chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Woke up next morning after shots & pts (L) arm is swollen from elbow to shoulder, has a red tent and keeps a fever.
Age: 4.0
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner professional refers to a 4 years old pediatric patient. On 18-MAY-2012, the patient was vaccinated with dose 1 GARDASIL instead of Polio vaccine due to a human error. It was unknown if the patient had sought medical attention. No adverse effect reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Nausea, Weight decreased
Clinical narrative: This spontaneous report as received from a nurse (L.P.N.) refers to an approximately 14 years old female patient with none of pertinent Medical History, none of drug Reactions/Allergies. The patient was vaccinated with dose 1, 0.5 ml GARDASIL (lot number reported as 0475AE, exp date: 13-DEC-2014) on 13-AUG-2012. No other co-suspects were reported. Concomitant medications included ANAPROX and BACTROBAN. The patient has lost 13 pounds in 15 days following vaccination (date unspecified). Patient experienced loss of appetite and nausea. Patient had called the office. No treatment was given. No lab diagnostics studies performed. The outcome of lost 13 pounds in 15 days following vaccination, loss of appetite and nausea were unknown. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: HIBV, PPV, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker concerning a 60 day old infant patient who on 27-APR-2012 might have been inadvertently administered a dose of PNEUMOVAX 23 (Lot#, dose and route not reported) instead of PREVNAR. The reporter was unsure if this did indeed happen and the administration of PNEUMOVAX 23 vaccine to this infant could not be ruled out. No adverse effect reported. It was not known if the patient sought for medical attention. Follow up information has been received from medical assistant refers to a 60 day old female patient who on 27-APR-2012 was vaccinated with a dose of PNEUMOVAX 23 (dose and duration not reported) (lot # reported as F89912). On the same day the patient received a dose of LIQUID PEDVAXHIB (dose, route not reported) lot # reported as 1475AA, a dose of ROTATEQ (dose and route not reported) lot# reported as 0529AA, and a dose of PEDIARIX. The medical assistant stated that the office used an electronic records system. The office had scheduled vaccines for the patient at 2, 4 and 6 months and pre-entered the lot numbers of the vaccines into the system. The medical assistant stated that the pediatric nurse who administered the vaccines to the patient may had inadvertently entered PNEUMOVAX 23 instead of PREVNAR when she was documenting the vaccine that was administered. The medical assistant stated that they are "pretty sure" the patient received the PREVNAR vaccine and not PNEUMOVAX 23. The medical assistant stated that the patient was in the office in June 2012 and was fine at that time. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age with thyroid condition and no drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (Lot # 0566AE, expiration date 01-APR-2013) SC on 18-SEP-2012. No other co-suspects were reported. Concomitant medications included LEVOXYL. The pharmacist reported that on an unknown date, the patient experienced a small red rash at the injection site. The pharmacist recommended her BENADRYL and ADVIL. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 70 years old female patient with no pertinent medical history and allergy to "statins" and epinephrine who on 11-SEP-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number not reported) at zoster clinic. Concomitant medications included unspecified medications that the patient had been on a long time, nothing new. The licensed practical nurse reported that on 12-SEP-2012, the patient noticed a pin pricking sensation all over her body. The patient had an office visit that same day, on 12-SEP-2012, where physician decided to observe the patient. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for the patient noticed a pin picking sensation all over body was unknown for ZOSTAVAX. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 78 years old male physician with no pertinent medical history and no drug reactions or allergies reporting on himself. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) on 15-JAN-2008. No other co-suspects were reported. Concomitant medications included atenolol, cholestyramine resin, simvastatin (manufacturer unknown), NEXIUM, hydrochlorothiazide (manufacturer unknown) and an unspecified herbal medicine. The physician reported that on 17-SEP-2008 he developed mild herpes zoster on his left arm. He also reported that he recently developed on an unknown date, a worse case of herpes zoster on his right lower leg. The patient sought unspecified medical attention. The patient was treated with valacyclovir hydrochloride. There were no Lab diagnosis or studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 68 years old female patient with no pertinent medical history and no drug reactions or allergies. The patient's medical history included shingles. The patient was vaccinated with a dose of ZOSTAVAX (Lot # H011049 expiration date 05-AUG-2013) SC on 10-SEP-2012. No other co-suspects were reported. Concomitant medications included: metoprolol. The nurse reported that on 15-SEP-2012, the patient developed a rash on her right torso that looks like shingles. The patient did not receive treatment for the adverse event. The outcome of rash on her right torso that looks like shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 48 years old female patient. The patient was vaccinated with ZOSTAVAX (lot # and dose not reported) on 02-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 02-AUG-2012 the patient experienced red, sore area, raised and swollen at the injection site. The patient sought unspecified medical attention-called the pharmacist. No treatment was given. The outcome of patient was not reported. The reporting pharmacist did not assess the causality of the events. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: This spontaneous report as received from a physician refers to a 65 years old male patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # and dose not reported) on 18-DEC-2009. No other co-suspects were reported. There were no concomitant medications. On 23-JUL-2012 the patient was having joint and muscle pain from knees to groin area. No treatment was given for the events. The patient sought unspecified medical attention. The outcome of joint and muscle pain from knees to groin area was unknown. The relatedness for the reported events was unknown for ZOSTAVAX. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Grip strength decreased, Hypoaesthesia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male physician of unknown age with diabetes and Parkinson's disease who on 30-AUG-2012, was vaccinated SQ with a dose of ZOSTAVAX (dose and lot # not reported). It was reported that the physician developed numbness of his left hand and arm on 31-AUG-2012 on awakening. The numbness had continued and the physician had difficulty holding things with his left hand. The physician was currently seeing patients and planned to contact his unspecified primary care physician. The physician did not seek medical attention and did not receive any treatment. At the time of the report, the physician had not recovered. The relatedness for numbness of his left hand and arm and difficulty holding things with the left hand was unknown for ZOSTAVAX. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning a child who on 14-AUG-2012, was vaccinated with a dose of M-M-R II (lot# 1251AA, exp 01-AUG-2013). The nurse stated that the child might have been vaccinated with improperly stored M-M-R II. M-M-R II was exposed to 68 F for 9 hours and then on Wednesday last week "on 15-AUG-2012", the temperature went to 48F for 1 hour. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 04-SEP-2012. Lot# was reported as 0709AE, expiration date: 04-JAN-2014. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reports received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008613, 1209USA008614. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner refers to a female patient of unknown age who on 21-AUG-2012 was vaccinated with an expired dose of ZOSTAVAX (dose and route not reported), lot # 671020/0746AA, exp date 18-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a male patient of unknown age who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient developed red bumps following receipt of a dose of ZOSTAVAX. No treatment information was reported. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 20-AUG-2012. Lot# was reported as 0493AE, expiration date: 08-DEC-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6 C for total of 19 hours (2 excursions), -4.8 C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reported received from same source. 1209USA00725, 1209USA008597, 1209USA008598, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (Merck) (lot # 668253/0926Z; Expiry date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 03-SEP-2012. Lot# was reported as 0709AE, expiration date: 04-JAN-2014. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reports received from same source. 1209USA007525 1209USA008597 1209USA008598 1209USA008599 1209USA008600 1209USA008601 1209USA008602 1209USA008603 1209USA008604 1209USA008605 1209USA008606 1209USA008607 1209USA008608 1209USA008609 1209USA008611 1209USA008612 1209USA008613 1209USA008614. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report was received from a 63 year old registered nurse regarding herself. The patient concurrent conditions included diabetes, cancer, penicillin allergy and tetanus toxoid allergy. The patient was vaccinated with ZOSTAVAX (lot # not reported), 0.65 ml intramuscularly on 06-SEP-2012 instead of subcutaneously. Concomitant medications included FEMARA, lisinopril, amlodipine, calcium (unspecified), glucosamine, ursodiol, multivitamin and LEVEMIR. On 07-SEP-2012, the patient reported that she received ZOSTAVAX IM (intramuscularly) instead of SQ (subcutaneously) and experienced minimal site tenderness. No treatment was given, no laboratories diagnostic test were performed and the patient did not seek medical attention. The outcome of the event was reported as recovering at the time of this report. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from health care worker referring a 16 year old patient of unknown age who was vaccinated with a dose of ZOSTAVAX (lot # H009779, Exp 27-MAR-2013) (dose and route not reported) on 27-AUG-2012 inadvertently instead of VARIVAX. No adverse effects reported. Additional information not expected.
Age: 0.9
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant, concerning a 9 months old patient, who on 30-AUG-2012 was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (route, and frequency were not reported). There were not adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) 2-3 weeks ago (approximately on 24-AUG-2012). No other co-suspects were reported. No concomitant medications were reported. The physician reported that one week after the vaccination the patient developed shingles on the chest area. No treatment information was reported. The patient sought unspecified medical attention. The outcome of shingles on the chest was reported as recovering. The relatedness for shingles on the chest was not provided for ZOSTAVAX. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a 73 year old female patient regarding herself. The patient's concurrent conditions included diabetes, high blood pressure, edema and arthritis. The patient was vaccinated with ZOSTAVAX, Dose 1 injection, administered under the skin in the right arm on 01-SEP-2012. Concomitant medications included flu vaccine which was administered on 01-SEP-2012, metformin, "Glybaride", Lothartin", "Hydrochlorizide", "eye pill- vitamins for eye", "liver pill-over the counter", multivitamin, iron pills and aspirin (Bayer's aspirin 80mg daily). On 02-SEP-2012, the patient had a red hard lump that was warm and caused sore muscle type pain in and around the injection site after receiving ZOSTAVAX. The patient did not seek medical attention. The outcome of the event was unknown. Additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age who on an known date, was vaccinated with a dose of VARIVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that at unspecified time in the past after receiving VARIVAX the patient developed shingles. No treatment information was reported. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for patient developed shingles after receiving VARIVAX (merck) was unknown for VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. On 12-SEP-2012, the patient was vaccinated with expired ZOSTAVAX of lot number 670616/0617AA. Expiry date was provided as 26-JUL-2012. No concomitant medications were reported. The patient was not experiencing any known symptoms. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This report was received from Novartis and was assigned manufacturer report number PHEH2012US016500 refers to a patient of unknown age. The patient was vaccinated with M-M-R II (lot #, dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced swelling, redness, warmth at injection site. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. The original reporter is a nurse. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Pruritus generalised
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 52 years old female patient. The patient's medical history included: a reaction to injections containing mercury in the past and a reaction that caused 5 day long hospitalization from clindamycin in the past. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # not reported) subcutaneously "8 years ago", in approximately 2004. Concomitant medications included: LEVAQUIN. It was reported that the patient developed an allergic reaction where she began itching from her feet upward that spread over her whole body "8 years ago", in approximately 2004. And the patient sought for unspecified medical attention and unspecified lab diagnostic studies was performed. The reaction was effectively treated with BENADRYL. The outcome was reported as recovered. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 7 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient (id# 566) of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 02-SEP-2012. Lot# was reported as 0709AE, expiration date: 04-JAN-2014. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes." This is one of several reported received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 04-SEP-2012. Lot# was reported as 0709AE, expiration date: 04-JAN-2014. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (3 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursion) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reports received from same source. 1209USA007525 1209USA008597 1209USA008598 1209USA008599 1209USA008600 1209USA008601 1209USA008602 1209USA008603 1209USA008604 1209USA008605 1209USA008606 1209USA008607 1209USA008608 1209USA008609 1209USA008610 1209USA008611 1209USA008612 1209USA008614. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 04-SEP-2012.. Lot # was reported as 0709AE, expiration date: 04-JAN-2012. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), 04.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour 10 minutes." This is one of several reports received from the same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008612, 1209USA008613, 1209USA008614 Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 ON 04-SEP-2012. Lot# was reported as 0709AE, expiration date: 04-JAN-2014. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursions exposed to 18.4C for 1 hour and 10 minutes." This is one of several reports received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient (id# 925) of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 14-AUG-2012. Lot# was reported as 0087AE, expiration date: 18-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes." This is one of several reported received from same source: 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated a dose of VARIVAX (Merck) (0.5 ml one dose, Subcutaneous, lot # not reported) between 9 AM and 10 AM on 29-AUG-2012 and was inadvertently given an extra dose of VARIVAX (Merck) (lot # and dose not reported) at 4:25 PM on the same day on 29-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired (Merck) VARIVAX (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 28-AUG-2012. Lot # was reported as 0087AE, expiration date: 18-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information as reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, 0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reports received from same source. 1209USA007525 1209USA008597 1209USA008598 1209USA008599 1209USA008600 1209USA008601 1209USA008603 1209USA008604 1209USA008605 1209USA008606 1209USA008607 1209USA008608 1209USA008609 1209USA008610 1209USA008611 1209USA008612 1209USA008613 1209USA008614 Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 30-AUG-2012. Lot # was reported as 0493AE, expiration date: 08-DEC-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 8-0 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reports received from the same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614 Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 31-AUG-2012. Lot # was reported as 0709AE, expiration date: 04-JAN-2014. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), 04.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reports received from the same source. 1209USA007525 1209USA008597 1209USA008598 1209USA008599 1209USA008600 1209USA008601 1209USA008602 1209USA008603 1209USA008604 1209USA008605 1209USA008606 1209USA008608 1209USA008609 1209USA008610 1209USA008611 1209USA008612 1209USA008613 1209USA008614 Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 31-AUG-2012. Lot# was reported as 0493AE, expiration date: 08-DEC-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reports received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 31-AUG-2012. Lot # was reported as 0217AE, expiration date: 22-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hours). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8/3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes. This is one of several reports received from the same source. 1209USA007525, 1290USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient (id# 6426) of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 02-SEP-2012. Lot# was reported as 0709AE, expiration date: 04-JAN-2014. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 14-AUG-2012 to 28-AUG-2012, lowest temp excursion exposed at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reported received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient (id# 488) of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 29-AUG-2012. Lot# was reported as 0217AE, expiration date: 22-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reported received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient (id# 422) of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 24-AUG-2012. Lot# was reported as 0087AE, expiration date: 18-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reported received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a 67 years old female patient regarding herself with high blood pressure. The patient's medical history included MRSA (Methicillin-resistant staphylococcal aureus infection) after elbow surgery. On 25-MAY-2012, the patient was vaccinated with ZOSTAVAX (dosing details and the lot number were unspecified). Concomitant medications included lisinopril, hydrochlorothiazide, MAXZIDE, TRAVATAN, CELEXA, KLONOPIN and PRILOSEC. On an unknown date in June 2012, the patient experienced intermittent feeling of something biting her behind left ear and then the feeling moved to her right ear. One ear clears and then the feeling seemed to go further. It started with intense sting or bite to start. There was pain and then bumps came up. The itching began and then they disappeared. The reporter thinks that she had shingles. The consumer reported that she did not tell her physician yet or her family because she did not want them to think that she had "cooties". She gave blood every week and they never found anything wrong in her blood. She was advised to contact her physician. No medical attention was sought. As a treatment the patient received camphophenique. No laboratory test was performed. The events were reported as not recovered/not resolved (also mentioned as disappeared by the reporter). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensory disturbance
Clinical narrative: This spontaneous report as received from a 67 years old female patient regarding herself with high blood pressure. The patient's medical history included MRSA (Methicillin-resistant staphylococcal aureus infection) after elbow surgery. On 25-MAY-2012, the patient was vaccinated with ZOSTAVAX (dosing details and the lot number were unspecified). Concomitant medications included lisinopril, hydrochlorothiazide, MAXZIDE, TRAVATAN, CELEXA, KLONOPIN and PRILOSEC. On an unknown date in June 2012, the patient experienced intermittent feeling of something biting her behind left ear and then the feeling moved to her right ear. One ear clears and then the feeling seemed to go further. It started with intense sting or bite to start. There was pain and then bumps came up. The itching began and then they disappeared. The reporter thinks that she had shingles. The consumer reported that she did not tell her physician yet or her family because she did not want them to think that she had "cooties". She gave blood every week and they never found anything wrong in her blood. She was advised to contact her physician. No medical attention was sought. As a treatment the patient received camphophenique. No laboratory test was performed. The events were reported as not recovered/not resolved (also mentioned as disappeared by the reporter). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 21-AUG-2012. Lot# was reported as 0217AE, expiration date: 22-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reported received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 63 years old male patient. The patient was vaccinated with (Merck) VARIVAX (lot number, dose and route not reported) on 17-AUG-2012, accidentally. The patient's relevant medical history, concomitant medications, and past drug history were unknown. No other co-suspects were reported. No concomitant medications were reported. The patient was supposed to have been administered ZOSTAVAX, but was accidentally given (Merck) VARIVAX. It was unknown if there was any relevant laboratory data. As of 17-AUG-2012, the outcome of the patient receiving the (Merck) VARIVAX instead of ZOSTAVAX was unknown, and it was unknown if the consumer to receive an unknown dose of (Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient (id# 839) of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 15-AUG-2012. Lot# was reported as 0217AE, expiration date: 22-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reported received from same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot # 672675/0068AE, EXP 03-APR-2013) subcutaneous 0.5 ml on 19-SEP-2012 because only 0.5 ml could be withdrawn from a vial of ZOSTAVAX following reconstitution with the entire contents of the Diluent vial (lot number H013939). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. PQC is involved. This is one of several reports from the same source. Additional information is not expected.
Age: 1.14
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 18 months old female patient. The patient had no known pertinent medical history. On 16-MAY-2008 the patient was vaccinated with dose 1 (Merck) VARIVAX (lot# was unknown). On 03-OCT-2012, sometime post vaccination child, "when child was a little over a year old", she developed shingles, which was confirmed by the doctor. The patient was seen by the doctor to seek medical attention. Child was fully recovered. Additional information has been requested.