chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's pertinent medical history, current conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml (strength, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced a severe pain at the injection site that lasted much longer than usual. The outcome of injection site pain was not reported. The relationship between of injection site pain and the suspect therapy was unknown at the time of the report. No product quality complaint (PQC) was involved in the report. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions: one for 712 hours with lowest recorded temperature of 33 F (0.555555556 Celsius) and other one for 216 hours with lowest recorded temperature of 32 F (0 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history and allergies were not reported. Concomitant therapies were not provided. On 12-JUL-2016, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB "10 microgram/1 ml, 10X1 DS/V TF", with lot number L042846 and expiration date 15-SEP-2017, (dosage schedule, route and anatomical location were not reported), which was stored at 12 Celsius Degrees for 144 hours. The type of excursion and the storage criteria were reported as refrigerator (R) and the vaccine status in excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and allergies were not reported. Concomitant therapies were not provided. On 08-JUL-2016, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB  "10 microgram/1 ml, 10X1 DS/V TF" with lot number L042846 and expiration date of 15-SEP-2017, (dosage schedule, route and anatomical location were not reported), which was stored at 12 Celsius Degrees for 136 hours. The type of excursion and the storage criteria were reported as refrigerator (R) and the vaccine status in excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and allergies were not reported. Concomitant therapies were not provided. On 17-MAY-2016, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB "10 microgram/1 ml, 10X1", DS/VTF" with lot number L042846 and expiration date 15-SEP-2017, (dosage schedule, route and anatomical location were not reported), which was stored at 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for 112 hours (lowest recorded temperature). The type of excursion and the storage criteria were reported as refrigerator (R) and the vaccine status in excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and allergies were not reported. Concomitant therapies were not provided. On 21-JUL-2016, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB "10 microgram/1 ml, 10X1 DS/V TF" with lot number L042846 and expiration date of 15-SEP-2017, (dosage schedule, route and anatomical location were not reported), which was stored at 12 Celsius Degrees for 144 hours. The type of excursion and the storage criteria were reported as refrigerator (R) and the vaccine status in excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and allergies were not reported. Concomitant therapies were not provided. On 19-JUL-2016, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB "10 microgram/1 ml, 10X1 DS/V TF" with lot number L042846 and expiration date of 15-SEP-2017, (dosage schedule, route and anatomical location were not reported), which was stored at 12 Celsius Degrees for 144 hours. The type of excursion and the storage criteria were reported as refrigerator (R) and the vaccine status in excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Feeling cold, Pain in extremity, Pyrexia
Clinical narrative: Around evening, couldn't move LA, felt sore. 100mg CELEBREX 2x. Pennsade? muscle relaxer. Overnight, cold and fever. Next day 100mg CELEBREX 2x and 1000mg TYLENOL.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and allergies were not reported. Concomitant therapies were not provided. On 13-JUL-2016, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB "10 microgram/1 ml, 10X1 DS/V TF" with lot number L042846 and expiration date of 15-SEP-2017, (dosage schedule, route and anatomical location were not reported). On unspecified dates, the RECOMBIVAX HB had two temperature excursions of 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for 304 hours and 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for 40 hours (lowest recorded temperatures). The type of excursion and the storage criteria were reported as refrigerator (R) and the vaccine status in excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Migraine
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 19 year old female patient. Medical history and concurrent medications were not provided. On an unknown date the patient was vaccinated with GARDASIL 9. On an unknown date the patient experienced migraine and some redness and pain around the injection site. The outcome of the events was unknown. See case 1610USA005927 from the same reporter regarding the patient's 18 year old sister who experienced the same events. Addition information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 712 hours with lowest recorded temperature of 33 F (0.555555556 Celsius) and other one for 216 hours and lowest recorded temperature of 32 F (o Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has ben requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 14-APR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 680 hours with lowest recorded temperature of 33 F(0.555555556 Celsius) and other one for 32 hours with lowest recorded temperature of 32 F (0 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare provider, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored GARDASIL 9 (lot # M016193, expiration date 24-APR-2017) that were improperly stored (Temperature/Time frame: 49F for 1 hour and 48F for 1 hour). The vaccines did not experienced previous temperature excursions. The data logger was reported as Yes. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 712 hours with the lowest recorded temperature of 33 F (0.555555556 Celsius) and other one for 32 hours with lowest recorded temperature of 32 F (0 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". 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: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had four temperature excursions; one for 712 hours with lowest recorded temperature of 33 F (0.555555556 Celsius), other one for 216 hours with lowest recorded temperature of 32 F (Celsius) other one for 64 hours with lowest temperature of 34 F (1.11111111 Celsius) and other one for 64 hours with lowest recorded temperature of 31 F (-0.555555556 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". 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: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 14-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 32 hours with lowest recorded temperature of 32 F (0 celsius) and other one for 712 hours with lowest recorded temperature of 33 F (0.555555556 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". 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: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 06-APR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 488 hours with the lowest recorded temperature of 33 F (0.555555556 Celsius) and other one for 32 hours with lowest recorded temperature of 32 F (0 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 68 year old female patient of unknown age The patient's concurrent conditions, medical history and concomitant medications were not provided. On 13-DEC-2010, the patient was vaccinated with the first dose of ZOSTAVAX subcutaneous (Lot number, expiration date and dose were not provided). On 02-NOV-2012, the patient received a second dose of ZOSTAVAX (Lot number reported as HD11332 expiration date 08-SEP-2013) dose and route were not provided. On an unspecified date in July 2014, the patient experienced shingles. The reporter stated that they reviewed the patient's record on an unspecified date and learned of the second dose of ZOSTAVAX. At the time of the report, the outcome of herpes zoster was reported as recovered/resolved (also reported as "the patient was alive and well"). The reporter did not assess the causal relationship between the adverse event and the vaccination with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse referring to a unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medications were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored GARDASIL 9 lot # L020015 with expiration date: 16-AUG-2017 and lot# L043214 expiration date: 30-AUG-2017 (dose and route were not provided). No adverse event was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Wrong drug administered
Clinical narrative: I gave PEDIARIX and Hepatitis B. I should have given Hib (PEDVAX) instead of Hep B.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Musculoskeletal discomfort, Myalgia
Clinical narrative: Deltoid with erythema, warmth, tenderness to palpation. Treated for cellulitis with antibiotics.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant via representative for immunization program referring to unspecified multiple patients of unknown age and gender. On unknown dates in October 2016, the patients were vaccinated with doses of PROQUAD (lot # M031567, expiration date 24-DEC-2017, dose, route not provided). That vaccine had been maintained at proper temperatures except there was missing data from data logger for one week in October 2016 and unspecified doses might have been administered with no adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-APR-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported). On unspecified dates, the PNEUMOVAX 23 had four temperature excursions of 32 Fahrenheit (F) Degrees (0 Celsius) for 152 hours, 31 Fahrenheit (F) Degrees (-0.555555556 Celsius) for 32 hours, 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for 88 hours, and 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for 40 hours (lowest recorded temperatures). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor was product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 712 hours with lowest recorded temperature of 33 F (0.555555556 celsius) and other one for 216 hours with lowest recorded temperature of 32 F (0 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 13-OCT-2016 from a medical assistant who reported that multiple unspecified patients were inadvertently administered improperly stored vaccines from 08-SEP-2016 to 12-OCT-2016. The vaccines involved were VAQTA, OMPC PEDVAX, RECOMBIVAX, ROTATEQ (lot number and expirations not provided). Temperature was 15 C for 3 hours and 40 minutes as per data logger. No adverse effects reported. Additional information not expected. No additional information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: This spontaneous report was received from currently 66-year-old female nurse, who was reporting on herself via a company representative. No information regarding the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, (reported as "at the age of 60"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). The patient was unsure how the vaccine was stored and at the time of the report she wanted to receive a second dose  of ZOSTAVAX. The patient asked what are the side effects of receiving a second dose of ZOSTAVAX. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Injection site discomfort, Injection site mass, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 11-year-old male patient who received BEXSERO (batch number 148901B, expiry date 30th September 2016). On 26th February 2016, the patient received 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, less than a week after receiving BEXSERO, the patient experienced injection site lump, injection site warmth, injection site swelling, injection site tenderness, injection site rash, injection site discomfort and joint range of motion decreased. The patient was treated with ibuprofen and no-drug therapy (Cold Compresses). On and unknown date, the outcome of the injection site lump, injection site warmth, injection site swelling, injection site tenderness, injection site rash, injection site discomfort and joint range of motion decreased were recovered/resolved. It was unknown if reporter considered injection site lump, injection site warmth, injection site swelling, injection site tenderness, injection site rash, injection site discomfort and joint range of motion decreased to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO vaccine in the left arm. On 2nd March 2016, the patient was seen in office due to local reactions consisting of pain, lump, swelling, rash and difficulty with range of motion and no fluctuance was observed. The physician assessment about the events were local vaccine response. The event were managed with Ibuprofen initially 300 gm weaning back as arm pain settled. Gentle massages and ranging were given to the patient as tolerated. He was also treated with topical cool compresses frequently. The physician had asked the patient to call if the events were not improving and no contraindication were suggested for future vaccines. After patient's reaction to 2nd dose of BEXSERO (see case US2016123683) it was brought to reporter's attention that he had a reaction to the 1st dose as well.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Injection site warmth, Joint range of motion decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 11-year-old male patient who received BEXSERO (batch number 148901B, expiry date 30th September 2016). On 26th February 2016, the patient received 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, less than a week after receiving BEXSERO, the patient experienced injection site lump, injection site warmth, injection site swelling, injection site tenderness, injection site rash, injection site discomfort and joint range of motion decreased. The patient was treated with ibuprofen and no-drug therapy (Cold Compresses). On and unknown date, the outcome of the injection site lump, injection site warmth, injection site swelling, injection site tenderness, injection site rash, injection site discomfort and joint range of motion decreased were recovered/resolved. It was unknown if reporter considered injection site lump, injection site warmth, injection site swelling, injection site tenderness, injection site rash, injection site discomfort and joint range of motion decreased to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO vaccine in the left arm. On 2nd March 2016, the patient was seen in office due to local reactions consisting of pain, lump, swelling, rash and difficulty with range of motion and no fluctuance was observed. The physician assessment about the events were local vaccine response. The event were managed with Ibuprofen initially 300 gm weaning back as arm pain settled. Gentle massages and ranging were given to the patient as tolerated. He was also treated with topical cool compresses frequently. The physician had asked the patient to call if the events were not improving and no contraindication were suggested for future vaccines. After patient's reaction to 2nd dose of BEXSERO (see case US2016123683) it was brought to reporter's attention that he had a reaction to the 1st dose as well.
Sex: U
Vaccine: HPV9, MEN, TDAP
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a registered nurse via company representative and refers to an unspecified number of adolescent patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 injection (dose, route of administration, lot# and expiry date were not reported). Other suspect therapies included TDAP and (dose and route of administration were not reported for any of the suspect vaccines). All suspect vaccines were administered at the same time. On an unknown date, reported as 15 minutes after receiving the vaccines, the patient felt faint and lightheaded, and some of them might have fainted in the office. The patients sought medical attention. The patients recovered from the events on unspecified dates. The relatedness between the events and the suspect vaccines was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Migraine
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 18 year old female patient. Medical history and concurrent medications were not provided. On an unknown date the patient was vaccinated with GARDASIL 9. On an unknown date the patient experienced migraine and some redness and pain around the injection site. The outcome of the events was unknown. See case 1611USA000927 from the same reporter regarding the patient's 19 year old sister who experienced the same events. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 21-MAY-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported). On unspecified dates, the PNEUMOVAX 23 had four temperature excursions of 32 Fahrenheit (F) Degrees (0 Celsius) for 152 hours, 31 Fahrenheit (F) Degrees (-0.555555556 Celsius) for 32 hours, 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for 248 hours, and 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for 40 hours (lowest recorded temperatures). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor was product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, the patients received an improperly stored doses of ZOSTAVAX (lot # L036823 with expiration date: 24-DEC-2016 and lot # L032397 with expiration date: 26-NOV-2016; dose and route of administration were not reported). The administered doses of vaccine were exposed to a temperature of 27 Fahrenheit (F) degrees for 30 minutes. No previous temperature excursions were reported. It was unknown if data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: F
Vaccine: HPV9
Symptoms: Chest pain, Dizziness, Dyspnoea, Eructation, Headache
Clinical narrative: This spontaneous report was received from a nurse regarding a 17 year old female patient. The patient's medical history included nausea in May 2016 (on an unspecified date) and ear disorder (on unspecified dates). No known drug allergies. On 27-JUL-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot# unknown) intramuscularly in her left arm. The patient had no concomitant therapies. The patient experienced chest pain and shortness of breath immediately after receiving GARDASIL 9. In the evening of 27-JUL-2016, the patient experienced left sided chest pain along her sternal border that was not sharp (pain scale of 3 out of 10 on an unspecified pain scale) for 4 seconds "while sitting on the couch". On 28-JUL-2016, the patient was seen by the physician and had shoulder discomfort, dizziness, headache, light sensitivity, increase in burping (no throat burning or vomit), no fever and no chest pain. The patient did not receive any treatment for the events. On 29-JUL-2016, the patient had an X-ray at an unspecified facility that was "negative" in unspecified findings. The patient experienced the symptoms "on and off" again over two and half months with no specifics on which symptoms and no specific dates. The patient has an appointment for follow-up with physician on 15-OCT-2016. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Musculoskeletal discomfort, Photophobia, X-ray normal
Clinical narrative: This spontaneous report was received from a nurse regarding a 17 year old female patient. The patient's medical history included nausea in May 2016 (on an unspecified date) and ear disorder (on unspecified dates). No known drug allergies. On 27-JUL-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot# unknown) intramuscularly in her left arm. The patient had no concomitant therapies. The patient experienced chest pain and shortness of breath immediately after receiving GARDASIL 9. In the evening of 27-JUL-2016, the patient experienced left sided chest pain along her sternal border that was not sharp (pain scale of 3 out of 10 on an unspecified pain scale) for 4 seconds "while sitting on the couch". On 28-JUL-2016, the patient was seen by the physician and had shoulder discomfort, dizziness, headache, light sensitivity, increase in burping (no throat burning or vomit), no fever and no chest pain. The patient did not receive any treatment for the events. On 29-JUL-2016, the patient had an X-ray at an unspecified facility that was "negative" in unspecified findings. The patient experienced the symptoms "on and off" again over two and half months with no specifics on which symptoms and no specific dates. The patient has an appointment for follow-up with physician on 15-OCT-2016. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Joint range of motion decreased, Tendon injury, X-ray
Clinical narrative: Upper L arm very sore and is still sore all the time. During sleep, pain increases and arm "goes to sleep" numbness, loss of range of motion (after 5 mos.).
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant via representative for Immunization program referring to unspecified multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with unspecified doses of GARDASIL 9 (lot # M016193, expiration date 24-APR-2018, dose, route not provided), which were improperly stored since December 2015. Medical assistant stated doses reached 49.6 F but medical assistant unable to quantify all excursion. Data logger: Y. Medical assistant brought office manager to phone who stated no adverse effects had been reported to the office of doses that were administered. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a medical assistant via representative for Immunization program referring to unspecified multiple patients of unknown age and gender. On unknown dates in October 2016, the patients were vaccinated with doses of VARIVAX (lot # M009765, expiration date 23-FEB-2018, dose, route not provided). That vaccine had been maintained at proper temperatures except there was missing data from logger for one week in October 2016 and unspecified doses might have been administered with no adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant via representative for Immunization program referring to unspecified multiple patients of unknown age and gender. On unknown dates in October 2016, the patients were vaccinated with doses of M-M-R II (lot # L037356, expiration date 28-SEP-2017, dose, route not provided). That vaccine had been maintained at proper temperatures except there was missing data from data logger for one week in October 2016 and unspecified doses might have been administered with no adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route of administration, anatomical location, lot # and expiration date were not provided). On an unknown date, after receiving PNEUMOVAX 23, the patient developed swelling in the arm. It was unknown if any treatment for adverse event was given or if the patient had any lab diagnostic studies performed. The outcome of the adverse event was unknown. The patient sought an unspecified medical attention. The relatedness between the adverse event and PNEUMOVAX 23 was not reported. 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 multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored with VARIVAX, injection, lot # L017146, expiry date 13-MAY-2017 and lot # L035127, expiry date 14-SEP-2017 (dose, route and site of administration were not reported). No adverse were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date of 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 712 hours with lowest recorded temperature of 33 F (0.555555556 Celsius) and other one for 216 hours with lowest recorded temperature of 32 F (0 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practice nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unspecified dates the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L035880 (expiration date: 11-AUG-2018) or lot # M006710 (expiration date: 06-DEC-2018) (doses and routes of administration were not reported). There was no adverse effect reported. Administered doses of vaccines had been stored at the temperature of 0.5 Celsius degrees for 1 month and of 0.6 Celsius degrees for 2.5 months. Data logger was involved. There were no previous temperature excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Somnolence, Unresponsive to stimuli
Clinical narrative: This case was reported by a physician and described the occurrence of unresponsive to stimuli in a 3-year-old male patient who received BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced unresponsive to stimuli (serious criteria GSK medically significant), injection site pain, injection site swelling and somnolence. On an unknown date, the outcome of the unresponsive to stimuli, injection site pain, injection site swelling and somnolence were unknown. It was unknown if the reporter considered the unresponsive to stimuli, injection site pain, injection site swelling and somnolence to be related to BEXSERO. Additional details were provided as follows: Patient's previous vaccination included 1st dose of BEXSERO. Right after vaccination with 2nd dose, of BEXSERO, the patient experienced pain, swollenness of the injection site, somnolence and non responsiveness to external stimulus. Further follow up would be requested.
Age: 89.0
Sex: M
Vaccine: FLU4, PNC13, FLUX, PNC13
Symptoms: Rash
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016464365) on 21-Oct-2016. This case involves a 89-year-old male patient who was vaccinated with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (FLU VACCINE) (batch number: UI443AA, expiry date, dose, dose in series not reported) in left arm and PREVNAR 13 (batch number: L99273, expiry date: Feb-2017, dose, dose in series not reported) in right arm on 01-Oct-2015. Patient had medical history of dementia, Skin cancer (over seven years skin cancer on face history of skin cancer surgeries), stroke, short term memory loss (related to stroke) and breaking out from bandaid use. Concomitant medications were not reported. On an unknown date of Oct-2015, following the vaccination, patient developed a rash on his arm. It was also reported that it was looked like a rash caused by injection. Lab test was not reported. Patient had been treated with cortisone 10 cream. The outcome of the events was reported as not recovered on an unknown date. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthropathy, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity, Swelling
Clinical narrative: Painful arm (left).
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tendonitis, X-ray
Clinical narrative: Painful arm (left).
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Painful arm (left).
Age: 58.0
Sex: U
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Herpes zoster
Clinical narrative: Initial unsolicited report received from a nurse on 24 October 2016. This case involves a 58-years-old patient (gender not reported) who was vaccinated with INFLUENZA VACCINE (Flu Shot) and PREVNAR 13 (lot number, expiration date, dose, dose in series, route and site of administration were not reported for both vaccine) on 20 September 2016. The medical history and concomitant medications were not reported. On an unspecified date within two weeks following vaccination, the patient came down with shingles. Laboratory test and the corrective treatment were not reported. The outcome of the event was not reported. Upon internal review the case was considered as serious because of important medical event: shingles. List of the documents held by sender: none.; Sender's Comments: This case concerns a 58 year old patient who developed shingles after receiving FLU SHOT simultaneously with PREVNAR 13 vaccine. Details regarding medical history of the patient, vaccination history, concomitant medications, immune status of the patient and reporter causality were not reported. However details regarding medical history, concurrent conditions, patient immune status at the time of vaccination and other etiologies would be helpful to further assess this case. Based on the available information, role of particular vaccine cannot be assessed since multiple vaccines were administered simultaneously.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported swelling, redness and warm to touch in area where vaccine administered. Appears to be tracking down arm. Both vaccinations administered in (L) deltoid due to patient history of right side mastectomy.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported swelling, redness and warm to touch in area where vaccine administered. Appears to be tracking down arm. Both vaccinations administered in (L) deltoid due to patient history of right side mastectomy.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer referring to her currently 67 year old husband. On an unknown date the patient was vaccinated with ZOSTAVAX (19400 PEU; strength, dosage, frequency and route unspecified). On an unknown date the patient developed a terrible case of shingle, which had required "multiple" unspecified treatments. The patient sought medical attention. Lots of lab diagnostic studies were performed. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Laboratory test
Clinical narrative: Information has been received from a consumer referring to her currently 67 year old husband. On an unknown date the patient was vaccinated with ZOSTAVAX (19400 PEU; strength, dosage, frequency and route unspecified). On an unknown date the patient developed a terrible case of shingle, which had required "multiple" unspecified treatments. The patient sought medical attention. Lots of lab diagnostic studies were performed. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reports pain in her arm and states she is having trouble lifting her arm.
Age: 74.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reports pain in her arm and states she is having trouble lifting her arm.
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Abdominal pain upper, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Severe stomach cramping, fever, diarreha, vomiting lasting more than 24 hours; no treatment.
Age: 87.0
Sex: F
Vaccine: PNC
Symptoms: Gait disturbance, Pharyngeal oedema, Swelling face, Urticaria
Clinical narrative: Could hardly talk, could not take meds. Throat swelled. Throat better toward evening.  Woke on 10/18/2016 with lips and lower face swollen and hives begin-ning throughout body. To urgent care.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain in left arm, unable to move left arm, hand numbness and tingling.