chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Pharyngeal swelling, Swollen tongue, Throat tightness
Clinical narrative: 10:15- Pt initially c/o left arm numbness sensation, brought back to observation area  10:20- Pt c/o thick throat sensation - Emergency Response Team Called  10:22- Pt c/o increased throat sensation "swelling in back of my tongue and throat" with onset of difficulties breathing- Epinephrine Auto-Injector 0.3mg administered.  10: 26- Emergency Response team arrives  10:28- Pt transported to ER for evaluation
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching, full body rash, OTC antihistamines for tx
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient received the Covid-19 vaccine. He reports symptoms of Other: Dizziness. I have observed Patient as he reports signs of dizziness while in the observation area, about 15 min after vaccine.  Moderna Lot # 023M20A  Denies c/o itching, difficulty swallowing, breathing, nausea or SOB.  Color is pink, speaking clearly, alert and oriented.  States he worked all night at this job, has not eaten breakfast and came straight from work to receive the covid vaccine. Left deltoid area without reaction type symptoms, no redness, warmth, swelling or bleeding.   Treatment/intervention  -  Vital signs as noted:  0948am SBP - 132/96, HR 65 sinus, RR 20, SPO2 99% Pt Placed on cot, laying supine. Dizziness remains. Water provided. 1000am SBP - 128/92, HR 68 sinus, RR18, SPo2 98%  Additional water and fruit snacks provided. Taking well PO. Remains on cot, head of bed elevated, dizziness less then earlier. 1020am -SBP -126/94, HR 78 sinus, RR 18, SPO2 98% Pt Sitting at edge of bed, denies dizziness at this time.  No complaints.   1030 - Standing, no complaints.  Pt monitored for 30 minutes. Gait steady as walking to leave facility. Advised if any concerns or issues arise to seek medical attention if needed. Verbalized understanding. Also recommended to reach out to PCP for follow-up for SBP results today. RN
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Arm is puffy and achy at injection site
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: Rash at injection site, hard and hot skin
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Patient experienced a near-syncope event 20mins post vaccine. Presented to ED. No anaphylactic symptoms expressed. Assessed and released
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Transient ischaemic attack
Clinical narrative: I developed Bell's palsy on 2/21/2021, I do have a previous hx of this . It's a very mild case . On 3/01/2021 I suffered a TIA.  Waiting on getting MRI  to see if there's any blockage. All my vital signs were within normal limits. Not for sure there's a correlation .
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Pyrexia, Urticaria
Clinical narrative: Hives on upper left arm, not at the same spot as injection site, about 27 hours after vaccine administration. Hives on face and ears about in addition to hives on arm about 30 hours after vaccine administration. 44-48 hours after vaccine administration, still experiencing hives on face in addition to nausea, dizziness when moving and standing, fatigue, and feeling feverish (but do not actually have a fever).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Erythema, Headache, Injection site swelling
Clinical narrative: Had an allergic reaction to the vaccine in the right arm.  Swelling around injection site, fever, redness, headaches (still ongoing), shortness of breath (still ongoing), lightheadedness  (ongoing), nausea (ongoing).  On medications for headaches.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Had an allergic reaction to the vaccine in the right arm.  Swelling around injection site, fever, redness, headaches (still ongoing), shortness of breath (still ongoing), lightheadedness  (ongoing), nausea (ongoing).  On medications for headaches.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nausea
Clinical narrative: Continuing to be nauseated and some shortness of breath
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives on back of arm near injection site, lower back and legs
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Chills; fever; nausea; body aches and headache
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Electrocardiogram abnormal, Feeling hot, Hyperhidrosis
Clinical narrative: Developed chest pain,  heart racing,  hot, sweaty,  nauseous, feeling faint.  Lost consciousness.  Evaluated by EMS-regained consciousness, c/o nausea,  vitals done. Placed on stretcher, EKG done -HR 50, rhythm sinus bradycardia.  Transported to emergency room via rescue squad.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations
Clinical narrative: Developed chest pain,  heart racing,  hot, sweaty,  nauseous, feeling faint.  Lost consciousness.  Evaluated by EMS-regained consciousness, c/o nausea,  vitals done. Placed on stretcher, EKG done -HR 50, rhythm sinus bradycardia.  Transported to emergency room via rescue squad.
Sex: M
Vaccine: UNK
Symptoms: Immunodeficiency, Non-Hodgkin's lymphoma stage IV
Clinical narrative: Jeopardized immune system due to non-hodgins  lymphoma stage 4 cancer
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever, Fatigue, Sore Arm
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Urticaria
Clinical narrative: sore arm radiating pain down arm huge welt (red)  starting the next day still continuing 2 weeks and 2 days later
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Nausea, Oropharyngeal discomfort
Clinical narrative: Patient reported confusion, "clogged throat" and nausea. RN took vital signs and asked MD to come assess the patient. MD determined epinephrine administration was appropriate. 0.3mg epi administered IM with epi-pen autoinjector and EMS called. EMS administered Benadryl and took the patient to the ED.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Dizziness, Nausea
Clinical narrative: Nausea Dizziness / lightheaded  Weakness Anxiety
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Throat tightness
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: During observation period, vaccine recipient complain of throat tightness and headache. They were monitoring by EMS. No further intervention needed.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Pain, Syncope
Clinical narrative: Vasovagal Syncope- fainting about 15 hours after the 2nd dose vaccine was administered. Contacted PCP for consult.   Brain fog, headache, nausea, body aches.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: This was second injection. She did have worse reaction to first shot and was sent to ED and also cleared by her PCP. This time she has tingling of the tongue. She immediately took Benadryl. Issues subsided and sent home with instructions to call PCP or go to ED if symptoms returned.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: at the injection Site My arm was very red and hot, itched a lot and pretty large. Went to my Dr they thought it might was infected and  gave me an IV of steroid and IV Pepcid, was Also given from the pharmacy methylprednisolone 4 mg  dose pack
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented to ED three post vaccine with increasing redness/swelling at the injection site.  No issues identified. Patient received Doxycycline and Benadryl prescriptions.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea started later that day and has lasted approx. 10 days
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Swelling face
Clinical narrative: Left arm pain, chills and body aches, left face swelling
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever 101 degrees, nausea, fatigue, chills, no appetite.  Tylenol taken for fever.  Symptoms lasted for 48 hours with fatigue extending to 3rd day.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Laboratory test, Lymphadenopathy, Swelling
Clinical narrative: I started having swelling, armpit got swollen (lymph nodes), top clavicle got really large and under neck lymph nodes got swollen. I'm still exp swelling top clavicle lasting 2 months. I did see my PCP was told it was  inflammatory response.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: tingling on right side of arm and lips monitored vital signs all WNL,  assessed for signs of stroke none present felt better and left after speaking with MD
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling hot, Hot flush
Clinical narrative: Patient reported that 8 days after vaccination, she started feeling "hot under the skin, like menopause."  (Patient vaccinated 2/11/21, adverse effect reportedly started 2/19/21).  She did not have a fever.  These "hot flashes" would come and go, and were still occurring when she called me on 2/23/21. The patient reported feeling more short of breath than usual, although she also reported a history of COPD.  Patient also reported she takes clozapine and the dose had been reduced by her psychiatrist between 2/8/21 and 2/15/21 due to "low blood count." The patient did report these adverse effects to both her primary physician and psychiatrist.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction, Rash macular
Clinical narrative: A round pinkish-red blotchy area of my skin, that's firm about 1 to 2 inches in diameter at the injection site causing pain, soreness, burning and itchiness.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood culture negative, Cellulitis, Computerised tomogram abnormal, Debridement
Clinical narrative: On 02/17/2021, patient received the second dose of COVID-19 Moderna vaccine in the left arm. Approximately 3 days post-administration, patient developed pain, swelling and erythema of the shoulder extending to the posterior/proximal anterior sections of the arm. Patient was unable to move arm due to swelling and presented to the Medical Center Emergency Department on 02/22/2021. A CT of the extremities revealed cellulitis, myositis, and possible fasciitis without abscesses. Subsequent MRI found myositis and cellulitis without evidence of osteomyelitis. Patient began to develop erthematous blotches and an Infectious disease consult was placed. Patient was started on broad-spectrum antibiotics (Ceftriaxone, vancomycin, and clindamycin). After cultures were obtained, patient was de-escalated to ceftriaxone. Two sets of blood cultures taken prior to antibiotics and a left arm swab showed no growth (finalized). On 02/26/2021 patient underwent incision and debridement of left arm with findings of edematous soft tissue without abscess or necrosis. On 02/28/2021 all antibiotics were discontinued per Infectious Disease provider due to lack of concern for infection.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Laboratory test, Magnetic resonance imaging abnormal, Mobility decreased, Myositis
Clinical narrative: On 02/17/2021, patient received the second dose of COVID-19 Moderna vaccine in the left arm. Approximately 3 days post-administration, patient developed pain, swelling and erythema of the shoulder extending to the posterior/proximal anterior sections of the arm. Patient was unable to move arm due to swelling and presented to the Medical Center Emergency Department on 02/22/2021. A CT of the extremities revealed cellulitis, myositis, and possible fasciitis without abscesses. Subsequent MRI found myositis and cellulitis without evidence of osteomyelitis. Patient began to develop erthematous blotches and an Infectious disease consult was placed. Patient was started on broad-spectrum antibiotics (Ceftriaxone, vancomycin, and clindamycin). After cultures were obtained, patient was de-escalated to ceftriaxone. Two sets of blood cultures taken prior to antibiotics and a left arm swab showed no growth (finalized). On 02/26/2021 patient underwent incision and debridement of left arm with findings of edematous soft tissue without abscess or necrosis. On 02/28/2021 all antibiotics were discontinued per Infectious Disease provider due to lack of concern for infection.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema, Peripheral swelling, Rash macular
Clinical narrative: On 02/17/2021, patient received the second dose of COVID-19 Moderna vaccine in the left arm. Approximately 3 days post-administration, patient developed pain, swelling and erythema of the shoulder extending to the posterior/proximal anterior sections of the arm. Patient was unable to move arm due to swelling and presented to the Medical Center Emergency Department on 02/22/2021. A CT of the extremities revealed cellulitis, myositis, and possible fasciitis without abscesses. Subsequent MRI found myositis and cellulitis without evidence of osteomyelitis. Patient began to develop erthematous blotches and an Infectious disease consult was placed. Patient was started on broad-spectrum antibiotics (Ceftriaxone, vancomycin, and clindamycin). After cultures were obtained, patient was de-escalated to ceftriaxone. Two sets of blood cultures taken prior to antibiotics and a left arm swab showed no growth (finalized). On 02/26/2021 patient underwent incision and debridement of left arm with findings of edematous soft tissue without abscess or necrosis. On 02/28/2021 all antibiotics were discontinued per Infectious Disease provider due to lack of concern for infection.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Inflammation, Pain in extremity, Pruritus
Clinical narrative: pt stated that the same day after she got her vax she had typical symptoms like fatigue and soreness of the arm but she took a hot bath and developed itching on her right leg on the upper part of the calve. It was bright red and now it has turned into a purple raised area.  She has also has some spots developing  above the knee on the same leg.  She has used  Benadryl topical. She will see her PCP on 3/2/2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: pt stated that the same day after she got her vax she had typical symptoms like fatigue and soreness of the arm but she took a hot bath and developed itching on her right leg on the upper part of the calve. It was bright red and now it has turned into a purple raised area.  She has also has some spots developing  above the knee on the same leg.  She has used  Benadryl topical. She will see her PCP on 3/2/2021.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Body aches, chills, headaches, fever, fatigue, hives on inner thighs and shin.  The body aches and fatigue began about 1730 the night of the injection.  The chills, fever,  and headache started about 1930 the same day as the vaccine.  Woke up with hives on inner thighs and shin the next morning which went away the following morning.  They lasted about 24 hours.  The other symptoms lasted about 40 hours.  The headache did linger for a few days.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Body aches, chills, headaches, fever, fatigue, hives on inner thighs and shin.  The body aches and fatigue began about 1730 the night of the injection.  The chills, fever,  and headache started about 1930 the same day as the vaccine.  Woke up with hives on inner thighs and shin the next morning which went away the following morning.  They lasted about 24 hours.  The other symptoms lasted about 40 hours.  The headache did linger for a few days.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Injection site rash
Clinical narrative: Today I noticed and felt a large, swollen rash on my left arm at injection site. It is warm to the touch. I got the injection on 17-Feb.  Before the rash, I also started having a mild, nagging cough about 1 week ago.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Pain in extremity
Clinical narrative: "57yoF requesting covid eval teacher, got 2nd covid vax 2/24 at 12:15pm, had ha started that night maybe 8 hrs later, fatigue also since 2/24 night and missed work 2/25 and 2/26. started feeling better fri 2/26 around 1pm. needs dr note to rtw or covid test. 1st vax asx other than little bit of arm pain."
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Pain in extremity
Clinical narrative: Patient stated  on Saturday afternoon she could feel the vaccine traveling to her head.  Described the Headache as a severe Hangover feeling.  She reported she stayed in bed all day Sunday.  On Sunday the HA moved over her right eye, described as a "dull pain"  She also reported her arm to be "very" sore.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash, Urticaria
Clinical narrative: Hives and rash covering about 80% of body. Itching and burning sensation. Raised welts on torso, arms, legs, back. No reaction on face or genitals. Occurred when I woke up on Saturday morning with only hives on arms. It spread throughout the day to cover the entire body. On Sunday body was covered in more hives.  Took benedryl and Claritin starting day 1 of symptoms but it didn?t help. Continued to take. On Sunday evening took Pepcid AC.  Starting to resolve as of Monday morning (now).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Rash
Clinical narrative: Arm is red in large patches (the size of the palm of my h and) above and below the injection site itself. Area is slightly raised and warm to the touch. Itches slightly.  Slightly painful to touch.  Redness was noticed Sunday morning (2/28), but may have been there Saturday night - I just wasn't attentive.  No treatment - unspecified Dr. office just asked that I report it, but not that I need to be seen  by a physician in person.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Extreme itching around waist and hips and thighs started around 4:00 pm the day after receiving the first dose of vaccine and still continuing today 3/01/2021
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Pain in extremity
Clinical narrative: After almost 30 hours, after the second injection, And with only a soar arm, I began to experience low blood pressure. Over the course of the next  6 hours, my blood pressure plummeted to 82/63. I countered this by intaking large amounts of salt, and ultimately took my Diltiazem and some Tylenol PM.  Around 3 am my blood pressure returned to normal and currently holding steady at 118/83,  I am monitoring it throughout the day, but it seems stable.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Complained of pain all afternoon after. Randomly expressed discomfort over next two days. On the third day, a red bump, surrounded by redness appeared on the spot where the MMRV shot was given.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient stayed for 30 minute observation after vaccine was given; patient complained of itching on nose, arms, back, legs and ears at the 30 minutes.  Patient was given 25 mg of diphenhydramine IM.  Patient observed for 30 minutes more and says she was feeling better.  Follow up on patient on 2/16/21  patient says she took another Benadryl when she got home and slept well and had no issues.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diplopia, Dizziness, Feeling abnormal, Hypoaesthesia oral
Clinical narrative: Immediately felt light headed, like seeing double and I can't explain it. It is still continuing now but not as bad.  The next day I had chills and my fever went up to 101, I took about 6 Tylenol and 6 Advil to bring the fever down. The following day I was feeling better. The yesterday I woke up with a weird feeling on the left side of my lower lip, it is like numbness, like just it feels weird.  I have an appointment with my doctor tomorrow.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Pyrexia
Clinical narrative: Immediately felt light headed, like seeing double and I can't explain it. It is still continuing now but not as bad.  The next day I had chills and my fever went up to 101, I took about 6 Tylenol and 6 Advil to bring the fever down. The following day I was feeling better. The yesterday I woke up with a weird feeling on the left side of my lower lip, it is like numbness, like just it feels weird.  I have an appointment with my doctor tomorrow.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Headache, Injection site erythema
Clinical narrative: Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness.  The injection was on Friday and Saturday we woke up with the side effects.  Sunday we were much better and Monday  better.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness.  The injection was on Friday and Saturday we woke up with the side effects.  Sunday we were much better and Monday  better.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hand deformity, Hyperventilation, Hypoaesthesia
Clinical narrative: About 10 min after injection, experience dizziness, lightheadedness, also described numbness to face and drawing of hands.  stated she could move her hands, developed some tachypnea and mild SOB with hyperventilation.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tachypnoea
Clinical narrative: About 10 min after injection, experience dizziness, lightheadedness, also described numbness to face and drawing of hands.  stated she could move her hands, developed some tachypnea and mild SOB with hyperventilation.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Patient has shingles . Date of vaccine was 2/3/21 Onset of shingles rash was 2/24/21 Upper back/flank rash  Confirmed by medical provider on 3/1/21
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itchy and red approximately 2-3 inch spot on injection site noted on 2/28/2021 around 4a.m.  Applied hydrocortisone cream and ice intermittently during the day.  No itching morning of 3/1/2021; redness same as previous day.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Needle was loose on syringe and most of dose came out around the connection between needle and syringe.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Hypoaesthesia oral, Lethargy
Clinical narrative: Lips went numb, area around mouth went numb, fever, aches, diarrhea, chills, headache, tingling in arm, lethargic
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pyrexia
Clinical narrative: Lips went numb, area around mouth went numb, fever, aches, diarrhea, chills, headache, tingling in arm, lethargic
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: Patient received second dose of vaccine, but half the dose squeezed out of the syringe. Moderna recommended giving  a second dose if more than half the vaccine was lost, which the patient believed it was.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chills, Decreased appetite, Electrocardiogram normal, Fatigue
Clinical narrative: Injection site pain Extreme tiredness  Headache  Muscle, body aches Chills Fever  Nausea No appetite  Swollen lymph nodes Feels horrible
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Injection site pain, Lymphadenopathy, Myalgia
Clinical narrative: Injection site pain Extreme tiredness  Headache  Muscle, body aches Chills Fever  Nausea No appetite  Swollen lymph nodes Feels horrible
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Injection site pain Extreme tiredness  Headache  Muscle, body aches Chills Fever  Nausea No appetite  Swollen lymph nodes Feels horrible
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chills, Decreased appetite, Electrocardiogram, Fatigue
Clinical narrative: Injection site pain Extreme tiredness  Headache  Muscle, body aches Chills Fever  Nausea No appetite  Swollen lymph nodes Feels horrible
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: Injection site pain Extreme tiredness  Headache  Muscle, body aches Chills Fever  Nausea No appetite  Swollen lymph nodes Feels horrible
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Injection site pain Extreme tiredness  Headache  Muscle, body aches Chills Fever  Nausea No appetite  Swollen lymph nodes Feels horrible
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: After vaccination, the vaccine recipient had a syncopal episode. They were observed by EMS. No further intervention required.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: The next morning after I woke up with a low grade fever, body aches, fatigued and beginned getting chills about 6hrs after I woke up and about 6pm that evening the fever broke and all symptoms subsided
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Rash papular
Clinical narrative: Red raised circular rash at injection. Treatment: Benadryl Outcome: Rash has not spread, does not interfere with ADLs.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Patient diagnosed with shingles outbreak about 2.5 weeks after 1st shot
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Pruritus, Rash
Clinical narrative: Rash on back of hands.  Started in small area above thumb, spread to whole left hand (same side as injection), then to right hand.  Itching comes and goes.  Has no improved yet.  Whole body was itchy the day after the vaccine.  Lasted 1 day.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Itching , redness and swelling around the injection site.   Felt warm and formed a hard knot.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Injection site erythema, Injection site induration
Clinical narrative: On day 5 after the shot, that evening got chills, headache, diarreah.  On day7 injections site became more tender than it had been, the injection site became red and the redness grew.  injection site somewhat swollen, hard and hot to the touch
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On day 5 after the shot, that evening got chills, headache, diarreah.  On day7 injections site became more tender than it had been, the injection site became red and the redness grew.  injection site somewhat swollen, hard and hot to the touch
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Injection site pain, Myalgia, Pain in extremity, Paraesthesia oral
Clinical narrative: Day of shot: pain in arm, severe muscle pain in legs, numbness of tongue. Second day:numb tongue, red rash when water applied to face, severe leg pain, sore at injection site.  3 tingling tongue, rash face
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Day of shot: pain in arm, severe muscle pain in legs, numbness of tongue. Second day:numb tongue, red rash when water applied to face, severe leg pain, sore at injection site.  3 tingling tongue, rash face
Age: 78.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema
Clinical narrative: Three         Large red areas underneath injection site.  First one on February 9, second one February 10 and third one February 11.  No swelling or heat.  No itching
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-mont-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On 20-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; 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-009507513-2102USA003923: US-009507513-2102USA004059:
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to an 2-year-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On 22-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; 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-009507513-2102USA003923: US-009507513-2102USA004059:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; multiple outbreaks of herpes zoster; This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or around 16-NOV-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient experienced was treated by providers in for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: multiple outbreaks of herpes zoster and post herpetic neuralgia. The patient claimed damages as a result of injury to themselves, loss of consortium, loss of services and economic losses. The outcome of the events was unknown. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was related.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Very sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of no adverse event (received several years ago).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The patient received the 1st part of this new vaccine (Shingrix) with just a very sore arm. For tolerance of 2nd dose of Shingrix, refer case US2021AMR000333.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR000333:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: second dose / 2 months following the first / I've had Shingles 5 months ago; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (5 months ago from the date of reorting). Previously administered products included Ganciclovir.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had shingles. For the tolerance of 2nd dose, refer linked case US2021AMR000330.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR000330:same patient (2nd dose)
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: RASH ON UPPER BODY; This case was reported by a nurse via sales rep and described the occurrence of rash in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2020, the patient received Shingrix. On 17th December 2020, 2 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient visited emergency room with rash on upper body. The patient was seen on 12th January 2021 but still she was with rash. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chest pain, Heart rate increased, Hypersensitivity
Clinical narrative: allergic reaction; Pressure in the chest; pain in chest; Heart rate increased; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced allergic reaction, chest pressure, chest pain and heart rate increased. On an unknown date, the outcome of the allergic reaction, chest pressure, chest pain and heart rate increased were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, chest pressure, chest pain and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The age at vaccination was not reported. The patient received Shingrix over a year ago (was not sure of the exact date of vaccination). The patient experienced an allergic reaction that was described as pain and pressure in the chest and her heart rate increased. The patient stated she won't get the 2nd dose. The events were reported directly from patient with no information provided from healthcare professional (HCP) or any details from vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Pain, Pyrexia
Clinical narrative: headache; body ache; chills; freezing cold; potential fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 15th October 2020, 1 hr 30 min after receiving Shingrix, the patient experienced headache, general body pain, chills, feeling cold and fever. On an unknown date, the outcome of the headache, general body pain, chills, feeling cold and fever were recovered/resolved.   It was unknown if the reporter considered the headache, general body pain, chills, feeling cold and fever to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced headache, body ache, chills, freezing cold and a potential fever and all were resolved within 24 hours.   This case was linked with case US2021AMR008919, reported by the same reporter.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR008919:same patient, 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: arm is still sore at the site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got her 1st dose of Shingrix vaccine 2 months ago and her arm was still sore at the site of injection which had not improved. The reporter did not consent to follow up.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 85 or 86 years. After receiving Shingrix, the patient's arm hurt for about an hour before resolving. The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2021AMR028492.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028492:same patient
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Carotid artery occlusion, Chills, Gait disturbance
Clinical narrative: Weakness; 80% blockage of the carotid artery; Could not walk; chills; A spontaneous report was received from a consumer regarding her spouse, a 70-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 80% blockage of the carotid artery/carotid artery occlusion, could not walk/gait disturbance. Weakness/asthenia and chills.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 20 January 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 29 January 2021, approximately ten days after the mRNA-1273 vaccine was given, the patient experienced 80% blockage of the carotid artery, he could not walk, weakness and chills. He was taken to the emergency room, where he was admitted for two weeks. During this time, he had carotid artery surgery. His primary care doctor could not confirm whether he had a TIA. The consulting neurologist thought the symptoms might be related to the vaccine.   Action taken with mRNA-1273 was not reported.  The outcome of the events, 80% blockage of the carotid artery, he could not walk, weakness and chills, were considered unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm hurt; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who had arm hurt (pain in extremity), when received vaccine INFLUENZA VACCINE.  Medical history,medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was arm hurt (pain in extremity) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: UNK
Symptoms: Illness
Clinical narrative: sick; Initial information received on 20-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves adult patient (unspecified age and gender) who experienced sick (illness), while he/she received vaccine INFLUENZA USP TRIVAL A-B WHOLE VIRION VACCINE [FLUZONE (WHOLE)].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B WHOLE VIRION VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness), unknown latency following the administration of INFLUENZA USP TRIVAL A-B WHOLE VIRION VACCINE for prophylactic vaccination.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Discomfort, Musculoskeletal stiffness
Clinical narrative: she pushes on the joint, the joint itself doesn't hurt, but there is incredible discomfort; tightness in her hands, tightness is mostly in her fingers and sometimes in her feet; joint soreness and tightness in her hands; Initial information received on 12-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves adult female patient who had joint soreness and tightness in her hands (arthralgia), she pushes on the joint, the joint itself doesn't hurt, but there is incredible discomfort and tightness in her hands, tightness is mostly in her fingers (discomfort) and sometimes in her feet (musculoskeletal stiffness), while she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious joint soreness and tightness in her hands (arthralgia), she pushes on the joint, the joint itself doesn't hurt, but there is incredible discomfort and tightness in her hands, tightness is mostly in her fingers (discomfort) and sometimes in her feet (musculoskeletal stiffness), unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not recovered.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: patient had recieved two doses of 0.5ml Fluzone HD Quad vaccinations, in the left deltoid on 10/27/20 and 11/16/2020 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- US-SANOFI-00479869) and transmitted to Sanofi on 17-Feb-2021  This case involves a 80 year old male patient who was administered of 0.5 ml QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ536AA,expiry date: 30-JUN-2021) via unknown route in left deltoid for prophylactic vaccination (extra dose administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to extra dose administered (latency same day).  The caller stated that patient PH had recieved two doses of 0.5ml Fluzone HD Quad vaccinations, in the left deltoid on 10/27/20 and 11/16/2020. Staff person had administered the last vaccination.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.