chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: Received my first vaccine 1/6/2021. I was very nervous about the vaccine, so I brought 4 epi-pens with me. My PCP and allergist advised me to sit x30 minutes after the shot. 25 minutes after receiving the shot, I felt very warm.  I looked at my hands and they were fire-cracker red in color. I began doffing my sweatshirt and my arms/neck/stomach and back were had a spotty rash. There was no hives/areas of elevation.  Nurses took my BP.  40 minutes without medication, rash and warmth resolved. A few hours later, I had a terrible headache and then around 8pm, I started with bad aches, chills, fever of 101. I took tylenol and did not resolved. The next AM, symptoms continued. I took advil and this had a better effect with sx resolving. My second dose, I received on 2/5/2021. I had a similar response about 10 minutes after the shot but warmth/reddness did not last as long, ~5-10 minutes. Had my BP taken, which was elevated (probably from my own anxiety). a few hours after the shot, I began with the headache, chills and fever--- though all mild. fever was 99 degrees the next day. 2/8/2021, I felt very fatigued and weird for a few hours. this seem to pass and I have felt normal since; just very tired. *** additionally, I did have COVID-19, testing positive 11/11/2020. my sx were mild compared to others.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Injection site pain, Pain
Clinical narrative: Symptoms started around 7:00 PM. They consisted of body aches, chills, headache, temp of 102 at its peak, injection site pain.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypertension, Injection site pain, Tachycardia
Clinical narrative: Hypertension,  tachycardia, and shortness of breath for one hour. Burning sensation on the injection site.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Pt Feels itchy with past history of anaphylaxis to peanuts.  Pt Monitored no treatment or transport.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lympnode under left arm. Size of a tennis ball
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain, Pyrexia, Tremor
Clinical narrative: Fever 101.1 three hours Shaking Feeling very cold Body aches
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Immune thrombocytopenia, Platelet count decreased
Clinical narrative: Pt was found to have ITP-low platelets of 1000 during routine lab work done on 2/2/2021. Pt is asymptomatic--unknown if this is due to recent COVID infection in late Dec/early Jan or due to vaccine. He has responded to steroids and counts are improving.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: On 2/3 area from injection site to elbow became erythematous, pruritic, and edematous. Symptoms continued through today (2/5/2021).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Sore, swelling and redness at injection sight. After 1 week itching at  injection site
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Headache, Injection site pain, Joint swelling, Pain in extremity
Clinical narrative: I started having muscular pain at the vaccine shot sight and fever 7 hours after taking the vaccine.  The next day I noticed multiple swellings of varying diameter (4 eruptions) on the back side of my left arm and right ankle.  Within 24-hours, these swellings spread to my right arm and left foot.  By February 09, 2021, the swelling had spread from my foot to the outer side of my legs. As at the time of filing this report, I am having pains on my feet that is making walking unbearable and the swellings (eruptions, both in number and size) are increasing on my legs and arms, which are painful to the touch. I am also running  a fever with headache.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: I started having muscular pain at the vaccine shot sight and fever 7 hours after taking the vaccine.  The next day I noticed multiple swellings of varying diameter (4 eruptions) on the back side of my left arm and right ankle.  Within 24-hours, these swellings spread to my right arm and left foot.  By February 09, 2021, the swelling had spread from my foot to the outer side of my legs. As at the time of filing this report, I am having pains on my feet that is making walking unbearable and the swellings (eruptions, both in number and size) are increasing on my legs and arms, which are painful to the touch. I am also running  a fever with headache.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Erythema nodosum, Nodule, Pain, Peripheral swelling
Clinical narrative: I started having muscular pain at the vaccine shot sight and fever 7 hours after taking the vaccine.  The next day I noticed multiple swellings of varying diameter (4 eruptions) on the back side of my left arm and right ankle.  Within 24-hours, these swellings spread to my right arm and left foot.  By February 09, 2021, the swelling had spread from my foot to the outer side of my legs. As at the time of filing this report, I am having pains on my feet that is making walking unbearable and the swellings (eruptions, both in number and size) are increasing on my legs and arms, which are painful to the touch. I am also running  a fever with headache.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Skin warm
Clinical narrative: I started having muscular pain at the vaccine shot sight and fever 7 hours after taking the vaccine.  The next day I noticed multiple swellings of varying diameter (4 eruptions) on the back side of my left arm and right ankle.  Within 24-hours, these swellings spread to my right arm and left foot.  By February 09, 2021, the swelling had spread from my foot to the outer side of my legs. As at the time of filing this report, I am having pains on my feet that is making walking unbearable and the swellings (eruptions, both in number and size) are increasing on my legs and arms, which are painful to the touch. I am also running  a fever with headache.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Fatigue, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Body aches, fever, fatigue, swollen lymph nodes, soreness red and inflamed at injection site. Anaphylaxis later that night and next day
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Body aches, fever, fatigue, swollen lymph nodes, soreness red and inflamed at injection site. Anaphylaxis later that night and next day
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: The injection site was sore immediately following the injection and for the next 7 or 8 hours.  Then the pain at the injection site became worse so that it was painful to lay on that side in bed.   I took 400 mg. ibuprofen around 9 am the following morning, and again at around 1:00, and the pain subsided.  The injection site remained sore and tired, but the really bad pain was gone.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Pain in extremity
Clinical narrative: When the nurse gave me the first dose, she said "your arm is so small I thought I might of hit your bone".  When I got home and took the Band-Aid off there was a small red mark, which went away  by the next morning. Then  next day after that I started having extreme pain and numbness in my left arm. The pain is from my shoulder, to my fingertips, and under my arm. It is still hurting today. I have been taking Advil, putting pain cream on it. It is still hurting as of now.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bell's palsy, Chills, Dysphagia, Ear discomfort
Clinical narrative: first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles pain all over, and it moved around. like sometimes she felt like an elephant on her lap., lower backpain , head pain, itching all over on and off. rash on her left arm and all along the inside of her arm all the way down for two days and on third left side of head. Day 3 pain with chewing, numbness on the left side inside the mouth with swallowing, combination of numbness and pain on left cheek. pain on the left side of face, neck cheek and chaw line. the neck was numb to touch and didn't feel cold or hot on left side. popping in her ear and inside mouth like pop rocks. and lots of throbbing in the TMJ joint. I could touch it and i could feel the throbbing in my finger. lasted until day 8 and then resolved slowly a little bit each day.  was diagnosed with modified bells paulsey.  with sensory involvement and didn't treat with steroids. and able to swallow but it felt numb.  FaceTime with the INT to gather this info
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Headache, Hypoaesthesia, Hypoaesthesia oral, Myalgia
Clinical narrative: first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles pain all over, and it moved around. like sometimes she felt like an elephant on her lap., lower backpain , head pain, itching all over on and off. rash on her left arm and all along the inside of her arm all the way down for two days and on third left side of head. Day 3 pain with chewing, numbness on the left side inside the mouth with swallowing, combination of numbness and pain on left cheek. pain on the left side of face, neck cheek and chaw line. the neck was numb to touch and didn't feel cold or hot on left side. popping in her ear and inside mouth like pop rocks. and lots of throbbing in the TMJ joint. I could touch it and i could feel the throbbing in my finger. lasted until day 8 and then resolved slowly a little bit each day.  was diagnosed with modified bells paulsey.  with sensory involvement and didn't treat with steroids. and able to swallow but it felt numb.  FaceTime with the INT to gather this info
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Oral pain, Pruritus, Pyrexia, Rash
Clinical narrative: first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles pain all over, and it moved around. like sometimes she felt like an elephant on her lap., lower backpain , head pain, itching all over on and off. rash on her left arm and all along the inside of her arm all the way down for two days and on third left side of head. Day 3 pain with chewing, numbness on the left side inside the mouth with swallowing, combination of numbness and pain on left cheek. pain on the left side of face, neck cheek and chaw line. the neck was numb to touch and didn't feel cold or hot on left side. popping in her ear and inside mouth like pop rocks. and lots of throbbing in the TMJ joint. I could touch it and i could feel the throbbing in my finger. lasted until day 8 and then resolved slowly a little bit each day.  was diagnosed with modified bells paulsey.  with sensory involvement and didn't treat with steroids. and able to swallow but it felt numb.  FaceTime with the INT to gather this info
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis, Temporomandibular joint syndrome
Clinical narrative: first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles pain all over, and it moved around. like sometimes she felt like an elephant on her lap., lower backpain , head pain, itching all over on and off. rash on her left arm and all along the inside of her arm all the way down for two days and on third left side of head. Day 3 pain with chewing, numbness on the left side inside the mouth with swallowing, combination of numbness and pain on left cheek. pain on the left side of face, neck cheek and chaw line. the neck was numb to touch and didn't feel cold or hot on left side. popping in her ear and inside mouth like pop rocks. and lots of throbbing in the TMJ joint. I could touch it and i could feel the throbbing in my finger. lasted until day 8 and then resolved slowly a little bit each day.  was diagnosed with modified bells paulsey.  with sensory involvement and didn't treat with steroids. and able to swallow but it felt numb.  FaceTime with the INT to gather this info
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Impaired work ability, Myalgia, Pyrexia
Clinical narrative: Severe headache, severe muscle achiness, that lasted more than 24 hours and prohibited working. mild fever/chills;
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Rash, Urticaria
Clinical narrative: groin rash 4 hours after vaccine - resolved 24 hours, took 2 doses of diphenhydramine,  scattered hives still present  early day 2,  severe upper back pain 24 hours after vaccine resolved within 3 hours with acetaminophen/heating pad
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Red patch about 4 inches by 4 inches on upper left shoulder near injection site, and two or three  red dots in skin
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Irritability, Peripheral swelling, Poor feeding infant, Screaming
Clinical narrative: Around 6:30pm baby started crying uncontrollably. I breastfeed and he wouldn't take the breast. He was screaming loud and squeaking  and was non stop crying for an hour. I had already given him motrin because he was very uncomfortable from the beginning, i also gave him a warm bath to see if that would calm him down it did for about 5 minutes then the screaming started again. His entire leg swelled up thats  why i gave him a warm bath.  i called the doctors office the answering service and told me to give him benadryl.   Our son is irritable everyday since the vaccine. Hes usually happy and playful he playful but get easily irradiated, which is not his normal. Im praying he goes back to being the sweet calm baby we had.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Date and time of vaccination: (list both if they received both shots): 1-7-2021 approx. @ 11:30am: 2-4-2021 approx. @ 11:30am: Brand and lot of vaccine: Moderna LOT #  211L20A: Moderna LOT # unable to read per client.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding, Herpes zoster, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: I received my first Pfizer Covid-19 vaccine on January 19, 2021.  I didn't have any immediate reaction after receiving the injection, aside from a sore arm.  I'd like to note that when I received the vaccine I was breastfeeding as I do not know if this contributed to my reaction.  About two days after receiving the vaccine, on January 21, 2021, I noticed a red itchy rash underneath my left breast.  I initially thought this could be a complication associated with breastfeeding known as Mastitis.  By the weekend the symptoms had decreased around my left breast and I developed a strong itchy sensation on the left side of my back.  On January 25, 2021 I noticed I had a red rash on the left side of my back, on my left side and on my left breast.  On January 27, 2021, I contacted my dermatologist and made an appointment thinking I had a rash.  On January 28, 2021 I went to see Physician Assistant.  During this visit diagnosed with Shingles.  I do not know if the Covid-19 vaccine lead to developing Shingles.  I wanted to share my experience in case there were other patients who received the Covid-19 vaccine and developed Shingles as a rare side effect.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: I received my first Pfizer Covid-19 vaccine on January 19, 2021.  I didn't have any immediate reaction after receiving the injection, aside from a sore arm.  I'd like to note that when I received the vaccine I was breastfeeding as I do not know if this contributed to my reaction.  About two days after receiving the vaccine, on January 21, 2021, I noticed a red itchy rash underneath my left breast.  I initially thought this could be a complication associated with breastfeeding known as Mastitis.  By the weekend the symptoms had decreased around my left breast and I developed a strong itchy sensation on the left side of my back.  On January 25, 2021 I noticed I had a red rash on the left side of my back, on my left side and on my left breast.  On January 27, 2021, I contacted my dermatologist and made an appointment thinking I had a rash.  On January 28, 2021 I went to see Physician Assistant.  During this visit diagnosed with Shingles.  I do not know if the Covid-19 vaccine lead to developing Shingles.  I wanted to share my experience in case there were other patients who received the Covid-19 vaccine and developed Shingles as a rare side effect.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Hyperhidrosis, Injection site erythema, Injection site pruritus
Clinical narrative: 12 hours after receiving vaccine, patient developed sweats, chills, temperature to 101.4, and myalgias. Symptoms lasted 48 hours. Over last 24 hours patient has developed redness and itching over the injection site on the right arm.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: 12 hours after receiving vaccine, patient developed sweats, chills, temperature to 101.4, and myalgias. Symptoms lasted 48 hours. Over last 24 hours patient has developed redness and itching over the injection site on the right arm.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash on back of hands, palmar aspect of fingers, upper arms, anterior thighs, posterior lower legs, heels and plantar aspect of feet. It's red and itchy.  Looks like multiple separate round circles ranging in size from punctate to as big as a nickle. I woke up with it Sunday morning and slowly more spots have appeared. None of the original spots have started fading, all of them still itch.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills, fever, body aches, headache
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Tachycardia
Clinical narrative: Pt reported tachycardia post receiving vaccination.  Pt reported PMHX of anxiety.  Symptoms response within 5 minutes.  No Treatment or Transport.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: Pt reported tachycardia post receiving vaccination.  Pt reported PMHX of anxiety.  Symptoms response within 5 minutes.  No Treatment or Transport.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Diarrhoea, Fatigue, Injection site induration
Clinical narrative: SHOULDER PAIN, FROZEN SHOULDER, STABBING PAIN CLAVICAL AREA, INJECTIONS SITE IRRITATED DAYS 2- 14 SWOLLEN, ITCHY WITH HARD LUMP. DAY 14 CHILLS , DAY 1-14 STOMACH PROBLEMS, DIARREHA DAYS 2-6, FATIGUE OFF AND ON
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site irritation, Injection site mass, Injection site pruritus, Injection site swelling, Periarthritis
Clinical narrative: SHOULDER PAIN, FROZEN SHOULDER, STABBING PAIN CLAVICAL AREA, INJECTIONS SITE IRRITATED DAYS 2- 14 SWOLLEN, ITCHY WITH HARD LUMP. DAY 14 CHILLS , DAY 1-14 STOMACH PROBLEMS, DIARREHA DAYS 2-6, FATIGUE OFF AND ON
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling
Clinical narrative: I have had a sore left arm since receiving the first dose on 1/16. VAERS report was put in and e-confirmation 294505. First dose was given in the right arm but caused pain in the left arm. With the 2nd dose due to the pain in the left arm, I got the 2nd dose in the right arm. There was just a sting when they put in the needle in. Today 2/10/2012 around 2-3 am I woke up and my arm is swollen. It is a little discomfort when I move my right arm.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache beginning 2/9 around 16:30 with nausea beginning 2/10 am.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Lip swelling, Oral herpes
Clinical narrative: Two days after injection noted swelling to lips not both at the same time but goes back and forth between the two, then two days later noted fever blister on bottom lip and tongue felt sensitive. These sx have continued off and on.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Day after initial injection, recipient experienced:  fever, chills, headache, muscle aches, intense joint pain, fatigue, diarrhea
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Day after initial injection, recipient experienced:  fever, chills, headache, muscle aches, intense joint pain, fatigue, diarrhea
Age: 45.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE reported; The patient is 46 years old. He got the 2nd dose on 10/24/2020. He was 45 years old when he started getting the series in June, so he had to get a doctor's note for the other ones since he was outside the age recommendations; Information has been received from a pharmacist referring to a 46 years old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.     On 28-JUN-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, intramuscular for prophylaxis (strength, lot# and expiration date were not provided). On 24-OCT-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, intramuscular for prophylaxis. The patient was 45 years old when he started getting the series in June, and he was 46 years old when he got the second dose, so he had to get a doctor's note for the other ones since he was outside the age recommendations (product administered to patient of inappropriate age). There was no other adverse event or product quality complaints (PQC). The outcome of the events was unknown. The reporter causality assessment was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Bacterial infection, Cellulitis, Erythema, Peripheral swelling, Pruritus
Clinical narrative: methicillin-resistant Staphylococcus aureus (MRSA)/itching, erythema in all extremities; right upper extremity cellulitis/continued worsening swelling and erythema of the right upper extremity cubital fossa and a reaction with superimposed bacterial upper extremity infection; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or around 02-FEB-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered itching, erythema in all extremities with continued worsening swelling and erythema of the right upper extremity cubital fossa and a reaction with superimposed bacterial upper extremity infection. The pt was diagnosed with right upper extremity cellulitis and methicillin-resistant Staphylococcus aureus (MRSA). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of Staphylococcal infection and cellulitis were considered to be disabling. Upon internal review, the events of Staphylococcal infection and cellulitis were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Staphylococcal infection
Clinical narrative: methicillin-resistant Staphylococcus aureus (MRSA)/itching, erythema in all extremities; right upper extremity cellulitis/continued worsening swelling and erythema of the right upper extremity cubital fossa and a reaction with superimposed bacterial upper extremity infection; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or around 02-FEB-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered itching, erythema in all extremities with continued worsening swelling and erythema of the right upper extremity cubital fossa and a reaction with superimposed bacterial upper extremity infection. The pt was diagnosed with right upper extremity cellulitis and methicillin-resistant Staphylococcus aureus (MRSA). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of Staphylococcal infection and cellulitis were considered to be disabling. Upon internal review, the events of Staphylococcal infection and cellulitis were determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: HCP office to report a temperature excursion for GARDASIL 9/ One GARDASIL 9 vaccine was administered to a patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.       On 07-JAN-2021, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1637651 was confirmed to be valid, expiration date 09-JUN-2022, 0.5 milliliter (vaccine schedule, route of administration and anatomical location were not provided) for prophylaxis.   The temperature excursion was 14.99 Celsius degrees (C) for 2 hours and 15 minutes. There were no previous excursions reported. The digital data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On an unknown date in 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On unknown dates, subsequent to the pt's zoster vaccine live (ZOSTAVAX) use, the pt was treated by healthcare providers at a family health center for shingles, and other zoster-related conditions. As a direct and proximate result of the pt's zoster vaccine live (ZOSTAVAX) use, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This case was reported by a other health professional via call center representative and described the occurrence of shortness of breath in a 50-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced shortness of breath. The patient was treated with steroids nos (Oral Steroids). On an unknown date, the outcome of the shortness of breath was unknown.   It was unknown if the reporter considered the shortness of breath to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:  The age at the vaccination was not reported. After receiving dose of Influenza vaccine Quadrivalent unspecified season, the patient experienced shortness of breath. The patient required a course of oral steroids. The patient said was there any components of the Shingrix vaccine like the ingredients in the influenza vaccine. The patient would like to have the Shingrix vaccinations, but Iwould like to ensure receiving the vaccinations would be safe for her. The reporter consent to follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Headache, Impaired work ability
Clinical narrative: After 1 vaccine Fatigue and headache approx 8 hours after shot - resolved without medication. Did not miss work  After 2 shot, Fever and chills approx 14 hrs after the shot.  Resolved after 24 hours - took fever reducing medication- combination  Advil and Tylenol Headaches, pain at the injection site, arm pit pain missed one day of work
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: After 1 vaccine Fatigue and headache approx 8 hours after shot - resolved without medication. Did not miss work  After 2 shot, Fever and chills approx 14 hrs after the shot.  Resolved after 24 hours - took fever reducing medication- combination  Advil and Tylenol Headaches, pain at the injection site, arm pit pain missed one day of work
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 2? diameter red area surrounding injection site that is itchy and painful upon pressure ( ?COVID arm?)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness - lasted a few days About 24 hours after injection - fatigue, chills, low grade fever 100.3 - lasted a few hours
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pain in extremity
Clinical narrative: General fatigue  Red, sore arm
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Systemic: Nausea-Mild; lasted 1 day
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nodule, Pyrexia, Rheumatoid factor negative, Urticaria
Clinical narrative: Broke out in hives on arms and hands. Hives on hand turned into painful nodules.  Joint pain in shoulders and hips. Low grade fever.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Headache, Pain
Clinical narrative: Severe chest tightness and chest pain ensues the next morning. I also had chills, body ache, and headache all day.  This lasted until nighttime the same day.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea exertional, Fatigue, Myalgia, Pyrexia
Clinical narrative: The day after the second dose of vaccine I experienced usual myalgia, arthralgia, fatigue and fever. Resolved with Motrin.  Two days after the vaccine I experienced significant dyspnea on exertion. No associated symptoms. No wheezing. Normal heart rate. Never experienced anything similar in the past. Resolved after two days without intervention.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperaesthesia
Clinical narrative: Had previous COVID-19 infection following an exposure to a confirmed case in early December 2020, during which my symptoms were classified as moderate in severity. On 2/4/2021, received 2nd dose in the series at 11:40am, no acute adverse events in the 15 minutes post-vaccination and returned home. At 3:00pm that day, developed noticeable fatigue, myalgia, nausea, experiencing 1st episode of vomiting at 3:20pm. On 2/5 at 1:00am, woken up with new onset fever (102.2F), chills, rigors, sweats, systemic joint pain, skin sensitivity, left arm pain and prominent axillary lymph node swelling. On 2/6 at 2:00am, headache onset, Tmax now 102.7F. On 2/7 at 7:30am, woke up with minimal arm soreness, resolution of other symptoms
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lymphadenopathy, Myalgia, Nausea, Pain in extremity
Clinical narrative: Had previous COVID-19 infection following an exposure to a confirmed case in early December 2020, during which my symptoms were classified as moderate in severity. On 2/4/2021, received 2nd dose in the series at 11:40am, no acute adverse events in the 15 minutes post-vaccination and returned home. At 3:00pm that day, developed noticeable fatigue, myalgia, nausea, experiencing 1st episode of vomiting at 3:20pm. On 2/5 at 1:00am, woken up with new onset fever (102.2F), chills, rigors, sweats, systemic joint pain, skin sensitivity, left arm pain and prominent axillary lymph node swelling. On 2/6 at 2:00am, headache onset, Tmax now 102.7F. On 2/7 at 7:30am, woke up with minimal arm soreness, resolution of other symptoms
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Had previous COVID-19 infection following an exposure to a confirmed case in early December 2020, during which my symptoms were classified as moderate in severity. On 2/4/2021, received 2nd dose in the series at 11:40am, no acute adverse events in the 15 minutes post-vaccination and returned home. At 3:00pm that day, developed noticeable fatigue, myalgia, nausea, experiencing 1st episode of vomiting at 3:20pm. On 2/5 at 1:00am, woken up with new onset fever (102.2F), chills, rigors, sweats, systemic joint pain, skin sensitivity, left arm pain and prominent axillary lymph node swelling. On 2/6 at 2:00am, headache onset, Tmax now 102.7F. On 2/7 at 7:30am, woke up with minimal arm soreness, resolution of other symptoms
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever starting 12 hours after injection and continuing intermittently for the following 24-48 hours. Swelling, tenderness of armpit area on injection side, fatigue, achey body
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Myalgia,myarthia,headache
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: The patient lives in a Nursing Home and was given 3 doses of the vaccination. They received the vaccinations on 12/29/2020, 01/19/2020 and on 02/09/2021.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Dysphagia, Headache
Clinical narrative: The symptoms began 10 minutes after administration of the vaccine on 2/9. The symptoms were: dizzy, lightheaded but BP elevated to 140s systolic, chest tightness, globus sensation with some difficulty swallowing but able to swallow zyrtec then head pain / headache that radiates down to neck. Given zyrtec. Not SOB and not wheezing, no rash or objective swelling of the face or oropharynx. The nurse reports that she cannot move her tongue very well.  The treatment of the reaction was:   o Antihistamines: zyrtec 10mg  o Sent patient to ED
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Sensation of foreign body, Tongue movement disturbance
Clinical narrative: The symptoms began 10 minutes after administration of the vaccine on 2/9. The symptoms were: dizzy, lightheaded but BP elevated to 140s systolic, chest tightness, globus sensation with some difficulty swallowing but able to swallow zyrtec then head pain / headache that radiates down to neck. Given zyrtec. Not SOB and not wheezing, no rash or objective swelling of the face or oropharynx. The nurse reports that she cannot move her tongue very well.  The treatment of the reaction was:   o Antihistamines: zyrtec 10mg  o Sent patient to ED
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever lasted 12 hours
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia with heart rate into the 140s starting 7mins after injection. Subsided over the course of 2 hours.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Lip pruritus, Paraesthesia oral, Pruritus
Clinical narrative: 1200 vaccine administered 1230 c/o lips tingling 1237 25 mg Benadryl po given 1245 lips continue to tingle, c/o itching all over body SAO2 95% on room air. Benadryl 25 mg po given. Breathing without diffuculty 1252 c/o still itching sao2 98%, HR 88, Resp 18, lungs clear 1334 99.7, Resp 18,HR 84 c/o itchy lips and tongue tingling, lungs clear 1356 Epi administered into Rt thigh B/P 140/60, 97.7, HR 82, Resp 18 1402 C/o feeling jittery, lips not tingling SAO2 99.0  1415 160/78  resp 18, tip of tongue tingling, itching gone 1423 Discharged to home. Ambulatory. Instructed to follow up with PCP. Verbalized understanding
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pruritus
Clinical narrative: Moderna COVID-19 Vaccine EUA: Patient received vaccine and began to feel woozy. The started itching on their chest, back, arms, and hands. The patient then was sent to the emergency department. Symptoms were just itching, no rash, no swelling. During re-evaluation, patient was stable and was discharged to home with a prescription for Medrol Dose pack.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Underage client given first dose of Moderna vaccine which has not been cleared for use in clients under the age of 18 years old. No treatment required at time of vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Full blood count, Metabolic function test
Clinical narrative: ANAPHYLASXIS/DIFFICULTY BREATHING - ER EVALUATION AND 23 HR OBSERVATION; MED ADMINISTRATION OF EPI X3; BENADRYL; FAMOTIDINE; STEROIDS.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hyperhidrosis, Language disorder, Nausea, Panic reaction
Clinical narrative: "This patient seen by facility on 1/13/21 after reaction to her first dose was told that she needed PEG/polysorbate skin testing prior to her second dose.  For unknown reason the patient arrived to vaccine clinic on 2/9/21 without allergy skin testing or follow up. She reportedly told them that she was ""cleared by Occ health"" after her first reaction and the administering RN said that there was no flag on her chart so she was given the vaccine.  Unfortunately, immediately after she got it, she developed throat tightening and got zyrtec. The reaction progressed very quickly (minutes) to diaphoresis, panic, grabbing at throat saying she was suffocating, nausea, and difficulty verbalizing. She was diffusely red but no hives. They couldn't get a BP and O2 sat and temp were normal but they put her on a non-rebreather and gave her Epi. Rapid response was called and she was taken to the ED.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Suffocation feeling, Throat tightness
Clinical narrative: "This patient seen by facility on 1/13/21 after reaction to her first dose was told that she needed PEG/polysorbate skin testing prior to her second dose.  For unknown reason the patient arrived to vaccine clinic on 2/9/21 without allergy skin testing or follow up. She reportedly told them that she was ""cleared by Occ health"" after her first reaction and the administering RN said that there was no flag on her chart so she was given the vaccine.  Unfortunately, immediately after she got it, she developed throat tightening and got zyrtec. The reaction progressed very quickly (minutes) to diaphoresis, panic, grabbing at throat saying she was suffocating, nausea, and difficulty verbalizing. She was diffusely red but no hives. They couldn't get a BP and O2 sat and temp were normal but they put her on a non-rebreather and gave her Epi. Rapid response was called and she was taken to the ED.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site pain
Clinical narrative: severe pain at injection site     little  shortness of breath
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Nausea
Clinical narrative: sore arm within a few hours, then at 2 am, Temp 100.4-101.4, body aches, chills, Headache and slight nausea. Slept poorly all night. Symptoms continue today with fatigue, although somewhat improved
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Poor quality sleep
Clinical narrative: sore arm within a few hours, then at 2 am, Temp 100.4-101.4, body aches, chills, Headache and slight nausea. Slept poorly all night. Symptoms continue today with fatigue, although somewhat improved
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Within about 12 hours, mild to moderate soreness at site of injection, headache, muscle aches and fatigue.  Symptoms lasted less than 12 hours and were relieved with one dose of Tylenol.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Nausea (lasted 24 hours, no alleviating factors)  Severe Headache (lasted 12 hours, alleviated with acetominophen)  Fever (peaked at 102°, lasted 12 hours, alleviated with acetaminophen)
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: That night, I was drenched in sweat yet I felt chills at the same time. I had severe headaches and vertigo by the next morning, nausea, and debilitating joint pain. By day 3, I continued experiencing headaches and spontaneous vertigo. I have been extremely tired and can sleep for hours.  Day 4, I was feeling much better. I went out that night, and after only 2 drinks, the vertigo came back so badly, I wasn't able to drive home. For the following days till today, I am still experiencing terrible headaches that will not even lessen with medication, spontaneous vertigo although they don't last too long any more, and I am extremely tired all the time.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: That night, I was drenched in sweat yet I felt chills at the same time. I had severe headaches and vertigo by the next morning, nausea, and debilitating joint pain. By day 3, I continued experiencing headaches and spontaneous vertigo. I have been extremely tired and can sleep for hours.  Day 4, I was feeling much better. I went out that night, and after only 2 drinks, the vertigo came back so badly, I wasn't able to drive home. For the following days till today, I am still experiencing terrible headaches that will not even lessen with medication, spontaneous vertigo although they don't last too long any more, and I am extremely tired all the time.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Migraine, Mobility decreased, Nausea
Clinical narrative: I woke up around 2:30am with chills, fever, body aches and  had a hard time moving my left arm. I took 100mg of acetaminophen and felt some relief, but after 3hrs the symptoms came back. I continued to take 1000mg of acetaminophen and  800mg ibuprofen alternately every 4hrs with a little relief but the chills and body aches continued for 24hrs with intermittent nausea and diarrhea.  The second day I woke up with a migraine that lasted around 24hrs with no relief from symptoms even when taking  OTC migraine relief medications. On the third day post vaccine I woke up feeling  completely fine and have not had any lingering symptoms.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: I woke up around 2:30am with chills, fever, body aches and  had a hard time moving my left arm. I took 100mg of acetaminophen and felt some relief, but after 3hrs the symptoms came back. I continued to take 1000mg of acetaminophen and  800mg ibuprofen alternately every 4hrs with a little relief but the chills and body aches continued for 24hrs with intermittent nausea and diarrhea.  The second day I woke up with a migraine that lasted around 24hrs with no relief from symptoms even when taking  OTC migraine relief medications. On the third day post vaccine I woke up feeling  completely fine and have not had any lingering symptoms.