chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm
Clinical narrative: LARGE, RED , WARM AREA ON ARM
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Tinnitus since March 13
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Myalgia, Neck pain
Clinical narrative: Pain began in both my shoulders and neck. As it intensified it spread throughout my body: down my left arm into my wrist, to my back and hip area (i have had issues here for 20 years), into my knees and ankles and into my left calf muscle. Further, it gave me a bad headache. i was so uncomfortable I got very little sleep that night. It continues into the following day and didn't begin to subside until about 4:00 pm. The pain in my left shoulder and arm continued off and on until today, 03/19/2021, and was at it's worst when laying down and first thing in the morning upon waking up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain began in both my shoulders and neck. As it intensified it spread throughout my body: down my left arm into my wrist, to my back and hip area (i have had issues here for 20 years), into my knees and ankles and into my left calf muscle. Further, it gave me a bad headache. i was so uncomfortable I got very little sleep that night. It continues into the following day and didn't begin to subside until about 4:00 pm. The pain in my left shoulder and arm continued off and on until today, 03/19/2021, and was at it's worst when laying down and first thing in the morning upon waking up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: I got it at 8:50am at l Hospital . So far my arm is just sore and I?m a little bit tired.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Severe headache lasting longer than 12 hours.  Fatigue. Queasy.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: SORE ARM, BODYACHES
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Tremor
Clinical narrative: SEVERE headache and nausea.  Chills, shakiness, fatigue
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Migraine, Musculoskeletal stiffness, Paraesthesia, Skin tightness
Clinical narrative: migraines, tingly body, tight left side of face, stiff neck, cloudy mind
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Headache, Pain
Clinical narrative: Sever head ache very much in pain. light headed and dizzy.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Persistent muscle and joint aches: wrist, shoulder, hands and elbows.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The vaccine was administered to a patient outside of the age indication.  Patient was 17 yrs old at the time of vaccination.  No adverse events noted.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: CHILLS, SORE ARM
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Paraesthesia oral, Throat irritation
Clinical narrative: itchy scratchy throat with mild tingling sensation around lips
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: menstrual bleeding for 42  days from feb6.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Hyperhidrosis, Pallor, Vomiting
Clinical narrative: Vomited, pale skin,  clammy, diaphoretic
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait inability
Clinical narrative: dizziness 15 minutes after receiving the shot . Not able to walk .  No shortness of breath, or ,chest pain or rash.  Noted to have a thready pulse.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Appendicectomy, Appendicitis, Chills
Clinical narrative: 24 hours after injection: sharp stomach pain that roamed around the abdomen,  27 hours after injection: fever and chills, abdominal pain did not go away by night so I went to the ER 35 hours after injection.  I had a urinalysis, blood test, and an ultrasound to find the site of pain.  The ultrasound showed appendicitis.  41 hours after injection I had an appendectomy
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Urine analysis, White blood cell count normal
Clinical narrative: 24 hours after injection: sharp stomach pain that roamed around the abdomen,  27 hours after injection: fever and chills, abdominal pain did not go away by night so I went to the ER 35 hours after injection.  I had a urinalysis, blood test, and an ultrasound to find the site of pain.  The ultrasound showed appendicitis.  41 hours after injection I had an appendectomy
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Appendicitis, Blood test, Chills, Pyrexia
Clinical narrative: 24 hours after injection: sharp stomach pain that roamed around the abdomen,  27 hours after injection: fever and chills, abdominal pain did not go away by night so I went to the ER 35 hours after injection.  I had a urinalysis, blood test, and an ultrasound to find the site of pain.  The ultrasound showed appendicitis.  41 hours after injection I had an appendectomy
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Ultrasound abdomen, Urine analysis
Clinical narrative: 24 hours after injection: sharp stomach pain that roamed around the abdomen,  27 hours after injection: fever and chills, abdominal pain did not go away by night so I went to the ER 35 hours after injection.  I had a urinalysis, blood test, and an ultrasound to find the site of pain.  The ultrasound showed appendicitis.  41 hours after injection I had an appendectomy
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Feeling abnormal, Hypoaesthesia oral, Insomnia
Clinical narrative: (Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up around 12 hours after having the vaccine and felt a strange sensation in my head, almost like a helmet of fog over my head, sort of a numb feeling, and I noticed that also my eyes and lips felt numb. I ate a grapefruit as I usually do (not sectioned by myself). I felt extremely lethargic, had joint pain and a weakness. I usually have tea and toast in the morning and as I was at the table buttering my toast, I had an overwhelming nausea come on. I then woke up on the floor. My companion told me I went unconscious and slipped off the chair. Perhaps the whole episode was a maximum of 20 seconds. My first words were "Where am I?" and my companion told me. I rest on the floor, directed my companion to read on the internet about stroke and we ascertained I was okay, so I was thinking completely clearly. In any case, I had the fog in my head the entire day, and also today, but I feel a little better and was able to eat after 4 hours of rest. I wasn't able to fall asleep but I rested the entire day and slept a couple of hours during the night, which is not like me. I usually don't have any problem sleeping.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Loss of consciousness, Nausea
Clinical narrative: (Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up around 12 hours after having the vaccine and felt a strange sensation in my head, almost like a helmet of fog over my head, sort of a numb feeling, and I noticed that also my eyes and lips felt numb. I ate a grapefruit as I usually do (not sectioned by myself). I felt extremely lethargic, had joint pain and a weakness. I usually have tea and toast in the morning and as I was at the table buttering my toast, I had an overwhelming nausea come on. I then woke up on the floor. My companion told me I went unconscious and slipped off the chair. Perhaps the whole episode was a maximum of 20 seconds. My first words were "Where am I?" and my companion told me. I rest on the floor, directed my companion to read on the internet about stroke and we ascertained I was okay, so I was thinking completely clearly. In any case, I had the fog in my head the entire day, and also today, but I feel a little better and was able to eat after 4 hours of rest. I wasn't able to fall asleep but I rested the entire day and slept a couple of hours during the night, which is not like me. I usually don't have any problem sleeping.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swollen painful lymphnode under armpit.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: 23 y/o complaining of anxiety. Patient states experiecing anxiety. Patient refused further treatment
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: 100.4 degree  fever and chills.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Polymerase chain reaction, Pyrexia
Clinical narrative: 100.4 degree  fever and chills.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODYACHES
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Three days following the shot, on 3/15, I lost all hearing in my right ear.  The following day some of the hearing returned, but a hollow ,reverberating sound was present when talking or listening to others. By day three my hearing was back to normal, and the unusual sounds were gone. I had NEVER had any hearing issues prior to this. I?m glad my hearing is normal again.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: RpH from pharmacy, was the immunizer that administered Covid vaccine for the health facility. He was incorrectly given a list of patients that needed to receive a second dose of the Covid vaccine . Unfortunately, the patients had already received their second dose on 2/2/2021 and received a third dose. The patients  were not able to communicate the receipt of the second dose earlier.  The dose had not been updated in the patient's chart correctly. Once the error had been discovered, vaccinations were stopped until a correct patient list could be produced. Facility was instructed to watch and monitor the patients for adverse effects and report them through the VAERS reporting system.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient received first dose of Pfizer COVID vaccine on 2/24/21 (lot # EN6198).  Patient reported dizziness/lightheadedness and nausea/vomiting after receiving the vaccines.  No other detail was noted in patient?s MAR.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Due to error in mixing, the patient only received the diluent and not the vaccine
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Malaise, Paraesthesia
Clinical narrative: Patient received second dose of Pfizer at 10:16 AM and was waiting in the waiting area.  Reports no issues with the first does.  At 10:39, observer alerted writer that patient stated she wasn't feeling well.   Pt was brought back to close observation room.  Initial BP was elevated, other VSS.  She c/o chest pressure and that she can feel "every vein in my body".  Denies any shortness of breath.   Reports h/o CAD.  Carries nitro with her.   At 10:49 AM, reports that chest pressure is increased and now is feeling "tingling all over".  States that the pressure doesn't feel as though she need Nitro.   Advised that, due to symptoms, would recommend f/u in ED if symptoms continue.   At 10:55 AM, Patient requests to be taken to the ED.  Husband is accompanying her today.   Patient was taken via wheelchair by HCP.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyskinesia, Electrocardiogram normal, Fall, Gait disturbance
Clinical narrative: Approximately 23 hours after administration of Moderna #2 vaccine, subject began loosing muscle strength and control, especially of the legs.  The symptoms became severe enough that he had trouble standing, walking and, ultimately, suffered a fall.  Normally, the subject is able to maintain all functions of independent daily living, exercises regularly and is able to walk more than 5 miles.  These symptoms were also present in similar severity, within a similar time frame after receiving Moderna #1 vaccination. The subject had received a positive test for Covid 19 in late November, 2020 and was largely asymptomatic.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills, headache, muscle aches, fever
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Injection site erythema, Injection site mass
Clinical narrative: Large, painful red lump at the injection site. About the size of a baby's fist. Started the evening after I got the vaccine and is still present.  I also began getting lightheaded the day after the vaccine. I started noticing it roughly 24 hours after the vaccine. I had Covid previously and it was the same feeling of being lightheaded that I had while I had Covid-19. I'm still getting lightheaded two days after the vaccine, but it's not as bad.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness and nausea.  Symptoms cleared after 3 1/2 days.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: Left arm fatigued, sore, still painful after over a week. Pain radiates down arm. Issue is not getting worse just staying the same.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Vomiting
Clinical narrative: Chills, rigors, extreme lethargy. vomiting
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose less than 24 days from first dose (23 days).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Sensitive skin
Clinical narrative: At first just a sore arm but on the 13th in the evening noticed burning in my legs which over the next few days became severe there and moderate over other areas of the body with skin being very sensitive to clothes rubbing on it.  This had happened before with the shingles vaccine given 10/11/2012 which was reported to VAERS.  That resulted in two neurologist visits and an MRI finding nothing.  But symptoms continued and Lyrica 50mg and 75 mg was needed to function and sleep.  This lasted with varying degrees of intensity about the life of the vaccine and happened again with a Fluvirin given on 10/17/214 with symptoms starting on the 31st and lasting for quite awhile requiring Lyrica.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Neck pain, Pain in extremity, Respiratory rate increased
Clinical narrative: Develop lightheadedness/dizziness, Rapid Respirations, Left arm and neck pain 30 minutes after receiving 2nd dose. Had same but milder sx. After 1st she thought was related to anxiety. Had skipped Baclofen and Gabapentin this A.M.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood potassium normal, Paralysis
Clinical narrative: weakness, paralysis, administered stress dose IV dexamethasone, regained strength in 1 hour
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: PT STATES LEFT HAND IS STARTING TO SWELL AFTER RECIEVING MODERNA SHOT IN LET ARM
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Immediate post-injection reaction, Injection site pain, Tinnitus
Clinical narrative: Metallic taste in mouth - 5 min after injection Ringing ears - 45 min after injection Pain  at injection site - immediate after injection
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Oxygen saturation decreased, Pain in extremity
Clinical narrative: After 1st shot, patient experience expected pain at injection site.  After the second shot, patient complained of generalized pain in Shoulder, Hip, and Opposite Arm of injection.  Patient additionally complains of decrease in O2 sat from baseline of 93% to 82% on exertion and 88% at rest.  Patient instructed to follow-up with primary care physician.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Joint pain and fatigue.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Erythema, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: My arm started to hurt the next day and for five days after. I developed a rash after two days on my neck, chest, trunk and the insides of my arm. I have gotten a similar rash post viral before. I had the rash for three days. I took Tylenol for the arm pain which was red swollen and hot.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: My arm started to hurt the next day and for five days after. I developed a rash after two days on my neck, chest, trunk and the insides of my arm. I have gotten a similar rash post viral before. I had the rash for three days. I took Tylenol for the arm pain which was red swollen and hot.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Dysphagia, Paraesthesia, Pharyngeal swelling
Clinical narrative: Pt received 2nd dose of Pfizer Covid vaccine today approx 9:14AM; pfizer lot number EL9266. Patient has hx of throat swelling from PO Sulfa. Pt alerted nurse at 9:35AM that she was experiencing a generalized prickle sensation. P60 O2RA 97%. At 09:54AM pt experiencing widespread prickle sensation, tightening in throat, difficulty swallowing, disorientation, and light headedness. Epi 0.3mg auto injector(Lot 0FM534) administered left leg 9:54AM per RN; BP 198/72 P75, O2RA 98%. EMS called 9:55AM, arrived at 9:59AM and assumed care of patient. Patient transported to Hospital.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Pt received 2nd dose of Pfizer Covid vaccine today approx 9:14AM; pfizer lot number EL9266. Patient has hx of throat swelling from PO Sulfa. Pt alerted nurse at 9:35AM that she was experiencing a generalized prickle sensation. P60 O2RA 97%. At 09:54AM pt experiencing widespread prickle sensation, tightening in throat, difficulty swallowing, disorientation, and light headedness. Epi 0.3mg auto injector(Lot 0FM534) administered left leg 9:54AM per RN; BP 198/72 P75, O2RA 98%. EMS called 9:55AM, arrived at 9:59AM and assumed care of patient. Patient transported to Hospital.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Nausea
Clinical narrative: Low grade fever, chills, headache, nausea, body aches, lack of energy, lack of appetite
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Low grade fever, chills, headache, nausea, body aches, lack of energy, lack of appetite
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Ear swelling, White coat hypertension
Clinical narrative: 3/19/2021  Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms: patient reported feeling of Swelling of right eye ear.   Assessment : Time of assessment . Actions taken: Vitals signs taken @ 1120 BP 180/84, P-73, O2-99%, held in observation for another 15 mins, husband with her, she reports decrease in symptoms, she also she reports that she took homeopathic drops labeled, vaccine related symptom, she also reported experiencing " white coat syndrome', she reports that she takes nothing for BP.     There were no vitals filed for this visit.   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30  minutes. Discharged home.with husband
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hot flush, Pain
Clinical narrative: BODYACHES, CHILLS, HOT FLASHES
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient 17 years old at time of injection
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Menstruation irregular, Vaginal haemorrhage
Clinical narrative: Approximately one hour after receiving the vaccine, I had light vaginal spotting. Within a few hours, the spotting increased to a light bleeding with fatigue and cramping in the abdomen and has remained this way. I am still currently bleeding. My last period ended 3/7/21. My period is never irregular.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature increased, Chills, Nausea, Pain
Clinical narrative: Body aches particularly lower back, fatigue, temperature 103.2, chills, nausea. Self treatment - Ibuprophen, hydration.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: big red circle below the injection site. hot, swollen and red.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: big red circle below the injection site. hot, swollen and red.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, and hard bump at injection site. Bump painful and hot to the touch
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Exceptionally healthy Patient suffered a stroke within  5-6 days after receiving the J & J vaccine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Loss of consciousness, Syncope
Clinical narrative: Patient with syncope after vaccination and unconscious for at least 5 minutes. BP initially low, but later recovered when alert. Provided rest and water. After about 20 minutes, patient asymptomatic and back to baseline. Sent home.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Malaise
Clinical narrative: Patient reported lightheadedness and not feeling well witin 15 min of receiving his vaccine. Felt impending doom with Pulse Ox of 80%.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: HCP, was the immunizer that administered Covid vaccine for the Health facility. He was incorrectly given a list of patients that needed to receive a second dose of the Covid vaccine . Unfortunately, the patients had already received their second dose on 2/2/2021 and received a third dose. The patients  were not able to communicate the receipt of the second dose earlier.  The dose had not been updated in the patient's chart correctly. Once the error had been discovered, vaccinations were stopped until a correct patient list could be produced. Facility was instructed to watch and monitor the patients for adverse effects and report them through the VAERS reporting system.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose less than 24 days from 1st dose (23 days).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: NAUSEA/VOMITING, HEADACHE,
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: "Covid arm" - site remained somewhat hard after the injection.  One week after first vaccine shot, the area became very itchy.  I came home to discover it is hot and red, approximately 3-4 inch circle around the injection site.  Have applied topical hydrocortisone
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Due to error in mixing, the patient received the diluent only
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Mobility decreased
Clinical narrative: LOST MOTION RANGE IN THE RIGHT ARM,  EXPERINCING PAIN  AT THE INJECTION SITE. HEADACHES
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Skin warm
Clinical narrative: Red rash with itching and warmth
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cerebrovascular accident, Sleep disorder, Tachycardia
Clinical narrative: Systemic: amxious and rerestlessness-Medium, Systemic: Stroke-Medium, Systemic: Tachycardia-Medium, Systemic: Unable to Sleep-Medium, Additional Details: patient has autoimmune disease.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Body aches, nausea, and fatigue were the first adverse symptoms, followed by a 100 degree fever a few hours later with extreme injection sight pain.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: BODYACHES, ARM SORENESS, CHILLS
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature decreased, Chills, Fatigue, Injection site pain
Clinical narrative: I received the vaccine on Monday. Tuesday I felt like I had the virus again-tiredness, slight temperature, chills, intense pain at injection site, slight stomach discomfort. What surprised me and the reason I am reporting this is the symptoms, though gradually better, persisted until Friday-4 days. I was expecting to be down for a day or two, but length of the aftereffects surprised me. I had a strong case of Covid in January 2020.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Nervousness
Clinical narrative: Pt received vaccine and reported feeling flush and shaky. Pt was escorted via wheelchair from a vaccination pod to an observation unit where she was observed and monitored for +30 minutes. Vitals were 114/74, O2 94%, HR 80. Pt reported using albuterol as a rescue inhaler and G Breo regularly.  Pt verified symptoms had subsided and was escorted via wheelchair from the premise.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site pain, Nausea, Pain
Clinical narrative: Injection site pain, body aches, headache, dizziness, nausea, and tiredness. Injection site pain started immediately after vaccine given and continued until now (approx. 24 hours later) . Body aches, headache, dizziness, nausea, and tiredness started about 8 hours after injection and continued until now (approx. 24 hours later)
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on most of body; feet, legs, arms, hands.  Hives are widespread and itchy.  They continue to spread.  No welling in or around mouth and no difficulty breathing.  Only treatment so far has been with benadryl tablets.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose less than 24 days from 1st dose at 23 days.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Pulmonary pain, Tremor
Clinical narrative: Shaking and chills 8 hours after shot shortness of breath , painful sensation in lungs. 3/19- lungs still do not feel right. Other symptoms resolved.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Sensory disturbance, Tremor
Clinical narrative: Shaking and chills 8 hours after shot shortness of breath , painful sensation in lungs. 3/19- lungs still do not feel right. Other symptoms resolved.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Vision blurred
Clinical narrative: 3/19/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  . BLURIED VISION Assessment : Time of assessment . 1034AM   Actions taken:      VS TAKEN, BP-130/89, HR-72, O2 100%, WATER OFFERED AND DRINKING, ENCOURAGED TO EAT AS SHE VOICES THAT SHE HAS NOT HAD FOOD TODAY, HAD DRIVER WITH HER.   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for . minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/19/2021 10:00 AM 0.3 mL 12/11/2020 Intramuscular
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was incorrect age to receive the vaccine. No reactions have occurred at the time of the report.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site pruritus
Clinical narrative: Itching about the injection site 03/16/21. Redness and heat over lateral triceps and biceps 03/18/21. Applied .1 triamcinolone: improving
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Due to an error in mixing, the patient only received the diluent
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Throat tightness, Wheezing
Clinical narrative: several hours, 8, after getting the COVIDvaccine, my throat began to feel tight and my chest began to feel tight as well.  I began to wheeze and notice that my breathing had changed and it was not normal.  symptoms similar to anaphylaxis of when I was given Rocephin in my teen years and had anaphylaxis within a minute of receiving that medication.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Secretion discharge
Clinical narrative: Nausea and uncontrollable bowels with mucous discharge for 2 days.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Night sweats, Pain in extremity, Sleep disorder
Clinical narrative: Extreme chills started at +/- 8:30 pm.  Patient went to bed - fell asleep at about 8:45.  Woke up periodically during the night drenched with sweat.  Got up the following morning at about 8:00 am.  Arm was sore but tolerable.  Temperature was 98 F.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vaccine for Covid-19 received Thursday 2/11/21 severe vertigo started 3am Monday 2/15/21. Lasted 4 days.  For next 3 weeks mild vertigo only at night when laying down and rolling over, or when up if bending over head down, or tilt head back.  Lasted until Tuesday March 9,2021
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Rph from Walgreens, was the immunizer that administered Covid vaccine for the  facility. He was incorrectly given a list of patients that needed to receive a second dose of the Covid vaccine . Unfortunately, the patients had already received their second dose on 2/2/2021 and received a third dose. The patients  were not able to communicate the receipt of the second dose earlier.  The dose had not been updated in the patient's chart correctly. Once the error had been discovered, vaccinations were stopped until a correct patient list could be produced. Facility was instructed to watch and monitor the patients for adverse effects and report them through the VAERS reporting system.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: extreme fatigue, body aches, increase in headache pain x 5 days
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin burning sensation
Clinical narrative: Patient is a 50 year old woman who presents 10 minutes post-vaccination of her first Moderna vaccine in the left deltoid.  She describes that 5 minutes following vaccination that she started to experience pain in the left arm, which was then followed by a burning sensation in her left upper back and mid sternum.  She denies a history of similar episodes.  She denies a history of reactions to vaccines received in the past.  She does describe sensitivities to the top 8 allergen foods, relating that she experiences abdominal bloating.  She also describes a sensitivity to codeine, specifically Tylenol #4, relating that she experiences itching of the skin.  She denies chest pain, headache, lightheadedness, dizziness, cramping abdominal pain, nausea, vomiting, diarrhea, urticaria, pruritus, swelling of the lips, mouth, and tongue.  Past medical history of obesity.   During medical observation, while waiting for EMS to arrive onsite, the patient began to describe the feeling of something "being stuck in her throat," relating that it "felt odd to swallow" and that she was experiencing a metallic taste in her mouth.  Upon examination, no signs of swelling of the throat, lips, and tongue.  Neck was supple and without signs of edema.  Bilateral lungs were clear to auscultation in all fields.  No audible wheezing or stridor.  No visible use of accessory muscles.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Motor dysfunction, Pain in extremity
Clinical narrative: Pain on left arm. Limited motion of left arm.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: 10 minutes after injection, patient with feeling of heart racing. No other symptoms at all including SOB, wheezing, vomiting, diarrhea, rash, abdominal pain. Vitals: HR 82, Sat 99%, BP 123/68. Patient given ice pack and observed for 30 minutes with no other symptoms. Released home without issue. Instructed to F/u with PCM.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test negative
Clinical narrative: Patient reported temporary loss of taste and smell one week following second Moderna CoVid 19 vaccine
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Heart rate increased, Muscular weakness, Pyrexia
Clinical narrative: Woke up at 4:30 AM, felt feverish, got worse as the day progressed. Developed a headache, fast pulse, chills, muscle weakness, etc. took 1000mg Tylenol at 1 PM and 7 PM, symptoms got better each time.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Oropharyngeal discomfort, Pruritus, Urticaria
Clinical narrative: approx 15 min after patient was given moderna covid vaccine she started to experience hives on trunk and face and itching all over body with substernal chest pain weird feeling in the throat. Pt was given benadryl IM.  Hives and itching greatly reduced, other sx remained. pt was reassessed multiple times and sent home.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion for VARlVAX / 1 dose of the vaccine had been administered after the excursion occurred; This spontaneous report was received from a register nurse referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.    On 19-FEB-2021, the varicella virus vaccine live (oka/merck)(VARIVAX) with lot number T017682 and expiration date of 21-MAY-2022 was improperly stored dose . The vaccine was exposed to a temperature excursion of 31.4 °F with a time frame of 30 hours. There was no previous temperature excursion. A "data logger" was involved.   On an unspecified date in 2021, was identified that 1 dose of the varicella virus vaccine live (oka/merck)(VARIVAX) was administered after the excursion occurred; at a dose of 0.5 milliliter, once, subcutaneously for prophylaxis (anatomical location was not reported). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE information.; incorrect product storage; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S027465, 0.5 milliliter, expiration date 02-MAR-2021, orally for prophylaxis.     Since 01-NOV-2020, the Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) was exposed to multiple excursions that acumulate 2 hrs. There was no adverse event.  Digital data logger: yes.  This is one ov several reports from the same reporter; Sender's Comments:  US-009507513-2103USA001343: US-009507513-2103USA001024: US-009507513-2103USA001252:
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No patient reaction has been noted.; patient received second dose of GARD ASIL 9-1 month and 9 days after first dose instead of recommended 2 month interval/ Vaccine Administered earlier than recommended; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On an unknown date in approximately January 2021, 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) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis.  On 01-MAR-2021 (also reported as 1 month and 9 days after first dose), 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) prefilled syringe injection, 0.5 milliliter, lot # S028738, expiration date 30-APR-2022 (injection site and route of administration were not reported) for prophylaxis. The vaccine was administered earlier than recommended 2 month interval. No patient reaction has been noted. 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: S028738; expirationdate: 03-APR-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
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine administered; Caller states they received a shipment of GARDASIL 9 late. Caller states FedEx tried to deliver it on 2/26/2021, but they were unable to and it was actually delivered on 3/1/2021.; This spontaneous report was received from a medical assistant and refers to a 11-year-old patient of unknown gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product.  On 01-MAR-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) prefilled syringe injection, 0.5 milliliter, lot # T008151, expiration date 21-JUN-2021 (injection site and route of administration were not reported) for prophylaxis.  The reporter stated they received a shipment of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) late. They tried to deliver it on 26-FEB-2021, but they were unable to and it was actually delivered on 01-MAR-2021 and administered to a patient. The temperature excursion details were unknown. The digital data logger was not involved in recording the temperature excursion details. It was unknown if the previous temperature excursion had occurred.  This is one of two reports received from the same reporter. 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: devicelotnumber: T008151; expirationdate: 21-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; Sender's Comments:  US-009507513-2103USA001107:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; Improperly stored vaccine administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product.  On 03-MAR-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) prefilled syringe injection, 0.5 milliliter, lot # T033369, expiration date 26-MAY-2022 (injection site and route of administration were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of 11 degrees Celsius for 1 hour. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There was no additional adverse event information. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T033369; expirationdate: 26-MAY-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: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 22-OCT-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered varicella-like rash, redness, blisters, bumps and ongoing pain in her legs and buttocks and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presenting prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her 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 of the product, 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 of zoster vaccine live (ZOSTAVAX), 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 event was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the event shingles to be disability.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 22-OCT-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered varicella-like rash, redness, blisters, bumps and ongoing pain in her legs and buttocks and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presenting prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her 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 of the product, 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 of zoster vaccine live (ZOSTAVAX), 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 event was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the event shingles to be disability.
Sex: F
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 40 year old female patient with chronic lymphocytic leukaemia. She received one course of antibiotics in the year before enrollment. There was no therapy prior to ibrutinib.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 4. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 1. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA005447, US-009507513-2103USA005448, US-009507513-2103USA005449, US-009507513-2103USA005450, US-009507513-2103USA005451, US-009507513-2103USA005452, US-009507513-2103USA005453, US-009507513-2103USA005454, US-009507513-2103USA005455).  Company Causality Assessment: 2103USA005447; Sender's Comments:  US-009507513-2103USA005447: US-009507513-2103USA005448:Original Case : 2103USA003406 US-009507513-2103USA005449:Original Case : 2103USA003406 US-009507513-2103USA005450: US-009507513-2103USA005451: US-009507513-2103USA005452: US-009507513-2103USA005453: US-009507513-2103USA005454: US-009507513-2103USA005455: