chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu Vaccine was not administered correctly.  the dose was not injected into the muscle of the arm as recommended.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Asthenia, Chest pain, Eye swelling, Fatigue
Clinical narrative: I became severely ill approx 3-4 hours after the shot. Ran a fever of 101.4, bad sore throat, runny nose, congestion, chest hurt, eyes and head swelled up, eyes red rimmed, bloodshot, swollen, mouth swollen, lips numb, nausea, stomach upset and could not eat for several days, ears ringing, feet, hands, neck, leg soreness, overall fatigue, lethargy, weakness.  I did not get hives, but it felt like an allergic reaction in all other ways.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Feeding disorder, Hypoaesthesia oral, Illness, Lethargy, Mouth swelling
Clinical narrative: I became severely ill approx 3-4 hours after the shot. Ran a fever of 101.4, bad sore throat, runny nose, congestion, chest hurt, eyes and head swelled up, eyes red rimmed, bloodshot, swollen, mouth swollen, lips numb, nausea, stomach upset and could not eat for several days, ears ringing, feet, hands, neck, leg soreness, overall fatigue, lethargy, weakness.  I did not get hives, but it felt like an allergic reaction in all other ways.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Neck pain, Ocular hyperaemia, Oropharyngeal pain, Pain in extremity
Clinical narrative: I became severely ill approx 3-4 hours after the shot. Ran a fever of 101.4, bad sore throat, runny nose, congestion, chest hurt, eyes and head swelled up, eyes red rimmed, bloodshot, swollen, mouth swollen, lips numb, nausea, stomach upset and could not eat for several days, ears ringing, feet, hands, neck, leg soreness, overall fatigue, lethargy, weakness.  I did not get hives, but it felt like an allergic reaction in all other ways.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, Skin swelling, Tinnitus
Clinical narrative: I became severely ill approx 3-4 hours after the shot. Ran a fever of 101.4, bad sore throat, runny nose, congestion, chest hurt, eyes and head swelled up, eyes red rimmed, bloodshot, swollen, mouth swollen, lips numb, nausea, stomach upset and could not eat for several days, ears ringing, feet, hands, neck, leg soreness, overall fatigue, lethargy, weakness.  I did not get hives, but it felt like an allergic reaction in all other ways.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu Vaccine was not administered correctly.  the dose was not injected into the muscle of the arm as recommended.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu Vaccine was not administered correctly.  the dose was not injected into the muscle of the arm as recommended.
Age: 91.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Rash erythematous, Skin warm
Clinical narrative: Right arm swelled about 2 inches below injection site, which was 2 inches below shoulder.  It swelled down to within 2 inches of the wrist.  My right arm was swelled, red rash and hot to touch.  The swelling continue to grow for 3 days until I took 2 benadryl every 6 hours as directed by the urgent care doctor, on November 22 at 5:00 pm.
Age: 1.42
Sex: M
Vaccine: DTAP, FLU4, VARCEL
Symptoms: Contusion, Injection site erythema, Injection site mass
Clinical narrative: Left thigh "lump" and redness reported by Mother 12/1/20 via phone call. Mother states that she believes this was where subcutaneous injection was given on 11/20/20. Mother noticed this on 11/30/20.  Patient was seen by PCP on 12/1/20 and reported back to writer that the PCP feels this is a deep tissue bruise. Patient's mother to monitor at home.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chest pain, Erythema, Induration, Neck pain
Clinical narrative: Hours after vaccination developed pain and swelling of upper arm that caused extreme pain, developed weakness of right arm. Pain extending up neck, into chest and down forearm. Small area of erythema and induration.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Hours after vaccination developed pain and swelling of upper arm that caused extreme pain, developed weakness of right arm. Pain extending up neck, into chest and down forearm. Small area of erythema and induration.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Patient reported full body hives for 2 weeks after the incident. Patient reported she got a cream that settled the rash but was still there for a few more weeks.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu Vaccine was not administered correctly.  the dose was not injected into the muscle of the arm as recommended.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 96.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: The daughter-in-law stated that the patient has a 3x 5 red, raised area where the vaccine was given.  Stated that she circled the reddened area and will keep an eye on the area for worsening.  The patient sees her PCP tomorrow for another reason but will ask PCP to look at the site.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Pain in shoulder has not gone away in over a month
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 19.0
Sex: M
Vaccine: FLU4, IPV, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: The patient experienced a Syncopal episode immediately after receiving these immunizations and regained consciousness without intervention
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Decreased appetite, Fall, Fatigue
Clinical narrative: nausea, vomiting, fainted, fell down twice from weakness, fever 102.2 for 3 days and fever 5 days total, swelling and pain at injection arm that continues, no appetite, extreme chills 3 days and shaking, extreme fatigue
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Nausea, Pyrexia, Syncope
Clinical narrative: nausea, vomiting, fainted, fell down twice from weakness, fever 102.2 for 3 days and fever 5 days total, swelling and pain at injection arm that continues, no appetite, extreme chills 3 days and shaking, extreme fatigue
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Tremor, Vomiting
Clinical narrative: nausea, vomiting, fainted, fell down twice from weakness, fever 102.2 for 3 days and fever 5 days total, swelling and pain at injection arm that continues, no appetite, extreme chills 3 days and shaking, extreme fatigue
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu Vaccine was not administered correctly.  the dose was not injected into the muscle of the arm as recommended.
Age: 89.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu Vaccine was not administered correctly.  the dose was not injected into the muscle of the arm as recommended.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 31.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA - Shot administered into my bursa.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 24.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: presented with complaint of pain and swelling in arm at injection site.  also, stated that are at site felt warm.  instructed to use cold compress and to take either Tylenol or ibuprofen for the pain.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills, fatigue and headache
Age: 85.0
Sex: M
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Headache, Lip swelling, Oral discomfort
Clinical narrative: Patient said "a little later after receiving the vaccine", she started to experience lip swelling, eye swelling, inside of mouth "felt like it was on fire", and she had a headache. She said she never had any difficulty breathing. She said the symptoms went away in less that 24 hours and she "felt fine". She reported this information to the pharmacist on Dec 2, 2020.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine intended for age 18 and older- No reported adverse response.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Immediate post-injection reaction, Syncope
Clinical narrative: Syncope, immediately on getting vaccine
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Patient has a red welt the size is 9.5x 6 cm. on his right thigh. Red and swollen and warm to touch
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Vertigo
Clinical narrative: I only know the vaccine to be "AIIV4" influenza vaccine, so I guessed at "affluvial."  I tried to get out of bed the following morning (Oct 15), but had to lie back down quickly because of very strong vertigo.  I had no sense of balance at all and the only thing I could do was fall back onto the be.  After the initial bout of vertigo, I got up very slowly  and was okay to be proceed with my day after a few minutes.  Similar issue occurred the next morning  (Oct 16) but not quite as bad and issues resolved within a half minute or so.   Thereafter, I had no further vertigo issues.  I had not had vertigo before this event and none since.  I had not had vertigo before this
Age: 18.0
Sex: U
Vaccine: FLU4, HEP, RV1, UNK, UNK
Symptoms: Unevaluable event
Clinical narrative: INFAKT HIGH PLE SURE
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Muscle spasms, Pain in extremity, Posture abnormal, Somnolence
Clinical narrative: Timer set for 15min and pt left in exam room with mother, brother. Immediately after and for about 10 minutes, mom says pt complained of pain in her Left arm. Pt moved from exam table to sit in chair next to mom. Around 14 minutes after vaccines were given, pt seemed to lean heavily on mom, and mom said it seemed like she fainted, and her L arm "spasmed." Brother ran into hallway to get a nurse, and by time nurse came in pt was alert again, although drowsy. She said "everything went black." Entire episode lasted about 20 seconds. Nurse moved patient to exam table to lie down. Declined any water. She denied headache, dizziness, or nausea, and left clinic about 10-15 minutes later.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Syncope, Visual impairment
Clinical narrative: Timer set for 15min and pt left in exam room with mother, brother. Immediately after and for about 10 minutes, mom says pt complained of pain in her Left arm. Pt moved from exam table to sit in chair next to mom. Around 14 minutes after vaccines were given, pt seemed to lean heavily on mom, and mom said it seemed like she fainted, and her L arm "spasmed." Brother ran into hallway to get a nurse, and by time nurse came in pt was alert again, although drowsy. She said "everything went black." Entire episode lasted about 20 seconds. Nurse moved patient to exam table to lie down. Declined any water. She denied headache, dizziness, or nausea, and left clinic about 10-15 minutes later.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration
Clinical narrative: Pt describes, injection site as pea-sized white spot with brown discoloration around it. Not sore or painful
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: vision problems
Age: 34.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Pt Called the pharmacy on Dec. 1st, said she had a fever, body aches and soreness and redness in the injection site of right arm. pt was counselled. Pt's husband called on Dec. 2nd with an update that pt had been diagnosed with Cellulitis in the injection site of Right arm. she received antibiotics and IV fluids.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: within 2 hours patient had total body hives and intense itching. no throat swelling, cough, or vomiting. Took 25 mg of benedryl and her symptoms have improved. took a second dose 6 hours later.
Age: 20.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Swollen, hot to the touch, redness, itch, 1 small hive, pain/tenderness
Age: 20.0
Sex: F
Vaccine: FLUR4
Symptoms: Tenderness, Urticaria
Clinical narrative: Swollen, hot to the touch, redness, itch, 1 small hive, pain/tenderness
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Injection site pain
Clinical narrative: Extreme fatigue (slept for deeply for three hours). Weakness. Slight dizzyness. Very minor issues with breathing but can get a full, deep breath. Significant aching at injection site. Nothing severe, however, warranting emergency care.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza, Lethargy, Tremor
Clinical narrative: Extreme flu symptoms. Shaker, tempuraturek, lethargy
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw, Swelling face
Clinical narrative: Pain and swelling of jaw on the right side ( for lot number I used the number on the prescription receipt)
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Insomnia, Pyrexia
Clinical narrative: Shivering, fever, administration site pain, sleeplessness,
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: PATIENT CALLED ON 11/2/2020 TO REPORT THAT SHE HAS HAD CONTINUED ACHING IN LEFT ARM AND PAIN ON LIFTING IT SINCE 3 DAYS AFTER HER FLU VACCINATION ON 10/16/2020. SHE WAS ADVISED TO CONTACT HER PHYSICIAN AND HAVE AN ASSESSMENT DONE. SHE STATED SHE HAD AN UPCOMING APPT. IN A FEW DAYS AND WOULD LET US KNOW THE OUTCOME.
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 12/01/20: headache in evening after injection, resolved with 400 mg Advil; generally feeling ?icky? 12/02/20: headache upon waking, mild nausea, resolved with 400 mg Advil and light meal; headache returned in afternoon; headache persists into evening, nausea returns (too intense to eat), chills, generally feeling lousy and want to go to bed 12/01/20: arm hurts after injection, muscular soreness all day, hurts to sleep on left side 12/02/20: arm very sore at injection site, red, swollen
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Malaise, Myalgia, Nausea, Pain in extremity, Sleep disorder
Clinical narrative: 12/01/20: headache in evening after injection, resolved with 400 mg Advil; generally feeling ?icky? 12/02/20: headache upon waking, mild nausea, resolved with 400 mg Advil and light meal; headache returned in afternoon; headache persists into evening, nausea returns (too intense to eat), chills, generally feeling lousy and want to go to bed 12/01/20: arm hurts after injection, muscular soreness all day, hurts to sleep on left side 12/02/20: arm very sore at injection site, red, swollen
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Anal incontinence, Anti-aquaporin-4 antibody, Antibody test normal, Back pain, Blood thyroid stimulating hormone
Clinical narrative: 10/7/20, about 2 weeks after receiving IM seasonal flu and Shingrex vaccine she developed back pain, numbness in legs which progressed to paraplegia over the course of around 6 hours.  MRI showed GAD enhancing partial transverse myelitis.  Treated with IV corticosteroid and over the course of 2 months she has improved quite a bit, walking without use of gait aid but remains incontinent of bowel and bladder and has disabling neuropathic pain.   CSF analysis,  MRI of the brain and repeat MRI of the cord shows that she does not have multiple sclerosis.  She was negative for the MOG and AQP4 antibody in serum.    she is diagnosed with transverse myelitis and this is suspected to have been triggered in some way by the vaccination.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: CSF test normal, Hypoaesthesia, Magnetic resonance imaging abnormal, Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal
Clinical narrative: 10/7/20, about 2 weeks after receiving IM seasonal flu and Shingrex vaccine she developed back pain, numbness in legs which progressed to paraplegia over the course of around 6 hours.  MRI showed GAD enhancing partial transverse myelitis.  Treated with IV corticosteroid and over the course of 2 months she has improved quite a bit, walking without use of gait aid but remains incontinent of bowel and bladder and has disabling neuropathic pain.   CSF analysis,  MRI of the brain and repeat MRI of the cord shows that she does not have multiple sclerosis.  She was negative for the MOG and AQP4 antibody in serum.    she is diagnosed with transverse myelitis and this is suspected to have been triggered in some way by the vaccination.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Myelitis transverse, Neuralgia, Paraplegia, Urinary incontinence, Vitamin B12
Clinical narrative: 10/7/20, about 2 weeks after receiving IM seasonal flu and Shingrex vaccine she developed back pain, numbness in legs which progressed to paraplegia over the course of around 6 hours.  MRI showed GAD enhancing partial transverse myelitis.  Treated with IV corticosteroid and over the course of 2 months she has improved quite a bit, walking without use of gait aid but remains incontinent of bowel and bladder and has disabling neuropathic pain.   CSF analysis,  MRI of the brain and repeat MRI of the cord shows that she does not have multiple sclerosis.  She was negative for the MOG and AQP4 antibody in serum.    she is diagnosed with transverse myelitis and this is suspected to have been triggered in some way by the vaccination.
Age: 54.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient came to the pharmacy and had a large red area/rash on the arm the vaccines were given. The red area was about 1-2 inches by 3-4 inches. She reported it was itchy, hurting, and swollen. She stated that on the day of the vaccine and for 2 days after she was unable to move her arm due to swelling and pain but starting on the 4th day that symptom improved. She also reported having a fever and body aches for 3 days after receiving the immunizations.
Age: 54.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient came to the pharmacy and had a large red area/rash on the arm the vaccines were given. The red area was about 1-2 inches by 3-4 inches. She reported it was itchy, hurting, and swollen. She stated that on the day of the vaccine and for 2 days after she was unable to move her arm due to swelling and pain but starting on the 4th day that symptom improved. She also reported having a fever and body aches for 3 days after receiving the immunizations.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Headache
Clinical narrative: Pt reported headache and dizziness after vaccines were administered.  Pt was advised to sit down for 15 minutes.  Pts BP was taken  and pt was given a Pedialyte Popsicle .  After 15 minutes pt reported feeling better and BP was taken again.  Pt able to ambulate safely and without assistance. Nurse walked pt to Clinic front door to make sure pt was okay .
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever (100F)  Nausea,  Headache, Fatigue,  Body Aches
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Angiotensin converting enzyme, Anti-aquaporin-4 antibody negative, Antibody test positive, Antinuclear antibody negative, Blindness
Clinical narrative: R eye pain developing around 1-2 weeks after influenza vaccine. The eye pain evolved over the course of a few weeks to a small monocular visual field defect and then to severe monocular visual loss with color vision loss in addition to T2/FLAIR and GAD+ signal in  the right optic nerve on MRI consistent with optic neuritis.  Treated with high dose IV corticosteroid and has experienced nearly complete recovery.  CSF was normal but the MOG ab was found in serum.  she was diagnosed with MOG ab related optic neuritis.  This is considered to be possibly related to vaccinatoin.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: C-reactive protein normal, CSF test normal, Colour blindness, Eye pain, Magnetic resonance imaging abnormal
Clinical narrative: R eye pain developing around 1-2 weeks after influenza vaccine. The eye pain evolved over the course of a few weeks to a small monocular visual field defect and then to severe monocular visual loss with color vision loss in addition to T2/FLAIR and GAD+ signal in  the right optic nerve on MRI consistent with optic neuritis.  Treated with high dose IV corticosteroid and has experienced nearly complete recovery.  CSF was normal but the MOG ab was found in serum.  she was diagnosed with MOG ab related optic neuritis.  This is considered to be possibly related to vaccinatoin.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Magnetic resonance imaging brain, Magnetic resonance imaging spinal, Optic neuritis, Visual field defect
Clinical narrative: R eye pain developing around 1-2 weeks after influenza vaccine. The eye pain evolved over the course of a few weeks to a small monocular visual field defect and then to severe monocular visual loss with color vision loss in addition to T2/FLAIR and GAD+ signal in  the right optic nerve on MRI consistent with optic neuritis.  Treated with high dose IV corticosteroid and has experienced nearly complete recovery.  CSF was normal but the MOG ab was found in serum.  she was diagnosed with MOG ab related optic neuritis.  This is considered to be possibly related to vaccinatoin.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Generalised tonic-clonic seizure, Loss of consciousness
Clinical narrative: Pt had an episode of loss of consciousness and brief tonic clonic/seizure like activity
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza, Injection site rash, Injection site reaction, Rash erythematous
Clinical narrative: pt had flu symptoms for a few days and also developed a large, red, rash on the arm around site of injection
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever 100.7 and body aches and chills
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated, Palpitations
Clinical narrative: Patient reports waking at midnight 11/29/20 about 10 hours after the shot with racing heart (reports about 105 bpm) and says this triggered her pre-existing a-fib.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Inflammation, Skin warm, Swelling
Clinical narrative: Red swelling size of orange. Skin is raised and warm to the touch. Rapidly spreading to this size over 24 hours.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia, Urticaria
Clinical narrative: headache, body aches, slight fever, hives
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Shingrix 50MCG Inj(IM)SNGDSE VL10pk  Shot #1 received on 9/15/20, Shot #2 on 12/1/20 at 3:00pm, at 2:00am got a headache, took Tylenol and about 2:10 nausea and threw up several times, again at 7:00am threw up, headache lasted until about 8pm 12/2/20.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Infection, Peripheral swelling, Skin discolouration, Skin warm
Clinical narrative: Per patient: "right arm turned black and swelled from shoulder to wrist and was hot to touch. Noticed on day 8 after vaccine, went to hospital on day 11. Had to get antibiotics for infection"
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms including elevated temperature (99*) for 2 days.
Age: 54.0
Sex: F
Vaccine: FLUA4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Impaired work ability, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Vaccination Complaint On 1/3/2020, I was administered the flublok quad injection by Nurse Practitioner in my upper right arm. I immediately began to experience severe pain but thought the pain would subside after a couple of days but the pain continued to worsen. About 3 weeks later, I became extremely ill and ended up taking off work for a couple of days due to effects of the shot. All total, I continued to be ill for 3 weeks while the pain in my right arm continued to worsen. As-a-matter-of-fact, by April, the pain had become severely worse. I did not visit the emergency room because the Corona virus was running its course and I didn't want to visit a hospital, nor did I have a primary care physician at the time.  Consequently, I decided to return to the Pharmacy Clinic to speak with whomever was working, and to my surprise, NP happened to be the person with whom I spoke.  I explained to her that I was having severe pain in my arm that was radiating from the spot of the injection, and up and down my arm and to my hand and fingers, causing numbness in my right hand and fingers. Today, I'm still having this issue but it appears as my left arm has also started to feel the same way. NP prescribed two drugs 1) celecoxib 200 MSG 2) diclofenac and 3) orphenadrine.  I began taking the muscle relaxer once I had purchased the prescription, but the pain continues, and it appears as though the weather is making the pain worse as of today.  When I wake up in the mornings, the fingers in both my right hand are numb, and my entire are feels numb from time to time, especially in the upper part of my right arm and shoulder. Also, there are times when the fingers in my left hand are numb too.  NP also provided me with paperwork about how to file a vaccination complaint with the agency, which I had never heard of until I began to experience adverse issues with the flu vaccination.
Age: 54.0
Sex: F
Vaccine: FLUA4
Symptoms: Malaise, Pain, Pain in extremity, Sensitivity to weather change
Clinical narrative: Vaccination Complaint On 1/3/2020, I was administered the flublok quad injection by Nurse Practitioner in my upper right arm. I immediately began to experience severe pain but thought the pain would subside after a couple of days but the pain continued to worsen. About 3 weeks later, I became extremely ill and ended up taking off work for a couple of days due to effects of the shot. All total, I continued to be ill for 3 weeks while the pain in my right arm continued to worsen. As-a-matter-of-fact, by April, the pain had become severely worse. I did not visit the emergency room because the Corona virus was running its course and I didn't want to visit a hospital, nor did I have a primary care physician at the time.  Consequently, I decided to return to the Pharmacy Clinic to speak with whomever was working, and to my surprise, NP happened to be the person with whom I spoke.  I explained to her that I was having severe pain in my arm that was radiating from the spot of the injection, and up and down my arm and to my hand and fingers, causing numbness in my right hand and fingers. Today, I'm still having this issue but it appears as my left arm has also started to feel the same way. NP prescribed two drugs 1) celecoxib 200 MSG 2) diclofenac and 3) orphenadrine.  I began taking the muscle relaxer once I had purchased the prescription, but the pain continues, and it appears as though the weather is making the pain worse as of today.  When I wake up in the mornings, the fingers in both my right hand are numb, and my entire are feels numb from time to time, especially in the upper part of my right arm and shoulder. Also, there are times when the fingers in my left hand are numb too.  NP also provided me with paperwork about how to file a vaccination complaint with the agency, which I had never heard of until I began to experience adverse issues with the flu vaccination.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: & Arm Weakness, Neuropathy LIDOCAINE UNITS use 1 5 % patch to R chest at night for 12 hours, remove during the day ,GABAPENTIN 300 MG HS
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Dizziness & Nausea Vomiting
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: SkinRash Hydrocortisone 1 gm prn patient instructed to obtain otc, diphenhydramine 25 mg prn patient instructed to obtain otc
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash CETIRIZINE
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Lip swelling, Pruritus, Swollen tongue, Urticaria
Clinical narrative: around 5:30pm pt called answering service/on call and reported she started getting itchy & hives all over her body. Lips & tongue felt swollen. Pt felt itchy for 1 hr prior to hives appearing.  On call instructed pt to take 2 benadryl s/sx mostly resolved by AM
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia, Swelling face
Clinical narrative: & facial swelling, muscle pain
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea
Clinical narrative: Narrative: Symptoms: & Shortness of breath Treatment:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Confusional state, Hypotension, Loss of consciousness, Nausea
Clinical narrative: Patient left the pharmacy ambulating well and with full cognition. She went to her car and states that she became very nauseous and clammy. She called back into the store and told us what was going on. The pharmacist went to check on her and found her to be very confused and going in and out of consciousness. The pharmacist alerted a technician and 911 was called to evaluate. Upon their arrival they found the patient to be hypotensive (about 80/about60) and they took her to the ER for further evaluation. The patient was contacted the next day by the pharmacy staff and is well and has scheduled follow up appointments with her PCP to rule out any other underlying issue that might have cuased this.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Diarrhoea, Headache, Myalgia, Tachycardia
Clinical narrative: Headache, Myalgia, Angioedema, Diarrhea & Tachycardia
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Rash erythematous, Urticaria
Clinical narrative: rash with erythema and urticaria down medical aspect of (L) arm to the elbow, bruising at the site
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Oropharyngeal pain
Clinical narrative: & sore throat
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site infection
Clinical narrative: infection at injection site. was prescribed Bactrim DS 800-160mg and cephalexin 250mg.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Discomfort at injection site. Red and swollen at site. Warm to touch at site. Monitoring redness and tracking for worsening s/s. NP started on Bactrim for cellulitis.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Anaphylactic reaction, Dizziness, Electrocardiogram, Hypertension
Clinical narrative: Narrative:  Per note dated 5/8/20: -Anaphylactic protocol immediately initiated. EpiPen administered, 50 mg Benadryl IV, 20 mg famotidine IV, Solu-Medrol 125 mg IM stat issued. 500 mL normal saline started. EKG obtained which demonstrated normal sinus rhythm. Within 5 minutes of medications administration, patient states all symptoms are resolved however now complaining of some diffuse abdominal cramping and some nausea. Zofran 4 mg by mouth administered, CBC, CMP, UA and culture, hCG test ordered Symptoms:  Dizziness, SkinRash, Rash, UrticariaPruritus, NauseaVomiting, HYPERtension & Tachycardia Treatment:
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Nausea, Pruritus, Rash, Tachycardia
Clinical narrative: Narrative:  Per note dated 5/8/20: -Anaphylactic protocol immediately initiated. EpiPen administered, 50 mg Benadryl IV, 20 mg famotidine IV, Solu-Medrol 125 mg IM stat issued. 500 mL normal saline started. EKG obtained which demonstrated normal sinus rhythm. Within 5 minutes of medications administration, patient states all symptoms are resolved however now complaining of some diffuse abdominal cramping and some nausea. Zofran 4 mg by mouth administered, CBC, CMP, UA and culture, hCG test ordered Symptoms:  Dizziness, SkinRash, Rash, UrticariaPruritus, NauseaVomiting, HYPERtension & Tachycardia Treatment:
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria, Vomiting
Clinical narrative: Narrative:  Per note dated 5/8/20: -Anaphylactic protocol immediately initiated. EpiPen administered, 50 mg Benadryl IV, 20 mg famotidine IV, Solu-Medrol 125 mg IM stat issued. 500 mL normal saline started. EKG obtained which demonstrated normal sinus rhythm. Within 5 minutes of medications administration, patient states all symptoms are resolved however now complaining of some diffuse abdominal cramping and some nausea. Zofran 4 mg by mouth administered, CBC, CMP, UA and culture, hCG test ordered Symptoms:  Dizziness, SkinRash, Rash, UrticariaPruritus, NauseaVomiting, HYPERtension & Tachycardia Treatment:
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Pruritus
Clinical narrative: Diarrhea & pruritus
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Headache, Nausea, Vomiting
Clinical narrative: Headache, NauseaVomiting & labored breathing, chills
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Oedema, Rash
Clinical narrative: SkinRash & EDEMA
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: & injection site pain
Age: 71.0
Sex: M
Vaccine: HEPAB
Symptoms: Flushing, Hepatitis A antibody negative, Hepatitis B antibody negative, Pruritus, Rash
Clinical narrative: Nattative:  Patient received Twinrix (hepatitis A/B combination) vaccine on 10/4/2019. Two weeks later on 10/18/2019, patient was seen again by same provider and clinic with skin eruption on his lower abdomen and back for 1.5 days. He started to feel itchy while riding his motorcycle, and then started to notice hives to the areas mentioned above. He did not have any signs or symptoms of angioedema (tongue swelling, throat closure, respiratory difficulties), but also felt his face was flushed and the hives were noted on the 10/18/2019 face-to-face visit. Symptoms:  UrticariaPruritus & Skin erruption and flushing Treatment:  METHYLPREDNISOLONE 4 MG Other Take as directed on package instructions ,CALCIPOTRIENE 0.005% BID Apply to affected area on skin
Age: 71.0
Sex: M
Vaccine: HEPAB
Symptoms: Urticaria
Clinical narrative: Nattative:  Patient received Twinrix (hepatitis A/B combination) vaccine on 10/4/2019. Two weeks later on 10/18/2019, patient was seen again by same provider and clinic with skin eruption on his lower abdomen and back for 1.5 days. He started to feel itchy while riding his motorcycle, and then started to notice hives to the areas mentioned above. He did not have any signs or symptoms of angioedema (tongue swelling, throat closure, respiratory difficulties), but also felt his face was flushed and the hives were noted on the 10/18/2019 face-to-face visit. Symptoms:  UrticariaPruritus & Skin erruption and flushing Treatment:  METHYLPREDNISOLONE 4 MG Other Take as directed on package instructions ,CALCIPOTRIENE 0.005% BID Apply to affected area on skin
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria, Wheezing
Clinical narrative: Hives broke out around entire abdomen + upper thighs. No trouble breathing but Patient did state they "Felt slight wheeze" earlier. Took Benadryl 50 mg + is better
Age: 75.0
Sex: M
Vaccine: VARCEL
Symptoms: Myalgia
Clinical narrative: Narrative:  Symptoms:  Myalgia Treatment:
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Arteriogram carotid normal, Cardiac stress test abnormal, Computerised tomogram head normal, Dizziness, Epigastric discomfort
Clinical narrative: Patient reports that 2 hours after he received the Shingrix vaccination clinic he developed epigastric discomfort and felt dizzy as if he would faint. He then vomited and seemed to feel better. Because of the symptoms he presented to on Hospital emergency room and there was admitted for evaluation of syncope. Patient recalls that he underwent a CT scan of the brain which was okay, carotid duplex ultrasound studies which he reports was okay, was seen by Cardiologist and underwent a nuclear cardiac stress test which was abnormal. Under the direction of provider the patient was started on the above medications as indicated. He has been scheduled for a cardiac catheterization by provider for January 10, 2019 due to the abnormal findings on the nuclear cardiac stress test suspicious for angiographically significant coronary artery disease. Currently feels okay. Symptoms:  Dizziness, Headache & NauseaVomiting Treatment:  Metoprolol 12.5 mg BID ,Aspirin 81 mg every day ,Atorvastatin 20 mg every day
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient reports that 2 hours after he received the Shingrix vaccination clinic he developed epigastric discomfort and felt dizzy as if he would faint. He then vomited and seemed to feel better. Because of the symptoms he presented to on Hospital emergency room and there was admitted for evaluation of syncope. Patient recalls that he underwent a CT scan of the brain which was okay, carotid duplex ultrasound studies which he reports was okay, was seen by Cardiologist and underwent a nuclear cardiac stress test which was abnormal. Under the direction of provider the patient was started on the above medications as indicated. He has been scheduled for a cardiac catheterization by provider for January 10, 2019 due to the abnormal findings on the nuclear cardiac stress test suspicious for angiographically significant coronary artery disease. Currently feels okay. Symptoms:  Dizziness, Headache & NauseaVomiting Treatment:  Metoprolol 12.5 mg BID ,Aspirin 81 mg every day ,Atorvastatin 20 mg every day
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Skin discolouration
Clinical narrative: & Skin discoloration
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Narrative: Symptoms: SkinRash & RASH Treatment: HYDROXYZINE 50 MG TID
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Narrative: Symptoms:  & INJ SITE SWOLLEN RED , HOT TO ELBOW Treatment:  METHYLPREDNISOLONE DOSPAK MG Unknown
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Narrative: Symptoms:  SkinRash Treatment:
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Formication
Clinical narrative: Pt. reports after receiving vaccine, it felt like something was crawling on his arm and neck
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Palpitations
Clinical narrative: Narrative: Symptoms:  Palpitations Treatment:
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: SkinRash
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Narrative:  Pt did not require any treatment. This event was reported when pt received Zostavax, pt refused shingrix. Symptoms:  SkinRash & RASH Treatment:
Age: 30.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema
Clinical narrative: & skin redness
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Syncope, Wheezing
Clinical narrative: CoughWheeze & Syncope
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Narrative: generalized erythema of upper arm same day; improving after 24 hours; serum reaction. Symptoms: ErythemaMultiform Treatment:
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Oedema, Rash
Clinical narrative: SkinRash, Rash & EDEMA; RASH TRIAMCINOLONE 40 MG ONCE
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Narrative: Symptoms: & Swelling and pain Treatment:
Age: 79.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia
Clinical narrative: Caller got Tetnas injection on 5/26/2020 in the right upper arm. Days later patient began having pain in right arm and vibration of pain down into the thumb.  Mostly at night and if the arm is moved into a certain bent position patient is having tingling and  numbness.
Age: 79.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Injection site pain, Pain, Paraesthesia
Clinical narrative: Caller got Tetnas injection on 5/26/2020 in the right upper arm. Days later patient began having pain in right arm and vibration of pain down into the thumb.  Mostly at night and if the arm is moved into a certain bent position patient is having tingling and  numbness.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: product storage error; This spontaneous report was received from the administrator from the doctor's office referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.       On 20-OCT-2020 the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot # S027467, expiration date 02-MAR-2021, for prophylaxis(dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).         The vaccine was stored in a temperature of 17.2 degree Fahrenheit (°F) for 1 hour and 30 minutes as recorded by a data logger. There was a previous temperature excursion of 12.2F for 1 hour.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Adverse reaction or side effect: N/A; PNEUMOVAX administered on 24-APR-2011, 30-NOV-2015 and 01-DEC-2016; This spontaneous report was received from a lawyer and refers to a 69 year old male patient. The patient's concurrent conditions, concomitant medications and drug allergies/reactions were not reported. The patient had a history of shingles while on prior therapy with zoster live vaccine (ZOSTAVAX) (case #1905USA010000 which was part of a litigation process) and product use for unapproved indication while on therapy with alendronate sodium (FOSAMAX) (case #2012USA000182)  On 26-APR-2011, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported. The patient also received additional doses of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) on 30-NOV-2015 and 01-DEC-2016 (inappropriate schedule of product administration).  The patient did not experience adverse reaction or side effects with the vaccine.; Sender's Comments:  US-009507513-1905USA010000: US-009507513-2012USA000182: