chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 79-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were unknown. The reporter considered the erythema of extremities and swelling arm to be probably related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine on the left arm. The health care professional reported that the patient experienced redness and swelling of arm. The adverse events occurred lower on the arm where the vaccine was given. The health care professional was not sure if it had been resolved. This case has been linked with US2018102492, reported by the same reporter.
Sex: M
Vaccine: MMR, VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a 56-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included MMR vaccine. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced chills, muscle pain and fatigue. On an unknown date, the outcome of the chills, muscle pain and fatigue were recovered/resolved. The reporter considered the chills, muscle pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient also received an MMR that same day of SHINGRIX vaccine. The nurse reported to sales account manager that her husband received SHINGRIX within the last couple of weeks and on that evening of the vaccination, he experienced muscle aches and chills that night, but then also within a day he experienced fatigue. All his events were resolved on an unspecified date. This case linked to US2018GSK102897, reported by the same reporter.
Age: 33.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Infection, Skin warm, Swelling
Clinical narrative: Patient needed proof of Varicella to go to LPN school. She thought she had Varicella disease as child but has no record so she needed to get vaccinated instead of titers as it was cheaper. She came in today with large red bullseye measuring 11 CM. Middle red with lighter red extending from middle red. Very swollen and hot but no fever. She tried Ibuprofen, BENADRYL (said made worse) and cold compresses.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Vacine 5/30/18. Reoccurent soreness at injection site 6/9/18. Headache 6/11/19. Nauseated 6/12/18. Fever (99.4) 6/13/18.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Local reaction left thigh, red area 4.5 x 5 inches started 24 hours after vaccine seen in clinic 2 days after will f/u tomorrow.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Patient experiencing fatigue daily since the vaccine.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Lethargy, Pyrexia
Clinical narrative: Mild fever 6 hrs. Joint pain 6 hrs. Lethargy 9 hrs.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Pt. received the 1st dose of TRUMENBA yesterday - last night pts. arm felt hard and began to swell and was red, this am it had grown and doesn't seem to be getting smaller and is painful. Was seen in office today by MD who instructed pt. to apply ice periodically and use TYLENOL when needed for pain. Instructed to return to clinic PRN.
Age: 9.0
Sex: M
Vaccine: DT, PPV
Symptoms: Crying, Hyperhidrosis, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: 9 y.o. child here today for dT and PPSV 23 per Dr. script.  Please see attached prescription under attached clinical documents. Father states child was at pulmonologist recently and was told child is allergic to multiple environmental factors. Father given VIS for both vaccines. Child given dT IM in (L) deltoid and PPSV 23 IM in (R) deltoid. Child was crying while receiving vaccines but tolerated well. Child left with father on own accord. Father returned to clinic stating that when child got in car and placed seatbelt on he had seizure like activity, body was contorted and child was unresponsive. Father brought returned inside clinic with child, available nurses on staff took child vitals - BP: 110/75, P:100, T:97.7, R:19. Child was diaphoretic when he returned to clinic and was responsive to commands. ARNP called to clinic to exam child. ARNP determined child needs to go to ER for further evaluation and he also spoke to child's pediatrician after father called him. VAERS report completed.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Day 1 Post SHINGRIX #1 injection: Woke to chills, 101 oral temperature, headache, Right arm soreness, mild swelling and some redness at injection site. Rested, then alternated taking Extra-Strength TYLENOL (2 tabs) with ADVIL (4 tabs) every 4 hours and drinking water. Symptoms persisted throughout day with oral temperature not below 100.6 until 8:00 PM.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Day 1 Post SHINGRIX #1 injection: Woke to chills, 101 oral temperature, headache, Right arm soreness, mild swelling and some redness at injection site. Rested, then alternated taking Extra-Strength TYLENOL (2 tabs) with ADVIL (4 tabs) every 4 hours and drinking water. Symptoms persisted throughout day with oral temperature not below 100.6 until 8:00 PM.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Pyrexia, Rash, Skin warm
Clinical narrative: Patient mentioned she had a small rash on first dose, but this time the rash was big as the size of palm, warm to touch, painful, chills, fever, and pain in stomach. She had to return back to home from work yesterday. She took ADVIL for pain. All her symptoms today are gone except the rash.  Pharmacist suggested to report it to primary care doctor. We reported to Glaxo as well. Patient was also advised to seek medical attention if the symptoms resume or worsens.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Injection site pain, Injection site rash
Clinical narrative: Patient mentioned she had a small rash on first dose, but this time the rash was big as the size of palm, warm to touch, painful, chills, fever, and pain in stomach. She had to return back to home from work yesterday. She took ADVIL for pain. All her symptoms today are gone except the rash.  Pharmacist suggested to report it to primary care doctor. We reported to Glaxo as well. Patient was also advised to seek medical attention if the symptoms resume or worsens.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Similar reaction on previous exposure to drug
Clinical narrative: Patient mentioned she had a small rash on first dose, but this time the rash was big as the size of palm, warm to touch, painful, chills, fever, and pain in stomach. She had to return back to home from work yesterday. She took ADVIL for pain. All her symptoms today are gone except the rash.  Pharmacist suggested to report it to primary care doctor. We reported to Glaxo as well. Patient was also advised to seek medical attention if the symptoms resume or worsens.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash macular, Urticaria
Clinical narrative: Patient given vaccine. Grandma left room and headed to front desk. Grandma then came back around to medical assistant area stating patient broke out with hives/rash. Patient appeared to have 2-3 red blotchy spots on his forehead, 1-2 blotchy red areas on chest, and 1 blotchy red area on left arm above elbow. Injection sites were noted to have a red rash around both areas of each thigh so that the red rashy area covered most of the outer thigh area. Patient and grandma shown to closest exam room and one medical assistant stayed with grandma and patient while another went to get the doctor. The patient was examined by the doctor and the doctor ordered 3mL BENADRYL 12.5/5mL. Patient and grandma waited for 20 minutes per the doctors instruction and was in exam room closest to medical assistant station in case of further problems  After 20 min patient was re-examined and red blotchy areas on forehead, chest, and left arm where gone. The red rash on right thigh had lessened some and band aids where still applied in that area. The left thigh still had the same area size of red rash as when grandma first notified us but the area of rash had not gotten any larger. The band aids on the left thigh had been removed by grandma. Was checked with doctor and allowed to go home with instruction to call if any further problems and grandma expressed verbal understanding. Patient to also be referred to allergist.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: About 5:30 p.m. 6/11/2018 -- about 5:00 pm 6/12/2018: flu-like aching all over body, especially shoulders, back, knees and legs; intermittent chills and cold sweats; treatment: TYLENOL ER (650mg) at 6:00 pm, 3:00 am and then 2pm the next afternoon. By 5:00 pm on 6/12 the symptoms lessened dramatically and were completely gone by 7:00pm that day. Local of vaccination, upper left arm, from moments after the injection; sore, increasingly red, increasingly warm, pain with touch and movement, especially lifting arm. These symptoms are still present today, 6.13, although lessening.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain
Clinical narrative: About 5:30 p.m. 6/11/2018 -- about 5:00 pm 6/12/2018: flu-like aching all over body, especially shoulders, back, knees and legs; intermittent chills and cold sweats; treatment: TYLENOL ER (650mg) at 6:00 pm, 3:00 am and then 2pm the next afternoon. By 5:00 pm on 6/12 the symptoms lessened dramatically and were completely gone by 7:00pm that day. Local of vaccination, upper left arm, from moments after the injection; sore, increasingly red, increasingly warm, pain with touch and movement, especially lifting arm. These symptoms are still present today, 6.13, although lessening.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Effusion, Oedema peripheral
Clinical narrative: Isolated axillary fossa swelling in arm that received vaccine. This was fluid/effusion. No apparent adenopathy. Fluid not assessed. Resolved after 3 days spontaneously, no treatment needed.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Hypoaesthesia, Immediate post-injection reaction, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Pharmacist gave too high on arm (almost shoulder area). Patient reported immediate numbness and loss of strength in arm. He did take 400mg Ibuprofen to help with swelling in area and stated that it did help. Today patient states his arm is doing better, but still lacking strength. Will follow up in a few days to assess if further medical attention is needed.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Peripheral swelling
Clinical narrative: Reports that she had significant swelling of her arm after receiving the PNEUMOVAX 23 vaccine during her 5/30/18 office visit, and as the swelling went down, she started having the dizziness that took her to the ED for evaluation on 6/6/18. They stated that her reaction should be reported.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Rash
Clinical narrative: Rash over entire abdomen and sides within 15 minutes of administration.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Patient has extreme pain at site of injection and affected arm (L), fever, and limited mobility of extremity.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Seizure
Clinical narrative: Seizure.
Age: 1.25
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eczema, Erythema, Pyrexia, Rash
Clinical narrative: Child developed fever on Friday 1 week after receiving the vaccines, then had rash on Monday morning. Rash mostly on trunk, with ABD the worst. Extremities and head with a few raised red areas. No pustules noted at this time.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted with in one minute after the vaccine was administered.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Fainted minutes after receiving vaccines. Monitored in office and felt better after a few minutes.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Hypersomnia, Influenza like illness, Lethargy
Clinical narrative: Body aches, lethargy, sore arm. Felt like I had the flu for 2 days. Slept a lot. Generally uncomfortable. Felt tired for 5 days.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Body aches, lethargy, sore arm. Felt like I had the flu for 2 days. Slept a lot. Generally uncomfortable. Felt tired for 5 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Feeding disorder, Nausea, Somnolence
Clinical narrative: The patient reported to a staff pharmacist here that she has been sleeping since noon today and is nauseous. She has diarrhea, said "I need an IV" and can't eat.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Patient called this afternoon and stated that her arm where she was immunized yesterday was very sore, red, and swollen. And was hoping it would pass, however, this morning she noticed that it was even more swollen, red, and painful. Patient was advised talk to her provider and in the meantime could take ADVIL for the pain and inflammation as well as BENADRYL. Patient stated that she had ADVIL in her home but didn't have the BENADRYL. She did come into the pharmacy and her arm was looked at. Visibly red and swollen radiating down into the upper part of her forearm at that time she did state that the provider recommended that she go to urgent care because they had no available appointments today. Patient stated that she did not want to go to urgent care because it was too far away and expensive. While in the pharmacy she did purchase BENADRYL. She was also advised to call her doctors office in the morning and see if there were any cancellations to get seen. Also advised to seek emergent medical care if symptoms were to worsen. She stated she would be monitoring the site, and we at the pharmacy will be following up with the patient tomorrow.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Fever, nausea, sore arm, fatigue, muscle pain, headache.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, nausea, sore arm, fatigue, muscle pain, headache.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm soreness that began 6 hours after administration and is still sore on 6/13/18 when the shot was received 6/8/18.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site erythema, Oedema, Pharyngeal oedema
Clinical narrative: Edema, difficulty breathing, swelling in throat. Redness at site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Vomiting
Clinical narrative: Insomnia on 6/11/18, nausea including 1 episode of vomiting 6/12/18.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PT GOT SHINGLES AS DIAGNOSED PER HER DR.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: Patient reports experiencing severe back pain on the lower left side right above his buttocks a couple hours after the shot. He said this continued for a couple days afterward. He did not report that he got any treatment for it.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Rash
Clinical narrative: Tired, dizzy, rash. BUT I always get this rash when I have been sick __ e.g. cold or flu.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Arm is red, itchy, swollen, patient stated that it feels warm. Patient received shot on 06/08/18 and presented to the pharmacy on 06/13/18. Recommends the patient take some BENADRYL to help with symptoms and contact the doctor in the morning to be evaluated for a possible antibiotic.
Age: 21.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Cold sweat, Dizziness, Feeling hot, Pain in extremity, Pallor
Clinical narrative: I received a tetanus booster (90715) in the right arm, then received the GARDASIL (90651) shot in the left. I was told the prick wouldn't hurt until after the injection. I felt nothing until a moment later where it felt like I had been punched in the arm. I then got up and went to check out. While waiting to check out, I got very warm and started overheating. I asked if I could have some water, and was immediately sat down. I continued to worsen and feel on the verge of fainting, and was then wheeled in a wheelchair to an open room to lay down. It took me 20 min before I was able to sit up. Throughout the day, I continued to feel clammy and have spells of cold sweats here and there. At the time of the shot, I lost all color in my face and I did not fully regain it until the following morning. This was injection 1/3 for this vaccine progression.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abnormal behaviour, Crying, Injection site erythema, Injection site warmth, Insomnia
Clinical narrative: Day of injection: Fever of 101.6, extreme tenderness, fussiness, mood/behavioral changes, lethargy, crying, sleeplessness, restlessness, nausea. Day after injection: Same as above, with added large area of redness & skin is warm to the touch - both at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Irritability, Lethargy, Mood altered, Nausea, Pyrexia
Clinical narrative: Day of injection: Fever of 101.6, extreme tenderness, fussiness, mood/behavioral changes, lethargy, crying, sleeplessness, restlessness, nausea. Day after injection: Same as above, with added large area of redness & skin is warm to the touch - both at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Restlessness, Tenderness
Clinical narrative: Day of injection: Fever of 101.6, extreme tenderness, fussiness, mood/behavioral changes, lethargy, crying, sleeplessness, restlessness, nausea. Day after injection: Same as above, with added large area of redness & skin is warm to the touch - both at injection site.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient presented to pharmacy stating injection was given day prior and 3 hours after the injection the arm was red and painful upon touch near the injection site. Patient took TYLENOL and was doing ice packs. Now on second day the patient has pain to touch from the top of her arm near shoulder to the elbow on injection arm and is now red from about 2 inches below the injection site to the elbow. I instructed patient to take 2 BENADRYL tonight and continue with ice packs and I will reach out in the morning tomorrow to instruct further if needed.
Age: 47.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Induration, Injection site erythema, Injection site pruritus, Pain, Pain in extremity
Clinical narrative: Pt states after receiving vaccinations, experienced a high grade  fever for 3 days. Also states had itching and redness around injection site on left arm. Pt also states has been taking ibuprofen 600mg q4h to help control the pain. Chief complaint is pain and lipoma like pain in left arm described as "hard ball" in her arm.
Age: 47.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Pt states after receiving vaccinations, experienced a high grade  fever for 3 days. Also states had itching and redness around injection site on left arm. Pt also states has been taking ibuprofen 600mg q4h to help control the pain. Chief complaint is pain and lipoma like pain in left arm described as "hard ball" in her arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: Extreme soreness at injection site/joint and muscle pain.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage, Ultrasound antenatal screen
Clinical narrative: This serious spontaneous case, initially received on 27-Mar-2018, from a 30-year-old, adult, female pregnant patient. The patient was pregnant twice in the past and had no history of still birth/miscarriage or birth defect/congenital anomaly. The patient had no significant medical history, no paternal/maternal history and no family history of miscarriages. The patient's concomitant medication was not reported. The patient had no stress recently. The patient's last menstrual period was 10-Oct-2017 (estimated date of delivery reported as 29-Jul-2018). Reportedly, the patient was not aware of the pregnancy before the vaccination. On 20-Oct-2017, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: arm, batch number: 195227, expiry date: 31-May-2018, dose: not reported) (explicitly coded as vaccine exposure during pregnancy). On an unspecified date, the patient underwent ultrasound (results not reported, before miscarriage). On 25-Nov-2017, after 1 month 6 days of vaccination, the patient experienced spontaneous abortion, associated with heavy bleeding. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious. Follow-up information received on 20-Apr-2018: It was reported that, the patient had no history of recent stresses or no family history of miscarriages. An ultrasound was done to the patient prior to the miscarriage. Narrative was amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This is a serious spontaneous case, initially received on 01-Nov-2017, from a nurse, concerning a female pregnant patient of unspecified age. On an unspecified date in 2016 (as reported, last year), the pregnant patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, frequency: once (as reported), batch number, expiry date: not reported). On an unspecified date (reported as in past), after vaccination, the patient had miscarriage. It was reported that the patient was pregnant again and was in first trimester. She did not receive flu vaccine yet and plans to delay the vaccination a little longer until the first trimester. Follow-up received from other health professional (nurse) on 01-Feb-2018: Follow-up for this case is not being sought as consumer refuses to be contacted for any further information. No changes were made in the narrative, as no additional information received.
Sex: M
Vaccine: FLUX
Symptoms: Diplegia
Clinical narrative: This initial serious spontaneous case, was received on 27-Nov-2017, from other non-health professional, concerning a patient of unspecified age and gender. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after administration of flu vaccine, the patient experienced "paralyzed legs" for several days. The outcome of the event was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Biopsy peripheral nerve abnormal, Electromyogram abnormal, Hemiparesis, Hyporeflexia, Nerve degeneration
Clinical narrative: This is a serious literature-spontaneous case. This case was initially received on 14-Jun-2017, which was reported by other health professional, concerning a 67-year-old male elderly patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, batch number, expiry date, route of administration: not reported). It was reported that the patient had an abrupt onset left arm pain, 2 weeks following influenza vaccination. Approximately 1 month later, he developed left wrist drop accompanied by sensory loss. Neurologic exam revealed weakness predominantly in the left greater than right radial and median innervated muscles, right scapular winging, sensory loss in the left radial nerve distribution, and hyporeflexiain the upper extremities. Electrodiagnostic studies showed bilateral radial nerve palsy, left greater than right. A left superficial radial sensory nerve biopsy, done within a month of onset showed clear evidence of epineurial microvasculitis and axonal degeneration. He was treated with SOLU MEDROL and subsequently cyclophosphamide was added. At 6-month follow-up, he made remarkable recovery with complete resolution of pain and slow but definite improvement of strength. The outcome of the other events was not reported. The reporter did not provide the causality between the events and suspect product (INN Flu Vaccine Seasonal).
Sex: M
Vaccine: FLUX
Symptoms: Neurological examination abnormal, Pain in extremity, Radial nerve palsy, Sensory loss, Vasculitis
Clinical narrative: This is a serious literature-spontaneous case. This case was initially received on 14-Jun-2017, which was reported by other health professional, concerning a 67-year-old male elderly patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, batch number, expiry date, route of administration: not reported). It was reported that the patient had an abrupt onset left arm pain, 2 weeks following influenza vaccination. Approximately 1 month later, he developed left wrist drop accompanied by sensory loss. Neurologic exam revealed weakness predominantly in the left greater than right radial and median innervated muscles, right scapular winging, sensory loss in the left radial nerve distribution, and hyporeflexiain the upper extremities. Electrodiagnostic studies showed bilateral radial nerve palsy, left greater than right. A left superficial radial sensory nerve biopsy, done within a month of onset showed clear evidence of epineurial microvasculitis and axonal degeneration. He was treated with SOLU MEDROL and subsequently cyclophosphamide was added. At 6-month follow-up, he made remarkable recovery with complete resolution of pain and slow but definite improvement of strength. The outcome of the other events was not reported. The reporter did not provide the causality between the events and suspect product (INN Flu Vaccine Seasonal).
Sex: M
Vaccine: FLUX
Symptoms: Winged scapula
Clinical narrative: This is a serious literature-spontaneous case. This case was initially received on 14-Jun-2017, which was reported by other health professional, concerning a 67-year-old male elderly patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, batch number, expiry date, route of administration: not reported). It was reported that the patient had an abrupt onset left arm pain, 2 weeks following influenza vaccination. Approximately 1 month later, he developed left wrist drop accompanied by sensory loss. Neurologic exam revealed weakness predominantly in the left greater than right radial and median innervated muscles, right scapular winging, sensory loss in the left radial nerve distribution, and hyporeflexiain the upper extremities. Electrodiagnostic studies showed bilateral radial nerve palsy, left greater than right. A left superficial radial sensory nerve biopsy, done within a month of onset showed clear evidence of epineurial microvasculitis and axonal degeneration. He was treated with SOLU MEDROL and subsequently cyclophosphamide was added. At 6-month follow-up, he made remarkable recovery with complete resolution of pain and slow but definite improvement of strength. The outcome of the other events was not reported. The reporter did not provide the causality between the events and suspect product (INN Flu Vaccine Seasonal).
Age: 86.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Hives all over body - day 2.
Age: 0.83
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: The patient was given KINRIX instead of separate vaccine DTAP and IPV. Which the doctor ordered separate vaccines. I made the error and combined both vaccines instead. Pt. has not called with any complaints.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Well defined, limited red, raised rash periumbilical, (L) hip. No drainage, no pain, positive itch.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypersomnia, Irritability, Pyrexia, Teething
Clinical narrative: Fever 102, fussy. Had vaccines yesterday, fever today of 102, she is at day care and they gave her Ibuprofen, 15 mins later they checked temp and down to 100.2. She spoke with daycare and she was a bit fussy but also teething, she started falling asleep. Yesterday she slept a lot and slept all night long. Action Taken: Advised mom we don't recommend ibuprofen until age 6 month. To recheck temp later to see if it is going down. Fever can last up to 48 hr if due to vaccines. To be seen if unconsolable, not eating, not drinking, diarrhea, vomiting or having wet diapers. To keep her comfortable with TYLENOL, and to call us if any concerns. Dr. called and spoke with mom, she is better now, mom saw her at noon and temp was 99 and she was acting ok, she nursed well. Gave her INFANT TYLENOL. She seems better, please do VAERS.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Injection site oedema, Tenderness
Clinical narrative: Erythema, tenderness, edema (R) deltoid at site of BEXSERO injection.
Age: 40.0
Sex: M
Vaccine: HEPA, MMR, TDAP
Symptoms: Abdominal pain, Injection site rash, Muscle spasms, Myalgia, Rash
Clinical narrative: Vaccines administered 6-4-18 8:45 AM. Symptoms started 6-5-18 AM - C/O abdominal pain, muscle ache/cramps in calf right one mostly. 6-8-18 rash started on upper arms and abdomen. Rash is still present 6-13-18.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Macule, Swelling, Tenderness
Clinical narrative: Pt presented with erythematous less than 2 cm, oval macules clustered on medial anterior left proximal bicep, mild induration w/TTP beneath, minimal visible swelling, no purulence/drainage/vesicles.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Fatigue, Headache, Heart rate increased, Injection site pain
Clinical narrative: Hurt right away got worse at site. Got tired that evening. Next day 6-12-18 achy all over, headache. Blood pressure up 30 points, heart rate up 20 points. Resolved 6-13-18.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurt right away got worse at site. Got tired that evening. Next day 6-12-18 achy all over, headache. Blood pressure up 30 points, heart rate up 20 points. Resolved 6-13-18.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant, and refers to a 31 year old female patient. The patient did not have concurrent conditions, pertinent medical history and allergies reported. On 18-MAY-2018, the patient was vaccinated with VARIVAX lot # N010108 with expiry date on 28-MAR-2019, for prophylaxis. Other suspect therapies included sterile diluent (MERCK). Concomitant therapies included iron (unspecified), minerals (unspecified), vitamins (prenatal vitamins). The medical assistant reported that the patient was 5 months pregnant at the time of vaccination, however no adverse events were reported.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant, and refers to a 31 year old female patient. The patient did not have concurrent conditions, pertinent medical history and allergies reported. On 18-MAY-2018, the patient was vaccinated with VARIVAX lot # N010108 with expiry date on 28-MAR-2019, for prophylaxis. Other suspect therapies included sterile diluent (MERCK). Concomitant therapies included iron (unspecified), minerals (unspecified), vitamins (prenatal vitamins). The medical assistant reported that the patient was 5 months pregnant at the time of vaccination, however no adverse events were reported.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood culture negative, Chest X-ray normal, Chills, Culture urine negative, Dizziness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 61-year-old male patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) and (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Concomitant products included SHINGRIX. On 31st May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced fever (serious criteria hospitalization). On an unknown date, the patient experienced myalgia and pharmaceutical product complaint. On an unknown date, the outcome of the fever, myalgia and pharmaceutical product complaint were unknown. The reporter considered the fever to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the myalgia to be related to SHINGRIX. The patient received SHINGRIX on the left arm. On 28th March 2018, the patient received 1st dose of SHINGRIX, and no adverse event was reported on that date. Less than a month after receiving SHINGRIX the patient experienced myalgia. The batch number of the adjuvant/liquid was D3L5G with an expiry of 11/29/2020. After the 2nd dose, the patient experienced fever, and needed to be hospitalized. The pharmacist reported that he had been giving SHINGRIX injections since January 2018 and said that this last batch of SHINGRIX might be suspect. He reported that the patient experienced Adverse drug reactions (ADE's) unlike previous injections. The reporter did not have any product to return and was not seeking reimbursement. When asked, the pharmacist reported there was nothing unusual about the vials or the box. The side effect profile and percentages of ADEs experienced were reviewed. The pharmacist also reported via VAERS. This case is 1 of the 7 linked cases reported by the same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 61-year-old male patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) and (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Concomitant products included SHINGRIX. On 31st May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced fever (serious criteria hospitalization). On an unknown date, the patient experienced myalgia and pharmaceutical product complaint. On an unknown date, the outcome of the fever, myalgia and pharmaceutical product complaint were unknown. The reporter considered the fever to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the myalgia to be related to SHINGRIX. The patient received SHINGRIX on the left arm. On 28th March 2018, the patient received 1st dose of SHINGRIX, and no adverse event was reported on that date. Less than a month after receiving SHINGRIX the patient experienced myalgia. The batch number of the adjuvant/liquid was D3L5G with an expiry of 11/29/2020. After the 2nd dose, the patient experienced fever, and needed to be hospitalized. The pharmacist reported that he had been giving SHINGRIX injections since January 2018 and said that this last batch of SHINGRIX might be suspect. He reported that the patient experienced Adverse drug reactions (ADE's) unlike previous injections. The reporter did not have any product to return and was not seeking reimbursement. When asked, the pharmacist reported there was nothing unusual about the vials or the box. The side effect profile and percentages of ADEs experienced were reviewed. The pharmacist also reported via VAERS. This case is 1 of the 7 linked cases reported by the same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction, Myalgia, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 61-year-old male patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) and (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Concomitant products included SHINGRIX. On 31st May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced fever (serious criteria hospitalization). On an unknown date, the patient experienced myalgia and pharmaceutical product complaint. On an unknown date, the outcome of the fever, myalgia and pharmaceutical product complaint were unknown. The reporter considered the fever to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the myalgia to be related to SHINGRIX. The patient received SHINGRIX on the left arm. On 28th March 2018, the patient received 1st dose of SHINGRIX, and no adverse event was reported on that date. Less than a month after receiving SHINGRIX the patient experienced myalgia. The batch number of the adjuvant/liquid was D3L5G with an expiry of 11/29/2020. After the 2nd dose, the patient experienced fever, and needed to be hospitalized. The pharmacist reported that he had been giving SHINGRIX injections since January 2018 and said that this last batch of SHINGRIX might be suspect. He reported that the patient experienced Adverse drug reactions (ADE's) unlike previous injections. The reporter did not have any product to return and was not seeking reimbursement. When asked, the pharmacist reported there was nothing unusual about the vials or the box. The side effect profile and percentages of ADEs experienced were reviewed. The pharmacist also reported via VAERS. This case is 1 of the 7 linked cases reported by the same reporter.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 51-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) and (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Concomitant products included ADACEL. On 30th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 2nd June 2018, 3 days after receiving SHINGRIX, the patient experienced fever, injection site warmth and injection site pain. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fever, injection site warmth, injection site pain and pharmaceutical product complaint were unknown. The reporter considered the fever, injection site warmth and injection site pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. On the same day, the patient received a dose of ADACEL concomitantly. The batch number of the adjuvant/liquid was D3L5G with an expiry of 11/29/2020. The pharmacist reported that he had been giving SHINGRIX injections since January 2018 and said that this last batch of SHINGRIX might be suspect. He reported that the patient experienced Adverse drug reactions (ADE's) unlike previous injections. The reporter did not have any product to return and was not seeking reimbursement. When asked, the pharmacist reported there was nothing unusual about the vials or the box. The side effect profile and percentages of ADEs experienced were reviewed. The pharmacist also reported via VAERS. This case is 1 of the 7 linked cases reported by the same reporter.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Injection site pain, Injection site warmth, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 51-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) and (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Concomitant products included ADACEL. On 30th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 2nd June 2018, 3 days after receiving SHINGRIX, the patient experienced fever, injection site warmth and injection site pain. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fever, injection site warmth, injection site pain and pharmaceutical product complaint were unknown. The reporter considered the fever, injection site warmth and injection site pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. On the same day, the patient received a dose of ADACEL concomitantly. The batch number of the adjuvant/liquid was D3L5G with an expiry of 11/29/2020. The pharmacist reported that he had been giving SHINGRIX injections since January 2018 and said that this last batch of SHINGRIX might be suspect. He reported that the patient experienced Adverse drug reactions (ADE's) unlike previous injections. The reporter did not have any product to return and was not seeking reimbursement. When asked, the pharmacist reported there was nothing unusual about the vials or the box. The side effect profile and percentages of ADEs experienced were reviewed. The pharmacist also reported via VAERS. This case is 1 of the 7 linked cases reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Pain in extremity, Rash
Clinical narrative: Next day glands on neck--both sides-- were swollen. Had a big lump at site of injection; it was very noticeable. Patient also reports sore throat and runny nose. On 6/6 shingles outbreak on buttocks started. Patient called pharmacist who recommended it treat it with calamine lotion. Two days later, 2nd outbreak developed and following day had a third outbreak. Patient called back the pharmacist on 6/10 and called doctor 6/12. Doctor confirmed that they were shingles and to continue same treatment. Today, patient is getting better slowly, throat is better, nose not running as much and lump in arm almost gone. Patient received shingles vaccine years ago and had 3 outbreaks over time.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site mass, Lymphadenopathy, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Next day glands on neck--both sides-- were swollen. Had a big lump at site of injection; it was very noticeable. Patient also reports sore throat and runny nose. On 6/6 shingles outbreak on buttocks started. Patient called pharmacist who recommended it treat it with calamine lotion. Two days later, 2nd outbreak developed and following day had a third outbreak. Patient called back the pharmacist on 6/10 and called doctor 6/12. Doctor confirmed that they were shingles and to continue same treatment. Today, patient is getting better slowly, throat is better, nose not running as much and lump in arm almost gone. Patient received shingles vaccine years ago and had 3 outbreaks over time.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling cold, Hot flush, Pain
Clinical narrative: Extreme aches and pain, hot flashes, cold chills, tremendous weakness for 24 hours.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Gout
Clinical narrative: Gout Attack.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Nausea, Vomiting
Clinical narrative: Patient reported dizziness, nausea, vomiting, and chills. No report of difficulty breath or syncope. This started "a few hours" after administration and after patient had done strenuous activity. Patient referred to ED if primary care could not visit primary care immediately or if symptoms worsened. Verbally given list of early signs of anaphylaxis and also ADRs associated with Bexsero.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Pain, Swelling, Urticaria
Clinical narrative: Patient had severe body aches the evening of the shot day. She later developed welts in the shot area. A large area from above elbow to shoulder on injection site arm became warm to touch. A couple days later she developed a large puffy spot that was not sore or itchy on her stomach. Symptoms resolved without seeking further medical attention. Patient did accept Band-Aid to the injection site after vaccination administration. It is possible that welts were an allergic reaction to the adhesive.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Information has been received from a nurse referring to a 14 month old female patient. The patient had no adverse event previously, no illness at time of vaccination and no pre-existing physician-diagnosed allergies, birth defects or medical conditions. The patient's birth weight was 3.755 kg. The patient's concomitant therapy included sterile diluent(manufacturer unknown). On 10-MAY-2018 (previously reported as 24-APR-2018), the patient was vaccinated with the first dose of improperly stored (frozen out of range temperatures recorded) VARIVAX (1 DF, subcutaneous, lot # N019133, expiration date 22-JUN-2019) for prophylaxis. Freeze temperature excursion 5.3 Fahrenheit (F), 5.9F, 6.8F, 8.8F, 11.8 over 23-APR-2018 to 02-MAY-2018 of total 4hours 15min intermittently. Glycol bottle leaked and was replaced, the far froze. No treatment was given to the patient. The outcome of the event was not reported. The causality assessment between the event and VARIVAX was not reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA006356: US-009507513-1805USA000738.
Age: 4.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Product storage error
Clinical narrative: Information has been received from a pediatric nurse practitioner referring to a 4 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 26-APR-2018, the patient was vaccinated with the first dose of PROQUAD (therapy type: rHA, subcutaneous, lot # N020620, expiration date auto generated as 22-JAN-2019; dose were not reported) and the first dose of VAQTA (intramuscular, lot# N020689, expiration date auto generated as 22-OCT-2018) for prophylaxis. Both of the drugs were freeze temperature excursion. The patient's dose were valid and not recommended to repeat. No treatment was given to the patient. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA006349.