chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered a Flublok vaccine to a 9 year-old child with no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist on 12-Oct-2020.  This case involved a 9-year-old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2049, Expiration date- 30-Jun-2021) via intramuscular route in the left arm (Product administered to patient of inappropriate age) for prophylactic vaccination on 10-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.   No other vaccines were given.  This was a case of actual medication error due to Inappropriate age at vaccine administration (Latency: Same day).  At the time of reporting 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: 29.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt c/o left arm swelling and warmth distal to injection site.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Injection site erythema, Injection site warmth, Pain
Clinical narrative: The patient reported shortness of breath, coughing, malaise, body aches and fever. The injection site was warm and red. Symptoms occurred roughly 4 or 5 hours after the administration. Symptoms still present about 18 hours later but had markedly improved.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: The patient reported shortness of breath, coughing, malaise, body aches and fever. The injection site was warm and red. Symptoms occurred roughly 4 or 5 hours after the administration. Symptoms still present about 18 hours later but had markedly improved.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: swollen arm below injection site that is red and painful.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Diplopia, Headache, Migraine, Nausea, Neck pain
Clinical narrative: Every year I get migraine headaches, including double vison, neck pain, head pain 10/10, nausea, and pain for 3 days currently.  I get the pediatric dose  every year
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Every year I get migraine headaches, including double vison, neck pain, head pain 10/10, nausea, and pain for 3 days currently.  I get the pediatric dose  every year
Age: 66.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient came into office on 10/29 c/o pain, redness, warm to the touch and hard feeling near injection site in her left arm. On the day she was given the Prevnar 13 vaccine she had some pain and noticed hardness near injection site. On or around 10/27 she noticed redness spreading throughout the front of her upper left arm, still having pain, hardness and now warm to the touch. In office she was diagnosed with cellulitis related to adverse reaction to vaccine for which she was prescribed Keflex 500 mg and will take 1 capsule every 6 hours for 5 days and then follow up with us again in 2 weeks.
Age: 66.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Skin warm, Vaccination complication
Clinical narrative: Patient came into office on 10/29 c/o pain, redness, warm to the touch and hard feeling near injection site in her left arm. On the day she was given the Prevnar 13 vaccine she had some pain and noticed hardness near injection site. On or around 10/27 she noticed redness spreading throughout the front of her upper left arm, still having pain, hardness and now warm to the touch. In office she was diagnosed with cellulitis related to adverse reaction to vaccine for which she was prescribed Keflex 500 mg and will take 1 capsule every 6 hours for 5 days and then follow up with us again in 2 weeks.
Age: 38.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injected limb mobility decreased, Injection site haemorrhage, Injection site pain, Injection site reaction, Loss of personal independence in daily activities
Clinical narrative: Got flu shot in left deltoid and Gardasil 9 in right deltoid on Tuesday (10/20).  Gardisil stung on injection with some bleeding, but stinging was present in both of other 2 injections in series and they then had essentially no ongoing pain. Both shoulders still a little sore (right greater than left) Friday (10/23) but was able to do a LIGHT 20 min rowing workout. Left arm essentially pain free by saturday 10/24. In right arm on Saturday there was significant pain (worse than previous day) and stiffness in right shoulder.  limited mobility. Difficulty with ADLs (unable to lift arm to brush hair or take on/off shirts overhead without help, difficulty opening drawers/doors with right arm) due to pain. Somewhat responsive to NSAIDS. Pain has gradually lessened by today (day of reporting, 10/30, 10 days post vaccine) but still painful and stiff in mornings and can still illicit 8/10 pain in Right shoulder with certain motions, especially when extended overhead and can barely get shirts on/off. Have not rowed or exercised or anything that could inflame shoulder since 10/23.
Age: 38.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Got flu shot in left deltoid and Gardasil 9 in right deltoid on Tuesday (10/20).  Gardisil stung on injection with some bleeding, but stinging was present in both of other 2 injections in series and they then had essentially no ongoing pain. Both shoulders still a little sore (right greater than left) Friday (10/23) but was able to do a LIGHT 20 min rowing workout. Left arm essentially pain free by saturday 10/24. In right arm on Saturday there was significant pain (worse than previous day) and stiffness in right shoulder.  limited mobility. Difficulty with ADLs (unable to lift arm to brush hair or take on/off shirts overhead without help, difficulty opening drawers/doors with right arm) due to pain. Somewhat responsive to NSAIDS. Pain has gradually lessened by today (day of reporting, 10/30, 10 days post vaccine) but still painful and stiff in mornings and can still illicit 8/10 pain in Right shoulder with certain motions, especially when extended overhead and can barely get shirts on/off. Have not rowed or exercised or anything that could inflame shoulder since 10/23.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Paraesthesia, Sleep disorder
Clinical narrative: Patient describes soreness in shoulder down into elbow with some some slight tingling in forearm/hand later that day.  the soreness did worsen at night and had trouble sleeping.  The pain didn't worsen but has not lessened either.  after a few days she went to her primary care physician who thought it may be a site injection issue and referred her to an orthopedic doctor to rule out a nerve issue.  She contacted us the following Wednesday (1 week) after the vaccine administration to let us know of the issue.  I reached her on Thursday  to get the information to complete this report.  She was to see the orthopedic doctor on 10/30/2020
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: intense pain, redness, and swelling at injection site within hours of administration
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Feeling hot, Pain
Clinical narrative: Low grade temp (99.3), chills, sensation of feeling "hot" and achiness
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Pt received Influenza vaccine on 10/28/2020. Noticed urticaria & swelling at site. No fever. RX: Benadryl + Clindamycin.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Gait disturbance, Joint swelling
Clinical narrative: Started the day after receiving flu vaccine. Swelling in Right knee. Pain also in the effected knee.  By late evening very painful and walking difficulty. Notified Hospital Employee health nurse on 10/09/2020 and received this form to complete.  Knee swelling and pain was better in the morning two days after vaccine.  Third day was back to normal.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Blood pressure increased, Syncope
Clinical narrative: Shortly after receiving 2 vaccines in (L) arm - he walked out of room on his own & suddenly collapsed on to the wall in the hallway. I rushed to assist when I heard the bang on the wall & found him sitting in an awkward position - unaware of his surroundings. I laid him down on the floor & elevated his lower extremities. He slowly recuperated & became oriented to place/person/time. He stated he felt better & understood that he fainted & stated that it happen to him when he gets blood drawn. The nurse & I lifted him when he felt he could walk, sat on a chair & kept monitoring him for another 10-15 minutes. We took his blood pressure, which was slightly elevated (135/65) & gave instructions to him & his mother for him to rest, drink fluids, eat & not drive today. They were understanding of the instructions and proceeded to leave the office. I called the house @ 4:15PM to ask for a F-U report, got An Answering machine & LMTCB. 10/30/20 10:30 AM ADDENDUM: I reached out to Mom again & she returned call informing that Patient was back to normal - yesterday.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Migraine, Pain in extremity
Clinical narrative: (R) arm pain, Migraine and chills with pneumovax23
Age: 63.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Back pain, Decreased appetite, Dyspnoea, Eye swelling, Headache
Clinical narrative: 10/28/20 Patient called clinic & said 3 - 4 HRS after injections he developed decreased back pain, shortness of breath (increased) fever, loss of appetite, nausea, eyes swelled a little, headache. Took double dose of nebulizer treatment. 10/24 - 0300 pt said felt better.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: 10/28/20 Patient called clinic & said 3 - 4 HRS after injections he developed decreased back pain, shortness of breath (increased) fever, loss of appetite, nausea, eyes swelled a little, headache. Took double dose of nebulizer treatment. 10/24 - 0300 pt said felt better.
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: The patient was diagnosed with postherpetic neuralgia; Patient developed bronchitis; Suffered a painful and debilitating shingles outbreak across her face, in her ears, and around her eyes; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 17-OCT-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a painful and debilitating shingles outbreak across her face, in her ears, and around her eyes. These injuries persisted for weeks and the pt was diagnosed with postherpetic neuralgia. Additionally, the pt developed bronchitis. It was also specified that the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were caused by zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling due to serious, permanent and incurable injuries.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Loss of personal independence in daily activities, Nausea
Clinical narrative: injection site very tender; severely incapacitated; headache; body and headaches; chills; nausea; This case was reported by a physician and described the occurrence of injection site tenderness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea. On an unknown date, the outcome of the injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. After the 1st dose of Shingrix, the patient was severely incapacitated with body and headaches, chills, nausea for at least 24 hours. The injection site was also very tender. The patient considered it as an awful experience. For tolerance of 2nd dose of Shingrix, refer case US2020AMR215176.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215176:same patient, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: injection site very tender; severely incapacitated; headache; body and headaches; chills; nausea; This case was reported by a physician and described the occurrence of injection site tenderness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea. On an unknown date, the outcome of the injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. After the 1st dose of Shingrix, the patient was severely incapacitated with body and headaches, chills, nausea for at least 24 hours. The injection site was also very tender. The patient considered it as an awful experience. For tolerance of 2nd dose of Shingrix, refer case US2020AMR215176.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215176:same patient, 2nd dose
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: developed a task on her arm and torso / rash resolved on its own; This case was reported by a nurse via sales rep and described the occurrence of rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix. On 30th August 2020, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix  and developed a task on her arm and torso 3 days later. The patient did not report it or self medicate. The rash resolved on its own after 2 days.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Limb discomfort, Neuralgia, Ophthalmic herpes zoster
Clinical narrative: Residual nerve pain; Probably had some discomfort of the (injected) arm; Not gone to get Shingrix shot number 2; Shingles on her head, eye; Terrible case of shingles on her head, eye, temple, scalp area; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 29th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In May 2019, 8 weeks after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced nerve pain, arm discomfort and incomplete course of vaccination. On an unknown date, the outcome of the ophthalmic herpes zoster and nerve pain were not recovered/not resolved and the outcome of the shingles was resolved with sequelae and the outcome of the arm discomfort was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles, nerve pain and arm discomfort to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. The patient received vaccine in left deltoid. She did not know if it was given intramuscularly because she did not look at the size of the needle. She did not have the lot number/expiry date but did provide the name and contact information of the pharmacy who administered it. She stated that she did not remember having any side effects after receiving the shot but she said she probably had some discomfort of the (injected) arm. Eight weeks after having the shot she developed a terrible case of shingles on her head, eye, temple, scalp area. The patient was not fully recovered because she still had residual nerve pain on the left side of her head. The patient did not went get Shingrix shot number 2 and she had past the 6 month window, which led to incomplete course of vaccination. She stated that her primary care physician wants her to get the Shingrix shot number 2. She spoken with a pharmacy and they told her that she would have to re-start the series but the patient did not want to restart the series. The reporter consented to follow up. This was a medication error with harm.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster cutaneous disseminated, Rash, Rash vesicular
Clinical narrative: Patient presents with a rash which first appeared two days after receiving the Shringrix vaccine. It is gradually getting worse. There are islands of erythema with clear and opaque vesicles embedded. The rash is tender but not painful. The distribution is on the left jaw, left lateral neck and left posterior neck (V3 and C2 dermatomes). No exposures could be elicited which would indicate a delayed hypersensitivity reaction such as poison oak.  Viral culture sent and patient started on valacyclovir for 7 days. Shingrix is an inactivated vaccine so I searched high and low for another cause for his cutaneous vesicular rash but non could be identified. I came to the conclusion that somehow the patient got shingles from Shingrix. If the viral culture comes back positive, I plan to request a consultation with concern that the batch of vaccines may not be completely inactive.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness, Viral test
Clinical narrative: Patient presents with a rash which first appeared two days after receiving the Shringrix vaccine. It is gradually getting worse. There are islands of erythema with clear and opaque vesicles embedded. The rash is tender but not painful. The distribution is on the left jaw, left lateral neck and left posterior neck (V3 and C2 dermatomes). No exposures could be elicited which would indicate a delayed hypersensitivity reaction such as poison oak.  Viral culture sent and patient started on valacyclovir for 7 days. Shingrix is an inactivated vaccine so I searched high and low for another cause for his cutaneous vesicular rash but non could be identified. I came to the conclusion that somehow the patient got shingles from Shingrix. If the viral culture comes back positive, I plan to request a consultation with concern that the batch of vaccines may not be completely inactive.
Age: 45.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site paraesthesia, Injection site pruritus, Injection site rash, Rash
Clinical narrative: Patient c/o of a reaction post MMR vaccination that was administered on 10/9/2020.  Reports an itchy/tingling rash at the injection site that started on 10/13.  States that the rash began to spread over her generalized body over the following days.  Denies drainage.  Denies pain.  Denies shortness of breath, chest pain, wheezing, or a fever.  Has not taken any OTC medication for the symptom relief.  States that no other household members have similar symptoms.  Denies the use of any new body products.    Reports a normal appetite and activity.  No other complaints at this time.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site, Tenderness
Clinical narrative: Intern injected too high into the shoulder area leaving the arm extremely sore, tender to touch, and difficult to move without experiencing pain
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site rash, Injection site warmth
Clinical narrative: Patient called today and stated she had rash, heat, and discomfort at site and around site of injection.  She will monitor it.  If it continues and does not resolve, she will follow up with prescriber.  She may use benadryl and an ice pack to decrease swelling and discomfort.
Age: 36.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Headache, Injection site erythema, Skin warm
Clinical narrative: Headache, generalized fatigue, area of redness at injection site, warm to the touch - states started evening of injection  States remembers having similar reaction as a child but can't remember what the injection was.  After discussing with her mother it was discovered it was after DTP injection and arm redness was more sever than current reaction.  Referred employee to Prevnar 13 VIS that was given at time of injection regarding contraindication with Prevnar 13 and diptheria toxoid.  Employee states has not had any issues with Td booster since childhood reaction.  Employee offered appointment with occupational health physician or PCP declined stating if arm redness became worse over the weekend she would make an appointment.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pain, increased warmth, redness,itching around injection site about 24 hours after receiving the vaccine.
Age: 60.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Injection site swelling
Clinical narrative: Left arm was swollen at injection site after receiving vaccination
Age: 60.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: Left arm was swollen at injection site after receiving vaccination
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Rash
Clinical narrative: PATIENT HAS RASH ALL OVER ARMS, CHEST, ABD AND BACK. HAD BODY ACHES AND FATIGUE AS WELL.
Age: 17.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Anal incontinence, Aphasia, Drooling, Fall, Seizure
Clinical narrative: Stepmother and father report that on Sunday morning 10-25-20, patient was fixing  a sandwich in kitchen. They heard him say aloud oh no, no, no and he walked to front door. They heard him fall to the floor. They found him convulsing and shaking. He was drooling and could not speak. He did defecate. They said he had steady shaking for approximately 6-8 minutes. He vomited afterwards. Report that it was about 30 minutes before he "came to".   They did not take him to the ER this time nor call an ambulance. (Report that when he had seizure 2 years ago they took him to ER, in May 2020 they called an ambulance.) They called hospital  Monday morning 10/26/20 to give report of seizure. He had an appointment with his physician afternoon of 10/26/20. Dr. is referring him to a neurologist. Parents are awaiting an appointment from the referral. He has had  no further seizure activity and no injuries from the seizure.
Age: 17.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Tremor, Vomiting
Clinical narrative: Stepmother and father report that on Sunday morning 10-25-20, patient was fixing  a sandwich in kitchen. They heard him say aloud oh no, no, no and he walked to front door. They heard him fall to the floor. They found him convulsing and shaking. He was drooling and could not speak. He did defecate. They said he had steady shaking for approximately 6-8 minutes. He vomited afterwards. Report that it was about 30 minutes before he "came to".   They did not take him to the ER this time nor call an ambulance. (Report that when he had seizure 2 years ago they took him to ER, in May 2020 they called an ambulance.) They called hospital  Monday morning 10/26/20 to give report of seizure. He had an appointment with his physician afternoon of 10/26/20. Dr. is referring him to a neurologist. Parents are awaiting an appointment from the referral. He has had  no further seizure activity and no injuries from the seizure.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever of 101.4 for 48 hours, chills, muscle aches, headache, nausea. Stayed in bed for 3 days
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: fever - shivered all night; ached all over, headache, dizziness the next morning. Lasting 2.5 days
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Nausea, Pain, Vomiting
Clinical narrative: Patient state that she alway experiences symptoms after receiving shots.  Chief compliant was headache, chills with body aches and nausea and vomiting.  These symptoms were still occurring on day 2 when I interviewed the patient.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Magnetic resonance imaging, Movement disorder, Product administered at inappropriate site
Clinical narrative: Pt reported that vaccine was given too high. He experienced severe shoulder pain and soreness for several days afterwards before seeking medical advise. He stated that he was not able to move his arm very well. His provider thought that it maybe had been injected into the cartilage and it was causing his increased soreness and shoulder pain. MRI was taken. He stated he is undergoing physical therapy to regain the use of his shoulder/arm and recently was prescribed a steroid and NSAID to help with this injury.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: patient's left arm was extremely swollen, sore, red and hot to the touch, and she was sick in bed the evening she got her shots.  She went to the doctor and was given a steroid shot and put on oral steroids
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Ear swelling, Fatigue
Clinical narrative: Patient said that his ear swelled the day after he received the flu shot.  He also said he feels run down/ tired since the flu shot.  Swelling is still there per patient.  Patient is contacting us a few days later. I referred him to his PCP.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Myalgia, Vomiting
Clinical narrative: Headache, vomiting, diarrhea, muscle aches ,
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Next day patient reports redness, warmth and swelling extending 5in x 5in below injection site. No fever or pain. MD assessed on 10/30/2020, no infection diagnosed.
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site swelling, Rash
Clinical narrative: PATIENT DESCRIBED A RASH ON THE WHOLE LEFT SIDE OF THE BODY AND SWEELING (ROUGHLY THE SIZE OF AN EGG) AROUND 3 INCHES BELOW THE INJECTION SITE)
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: I don't know
Age: 1.25
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV
Symptoms: Wrong product administered
Clinical narrative: I GAVE THE WRONG DTAP - I GAVE KINRIX WHEN HE NEEDED PEDIARIX
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Erythema of eyelid, Eye pain, Eye swelling
Clinical narrative: Later in the day after the vaccine was administered, the patient began having an aching in all joints that continued into the next day. On the third day, she woke up to swelling and redness in her right cheek that began to move upward into her eye and eyelid. The skin was warm to the touch and the right cheekbone and inner eye orbital was very painful to the touch. The next day the right eye was swollen completely shut and there was eye pain. It has begun to move into the left eye at this point.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Ocular hyperaemia, Skin warm, Swelling face, Swelling of eyelid, Tenderness
Clinical narrative: Later in the day after the vaccine was administered, the patient began having an aching in all joints that continued into the next day. On the third day, she woke up to swelling and redness in her right cheek that began to move upward into her eye and eyelid. The skin was warm to the touch and the right cheekbone and inner eye orbital was very painful to the touch. The next day the right eye was swollen completely shut and there was eye pain. It has begun to move into the left eye at this point.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain in extremity, Pruritus, Tenderness, Urticaria
Clinical narrative: On R arm: Hives, itching, tenderness and pain all the way to wrist Systemic: fatigue, low grade fever, soreness at injection site Ongoing
Age: 29.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Vision blurred
Clinical narrative: Patient has a history of fainting with vaccinations or needles at her doctors office.  Patient let us know of this ahead of time, and also that this was her first time receiving the flu shot to her knowledge.  Immediately after receiving the vaccination, patient stated she felt light-headed and like she was going to faint, so we advised her to remain seated and elevated her legs.  She then stated she began to feel that her vision was becoming blurred, at which point we had called 911 to assess her.  Paramedics arrived and assessed the patient, she began feeling a bit nauseous as well, her BP was 85/50, however they checked her online medical record on her phone and noticed her BP is normally quite "low".  They felt she was improving and advised her she did not need further medical treatment/supervision.
Age: 11.0
Sex: M
Vaccine: FLUC4, MNQ
Symptoms: Induration, Urticaria
Clinical narrative: right arm with 5 in induration within 12 hours of vaccine (menveo) left arm with 1.5 in induration within 12 hours of vaccine (influenza) patient also noted to have intermittent hives since immunization
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Patient complained of soreness/tenderness in arm that lasted for 6 days. No pain at time of injection.
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient had severe pain in left arm that would throb throughout the day and she had difficulty raising her arm over her head. She went to her PCP to assess and they couldn't find anything wrong in the area. Pain resolved over time (gone after 7 days) and is no longer present.
Age: 24.0
Sex: M
Vaccine: ANTH, FLU4, JEV1
Symptoms: Cardiac monitoring, Dyspnoea, Peripheral coldness
Clinical narrative: Pt presented with SOB and complaints to coldness to his Left arm. Epi was administered and pt was transferred to the ER for observation.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Swelling and redness/warmth at site and fever greater than 101 the day after the injection.  No difficulty breathing or hives.  Pt was seen in clinic on 10/24/20 and advised to return to clinic prn and reach out to patient's transplant team and let them know of the reaction.
Age: 87.0
Sex: F
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Patient called the pharmacy asking about side effects regarding the flu vaccine she recieved a month ago. She says for the last month her injection arm has been sore, she's having difficulty lifting it up, and has diffiiculty doing normal daily tasks. Pharmacist spoke with her and informed the patient it could be an administration technique error where the vaccine is given either too high or too low. Pharmacist explained an event like this isn't normal and thanked her for calling. Patient is thinking about contacting her doctor.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Fall, Unresponsive to stimuli
Clinical narrative: Heard code blue and patient was found going from sitting position attempting to get into chair, per front desk patient fell. Was found responsive at time of code who reports child fell. He was then assisted back down to a lying position and legs were then elevated. BP 122/74-78. No acute respiratory distress, no dizziness or HA. Alert and denies having had a meal for day. Was monitored for 10 additional minutes and felt better. Before discharge BP 118/70-82  O2 sat 99%, respirations even unlabored .
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymphangitis, Malaise
Clinical narrative: After you having the vaccine, she experienced soreness which continued to redden, swell and get very hot to the touch and was feeling sick and went to bed early.  The swelling was moving down her arm. She called the pharmacy, and was instructed to take Benadryl every 4 to 6 hours. The swelling went down to about 4 inches from her wrist and had two red lines coming from under her arm. On Monday, called the doctor's office and saw with the P.A. which diagnosed her with lymphangitis.  was given doxycycline by the P.A.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: After you having the vaccine, she experienced soreness which continued to redden, swell and get very hot to the touch and was feeling sick and went to bed early.  The swelling was moving down her arm. She called the pharmacy, and was instructed to take Benadryl every 4 to 6 hours. The swelling went down to about 4 inches from her wrist and had two red lines coming from under her arm. On Monday, called the doctor's office and saw with the P.A. which diagnosed her with lymphangitis.  was given doxycycline by the P.A.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Sleep disorder
Clinical narrative: the evening of the immunization the patient experienced chills, nausea, severe aching all over and she couldn't sleep. she did not have that rxn with the 1st dose.
Age: 75.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Headache, Herpes zoster, Pain
Clinical narrative: Patient exp body aches and headaches next day after the Shingles vaccination which lasted 1 week and a half. As a result of the vaccination patient got Shingles.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Rash, Skin warm
Clinical narrative: Pt presented with a rash on her left arm on 10/30/20 at the pharmacy. Rash was hot to the touch and hurt. I advised the patient to try diphenhydramine OTC to rule out an allergic reaction. 4 hours later I called the pt and her arm was still sore and the rash had not improved after taking diphenhydramine. I advised her to follow up with her dr and they prescribed doxycycline.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Fatigue, Impaired work ability, Pain, SARS-CoV-2 test negative
Clinical narrative: Approximately 16 hours after receiving vaccine, started feeling very tired and achy. Symptoms increased over the next two hours.  Went home from work after lunch (1:30 p.m.) and took temperature, which was 101.  Called PCP who advised monitoring symptoms and, if fever still present next day, call them back. Fever resolved by next morning and tiredness and aches gradually resolved over next 24 hours.  By Saturday late morning (10/24/20), all symptoms resolved.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: rash on the right upper arm adjacent to the site of vaccination
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Erythema, Induration, Injected limb mobility decreased, Injection site erythema, Injection site induration
Clinical narrative: Patient received vaccines on 10/28/2020. She received both meningitis vaccines in the same arm (L). Patient states arm was sore post administration, and the pain lasted throughout the day. The next day, L arm was red, swollen, hard, and hot to touch. Patient states it hurts to lift arm.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Peripheral swelling, Skin warm
Clinical narrative: Patient received vaccines on 10/28/2020. She received both meningitis vaccines in the same arm (L). Patient states arm was sore post administration, and the pain lasted throughout the day. The next day, L arm was red, swollen, hard, and hot to touch. Patient states it hurts to lift arm.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site urticaria, Pruritus, Swelling
Clinical narrative: Per patient- her arm is swollen, red, itchy and looks likes hives an inch below the injection site.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Fever, chills, tiredness, soreness at the injection site
Age: 78.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling on bicep area that continued for 2 days post injection.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODE IN PATIENT'S RIGHT ARM
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Lip swelling, Lymphadenopathy, Swelling face
Clinical narrative: SWOLLEN LYMPH NODE IN PATIENT'S RIGHT ARM
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient reports she has had pain in the left arm around the injection site since the day after she received the vaccine.  We are now one month post-vaccination, so this is an unexpected adverse event.  She reports that the pain sometimes radiates down her arm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient received Pnuemovax-23 around 6:45pm at pharmacy - she called pharmacy in morning saying that her arm was very swollen and red on the inside of her elbow.  I talked to her and asked if this was near the injection site and she said that it was further down and on the inside of her arm.  Later in the day we got a prescription for antibiotic from her PCP.  Her husband (a healthcare provider) came in and said that the antibiotic was precautionary in case it continued to spread and/or infection occurred.   Currently treating with hot/cold and benadryl.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Blood urine present, Dysmenorrhoea, Full blood count, Pain, Pregnancy test
Clinical narrative: patient felt fine immediately after shot, she fainted about 8 or 9 pm that evening.  She then felt body aches especially in her arms and legs from then and for 24 hours after.  She felt crampy due to oncoming menses so she took 400 mg ibuprofen,.  She took 400 mg more 2 hours later.  This second dose made her feel better.  The next morning  she felt a bit groggy but when she got up she felt fine and has not taken medications since.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Somnolence, Syncope, Thyroid function test, Urinary tract infection, Urine analysis abnormal
Clinical narrative: patient felt fine immediately after shot, she fainted about 8 or 9 pm that evening.  She then felt body aches especially in her arms and legs from then and for 24 hours after.  She felt crampy due to oncoming menses so she took 400 mg ibuprofen,.  She took 400 mg more 2 hours later.  This second dose made her feel better.  The next morning  she felt a bit groggy but when she got up she felt fine and has not taken medications since.
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity, Poor quality sleep
Clinical narrative: Patient had soreness in arm since injection. He says it's difficult to raise arm, he cannot sleep well because it hurts to sleep on this arm. He indicated pain at top of shoulder down thru elbow area. He showed technician and pharmacist that he believes the shot was given a few inches down from top of shoulder
Age: 66.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was no adverse event.  Patient was given a second dose of Fluzone HD.  This would have been her second immunization. She received one on  8/19/2020.  Patient showed no signs or symptoms of adverse event.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Patient came to pharmacy window asking for flu shot. Ran prescription and a prompt for prevnar13 came up. I checked in All Transactions tab of patient profile and saw she's gotten the pneumovax23 on 10/02/2018. I asked the patient whether she has gotten the prevnar13 shot before to which she replied no. I've counseled on the vaccine in regards to what it is, how it works, potential side effects. She stated she wanted to receive the prevnar13 shot as well. It was covered under Medicare Part B. After patient received both vaccines of the HD flu and prevnar13, I was made aware by my technician afterwards that she actually has gotten the prevnar13 awhile back and had let me know that the All Transactions tab only shows up to 17 months previously from the current date. Her last prevnar13 shot was completed on 09/29/2017 .  Patient currently on 10/30/20 has received both the Prevnar13 and Fluad HD vaccine.  I've spoke with the patient and had let her know upon checking she did receive the prevnar13 vaccine previously. She mentioned she hadn't had any issues with the last pneumonia shot (pneumovax23) other than some muscle tenderness. She had emotional concern of 2/10 but explained most likely she wouldn't receive a large benefit from the same vaccine but wouldn't harm her as she's gotten the vaccine previously. Pt was contempt with the answer and was glad a follow up call was done. Currently, no known issues had arise and had let patient know to contact the pharmacy if there is any questions or concerns.
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope post vaccine administration. Patient regained consciousness shortly after. Ice packs were placed on wrist as patient regained composure. Patient is a minor and parent was present stating this is expected reaction to stressful events. Emergency services were refused. Patient was sent home with parent and reported no further symptoms 2 hours post vaccination.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Acoustic stimulation tests, Auditory disorder, Nausea, Tinnitus, Vertigo
Clinical narrative: Patient reports vertigo, tinnitus, nausea/vomiting for 2 days, 1.5 days after receiving the vaccine. States that she is having auditory issues and is being tested for hearing loss.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Patient reports vertigo, tinnitus, nausea/vomiting for 2 days, 1.5 days after receiving the vaccine. States that she is having auditory issues and is being tested for hearing loss.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: Service member received smallpox and anthrax # 1 on 19 Jul 06 without any apparent difficulties. On 30 Jul 06 @ 2 AM he began having constant, non-radiating chest pains described as both dull and sharp at various intervals. The pains ranged in severity from 4-5/10 to 8-9/10 VAS, were worse when lying down, with increased physical activity and with rapid or deep respirations. Additionally he describes episodes of SOB with exertion, an awareness of rapid heart beat sensation within his chest and a cough productive for small amounts of clear mucus. While running during a physical training exercise he collapsed with a witness episode of loss of consciousness (only for a few seconds).There was no bowel or bladder control or any seizure activity. He took no medication for pain relief. He was admitted to  Medical Center where he had an abnormal EKG sinus rhythm with diffuse ST elevation with upright T-waves and P-R segment depression in multiple leads consistent with acute pericarditis. Labs-elevated cardiac enzymes  troponin I 7.42, CPK 532,  CPK-MB 22.2, CKP-MB percentage 4.1%; D. dimmer slightly elevated 572; slightly elevated AST & total protein 8.4 ; CBC- low MCV 76.8, low MCH; BMP  Normal.  He was placed on telemetry with serial cardiac enzymes and EKGs. An echo was performed and he was medicated with Prednisone, Ibuprofen and Protonix. Smoker
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood creatinine normal
Clinical narrative: Service member received smallpox and anthrax # 1 on 19 Jul 06 without any apparent difficulties. On 30 Jul 06 @ 2 AM he began having constant, non-radiating chest pains described as both dull and sharp at various intervals. The pains ranged in severity from 4-5/10 to 8-9/10 VAS, were worse when lying down, with increased physical activity and with rapid or deep respirations. Additionally he describes episodes of SOB with exertion, an awareness of rapid heart beat sensation within his chest and a cough productive for small amounts of clear mucus. While running during a physical training exercise he collapsed with a witness episode of loss of consciousness (only for a few seconds).There was no bowel or bladder control or any seizure activity. He took no medication for pain relief. He was admitted to  Medical Center where he had an abnormal EKG sinus rhythm with diffuse ST elevation with upright T-waves and P-R segment depression in multiple leads consistent with acute pericarditis. Labs-elevated cardiac enzymes  troponin I 7.42, CPK 532,  CPK-MB 22.2, CKP-MB percentage 4.1%; D. dimmer slightly elevated 572; slightly elevated AST & total protein 8.4 ; CBC- low MCV 76.8, low MCH; BMP  Normal.  He was placed on telemetry with serial cardiac enzymes and EKGs. An echo was performed and he was medicated with Prednisone, Ibuprofen and Protonix. Smoker