chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Nausea, Pain, Photophobia
Clinical narrative: Chills, joint and body aches, mild nausea, photophobia 24 hrs after administration of Tdap.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: 1 day history of fever. TYLENOL as needed every 4-6 hours. No outcomes yet.
Age: 70.0
Sex: F
Vaccine: YF
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site became swollen after vaccination, became increasingly swollen and now is the size of a baseball. Constant itching, mild intermittent pain. No systemic symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 14-JUL-2017 from a pharmacist regarding an unspecified patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 14-JUL-2017, an unspecified nurse inadvertently administered an expired dose of ZOSTAVAX (lot # M018453, exp 28-JUN-2017) (dose, route, site of administration not reported) to an unspecified patient. No adverse effects reported. The outcome of the event was unknown. The pharmacist reported that the ZOSTAVAX was stored at the appropriate storage condition specified in the product label through the date of administration. No additional information was provided. Additional information has been requested.
Age: 38.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 14-JUL-2017 from a registered nurse regarding a 38 year old patient of unknown gender. Medical history, concurrent conditions and concomitant medications were not reported. On 12-JUL-2017, the patient was administered a dose of VARIVAX (lot # L025206, exp 07-JUL-2017) (dose, route, and site of administration not reported). No adverse effects were reported.  The outcome of the event was unknown. Additional information has been requested. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1707USA009935: US-009507513-1707USA009936.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Epistaxis
Clinical narrative: Information was received on 13-JUL-2017 from a registered nurse regarding a 13 year old male patient. Medical history, concurrent conditions and concomitant medications were reported as none. On 12-JUL-2017, the patient was vaccinated with GARDASIL 9 (lot # N007931, exp 17-NOV-2019) intramuscularly (dose and site of administration not reported). On 13-JUL-2017, the patient experienced two nosebleeds. The patient did not experience any trauma to his nose. He did not seek medical attention as he was able to stop the nosebleeds on his own with pressure. The relationship between the nosebleeds and GARDASIL 9 was not provided. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from licensed practical nurse regarding multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On multiple unknown dates, multiple unspecified patients were administered improperly stored doses of PROQUAD, (lot number reported as N001489, expiration date 12-JUN-2018) or ZOSTAVAX (lot # M032141, expiration date 27-OCT-2017 and lot # M035692, expiration date 07-NOV-2017) (dose and site of administration for both vaccines were not reported) subcutaneously for prophylaxis. Concomitant medications included sterile diluent (lot number and expiration are unknown) which was properly stored. No adverse effects were reported. The vaccine doses were stored at 15 degrees Fahrenheit to 46 degrees Fahrenheit for a time frame of 2 hours 20 minutes for ZOSTAVAX and 40 minutes for PROQUAD. There was no previous temperature excursion reported. The call was made because of a data logger. No additional information is available. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received on 03-JUL-2017 from a 70 year old female patient with allergies to KEFLEX, BACTRIM, penicillin, cephalosporin and clindamycin. Patient reported that she received ZOSTAVAX vaccine (dosage, lot#/expiration not reported) in December 2009 and she now has "shingles" (onset reported as 26-JUN-2017). The patient was prescribed by her physician valacyclovir and prednisone for her treatment of shingles. Outcome of shingles was not reported. No further adverse event information provided. The patient requested to be reimbursed for the medical expenses she accrued for her treatment of shingles. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage and 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 ROTATEQ. Additional information has been requested. Sender's Comments: US-009507513-1707USA009900: US-009507513-1707USA009901.
Sex: U
Vaccine: HEP, HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB lot # M037248, expiration date 21-FEB-2019, for prophylaxis. Other suspect therapies included GARDASIL 9 lot # N002720, expiration date 12-MAY-2019, for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Vaccine Coordinator referring to an unspecified number of patients of unknown demographics. On 20-JUL-2017 and 21-JUL-2017, the patients were vaccinated with improperly stored VARIVAX (lot # M044347, expiration date 04-NOV-2018, lot # N000681, expiration date 06-JAN-2019 and lot # reported as N012618, expiration date 21-APR-2019), subcutaneous for prophylaxis. It was also reported that the sterile diluent was properly stored. The temperature/time frame was 15 degrees Fahrenheit to 46 degrees Fahrenheit for 2 hours and 15 minutes with a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours. (Digital data logger). No adverse events were reported. This is one of two reports received from the same source (Linked report MARRS # 1707USA009932). Sender's Comments: US-009507513-1707USA009932.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. On an unknown date the patient experienced incorrect product storage and 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 GARDASIL 9. Additional information has been requested. Sender's Comments: US-009507513-1707USA009901: US-009507513-1707USA009810.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Vaccine Coordinator referring to an unspecified number of patients of unknown demographics. On 20-JUL-2017 and 21-JUL-2017, the patients were vaccinated with improperly stored PROQUAD (lot # N002325 expiration date 19-JUL-2019), subcutaneous for prophylaxis. It was also reported that the sterile diluent was properly stored. The temperature/time frame was 15 degrees Fahrenheit to 46 degrees Fahrenheit for 2 hours and 15 minutes with a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours. (Digital data logger). No adverse events were reported. This is one of two reports received from the same source (Linked report MARRS # 1707USA009884). Sender's Comments: US-009507513-1707USA009884.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 14-JUL-2017 from a registered nurse regarding a 31 year old female patient. Medical history, concurrent conditions and concomitant medications were not reported. On 12-JUL-2017, the patient was administered an expired dose of VARIVAX (lot # L025206, exp 07-JUL-2017) (dose, route, and site of administration not reported). No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1707USA002872: US-009507513-1707USA009936.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 14-JUL-2017 from a registered nurse regarding a 31 year old female patient. Medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2017, the patient was administered an expired dose of VARIVAX (lot # L025206, exp 07-JUL-2017) (dose, route, and site of administration not reported). No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1707USA002872: US-009507513-1707USA009935.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Malaise, Myalgia, Pyrexia, Rhabdomyolysis
Clinical narrative: Malaise, Fever to 102.5, Headache, Myalgia, Rhabdomyolysis.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Rash erythematous, Skin warm
Clinical narrative: flaming red rash across shoulder and biceps, hot to touch, occurred less than 24 hours of injection Disagnosed as cellutis, being treated currently with Bactrim and prednisolone.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Pt today presents with c/o musculoskeletal pains x 5 days. Injury: none, but had her final GARDASIL injection on 7/17;  Location: L arm;  Symptoms: pain and aching radiating to L neck; Exacerbating factors: movement;  Relieving factors: rest; Has a cleaning business and it is painful;  Has taken very little OTC medication
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Rash on both lower extremities, left greater than right, that appeared as hives. Patient was offered IM BENADRYL (no PO BENADRYL was available in clinic) and parents declined. He was observed in clinic for 30 minutes with almost clear resolution of rash (hives improved, erythema of lower extremities remained). Parents were instructed to give PO BENADRYL at home and monitor for further signs of reaction.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: About 3 hours after receiving the vaccines the 2 year old started having an itchy erythematous rash on bilateral lower extremities with a lesser amount on the bilateral upper extremities. His mother put on 1% hydrocortisone cream and this morning it was improved. He still has some rash now (about 22 hours post vaccine), but his mother reports that it is much improved since yesterday. He no longer seems to be scratching and it is not bothering him. There were no other medications yesterday, no changes in foods, laundry detergents, soaps, or activities.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Hypersensitivity, Injection site reaction, Rash, Rash papular, Rash pruritic
Clinical narrative: About 3 hours after receiving the vaccines the 2 year old started having an itchy erythematous rash on bilateral lower extremities with a lesser amount on the bilateral upper extremities. His mother put on 1% hydrocortisone cream and this morning it was improved. He still has some rash now (about 22 hours post vaccine), but his mother reports that it is much improved since yesterday. He no longer seems to be scratching and it is not bothering him. There were no other medications yesterday, no changes in foods, laundry detergents, soaps, or activities.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 62.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Asthenia, Cough, Influenza like illness, Myalgia
Clinical narrative: Following vaccination, flu-like symptoms, with myalgia, arthralgia, cough, cold, fever of 101.4 and weakness. These treated with supportive care and symptoms lasted 48 hours and then slowly improved. After 72 hours symptoms completely resolved.
Age: 62.0
Sex: F
Vaccine: MNQ
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: Following vaccination, flu-like symptoms, with myalgia, arthralgia, cough, cold, fever of 101.4 and weakness. These treated with supportive care and symptoms lasted 48 hours and then slowly improved. After 72 hours symptoms completely resolved.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Drug administered at inappropriate site, Injection site pain, Pain, Pyrexia
Clinical narrative: Fevers to 104F, chills, body aches within 4 hours of vaccine lasting 4 days, also with right shoulder pain. Review of injection site appears to be too cephalad and may have been injected into the right subacromial bursa.
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Breast pain, Crying, Erythema, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Patient received the PNEUMOVAX 23 vaccination on Saturday afternoon July 22, 2017.  The following account was given over the phone on 7/25/17 by the patient. She states that she bled from the vaccination site for 3 hours after the vaccination but not heavily. On Sunday morning she states that she could not raise her arm or brush her hair. She was in pain. She used Tylenol to treat the pain. On Monday she went to work. She states this was the worst day; the pain was so great that she was crying, felt like she "wanted to cut my arm off", and considered going to the emergency department for treatment. She was unable to move her arm and had no function in that arm. She works at a clinic and a nurse observed that her whole arm looked red and there was swelling at injection site although not officially seen. She described the pain further as throbbing and agonizing. She also stated that the pain was felt under her arm, breast, shoulder (top and back) and went down into her fingers. She used Tylenol and ice packs to treat the pain. Today, she says she has a call into her provider and hopes to see her tomorrow. The pain is slightly less today (7/25/17) but is still painful, and hard to lift arm and can't lift anything heavy.
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity, Vaccination site haemorrhage
Clinical narrative: Patient received the PNEUMOVAX 23 vaccination on Saturday afternoon July 22, 2017.  The following account was given over the phone on 7/25/17 by the patient. She states that she bled from the vaccination site for 3 hours after the vaccination but not heavily. On Sunday morning she states that she could not raise her arm or brush her hair. She was in pain. She used Tylenol to treat the pain. On Monday she went to work. She states this was the worst day; the pain was so great that she was crying, felt like she "wanted to cut my arm off", and considered going to the emergency department for treatment. She was unable to move her arm and had no function in that arm. She works at a clinic and a nurse observed that her whole arm looked red and there was swelling at injection site although not officially seen. She described the pain further as throbbing and agonizing. She also stated that the pain was felt under her arm, breast, shoulder (top and back) and went down into her fingers. She used Tylenol and ice packs to treat the pain. Today, she says she has a call into her provider and hopes to see her tomorrow. The pain is slightly less today (7/25/17) but is still painful, and hard to lift arm and can't lift anything heavy.
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Weight bearing difficulty
Clinical narrative: Patient received the PNEUMOVAX 23 vaccination on Saturday afternoon July 22, 2017.  The following account was given over the phone on 7/25/17 by the patient. She states that she bled from the vaccination site for 3 hours after the vaccination but not heavily. On Sunday morning she states that she could not raise her arm or brush her hair. She was in pain. She used Tylenol to treat the pain. On Monday she went to work. She states this was the worst day; the pain was so great that she was crying, felt like she "wanted to cut my arm off", and considered going to the emergency department for treatment. She was unable to move her arm and had no function in that arm. She works at a clinic and a nurse observed that her whole arm looked red and there was swelling at injection site although not officially seen. She described the pain further as throbbing and agonizing. She also stated that the pain was felt under her arm, breast, shoulder (top and back) and went down into her fingers. She used Tylenol and ice packs to treat the pain. Today, she says she has a call into her provider and hopes to see her tomorrow. The pain is slightly less today (7/25/17) but is still painful, and hard to lift arm and can't lift anything heavy.
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site haemorrhage, Loss of consciousness, Mobility decreased
Clinical narrative: Patient received the PNEUMOVAX 23 vaccination on Saturday afternoon July 22, 2017.  The following account was given over the phone on 7/25/17 by the patient. She states that she bled from the vaccination site for 3 hours after the vaccination but not heavily. On Sunday morning she states that she could not raise her arm or brush her hair. She was in pain. She used Tylenol to treat the pain. On Monday she went to work. She states this was the worst day; the pain was so great that she was crying, felt like she "wanted to cut my arm off", and considered going to the emergency department for treatment. She was unable to move her arm and had no function in that arm. She works at a clinic and a nurse observed that her whole arm looked red and there was swelling at injection site although not officially seen. She described the pain further as throbbing and agonizing. She also stated that the pain was felt under her arm, breast, shoulder (top and back) and went down into her fingers. She used Tylenol and ice packs to treat the pain. Today, she says she has a call into her provider and hopes to see her tomorrow. The pain is slightly less today (7/25/17) but is still painful, and hard to lift arm and can't lift anything heavy.
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient received the PNEUMOVAX 23 vaccination on Saturday afternoon July 22, 2017.  The following account was given over the phone on 7/25/17 by the patient. She states that she bled from the vaccination site for 3 hours after the vaccination but not heavily. On Sunday morning she states that she could not raise her arm or brush her hair. She was in pain. She used Tylenol to treat the pain. On Monday she went to work. She states this was the worst day; the pain was so great that she was crying, felt like she "wanted to cut my arm off", and considered going to the emergency department for treatment. She was unable to move her arm and had no function in that arm. She works at a clinic and a nurse observed that her whole arm looked red and there was swelling at injection site although not officially seen. She described the pain further as throbbing and agonizing. She also stated that the pain was felt under her arm, breast, shoulder (top and back) and went down into her fingers. She used Tylenol and ice packs to treat the pain. Today, she says she has a call into her provider and hopes to see her tomorrow. The pain is slightly less today (7/25/17) but is still painful, and hard to lift arm and can't lift anything heavy.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Urticaria immediately after DTaP, but no anaphylaxis.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Limb mass, Peripheral swelling, Pruritus, Vaccination complication
Clinical narrative: Vaccine reaction 1 day after the administration. Swollen lump 6" x 4" left arm, with redness and itchiness.
Age: 20.0
Sex: F
Vaccine: HEP, RAB
Symptoms: Injection site dermatitis
Clinical narrative: Dermatitis type reaction near Hepatitis injection site approximately 6 hrs after injection.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: On 7/24 the arm that the MMR was given in started with just itching when she reached home a rash (bumps) appeared on that same arm. On 7/25 rash had spread to both arms, neck and legs. She was given DECADRON and told to take ZYRTEC.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at the injection site that began a few hours after the injection was given. He was given ULTRAM 50mg Q6 hr PRN pain #10.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: After administering vaccines pt. passed out.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pt. reports soreness in shoulder 2-3 days after vaccine. Soreness still present 30 days after vaccine. (Left arm same as vaccine).
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient came to clinic for 12 year annual physical. Patient was due for second dose of HPV but was given meningococcal instead.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Hyperacusis, Photophobia
Clinical narrative: Information was received from a medical assistant regarding a 13 year old male patient who received a dose of GARDASIL 9 on 04-OCT-2016 for the prevention of Human Papilloma Virus (HPV) (lot# M0160193, expiration 24-APR-2018), intramuscularly in the left deltoid. Concomitant medication included PROVENTIL and ADVAIR DISKUS. The mother of the patient reported that her son experienced light and noise sensitivity after receiving the GARDASIL 9 vaccine. When he hears a loud noise he starts crying or runs out of the room. Light sensitivity stopped but noise sensitivity continues. No medical attention was sought and no treatment was given to the patient. Causality was not reported.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Crying, Hyperacusis, Photophobia
Clinical narrative: Information was received from a medical assistant regarding a 13 year old male patient who received a dose of GARDASIL 9 on 04-OCT-2016 for the prevention of Human Papilloma Virus (HPV) (lot# M0160193, expiration 24-APR-2018), intramuscularly in the left deltoid. Concomitant medication included PROVENTIL and ADVAIR DISKUS. The mother of the patient reported that her son experienced light and noise sensitivity after receiving the GARDASIL 9 vaccine. When he hears a loud noise he starts crying or runs out of the room. Light sensitivity stopped but noise sensitivity continues. No medical attention was sought and no treatment was given to the patient. Causality was not reported.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous report as received from a other refers to a female patient of unknown age. On 25-MAY-2017 the patient was vaccinated with VARIVAX lot # N001528, 1 DF, intramuscular for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect route of drug administration. The outcome of incorrect route of drug administration is unknown. The reporter considered incorrect route of drug administration to be not related to VARIVAX. Follow-up information has been received from the patient on 30-JUN-2017. On approximately 08-JUN-2017, reported as approximately 2 weeks after receiving the VARIVAX, the patient became pregnant. The date of conception was estimated to 08-JUN-2017. The patient became pregnant with last menstrual period of 25-MAY-2017 and estimated due date of 01-MAR-2018. Initial exposure to VARIVAX was on the first trimester. No prenatal test and results were reported. The pregnancy outcome was pending. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous report as received from a other refers to a female patient of unknown age. On 25-MAY-2017 the patient was vaccinated with VARIVAX lot # N001528, 1 DF, intramuscular for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect route of drug administration. The outcome of incorrect route of drug administration is unknown. The reporter considered incorrect route of drug administration to be not related to VARIVAX. Follow-up information has been received from the patient on 30-JUN-2017. On approximately 08-JUN-2017, reported as approximately 2 weeks after receiving the VARIVAX, the patient became pregnant. The date of conception was estimated to 08-JUN-2017. The patient became pregnant with last menstrual period of 25-MAY-2017 and estimated due date of 01-MAR-2018. Initial exposure to VARIVAX was on the first trimester. No prenatal test and results were reported. The pregnancy outcome was pending. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 32 year old female patient. On 29-JUN-2017 the patient was vaccinated with VAQTA lot # M009786 for prophylaxis. On 29-JUN-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to VAQTA. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DT
Symptoms: Abdominal pain, Decreased appetite, Erythema, Hypotonia, Injection site erythema
Clinical narrative: Here with Mom for lethargy and concern for adverse reaction to Td vaccine, which she received on 4/24. Her arm was red, and spreading intermittently. She was seen on 5/1 by Dr. for concern for allergic reaction. Mom gave BENADRYL once on 5/1 when the redness spread to her chest, which helped. No BENADRYL since that time. She has been napping every day for ~2 hours since she received the vaccine. This morning she wouldn't wake up per Mom. She is awake now and walked to and from the car. No fevers. She threw up on the way to the office, but Mom reports that she does get motion sickness. No diarrhea. Decreased appetite today, she took two sips of water in the car and then threw up. No rash now. +Abdominal pain today. No dysuria. Last BM was yesterday, which was normal. No sore throat. No ear pain. No sick contacts at home. She is in school. Mom reports that she was limp for ~36 hours after she got DTaP at age 2 months.
Age: 4.0
Sex: F
Vaccine: DT
Symptoms: Lethargy, Somnolence, Vaccination complication, Vomiting
Clinical narrative: Here with Mom for lethargy and concern for adverse reaction to Td vaccine, which she received on 4/24. Her arm was red, and spreading intermittently. She was seen on 5/1 by Dr. for concern for allergic reaction. Mom gave BENADRYL once on 5/1 when the redness spread to her chest, which helped. No BENADRYL since that time. She has been napping every day for ~2 hours since she received the vaccine. This morning she wouldn't wake up per Mom. She is awake now and walked to and from the car. No fevers. She threw up on the way to the office, but Mom reports that she does get motion sickness. No diarrhea. Decreased appetite today, she took two sips of water in the car and then threw up. No rash now. +Abdominal pain today. No dysuria. Last BM was yesterday, which was normal. No sore throat. No ear pain. No sick contacts at home. She is in school. Mom reports that she was limp for ~36 hours after she got DTaP at age 2 months.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant and a nurse refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot# M004330, expiration date 26-JAN-2018; lot# M009766, expiration date 23-FEB-2018; lot# M044349, expiration date 04-NOV-2018; lot# M049126, expiration date 15-DEC-2018; lot# M019641, expiration date 20-APR-2018; lot# M041513, expiration date 11-OCT-2018 and reported as lot# N012488, expiration date 20-APR-2018 (requires lot# verification) (doses and routes of administration were not reported for all) reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -14 Celsius degrees to -10 Celsius degrees for 16 hours. Data logger was not involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA009797.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse concerning a 20 year old patient (gender not specified). The patient's medical history, concurrent condition and concomitant medication use were not provided. On unknown dates the patient completed the hepatitis B vaccine series (manufacturer unknown), (route unknown) for prophylaxis. The nurse reported that the patient had titers dawn (unspecified date and reason) that showed the patient had a low immune response to Hepatitis B. The 20 year old patient was administered a pediatric dose of RECOMBIVAX HB (lot#, route, total dosage and date of vaccination not specified) due to having a low immune response to Hepatitis B. No further information was provided. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist concerns a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 05-JUL-2017 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (route unknown), lot # M003027, expiration date 21-JUN-2017, for prophylaxis. No adverse event was reported. The outcome of the event was unknown. Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old male patient with penicillin allergy, preexisting neck pain and Diabetes Type II. On 21-MAY-2017 the patient was vaccinated with PNEUMOVAX 23, intramuscular (lot# and expiration date not reported) for prophylaxis. On 28-MAY-2017 (reported a week later) after receiving PNEUMOVAX 23, the patient experienced tingling and weakness in the fingers of both extremities and has been unable to swim and visit the gym. The patient did visit his physician and no treatment had been given. The outcome of tingling and weakness in the fingers of both extremities was reported as not recovered. Tingling and weakness in the fingers of both extremities was considered disabling. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Balance disorder, Blood test normal, Coordination abnormal, Discomfort
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old male patient with penicillin allergy, preexisting neck pain and Diabetes Type II. On 21-MAY-2017 the patient was vaccinated with PNEUMOVAX 23, intramuscular (lot# and expiration date not reported) for prophylaxis. On 28-MAY-2017 (reported a week later) after receiving PNEUMOVAX 23, the patient experienced tingling and weakness in the fingers of both extremities and has been unable to swim and visit the gym. The patient did visit his physician and no treatment had been given. The outcome of tingling and weakness in the fingers of both extremities was reported as not recovered. Tingling and weakness in the fingers of both extremities was considered disabling. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Injection site pain, Muscular weakness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old male patient with penicillin allergy, preexisting neck pain and Diabetes Type II. On 21-MAY-2017 the patient was vaccinated with PNEUMOVAX 23, intramuscular (lot# and expiration date not reported) for prophylaxis. On 28-MAY-2017 (reported a week later) after receiving PNEUMOVAX 23, the patient experienced tingling and weakness in the fingers of both extremities and has been unable to swim and visit the gym. The patient did visit his physician and no treatment had been given. The outcome of tingling and weakness in the fingers of both extremities was reported as not recovered. Tingling and weakness in the fingers of both extremities was considered disabling. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old male patient with penicillin allergy, preexisting neck pain and Diabetes Type II. On 21-MAY-2017 the patient was vaccinated with PNEUMOVAX 23, intramuscular (lot# and expiration date not reported) for prophylaxis. On 28-MAY-2017 (reported a week later) after receiving PNEUMOVAX 23, the patient experienced tingling and weakness in the fingers of both extremities and has been unable to swim and visit the gym. The patient did visit his physician and no treatment had been given. The outcome of tingling and weakness in the fingers of both extremities was reported as not recovered. Tingling and weakness in the fingers of both extremities was considered disabling. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients. The patients' medical history, concomitant medications, concurrent conditions, drug and allergy history were not provided. It was reported that on unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23, lot number M037533, expiration date 17-MAY-2018 (dosage and administration route were not reported) for prophylaxis. Temperatures and time frames registered in the data logger, were: 0°Centigrades (C) to 1°C (0.8°C) for 34 hours; 9°C to 25°C (8.7°C) for 27 hours and 26°C or warmer (26.2°C) for 27 hours. No adverse effects were reported. This is one of of several reports from the same reporter. Sender's Comments: US-009507513-1707USA005547: US-009507513-1707USA005549: US-009507513-1707USA005550: US-009507513-1707USA005551: US-009507513-1707USA004510.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients. The patients' medical history, concomitant medications, concurrent conditions, drug and allergy history were not provided. It was reported that on unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB, lot number M046133, expiration date 26-SEP-2019 (dose and administration route were not reported) for prophylaxis. Temperatures and time frames registered in the data logger, were: 0°Centigrades (C) to 1°C (0.8°C) for 34 hours; 9°C to 25°C (8.7°C) for 27 hours and 26°C or warmer (26.2°C) for 27 hours. No adverse effects were reported. This is one of of several reports from the same reporter. Sender's Comments: US-009507513-1707USA004510: US-009507513-1707USA005547: US-009507513-1707USA005548: US-009507513-1707USA005550: US-009507513-1707USA005551.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients. The patients' medical history, concomitant medications, concurrent conditions, drug and allergy history were not provided. It was reported that on unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot number M006708, expiration date 02-JUN-2018 (dose and administration route were not reported) for prophylaxis. Temperatures and time frames registered in the data logger, were: 0°Centigrades (C) to 1°C (0.8°C) for 34 hours; 9°C to 25°C (8.7°C) for 27 hours and 26°C or warmer (26.2°C) for 27 hours. No adverse effects were reported. This is one of of several reports from the same reporter.; Sender's Comments:  US-009507513-1707USA004510: US-009507513-1707USA005547: US-009507513-1707USA005548: US-009507513-1707USA005549: US-009507513-1707USA005551:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients. The patients' medical history, concomitant medications, concurrent conditions, drug and allergy history were not provided. It was reported that on unknown dates, the patients were vaccinated with improperly stored doses of and VAQTA, lot number L015460, expiration date 20-JUL-2017 (dose, frequency and administration route were not reported) for prophylaxis. Temperatures and time frames registered in the data logger, were: 0°Centigrades (C) to 1°C (0.8°C) for 34 hours; 9°C to 25°C (8.7°C) for 27 hours and 26°C or warmer (26.2°C) for 27 hours. No adverse effects were reported. This is one of of several reports from the same reporter. Sender's Comments: US-009507513-1707USA004510: US-009507513-1707USA005547: US-009507513-1707USA005548: US-009507513-1707USA005549: US-009507513-1707USA005550.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: Information was received from a pharmacy student concerning a patient of unknown age and gender. No specific information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The pharmacy intern stated that on an unknown date in 2017 (reported as "recently"), the "patient potentially with unspecified immunocompromising condition leading to a planned transplantation" (unspecified), received a dose of VARIVAX (lot number, dosage, and route of administration not provided). The pharmacy intern stated that the patient did not experience any adverse effects. The transplant was still pending. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPVX, MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored vaccine of one of the following vaccines, but she was unsure which of the lots the unspecified patient received. The nurse reported that, no lot was given to a patient after the lot's expiration date. Names of the vaccine involved: PROQUAD: (K025760, expiry date 08-JUN-2016) (L005297, expiry date 17-AUG-2016)  (L030591, expiry date 10-FEB-2017) (L034931, expiry date 03-MAR-2017) (L040413, expiry date 13-APR-2017) (L046506, expiry date 17-MAY-2017) (M002053, expiry date 11-JUL-2017) (M006102, expiry date 01-AUG-2017)(M011664, expiry date 08-SEP-2017) (M037009, expiry date 21-FEB-2018) (M043306, expiry date 24-APR-2018); VARIVAX: (J013900, expiry date 30-OCT-2015) (K021484, expiry date 03-NOV-2016) (K026385, expiry date 15-DEC-2016) (L002868, expiry date 27-JAN-2017) (L012036, expiry date 07-APR-2017) (L023593, expiry date 26-JUN-2017) (L029466, expiry date 06-AUG-2017) (L035126, expiry date 14-SEP-2017) (L044419, expiry date 14-OCT-2017) (L049532, expiry date 08-DEC-2017) (M005974, expiry date 02-FEB-2018) (M009765, expiry date 23-FEB-2018) (M025864, expiry date 24-MAY-2018) (M028553, expiry date 07-JUN-2018) (M030138, expiry date 15-JUN-2018) (M034586, expiry date 27-JUL-2018) (M036272, expiry date 17-AUG-2018) (M038859, expiry date 14-SEP-2018) (M041513, expiry date 11-OCT-2018) (M045205, expiry date 11-NOV-2018); VAQTA: (L039659, expiry date 15-MAR-2017) (L023936, expiry date 15-MAR-2017) (K019560, expiry date 02-JUN-2017) (M018644, expiry date 20-SEP-2017) (M027879, expiry date 24-JAN-2018) (M022924, expiry date 24-JAN-2018) (M033611, expiry date 02-MAR-2018) (M039202, expiry date 11-MAR-2018) (N005274, expiry date 03-APR-2018); GARDASIL 9:  (L000610, expiry date 31-JAN-2017) (L044475, expiry date 12-MAY-2017) (L013429, expiry date 21-JUL-2017) (L025737, expiry date 28-JUL-2017) (L016428, expiry date 30-JUL-2017) (L019297, expiry date 18-AUG-2017) (M005714, expiry date 03-OCT-2017) (M011117, expiry date 07-DEC-2017) (M009378, expiry date 23-APR-2018) (M026306, expiry date 30-APR-2018) (M017983, expiry date 30-MAY-2018) (M031557, expiry date 07-APR-2019) (M041212, expiry date 21-JUN-2019) (M041990, expiry date 28-JUN-2019); RECOMBIVAX HB: (K020216 17-SEP-2016) (K021444 17-SEP-2016); GARDASIL: (K010574, expiry date 08-APR-2017) (K011562, expiry date 08-APR-2017). The vaccines PROQUAD and VARIVAX were exposed to a temperature range of 6 degrees F to 14 degrees F for a time frame of 72 hours. The vaccines VAQTA, GARDASIL, GARDASIL 9, RECOMBIVAX HB were exposed to a temperature of 28 degrees F for a time period of 120 hours. No previous temperature excursion was reported. There were no product quality complaints (PQC) involved. Data digital logger was involved. No adverse effects were reported. No additional information was provided.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse reporting on a 14 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, when the patient was 13 years old, she received an unspecified dose of GARDASIL for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, "about a year later" (inappropriate schedule of drug administration) she received an unspecified dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (interchange of vaccine products). No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: This spontaneous report has received from a medical assistant, referring to a 22 year old patient (gender unknown). No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 17-JUL-2017, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB, lot # M029233, expiration date 09-AUG-2018, (dose and strength were not provided) for prophylaxis.
Sex: U
Vaccine: VARCEL
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 20-JUL-2017 the patient was vaccinated with VARIVAX lot # M039318 for prophylaxis. On an unknown date the patient experienced underdose, no adverse event and needle issue. The outcome of underdose, no adverse event and needle issue is unknown. The reporter considered underdose, no adverse event and needle issue to be not related to VARIVAX. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot # N002720, expiration date 12-MAY-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.