chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Erythema, swelling, tenderness, warmth starting 1-2 days after vaccination, has persisted for 1 week and is now starting to regress.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Cellulitis, Erythema, Tenderness
Clinical narrative: Red strip and tenderness of skin near the shot area. Received medicine for cellulitis.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified patients of unknown age and gender. On an unknown date, an unspecified number of unspecified patients received a second dose of ZOSTAVAX (frequency, route and lot# were not reported). No adverse experiences reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ankle fracture
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No medical history and current conditions were provided. On 26-JUN-2015 the patient was vaccinated with an unspecified dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided). There was not concomitant medication reported. On an unspecified date, in June 2015, the patient broke his ankle. The patient may started 10 days of therapy with 40mg of unspecified steroids. No laboratory tests were provided. At the time of the report the outcome of broken ankle was unknown. The reporter did not suspect a causal relationship between the vaccine administration with ZOSTAVAX and the broken ankle. The reporter consider the broken ankle to be a serious adverse event (medically significant). Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ankle fracture, Fall
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No medical history and current conditions were provided. On 26-JUN-2015 the patient was vaccinated with an unspecified dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided). There was not concomitant medication reported. On an unspecified date, in June 2015, the patient broke his ankle. The patient may started 10 days of therapy with 40mg of unspecified steroids. No laboratory tests were provided. At the time of the report the outcome of broken ankle was unknown. The reporter did not suspect a causal relationship between the vaccine administration with ZOSTAVAX and the broken ankle. The reporter consider the broken ankle to be a serious adverse event (medically significant). Additional information has been requested.
Age: 1.53
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to 18 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 28-JAN-2015, the patient was vaccinated with the dose of PEDVAHXIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. No adverse events were experienced. This is one of several reports form the same reporter. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-DEC-2014, the patient was vaccinated with the dose of PEDVAXHIB lot # K008680 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. No adverse events were experienced. This is one of several reports from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: After 2nd dose patient experienced nausea, vomiting, fever 104.5 F, violent chills.
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 an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date in 2015, an unspecified number of patients might have been vaccinated with a dose of improperly stored VAQTA, lot # K019560, expiration date 02-JUN-2017 (route of administration, doses, dose numbers not reported). VAQTA was improperly exposed to temperatures of 90F for 24 hours on 28-MAY-2015 and 91F for 24 hours on 29-MAY-2015. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.05
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 21-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. No adverse events were experienced. This is one of several reports from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient felt hot on her arm and it was swollen were the vaccine was placed at.
Age: 96.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. resides in assisted living. Reported to us today (L) deltoid injection site with red, raised swollen area 5x6 inches. Applying ice to site.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age. No medical history and concurrent conditions were reported. On 19-MAY-2015, the patient was vaccinated inadvertently with M-M-R II (lot number: K011317 and expiry date 13-AUG-2016) 0.5 ml injection subcutaneously and VARIVAX (Merck) (lot number: L001335 and expiry date: 13-JAN-2017) (dose and route of administration was not reported) concomitantly that had been stored improperly. No concomitant medications were reported. No adverse effects reported. The outcome of properly stored product was unknown. The reporter considered improperly stored product to be not related to M-M-R II and VARIVAX (Merck). No product quality complaint (PQC) was filed. No further information provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a Nurse referring to a patient of unknown gender and age. No concurrent or clinical history was reported. On 25-JUN-2015 the patient was vaccinated with an expired dose of M-M-R II (Lot # J003004) 0.5 ml intramuscular (incorrect route of drug administration). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to an unspecified patient of unknown age. No medical history and concurrent conditions were reported. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (lot number: L005293 and expiry date: 17-AUG-2016) (dose and route of administration was not reported) which was also exposed to a supported temperature excursion of 17 Fahrenheit (F) for 8 hours and it was administered to unspecified patient after this temperature excursion occurred (incorrect drug storage). No concomitant medications were reported. No adverse effects reported. The outcome of incorrect drug storage was unknown. The reporter considered incorrect product storage to be not related to PROQUAD (Merck). No product quality complaint (PQC) was filed. No further information provided. This is one of the several reports of the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Hyperhidrosis, Rectal haemorrhage
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a 62 years old male patient with polyp in colon and others possibly unspecified conditions. On 06-APR-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml, (lot #, expiration date and route were not reported). The patient's concomitant therapies were not reported. On the same date after vaccination with ZOSTAVAX the patient was told to wait in the office for 30 minutes. Then, the patient was at home and about 2 hours later he started bleeding profusely however, the patient only could specify rectal bleeding, he also experienced stomach pain and sweating. The reporter stated that the patient had improved within 24 hours however was not sure if medical attention was sought. At the time of the report, the outcome of started to bleed profusely however, the patient only could specify rectal bleeding, also experienced stomach pain and sweating was reported as recovered/resolved on 07-APR-2015. The relatedness between the events and therapy with ZOSTAVAX was not reported.  Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Blister, Irritability, Pruritus, Pyrexia, Rash
Clinical narrative: Rash- Four blisters at onset, itches. Fussy. Slight fever.
Age: 0.16
Sex: M
Vaccine: DTAP
Symptoms: Diet refusal, Posture abnormal, Screaming
Clinical narrative: High pitched scream for over 7 hours straight. He wouldn't eat and would randomly scream himself to sleep for 5 mins only to wake up screaming again. He would hold his head like he was in pain and got worse if we tried to hold him.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash on employees neck and trunk after receiving the Varivax.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Blister, Erythema, Joint stiffness, Joint swelling
Clinical narrative: Developed hive like welts.  Injection was in upper left arm and all symptoms were on my left side. Largest hive/welt at base and left side of wrist and another at base of ring finger (pus like fill and later both opened).  Back of hand and wrist became red, hot, and swollen.  Other red marks, hives or whatever that did not open, were on the tips of the index, middle and ring fingers, the base of my neck, left side, and the top of, I think, my middle toe.  Next day, June 19, felt listless and w/o energy and joints seemed stiff so I sat and napped off and on.  Called Clinic and left message of reactions.  Took antihistamine later, probably week of June 21, not recall how many.  June 28 I got medication: Prednisone 20mg to take for 5 days (one day left) and Cephalexin 500mg for 7 days (3 days left).  The welts are improving and the swelling is reduced as is the red area and a secondary blister like bubble that arose perhaps about June 24 or 25 on the inside of my upper left arm has pretty much resolved (it broke open and drained a small amount of clear liquid).  I think I am now on the mend and hope for complete recovery in the coming days.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Listless, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Developed hive like welts.  Injection was in upper left arm and all symptoms were on my left side. Largest hive/welt at base and left side of wrist and another at base of ring finger (pus like fill and later both opened).  Back of hand and wrist became red, hot, and swollen.  Other red marks, hives or whatever that did not open, were on the tips of the index, middle and ring fingers, the base of my neck, left side, and the top of, I think, my middle toe.  Next day, June 19, felt listless and w/o energy and joints seemed stiff so I sat and napped off and on.  Called Clinic and left message of reactions.  Took antihistamine later, probably week of June 21, not recall how many.  June 28 I got medication: Prednisone 20mg to take for 5 days (one day left) and Cephalexin 500mg for 7 days (3 days left).  The welts are improving and the swelling is reduced as is the red area and a secondary blister like bubble that arose perhaps about June 24 or 25 on the inside of my upper left arm has pretty much resolved (it broke open and drained a small amount of clear liquid).  I think I am now on the mend and hope for complete recovery in the coming days.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Listless, Pain in extremity
Clinical narrative: Extreme pain in pad area at base of left thumb.  The injection was in the left upper arm.  I took Aleve every 6 hours for a day or more.  The pain subsided and left after 2 days.  On June 10th I was listless and without energy so sat most of the day and napped on and off.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever developed eight hours after vaccination. Baby was fussy. Fever lasted approximately 30 hours.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site urticaria
Clinical narrative: Approximately 7 minutes after vaccine was administered patient developed hives in a 3" diameter around the vaccine site. The vaccine was GARDASIL 9.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient got PREVNAR injection on 6/23/15. She came back on 6/30/15 her injection site red and warm. Told the patient to follow up with MD and I called MD to let them know about it.
Age: 1.01
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Mild redness to left thigh.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pruritus
Clinical narrative: Pink color/itching at injection site.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt rec'd ADACEL inj. (L) arm 6/24/15. Pt developed swelling, bruising, redness, pruritus on (L) upper arm. Pt. went to see Dr 7/1/15 started on MEDROL dose pack and triamcinolone cream BID.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature, Dyspnoea, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient left arm and shoulder, history of temperature and shortness of breath at home. 12x12 cm swelling left upper arm distal to injection site. Treated with 40mg triamcinolone, albuterol IM and ALLEGRA.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Pruritus, Rash macular
Clinical narrative: Red splotches on face and lips-it burns, itches and is painful. Red on left arm shingle shot given in right arm. Shot given 1pm 6-28-15 and got reaction few hours later. Went to doctor 6-30-15 and received BENADRYL, ZYRTEC and ZANTAC.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Blister, Erythema, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Arm became red, swollen and sore with little pain at injection site. Patient broke out in about 7-8 blisters that have now drained and started to heal. He used peroxide solution for treatment.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Induration, Pain, Skin warm
Clinical narrative: On night of vaccine developed pain, swelling, redness, chills. Progressed for 2-3 days. Has decreased in swelling and pain. No SOB, no wheezing. Exam with mouth induration 30 x 20 mm. Temp 98.6 BO 114/70. Tx VISTARIL 25mg TID.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: On night of vaccine developed pain, swelling, redness, chills. Progressed for 2-3 days. Has decreased in swelling and pain. No SOB, no wheezing. Exam with mouth induration 30 x 20 mm. Temp 98.6 BO 114/70. Tx VISTARIL 25mg TID.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Head injury, Musculoskeletal stiffness
Clinical narrative: Within minutes after receiving vaccines, patient experienced a spell of whole-body stiffening, which lasted a few seconds and he banged his head on a window. After 30 minutes sat/stood w/o dizziness.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None at this time.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None to report at this time.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to patient of unknown age. No medical history and concurrent conditions were reported. On 20-MAY-2015, the patient was vaccinated inadvertently with M-M-R II (lot number: K011317 and expiry date 13-AUG-2016) 0.5 ml injection subcutaneously and VARIVAX (Merck) (lot number: L001335 and expiry date: 13-JAN-2017) (dose and route of administration was not reported) concomitantly that had been stored improperly. No concomitant medications were reported. No adverse effects reported. The outcome of improperly stored product was unknown. The reporter considered incorrect product storage to be not related to M-M-R II and VARIVAX (Merck). No product quality complaint (PQC) was filed. No further information provided. This is one of the several reports of the same reporter. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: Vaccne was given on 6/24/15. Patient saw redness at site of injection on 6/25/15 and the site was warm. The irritated area grew over time and on 7/1/15 when the pt came it was about 6" x 4" and was warm/hot.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of PEDVAXHIB lot # K002746, K008878, K025002 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 17-year-old male patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown dates, the patient received two doses of GARDASIL (dose, route of administration, anatomical location; lot# and expiration dates were not reported). On 23-JUN-2015, the patient received a dose of GARDASIL 9 (dose, route of administration, anatomical location; lot# and expiration date were not reported) to complete the 3 dose series of an human papillomavirus (HPV) vaccine. No adverse effects were reported. 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 unknown number of patients (age and gender were not reported). Pertinent medical history and drug allergies or drug reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of VAQTA (lot number, expiration date, dose and route of administration were not reported). Concomitant medication was not reported. No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of three patients from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On unknown dates, the patient received the hepatitis B vaccine (manufacturer unknown) series, (doses, routes, lot # and expiration date were not provided). On an unknown date, the patient had unspecified lab work completed which exhibited "lower than the recommended hepatitis B antibody level". The patient did not receive any treatment for the event. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date in 2010 the patient was vaccinated with VAQTA (also reported as hepatitis A vaccine (manufacturer unspecified) VAQTA could not be ruled out) (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date in 2014 the patient was administered with a dose of VAQTA (lot number and expiry date unknown) (dosing regimen and frequency unknown) (Received unspecified hepatitis A vaccine (VAQTA could not be ruled out) in 2010 and VAQTA in 2014 (inappropriate schedule of drug administration). No adverse effect was reported. The action taken with the therapy with VAQTA was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VAQTA was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concurrent concomitant medication was provided. No adverse events were experienced. This is one of several reports receive from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Thi spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 18 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. No adverse events were experienced. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.05
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 07-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. No adverse events were experienced. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 21-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date in 2015, an unspecified number of patients might have been vaccinated with a dose of improperly stored ROTATEQ, route default to oral, lot # L004453, expiration date 27-MAY-2016 (doses, dose numbers not reported). ROTATEQ was improperly exposed to temperatures of 90F for 24 hours on 28-MAY-2015 and 91F for 24 hours on 29-MAY-2015. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.21
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 10 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 07-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.39
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 08-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports 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 healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of VAQTA lot # K007827 (expiration date, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports 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 health care worker refers to an unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. The reporter stated that since 16-JUN-2015, the patients were vaccinated with doses of VAQTA (Lot # K019560, expiration date 02-JUN-2017; lot # K008333, expiration date 10-MAR-2017; lot # K010579, expiration date 12-FEB-2017) (doses and route were not specified), which were exposed to temperatures outside of the recommended range. No concomitant medications were reported. No adverse experience had been observed or reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PROQUAD (Merck) (strength, dosage and frequency), lot# L006390 with expiration date of 26-AUG-2015, orally (incorrect product storage). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Erythema, Pain, Rash erythematous
Clinical narrative: Information has been received from a 90 year old female consumer referring to herself. No pertinent medical history was reported. On 17-JUN-2015, around 11:00, the patient was vaccinated with a dose of 0.65ml ZOSTAVAX (lot # K016325, expiration date 24-DEC-2015), subcutaneously. No concomitant medication included. On the same day, the patient experienced burning and stinging in both leg after administration. In that evening, her legs felt like "they were on fire" and were "marked with red dots". On that day, the patient developed red patches and blisters on both legs. The patient contacted her unspecified physician via telephone and she advised her to take BENADRYL. No lab diagnostics studies were performed. The outcome of blister was unknown. The patient stated she was recovering from other AEs and she was presently still taking BENADRYL. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Pain, Rash erythematous
Clinical narrative: Information has been received from a 90 year old female consumer referring to herself. No pertinent medical history was reported. On 17-JUN-2015, around 11:00, the patient was vaccinated with a dose of 0.65ml ZOSTAVAX (lot # K016325, expiration date 24-DEC-2015), subcutaneously. No concomitant medication included. On the same day, the patient experienced burning and stinging in both leg after administration. In that evening, her legs felt like "they were on fire" and were "marked with red dots". On that day, the patient developed red patches and blisters on both legs. The patient contacted her unspecified physician via telephone and she advised her to take BENADRYL. No lab diagnostics studies were performed. The outcome of blister was unknown. The patient stated she was recovering from other AEs and she was presently still taking BENADRYL. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. Since an unspecified date in May 2015, the patients had been administered improperly stored doses of ROTATEQ (lot number L004453, expiration date 27-MAY-2016, dose was unknown) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients (age and gender were not reported). Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with an unspecified doses of improperly stored RECOMBIVAX HB (lot number, expiration date, dose, strength, route of administration and frequency were not reported). Concomitant medication was not reported. No adverse effects were reported. This is one of three reports form the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a consumer refers to his son of unknown age. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with the fourth dose of GARDASIL 0.5 ml, intramuscular (lot number and expiration date were not provided). Concomitant therapy information was not provided. On an unknown date, there was an extra dose administered as the patient received a fourth dose of GARDASIL. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information is not expected. No contact details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. Since 28-MAY-2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot #, strength, route of administration and dose were not provided). No adverse experiences were reported. Product quality complaint (PQC) was not involved. Additional information is not expected because the reporter did not consent for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 24-JUN-2015 the patient was vaccinated with improperly stored a single dose of ZOSTAVAX injection, subcutaneously (lot number, strength and dose were not reported). No adverse effects were reported. The outcome of the patient's event was not reported. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 16-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K00874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous reprot as receive from a nurse practitioner refers to a 15 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 19-DEC-2014, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date in 2015, an unspecified number of patients might have been vaccinated with a dose of improperly stored RECOMBIVAX HB, lot # K016005, expiration date 27-AUG-2016 (route of administration, doses, dose number not reported). RECOMBIVAX HB was improperly exposed to temperatures of 90F for 24 hours on 28-MAY-2015 and 91F for 24 hours on 29-MAY-2015. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLU3, HPVX
Symptoms: Condition aggravated, Keratosis pilaris, Local reaction
Clinical narrative: Patient is currently a 16-year-old boy with a past medical history significant for chronic rhinitis, keratosis pilaris, and migraine headaches who describes an adverse event following immunization after his HPV #1 vaccine that he received at 14yo (on 7 Dec 2012). Patient describes large local reaction as well as significant worsening of his underlying keratosis pilaris that prompted medical evaluation and treatment with topical medications. Symptoms slowly resolved over a few weeks.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age and gender. Patients' medical history and concurrent conditions were not reported. Between 06-APR-2015 and 30-APR-2015, unspecified number of patients were vaccinated with a dose of improperly stored VARIVAX (Merck) (dose, lot# and route were not reported). No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot numbers or dates of vaccination. Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates and lot numbers with expiration dates of the patients who received VARIVAX (Merck) which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the dates of 06-APR-2015 and 30-APR-2015. On 07-APR-2015, a female patient of unknown age received VARIVAX (Merck) (lot number K018963, expiration date 15-OCT-2016). The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the VARIVAX (Merck) vaccine which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015, no vaccines were left from the event. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age and gender. Patients' medical history and concurrent conditions were not reported. Between 06-APR-2015 and 30-APR-2015, unspecified number of patients were vaccinated with a dose of improperly stored VARIVAX (Merck) (dose, lot# and route were not reported). No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot numbers or dates of vaccination. Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates and lot numbers with expiration dates of the patients who received VARIVAX (Merck) which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the dates of 06-APR-2015 and 30-APR-2015. On 07-APR-2015, a female patient of unknown age received VARIVAX (Merck) (lot number K018963, expiration date 15-OCT-2016). The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the VARIVAX (Merck) vaccine which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015, no vaccines were left from the event. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Peripheral swelling, Tenderness, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist and after the initial call by the consumer refers to a 61 year old male patient. The patient's medical history included an allergy to sulfa drugs. On 29-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L006380, expiry date: 25-MAY-2016, subcutaneous (dose was not reported) for vaccination. There was no concomitant medication also reported as some pain medications (brand not specified). On the same date (four hours after vaccination), the patient vomited (vomiting). He also told the pharmacist that the injection site was swollen (injection site swelling) and red (injection site erythema) and was suffering from a headache. The patient reported that he experienced "low grade fever 99%" (pyrexia), and although the swelling was going down his arm (peripheral swelling) was still red (erythema), warm to the touch (skin warm) and he has begun itching at the injection site (injection site pruritus). The consumer sought medical attention and called pharmacy. There was no treatment received or laboratories diagnostics performed. The patient also provided the physician's information. The outcome of vomiting, erythema, peripheral swelling, pyrexia, skin warm, injection site pruritus, headache, injection site erythema and injection site swelling was reported as not recovered at the time of the report. The relatedness between the events above mentioned and ZOSTAVAX was not provided. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist and after the initial call by the consumer refers to a 61 year old male patient. The patient's medical history included an allergy to sulfa drugs. On 29-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L006380, expiry date: 25-MAY-2016, subcutaneous (dose was not reported) for vaccination. There was no concomitant medication also reported as some pain medications (brand not specified). On the same date (four hours after vaccination), the patient vomited (vomiting). He also told the pharmacist that the injection site was swollen (injection site swelling) and red (injection site erythema) and was suffering from a headache. The patient reported that he experienced "low grade fever 99%" (pyrexia), and although the swelling was going down his arm (peripheral swelling) was still red (erythema), warm to the touch (skin warm) and he has begun itching at the injection site (injection site pruritus). The consumer sought medical attention and called pharmacy. There was no treatment received or laboratories diagnostics performed. The patient also provided the physician's information. The outcome of vomiting, erythema, peripheral swelling, pyrexia, skin warm, injection site pruritus, headache, injection site erythema and injection site swelling was reported as not recovered at the time of the report. The relatedness between the events above mentioned and ZOSTAVAX was not provided. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Skin warm, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist and after the initial call by the consumer refers to a 61 year old male patient. The patient's medical history included an allergy to sulfa drugs. On 29-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L006380, expiry date: 25-MAY-2016, subcutaneous (dose was not reported) for vaccination. There was no concomitant medication also reported as some pain medications (brand not specified). On the same date (four hours after vaccination), the patient vomited (vomiting). He also told the pharmacist that the injection site was swollen (injection site swelling) and red (injection site erythema) and was suffering from a headache. The patient reported that he experienced "low grade fever 99%" (pyrexia), and although the swelling was going down his arm (peripheral swelling) was still red (erythema), warm to the touch (skin warm) and he has begun itching at the injection site (injection site pruritus). The consumer sought medical attention and called pharmacy. There was no treatment received or laboratories diagnostics performed. The patient also provided the physician's information. The outcome of vomiting, erythema, peripheral swelling, pyrexia, skin warm, injection site pruritus, headache, injection site erythema and injection site swelling was reported as not recovered at the time of the report. The relatedness between the events above mentioned and ZOSTAVAX was not provided. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ankle fracture
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old male patient. There were no pertinent medical history or drug allergies/drug reactions. On 26-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX, (dose and route were not reported), lot # K016324, expiration date 24-DEC-2015. The patient's concomitant therapies were not reported. On 27-JUN-2015, the patient "tripped over a rug and went down a set of stairs and broke his ankle in three different places". the patient was taken to the hospital and was prescribed prednisone (manufacturer unknown) and an unspecified pain medication. At the time of the report, the outcome of tripped over a rug and went down a set of stairs and broke his ankle in three different places was reported as not recovered/not resolved. The relatedness between the events and therapy with ZOSTAVAX, was not reported. The reporter considered the event to be serious due to significant disability. Additional information has been requested.