chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: 61 yo female with PMH CAD, Acute MI, Gastric Ulcer, Prediabetes, OA, SOB, Ptosis of R eyelid, pulmonary emphysema, GERD, Iron deficiency anemia. Patient reports to outpatient provider for appointment and received influenza and PNEUMOVAX vaccines and both were delivered IM into the L deltoid. The patient had no contraindications to injection. Within an hour of the combination injection, the patient developed significant swelling, redness, and pain spreading down the L arm and persisted for several days. She did not report anaphylactic symptoms and her arm pain and swelling improved with symptomatic management.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Bedridden, Discomfort, Influenza like illness, Muscular weakness
Clinical narrative: Initial unsolicited misuse report received from a nurse on 06 Dec 2016. This case involves a 61-year-old female patient who was vaccinated with a dose of Fluzone HD intramuscularly (Batch number: UI626AA, expiry date: 09 Mar 2017, dose and dose in series were not reported) in the left deltoid on 05 Nov 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as type 1 diabetic, hypothyroidism, left eye blindness and osteopenia. Illness at the time of vaccination was reported as no. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unspecified date, following the vaccination (reported as patient did not give a clear indication as to when symptoms started), the patient was unable to walk, all muscles were weak and heavy. It was reported that within three days, she improved, but needed to use a walker for 1.5 weeks when she did not usually use it. Patient had no other symptoms. It was also a case of inappropriate age at vaccine administration. Laboratory investigations were not provided. Corrective treatment was not reported. On an unknown date, patient recovered from the events. Upon internal review, the company decided to consider the event as serious due to important medical event: unable to walk. List of documents held by sender: none. Sender's Comments: This poorly documented case as patient was unable to walk and had muscle weakness and heavy following FLUZONE HD vaccine. Time to onset is unknown, additional information regarding patient's medical history, infectious history, past vaccination history and its tolerance are need to further assess the case. Patient might had generalized lower limb weakness which may lead to abasia which suggest detail history is needed. Based on available information the role of vaccination cannot be assessed.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Walking aid user
Clinical narrative: Initial unsolicited misuse report received from a nurse on 06 Dec 2016. This case involves a 61-year-old female patient who was vaccinated with a dose of Fluzone HD intramuscularly (Batch number: UI626AA, expiry date: 09 Mar 2017, dose and dose in series were not reported) in the left deltoid on 05 Nov 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as type 1 diabetic, hypothyroidism, left eye blindness and osteopenia. Illness at the time of vaccination was reported as no. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unspecified date, following the vaccination (reported as patient did not give a clear indication as to when symptoms started), the patient was unable to walk, all muscles were weak and heavy. It was reported that within three days, she improved, but needed to use a walker for 1.5 weeks when she did not usually use it. Patient had no other symptoms. It was also a case of inappropriate age at vaccine administration. Laboratory investigations were not provided. Corrective treatment was not reported. On an unknown date, patient recovered from the events. Upon internal review, the company decided to consider the event as serious due to important medical event: unable to walk. List of documents held by sender: none. Sender's Comments: This poorly documented case as patient was unable to walk and had muscle weakness and heavy following FLUZONE HD vaccine. Time to onset is unknown, additional information regarding patient's medical history, infectious history, past vaccination history and its tolerance are need to further assess the case. Patient might had generalized lower limb weakness which may lead to abasia which suggest detail history is needed. Based on available information the role of vaccination cannot be assessed.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Discomfort, Drug administered to patient of inappropriate age, Muscular weakness, Walking aid user
Clinical narrative: Initial unsolicited misuse report received from a nurse on 06 Dec 2016. This case involves a 61-year-old female patient who was vaccinated with a dose of Fluzone HD intramuscularly (Batch number: UI626AA, expiry date: 09 Mar 2017, dose and dose in series were not reported) in the left deltoid on 05 Nov 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as type 1 diabetic, hypothyroidism, left eye blindness and osteopenia. Illness at the time of vaccination was reported as no. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unspecified date, following the vaccination (reported as patient did not give a clear indication as to when symptoms started), the patient was unable to walk, all muscles were weak and heavy. It was reported that within three days, she improved, but needed to use a walker for 1.5 weeks when she did not usually use it. Patient had no other symptoms. It was also a case of inappropriate age at vaccine administration. Laboratory investigations were not provided. Corrective treatment was not reported. On an unknown date, patient recovered from the events. Upon internal review, the company decided to consider the event as serious due to important medical event: unable to walk. List of documents held by sender: none. Sender's Comments: This poorly documented case as patient was unable to walk and had muscle weakness and heavy following FLUZONE HD vaccine. Time to onset is unknown, additional information regarding patient's medical history, infectious history, past vaccination history and its tolerance are need to further assess the case. Patient might had generalized lower limb weakness which may lead to abasia which suggest detail history is needed. Based on available information the role of vaccination cannot be assessed.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a consumer refers to a 69 year old female patient. The patient historical and concurrent conditions were not reported. The patients concomitant medications included Synthroid (also reported as Synehroid), calcium and Vitamin D. On 06-DEC-2016 the patient was vaccinated with PNEUMOVAX23 lot # M018624, subcutaneously for immunization. The patient experienced bruising after being vaccinated with PNEUMOVAX23. On 07-DEC-2016, after onset of therapy the patient experienced cellulitis and was treated by her physician who prescribed cephalexin. The outcome of contusion and cellulitis was reported as recovering. The action taken is not applicable. The causality was not reported. Upon internal review the event cellulitis was considered to be medically significant. There was no product quality complaint (PQC) reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Contusion
Clinical narrative: Information has been received from a consumer refers to a 69 year old female patient. The patient historical and concurrent conditions were not reported. The patients concomitant medications included Synthroid (also reported as Synehroid), calcium and Vitamin D. On 06-DEC-2016 the patient was vaccinated with PNEUMOVAX23 lot # M018624, subcutaneously for immunization. The patient experienced bruising after being vaccinated with PNEUMOVAX23. On 07-DEC-2016, after onset of therapy the patient experienced cellulitis and was treated by her physician who prescribed cephalexin. The outcome of contusion and cellulitis was reported as recovering. The action taken is not applicable. The causality was not reported. Upon internal review the event cellulitis was considered to be medically significant. There was no product quality complaint (PQC) reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Information has been received from a nurse via a company representative referring to a patient of unknown age. Information about the patient's concurrent condition, medical history, drug reactions/allergies and concomitant therapy was unknown. On 21-NOV-2016, during the same appointment, the patient was inadvertently vaccinated with VARIVAX (dose, route of administration, lot # and expiration date were unknown) for prophylaxis and PROQUAD (dose, route of administration, lot # and expiration date were unknown) for prophylaxis (Multiple drug overdose accidental). No symptoms was reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse via a company representative referring to a patient of unknown age. Information about the patient's concurrent condition, medical history, drug reactions/allergies and concomitant therapy was unknown. On 21-NOV-2016, during the same appointment, the patient was inadvertently vaccinated with VARIVAX (dose, route of administration, lot # and expiration date were unknown) for prophylaxis and PROQUAD (dose, route of administration, lot # and expiration date were unknown) for prophylaxis (Multiple drug overdose accidental). No symptoms was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were not reported) lot # L040054 and expiry date: 26-DEC-2017 for prophylaxis. The vaccine was exposed to a temperature frame of 33.20 Fahrenheit for 20 minutes. There were no previous excursions and there was no data logger involved. No adverse events were reported and there was no product quality complaint (PQC). Follow up information has been received from the vaccine coordinator via a telephone call on 15-DEC-2016. The coordinator was unable to provide any further information. This is one of the two reports from the same reporter. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1610USA010971: MERCK 1610USA009679: Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning to unspecified number patients of unknown age and gender. Concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates since 29-SEP-2016, the patients received improperly stored doses of improperly stored of GARDASIL 9 (lot # M016193, expiration date 24-APR-2018) for prophylaxis. The vaccines were stored at 31.6 F for 30 minutes. The temperature excursions were detected by a "data logger". There was no previous temperature excursion. The medical assistant was not aware of any adverse effects. This is one of several reports received from the same reporter. As of 12-DEC-2016, all telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA014766: MERCK 1610USA014741: Mfr number.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PROQUAD (lot # M011663, expiration date 08-SEP-2017; lot # M018637, expiration date: 11-OCT-2017) (dose and route were not provided) for prophylaxis. The temperature excursion was of 11F in a time frame of 30 minutes. Data logger was reported as Yes. No adverse effects were reported.  No product quality complaint was involved. This is one of the several reports received from the same reporter. On 13-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA015290: US-009507513-1610USA015314: US-009507513-1610USA015315: US-009507513-1610USA015317: MERCK 1610USA015316:Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored VARIVAX (lot # L048465, expiration date 02-DEC-2017; lot # M009765, expiration date 23-FEB-2018); which were exposed to temperature of 11F for 30 minutes. There was not previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. On 13-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA015290:US-009507513-1610USA015314: US-009507513-1610USA015315:US-009507513-1610USA015316: US-009507513-1610USA015317:,MERCK 1610USA015317:Mfr number.
Sex: M
Vaccine: HPV9
Symptoms: Vertigo
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative and refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route of administration, lot# and expiry date were not reported) for routine vaccination. Concomitant medications were not reported. On an unknown date, one month after receiving GARDASIL 9, the patient experienced vertigo lasting for an unspecified duration of time. The outcome of vertigo was reported as fully recovered. The relatedness between the event and the vaccine was not reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse referring to a adult male patient of unknown age. Information about concurrent condition, concomitant medication and medical history was unknown. On 16-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # M032635, expiration date 05-MAY-2018) )(dose and route were not reported) for prophylaxis. In November 2016, at an unspecified time after that, the patient noticed redness, swelling, and some mild pain and itching at the injection site. On 18-NOV-2016, patient came to physician office to report the above symptoms. The nurse reported that patient stated that the redness, swelling, pain and itching had all diminished to "about 50% of what they were yesterday (17-NOV-2016)". An unnamed health care provider at office recommended supportive care with cold compresses and ibuprofen to improve comfort during recovery. The outcome of the events was recovering. The causality between the events and PNEUMOVAX 23 was not provided. Additional information is not expected as no consent to contact the HCP.
Sex: U
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, Injection site pain, Underdose
Clinical narrative: This spontaneous report was received from a pharmacy intern and refers to a patient of unknown gender and age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-NOV-2016, the patient was vaccinated with a dose of GARDASIL 9 (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On 22-NOV-2016, upon insertion of the needle, the patient experienced pain and jerked arm away. Only a partial amount of vaccine was administered. The outcome of the event was unknown. The patient sought medical attention by an office visit. The relatedness between the event and therapy with GARDASIL 9 was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a currently 66 year old female patient. There was no information about concurrent condition, concomitant medication and medical history.   On an unknown date, the patient was vaccinated with a partial dose of  PNEUMOVAX23 (strength and dose unknown) (lot # M040004, expiration date 20-MAY-2018) intramuscularly for prophylaxis due to a defect with PNEUMOVAX23 pre-filled syringe (product quality issue). Because the patient didn't receive a full dose of PNEUMOVAX23, she administered a second dose of PNEUMOVAX23 (strength and dose unknown) (lot # M040004, expiration date 20-MAY-2018, intramuscular) during the same vaccination session.  The patient had not experienced an adverse effect. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patient. On an unknown date the patient was vaccinated with VARIVAX (dose, route and frequency were not reported, lot# reported as M030138, EXP 15-JUN-2018).   The nurse reported the vaccine was exposure at 4.5 Celsius for 3 hours and 15minutes and then 5 Celsius for 4 hours and 5 minutes before administration. No adverse effect was reported. This is one of the reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008060: US-009507513-1612USA008061: US-009507513-1612USA001370:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in October 2016 (reported as between 09-OCT-2016 to 21-OCT-2016 ), the patients were vaccinated with improperly stored GARDASIL 9 lot # M011840, expiry date: 01-FEB-2018, lot # M013636, expiry date: 15-FEB-2018 (dosing details and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to the temperature of 30.2F during a time frame of 12 days. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003199.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous report received from a consumer via pharmacist via Varicella Zoster Virus Identification program (VZVIP) referred to a male patient of unknown age. The patient's medical history, concurrent conditions were not reported. The pharmacist reported that on 14-NOV-2016, the patient received a dose of ZOSTAVAX (dose, route, lot number and expiry date not reported) and an unspecified flu vaccine (concomitant medication) both given in an unspecified arm. Within a week of receiving ZOSTAVAX, the patient developed itchiness on the back of his neck and rash on his legs. At the time of this report, the events were not recovered. Causality assessment was not reported.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician via a company representative referring to a male patient of unknown age. Information about concurrent condition, medical history, drug reactions/allergies and concomitant medication were unknown. On an unknown date in 2016, the patient was sent to an unspecified pharmacy to receive a flu vaccine, but the patient was confused and thought he was possibly vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were unknown) for prophylaxis. The physician was not quite sure if the patient even received ZOSTAVAX. On an unknown date in 2016, the patient developed "Guillain-Barre" after possibly receiving ZOSTAVAX. The patient sought medical attention by seeing physician. And then the patient was "hospitalized in an unspecified nursing home" for 6 months. The patient was received treatment for the event. It was unknown the specific dates the patient went into the unspecified nursing home. The patient was currently out of the nursing home. The outcome of Guillain-Barre syndrome was reported as recovered. The causality assessment between the event and ZOSTAVAX was not reported. Upon internal review, "Guillain-Barre" was determined to be medically significant and the physician considered the event to be disability and life-threatening. Additional information has been requested.
Age: 23.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 23 year old patient of unknown gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 29-NOV-2016, this adult patient was vaccinated with PROQUAD (inappropriate age at vaccine administration) lot # M031566, expiry date: 24-DEC-2017, 0.5 ml once subcutaneously for prophylaxis. No adverse effects were reported. There were no product quality complaints (PQC) involved. 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 a medical assistant refers to a 13 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 17-MAY-2016, the patient received GARDASIL (lot #L028664, expiry date: 25-MAY-2017) first dose (route: intramuscular). The patient received second dose on 22-AUG-2016 and did not want to finish series (inappropriate schedule of vaccine administered). No side effects reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant medication was not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M027117 with expiration date: 26-JUL-2017 (route and dosage schedule were not reported) for prophylaxis. The administered doses of vaccine were exposed to 18.27 Fahrenheit for an unspecified amount of time. Data logger was involved and there was no previous temperature excursion reported. There were no adverse effects reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that on 07-DEC-2016, the patient received improperly stored PNEUMOVAX 23 (lot# M037669,exp. date 09-MAY-2016). No adverse effects reported. The vaccines were stored at 69F for 1 week. The call was because of data logger. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 30-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 ((lot # M008766 (not valid), expiry date: 15-OCT-2017) (route: intramuscular). On the same day, the patient had received another dose of PNEUMOVAX 23 (inappropriate schedule of vaccine administered). No side effects reported. The outcome of the events was unknown. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse via a company representative referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On 09-DEC-2016, the patient received an expired dose of M-M-R II (therapy type rHA, lot # K000738, expired date on 16-JAN-2016, dose was unknown) for prophylaxis. No adverse event was reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse via a company representative referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On 09-DEC-2016, the patient received an expired dose of M-M-R II (therapy type rHA, lot # K000738, expired date on 16-JAN-2016, dose was unknown) for prophylaxis. No adverse event was reported. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 6 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 30-NOV-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M019708 with an expiration date of 25-OCT-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 4 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 23-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M019708 with an expiration date of 25-OCT-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 4 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 08-JUL-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Then, on 21-SEP-2016, the patient was also vaccinated with another improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M019708 with an expiration date of 25-OCT-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The  temperature excursion reported was 1 degree Celsius (C) for 48 hours for both doses. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 8 weeks old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 06-JUN-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Then, on 15-SEP-2016, the patient was also vaccinated with another improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M019708 with an expiration date of 25-OCT-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The  temperature excursion reported was 1 degree Celsius (C) for 48 hours for both doses. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 3 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 12-NOV-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 6 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 26-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The  temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 4 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 20-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 6 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 14-JUL-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The  temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 6 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 6 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 06-JUN-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 6 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 24-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patient.  On an unknown date the patient was VARIVAX (dose, route and frequency were not reported, lot# reported as M024675, EXP 18-MAY-2018).   The nurse reported the vaccine was exposure at 4.5 Celsius for 3 hours and 15minutes and then 5 Celsius for 4 hours and 5 minutes before administration. No adverse effect was reported. This is one of the reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA001370: US-009507513-1612USA008061: US-009507513-1612USA008060:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patient. On an unknown date the patient was vaccinated with VARIVAX (dose, route and frequency were not reported, lot# reported as M028459, EXP 07-JUN-2018). The nurse reported the vaccine was exposure at 4.5 Celsius for 3 hours and 15 minutes and then 5 Celsius for 4 hours and 5 minutes before administration. No adverse effect was reported. This is one of the reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA001370: US-009507513-1612USA008061: US-009507513-1612USA008060.
Sex: M
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016533379) on 05-Dec-2016. This case involves a male patient (onset age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date (it was reported 13 Jun 2007), unspecified timeframe following vaccination the patient experienced allergy to vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a nurse via other company (Pfizer) (Manufacturer Report Number: 2016459272) on 05-Dec-2016. This case involves a female patient (onset age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, unspecified time frame following vaccination, the patient experienced allergy to Tetanus Vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Headache, Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Initial unsolicited report received from a health care professional on 06-Dec-2016. This case involves a patient 44 year old female patient who was vaccinated with a first dose of ADACEL via intramuscular route (Batch number: U5521AA, expiry date- 10-Dec-2018) in left deltoid on 01-Dec-2016. Patient's medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported. Illness at the time of vaccination was also not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 02-Dec-2016, one day following the vaccination, the patient reported nausea, headache and shortness of breath as well as a large local reaction of redness and warmth at the injection site. Patient required emergency room (ER)/ doctor visit. Laboratory investigations were not reported. Corrective treatment reported as MEDROL pack and SOLU-MEDROL for injection site reaction. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Initial unsolicited report received from a health care professional on 06-Dec-2016. This case involves a patient 44 year old female patient who was vaccinated with a first dose of ADACEL via intramuscular route (Batch number: U5521AA, expiry date- 10-Dec-2018) in left deltoid on 01-Dec-2016. Patient's medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported. Illness at the time of vaccination was also not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 02-Dec-2016, one day following the vaccination, the patient reported nausea, headache and shortness of breath as well as a large local reaction of redness and warmth at the injection site. Patient required emergency room (ER)/ doctor visit. Laboratory investigations were not reported. Corrective treatment reported as MEDROL pack and SOLU-MEDROL for injection site reaction. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Fatigue, Hyperhidrosis, Lethargy
Clinical narrative: Initial unsolicited case received from a consumer on 05 December 2016. This case involves a 70 years old male patient who was vaccinated with a dose of Fluzone HD (Batch number, Expiry date, dose was not reported) via intramuscularly route at left deltoid on 03 Oct 2016. The patient's Illness at time of vaccination reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as not known allergies. The patient concomitant medications were not reported. On 11 October 2016, 8 days (reported as one week) following the vaccination, the patient experienced fever, muscles aches, tiredness, lethargic, sweating. On unspecified date, following the vaccination patient also lost 15 pounds (lbs). The patient required doctor visit. The patient lab tests included blood tests and computed tomography (CAT) scan. It was reported that patient didn't know the result. Corrective treatment was not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia, Weight decreased
Clinical narrative: Initial unsolicited case received from a consumer on 05 December 2016. This case involves a 70 years old male patient who was vaccinated with a dose of Fluzone HD (Batch number, Expiry date, dose was not reported) via intramuscularly route at left deltoid on 03 Oct 2016. The patient's Illness at time of vaccination reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as not known allergies. The patient concomitant medications were not reported. On 11 October 2016, 8 days (reported as one week) following the vaccination, the patient experienced fever, muscles aches, tiredness, lethargic, sweating. On unspecified date, following the vaccination patient also lost 15 pounds (lbs). The patient required doctor visit. The patient lab tests included blood tests and computed tomography (CAT) scan. It was reported that patient didn't know the result. Corrective treatment was not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016522203) on 05-Dec-2016. This case involves a 65-year-old female patient who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, unspecified timeframe following vaccination, the patient experienced allergy to Tetanus Vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by the sender: None.
Sex: M
Vaccine: TTOX
Symptoms: Allergy to vaccine, Swelling
Clinical narrative: Initial unsolicited report received from a health care professional via other company (Pfizer) (Manufacturer Report Number: 2016524310) on 05 December 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (TETANUS TOXOID) (Batch number, expiry date, dose, route and site of administration was not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date after the vaccination, the patient had tetanus toxoid allergy/swelling. The patient lab tests and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Headache, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a consumer (Pfizer) (Manufacturer Report Number: 2016545037) on 08-Dec-2016. This case involves a female patient (onset age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 20-Oct (unspecified year). Patient's medical history and concomitant medications were not reported. It was also reported patient was on lot of medication. On an unspecified date, unspecified timeframe following vaccination the patient experienced red and swollen arm along with the headache. It was reported that patient went to see the doctor on 17-Nov (unspecified year). Laboratory investigations were not reported. It was reported that she received Vaseline as a corrective treatment. The outcome of the events were not reported. List of documents held by sender: none.