chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a 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 (Merck) (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: 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-2051 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, 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-MAY-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, 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-JUN-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, 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: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 29-APR-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (dose and lot # not reported) orally. No adverse effect was reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEP, VARCEL, VARCEL
Symptoms: Dizziness, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 46 year old female patient. It was reported that the patient was not pregnant. There was no pertinent medical history and drug reactions or allergies reported. On 01-JUN-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K010336, expiry date 22-JUL-2016) (0.5 ml, 1 dose) subcutaneously. No concomitant medications were reported. On 02-JUN-2015, the patient experienced right arm pain, rash at the site of injection and swelling. The patient self medicated with an unspecified dose of ADVIL on 02-JUN-2015. These was no lab diagnostic studies performed. The patient sought medical attention and came into the pharmacy. The action taken with the therapy with VARIVAX (Merck) was unknown. The outcome of the events was reported as not recovered. The relatedness of the events to the therapy with VARIVAX (Merck) was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEP, VARCEL, VARCEL
Symptoms: Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 46 year old female patient. It was reported that the patient was not pregnant. There was no pertinent medical history and drug reactions or allergies reported. On 01-JUN-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K010336, expiry date 22-JUL-2016) (0.5 ml, 1 dose) subcutaneously. No concomitant medications were reported. On 02-JUN-2015, the patient experienced right arm pain, rash at the site of injection and swelling. The patient self medicated with an unspecified dose of ADVIL on 02-JUN-2015. These was no lab diagnostic studies performed. The patient sought medical attention and came into the pharmacy. The action taken with the therapy with VARIVAX (Merck) was unknown. The outcome of the events was reported as not recovered. The relatedness of the events to the therapy with VARIVAX (Merck) was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a register nurse, refers to a 68 year old female patient, with hypertension and hypersensitivity to codeine and unspecified angiotensin converting enzyme (ACE). On 15-JUN-2015 the patient was vaccinated with PNEUMOVAX 23 in the left arm, (route, dosage, lot# and expiration date were not reported). Concomitant therapies included PREVNAR 13 administered on 03-APR-2015 and amlodipine, diltiazem, lisinopril, metronidazole and levothyroxine sodium. On 15-JUN-2015, the patient visited the emergency room because she was experiencing pain in extremity, injection site erythema and application site swelling. The same day she was discharge and then on 18-JUN-2015 she visited her physician, who prescribed ibuprofen as needed for pain and swelling. The outcome of pain in extremity, injection site erythema and application site swelling was reported as recovering. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Application site swelling, Injection site erythema, Pain in extremity
Clinical narrative: This spontaneous report was received from a register nurse, refers to a 68 year old female patient, with hypertension and hypersensitivity to codeine and unspecified angiotensin converting enzyme (ACE). On 15-JUN-2015 the patient was vaccinated with PNEUMOVAX 23 in the left arm, (route, dosage, lot# and expiration date were not reported). Concomitant therapies included PREVNAR 13 administered on 03-APR-2015 and amlodipine, diltiazem, lisinopril, metronidazole and levothyroxine sodium. On 15-JUN-2015, the patient visited the emergency room because she was experiencing pain in extremity, injection site erythema and application site swelling. The same day she was discharge and then on 18-JUN-2015 she visited her physician, who prescribed ibuprofen as needed for pain and swelling. The outcome of pain in extremity, injection site erythema and application site swelling was reported as recovering. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Diarrhoea, Dizziness, Heart rate increased, Hypoaesthesia oral
Clinical narrative: Pt received ZOSTAVAX today and has some localized redness at site.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Peripheral swelling, Swelling face, Swollen tongue
Clinical narrative: Pt received ZOSTAVAX today and has some localized redness at site.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pt received ZOSTAVAX today and has some localized redness at site.
Age: 1.06
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Skins lesion raised nodular rash (similar to insect bite), multiple.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Very Sore Right Arm where PPV23 Vaccine administered, followed by flu like achy muscles throughout whole body while sleeping. Swelling of right arm & redness to noticed when waking on morning of 19 Jun 15. Flu like achiness, moderate swelling of right, upper arm, and moderate fatigue continue through day. Right upper arm muscle very sore. Symptoms started to improve on 20 Jun 15, with swelling of right upper arm shifting down. Swelling continue to drift down to slightly below right elbow (with redness) for several days. All symptoms continued with time, and where completely gone on morning of 24 Jun 15.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Myalgia, Peripheral swelling
Clinical narrative: Very Sore Right Arm where PPV23 Vaccine administered, followed by flu like achy muscles throughout whole body while sleeping. Swelling of right arm & redness to noticed when waking on morning of 19 Jun 15. Flu like achiness, moderate swelling of right, upper arm, and moderate fatigue continue through day. Right upper arm muscle very sore. Symptoms started to improve on 20 Jun 15, with swelling of right upper arm shifting down. Swelling continue to drift down to slightly below right elbow (with redness) for several days. All symptoms continued with time, and where completely gone on morning of 24 Jun 15.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Extreme fussiness uncontrollable crying red and swollen at the injection site.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MMR, MNQ, VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting-starting 8 hours after immunizations given-reported to our facility the morning after.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm red, swollen, tender at injection site. Treatment: ORAPRED 15mg/5mL with BENADRYL.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient has raised bump at injection site after ZOSTAVAX immunization.
Age: 1.13
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous report was received from a health care professional refers to an approximately 13 month old female patient. Drug reactions/allergies were none. On 27-MAY-2015 the patient was vaccinated with M-M-R II (lot # K021952; expiry: 10-NOV-2016), 0.5 ml, intramuscular injection. Concomitant medications and medical history were reported as none. On 27-MAY-2015, the nurse reported that a patient developed a welt, redness, and swelling at the injection site within five minutes of receiving the vaccine. The nurse reported that the patient received the M-M-R II intramuscularly (inappropriate route of vaccination). The nurse stated that the patient will be coming back today on 27-MAY-2015, at an unspecified time to see if the welt, redness, and swelling were resolved. No lab tests done. Patient sought medical attention and the physician instructed that the patient take unspecified antihistamines and to apply an ice pack to the injection site. The outcome of all the events at the time of this report and medication error was unknown. Causality assessment for the events was not reported. This case is linked to: 1506USA012544 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Fatigue
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age with unspecified pertinent medical history, drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, lot number and route were not provided). Concomitant medication was not reported. On an unknown date, while on therapy with GARDASIL, the patient experienced fatigue and abdominal pain. The patient sought medical attention by visiting the physician. The outcome of abdominal pain and fatigue was unknown. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist, as part of a marketing research program conducted, refers to a 16 year male patient with no relevant concurrent conditions". Medical history was not provided. In March-2014 the patient was vaccinated with the first dose of GARDASIL (Dosage, Lot number and expiration date were not provided) in the arm for prevention of HPV. There was no concomitant therapy. Approximately in March-2014, the next day after the vaccination with GARDASIL, the patient experienced a sore arm and he was complaining about how much his arm hurt. There was no diagnostic test performed. On unknown date the patient got all remaining doses of GARDASIL. The outcome of a sore arm was reported as recovered/resolved. The reporter considered a sore arm to be related to GARDASIL. Additional information is not expected because there is not consent to contact the physician.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ, orally, (dose, lot number and expiration date were not reported). No adverse experiences were 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: This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On an unknown dates the patients were vaccinated with the improperly stored (Oka/Merck) VARIVAX (dose volume, routes of administration, lot numbers were not reported). No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Breath holding, Concussion, Fall, Immediate post-injection reaction, Presyncope
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a 12 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patient was vaccinated with three doses of GARDASIL (dose, route of administration,  lot # and expiration date were not reported). The patient experienced two sports related concussion after beginning the GARDASIL series. The first one in October 2014 and the second one in December 2014 just two weeks prior to receiving his final dose of GARDASIL. On an unknown date (reported as immediately following administration of his third and final dose of GARDASIL, the patient experienced seizure. It was reported that the registered nurse just finished administering the vaccine and was getting ready to withdraw the needle (it was still imbedded in the patient's arm) and the patient "fell off the needle" and had a seizure. The mother caught the patient. An unspecified physician came in to assess the situation and determined the patient did not require an Emergency Room visit. The nurse stated that she believed that the patient was holding his breath and had some sort of vasovagal. The outcome of the adverse events was unknown. The relatedness between the adverse events and the vaccination with GARDASIL was not reported. Upon internal review the adverse event of seizure was considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a 12 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patient was vaccinated with three doses of GARDASIL (dose, route of administration,  lot # and expiration date were not reported). The patient experienced two sports related concussion after beginning the GARDASIL series. The first one in October 2014 and the second one in December 2014 just two weeks prior to receiving his final dose of GARDASIL. On an unknown date (reported as immediately following administration of his third and final dose of GARDASIL, the patient experienced seizure. It was reported that the registered nurse just finished administering the vaccine and was getting ready to withdraw the needle (it was still imbedded in the patient's arm) and the patient "fell off the needle" and had a seizure. The mother caught the patient. An unspecified physician came in to assess the situation and determined the patient did not require an Emergency Room visit. The nurse stated that she believed that the patient was holding his breath and had some sort of vasovagal. The outcome of the adverse events was unknown. The relatedness between the adverse events and the vaccination with GARDASIL was not reported. Upon internal review the adverse event of seizure was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) referring to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX, (lot# and expiration date were unknown) 0.65 ml, subcutaneously. The number of doses and patients were unspecified. There was no adverse event reported. Additional information is not expected as there is no consent for 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-APR-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD, 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: RV5
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 ROTATEQ  orally (dose, strength, frequency and lot# were not reported). No adverse effects were reported. This is one of several cases 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 10-FEB-2015 the patient was received improperly stored VARIVAX (Merck) (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 product.
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 15-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD, 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 09-MAR-2015 the patient was received improperly stored VARIVAX (Merck) (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: U
Vaccine: PPV
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 PNEUMOVAX 23 (dose, strength, frequency, route and lot# were not reported). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patients concurrent condition and medical history were not reported. On 16-JUN-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (strength, lot # and expiration date were unknown, 0.65 ml) subcutaneously. No adverse effects were 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 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 VARIVAX (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.
Sex: U
Vaccine: HPV4
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 GARDASIL (dose, strength, frequency, route and lot# were not reported). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: Gave wrong vaccine. Gave Prevnar 13 when HIB should have been given.
Age: 68.0
Sex: M
Vaccine: TYP
Symptoms: Asthenia, Chills, Cough, Decreased appetite, Frequent bowel movements
Clinical narrative: On Monday evening, client "could not hold food" but denied diarrhea. Client stated that he had well formed bowel movements (most of the time) every 2-3 hours on Monday, then had 3-5 bowel movements on Tuesday. Client stated he felt a lower intestinal pain that was relieved by having a bowel movement. Client states he still felt this pain yesterday and today when he has to urinate and is relieved by urination. Client also reported feeling weak and felt his quadriceps and legs felt "strained" when he went for a hike. From Wednesday until today (Thursday) client reports feeling weak, having shivers, and sweating. Client states he has "cycles" of sweating, feeling better, shivering, feeling weak, then sweating again. Per client, he has not been able to eat well since Tuesday. He reports only being able to eat during the period of time after sweating when he feels better. Client also reports not sleeping well for the past 2 nights. Client also states he developed a cough on Tuesday.
Age: 68.0
Sex: M
Vaccine: TYP
Symptoms: Gastrointestinal pain, Hyperhidrosis, Limb discomfort, Poor quality sleep
Clinical narrative: On Monday evening, client "could not hold food" but denied diarrhea. Client stated that he had well formed bowel movements (most of the time) every 2-3 hours on Monday, then had 3-5 bowel movements on Tuesday. Client stated he felt a lower intestinal pain that was relieved by having a bowel movement. Client states he still felt this pain yesterday and today when he has to urinate and is relieved by urination. Client also reported feeling weak and felt his quadriceps and legs felt "strained" when he went for a hike. From Wednesday until today (Thursday) client reports feeling weak, having shivers, and sweating. Client states he has "cycles" of sweating, feeling better, shivering, feeling weak, then sweating again. Per client, he has not been able to eat well since Tuesday. He reports only being able to eat during the period of time after sweating when he feels better. Client also reports not sleeping well for the past 2 nights. Client also states he developed a cough on Tuesday.
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 and gender. The patient's medical history was not reported. On 27-APR-2015 the patient was received improperly stored (Oka/Merck) 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: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist via company representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot#, expiration date, dose, strength and route were not reported). No adverse effects reported. It was unknown if the patient sought medical attention. 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 24-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: 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 11-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 29-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: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Mobility decreased, Tenderness
Clinical narrative: Arm was tender to touch, unable to move affected arm in certain directions. Very limited motion to affected arm. Unable to perform daily tasks.
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered, Injection site extravasation
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. The patient had no known drug allergies. On an unspecified date in June 2015 (reported as "about a week ago"), the patient was vaccinated intramuscularly with a dose of GARDASIL lot # K014191, expiry date 10-MAY-2017, for prevention of HPV. The reporter stated that when the dose was withdrawn into a syringe and inserted into the patient's muscle, upon plugging the syringe the dose leaked out of the patient's injection site. During the same visit, the physician gave the patient the second full dose of GARDASIL (lot # and expiry date unspecified). No treatment was given for reported events and none lab diagnostics test were performed. The outcome and causality of the event was unknown. 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 13-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 21-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 16-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: 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 15-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot 3 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: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Eye swelling, Peripheral swelling, Rash generalised, Urticaria, Vomiting
Clinical narrative: The patients mother stated he had a rash and hives all over his body and his eyes and hands were swollen. He was also vomiting. She gave him BENADRYL and called us for treatment.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site reaction, Injection site swelling, Lethargy
Clinical narrative: Fever, headache, myalgia, lethargic. Locally at injection site->swelling, redness, muscle pain.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, headache, myalgia, lethargic. Locally at injection site->swelling, redness, muscle pain.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Decreased appetite, Erythema, Fatigue, Gait disturbance
Clinical narrative: Headache, fever which resolved in 24 hours and with ASA. Still has loss of appetite, nausea and fatigue. Severe pain-vice-like which moved from (L) arm to chest, spine and down (L) side and lasted 2-3 days and moved to (R) leg. Weakness in legs, difficulty walking. Some spasms (L) arm was "lumpy" swollen and red area 5-6" long. Legs remain weak but improving. Pain also occurred in previous surgical area of neck, spine and shoulder.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Muscle spasms, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: Headache, fever which resolved in 24 hours and with ASA. Still has loss of appetite, nausea and fatigue. Severe pain-vice-like which moved from (L) arm to chest, spine and down (L) side and lasted 2-3 days and moved to (R) leg. Weakness in legs, difficulty walking. Some spasms (L) arm was "lumpy" swollen and red area 5-6" long. Legs remain weak but improving. Pain also occurred in previous surgical area of neck, spine and shoulder.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Procedural pain, Pyrexia, Spinal pain, Upper extremity mass
Clinical narrative: Headache, fever which resolved in 24 hours and with ASA. Still has loss of appetite, nausea and fatigue. Severe pain-vice-like which moved from (L) arm to chest, spine and down (L) side and lasted 2-3 days and moved to (R) leg. Weakness in legs, difficulty walking. Some spasms (L) arm was "lumpy" swollen and red area 5-6" long. Legs remain weak but improving. Pain also occurred in previous surgical area of neck, spine and shoulder.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Swelling face
Clinical narrative: Swelling of lips and lower face 10-15 hours after shingles vaccine - patient was sleeping at onset - noticed at 3:30 am 6-25-15.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left arm pain, redness, and swelling with warmth on the day following injection lasting two weeks with gradual improvement.
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-MAR-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: 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 06-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.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: Pt calling d/t having possible reaction to PNEUMOVAX vaccine given on 06/18/2015. Pt states given vaccine at approx 0830 and was feeling fine until evening during dinner. Pt states at this time her shoulder became extremely painful and pt couldn't move it. Pt states she took IBP for relief and has used ice. Pt states she fell asleep on her couch and at approximately 0130 woke up with nausea and vomiting. Pt states she took temperature and was 99.4 and exp chills and sweats. Pt states these symptoms continued through late AM. Pt states left shoulder/arm pain continued as well as a HA. Pt attempted to control symptoms with ice, IBP, and EXCEDRIN. At present pt states nausea, vomiting, chills, sweats, temp, and HA have all been relieved. Pt states at this time pt is still exp left shoulder/arm pain, and that injection site is swollen with red rash. Pt states call is to inform them of reaction and possible allergy. Pt advised that if symptoms return to seek emergency attention. Please advise pt if anything further is necessary.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pt calling d/t having possible reaction to PNEUMOVAX vaccine given on 06/18/2015. Pt states given vaccine at approx 0830 and was feeling fine until evening during dinner. Pt states at this time her shoulder became extremely painful and pt couldn't move it. Pt states she took IBP for relief and has used ice. Pt states she fell asleep on her couch and at approximately 0130 woke up with nausea and vomiting. Pt states she took temperature and was 99.4 and exp chills and sweats. Pt states these symptoms continued through late AM. Pt states left shoulder/arm pain continued as well as a HA. Pt attempted to control symptoms with ice, IBP, and EXCEDRIN. At present pt states nausea, vomiting, chills, sweats, temp, and HA have all been relieved. Pt states at this time pt is still exp left shoulder/arm pain, and that injection site is swollen with red rash. Pt states call is to inform them of reaction and possible allergy. Pt advised that if symptoms return to seek emergency attention. Please advise pt if anything further is necessary.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Pt calling d/t having possible reaction to PNEUMOVAX vaccine given on 06/18/2015. Pt states given vaccine at approx 0830 and was feeling fine until evening during dinner. Pt states at this time her shoulder became extremely painful and pt couldn't move it. Pt states she took IBP for relief and has used ice. Pt states she fell asleep on her couch and at approximately 0130 woke up with nausea and vomiting. Pt states she took temperature and was 99.4 and exp chills and sweats. Pt states these symptoms continued through late AM. Pt states left shoulder/arm pain continued as well as a HA. Pt attempted to control symptoms with ice, IBP, and EXCEDRIN. At present pt states nausea, vomiting, chills, sweats, temp, and HA have all been relieved. Pt states at this time pt is still exp left shoulder/arm pain, and that injection site is swollen with red rash. Pt states call is to inform them of reaction and possible allergy. Pt advised that if symptoms return to seek emergency attention. Please advise pt if anything further is necessary.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of  improperly stored VAQTA, (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Age: 0.09
Sex: M
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 week (also reported as 2 months) old male patient. No concurrent condition or medical history reported. On 21-APR-2015 at 11:58 hours, the patient was vaccinated with one 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 to be revaccinated. The patient was vaccinated at private doctor's office and the vaccine was purchased with public funds. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Certified Medical Assistant (C.M.A.) referring to unspecified patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of MMR II (lot #, strength, route of administration and dose were not provided). No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old male patient. No concurrent condition or medical history reported. On 21-APR-2015 at 15:00 hours, the patient vaccinated with 1 dose of GARDASIL intramuscularly in LD (Lot# K007828, expiry date: 02-MAR-2017) 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 unstable to be vaccinated. The patient was vaccinated at private doctor's office and the vaccine was purchased with public 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 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.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 23-JUN-2015 the patient was vaccinated with a dose of an improperly stored VARIVAX (dose, dose #, lot #, route and application site were not reported). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 15 year old patient of an unknown gender. The patient's current conditions and medical history were not reported. On 05-MAY-2015, the patient was accidentally vaccinated with dose of ZOSTAVAX (unknown route, strength and anatomical location) instead of VARIVAX. Concomitant medications were not reported. No adverse effect was reported. The outcome of the event was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored PROQUAD (lot number K001854, expiry date 06-AUG-2015) or (lot number K0118144, expiry date 06-AUG-2015) (also reported as the healthcare worker could not identify the lot number) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the PROQUAD (Merck) underwent multiple supported temperature excursions. The action taken with the therapy with PROQUAD (Merck) was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with PROQUAD (Merck) 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: PPV
Symptoms: Incorrect product storage, Product quality issue
Clinical narrative: This spontaneous report was received from a pharmacy student and refers to an unspecified amount of patients (reported as a "few") of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (lot #, expiration date, route of administration and dose were not reported). The pharmacy student reported that, on an unknown date, a vial of PNEUMOVAX 23 was cloudy and went through an unspecified temperature excursion and after it had been left out of the refrigerator for a couple of hours. The product was not supported as to whether it should be used because the reporter did not have the proper product information to be checked. The pharmacy student reported the product was placed back into the fridge and it was no longer cloudy, it returned to its normal color. Product quality complaint (PQC) was filed. Additional information is not expected, as there are no contact details.