chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 40 year (reported as early 40's) old female patient. Pertinent medical history was unspecified by reporter. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (intramuscular, dose, route of administration and anatomical location was unknown). Concomitant medications included influenza virus vaccine (unspecified) (given in other arm, dose, and route of administration unknown). On an unknown date the patient experienced severe swelling at injection site with painful redness. The outcome of the events was unknown. The causality was unknown. No additional information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Erythema, Feeling abnormal, Injected limb mobility decreased, Neck pain
Clinical narrative: Started feeling some left arm, neck, back and thumb soreness 4-5 hours after getting imm. By late evening could not lift left arm. Yesterday had a fever most of the day and last night saw some redness on left arm. Is raised/"welty" Today arm is still sore but can move better. Right arm is a little sore (had flu shot in right arm). Feels "crummy". ST. Feels feverish but no elevated temp.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia, Swelling, Urticaria
Clinical narrative: Started feeling some left arm, neck, back and thumb soreness 4-5 hours after getting imm. By late evening could not lift left arm. Yesterday had a fever most of the day and last night saw some redness on left arm. Is raised/"welty" Today arm is still sore but can move better. Right arm is a little sore (had flu shot in right arm). Feels "crummy". ST. Feels feverish but no elevated temp.
Age: 0.67
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with VAQTA. Dose, route, lot number and expiration date were not reported. The health care worker reported that VAQTA was improperly stored and administered to unspecified number of patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history was unspecified by reporter. On 02-OCT-2014 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (dose, route of administration and lot number was unknown, expiry date: 11-JUN-2014). Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Local swelling, Ultrasound Doppler normal
Clinical narrative: This spontaneous report as received from a female Nurse patient of unknown age concerning herself. On 16-SEP-2014 (also reported as 2 days ago) the patient was vaccinated with PNEUMOVAX 23 lot # K007821; expiry: 06-JUN-2015, dose 1 in the right arm. No concomitant medications reported. Approximately on an unknown date in September 2014 the patient experienced swelling on arm, swelling looks cellulitic, arm is red and injection site so swollen that her right arm is 4 cm (centimeters) larger in circumference than her left arm. She stated that she received the dose two days ago. She stated that the injection site was so swollen, that her right arm was 4 cm larger in circumference than her left arm. She stated that she saw her physician and that they used a doppler to rule out a blood clot. She stated that she was started on KEFLEX. The nurse stated that this swelling looks cellulitic. The nurse stated that she would like to request a lot check on with lot K007821 expiry: 06-JUN-2015. She stated that she would like to be contacted concerning the results of the lot check by email or by a call on her cell phone. the outcome of arm is red, injection site so swollen that her right arm is 4 cm larger in circumference than her left arm and swelling on arm, swelling looks cellulitic is unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist, via a company representative, refers to a male patient of unknown age. The patient had a prior history of shingles before receiving ZOSTAVAX. No information on his concurrent conditions or concomitant drugs was provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, 1 injection, site and route of administration, lot#, expiration date unknown. It was reported that since receiving ZOSTAVAX the patient experienced two outbreaks of shingles (dates unspecified). The patient did not seek medical attention. Therapy with ZOSTAVAX was reportedly continued. The outcome of two outbreaks of shingles was unknown. Relatedness between use of ZOSTAVAX and the adverse event was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 year old female patient. No pertinent medical history was reported. On 27-SEP-2014, the patient was vaccinated with PNEUMOVAX23 1 injection, once, in left arm (lot # J009827 and expiration date was 10-AUG-2014). Concomitant medications was not reported. On 27-SEP-2014, she was accidentally gave an expired PNEUMOVAX23. She did not have any complaints when she left the pharmacy. It was unknown if there was any relevant laboratory data. As of 27-SEP-2014, it was unknown if she will receive PNEUMOVAX23 again. The outcome of giving the expired vaccine was unknown but she did not have any complaints when she left the pharmacy. The pharmacist stated that the patient was a walk-in and not referred by a physician. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. On unspecified date in the week of September 22, 2014 the patient was vaccinated with a single dose of ZOSTAVAX, 0.65 ml, subcutaneous, (lot number and expiration date not reported) On unspecified date in the week of September 22, 2014 the patient experienced a raised round red area at the injection site while using ZOSTAVAX. The patient did not seek medical attention. At the time of the report the outcome of a raised round red area at the injection site was unknown. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician (the patient's mother) refers to a 7 year old male patient. In 2010 (exact date unspecified) the patient was vaccinated with GARDASIL (0.5 ml, intramuscular, anatomical location, lot number were not reported) when he was 7 years of age. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unknown number of patients of unknown age and gender. Patients concurrent conditions and relevant medical history was no reported. On an unknown dates (since 2 weeks), unknown number of patients were vaccinated with improperly stored ZOSTAVAX (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 15-AUG-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: K001231, expiration date: 27-JAN-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 21-AUG-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: K001231, expiration date: 27-JAN-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a physician assistant via company representative to a 68 year old female patient. Pertinent medical history was unspecified by reporter. On 29-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K004483, expiry date: 16-AUG-2015, dose: 1 ml, route of administration was reported as IM or SQ). Concomitant medications were unspecified by reporter. On an unknown date the patient experienced cellulitis. The reporter was unable to provide any details regarding the event. The patient did seek medical attention with doctors (details unspecified). Antibiotics (details were unspecified) were given as a treatment for the event. The outcome of cellulitis was reported as recovering/resolving. The causality was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. The patient's medical history and current conditions are not reported. On 30-SEP-2014 the patient was vaccinated with ZOSTAVAX (lot # J007207 and expiry date 20-SEP-2014. It was reported that the patient was inadvertently administered an expired dose of ZOSTAVAX. No adverse events reported. Product quality complaint was not reported. The outcome of the event is unknown. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 year old female patient with allergy to codeine, ULTRAM, sulfa drugs and pneumonia. On 29-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K007822, expiry date: 15-AUG-2015, in the left arm, dose and route of administration was unknown). Other suspect therapies included influenza virus vaccine (unspecified) (vaccinated on 29-SEP-2014 in the left arm, dose and route of administration was unknown). The reporter stated that the patient received an unspecified pneumococcal vaccine (manufacturer unknown) previously on an unspecified date but did not experience a reaction from that administration. On 01-OCT-2014, the patient experienced 5 inches of redness near the injection sites which was very painful and itchy. The reporter also stated that the patient's scalp was also very itchy. Patient had called pharmacy and sought medical attention. BENADRYL and MOTRIN (dose and frequency unknown) was given as a treatment for the event. No lab tests were conducted. The outcome of the events was reported as not recovered/not resolved. The causality was unknown. No further information was provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 4 year old male patient (child). On 17-JUL-2014 at 09:12 am, the patient might have been immunized with a dose of PROQUAD lot number J015596, expiration date 05-JUN-2015, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to a patient of unknown age and gender. On 06-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (Lot# unspecified), injection, strength was reported as 25/0.5 Y (dose, frequency and route unspecified). The product expired on 16-JUL-2014. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 30-SEP-2014 the patient was vaccinated with PNEUMOVAX23 injection (dosing regimen unspecified). On 30-SEP-2014, the patient inadvertently administered 2 doses of PNEUMOVAX23. No adverse effect reported. The outcome of inadvertently administered 2 doses of PNEUMOVAX23 and no adverse effect reported is unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 4 year old (also reported as age 5, units not provided) female patient (child). On 28-APR-2014 at 4:49 pm, the patient might have been immunized with a dose of PROQUAD (Merck) lot number J015596, expiration date 05-JUN-2015, in the left thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Chills, Hyperventilation, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 14 year old female patient. The patient had no pertinent medical history and no previous drug reactions or allergies. On 04-AUG-2014, the patient was vaccinated with the first dose of GARDASIL lot # K005083, exp. date: 04-NOV-2016, 0.5 ml, intramuscularly (anatomical location was not reported). On the same day, 04-AUG-2014, the patient was vaccinated VAQTA, lot #K007791, exp. date: 22-AUG-2016, dose, route and anatomical location were not reported. At the time of vaccination the patient was not taking any medications but had recently weaned off of ACCUTANE. On 04-AUG-2014, later that evening, the patient experienced fever, hyperventilation, chills and nausea. The patient sought medical attention, he called to the office. No laboratory tests were performed. The reporter stated that there was no treatment given for the adverse events. The outcome of hyperventilation, chills, nausea and fever was reported as recovered on the same night, on 04-AUG-2014. The relatedness between vaccination with GARDASIL and VAQTA and the adverse events was not reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 81 year old female patient. The patient's medical history included tuberculosis for which she was treated "for a year or more". The reporting pharmacist could not clarify whether or not patient had any other disease states. On an unspecified date in approximately September 2008 also reported as "approximately 6 years ago", the patient was vaccinated with the first dose of PNEUMOVAX23 (route of administration, indication and lot # were not specified). After she was treated "for a year or more" for tuberculosis, she was prescribed to receive a second dose of PNEUMOVAX23 as recommended her physician. On 26-SEP-2014 also reported as "today", the patient was vaccinated with expired dose of PNEUMOVAX23 (second dose, route of administration was not specified (lot # H022280, exp date: 16-JUL-2014). The reporting pharmacist stated that when he looked at the expiration date on the vial, 16-JUL-2014, he initially thought the expiration date was the 14-JUL-2016. After the dose of PNEUMOVAX23 was administered to the patient and the pharmacist was documenting the administration, he realized that the date was actually referring to 16-JUL-2014. No adverse experience was observed or reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 55 year old female patient with drug reaction/allergies to codeine. No concurrent condition and medical history was reported. On 29-SEP-2014 the patient was vaccinated with PNEUMOVAX 23, inj 10 vials of 1 (lot# K004281 and expiration date 22-MAR-2014) (0.5ml), intramuscularly in the right arm. Concomitant therapies included amitriptyline hydrochloride, calcium, vitamin D, MAXALT, ZANTAC, naproxen and PROZAC. On 01-OCT-2014, the patient experienced red circular swelling around injection site after receiving PNEUMOVAX 23 and patient was diagnosed with cellulitis. The patient developed 2 to 3 red, circular swelling in the right arm where PNEUMOVAX 23 was administered. No diagnostic tests were reported. The patient did seek medical attention by visiting the office. The treatment of MEDROL DOSE PAK and KEFLEX was given for all the events. The outcome of all the events was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with COMVAX. Dose, route, lot number and expiration date were not reported. The health care worker reported that COMVAX was improperly stored and administered to unspecified number of patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 2 year old male patient. On 09-JAN-2014 at 12:17 pm, the patient might have been immunized with a dose of PROQUAD (Merck) lot number J005179, expiration date 03-NOV-2014, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with (Oka-Merck) PROQUAD which was exposed to unknown temperatures out of the recommended for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 4 year old female patient (child). On 10-JAN-2014 at 8:48 am, the patient might have been immunized with a dose of (Oka-Merck) PROQUAD lot number J005179, expiration date 03-NOV-2014, in the right thigh (dose number and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with (Oka-Merck) PROQUAD which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 4 year old (also reported as age 5, units not provided) female patient (child). On 25-MAR-2014 at 4:21 pm, the patient might have been immunized with a dose of (Oka-Merck) PROQUAD lot number J0155596, expiration date 05-JUN-2015, in the left thigh (dose number, route and dose were not reported) which was not stored at the inappropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unknown demographics. The Patient's medical history and current conditions are not reported. On 30-SEP-2014, the patient was inadvertently administered (Oka/Merck) VARIVAX instead of ZOSTAVAX. The patient experienced no adverse effects. Product quality complaint was not reported. The outcome of the events is unknown. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with (Oka-Merck) PROQUAD which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 4 year old (also reported as age 5, units not provided) female patient (child). On 28-JUL-2014 2:36 pm, the patient might have been immunized with a dose of  (Oka-Merck) PROQUAD lot number K007158, expiration date 12-NOV-2015, in the right thigh (dose number, route and dose were not reported) which was not stored at the inappropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Abnormal dreams, Aggression, Chills, Disorientation, Feeling abnormal
Clinical narrative: Shoulder hurting at injection site, headache, chills, bad dreams. Next day, felt shaky and disoriented. 3 days later called doctor who provided no recommendations. Continue to feel shaky, chills, nightmares. Nightmares worsen over time, woke up screaming. It affected neurological system/feels poisoned. Temper changed, affected memory. Shocked that vax is given to children, read on the internet that it is forbidden in another country. Doctor did not given vax info before immunization.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Memory impairment, Nervous system disorder, Nightmare
Clinical narrative: Shoulder hurting at injection site, headache, chills, bad dreams. Next day, felt shaky and disoriented. 3 days later called doctor who provided no recommendations. Continue to feel shaky, chills, nightmares. Nightmares worsen over time, woke up screaming. It affected neurological system/feels poisoned. Temper changed, affected memory. Shocked that vax is given to children, read on the internet that it is forbidden in another country. Doctor did not given vax info before immunization.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Screaming, Tremor
Clinical narrative: Shoulder hurting at injection site, headache, chills, bad dreams. Next day, felt shaky and disoriented. 3 days later called doctor who provided no recommendations. Continue to feel shaky, chills, nightmares. Nightmares worsen over time, woke up screaming. It affected neurological system/feels poisoned. Temper changed, affected memory. Shocked that vax is given to children, read on the internet that it is forbidden in another country. Doctor did not given vax info before immunization.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified date, the patients were vaccinated with VARIVAX which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 22 year old female patient. On 28-JUL-2014 at 11:47 am, the patient might have been immunized with a dose of (Oka/Merck) VARIVAX lot number J009165, expiration date 24-JUL-2015, in the right upper arm (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding 5 year old female patient (child). On 29-JUL-2014 at 1:32 pm, the patient might have been immunized with a dose of PROQUAD (Merck) lot number K007158, expiration date 12-NOV-2015, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified, The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Age: 0.52
Sex: F
Vaccine: DTAP, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 7 month old female patient. There was no pertinent medical history and concomitant therapy reported. On 08-AUG-2014 the patient was vaccinated with the first dose of ROTATEQ (oral, dose, frequency and lot # not reported). On 08-JUL-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # J010985, expiration date 24-APR-2015, oral, dose and frequency not reported). On 08-AUG-2014 the patient was vaccinated with the third dose of ROTATEQ (lot # J015690, expiration date 14-OCT-2015, oral, dose and frequency not reported). The physician reported that on 23-SEP-2014 the patient had an adverse effect after receiving the third dose of ROTATEQ, it was reported that the adverse event was intussusception. The patient was taken to the emergency room (ER) but was not admitted (also reported as the adverse event (AE) occurred after the third dose). The patient was given unspecified treatment for the adverse event. The outcome of the event was reported as recovered (in an approximately September 2014). The relatedness between the event and ROTATEQ was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 25-SEP-2014, the patient was vaccinated inadvertently with GARDASIL dose 4, 0.5 ml, intramuscular. Lot number and expiration date were not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 07-FEB-2014 the patients were vaccinated with MMR II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pallor, Pyrexia, Rash generalised, Rash macular
Clinical narrative: Patient came for her routine 1 year well check-up. Received her MMR and Var vaccines. 1-2 days later developed 103 fevers x 2-3 days. Mom sought reevaluation at an urgent care center was noted to have macular generalized blanching rash.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 year old patient of an unknown gender. On an unknown date the patient was vaccinated with a third dose of VAQTA, (dose, route, lot number and expiration date not reported). No adverse effect reported. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PPV, TDAP, TTOX
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Dizziness and dyspnea.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema multiforme, Rash
Clinical narrative: Rash, erythema multiforme and diarrhea.
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Patient reports to the clinic on 4/4/2013 with a rash.
Age: 32.0
Sex: F
Vaccine: MEN
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Got shot at 2:30 pm and started developing itching, redness and swelling at injection site-swelling was at 8 cm diameter at 4:30 pm - was firm and warm to the touch. Started decreasing by 8:30 am after she was instructed to take our capsule of diphenhydramine. Today swelling is significantly decreased. No longer red or itching-probably local allergic reaction.
Age: 32.0
Sex: F
Vaccine: MEN
Symptoms: Injection site warmth
Clinical narrative: Got shot at 2:30 pm and started developing itching, redness and swelling at injection site-swelling was at 8 cm diameter at 4:30 pm - was firm and warm to the touch. Started decreasing by 8:30 am after she was instructed to take our capsule of diphenhydramine. Today swelling is significantly decreased. No longer red or itching-probably local allergic reaction.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 24-SEP-2014, the patient was vaccinated with ROTATEQ oral liquid (dose, lot number and expiration date not reported) which was improperly stored (hat was supported). No adverse effects reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified healthcare worker refers to a 24 year old female patient. No concurrent conditions or medical history were provided. On 02-OCT-2014 (reported as: yesterday), the patient was vaccinated with the first dose of GARDASIL injection, administered intramuscularly at a dose of 0.5 ml (lot # J007850 with expiry date: 07-APR-2016), that had been improperly stored at -13C. No concomitant medications were reported. The dose administered on 02-OCT-2014 was intended to be the patient's first dose of GARDASIL, but the dose would not be counted as valid. The plan of care for this patient was to administer a dose of GARDASIL to her on the day that she was scheduled to receive her second dose of vaccine. The dose administered on that day, on 02-DEC-2014 (reported as "two months from yesterday"), would be counted as the first dose in her GARDASIL series. The patient had not reported or demonstrated any adverse effects. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history was unspecified by reporter. On 03-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J004332, dose, route of administration and anatomical location was unknown) which was expired on 26-SEP-2014. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history was unspecified by reporter. On 30-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J004332, expiry date: 26-SEP-2014, dose: 0.5 ml, route of administration and anatomical location was unknown). Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 04-SEP-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: K003822, expiration date: 14-MAR-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Mobility decreased
Clinical narrative: (R) upper arm red, decreased mobility, redness extends around to back of arm.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 40 year (reported as early 40s) old female patient. Pertinent medical history was unspecified by reporter. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (intramuscular, dose, route of administration and anatomical location was unknown). Concomitant medications were unspecified by reporter. On an unknown date the patient experienced severe swelling at injection site with painful redness. The outcome of the events was unknown. The causality was unknown. No additional information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 14-AUG-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: K001231, expiration date: 27-JAN-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (dose, route and lot number were not provided). On an unknown date, the nurse reported that since unspecified date, improperly stored VARIVAX (Merck) (lot # J009726, expiry date: 07-AGU-2015) was administered to patients and no adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The nurse informed that on 28-AUG-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: K001231 expiration date: 27-JAN-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 07-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 lot # H013847 with expiration date: 15-MAR-2014, 0.5 ml, intramuscularly. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (dose, route and lot number were not provided). On an unknown date, the nurse reported that since unspecified date, improperly stored VARIVAX (Merck) (lot # K002045, expiry date: 10-FEB-2016) was administered to patients and no adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a medical assistant or nurse via a company representative refers to a 34 year old female patient. On 12-SEP-2012 the patient was vaccinated with PNEUMOVAX 23 subcutaneous (dose and lot# were not reported). Concomitant therapies included B-12 injection that was injected on the patient's right arm. On 12-SEP-2012, within 24 hours after the patient was vaccinated, she experienced significant pain, redness and swelling that included a rash (extended through most of her left arm) at the injection site of PNEUMOVAX 23. On unknown date the patient also experienced fever of 101 F that lasted for three days. Patient took TYLENOL and ALEVE on her own on unknown date. There were not laboratory studies performed. Patient did not seek medical attention; however a call was made to physician to inquired about the adverse events. The outcome of the events was unknown. Additional information is not expected due to the physician did not want to be contacted.
Sex: F
Vaccine: HPV4
Symptoms: Sinusitis
Clinical narrative: This spontaneous report as received from a consumer concerning her daughter, a female patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. On 19-MAR-2014 the patient was vaccinated with first dose of GARDASIL (lot number, dose and route unspecified). On 19-MAY-2014 the patient was vaccinated with second dose of GARDASIL (lot number, dose and route unspecified). Concomitant medications were not reported. On an unknown date in June 2014 the patient came down with sinus infection. The patient was treated with 3 day course of prednisone. The outcome of sinus infection is unknown. The causality of the event with GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 26-AUG-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: K001231, expiration date: 27-JAN-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was not reported. Approximately on an unknown date in 2011 (reported as three years ago), patient was vaccinated with first dose of GARDASIL (0.5 ml) (lot number unknown), intramuscular. On 23-SEP-2014 the patient was vaccinated with second dose of GARDASIL (0.5 ml) (lot number unknown), intramuscularly. Concomitant medications were not reported. No adverse events were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Additional information has been requested.