chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Impaired work ability, Injection site erythema, Injection site swelling, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. An 18-year-old male patient of an unspecified ethnicity received his first dose of TRUMENBA, via an unspecified route of administration at the age of 18-years on 27Jun2016 at 0.5 ml, single for immunization. The patient's medical history and concomitant medications were not reported. The patient had redness and swelling at injection site, fever, felt weak and body aches which occurred on Jun2016 after the first dose, and concerned about getting the 2nd dose. The patient missed 3 days of work. The events took place after use of product. The outcome of the events was unknown.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. An 18-year-old male patient of an unspecified ethnicity received his first dose of TRUMENBA, via an unspecified route of administration at the age of 18-years on 27Jun2016 at 0.5 ml, single for immunization. The patient's medical history and concomitant medications were not reported. The patient had redness and swelling at injection site, fever, felt weak and body aches which occurred on Jun2016 after the first dose, and concerned about getting the 2nd dose. The patient missed 3 days of work. The events took place after use of product. The outcome of the events was unknown.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration
Clinical narrative: Area of induration at site of QUADRACEL injection at left deltoid, erythema of arm ranging from injection site to just above elbow, mild associated discomfort in this area.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site erythema, Nausea, Pain in extremity
Clinical narrative: Chills, fever, nausea, tiredness, redness at injection site and a sore arm.  Reaction lasted about 36 hours.  I recovered fully.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Chills, fever, nausea, tiredness, redness at injection site and a sore arm.  Reaction lasted about 36 hours.  I recovered fully.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Mass, Skin warm, Swelling
Clinical narrative: The night following the immunization patient reported tender, warmth, redness, and swelling.  Also noticed a lump on her neckline, which is abnormal to patient.  Patient seen in clinic 6 days after immunization.  Treatment of cellulitis with antibiotic therapy at this time for reaction.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: The night following the immunization patient reported tender, warmth, redness, and swelling.  Also noticed a lump on her neckline, which is abnormal to patient.  Patient seen in clinic 6 days after immunization.  Treatment of cellulitis with antibiotic therapy at this time for reaction.
Age: 17.0
Sex: F
Vaccine: TTOX, UNK
Symptoms: Psoriasis
Clinical narrative: Developed psoriasis on scalp shortly after. Have been dealing with it for 13 years now.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Crying, Fluid intake reduced, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, body aches, fever started around 2 PM. By 8 PM child was crying and not wanting to drink fluids. Mom is  a nurse and had him drink water and used cool cloth for fever. Temp got up to 102 even with Tylenol and Ibuprofen staggered dosing. Felt better next day and by 5 PM on 6/29 he was completely recovered.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse, concerning to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 02-JUN-2017, the patient was inadvertently vaccinated with an improperly stored dose of VARIVAX single dose, subcutaneous, (lot # M042858 and expiration date 21-OCT-2018) for prophylaxis that was reconstituted with a properly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported). No adverse effects were reported. The vaccine was stored at a temperature of 7° Fahrenheit, time frame of 40 minutes (supported); no previous temperature excursion was reported. Digital Data logger was involved.
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Skin reaction
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 22 year old female patient with no pertinent medical history, concurrent conditions and drug reactions. On an unspecified date in November 2016, the patient was vaccinated with the first dose of GARDASIL 9 which had a lot # M041990 and expiration date on 08-JUN-2019 (dose and route of administration were not provided) for vaccination (prophylaxis). On 16-MAY-2017, the patient was vaccinated with the third dose of GARDASIL 9 in the right arm. Concomitant therapies included DEPO-PROVERA. On approximately 23-MAY-2017, (reported as one week after she received the third dose of the vaccine), the patient experienced a lump in her right arm, near the site where GARDASIL 9 was injected. The patient was seen in the office on 05-JUN-2017, for this lump which the physician assessed as a 2 cm x 1cm localized soft mass, non tender, no induration, no ecchymosis with no difficulty in mobility and with no sensory changes. The patient had not treated the area, and declined any diagnostic treatment; therefore, no lab diagnostics studies were performed. The physician diagnosed the mass, as a delayed injection site reaction to the GARDASIL 9 and she did not receive any treatment. At the reporting time, the outcome of the patient for delayed injection site reaction to the vaccine was reported as not recovered. The reporter considered delayed injection site reaction to be related to GARDASIL 9.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: This spontaneous report was received from a registered nurse referring to 88 year old male patient with gastric reflux. The patient's medical history included transient ischaemic attack. Concomitant therapies included PLAVIX, simvastatin, clonazepam and vitamin D (unspecified). On 02-JUN-2017, the patient was vaccinated with PNEUMOVAX 23 with lot # N005096 and expiration date 22-OCT-2018 for vaccination (prophylaxis) (route, dose, dose number, frequency and anatomical location were unknown).  No product quality complaint (PQC) was involved. On 05-JUN-2017, the patient reported to his primary physician that on an unspecified date in June 2017, he experienced redness and swelling around the injection site, and the skin was tender to touch. No laboratory diagnostic studies were performed. His physician wrapped his arm, and applied a cold compress and instructed him to take TYLENOL as treatment. At the time of reporting, the outcome of injection site erythema, Injection site swelling and pain of skin was unknown. The causality between the events and the therapy with PNEUMOVAX 23 was unknown.
Age: 20.0
Sex: U
Vaccine: HEP
Symptoms: Seroconversion test negative
Clinical narrative: This spontaneous report has been received from a nurse, referring to a 20 year old patient of an unknown gender. The patient's medical history, concurrent conditions, drug and allergy history were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB 2.5/0.5 (units were not provided) injection (dose scheduled, route, lot# and expiration date were not provided) for prevention of Hepatitis B. The patient's concomitant therapies were not provided. It was reported that the patient failed to seroconvert (seroconversion test negative). The outcome of seroconversion test negative was unknown. At the time of this report, the causality between RECOMBIVAX HB and the above mentioned event was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning an adult patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unknown date, the patient, that was older than 26 year-old, was vaccinated with GARDASIL 9 injection (dose, frequency, route of administration, lot number and expiration date were not reported) for an unknown indication. No adverse effects were reported. Additional information is not expected, as no consent to contact the reporter was granted.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 56 years old male patient. The patient did not have pertinent medical history. Patient's drug allergies included codeine. On 12-JUN-2017, the patient was vaccinated subcutaneously with ZOSTAVAX lot # M039453, expiration date 19-DEC-2017, 1 DF in the right arm for prevention of shingles. The vaccine was reconstituted with a sterile diluent (manufacturer unknown) lot # N007932, expiration date 06-MAY-2018. On 13-JUN-2017, the patient developed redness at the injection site. At the reporting time, the patient did not recover from the event. The relatedness between the injection site erythema and ZOSTAVAX was not provided.
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 patient of unknown age and gender. The patient's medical history, concomitant medications, concurrent conditions, drug and allergy history were not reported. On 12-NOV-2013, when the patient was under 65 years of age, he/she was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. Then on 05-JAN-2016, the patient received a dose of PREVNAR 13 (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. (Extra dose administered) and subsequently, on 12-JUN-2017 the patient received another dose of PNEUMOVAX 23. The pharmacist reported that these 2 doses of PNEUMOVAX 23 were administered at an interval of less than 5 years apart (Inappropriate schedule of drug administration). No adverse effects were reported. This is one of the two reports received from the same source. Sender's Comments: US-009507513-1706USA006883.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning a 1 year old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-JUN-2017, the patient was vaccinated with properly stored, but expired dose of M-M-R II lot # L015279 and expiration date of 30-APR-2017 (dose and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent used for reconstitition (lot # and expiration date of the sterile diluent were not provided). No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to an approximately 61 year old female patient. The patient's medical history, concurrent conditions, drug and allergy history were not reported. The patient's concomitant medication was not reported. On 15-MAY-2017, the patient was vaccinated with ZOSTAVAX, subcutaneous injection, lot # M039452 and expiration date 19-DEC-2017 (strength was not provided) for prophylaxis, reconstituted with a sterile diluent. On 16-MAY-2017, the patient returned to the pharmacy with red warm area around the injection site about the size of grapefruit in diameter to consult with the pharmacist. The reporting pharmacist, referred the patient to a physician office, but only if the redness went outside of an specified diameter area other than the one provided by the patient on their conversation. At the time of report, the outcome of injection site erythema and injection site warmth was unknown. The causality assessment between ZOSTAVAX and the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on 30-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "single dose", intramuscularly, lot # M035486 with expiration date of 05-JUN-2019, for prophylaxis (anatomical location and frequency were not reported). No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 12 hours 29 minutes (supported). No previous temperature excursion was performed. The call was because of a "data logger". Additional information is not expected because there is no consent to contact the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional referring to a patient of unknown age and gender.  The patient's concurrent conditions, pertinent medical history and concomitant medications were not provided. On 16-JUN-2017, the patient was vaccinated with a expired dose of VAQTA lot # M022556 expiry date on 26-MAY-2017, (route of administration and dose not reported)  for prophylaxis. No adverse effects were reported.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old male patient. On an unknown dates, the patient was vaccinated with the first and the second dose of GARDASIL 9 dose for prophylaxis. According the physician, the patient received the third dose of GARDASIL 9 (lot and expiration date unknown by reporter) one month after the second dose was given. No adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 13 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent condition, drug and allergy history. On 15-AUG-2016, the patient was vaccinated with an unspecified dose of PROQUAD, lot number L050907 with expiration date 14-JUN-2017, for prophylaxis (dose, frequency, route of administration and anatomical location were not reported). Concomitant medications included sterile diluent (manufacturer unknown, lot number and expiration date were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster
Clinical narrative: This spontaneous report was received from an internal medicine and geriatrics specialist physician, referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions. On an unknown date, the patient received a version of ZOSTAVAX INJECTION in another country (dose, route of administration, lot number and expiration date were not provided) for prevention of shingles and then, on an unspecified date, she was revaccinated with ZOSTAVAX in this country. Concomitant therapies included sterile diluent (MRK INJ). On an unknown date, "several months later", the patient developed shingles (herpes zoster) after receiving latter version of the vaccine. It was also reported that the patient sought medical attention. The outcome of the patient for herpes zoster was unknown. At the reporting time the causality assessment between ZOSTAVAX and herpes zoster was unknown.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a 61 year old female patient who was reporting on herself. The patient had no pertinent medical history and no drug reactions or allergies. Her concomitant medications included atenolol (+) chlorthalidone. On 24-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and site of administration, lot number and expiry date were not reported) for shingles prevention. On approximately 28-MAY-2017, reported as 4 to 7 days after receiving ZOSTAVAX, the patient experienced a rash on her arm. The patient sought medical attention. No treatment was given for the event. Laboratory diagnostic studies were performed, but the results were not provided. No product quality complaint was reported. The outcome of rash on the arm was unknown at the time of reporting. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as there was no permission to contact the reporter.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 12 year-old patient of an unknown gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 16-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose, route and anatomical location were not reported), lot # M034780 with expiration date on 15-APR-2019, for prophylaxis; which experienced a temperature excursion between 47 and 77 Fahrenheit degrees for 50 minutes on 16-MAY-2017 (also reported as 18-05-2017). Previous temperature excursion was between 47 and 77 Fahrenheit degrees for 3 hours. Data logger was involved. No adverse effects were reported and no additional information was provided. A product quality complaint was not involved. This is one of the multiple reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA008599: US-009507513-1706USA001035: US-009507513-1706USA001033: US-009507513-1706USA001034.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Local reaction
Clinical narrative: Patient wished to not receive the vaccine in the arm because she didn't want her arm to be sore. There was a possibility of giving the vaccine in the hip. When discussed with the nurse who looked at the site of injection, site was determined to be vastus lat (thigh). Patient had a local inflammatory reaction to the vaccination.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Pt reports that had generalized rash on body, multiple tiny red bumps, intermittently itch. Rash remained for about a month.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Infrequent bowel movements, Injection site mass, Mucous stools, Pyrexia, Selective eating disorder
Clinical narrative: Patient developed rectal temperature 101.4 about 10 hours after vaccination. Called office, advised to give Tylenol. Went to ED later that night and diagnosed with fever after vaccination. Developed lump at right thigh injection site. The next day was not breastfeeding as much but was having good urine output. Since this time mother states his stools have been less frequent and containing mucus, and he has been smiling and babbling less than before. Has been seen in office twice since with normal examination, good weight gain.
Age: 66.0
Sex: M
Vaccine: HEPAB, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid at immunization site red, swollen and warm to touch.
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a female patient who received Influenza vaccine Quadrivalent. In November 2015, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that in all her life she had vaccines, but this time she received the flu vaccine and this was not good experience for here. The patient did not report any details, but was still suffering from the consequences.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle strain, Musculoskeletal pain, Pain in extremity, Periarthritis, Rotator cuff syndrome
Clinical narrative: Flu vaccination on 11-4-16, shortly after had pain on left shoulder/arm. Was told "it's a pulled muscle". Had x-ray - switched physicians - sent to orthopedic, was told injured rotator cuff and frozen shoulder.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb
Clinical narrative: Flu vaccination on 11-4-16, shortly after had pain on left shoulder/arm. Was told "it's a pulled muscle". Had x-ray - switched physicians - sent to orthopedic, was told injured rotator cuff and frozen shoulder.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Large erythematous induration of the left upper arm.
Age: 26.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Blood pressure decreased, Hyperhidrosis, Nausea, Pallor, Visual impairment
Clinical narrative: At 0940 employee received both injections, right after second injection employee complaining nausea, the stated his vision was changing only seeing white, employee became diaphoretic, pale, blood pressure dropped, BP 70/52, P 48 ( which employee states he runs lower due to being a runner). RN placed 02 2 liters, continued to monitor employee, ice pack provider, employee remained alert and orientated, responding to questions. 0950 BP rechecked 94/60, employee remained alert, vision back to normal. Medical continued to monitor employee till 10:30, remained stable, and asymptomatic during the remainder of his time in medical.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Injection site discomfort, Injection site pain, Malaise, Pain
Clinical narrative: I FELT AN UNUSUAL FEELING IN MY ARM WHEN THE INJECTION OCCURRED AND SAID THAT DID NOT FEEL RIGHT. LATER I FELT KIND OF SICK LIKE AS IF I WAS COMING DOWN WITH SOMETHING. TWO DAYS LATER I VOMITED. I HAD A FEVER AND WAS IN BED FOR 7 DAYS. I AM NOT SURE WHAT DAY THE PAIN IN MY ARM INCREASED BUT IT HAS BEEN HURTING SINCE THEN AT THE SITE OF INJECTION AND WHEN I STRETCH OR RAISE MY ARM. IT TAKES MY BREATH AWAY
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Vomiting
Clinical narrative: I FELT AN UNUSUAL FEELING IN MY ARM WHEN THE INJECTION OCCURRED AND SAID THAT DID NOT FEEL RIGHT. LATER I FELT KIND OF SICK LIKE AS IF I WAS COMING DOWN WITH SOMETHING. TWO DAYS LATER I VOMITED. I HAD A FEVER AND WAS IN BED FOR 7 DAYS. I AM NOT SURE WHAT DAY THE PAIN IN MY ARM INCREASED BUT IT HAS BEEN HURTING SINCE THEN AT THE SITE OF INJECTION AND WHEN I STRETCH OR RAISE MY ARM. IT TAKES MY BREATH AWAY
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Electrocardiogram abnormal, Feeling abnormal, Heart rate irregular
Clinical narrative: 12 year old client received HPV9 at off-site clinic at 11:00am. Client reported feeling "weird" at 11:03am. 7-Up and cold compress given, moved near door for fresh air. After 15 minutes, issue unresolved. Client referred to Paramedic on site. Paramedic administered O2, monitored vital signs with client in chair. Paramedic noted irregular heartbeat via EKG. After 40 minutes of monitoring and assessment, paramedic recommended transport to Hospital. MOC declined and transported client herself. Per follow up with MOC by telephone on 7/11/17, no treatment required at Emergency Room or further follow up required.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: 10 year old clinic received HPV9 at off site clinic, at 11:00am. Client reported feeling dizzy immediately after administration. Client lowered head between knees, given soda and cold compress. At 11:16 am, issue unresolved. Referred to paramedics on site. Paramedic assessed client, O2 given, and fully recovered by 11:30 am.
Sex: M
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter via a company representative, concerning unspecified number of male patients (reported as "boys") of unknown age. There were no concurrent conditions, medical history or concomitant medications reported. On unspecified dates, the patients were vaccinated with GARDASIL (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. It was mentioned by the unspecified reporter, that he/she heard that the unspecified patients were not affected the same way (adverse event). At the time of the report, it was unknown the outcome of the adverse event. The causality between the adverse event and GARDASIL was unknown. This is one of several reports from the same source. Sender's Comments: US-009507513-1706USA000467: US-009507513-1706USA000478: US-009507513-1706USA000486.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified patient of unknown age and gender that on an unknown date was vaccinated with an incorrect stored dose of PROQUAD lot # M048201 expiration date 05-JUN-2018, for prophylaxis; which experienced a temperature excursion to -13.4 Centigrade degrees for 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site bruising, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a female patient of unknown age. Her medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported. On 11-MAY-2017, the patient was vaccinated with ZOSTAVAX (strength and dose were not reported) lot # M039452 with expiration date of 19-DEC-2017, intramuscularly (incorrect route of drug administration) for prophylaxis. It was reported that, since an unspecified date in 2017, the patient experienced bruising and soreness at the injection site; therefore, the patient complained of the events with the pharmacist on 15-JUN-2017 but no treatment or intervention to prevent serious criteria was performed. At the time of reporting, the outcome of injection site bruising and injection site pain was resolving. The reporter's causality assessment between injection site bruising and injection site pain with ZOSTAVAX was not provided. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1707USA000975.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-JUN-2017, the patient was vaccinated with an expired dose of VAQTA with lot number M003025 with expiration date of 26-MAY-2017 (strength, dose, anatomical location and route of administration were unknown) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a multiple unknown number of patients of unknown age and gender. No medical history, allergies nor concomitant therapies were provided for these patients. On an unknown date, the patients were vaccinated with a dose of VARIVAX (strength, dose, route, lot #, and the expiration date were not reported) for prophylaxis. On multiple unspecified dates, the patients were vaccinated with an improperly stored VARIVAX and reconstituted with the properly stored sterile diluent (manufacturer unknown). The vaccine was exposed to a -14 to -10 degrees Celsius for an hour. There was no previous excursion and there was a data logger. No adverse effects were reported. This is one of multiple reports from the same source. Sender's Comments: US-009507513-1707USA000976.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 20-JUN-2017, the patients were inadvertently vaccinated subcutaneously with improperly stored single doses of PROQUAD injection (lot # M044020; expiration date: 01-MAY-2018; exact doses were not reported). The doses of PROQUAD were reconstituted with a properly stored sterile diluent (MERCK). The reporter stated that the administered doses of PROQUAD were stored at temperature range between 15 degrees Fahrenheit (F) to 46 degrees F for 30 minutes on an unknown date. Previous temperature excursions included storage at the temperature in the range of 6 degrees F to 14 degrees F for 5 hours 49 minutes on unknown dates. Data logger was used to detect temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1706USA009892.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
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 ZOSTAVAX, 1 DF for prophylaxis. Other suspect therapies included VARIVAX. Concomitant therapies included sterile diluent. On an unknown date, the patient experienced wrong drug administered and no adverse event. The outcome of wrong drug administered and no adverse event is unknown. The reporter considered wrong drug administered and no adverse event to be not related to ZOSTAVAX and VARIVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. No information regarding medical history or concurrent conditions was provided. On an unspecified date, the patient received ZOSTAVAX (lot # not provided). On an unspecified date two years later, the patient developed shingles that radiated from the right torso down the right leg. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported. On unknown dates, the unspecified patients were vaccinated with ZOSTAVAX (dose, route, lot #, and expiration date were not reported) for prophylaxis. Later, on unknown dates, the patients complained of redness and soreness at the injection sites (injection site erythema and injection site pain). At the time of reporting, the outcome of injection site erythema and injection site pain was unknown. Additionally, the relatedness between the aforementioned events and ZOSTAVAX was not provided. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1706USA007406.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a multiple unknown number of patients of unknown age and gender. No medical history, allergies nor concomitant therapies were provided for these patients. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (strength, dose, route, lot #, and the expiration date were not reported) for prophylaxis. On multiple unspecified dates, the patients were vaccinated with an improperly stored ZOSTAVAX and reconstituted with the properly stored sterile diluent (manufacturer unknown). The vaccine was exposed to at -9 to -8 degrees Celsius for an hour and 15 minutes. There was no previous excursion and there was a data logger. No adverse effects were reported. This is one of multiple reports from the same source. Sender's Comments: US-009507513-1706USA007593.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: LUE pain and hives, (L) arm and hand pain. Generalized body aches, fever, RUE erythema and pain. B/L shoulder pain.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: LUE pain and hives, (L) arm and hand pain. Generalized body aches, fever, RUE erythema and pain. B/L shoulder pain.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Irritability, Middle insomnia
Clinical narrative: Left leg red, not warm no fever - noted this am. Was fussy after imms yesterday and wakeful during the night.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Injection site pain, Neck pain, Pain
Clinical narrative: 5 MIN AFTER THE VACCINE, PT REPORTED: felt pain from the injection site, radiating down to L ankle, describes as overall throbbing except for L axilla which is more like a stabbing pain - then 5 min later, felt intermittent pain on R side;  about 5 min later had brief episode of neck pain & HA, which resolved spontaneously;  pt was observed for another 30 min (about 1 hour after the vaccine was given), and only felt pain at the injection site.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling at injection site.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Arthritis, Injection site pain, Pain in extremity, X-ray limb abnormal
Clinical narrative: Persistent pain in left arm since the injection - Pain in upper arm and shoulder with raising arm to reach for items. Recommended patient to physical therapy for treatment.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Itchiness, redness, and rash within 3 hours post vaccination. Began in armpits, then spread to bilateral flank area. Symptoms reduced after 12 hours after treating with BENADRYL PO, then reappeared approximately 24 hours after vaccination, treated with BENADRYL again, then symptoms completed cleared by 48 hours.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Excessive eye blinking
Clinical narrative: Mom reports that the day after receiving vaccines, husband noted that child was blinking a lot.  This persisted for approximately 3-5 days. During this time, mother reports she gave child OTC alpha lipoic acid mixed in a drink.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Presyncope, Seizure
Clinical narrative: Patient passed out a few minutes after vaccines were given. Patient then began to have a seizure. Medical provider classified as vasovagal event.
Age: 22.0
Sex: F
Vaccine: JEV1
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Patient experienced severe nausea, headaches, body aches and mild fever approximately 3-4 hours after immunization at clinic. Patient reports that with initial Japanese Encephalitis immunization had the body aches and mild fever symptoms but no nausea.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site rash
Clinical narrative: Rash on left arm near injection site x 5 days.
Age: 28.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Aphthous ulcer, Arthralgia, Chills, Dyschezia, Dysuria
Clinical narrative: Initial symptoms of low grade fever (100-101 degrees Fahrenheit) and body chills beginning approximately 8:30 PM the evening of the date of vaccinations. Acetaminophen and ibuprofen  taken PRN. Low grade fever and general malaise persisted intermittently over 48-72 hours following injection. Profound knee/ankle/and achilles tendon soreness began the day following the vaccination administration and persisted approximately 5 days. Two oral aphthous ulcers and approx. 10-15 vaginal aphthous ulcers presented within 24-48 hours after vaccination and persisted for 7-10 days (peak day 4 following vaccination). Vaginal aphthous ulcers were accompanied by a burning sensation with urination and moderately painful bowel movements.  Very minor rectal bleeding with 2-3 bowel movements due peak of vaginal discomfort.
Age: 28.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Herpes simplex test negative, Malaise, Pyrexia, Rectal haemorrhage, Tendon pain
Clinical narrative: Initial symptoms of low grade fever (100-101 degrees Fahrenheit) and body chills beginning approximately 8:30 PM the evening of the date of vaccinations. Acetaminophen and ibuprofen  taken PRN. Low grade fever and general malaise persisted intermittently over 48-72 hours following injection. Profound knee/ankle/and achilles tendon soreness began the day following the vaccination administration and persisted approximately 5 days. Two oral aphthous ulcers and approx. 10-15 vaginal aphthous ulcers presented within 24-48 hours after vaccination and persisted for 7-10 days (peak day 4 following vaccination). Vaginal aphthous ulcers were accompanied by a burning sensation with urination and moderately painful bowel movements.  Very minor rectal bleeding with 2-3 bowel movements due peak of vaginal discomfort.
Age: 28.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Vaginal ulceration, Vulvovaginal discomfort
Clinical narrative: Initial symptoms of low grade fever (100-101 degrees Fahrenheit) and body chills beginning approximately 8:30 PM the evening of the date of vaccinations. Acetaminophen and ibuprofen  taken PRN. Low grade fever and general malaise persisted intermittently over 48-72 hours following injection. Profound knee/ankle/and achilles tendon soreness began the day following the vaccination administration and persisted approximately 5 days. Two oral aphthous ulcers and approx. 10-15 vaginal aphthous ulcers presented within 24-48 hours after vaccination and persisted for 7-10 days (peak day 4 following vaccination). Vaginal aphthous ulcers were accompanied by a burning sensation with urination and moderately painful bowel movements.  Very minor rectal bleeding with 2-3 bowel movements due peak of vaginal discomfort.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Pruritus, Rash, Viral test positive
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 21 month old female patient. The patient's concurrent conditions and medical history were not reported. In approximately June 2016 (reported as a year ago), the patient was vaccinated with VARIVAX (dose, route, lot number and expiration date not reported) to prevent chicken pox. There was no concomitant medication reported. The parents of the patient reported to the physician that their daughter developed a case of shingles on an unspecified date in June 2017 (reported as later last week). The parents reported that their daughter was also seeing a dermatologist for "the itchy skin" and the "bad rash" and she was also receiving treatment for the adverse event. It was also reported that an unspecified test was done and results came back as herpes zoster. The outcome of herpes zoster was reported as not recovered. The causality between the herpes zoster and the VARIVAX was not provided.
Sex: M
Vaccine: HPV9, MEN
Symptoms: Feeling abnormal, Malaise, Pyrexia
Clinical narrative: This spontaneous report has been received from a physician via company representative referring to an 18 year old male patient. Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was not provided. On approximately 06-JUN-2017 (reported as last week), the patient was vaccinated with GARDASIL 9 dose 1, (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis, along with meningococcal vaccine (unspecified). On an unspecified day in June 2017, the patient experienced fever, became sick with fever and was feeling really bad. The outcome of feeling abnormal, malaise and pyrexia was unknown as well as the causal relationship between the events and the aforementioned vaccines. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to six patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot# M017336, expiry date 05-OCT-2017; albumin status, exact dose and route of administration were not reported), reconstituted with properly stored sterile diluent (MRK). The doses of the vaccine were exposed to a temperature excursion of 6 to 14 degrees Fahrenheit for a time frame of 6 hours, on an unspecified date. There were no previous temperature excursions. A Digital Data Logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000995.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 26-JUN-2017 from a nurse who reported that multiple unspecified patients received improperly stored PROQUAD (lot# M037651, expiration 28-FEB-2018) or VARIVAX (lot# M041081, expiration 06-OCT-2018) on unspecified dates. Temperature was 15F to 46 F (18.9F) for a time frame of one hour and 35 minutes. Previous temperature excursion was 15F to 46 F (22.9F) for four hours and 10 minutes. Call was because of a data logger. The diluent used to reconstitute the PROQUAD and VARIVAX was properly stored. No adverse effects reported. No further information was provided. Nurse agreed to follow-up. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to four patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot# M025870, expiry date 24-MAY-2018; exact dose and route of administration were not reported), reconstituted with properly stored sterile diluent (MRK). The doses of the vaccine were exposed to a temperature excursion of 6 to 14 degrees Fahrenheit for a time frame of 6 hours, on an unspecified date. There were no previous temperature excursions. A Digital Data Logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA011270.
Age: 69.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Neuralgia
Clinical narrative: Patient was complaining about nerve pain he was experiencing shortly after the vaccinations took place. He is still receiving medical treatment for this.
Age: 23.0
Sex: M
Vaccine: HEPAB, RAB
Symptoms: Feeling cold, Feeling hot, Hyperhidrosis
Clinical narrative: TWINRIX was administered first with no reaction noted. IMOVAX was administered second in the same arm. Within ten seconds the patient complained of feeling warm. He was given water to drink. He began sweating profusely within five minutes. Then he complained of feeling cold. The symptoms lasted for fifteen minutes then he indicated he was feeling better. He stayed at the pharmacy for thirty more minutes. The patient indicated he was better and decided to leave. The patient was called later in the evening and he indicated he was feeling fine. No dizziness, nausea or breathing difficulties were noted.
Age: 72.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Given wrong dose: gave pediatric dose instead of adult.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PPV, VARZOS
Symptoms: Neuralgia
Clinical narrative: Patient's husband said she is experiencing nerve pain all over her body.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PPV, VARZOS
Symptoms: Dyspnoea, Musculoskeletal pain, Pain in extremity, Spinal X-ray
Clinical narrative: Patient's husband said she is experiencing nerve pain all over her body.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PPV, VARZOS
Symptoms: Back pain, Loss of personal independence in daily activities, Musculoskeletal pain, Pain in extremity, Sciatica
Clinical narrative: Patient's husband said she is experiencing nerve pain all over her body.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient's arm was red and swollen near the injection site. She said it was very painful and was itching. She did visit her doctor but she did not treat. She asked her to come to the pharmacy and show us so we could report it. It looked like a normal reaction to the shot. I told her she could use a moist compress to ease the pain and itching. She will follow up with us if she continues to have problems.
Age: 1.33
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Abasia, Aggression, Blood test normal, Crying, Cyanosis
Clinical narrative: Extreme leg pain (wouldn't walk, didn't want held, rolled around on floor in agony). Screamed and cried for 6 hours after shot. Fever started off and on for almost 2 weeks (up to 103 but don't know what the spike that caused the seizure was). Febrile seizure (7/5/17). Patient's paralysis RT side (7/5/17). Helicopter (7/5/17). Rash (7/7/17-7/9/17). Tylenol and Ibuprofen wasn?t controlling fever. Loss of appetite. Had to give her bottle to feed her. Stopped breathing (blue lips, limp body) (7/5/17). Had to do CPR (7/5/17). Irritable, moody, very unhappy, sad, cried for no apparent reason through the day and night, extremely tired but wouldn't sleep for 2 weeks after shots. Diarrhea for a week after shots. Throwing up 1-3 times per day after shots until 7/3/17. Wouldn't even take a bath without a screaming tantrum after vaccines until 7/10/17. Seizure caused her to fall off a chair and hit her head.
Age: 1.33
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Depressed mood, Diarrhoea, Fall, Fatigue
Clinical narrative: Extreme leg pain (wouldn't walk, didn't want held, rolled around on floor in agony). Screamed and cried for 6 hours after shot. Fever started off and on for almost 2 weeks (up to 103 but don't know what the spike that caused the seizure was). Febrile seizure (7/5/17). Patient's paralysis RT side (7/5/17). Helicopter (7/5/17). Rash (7/7/17-7/9/17). Tylenol and Ibuprofen wasn?t controlling fever. Loss of appetite. Had to give her bottle to feed her. Stopped breathing (blue lips, limp body) (7/5/17). Had to do CPR (7/5/17). Irritable, moody, very unhappy, sad, cried for no apparent reason through the day and night, extremely tired but wouldn't sleep for 2 weeks after shots. Diarrhea for a week after shots. Throwing up 1-3 times per day after shots until 7/3/17. Wouldn't even take a bath without a screaming tantrum after vaccines until 7/10/17. Seizure caused her to fall off a chair and hit her head.