chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to a 4 weeks old white female patient. The patient had no pre-existing allergies, birth defects, medical conditions or illness at the time of vaccination. The patient's other pertinent medical history was not reported. On 03-FEB-2016 at 10:50, the patient was inadvertently vaccinated with the first dose of VAQTA 25/0.5 ml, lot number L032749, in right thigh (dose, route of administration and expiration date were not provided). The patient's concomitant medications were not reported. At the time of reporting (reported as so far), the patient experienced no adverse events. No product quality complaint was involved. No lab diagnostic studies were performed. This is one of two reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received form a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L037562, expiration date 29-SEP-2017;' Lot # L025205, expiration date 07-JUL-2017; dose and route were unknown). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Exposure via direct contact, Injection site extravasation
Clinical narrative: Information has been received from a pharmacist referring  to a patient of unknown age and gender The patient's concurrent and historical conditions were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, injection, site location, lot # and expiration date unknown) subcutaneously. Concomitant medication was not reported. The reporter stated that when the needle was removed, a drop of ZOSTAVAX came out of the injection site into the patient's skin. Outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # was reported as L040415, expiration date 13-APR-2017; lot# L040413, expiration date 13-APR-2017; lot# L007230, expiration date 03-SEP-2016; lot# L050907, expiration date 14-JUN-2017; dose and route was unknown). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Basophil count decreased, Basophil percentage, Blood thyroid stimulating hormone normal, Differential white blood cell count
Clinical narrative: Initial unsolicited report received from a nurse 5 August 2015. A 14-year-old male patient, concomitant medications was not reported, had received a dose of IMOVAX RABIES (batch number, expiry date, route and site of administration were not reported) on 27 July 2015 and continued post exposure series and received Imovax on day 7 of the series 31 July 2015. Patient also received a first dose of IMMUNOGLOBULIN HUMAN ANTIRABIES (HRIG) (batch number, expiry date, route and site of administration were not reported) 24 July 2015 and first dose of RABAVERT (batch number 556011A, expiry date, route and site of administration were not reported) intramuscularly on 24 July 2015. Illness at the time of vaccination was sinus, cold symptoms and feeling tired. Reported denies the patient pre-existing physician diagnosed allergies, birth defects, medical conditions. On 27 July 2015, i.e. same day after vaccination patient had experienced feeling fatigue and loss of energy. It was reported that, patient had required emergency room (ER). It was reported that patient was evaluated by physician who informed that not vaccine related and ordered blood work to determine cause of patient's symptoms and corrective treatments was not reported. At the time of this report, outcome of event was unknown. Documents held by sender: none. Follow up information received from a nurse on 3 September 2015. Patient had received 1 ml of Imovax rabies (lot number K1613) intramuscularly in left deltoid. Lab data included white blood cell (wbc) count 7.5 K/ul, red blood cell (rbc) count 5.22 m/ul, hemoglobin g/dl 14.5, hematocrit 44.1 percent, MCV 85 fl, MCH 27.8 pg, mchc 32.9 g/dl, rdw (Red cell distribution width) 12.1 percent, platelet count 372 k/ul, diff type automated, neutrophil 59 percent, lymphocytes 30, monocytes 8 percent, eosinophils 3 percent, basophils 0 percent, abs. neutrophils 4.4 k/ul, abs. lymphocyte 2.2 k/ul, Abs, monocytes 0.6 percent, abs. eosinophils 0.2 k/ul, abs. basophils 0.0 k/ul, Free T4: 1.23 NG/DL and Free T4: 1.23 NG/DL. Follow up report received from a nurse on 27 October 2015. It was reported that medical history, other medications, pre-existing physician diagnosed allergies, birth defects and medical conditions were none. The patient had received Rabies vaccine, day 14 on 5 August 2015. On 24 July 2015 patient went in emergency room for HRIG and rabies vaccine. On 15 August 2015 patient was recovered from the mentioned events. List of documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: RAB
Symptoms: Eosinophil count normal, Eosinophil percentage, Fatigue, Haematocrit normal, Haemoglobin normal
Clinical narrative: Initial unsolicited report received from a nurse 5 August 2015. A 14-year-old male patient, concomitant medications was not reported, had received a dose of IMOVAX RABIES (batch number, expiry date, route and site of administration were not reported) on 27 July 2015 and continued post exposure series and received Imovax on day 7 of the series 31 July 2015. Patient also received a first dose of IMMUNOGLOBULIN HUMAN ANTIRABIES (HRIG) (batch number, expiry date, route and site of administration were not reported) 24 July 2015 and first dose of RABAVERT (batch number 556011A, expiry date, route and site of administration were not reported) intramuscularly on 24 July 2015. Illness at the time of vaccination was sinus, cold symptoms and feeling tired. Reported denies the patient pre-existing physician diagnosed allergies, birth defects, medical conditions. On 27 July 2015, i.e. same day after vaccination patient had experienced feeling fatigue and loss of energy. It was reported that, patient had required emergency room (ER). It was reported that patient was evaluated by physician who informed that not vaccine related and ordered blood work to determine cause of patient's symptoms and corrective treatments was not reported. At the time of this report, outcome of event was unknown. Documents held by sender: none. Follow up information received from a nurse on 3 September 2015. Patient had received 1 ml of Imovax rabies (lot number K1613) intramuscularly in left deltoid. Lab data included white blood cell (wbc) count 7.5 K/ul, red blood cell (rbc) count 5.22 m/ul, hemoglobin g/dl 14.5, hematocrit 44.1 percent, MCV 85 fl, MCH 27.8 pg, mchc 32.9 g/dl, rdw (Red cell distribution width) 12.1 percent, platelet count 372 k/ul, diff type automated, neutrophil 59 percent, lymphocytes 30, monocytes 8 percent, eosinophils 3 percent, basophils 0 percent, abs. neutrophils 4.4 k/ul, abs. lymphocyte 2.2 k/ul, Abs, monocytes 0.6 percent, abs. eosinophils 0.2 k/ul, abs. basophils 0.0 k/ul, Free T4: 1.23 NG/DL and Free T4: 1.23 NG/DL. Follow up report received from a nurse on 27 October 2015. It was reported that medical history, other medications, pre-existing physician diagnosed allergies, birth defects and medical conditions were none. The patient had received Rabies vaccine, day 14 on 5 August 2015. On 24 July 2015 patient went in emergency room for HRIG and rabies vaccine. On 15 August 2015 patient was recovered from the mentioned events. List of documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: RAB
Symptoms: Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: Initial unsolicited report received from a nurse 5 August 2015. A 14-year-old male patient, concomitant medications was not reported, had received a dose of IMOVAX RABIES (batch number, expiry date, route and site of administration were not reported) on 27 July 2015 and continued post exposure series and received Imovax on day 7 of the series 31 July 2015. Patient also received a first dose of IMMUNOGLOBULIN HUMAN ANTIRABIES (HRIG) (batch number, expiry date, route and site of administration were not reported) 24 July 2015 and first dose of RABAVERT (batch number 556011A, expiry date, route and site of administration were not reported) intramuscularly on 24 July 2015. Illness at the time of vaccination was sinus, cold symptoms and feeling tired. Reported denies the patient pre-existing physician diagnosed allergies, birth defects, medical conditions. On 27 July 2015, i.e. same day after vaccination patient had experienced feeling fatigue and loss of energy. It was reported that, patient had required emergency room (ER). It was reported that patient was evaluated by physician who informed that not vaccine related and ordered blood work to determine cause of patient's symptoms and corrective treatments was not reported. At the time of this report, outcome of event was unknown. Documents held by sender: none. Follow up information received from a nurse on 3 September 2015. Patient had received 1 ml of Imovax rabies (lot number K1613) intramuscularly in left deltoid. Lab data included white blood cell (wbc) count 7.5 K/ul, red blood cell (rbc) count 5.22 m/ul, hemoglobin g/dl 14.5, hematocrit 44.1 percent, MCV 85 fl, MCH 27.8 pg, mchc 32.9 g/dl, rdw (Red cell distribution width) 12.1 percent, platelet count 372 k/ul, diff type automated, neutrophil 59 percent, lymphocytes 30, monocytes 8 percent, eosinophils 3 percent, basophils 0 percent, abs. neutrophils 4.4 k/ul, abs. lymphocyte 2.2 k/ul, Abs, monocytes 0.6 percent, abs. eosinophils 0.2 k/ul, abs. basophils 0.0 k/ul, Free T4: 1.23 NG/DL and Free T4: 1.23 NG/DL. Follow up report received from a nurse on 27 October 2015. It was reported that medical history, other medications, pre-existing physician diagnosed allergies, birth defects and medical conditions were none. The patient had received Rabies vaccine, day 14 on 5 August 2015. On 24 July 2015 patient went in emergency room for HRIG and rabies vaccine. On 15 August 2015 patient was recovered from the mentioned events. List of documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: RAB
Symptoms: Monocyte count normal, Monocyte percentage, Neutrophil count normal, Neutrophil percentage, Platelet count normal
Clinical narrative: Initial unsolicited report received from a nurse 5 August 2015. A 14-year-old male patient, concomitant medications was not reported, had received a dose of IMOVAX RABIES (batch number, expiry date, route and site of administration were not reported) on 27 July 2015 and continued post exposure series and received Imovax on day 7 of the series 31 July 2015. Patient also received a first dose of IMMUNOGLOBULIN HUMAN ANTIRABIES (HRIG) (batch number, expiry date, route and site of administration were not reported) 24 July 2015 and first dose of RABAVERT (batch number 556011A, expiry date, route and site of administration were not reported) intramuscularly on 24 July 2015. Illness at the time of vaccination was sinus, cold symptoms and feeling tired. Reported denies the patient pre-existing physician diagnosed allergies, birth defects, medical conditions. On 27 July 2015, i.e. same day after vaccination patient had experienced feeling fatigue and loss of energy. It was reported that, patient had required emergency room (ER). It was reported that patient was evaluated by physician who informed that not vaccine related and ordered blood work to determine cause of patient's symptoms and corrective treatments was not reported. At the time of this report, outcome of event was unknown. Documents held by sender: none. Follow up information received from a nurse on 3 September 2015. Patient had received 1 ml of Imovax rabies (lot number K1613) intramuscularly in left deltoid. Lab data included white blood cell (wbc) count 7.5 K/ul, red blood cell (rbc) count 5.22 m/ul, hemoglobin g/dl 14.5, hematocrit 44.1 percent, MCV 85 fl, MCH 27.8 pg, mchc 32.9 g/dl, rdw (Red cell distribution width) 12.1 percent, platelet count 372 k/ul, diff type automated, neutrophil 59 percent, lymphocytes 30, monocytes 8 percent, eosinophils 3 percent, basophils 0 percent, abs. neutrophils 4.4 k/ul, abs. lymphocyte 2.2 k/ul, Abs, monocytes 0.6 percent, abs. eosinophils 0.2 k/ul, abs. basophils 0.0 k/ul, Free T4: 1.23 NG/DL and Free T4: 1.23 NG/DL. Follow up report received from a nurse on 27 October 2015. It was reported that medical history, other medications, pre-existing physician diagnosed allergies, birth defects and medical conditions were none. The patient had received Rabies vaccine, day 14 on 5 August 2015. On 24 July 2015 patient went in emergency room for HRIG and rabies vaccine. On 15 August 2015 patient was recovered from the mentioned events. List of documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: RAB
Symptoms: Red blood cell count normal, Red cell distribution width normal, Thyroxine free normal, White blood cell count normal
Clinical narrative: Initial unsolicited report received from a nurse 5 August 2015. A 14-year-old male patient, concomitant medications was not reported, had received a dose of IMOVAX RABIES (batch number, expiry date, route and site of administration were not reported) on 27 July 2015 and continued post exposure series and received Imovax on day 7 of the series 31 July 2015. Patient also received a first dose of IMMUNOGLOBULIN HUMAN ANTIRABIES (HRIG) (batch number, expiry date, route and site of administration were not reported) 24 July 2015 and first dose of RABAVERT (batch number 556011A, expiry date, route and site of administration were not reported) intramuscularly on 24 July 2015. Illness at the time of vaccination was sinus, cold symptoms and feeling tired. Reported denies the patient pre-existing physician diagnosed allergies, birth defects, medical conditions. On 27 July 2015, i.e. same day after vaccination patient had experienced feeling fatigue and loss of energy. It was reported that, patient had required emergency room (ER). It was reported that patient was evaluated by physician who informed that not vaccine related and ordered blood work to determine cause of patient's symptoms and corrective treatments was not reported. At the time of this report, outcome of event was unknown. Documents held by sender: none. Follow up information received from a nurse on 3 September 2015. Patient had received 1 ml of Imovax rabies (lot number K1613) intramuscularly in left deltoid. Lab data included white blood cell (wbc) count 7.5 K/ul, red blood cell (rbc) count 5.22 m/ul, hemoglobin g/dl 14.5, hematocrit 44.1 percent, MCV 85 fl, MCH 27.8 pg, mchc 32.9 g/dl, rdw (Red cell distribution width) 12.1 percent, platelet count 372 k/ul, diff type automated, neutrophil 59 percent, lymphocytes 30, monocytes 8 percent, eosinophils 3 percent, basophils 0 percent, abs. neutrophils 4.4 k/ul, abs. lymphocyte 2.2 k/ul, Abs, monocytes 0.6 percent, abs. eosinophils 0.2 k/ul, abs. basophils 0.0 k/ul, Free T4: 1.23 NG/DL and Free T4: 1.23 NG/DL. Follow up report received from a nurse on 27 October 2015. It was reported that medical history, other medications, pre-existing physician diagnosed allergies, birth defects and medical conditions were none. The patient had received Rabies vaccine, day 14 on 5 August 2015. On 24 July 2015 patient went in emergency room for HRIG and rabies vaccine. On 15 August 2015 patient was recovered from the mentioned events. List of documents held by sender: none.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot # L045713, expiration date 14-JAN-2017; lot # L023936, expiration date 15-MAR-2017; dose was unknown) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored MMR II (lot # was reported as L028273, expiration date 28-JUL-2017; lot # L012479, expiration date 10-APR-2017; lot # L015279, expiration date 30-APR-2017; dose and route were unknown). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via direct contact, Injection site extravasation
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient's concurrent and historical conditions were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, injection site location, lot # and expiration date unknown) subcutaneously. Concomitant medication was not reported., The reporter stated that when the needle was removed, a drop of ZOSTAVAX came out of the injection site onto the patient's skin. Outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot # L040459, expiration date 06-APR-2017; lot# K010215, expiration date 05-MAY-2017; lot# K008931, expiration date 04-MAR-2017; dose and route were unknown). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot #L045711, expiration date 08-MAY-2017; lot# L023230, expiration date 28-JUL-2017; lot# L014415, expiration date 25-JUL-2017; dose and route were unknown). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L044694, expiration date 04-FEB-2018; lot # was reported as L040458, expiration date 04-FEB-2018; lot # L027733, expiration date 13-SEP-2017, lot # L033343, expiration date 13-SEP-2017; dose and route were unknown). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. On 10-MAR-2016 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # K019502, expiration date 04-FEB-2016) intramuscularly (dose was not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot # L023936, expiration date 15-MAR-2017; lot # L045713, expiration date 14-JAN-2017; dose and route were unknown). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to 3 patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Since 14-MAR-2016 the patients were vaccinated with doses of ROTATEQ which were improperly stored (dose unknown, lot# L027719, expiration date 28-APR-2017; lot# reported as L037291, expiration date 31-MAY-2017) orally. The vaccines were stored at 34.1F for 38 minutes and previously stored at 33.6F for 40 minutes. No adverse effects were reported. Lot# L037291 is an invalid lot number for ROTATEQ. Additional information has been requested.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a currently 90 year old male patient referring to himself. There was no medical history or drug reaction/allergies reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (1 shot, subcutaneous, dose and lot # were unknown). No concomitant therapy was reported. On an unknown date after administration, the patient developed rash. No treatment was given to  him. The patient sought unspecified medical attention on an unknown date. The outcome of the event was unknown. Additional information is not expected since the reporter refused to answer further questions and no contact information was provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (also reported as healthcare worker) and refers to a patient of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On 21-MAR-2016 the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # L050907, expiration date 14-JUN-2017, dose and route not specified). The vaccine was stored at 10 F for 45 minutes. No adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site cellulitis, Pain, Skin warm
Clinical narrative: Red, Hot, Sore subsequently developed cellulitis at injection site requiring antibiotic.
Age: 0.24
Sex: F
Vaccine: HIBV
Symptoms: Crying, Injection site erythema, Injection site swelling, Pyrexia, Screaming
Clinical narrative: Baby screamed a high pitched cry for 2.5 hours and was inconsolable. Leg swelled from hip to thigh and turned red on the side of the injection site. Low grade fever of 99.8.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site hard, red, swollen, and warm.  Possible early infection.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-MAR-2016 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (1350U, lot # L031068 with the expiration date 18-AUG-2017, dose and route were unknown). The patient's concomitant medication was not reported. No adverse effects reported. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (also reported as healthcare worker) and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 21-MAR-2016 the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # L040413, expiration date 13-APR-2017, dose and route not specified). The vaccine was stored at 10 F for 45 minutes. No adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with unspecified improperly stored doses of (Merck) VARIVAX (dose, unit and route not reported, Lot # L031066 with Exp. date 18-AUG-2017, Lot# L034367 with Exp. date 08-SEP-2017 and Lot# L020000 with Exp. date 02-JUN-2017). The vaccinates were exposed to 24.3 F for 2 hours 43 minutes. There was previous temperature excursion reported. For vaccinates with Lot# L031066, they had been exposed to 36.7 F for 18 hours 25 minutes or 21 hours 8 minutes in total. For vaccinates with Lot# L020000and Lot# L034367, they had been exposed to 36.7 F for 13 hours. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On unspecified dates the patients were vaccinated with improperly stored GARDASIL 9 (dosing regimen unspecified) (L020015, expiration 16-AUG-2017). Excursion details are as follows: temperature: 32F, time frame: 24 hours, there was no previous temperature excursion. It was back in range. It was a call because of a data logger. No adverse effect reported. Call disconnected before any additional information was obtained. No additional information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On unspecified dates the patients were vaccinated with improperly stored GARDASIL injection (dosing regimen unspecified) (K011562, expiration 08-APR-2017). Excursion details are as follows: temperature: 32F, Time frame: 24 hours, it was back in range. There was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. Call disconnected before any additional information was obtained. No additional information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Headache, Pain, Swelling
Clinical narrative: 03-16-16 Rec'd VARIVAX SC (RA). 03-17-16. Pt reports localized redness, soreness and swelling with 1 blister noted. By evening had bad headache. 03-18-16 Went to PMD for a annual exam. Pt still c/o of above symptoms-steroid injection given. 03-20-16-all symptoms gone.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus, Swelling
Clinical narrative: (R) upper arm with blanching/redness noted approx. 1/2 dollar size. Pt c/o itching- mild swelling which was improving remarkably. No evidence of cellulitis. Tx: Rest, ice and BENADRYL PRN. Pt declined and will continue to monitor.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling and redness to right deltoid region with an area of induration.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Headache, Pain, Swelling
Clinical narrative: 60 YOM with PMH T2DM received PREVNAR-13 vaccination on 11/18/2015 and reported having a very painful reaction with headache, erythema, and swelling the night of his vaccination.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a child patient who received PEDIARIX. On an unknown date, the patient received the 1st dose of PEDIARIX (intramuscular). On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. The reporter considered the fever to be almost certainly related to PEDIARIX. Additional details provided were as follows: The patient experienced high fever. Limited information was provided by the sale representative from the physician. This was 1 of 4 cases reported by the same reporter (US2016038398, US2016038402 and US2016038403).
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Blood test, Constipation, Dizziness, Nausea
Clinical narrative: Lower abdominal cramping, constipation, dizziness and nauseous for over 3 months without stopping.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Stool analysis, Ultrasound scan, Urine analysis, X-ray
Clinical narrative: Lower abdominal cramping, constipation, dizziness and nauseous for over 3 months without stopping.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a child patient who received PEDIARIX. On an unknown date, the patient received the 1st dose of PEDIARIX (intramuscular). On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. The reporter considered the fever to be almost certainly related to PEDIRIX. Additional details provided were as follows: The patient experienced high fever. Limited information was provided by the sales representative from the physician. This was 1 of the 4 cases reported by the same reporter (US2016038398, US2016038401 and US 20160384012).
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a child patient who received PEDIARIX (batch number UNKNOWN, expiry date unknown). On an unknown date, the patient received the 1st dose of PEDIARIX (intramuscular). On an unknown date, the dose was an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. The reporter considered the fever to be almost certainly related to PEDIARIX. Additional details provided were as follows: The patient experienced high fever. Limited information was provided by the sale representative from the physician. This was 1 of the 4 cases reported by the same reporter (US2016038398, US2016038401 and US2016038403).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses GARDASIL (dose and route were not reported, lot # K011325, expiration date 08-APR-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Biopsy muscle, Bone scan, Compartment syndrome, Computerised tomogram
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 18 year old female patient (reported as currently 19 year old). The patient had drug allergies to BACTRIM and possible prednisone (manufacturer unknown). No medical history was reported. On 17-FEB-2014, 06-MAY-2014 and 17-OCT-2014, the patient was vaccinated with 3 dose series of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included SUDAFED and BENADRYL for allergies. On an unknown date in January 2015, the patient experienced leg pain and was hospitalized and bilateral fasciotomy was performed on her calves due to compartment syndrome. It was unspecified when the patient was discharged. On 28-SEP-2015, the patient was again hospitalized for bilateral thigh and calf pain of unknown etiology and diagnostics ruled out a second case of compartment syndrome. On 08-OCT-2015, the patient was discharged from the hospital. On an unknown date the patient experienced bilateral numbness, weakness and significant pain of the thighs and depression and this caused the patient to delay her college career. On an unknown dates, the patient underwent computerized tomogram (CT), magnetic resonance imaging (MRI), bone scan and muscle biopsies and the results were not reported. The patient sought medical attention. The outcome of the events was reported as not recovered. The patient's pediatric orthopaedic surgeon suggested this condition (compartment syndrome which was life threatening) could be related to GARDASIL. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality complaint reported. The reporter considered leg pain, bilateral thigh and calf pain were serious due to hospitalization. The reporter considered compartment syndrome was serious due to hospitalization and life-threatening. The reporter considered bilateral numbness, weakness and significant pain of the thighs, depression and this caused the patient to delay her college career were serious due to disability. This case is linked to case # 1603USA011428 via same patient link. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Fasciotomy, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 18 year old female patient (reported as currently 19 year old). The patient had drug allergies to BACTRIM and possible prednisone (manufacturer unknown). No medical history was reported. On 17-FEB-2014, 06-MAY-2014 and 17-OCT-2014, the patient was vaccinated with 3 dose series of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included SUDAFED and BENADRYL for allergies. On an unknown date in January 2015, the patient experienced leg pain and was hospitalized and bilateral fasciotomy was performed on her calves due to compartment syndrome. It was unspecified when the patient was discharged. On 28-SEP-2015, the patient was again hospitalized for bilateral thigh and calf pain of unknown etiology and diagnostics ruled out a second case of compartment syndrome. On 08-OCT-2015, the patient was discharged from the hospital. On an unknown date the patient experienced bilateral numbness, weakness and significant pain of the thighs and depression and this caused the patient to delay her college career. On an unknown dates, the patient underwent computerized tomogram (CT), magnetic resonance imaging (MRI), bone scan and muscle biopsies and the results were not reported. The patient sought medical attention. The outcome of the events was reported as not recovered. The patient's pediatric orthopaedic surgeon suggested this condition (compartment syndrome which was life threatening) could be related to GARDASIL. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality complaint reported. The reporter considered leg pain, bilateral thigh and calf pain were serious due to hospitalization. The reporter considered compartment syndrome was serious due to hospitalization and life-threatening. The reporter considered bilateral numbness, weakness and significant pain of the thighs, depression and this caused the patient to delay her college career were serious due to disability. This case is linked to case # 1603USA011428 via same patient link. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 18 year old female patient (reported as currently 19 year old). The patient had drug allergies to BACTRIM and possible prednisone (manufacturer unknown). No medical history was reported. On 17-FEB-2014, 06-MAY-2014 and 17-OCT-2014, the patient was vaccinated with 3 dose series of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included SUDAFED and BENADRYL for allergies. On an unknown date in January 2015, the patient experienced leg pain and was hospitalized and bilateral fasciotomy was performed on her calves due to compartment syndrome. It was unspecified when the patient was discharged. On 28-SEP-2015, the patient was again hospitalized for bilateral thigh and calf pain of unknown etiology and diagnostics ruled out a second case of compartment syndrome. On 08-OCT-2015, the patient was discharged from the hospital. On an unknown date the patient experienced bilateral numbness, weakness and significant pain of the thighs and depression and this caused the patient to delay her college career. On an unknown dates, the patient underwent computerized tomogram (CT), magnetic resonance imaging (MRI), bone scan and muscle biopsies and the results were not reported. The patient sought medical attention. The outcome of the events was reported as not recovered. The patient's pediatric orthopaedic surgeon suggested this condition (compartment syndrome which was life threatening) could be related to GARDASIL. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality complaint reported. The reporter considered leg pain, bilateral thigh and calf pain were serious due to hospitalization. The reporter considered compartment syndrome was serious due to hospitalization and life-threatening. The reporter considered bilateral numbness, weakness and significant pain of the thighs, depression and this caused the patient to delay her college career were serious due to disability. This case is linked to case # 1603USA011428 via same patient link. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was  received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ (orally, dose was not reported, lot # L013197, expiration date 26-Jan-2017). There was no adverse event reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' were vaccinated with an improperly stored doses of RECOMBIVAX HB (dose and route were not reported, lot # K020216, expiration date 17-SEP-2016). There was no adverse event reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. No concurrent condition, medical history or concomitant therapy was reported. On 09-FEB-2015 or after the date, an unspecified number of patients were vaccinated with improperly stored doses of VAQTA (lot # L007559 with expiration date of 01-JUN-2017, dose and route unknown). The excursion was reported as temperature at 47 for 23 hours and no previous temperature excursion was reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of VAQTA (dose and route were not reported , lot # K026529, expiration date 02-JUN-2017). There was no adverse event reported. Additional ifnromation has been requested.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 2-year-old female patient who received PEDIARIX (batch number A4H53, expiry date unknown). On 14th January 2016, the patient experienced fever. On an unknown date, the outcome of the fever was recovered./resolved. The reporter considered the fever to be almost certainly related to PEDIARIX. Additional details provided were as follows: The patient experienced high fever. This was 1 of the 4 cases reported by the same reporter (US2016038401, US2016038402, US2016038403).
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Eye disorder, Laboratory test, Ophthalmological examination, Peripheral swelling
Clinical narrative: High fever, arm swelled big and red, 2 weeks later had eye problem, went to ophthalmologist who stated at was a reaction to vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccination complication, X-ray normal
Clinical narrative: High fever, arm swelled big and red, 2 weeks later had eye problem, went to ophthalmologist who stated at was a reaction to vaccine.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea
Clinical narrative: GARDASIL given, pt has headaches and nausea that lasted 5-10 min. Pt give BENADRYL 25 mg in office. BP was nl.
Age: 56.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Pt left arm swollen red, warm to touch, spreading down arm. Itchy and painful.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Injection site rash
Clinical narrative: Localized rash at injection site (right deltoid area).
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Rash that spread to elbow and upper shoulder swollen, itching, heat, painful.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Lethargy, Mental status changes, Pyrexia, Skin warm
Clinical narrative: 12 hours after DTAP and HIB, started with fever, shaking, lethargy, leg redness, warm to touch, tachypnea, tachycardia, vomiting, altered mental status.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Tachycardia, Tachypnoea, Tremor, Vomiting
Clinical narrative: 12 hours after DTAP and HIB, started with fever, shaking, lethargy, leg redness, warm to touch, tachypnea, tachycardia, vomiting, altered mental status.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Administered IM instead of subq.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Feeling abnormal, Mouth ulceration, Peripheral swelling, Swollen tongue
Clinical narrative: Patient said about 5 hours after receiving the vaccine he experienced swelling in arm, tongue swelling, tongue/mouth ulcers, was "swimmy headed", had shortness of breath, and his blood pressure was 161/135. He went to the emergency department.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Tongue ulceration
Clinical narrative: Patient said about 5 hours after receiving the vaccine he experienced swelling in arm, tongue swelling, tongue/mouth ulcers, was "swimmy headed", had shortness of breath, and his blood pressure was 161/135. He went to the emergency department.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site reaction, Injection site swelling, Pallor
Clinical narrative: Swelling to right thigh 48 hours after administration. Area of swelling 4 inches x 6 inches - red/purple raised - blanches, no induration, not warm to ER Wed 3-9-16.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Patient experiencing severe pain in injection site area.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Rash.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Dysphemia
Clinical narrative: Stuttering began within 72 hrs of VARIVAX and has persisted.
Age: 24.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Body aches, fever as soon as injection was given. Fatigue experienced next day. 4 days with symptoms.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Patient came by 7 days post vaccination, mentioning soreness/redness at injection site. On 3/15/16, patient had a softball size blister on her (L) deltoid that PM. Recommended OTC for relief and to monitor.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain, Pyrexia
Clinical narrative: Developed fever that cont. for 2 days. Taking TYLENOL given MD. Myalgia, body aches (localized), red, swollen, itchy at injection, cold compress applied. Developed rash on face 3/11P (L side inly), rash cont. slowly reduced but still present 3 days later. Treated with antibiotic.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Developed fever that cont. for 2 days. Taking TYLENOL given MD. Myalgia, body aches (localized), red, swollen, itchy at injection, cold compress applied. Developed rash on face 3/11P (L side inly), rash cont. slowly reduced but still present 3 days later. Treated with antibiotic.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 22-MAR-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K019388 exp. 20-JAN-2016)(dose and route of administration were not reported). There was no adverse effects reported. No product quality issue was involved. Additional information has been requested.