chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Injection site pain, Nausea, Vomiting
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Patient reports painful blisters breaking out on face-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Hangover, Pyrexia
Clinical narrative: Fever chills through the night. ?Hangover? feeling next day. Fine by 3rd day.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Muscle spasms, Pyrexia
Clinical narrative: Had to leave work with Fever, terrible muscle cramps,  couldn?t hold my head up, splitting headache
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pruritus, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Deafness, Dizziness, Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic:  difficulty hearing-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: We called 911. EMT came in. All the vital signs were normal. After 30 minutes, the patient recovered.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic:  difficulty hearing-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: We called 911. EMT came in. All the vital signs were normal. After 30 minutes, the patient recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Additional Details: Patient complains of tenderness at injection site as well as itching. She also complains of a knot in her shoulder at the injection site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Loss of personal independence in daily activities, Malaise
Clinical narrative: Significant redness at the vaccination site, still a large red circle around the injection point now, even 3 days later. Low grade fever onset approximately 24 hours after injection, followed by chills, an generally feeling unwell - lasted for approximately 30 hours. Treated with ibuprofen every 4-6 hours to control fever. Caused me to be home, in bed, for approximately 30 hours. I have recovered from the fever and related symptoms. The red, sore injection site remains. I experienced the red, sore injection site with the first dose of the Zoster vaccine and it took ~1 week to resolve.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Significant redness at the vaccination site, still a large red circle around the injection point now, even 3 days later. Low grade fever onset approximately 24 hours after injection, followed by chills, an generally feeling unwell - lasted for approximately 30 hours. Treated with ibuprofen every 4-6 hours to control fever. Caused me to be home, in bed, for approximately 30 hours. I have recovered from the fever and related symptoms. The red, sore injection site remains. I experienced the red, sore injection site with the first dose of the Zoster vaccine and it took ~1 week to resolve.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Hypersensitivity, Syncope
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Fainting / Unresponsive-Medium
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Fainting / Unresponsive-Medium
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 10 hours after injection, I woke up with a splitting headache, 100.4 fever, fatigue, body aches, vomiting  This lasted for approximately 20 hours.  Then my fever broke and felt about 80% better.  Fever, body aches and fatigue came back at the 25 hour mark post injection and lasted until 6:00am or 39 hours post injection time.  Tylenol, Motrin and Pedialyte was taken.    Slight fatigue and weakness still at 60 hours.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 10 hours after injection, I woke up with a splitting headache, 100.4 fever, fatigue, body aches, vomiting  This lasted for approximately 20 hours.  Then my fever broke and felt about 80% better.  Fever, body aches and fatigue came back at the 25 hour mark post injection and lasted until 6:00am or 39 hours post injection time.  Tylenol, Motrin and Pedialyte was taken.    Slight fatigue and weakness still at 60 hours.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Fatigue
Clinical narrative: Joint pain, bone pain, chills, fatigue.  The joint pain and bone pain lasted 24 hours - 7 out of 10.  Lasted but to a lesser degree until 48 hours.  Chills and fatigue lasted 36 hours   Treated with Advil 2 tabs q 6 hours.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Pain in extremity, Swollen tongue
Clinical narrative: Patient received vaccine and approximately 30 minutes afterwards began experiencing tongue swelling, bilateral hip, knee, leg and shoulder pain, and dizziness.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged lymph node under arm pit size of golf ball
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Decreased appetite, Headache, Hyperhidrosis
Clinical narrative: Chills, sweat, lethargic, headache, loss of appetite, sleepiness, back pain, menstruation (after none for 10+ years), body aches, hives
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain, Postmenopausal haemorrhage, Somnolence, Urticaria
Clinical narrative: Chills, sweat, lethargic, headache, loss of appetite, sleepiness, back pain, menstruation (after none for 10+ years), body aches, hives
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: I experienced fever, chills, exhaustion, body aches within the 24 hour period following my vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: Aches, sore arm, fatigue, low-grade fever
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Felt like a cold for exactly 12 hours. I slept for 11 of them. Fever, chills, body aches.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Starting on 28th of march on Headache Muscle aches especially at injection site Injection site is hot Tiredness  Overall unwell feeling
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature abnormal, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: Starting on 28th of march on Headache Muscle aches especially at injection site Injection site is hot Tiredness  Overall unwell feeling
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site warmth
Clinical narrative: Starting on 28th of march on Headache Muscle aches especially at injection site Injection site is hot Tiredness  Overall unwell feeling
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Migraine headache for 2 days
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Headache, Hypoaesthesia, Neuralgia
Clinical narrative: I seem to be getting a new addition every day. Day 1 sore arm and chills Day2 neuralgia - on right headache, jaw pain, numbness in eye and ear and face. Heavy,wheezines in right lung. A total of 6 Tylenol eased pain. Day 3. Tremors. Body feels as if it's vibrating inside. Ongoing
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw, Tremor, Vibratory sense increased, Wheezing
Clinical narrative: I seem to be getting a new addition every day. Day 1 sore arm and chills Day2 neuralgia - on right headache, jaw pain, numbness in eye and ear and face. Heavy,wheezines in right lung. A total of 6 Tylenol eased pain. Day 3. Tremors. Body feels as if it's vibrating inside. Ongoing
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue, headache, low grade fever
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Thalassaemia
Clinical narrative: Systemic: Tachycardia-Medium, Additional Details: Difficulty swallowing
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Contracted again/ took test on 03/27/2021
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: Bell?s Palsey on Left side
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient received first dose of Pfizer COVID vaccine. Several minutes later, patient felt faint, got up to inform family to inform pharmacist, and fell to the ground
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest discomfort, Dyspnoea, Feeling abnormal, Hallucination
Clinical narrative: Night of vaccine felt heaviness on chest - using elliptical machine as usual and felt out of breath very quickly within 15 minutes.  Normally do 30 minutes and can speak through it.  Just thought I was tired. Overnight joint pain significant in knees, fingers and shoulder blades.  Husband told me I was moaning throughout the night and turning from side to side.  Got up to go to the bathroom once and head felt foggy. Morning got up as usual  and quickly became light headed.  Started to black out to the point where sitting down and putting my head down didn?t help.  Was blacked out and yelled for my husband.  Husband carried me to the couch what I was saying he thought I was hallucinating.  Began to have whole body trembling - not necessarily chills just trembling.  After about an hour subsided.  Blacking out lasted on and off throughout the day.  O2 stats between 91 and 94 throughout the day, fast heart rate 90+.  No fever.  Stayed in bed all day, barely moved.  Restless and couldn?t get comfortable - very bad headache.  Going in and out of sleep.   Treated with Tylenol arthritis and ibuprofen.  Drank water and some hot tea.  Very hard to even drink anything. Next day felt like I had been sick although by 5pm seemed to be back to baseline.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Loss of consciousness, Movement disorder, Pain in extremity, Restlessness
Clinical narrative: Night of vaccine felt heaviness on chest - using elliptical machine as usual and felt out of breath very quickly within 15 minutes.  Normally do 30 minutes and can speak through it.  Just thought I was tired. Overnight joint pain significant in knees, fingers and shoulder blades.  Husband told me I was moaning throughout the night and turning from side to side.  Got up to go to the bathroom once and head felt foggy. Morning got up as usual  and quickly became light headed.  Started to black out to the point where sitting down and putting my head down didn?t help.  Was blacked out and yelled for my husband.  Husband carried me to the couch what I was saying he thought I was hallucinating.  Began to have whole body trembling - not necessarily chills just trembling.  After about an hour subsided.  Blacking out lasted on and off throughout the day.  O2 stats between 91 and 94 throughout the day, fast heart rate 90+.  No fever.  Stayed in bed all day, barely moved.  Restless and couldn?t get comfortable - very bad headache.  Going in and out of sleep.   Treated with Tylenol arthritis and ibuprofen.  Drank water and some hot tea.  Very hard to even drink anything. Next day felt like I had been sick although by 5pm seemed to be back to baseline.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Night of vaccine felt heaviness on chest - using elliptical machine as usual and felt out of breath very quickly within 15 minutes.  Normally do 30 minutes and can speak through it.  Just thought I was tired. Overnight joint pain significant in knees, fingers and shoulder blades.  Husband told me I was moaning throughout the night and turning from side to side.  Got up to go to the bathroom once and head felt foggy. Morning got up as usual  and quickly became light headed.  Started to black out to the point where sitting down and putting my head down didn?t help.  Was blacked out and yelled for my husband.  Husband carried me to the couch what I was saying he thought I was hallucinating.  Began to have whole body trembling - not necessarily chills just trembling.  After about an hour subsided.  Blacking out lasted on and off throughout the day.  O2 stats between 91 and 94 throughout the day, fast heart rate 90+.  No fever.  Stayed in bed all day, barely moved.  Restless and couldn?t get comfortable - very bad headache.  Going in and out of sleep.   Treated with Tylenol arthritis and ibuprofen.  Drank water and some hot tea.  Very hard to even drink anything. Next day felt like I had been sick although by 5pm seemed to be back to baseline.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chest discomfort, Headache, Muscle spasms
Clinical narrative: Night of vaccine felt heaviness on chest - using elliptical machine as usual and felt out of breath very quickly within 15 minutes.  Normally do 30 minutes and can speak through it.  Just thought I was tired. Overnight joint pain significant in knees, fingers and shoulder blades.  Husband told me I was moaning throughout the night and turning from side to side.  Got up to go to the bathroom once and head felt foggy. Morning got up as usual  and quickly became light headed.  Started to black out to the point where sitting down and putting my head down didn?t help.  Was blacked out and yelled for my husband.  Husband carried me to the couch what I was saying he thought I was hallucinating.  Began to have whole body trembling - not necessarily chills just trembling.  After about an hour subsided.  Blacking out lasted on and off throughout the day.  O2 stats between 91 and 94 throughout the day, fast heart rate 90+.  No fever.  Stayed in bed all day, barely moved.  Restless and couldn?t get comfortable - very bad headache.  Going in and out of sleep.   Treated with Tylenol arthritis and ibuprofen.  Drank water and some hot tea.  Very hard to even drink anything. Next day felt like I had been sick although by 5pm seemed to be back to baseline.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased, Presyncope
Clinical narrative: Night of vaccine felt heaviness on chest - using elliptical machine as usual and felt out of breath very quickly within 15 minutes.  Normally do 30 minutes and can speak through it.  Just thought I was tired. Overnight joint pain significant in knees, fingers and shoulder blades.  Husband told me I was moaning throughout the night and turning from side to side.  Got up to go to the bathroom once and head felt foggy. Morning got up as usual  and quickly became light headed.  Started to black out to the point where sitting down and putting my head down didn?t help.  Was blacked out and yelled for my husband.  Husband carried me to the couch what I was saying he thought I was hallucinating.  Began to have whole body trembling - not necessarily chills just trembling.  After about an hour subsided.  Blacking out lasted on and off throughout the day.  O2 stats between 91 and 94 throughout the day, fast heart rate 90+.  No fever.  Stayed in bed all day, barely moved.  Restless and couldn?t get comfortable - very bad headache.  Going in and out of sleep.   Treated with Tylenol arthritis and ibuprofen.  Drank water and some hot tea.  Very hard to even drink anything. Next day felt like I had been sick although by 5pm seemed to be back to baseline.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Palpitations
Clinical narrative: BP 153/89, HR 84,O2 100%, 12 lead normal.  Anxiety, weakness, palpitations. Exit time 11:22 am.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Pain in extremity
Clinical narrative: Triggered a migraine headache from night of injection, off and on through today 3/29. Sore arm the day after but has since gone away. Fatigue/tiredness for the first 24hr after injection.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose decreased, Decreased appetite, Nausea
Clinical narrative: Severe nausea for 1.5 days.  Lack of eating caused blood sugar to drop.  Felt very weak.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash/whelps over entire body that is increasing in size
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Impaired work ability, Pain, Product administered to patient of inappropriate age
Clinical narrative: There was not an unusual reaction other than temp around 101 and body ache. However, she was not 18 at the time of administration. Due to temp Patient consulted MD for note for a excuse from work leave
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia oral, Nausea, Peripheral swelling, Pruritus
Clinical narrative: numbness in lips and mouth, nausea, swelling of arm, large rash following swelling, itching following swelling, severe headache,
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: numbness in lips and mouth, nausea, swelling of arm, large rash following swelling, itching following swelling, severe headache,
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: On the day after my 2nd dose, I had the typical low grade fever, chills, and aches. But on the 2nd day, I woke up with a red rash all around my torso and down both arms. It did not itch and was gone by the 3rd day.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: I have a bumpy, red itchy rash on my arm and a lump/bump at injection site. It is warm to the touch
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: BP 179/75, O2 100%, HR 124. Palpitation Exit 2:55 pm
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Nausea, Pyrexia
Clinical narrative: 102.7 fever for 24 hours - 100.3 for 14 hours Severe nausea Extreme tiredness - slept 34 of 36 hours Migraine Site swelling
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Sensitivity under right ear at lymph glands, no treatment; lasted two days
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Pt received injection at 1836. Pt c/o generalized fatigue. Pt had been waiting in line >3 hours. Pt stated feeling more alert at 1855 and released from observation.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Chills, fever, aches, fatigue, Covid arm (swelling and red around injection site), swelling and soreness under armpit of same arm
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills, fever, aches, fatigue, Covid arm (swelling and red around injection site), swelling and soreness under armpit of same arm
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: sudden back and muscle spasms lasting 2-3 weeks, mild overall but persistent and reported back to us as PCP clinic. Seemed to resolve by shot 2 on 2/11/21
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Lip swelling, Peripheral swelling, Pharyngeal swelling, Rash, Urticaria
Clinical narrative: Hives, rash, swollen fingers and hands, swollen lips, swollen throat
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Received Pfizer Vaccine #1 on 3/27/21. Fifteen minutes after receiving the Vaccine, patient reported ?tingling of lips?. Was given a water bottle and feeling did not go away. Patient requested Benadryl stating ?I take Benadryl all the time.? His dad was driving him home. Benadryl 25mg PO was administered. 15 minutes after Benadryl administration, patient reported tingling of lips resolved.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA -- Fatigue, nausea since receiving the vaccine.  Took Motrin a few hours after the vaccine.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Full blood count, Injection site hypoaesthesia, Limb discomfort
Clinical narrative: L arm numbness/heaviness 5 days prior to arrival
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Skin warm
Clinical narrative: Achiness in legs, then chills, and then my legs felt like they were on fire. The next day I had a terrible headache and very tired.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypogeusia, Parosmia
Clinical narrative: Sense of smell off (things smelled like rotten eggs), sense of taste dulled, metallic taste for 24 hours
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Headache, Fever, Chills, soreness in left arm, neck, and head. 48 hrs
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia
Clinical narrative: Headache for ~48 hours (ibuprofen taken without relief) Sleeplessness  Fatigue
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Death, Hyperglycaemia, Mental status changes
Clinical narrative: altered mental status cardiac arrest hyperglycemia death
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Pt received vaccine at 1159. 1224 pt c/o "tingling" lips and tongue only. No redness, swelling, hives, sob. Benadryl 50mg/20ml given PO. 1236 Pt reports reduction of symtoms and wants to leave. Pt released to home being driven by another person.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neuralgia, Sciatica
Clinical narrative: Previous mild Sciatica, knee pain, nerve pain in the left side became extreme the next day. Nothing relieved pain. Nothing was done the day of injection that would cause this. Pain continues to be so severe seeing spine specialist and scheduled for injections.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Nausea
Clinical narrative: Swollen Lymph Nodes, chills, headache, nauseous stomach, pain radiating in left boob & left back, and tireness
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Swollen Lymph Nodes, chills, headache, nauseous stomach, pain radiating in left boob & left back, and tireness
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE information; temperature excursion for PROQUAD; This spontaneous report as received from an officer manager refers to a 4 year old patient of an unknown gender.      Caller stated the vaccines went through the temperature excursion on 16-FEB-2021 and their facility reported it to Vaccine reporting program, but it was unaware they needed to report the excursion. Caller stated during that time (unspecified date in 2021), the vaccines were administered to patients. On 08-MAR-2021, the patient was vaccinated with incorrect storage measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA (recombinant human albumin)) lot # T027111 with expiration date of 07-FEB-2022, 0.5 milliliter, for prophylaxis (route of administration was not provided). The vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experience a temperature of -10 C, during 1 hour and 15 minutes. There was not previous temperature excursion. It was not called because of a data logger. No additional adverse event (AE) information. No product quality complaint (PQC) reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Pruritus, Thrombosis
Clinical narrative: Blue/black blood clot on middle finger right hand; Burning in middle finger on right hand; Itchiness on middle finger on right hand; Pain in middle finger on right hand; A spontaneous report was received from a Consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events burning in middle finger on right hand/burning sensation, itchiness on middle finger on right hand/pruritus, pain in middle finger on right hand/pain in extremity, blue black blood clot on middle finger right hand/thrombosis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 JAN 2021 1.00 pm, after taking mRNA-1273, the patient felt weird sensation in right hand middle finger. She felt burning, itchiness, pain and had a dark blue/black blood clot on inside of finger. 2 hours later it started to fade down (purple in color). In the evening it was considerably lighter. On 21 Jan 2021 there was a light imprint of the blood clot. Blood clot went away later that day. Patient did not received treatment.  Action taken with mRNA-1273 in response to the events was not reported.  On 20 Jan 2021 the outcome of events burning in middle finger, itchiness on middle finger on right hand, pain in middle finger on right hand was resolving. On 21 Jan 2021 the outcome of event blue black blood clot on middle finger right hand was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; A spontaneous report was received from a consumer concerning a 73-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia.   The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 12 Jan 2021, approximately six days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 17 Jan 2021, the patient started experiencing cold symptoms. The patient had pneumonia and was hospitalized on 18 Jan 2021. Since the patient was taking antibiotics, healthcare professional recommended to wait on the second dose of the vaccine. The second dose was scheduled 49 days after the first one. The reporter stated that the patient was immunosuppressed. Treatment information included antibiotics.    Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, pneumonia, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Flushing, Heart rate decreased
Clinical narrative: feeling faint; internal sensation jolt; increase blood pressure; pulse declined; face flush; fatigue; A spontaneous report was received from a consumer, concerning a 68-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced internal sensation body jolt, feeling faint, increase blood pressure, pulse declined, face flush, fatigue.   The patient's medical history includes allergic to codine drug. Concomitant product use was not provided by the reporter.  On 12-Feb-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 029L20A) via intramuscularly for prophylaxis of  COVID-19 infection.   On 12-feb-2021,he experienced internal sensation body jolt, feeling faint, increase blood pressure, pulse declined, face flush, fatigue. After 45 minutes following injection his blood pressure are as follows 145/90 mmhg,172/92 mmhg, Late 1 hr of injection blood pressure was decreased . No HCP consulted, advised him to consult HCP before receiving second vaccine.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events were unknown; Reporter's Comments: This case concerns a 68-year-old female who had a serious unexpected event of syncope along with nonserious unexpected myoclonus, blood pressure increased, heart rate decreased, flushing, and fatigue.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myoclonus, Syncope
Clinical narrative: feeling faint; internal sensation jolt; increase blood pressure; pulse declined; face flush; fatigue; A spontaneous report was received from a consumer, concerning a 68-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced internal sensation body jolt, feeling faint, increase blood pressure, pulse declined, face flush, fatigue.   The patient's medical history includes allergic to codine drug. Concomitant product use was not provided by the reporter.  On 12-Feb-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 029L20A) via intramuscularly for prophylaxis of  COVID-19 infection.   On 12-feb-2021,he experienced internal sensation body jolt, feeling faint, increase blood pressure, pulse declined, face flush, fatigue. After 45 minutes following injection his blood pressure are as follows 145/90 mmhg,172/92 mmhg, Late 1 hr of injection blood pressure was decreased . No HCP consulted, advised him to consult HCP before receiving second vaccine.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events were unknown; Reporter's Comments: This case concerns a 68-year-old female who had a serious unexpected event of syncope along with nonserious unexpected myoclonus, blood pressure increased, heart rate decreased, flushing, and fatigue.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Eyelid irritation, Facial discomfort, Facial paralysis, Feeling abnormal
Clinical narrative: It was a feeling of paralyzed type of thing/lip was drooping-eyelid; Feeling that went up to my neck, head, cheek, forehead around my eye; Feeling that went up to my neck; Right face looked funny; Whole right side did not look correct; Blood pressure has gone up\blood pressure was 215 over 90-something; Her right eyelid drooped; A spontaneous report  was received from a consumer concerning a 71 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a feeling that  went back her head, cheek, forehead around her eye/ facial discomfort, feeling that went up to her neck/ musculoskeletal discomfort,  It was a feeling of paralyzed type of thing/ facial paralysis, her right face looked funny/ feeling abnormal, lip was drooping/facial paralysis, right eyelid drooped/ eyelid irritation, whole right side did not look correct/ hemiplegia, her blood pressure had gone up/ Hypertension.  The patient's medical history as provided by the reporter included hypertension. Concomitant medications reported included atenolol,chlortalidone.  On 28 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 012A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced a feeling that went up her neck, head, cheek, forehead around her eye. It was a feeling of paralyzed type of thing. Her right face looked funny, lip was drooping, eyelids, whole right side did not look correct. The patient's blood pressure was 215.   Treatment information provided included doctor gave her a little bit more unspecified medication.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, a feeling that  went back her neck, head, cheek, forehead around her eye, It was a    feeling of paralyzed type of thing, her right face looked funny, lip was drooping, right eyelid drooped were resolved. The outcome of events, whole right side did not look correct, her blood pressure had gone up were unknown.  Follow-up received on 17 Mar 2021, outcome of events updated.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events, a causal relationship with the events cannot be excluded. However, patient is hypertensive and the blood pressure recording was 215. which also stands as a confounder and alternative etiology
Sex: F
Vaccine: COVID19
Symptoms: Hemiplegia, Hypertension, Musculoskeletal discomfort
Clinical narrative: It was a feeling of paralyzed type of thing/lip was drooping-eyelid; Feeling that went up to my neck, head, cheek, forehead around my eye; Feeling that went up to my neck; Right face looked funny; Whole right side did not look correct; Blood pressure has gone up\blood pressure was 215 over 90-something; Her right eyelid drooped; A spontaneous report  was received from a consumer concerning a 71 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a feeling that  went back her head, cheek, forehead around her eye/ facial discomfort, feeling that went up to her neck/ musculoskeletal discomfort,  It was a feeling of paralyzed type of thing/ facial paralysis, her right face looked funny/ feeling abnormal, lip was drooping/facial paralysis, right eyelid drooped/ eyelid irritation, whole right side did not look correct/ hemiplegia, her blood pressure had gone up/ Hypertension.  The patient's medical history as provided by the reporter included hypertension. Concomitant medications reported included atenolol,chlortalidone.  On 28 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 012A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced a feeling that went up her neck, head, cheek, forehead around her eye. It was a feeling of paralyzed type of thing. Her right face looked funny, lip was drooping, eyelids, whole right side did not look correct. The patient's blood pressure was 215.   Treatment information provided included doctor gave her a little bit more unspecified medication.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, a feeling that  went back her neck, head, cheek, forehead around her eye, It was a    feeling of paralyzed type of thing, her right face looked funny, lip was drooping, right eyelid drooped were resolved. The outcome of events, whole right side did not look correct, her blood pressure had gone up were unknown.  Follow-up received on 17 Mar 2021, outcome of events updated.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events, a causal relationship with the events cannot be excluded. However, patient is hypertensive and the blood pressure recording was 215. which also stands as a confounder and alternative etiology
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Vaccination site erythema, Vaccination site induration, Vaccination site paraesthesia, Vaccination site pruritus
Clinical narrative: neuropathy; tingling sensation from the upper arm to the fingers; Hot; Large red area on the left arm; small lump close to the vaccination site; itchy; A spontaneous report was received from a consumer concerning a 84-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a large, red area that was hot and itchy,  small lump close to the vaccination site,neuropathy, a "badness site" in the left arm, with a tingling sensation from the upper arm to the fingers.  The patient's medical history, as provided by the reporter, included seasonal allergy,high blood pressure and high cholesterol. Concomitant medications reported included  high blood pressure medications and simvastatin for high cholesterol.  On 07 Jan 2021 prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 025L20A)) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 02 Feb 2021 the patient received their second  of two planned doses of mRNA-1273 (Lot number: unknown)  in the right arm for prophylaxis of COVID-19 infection  .   On 07 Jan 2021, after receiving vaccination of mRNA-1273,  the patient felt  large, red area that was hot and itchy,  small lump close to the vaccination site,neuropathy, a "badness site" in the left arm, with a tingling sensation from the upper arm to the fingers.  Treatment for the events included  physical therapy to recover the mobility of this arm. Action taken with mRNA-1273 in response to the events was not reported.   The  outcome of the events, a large, red area that was hot and itchy,  small lump close to the vaccination site were considered resolved on 14 Jan 2021 and the outcome of events neuropathy, a "badness site" in the left arm, with a tingling sensation from the upper arm was unknown .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: neuropathy; tingling sensation from the upper arm to the fingers; Hot; Large red area on the left arm; small lump close to the vaccination site; itchy; A spontaneous report was received from a consumer concerning a 84-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a large, red area that was hot and itchy,  small lump close to the vaccination site,neuropathy, a "badness site" in the left arm, with a tingling sensation from the upper arm to the fingers.  The patient's medical history, as provided by the reporter, included seasonal allergy,high blood pressure and high cholesterol. Concomitant medications reported included  high blood pressure medications and simvastatin for high cholesterol.  On 07 Jan 2021 prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 025L20A)) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 02 Feb 2021 the patient received their second  of two planned doses of mRNA-1273 (Lot number: unknown)  in the right arm for prophylaxis of COVID-19 infection  .   On 07 Jan 2021, after receiving vaccination of mRNA-1273,  the patient felt  large, red area that was hot and itchy,  small lump close to the vaccination site,neuropathy, a "badness site" in the left arm, with a tingling sensation from the upper arm to the fingers.  Treatment for the events included  physical therapy to recover the mobility of this arm. Action taken with mRNA-1273 in response to the events was not reported.   The  outcome of the events, a large, red area that was hot and itchy,  small lump close to the vaccination site were considered resolved on 14 Jan 2021 and the outcome of events neuropathy, a "badness site" in the left arm, with a tingling sensation from the upper arm was unknown .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough
Clinical narrative: tested positive for COVID; cough; A spontaneous report was received from a consumer, concerning a 66 years old male patient, who received Moderna's COVID-19 vaccine and was hospitalized due to COVID-19 and Cough.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.                                                                                                                                              On 11 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 12 Mar 2021, the patient tested positive for COVID -19 and was administered Monoclonal antibody infusion at hospital on 15 Mar 2021. The patient was scheduled to get second dose of Moderna COVID-19 vaccine on 13 Mar 2021 but it was rescheduled for 29 Mar 2021.  The patient was prescribed benzonatate for cough.  Treatment details included monoclonal antibodies and benzonante.  The second dose of mRNA-1273 was delayed in response to the events.  The outcome of the events, COVID-19 and cough was considered to be not resolved at the time of this report.; Reporter's Comments: This case concerns a 66 Y/O M hospitalized with serious unexpected events of COVID-19 and cough.  Event onset 30 days after first dose mRNA-1273. Treated with monoclonal antibodies and benzonante. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Pregnant patient miscarried; got pregnant in between the first and second dose; A spontaneous report was received from a pharmacist ,concerning a 38-year-old, female patient , who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced getting pregnant in between the first and second doses (Exposure during pregnancy) and miscarried/abortion spontaneous.  The patient's medical history was not reported. Concomitant medications were not reported.  On 15 Jan 2021, patient received the first of two planned doses of mRNA-1273 (Lot/batch: unknown) vaccine intramuscularly for prophylaxis of COVID-19 infection.  Between an unknown date and 17 Mar 2021, the patient become pregnant and experienced a miscarriage.  On March 17 2021, the patient received the second of two planned doses of mRNA-1273 (Lot/batch: unknown) vaccine for prophylaxis of COVID-19 infection.  The event, miscarriage, was medically significant.  Laboratory details were not reported. Treatment information was not reported.  Action taken with mRNA-1273  in response to the events was not applicable.  At the time of report , the outcome of events; got pregnant in between first and second dose and pregnant patient miscarried were, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Neoplasm malignant
Clinical narrative: Cancer; Shingles; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy dates unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had cancer and shingles. The patient had developed the shingles due to the chemotherapy (for the cancer). The patient got the shingles after the first dose, and around the time of the second (but was not sure it before or after). The patient was also on radiation therapy for cancer and valaciclovir (VALTREX) for the shingles. The outcome of the events, cancer and shingles, was unknown.  Information on the batch/lot number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Blood pressure increased, Blood pressure systolic, Body temperature, Burning sensation
Clinical narrative: Frequent arrhythmias; 20 point systolic BP rise; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue; audible pulse in ears; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6200), via an unspecified route of administration administered in left arm on 19Feb2021 18:00 (at the age of 81-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The reported facility type was a hospital. No other vaccine in four weeks. The patient did not have covid prior vaccination and was not covid tested post vaccination. Medical history included Hashimotos Thyroiditis, irritable bowel syndrome (IBS), food and seasonal allergies, allergies Iodine isotope contrast, latex, cows milk protein. Concomitant medications included levothyroxine sodium (SYNTHROID); amlodipine and spironolactone. The patient previously took paracetamol (TYLENOL) and thiomersal and experienced allergies from these drugs. The patient experienced frequent arrhythmias day after; several days of 20 point systolic BP rise; audible pulse in ears; sense of danger; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue all on 20Feb2021 at 13:00. After 20 days (in Mar2021), all has abated but muscle weakness and fatigue. Unwilling to risk the booster. There was no treatment for the events. The outcome of the events muscular weakness and fatigue was not recovered while for the remaining events was recovered with sequelae in Mar2021.