chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 24 unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX lot # reported as M020900 with an expiration date: 27-APR-2018, subcutaneously for prophylaxis (dose and frequency were not reported). Administered doses of VARIVAX experienced temperature excursion of 6.2 degree Fahrenheit for 14 hours and 28 minutes, on 02-AUG-2016; 6.2 degree Fahrenheit for 13 hours and 45 minutes on 05-AUG-2016; 6.2 degree Fahrenheit for 14 hours and 10 minutes on 11-AUG-2016, 6.2 degree Fahrenheit for 13 hours and 59 minutes on 22-AUG-2016, 6.2 degree Fahrenheit for 61 hours and 50 minutes on 29-AUG-2016. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported. Lot number M020900 is an invalid lot number for VARIVAX. As of 17-NOV-2016, all telephone attempts to obtain follow up information have been unsuccessful. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1609USA009328:, MERCK 1610USA001427:Mfr number.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of improperly stored doses of M-M-R II (rHA) (lot# L040960, batch/lot# M008588, expiry dates and dosing details not known) for prophylaxis. The lot# L040960 was stored at 9.6 Celsius(C) for 46 hours and batch/lot# M008588 was stored at 9.6 Celsius(C) for 19 hours. No adverse effects were reported. There was no product quality complaint (PQC) involved. Lot number M008588 has been verified to be a valid lot number for M-M-R II. As of 02-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: MERCK 1610USA001709:Mfr number.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer referring to three patients of unknown ages a genders. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). It was reported that, on unknown dates, the vaccine was administered to five patients and three of them came down with shingles (one of the cases was captured in MARRS # 1612USA000543). The outcome of herpes zoster was unknown at the time of the report. The causality assessment between the event and the suspect product was not reported. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up. Sender's Comments: US-009507513-1612USA000543.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report concerning a male patient of unknown age, was received from the patient's wife. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date, the patient got shingles, went right the doctor and got his medicine. It was reported that he was out of comission for about a week. The outcome of herpes zoster was reported as recovering (also reported as unknown) as the patient felt better after taking his medicine. The causality assessment between the event and the suspect product was not reported. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up. Sender's Comments: US-009507513-1611USA012814.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Patient reported Right Arm pain from shoulder joint to wrist day after vaccine administered on 11/15/16. 12/7/16 patient still experiences some shoulder joint pain, possibly in tendon.
Age: 76.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Consciousness fluctuating, Hyperhidrosis, Hypotension, Immunisation reaction
Clinical narrative: Patient reports passing out and being transported to the emergency room via ambulance after experiencing severe pain in the right arm. She had severe pain in the right arm, chills, sweating and nausea. Once EMS arrived patient was in and out of consciousness and unable to assist them in maneuvering herself. Once in the hospital patient had hypotension as well and was admitted for 24 hours following 6 hours in the emergency room.
Age: 76.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Loss of consciousness, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Patient reports passing out and being transported to the emergency room via ambulance after experiencing severe pain in the right arm. She had severe pain in the right arm, chills, sweating and nausea. Once EMS arrived patient was in and out of consciousness and unable to assist them in maneuvering herself. Once in the hospital patient had hypotension as well and was admitted for 24 hours following 6 hours in the emergency room.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis around injection site.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Crying, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Rash erythematous
Clinical narrative: Immediate swelling, redness, and a large 15cm induration to injection site (right thigh).  Inconsolable crying in an otherwise happy baby.  Red spots on forehead.  Gave 12.5mg Benadryl and 160mg Tylenol.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site warm to touch. Length of bicep is red and slightly swollen. Possibly spreading down arm. Patient went to doctors office and got out-patient treatment of doxycycline and prednisone.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Malaise, Pain, Pruritus
Clinical narrative: Injection site swelling, pain, itching, overall malaise.
Age: 0.25
Sex: M
Vaccine: DTAPIPV, HIBV, RVX
Symptoms: Drug administered to patient of inappropriate age, Incorrect product formulation administered
Clinical narrative: He was given the wrong shot.  The DTaP and polio combination shot that was labeled for 4 to 6 year old was given instead of the 4 month old. Also the hib was not mixed so he was only given the water instead of the vaccine.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient woke up from a nap and complained of warm, red, raised, itching area about 2 inches in diameter at the site of injection (left arm, IM injection)--- no trouble breathing,no systemic rash, no facial involvement.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and warmth to the touch at injection site.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Epistaxis, Fall, Gingival pain, Laceration, Syncope
Clinical narrative: Patient fainted and fell to the ground within minutes after the flu shot. Patient was discovered when he stood up from the fall outside of the pharmacy drop-off area with bloody nose, few lacerations, and a missing tooth. Pharmacist assessed patient and he said he was fine. Pharmacy staff and store staff helped patient cleaned up and was feeling fine when Aunt came to pick patient up about 25 minutes later.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Tooth loss
Clinical narrative: Patient fainted and fell to the ground within minutes after the flu shot. Patient was discovered when he stood up from the fall outside of the pharmacy drop-off area with bloody nose, few lacerations, and a missing tooth. Pharmacist assessed patient and he said he was fine. Pharmacy staff and store staff helped patient cleaned up and was feeling fine when Aunt came to pick patient up about 25 minutes later.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Redness, local injection site reaction.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Nurse inadvertently administered 3rd dose of vaccine series without verifying pregnancy status. Pt informed vaccine would be reported to VAERS. Pt states she was not worried.
Age: 5.0
Sex: F
Vaccine: MMR, TD
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Large swelling and redness to arm.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Crying, Injection site erythema, Injection site induration, Injection site pain, Pain
Clinical narrative: Excessive crying and redness at the site of injection with pain during moving the legs actively needing 1 ml of 160/5ml Tylenol and induration at the site of vaccines- Pediarix and PCV on the left thigh with 3 cm diameter induration on 12/6 when they came back to see me. Will follow up in 2 days to see if it is resolving. Vaccine administered 12/5. Seen again by PCP 12/7 - patient moving legs actively but induration of 3 cm still palpated.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Pyrexia
Clinical narrative: Patient received his PEDIARIX PCV on the left thigh - vaccines on 12/1 and mother noted that he had hard red bumps and unable to move his leg for 1 day. They have been massaging it and it has gotten smaller. She did give him 1 ml of TYLENOL 160/ 5ml on the day of vaccine due to fever of 99. On the follow up visit on 12/5 I palpated 2 cm induration of the left thigh at the site of vaccines but the baby was moving his legs and feeding and active.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC
Symptoms: Dyspnoea
Clinical narrative: Difficulty Breathing.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Constant pain in the vaccinated arm for 3 months and counting.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose decreased, Decreased appetite, Nodule, Ultrasound scan, Vision blurred
Clinical narrative: Patient states she experienced blurred vision, decreased appetite, low blood sugar and a knot under her arms requiring a doctors visit resulting in an ultrasound and antibiotic treatment.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Appetite disorder, Axillary pain, Blood glucose decreased, Dizziness, Local swelling
Clinical narrative: Patient states she experienced blurred vision, decreased appetite, low blood sugar and a knot under her arms requiring a doctors visit resulting in an ultrasound and antibiotic treatment.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lymph node pain, Malaise, Nausea, Poor quality sleep, Ultrasound scan
Clinical narrative: Patient states she experienced blurred vision, decreased appetite, low blood sugar and a knot under her arms requiring a doctors visit resulting in an ultrasound and antibiotic treatment.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Visual impairment
Clinical narrative: Patient states she experienced blurred vision, decreased appetite, low blood sugar and a knot under her arms requiring a doctors visit resulting in an ultrasound and antibiotic treatment.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axonal neuropathy, CSF protein increased, Electroencephalogram abnormal, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Pt awoke with generalized weakness of peripheral muscles, progressed through the day to extreme weakness of legs. Presented to ED where she was diagnosed with Guillain Barre.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nuclear magnetic resonance imaging brain normal
Clinical narrative: Pt awoke with generalized weakness of peripheral muscles, progressed through the day to extreme weakness of legs. Presented to ED where she was diagnosed with Guillain Barre.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Acute motor axonal neuropathy, Cytomegalovirus test negative, Guillain-Barre syndrome, Lumbar puncture abnormal, Quadriplegia
Clinical narrative: Pt awoke with generalized weakness of peripheral muscles, progressed through the day to extreme weakness of legs. Presented to ED where she was diagnosed with Guillain Barre.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: West Nile virus test negative
Clinical narrative: Pt awoke with generalized weakness of peripheral muscles, progressed through the day to extreme weakness of legs. Presented to ED where she was diagnosed with Guillain Barre.
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Injection site rash, Loss of consciousness, Syncope
Clinical narrative: Syncope without warning at 6:00pm, "blacked out" for approximately 10 seconds. Rash at injection site approximately 3.5cm wide and 5cm tall, not noticed until 8:36pm same day. Blood pressure 144/85 mmHg Right arm, HR 84 bpm. Still dizzy and lightheaded at 9:05pm same day.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Body temperature decreased, Chills, Headache
Clinical narrative: Chills, low temperature, shivers, weakness, headache.  Happens every time flu shot has been administered for the past 6 years.
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Tenderness
Clinical narrative: Case number PHEH2016US031086 is initial spontaneous case received from other health care professional on 25 Nov 2016. This report refers to male patient of unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1620301, expiry date not reported) at a dose of 0.5 ml intramuscular on 24 Oct 2016. On the same day, the patient experienced localized tenderness and painful range of motion. The patient received large doses of NSAIDS (unspecified) and ice to improve. The patient could not use arm for 2 to 3 days. The outcome of the events was reported as complete recovery on 28 Oct 2016. The seriousness of the events was reported as disability. The causality of the events was not reported.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of loss of consciousness in a 41-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5S349, expiry date 31st May 2017). Concomitant products included MOBIC and TOPAMAX. On 16th November 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 16th November 2016, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced loss of consciousness (serious criteria hospitalization, disability, GSK medically significant, life threatening and other: As per reporter). On an unknown date, the outcome of the loss of consciousness was recovering/resolving. The reporter considered the loss of consciousness to be possibly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was reported by GlaxoSmithKline Nurse Practitioner (NP). The patient received FLULAVAL QUADRIVALENT in the right arm. The patient was taken from the GSK vaccine administration site by emergency medical room (EMS) and was hospitalized for three days. The nurse practitioner reported that the patient stated that the physician at the hospital said that the loss of consciousness was related to the FLULAVAL QUADRIVALENT.    This case was reported by a nurse via call center representative and described the occurrence of loss of consciousness in a 41-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5S349, expiry date 31st May 2017). Concomitant products included MOBIC and TOPAMAX. On 16th November 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 16th November 2016, less than a day after receiving of FLULAVAL QUADRIVALENT, the patient experienced loss of consciousness (serious criteria hospitalization, disability, GSK medically significant, life threatening and other: As per reporter). On an unknown date, the outcome of the loss of consciousness was recovering/resolving. The reporter considered the loss of consciousness to be possibly related to of FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was reported by GlaxoSmithKline Nurse Practitioner (NP). The patient received FLULAVAL QUADRIVALENT in the right arm. The patient was taken from the GSK vaccine administration site by emergency medical room (EMS) and was hospitalized for three days. The nurse practitioner reported that the patient stated that the physician at the hospital said that the loss of consciousness was related to the FLULAVAL QUADRIVALENT.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Fatigue, Headache, Injection site bruising, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 13-year-old male patient who received FLUARIX QUADRIVALENT. On 25th October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injection site bruising, headache, fatigue, drowsiness, muscle pain and stomach pain. On an unknown date, the outcome of the injection site pain, injection site bruising, headache, fatigue, drowsiness, muscle pain and stomach pain were unknown. It was unknown if the reporter considered the injection site pain, injection site bruising, headache, fatigue, drowsiness, muscle pain and stomach pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows:  The reporting nurse was patients mother. The nurse stated that the patient received vaccine at hospital. The reporter did not have batch number. The reporter stated she had read the package label and was aware of the continuous discharge certificate (CDC) recommendation, but looking for any additional information. This case is one of the 4 cases, reported by the same reporter.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Somnolence
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 13-year-old male patient who received FLUARIX QUADRIVALENT. On 25th October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injection site bruising, headache, fatigue, drowsiness, muscle pain and stomach pain. On an unknown date, the outcome of the injection site pain, injection site bruising, headache, fatigue, drowsiness, muscle pain and stomach pain were unknown. It was unknown if the reporter considered the injection site pain, injection site bruising, headache, fatigue, drowsiness, muscle pain and stomach pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows:  The reporting nurse was patients mother. The nurse stated that the patient received vaccine at hospital. The reporter did not have batch number. The reporter stated she had read the package label and was aware of the continuous discharge certificate (CDC) recommendation, but looking for any additional information. This case is one of the 4 cases, reported by the same reporter.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Middle insomnia, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a female patient who received FLUARIX QUADRIVALENT. On 20th October 2016, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injected limb mobility decreased, pain in arm, nocturnal awakening and tingling of extremity. On an unknown date, the outcome of the injection site pain, injected limb mobility, pain in arm, nocturnal awakening and tingling of extremity were unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, pain in arm, nocturnal awakening, and tingling of extremity to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not reported previously to anyone. The age at vaccination was not reported. The patient received FLUARIX QUADRIVALENT on an arm. The patient experienced pain at the injection site for a couple of days, and for the last couple of weeks from the date of reporting she experienced pain in her arm starting at her shoulder and extending down in to her elbow. Sometimes the pain also tingle down in to her thumb. It was difficult for her to raise her arm. On more than one occasion, the pain had caused her to wake up during the night. Field representative was unable to provide any additional details.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: C-reactive protein increased, Injection site pain, Red blood cell sedimentation rate increased
Clinical narrative: Persistent pain in arm at injection site for 2 months. Did not respond to MEDROL dosepak or Ibuprofen.
Age: 62.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Arthralgia, Hypoaesthesia, Injected limb mobility decreased, Middle insomnia, Muscle spasms
Clinical narrative: 10/15: (L) arm felt stiff and sore. 10/16: Couldn't move arm and has been bothering patient ever since. Kept getting Charlie horse constantly at night and would wake her up in pain. 10/27 doctor visit did not give any treatment. Doctor did not give anything. Thought it was related to other health problems. 11/2 doctor prescribed cortisone/steroids but did not take it. No longer has charley horse but could not sleep well because of the pain. Cant trust movement in arm would drop things. Never had problem before with vaccines. Not sure it hit a nerve or had a reaction. Experiencing problems in arm; joint pain, limited movement, pain from shoulder down to arm. Arm goes to sleep, not as painful as charley horse but still is nerve racking because cant trust movement in arm. Had doctor apt on 11/30 and another scheduled for 12/30.
Age: 62.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Musculoskeletal stiffness, Pain in extremity, Poor quality sleep
Clinical narrative: 10/15: (L) arm felt stiff and sore. 10/16: Couldn't move arm and has been bothering patient ever since. Kept getting Charlie horse constantly at night and would wake her up in pain. 10/27 doctor visit did not give any treatment. Doctor did not give anything. Thought it was related to other health problems. 11/2 doctor prescribed cortisone/steroids but did not take it. No longer has charley horse but could not sleep well because of the pain. Cant trust movement in arm would drop things. Never had problem before with vaccines. Not sure it hit a nerve or had a reaction. Experiencing problems in arm; joint pain, limited movement, pain from shoulder down to arm. Arm goes to sleep, not as painful as charley horse but still is nerve racking because cant trust movement in arm. Had doctor apt on 11/30 and another scheduled for 12/30.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Arthralgia, Blood pressure increased, Confusional state, Injection site pain, Joint range of motion decreased
Clinical narrative: Fever, acute joint pain, mental confusion, elevated blood pressure, limited arm movement range and injection site soreness.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever, acute joint pain, mental confusion, elevated blood pressure, limited arm movement range and injection site soreness.
Age: 90.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site haematoma
Clinical narrative: At injection site, 3" x 2" hematoma or fluid pocket developed. Palpated it and it was soft and fluid filled. No pain, no SOB, no tingling or discomfort. Color was dark purple.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Received vaccine 11-28-16. This morning mom noted red rash over injection site and it was firm to touch. -Left deltoid with a 3x3 inch area of redness. Mildly warm to touch. ROM normal.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Lip swelling
Clinical narrative: Patient experienced swelling on his lips, appear dropped.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Pain in extremity
Clinical narrative: Received Imm 11-28-16. Mom noticed red itchy rash at injection site last evening, it was firm to touch. This morning she had arm pain while putting on her shirt. Left deltoid with 4 x 4 inch area of redness some induration, mildly warm. ROM normal.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Feeling cold, Nausea, Pyrexia
Clinical narrative: 102 degree F fever, coughing badly, shivering nausea, feeling freezing cold.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4GX4F, expiry date 30th June 2017). On 17th November 2016, the patient received FLUARIX QUADRIVALENT 0.5 ml. On 23rd November 2016, 6 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unchanged. It was unknown if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: On the day of reporting the patient came to reporter and was still having pain in the right arm after receiving FLUARIX QUADRIVALENT in the right deltoid. No other information was provided nor any other adverse event was reported.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Dysphagia, Dyspnoea, Eye discharge, Eye pain, Ocular hyperaemia
Clinical narrative: Had shot on 11/29/16 around 11:30 AM. at 6:30 had to go to ER: experienced breathing problem. Complete red and sore eyes with white fluid coming out when rubbed, sore throat with swallowing problem. Was given 4 medications and injection at hospital observed for one hour. Sent home with prescription for CLARITIN and ZANTAC for 3 days.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Oropharyngeal pain
Clinical narrative: Had shot on 11/29/16 around 11:30 AM. at 6:30 had to go to ER: experienced breathing problem. Complete red and sore eyes with white fluid coming out when rubbed, sore throat with swallowing problem. Was given 4 medications and injection at hospital observed for one hour. Sent home with prescription for CLARITIN and ZANTAC for 3 days.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Palpitations, Vaccination complication
Clinical narrative: Employee stated she had racing heart within 30 mins to receiving the flu shot. Was seen in the ER and they stated it was anxiety per the employee. Seen by cardiologist who could only come up with severe reaction to flu vaccine. No previous history when flu shot given in past years.
Age: 8.0
Sex: U
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Pt fainted at check out desk about 1 minute after receiving vaccine, was passed out for about 15 seconds. Pt was brought back to room, feet elevated, and evaluated by MD.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Local reaction, Palpitations, Pharyngeal oedema
Clinical narrative: 30 minutes after receiving flu vaccine she had a local reaction as well as throat swelling, palpitations, and difficulty breathing.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Nausea, Pyrexia, Syncope, Vomiting
Clinical narrative: Pt reported fever and N/V on day following vaccine. At one point he fainted for about 5 minutes and was taken to the ER after that. He recovered completely.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Headache, Pain, Vomiting
Clinical narrative: Vomiting, diarrhea, headache, body ache.
Age: 50.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Induration, Pruritus, Rash, Skin warm
Clinical narrative: 4 x 6 cm area of induration, redness with warmth and rash, itching x 10 days.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: 16 x 7 cm area with erythema and warmth.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injection site urticaria
Clinical narrative: Urticaria at injection site within 2-3 days of GARDASIL administration - local care only (right deltoid),
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Poor quality sleep
Clinical narrative: Dull, ongoing pain at site of injection; occasionally wakes me up if sleeping on left arm (injected arm), sore to the touch.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Dysphonia, Hypoaesthesia, Muscle spasms, Neuralgia
Clinical narrative: Symptoms began 2 days after vaccine and progressed: spasms/burning in testicles, bladder, thighs, legs; numbness in buttocks, penis; frequent urination and urinary retention; hoarseness; sexual dysfunction; neuropathic burning in legs, feet, palms.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Pollakiuria, Sexual dysfunction, Urinary retention
Clinical narrative: Symptoms began 2 days after vaccine and progressed: spasms/burning in testicles, bladder, thighs, legs; numbness in buttocks, penis; frequent urination and urinary retention; hoarseness; sexual dysfunction; neuropathic burning in legs, feet, palms.
Sex: U
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Swollen lower limb. Since Monday patient says its fine.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm 1+1/2 days then hard swollen, is still swollen.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Heart rate increased, Malaise, Nausea
Clinical narrative: After receiving the flu shot in the afternoon she was fine then at night she starts having fever >101, nausea, chills, headache, increase heart rate and noticed her veins/blood vessels swollen. She felt very sick and went to ER.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vein disorder
Clinical narrative: After receiving the flu shot in the afternoon she was fine then at night she starts having fever >101, nausea, chills, headache, increase heart rate and noticed her veins/blood vessels swollen. She felt very sick and went to ER.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema multiforme, Urticaria
Clinical narrative: Received flu vaccine on 12/5/16 at 530pm, on 12/6/16 at 3pm child developed hives on (R)deltoid, face, and buttocks. Child was picked up form daycare given BENADRYL, then at 1030 pm mom went to give BENADRYL again and hives were all over legs, trunk, stomach, back, hands, feet. Saw pediatrician on 12/7/16 at 9am diagnosed with erythema multiforme rash unknown etiology started on prednisone therapy 12/7/16. No fever.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills, Cold sweat, Pain, Tremor
Clinical narrative: Pt developed chills and body aches after receiving flu vaccine. Next day she threw up without warning and has had some chest burning. She also reports feeling clammy and shaky.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Pt developed chills and body aches after receiving flu vaccine. Next day she threw up without warning and has had some chest burning. She also reports feeling clammy and shaky.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Chest pain, Conjunctivitis, Eye inflammation, Eye irritation
Clinical narrative: Feeling ill, horrible aches 4 days straight. They went away by 10/28, 10/29, 10/30. Fever started on 10/31/16. 11/1 and 11/2 headaches started again. 11/13 woke up with tongue swelling and throat shut, horrible body aches, headaches. 11/4 went to doctor, given NAPROSYN for headaches, did not help so stopped taking it. Body aches. Fever only at night time only. 11/5 and 11/6 still feeling ill. Week of 11/7 feeling better. 11/14 was sick again, doctor thought it was sinus infection so ordered amoxicillin. Completed treatment. Eyes started to get red and irritated through 11/17. On 11/15 doctor thought it was pink eye. Had muscle pain and muscle pain. 11/26 Tongue swollen up again and eyes red, irritated and teary. Even had a little chest pain because scared. 11/28 went to eye surgeon consultation. Had inflammation on retina of eyes. Given steroids, neomycin. Has rheumatoid specialist appointment tomorrow for the acute retina inflammation.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lacrimation increased, Malaise, Myalgia, Ocular hyperaemia
Clinical narrative: Feeling ill, horrible aches 4 days straight. They went away by 10/28, 10/29, 10/30. Fever started on 10/31/16. 11/1 and 11/2 headaches started again. 11/13 woke up with tongue swelling and throat shut, horrible body aches, headaches. 11/4 went to doctor, given NAPROSYN for headaches, did not help so stopped taking it. Body aches. Fever only at night time only. 11/5 and 11/6 still feeling ill. Week of 11/7 feeling better. 11/14 was sick again, doctor thought it was sinus infection so ordered amoxicillin. Completed treatment. Eyes started to get red and irritated through 11/17. On 11/15 doctor thought it was pink eye. Had muscle pain and muscle pain. 11/26 Tongue swollen up again and eyes red, irritated and teary. Even had a little chest pain because scared. 11/28 went to eye surgeon consultation. Had inflammation on retina of eyes. Given steroids, neomycin. Has rheumatoid specialist appointment tomorrow for the acute retina inflammation.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Red blood cell sedimentation rate increased, Sinusitis, Swollen tongue
Clinical narrative: Feeling ill, horrible aches 4 days straight. They went away by 10/28, 10/29, 10/30. Fever started on 10/31/16. 11/1 and 11/2 headaches started again. 11/13 woke up with tongue swelling and throat shut, horrible body aches, headaches. 11/4 went to doctor, given NAPROSYN for headaches, did not help so stopped taking it. Body aches. Fever only at night time only. 11/5 and 11/6 still feeling ill. Week of 11/7 feeling better. 11/14 was sick again, doctor thought it was sinus infection so ordered amoxicillin. Completed treatment. Eyes started to get red and irritated through 11/17. On 11/15 doctor thought it was pink eye. Had muscle pain and muscle pain. 11/26 Tongue swollen up again and eyes red, irritated and teary. Even had a little chest pain because scared. 11/28 went to eye surgeon consultation. Had inflammation on retina of eyes. Given steroids, neomycin. Has rheumatoid specialist appointment tomorrow for the acute retina inflammation.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: Feeling ill, horrible aches 4 days straight. They went away by 10/28, 10/29, 10/30. Fever started on 10/31/16. 11/1 and 11/2 headaches started again. 11/13 woke up with tongue swelling and throat shut, horrible body aches, headaches. 11/4 went to doctor, given NAPROSYN for headaches, did not help so stopped taking it. Body aches. Fever only at night time only. 11/5 and 11/6 still feeling ill. Week of 11/7 feeling better. 11/14 was sick again, doctor thought it was sinus infection so ordered amoxicillin. Completed treatment. Eyes started to get red and irritated through 11/17. On 11/15 doctor thought it was pink eye. Had muscle pain and muscle pain. 11/26 Tongue swollen up again and eyes red, irritated and teary. Even had a little chest pain because scared. 11/28 went to eye surgeon consultation. Had inflammation on retina of eyes. Given steroids, neomycin. Has rheumatoid specialist appointment tomorrow for the acute retina inflammation.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Swelling described as size of half a golf ball with warmth. Reported no respiratory issues or chest pain.
Sex: U
Vaccine: DTAP, DTAPIPV, FLU4, HEP, HEPA, TDAP
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of drug maladministration in a patient who received INFANRIX. Co-suspect products included HAVRIX, KINRIX, BOOSTRIX, ENGERIX B and FLUARIX Quadrivalent for an unknown indication. On an unknown date, the patient received INFANRIX at an unknown dose, HAVRIX at an unknown dose, KINRIX at an unknown dose, BOOSTRIX at an unknown dose, ENGERIX B at an unknown dose and FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, HAVRIX, KINRIX, BOOSTRIX, ENEGRIX B AND FLUARIX Quadrivalent, the patient experienced drug maladministration. On an unknown date, the outcome of the drug maladministration was unknown. Additional details were provided as follows: The patient age at vaccination was not reported. The healthcare professional stated that the adverse event was already reported. The patient received INFANRIX, HAVRIX, KINRIX, BOOSTRIX, ENGERIX B AND FLUARIX, which led to maladministration. The healthcare professional did not provide details concerning the number of patients, individual patient info or vaccine lot numbers and expiration dates.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site pruritus
Clinical narrative: Since injection develop red band around bicep, had constant dull ache, numbness, itch. The center of injection dark in color and very sensitive to touch. Rash and Urticaria Pruritus. Methylprednisolone, diphenhydramine.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Since injection develop red band around bicep, had constant dull ache, numbness, itch. The center of injection dark in color and very sensitive to touch. Rash and Urticaria Pruritus. Methylprednisolone, diphenhydramine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling of right upper thigh. No erythema or heat. No pain.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site bleeding in a 57-year-old female patient who received BOOSTRIX. Concurrent medical conditions included blood cholesterol abnormal. Concomitant products included ZOSTAVAX and medication unknown, medication unknown (Cholesterol medication (NOS)). On 27th November 2016, the patient received BOOSTRIX. On an unknown date, immediately after receiving BOOSTRIX, the patient experienced injection site bleeding and injection site bruising. On an unknown date, the outcome of the injection site bleeding was recovered/resolved and the outcome of the injection site bruising was not recovered/not resolved. It was unknown if the reporter considered the injection site bleeding and injection site bruising to be related to BOOSTRIX. Additional details were provided as follows: The reporter is spouse of the patient. The patient received BOOSTRIX along with ZOSTAVAX vaccine on the same arm. However, reporter stated that the ZOSTAVAX vaccine was given at a different spot on the same arm. It was reported that, the patient bled at the injection site upon injection. The patient also experienced bruise at the injection site where she received the BOOSTRIX vaccine and she was still having bruise at the time of reporting. The reporter was concerned that the patient might not get all the vaccine that she was supposed to get.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Malaise, Pyrexia
Clinical narrative: Pt received FLUZONE HD on 11/26/16 and PREVNAR 13 on 12/1/16. Both vaccines given by same person. Pt felt ill and had fever starting 12/3/16 and presented with cellulitis on 12/5/16. Sent to urgent care and received KEFLEX on 12/5/16.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Amnesia, Asthenia, Bacterial infection, Fatigue, Influenza like illness
Clinical narrative: Pain in arm - really swollen - flu-like symptoms. Next day - day 2 - red lines 4 x 7 around vaccination spot - went to Dr. was put on a prescription for bacteria infection. Memory loss, tired and no energy.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pain in arm - really swollen - flu-like symptoms. Next day - day 2 - red lines 4 x 7 around vaccination spot - went to Dr. was put on a prescription for bacteria infection. Memory loss, tired and no energy.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site inflammation, Pyrexia
Clinical narrative: Inflammation at injection site. Low grade fever, some sweating.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: New daily persistent headache, Nuclear magnetic resonance imaging normal
Clinical narrative: Daily persistent HA since 2nd GARDASIL on 8/6/16.
Age: 0.83
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Hepatitis B antibody negative, Inappropriate schedule of drug administration, Therapy non-responder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 2-week-old female patient who received ENGERIX B pediatric. Co-suspect products included ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B adult (batch number K35HY, expiry date 14th April 2018). On 16th November 1998, the patient received the 1st dose of ENGERIX B pediatric. On 14th December 1998, the patient received the 2nd dose of ENGERIX B pediatric. On 14th September 1999, the patient received the 3rd dose of ENGERIX B pediatric. On an unknown date, the patient received the 4th dose of ENGERIX B adult. On 14th September 1999, not applicable after receiving ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B adult, an unknown time after receiving ENGERIX B pediatric and not applicable after receiving ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B adult, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced therapy non-responder, accidental overdose and adult product administered to child. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long, accidental overdose and adult product administered to child were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B pediatric. Additional details were provided as follows: This case was reported by a vaccine coordinator. The patient received 3rd dose of ENGERIX B pediatric longer than the recommended schedule, which led to the lengthening of the vaccination schedule. The staff member of the reporter inadvertently administered an adult dose of ENGERIX B to the patient at an age of 17 years. This led to an accidental overdose and an adult product administered to child. The patient received 4th dose of ENGERIX B due to being a therapy non-responder. The reported lot number (K35H8Y) for 4th dose of ENGERIX B adult did not exist and was updated to K35HY as per the sales database. There was discrepancy in vaccination date of 4th dose and clarification was requested for the same.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Pain and redness at injection sites "knot on left deltoid that went down overnight" (per pt.) Hard raised area noted to right deltoid approx 3 inches x 3 inches at injection site.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to injection sites.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Patient diagnosed by PCP with adverse event of cellulitis and was prescribed antibiotics. Patient got vaccinated 11/21/16 and went to doctor on 11/26/16.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received KINRIX vaccine afternoon of 11/15/16. Parent noticed last night pt had 4" x 2" swelling and redness at injection site. No fever.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: The day after getting the vaccination, I developed a baseball-sized red patch on the inner, upper part of the vaccinated arm near the armpit. The second day after the vaccination, I also got multiple dime-sized, red spots on the upper arm near the injection site.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Mother took pt to ER for swelling of inj. site.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash
Clinical narrative: Rash on L arm, painful, went down into the upper chest. Rash gone but very sore. Pt. took ADVIL.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Deafness unilateral
Clinical narrative: Loss of hearing 11/24/16 (right ear) Rx with prednisone (11/25-12/1); resolved.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus, Skin discolouration
Clinical narrative: Very swollen right arm, itching, and turned a dark color as if bruised. Went to the E.R. about 5:15PM on 11-14-16. Gave me a cream to use morning and ngt. and take BENADRYL every 4 hours. Was back to normal in about 5-days.