chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Hyperhidrosis, Rash, Skin warm
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 739058), concerns 29-year-old, adult female patient. The patient had no current illness. On 02-Feb-2018, the patient was administered FLUCELVAX QIVc, dose: 0.5 ml, frequency: 1, route of administration: intramuscular, batch number: 195243, anatomical location: unknown and expiry date: not reported. On 04-Feb-2018, two days after vaccination, the patient developed rash that was spreading across the arm with sweating and warmth. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 739392), concerns a 10-year-old female child. The patient no relevant medical history, allergies, concomitant medications and current illness. On 11-Feb-2018, the patient was administered FLUCELVAX (QIVc), dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 196498, expiry date: not reported. On the same day after vaccination, the patient developed hives which spread to abdomen and thighs. The symptoms continued off and on for about 7 days. On an unspecified date in Feb-2018, the events resolved without any specific treatment. On an unspecified date, the patient had an office visit. The reporter assessed this case as non-serious.
Age: 72.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 739690), concerns a 72-year-old, elderly, male patient. On 19-Jan-2018, the patient was administered FLUCELVAX (QIVc), dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195216, expiry date: not reported. On 21-Jan-2018, 2 days after vaccination, the patient experienced itching and rash. On an unspecified date, the patient had an office visit. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: This spontaneous case reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 740487), concerns a 57-year-old, adult female patient. The patient had no relevant medical history, current illness and drug reactions or allergies. On 06-Feb-2018, the patient was administered FLUCELVAX QIVc, dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, batch number: 196498, anatomical site: left arm and expiry date: not reported. On 08-Feb-2018, two days after the vaccine administration, the patient experienced pain at the injection site which was not immediately associated with the vaccination. The patient reported that the pain in her muscle at the injection site had not gone away after the vaccination. At the time of the report, the patient had not recovered from the event. The reporter assessed the case as non-serious.
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 741661), concerns a 39-year-old, adult, male patient. The patient had no relevant medical history, allergies, current illness and concomitant medications. On 27-Nov-2017, the patient was administered FLUCELVAX (QIVc), dose: 0.5 ml (frequency reported as unknown), route of administration: intramuscular, anatomical location: left deltoid, batch number: 195223, expiry date: not reported. On 27-Nov-2017, soon after the vaccination, the injection site was very sore and was chronically sore for the months which followed. On an unspecified date, the patient had an office visit. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: This spontaneous report, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 742828), concerns a 47-year-old, adult, female patient. The patient's concomitant medication included duloxetine, gabapentin and MONONESSA. The patient had no current illness at the time of vaccination. On 28-Jan-2018, the patient was administered FLUCELVAX (QIVc), dose: 0.5 ml (frequency reported as 1), route of administration: injection (reported as SYR), anatomical location: right arm, batch number: 195242, expiry date: not reported. On 01-Feb-2018, 4 days after vaccination, the patient experienced a sharp stabbing pain in right arm where flu shot was given. The patient experienced pain only upon laying on the injected arm or after using the deltoid muscle for a while. On an unspecified date, the patient reported the event. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 73.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood test, Computerised tomogram, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744360), concerns a 73-year-old, elderly male patient. The patient's historical condition included knee arthritis (on an unspecified date). The patient had no current illness. On 03-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195215 (reported as 19521S), expiry date: not reported]. On the same day, after vaccination, the patient experienced pain in left arm and shoulder. The patient was unable to raise arm above head or lift anything substantial. It was reported that, the patient had made a physician office visit. On an unspecified date, X-ray, computerized axial tomography (CAT) scan, magnetic resonance imaging (MRI) and blood work were performed (results were awaiting). At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Follow up retrieved from VAERS (VAERS ID: 744360) reported to VAERS by other health professional on 25-Sep-2018: The suspect product was changed from INN Flu vaccine seasonal to FLUCELVAX QIV as per the batch number and listedness was done accordingly. The batch number of suspect vaccine was updated as 195215. The route of administration of suspect vaccine was updated from unknown to intramuscular and anatomical site was updated from unknown to left arm in product tab. The narrative and case comment were amended accordingly.
Age: 73.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity, Weight bearing difficulty, X-ray
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744360), concerns a 73-year-old, elderly male patient. The patient's historical condition included knee arthritis (on an unspecified date). The patient had no current illness. On 03-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195215 (reported as 19521S), expiry date: not reported]. On the same day, after vaccination, the patient experienced pain in left arm and shoulder. The patient was unable to raise arm above head or lift anything substantial. It was reported that, the patient had made a physician office visit. On an unspecified date, X-ray, computerized axial tomography (CAT) scan, magnetic resonance imaging (MRI) and blood work were performed (results were awaiting). At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Follow up retrieved from VAERS (VAERS ID: 744360) reported to VAERS by other health professional on 25-Sep-2018: The suspect product was changed from INN Flu vaccine seasonal to FLUCELVAX QIV as per the batch number and listedness was done accordingly. The batch number of suspect vaccine was updated as 195215. The route of administration of suspect vaccine was updated from unknown to intramuscular and anatomical site was updated from unknown to left arm in product tab. The narrative and case comment were amended accordingly.
Age: 37.0
Sex: M
Vaccine: FLUC4, HEP
Symptoms: Urticaria
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 758368), concerns a 37-year-old, adult male patient. The patient had no relevant medical history and current illness. The patient had no known drug allergies (NKDA). The concomitant medication was unknown. On 14-Feb-2018, the patient received FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration, anatomical location, batch number and expiry date: not reported). The patient also received a non-company suspect vaccine, ENGERIX-B (frequency reported as 2, route of administration: intramuscular, dose, anatomical location, batch number and expiry date: not reported). On 17-Feb-2018, 3 days after vaccination, the patient developed generalised urticarial rash without anaphylaxis. On an unspecified date the patient made an emergency room visit. At the time of this report, the patient had recovered from the event. The reported assessed the case as non-serious. Update received on 12-Oct-2018: Non-significant case correction (IRD: 25-Sep-2018): The case comment was amended by adding the statement 'causal role of the suspect vaccine cannot be ruled out completely'.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Pain, Rotator cuff syndrome
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 759322), concerns a 61-year-old, adult male patient. On 29-Aug-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On the same day, immediately after vaccination, the patient experienced pain (immediate post-injection reaction) and was diagnosed with rotator cuff injury. On an unspecified date, the patient made an office visit. On an unspecified date, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS (VAERS ID: 768657) and initially received on 30-Oct-2018, concerning a 56-year-old, adult female patient. The patient's current conditions included pain, sleep disturbance, rheumatoid arthritis, nerve pain and constipation (reported as medical history). The patient was allergic to bacitracin and neomycin. The patient's concomitant medications included Methotrexate, Promethazine, LYRICA, Zolpidem, Tramadol, Folic acid, Vitamin D, Diazepam, MIRALAX, Acetaminophen w/oxycodone for unknown indication. On 30-Aug-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 252656 and expiry date: not reported]. On the same day after the vaccination, the patient felt lightheaded, and nausea. The patient was treated was treated with Diphenhydramine (50 mg, orally) while still at the pharmacy. The patient went home after 15 minutes of sitting in the pharmacy area. It was reported that, the patient vomited when she got home, and immediately felt better after emesis. On the same day, the patient had recovered from the events. The reporter assessed the case as non-serious. (Significant) case amendment (30-Oct-2018): The suspect product coding was corrected from FLUCELVAX TIV to FLUCELVAX QIVc. The narrative and case comment were amended accordingly.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: Syncopal episode, diaphoresis.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Feeling abnormal, Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received SHINGRIX (batch number A4D72, expiry date 23rd May 2021) for prophylaxis. On 28th December 2018, the patient received the 1st dose of SHINGRIX. On 28th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 29th December 2018, the patient experienced injection site warmth, difficulty sleeping, disorientation and appetite absent. On 31st December 2018, the outcome of the injection site pain, injection site warmth, difficulty sleeping, disorientation and appetite absent were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site warmth, difficulty sleeping, disorientation and appetite absent to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient planned to follow up with her physician on 16th January 2019. The patient stated that she had reported the adverse events to the Department of Health via another agency. The reporter gave consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received SHINGRIX (batch number A4D72, expiry date 23rd May 2021) for prophylaxis. On 28th December 2018, the patient received the 1st dose of SHINGRIX. On 28th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 29th December 2018, the patient experienced injection site warmth, difficulty sleeping, disorientation and appetite absent. On 31st December 2018, the outcome of the injection site pain, injection site warmth, difficulty sleeping, disorientation and appetite absent were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site warmth, difficulty sleeping, disorientation and appetite absent to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient planned to follow up with her physician on 16th January 2019. The patient stated that she had reported the adverse events to the Department of Health via another agency. The reporter gave consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Disorientation, Injection site pain, Injection site warmth, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received SHINGRIX (batch number A4D72, expiry date 23rd May 2021) for prophylaxis. On 28th December 2018, the patient received the 1st dose of SHINGRIX. On 28th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 29th December 2018, the patient experienced injection site warmth, difficulty sleeping, disorientation and appetite absent. On 31st December 2018, the outcome of the injection site pain, injection site warmth, difficulty sleeping, disorientation and appetite absent were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site warmth, difficulty sleeping, disorientation and appetite absent to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient planned to follow up with her physician on 16th January 2019. The patient stated that she had reported the adverse events to the Department of Health via another agency. The reporter gave consent to follow up.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Injection site swelling, Pruritus, Rash erythematous, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received PREVNAR 13; (lot number: X11298, expiry date: Sep2020), via an unspecified route of administration on 16Jan2019 at a single dose to prevent pneumonia. The patient's medical history and concomitant medications were not reported. The patient has been administered the PREVNAR 13 and had reaction at the site and had swelling and redness on 17Jan2019. No treatment was given yet as they were monitoring as per doctor's order. The outcome of the events vaccination site swelling and vaccination site erythema was not recovered. Sender's Comments: Linked Report(s): US-PFIZER INC-2019031228 same product and similar events, different patient.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Swelling, Tenderness
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received PREVNAR 13; (lot number: X11298, expiry date: Sep2020), via an unspecified route of administration on 16Jan2019 at a single dose to prevent pneumonia. The patient's medical history and concomitant medications were not reported. The patient has been administered the PREVNAR 13 and had reaction at the site and had swelling and redness on 17Jan2019. No treatment was given yet as they were monitoring as per doctor's order. The outcome of the events vaccination site swelling and vaccination site erythema was not recovered. Sender's Comments: Linked Report(s): US-PFIZER INC-2019031228 same product and similar events, different patient.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received PREVNAR 13; (lot number: X11298, expiry date: Sep2020), via an unspecified route of administration on 16Jan2019 at a single dose to prevent pneumonia. The patient's medical history and concomitant medications were not reported. The patient has been administered the PREVNAR 13 and had reaction at the site and had swelling and redness on 17Jan2019. No treatment was given yet as they were monitoring as per doctor's order. The outcome of the events vaccination site swelling and vaccination site erythema was not recovered. Sender's Comments: Linked Report(s): US-PFIZER INC-2019031228 same product and similar events, different patient.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age received PREVNAR 13; (lot number: X11298, expiry date: Sep2020), via an unspecified route of administration on 16Jan2019 at a single dose to prevent pneumonia. The patient's medical history and concomitant medications were not reported. The patient has been administered the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and had reaction at the site and had swelling, redness and experienced the itching on 17Jan2019. No treatment was given yet as they were monitoring as per doctor's order. The nurse stated that itchiness was not there at this time but it was there at the beginning. Patient was not complaining about the itchiness at this time. The outcome of the events vaccination site swelling and vaccination site erythema was not recovered while vaccination site pruritus was recovered on an unknown date. Sender's Comments: Linked Report(s): PFIZER INC-2019031235 same product and similar events, different patients.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age received PREVNAR 13; (lot number: X11298, expiry date: Sep2020), via an unspecified route of administration on 16Jan2019 at a single dose to prevent pneumonia. The patient's medical history and concomitant medications were not reported. The patient has been administered the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and had reaction at the site and had swelling, redness and experienced the itching on 17Jan2019. No treatment was given yet as they were monitoring as per doctor's order. The nurse stated that itchiness was not there at this time but it was there at the beginning. Patient was not complaining about the itchiness at this time. The outcome of the events vaccination site swelling and vaccination site erythema was not recovered while vaccination site pruritus was recovered on an unknown date. Sender's Comments: Linked Report(s): PFIZER INC-2019031235 same product and similar events, different patients.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Noted visual disturbance driving home from clinic about 11:30. Came home and set in recliner. Rt arm began to swell and hurt. Took BENADRYL 25mg at 5pm and applied ice to swollen rt upper arm. Awaken with pain and swelling in rt. arm. temp 102.F at 2am, took pain medication and ice to arm. Friday rt arm swollen and red took another BENADRYL and ice to rt upper arm. Saturday continue with 99.4 temp, ice pk to rt upper arm. Sunday rt upper arm continued to be swollen and red. Monday rt upper arm swelling and redness subsiding.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Visual impairment
Clinical narrative: Noted visual disturbance driving home from clinic about 11:30. Came home and set in recliner. Rt arm began to swell and hurt. Took BENADRYL 25mg at 5pm and applied ice to swollen rt upper arm. Awaken with pain and swelling in rt. arm. temp 102.F at 2am, took pain medication and ice to arm. Friday rt arm swollen and red took another BENADRYL and ice to rt upper arm. Saturday continue with 99.4 temp, ice pk to rt upper arm. Sunday rt upper arm continued to be swollen and red. Monday rt upper arm swelling and redness subsiding.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Angioedema, Cheilitis, Eye swelling, Gait disturbance, Lip swelling
Clinical narrative: She has developed recurrent bouts of severe angioedema which the doctor has deemed to be possibly life threatening. Her face, eyes, and lips swell to the point that the skin breaks leaving sores on her lips. The Dr has prescribed an EPI-PEN due the possibility of sudden anaphylaxis. Pain occurs in the hands and feet as well making it difficult to walk and hold objects.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of personal independence in daily activities, Pain in extremity, Skin disorder, Swelling face
Clinical narrative: She has developed recurrent bouts of severe angioedema which the doctor has deemed to be possibly life threatening. Her face, eyes, and lips swell to the point that the skin breaks leaving sores on her lips. The Dr has prescribed an EPI-PEN due the possibility of sudden anaphylaxis. Pain occurs in the hands and feet as well making it difficult to walk and hold objects.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Allergy to synthetic fabric, Headache, Paraesthesia, Pruritus
Clinical narrative: One month after vaccine, body started to itch. And allergies to polyester, shock when touching metals objects.. Now headache.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Body aches and chills during the night. Body aches continue in the morning.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old male patient. The patient had scabies (acarodermatitis) at the time of vaccination but he did not have any pre-existing physician-diagnosed allergy, birth defects or medical conditions. Concomitant medications included permethrin. On 21-SEP-2018, the patient was vaccinated with the first dose of M-M-R II lot # R011802, expiration date: 21-OCT-2019, subcutaneously (SC) in the left thigh (LT); and the third dose of diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid, lot # C5325BA (expiration date not provided), intramuscularly (IM) in the right thigh (RT). All the vaccines were administered for prophylaxis and purchased with public funds. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) as recorded from a digital data logger which ocurred at the time of storage in clinical practice. None adverse effects were reported. Also, the patient received an unspecified treatment for the experience. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA002756: US-009507513-1901USA002765: US-009507513-1901USA002758: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002763: US-009507513-1901USA002764: US-009507513-1901USA002755: US-009507513-1901USA002754: US-009507513-1809USA010598: US-009507513-1901USA002757:
Age: 1.42
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 1 year old male patient. The patient's medical history included cardiac murmur (reported as resolved). He did not have any pre-existing physician-diagnosed allergy, birth defects or illness at time of vaccination. On 13-SEP-2018, the patient was vaccinated with the first dose of varicella VARIVAX lot # N034551, expiration date: 05-DEC-2019, subcutaneously (SC) in the right thigh (RT); with the first dose of M-M-R II, lot # N023024, expiration date: 23-AUG-2019, SC in the left tight (LT); with the first dose of VAQTA lot # R006210, expiration date: 22-APR-2019, intramuscularly (IM) in RT; and with the fourth dose of PREVNAR 13, lot # T94429 (expiration date not provided), IM, LT. All the vaccines were administered for prophylaxis and purchased with public funds. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) (product storage error) as recorded from a digital data logger which ocurred at the time of storage in clinical practice. None adverse effects were reported. Also, the patient received an unspecified treatment for the experience. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA002757: US-009507513-1901USA002758: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002763: US-009507513-1901USA002764: US-009507513-1901USA002765: US-009507513-1901USA002756: US-009507513-1901USA002755: US-009507513-1901USA002753: US-009507513-1809USA010598.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a registered nurse refers to a 4 year old female patient. The patient's illness and medical conditions at time of vaccination included epilepsy, developmental delay, failure to thrive (FTT) and insomnia. Historical vaccines were not reported. On 20-SEP-2018, the patient was vaccinated with M-M-R II dose 2, subcutaneous in the left thigh and with QUADRACEL. Both vaccines were administered for prophylaxis and purchased with public funds. Other suspect therapies included levetiracetam (KEPPRA) 1.4 ml total dose orally for epilepsy, and clonidine 0.1 mg total dose orally for insomnia. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) (product storage error) as recorded from a digital data logger which ocurred at the time of storage in clinical practice. No adverse effect was reported. Lot number R011802 is an invalid lot number for M-M-R II. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA002753: US-009507513-1901USA002754: US-009507513-1901USA002755: US-009507513-1901USA002756: US-009507513-1901USA002757: US-009507513-1901USA002758: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002763: US-009507513-1901USA002764: US-009507513-1809USA010598:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age. Information about medical history, concurrent condition and concomitant medications was unknown. On an unknown date the patient was vaccinated with M-M-R II (lot#, expiration date, strength, dose, frequency and route were not reported), which might have been reconstituted with diluent (lot#, expiration date, manufacturer unspecified) other than diluent supplied by Merck (product preparation error). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-AUG-2010, the patient was vaccinated with M-M-R II, subcutaneously (dose, lot# and expiry date were not provided) and then, on 23-AUG-2010, the patient received a dose of VARIVAX (dose, route of administration, lot# and expiry date were not reported), both for prophylaxis. No known adverse effects were reported.
Sex: U
Vaccine: HEP, HEPA, HPV9, PPV, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a nurse and refers to an unspecified number of patients (reported as several) of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N017701, expiration date 09-JUN-2019 (dose, site and route of administration were not reported), GARDASIL 9 lot # N022952, expiration date 14-JUN-2020 (dose, site and route of administration were not reported), VAQTA lot # R014952, expiration date 09-AUG-2019 (dose, site and route of administration were not reported), PNEUMOVAX 23 (dose, site and route of administration were not reported) and ROTATEQ (dose, site and route of administration were not reported), all for prophylaxis, as well as RECOMBIVAX HB lot # N011851, expiration date 19-DEC-2019 (dose, site and route of administration and indication were not reported). The vaccines were reconstituted with sterile diluent, lot # N021894, expiration date 28-NOV-2019 and lot # M036841, expiration date 17-APR-2019 (no details about storage provided). VARIVAX was stored improperly in temperature of -10 degrees Celsius for 20 hours. The other vaccines were stored improperly in temperature of 9.5 degrees Celsius for 20 hours. Other temperature excursions included improper storage of VARIVAX in temperature of 10 degrees Celsius for 60 hours and GARDASIL 9, RECOMBIVAX HB and VAQTA in temperature of 15.5 degrees Celsius for 60 hours. There were no prior excursion for PNEUMOVAX 23 and ROTATEQ. The temperature was measured with Digital Data Logger. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a clinic manager (also reported as "healthcare professional") regarding a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an 15-JAN-2019, the patient was vaccinated with a dose of M-M-R II (dose, frequency, and route of administration were not provided, Lot # M045393, expiration date: 14-NOV-2018) for prophylaxis reconstituted with sterile diluent (lot # M019899, expiration date: 22-OCT-2018) that was expired. No adverse effect was reported.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 03-FEB-2005, the patient was vaccinated with M-M-R II (strength, dose, dose number, route, lot # and expiration date were not reported) for prophylaxis. On 14-SEP-2018, the patient was vaccinated with VARIVAX (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis. Within one month interval with varicella VARIVAX, on 11-OCT-2018, the patient was vaccinated with another dose of M-M-R II (dose detail, route, lot # and expiration date were not reported) (inappropriate schedule of product administration). As it reported, the patient received another VARIVAX (dose detail, route, lot # and expiration date were not reported) on 15-OCT-2018. No adverse symptoms were reported.
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 19-NOV-2018, the patient was vaccinated with improperly stored M-M-R II (lot # N024698, expiration date 08-SEP-2019) and VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute M-M-R II was properly stored. No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 21-NOV-2018, the patient was vaccinated with improperly stored M-M-R II (lot # N024698, expiration date 08-SEP-2019) and VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute M-M-R II was properly stored. No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 09-NOV-2018, the patient was vaccinated with improperly stored M-M-R II (lot # N024698, expiration date 08-SEP-2019) and VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute M-M-R II was properly stored. No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 11-DEC-2018, the patient was vaccinated with improperly stored M-M-R II (lot # N024698, expiration date 08-SEP-2019) and hepatitis VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute M-M-R I) was properly stored. No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 12-DEC-2018, the patient was vaccinated with improperly stored M-M-R II (lot # N024698, expiration date 08-SEP-2019) and VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute M-M-R II was properly stored. No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 26-NOV-2018, the patient was vaccinated with improperly stored M-M-R II (lot # N024698, expiration date 08-SEP-2019) and VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute M-M-R II was properly stored. No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 03-OCT-2018, the patient was vaccinated with improperly stored M-M-R II (lot # N025895, expiration date 19-SEP-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute M-M-R II was properly stored. No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 19-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 19-DEC-2018, the patient was vaccinated with improperly stored  ROTATEQ (lot # R015435, expiration date 17-APR-2020) and RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 05-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 02-JAN-2019, the patient was vaccinated with improperly stored ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 12-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) and ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 16-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 17-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 19-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 21-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 30-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 03-JAN-2019, the patient was vaccinated with improperly stored ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125: