chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: M
Vaccine: HEP, IPV
Symptoms: Skin irritation, Streptococcus test negative
Clinical narrative: Tuesday (aug 25, 2020):  received two shots at his 9 month check up (really 10 mos old ). He received the polio and 1st Hep B vaccine.  Tuesday Late Night: started with a low-grade fever and got up to 100. Restless sleep Wednesday: Morning temp was 103.2 so I gave him Tylenol. Kept up with Tylenol all day and he reached temp of 103.7. He was lethargic, only wanted to breastfeed (no table food), and constant crying.  Thursday: Still screaming/throwing head back. Temp down to 101. Gave Tylenol. Only stopped screaming long enough to breastfeed. Called doctor. They didn?t want to see him since it had only been two days and said this reaction is normal.  Friday: Still screaming/throwing head back, temp at 100. Started pulling on ears, neck, and hair. Gave Tylenol.  Saturday: Fever is gone, still screaming, small rash started on face and behind ears and side of neck Sunday: Still pulling on ears, neck, and hair. No fever. Rash is all over body now. Still screaming/throwing head back but there are longer breaks between episodes. Monday: Called doctor but she isn?t there today. Rash looks redder and more irritated. Went to urgent care. They did strep test (came back negative) and checked his ears (they looked fine). He prescribed Tylenol.   Tuesday: No temp, still has rash, not as irritable but still signs of being uncomfortable
Age: 23.0
Sex: F
Vaccine: FLU4, RAB
Symptoms: Chills, Hyperaesthesia, Pain of skin
Clinical narrative: Later that evening after receiving the immunizations, the patient reported chills and extremely sensitive and painful skin. The patient took ibuprofen before bed that night and the next day, her symptoms had subsided.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Rash
Clinical narrative: Face rash, Eye swollen on same side as injection site
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Incisional drainage, Injection site abscess, Injection site pain, Injection site swelling, Sepsis
Clinical narrative: On 7/16, pt represented to Emergency Department with pain and swelling on her left tricep. Patient was diagnosed with an abscess on her tricep. An I&D was performed and patient left AMA. On a subsequent visit to the ED on 7/21, the patient was admitted and placed on IV and PO antibiotics for the abscess due to sepsis.
Age: 66.0
Sex: M
Vaccine: FLU4, FLU4, PPV
Symptoms: Body temperature increased, Chills, Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Temperature of 103 F for 2 days, severe chills and body aches. Severe pain in right arm at injection sight with significant redness and arm felt hot.
Age: 66.0
Sex: M
Vaccine: FLU4, FLU4, PPV
Symptoms: Pain
Clinical narrative: Temperature of 103 F for 2 days, severe chills and body aches. Severe pain in right arm at injection sight with significant redness and arm felt hot.
Age: 66.0
Sex: M
Vaccine: FLU4, FLU4, PPV
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Temperature of 103 F for 2 days, severe chills and body aches. Severe pain in right arm at injection sight with significant redness and arm felt hot.
Age: 55.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Local reaction on right arm of erythema, warmth to the touch extending down medial aspect of arm to elbow as well as fever measured at home of 101.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Dysphagia, Lip oedema, Lip pruritus, Swollen tongue, Tongue oedema
Clinical narrative: On 09/02/2020 around 230 pm Patient was back at our office stating that she had a itchy tongue and lips, swollen tongue, difficulty swallowing.  I asked Pt when these Sx started and she said they started at about 1:15pm or so after she had eaten lunch.  Upon examination by Staff no apparent distress and noted to have mild edema to lower lip and tongue.  Lungs clear and equal bilaterally.  Heart rate regular rhythm with good perfusion.  Normal blood pressure.  Ordered epi and benadryl stat, called 911 to transport to hospital for continued monitor should rebound reaction occur.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Tongue pruritus
Clinical narrative: On 09/02/2020 around 230 pm Patient was back at our office stating that she had a itchy tongue and lips, swollen tongue, difficulty swallowing.  I asked Pt when these Sx started and she said they started at about 1:15pm or so after she had eaten lunch.  Upon examination by Staff no apparent distress and noted to have mild edema to lower lip and tongue.  Lungs clear and equal bilaterally.  Heart rate regular rhythm with good perfusion.  Normal blood pressure.  Ordered epi and benadryl stat, called 911 to transport to hospital for continued monitor should rebound reaction occur.
Age: 65.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Arthralgia, Decreased appetite, Diarrhoea, Eye irritation, Fatigue
Clinical narrative: Fever of 99.3 taken 1 hour after administration of APAP; fatigue; sore muscles, diahrrea, headache, sore joints, burning eyes, hyperalgesia, decreased appetite
Age: 65.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Headache, Hyperaesthesia, Myalgia, Pyrexia
Clinical narrative: Fever of 99.3 taken 1 hour after administration of APAP; fatigue; sore muscles, diahrrea, headache, sore joints, burning eyes, hyperalgesia, decreased appetite
Age: 27.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea and dizziness starting 20 hours after vaccination lasting for more than 4 hours.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Dyspnoea, Headache
Clinical narrative: Patient stated they had difficulty breathing, a headache, and a temperature 102.6.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Allergic respiratory symptom, Rhinorrhoea, Throat irritation
Clinical narrative: Patient called on 9/02/2020. Patient complained of a runny nose, throat being very itchy, and allergy like symptoms on the night that she recieved the vaccination. She said she did not have any swelling or redness in the arm. She said she would take flonase and it would calm the symptoms down, but she said that the symptoms would come back. I counseled her to use an otc benadryl dose if she was experiencing another flare of the allergy symptoms. I also recommended that she go see her doctor if the symptoms continued for further treatment. She has never had any allergy related symptoms to the flu shot in the past. I talked with the patient and she did want me to submit a VAERS form.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Mobility decreased, Nausea, Pain, Paraesthesia
Clinical narrative: Pt reported pain lasting several days and got worse causing nausea and vomiting. Pt reported reduced mobility causing her to miss a day of work after vaccination. Prolonged pain, tingling, etc. Reported that immunizer standing while the patient was sitting could've contributed to pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Pt reported pain lasting several days and got worse causing nausea and vomiting. Pt reported reduced mobility causing her to miss a day of work after vaccination. Prolonged pain, tingling, etc. Reported that immunizer standing while the patient was sitting could've contributed to pain.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Mild headache, 2 degrees fever, chills. Onset 6 hrs after vaccination, lasted about 36 hours
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity, Pain of skin
Clinical narrative: Shoulder immediately sore and has been for 8 months and three weeks.  In the past month, I have developed pain in my forearm and right hand (shot was administered in right shoulder)
Age: 58.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: Patient received both vaccines and sat in the immunization both for a few minutes with me discussing new medication he was starting and made no statement about change in feeling. After the consultation, he then proceeded to self check out to pay for his items while I returned to the pharmacy to start the next immunization. Assistant manager came and told me someone fainted. I then proceeded with the emergency kit to check on the patient. Patient was sitting in a chair sweating profusely when I arrived but was awake. Patient said he didn't recall fainting but just woke up with everyone standing above him checking on him. COS stated he was watching Patient at check out and then watched Patient slowly slump over and faint.  Patient declined any treatment at the time. His wife came to pick him up where I walked him out to the car in case of a second instance but stated he felt fine at the time he and his wife left for the evening.
Age: 87.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: When patient was leaving he said he felt lightheaded so sat on floor, then fainted from sitting position.  He was non resposive for about 1 min. Then was talking, knew where he was and what had just happened.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Lethargy, Pallor, Tremor
Clinical narrative: AFTER VACCINES WERE GIVEN MOM WAS TOLD TO TAKE PATIENT TO RESTROOM FOR URINE COLLECTING. MOM RETURNED WITHOUT REACHING BATHROOM STATING PATIENT WAS SHAKING. PATIENT APPEARED PALE AND LETHARGIC BUT WAS RESPONDING.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Shoulder injury related to vaccine administration
Clinical narrative: Patient said she developed SIRVA after receiving her flu shot on 8/28.  She can't move her arm
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Injection site reaction, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: patient reported low-grade fever, muscle aches, exhaustion, and blotchy/red arms around the injection site, she also said that there was some warmth to her arms around the spot of injection
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash macular
Clinical narrative: patient reported low-grade fever, muscle aches, exhaustion, and blotchy/red arms around the injection site, she also said that there was some warmth to her arms around the spot of injection
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pt has sore arm, muscle from deltoid muscle, up arm to shoulder and to back on shoulder blade since 7/25/20
Age: 31.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness,itchiness,swelling, warmth on injection site. pt stated experiancing fatige for 1 wk. all other symptoms resolved within that time frame.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Nausea, Peripheral swelling
Clinical narrative: Patient stated nausea and vomiting along with entire left arm redness and swelling
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Patient stated nausea and vomiting along with entire left arm redness and swelling
Age: 82.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Product administered at inappropriate site
Clinical narrative: Gave injection slightly outside of deltoid muscle and patient had redness on arm
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site bruising, Injection site pain, Insomnia
Clinical narrative: Sore arm at injection site within two hours of shot.  Then by 6 p.m. or so that night, body aches, headache, chills and fever.  Feeling like I had been hit by a truck.  Difficulty sleeping as it was painful to roll over.  Arm at the injection site is bruised today.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Sore arm at injection site within two hours of shot.  Then by 6 p.m. or so that night, body aches, headache, chills and fever.  Feeling like I had been hit by a truck.  Difficulty sleeping as it was painful to roll over.  Arm at the injection site is bruised today.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Guillain-Barre syndrome, Vaccination complication
Clinical narrative: patient mentioned that 2 days after recieving the flu shot his back startedhurting. He cantacted me and i advised him to call his physician he did and the dr said it is the flu shot and it is GBS and for him to to take vitamin B6. Before recieving the flu shot he did not mention any previous reactions. Patient is doing better.
Age: 80.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Gait disturbance, Joint stiffness
Clinical narrative: THE PATIENT CALLED AND DESCRIBED THAT SHE HAD KNEE PAIN AT BOTH KNEES AND IT WAS HARD TO WALK AND BEND HER KNEES THE MORNING AFTER HER FLU SHOT ESPECIALLY WHEN SHE FIRST GOT OUT OF BED. IT GOT BETTER DURING THE DAY. SHE HAD NO ARM PAIN, NO SWELLING,NO  ITCH OR NO REDNESS AT THE INJECTION SITE.  SHE SAID HER ARM WAS FINE.  I INSTRUCTED HER TO TAKE A PAIN RELIEVER LIKE ACETAMINOPHEN AND CALL HER DOCTOR IF NOT BETTER IN A FEW DAYS. I WILL TALK TO HER AGAIN IN A DAY OR TWO.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Tenderness
Clinical narrative: pt said the injection site was red and itchy and his arm was tender to the touch. He said its been getting better. It started after a couple days after the shot but its been a week so he called us. pharmacist advised him to take benadryl and we wil follow up again tomorrow
Age: 78.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Burning sensation, Sensitive skin
Clinical narrative: left arm and hand developed burning sensations with fingers being sensitive
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Ear pain, Ear pruritus, Erythema, Feeling hot
Clinical narrative: I felt unwell about 6 hours after having the vaccine, around 1-00 on August 31.. That evening I had a slight headache and increasing ear pain in my right ear., feeling a little hot all over. My left arm where the shot was given was swollen and tender. Starting at 8:00 AM on September 2, I started getting a painful, red, bumpy, itchy rash on my buttocks, closest to the anus. Within an hour, the rash spread to the back of my thighs, then to the sides of my thighs.  As the day progressed, the rash moved to my back (flanks only), then to my arms, underside mostly, but also little whitish bumps on my arms with a lot of redness. By 6:00 PM the same day, my ears were hot and itchy.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Rash, Rash erythematous
Clinical narrative: I felt unwell about 6 hours after having the vaccine, around 1-00 on August 31.. That evening I had a slight headache and increasing ear pain in my right ear., feeling a little hot all over. My left arm where the shot was given was swollen and tender. Starting at 8:00 AM on September 2, I started getting a painful, red, bumpy, itchy rash on my buttocks, closest to the anus. Within an hour, the rash spread to the back of my thighs, then to the sides of my thighs.  As the day progressed, the rash moved to my back (flanks only), then to my arms, underside mostly, but also little whitish bumps on my arms with a lot of redness. By 6:00 PM the same day, my ears were hot and itchy.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Skin warm
Clinical narrative: I felt unwell about 6 hours after having the vaccine, around 1-00 on August 31.. That evening I had a slight headache and increasing ear pain in my right ear., feeling a little hot all over. My left arm where the shot was given was swollen and tender. Starting at 8:00 AM on September 2, I started getting a painful, red, bumpy, itchy rash on my buttocks, closest to the anus. Within an hour, the rash spread to the back of my thighs, then to the sides of my thighs.  As the day progressed, the rash moved to my back (flanks only), then to my arms, underside mostly, but also little whitish bumps on my arms with a lot of redness. By 6:00 PM the same day, my ears were hot and itchy.
Age: 86.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Immediate post-injection reaction
Clinical narrative: Patient described shoulder pain occurring at the time of injection as well as 7 days later.
Age: 24.0
Sex: M
Vaccine: FLU4, HPV9, TDAP
Symptoms: Fall, Headache, Syncope
Clinical narrative: SYNCOPE. FELL DOWN FROM THE SEAT. WAS RESPONSIVE BUT COMPLAINED OF HEADACHE. HEADACHE RESOLVED AFTER RESTING FOR FEW MINUTES
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: pts wife came in today to get shingrix shot and indicated that husband developed a fever and headache from either the shingrix vaccine or flu vaccine. when i talked with pt he indicated that the after taking naproxen and tylenol his fever was going down from 99.2 f and his headache was gone. dr suggested going to er to be evaluated. pt says he's getting better and didn't think it was necessary
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Gait inability, Injection site cellulitis, Pyrexia
Clinical narrative: Injection given in AM at visit. Sometime in the PM she developed a Fever of 102, was given Tylenol. Temp did go down to 100, pt had chills, generalized weakness & unable to ambulate. Adm to Hosp with Dx of cellulitis RUE where vaccine was given. Tx with IV antibiotics
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: After receiving flu vaccine above, Pt. experienced redness and swelling that Pt's parents state "looks like a water balloon" - regarding swelling in Pt's (L) thigh. 2 days later at time of this report, Pt's (L) thigh continues to be red and swollen. Pt. did not/does not have difficulty breathing or swelling.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: itching + rash all over Dr. prescribed: Betamethasone 5% DP + hydroxyzine HCl 25mg 3x daily + Pepcid 40mg.  When continued on Hydroxyzine continued to  get worse, for 2 weeks. Went off  Hydroxyzine then in about 5 days later  began to get better. Now about 1 wk. later  it is almost gone.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swollen left arm.  Started swelling last night ~ 1/2 egg at injection site , now spreading and sore
Age: 36.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Axillary nerve injury, Burning sensation, Bursal fluid accumulation, Cervical radiculopathy, Electromyogram abnormal
Clinical narrative: immediate (L) shoulder pain & one day of numbness down to index finger seen in clinic 10/16/18 with poss (L) shoulder tendinitis, Rx with cold, ibuprofen  ongoing shoulder pain, pt called 8/13/19 with ongoing sx  -received in clinic 8/15/19 shoulder x-ray with mild narrowing of acromiohumeral distance. -seen by ortho 8/16/19 - mech of injury was flu vaccination Dx with shoulder rotator cuff tendinopathy Rx ice, NSAID, shoulder MRI which showed lateral downsloping acromion with small subacromial/subdeltoid bursa fluid, correlate for rotator cuff impingement -10/15/19 - cortisone injection by ortho for impingement -12/19/19 - some improvement in pain now report burning, tingling down arm -re-eval by me 1/7/2020 - ulnar neuropathy vs cervical radiculopathy of gabapentin  refer for NCS -1/21/2020 seen by ortho given 2nd cortisone injection -2/6/2020 EMG, NCS with (L) axillary mononeuropathy of unclear significance. -2/19/2020 (L) brachial plexus MRI ordered, done 3/7/2020 "Normal MRI (L) brachial plexus" - referred to neurologist -telephone visit with Neurologist dx with (L) axillary nerve injury from vaccination on 9/18. Unclear mechanical or immune mediated
Age: 36.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Magnetic resonance imaging abnormal, Mononeuropathy
Clinical narrative: immediate (L) shoulder pain & one day of numbness down to index finger seen in clinic 10/16/18 with poss (L) shoulder tendinitis, Rx with cold, ibuprofen  ongoing shoulder pain, pt called 8/13/19 with ongoing sx  -received in clinic 8/15/19 shoulder x-ray with mild narrowing of acromiohumeral distance. -seen by ortho 8/16/19 - mech of injury was flu vaccination Dx with shoulder rotator cuff tendinopathy Rx ice, NSAID, shoulder MRI which showed lateral downsloping acromion with small subacromial/subdeltoid bursa fluid, correlate for rotator cuff impingement -10/15/19 - cortisone injection by ortho for impingement -12/19/19 - some improvement in pain now report burning, tingling down arm -re-eval by me 1/7/2020 - ulnar neuropathy vs cervical radiculopathy of gabapentin  refer for NCS -1/21/2020 seen by ortho given 2nd cortisone injection -2/6/2020 EMG, NCS with (L) axillary mononeuropathy of unclear significance. -2/19/2020 (L) brachial plexus MRI ordered, done 3/7/2020 "Normal MRI (L) brachial plexus" - referred to neurologist -telephone visit with Neurologist dx with (L) axillary nerve injury from vaccination on 9/18. Unclear mechanical or immune mediated
Age: 36.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Nasopharyngitis, Nerve conduction studies abnormal, Neuropathy peripheral, Paraesthesia, Rotator cuff syndrome
Clinical narrative: immediate (L) shoulder pain & one day of numbness down to index finger seen in clinic 10/16/18 with poss (L) shoulder tendinitis, Rx with cold, ibuprofen  ongoing shoulder pain, pt called 8/13/19 with ongoing sx  -received in clinic 8/15/19 shoulder x-ray with mild narrowing of acromiohumeral distance. -seen by ortho 8/16/19 - mech of injury was flu vaccination Dx with shoulder rotator cuff tendinopathy Rx ice, NSAID, shoulder MRI which showed lateral downsloping acromion with small subacromial/subdeltoid bursa fluid, correlate for rotator cuff impingement -10/15/19 - cortisone injection by ortho for impingement -12/19/19 - some improvement in pain now report burning, tingling down arm -re-eval by me 1/7/2020 - ulnar neuropathy vs cervical radiculopathy of gabapentin  refer for NCS -1/21/2020 seen by ortho given 2nd cortisone injection -2/6/2020 EMG, NCS with (L) axillary mononeuropathy of unclear significance. -2/19/2020 (L) brachial plexus MRI ordered, done 3/7/2020 "Normal MRI (L) brachial plexus" - referred to neurologist -telephone visit with Neurologist dx with (L) axillary nerve injury from vaccination on 9/18. Unclear mechanical or immune mediated
Age: 36.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Tendon disorder, Vaccination complication, X-ray limb abnormal
Clinical narrative: immediate (L) shoulder pain & one day of numbness down to index finger seen in clinic 10/16/18 with poss (L) shoulder tendinitis, Rx with cold, ibuprofen  ongoing shoulder pain, pt called 8/13/19 with ongoing sx  -received in clinic 8/15/19 shoulder x-ray with mild narrowing of acromiohumeral distance. -seen by ortho 8/16/19 - mech of injury was flu vaccination Dx with shoulder rotator cuff tendinopathy Rx ice, NSAID, shoulder MRI which showed lateral downsloping acromion with small subacromial/subdeltoid bursa fluid, correlate for rotator cuff impingement -10/15/19 - cortisone injection by ortho for impingement -12/19/19 - some improvement in pain now report burning, tingling down arm -re-eval by me 1/7/2020 - ulnar neuropathy vs cervical radiculopathy of gabapentin  refer for NCS -1/21/2020 seen by ortho given 2nd cortisone injection -2/6/2020 EMG, NCS with (L) axillary mononeuropathy of unclear significance. -2/19/2020 (L) brachial plexus MRI ordered, done 3/7/2020 "Normal MRI (L) brachial plexus" - referred to neurologist -telephone visit with Neurologist dx with (L) axillary nerve injury from vaccination on 9/18. Unclear mechanical or immune mediated
Age: 36.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Axillary nerve injury, Nerve conduction studies abnormal
Clinical narrative: immediate (L) shoulder pain & one day of numbness down to index finger seen in clinic 10/16/18 with poss (L) shoulder tendinitis, Rx with cold, ibuprofen  ongoing shoulder pain, pt called 8/13/19 with ongoing sx  -received in clinic 8/15/19 shoulder x-ray with mild narrowing of acromiohumeral distance. -seen by ortho 8/16/19 - mech of injury was flu vaccination Dx with shoulder rotator cuff tendinopathy Rx ice, NSAID, shoulder MRI which showed lateral downsloping acromion with small subacromial/subdeltoid bursa fluid, correlate for rotator cuff impingement -10/15/19 - cortisone injection by ortho for impingement -12/19/19 - some improvement in pain now report burning, tingling down arm -re-eval by me 1/7/2020 - ulnar neuropathy vs cervical radiculopathy of gabapentin  refer for NCS -1/21/2020 seen by ortho given 2nd cortisone injection -2/6/2020 EMG, NCS with (L) axillary mononeuropathy of unclear significance. -2/19/2020 (L) brachial plexus MRI ordered, done 3/7/2020 "Normal MRI (L) brachial plexus" - referred to neurologist -telephone visit with Neurologist dx with (L) axillary nerve injury from vaccination on 9/18. Unclear mechanical or immune mediated
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Area is red, slightly swollen and hot. Advised patient to contact doctor.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Shingrix shot to Lf Arm sore, Red, Hot to touch. Suggested Ice Pack/Cold Compress/Tylenol, and call to doctor.
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Post injection site Reaction, Redness, heat Swelling, achiness
Age: 72.0
Sex: F
Vaccine: FLUA4, PPV, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever & chills for greater than 2 days
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: Migraine Headaches started day After 2nd Shingrix vaccine.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Lip swelling
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, redness and hardness in the arm where she received the injection; Redness and hardness in the arm where she received the injection; Hardness in the arm where she received the injection; Pain in her arm was "killing me."; Head spinning; Did not feel good; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th August 2020, 15 min after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, induration, pain in arm, head spinning and feeling unwell. On 26th August 2020, the outcome of the swelling arm, erythema of extremities, induration and pain in arm were not recovered/not resolved and the outcome of the head spinning and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities, induration, pain in arm, head spinning and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix and within about 15 minutes of receiving it, the patient started to experience swelling, redness and hardness in the arm where she received the injection.   The patient also started to experience her head spinning.  The patient stated that the pain in her arm was killing her.  The patient also reported that she did not feel good for a few days.  Her arm was still red, hard, sore and swollen.  The patient stated it may be getting worse. The patient advised her to follow up with her HCP. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, redness and hardness in the arm where she received the injection; Redness and hardness in the arm where she received the injection; Hardness in the arm where she received the injection; Pain in her arm was "killing me."; Head spinning; Did not feel good; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th August 2020, 15 min after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, induration, pain in arm, head spinning and feeling unwell. On 26th August 2020, the outcome of the swelling arm, erythema of extremities, induration and pain in arm were not recovered/not resolved and the outcome of the head spinning and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities, induration, pain in arm, head spinning and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix and within about 15 minutes of receiving it, the patient started to experience swelling, redness and hardness in the arm where she received the injection.   The patient also started to experience her head spinning.  The patient stated that the pain in her arm was killing her.  The patient also reported that she did not feel good for a few days.  Her arm was still red, hard, sore and swollen.  The patient stated it may be getting worse. The patient advised her to follow up with her HCP. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vertigo
Clinical narrative: Swelling, redness and hardness in the arm where she received the injection; Redness and hardness in the arm where she received the injection; Hardness in the arm where she received the injection; Pain in her arm was "killing me."; Head spinning; Did not feel good; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th August 2020, 15 min after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, induration, pain in arm, head spinning and feeling unwell. On 26th August 2020, the outcome of the swelling arm, erythema of extremities, induration and pain in arm were not recovered/not resolved and the outcome of the head spinning and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities, induration, pain in arm, head spinning and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix and within about 15 minutes of receiving it, the patient started to experience swelling, redness and hardness in the arm where she received the injection.   The patient also started to experience her head spinning.  The patient stated that the pain in her arm was killing her.  The patient also reported that she did not feel good for a few days.  Her arm was still red, hard, sore and swollen.  The patient stated it may be getting worse. The patient advised her to follow up with her HCP. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE details; temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving VARN AX states that there have been administered doses; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 25-AUG-2020, the patient was vaccinated with an improperly stored dose  of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002843, expiration date 23-JAN-2022 for prophylaxis (strength, dose, frequency, and route of administration were not reported).  The improperly stored vaccine experienced an intermitent temperature excursion between -14 degree Celsius (°C) to 10°C (max -9.5°C) for 38 hours and 30 minutes with no previous temperature excursion.  The call was made due to a digital data logger. No adverse symptoms were reported.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving VARN AX states that there have been administered doses; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 25-AUG-2020, the patient was vaccinated with an improperly stored dose  of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002843, expiration date 23-JAN-2022 for prophylaxis (strength, dose, frequency, and route of administration were not reported).  The improperly stored vaccine experienced an intermitent temperature excursion between -14 degree Celsius (°C) to 10°C (max -9.5°C) for 38 hours and 30 minutes with no previous temperature excursion.  The call was made due to a digital data logger. No adverse symptoms were reported.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Erythema, Nodule, Pain, Skin warm, Swelling
Clinical narrative: The employee was noted with a hematoma, bruising, redness, swelling and tenderness to touch at the right arm infection site.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: The employee was noted with a hematoma, bruising, redness, swelling and tenderness to touch at the right arm infection site.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Vaccination error
Clinical narrative: No other adverse event (AE) was reported; The patient received one dose of Pneumovax 23 in error; This spontaneous report has been received form a physician referring to a 14-year-old female patient. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On 25-AUG-2020, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, via intramuscular route, as immunization (lot number reported and validated as S029542, expiration date not reported but upon internal validation established as 10-JUN-2021;  strength, dosage, anatomical site of vaccination and vaccination scheme frequency were not reported).   It was reported that the patient received this vaccine in error (product administration error) however, no adverse events were reported (no adverse event). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report has been received from a registered nurse concerning to a 5-years-old male patient.   Information concerning patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.   On 14-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dosage regimen and route of administration were not reported), lot # T002848, expiration date 23-JAN-2022, administered as prophylaxis. The vaccine was reconstituted on a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # S008566, expiration date 16-NOV-2021).   The improperly stored dose experienced a temperature between (-14 degrees Celsius (°C) to -10 °C) average temperature was (-12.1 °C), for 3 hours, with multiple excursions of -9 °C to 8 °C, average temperature was -7.5 °C for 8 hours 30 minutes. The call was due to a digital data logger. There was not previous temperature excursions. No additional information was provided.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller stated that on 8/19/2020, the patient was administered improperly stored V ARlVAX (reconstituted with properly stored Merck STERILE DILUEN); This spontaneous report was received from a registered Nurse referring to a 5 years old female patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On 19-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002848, expiration date 23-JAN-2022 for prophylaxis (reconstituted with properly stored Merck sterile diluent) lot # S008566 expiration date 16-NOV-2021 (dose, frequency and route of administration were not reported) (Product storage error).  The improperly stored suspect vaccine experienced multiple temperature of - 14 Celsius degrees (°C) to 10°C (average -12.1°C) for 3 hours (multiple excursions); -9°C to 8°C ( average -7.5 °C )  for 8 hours and 30 minutes (multiple excursions).  The call was made due to a digital data logger. No previous temperature excursion was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; Improperly stored vaccine was administered .; This non-valid spontaneous report was received from a certified medical assistant and refers to an unspecified patients. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   Since 22-JUN-2020, unspecified patient was vaccinated with unspecified amount of improperly sored dosed of varicella virus vaccine live (Oka/Merck) lot # S031497 was confirmed to be valid, expiration date 07-OCT-2021 and lot # reported as T010318 with expiration date reported as 24-MAR-2022 (exact dose, route and site of administration were not provided), for prophylaxis. No additional adverse effects reported.  Administered doses of vaccine was exposed to the temperature between -9 to 8 degrees Celsius (C) for 1 hour and 5 minutes. It was unknown if there was any previous temperature excursion. The call was because of a digital data logger.  This is non-valid report due to lack of patients' identifiers.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion that was intermittent beginning 28-JUL-2020 / there have been administered doses; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  Since 28-JUL-2020 (conflicting information also reported as 30-JUL-2020), varicella virus vaccine live (Oka/Merck) (VARIVAX) had intermittent temperature excursion, the vaccine was stored at a temperature of -14 degrees Celsius (C) to -10 C (max -9.5C), during a time frame total of 38 hours and 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  On an unspecified date, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliter (ml) (lot number S032357 which has been verified to be valid, expiration date reported and validated as 14-OCT-2021) (it was also reported that the lot number: T002843; expiration date: 23-JAN-2022 was involved, however, information of administration was not provided) (vaccination scheme, frequency, route of administration and anatomical site of injection were not reported), as prophylaxis (product storage error).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014689: US-009507513-2008USA014711: US-009507513-2008USA014749: US-009507513-2008USA014777: US-009507513-2008USA014790: US-009507513-2008USA014797:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion that was intermittent beginning 28-JUL-2020 / there have been administered doses; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  Since 28-JUL-2020 (conflicting information also reported as 24-AUG-2020), measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) had intermittent temperature excursion, the vaccine was stored at a temperature of -14 degrees Celsius (C) to -10 C (max -9.5C), during a time frame total of 38 hours and 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  On an unspecified date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (T009929 lot number which has been verified to be valid, expiration date reported and validated as 16-SEP-2021) (vaccination scheme, frequency, route of administration and anatomical site of injection were not reported), as prophylaxis (product storage error).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014788: US-009507513-2008USA014811: US-009507513-2008USA014853: US-009507513-2008USA014854: US-009507513-2008USA014858:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; temperature excursion that was intermittent beginning 28-JUL-2020 / there have been administered doses; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  Since 28-JUL-2020 (conflicting information also reported as 10-AUG-2020), varicella virus vaccine live (Oka/Merck) (VARIVAX) had intermittent temperature excursion, the vaccine was stored at a temperature of -14 degrees Celsius (C) to -10 C (max -9.5C), during a time frame total of 38 hours and 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  On an unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliter (ml) (lot number S032357 which has been verified to be valid, expiration date reported and validated as 14-OCT-2021) (it was also reported that the lot number: T002843; expiration date: 23-JAN-2022 was involved, however, information of administration was not provided) (vaccination scheme, frequency, route of administration and anatomical site of injection were not reported), as prophylaxis (product storage error). No additional adverse events were reported in the patient.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014701: US-009507513-2008USA014689: US-009507513-2008USA014749: US-009507513-2008USA014777: US-009507513-2008USA014790: US-009507513-2008USA014797:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored of the improperly stored temperature excursion; This spontaneous report was received from a nursing assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported.   On 20-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, for prophylaxis, lot # S038698 and expiration date reported as 01-DEC-2021.  The temperature exursion was reported as -10.°C, on a time frame of 1 hour and 53 minutes. There was no previous temperature excursion.   A digital data logger was involved.   This is one of several reports received from the same souce.; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA015035: US-009507513-2009USA000113: US-009507513-2009USA000117: US-009507513-2009USA000132: US-009507513-2008USA014806: US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014705: US-009507513-2008USA014757: US-009507513-2008USA014803: US-009507513-2008USA014825: US-009507513-2008USA014888:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Temperature excursion of vaccine; This spontaneous report was received from a nursing assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported.   On 11-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, for prophylaxis, lot # S038698 and expiration date reported as 01-DEC-2021 (strength, frequency and route of administration were not reported).  The temperature exursion was reported as -10.°C, on a time frame of 1 hour and 53 minutes. There was no previous temperature excursion.   A digital data logger was involved.   This is one of several reports received from the same souce.; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA015035: US-009507513-2009USA000113: US-009507513-2009USA000117: US-009507513-2009USA000132: US-009507513-2008USA014806: US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014705: US-009507513-2008USA014757: US-009507513-2008USA014803: US-009507513-2008USA014825: US-009507513-2008USA014888:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Temperature excursion that was intermittent; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.   Since 27-JUL-2020 (also reported as 28-JUL-2020), varicella virus vaccine live (oka/merck)(VARIVAX) were improperly stored and had temperature excursions.   On an unspecified date in 2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml for prophylaxis, lot #S032357 and expiration reported as 14-OCT-2021 and lot #T002843 and expiration date reported as 23-JAN-2022 ) (strength, frequency and route of administration were not reported)  The temperature excursion was reported from -14°C to -10°C (max -9.5°C), during a time frame of 38 hours and 30 minutes. There was no previous temperature excursion.   A digital data logger was involved.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2008USA014701: US-009507513-2008USA014711: