chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: A rash developed on patient's back. Rash was red and itchy and spread to patient's face and trunk area. Mom did bring baby in for an appointment on June 21, 2019. 1 yr vaccinations were given on June 13m 2019 in our office.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Extra dose administered
Clinical narrative: Pt received Pediatric Hep A and Gardasil-9 vaccines on 6/19/19 and came back to our office on 6/25/19 and received another Pediatric Hep A and Gardasil-9 vaccines. Our EHR system was down on 6/25/19 and vaccines weren't transferring over since June 13th 2019.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Vertigo
Clinical narrative: Shot on Wed.  Fri. AM slightly off balance when doing my 30 minute walk. It worsened as the day progressed. Only felt like sitting in the recliner all evening. The room was spinning when I went to bed and when getting up on Sat. A.M. It improved on Sat.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chest pain, Herpes zoster, Hyperaesthesia
Clinical narrative: patient received vaccination on 5/22/19. She called on 6/7/19 reported pain in elbow, shoulder, sternum, below left breast, under arm, back, moderate pain & skin feeling sensitive to touch since 6/1/19. Few red bumps. No rash or redness in injection site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Musculoskeletal pain, Pain in extremity, Rash papular
Clinical narrative: patient received vaccination on 5/22/19. She called on 6/7/19 reported pain in elbow, shoulder, sternum, below left breast, under arm, back, moderate pain & skin feeling sensitive to touch since 6/1/19. Few red bumps. No rash or redness in injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema
Clinical narrative: Mom noticed 2 dots of redness and progressively got worse during the day. Mom noticed this a.m. approx 08:00.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever & CHILLS, BODY ACHES ACETAMINOPHEN PRN
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Local swelling, fever, redness, extreme pain and immobility of left arm progressive throughout 6/26/2019 and then no better on 6/27/19 went to ER
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Right arm started hurting 2 hours after shot by the end of the night he couldn't lift his arm from his side. Pain is constant, hurts when he uses it. Not sleeping since shots. Was getting shooting pains up his arm. Hot & ice packs, stretching & ibuprofen
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: sore left arm with possibility of nausea and vomiting Patient presents to the office today for: injury, right foot. He reports receiving a puncture injury to his right foot x2 days ago [Saturday] by stepping down on a nail while replacing carpet. He doesn't think the nail was rusty and notes "it went in and out quickly" The area is swollen and a bit bruised. Was wearing both shoes and socks. Denies fever, chills. The injury has remained stable, feels the same no better or worse. He felt well enough to go motorcycle riding over at the coast the next day.
Age: 22.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Vaccine error report: On 11/20/2007, this 22 year old client received pediatric formulations of Hepatitis-A and Hepatitis-B. Per CDC info, client was notified that she should repeat the correct doses of both Hep A and Hep B at her earliest convenience. Repeat doses  of adult formulations scheduled for 11/21/2007. No adverse events.  11/27/2007: Patient reported no adverse events after receiving adult doses.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: this is an update to report # 795003-1 She received rabies #1 (Imovax PMC N1B902M) 29 OCT 18 to her left arm without AE. Rabies #2 (Imovax PMC N1B902M) receipt was 05 Nov 18 (day 7) to her left. The site was "high" and she had pain onset  at about 48 hours. She recalls it being uncomfortable, achy, but this pain was not profound.She does not recall deatials about about its resolution. Rabies #3 (Imovax PMC N1B902M) 19 Nov 2018 (day 21); left arm. This time the site was "low". She had profound left shoulder pain onset at 24 hours. She also received Tdap, documented right arm (SKB 33T42).  Left shoulder pain was excruciating at 10/10.  She states very tender at site and the slightest brush was very painful, but no local inflammation symptoms of erythema, edema or warmth. She states the pain was severe ache and sharp with some movements. It affected function, particularly reaching.  She states she saw PCP on 12 DEC 18 (day 44) and  was put on Naprosyn which was not helpful. She returned 4 Jan 2019 and received ortho and neuro referral. She had an MRI 10 JAN 2019 which per radiology did not demonstrate pathology. She saw Ortho on 15 JAN 2019 who stated MRI demonstrated significant RTC tendinitis and thickened bursa and she was treated with steroid injection, which provided relief for four days but then pain returned.  She reports she then saw neuro who noted weakness, paresthesia's & ANL NCS/EMG. she was diagnosed brachial neuritis
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Asthenia, Blood thyroid stimulating hormone normal, Bursa disorder, Discomfort, Electromyogram abnormal
Clinical narrative: this is an update to report # 795003-1 She received rabies #1 (Imovax PMC N1B902M) 29 OCT 18 to her left arm without AE. Rabies #2 (Imovax PMC N1B902M) receipt was 05 Nov 18 (day 7) to her left. The site was "high" and she had pain onset  at about 48 hours. She recalls it being uncomfortable, achy, but this pain was not profound.She does not recall deatials about about its resolution. Rabies #3 (Imovax PMC N1B902M) 19 Nov 2018 (day 21); left arm. This time the site was "low". She had profound left shoulder pain onset at 24 hours. She also received Tdap, documented right arm (SKB 33T42).  Left shoulder pain was excruciating at 10/10.  She states very tender at site and the slightest brush was very painful, but no local inflammation symptoms of erythema, edema or warmth. She states the pain was severe ache and sharp with some movements. It affected function, particularly reaching.  She states she saw PCP on 12 DEC 18 (day 44) and  was put on Naprosyn which was not helpful. She returned 4 Jan 2019 and received ortho and neuro referral. She had an MRI 10 JAN 2019 which per radiology did not demonstrate pathology. She saw Ortho on 15 JAN 2019 who stated MRI demonstrated significant RTC tendinitis and thickened bursa and she was treated with steroid injection, which provided relief for four days but then pain returned.  She reports she then saw neuro who noted weakness, paresthesia's & ANL NCS/EMG. she was diagnosed brachial neuritis
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Haematocrit normal, Haemoglobin normal, Injected limb mobility decreased, Injection site pain, Metabolic function test normal
Clinical narrative: this is an update to report # 795003-1 She received rabies #1 (Imovax PMC N1B902M) 29 OCT 18 to her left arm without AE. Rabies #2 (Imovax PMC N1B902M) receipt was 05 Nov 18 (day 7) to her left. The site was "high" and she had pain onset  at about 48 hours. She recalls it being uncomfortable, achy, but this pain was not profound.She does not recall deatials about about its resolution. Rabies #3 (Imovax PMC N1B902M) 19 Nov 2018 (day 21); left arm. This time the site was "low". She had profound left shoulder pain onset at 24 hours. She also received Tdap, documented right arm (SKB 33T42).  Left shoulder pain was excruciating at 10/10.  She states very tender at site and the slightest brush was very painful, but no local inflammation symptoms of erythema, edema or warmth. She states the pain was severe ache and sharp with some movements. It affected function, particularly reaching.  She states she saw PCP on 12 DEC 18 (day 44) and  was put on Naprosyn which was not helpful. She returned 4 Jan 2019 and received ortho and neuro referral. She had an MRI 10 JAN 2019 which per radiology did not demonstrate pathology. She saw Ortho on 15 JAN 2019 who stated MRI demonstrated significant RTC tendinitis and thickened bursa and she was treated with steroid injection, which provided relief for four days but then pain returned.  She reports she then saw neuro who noted weakness, paresthesia's & ANL NCS/EMG. she was diagnosed brachial neuritis
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Nerve conduction studies abnormal, Nuclear magnetic resonance imaging abnormal, Pain, Paraesthesia, Peripheral motor neuropathy
Clinical narrative: this is an update to report # 795003-1 She received rabies #1 (Imovax PMC N1B902M) 29 OCT 18 to her left arm without AE. Rabies #2 (Imovax PMC N1B902M) receipt was 05 Nov 18 (day 7) to her left. The site was "high" and she had pain onset  at about 48 hours. She recalls it being uncomfortable, achy, but this pain was not profound.She does not recall deatials about about its resolution. Rabies #3 (Imovax PMC N1B902M) 19 Nov 2018 (day 21); left arm. This time the site was "low". She had profound left shoulder pain onset at 24 hours. She also received Tdap, documented right arm (SKB 33T42).  Left shoulder pain was excruciating at 10/10.  She states very tender at site and the slightest brush was very painful, but no local inflammation symptoms of erythema, edema or warmth. She states the pain was severe ache and sharp with some movements. It affected function, particularly reaching.  She states she saw PCP on 12 DEC 18 (day 44) and  was put on Naprosyn which was not helpful. She returned 4 Jan 2019 and received ortho and neuro referral. She had an MRI 10 JAN 2019 which per radiology did not demonstrate pathology. She saw Ortho on 15 JAN 2019 who stated MRI demonstrated significant RTC tendinitis and thickened bursa and she was treated with steroid injection, which provided relief for four days but then pain returned.  She reports she then saw neuro who noted weakness, paresthesia's & ANL NCS/EMG. she was diagnosed brachial neuritis
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Product administered at inappropriate site, Radiculitis brachial, Red blood cell count normal, Rotator cuff syndrome, Urine analysis normal
Clinical narrative: this is an update to report # 795003-1 She received rabies #1 (Imovax PMC N1B902M) 29 OCT 18 to her left arm without AE. Rabies #2 (Imovax PMC N1B902M) receipt was 05 Nov 18 (day 7) to her left. The site was "high" and she had pain onset  at about 48 hours. She recalls it being uncomfortable, achy, but this pain was not profound.She does not recall deatials about about its resolution. Rabies #3 (Imovax PMC N1B902M) 19 Nov 2018 (day 21); left arm. This time the site was "low". She had profound left shoulder pain onset at 24 hours. She also received Tdap, documented right arm (SKB 33T42).  Left shoulder pain was excruciating at 10/10.  She states very tender at site and the slightest brush was very painful, but no local inflammation symptoms of erythema, edema or warmth. She states the pain was severe ache and sharp with some movements. It affected function, particularly reaching.  She states she saw PCP on 12 DEC 18 (day 44) and  was put on Naprosyn which was not helpful. She returned 4 Jan 2019 and received ortho and neuro referral. She had an MRI 10 JAN 2019 which per radiology did not demonstrate pathology. She saw Ortho on 15 JAN 2019 who stated MRI demonstrated significant RTC tendinitis and thickened bursa and she was treated with steroid injection, which provided relief for four days but then pain returned.  She reports she then saw neuro who noted weakness, paresthesia's & ANL NCS/EMG. she was diagnosed brachial neuritis
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: White blood cell count increased
Clinical narrative: this is an update to report # 795003-1 She received rabies #1 (Imovax PMC N1B902M) 29 OCT 18 to her left arm without AE. Rabies #2 (Imovax PMC N1B902M) receipt was 05 Nov 18 (day 7) to her left. The site was "high" and she had pain onset  at about 48 hours. She recalls it being uncomfortable, achy, but this pain was not profound.She does not recall deatials about about its resolution. Rabies #3 (Imovax PMC N1B902M) 19 Nov 2018 (day 21); left arm. This time the site was "low". She had profound left shoulder pain onset at 24 hours. She also received Tdap, documented right arm (SKB 33T42).  Left shoulder pain was excruciating at 10/10.  She states very tender at site and the slightest brush was very painful, but no local inflammation symptoms of erythema, edema or warmth. She states the pain was severe ache and sharp with some movements. It affected function, particularly reaching.  She states she saw PCP on 12 DEC 18 (day 44) and  was put on Naprosyn which was not helpful. She returned 4 Jan 2019 and received ortho and neuro referral. She had an MRI 10 JAN 2019 which per radiology did not demonstrate pathology. She saw Ortho on 15 JAN 2019 who stated MRI demonstrated significant RTC tendinitis and thickened bursa and she was treated with steroid injection, which provided relief for four days but then pain returned.  She reports she then saw neuro who noted weakness, paresthesia's & ANL NCS/EMG. she was diagnosed brachial neuritis
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Allergy to vaccine
Clinical narrative: Allergy to Prevnar13; This is a spontaneous report from a contactable physician. This physician reported same event for three patients. This is the 2nd of 3 reports.  A patient of unspecified age and gender received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for pneumococcal vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced allergy to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on an unspecified date. Outcome of the event was recovered on an unspecified date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019272471 same reporter/drug/event, different patient;US-PFIZER INC-2019272500 same reporter/drug/event, different patient
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Infection, Swelling
Clinical narrative: Several swelling and infection
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, IPV, MMR, UNK
Symptoms: Mumps, Parotitis, Rubulavirus test positive
Clinical narrative: HIB on the same date as MMR II; "the patient had an outbreak of mumps that was confirmed through blood work on May 10, 2019". "Patient received both MMR II vaccines on schedule".; This spontaneous report was received from a physician and refers to a non-pregnant 8 year old female patient. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 08-SEP-2011, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously, in the right deltoid, for prevention of mumps measles and rubella, reported lot# 1484Z (expiration date was not reported).  On the same date, the patient, the patient also received Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) Lot# reported as UH390AA, by intramuscular route in the left thigh.  On 14-JUN-2017, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously, in the right deltoid, for prevention of mumps measles and rubella, reported lot# reported as M043309 (expiration date was not reported). On the same date, the patient was also vaccinated with  Hepatitis A Vaccine, Inactivated (VAQTA) lot# reported as M042658, by intramuscular route in the deltoid; the third dose of poliovirus vaccine inactivated by subcutaneous route in the deltoid; and the 4th dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid by intramuscular route, in the deltoid.  It was reported that the patient had an outbreak of mumps that was confirmed through blood work on 10-MAY-2019 (Mumps antibody test), which result was 239 AU/mL, positive (mumps antibody test positive) and the patient was diagnosed with parotitis. The patient sought medical attention with pediatrician.  The pediatrician administered a third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on 24-MAY-2019, subcutaneously, in the right deltoid, for prevention of mumps measles and rubella (lot/batch # and expiration date were not reported).   At the time of reporting, the outcome of parotitis was resolved on an unknown date in 2019.The causality assessment between mumps and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.   Lot number M043309 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  Lot Number M042658 is an invalid lot number for Hepatitis A Vaccine, Inactivated (VAQTA)  Lot Number UH390AA is an invalid lot number for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB)  This is one of several reports received from the same source.  All available medical records will be provided upon request.
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; a patient received a dose of PROQUAD that was reconstituted with expired diluent; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.     On 30-MAY-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, frequency and route were not reported) (lot # R015740, expiration date: 02-DEC-2019) for prophylaxis. It was used to reconstitute expired sterile diluent (strength, doce and frequency were not reported) (lot # N027625, expiration date: 19-MAY-2019) subcutaneously for prophylaxis (expired product administered). No adverse effects were reported in the patient.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: she was vaccinated with MMR as a child, but always shows negative titers; Information has been received from a female physician of unknown age refers to herself. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.  On an unknown date when the patient was a child, she was vaccinated measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis, but always should negative titers (Antibody test negative). The outcome of antibody test negative was unknown.    Causality assessment was not provided.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; the patient was inadvertently administered an expired dose of GARDASIL 9 (lot: M037770; Exp: 06/01/2019) on 06/14/2019; Information has been received from a pharmacist referring to a 24 year old patient of unknown gender. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.     On 14-JUN-2019, the patient was inadvertently administered an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # M037770, expiration date 01-JUN-2019; strength and dose were unknown) intramuscularly for prophylaxis. No adverse effects was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored vaccine; This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported.  On 17-JUN-2019, the patient was vaccinated with one improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose and frequency were not reported) (lot # S002394, expiry date: 23-JAN-2021) subcutaneously for prophylaxis. The sterile diluent (DILUENT MRK) injection was stored at recommended temperature. The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in temperature of -9 degree Celsius (C) to 8 C for 45 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.
Age: 80.0
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 female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 10-AUG-2009 (at the age of 80), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a healthcare provider at a health center for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient was treated by a healthcare provider at the same health center for the following injuries resulting from her use of zoster vaccine live (ZOSTAVAX): shingles.  The outcome of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   .
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Information regarding concurrent conditions, medical history, and concomitant medications was not provided. On or around 21-JUN-2017, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) for prevention of shingles (dose, route, anatomical location, lot number, and expiration date were not provided). Shortly thereafter (estimated to be in 2017), the patient suffered a severe rash. Approximately on 24-JUN-2017, three days later, the physician diagnosed shingles. The symptom resulted in physical limitations, not present before vaccination. The patient was also experiencing mental and emotional distress due to result of physical limitations and seriousness of her condition.  The patient sustained severe and permanent personal injuries. The outcome of shingles was considered not resolved.  The reporter considered shingles to be related to zoster vaccine live( ZOSTAVAX).  The reporter considered shingles to be disabling.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions reported; patient received one dose of expired VAQTA; This spontaneous report was received from a nurse and refers to an 18-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.   On 17-JUN-2019, the patient was vaccinated with a one dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), intramuscular, lot # R009953, expiration date 12-JUN-2019 (frequency and anatomical location were not reported) for prophylaxis.  On 17-JUN-2019, the patient received an expired dose of hepatitis a vaccine, inactivated (VAQTA). No adverse reactions were reported. There was no temperature excursion.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008316:
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Skin lesion
Clinical narrative: rash and skin lesions on her abdomen, back, arms and legs; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On or around 17-SEP-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage, vaccination site and route of administration were not provided) for routine adult health maintenance and for its intended purpose: the prevention of shingles. Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered an abrupt and sudden onset of rash and skin lesions on her abdomen, back, arms and legs. She continued to suffer from rash outbreaks throughout her body at the reporting time. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).  The event of abrupt and sudden onset of rash and skin lesions on her abdomen, back, arms and legs was considered to be disabling.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis reactive, Hypoacusis, Polymyalgia rheumatica
Clinical narrative: reactive arthritis/polymyalgia rheumatica symptoms; decreased hearing; reactive arthritis/polymyalgia rheumatica symptoms; post-vaccination related joint pain; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On or about 22-JUN-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage, vaccination site and route of administration were not provided), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine (onset date not further specified), the pt suffered and was diagnosed with decreased hearing, reactive arthritis/polymyalgia rheumatica symptoms and post-vaccination related joint pain. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using Company's product. The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of his condition. The outcome of the events was unknown The causality assessment was related.   Upon internal review, the event of polymyalgia rheumatica symptoms was considered to be medically significant.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported; The patient received PROQUAD and VARIVAX on 6/24/2019; This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant medications included sterile diluent.   On 24-JUN-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rHA) and with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # R034394, expiration date: 27-NOV-2020) for prophylaxis. Dose, dose number, route of administration and anatomical location were not reported for both vaccines. No adverse effects were reported.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 18 years old patient received an adult dose of VAQTA; NO ADVERSE EFFECT; This spontaneous report was received from a healthcare professional (Medical assistant) refers to an 18-year-old patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) vial 50 (unit unspecified) via intramuscular route for prophylaxis. (lot # S001832, expiry date: 12-MAY-2020).        On an unknown date, the 18-year-old patient received an adult dose of hepatitis a vaccine, inactivated (VAQTA) (incorrect dose administered) and no adverse effect reported.  No PQC involved. The outcome of incorrect dose administered and no adverse event was unknown. Reporter's causality was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; patient was administered an improperly stored VARIVAX; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown.  On 24-JUN-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S000132 and expiration date 02-JAN-2021 for prophylaxis (dose, strength, route of administration, and frequency were unknown).  The patient experienced no adverse effects. The temperature excursion was of 6°F to 14°F (8.2 F) for 1 hour and 25 minutes; 15°F to 46°F (16 F) for 5 minutes. No digital data logger was involved.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Pyrexia
Clinical narrative: 12 hours later the patient experienced a fever of 101.3 F and headache; 12 hours later the patient experienced a fever of 101.3 F and headache; This spontaneous report was received from a consumer, via a company representative, and refers to a 13 year old male patient. The patient had no pertinent medical history or allergies. No information was provided regarding the patient's concurrent conditions and concomitant medications.  On 25-JUN-2019, 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) intramuscular (strength, dose, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unspecified date in June 2019, reported as "12 hours later", the patient experienced a fever of 101.3 degree Fahrenheit (°F) (pyrexia) and headache. Fever decreased to 99 °F at an unspecified time.  At the reporting time, the patient had not recovered from his pyrexia and headache. The reporter did not provided the causality assessment between the aforementioned events and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. In June 2019, 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 provided as follows: The age at vaccination was not reported. The patient was currently experiencing an outbreak of shingles between doses 1 and 2.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Fatigue, Injection site pain, Injection site swelling, Swelling
Clinical narrative: swelling from the injection site up to the left side of neck; fatigue; soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number H549S, expiry date 1st October 2021) for prophylaxis.   On 17th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th June 2019, less than a day after receiving Shingrix, the patient experienced fatigue and injection site pain. On 18th June 2019, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb, fatigue and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, fatigue and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid and developed fatigue and soreness at the injection site on the same day that she received the vaccine.  The day after receiving the vaccine, patient developed swelling from the injection site  on left deltoid all the way up to the left side of her neck.
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient received a expired Quadracel vaccine on 21Jun2019/No AE; Initial information received on 24-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four years old female patient who received a fifth dose of expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] vaccine on 21-Jun-2019 which was already expired on 20-Jun-2019 lot C5222AA via intramuscular route in the right deltoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).  It was an actual medication error due to expired vaccine used.  There were not side effects.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  The outcome was reported as unknown.  List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 2-year old patient received second dose of Quadracel vaccine/No AE; Initial information received on 24-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 25 months old male patient (reported as 2 years) who received a 0.5 ml second dose in series of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5635AA, Expiration Date: 18-Jun-2021 via intramuscular route in the left thigh on 10-Jun-2019 .  The patient' past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  It was an actual medication error due to Inappropriate age at vaccine administration.  No adverse event none reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  The outcome of event was reported as unknown.  List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Circumoral swelling, Dry skin, Eye irritation, Eyelid rash, Pruritus
Clinical narrative: WIthin hours of receiving HPV #2 on 6/19/19, patient developed peri-oral burning and itching and swelling. Since that time, she also developed a new dry, rough rash over upper eyelids and itching around eyes. Sxs did improve some with Benadryl but have continued to wax and wane. No vomiting, diarrhea, trouble breathing or mental status changes. She is also allergic to peanuts and has allergic rhinnitis.
Age: 0.75
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel was given to a 9 month old which is not the recommended age ( 4 years and up)- No signs or symptoms of any reactions
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Herpes zoster, Injection site hypersensitivity, Pruritus, Rash
Clinical narrative: shingles; rash; Itching; Hives on back/Itching hives; Swelling below the injection site; Bruise; injection site is sensitive; This case was reported by a consumer via call center representative and described the occurrence of hives in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2019, the patient received the 2nd dose of Shingrix. On 9th June 2019, less than a day after receiving Shingrix, the patient experienced hives, local swelling and pruritus. In June 2019, the patient experienced contusion and injection site hypersensitivity. On an unknown date, the outcome of the hives, contusion, injection site hypersensitivity and pruritus were not recovered/not resolved and the outcome of the local swelling was unknown.   It was unknown if the reporter considered the hives, local swelling, contusion, injection site hypersensitivity and pruritus to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The patient experienced swelling below the injection site that started within an hour of receiving the vaccination. The patient developed hives covering his back, on the same day. The hives itch. The hives were unchanged at the time of reporting.  At the time of reporting, less than a week after vaccination, the patient had a bruise below the injection site and the injection site was sensitive. This case has been linked to US2019106865, reported by the same reporter.   Follow up information received from consumer on 19th June 2019: On 13th June 2019, the patient went to the emergency room and was diagnosed as having a rash.  On 19th June 2019 at the reporting date, the patient was seen by his Primary Care Physician (PCP) and was diagnosed as having shingles. The VAERS information updated.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: shingles; rash; Itching; Hives on back/Itching hives; Swelling below the injection site; Bruise; injection site is sensitive; This case was reported by a consumer via call center representative and described the occurrence of hives in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2019, the patient received the 2nd dose of Shingrix. On 9th June 2019, less than a day after receiving Shingrix, the patient experienced hives, local swelling and pruritus. In June 2019, the patient experienced contusion and injection site hypersensitivity. On an unknown date, the outcome of the hives, contusion, injection site hypersensitivity and pruritus were not recovered/not resolved and the outcome of the local swelling was unknown.   It was unknown if the reporter considered the hives, local swelling, contusion, injection site hypersensitivity and pruritus to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The patient experienced swelling below the injection site that started within an hour of receiving the vaccination. The patient developed hives covering his back, on the same day. The hives itch. The hives were unchanged at the time of reporting.  At the time of reporting, less than a week after vaccination, the patient had a bruise below the injection site and the injection site was sensitive. This case has been linked to US2019106865, reported by the same reporter.   Follow up information received from consumer on 19th June 2019: On 13th June 2019, the patient went to the emergency room and was diagnosed as having a rash.  On 19th June 2019 at the reporting date, the patient was seen by his Primary Care Physician (PCP) and was diagnosed as having shingles. The VAERS information updated.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site redness; Raised injection Site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The pharmacist reports the patient's injection site was red and raised. The health care professional describes injection site redness as being approximately 3 inches by 2 inches in size.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling
Clinical narrative: Injection site redness; Injection site swelling; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date 13th September 2021) for prophylaxis.   On 13th June 2019, the patient received the 1st dose of Shingrix. On 13th June 2019, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb. On 16th June 2019, the patient experienced injection site erythema. On 19th June 2019, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient experienced redness and swelling around injection site that extended half of his bicep. The health care professionals confirms that the event had completely resolved.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness and nausea. On an unknown date, the outcome of the dizziness and nausea were unknown.   It was unknown if the reporter considered the dizziness and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced dizziness and nausea with Shingrix vaccine. The patient did not provide any demographic information and disconnected the call prior to any questions being asked in regards to the adverse event.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Mobility decreased
Clinical narrative: Swelling and redness at injection site - immediate and still suffering 6/28/2019.  Cannot raise my arm Headache - immediate and still suffering 6/28/2019 Muscle ache - started 6/27/2019  still suffering 6/28/2019
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Swelling and redness at injection site - immediate and still suffering 6/28/2019.  Cannot raise my arm Headache - immediate and still suffering 6/28/2019 Muscle ache - started 6/27/2019  still suffering 6/28/2019
Age: 20.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Computerised tomogram, Haemorrhage intracranial, Head injury, Loss of consciousness, Skull fractured base
Clinical narrative: The patient had syncopal episode, hit her head.  She was unconscious  for about 1 minute.  She suffered basilar skull fracture and intracranial bleed
Age: 20.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: The patient had syncopal episode, hit her head.  She was unconscious  for about 1 minute.  She suffered basilar skull fracture and intracranial bleed
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 07-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) at a pharmacy (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster and was treated by a physician. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product name confusion, Wrong product administered
Clinical narrative: No adverse reactions were reported; inadvertently received PROQUAD. and VARIVAX instead of M-M-R II and VARIVAX; inadvertently received PROQUAD. and VARIVAX instead of M-M-R II and VARIVAX; inadvertently received PROQUAD. and VARIVAX; Information has been received from a registered nurse referring to a 12 month old patient of unknown gender. Information about pertinent medical history, concurrent conditions, and drug reactions/allergies was not provided. Concomitant medication included sterile diluent (lot numbers and expiration dates were not known)  On25-JUN-2019, the patient received Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number, expiration date, dose/frequency, route were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX), (lot number, expiration date, dose/frequency, route were not reported) for prophylaxis (Inappropriate schedule of vaccine administered and overdose). Nurse reported the patient was inadvertently received Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and varicella virus vaccine live (Oka/Merck) (VARIVAX) instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX)due to product confusion(Wrong vaccine administered). No adverse reactions were reported.