "Nah, people make things up." I'm so glad that I'm vaccinated, but people need to be forewarned of those kinds of side effects. They have to be aware because that was dangerously sick and was totally unprepared to combat it. 103+ degree fever and this kinds of symptoms aren't things that a person should have to try to make it through alone.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain of skin, Pyrexia, Sensitive skin, Sleep disorder
Clinical narrative: Skin began to ache and became sensitive about 11 hours after vaccine was received.  Began having chills, lethargy, body aches (it felt like both inside of body and outside of skin), nausea, and high fever. Took Tylenol and Advil to attempt to alleviate symptoms. Could not get to sleep until about 12:30 a.m. and woke up at 2:30 a.m. with headache, extreme chilling, and intense body aches. I didn't know if I could walk. I put a sweatshirt and a coat on, and my teeth were chattering uncontrollably. I can't remember the last time that I was that sick. I contemplated going to the ER but didn't think I could drive. The entire day was a headache, nausea and lethargy. When at the clinic, I stated that I had heard that there could be some minor side effects with the 2nd shot and was told, "Nah, people make things up." I'm so glad that I'm vaccinated, but people need to be forewarned of those kinds of side effects. They have to be aware because that was dangerously sick and was totally unprepared to combat it. 103+ degree fever and this kinds of symptoms aren't things that a person should have to try to make it through alone.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Incorrect route of product administration, Injection site movement impairment, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: My left should and upper arm, started becoming sore and stiff the same evening I received the injection which was on a Friday and by Sunday my arm was very painful and I could not move my arm in any direction. Dr. diagnosed it as being a frozen shoulder due to the injection being improperly administered. Currently going through 8 weeks of physical therapy and if my arm and shoulder haven't had significant improvement by the end of June, I may have to have surgery. Constant pain every day now for 3 months, can't sleep well as pain keeps me up at night, difficulty getting dressed and undressed, driving a car and doing my hair, can't lift anything and every time after therapy I suffer from severe pain for two to three days after.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Periarthritis, Sleep disorder, X-ray normal
Clinical narrative: My left should and upper arm, started becoming sore and stiff the same evening I received the injection which was on a Friday and by Sunday my arm was very painful and I could not move my arm in any direction. Dr. diagnosed it as being a frozen shoulder due to the injection being improperly administered. Currently going through 8 weeks of physical therapy and if my arm and shoulder haven't had significant improvement by the end of June, I may have to have surgery. Constant pain every day now for 3 months, can't sleep well as pain keeps me up at night, difficulty getting dressed and undressed, driving a car and doing my hair, can't lift anything and every time after therapy I suffer from severe pain for two to three days after.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Additional Details: During the 15 minute monitoring period patient complained of dizziness and lightheadedness. Sat on floor, gave pt bottle of water and instructed her to lower her head. She never lost consciousness. She called her father to pick her up as she refused any suggestion of 911. By the time her family member arrived she was feeling much better. I walked her out to the parking lot and spoke to her ride. I called her at   7:10pm and she had slept/napped and felt back to normal.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Carditis, Chest pain, Pericarditis
Clinical narrative: Within a week went to hospital with severe chest pains. Diagnosed with inflammation around and in my heart
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Malaise, Pain
Clinical narrative: Pain at injection site, body pain, fatigue, malaise
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Systemic: slight numbness left leg,patient was able to walk-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient complained of slight numbness in his left leg after the shot. according to daughter he sometimes gets numbness in his leg. it has happened before, just not with a vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Chest wall mass, Ear discomfort, Heavy menstrual bleeding
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: heavy menstrual flow for 2 periods after her 2nd vaccine, ears feel blocked, lump in chest, chest pain
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Ear discomfort, Headache, Lymphadenopathy
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: heavy menstrual flow for 2 periods after her 2nd vaccine, ears feel blocked, lump in chest, chest pain
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular, Tinnitus, Ultrasound scan, Vaginal haemorrhage
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: heavy menstrual flow for 2 periods after her 2nd vaccine, ears feel blocked, lump in chest, chest pain
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain of skin, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Fever-Medium, Systemic: Nausea-Medium, Additional Details: Patient describes also skin painful to touch along with pain all over her body. Describes pain as the worst she has ever had.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Pt claims he has constant pain radiating from his left deltoid all the way to his biceps and triceps.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting every 20 minutes for a period of 3 times.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Diarrhoea, Dyspnoea, Nausea, Pain
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Diarrhea-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Received 2 nd dose of Moderna shot on Sunday.  Sunday night and Monday, patient states he had vomting and diarrhea.   Vomiting and diarrhea stop on Monday.  Monday night and Tuesday, bodyache.  Tuesday night and Wednesday, patient has asthmatic symptoms.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Diarrhea-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Received 2 nd dose of Moderna shot on Sunday.  Sunday night and Monday, patient states he had vomting and diarrhea.   Vomiting and diarrhea stop on Monday.  Monday night and Tuesday, bodyache.  Tuesday night and Wednesday, patient has asthmatic symptoms.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Caesarean section, Exposure during pregnancy, Foetal growth restriction, Placental disorder, Ultrasound Doppler abnormal
Clinical narrative: Intrauterine growth restriction. Treated with Csection at 37 weeks on 5/10/21 ( original estimated due date was 5/28/21). Birthweight only 4lbs 2oz.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound antenatal screen abnormal
Clinical narrative: Intrauterine growth restriction. Treated with Csection at 37 weeks on 5/10/21 ( original estimated due date was 5/28/21). Birthweight only 4lbs 2oz.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue, aches, fever, chills
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Fatigue, Pain, Pyrexia
Clinical narrative: Patient presented to emergency department on 4/22/2021 with symptoms of shortness of breath, fatigue, body aches, and fever. Patient was diagnosed with COVID-19 infection on  4/17/2021 with symptoms starting on 4/14/2021. Patient was treated with dexamethasone, remdesivir, and supplemental oxygen. Patient has clinically improved and was discharged from hospital on 4/28/2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient presented to emergency department on 4/22/2021 with symptoms of shortness of breath, fatigue, body aches, and fever. Patient was diagnosed with COVID-19 infection on  4/17/2021 with symptoms starting on 4/14/2021. Patient was treated with dexamethasone, remdesivir, and supplemental oxygen. Patient has clinically improved and was discharged from hospital on 4/28/2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Error: Diluent Administered Instead of Vaccine
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Arthralgia, Fatigue, Full blood count normal, Immediate post-injection reaction
Clinical narrative: Soreness an arm immediately after. Three weeks later began having severe joint pain, chronic fatigue and hives with extreme itching
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: Soreness an arm immediately after. Three weeks later began having severe joint pain, chronic fatigue and hives with extreme itching
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension
Clinical narrative: Systemic: Headache-Medium, Systemic: Hypertension-Mild, Additional Details: said her head started hurting her from behind. her bp was 140/77 heart rade 77. told her to take tylenol and her regular meds. if her headache persists or gets worse to go to the er. her son has a bp cuff and will check her bp
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Sensation of foreign body
Clinical narrative: Patient felt like a lump in his throat.  No difficulty breathing or swallowing.  VS 110/70 P. 56 Patient drank water and felt a little better.  He went outside and felt better after removing mask.  He felt it was starting to go away but was still there on one side.  Both parents were with him and he went to the ER with them in their vehicle.  This was dose 2 of Pfizer and he had no difficulty with the first dose.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Nausea
Clinical narrative: Severe fatigue sleeping 20+ hours, nausea, headaches
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Hypotension, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Additional Details: patient sweating, feeling like she was going to faint BP was 98/64
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Additional Details: patient sweating, feeling like she was going to faint BP was 98/64
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event, vaccine was 2 days expired.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu-like symptoms. Headache, slight fever, body aches, loss of appetite. Began approximately 7hrs post injection, peaked in intensity approximately 15hrs post injection, then declined in intensity until fully dissipated approximately 48hrs post injection.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Oral herpes, Pruritus
Clinical narrative: Felt flushed and itchy right after. Broke out in cold sores within 28 hours of second shot.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing
Clinical narrative: Flushed light headed
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Injection site pain, Nervous system disorder
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: shingle disease-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Medium, Additional Details: pt got shingle disease after moderna shot dignosed with her md
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered vaccine to minor
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered vaccine to minor, mother was present for 2nd dose.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered vaccine to minor Father  reported no reaction to the vaccine. Daughter in good condition; no signs or symptoms of distress reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered vaccine to minor Patient mother  reported no adverse side effects. Daughter in good condition; no reported signs or symptoms of distress.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered vaccine to minor. Mother consented for 2nd dose. No reaction noted after 1st dose.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 16 years old and he received Moderna vaccine instead of Pfizer.  No treatment required. No signs or symptoms reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered vaccine to minor.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered vaccine to minor. Mother  consented on 2nd dose. No symptoms reported from 1st dose.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Haematochezia, Hyperhidrosis, Presyncope
Clinical narrative: Had bloody stool followed by dizziness, ringing in ears, loss of strength, heavy sweats-- nearly passed out. Most symptoms passed after event  but was weak for the rest of the day.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Had bloody stool followed by dizziness, ringing in ears, loss of strength, heavy sweats-- nearly passed out. Most symptoms passed after event  but was weak for the rest of the day.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pharyngeal swelling, Urticaria, Vomiting
Clinical narrative: hives on arms and chest, swollen throat, nausea vomiting
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pain, Photophobia, Pyrexia
Clinical narrative: Woke up the next day my eyes were extremely sensitive to light , headache (all day), body aches low grade fever and no energy.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, RV1
Symptoms: Abdominal discomfort, Cough, Feeding intolerance, Hypersensitivity, Mucous stools
Clinical narrative: The cough started about a week after vaccination(s), sleep problems started at the same time, stomach issues (not tolerating feedings, mucus poop)  The doctor said the cough was allergies, prescribed allergy medication, and breathing treatments.  We did not do the allergy medications and only did breathing treatments for a week.  The cough persisted until the child was 7 months old.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, RV1
Symptoms: Sleep disorder
Clinical narrative: The cough started about a week after vaccination(s), sleep problems started at the same time, stomach issues (not tolerating feedings, mucus poop)  The doctor said the cough was allergies, prescribed allergy medication, and breathing treatments.  We did not do the allergy medications and only did breathing treatments for a week.  The cough persisted until the child was 7 months old.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypersensitivity, Skin reaction
Clinical narrative: Delayed localized hypersensitivity reaction at site of vaccine
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pruritus, Pain
Clinical narrative: About 8 hours after my second shot, I developed a fever, headache and body ache. Those symptoms and general tiredness lasted about 36 hours and then vanished. Then, about two weeks after my second Moderna shot, the injection site (upper left arm) was itchy. There is now a red spot around the site, about 1-2 cm wide at the moment (17 days after). No pain.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: About 8 hours after my second shot, I developed a fever, headache and body ache. Those symptoms and general tiredness lasted about 36 hours and then vanished. Then, about two weeks after my second Moderna shot, the injection site (upper left arm) was itchy. There is now a red spot around the site, about 1-2 cm wide at the moment (17 days after). No pain.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cold sweat, Cyanosis, Dyspnoea, Eye movement disorder
Clinical narrative: A few minutes after giving vaccination, patient's mother and caregiver stated that he was having a reaction.  Patient can only use his eyes to respond "yes" or "no" since he is non-verbal and when he would not respond to his mother's questions with his eyes she became very panicked and alerted the pharmacy staff.  When I got to the patient he was very clammy, sweating, and breathing heavy.  She said his eyes had rolled back in his head and his tongue had turned blue.  I propped his legs up on a chair and took his blood pressure with an automatic blood pressure cuff and it was 164/124 with pulse 95.  I decided to contact EMS for assistance. Retook BP  few minutes later and it was the same.  EMS arrived and stated it was most likely a reaction to being afraid of needles but would take him to get checked out.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fear of injection, Hyperhidrosis, Unresponsive to stimuli
Clinical narrative: A few minutes after giving vaccination, patient's mother and caregiver stated that he was having a reaction.  Patient can only use his eyes to respond "yes" or "no" since he is non-verbal and when he would not respond to his mother's questions with his eyes she became very panicked and alerted the pharmacy staff.  When I got to the patient he was very clammy, sweating, and breathing heavy.  She said his eyes had rolled back in his head and his tongue had turned blue.  I propped his legs up on a chair and took his blood pressure with an automatic blood pressure cuff and it was 164/124 with pulse 95.  I decided to contact EMS for assistance. Retook BP  few minutes later and it was the same.  EMS arrived and stated it was most likely a reaction to being afraid of needles but would take him to get checked out.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Chromaturia, Decreased appetite, Fatigue, Headache
Clinical narrative: headache, chills, vomiting, extreme exhaustion, body aches, lack of appetite, brown urine, chills, hot flashes Symptoms lasted 5 days, on and off throughout each day.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Pain, Vomiting
Clinical narrative: headache, chills, vomiting, extreme exhaustion, body aches, lack of appetite, brown urine, chills, hot flashes Symptoms lasted 5 days, on and off throughout each day.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Pain, Shoulder injury related to vaccine administration
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: pain radiating from shoulder-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test normal, Dizziness, Feeling hot, Syncope
Clinical narrative: Approximately 10 minutes after receiving the injection, patient states that he felt hot, lightheaded, and had stomach pain. As he was moving to a recliner, patient passed out. The pharmacist called 911, and raised patient legs onto a chair. Patient woke back up, and the pharmacist said that his eyes were "not normal".  Paramedics arrived, and transported patient to the emergency room. Patient states that he was at the ER for approximately 2 hours, and then discharged. While at the ER, he received IV fluids and blood work was performed. He has not had any other complications besides a sore arm at the site of injection.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no Problems reported.   Patient vaccine was given a dose that was  in the refrigerator for 37 days.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Hypoacusis, degraded hearing
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: Flu symptoms- fever, chills, headache, sweating,  lasting until morning of the next day (June 2). full recovery morning of June 3.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Nausea, Respiratory rate decreased
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: patient was initially feeling nauseous and vomited. She did not lose consciousness or forget memory. She was unresponsive to questions, but were able to move her body and hands to touch. Her breathing did not stop -- but seemed like it was slowing down. She received one dose of epipen. After few minutes, she was responsive and was able to reply in short words and was aware of the situation and where she was.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: patient was initially feeling nauseous and vomited. She did not lose consciousness or forget memory. She was unresponsive to questions, but were able to move her body and hands to touch. Her breathing did not stop -- but seemed like it was slowing down. She received one dose of epipen. After few minutes, she was responsive and was able to reply in short words and was aware of the situation and where she was.