chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Patient received vaccine on 5/5/17 and went to urgent care that evening and was started on KEFLEX x10 days. By time of appointment on 5/9 the swelling and redness was greatly reduced per MD. Symptoms: Erythema, cellulitis. Treatment: Cephalexin 500 mg QID.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Rash - started 7/21, multiple stages consistent with varicella.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site redness and swelling.
Age: 27.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red induration 3in x 2in, some discomfort and hot to touch. Pt to treat with BENADRYL and return to clinic if it gets worse or no improvement. Located Right upper arm, subq area.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Blister, Pyrexia, Rash, Scab
Clinical narrative: 2 days following vaccinations she developed a fever lasting 4 days. 7/19/17 developed a rash (Mom initially thought bug bites) that became blistering and then scabbed. Started on arms and legs and some spread to head, neck and trunk.
Age: 25.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Two Hep B shots given at the same time to and adult male client. No signs or symptoms of reactions.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: HPV1, OJ given before, 2 min after inj - dizzy, nauseous and pale. Pt laid back, water, sucker and cool compress given. BP 87/56, HR 58. Monitored for 25 min. VS improved. Pt said he felt better after interventions.
Age: 19.0
Sex: F
Vaccine: JEV1, RAB
Symptoms: Immediate post-injection reaction, Loss of consciousness, Pallor, Seizure like phenomena, Underdose
Clinical narrative: While administering 2nd vaccine (IMOVAX) pt: stated her eyes were "going black", turned a pale color, and proceeded to pass out in the chair. We elevated her feet and moved her to a reclined position. Pt. came to within 1 minute, Pt appeared to have seizure-like movements for a few seconds before passing out. Pt rested for 15-20 minutes and felt well enough to leave with mom. Pt only received only 1/4 vaccine b4 passing out. I removed needle as patient passed out.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Myalgia, Nausea
Clinical narrative: Nausea/light headed. Muscles aches.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Urticaria developed the day after vaccine.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Body temperature increased, Chills, Neck pain, Pain
Clinical narrative: Temperature of 102 degrees, body aches, chills and neck pain that lasted for 24 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Pt came into the office today with a 4 cm across annular reaction on R arm around the injection site. Pt stated it started the day after getting the vaccine and her friends told her to go back to the doctors. No labs or tx. Recommended antihistamines.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Paraesthesia
Clinical narrative: Pt. complaint of fingers tingling, numbness on both hands, body weakness and Rt. leg, imbalance with weakness. Symptoms started 1 week after the shot. To add to symptoms: fatigue and getting tired very quick from any activity. Dizziness and losing balance for seconds unexpectedly. Pain on right side of body from injection site to right leg. Sudden loss of power and strength to left up leg. Extreme weakness, hands often. Body parts coordination problem. Difficulty to run, I feel very heavy when I am not.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Balance disorder, Blood test normal, Coordination abnormal, Discomfort
Clinical narrative: Pt. complaint of fingers tingling, numbness on both hands, body weakness and Rt. leg, imbalance with weakness. Symptoms started 1 week after the shot. To add to symptoms: fatigue and getting tired very quick from any activity. Dizziness and losing balance for seconds unexpectedly. Pain on right side of body from injection site to right leg. Sudden loss of power and strength to left up leg. Extreme weakness, hands often. Body parts coordination problem. Difficulty to run, I feel very heavy when I am not.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Injection site pain, Muscular weakness
Clinical narrative: Pt. complaint of fingers tingling, numbness on both hands, body weakness and Rt. leg, imbalance with weakness. Symptoms started 1 week after the shot. To add to symptoms: fatigue and getting tired very quick from any activity. Dizziness and losing balance for seconds unexpectedly. Pain on right side of body from injection site to right leg. Sudden loss of power and strength to left up leg. Extreme weakness, hands often. Body parts coordination problem. Difficulty to run, I feel very heavy when I am not.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain, Paraesthesia
Clinical narrative: Pt. complaint of fingers tingling, numbness on both hands, body weakness and Rt. leg, imbalance with weakness. Symptoms started 1 week after the shot. To add to symptoms: fatigue and getting tired very quick from any activity. Dizziness and losing balance for seconds unexpectedly. Pain on right side of body from injection site to right leg. Sudden loss of power and strength to left up leg. Extreme weakness, hands often. Body parts coordination problem. Difficulty to run, I feel very heavy when I am not.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Blood urine present, Chills, Chromaturia, Diarrhoea, Headache
Clinical narrative: Flu like symptoms  vomiting, fever, chills, body ache, head ache,urinary pain during urination ,darked /bloody urine, diarrhea.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Influenza like illness, Injection site pain, Pain, Pyrexia, Vomiting
Clinical narrative: Flu like symptoms  vomiting, fever, chills, body ache, head ache,urinary pain during urination ,darked /bloody urine, diarrhea.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Pt developed diffuse vesicular rash.  No fever or URI sx.  Supportive care recommended.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blister, Full blood count, Metabolic function test, Microscopy, Rash erythematous
Clinical narrative: I do not know which brand of Tdap and meningococcal vaccine the patient received. The patient and her father report starting with an itchy, raised red rash a couple hours after receiving the vaccinations which progressed over the subsequent 24 hours. She was examined the following day at Urgent Care.  They noted a diffuse red papular rash with pustules and vesicles. She was treated with prednisone 30mg. She was seen the next morning (7/29/17) at Clinic and examined by Dr.  The famiy noted slightly less itch, but continued rash. They denied all other symptoms. She again was noted to have a diffuse red papular rash with pustules and vesicles. I have ordered a urinalysis with microscopy, CBC and CMP.  I increased her prednisone dose to 30mg BID to taper.  She will follow up in 2 days with her PCP, Dr.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Rash papular, Rash pruritic, Rash pustular, Urine analysis
Clinical narrative: I do not know which brand of Tdap and meningococcal vaccine the patient received. The patient and her father report starting with an itchy, raised red rash a couple hours after receiving the vaccinations which progressed over the subsequent 24 hours. She was examined the following day at Urgent Care.  They noted a diffuse red papular rash with pustules and vesicles. She was treated with prednisone 30mg. She was seen the next morning (7/29/17) at Clinic and examined by Dr.  The famiy noted slightly less itch, but continued rash. They denied all other symptoms. She again was noted to have a diffuse red papular rash with pustules and vesicles. I have ordered a urinalysis with microscopy, CBC and CMP.  I increased her prednisone dose to 30mg BID to taper.  She will follow up in 2 days with her PCP, Dr.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Neck pain
Clinical narrative: Pain ache on both sides of the lower spine. Thursday, neck pain on both sides of the spine. Not a sharp pain. A constant pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site rash, Injection site warmth, Rash, Rash erythematous
Clinical narrative: Committed next day, injection site remained warm/hot to touch for a couple of days, two days after shot a rash started on upper arms, neck (on top of eczema), chin, and cheeks. Rash lasted about 2-3 days but unclear if some remain because there's still additional red bumps/spots in areas not previously with eczema.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Appendicectomy, Appendicitis perforated, Endometriosis, Menorrhagia
Clinical narrative: She started her menstruations and they was extremely heavy she was dignosed with Endometriosis and had to have her appendix removed because they have ruptured.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose fluctuation, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Starting Wednesday, July 26th patient reported redness and swelling/pain at injection site for immunization given 7/20/17. She also reported nausea, fatigue and fluctuating blood sugars.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea
Clinical narrative: Starting Wednesday, July 26th patient reported redness and swelling/pain at injection site for immunization given 7/20/17. She also reported nausea, fatigue and fluctuating blood sugars.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Severe heat, redness and soreness extending from below injection site to just above elbow. Headache. Light nausea.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching and pain at site > 6 days.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: First night showed up as an approx 3 inch round rash on her thigh around the injection site. No other symptoms at the time. Second night (tonight) it has spread to around a 4 inch rash and it's now itchy.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain, on left upper arm at injection site.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Dizziness, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: I suffered severe headaches for over one week, right arm extremely sore, chills, fatigue, dizziness, aching body, congestion, runny nose, aching throat, restlessness.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Pain in extremity, Respiratory tract congestion, Restlessness, Rhinorrhoea
Clinical narrative: I suffered severe headaches for over one week, right arm extremely sore, chills, fatigue, dizziness, aching body, congestion, runny nose, aching throat, restlessness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At the site of shot, red, warm, hard, raised, very sore, hard to sleep.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: At the site of shot, red, warm, hard, raised, very sore, hard to sleep.
Age: 0.08
Sex: M
Vaccine: RV1
Symptoms: Gastrooesophageal reflux disease, Pyrexia
Clinical narrative: Fever developed the day after the vaccine along with reflux symptoms. The fever lasted for 2 days but reflux symptoms persisted and worsened for over 3 weeks, requiring prescription medication (ZANTAC).
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain, Rotator cuff syndrome
Clinical narrative: Influenza vaccine info above surmised from military MEDPROS; which listed "Influenza, INJ, QUADRIVALENT PRES FREE; CSL Biotherapies as Manufacturer... - Patient received IM influenza vaccination (only vaccination that day) in R deltoid on 12Oct2016 at off-site ?vaccination clinic?. Initial vaccination was unremarkable. She initially sought care for continued pain and limitation in ability to abduct R arm due to pain on 1Nov2016. At that encounter; it was noted that she also experienced pain with any arm movement (not at rest) and did not note anything unusual initially after vaccination (e.g. no swelling, bruising). At subsequent visit with reporting Provider on 6April2017, she also noted that she experienced normal pain with vaccination at time of vaccination, that just persisted.  Physician who saw patient on 1Nov2016 suspected impingement (based on history and PE, noting impingement tests were positive), and patient noted that vaccination spot may have been high on the shoulder, near the acromion. Patient followed up with reporting Provider on 31Jan2017, and complained to screening medic of feeling pain in shoulder a couple days after being given influenza vaccine, and noted continued pain that was provoked when doing activities and when lifting arm. Patient had TTP over R deltoid. Full ROM was present, but she noted pain in R deltoid region with R arm abduction. SIRVA was suspected at that time. Imaging studies were ordered. X-ray on 15 Mar 2017 was unremarkable. MRI on 15Mar2017 noted normal deltoid, with no evidence to suggest myositis. A Partial-thickness, interstitial tear of the distal infraspinatus tendon, extending from the footplate to the myotendinous junction, with associated subchondral cystic change in the humeral head was noted. There was no evidence of full-thickness tear, or other abnormality. Patient was seen on 6 April by reporting Provider. She noted improving, but still present deltoid region pain with should abducting activities. No infraspinatus weakness or pain with infraspinatus movement was appreciated at that encounter. Patient saw Physical Therapy and Orthopedic Service on 17April2017.  Per, Ortho note: Continued pain was noted, especially with overhead lifting motions. PE notable as follows: ROM testing was normal. Impingement testing was positive. Diagnosed with ?impingement vs. tendonitis?  No surgical indication was found at that time.  Reporting Provider talked to patient on 30July2017.  She says overall pain picture is improving. She still has slight pain with R arm abduction. It is unknown at this time whether the clinic will/has awarded disability for R shoulder. She is still waiting for a determination on that.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Tendonitis, X-ray normal
Clinical narrative: Influenza vaccine info above surmised from military MEDPROS; which listed "Influenza, INJ, QUADRIVALENT PRES FREE; CSL Biotherapies as Manufacturer... - Patient received IM influenza vaccination (only vaccination that day) in R deltoid on 12Oct2016 at off-site ?vaccination clinic?. Initial vaccination was unremarkable. She initially sought care for continued pain and limitation in ability to abduct R arm due to pain on 1Nov2016. At that encounter; it was noted that she also experienced pain with any arm movement (not at rest) and did not note anything unusual initially after vaccination (e.g. no swelling, bruising). At subsequent visit with reporting Provider on 6April2017, she also noted that she experienced normal pain with vaccination at time of vaccination, that just persisted.  Physician who saw patient on 1Nov2016 suspected impingement (based on history and PE, noting impingement tests were positive), and patient noted that vaccination spot may have been high on the shoulder, near the acromion. Patient followed up with reporting Provider on 31Jan2017, and complained to screening medic of feeling pain in shoulder a couple days after being given influenza vaccine, and noted continued pain that was provoked when doing activities and when lifting arm. Patient had TTP over R deltoid. Full ROM was present, but she noted pain in R deltoid region with R arm abduction. SIRVA was suspected at that time. Imaging studies were ordered. X-ray on 15 Mar 2017 was unremarkable. MRI on 15Mar2017 noted normal deltoid, with no evidence to suggest myositis. A Partial-thickness, interstitial tear of the distal infraspinatus tendon, extending from the footplate to the myotendinous junction, with associated subchondral cystic change in the humeral head was noted. There was no evidence of full-thickness tear, or other abnormality. Patient was seen on 6 April by reporting Provider. She noted improving, but still present deltoid region pain with should abducting activities. No infraspinatus weakness or pain with infraspinatus movement was appreciated at that encounter. Patient saw Physical Therapy and Orthopedic Service on 17April2017.  Per, Ortho note: Continued pain was noted, especially with overhead lifting motions. PE notable as follows: ROM testing was normal. Impingement testing was positive. Diagnosed with ?impingement vs. tendonitis?  No surgical indication was found at that time.  Reporting Provider talked to patient on 30July2017.  She says overall pain picture is improving. She still has slight pain with R arm abduction. It is unknown at this time whether the clinic will/has awarded disability for R shoulder. She is still waiting for a determination on that.
Age: 25.0
Sex: M
Vaccine: ANTH, MMR
Symptoms: Chills, Fatigue, Feeling abnormal, Hyperhidrosis, Influenza like illness
Clinical narrative: RECIEVED VACCINATIONS ON 28TH OF JULY 2017 SORE AROUND THE INJECTION SITE A LITTLE FATIGUE THROUGHOUT THE DAY CONTINUED NORMAL ACTIVITIES. AROUND 11:45 STARTED TO FEEL BAD WOKE UP MULTIPLE TIME THROUGHOUT THE NIGHT IN CHILLS/SWEATING AND FLU LIKE SYMPTOMS. THOSE SYMPTOMS CONTNUED THROUGH THE DAY OF THE 29TH OF JULY AND STARTED TO SUBSIDE AROUND 1200 TO 1300 OF THE 29TH OF JULY.
Age: 25.0
Sex: M
Vaccine: ANTH, MMR
Symptoms: Injection site pain
Clinical narrative: RECIEVED VACCINATIONS ON 28TH OF JULY 2017 SORE AROUND THE INJECTION SITE A LITTLE FATIGUE THROUGHOUT THE DAY CONTINUED NORMAL ACTIVITIES. AROUND 11:45 STARTED TO FEEL BAD WOKE UP MULTIPLE TIME THROUGHOUT THE NIGHT IN CHILLS/SWEATING AND FLU LIKE SYMPTOMS. THOSE SYMPTOMS CONTNUED THROUGH THE DAY OF THE 29TH OF JULY AND STARTED TO SUBSIDE AROUND 1200 TO 1300 OF THE 29TH OF JULY.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site urticaria, Pyrexia, Urticaria
Clinical narrative: 100 degree fever and hives all over legs, feet, hands, arms and face. It began at 7AM the morning after the vaccines were given and are still persisting 48 hours after the vaccines were given. Tylenol was given twice (every 4 hours) for the fever and Children's Benadryl has been given every 4 hours (total of 4 does so far) The Doctor on-call has prescribed prednisone for the hives, but it has not been given yet.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Blood test normal, Chest X-ray, Electrocardiogram normal, Hypotension, Loss of consciousness
Clinical narrative: Instantly complained of pain and tingling in the left arm that traveled up towards the head. Instructed to sit in a chair for a few minutes. After sitting down, patient complained of not feeling well and passed out. He remained unconscious for approximately 2 minutes (best guess). When he regained consciousness, he was still very out of it and complained of needing to vomit. As he vomited, he lost consciousness again. He regained consciousness approximately 30=45 seconds later. This time he was much more coherent but vomited again. The doctor and nurses laid him down with feet elevated and he remained conscious.  He appeared to have low blood pressure. The doctor called the ambulance and he was transported to Medical Center. He remained in the ER for observation and tests and was released around 10pm that night.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Malaise, Nausea, Pain in extremity, Paraesthesia, Vomiting
Clinical narrative: Instantly complained of pain and tingling in the left arm that traveled up towards the head. Instructed to sit in a chair for a few minutes. After sitting down, patient complained of not feeling well and passed out. He remained unconscious for approximately 2 minutes (best guess). When he regained consciousness, he was still very out of it and complained of needing to vomit. As he vomited, he lost consciousness again. He regained consciousness approximately 30=45 seconds later. This time he was much more coherent but vomited again. The doctor and nurses laid him down with feet elevated and he remained conscious.  He appeared to have low blood pressure. The doctor called the ambulance and he was transported to Medical Center. He remained in the ER for observation and tests and was released around 10pm that night.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Arthritis, Myalgia, Swelling
Clinical narrative: Pt reports approx 5 days after vaccination - started having severe muscle and joint pain and swelling - "worst arthritis flare ever".  No other illness at the time, - no fever, chills or flu -like symptoms/ Lasted  approx 5-6 days. Concerned that she might have reaction if gets Tdap in future. (may need pertussis update since managing RN students in clinical).
Age: 0.83
Sex: M
Vaccine: MMR
Symptoms: Rash papular, Viral rash, Viral test positive
Clinical narrative: Red bumps on face, hands, body, feet.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Oedema peripheral, Pain, Peripheral swelling, Vomiting
Clinical narrative: Arm became swelled on inside blocking blood flow. (edema). Nausea and vomiting and pain. Went to ER gave IV fluids.
Sex: U
Vaccine: MENB
Symptoms: Feeling abnormal, Headache
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of headache in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced headache and feeling abnormal. On an unknown date, the outcome of the headache and feeling abnormal were unknown. It was unknown if the reporter considered the headache and feeling abnormal to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The GSK MSL received call from unknown person, who stated that the 2 teenage patient received BEXSERO (dose unknown) and experienced headache and feeling out of it. The person asked about mental status changes with BEXSERO. The MSL was not aware if the representative to the practice had or had not reported these events already. The reporter also noted that she received the call on 18th July or 20th July. The reporter had very limited information. This case has been linked with case US2017115591, as reported by same reporter.
Age: 0.58
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, Injection site discolouration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 5-month-old female patient who received HIBERIX (batch number 5FC3Z, expiry date 20th January 2018). Co-suspect products included HIBERIX (batch number 4294M, expiry date 20th January 2018) and HIBERIX (batch number 4B745, expiry date 23rd February 2018). On 9th January 2017, the patient received the 1st dose of HIBERIX. On 21st April 2017, the patient received the 2nd dose of HIBERIX. On 30th June 2017, the patient received the 3rd dose of HIBERIX. On 21st April 2017, not applicable after receiving HIBERIX and HIBERIX, unknown after receiving HIBERIX and not applicable after receiving HIBERIX and HIBERIX, the patient experienced drug dose administration interval too long. On 30th June 2017, the patient experienced drug dose administration internal too long. On an unknown date, the patient experienced injection site hyperpigmentation, injection site hyperpigmentation and injection site hyperpigmentation. On an unknown date, the outcome of the injection site hyperpigmentation and injection site hyperpigmentation were recovered/resolved and the outcome of the injection site hyperpigmentation was not recovered/not resolved and the outcome of the drug dose administration internal too long and drug dose administration interval too long were unknown. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation and drug dose administration interval too long to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation and drug dose administration interval too long to be related to HIBERIX. Additional details were reported as follows: The health care provider was called back with additional patient details regarding an adverse event he reported on 13th June 2017. He stated that the patients developed a hyperpigmented dark spot at the site of the injection of HIBERIX that was not resolved. It occurred with all three doses of HIBERIX which the patient received. The patient received 2nd and 3rd dose of HIBERIX later than the recommended schedule, which led to lengthening of vaccination schedule. In 2017, the events after the 1st and 2nd doses were resolved. This case was 1 of 3 cases reported by same reporter.
Age: 0.58
Sex: M
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, Injection site discolouration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 5-month-old male patient who received HIBERIX (batch number 5FC3Z, expiry date 20th January 2018). Co-suspect products included HIBERIX (batch number 4294M, expiry date 20th January 2018) and HIBERIX (batch number 4B745, expiry date 23rd February 2018). On 9th January 2017, the patient received the 1st dose of HIBERIX. On 21st April 2017, the patient received the 2nd dose of HIBERIX. On 30th June 2017, the patient received the 3rd dose of HIBERIX. On 21st April 2017, not applicable after receiving HIBERIX and HIBERIX, unknown after receiving HIBERIX and not applicable after receiving HIBERIX and HIBERIX, the patient experienced drug dose administration interval too long. On 30th June 2017, the patient experienced drug dose administration internal too long. On an unknown date, the patient experienced injection site hyperpigmentation, injection site hyperpigmentation and injection site hyperpigmentation. Rechallenge with HIBERIX was positive. Rechallenge with HIBERIX was positive. On an unknown date, the outcome of the injection site hyperpigmentation and injection site hyperpigmentation were recovered/resolved and the outcome of the injection site hyperpigmentation was not recovered/not resolved and the outcome of the drug dose administration internal too long and drug dose administration interval too long were unknown. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. Additional details were reported as follows: The health care provider was called back with additional patient details regarding an adverse event he reported on 13th June 2017. He stated that the patients developed a hyperpigmented dark spot at the site of the injection of HIBERIX that was not resolved. It occurred with all three doses of HIBERIX which the patient received. The patient received 2nd and 3rd dose of HIBERIX later than the recommended schedule, which led to lengthening of vaccination schedule. This case was 1 of 3 cases reported by same reporter.
Age: 0.58
Sex: M
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discolouration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 5-month-old male patient who received HIBERIX (batch number 5FC3Z, expiry date 20th January 2018). Co-suspect products included HIBERIX (batch number 4294M, expiry date 20th January 2018) and HIBERIX (batch number 4B745, expiry date 23rd February 2018). On 9th January 2017, the patient received the 1st dose of HIBERIX. On 21st April 2017, the patient received the 2nd dose of HIBERIX. On 30th June 2017, the patient received the 3rd dose of HIBERIX. On 21st April 2017, not applicable after receiving HIBERIX and HIBERIX, unknown after receiving HIBERIX and not applicable after receiving HIBERIX and HIBERIX, the patient experienced drug dose administration interval too long. On 30th June 2017, the patient experienced drug dose administration internal too long. On an unknown date, the patient experienced injection site hyperpigmentation, injection site hyperpigmentation and injection site hyperpigmentation. Rechallenge with HIBERIX was positive. Rechallenge with HIBERIX was positive. On an unknown date, the outcome of the injection site hyperpigmentation and injection site hyperpigmentation were recovered/resolved and the outcome of the injection site hyperpigmentation was not recovered/not resolved and the outcome of the drug dose administration internal too long and drug dose administration interval too long were unknown. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. Additional details were reported as follows: The health care provider was called back with additional patient details regarding an adverse event he reported on 13th June 2017. He stated that the patients developed a hyperpigmented dark spot at the site of the injection of HIBERIX that was not resolved. It occurred with all three doses of HIBERIX which the patient received. The patient received 2nd and 3rd dose of HIBERIX later than the recommended schedule, which led to lengthening of vaccination schedule. This case was 1 of 3 cases reported by same reporter.
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult female patient who received Hepatitis B vaccine. Co-suspect products included ENGERIX B. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. In December 2016, the patient received ENGERIX B. In July 2017, unknown after receiving Hepatitis B vaccine and less than a year after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and therapy non-responder were unknown. It was unknown if the reporter considered the therapy non-responder and therapy non-responder to be related to Hepatitis B vaccine. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B. Additional details were provided as follows: This case was reported by a nurse, who herself was the patient. The age at vaccination was not reported, but it could be 41 years or 42 years. The patient received a full series of an unknown brand of hepatitis B vaccine in 1991 and had negative titers drawn in 1995. Thus, leading to be a therapy non-responder. In December 2016, one dose of ENGERIX-B was given as a booster dose to the patient. In July 2017, two weeks before the reporting date, negative titers were drawn. Thus, again leading the patient to be a therapy non-responder.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Fatigue, Migraine, Paraesthesia, Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a 17-year-old female patient who received BEXSERO. On 7th July 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 7th July 2017, 2 hrs after receiving BEXSERO, the patient experienced fatigue, fever and migraine. In July 2017, the patient experienced tingling and tremor. In July 2017, the outcome of the fatigue, fever, migraine, tingling and tremor were recovered/resolved. It was unknown if the reporter considered the fatigue, fever, migraine, tingling and tremor to be related to BEXSERO. Additional details were reported as follows: The patient's age at vaccination was 17 years and 7 months old. Six hours after vaccination, the patient experienced migraine and had fever of 100 degree F. Fifteen hours post vaccination, the patient was shaky, her fingers felt tingly and had fever of 102 degree F. The reporter did not know if the vaccine was administered at the main office or at the satellite office.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Fatigue, Feeling abnormal, Migraine, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a 17-year-old female patient who received BEXSERO. On 7th July 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 7th July 2017, 2 hrs after receiving BEXSERO, the patient experienced fatigue, fever and migraine. In July 2017, the patient experienced tingling and tremor. In July 2017, the outcome of the fatigue, fever, migraine, tingling and tremor were recovered/resolved. It was unknown if the reporter considered the fatigue, fever, migraine, tingling and tremor to be related to BEXSERO. Additional details were reported as follows: The patient's age at vaccination was 17 years and 7 months old. Six hours after vaccination, the patient experienced migraine and had fever of 100 degree F. Fifteen hours post vaccination, the patient was shaky, her fingers felt tingly and had fever of 102 degree F. The reporter did not know if the vaccine was administered at the main office or at the satellite office.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Tremor
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a 17-year-old female patient who received BEXSERO. On 7th July 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 7th July 2017, 2 hrs after receiving BEXSERO, the patient experienced fatigue, fever and migraine. In July 2017, the patient experienced tingling and tremor. In July 2017, the outcome of the fatigue, fever, migraine, tingling and tremor were recovered/resolved. It was unknown if the reporter considered the fatigue, fever, migraine, tingling and tremor to be related to BEXSERO. Additional details were reported as follows: The patient's age at vaccination was 17 years and 7 months old. Six hours after vaccination, the patient experienced migraine and had fever of 100 degree F. Fifteen hours post vaccination, the patient was shaky, her fingers felt tingly and had fever of 102 degree F. The reporter did not know if the vaccine was administered at the main office or at the satellite office.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: PMR. See time line and Doctor list. Ongoing treatment by Dr.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Enterovirus test, Generalised tonic-clonic seizure, Polymerase chain reaction
Clinical narrative: Patient has had multiple seizures since his 6 month immunizations. They started June 13th and his last one was July 11.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Electroencephalogram abnormal, Epilepsy, Nuclear magnetic resonance imaging normal, Seizure
Clinical narrative: Patient has had multiple seizures since his 6 month immunizations. They started June 13th and his last one was July 11.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Nurse received via a Pfizer sales representative.  A 18-years-old female patient received on 14Jul2017  the first dose of TRUMENBA (lot R45077, exp date Jul2018, NDC number: 0005010005), at 0.5 ml, single and MENACTRA (lot U5392AB, exp date 18Sep2017, NDC number: 4928158905), both via an unspecified route of administration for immunisation. The patient received meningococcal group b and meningococcal vaccine a/c/y/w conj (dip tox) in the same arm on the same day. Medical history included ongoing hypertension, ongoing polycystic ovaries and ongoing insulin resistance. Concomitant medication included ongoing metformin (unknown manufacturer) for insulin resistance, ongoing dicycloverine hydrochloride (BENTYL) at 10 mg, ongoing lisinopril and hydrochlorothiazide (unknown manufacturer) for hypertension, and drospirenone, ethinylestradiol (VESTURA) for polycystic ovaries. On 18Jul2017 the patient experienced a local reaction, cellulitis in the arm at the injection site. The patient had still cellulitis on 21Jul2017. The nurse treated it with Cephalexin and methylprednisolone (MEDROL DOSEPAK) on 21Jul2017. The final outcome of the event was unknown.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: This is a spontaneous report from a contactable Nurse received via a Pfizer sales representative.  A 18-years-old female patient received on 14Jul2017  the first dose of TRUMENBA (lot R45077, exp date Jul2018, NDC number: 0005010005), at 0.5 ml, single and MENACTRA (lot U5392AB, exp date 18Sep2017, NDC number: 4928158905), both via an unspecified route of administration for immunisation. The patient received meningococcal group b and meningococcal vaccine a/c/y/w conj (dip tox) in the same arm on the same day. Medical history included ongoing hypertension, ongoing polycystic ovaries and ongoing insulin resistance. Concomitant medication included ongoing metformin (unknown manufacturer) for insulin resistance, ongoing dicycloverine hydrochloride (BENTYL) at 10 mg, ongoing lisinopril and hydrochlorothiazide (unknown manufacturer) for hypertension, and drospirenone, ethinylestradiol (VESTURA) for polycystic ovaries. On 18Jul2017 the patient experienced a local reaction, cellulitis in the arm at the injection site. The patient had still cellulitis on 21Jul2017. The nurse treated it with Cephalexin and methylprednisolone (MEDROL DOSEPAK) on 21Jul2017. The final outcome of the event was unknown.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Injection site cellulitis
Clinical narrative: This is a spontaneous report from a contactable Nurse received via a Pfizer sales representative.  A 18-years-old female patient received on 14Jul2017  the first dose of TRUMENBA (lot R45077, exp date Jul2018, NDC number: 0005010005), at 0.5 ml, single and MENACTRA (lot U5392AB, exp date 18Sep2017, NDC number: 4928158905), both via an unspecified route of administration for immunisation. The patient received meningococcal group b and meningococcal vaccine a/c/y/w conj (dip tox) in the same arm on the same day. Medical history included ongoing hypertension, ongoing polycystic ovaries and ongoing insulin resistance. Concomitant medication included ongoing metformin (unknown manufacturer) for insulin resistance, ongoing dicycloverine hydrochloride (BENTYL) at 10 mg, ongoing lisinopril and hydrochlorothiazide (unknown manufacturer) for hypertension, and drospirenone, ethinylestradiol (VESTURA) for polycystic ovaries. On 18Jul2017 the patient experienced a local reaction, cellulitis in the arm at the injection site. The patient had still cellulitis on 21Jul2017. The nurse treated it with Cephalexin and methylprednisolone (MEDROL DOSEPAK) on 21Jul2017. The final outcome of the event was unknown.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Cellulitis, Local reaction
Clinical narrative: This is a spontaneous report from a contactable Nurse received via a Pfizer sales representative.  A 18-years-old female patient received on 14Jul2017  the first dose of TRUMENBA (lot R45077, exp date Jul2018, NDC number: 0005010005), at 0.5 ml, single and MENACTRA (lot U5392AB, exp date 18Sep2017, NDC number: 4928158905), both via an unspecified route of administration for immunisation. The patient received meningococcal group b and meningococcal vaccine a/c/y/w conj (dip tox) in the same arm on the same day. Medical history included ongoing hypertension, ongoing polycystic ovaries and ongoing insulin resistance. Concomitant medication included ongoing metformin (unknown manufacturer) for insulin resistance, ongoing dicycloverine hydrochloride (BENTYL) at 10 mg, ongoing lisinopril and hydrochlorothiazide (unknown manufacturer) for hypertension, and drospirenone, ethinylestradiol (VESTURA) for polycystic ovaries. On 18Jul2017 the patient experienced a local reaction, cellulitis in the arm at the injection site. The patient had still cellulitis on 21Jul2017. The nurse treated it with Cephalexin and methylprednisolone (MEDROL DOSEPAK) on 21Jul2017. The final outcome of the event was unknown.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Pruritus, Urticaria
Clinical narrative: Itching on upper back started 6pm sat evening. Woke up sunday morning 9am with inflamed upper back and hives. tremendous itching.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram, Exposure during pregnancy, Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: G5 P2 T2 AB 2 Living 2 SAB 1; EDC - 11/18/16, Birth Weight = 8lb 9.9oz; No adverse reactions noted after injection was given, no complaints from patient after it was given, patient left office ambulatory, without ill effects noted. on 11/9/16 pt called office complaining of pain in arm, despite using warm/cool compresses and taking Tylenol. Nurse advised patient that the Tetanus portion of the vaccine can cause the arm to feel very sore. To continue with cool compresses 20 minutes on / 20 minutes off, and to continue taking Tylenol every 4-6 hours.  Patient denied any redness at the site, and denied any chills or fever. Patient seen next day in office for her routine prenatal visit on 11/10/16. No mention.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Sleep disorder
Clinical narrative: G5 P2 T2 AB 2 Living 2 SAB 1; EDC - 11/18/16, Birth Weight = 8lb 9.9oz; No adverse reactions noted after injection was given, no complaints from patient after it was given, patient left office ambulatory, without ill effects noted. on 11/9/16 pt called office complaining of pain in arm, despite using warm/cool compresses and taking Tylenol. Nurse advised patient that the Tetanus portion of the vaccine can cause the arm to feel very sore. To continue with cool compresses 20 minutes on / 20 minutes off, and to continue taking Tylenol every 4-6 hours.  Patient denied any redness at the site, and denied any chills or fever. Patient seen next day in office for her routine prenatal visit on 11/10/16. No mention.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient. On 05-JUL-2017, the patient was vaccinated with ZOSTAVAX lot number reported as M0374655, for prophylaxis. In July 2017, the patient experienced injection site mass. The outcome of injection site mass was reported as not recovered/not resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration was unknown) as recommended for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about the dates of 07-JUL-2016, 09-JUL-2016 and 20-JUL-2016, the patient was treated by a nurse practitioner for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 09-AUG-2016, the patient was treated by a physician for ongoing and worsening symptoms of shingles and nerve pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further and proximate result, the patient has suffered and will continue to suffer significant ,medical expenses, pain and suffering, and other damages. The outcome of the events was not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 15-DEC-2015, the patient was vaccinated with ZOSTAVAX (dose, route of administration and lot number were not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUL-2016, the patient was treated by a physician for an ongoing vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a nurse refers to a patient of unknown age. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with VARIVAX lot # M005971 for prophylaxis. The Nurse reported that the vaccine administered was improperly stored. No adverse event reported. The outcome of incorrect product storage and no adverse event was unknown. Lot M005971 was stored at 12°C for 63 hours, and in the range of -14°C to-10°C for 487.5 hours. No previous temperature excursion. The call was not because of a "data logger". This is one of the several reports reported from same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA010910: US-009507513-1707USA010911: US-009507513-1707USA010912: US-009507513-1707USA010913: US-009507513-1707USA010914: US-009507513-1707USA010915: US-009507513-1707USA010916: US-009507513-1707USA010917: US-009507513-1707USA010918: US-009507513-1707USA010919: US-009507513-1707USA010920: US-009507513-1707USA010921: US-009507513-1707USA010922: US-009507513-1707USA010923.