chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a licensed practical nurse via company representative and refers to a female patient in her 70's (exact age was unknown). No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown day in approximately 2017, the patient was vaccinated with a one shot of PNEUMOVAX 23 injected subcutaneously (frequency, lot# and expiration date were not reported). On an unknown day in approximately September 2017 (also reported as within the past 5 days), after receiving PNEUMOVAX 23, the patient experienced "increased redness" at injection site. The patient sought medical attention and went to the clinic. As treatment, the patient was given antimicrobial (unspecified) "appropriate for cellulitis". Although, the reporter was not informed whether or not the patient had a confirmed case of cellulitis. The antimicrobial (unspecified) treatment was started after the begging of redness "within the past 5 days". Product quality complaint was not involved. The outcome of cellulitis was unknown. The causality assessment between the event and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous initial report was received from a nurse, referring to an unspecified age and gender patient. Patient's medical history, current conditions and concomitant medications were not reported. The Nurse informed that on an unspecified date the patient was vaccinated with an improperly stored ZOSTAVAX (strength, dose and route were not provided) Lot # M040146, expiration date 26-DEC-2017; reconstituted with properly stored sterile diluent (MERCK) Lot # L029308, expiration date 31-MAR-2018; indicated for prophylaxis. The storage temperature reported was -11 Celsius degrees with a time frame of 5 hours. No digital data logger was involved. Previous temperature excursion was not reported. No adverse event was reported.  .
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M040412, expiration date 30-JUN-2019) (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47 Fahrenheit (°F) degrees to 77 Fahrenheit (°F) degrees for 15 minutes. Also there was previous temperature excursion from 32 Fahrenheit (°F) degrees to 35 Fahrenheit (°F) degrees for 19 hours and 30 minutes and from 47 Fahrenheit (°F) degrees to 77 Fahrenheit (°F) degrees for 1 hour and 45 minutes. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA010094: US-009507513-1709USA010095: US-009507513-1709USA010756:
Sex: U
Vaccine: PPV
Symptoms: Injection site infection, Injection site pain
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown ages and genders. Information regarding the patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route and frequency were not reported) for prophylaxis. Information regarding concomitant medications was not reported. On an unknown date, the reporter stated that the patients were experiencing injection site pain and inflammation and he stated that "phenol from the vaccines" might be responsible for these events. At the reporting time, the outcome of injection site pain and injection site inflammation were not reported. The physician considered injection site pain and injection site inflammation to be related to PNEUMOVAX 23.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified amount of patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions. On unknown dates, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) lot # M011666 with expiration date on 08-MAR-2018 (dose and route of administration were no provided) for prophylaxis; which was reconstituted with properly stored sterile diluent (MRK). The doses of M-M-R II were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 2 hours 45 minutes which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010122: US-009507513-1709USA010123.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a clinical supervisor, concerning a 12 months old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 18-SEP-2017, the patient was vaccinated with PROQUAD lot # N012489 with expiration date on 17-OCT-2018; and VARIVAX lot # reported as N005796 with expiration date on 26-MAY-2018; both administered for prophylaxis (strength, dose, route of administration or anatomical location for neither of them was reported) and reconstituted with sterile diluent (manufacturer unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. Lot number N005796 is an invalid lot number for varicella virus vaccine live (Oka/Merck).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # N013521, expiry date 23-JAN-2019; lot # N003993, expiry date 20-OCT-2018 and lot # M036728, expiry date 20-MAY-2018 (dose, route of administration were not reported) for prophylaxis. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 38 minutes and from 47F to 77F for 3 hours and 14 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009203: US-009507513-1709USA010540: US-009507513-1709USA010541.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M000442, expiry date 31-MAR-2018 (dose, route of administration were not reported) for prophylaxis. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 38 minutes and from 47F to 77F for 3 hours and 14 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009203: US-009507513-1709USA010539: US-009507513-1709USA010541.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ) lot # M046000, expiry date 27-JUN-2018 and lot # M041768, expiry date 25-JUN-2018, orally (dose was not reported) for prophylaxis. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 38 minutes and from 47F to 77F for 3 hours and 14 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009203: US-009507513-1709USA010539: US-009507513-1709USA010540.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a counselor concerning a patient in their 30's of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in March 2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, lot number and expiration date were not reported) for prophylaxis. No adverse effect was reported.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 66 year old patient. On 16-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 dose 2, lot # N010106, for prophylaxis.  No adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. From 14-AUG-2017 to 19-SEP-2017, the patients were vaccinated with  improperly doses of PROQUAD lot number N004631; expiration date 07-AUG-2018 or lot number N010866; expiration date 01-OCT-2018 or lot number M033209; expiration date: 09-JAN-2018 (strength, dose and route of administration were not reported) for prophylaxis. The patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT). The temperature of excursion with PROQUAD was -14 to -10 Celsius degrees. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1709USA010743:
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist, referring to a 82 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-JUL-2015, the patient was vaccinated with the first dose of PNEUMOVAX 23 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. Later, on 19-SEP-2017, the patient received a second dose of PNEUMOVAX 23 (strength, dose, anatomical location and administration route were not reported) also for prophylaxis. No adverse symptoms were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. From 18-SEP-2017 to 20-SEP-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M042324 and expiration date on 10-JUN-2018, (dose and route of administration were not provided) for prophylaxis. The doses of PNEUMOVAX 23 were exposed to a temperature excursion of 32 degrees Fahrenheit (°F) to 35°F during a time frame of 2 hours 45 minutes which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the two reports received from the same source. Sender's Comments: US-009507513-1709USA010663.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. From 05-SEP-2017, through 20-SEP-2017, the patients were vaccinated with improperly stored ROTATEQ orally, lot # N000175 with expiration date on 20-SEP-2018, (dose was not reported) for prophylaxis. The doses of ROTATEQ were exposed to a temperature excursion of 10.4 degrees Celsius (°C) during a time frame of 50 minutes which was detected by the data logger. Previous temperature excursion was reported as 13.9°C for 173 minutes. There was no adverse events were reported. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA010722: US-009507513-1709USA010723.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in March 2013, the patient was vaccinated with the first dose of ZOSTAVAX (strength, anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis. On 19-SEP-2017, the patient received a second dose of ZOSTAVAX (strength, anatomical location, administration route, lot number and expiration date were not reported) also for prophylaxis. No adverse symptoms were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 66 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, lot number N003993, expiration date: 20-OCT-2018 (strength, dose and route of administration were not reported) for prophylaxis. On the same date, (also reported as "immediately"), the patient experienced redness and arm swelling in the injection site and got progressively worse. The patient was given BENADRYL 50 mg. At the time of the report, the patient was feeling much better from the events. The causality between the events and the PNEUMOVAX 23 was not reported.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a physician via a company representative referring to a currently 74 years old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 18-JUN-2014, the patient was vaccinated with ZOSTAVAX (strength, dose and route of administration were not provided) lot # J016258, expiration date 26-FEB-2015, for prevention of shingles. It was reported that on an unspecified date, the patient was diagnosed with shingles (herpes zoster). The reporter stated that the patient received treatment due the event (unspecified details), and sought medical attention as was treated by a physician. In addition, there was no intervention to prevent serious criteria. The patient's outcome for herpes zoster was reported as recovering/resolving. At the time of this report, the causality between the event and ZOSTAVAX was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. From 18-SEP-2017 to 20-SEP-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M041768 with expiration date on 25-JUN-2018 and lot # N005617 with expiration date on 30-OCT-2018, (dose and route of administration were not provided) for prophylaxis. The doses of ROTATEQ were exposed to a temperature excursion of 32 degrees Fahrenheit (°F) to 35°F during a time frame of 2 hours 45 minutes which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the two reports received from the same source. Sender's Comments: US-009507513-1709USA010565.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. From 05-SEP-2017, through 20-SEP-2017, the patients were vaccinated with improperly stored GARDASIL 9 lot # N007931 and expiration date on 17-NOV-2019 (dose and route of administration were not reported) for prophylaxis. The doses of GARDASIL 9 were exposed to a temperature excursion of 10.4 degrees Celsius (°C) during a time frame of 50 minutes which was detected by the data logger. Previous temperature excursion was reported as 13.9°C for 173 minutes. There was no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1709USA010722: US-009507513-1709USA010570:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. From 14-AUG-2017 to 19-SEP-2017, the patients were vaccinated with improperly doses of VARIVAX lot number M033212; expiration date 13-JUL-2018 or lot number N008828; expiration date 16-MAR-2019 or lot number M038858; expiration date: 14-SEP-2018 (strength, dose and route of administration were not reported) for prophylaxis. The patient's concomitant therapies included sterile diluent (MERCK). The temperature of excursion with VARIVAX was -14 to -10 Celsius degrees during 876 hours. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA010549.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # N002202, expiration date 04-NOV-2019 and lot # M037248, expiration date 21-FEB-2019) (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47 Fahrenheit (°F) degrees to 77 Fahrenheit (°F) degrees for 15 minutes. Also there was previous temperature excursion from 32 Fahrenheit (°F) degrees to 35 Fahrenheit (°F) degrees for 19 hours and 30 minutes and from 47 Fahrenheit (°F) degrees to 77 Fahrenheit (°F) degrees for 1 hour and 45 minutes. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA010094: US-009507513-1709USA010095: US-009507513-1709USA009372.
Sex: U
Vaccine: MENB
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This Physician reported a similar event for 2 patients. This is the first of two reports. A patient of unknown age, gender and race/ethnicity received on an unknown date first single dose of TRUMENBA for immunization. Medical history and concomitant medications were not reported. The patient had an extensive rash after receiving meningococcal group b rlp2086. Outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017408672 same reporter, event and drug/different patient.
Sex: U
Vaccine: MENB
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This Physician reported a similar event for 2 patients. This is the second of two reports. A patient of unknown age, gender and race/ethnicity received on an unknown date first single dose of TRUMENBA for immunization. Medical history and concomitant medications were not reported. The patient had an extensive rash after receiving meningococcal group b rlp2086. Outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017408555 same reporter, event and drug/different patient.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Pain in extremity
Clinical narrative: This case involves a 17-year-old female patient who was vaccinated with a second dose of MENACTRA (Batch number: U5835AB, expiry date was not reported), in deltoid left via intramuscular route on 31-Aug-2017. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): BACTRIM Allergy. The patient's concomitant medications were not reported. On 5-Sep-2017, five day following the vaccination, the patient experienced pain lifting the left arm in which had the injection. The patient had received first dose of MENACTRA on an unknown date. The patient required ER visit. The patient's laboratory data and corrective treatment were not reported. The patient was not recovered from event. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Rash, Skin warm, Urticaria
Clinical narrative: Initial unsolicited report received from a other non-healthcare professional on 06-Sep-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (Batch number, expiry date, route and site of administration was not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced very large welt that lasted a few days and was warm to the touch and a rash. The patient not sure if from the shot but did need to see a doctor for it. The patient's laboratory data and corrective treatment were not reported. On an unknown day, the patient was recovered from event (lasted a few days). List of documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Initial unsolicited report received from a pharmacist and additional information received from a consumer (patient himself) on 11-Sep-2017. This case involves a 66-year-old male patient who was vaccinated with first intramuscular dose of FLUZONE HD (batch number: UI832AC, expiration date: 20-Mar-2018, dose was not reported) in the right deltoid on 27-Aug-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported that the patient had nasal Allergies and history of back and neck pain but the patient did not have any illness at the time of vaccination. Concomitant medications were not reported. On 27-Aug-2017 in the night, same day following the vaccination, the patient had severe pain in his right deltoid area and sharp pain with range of motion, he has no redness heat or swelling at the injection site. He said for a few days it improved but, never went completely away and he was still working while he had the pain and he was out of town right now. It really hurts when he moved it a certain way and planned to see his doctor as soon as he returns. It was also reported that he let the pharmacy (where he was vaccinated) know he had the severe pain, the next day they told him that they had reports of that, so he was not worried, they advised that he see his doctor as soon as he could (required emergency room (ER)/ doctor visit). Laboratory investigations were reported as none. Corrective treatment was not reported. The outcome of the events was reported as not recovered (reported that today during a break, the patient called the pharmacy to let them know his arm was not better). List of documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Burning sensation, Irritability, Pyrexia, Skin warm
Clinical narrative: Fever of 102 degrees starting at 8 days following vaccines. Woke up from afternoon nap burning up (skin warm to the touch). Offered infant acetaminophen every 4-6 hours to manage fever. Some symptoms of fussiness/clinginess, as well. Had child sleep in portable crib in our room (parents' room) overnight to monitor more closely.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Patient received vaccines 9/14/17, on 9/15/17 she states she became ill, with nausea and fever. By 9/17 her arm where she received immunizations where red, painful and warm to the touch. Pt states she couldn't move her arm without pain. She was seen by her gynecologist on 9/19/17 and showed provider her arm. GYN provider directed patient to go to her primary care provider. She was seen by primary care office and was diagnosed with cellulitis and started on antibiotics. Pt then called office to let us know what had happened.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Patient received vaccines 9/14/17, on 9/15/17 she states she became ill, with nausea and fever. By 9/17 her arm where she received immunizations where red, painful and warm to the touch. Pt states she couldn't move her arm without pain. She was seen by her gynecologist on 9/19/17 and showed provider her arm. GYN provider directed patient to go to her primary care provider. She was seen by primary care office and was diagnosed with cellulitis and started on antibiotics. Pt then called office to let us know what had happened.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Allergy to vaccine, Anaphylactic reaction, Eye swelling, Oropharyngeal pain
Clinical narrative: Sore throat that was closing, severe stomach pain, swelling of eyes, at 1:00 pm, red rash following day. Hospital gave iv of benedryl and pepto for stomach pain. Follow up medication was diphenhydramine 50 mg at home. Symptoms persisted for 2-3 days. Diagnosis was allergy to flu shot (had never had one prior to this] and anaphylactic reaction.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Throat tightness
Clinical narrative: Sore throat that was closing, severe stomach pain, swelling of eyes, at 1:00 pm, red rash following day. Hospital gave iv of benedryl and pepto for stomach pain. Follow up medication was diphenhydramine 50 mg at home. Symptoms persisted for 2-3 days. Diagnosis was allergy to flu shot (had never had one prior to this] and anaphylactic reaction.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient walked into office with C/O red painful left upper arm after receiving Pneumonia 23 injection. No itching, no fever. She initially could not raise her left arm, but this is getting better. Has never had a reaction like this before. Had PREVNAR 13 last year without issue. The area of redness is inferior to her injection site, it is warm with no swelling and goes anteriorly and posteriorly, not completely circumferential. Dr. prescribed Clindamycin HCL 300 mgs oral capsule take one two times a day for 5 days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Nodule, Rash erythematous, Rash pruritic
Clinical narrative: 1 week after IMZ, pt developed 1/2 dollar size red itch rash with a nickle size knot underneath.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Abnormal behaviour, Crying, Diarrhoea, Diet refusal, Ear haemorrhage
Clinical narrative: 3 hours after vaccines: Zombie like behavior, extreme lethargy, pain at injection site. 8-10 hours after vaccines - Fever of 101.7, higher in the middle of the night. Irritability, inability to sleep, crying. 15 hours post vaccines - severe diarrhea, refusing to eat meals/bottles, rash and red spots around his eyes and mouth, multiplying. Broken blood vessels on one ear (so far). Continued fever - just got a message from daycare that he has a high fever and a parent needs to come pick him up.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Erythema, Injection site pain, Insomnia, Irritability, Lethargy
Clinical narrative: 3 hours after vaccines: Zombie like behavior, extreme lethargy, pain at injection site. 8-10 hours after vaccines - Fever of 101.7, higher in the middle of the night. Irritability, inability to sleep, crying. 15 hours post vaccines - severe diarrhea, refusing to eat meals/bottles, rash and red spots around his eyes and mouth, multiplying. Broken blood vessels on one ear (so far). Continued fever - just got a message from daycare that he has a high fever and a parent needs to come pick him up.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Oral mucosal eruption, Pyrexia, Rash
Clinical narrative: 3 hours after vaccines: Zombie like behavior, extreme lethargy, pain at injection site. 8-10 hours after vaccines - Fever of 101.7, higher in the middle of the night. Irritability, inability to sleep, crying. 15 hours post vaccines - severe diarrhea, refusing to eat meals/bottles, rash and red spots around his eyes and mouth, multiplying. Broken blood vessels on one ear (so far). Continued fever - just got a message from daycare that he has a high fever and a parent needs to come pick him up.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Hallucination, auditory, Headache, Nausea, Pain
Clinical narrative: Complained of fever of 103-104 degrees, had chills, generalized body aching, headache, nausea for 24-36 hours after onset of body aches and chills, auditory hallucinations. Took EXCEDRIN for headache and Ibuprofen for aches and pains.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Complained of fever of 103-104 degrees, had chills, generalized body aching, headache, nausea for 24-36 hours after onset of body aches and chills, auditory hallucinations. Took EXCEDRIN for headache and Ibuprofen for aches and pains.
Age: 11.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, TD
Symptoms: Eye movement disorder, Fatigue, Loss of consciousness, Muscle contractions involuntary, Seizure like phenomena
Clinical narrative: After administration of the last vaccine (HPV) I placed the needle and syringe in the sharps container and began applying bandages to the right arm. Before I could apply the bandage to the last injection site, the patient's eyes rolled back in his head and he lost consciousness. I called for help and opened a dose of ammonia inhalant. When the other nurse entered the treatment area, she noted that the patient's hands were balled up in fists. The patient began thrashing his arms and legs and exhibited seizure-like activity. Approximately 30-45 seconds after he lost consciousness, the patient awoke. He could not remember what had happened and did not remember receiving his vaccines. A cold compress was applied to his head. He then vomited once. His blood pressure was 110/60 and pulse was 88. He denied dizziness but reported feeling very tired. He and his father denied a history of similar symptoms. He was observed for approximately a half hour after the episode. A second blood pressure was 104/70.  It was recommended that the patient go to the emergency room but the father refused. It was then recommended that they contact the child's primary care physician. The patient was able to independently ambulate out of the clinic.
Age: 11.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, TD
Symptoms: Vomiting
Clinical narrative: After administration of the last vaccine (HPV) I placed the needle and syringe in the sharps container and began applying bandages to the right arm. Before I could apply the bandage to the last injection site, the patient's eyes rolled back in his head and he lost consciousness. I called for help and opened a dose of ammonia inhalant. When the other nurse entered the treatment area, she noted that the patient's hands were balled up in fists. The patient began thrashing his arms and legs and exhibited seizure-like activity. Approximately 30-45 seconds after he lost consciousness, the patient awoke. He could not remember what had happened and did not remember receiving his vaccines. A cold compress was applied to his head. He then vomited once. His blood pressure was 110/60 and pulse was 88. He denied dizziness but reported feeling very tired. He and his father denied a history of similar symptoms. He was observed for approximately a half hour after the episode. A second blood pressure was 104/70.  It was recommended that the patient go to the emergency room but the father refused. It was then recommended that they contact the child's primary care physician. The patient was able to independently ambulate out of the clinic.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: The patient had redness and rash on the left upper arm possibly related to the PNEUMOVAX vaccine.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Arthralgia, Condition aggravated, Depression, Dizziness
Clinical narrative: This spontaneous report was received from a consumer (the patient's parent) and refers to a non- pregnant female patient of unknown age. The patient's mother had a cervical cancer. The patient's concurrent condition included anxiety and depression. The reporter stated none drug reactions/allergies. No concomitant therapies were reported. On an unknown date, the patient was vaccinated with a third dose of GARDASIL (exact dose and route were not reported) for prophylaxis or with a dose of GARDASIL 9 (exact dose and route were not reported) for prophylaxis (exact type of human papillomavirus (HPV) vaccine was not specified)). On an unknown date, after the third dose of her vaccine series, the patient experienced unresponsive migraines, unexplained medical problems, gastrointestinal problems, anxiety, depression, she was fatigued and had a muscle and joint pain. The reporter stated, that the patient's anxiety and depression had worsened. She also experienced dizzy spells and panic attacks (on unknown dates), mainly in the previous two weeks, and 3 times in the previous 2 days. The patient was given a treatment for the events. No laboratory test were performed. The patient was not hospitalized . The outcome of the events was reported as not recovered. Causality assessment was not provided.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Gastrointestinal disorder, Ill-defined disorder, Migraine, Myalgia
Clinical narrative: This spontaneous report was received from a consumer (the patient's parent) and refers to a non- pregnant female patient of unknown age. The patient's mother had a cervical cancer. The patient's concurrent condition included anxiety and depression. The reporter stated none drug reactions/allergies. No concomitant therapies were reported. On an unknown date, the patient was vaccinated with a third dose of GARDASIL (exact dose and route were not reported) for prophylaxis or with a dose of GARDASIL 9 (exact dose and route were not reported) for prophylaxis (exact type of human papillomavirus (HPV) vaccine was not specified)). On an unknown date, after the third dose of her vaccine series, the patient experienced unresponsive migraines, unexplained medical problems, gastrointestinal problems, anxiety, depression, she was fatigued and had a muscle and joint pain. The reporter stated, that the patient's anxiety and depression had worsened. She also experienced dizzy spells and panic attacks (on unknown dates), mainly in the previous two weeks, and 3 times in the previous 2 days. The patient was given a treatment for the events. No laboratory test were performed. The patient was not hospitalized . The outcome of the events was reported as not recovered. Causality assessment was not provided.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Panic attack
Clinical narrative: This spontaneous report was received from a consumer (the patient's parent) and refers to a non- pregnant female patient of unknown age. The patient's mother had a cervical cancer. The patient's concurrent condition included anxiety and depression. The reporter stated none drug reactions/allergies. No concomitant therapies were reported. On an unknown date, the patient was vaccinated with a third dose of GARDASIL (exact dose and route were not reported) for prophylaxis or with a dose of GARDASIL 9 (exact dose and route were not reported) for prophylaxis (exact type of human papillomavirus (HPV) vaccine was not specified)). On an unknown date, after the third dose of her vaccine series, the patient experienced unresponsive migraines, unexplained medical problems, gastrointestinal problems, anxiety, depression, she was fatigued and had a muscle and joint pain. The reporter stated, that the patient's anxiety and depression had worsened. She also experienced dizzy spells and panic attacks (on unknown dates), mainly in the previous two weeks, and 3 times in the previous 2 days. The patient was given a treatment for the events. No laboratory test were performed. The patient was not hospitalized . The outcome of the events was reported as not recovered. Causality assessment was not provided.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, refers to 4 year-old patient of unknown gender. Medical history and current conditions were not reported. Concomitant medications include sterile diluent. On 13-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # M043306, exp. date: 24-APR-2018, albumin status: rHa) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccines were stored under temperature from -14 Celsius degrees (C) to -10 C with timeframe 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. The outcome of events was unknown. This is one of 11 reports received from the same reporter.; Sender's Comments: US-009507513-1708USA001467: US-009507513-1709USA005542: US-009507513-1709USA006806: US-009507513-1709USA006809: US-009507513-1709USA006813: US-009507513-1709USA006815: US-009507513-1709USA006816: US-009507513-1709USA006819: US-009507513-1709USA006820: US-009507513-1708USA001338:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 13-SEP-2017, the patient was administered an expired ZOSTAVAX (dose, route of administration and lot # were not reported), with expiration date on 27-JUL-2017, reconstituted with a non-expired sterile water diluent. No adverse effects were reported. Additional information is not expected as there was no consent to contact the reporter.
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 an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unspecified dates from 01-AUG-2017 to 14-SEP-2017, the patients were vaccinated with improperly stored doses of M-M-R II lot # reported as M035828, expiry date 28-MAY-2018 (albumin status, dose and route of administration were not reported). Concomitant therapies included sterile diluent. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 13 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Lot number M035828 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Sender's Comments: US-009507513-1709USA011237.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse concerning multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of PEDVAXHIB, lot# reported as: M047666, expiration date: 24-OCT-2019 for prophylaxis (route of administration was not reported). The administered dose of the vaccine experienced a temperature excursion 32 Fahrenheit (°F) to 35° Fahrenheit (°F) for 6 hours, as recorded by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010561.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Night sweats
Clinical narrative: Pt reports swelling at the injection site and having chills and night sweats for 2 nights. He denies pain, stating only some "regular" soreness at the injection site. Pt does not have thermometer at home to take temperature. Pt denies itching at injection site. RPh left message for MD to report events and at this time has not heard from MD. Instructed pt to take benadryl 25 mg, but he states he does not have any in the house. Recommended taking a medication for possible fever, and he states he will take ASA 325 mg, his preferred analgesic. Pt does not seem to be alarmed at this time, but states he "wants to get ahead of it." RPh instructed him to call 911 if he has trouble breathing, and to call back pharmacy if worsening symptoms. Pt states slight improvement of symptoms since onset on 9/20.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: The patient stated over the phone that she started having redness, soreness, swelling and itchiness starting the day of 9/18/17.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Red area around injection site.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Pt states she received the flu vaccine and 2 hrs after getting the vaccine she had bilateral leg weakness while ambulating, right mid torso numbness radiating into right shoulder down the right arm. Pt states she went to sleep and the symptoms and resolved when she woke up from her nap. At the time of her appointment the  following day she had mild pain at the site of injection and mild pain in the right wrist and right hand.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Post vaccination autoinoculation, Rash
Clinical narrative: Patient has cross-inoculation on left arm and trunk area with minimal rash on trunk area.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 4 inch x 2 inch red, hot, hard and tender area to the left thigh, antibiotics were ordered for 10 days.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Mass, Pyrexia
Clinical narrative: Injection site red, swollen, warm to touch. Lump felt. Patient states she had fever at home.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling, erythema of injection site.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Pain, Swelling
Clinical narrative: PT EXPERIENCED INCREASED REDNESS THAT BEGAN AT THE INJECTION SITE AND SPREAD DOWN TO THE ELBOW. THERE WAS ALSO SWELLING AND BODY ACHES.
Age: 81.0
Sex: M
Vaccine: UNK
Symptoms: Influenza like illness
Clinical narrative: Severe flu like symptoms.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Mobility decreased, Palpitations, Peripheral swelling
Clinical narrative: Fever, chills, heart palpitations for 3 days, arm limited movement for 2 days, arm red, swollen, warm, itchy still ongoing but to a lesser degree than several days ago.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Skin warm
Clinical narrative: Fever, chills, heart palpitations for 3 days, arm limited movement for 2 days, arm red, swollen, warm, itchy still ongoing but to a lesser degree than several days ago.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea
Clinical narrative: Had a pronounced headache and nausea.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Red swelling and itchy arm reported. Gave BENADRYL went to ER was given KEFLEX 500.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Chills, Hyperhidrosis, Myalgia, Pain
Clinical narrative: Tuesday 9/19/2017 minor muscle pain after the injection with hours, next day Wednesday 9/20/17 all over body aches and joint pain, by 3-4 PM fever minor 99.6 by 10 PM fever of 102.2, chills, body/muscle aches, joint pain. Ibuprofen taken did not lessen the symptoms, Thursday AM fever 99.6 minor body aches but by 9-10 PM fever of 101 more aches ibuprofen alleviated some symptoms (body aches and fever reduced), woke during the night in profuse sweating (2-3 AM); Friday 9/22/17 still dealing with body aches, joint pain fever of 99.6. - symptoms appear to be lessening - hopefully will be gone by tomorrow.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Tuesday 9/19/2017 minor muscle pain after the injection with hours, next day Wednesday 9/20/17 all over body aches and joint pain, by 3-4 PM fever minor 99.6 by 10 PM fever of 102.2, chills, body/muscle aches, joint pain. Ibuprofen taken did not lessen the symptoms, Thursday AM fever 99.6 minor body aches but by 9-10 PM fever of 101 more aches ibuprofen alleviated some symptoms (body aches and fever reduced), woke during the night in profuse sweating (2-3 AM); Friday 9/22/17 still dealing with body aches, joint pain fever of 99.6. - symptoms appear to be lessening - hopefully will be gone by tomorrow.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Injection site reaction: Swelling, warmth, redness, itchiness, goose-bump-like rash, mild pain around injection site. Became noticeable 18 hours after injection, and it is still noticeable 24 hours after onset.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Injection site reaction: Swelling, warmth, redness, itchiness, goose-bump-like rash, mild pain around injection site. Became noticeable 18 hours after injection, and it is still noticeable 24 hours after onset.