chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain
Clinical narrative: first injection with Shingrix on 11/19/2019 / has not yet received the 2nd shot in the series; sore arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pneumonia (Twice in fourth decade of age). Concurrent medical conditions included bronchiectasis and chronic lung disease.   On 19th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient s family history reported as mother had shingles twice. The patient's medical history reported as Pneumonia twice while in her forties and in April 2019, the patient diagnosed bronchiectasis after having third case of pneumonia. The patient experienced sore arm at the injection site which resolved after about 3 days. The patient not yet received the 2nd shot in the series, which led to incomplete course of vaccination. The reporter consent to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: fever; chills; weakness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, 6 weeks after receiving Shingrix, the patient experienced fever, chills and weakness. On an unknown date, the outcome of the fever, chills and weakness were recovered/resolved.   It was unknown if the reporter considered the fever, chills and weakness to be related to Shingrix.  Additional details were provided as follows: The reporter was the wife of the patient. The patient received Shingrix and approximately 6 weeks later, the patient experienced fever, chills and weakness.   The events had resolved.  The reporter did not wish to provide contact information for provider until after discussion with her husband and the doctor. She provided a case number if the decision was to allow contact with the doctor. For tolerances of 2nd dose, refer case US2020AMR086626, reported by same reporter for the same patient.
Sex: U
Vaccine: RAB
Symptoms: No adverse event, Product dose omission
Clinical narrative: patinet supposed to have the 2nd dose on 14May but did not get it, no AE; Initial information was received on 18-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient with unknown demographics who supposed to have the second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] on 14-May-2020 but did not get it.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication were not reported.  On 11-May-2020, the patient received a first dose (day 0) of RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number and expiry date were not reported) via unknown route in unknown administration site for post exposure immunization. Then was supposed to have the next dose on 14-May-2020 but missed that dose and came on 18-May-2020.  It was an actual medication error due to missed dose.  At the time of report, no adverse event was 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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: received an expired dose of Adacel/no AE; vaccine having been inappropriately stored/no AE; pregnant and received the vaccine several days ago/no AE; Initial pregnancy information received on 20-May-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] while she was pregnant.  The gestation period at onset and gestation period at exposure data needs to be populated, if available. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  It was of actual medication error due to incorrect product storage and expired vaccine used.  It was reported that no adverse event was experienced.  At time of reporting, the outcome of the pregnancy is unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  There will be no information available on the batch number for this case, currently.
Sex: U
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Vaccination site inflammation
Clinical narrative: redness and swelling at the injection site; redness at the injection site; swelling at the injection site; Initial information was received on 21-May-2020 regarding an unsolicited valid non-serious case received from a non health care professional.  This case involves a 24 months old patient who developed redness and swelling at the injection site (vaccination site inflammation) with symptoms (vaccination site erythema), (vaccination site swelling), while he/she received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received fourth dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious redness and swelling at the injection site (vaccination site inflammation) with symptoms (vaccination site erythema), (vaccination site swelling) (Unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Details of laboratory data were not reported.  Final diagnosis was vaccination site inflammation.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not reported.  There will be no information available on batch number for this case.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: intussesception confirmed/treated in ED on 5/23/20
Age: 66.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Pain in extremity
Clinical narrative: Injected whole arm was swollen; Injected arm was red; Injected arm was painful; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 95R52, expiry date 12th November 2020) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   On 13th November 2019, the patient received the 1st dose of Shingrix and FLUAD. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and pain in arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities and pain in arm were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and Fluad in the same arm and her whole arm injected arm was swollen (extensive swelling of vaccinated limb), red and painful. The pharmacist stated that the patient was due for her 2nd dose of Shingrix. The reporter was inquiring if the patient should receive the 2nd dose since she had such a reaction with the first dose. The reporter was unable to provide the which arm was used for administration. The reporter consented to follow up. The reporter stated that he was unable to provide email due to facility firewall.  Please follow up via mail.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient came in on 5/27/20 and said she was still experiencing pain in her left arm where she had the Shingrix vaccination. Patient stated that the reaction started 24 hours admin of the vaccine & that the pain was the same today as it was on 2/16/20 but this is the first time she is reporting it. Patient stated that she had discussed with her physician.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Severe swelling and pain at site of injection. Swelling enlarged daily for 3 days until it was the size of a grapefruit. Then it started to dissipate and finally went back to normal after 9 days.  Also pain to the touch for the 3 days but then it reduced. After 7 days it was still a little itchy.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Shingrix reaction: redness at site of Right deltoid
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site rash
Clinical narrative: rash on thighs
Age: 11.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Large local reaction left shoulder, tx ice/Benadryl/pain control
Age: 0.6
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Lip swelling, Swelling of eyelid
Clinical narrative: 9 hrs after shots pt had lip swelling on/off lasted 4hrs then resolved returned for 4hrs + resolved. Then (L) upper eyelid swelling x 4 hrs + resolved
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: no additional adverse effects reported; adult patient was administered a pedatric dose; adult patient was administered a pedatric dose; This spontaneous report was received from a medical assistant regarding a 57-year-old patient. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 04-FEB-2014, the adult patient was administered a pediatric dose of Hepatitis B vaccine (Recombinant) (thiomersal-free) (RECOMBIV AX HB ) 5/0.5 microgram/milliliter, lot J006681 and expiration date: 05-DEC-2015 and again on 27-OCT-2014, a pediatric dose of Hepatitis B vaccine (Recombinant) (thiomersal-free)(RECOMBIV AX HB) lot 1014855, expiration date 16-APR-2016 (route of administration was not reported) was administered by another clinic (incorrect dose administered). No additional adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS  WITH SWELLING AND PAIN AT INJECTION SITES
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Headache, Hyperhidrosis, Injection site pain, Myalgia
Clinical narrative: patient is a 19-year-old female presents today complaints of temp of 100.2, myalgias, soreness left deltoid site of injection, wheezing, tingling in her hands. Shortness of Breath headache and sweating fever
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Paraesthesia, Pyrexia, Wheezing
Clinical narrative: patient is a 19-year-old female presents today complaints of temp of 100.2, myalgias, soreness left deltoid site of injection, wheezing, tingling in her hands. Shortness of Breath headache and sweating fever
Age: 0.33
Sex: F
Vaccine: HIBV, PNC13, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Did not meet minimum age
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Dermatitis contact, Rash erythematous, Rash pruritic
Clinical narrative: Monday morning, February 17, 2020, I awoke with red itching rash over my upper body, face and lower body.  I thought I had been given shingles, no treatment. After seeing several doctors and receiving different diagnoses, I finally saw a dermatologist on April 17, 2020, who declared my condition caused by contact dermatitis.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a 2nd dose of Hep B on 05/01/20, no treatment necessary, patient showed no adverse reaction.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: did not meet minimum age
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: As far as we know there have been no adverse side effects.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema
Clinical narrative: Child spent the night at paternal grandmother's house on 5/23, mom saw him on 5/24 and noticed redness.  Redness has decreased over time.  No fever or pain.  He is using the arm normally.  Mom contacted Pediatrics, my office,  at 14:06 on 5/27/20 and was scheduled for a Telemedicine video appointment on the same day.  Dr. did the visit at around 16:40.  Mom is aware a VAERS report is being made.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Diarrhea, chills, fever, headache, fatigue, stomach pain
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Diarrhea, chills, fever, headache, fatigue, stomach pain
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, Rotator cuff syndrome, Surgery
Clinical narrative: intense pain at the injection site since he left the pharmacy; he felt his arm was very sore and he could not move it around; it triggered what felt like his rotator cuff needed surgery; it has the same since and he still is in pain
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Patient was brought to office by mom, She states that on Friday patient woke up and had a rash on her arm and Neck. Mom states that the rash has worsen and it itches and is hot to the touch. As off today 05/27/2020 mom states that her rash on her neck has mostly gone away but seems to be coming back. On the back of the right lower arm  patient has a welt about a nickle size, which is red and hot to the touch and has a yellow Bloch in the middle were Proquad was administered. Patient was evaluated by Provider and was given a dose of Benadryl in office and  mom was advised to watch patient and continue with Benadryl and go into UC if worsen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth, Rash, Rash pruritic, Skin warm, Urticaria
Clinical narrative: Patient was brought to office by mom, She states that on Friday patient woke up and had a rash on her arm and Neck. Mom states that the rash has worsen and it itches and is hot to the touch. As off today 05/27/2020 mom states that her rash on her neck has mostly gone away but seems to be coming back. On the back of the right lower arm  patient has a welt about a nickle size, which is red and hot to the touch and has a yellow Bloch in the middle were Proquad was administered. Patient was evaluated by Provider and was given a dose of Benadryl in office and  mom was advised to watch patient and continue with Benadryl and go into UC if worsen.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient was given the normal dose of fluzone quadrivalent instead of the high dose for 65+
Age: 69.0
Sex: F
Vaccine: FLUR4
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Sensory level
Clinical narrative: PATIENT DEVELOPED SIGNS AND SYMPTOMS OF GUILLAIN-BARRE SYNDROME. WEAKNESS OF LEGS A FEW WEEKS AFTER RECEIVING THE FLU VACCINE.  PATIENT HAD BEEN HOSPITALIZED AND GIVEN IMMUNE GLOBULIN AS WELL AS PHYSICAL THERAPY.  DIAGNOSIS CHANGED TO CIDP (CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY) DUE TO LACK OF PROGRESS.  ABLE TO WALK WITH ASSISTANCE.
Age: 69.0
Sex: F
Vaccine: FLUR4
Symptoms: Walking aid user
Clinical narrative: PATIENT DEVELOPED SIGNS AND SYMPTOMS OF GUILLAIN-BARRE SYNDROME. WEAKNESS OF LEGS A FEW WEEKS AFTER RECEIVING THE FLU VACCINE.  PATIENT HAD BEEN HOSPITALIZED AND GIVEN IMMUNE GLOBULIN AS WELL AS PHYSICAL THERAPY.  DIAGNOSIS CHANGED TO CIDP (CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY) DUE TO LACK OF PROGRESS.  ABLE TO WALK WITH ASSISTANCE.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Patient stated that her right arm was sore from the shot and it radiate pain to her elbow for 7 days.  Patient experienced sight fever.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: sore at injection site (upper left arm) up to my ear, tired, nausea, headache
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Patient got the injection around 5PM on 05/24/2020, then started feeling nauseous, fatigue and having a headache round 3AM on 05/25/2020. Patient stated that she had been feeling tired with a light headache ad nausea until now (08:42PM 05/27/2020)
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Urticaria
Clinical narrative: Patient got the injection around 5PM on 05/24/2020, then started feeling nauseous, fatigue and having a headache round 3AM on 05/25/2020. Patient stated that she had been feeling tired with a light headache ad nausea until now (08:42PM 05/27/2020)
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: LOW FEVER; SWELLING AT INJECTION SITE; MODERATE PAIN
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Blister, Erythema, Injection site erythema, Injection site papule, Injection site vesicles
Clinical narrative: Grandmother, called PNP on 5-21-20, Telemed visit. Skin lesion erythematous and vesicular papules on forehead and arm. No complaints of itching. No infection noted. Advised to call for signs of infection. Contagion precautions given.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Papule, Skin lesion
Clinical narrative: Grandmother, called PNP on 5-21-20, Telemed visit. Skin lesion erythematous and vesicular papules on forehead and arm. No complaints of itching. No infection noted. Advised to call for signs of infection. Contagion precautions given.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood pressure decreased, Depressed level of consciousness, Dizziness, Feeling hot, Loss of consciousness
Clinical narrative: About 5 minutes after vaccine was administered patient complained of feeling faint, warm, dizzy. I adjusted table so she could lean back. Mom watched her while I grabbed her an icepack. When I came back she stated she could not see. I called the doctor in the room to evaluate her, her Bp had dropped to 76/44 O2 was 100% HR was 98, called 911 patient had decreased level of consciousness responding only to painful stimuli approximately 5 minutes before coming to
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Visual impairment
Clinical narrative: About 5 minutes after vaccine was administered patient complained of feeling faint, warm, dizzy. I adjusted table so she could lean back. Mom watched her while I grabbed her an icepack. When I came back she stated she could not see. I called the doctor in the room to evaluate her, her Bp had dropped to 76/44 O2 was 100% HR was 98, called 911 patient had decreased level of consciousness responding only to painful stimuli approximately 5 minutes before coming to
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Malaise, Nausea, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: After receiving the 2 vaccines patient had a syncopal episode. She was un responsive for ~10 secs. She was then very nauseous and pale. Vital signs were normal. Vomited x2 episodes. After 45 min of observation she still did not feel well and was sent to ER.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Vomiting
Clinical narrative: After receiving the 2 vaccines patient had a syncopal episode. She was un responsive for ~10 secs. She was then very nauseous and pale. Vital signs were normal. Vomited x2 episodes. After 45 min of observation she still did not feel well and was sent to ER.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Vaccine administered Rt Deltoid 5/21/2020. 1AM 5/23 awoke with shaking chills, severe whole body muscle & joint pain, headache and Rt Deltoid swollen, 2inch red, tender. Resolved over 48hours.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Tremor
Clinical narrative: Vaccine administered Rt Deltoid 5/21/2020. 1AM 5/23 awoke with shaking chills, severe whole body muscle & joint pain, headache and Rt Deltoid swollen, 2inch red, tender. Resolved over 48hours.
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Balance disorder, Pallor, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: 12 month old Fever 101-102 x 4-5 days then resolved x 2days the Fever 104-105 x 5 days rash blanchable 10 days after vaccine. Has been at home 2nd to Covid 19 x 10-12 week no contact/decreased balance slowly improves.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Depressed level of consciousness, Dizziness, Fatigue, Nausea
Clinical narrative: mental fog; dizziness; fatigue; nausea; This case was reported by a consumer via call center representative and described the occurrence of consciousness clouding in a 29-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number K5F5R, expiry date unknown) for prophylaxis.   On 4th April 2019, the patient received Boostrix (intramuscular). On 6th April 2019, 2 days after receiving Boostrix, the patient experienced consciousness clouding (serious criteria GSK medically significant), dizziness, fatigue and nausea. On an unknown date, the outcome of the consciousness clouding, dizziness, fatigue and nausea were not recovered/not resolved.   The reporter considered the consciousness clouding, dizziness, fatigue and nausea to be related to Boostrix.  Additional information was provided as follows: The reporter was the patient himself. The patient received vaccine in left deltoid. On 6th April 2019, 2 days later the patient had a reaction that drastically changed his life. The patient experienced this consistently every day since then which had been over a year till the time of reporting. These events had not subsided. The patient indicated that prior to the shot he had never had these symptoms before. The patient believed these events to be related to the vaccine. The reporter consented to follow up.
Sex: U
Vaccine: PPV, PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; received a second dose of PNEUMOVAX 23 instead of the PREVNAR 13; This initial spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 26-AUG-2016, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter; lot #, expiration date and route were unknown) for prophylaxis. On 12-MAY-2020, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter; lot # S033516, expiration date 29-JUN-2021; route was unknown) instead of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (wrong product administered). No additional adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033516; expirationdate: 29-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation, referring to a patient of an unknown age and gender.  information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. In or about 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a healthcare provider due to shingles. It was reported that the patient would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; Information has been received from a lawyer regarding a case in litigation, referring to a patient of an unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 17-NOV-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a healthcare provider due to hearing loss. It was reported that the patient would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of hearing loss was considered to be not recovered. The reporter considered hearing loss to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of hearing loss was considered to be medically significant.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse events; Nurse reports on 5/6/2020 a 12 month old patient was inadvertently administered PROQUAD and VARIVAX; Nurse reports on 5/6/2020 a 12 month old patient was inadvertently administered PROQUAD and VARIVAX; This spontaneous report was received from a nurse and refers to a 12 month old patient of unknown gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 06-MAY-2020, the patient was vaccinated with both measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S030215 expiration date 25-MAR-2021; and varicella virus vaccine live (oka/merck)(VARIVAX) lot# S031495 expiration date 07-OCT-2021; both vaccines were administered for prophylaxis (dose, strength, frequency and route of administration were not reported).   No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; improperly stored VARIVAX was administered to patient on 5/18/2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On 18-MAY-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S012036 with expiration date 17-APR-2021; dose, frequency and route were not reported) for prophylaxis (product storage error). No adverse affects were reported.  The temperature excursion was 48.2 (unit not provided) for 4 hours. There was not previous temperature excursion. Data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; improperly stored VARIVAX was administered to patient on 5/1/2020; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.       On 01-MAY-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S012036 with expiration date 17-APR-2021; dose, frequency and route were not reported) for prophylaxis (product storage error). No adverse affects were reported.  The temperature excursion was 48.2 F for 4 hours. There was not previous temperature excursion. Data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, route and lot # not reported) for long-term prevention of shingles and/or zoster-related conditions.         On an unknown date, "shortly after" receiving zoster vaccine live (ZOSTAVAX), the patient experienced shingles and was treated by a healthcare provider at a medical office. As a direct and proximate result of the use of Zoster Vaccine Live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown.   The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: outbreak of shingles and tingling; Information was received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified date, he pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered an outbreak of shingles and tingling. As a result of these symptoms, the pt was seen and treated by medical providers in and is still under their care. 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 the company's product. The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt 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, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was reported as not resolved. The causal relationship of herpes zoster was reported as related to zoster vaccine live (ZOSTAVAX).   The reporter considered herpes zoster to be a disabling event.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Varivax following temperature excursion; no adverse event; This spontaneous report was received from a nurse and refers to unknown number of patients of  unknown age and gender. The patient's medical history, historical drugs and concurrent conditions were not reported.   On unknown dates, the patients were vaccinated with incorrect storage doses of varicella virus vaccine live (oka/merck) (VARIVAX) dose and route were not reported, (lot # S020965, expiration date 07-JUL-2021) for prophylaxis. Concomitant therapies included sterile diluent. The temperature was in the range of 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) (-2.5 C) for 4 hours. A data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 26-MAY-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S002505 (expiration date: 04-APR-2020) for prophylaxis (no additional dosage regimen information was provided). There was no temperature excursion. No additional information was provided.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; PROQUAD that underwent a temperature excursion were administered to an unspecified number of patients; Information has been received from a medical assistant, referring to an unspecified number of patients. Information about medical histories, concurrent conditions and concomitant therapies was unknown.   From 19-OCT-2019, unspecified doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (one dose, lot # S024054 which is invalid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), expiration date: 01-DEC-2020; route and strength were unknown) that underwent a temperature excursion were administered to the patients for prophylaxis.  Temperature excursion was reported as range -0.52 Celsius degrees(C) for time frame 10 hours and 34 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse effects were reported.  This is a non-valid case due to no patients identifiers.  Follow up information was received from a medical assistant referring to female patient of 4-year-old on 27-MAY-2020: On 09-NOV-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).  This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA009271:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; PROQUAD that underwent a temperature excursion were administered to an unspecified number of patients; This spontaneous report as received from a medical assistant refers to a 4-year-old male patient.  Information about medical histories, concurrent conditions and concomitant therapies was unknown.  On 07-NOV-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (one dose, lot # S024054 which is invalid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), expiration date: 01-DEC-2020; route and strength were unknown) that underwent a temperature excursion were administered to the patient for prophylaxis.  Temperature excursion was reported as range -0.52 Celsius degrees(C) for time frame 10 hours and 34 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse effects were reported.  This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA013604: US-009507513-2005USA009319:
Age: 1.33
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; PROQUAD that underwent a temperature excursion were administered to an unspecified number of patients; This spontaneous report as received from a medical assistant refers to a 16-months-old female patient.  Information about medical histories, concurrent conditions and concomitant therapies was unknown.  On 20-NOV-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (one dose, lot # S024054 which is invalid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), expiration date: 01-DEC-2020; route and strength were unknown) that underwent a temperature excursion were administered to the patient for prophylaxis.  Temperature excursion was reported as range -0.52 Celsius degrees(C) for time frame 10 hours and 34 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse effects were reported.   This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA013604: US-009507513-2005USA009271:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: chills; headache; feverish; sore throat; tired filling; aching; nausea; trembling; jaw ache; teeh ache; rapid heart beat; dizziness; This case was reported by a consumer via call center representative and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced chills, headache, fever, sore throat, tiredness, pain, nausea, tremor, jaw pain, toothache, heart rate increased and dizziness. On an unknown date, the outcome of the chills, headache, fever, sore throat, tiredness, pain, nausea, tremor, jaw pain, toothache, heart rate increased and dizziness were recovered/resolved.   It was unknown if the reporter considered the chills, headache, fever, sore throat, tiredness, pain, nausea, tremor, jaw pain, toothache, heart rate increased and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced headache, feverish, sore throat, chills, tired feeling, aching, nausea, trembling, jaw ache, teeth ache, rapid heart beat, dizziness for 4 months since second dose. The reporter reported to son who was a doctor and friend and sister and pharmacy where he/she received shot. Consent to follow up was granted.      Lab Comments: On an unknown date, lab test was performed.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Oropharyngeal pain, Pain, Pain in jaw, Pyrexia
Clinical narrative: chills; headache; feverish; sore throat; tired filling; aching; nausea; trembling; jaw ache; teeh ache; rapid heart beat; dizziness; This case was reported by a consumer via call center representative and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced chills, headache, fever, sore throat, tiredness, pain, nausea, tremor, jaw pain, toothache, heart rate increased and dizziness. On an unknown date, the outcome of the chills, headache, fever, sore throat, tiredness, pain, nausea, tremor, jaw pain, toothache, heart rate increased and dizziness were recovered/resolved.   It was unknown if the reporter considered the chills, headache, fever, sore throat, tiredness, pain, nausea, tremor, jaw pain, toothache, heart rate increased and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced headache, feverish, sore throat, chills, tired feeling, aching, nausea, trembling, jaw ache, teeth ache, rapid heart beat, dizziness for 4 months since second dose. The reporter reported to son who was a doctor and friend and sister and pharmacy where he/she received shot. Consent to follow up was granted.      Lab Comments: On an unknown date, lab test was performed.
Sex: U
Vaccine: VARZOS
Symptoms: Toothache, Tremor
Clinical narrative: chills; headache; feverish; sore throat; tired filling; aching; nausea; trembling; jaw ache; teeh ache; rapid heart beat; dizziness; This case was reported by a consumer via call center representative and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced chills, headache, fever, sore throat, tiredness, pain, nausea, tremor, jaw pain, toothache, heart rate increased and dizziness. On an unknown date, the outcome of the chills, headache, fever, sore throat, tiredness, pain, nausea, tremor, jaw pain, toothache, heart rate increased and dizziness were recovered/resolved.   It was unknown if the reporter considered the chills, headache, fever, sore throat, tiredness, pain, nausea, tremor, jaw pain, toothache, heart rate increased and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced headache, feverish, sore throat, chills, tired feeling, aching, nausea, trembling, jaw ache, teeth ache, rapid heart beat, dizziness for 4 months since second dose. The reporter reported to son who was a doctor and friend and sister and pharmacy where he/she received shot. Consent to follow up was granted.      Lab Comments: On an unknown date, lab test was performed.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak; This case was reported by a physician via call center representative and described the occurrence of shingles in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient received the 1st dose of Shingrix and developed shingles on unknown date.  The HCP reports that the patient was almost completely healed from a recent shingles outbreak. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site swelling, Nausea, Pyrexia, Swelling face
Clinical narrative: Swelling right deltoid and right face. Felt feverish, chilled and nausea.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: SkinRash, Rash, UrticariaPruritus & RASH METHYLPREDNISOLONE Medrol dose packs UNITS Unknown, DIPHENHYDRAMINE 1 TAB HS PRN ,CALAMINE Small amount UNITS QID
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: UrticariaPruritus & Redness DIPHENHYDRAMINE
Age: 40.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Induration, Oedema, Pain, Rash
Clinical narrative: Patient experienced intense pain, arm was a deep red color, hard and area was raised with other small lesions around the main area. Area took up majority of patient's upper arm.  SkinRash, Rash & Edema, pain  DIPHENHYDRAMINE 50 MG ONCE
Age: 40.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Skin lesion, Swelling
Clinical narrative: Patient experienced intense pain, arm was a deep red color, hard and area was raised with other small lesions around the main area. Area took up majority of patient's upper arm.  SkinRash, Rash & Edema, pain  DIPHENHYDRAMINE 50 MG ONCE