chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 59 year old patient received 0.5 mL flozone high dose vaccine/No AE; 59 year old patient received 0.5 mL flozone high dose vaccine/No AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old male patient who received 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment, vaccination and family history were not provided.  On 03-Feb-2020, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot UJ253AB, expiry date: 06-May-2020] via an intramuscular route at the right deltoid for prophylactic vaccination.  It was a case of overdose and actual medication error due to inappropriate age at vaccine administration.  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.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 12 months old patient recieved expired dose of Daptacel in error, no AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 18 months old female patient who received a 0.5 ml fourth dose expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] in error (Preferred term: expired product administered, (lot C5367AA) (expiry date- 30-Jan-2020) on 04-Feb-2020 via intramuscular route in the left vastus lateralis for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Fluzone Quadrivalent for Immunisation.  It was an actual medication error case due to expired product administered.  No adverse event reported at the time of reporting.  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.
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Intense arm pain at time of vaccination Intense ongoing arm pain for 3-4 weeks Difficulty sleeping at night Took Motrin and Tylenol for 3 weeks
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypersomnia, Lethargy, Pain, Pyrexia
Clinical narrative: I became lethargic and achy by 4 PM of Friday (the day I received the vaccine).  Early Saturday morning I became feverish, aching all over and had shivering that I could not seem to subside.  I slept the bulk of the day on Saturday and all night into Sunday morning about 6:00 AM.  Most of the symptoms had subsided by that time.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Immune system disorder, Induration, Injection site erythema, Injection site induration
Clinical narrative: Day of vaccination, and day after, my arm was sore, Two days later the soreness increased to pain  in my whole shoulder  and deltoid, and I had a light fever, felt achy all over. I attributed this to the TdaP vaccine.  That same Friday evening, my arm was really hurting, I left work early at 7 pm, and went home took two 200 mg  advil and fell asleep for 3 hours. After I awoke, I felt like I had a fever, and I took two 500 mg acetaminophen. My left arm hurt anyway I moved it, and had trouble laying on my left side to sleep. The next morning, my left arm was hurting more, it was red, swollen, warm to touch,  and hard all over the deltoid  and scapula area.  My husband took pictures. I took a hot bath.  I went to my son't drumlins competition, but I couldn't move any equipment because my are hurt at rest, and I had decreed range of motion.. On awakening on Sunday, my arm was worse, and the swelling increased to twice the size, about the size of my hand, and increased hardness all over the shoulder joint and half way down the humerus. I went to Urgent Care were the doctor told me I was having a severe immunological reaction to the vaccine and that it was not cellulitis. The doctor expressed concern to me about developing a frozen shoulder. She prescribed a 125 mg SoluMedrol Injection, ice, advil, and active ROM exercises. I asked her if I should report it to the VAERS system and she said yes. I asked her if this was an allergic reaction, and she said no. On Monday, I called by PCP And whose office administered the TdaP and let them know of the reaction, and to get the Lot #.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Insomnia, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Day of vaccination, and day after, my arm was sore, Two days later the soreness increased to pain  in my whole shoulder  and deltoid, and I had a light fever, felt achy all over. I attributed this to the TdaP vaccine.  That same Friday evening, my arm was really hurting, I left work early at 7 pm, and went home took two 200 mg  advil and fell asleep for 3 hours. After I awoke, I felt like I had a fever, and I took two 500 mg acetaminophen. My left arm hurt anyway I moved it, and had trouble laying on my left side to sleep. The next morning, my left arm was hurting more, it was red, swollen, warm to touch,  and hard all over the deltoid  and scapula area.  My husband took pictures. I took a hot bath.  I went to my son't drumlins competition, but I couldn't move any equipment because my are hurt at rest, and I had decreed range of motion.. On awakening on Sunday, my arm was worse, and the swelling increased to twice the size, about the size of my hand, and increased hardness all over the shoulder joint and half way down the humerus. I went to Urgent Care were the doctor told me I was having a severe immunological reaction to the vaccine and that it was not cellulitis. The doctor expressed concern to me about developing a frozen shoulder. She prescribed a 125 mg SoluMedrol Injection, ice, advil, and active ROM exercises. I asked her if I should report it to the VAERS system and she said yes. I asked her if this was an allergic reaction, and she said no. On Monday, I called by PCP And whose office administered the TdaP and let them know of the reaction, and to get the Lot #.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Pyrexia, Skin warm, Swelling
Clinical narrative: Day of vaccination, and day after, my arm was sore, Two days later the soreness increased to pain  in my whole shoulder  and deltoid, and I had a light fever, felt achy all over. I attributed this to the TdaP vaccine.  That same Friday evening, my arm was really hurting, I left work early at 7 pm, and went home took two 200 mg  advil and fell asleep for 3 hours. After I awoke, I felt like I had a fever, and I took two 500 mg acetaminophen. My left arm hurt anyway I moved it, and had trouble laying on my left side to sleep. The next morning, my left arm was hurting more, it was red, swollen, warm to touch,  and hard all over the deltoid  and scapula area.  My husband took pictures. I took a hot bath.  I went to my son't drumlins competition, but I couldn't move any equipment because my are hurt at rest, and I had decreed range of motion.. On awakening on Sunday, my arm was worse, and the swelling increased to twice the size, about the size of my hand, and increased hardness all over the shoulder joint and half way down the humerus. I went to Urgent Care were the doctor told me I was having a severe immunological reaction to the vaccine and that it was not cellulitis. The doctor expressed concern to me about developing a frozen shoulder. She prescribed a 125 mg SoluMedrol Injection, ice, advil, and active ROM exercises. I asked her if I should report it to the VAERS system and she said yes. I asked her if this was an allergic reaction, and she said no. On Monday, I called by PCP And whose office administered the TdaP and let them know of the reaction, and to get the Lot #.
Age: 47.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult patient was given pediatric dose of 0.5mL.  Merck & Co safety report
Age: 47.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult patient was given pediatric dose of 0.5mL.  Merck & Co safety report
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site mass, Pyrexia
Clinical narrative: localized skin mass beneath injection site 2cmx2cm in diameter ; mild redness with slight ecchymosis. 99F-101F fevers reported by mother and father 12-72 hours post injection.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Cough, Ear pruritus, Eye pruritus, Injection site pain
Clinical narrative: Woke suddenly at 1am to severe coughing fit,  itching (ears, eyes, throat) and mucus production (nasal).  Also noted I was wheezing (no issues with my asthma for more than 2 months- no inhaler use necessary and no wheezing).  Self treated with 50mg of Benadryl, inhaler used (ProAir).  Symptoms abated enough after approx 1 hour and stayed up for another 2 hours to make sure I didn't get worse.  Woke the next morning (6am) with throat and chest still feeling tight, but limited congestion and itchiness.  I've never had this vaccination before so this was my first exposure to it.  No hives or any other rash noted during this episode.  Prior titers drawn showed zero antibodies to Pneumonia which is one reason why my Dr. prescribed this for me.    Prior to the 1am reaction, my arm was sore at the injection site, but simply attributed that to typical side effect of a vaccination.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Respiratory tract congestion, Rhinorrhoea, Throat irritation, Throat tightness, Wheezing
Clinical narrative: Woke suddenly at 1am to severe coughing fit,  itching (ears, eyes, throat) and mucus production (nasal).  Also noted I was wheezing (no issues with my asthma for more than 2 months- no inhaler use necessary and no wheezing).  Self treated with 50mg of Benadryl, inhaler used (ProAir).  Symptoms abated enough after approx 1 hour and stayed up for another 2 hours to make sure I didn't get worse.  Woke the next morning (6am) with throat and chest still feeling tight, but limited congestion and itchiness.  I've never had this vaccination before so this was my first exposure to it.  No hives or any other rash noted during this episode.  Prior titers drawn showed zero antibodies to Pneumonia which is one reason why my Dr. prescribed this for me.    Prior to the 1am reaction, my arm was sore at the injection site, but simply attributed that to typical side effect of a vaccination.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Nausea, Pain in extremity
Clinical narrative: 3 hrs after vaccine, intense pain throughout arm, especially shoulder to elbow, prohibiting  lifting or movement of arm in any direction. Intensity continued for approx 20 hours & then began to lessen.  No sleep, pain pills used with no relief.   Milder pain still present after 72 hrs, mostly in shoulder.  Day after vaccine,  nausea present & attempt at eating resulted in throwing up food.  This continued for 24 hours.   NO redness, swelling, or even a mark where vaccine administered.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: 3 hrs after vaccine, intense pain throughout arm, especially shoulder to elbow, prohibiting  lifting or movement of arm in any direction. Intensity continued for approx 20 hours & then began to lessen.  No sleep, pain pills used with no relief.   Milder pain still present after 72 hrs, mostly in shoulder.  Day after vaccine,  nausea present & attempt at eating resulted in throwing up food.  This continued for 24 hours.   NO redness, swelling, or even a mark where vaccine administered.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Parent called the clinic on 11/13/2019, two days after immunization was given, to report that the site around where the immunization was given was red and swollen.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a currently 57-year-old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provided for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) by a healthcare provider. On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from the use of zoster vaccine live (ZOSTAVAX): shingles. The outcome of the event was not reported. The reporter felt the event was related to the suspect vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itching and tactile warmth at injection site of MMRV on right arm.  Treated with Keflex and mupriocin ointment.  Unable to contact patient to find out the current status.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient did not have reaction, he received and adult dose of Hep instead of the pediatric dose.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Mobility decreased
Clinical narrative: Client woke up with a headache @ 2:25p then developed inability to move was curled up in a fetal position this lasted approximately 2 1/2 hours. Client thought she had a temperature but did not check temperature had no difficulty breathing.
Age: 56.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site warmth, Skin infection
Clinical narrative: 2/1/20 14:24 Influenza vaccine given left deltoid, pneumonia vaccine given right deltoid. 2/2/20 17:24 Hep A vaccine given right deltoid.  2/3/20 in the A.M. on doctors rounds (9-11am usually) it was noted that pt had 10cm area left deltoid that was reddish, warm, with erythema.  Afebrile. Dx was infection of the skin. Keflex 250mg po qid x 20 doses ordered along with cold compressed & elevate as tolerated.  2/4/20 on MD rounds the nurse practitioner noted infection significantly improved, continue with Keflex. Encouraged to f/u outpatient if infection gets worse.  Pt discharged routinely.
Age: 20.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site warmth, Muscle spasms
Clinical narrative: Patient began having muscle spasms on Friday 2/7/2020. They were sporadic, becoming less frequent each day to the present. On Saturday evening the injection site became inflamed, hard, red, and hot to the touch. By Sunday morning the redness and the swelling had disappeared but still had a knot at the injection site. Today upon awakening she noticed red, blotchy area on arm below the injection site and to the left that was hot to touch. She had three spots that measured approx 4 x 6 cm, 5 x 6 cm, and 2 x 4 cm but all congrued together(not separated).
Age: 20.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Nodule
Clinical narrative: Patient began having muscle spasms on Friday 2/7/2020. They were sporadic, becoming less frequent each day to the present. On Saturday evening the injection site became inflamed, hard, red, and hot to the touch. By Sunday morning the redness and the swelling had disappeared but still had a knot at the injection site. Today upon awakening she noticed red, blotchy area on arm below the injection site and to the left that was hot to touch. She had three spots that measured approx 4 x 6 cm, 5 x 6 cm, and 2 x 4 cm but all congrued together(not separated).
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Lethargy, Pain, Pyrexia
Clinical narrative: Fever, achy, headache, lethargic / tired
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test, Blister, Blister rupture, Pain, Parasitic test
Clinical narrative: In about two weeks I noticed one morning I had itchy spots on my arms and shoulders.  I called my nurse practitioner to let her know I was sure I'd had a reaction to the vaccine. She said "Impossible."  Well the itchy spots were random but coming.  The worst place was the back.  I had blisters that would burst and crust over, so itchy and painful during the process.  I pushed on.  It was a mistake to not have pushed harder for my needs.  When I did go back to ask about the spots, she asked I was still in senior care work? Yes. It looks like you have Scabies - no tests - no biopsy - just go get Permithrin creme and follow the rules.  I got really bad, rash, itchy, ended up in hospital and then 8 days in a motel for care.  The spots have Never completely gone away - there seems to be a vicious cycle that occurs - break out, itchy, swell, as this clears others are appearing.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Scab, Staphylococcus test, Swelling
Clinical narrative: In about two weeks I noticed one morning I had itchy spots on my arms and shoulders.  I called my nurse practitioner to let her know I was sure I'd had a reaction to the vaccine. She said "Impossible."  Well the itchy spots were random but coming.  The worst place was the back.  I had blisters that would burst and crust over, so itchy and painful during the process.  I pushed on.  It was a mistake to not have pushed harder for my needs.  When I did go back to ask about the spots, she asked I was still in senior care work? Yes. It looks like you have Scabies - no tests - no biopsy - just go get Permithrin creme and follow the rules.  I got really bad, rash, itchy, ended up in hospital and then 8 days in a motel for care.  The spots have Never completely gone away - there seems to be a vicious cycle that occurs - break out, itchy, swell, as this clears others are appearing.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Flushing, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Patient got a flu vacc, immediately developed flushing, sweating. Said he has never  gottena flu vaccine in the past. No egg allergy. No shortness of breath, no  rashes. VSS. Given 25 mg benadryl 'po' from ward stock. Symptoms began to  subside after a few minutes. Patient given bed rest. Advised to see nursing staff if  he develops any more reaction. Patient agreed.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Appendicectomy, Barium enema, Colectomy, Colostomy, Enema administration
Clinical narrative: 1/13/2020  1130am at daycare vomiting. After he came from daycare he had a few episodes of vomiting and was more tired. No fever. Slight decreased po intake and urinated well.  No abd pain.At 12midnight 1/14/2020 he started with bloody stool filled the diaper-.1/14/2020 Mother took him to the ER. and He was transferred to Hospital barium enema showed - intusseption could not be reduced radiologically so he was taken for surgery. Partial colon resection and terminal ileum removal and appendectomy. Colostomy placed. Hospitalized in ICU and floor from 1/14/2020-1/25/2020. PO feeds started on POD 7. In the future surgeon plans to reverse colostomy.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Fatigue, Haematochezia, Hypophagia, Ileectomy, Intensive care
Clinical narrative: 1/13/2020  1130am at daycare vomiting. After he came from daycare he had a few episodes of vomiting and was more tired. No fever. Slight decreased po intake and urinated well.  No abd pain.At 12midnight 1/14/2020 he started with bloody stool filled the diaper-.1/14/2020 Mother took him to the ER. and He was transferred to Hospital barium enema showed - intusseption could not be reduced radiologically so he was taken for surgery. Partial colon resection and terminal ileum removal and appendectomy. Colostomy placed. Hospitalized in ICU and floor from 1/14/2020-1/25/2020. PO feeds started on POD 7. In the future surgeon plans to reverse colostomy.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception, Surgery, Vomiting
Clinical narrative: 1/13/2020  1130am at daycare vomiting. After he came from daycare he had a few episodes of vomiting and was more tired. No fever. Slight decreased po intake and urinated well.  No abd pain.At 12midnight 1/14/2020 he started with bloody stool filled the diaper-.1/14/2020 Mother took him to the ER. and He was transferred to Hospital barium enema showed - intusseption could not be reduced radiologically so he was taken for surgery. Partial colon resection and terminal ileum removal and appendectomy. Colostomy placed. Hospitalized in ICU and floor from 1/14/2020-1/25/2020. PO feeds started on POD 7. In the future surgeon plans to reverse colostomy.
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Vaccination site cellulitis
Clinical narrative: cellulitis at vaccine site
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Donor  came into the donation center 2 days after receiving her tetanus shot. Donors right shoulder is red and sore to the touch. The redness is approx. 6 inches x 4 inches wide .
Age: 1.67
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Pustule
Clinical narrative: pustule of skin, progressing to possible cellulitis. treating with bactroban, topical antibiotic. May need oral atb, but attempting tx with topical.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pruritus, Rash
Clinical narrative: Patient reports she developed a rash, itching and headache that occurred the same day as the immunization. Patient contacted prescribers office to report symptoms and the office requested the vaccine information (lot number, expiration date) which was faxed to them same day.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dissociation, Dizziness, Headache, Hypersensitivity, Impaired work ability
Clinical narrative: Patient reports she developed a rash, itching and headache that occurred the same day as the immunization. Patient contacted prescribers office to report symptoms and the office requested the vaccine information (lot number, expiration date) which was faxed to them same day.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient reports she developed a rash, itching and headache that occurred the same day as the immunization. Patient contacted prescribers office to report symptoms and the office requested the vaccine information (lot number, expiration date) which was faxed to them same day.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Anaphylactic reaction, Pharyngeal swelling, Swollen tongue
Clinical narrative: PATIENT WENT HOME AND WAS FINE UNTIL THE EVENING WHEN SHE FELT HER TONGUE AND THROAT SWELLING. WENT TO EMERGENCY ROOM AND WAS TREATED FOR ANAPHYLAXIS. PATIENT HAD NO AIRWAY OBSTRUCTION OR WHEEZING IN THE PATIENT NOTE, BUT I WAS NOT THE TREATING PROVIDER AND DO NOT HAVE ALL OF THE DETAILS
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Demyelinating polyneuropathy, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Numbness, tingling, pins and needles in hands and feet that progressed up the body.  Severe burning pain in legs and difficulty walking.  Shooting pain all over body.  Rapid weightloss (12 lbs in 14 days).  Symptoms began over 12 hours after vaccine administered.  They were slight and progressed over 3 weeks until it reached the worst, then started to slightly improve over several weeks.  Neurologist diagnosed as Acute Demyelinating Polyneuropathy, or Guillain Barre Syndrome
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal normal, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Numbness, tingling, pins and needles in hands and feet that progressed up the body.  Severe burning pain in legs and difficulty walking.  Shooting pain all over body.  Rapid weightloss (12 lbs in 14 days).  Symptoms began over 12 hours after vaccine administered.  They were slight and progressed over 3 weeks until it reached the worst, then started to slightly improve over several weeks.  Neurologist diagnosed as Acute Demyelinating Polyneuropathy, or Guillain Barre Syndrome
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Weight decreased
Clinical narrative: Numbness, tingling, pins and needles in hands and feet that progressed up the body.  Severe burning pain in legs and difficulty walking.  Shooting pain all over body.  Rapid weightloss (12 lbs in 14 days).  Symptoms began over 12 hours after vaccine administered.  They were slight and progressed over 3 weeks until it reached the worst, then started to slightly improve over several weeks.  Neurologist diagnosed as Acute Demyelinating Polyneuropathy, or Guillain Barre Syndrome
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm, Ultrasound scan normal
Clinical narrative: Patient received Pneumovax23 on 2/5/20 and experienced swelling in the same arm as vaccination (left) above and below the elbow, but not at the vaccination site, redness, and warmth on the morning of 2/7/20.  She consulted with the pharmacist on duty and the pharmacist assessed the arm and advised her to see her doctor.  She went the same day and was told it is most likely cellulitis and was prescribed SMZ/TMP ds bid for 7 days.  She was advised by her provider to go to hospital  to get ultrasound to make sure there was no blood clot.  The patient proceeded to the hospital that same day and based on ultrasound, there was no clot.  Pharmacist on duty followed up with patient 2/10/20 and patient was going back to provider for follow up.  She got an extension of her antibiotic for 3 more days.  According to the patient, over the course of the weekend, the swelling and redness significantly reduced and no longer warm to the touch.  She just has very slight redness and swelling as of today 2/10/20.  She will follow up with her provider when done with the antibiotics.  She did state that she had a history of frozen shoulder and she did fracture that same shoulder a few years ago.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Fatigue, Immediate post-injection reaction, Influenza like illness
Clinical narrative: Soreness at injection site almost immediately and worsened over next 25 hours.  10-12 hours after shot joint and muscle aches (feels like flu without the fever), 8 hours after shot and continuing for remainder of day diarrhea, fatigue.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: Soreness at injection site almost immediately and worsened over next 25 hours.  10-12 hours after shot joint and muscle aches (feels like flu without the fever), 8 hours after shot and continuing for remainder of day diarrhea, fatigue.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Chills, fever of 101.4. Fever was back to normal the following morning.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza A virus test, Influenza B virus test, Injection site reaction, Rash macular
Clinical narrative: rash-12x7cm dull erythematous macular rash (L) deltoid region Given by Dr.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient states he had sore arm after 2nd shingles. He thought it would resolve, but states even weeks later he lost range of motion when putting Left arm behind back. He also stated his arm felt numb multiple times post vaccine. He is starting PT this month. He is not sure if this is all related to vaccine but did state RPH who administered possibly gave the vaccine too high on the arm. He had vaccine in October and emailed my Pharmacy on 2/7/20 about this event. I met with patient and told him I would document his case. He starts PT (possible for rotator cuff damage) next week.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Body temperature increased, Febrile convulsion, Irritability, Seizure, Skin warm
Clinical narrative: Febrile seizure happened on 1/12, 2 days after 6 month vaccines per mom, was very hot and fussy, had seizure at hom at LR temp was 103. no records available Since then pt has been well, eating well, breast and table foods, happy
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccine administered on 1/30/20. Patient began having swelling on injection site ((R) deltoid) on 1/31/20. Reported to Clinic on 2/1/20. Swelling, Erythematous & tenderness noted to injection site. Doxycycline 100mg 2 times Daily given.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 27-FEB-2019, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a physician for  shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of herpes zoster was considered as not recovered. The lawyer considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Muscle twitching, Syringe issue
Clinical narrative: his muscle spasmed when she was injected; quite a large amount of fluid come out of his arm; a large drip that went down his arm; a large drip that went down his arm; This case was reported by a pharmacist via sales rep and described the occurrence of muscle spasm in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 9737P, expiry date 19th March 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th August 2019.).   On 28th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 28th January 2020, immediately after receiving Shingrix, the patient experienced muscle spasm, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the muscle spasm, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the muscle spasm to be related to Shingrix.  Additional details were provided as follows: The pharmacist vaccinated the patient with Shingrix she noted that when she injected the patient with the needle that his muscle spasmed when she was injected the fluid and noted quite a large amount of fluid come out of his arm after she took the needle out, which led to muscle spasm, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. She noted it was a large drip that went down his arm not the typical you may see one drop.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Immediate post-injection reaction, Muscle spasms
Clinical narrative: his muscle spasmed when she was injected; quite a large amount of fluid come out of his arm; a large drip that went down his arm; a large drip that went down his arm; This case was reported by a pharmacist via sales rep and described the occurrence of muscle spasm in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 9737P, expiry date 19th March 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th August 2019.).   On 28th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 28th January 2020, immediately after receiving Shingrix, the patient experienced muscle spasm, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the muscle spasm, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the muscle spasm to be related to Shingrix.  Additional details were provided as follows: The pharmacist vaccinated the patient with Shingrix she noted that when she injected the patient with the needle that his muscle spasmed when she was injected the fluid and noted quite a large amount of fluid come out of his arm after she took the needle out, which led to muscle spasm, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. She noted it was a large drip that went down his arm not the typical you may see one drop.
Age: 85.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, VARZOS
Symptoms: Chest pain, Herpes zoster, Rash
Clinical narrative: 1/10/20 (L) arm very sore + warm. Pain in (L) chest (intermittent) 1/12/20 Red rash on (L) Breast + under (L) arm. 1/13 saw Dr. confirmed shingles. Started acyclovir med. Suffered severe pain in (L) chest + back for next 3 weeks.
Age: 85.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, VARZOS
Symptoms: Back pain, Chest pain, Herpes zoster, Pain in extremity, Rash
Clinical narrative: 1/10/20 (L) arm very sore + warm. Pain in (L) chest (intermittent) 1/12/20 Red rash on (L) Breast + under (L) arm. 1/13 saw Dr. confirmed shingles. Started acyclovir med. Suffered severe pain in (L) chest + back for next 3 weeks.
Age: 85.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: 1/10/20 (L) arm very sore + warm. Pain in (L) chest (intermittent) 1/12/20 Red rash on (L) Breast + under (L) arm. 1/13 saw Dr. confirmed shingles. Started acyclovir med. Suffered severe pain in (L) chest + back for next 3 weeks.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Pruritus
Clinical narrative: Itchy rash around face and slight rash and call PCP office. Pt contacted PCP and was told by APN  to use   antihistamine zyrtec 10mg bid and Pepcid 20mg bid  to help with and to call if not better.  Rph also recommended HC1% crm otc if needed
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash around face and slight rash and call PCP office. Pt contacted PCP and was told by APN  to use   antihistamine zyrtec 10mg bid and Pepcid 20mg bid  to help with and to call if not better.  Rph also recommended HC1% crm otc if needed
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Product administered at inappropriate site
Clinical narrative: PATIENT CAME TO PICKED UP HER REGULAR MEDICINE ON 01/29/2020 . SHE MENTIONED HER VACCINE INJECTED ON 11/04/19 SITE WAS TOO HIGH ON HER ARM AND  CAUSED HER JOINT OF ARM HAD DIFFICULTY ON MOVEMENT FOR FEW DAYS. SHE JUST WANT MY NAME AND NO EXTRA  COMPLAINED OR SIGN OF DISCOMFORT AT 01/29/2020
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: REDNESS, TENDER, ITCHING, WARMTH
Sex: U
Vaccine: HEP, HEP
Symptoms: Underdose
Clinical narrative: the patient had hepatitis B titers checked as a requirement for employment and titers showed up as "not immune" on an unspecified date.; Nurse reported the 47 year old patient was inadvertently administered a pediatric dose ofEngerix B (lot YL2L3) on 10/23/2019.; This spontaneous report was received from a licensed practical nurse referring to a 47 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, vaccine dosage detail, route of administration, lot# and expiration date were not reported) series as a child for prophylaxis. On an unknown date, the patient had hepatitis B titers checked as a requirement for employment and titers showed not immune. On 23-OCT-2019, the patient was inadvertently administered a pediatric dose of hepatitis b virus vaccine rhbsag (yeast)(ENGERIX-B) (lot# YL2L3; strength, vaccine dosage detail, route of administration and expiration date were not reported) (incorrect dose administered) for prophylaxis. On 23-NOV-2019, the patient was administered an adult dose of hepatitis b virus vaccine rhbsag (yeast)(ENGERIX-B) (lot# B39CM; strength, vaccine dosage detail, route of administration and expiration date were not reported) for prophylaxis.  The outcome of the events was unknown. The causality between hepatitis B titers showed up as not immune and the therapies was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; She received her second vaccination of GARDASIL 9, 2 weeks after the scheuled date; This spontaneous report was received from a female patient of unknown age, reporting on herself. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 18-JAN-2020, the patient was supposed to have her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported), however, the patient received the second dose of her vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 2 weeks later, on 01-FEB-2020. No adverse reactions were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness bilateral, Deafness neurosensory
Clinical narrative: Bilateral sensorineural hearing; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 23-JUL-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date, the patient experienced bilateral sensorineural hearing loss. As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. In addition, the patient sustained severe and permanent personal injuries. The outcome of the event bilateral sensorineural hearing loss was considered as not recovered. The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of bilateral sensorineural hearing loss was determined to be medically significant. The event of bilateral sensorineural hearing loss was considered to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Acute kidney injury, Acute left ventricular failure, Bacteraemia, Coordination abnormal, Dyspnoea
Clinical narrative: acute systolic congestive heart failure; endocarditis; transient ischemic attack; bacteremia; acute kidney injury; mental status changes; metabolic encephalopathy secondary to endocarditis; Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 18-JUL-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date, the patient presented left sided weakness, shortness of breath, discoordination and zoster like rash. Then, the patient was diagnosed with acute systolic heart failure, endocarditis, transient ischemic attack, bacteremia, acute kidney injury, mental status changes, metabolic encephalopathy secondary to endocarditis and herpes zoster (shingles). On an unknown date, the patient was hospitalized due to the events. As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. In addition, the patient sustained severe and permanent personal injuries. The outcome of the events was considered as not recovered. The reporter considered all the events to be related to zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events of acute systolic heart failure, endocarditis, transient ischemic attack, bacteremia, acute kidney injury and metabolic encephalopathy secondary to endocarditis were determined to be medically significant. All the events were considered to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Endocarditis, Hemiparesis, Herpes zoster, Mental status changes, Metabolic encephalopathy
Clinical narrative: acute systolic congestive heart failure; endocarditis; transient ischemic attack; bacteremia; acute kidney injury; mental status changes; metabolic encephalopathy secondary to endocarditis; Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 18-JUL-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date, the patient presented left sided weakness, shortness of breath, discoordination and zoster like rash. Then, the patient was diagnosed with acute systolic heart failure, endocarditis, transient ischemic attack, bacteremia, acute kidney injury, mental status changes, metabolic encephalopathy secondary to endocarditis and herpes zoster (shingles). On an unknown date, the patient was hospitalized due to the events. As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. In addition, the patient sustained severe and permanent personal injuries. The outcome of the events was considered as not recovered. The reporter considered all the events to be related to zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events of acute systolic heart failure, endocarditis, transient ischemic attack, bacteremia, acute kidney injury and metabolic encephalopathy secondary to endocarditis were determined to be medically significant. All the events were considered to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Transient ischaemic attack
Clinical narrative: acute systolic congestive heart failure; endocarditis; transient ischemic attack; bacteremia; acute kidney injury; mental status changes; metabolic encephalopathy secondary to endocarditis; Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 18-JUL-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date, the patient presented left sided weakness, shortness of breath, discoordination and zoster like rash. Then, the patient was diagnosed with acute systolic heart failure, endocarditis, transient ischemic attack, bacteremia, acute kidney injury, mental status changes, metabolic encephalopathy secondary to endocarditis and herpes zoster (shingles). On an unknown date, the patient was hospitalized due to the events. As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. In addition, the patient sustained severe and permanent personal injuries. The outcome of the events was considered as not recovered. The reporter considered all the events to be related to zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events of acute systolic heart failure, endocarditis, transient ischemic attack, bacteremia, acute kidney injury and metabolic encephalopathy secondary to endocarditis were determined to be medically significant. All the events were considered to be disabling.