chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Vomiting
Clinical narrative: vomiting,  stomach pain,  pain under knee areas, diarrhea
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Cyanosis, Eczema, Nystagmus, Respiratory arrest, Seizure
Clinical narrative: - seizure lasting 30 seconds - face turned blue and stopped breathing - nystagmus intermittently for 24 hours - persistent eczema since injection
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: Severe pain in arm, then weakness.  Flu like symptoms: extreme fatigue, high fever (103.6), lack of appetite,, rash on face, arms, neck, legs, back, - over 80% of my body.   This condition lasted for 4 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Severe pain in arm, then weakness.  Flu like symptoms: extreme fatigue, high fever (103.6), lack of appetite,, rash on face, arms, neck, legs, back, - over 80% of my body.   This condition lasted for 4 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Limb discomfort, Pain, Pain in extremity
Clinical narrative: Arm became sore several hours after vaccination.  Continued to worsen, within 6-7 hours suffered severe pain and complete inability to move arm.  Pain radiated into neck, shoulder and back.  It is now 4 days following injection.  Pain has subsided only when arm is not moved, arm only slightly mobile, can raise arm very little and even that still causes considerable pain.  Cannot lift any weight with left hand.  I would have returned to doctor's office but it is a holiday weekend.  Have tried Aleve, ice packs, heating pad with little relief.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient said the her arm started hurting when the shot was given.  She said a rash developed at the injection site and became hot and itchy on the 2nd day.  It continued to spread down her arm from the injection site.  She said it was a little better today (5/27/2019).  She said she is going to call her doctor tomorrow.
Age: 72.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Pain in extremity, Skin warm
Clinical narrative: Unknown which DTaP patient received. She has induration and erythema of her entire lateral LUE to her elbow. Warmth, some pain, induration. Started 3 days after she received the tdap shot in the arm. Since yesterday, daughter said the erythema has doubled in size. Denies fever, chills.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site irritation, Injection site pain, Skin warm
Clinical narrative: Patient presented with redness around and for 2 to 3 inches below injection site with a possible welt noticed.  It was warm to the touch and she was experiencing injection site pain and irritation.  Upon follow up with patient the area got redder for another day but then started to dissipate and only a small amount of redness remains.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Swelling
Clinical narrative: Pt had a firm, well demarcated bump (8mm x 11mm). There was no lymphatic streaking. Received vaccine on 5/19 and was reported at doctor's office on 5/22.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: red itchy rash on upper arm
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Decreased appetite, Fatigue, Injection site pain, Night sweats
Clinical narrative: Patient called Pharmacy and reported that she is experiencing  adverse effects. Body aches and muscle pain at the sight of injection, fatigue, weakness Headache, fever and dizziness started on the next day of vaccination. Chills started on 5/23/19. As of 5/24/2019 Patient has no fever but has Headache, Severe Dizziness and overall weakness. As of 5/27/2019 Patient still experiencing Dizziness and having night sweats and loss of appetite.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: Patient called Pharmacy and reported that she is experiencing  adverse effects. Body aches and muscle pain at the sight of injection, fatigue, weakness Headache, fever and dizziness started on the next day of vaccination. Chills started on 5/23/19. As of 5/24/2019 Patient has no fever but has Headache, Severe Dizziness and overall weakness. As of 5/27/2019 Patient still experiencing Dizziness and having night sweats and loss of appetite.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling, Local reaction
Clinical narrative: Local injection site reaction - redness, swelling, rash on left arm, lasted 5 days
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site warmth, Swelling
Clinical narrative: Two days after receiving injection in left arm the injection site became red and hot to touch. Within three days it was severely red, hot to the touch, and continues to be.  I also have raised spot with sore arm and itching around red spot.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Rash pruritic
Clinical narrative: Shingles disease symptoms started on 5/6/19 as a itchy rash with out significant pain on patient's back. Presented to outpatient clinic on 5/9/19 and was given 7 day course of Acyclovir 800mg 5x daily.  As of today (5/27/19) rash is resolving and is no longer itching.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Chills, body aches, headache, fever of 102 (orally), fatigue, nausea, vomiting, pain, swelling, and redness at injection site,.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Chills, body aches, headache, fever of 102 (orally), fatigue, nausea, vomiting, pain, swelling, and redness at injection site,.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash
Clinical narrative: Rash on upper left arm and more fatigue than usual.  Took Ibuprofen and put cream on the rash.  Rash dissipated over 4-5 days.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pruritus
Clinical narrative: Fatigued from 5/20 - 5/21  Red itchy spot about 6 inches in diameter first appeared 5/20 and resolved on 5/23  the red itchy spot returned on 5/26 and looks like it will resolve by 5/28
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Child maltreatment syndrome, Computerised tomogram normal, Musculoskeletal pain, Neck pain
Clinical narrative: Pain in right neck, shoulder, and back between shoulder blade and kidney area.  Pain was intense and intermittently sharp, burning, pulsating and pins and needles.  Seen in ER on 05/14/2019.  When pain didn't let up, followed up with primary on 05/24/2019.  Prescribed gabapentin with successful reduction of pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Urine analysis normal
Clinical narrative: Pain in right neck, shoulder, and back between shoulder blade and kidney area.  Pain was intense and intermittently sharp, burning, pulsating and pins and needles.  Seen in ER on 05/14/2019.  When pain didn't let up, followed up with primary on 05/24/2019.  Prescribed gabapentin with successful reduction of pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Dizziness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: dizzinesss, loose/inflammed  joints, swollen/hot/red injection site and surrounding areas.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Loose body in joint
Clinical narrative: dizzinesss, loose/inflammed  joints, swollen/hot/red injection site and surrounding areas.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 2-MAY-201, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (strength, dose number, route and lot# were not specified) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated for shingles. The outcome of the event was not reported. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE SWELLING; This report was identified from a line listing obtained on request by the Company from the FDA (VAERS 737212) under the Freedom of Information Act, referring to a 10 years old female patient. The patient was reported to not have medical history or current illnesses. The patient's prior vaccinations were unknown. Concomitant medications included methylphenidate hydrochloride (reported as "Methylphenidate ER").  On 05-FEB-2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N020352, expiration date: 10-APR-2020, 1 dosage form for prophylaxis and with second dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) (expiration date was not provided), lot # 345B4, 1 dosage form, both intramuscularly in the right arm. On 06-FEB-2018, the patient experienced erythema, swelling and pain to injection site.      The outcome of injection site erythema, injection site swelling and injection site pain was unknown. The causality assessment between the events and suspect therapies was not provided.  Follow up information has been received from the FDA on 15-APR-2019 (VAERS 737212). It was reported that the primary reporter was a nurse practitioner. On 05-FEB-2018 at 14:30, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and with second dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX). On 06-FEB-2018 at 15:00, the patient experienced erythema, swelling and pain to injection site. Additionally details regarding the patient's vaccination were provided.  Follow up information received on 24-MAY-2019: The patient has recovered from  the reported Adverse event.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Dizziness, Dysgraphia, Extrasystoles, Impaired driving ability
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th March 2019, 1 days after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), dizziness and tiredness. On 1st April 2019, the patient experienced palpitation. On 4th April 2019, the patient experienced heartbeats skipped. On 13th May 2019, the patient experienced hives. On an unknown date, the patient experienced feeling unwell. On 29th March 2019, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the fainting, hives, heartbeats skipped, palpitation and tiredness were unknown and the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the fainting, hives, dizziness, heartbeats skipped, palpitation, tiredness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: Reporter indicated that the next day after receiving the SHINGRIX vaccination, the patient woke up at 7 am and felt dizzy. The patient walked into the bathroom and fainted. The patient got up and walked 20 feet to tell her husband something and she fainted again. This time when the patient got up, she went to bed. The dizziness resolved after an hour, but she felt wiped out after that. The patient describes that the patient felt sick like she was coming down with a cold for the next 2 to 3 days, feeling tired and worn out but she said she did not have congestion or other cold symptoms. On the following Monday (1st April 2019), she woke up at 3 am with heart palpitations. Tuesday (2nd April 2019), and Wednesday (3rd April 2019), the patient felt better. However on Thursday (4th April 2019), the patient experienced dizziness and palpitations, feeling like her heart was skipping a beat. The patient went to the emergency room (ER) at 10 pm that day. The patient had an Electrocardiogram (EKG) performed, a X-ray, and blood work but they all came back negative. The patient was referred for a monitor. On 15th April 2019, the patient got the Holter monitor and wore it for three weeks. The heart palpitations were picked up on the monitor. On 7th May 2019, the patient went to a cardiologist and a stress test was performed and an echocardiogram. The patient said that the cardiologist told her that he had several patients that experienced heart palpitations after receiving the SHINGRIX vaccine. On Monday, 13th May 2019, she reports that she has started breaking out in hives on both legs. The reporter consented to follow up. This case has been linked to the case US2019GSK093821, reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th March 2019, 1 days after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), dizziness and tiredness. On 1st April 2019, the patient experienced palpitation. On 4th April 2019, the patient experienced heartbeats skipped. On 13th May 2019, the patient experienced hives. On an unknown date, the patient experienced feeling unwell. On 29th March 2019, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the fainting, hives, heartbeats skipped, palpitation and tiredness were unknown and the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the fainting, hives, dizziness, heartbeats skipped, palpitation, tiredness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: Reporter indicated that the next day after receiving the SHINGRIX vaccination, the patient woke up at 7 am and felt dizzy. The patient walked into the bathroom and fainted. The patient got up and walked 20 feet to tell her husband something and she fainted again. This time when the patient got up, she went to bed. The dizziness resolved after an hour, but she felt wiped out after that. The patient describes that the patient felt sick like she was coming down with a cold for the next 2 to 3 days, feeling tired and worn out but she said she did not have congestion or other cold symptoms. On the following Monday (1st April 2019), she woke up at 3 am with heart palpitations. Tuesday (2nd April 2019), and Wednesday (3rd April 2019), the patient felt better. However on Thursday (4th April 2019), the patient experienced dizziness and palpitations, feeling like her heart was skipping a beat. The patient went to the emergency room (ER) at 10 pm that day. The patient had an Electrocardiogram (EKG) performed, a X-ray, and blood work but they all came back negative. The patient was referred for a monitor. On 15th April 2019, the patient got the Holter monitor and wore it for three weeks. The heart palpitations were picked up on the monitor. On 7th May 2019, the patient went to a cardiologist and a stress test was performed and an echocardiogram. The patient said that the cardiologist told her that he had several patients that experienced heart palpitations after receiving the SHINGRIX vaccine. On Monday, 13th May 2019, she reports that she has started breaking out in hives on both legs. The reporter consented to follow up. This case has been linked to the case US2019GSK093821, reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Cardiac stress test, Dizziness, Echocardiogram, Electrocardiogram ambulatory abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th March 2019, 1 days after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), dizziness and tiredness. On 1st April 2019, the patient experienced palpitation. On 4th April 2019, the patient experienced heartbeats skipped. On 13th May 2019, the patient experienced hives. On an unknown date, the patient experienced feeling unwell. On 29th March 2019, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the fainting, hives, heartbeats skipped, palpitation and tiredness were unknown and the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the fainting, hives, dizziness, heartbeats skipped, palpitation, tiredness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: Reporter indicated that the next day after receiving the SHINGRIX vaccination, the patient woke up at 7 am and felt dizzy. The patient walked into the bathroom and fainted. The patient got up and walked 20 feet to tell her husband something and she fainted again. This time when the patient got up, she went to bed. The dizziness resolved after an hour, but she felt wiped out after that. The patient describes that the patient felt sick like she was coming down with a cold for the next 2 to 3 days, feeling tired and worn out but she said she did not have congestion or other cold symptoms. On the following Monday (1st April 2019), she woke up at 3 am with heart palpitations. Tuesday (2nd April 2019), and Wednesday (3rd April 2019), the patient felt better. However on Thursday (4th April 2019), the patient experienced dizziness and palpitations, feeling like her heart was skipping a beat. The patient went to the emergency room (ER) at 10 pm that day. The patient had an Electrocardiogram (EKG) performed, a X-ray, and blood work but they all came back negative. The patient was referred for a monitor. On 15th April 2019, the patient got the Holter monitor and wore it for three weeks. The heart palpitations were picked up on the monitor. On 7th May 2019, the patient went to a cardiologist and a stress test was performed and an echocardiogram. The patient said that the cardiologist told her that he had several patients that experienced heart palpitations after receiving the SHINGRIX vaccine. On Monday, 13th May 2019, she reports that she has started breaking out in hives on both legs. The reporter consented to follow up. This case has been linked to the case US2019GSK093821, reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Electrocardiogram normal, Extrasystoles, Fatigue, Malaise, Palpitations
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th March 2019, 1 days after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), dizziness and tiredness. On 1st April 2019, the patient experienced palpitation. On 4th April 2019, the patient experienced heartbeats skipped. On 13th May 2019, the patient experienced hives. On an unknown date, the patient experienced feeling unwell. On 29th March 2019, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the fainting, hives, heartbeats skipped, palpitation and tiredness were unknown and the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the fainting, hives, dizziness, heartbeats skipped, palpitation, tiredness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: Reporter indicated that the next day after receiving the SHINGRIX vaccination, the patient woke up at 7 am and felt dizzy. The patient walked into the bathroom and fainted. The patient got up and walked 20 feet to tell her husband something and she fainted again. This time when the patient got up, she went to bed. The dizziness resolved after an hour, but she felt wiped out after that. The patient describes that the patient felt sick like she was coming down with a cold for the next 2 to 3 days, feeling tired and worn out but she said she did not have congestion or other cold symptoms. On the following Monday (1st April 2019), she woke up at 3 am with heart palpitations. Tuesday (2nd April 2019), and Wednesday (3rd April 2019), the patient felt better. However on Thursday (4th April 2019), the patient experienced dizziness and palpitations, feeling like her heart was skipping a beat. The patient went to the emergency room (ER) at 10 pm that day. The patient had an Electrocardiogram (EKG) performed, a X-ray, and blood work but they all came back negative. The patient was referred for a monitor. On 15th April 2019, the patient got the Holter monitor and wore it for three weeks. The heart palpitations were picked up on the monitor. On 7th May 2019, the patient went to a cardiologist and a stress test was performed and an echocardiogram. The patient said that the cardiologist told her that he had several patients that experienced heart palpitations after receiving the SHINGRIX vaccine. On Monday, 13th May 2019, she reports that she has started breaking out in hives on both legs. The reporter consented to follow up. This case has been linked to the case US2019GSK093821, reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Syncope, Urticaria, X-ray normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th March 2019, 1 days after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), dizziness and tiredness. On 1st April 2019, the patient experienced palpitation. On 4th April 2019, the patient experienced heartbeats skipped. On 13th May 2019, the patient experienced hives. On an unknown date, the patient experienced feeling unwell. On 29th March 2019, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the fainting, hives, heartbeats skipped, palpitation and tiredness were unknown and the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the fainting, hives, dizziness, heartbeats skipped, palpitation, tiredness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: Reporter indicated that the next day after receiving the SHINGRIX vaccination, the patient woke up at 7 am and felt dizzy. The patient walked into the bathroom and fainted. The patient got up and walked 20 feet to tell her husband something and she fainted again. This time when the patient got up, she went to bed. The dizziness resolved after an hour, but she felt wiped out after that. The patient describes that the patient felt sick like she was coming down with a cold for the next 2 to 3 days, feeling tired and worn out but she said she did not have congestion or other cold symptoms. On the following Monday (1st April 2019), she woke up at 3 am with heart palpitations. Tuesday (2nd April 2019), and Wednesday (3rd April 2019), the patient felt better. However on Thursday (4th April 2019), the patient experienced dizziness and palpitations, feeling like her heart was skipping a beat. The patient went to the emergency room (ER) at 10 pm that day. The patient had an Electrocardiogram (EKG) performed, a X-ray, and blood work but they all came back negative. The patient was referred for a monitor. On 15th April 2019, the patient got the Holter monitor and wore it for three weeks. The heart palpitations were picked up on the monitor. On 7th May 2019, the patient went to a cardiologist and a stress test was performed and an echocardiogram. The patient said that the cardiologist told her that he had several patients that experienced heart palpitations after receiving the SHINGRIX vaccine. On Monday, 13th May 2019, she reports that she has started breaking out in hives on both legs. The reporter consented to follow up. This case has been linked to the case US2019GSK093821, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: muscle aches; fever; extra dose; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number HN7LJ, expiry date 30th March 2020) for prophylaxis.   On 16th May 2019, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 16th May 2019, unknown after receiving Shingrix, the patient experienced extra dose administered. On 17th May 2019, the patient experienced muscle pain and fever. On an unknown date, the outcome of the muscle pain and fever were not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient inadvertently received a 3rd dose of Shingrix, which led to extra dose administered. One day after vaccination, the patient experienced fever and muscle aches. There adverse event onset date was discrepantly reported as 16th May 2019, however it was updated to 17th May 2019 as per the narrative descriotion and time to onset. The outcomes of the events were discrepantly reported as recivering in source document and not recovered. The health care professional did not consent to follow-up.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Myalgia, Pyrexia
Clinical narrative: muscle aches; fever; extra dose; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number HN7LJ, expiry date 30th March 2020) for prophylaxis.   On 16th May 2019, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 16th May 2019, unknown after receiving Shingrix, the patient experienced extra dose administered. On 17th May 2019, the patient experienced muscle pain and fever. On an unknown date, the outcome of the muscle pain and fever were not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient inadvertently received a 3rd dose of Shingrix, which led to extra dose administered. One day after vaccination, the patient experienced fever and muscle aches. There adverse event onset date was discrepantly reported as 16th May 2019, however it was updated to 17th May 2019 as per the narrative descriotion and time to onset. The outcomes of the events were discrepantly reported as recivering in source document and not recovered. The health care professional did not consent to follow-up.
Age: 70.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (13 times).   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient thought that she also had the other vaccine zostrax. The patient had shingles 13 times before 1st dose of Shingrix and just got 14th about. The patient said, this was an out of pocket expense for her. So she was not happy that she was having this issue.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Mass, Skin tightness, Skin warm, Tenderness
Clinical narrative: Huge lump the size of a softball (and growing)  tender, hot and very tight. Feels like a tremendous boil that could burst.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Allergy test negative, Chalazion, Dark circles under eyes, Ear pain, Eczema
Clinical narrative: 6/6/2017: Significant pain in ears, earache 6/8/2017: Developed measles rash on underarms 6/11/2017-6/13/2017: Fever 100-102 degrees; headache; significant eye pain; ongoing rash: sore throat 6/13/2017: Right eye becomes puffy, both eyes watery and very sensitive to light. 11/2018-current/ongoing: Eczema on all fingers with severe cracking, splitting and peeling of the skin on the fingertips, Worsening of purple coloring under eyes, and ongoing large swollen lymph node in neck.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Epstein-Barr virus antibody negative, Epstein-Barr virus test positive, Eye pain, Eye swelling, Fatigue
Clinical narrative: 6/6/2017: Significant pain in ears, earache 6/8/2017: Developed measles rash on underarms 6/11/2017-6/13/2017: Fever 100-102 degrees; headache; significant eye pain; ongoing rash: sore throat 6/13/2017: Right eye becomes puffy, both eyes watery and very sensitive to light. 11/2018-current/ongoing: Eczema on all fingers with severe cracking, splitting and peeling of the skin on the fingertips, Worsening of purple coloring under eyes, and ongoing large swollen lymph node in neck.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Lacrimation increased, Lymphadenopathy, Measles, Measles antibody positive
Clinical narrative: 6/6/2017: Significant pain in ears, earache 6/8/2017: Developed measles rash on underarms 6/11/2017-6/13/2017: Fever 100-102 degrees; headache; significant eye pain; ongoing rash: sore throat 6/13/2017: Right eye becomes puffy, both eyes watery and very sensitive to light. 11/2018-current/ongoing: Eczema on all fingers with severe cracking, splitting and peeling of the skin on the fingertips, Worsening of purple coloring under eyes, and ongoing large swollen lymph node in neck.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Mononucleosis heterophile test negative, Oropharyngeal pain, Photophobia, Platelet count increased, Pyrexia
Clinical narrative: 6/6/2017: Significant pain in ears, earache 6/8/2017: Developed measles rash on underarms 6/11/2017-6/13/2017: Fever 100-102 degrees; headache; significant eye pain; ongoing rash: sore throat 6/13/2017: Right eye becomes puffy, both eyes watery and very sensitive to light. 11/2018-current/ongoing: Eczema on all fingers with severe cracking, splitting and peeling of the skin on the fingertips, Worsening of purple coloring under eyes, and ongoing large swollen lymph node in neck.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rubella antibody positive, Skin exfoliation, Skin fissures, Streptococcus test negative
Clinical narrative: 6/6/2017: Significant pain in ears, earache 6/8/2017: Developed measles rash on underarms 6/11/2017-6/13/2017: Fever 100-102 degrees; headache; significant eye pain; ongoing rash: sore throat 6/13/2017: Right eye becomes puffy, both eyes watery and very sensitive to light. 11/2018-current/ongoing: Eczema on all fingers with severe cracking, splitting and peeling of the skin on the fingertips, Worsening of purple coloring under eyes, and ongoing large swollen lymph node in neck.
Age: 52.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Headache
Clinical narrative: diarrhea, began day before, possibly day of,  final dose. Low grade headache upon waking, usually gone within 2 hours untreated.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of PEDVAX HIB; This spontaneous report has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On unknown dates from September 2018 to October 2018, the patients were vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # N031492 and expiration date 31-MAY-2020, route, strength, dose and frequency were not reported) for prophylaxis. No adverse effects were reported.        The temperature excursion was 36 Fahrenheit to 46 Fahrenheit for 1 day, 6 hours and 33 minutes. Previous temperature excursion was 47 Fahrenheit to 77 Fahrenheit for 2 hours and 12 minutes. The call was because of a data logger.  Follow up information was received from the reporting physician on 24-MAY-2019 via an inbound call. It was reported that all telephone attempts to obtain follow-up information have been unsuccessful.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered a dose of improperly stored PROQUAD; no adverse effects reported; This spontaneous report has been from a nurse concerning a patient of unknown age gender and ethnicity.   The patient's concurrent conditions, medical history and drug reactions or allergies were not reported. Concomitant medications included sterile diluent.  On an unspecified date, the patient received a dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (product storage error) (dose number, route of administration and anatomical location were not reported) (lot #: R030799, expiration date: 22-APR-2020) as prophylaxis. The temperature was in the range of 15 degrees Fahrenheit to 46 degrees Fahrenheit (40.9 degrees Fahrenheit) for a total time frame of 50 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; Expired dose of Gardasil 9 was administered; This spontaneous report was received from a registered nurse and refes to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 02-MAY-2019, the patient was vaccinated with an expired dose of human papilloma virus rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), one dose, intramuscularly, lot # M033583, expiration date: 14-APR-2019 (exact dose and anatomical location were not provided) for prophylaxis. No adverse effects were reported.  This is a non-valid case due to lack of patient identifiers.  Follow-up information was received from a medical assistant on 21-MAY-2019. The patient was 30-year-old female. Her concurrent condition included human papilloma virus (HPV) infection.  On 02-MAY-2019, the patient was vaccinated with an expired dose of human papilloma virus rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), one dose, intramuscularly in left arm, lot # M033583, expiration date: 14-APR-2019 as a first dose for prophylaxis. The reporter stated that she filled out the consent form and the patient signed the form for the vaccine, then she administered the injection. After the patient left, medical assistant was putting the information into the system and could not precede with filling out the form because of the expiration date on the medication. The patient did not receive any treatment.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: negative titers and no immunity to measles, mumps, or rubella; negative titers and no immunity to measles, mumps, or rubella; negative titers and no immunity to measles, mumps, or rubella; Information has been received from a healthcare worker, referring to an unknown age female patient who was also the breastfeeding mother of a newborn baby. Information of and concomitant therapy was not provided.       On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis (reported as unknown if patient ever received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine).  On an unknown date, the patient had negative titers and no immunity to measles, mumps, or rubella. The outcome of the events was unknown. The relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Incorrect route of product administration, Injection site nodule
Clinical narrative: the patient was inadvertently administered a dose of PEDVAXHIB by the subcutaneous route instead of the intramuscular route; there is still a knot present in the area of administration of the right thigh; This spontaneous report as received from a pharmacist refers to a 2-month-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-APR-2019, the patient was inadvertently vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # R027329, expiration date: 12-JUL-2021, in the right tigh via subcutaneous route instead of the intramuscular route. On an unspecified date in 2019, the patient experienced knot present in the area of administration of the right thigh. At the time of the report, the knot was still present.  The causality assessment was not provided.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; improperly stored dose of vaccine was administered to the patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 26-APR-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # R026720, expiration date: 17-MAY-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.  Lot No. R026720 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported as 17-MAY-2020, but upon internal validation established as 17-MAR-2020.; Sender's Comments:  US-009507513-1905USA011854: US-009507513-1905USA011855: US-009507513-1905USA011856: US-009507513-1905USA011857: US-009507513-1905USA011858: US-009507513-1905USA011859: US-009507513-1905USA011860: US-009507513-1905USA011861:
Age: 48.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pharmacist reported that unspecified 48 year old patient was administered GARDASIL 9; No adverse effect reported.; This spontaneous report was received from a pharmacist referring to a 48 years old patient of unknown gender. Information of concurrent condition, pertinent medical history, concomitant medication and drug reactions/allergies was not provided.  On an unknown date, the patient was administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (also reported as for "possible exposure to human papillomavirus (HPV)") (inappropriate age at vaccine administration). No adverse effect reported. The causality of the event was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; an adult patient (unspecified age) was administered a PROQUAD vaccine; This spontaneous report was received from a nurse and refers to an adult patient of unknown age and gender. There was no information concerning the patient's pertinent medical history, concomitant medication, drug reactions or allergies provided. On 09-MAY-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, recombinant Human albumin (rHA), (lot # R020678, expiration date: 15-JAN-2020) (dose and route of administration were not provided) for prophylaxis. There were no adverse effects reported. The outcome of the event was unknown.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect; patient was inadvertently administered M-M-R II intramuscularly; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-MAY-2019, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) intramuscularly, lot # R036583, expiration date: 17-DEC-2020 (strength, dose and frequency were not reported) for prophylaxis, diluted in sterile diluent, lot # S002624, expiration date: 05-NOV-2021 (incorrect route of product administration). There were no adverse event reported.
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Back injury, Balance disorder, Chills, Condition aggravated
Clinical narrative: increased urinary incontinence; had a bad fall/fell on his back; fever; chills; balance issues/difficulty with balance; joint pain; has been complaining of not feeling well; This spontaneous report was received from a consumer referring to her husband of unknown age. The patient's concurrent conditions included urinary incontinence. On 02-MAY-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route and lot # not provided). Concomitant medications were not reported.        The patient's wife reported that in May 2019 "over the last few days", the patient had been complaining or not feeling well, joint pain, chills and having difficulty with balance. On 10-MAY-2019, the patient had mild fever of 37.6 °C. On the same date, the patient fell on his back in the bathroom and it was difficult for his wife to get him up. When she got the patient to his bed there was evidence of worsened urinary incontinence. The patient visited an urgent care clinic on 11-MAY-2019 and the doctor did not see the patient advising him to go to the emergency room. The reporter stated that the patient was still not steady on his feet. The outcome for increased urinary incontinence, not feeling well, chills and joint pain was reported as not recovered. The outcome for fever and fell on his back was unknown.
Sex: M
Vaccine: MMR
Symptoms: Fall, Malaise, Pyrexia, Urinary incontinence
Clinical narrative: increased urinary incontinence; had a bad fall/fell on his back; fever; chills; balance issues/difficulty with balance; joint pain; has been complaining of not feeling well; This spontaneous report was received from a consumer referring to her husband of unknown age. The patient's concurrent conditions included urinary incontinence. On 02-MAY-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route and lot # not provided). Concomitant medications were not reported.        The patient's wife reported that in May 2019 "over the last few days", the patient had been complaining or not feeling well, joint pain, chills and having difficulty with balance. On 10-MAY-2019, the patient had mild fever of 37.6 °C. On the same date, the patient fell on his back in the bathroom and it was difficult for his wife to get him up. When she got the patient to his bed there was evidence of worsened urinary incontinence. The patient visited an urgent care clinic on 11-MAY-2019 and the doctor did not see the patient advising him to go to the emergency room. The reporter stated that the patient was still not steady on his feet. The outcome for increased urinary incontinence, not feeling well, chills and joint pain was reported as not recovered. The outcome for fever and fell on his back was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; multiple patients were administered improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information concerning the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies provided. On 22-APR-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R023513, expiration date: 16-AUG-2020, subcutaneously)(exact dose was not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The administered dose of vaccine experienced a temperature excursion between -9 degrees Celsius (°C) to 8°C (-3.2C) for 5 hours 30 minutes. Digital data logger was involved in capturing the temperature excursion. There were no previous temperature excursions reported. No adverse effect was reported. This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1905USA009817:
Sex: U
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no know adverse effects; via the intramuscular route in error; Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concomitant medication, current condition and medical history of the patient was unknown.  On 14-MAY-2019, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA (recombinant Human albumin) (lot# N032749, expiration date 20-NOV-2019; strength and dose were unknown) diluted with sterile diluent (MERCK STERILE DILUENT) via intramuscular route in error for prophylaxis (incorrect route of product administration). No known adverse effects.