chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient was vaccinated with TDap and MENACTRA. After about 5 minutes post vaccination he felt dizzy, passed out. He recovered immediatly about 1 minute after passing out. He was dizzy for about 30 minutes and completely recovered after that.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient received vaccine on 8/11/17. On 8/12/17, I was informed that patient had broken out in hives, no hives near the site of administration (just in other areas).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Head discomfort, Muscular weakness, Throat irritation
Clinical narrative: Pt complained of legs feeling weak, head pressure and throat difficulty. This occurred within 5 mins of vaccine. I then called 911 and administered 1 dose of EPIPEN. Ambulance arrived right after.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Pallor
Clinical narrative: Patient was seen for nurse visit appointment for Hep A #2 and HPV 9 #2 per her PCP. Verified no allergies, asked if ever had any reactions to previous injections which patient stated "no". About 5 min after injection patient's sibling reported she looked pale and felt dizzy. Pt put in supine position, given water, cool compress applied, monitored for 15-20 min. BP's were checked. PCP was notified, Pt improved after monitoring.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Localized edema and erythema 10x13cm - Surrounding injection site - meningococcal (MENACTRA) - two days following immunization.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: Pt developed headache 20 min after receiving GARDASIL 9 HPV vaccine. Rated pain 5/10 on pain scale. Saw MD - gave Toradol 30mg IM.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever, soreness, exhaustion.
Age: 46.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Erythema, Local reaction, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Localized reaction. Left arm tripled in size, turned red, began itching and extremely painful. Strangely, this didn't start until about 7-8 hours after the actual shot. My husband is a physician of hematology and oncology, so he monitored me. I took a tablet of Benadryl by 11:00 pm. I could not elevate the arm until the following night due to an interview at a hospital out of state.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site urticaria, Palpitations
Clinical narrative: Within 15 minutes, I had hives on my arms, around injection site, tops of thighs and my stomach and chest. My heart was racing and I had a feeling of tightness in my throat. Breathing was fine. Called office and started BENADRYL immediately. Took BENADRYL continuous for 6 days. Hives would come back when it was getting close to time to take another dose. Injection site was hard and swollen, very sore and baseball size. After 5 days I contacted Dr. and was seen. Put on steroid for 6 days. Hives would come back usually in the evenings even on steroids and BENADRYL. After 10-11 days I think I am ok. 11th day was first day system free.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Throat tightness, Urticaria
Clinical narrative: Within 15 minutes, I had hives on my arms, around injection site, tops of thighs and my stomach and chest. My heart was racing and I had a feeling of tightness in my throat. Breathing was fine. Called office and started BENADRYL immediately. Took BENADRYL continuous for 6 days. Hives would come back when it was getting close to time to take another dose. Injection site was hard and swollen, very sore and baseball size. After 5 days I contacted Dr. and was seen. Put on steroid for 6 days. Hives would come back usually in the evenings even on steroids and BENADRYL. After 10-11 days I think I am ok. 11th day was first day system free.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Anxiety, Dyspnoea, Nausea, Paraesthesia, Tinnitus
Clinical narrative: Approx 90 mins post immunization, employee became anxious c/o ringing in his right ear, tingling in both legs (hips to toes), nausea, SOB (described as unable to get a good breath).
Age: 18.0
Sex: F
Vaccine: DTAP, HPV9
Symptoms: Muscular weakness, Tremor
Clinical narrative: Shaky hands and limb weakness.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: Patient's arm was very swollen and discolored.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Urticaria
Clinical narrative: Patient reported hives of the face and swelling/puffiness of the lips some 4-5 hours post-administration. Pharmacist recommended taking an oral benadryl capsule immediately and contacting her primary care physician. Pharmacist also recommended seeking immediate medical attention if SOB, wheezing, or difficulty breathing occurred.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient described the site of the injection being swollen, hot to the touch, and painful. Patient denies the reaction being systemic, itchy, or having a localized rash. Patient stated they were putting ice on it, advised for them to continue doing so. Advised, if the area is not improving, or getting worse, a visit to the doctor may be warranted.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Chills, Erythema, Joint swelling, Pyrexia
Clinical narrative: Redness, swelling of arm, one day of fever/ chills.
Age: 1.5
Sex: F
Vaccine: HEP
Symptoms: Chest X-ray normal, Cough, Dyspnoea, Lethargy, Pyrexia
Clinical narrative: She woke up in the AM slightly congested and with a very mild cough. About 30 mins after the vaccine she had a mild fever and was throwing up (in the car ride on the way home). Once home, she took a nap and woke up about an hour later with a high fever and very lethargic, and coughing/croupy sounding. The cough progressed throughout the day and by that evening was very harsh and she was having difficulty breathing. We went to the ER and she was given steroid breathing treatment, ibuprofen and albuterol breathing treatment. She began to feel better and was breathing better afterwards. She was seen at her regular doctor the following morning and still had a mild croupy cough with no other symptoms. Her pediatrician states that she likely had a virus and it was not related to the vaccine. By the end of the second day she sounded and acted back to her normal self.
Age: 1.5
Sex: F
Vaccine: HEP
Symptoms: Respiratory tract congestion, Viral infection, Vomiting
Clinical narrative: She woke up in the AM slightly congested and with a very mild cough. About 30 mins after the vaccine she had a mild fever and was throwing up (in the car ride on the way home). Once home, she took a nap and woke up about an hour later with a high fever and very lethargic, and coughing/croupy sounding. The cough progressed throughout the day and by that evening was very harsh and she was having difficulty breathing. We went to the ER and she was given steroid breathing treatment, ibuprofen and albuterol breathing treatment. She began to feel better and was breathing better afterwards. She was seen at her regular doctor the following morning and still had a mild croupy cough with no other symptoms. Her pediatrician states that she likely had a virus and it was not related to the vaccine. By the end of the second day she sounded and acted back to her normal self.
Age: 25.0
Sex: F
Vaccine: MMR, MNQ, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Shortly after receiving injections patient complained of dizziness, nausea and sweating. She requested and was given water. Patient was offered a dose of benadryl but refused (it was explained that it would help if this was an allergic reaction). Patient also refused EMT services. After about 40 minutes the patient reported feeling much better and the symptoms had subsided. Management took down relevent information pertaining to the incident and will follow up tomorrow with patient. Patient was also instructed to follow up with pharmacy if symptoms re-occurred or worsened and to seek medical attention.
Age: 47.0
Sex: M
Vaccine: TTOX
Symptoms: Arthralgia, Eyelid oedema, Full blood count normal, Headache, Injection site pain
Clinical narrative: Headaches, eyelid swelling, slight swelling and tenderness around injection sites. Pt states "I just don't feel well", joint and muscle pain. CBC, CMP and UA labs were done, results were within normal limits. Pt was prescribed Prednisone taper 40mg x3 days, 20mg x 3 days. Pt instructed to go to hospital ER if conditions worsen.
Age: 47.0
Sex: M
Vaccine: TTOX
Symptoms: Injection site swelling, Malaise, Metabolic function test normal, Myalgia, Urine analysis normal
Clinical narrative: Headaches, eyelid swelling, slight swelling and tenderness around injection sites. Pt states "I just don't feel well", joint and muscle pain. CBC, CMP and UA labs were done, results were within normal limits. Pt was prescribed Prednisone taper 40mg x3 days, 20mg x 3 days. Pt instructed to go to hospital ER if conditions worsen.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Induration, Lethargy, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: 3-4 hours after receiving vaccination, I developed swollen throat and congestion in sinuses. Later that night swollen throat developed into a sore throat and sinuses continued to be congested. I've next 3-4 days cold symptoms progressed with lethargy but seem to dissipate after day 4. Soon after cold symptoms disappeared, I developed bloodshot eyes specifically in the inner corners of my eyes - this lasted 3-4 days and was not helped by Visine allergy eye drops. After my eyes cleared up, I developed a tension-like headache with stiffness in my neck - the pain was exacerbated whenever I lifted my head up from laying down or bent over. This headache lasted 3-4 days with little relief after taking ibuprofen. During the last few days of the headache, I developed hard, raised red bumps on my face, neck, chest, shoulders, scalp, legs, and back. They were not clustered and developed blister-like heads 1 day after appearing along with an urge to itch. Total, I probably had 40-50 blisters. Additionally, at the onset of the blisters, I developed an enlarged, swollen lymph node located behind my right ear. I made an appt to get checked out ASAP and was seen by a nurse practitioner who diagnosed me with a mild case of chickenpox. The blisters began to form scabs 4-5 days after appearing and have begun to clear up - no new blisters have formed. I am not pregnant nor do I have an immunodeficiency disease to my knowledge.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Nasopharyngitis, Neck pain, Ocular hyperaemia, Oropharyngeal pain, Pain
Clinical narrative: 3-4 hours after receiving vaccination, I developed swollen throat and congestion in sinuses. Later that night swollen throat developed into a sore throat and sinuses continued to be congested. I've next 3-4 days cold symptoms progressed with lethargy but seem to dissipate after day 4. Soon after cold symptoms disappeared, I developed bloodshot eyes specifically in the inner corners of my eyes - this lasted 3-4 days and was not helped by Visine allergy eye drops. After my eyes cleared up, I developed a tension-like headache with stiffness in my neck - the pain was exacerbated whenever I lifted my head up from laying down or bent over. This headache lasted 3-4 days with little relief after taking ibuprofen. During the last few days of the headache, I developed hard, raised red bumps on my face, neck, chest, shoulders, scalp, legs, and back. They were not clustered and developed blister-like heads 1 day after appearing along with an urge to itch. Total, I probably had 40-50 blisters. Additionally, at the onset of the blisters, I developed an enlarged, swollen lymph node located behind my right ear. I made an appt to get checked out ASAP and was seen by a nurse practitioner who diagnosed me with a mild case of chickenpox. The blisters began to form scabs 4-5 days after appearing and have begun to clear up - no new blisters have formed. I am not pregnant nor do I have an immunodeficiency disease to my knowledge.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Pharyngeal oedema, Pruritus, Rash erythematous, Scab, Sinus congestion
Clinical narrative: 3-4 hours after receiving vaccination, I developed swollen throat and congestion in sinuses. Later that night swollen throat developed into a sore throat and sinuses continued to be congested. I've next 3-4 days cold symptoms progressed with lethargy but seem to dissipate after day 4. Soon after cold symptoms disappeared, I developed bloodshot eyes specifically in the inner corners of my eyes - this lasted 3-4 days and was not helped by Visine allergy eye drops. After my eyes cleared up, I developed a tension-like headache with stiffness in my neck - the pain was exacerbated whenever I lifted my head up from laying down or bent over. This headache lasted 3-4 days with little relief after taking ibuprofen. During the last few days of the headache, I developed hard, raised red bumps on my face, neck, chest, shoulders, scalp, legs, and back. They were not clustered and developed blister-like heads 1 day after appearing along with an urge to itch. Total, I probably had 40-50 blisters. Additionally, at the onset of the blisters, I developed an enlarged, swollen lymph node located behind my right ear. I made an appt to get checked out ASAP and was seen by a nurse practitioner who diagnosed me with a mild case of chickenpox. The blisters began to form scabs 4-5 days after appearing and have begun to clear up - no new blisters have formed. I am not pregnant nor do I have an immunodeficiency disease to my knowledge.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Tension headache, Varicella post vaccine
Clinical narrative: 3-4 hours after receiving vaccination, I developed swollen throat and congestion in sinuses. Later that night swollen throat developed into a sore throat and sinuses continued to be congested. I've next 3-4 days cold symptoms progressed with lethargy but seem to dissipate after day 4. Soon after cold symptoms disappeared, I developed bloodshot eyes specifically in the inner corners of my eyes - this lasted 3-4 days and was not helped by Visine allergy eye drops. After my eyes cleared up, I developed a tension-like headache with stiffness in my neck - the pain was exacerbated whenever I lifted my head up from laying down or bent over. This headache lasted 3-4 days with little relief after taking ibuprofen. During the last few days of the headache, I developed hard, raised red bumps on my face, neck, chest, shoulders, scalp, legs, and back. They were not clustered and developed blister-like heads 1 day after appearing along with an urge to itch. Total, I probably had 40-50 blisters. Additionally, at the onset of the blisters, I developed an enlarged, swollen lymph node located behind my right ear. I made an appt to get checked out ASAP and was seen by a nurse practitioner who diagnosed me with a mild case of chickenpox. The blisters began to form scabs 4-5 days after appearing and have begun to clear up - no new blisters have formed. I am not pregnant nor do I have an immunodeficiency disease to my knowledge.
Age: 20.0
Sex: F
Vaccine: MMRV
Symptoms: Arthralgia, Dyspnoea, Fatigue, Headache, Lethargy
Clinical narrative: Major swelling of all lymphnodes in the body. Achey joints and muscles. Low grade fever/fever like symptoms. Tiredness and shortness of breath at times. Headaches. Lethargy. I called the clinic for advice but they didn't know how to help, I'm going to get an appointment with the doctor.
Age: 20.0
Sex: F
Vaccine: MMRV
Symptoms: Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Major swelling of all lymphnodes in the body. Achey joints and muscles. Low grade fever/fever like symptoms. Tiredness and shortness of breath at times. Headaches. Lethargy. I called the clinic for advice but they didn't know how to help, I'm going to get an appointment with the doctor.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient received Bexsero at dose 1. MENVEO was administered at dose 2, instead of BEXSERO.  Patient did not complain of any adverse reaction/side affects.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Peripheral swelling, Skin discolouration, Tenderness
Clinical narrative: Mom reported her entire arm became purple and swollen following vaccine administration. Pt reported arm still feeling tender at most recent visit, 4 weeks after vaccine administration.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Depressed level of consciousness, Loss of consciousness, Malaise, Syncope
Clinical narrative: Completely passed out/fainted and was ill, semi-blacking out for around 30 minutes. Called 911. EMT said it was the 4th reporting of a fainting after the HPV vaccine that they had received.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage
Clinical narrative: I was 6 weeks pregnant. 2 days later after I had my flu vaccine, I started to bleed and lead to miscarriage eventually. I has flu shot yearly with no problem. I never had miscarriage before.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Asthenia, Electromyogram, Fatigue, Guillain-Barre syndrome
Clinical narrative: My mother reported having extreme fatigue immediately after vaccination administered and for two days. After a few days of improvement and feeling normal she woke up several days afterward and was unable to walk. After 6 days in the hospital with increasing weakness she was diagnosed with Guillain Barre Syndrome.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Lumbar puncture
Clinical narrative: My mother reported having extreme fatigue immediately after vaccination administered and for two days. After a few days of improvement and feeling normal she woke up several days afterward and was unable to walk. After 6 days in the hospital with increasing weakness she was diagnosed with Guillain Barre Syndrome.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Shortly after vaccine 2 vaccinations the patient experienced syncope and fainted. She lost consciousness but regained it within a few minutes. I layed her flat on her back and raised her legs as my technician stayed by her head and hold her hands. 911 was called as patient has a history of seizures. An EMT took her BP and HR which were w/in normal limits. Pt refused transportation but did sit with us for 30 minutes to ensure she did not return.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema multiforme, Full blood count, Metabolic function test
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 62 year old female patient. There was no information about the patient's medical history, concurrent conditions, concomitant medication or known allergies provided. On 21-JUN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N010109, expiry date 20-NOV-2018, intramuscularly for prophylaxis (exact dose was not reported). On 22-JUN-2017, the patient contacted the nurse practitioner and expressed concern that she had had erythema multiforme at the injection site on the left arm. The nurse practitioner ordered complete blood count (CBC) and CMP, but she had no results of the labwork. The patient was given treatment for the adverse events. The outcome of erythema multiforme and injection site erythema was reported as recovered on an unknown date in 2017. The causality assessment between the events and with PNEUMOVAX23 was not provided. Upon internal review, the event of erythema multiforme was determined to be medically significant. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema multiforme, Full blood count, Injection site reaction, Metabolic function test
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 62 year old female patient. There was no information about the patient's medical history, concurrent conditions, concomitant medication or known allergies provided. On 21-JUN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N010109, expiry date 20-NOV-2018, intramuscularly for prophylaxis (exact dose was not reported). On 22-JUN-2017, the patient contacted the nurse practitioner and expressed concern that she had had erythema multiforme at the injection site on the left arm. The nurse practitioner ordered complete blood count (CBC) and CMP, but she had no results of the labwork. The patient was given treatment for the adverse events. The outcome of erythema multiforme and injection site erythema was reported as recovered on an unknown date in 2017. The causality assessment between the events and with PNEUMOVAX23 was not provided. Upon internal review, the event of erythema multiforme was determined to be medically significant. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Fatigue, Migraine, Paraesthesia, Pyrexia, Tremor
Clinical narrative: 2 hr after vaccine administered - patient felt fatigued. 6 hr later fever to 100. Pt had a migraine. 15 hr later fever to 102, shaking tingling fingers felt "odd". 24 hr SX resolved.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Fatigue, Feeling abnormal, Migraine, Paraesthesia, Pyrexia
Clinical narrative: 2 hr after vaccine administered - patient felt fatigued. 6 hr later fever to 100. Pt had a migraine. 15 hr later fever to 102, shaking tingling fingers felt "odd". 24 hr SX resolved.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Tremor
Clinical narrative: 2 hr after vaccine administered - patient felt fatigued. 6 hr later fever to 100. Pt had a migraine. 15 hr later fever to 102, shaking tingling fingers felt "odd". 24 hr SX resolved.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a 11 year old female patient. Information on patient's concurrent conditions, medical history and concomitant medications was unknown. On 19-JUL-2017, the patient was vaccinated with GARDASIL 9 lot # M040412 (expiration date unknown), intramuscularly for prophylaxis. On 04-AUG-2017, the patient experienced "pain and spasms" at the injection site. The patient sought medical attention by contacting the physician. The outcome of the events injection site pain and injection site muscle spasm was unknown. Causality assessment was not provided by the reporter. There was no product quality complaint (PQC) involved.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain, Injection site reaction, Muscle spasms
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a 11 year old female patient. Information on patient's concurrent conditions, medical history and concomitant medications was unknown. On 19-JUL-2017, the patient was vaccinated with GARDASIL 9 lot # M040412 (expiration date unknown), intramuscularly for prophylaxis. On 04-AUG-2017, the patient experienced "pain and spasms" at the injection site. The patient sought medical attention by contacting the physician. The outcome of the events injection site pain and injection site muscle spasm was unknown. Causality assessment was not provided by the reporter. There was no product quality complaint (PQC) involved.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a retired physician refers to his wife, a 76 year old female patient. The patient's medical history was not reported. There were no drug reactions/allergies. On 08-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 (Strength, dose, frequency, anatomical location, route, lot/batch # and expiration date were not reported) for  "prevention vaccination". There were no concomitant therapies reported. On 09-AUG-2017, the patient developed tenderness and her inner arm was fiery red and on the same day, the patient was treated by applying ice packs and 1% hydro-cortisone cream to the arm as "home treatment". There were no lab diagnostics/studies performed. The patient did not seek medical attention. There was no product quality complaint involved. The outcome of the events was reported to be not recovered. The causality assessment was not provided by the reporting physician.
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Tenderness
Clinical narrative: This spontaneous report as received from a retired physician refers to his wife, a 76 year old female patient. The patient's medical history was not reported. There were no drug reactions/allergies. On 08-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 (Strength, dose, frequency, anatomical location, route, lot/batch # and expiration date were not reported) for  "prevention vaccination". There were no concomitant therapies reported. On 09-AUG-2017, the patient developed tenderness and her inner arm was fiery red and on the same day, the patient was treated by applying ice packs and 1% hydro-cortisone cream to the arm as "home treatment". There were no lab diagnostics/studies performed. The patient did not seek medical attention. There was no product quality complaint involved. The outcome of the events was reported to be not recovered. The causality assessment was not provided by the reporting physician.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with improperly stored vaccine RECOMBIVAX HB (dose, strength and frequency unknown) that underwent temperature excursion every day since May 2017. She also reported that the vaccines may also have had temperature excursions prior to May 2017. For RECOMBIVAX HB lot numbers are N006321 expiration 08-NOV-2019, M037248 expiration 21-FEB-2019. The vaccine was stored at 32 to 35 degrees Fahrenheit for 25 hours and 47 to 77 degrees Fahrenheit for 55 hours. There had not been a previous temperature excursion and the phone call was a result of the data logger.  No adverse effects were reported. This is one of the several reports from the same reporter. This report has been linked to reports 1707USA002962, 1708USA004862 and 1708USA004861. .; Sender's Comments: US-009507513-1707USA002962: US-009507513-1708USA004861: US-009507513-1708USA004862:
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 11 year old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 24-APR-2017 the patient was vaccinated with first dose of GARDASIL, Lot# M104929, expiration date 27-MAY2017 for prophylaxis. On 20-FEB-2017, the patient was vaccinated with second dose of GARDASIL, Lot# M104929, expiration date 27-MAY-2017 for prophylaxis. On 24-APR-2017, the patient was vaccinated with third dose of GARDASIL, Lot# M104929, expiration date 27-MAY2017 for prophylaxis. No adverse events.  No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a patient  of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 10-JUL-2017, an unspecified  patient may have been vaccinated with improperly stored dose of ZOSTAVAX 19400 PFU lot # N012493, expiration 17-MAR-2018 (dose and route of administration were not reported) for prophylaxis. Sterile diluent used to reconstitute the vaccine did not undergo a temperature excursion.  Temperature: 15 degrees Fahrenheit (°F) to 46°F Time Frame: 12 hours 19 minutes No previous temperature excursion Digital Data logger report was involved. No additional information was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity, Swelling
Clinical narrative: This spontaneous report has been received from a registered nurse concerning three unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was unknown. On unspecified dates, the patients received a dose of PNEUMOVAX 23 (lot # N010106, expiration date 15-NOV-2018; dose and route unknown) for prevention, respectively. On unknown dates, the patients experienced "severe pain at injection site, severe pain in the arm of administration and swelling within 24 hours of administration". The patients did not seek medical attention and no treatment was given for the events. No lab diagnostics studies were performed. The outcome of the events was unknown. The causality between the events and  PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were reported. On an unspecified date, an unspecified number of patients were vaccinated with an improperly stored dose of GARDASIL 9 (lot # N004799, expiration date15-NOV-2019) (dosage, frequency and route were not reported) for prophylaxis (Incorrect product storage). The vaccine was stored at a temperature from 32F to 35 F for 6 days. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. No adverse effect reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA003819: US-009507513-1708USA004001: US-009507513-1708USA004000:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from an office manager referring to amount of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M047661, expiration date 02-DEC-2018, dose and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent (STERILE DILUENT). The vaccine was exposed to temperature excursion of 6 F to 14 F for 11 hours 30 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effects were reported.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 12 month old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not reported. On 20-JUL-2017, the patient was inadvertently administered a dose of both PROQUAD (dose, route, lot# and expiration date were not reported) and VARIVAX (dose, route, lot# and expiration date were not reported) for prophylaxis (Accidental overdose), which was reconstituted with sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions and allergies and concomitant therapies was reported. On an unknown dates, multiple doses of improperly stored M-M-R II lot # L026553 with expiration date 16-JUL-2017 and M035388 with expiration date 02-AUG-2018 were administered to multiple unspecified patients for prophylaxis. Improperly stored vaccines underwent following temperature excursion: 9 Celsius degrees to 25 Celsius degrees (8.5 Celsius degrees) for 12 hours. Data logger was involved. No adverse event was reported.; Sender's Comments: US-009507513-1708USA005614: US-009507513-1708USA005615: US-009507513-1708USA005616: US-009507513-1708USA005617:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age. In 2017, the patients were vaccinated with ZOSTAVAX lot # N012614, expiry date 16-MAR-2018 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). In 2017, the patients experienced incorrect product storage. On an unknown date, the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX.    Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 5 unspecified patients of unknown age and gender. The patients' medical histories, concomitant medications and drug reactions or allergies were not reported. On multiple unknown dates, the patients were administered doses of improperly stored VARIVAX injection (lot # reported as N007937 with expiration date at 08-MAR-2019, for prophylaxis; strength, dose, route of administration and anatomical location were not reported), which were reconstituted with properly stored sterile diluent (STERILE DILUENT) (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported). The administered doses of vaccine were exposed to a temperature excursion between 6 degrees Fahrenheit (F) and 14 degrees Fahrenheit (F) for 1 hour and between 15 degrees Fahrenheit (F) and 46 degrees Fahrenheit (F) (also reported as 36 degrees Fahrenheit (F)) for 4 hours. There was no previous temperature excursion. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. Lot number N007939 is an invalid lot number for varicella virus vaccine live (oka/merck). Additional information has been requested.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dysgeusia, Hypoacusis, Neck pain, Rash
Clinical narrative: This spontaneous report as received from a other health professional refers to a 17 year old female patient with vestibular disorder, drug hypersensitivity, food allergy and cochlea implant. On 14-MAR-2017 the patient was vaccinated with GARDASIL 9 lot # M034780 for prophylaxis. Other suspect therapies included MENVEO. Concomitant therapies included albuterol (ALBUTEROL). On 14-MAR-2017, 1 day after onset of therapy the patient experienced rash and dysgeusia. On MAR-2017 the patient experienced neck pain and hypoacusis. The outcome of rash, hypoacusis, neck pain and dysgeusia is unknown.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: she got a case of shingles recently and pick up a prescription for Valacyclovir; Information has been received from a pharmacist referring to an 81 year old female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. In 2015 (reported as 2 years ago), the patient was vaccine with ZOSTAVAX (lot number, strength and dose were not reported) subcutaneously for shingles prevention. On 03-AUG-2017, the patient reported to a pharmacy that she got a case of shingles recently and pick up a prescription for valacyclovir (1gm, three times daily, for 3 additional days on 28-JUL-2017). Packet offered. Health care professional adamant about not receiving. Packet not faxed. Treatment had given for shingles. No lab diagnostics were performed. The outcome of shingles was reported as recovering. Action taken with ZOSTAVAX was not applicable. The relationship between the event and the vaccine was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. There was no information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies provided. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M042853 with the expiration date of 17-JUL-2019; dose number, exact dose and route of administration were not reported), for prophylaxis. No adverse effects were reported. The administered doses of vaccine experienced a temperature excursion of 51 Fahrenheit degrees for 15 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005640: US-009507513-1708USA005641:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Information has been received from a 63 year old female patient referring to herself. The patient had cancer, and allergic to erythromycin. Her medical history included sinus surgery, appendectomy and trigger fingers carpel tunnel. No other known allergies were reported. The concomitant medications included "several medication (names unknown)". In 2014, the patient was vaccine with ZOSTAVAX (lot number and dose were not reported) injection to prevent the shingles. The patient reported that she got the shingles in 2015 after getting ZOSTAVAX vaccine. She sought medical attention seeing a dermatologist, her primary doctor, and an ear, nose, throat specialist (ENT). She further stated "It was odd, it was different, it was itching and hurting at the same time, I had horrible headache. I would touch my head in certain areas and it would stop hurting it was really weird." She then further stated that she had a rash that started at the top of her head then to the right side of her face all throughout her ear and face. She also stated that she wasn't sure if she got the shingles or the reaction to it because she had cancer, and she wasn't sure which doctor gave her ZOSTAVAX. No lab test performed. The patient had received treatment. Action take with vaccine was not applicable. The outcome of the shingles was unknown. The relationship between the event and the vaccine was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated improperly stored doses of PROQUAD from lot# N002325 with expiry: 19-JUL-2018 and lot# M042502 with expiry 17-APR-2018 (dosing details not reported) for prophylaxis. Concomitant included sterile diluent (MERCK STERILE DILUENT). The vaccine stored at  9 degree Celsius to 8 degree Celsius for 38 minutes. The vaccine had no previous temperature excursion and the excursion was detected by data logger.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA003217:
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant drug were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, strength, route, lot # and expiration date unknown) for prophylaxis. On an unspecified date "several years ago", the patient "developed a varicella like rash" on an unspecified area of the body. Action taken with the vaccine was not applicable. The outcome of the event was unknown. The relationship between the event and vaccine was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from 60-year-old female patient who was also a healthcare worker, via a company representative, who was referring on herself. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). On an unknown date (reported as "about 10 days later"), the patient experienced injection site mass, injection site erythema, injection site pain and injection site pruritus. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of VAQTA single dose, lot# N005274, expiration date 03-APR-2018 (route of administration and anatomical location were not reported), were administered to the patients. No adverse effects have been reported. The doses were stored in a temperature of 30 degrees Fahrenheit for 2 hours and 15 minutes. Data logger was involved. There was no previous temperature excursion reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005633: US-009507513-1708USA005632:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4 year-old Hispanic patient of unknown gender. There was no information about the patient's pertinent medical history, drug reactions or allergies or concomitant therapies provided. On 23-JUN-2017 at 11:58, the patient was vaccinated with improperly stored VARIVAX, in the left thigh (lot # M047662 with the expiration date of 02-DEC-2018, second dose; exact dose and route of administration were not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse events were reported. The administered dose of vaccine experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This is one of several reports received from the same reporter..; Sender's Comments: US-009507513-1706USA009938:
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 15 month-old Black male patient. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 28-JUN-2017 at 19:04, the patient was vaccinated with improperly stored VARIVAX, in the right thigh (lot # M047662 with the expiration date of 02-DEC-2018; first dose, exact dose and route of administration were not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The patient was concomitantly vaccinated with a dose of M-M-R II. The administered dose of VARIVAX experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1706USA009938:
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 32 year old female patient with multiple sclerosis. The patient had mental health issues including major depression and anxiety. The patient was allergic to fluoxetine. On 03-AUG-2017, the patient was vaccinated with a dose of PNEUMOVAX23 (intramuscular left deltoid, lot # M042324 and expiration date 10-JUN-2018) for vaccination (prophylaxis). On an unspecified date in August 2017, within hours of receiving PNEUMOVAX23, the patient felt a fever, body aches, and nausea and began to vomit which prompted to the emergency room. While in the hospital (in August 2017), the patient began to have warmth and redness near the injection site and was diagnosed with cellulitis. The patient had been receiving intravenous (IV) vancomycin as treatment. As of 07-AUG-2017, the patient was still in the hospital and she felt that her arm was still sore and red and she felt the treatment had not yet kicked in.  At the reporting time, the patient did not recover from the events. The causality between the events and PNEUMOVAX23 was not reported. Upon internal review, cellulitis was determined to be medically significant.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 32 year old female patient with multiple sclerosis. The patient had mental health issues including major depression and anxiety. The patient was allergic to fluoxetine. On 03-AUG-2017, the patient was vaccinated with a dose of PNEUMOVAX23 (intramuscular left deltoid, lot # M042324 and expiration date 10-JUN-2018) for vaccination (prophylaxis). On an unspecified date in August 2017, within hours of receiving PNEUMOVAX23, the patient felt a fever, body aches, and nausea and began to vomit which prompted to the emergency room. While in the hospital (in August 2017), the patient began to have warmth and redness near the injection site and was diagnosed with cellulitis. The patient had been receiving intravenous (IV) vancomycin as treatment. As of 07-AUG-2017, the patient was still in the hospital and she felt that her arm was still sore and red and she felt the treatment had not yet kicked in.  At the reporting time, the patient did not recover from the events. The causality between the events and PNEUMOVAX23 was not reported. Upon internal review, cellulitis was determined to be medically significant.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: The information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gende. The patients' concurrent condition, medical history and concomitant therapy were reported. On an unspecified date, an unspecified number of patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot#N009802, expiration date 19-DEC-2019) (dosage, frequency and route were not reported) for prophylaxis(incorrect product storage). The vaccine was stored at a temperature from 32F to 35 F for 6 days. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. No adverse effect reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006766: US-009507513-1708USA004001: US-009507513-1708USA004000: