chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to two patients of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date, the patients were vaccinated with doses of GARDASIL (lot#, expiration date and doses were not reported) that were improperly stored. No adverse experiences reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 28-MAY-2015 the patient was received improperly stored VARIVAX (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Rash papular, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient without known drug reactions or allergies. Concurrent conditions included hypertension and hypercholesterolaemia. On 16-JUN-2015 the patient was vaccinated with a dose of ZOSTAVAX subcutaneous, 0.65 ml, lot # L002423, expiration date 23-APR-2016 (dose number and anatomical location were unspecified). Concomitant therapies included "a lot of chronic meds" (unspecified). On an unknown date in June 2015, after vaccination, the patient experienced a large, red spot on the arm that was itchy and warm to the touch and measuring approximately 3 inches in diameter around the site of injection. The patient sought medical attention by the pharmacist; no treatment was given for the events and none laboratory diagnostic studies were performed. The outcome of skin warm and rash papular was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative, refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with the first dose of GARDASIL, (dosage, route, lot # and expiration date were not reported). Concomitant therapy was not reported. The nurse practitioner reported that the patient was vaccinated in other facility, however during an office visit reported that on an unknown date she experienced alopecia. The outcome of alopecia was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from an unspecified healthcare professional, via company representative, refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were unspecified. On an unknown date, "many years ago", the patient was vaccinated with a dose of GARDASIL (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were unspecified by reporter. The same day, the patient experienced syncope at the physician's office after the vaccination. The reporter stated that the office called 911. Subsequently the patient was "OK" after this experience. The relatedness between the event and GARDASIL was not reported. Additional information is not expected as the reporter did not wish further contact.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Blood pressure decreased, Dizziness, Hypoacusis, Vision blurred, Vomiting
Clinical narrative: Pt vomited x1, feelings of faint, blurred vision, difficulty hearing. Decreased B/P. Symptoms resolved after 30 min, B/P increased. Pt sent home.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Reddened area approx. 1 3/4 x 2 1/4 cm, warm to touch surrounding injection site of left thigh.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter stated that on unspecified dates ranging from 15-JUN-2015 through 18-JUN-2015, the patients received doses that were improperly stored of GARDASIL (strength, lot number, expiration date, dose # and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Borrelia test, C-reactive protein, Full blood count, Metabolic function test
Clinical narrative: Diffuse polyneuropathy, myalgia and arthralgia. MRI, Neurology appt, Lab work. Treated with prednisone.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Nuclear magnetic resonance imaging, Polyneuropathy
Clinical narrative: Diffuse polyneuropathy, myalgia and arthralgia. MRI, Neurology appt, Lab work. Treated with prednisone.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Vision blurred
Clinical narrative: Pt states she got up from exam table, sat down in a chair, vision became blurry. She woke up on the floor. Pt was found sitting in waiting room. Assisted back to exam room. BP x 2 90/60 10 min later 110/70 P60. Examined by Dr.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Left arm redness, swelling. Fever 101 degrees. Pt went to clinic 6/24/15. Rx clindamycin 300mg 3x/day x10 d.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swelling, redness, itchy, slight pain area at 5" x 3".
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site vesicles
Clinical narrative: Rash around injection site (upper left arm) about 3 inches diameter. Itchy and not red, starting to blister on 6/18 AM.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Asthma, Balance disorder, Fall, Fine motor skill dysfunction, Hallucination
Clinical narrative: Asthma attacks treated with albuterol MDI, panic attacks hallucinations/suicidal thoughts treated with KLONOPIN. Recurring numbness in fingers, toes, and lips; decrease in fine motor function; falls due to losing balance, stabbing sensations in fingers and toes, constant gastrointestinal symptoms.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Panic attack, Suicidal ideation
Clinical narrative: Asthma attacks treated with albuterol MDI, panic attacks hallucinations/suicidal thoughts treated with KLONOPIN. Recurring numbness in fingers, toes, and lips; decrease in fine motor function; falls due to losing balance, stabbing sensations in fingers and toes, constant gastrointestinal symptoms.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter stated that on unspecified dates ranging from 15-JUN-2015 through 18-JUN-2015, the patients received doses that were improperly stored of PROQUAD (Merck) (strength, lot number, expiration date, dose # and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Incontinence, Seizure
Clinical narrative: Generalized seizure lasting 10 seconds with incontinence.
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not provided. On 18-JUN-2015, the patient was vaccinated with a dose of both RECOMBIVAX HB and PEDIARIX. No known adverse effects were reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a consumer (patient's friend) via market research program, refers to a 55 year old female patient. The patient's concurrent conditions and medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency and route were not reported). Concomitant medications were not reported. From an unknown date, the patient experienced itching for 3 months, which occurred on and off. The outcome of the event was reported as recovered/resolved with sequelae. The reporter considered the event to be related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 02-APR-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-APR-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-MAR-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 05-MAY-2015 the patient was received improperly stored VARIVAX (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 20-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 30-APR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-FEB-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 04-FEB-2015 the patient was received improperly stored VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not reported). One and a half years ago, on an unknown date approximately in 2014 after receiving ZOSTAVAX the patient experienced herpes zoster. Action taken was not applicable. The outcome of herpes zoster was unknown. The reporter did not provide the causality between the event and the suspect therapy. This is one of the two reports received from the same source. This case was linked to patient's husband case# 1506USA006473. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and a Healthcare worker refers to a patient of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On 08-MAY-2015, the patient was vaccinated with an improperly stored dose of VARIVAX Lot# J013729 expiration date 30-OCT-2015 (route and dose were not reported). There was no concomitant therapy reported. The temperature excursion for the VARIVAX was unsupported with in house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter stated that on unspecified dates ranging from 15-JUN-2015 through 18-JUN-2015, the patients received doses that were improperly stored of VARIVAX (strength, lot number, expiration date, dose # and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter stated that on unspecified dates ranging from 15-JUN-2015 through 18-JUN-2015, the patients received doses that were improperly stored of PEDVAXHIB (strength, lot number, expiration date, dose # and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (dose, strength, frequency, lot# and route were not reported). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 95.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Blood glucose normal, Partial seizures, Syncope
Clinical narrative: Patient had syncope with partial seizure after receiving MCV4 and HPV#2. Seizure episode lasted about a minute. O2 given, vitals taken, and glucose checked. Patient stabilized and in stable condition upon discharge.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 14-MAY-2015 the patient was received improperly stored VARIVAX (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 26-FEB-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age, regarding herself. The patient's medical history, concurrent conditions and concomitant medications were not unknown. On 10-JUN-2015, the patient was vaccinated with an expired dose of ZOSTAVAX, one vial, injection (lot number unspecified, expiry date 26-DEC-2014). The patient did not experience any adverse reactions. The patient did not seek medical attention. No product quality complaint (PQC) was involved. No further adverse event (AE) information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 04-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. on 07-APR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician refers to a 71 year old male patient. On an unknown date approximately in 2010 (reported as 5 years ago) the patient was vaccinated with ZOSTAVAX VIAL (dose, route and lot# were not reported) for shingles prevention. Concomitant therapies included carvedilol as well as other (unspecified) cardiac medications, unspecified thyroid medication, simvastatin, warfarin and FLOMAX. Approximately on 04-JUN-2015 (reported approximately six days ago) the patient developed a vesicular rash in an unspecified region of his body and was diagnosed with an active case of shingles. Patient sought medical attention by an office visit. Treatment was given to the patient. The patient was prescribed VALTREX and TYLENOL II for pain. No product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of shingles was reported as not recovered/not resolved. The reporter did not provide the causality between the event and the suspect therapy. This is one of the two reports received from the same source. This case was linked to patient's wife case# 1506USA013078. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 26-JAN-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker, refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received doses of VARIVAX (Merck) (dose, lot#, expiration date, route of administration were not reported) that were improperly stored. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 29-APR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 02-FEB-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 1.9
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a 23 month old male patient. The patient's medical history included rash from BACTRIM on unspecified date. No current conditions were provided. On 17-MAY-2015 the patient was vaccinated with VARIVAX (Merck), injection (dose, route of administration, and expiration date were not provided) (Lot number was reported as "H007201", which was confirmed as an invalid lot number for VARIVAX (Merck)). There were not concomitant medications. On 01-APR-2014 the patient developed shingles. The patient sought medical attention and received acyclovir for treatment. No laboratory tests were performed. On 29-APR-2014 the shingles were recovered. The reporter did not assess the relatedness between shingles and VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker, refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received doses of RECOMBIVAX HB (dose, lot#, expiration date, route of administration were not reported) that were improperly stored. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of an unknown age. The patient's current conditions and medical history were not reported. On 04-JUN-2015, the patient was vaccinated with first dose of ZOSTAVAX in the right arm and was inadvertently vaccinated with a second dose of ZOSTAVAX on 10-JUN-2015. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 17-APR-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) Lot# K008579, expiration date 13-DEC-2015 (route and dose were not reported). There was no concomitant therapy reported. The temperature excursion for PROQUAD (Merck) was unsupported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 09-FEB-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 25-MAR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: Pt presented with fine rash on the face and rednes/swelling of both arms. Skin on both arms was warm to touch.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dysphagia, Erythema, Peripheral swelling, Pharyngeal erythema, Rash
Clinical narrative: Pt presented with fine rash on the face and rednes/swelling of both arms. Skin on both arms was warm to touch.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 23-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Age: 0.53
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month (also reported as 7 month) old female patient. No concurrent condition or medical history reported. On 21-APR-2015 at 10:30 hours, the patient was vaccinated with third dose of RECOMBIVAX HB, (Lot# L001456) intramuscular (RVL) which was exposed to temperatures outside of the recommended range. On the same day, the refrigeration temperature was out of range for 30 minute (-1.8 degree Celsius). It was advised that the vaccine was not stable, patient was called to be revaccinated. The patient was vaccinated at private doctor's office and the vaccine was purchased with private funds. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information about medical history and concurrent conditions were reported for the patients. On unspecified dates, another nurse vaccinated the patients with VARIVAX (unknown strength, route and anatomical location) which had been removed from the freezer and thawing it at an unspecified room temperature for 20 minutes prior to administration. Concomitant medications were not reported. No adverse symptoms were reported. The outcome of the event was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored VARIVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the VARIVAX underwent multiple supported temperature excursions. The action taken with the therapy with VARIVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VARIVAX was unknown. There was no product quality complaint reported. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-JAN-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age. The medical assistant reported that the patient received one dose of PEDVAXHIB (indication and total dosage not provided) on 04-JUN-2015 that was not stored properly. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-MAY-2015 the patient was received improperly stored VARIVAX (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown demographics. No pertinent medical history, concurrent conditions or conditions or concomitant medications were reported. On an unknown date in May 2015, about a month ago, the patient was vaccinated with ZOSTAVAX, dose frequency and route unknown. On an unknown date in 2015, the patient was inadvertently administered a second dose of ZOSTAVAX (extra dose administered). No adverse effect reported. The outcome of extra dose administered was unknown. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 26-JAN-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 4.0
Sex: F
Vaccine: MMRV, DTAPIPV, MMRV
Symptoms: Dyspnoea, Erythema, Generalised erythema, Injection site erythema, Retching
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) and refers to a 4 year old female patient who had a cleft palate at birth. No pertinent medical history and drug allergies were reported. On 28-MAY-2015, the patient was vaccinated with her first dose of PROQUAD (Merck) lot #K019102 expiry 15-APR-2016, 0.5 ml, subcutaneously. No concomitant medications were reported. On 28-MAY-2015, minutes after vaccination, the patient experienced sneezing and gagging, followed by vomiting, shortness of breath, redness and hives covering the entire body all of which took place while the patient was still in the physician's office. The physician treated the patient with BENADRYL, DEPO MEDROL and epinephrine. The patient remained in the physician's office for two hours and her symptoms had improved well enough to be sent home with treatment medications EPIPEN and prednisone. On 29-MAY-2015, next day, the patient returned to the office and was examined by physician who noted that the patient had redness at the injection site and on her cheeks. The outcome of the events sneezing, gagging, vomiting, shortness of breath, redness and hives covering the entire body was reported as recovered on 29-MAY-2015. The outcome injection site redness and redness of cheeks was reported as unknown. The reporter did not assess the causality of all the events with PROQUAD (Merck). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, DTAPIPV, MMRV
Symptoms: Sneezing, Urticaria, Vomiting
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) and refers to a 4 year old female patient who had a cleft palate at birth. No pertinent medical history and drug allergies were reported. On 28-MAY-2015, the patient was vaccinated with her first dose of PROQUAD (Merck) lot #K019102 expiry 15-APR-2016, 0.5 ml, subcutaneously. No concomitant medications were reported. On 28-MAY-2015, minutes after vaccination, the patient experienced sneezing and gagging, followed by vomiting, shortness of breath, redness and hives covering the entire body all of which took place while the patient was still in the physician's office. The physician treated the patient with BENADRYL, DEPO MEDROL and epinephrine. The patient remained in the physician's office for two hours and her symptoms had improved well enough to be sent home with treatment medications EPIPEN and prednisone. On 29-MAY-2015, next day, the patient returned to the office and was examined by physician who noted that the patient had redness at the injection site and on her cheeks. The outcome of the events sneezing, gagging, vomiting, shortness of breath, redness and hives covering the entire body was reported as recovered on 29-MAY-2015. The outcome injection site redness and redness of cheeks was reported as unknown. The reporter did not assess the causality of all the events with PROQUAD (Merck). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, DTAPIPV, MMRV
Symptoms: Dyspnoea, Erythema, Flushing, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) and refers to a 4 year old female patient who had a cleft palate at birth. No pertinent medical history and drug allergies were reported. On 28-MAY-2015, the patient was vaccinated with her first dose of PROQUAD (Merck) lot #K019102 expiry 15-APR-2016, 0.5 ml, subcutaneously. No concomitant medications were reported. On 28-MAY-2015, minutes after vaccination, the patient experienced sneezing and gagging, followed by vomiting, shortness of breath, redness and hives covering the entire body all of which took place while the patient was still in the physician's office. The physician treated the patient with BENADRYL, DEPO MEDROL and epinephrine. The patient remained in the physician's office for two hours and her symptoms had improved well enough to be sent home with treatment medications EPIPEN and prednisone. On 29-MAY-2015, next day, the patient returned to the office and was examined by physician who noted that the patient had redness at the injection site and on her cheeks. The outcome of the events sneezing, gagging, vomiting, shortness of breath, redness and hives covering the entire body was reported as recovered on 29-MAY-2015. The outcome injection site redness and redness of cheeks was reported as unknown. The reporter did not assess the causality of all the events with PROQUAD (Merck). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, DTAPIPV, MMRV
Symptoms: Injection site urticaria, Pain, Retching, Rhinorrhoea, Sneezing
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) and refers to a 4 year old female patient who had a cleft palate at birth. No pertinent medical history and drug allergies were reported. On 28-MAY-2015, the patient was vaccinated with her first dose of PROQUAD (Merck) lot #K019102 expiry 15-APR-2016, 0.5 ml, subcutaneously. No concomitant medications were reported. On 28-MAY-2015, minutes after vaccination, the patient experienced sneezing and gagging, followed by vomiting, shortness of breath, redness and hives covering the entire body all of which took place while the patient was still in the physician's office. The physician treated the patient with BENADRYL, DEPO MEDROL and epinephrine. The patient remained in the physician's office for two hours and her symptoms had improved well enough to be sent home with treatment medications EPIPEN and prednisone. On 29-MAY-2015, next day, the patient returned to the office and was examined by physician who noted that the patient had redness at the injection site and on her cheeks. The outcome of the events sneezing, gagging, vomiting, shortness of breath, redness and hives covering the entire body was reported as recovered on 29-MAY-2015. The outcome injection site redness and redness of cheeks was reported as unknown. The reporter did not assess the causality of all the events with PROQUAD (Merck). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, DTAPIPV, MMRV
Symptoms: Urticaria, Vomiting
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) and refers to a 4 year old female patient who had a cleft palate at birth. No pertinent medical history and drug allergies were reported. On 28-MAY-2015, the patient was vaccinated with her first dose of PROQUAD (Merck) lot #K019102 expiry 15-APR-2016, 0.5 ml, subcutaneously. No concomitant medications were reported. On 28-MAY-2015, minutes after vaccination, the patient experienced sneezing and gagging, followed by vomiting, shortness of breath, redness and hives covering the entire body all of which took place while the patient was still in the physician's office. The physician treated the patient with BENADRYL, DEPO MEDROL and epinephrine. The patient remained in the physician's office for two hours and her symptoms had improved well enough to be sent home with treatment medications EPIPEN and prednisone. On 29-MAY-2015, next day, the patient returned to the office and was examined by physician who noted that the patient had redness at the injection site and on her cheeks. The outcome of the events sneezing, gagging, vomiting, shortness of breath, redness and hives covering the entire body was reported as recovered on 29-MAY-2015. The outcome injection site redness and redness of cheeks was reported as unknown. The reporter did not assess the causality of all the events with PROQUAD (Merck). Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous report as received from the patient's mother refers to her 15 year old son with no drug reactions or allergies and not medical history. In June 2014, the patient was vaccinated with the first dose of GARDASIL and in August 2014, was vaccinated with the second dose of GARDASIL, (lot number, expiration date, route and dose were reported for both doses). In late February 2015, the patient was vaccinated with the third dose of GARDASIL (Lot number, expiration date, dose and route were not reported). Although the patient's mother was not aware if GARDASIL or GARDASIL 9 was administered as third dose. There was no concomitant therapy. The reporter was not aware if the third dose of GARDASIL received was GARDASIL or GARDASIL 9. The patient's mother reported that the patient experienced a rash on his left hand, within May 2015 reported as "within past month", that came and went intermittently. she also reported that in June 2015 reported as "most recently, in the past few days" the patient experienced urticaria reported as "hives" on his back and chest, which were worse, in the evening, on two occasions. On 09-JUN-2015, the patient consulted the physician, who advised him to see an allergist. The physician provided to the reporter with the patient product information for GARDASIL. No laboratory diagnostics studies were performed. The patient's urticaria and rash were reported as resolved on 09-JUN-2015, after receiving BENADRYL as treatment. The outcome of interchange of vaccine products was unknown. The reporter did not assess the relatedness of GARDASIL to rash, urticaria and interchange of vaccine products. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 03-FEB-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.