chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent or historical condition was not provided. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L043620 with expiration date 02-NOV-2017, L049532 with expiration date 08-DEC-2017, M004329 with expiration date 26-JAN-2018, M009765 with expiration date 23-FEB-2018, L040421 with expiration date 15-OCT-2017, L045954 with expiration date 17-NOV-2017, M004328 with expiration date 26-JAN-2018, dose and route unknown). Concomitant therapy was not provided. There was no previous temperature excursion. The vaccine was stored under -12 celsius degree for 107 hours and 10 minutes. Data logger was not involved. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test
Clinical narrative: Information has been received from a registered nurse referring to a 25 year old female patient. The patient had no concurrent, historical condition and drug reaction or allergies. On 30-JUN-2016 the patient was vaccinated with VARIVAX (lot # M006156 with expiration date 05-FEB-2018, subcutaneous, once). There was no concomitant therapy. The patient called the office to state she was pregnant with last menstrual period (LMP) of 25-MAY-2016 and estimated due date (EDD) of 01-MAR-2017. The pregnancy outcome was pending. An unknown testing was performed to verify pregnancy. No adverse effects were reported. No treatment was given. The patient sought medical attention at doctor's office. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Tremor
Clinical narrative: A few hours after receiving the shots had shaking of his whole body while breastfeeding on 7/12/16. This lasted for 5-6 secs. He was fine the next day however on 7/14/16 had a similar episode while breastfeeding, again each episode lasted 5-6 secs. Mom tried holding his leg/thigh but it continued to shake. No fever.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder arm pain (Right)
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning four patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date (also reported as some doses were administered on 30-JUN-2016 and some doses were administered on unspecified dates), the four patients were vaccinated with PEDVAXHIB injection (lot number L042259, expiration date: 18-AUG-2018; and lot number reported as M010440, expiration date: 09-DEC-2018) (dose, route and anatomical location of administration were not reported), which were improperly stored at 32.7 F for 5 days. Additional temperature excursions reported maximum temperature 51.3 F for 84 hours and minimum temperature 27.7 for 314 hours. The PEDVAXHIB were back in range. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning three patient of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date (also reported as some doses were administered on  30-JUN-2016 and some doses were administered on unspecified dates), two unspecified patients were vaccinated with GARDASIL injection (lot number reported as M014929, expiration date: 27-MAY-2017)(dose, route and anatomical location of administration were not reported) and one unspecified patient was vaccinated with GARDASIL injection (lot number L040459, expiration date: 06-APR-2017) (dose, route and anatomical location of administration were not reported), which were improperly stored at 32.7F for 5 days. Additional temperature excursions reported maximum temperature 51.3 for 84 hours and minimum temperature 27.7 for 314 hours. The GARDASIL were back in range as reported. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Dtap 6/21/16 - swelling began then. Afebrile. 6" erythema with induration. treated with Cephalexin.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N.) concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. The Registered Nurse reported that on 07-MAR-2016, the patient received the first dose of VAQTA (Lot #, expiration date and dose were not reported), and about 3 months after the first dose the patient was vaccinated with the second dose of VAQTA (lot # L007559, expiration date 01-JUN-2017) (dose was not reported) which was too early according to the nurse. There were no concomitant medications reported. No adverse effects reported and there was no PQC involved. Additional information is not expected as there is no consent to consent to contact the reporter.
Age: 1.22
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Pt developed small wheal approximately 5 minutes after immunization on both legs at site of immunization. Wheal increased in size to approximately 5 cm by 20 minutes. No other signs of allergic reaction.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Drooling, Musculoskeletal stiffness, Neck pain, Salivary hypersecretion, Screaming
Clinical narrative: Patient reports child woke the day following vaccines with extremely painful and stiff neck. She reports that child was drooling, spitting and screaming out in pain. Able to take and move all limbs. No apparent seizure activity. Resolved completed by the following day and has not reoccurred.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) concerning a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent condition were not reported. The Registered Nurse reported that on an unspecified dates, these multiple unspecified patients were administered improperly stored doses of VAQTA (Lot # and doses were not reported) which was exposed to 8.8 C but it was unsure of cumulative time out of range and it was every 15 minutes then fluctuating every two hours. (Cumulative: unsure of time frame). There was no previous temperature excursion and the call was made because of a digital data logger. No adverse effects were reported. These is one of several cases from the same source (MARRS# 1607USA004237, 1607USA006260 and 1607USA006261). Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Swelling redness at sight and swelling in finger and hand redness at various areas on arm, fever > 101, pain cellulitis. IV antibiotics given at hospital (ER).
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Swelling redness at sight and swelling in finger and hand redness at various areas on arm, fever > 101, pain cellulitis. IV antibiotics given at hospital (ER).
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N.) concerning a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent condition were not reported. The Registered Nurse reported that on an unspecified dates, these multiple unspecified patients were administered improperly stored doses of RECOMBIVAX HB (Lot # and doses were not reported) which was exposed to 8.8° C but it was unsure of cumulative time out of range and it was every 15 minutes then fluctuating every two hours (Cumulative: unsure of time frame). There was no previous temperature excursion and the call was made because of a digital data logger. No adverse effects were reported. These is one of several cases from the same source (MARRS # 1607USA004237, 1607USA006260, and 1607USA006262). 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 Registered Nurse (R.N) concerning a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent condition were not reported. The Registered Nurse reported that on an unspecified dates, these multiple unspecified patients were administered improperly stored doses of GARDASIL 9 (Lot # and doses were not reported) which was exposed to 8.8 degrees C but it was unsure of cumulative time out of range and it was every 15 minutes then fluctuating every two hours (Cumulative: unsure of time frame). There was no previous temperature excursion and the call was made because of a digital data logger. No adverse effects were reported. These is one of several cases from the same source (MARRS # 1607USA004237, 1607USA006261 and 1607USA006262)
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N.) concerning a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent condition were not reported. The Registered Nurse reported that on an unspecified dates, these multiple unspecified patients were administered improperly stored doses of PEDVAXHIB (Lot # and doses were not reported) which was exposed to 8.8° C but it was unsure of cumulative time out of range and it was every 15 minutes then fluctuating ever two hours (Cumulative: unsure of time frame). There was no previous temperature excursion and the call was made because of a digital data logger. No adverse effects were reported. These is one of several cases from the same source (MARRS # 1607USA006260, 1607USA006261, and 1607USA006262). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Localized reaction with increased swelling and redness on 6/20/16. Patient prescribed diphenhydramine and hydrocortisone 2.5% cream.
Age: 16.0
Sex: M
Vaccine: HPV4, MENB, MNQ
Symptoms: Chills, Pyrexia
Clinical narrative: Developed fever and chills 1 1/2 hrs after vaccines administered.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Onset occurred approx 4 hours after administration. Erythema, edema, warmth, severe pain all localized at injection site. Size of erythema/edema-circular 3' in diameter.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pyrexia, Trismus
Clinical narrative: 16 hrs after vaccines, pt. developed fever and inability to open mouth "lock jaw" (lasted 45-60 mins). Hot compressed released jaw after 15 mins. This happen at 2am, went back to sleep, woke up 3am with locked jaw (3-4) would lock up about 2-3x every hour -> woke up OK 7am, no fever.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Pt fainted three times after vaccine administered.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified 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 unknown dates, the patients were vaccinated with the improperly stored doses of RECOMBIVAX HB lot number: K02144, expiration date on 17-SEP-2016 (strength, dose number, route and anatomical location were not provided). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified 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 unknown dates, the patient were vaccinated with improperly stored doses of VAQTA lot number: M011116, expiration date on 17-JUN-2017 (strength, dose number, routes and anatomical location were not provided). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified 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 unknown dates, the patients were vaccinated with the improperly stored doses of ROTATEQ orally, lot number: K019305, expiration date on 15-JUL-2016 (strength, dose number and anatomical location were not provided). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.83
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Irritability, Wrong drug administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of irritability in a 11-month-old female patient who received KINRIX (batch number 33X9T, expiry date 31st October 2017). Previously administered products included DTaP vaccine (1st dose). On 5th July 2016, the patient received KINRIX .5 ml. On 5th July 2016, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On 6th July 2016, the patient experienced irritability. On an unknown date, the outcome of the irritability, inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the irritability to be related to KINRIX. Additional details were provided as follows: The reporter stated that, a staff member inadvertently administered the 10 months and 20 days old patient with KINRIX as a 2nd dose in DTaP series, which led to inappropriate age at vaccination administration and wrong vaccine administered. The mother of the patient stated that, the patient was irritable. The call center representative did not ask for the lot number and expiry dates.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria, Pruritus generalised, Rash, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized pruritus in a 59-year-old female patient who received BOOSTRIX (batch number 43MP2, expiry date 15th August 2017). On 29th June 2016, the patient received BOOSTRIX .5 ml. On 30th June 2016, 1 days after receiving BOOSTRIX, the patient experienced generalized pruritus, injection site hives, hives and rash. The patient was treated with CLARITIN. On an unknown date, the outcome of the generalized pruritus, injection site hives, hives and rash were unknown. It was unknown if the reporter considered the generalized pruritus, injection site hives, hives and rash to be related to BOOSTRIX. Additional details were provided as follows: This case was previously reported to a manufacturer. No other vaccines were administered on the same day or 4 weeks prior to the suspect vaccine. On 29th June 2016, at 12 pm, the patient received a dose of BOOSTRIX in her right deltoid and the next day after receiving BOOSTRIX, she started itching everywhere on her body. She also experienced a rash of about an inch and half in diameter on her right breast and hives on the right hip and right upper arm. The itching was treated with CLARITIN. On 1st July 2016, the patient called the pharmacist to report the adverse events.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Erythema, Gait disturbance, Joint swelling, Macule, Peripheral swelling
Clinical narrative: Yest developed joint swelling and red middle fingers PIP. Better today feet puffy and difficulty walking. Rash this am on legs and arms. Scattered macules and rest of rash spidery. Now improving and lighter in color.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Rash
Clinical narrative: Yest developed joint swelling and red middle fingers PIP. Better today feet puffy and difficulty walking. Rash this am on legs and arms. Scattered macules and rest of rash spidery. Now improving and lighter in color.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Vaccine given 7-12-16. At 5pm 7-13-16, redness and swelling noted to injection site, left deltoid. Measured 3 1/2 x 6 cm. Presents to office 7-14-16 with increased redness and swelling measuring 10 x 11 cm. Mild itching, full ROM, denies pain.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 16-year-old female patient who received BEXSERO. Previously administered products included BEXSERO (1st dose received on an unknown date). On 5th July 2016, the patient received the 2nd dose of BEXSERO. O 7th July 2016, 2 days after receiving BEXSERO, the patient experienced injection site erythema, injection site warmth, injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site pain and injected mobility decreased were not recovered/not resolved. The reporter considered the injection site erythema, injection site warmth, injection site pain and injected limb mobility decreased to be almost certainly related to BEXSERO. Additional details were provided as follows: The medical assistant reported to Medical Science Liaison that, the patient had a coin sized red area around the injection site (left arm) that was hot to the touch. The patient's arm was painful and she cannot move it as a result. The parents had called the office, but the Medical Science Liaison (MSL) was not aware of the patient being seen by the office for this reaction.
Age: 38.0
Sex: F
Vaccine: HEPAB, MNQ
Symptoms: Inappropriate schedule of drug administration, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 38-year-old female patient who received MENVEO (batch number A15069, expiry date September 2016). Co-suspect products included TWINRIX adult. Concomitant products included TWINRIX adult, citalopram and Oral Contraceptives. On 11th May 2016, the patient received MENVEO (intramuscular) .5 ml. On 22nd June 2016, the patient received the 2nd dose of TWINRIX adult. On 12th May 2016, 1 days after receiving MENVEO and TWINRIX adult and not applicable after receiving TWINRIX adult, the patient experienced injection site swelling. On 22nd June 2016, the patient experienced drug dose administration interval too long. In May 2016, the outcome of the injection site swelling was recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the injection site swelling to be related to MENVEO. Additional details were provided as follows: The reporter stated that, the patient experienced swelling under her right arm after receiving MENVEO and TWINRIX vaccines. The swelling was under the right arm where MENVEO was administered. TWINRIX was administered in the opposite arm (left arm). In May 2016, the swelling resolved after one week. The patient did not have to seek medical attention. At the time of reporting, the patient received 2nd dose of TWINRIX adult later than recommended interval, which is more than 7 days after the one month mark of 12th June 2016. This led to lengthening of vaccination schedule.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, raise area and redness - localized to shot area.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Urticarial rash.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema and induration, 6X4cm erythema at left deltoid, status: unchanged.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent condition and medical history of the patient was not reported. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # reported as L003188, expiration date: 06-JUL-2016) (dose and route unspecified). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Rash (acute) within 24 hrs of vaccines administered.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent condition and medical history of the patient was not reported. On 22-APR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX23 (lot # reported as L003188, expiration date: 06-JUL-2016 (dose and route unspecified) (Incorrect storage of drug). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.39
Sex: M
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Administration of expired ROTAVIRUS (expiration was 6/7/16) admin ROTAVIRUS on 6/13/16. Mother of child aware and agreeable to bringing in child for repeat ROTAVIRUS
Age: 15.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: At approx. 10 pm the evening after receiving the injection pt. noticed his upper (L) arm was itchy, red, slight swelling and painful. Pt was seen at the office 7-13-16. Dr checked his arm. Local reaction, no Rx given. *Pt requested both injections given in same arm because he plays sports - Mom in agreement*
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Pyrexia, Vomiting
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of vomiting in a 18-year-old female patient who received BEXSERO. Concomitant products included MENACTRA. On an unknown date, the patient received BEXSERO. On an unknown date, several hours after receiving BEXSERO, the patient experienced vomiting, fever and dizziness. On an unknown date, the outcome for the vomiting, fever and dizziness were unknown. It was unknown if the reporter considered the vomiting, fever and dizziness to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, the patient received BEXSERO in one arm and MENACTRA the other arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: Local reaction - 1 day after vaccination pt. experienced redness and inflammation. Inflammation reduced but redness spread. Pt. went to see doctor. Doctor said not infected and prescribed ELOCON cream.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (L) arm - erythema (9 x 15 cm area), 1 cm area induration in center - (L) deltoid region. Had DTAP and IPV in this arm. Seen in office 7/8/16.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Axillary pain, Back pain, Blood culture negative, C-reactive protein, Full blood count normal
Clinical narrative: Received PREVNAR 13 on 6/16/2016 in left arm. Began experiencing itching skin and difficulty lift left arm 2 days later. Treated with topical Triamcinolone 0.1% cream. Returned to office 6/30/16 with continued left arm pain, headaches, sweats, pain into (L) axilla, (L) side of back and neck. Ordered labs: CRP, ESR, CBC, Blood culture. Prescribed AUGMENTIN. Pt still with pain on 7/5-ordered CT soft tissue LUE.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Hyperhidrosis, Injected limb mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Received PREVNAR 13 on 6/16/2016 in left arm. Began experiencing itching skin and difficulty lift left arm 2 days later. Treated with topical Triamcinolone 0.1% cream. Returned to office 6/30/16 with continued left arm pain, headaches, sweats, pain into (L) axilla, (L) side of back and neck. Ordered labs: CRP, ESR, CBC, Blood culture. Prescribed AUGMENTIN. Pt still with pain on 7/5-ordered CT soft tissue LUE.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Red blood cell sedimentation rate normal
Clinical narrative: Received PREVNAR 13 on 6/16/2016 in left arm. Began experiencing itching skin and difficulty lift left arm 2 days later. Treated with topical Triamcinolone 0.1% cream. Returned to office 6/30/16 with continued left arm pain, headaches, sweats, pain into (L) axilla, (L) side of back and neck. Ordered labs: CRP, ESR, CBC, Blood culture. Prescribed AUGMENTIN. Pt still with pain on 7/5-ordered CT soft tissue LUE.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgraphia, Immediate post-injection reaction, Impaired driving ability, Pain in extremity
Clinical narrative: Immediate pain in right arm from elbow to shoulder sometimes difficult to write sometimes difficult turning steering wheel. 11 weeks-no improvement.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, approximately in July 2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection (lot# L003188, expiry date 06-JUL-2015), 0.5 intramuscularly. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 0.03
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Silver dollar sized redness and swelling at imm. site Right arm.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Localized pain, redness and swelling no fever.
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This solicited report received from the patient's mother via Market Research Agency refers to a currently, an approximately 15 year-old male patient enrolled in a project. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported). The patient told the mother that the shot was painful. The outcome of the event was unknown. The relatedness between vaccination with GARDASIL and the event was not related. Additional information is not expected because the reporter did not agree for a contact with a doctor.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy and did not faint.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 15 years old patient of unknown age. The patient's medical history and concurrent condition were not reported. On 06-JUL-2016 the patient was inadvertently given a dose of PROQUAD (lot# M004892, expiration date 25-JUL-2017, therapy type rHA) subcutaneously. Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
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 medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (rHA, lot # M006106, expiry date 01-AUG-2017), subcutaneously. The vaccine was stored at 37.2 degrees F for 16 hours with no previous excursions. No adverse event was reported. The outcome of incorrect product storage and no adverse event was unknown. The reporter consider incorrect product storage and no adverse event to be not related to PROQUAD. Additional information has been requested. Lot # M006106 is a valid lot # for PROQUAD.
Age: 55.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Measles antibody negative, Rash erythematous, Rash maculo-papular
Clinical narrative: Facial: erythematous maculopapular confluent rash chest, abd, back: Lighter macular erythematous rash. Vaccine (MMR) given: 6-30-16. Date of eruption: 7-10-16. Temp: 99.7. Given DECADRON 4 mg IM, prednisone 10 mg taper, VISTARIL.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 11 patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored GARDASIL (dose, route of administration, lot number and expiration date were not reported, it was confirmed that it was not GARDASIL 9). Concomitant therapy was not reported. No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, 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 and concurrent conditions were not reported. On 01-FEB-2016 the patient received the first dose of HAVRIX (lot#, dose and route not reported). On 30-JUN-2016 (two months earlier than schedule date) the patient inadvertently received the second dose of VAQTA (lot# M012261, expiration date 01-FEB-2018, a dose, route not reported). Concomitant therapy was not reported. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 07-JUL-2016, the patient was administered a dose of expired, ROTATEQ (lot # K011952, expired on 17-JUN-2016 (dose unknown). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 18-APR-2016, the patient was inadvertently vaccinated with improperly stored GARDASIL 9 injection lot # L020015 with expiry date 16-AUG-2017 or lot# reported as L006546 with expiry date 27-NOV-2017 (dose, route of administration and anatomical location were not specified. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 08-JUN-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (LOT # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates in 2016, starting on or after 28-JUN-2016, patients were vaccinated with (Oka/Merck) VARIVAX (lot number L032391 and expiration date 26-AUG-2017, lot number M003439 and expiration date 19-JAN-2018, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 17.4F and the time frame was 1 hour 30 minutes. There was no previous temperature excursion. It was stated that the call was because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown date in 2016, starting on or after 28-JUN-2016, patients were vaccinated with PROQUAD (lot number L040411 and expiration date 13-APR-2017, lot number M010476 and expiration date 01-SEP-2017, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 17.4F and the time frame was 1 hour 30 minutes. There was no previous temperature excursion. It was stated that the call was because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is on of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA lot # M011116, expiry date 17-JUN-2017 and lot # K008333, expiry date 16-JUL-2017 (dose, route and site of administration were not reported). There were no known side effects reported. The vaccines experienced temperature excursion of maximum temperature of 22.7 degrees Celsius for 3 hours 48 minutes and minimum temperature of 0.2 degrees Celsius for 31 hours 1 minute. This is one of several reports received from the same source. 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 healthcare worker refers to multiple unknown patients of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported. On multiple unknown dates, patients were vaccinated with improperly stored (temperature: 1.3C, for 1 hour and 30 minutes, because of a "data logger") GARDASIL 9, lot # M005714, exp: 03-OCT-2017; lot # M004116, exp: 12-OCT-2017; lot # L045711, exp: 08-MAY-2017; lot # L048459, exp: 22-FEB-2018; lot # M007728, exp: 21-MAR-2018, (dose and frequency not reported). No adverse effects were reported. No previous temperature excursion was reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test abnormal, Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a 13 year old female patient. No information regarding the patient's concurrent conditions was provided. In 2004, the patient was vaccinated with the first dose of varicella virus vaccine live (manufacturer unknown), (dose, injection site, route of administration, lot number and expiration date were not reported). The second dose was administered in 2007. On an unknown date (reported as "recently"), the patient had a varicella virus antibody test performed which revealed that she did not have sufficient antibodies to the varicella virus, thus necessitating the booster. On 07-JUL-2016, the patient was vaccinated at her pediatrician's office with the third dose of varicella virus vaccine live (manufacturer unknown), in the arm, (dose, route of administration, lot number and expiration date were not provided). There were no concomitant medications reported. The reporter stated that on 08-JUL-2016, she noticed a large red bump on her daughter's arm where the vaccine was administered. The bump was 1.5 inches wide by 2 inches long. The patient sought medical attention via visiting her pediatrician, who believed that it was an injection site reaction. The outcome of having insufficient antibodies to the varicella virus and developing a large red bump on the arm where the vaccine was administered was unknown at the time of the report. The relatedness between the events and varicella virus vaccine live (manufacturer unknown) was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 08-JUN-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 14-MAR-2016, the patient was inadvertently vaccinated with improperly stored GARDASIL 9 injection, lot # L020015 with expiry date 16-AUG-2017 or lot # reported as L006546 with expiry date 27-NOV-2017 (dose, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for further contact.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 05-JUL-2016 the patient was vaccinated an expired dose of with VARIVAX (0.5 ml, lot# K008822, expiration date 19-JUN-2016) subcutaneously. Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-JUL-2016, the patient was vaccinated with GARDASIL with the expiration date of 18-JUN-2016 (lot # K023432, dose, route of administration and injection site were not provided). No adverse events were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding several patient's of unknown and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unspecified dates in 2016, the patients were vaccinated with improperly stored dose of ZOSTAVAX (via subcutaneous route, dose, lot # and expiration date were not reported). ZOSTAVAX doses had been in freezer that had been out of range since 02-JAN-2016 according to the data logger. There was no adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to multiple unknown patients of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported. On multiple unknown dates, patients were vaccinated with improperly stored (temperature: 1.3C, for 1 hour and 30 minutes, because of a "data logger") ROTATEQ, lot # L033545, exp: 30-MAY-2017; lot # L039141, exp: 08/16/2017; lot # L020861, exp: 25-JAN-2017, (dose and frequency not reported). No adverse effects were reported. No previous temperature excursion was reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to seven unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, between 28-JUN-2016 and 05-JUL-2016, the patients were vaccinated with improperly stored PROQUAD (recombinant human albumin (rHA); lot # L046510 with expiry date 19-MAY-2017; dose and frequency were not reported), subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regarding 3 patients of unknown demographics. There was no information about concurrent condition and historical medication. On 22-JUN-2016, 06-JUL-2016 and 11-JUL-2016 the patients were vaccinated with PNEUMOVAX 23, lot # K012424, expiration date- 05-JUN-2016. After the 3rd dose it was realized that the vaccine was expired. No known complaints were received from any of the patients. No treatment was given. No PQC (product quality complaint) was involved. The outcome of the event was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chest discomfort, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: This spontaneous report as received from a 50 year old female patient reporting on herself with asthma, drug allergy to ADVAIR and seasonal allergy. On 25-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX, 1 shot, subdermal. Dose, lot number and expiration date were not provided. Concomitant therapies included ALLEGRA, SINGULAIR AND VENTOLIN. On 25-MAY-2016, within 10 minutes after therapy with ZOSTAVAX the patient began to manifest symptoms. It was thought to be anaphylaxis as she had rapid pulse, swollen throat, shortness of breath and tightness in chest. The patient was rushed to an unspecified hospital and was hospitalized for unspecified length of time. She was discharged as they were unable to diagnose her; then, she visited a cardiologist who did an EKG and echocardiogram, which results were not provided. The patient was sent to unspecified hospital two other unspecified times for unstated lengths of time as her symptoms had persisted and had not improved at all. The patient stated that she had visited several specialists who had been unable to identify the condition, however, she had been on anxiety medication, acid reflux medication and several other unspecified medicines to rule out all possibilities. Additionally, the patient stated that she was receiving allergy shots around the time of the vaccination with ZOSTAVAX and she did not know if that contributed to the seemingly immune system related issues. Also, the patient reported an IgE blood test but she did not reported the result for this laboratory test. The outcome of the events was reported as not recovered. The causality between therapy with ZOSTAVAX and the events was unknown. Additional information has been requested.