chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received 08-MAY-2017 from a licensed practical nurse and refers to a 9 week old infant, unknown gender. There was no information provided about the patient's concurrent condition, concomitant therapy or medical history. On 13-SEP-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. The administered dose of ROTATEQ experienced a temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004981: Original Case: 1608USA012794 ROTATEQ; US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004944: US-009507513-1705USA004952: US-009507513-1705USA004953: US-009507513-1608USA012794: Original Case; US-009507513-1705USA004955: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004960: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1705USA004966: US-009507513-1705USA004967: US-009507513-1705USA004968: US-009507513-1705USA004973: US-009507513-1705USA004972: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004965: US-009507513-1705USA004942: US-009507513-1705USA004945: US-009507513-1705USA004946: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004974: US-009507513-1705USA004975: US-009507513-1705USA004976: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA005004: Original Case: 1608USA012908 VAQTA; US-009507513-1705USA005005: US-009507513-1705USA005006: US-009507513-1705USA005007: US-009507513-1705USA004887: Original Case: 1608USA012916 RECOMBIVAX HB; US-009507513-1705USA004888: US-009507513-1705USA004889: US-009507513-1705USA004890: US-009507513-1705USA004891: US-009507513-1705USA004892: US-009507513-1705USA004893: US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004896: US-009507513-1705USA004897: US-009507513-1705USA004898: US-009507513-1705USA004899.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed practical nurse concerning a 7 month old patient of unknown gender. There was no information provided about the patient's past medical history, concurrent conditions, or concomitant medication. On 21-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017), orally. No symptoms were reported. The administered dose of ROTATEQ experienced a temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions and no further temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004967: US-009507513-1705USA004965: US-009507513-1705USA004952: US-009507513-1608USA012794: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004976: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004960: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1705USA004966: US-009507513-1705USA004968: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004974: US-009507513-1705USA004975: US-009507513-1705USA005004: US-009507513-1705USA005005: US-009507513-1705USA005006: US-009507513-1705USA005007: US-009507513-1705USA004946: US-009507513-1705USA004887: US-009507513-1705USA004888: US-009507513-1705USA004889: US-009507513-1705USA004890: US-009507513-1705USA004891: US-009507513-1705USA004892: US-009507513-1705USA004893: US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004896: US-009507513-1705USA004897: US-009507513-1705USA004898: US-009507513-1705USA004899:
Sex: F
Vaccine: HEP
Symptoms: Drug administration error, Exposure via skin contact, Hepatitis B antibody negative, No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were unknown by the reporter. On an unknown date (reported as "as a teenager"), the patient was vaccinated with an unspecified number of doses of hepatitis b vaccine (recombinant) (manufacturer unknown) injection (exact dose, route of administration, lot # and expiry date were not reported), however she did not complete the three dose series. Then, on unknown dates, (reported as "as an adult"), the patient was administered the complete series of hepatitis b vaccine (recombinant) (manufacturer unknown) injection (exact dose, route of administration, lot # and expiry date were not reported). Subsequently, on an unknown date, the patient had titers drawn, which were negative. Due to these negative titers, on an unknown date, the patient began another series of hepatitis b vaccine (recombinant) (manufacturer unknown) injection (exact dose, route of administration, lot # and expiry date were not reported), however the nurse who was administering hepatitis b vaccine (recombinant) (manufacturer unknown) injection pulled the needle out of the patient's arm too soon and the liquid vaccine spilled down the patient's arm, possibly leading to a less than administered dose. No adverse effects were reported. It was not specified how many doses of hepatitis b vaccine (recombinant) (manufacturer unknown) injection the patient received in total. The outcome of the event of negative titers and causality between the event and hepatitis b vaccine (recombinant) (manufacturer unknown) were not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pyrexia, Rash erythematous
Clinical narrative: This spontaneous report was received from a physician concerning to a 65 year old female patient with hyperthyroidism. The patient did not have any known drug reactions/allergies. There were no concomitant medications. On 11-MAY-2017, the patient was vaccinated with ZOSTAVAX lot # M035693 with expiration date on 07-NOV-2017 with its respective diluent for prophylaxis (the strength, dose, frequency, and route were not provided). On 16-MAY-2017, the patient experienced severe pain at injection site, raised red rash the size of a quarter, flu like symptoms, and low grade of fever. There was not treatment given for the adverse event, and no laboratory studies were performed. At the reporting time, the patient had not recovered from the events. The causality assessment was not provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Laceration, Syringe issue
Clinical narrative: Initial unsolicited report received from a nurse on 10-May-2017. This case involves 64-year-old female patient, while administering dose of ADACEL (Batch number: U5604AA, expiration date-17-Mar-2019) dose, dose in series, route and site of administration were not reported) on 10-May-2017 finger got lacerated. It was also reported that report filed on Amerisource Bergen account. Medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was unknown. Illness at the time of vaccination was unknown. Any other vaccinations within four weeks of vaccinations were not reported. On 10-May-2017, during administration of vaccine the index and middle finger on the left hand were lacerated. Both lacerations were 0.25 inch in length and the other is less than 0.25 inch. It was also a case of syringe issue as during the vaccination 2 flanges on the side of the syringe broke off and the glass cut her fingers. Laboratory investigations and corrective treatment were not reported. Outcome of the event was not resolved. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pruritus, Rash erythematous, Rash papular
Clinical narrative: RAISED RED PAPULAR RASH 24 HOUR ONSET AFTER INJECTION ITCHY RED.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 72 year old female patient. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported. On 02-MAY-2017, the patient was vaccinated with a properly-stored dose of PNEUMOVAX23 lot # M037669 with expiration date 09-MAY-2018 intramuscularly in the deltoid muscle (side was not specified) (dose was not reported) for prophylaxis. The pharmacist reported that the patient reported to him that on an unknown date in may 2017 (reported as "at an unspecified time after receiving the PNEUMOVAX23 vaccine") she experienced "pain, swelling, rash and redness" around the injection site (injection site pain, injection site swelling, injection site rash and injection site erythema). The patient also reported to the pharmacist that the portion of her arm around the injection site "increased in size" (local swelling). The pharmacist noted that the patient reported that she experienced "a fever of 101 °Fahrenheit (F) up to maximum of 101.6 °F for approximately 60 hours" (pyrexia). Additionally, the patient reported to the pharmacist that she "noticed pain in the arm where the vaccine injection was given, to the point where it was difficult to raised her arm", and that she experienced "decreased mobility in moving that arm where the injection was given because of soreness". At the time of reporting, the outcome of local swelling, injection site erythema, injection site swelling, injection site pain, injected limb mobility decreased and injection site rash were not reported. No product quality complain was reported. The causal relationship between the events and the suspect therapy PNEUMOVAX23 was not provided. Additional information is not expected as there is no consent to contact the reporter.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 72 year old female patient. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported. On 02-MAY-2017, the patient was vaccinated with a properly-stored dose of PNEUMOVAX23 lot # M037669 with expiration date 09-MAY-2018 intramuscularly in the deltoid muscle (side was not specified) (dose was not reported) for prophylaxis. The pharmacist reported that the patient reported to him that on an unknown date in may 2017 (reported as "at an unspecified time after receiving the PNEUMOVAX23 vaccine") she experienced "pain, swelling, rash and redness" around the injection site (injection site pain, injection site swelling, injection site rash and injection site erythema). The patient also reported to the pharmacist that the portion of her arm around the injection site "increased in size" (local swelling). The pharmacist noted that the patient reported that she experienced "a fever of 101 °Fahrenheit (F) up to maximum of 101.6 °F for approximately 60 hours" (pyrexia). Additionally, the patient reported to the pharmacist that she "noticed pain in the arm where the vaccine injection was given, to the point where it was difficult to raised her arm", and that she experienced "decreased mobility in moving that arm where the injection was given because of soreness". At the time of reporting, the outcome of local swelling, injection site erythema, injection site swelling, injection site pain, injected limb mobility decreased and injection site rash were not reported. No product quality complain was reported. The causal relationship between the events and the suspect therapy PNEUMOVAX23 was not provided. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reaction or allergies and concomitant therapies was reported. On an unknown date, the patient was vaccinated with expired dose of M-M-R II (lot # M032153, albumin status was not provided) subcutaneously for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a field representative concerning to 3 patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were unknown. On unknown dates since the beginning of 2017, the patients were vaccinated with unspecified doses of ZOSTAVAX, subcutaneously, for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). Subsequently, on unspecified dates in 2017 (reported as about a month after each individual injection), each patient developed a mild case of shingles. The patients sought medical attention on unknown dates in 2017, however it was unknown if treatment was given for the adverse event, and if laboratory tests were performed. The physician also stated that there were no other serious adverse reactions or injection site reactions. It was unknown if the patients recovered from the event. The causal relationship between the event and the therapy with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On 11-MAY-2017, the patient was vaccinated with a dose of M-M-R II (strength, dose, frequency, route of administration, lot number and expiration date were not reported) and a dose of PROQUAD (strength, dose, frequency, route of administration, lot number and expiration date were not reported); both for prophylaxis. No adverse effects and no product quality complaints were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unknown date, the unspecified number of improperly stored doses of PROQUAD (lot number L050910, expiration date 14-JUN-2017) (dose, route of administration and anatomical location were not reported) reconstituted with properly stored sterile water diluent (MRK), were administered to the unspecified number of patients. No adverse effects have been reported. The doses were stored in temperatures from 47 degrees Fahrenheit to 77 degrees Fahrenheit (50 degrees Fahrenheit) for 14 hours. There was no previous excursion reported. The digital data logger was not involved. The product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA008134.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician referring to a 4-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 03-MAR-2017, the patient was vaccinated with PROQUAD, recombinant Human Albumin (rHA) (lot # M038861) (dose, route of administration, anatomical location and expiration date were not reported), which was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007310: US-009507513-1705USA007309: US-009507513-1705USA007311: US-009507513-1705USA010146: US-009507513-1705USA010144: US-009507513-1705USA010143: US-009507513-1703USA014463: US-009507513-1705USA010145: US-009507513-1705USA010147.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician referring to a 5-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 14-MAR-2017, the patient was vaccinated with PROQUAD recombinant Human Albumin (rHA) (lot # M038861) (dose, route of administration, anatomical location and expiration date were not reported) for prophylaxis, which was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007310: US-009507513-1705USA007309: US-009507513-1705USA007311: US-009507513-1705USA010146: US-009507513-1705USA010145: US-009507513-1705USA010142: US-009507513-1705USA010147: US-009507513-1705USA010144.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician referring to a 4-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 16-MAR-2017, the patient was vaccinated with PROQUAD recombinant Human Albumin (rHA) (lot # M040141) (dose, route of administration, anatomical location and expiration date were not reported) for prophylaxis, which was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007310: US-009507513-1705USA007309: US-009507513-1705USA007311: US-009507513-1705USA010146: US-009507513-1705USA010145: US-009507513-1705USA010143: US-009507513-1705USA010142: US-009507513-1705USA010147.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Right upper arm where injection was given underneath was very red, swollen, red, very painful. The arm stayed this way for 6 days before the swelling went down. There is still a hard bump in the patient's arm where the injection was placed at.
Sex: U
Vaccine: MMR
Symptoms: Rash, Secondary transmission
Clinical narrative: This spontaneous report as received from a pharmacist refers to a child of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The pharmacist stated that an on either 06-MAY-2017 or 07-MAY-2017 a child in the same family as the patient was vaccinated with M-M-R II, for prophylaxis (route, lot# and expiration date unknown). The following day (approximately 07-MAY-2017), the patient developed a rash (NOS). It was unknown if the patient sought medical attention. The outcome of the rash was unknown. No additional information was available. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse and refers to multiple 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 date, the patients were vaccinated with improperly stored doses of PROQUAD lot # M001152 with expiration date 05-JAN-2017, and lot #M007960 with expiration date 15-AUG-2017 (dosage and route of administration were not reported) for prophylaxis, which were exposed to a prior excursion a total of time in the range -14°C to -10°C (-11°C) for a time frame of 15 minutes because of data logger. Additionally, were also exposed to a current temperature excursion of -14°C to -10°C (-14°C) for 25 minutes because of data logger. No adverse effects were reported. One of this excursion temperature was in November 2016. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA011215:
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 22-MAY-2017, the patient received an expired dose of GARDASIL injection (lot # L035105 with expiration date at 14-MAY-2017; dose, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. 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 register nurse and refers to multiple 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 date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M004330 with expiration date 26-JAN-2018, and lot #L048465 with expiration date 07-JUL-2018 (dosage and route of administration were not reported) for prophylaxis, which in November 2016, which were exposed to a prior excursion a total of time in the range -14°C to -10°C (-11°C) for a time frame of 15 minutes because of data logger. Additionally, were also exposed to a current temperature excursion of -14°C to -10°C (-14°C) for 25 minutes because of data logger. No adverse effects were reported. One of this excursion temperature was in November 2016. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA005332.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable consumer communicated to a Pfizer vaccine sales representative. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date to an unspecified date at 0.5 ml for immunization.  The patient medical history and concomitant medications were not reported. The patient experienced red rash that appeared below the injection site (emphasized not at the injection site) and pain with the injection on an unspecified date with outcome of unknown.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Fatigue, Mobility decreased, Myalgia, Pain
Clinical narrative: Moderate Fatigue - Not enough energy to do normal chores such as dishes. Moderate Achiness - Hurts to walk around, hurts even while sitting. Moderate muscle soreness in deltoid muscle - unable to fully lift arm. Pain level = 4.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Localized reaction. Red, itchy, warm, swollen are of immunization.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 18.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Dizziness, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Following receiving her first dose of GARDASIL 9 and third dose of Hepatitis B vaccines she complained of feeling light-headed and "needing to sit down." She was then witnessed to slump to her knees. She was awake but non-responsive for 15-30 seconds. She was then alert and oriented to person, place, and time. She reports being in her usual state of health today. She admits to not eating breakfast today. She denies prior adverse vaccine reactions but reports fainting after receiving prior vaccinations on one occasion. She denies rhinoconjunctival, cutaneous, laryngeal, pulmonary, and GI symptoms. She denies a history of seizures.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 5x6 cm area of redness with induration on right lateral thigh.
Age: 32.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Soreness in shoulder. Persistent shoulder soreness, limited mobility and loss of strength.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Information was received on 11-MAY-2017 from a male consumer who is the patient. The patient did not report any medical history, concomitant medications or current conditions. On 11-APR-2017, the patient received a dose of ZOSTAVAX (lot, expiration dose and site were not reported). After receiving the vaccine, (date not specified) he had "joint, muscle and everything else pain". The outcome was not reported. It is unknown if he received any treatment. No other information was reported. Additional information is not expected. No contact information.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates since 24-APR-2017, the patients were vaccinated with improperly stored doses of PROQUAD (lot number M042499 with expiration date of 07-APR-2018, lot number M039448 with expiration date of 20-MAR-2018, lot number M033210 with expiration date of 09-JAN-2018 and lot number M031566 with expiration date of 24-DEC-2017; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 15 minutes at a temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit on unspecified dates, and a temperature excursion during 1 hour 54 minutes at a temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit on unspecified dates. No previous temperature excursion was reported. A data logger issue was involved. No adverse experiences were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA011317:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number M046924, expiration date 23-NOV-2018, lot number reported as M048200, expiration date 07-DEC-2018, lot number M045205, expiration date 11-NOV-2018, lot number M042857, expiration date 21-OCT-2018, lot number M032358, expiration date 05-JUL-2018, lot number M033906, expiration date 20-JUL-2018, lot number M037642, expiration date 01-SEP-2018 (doses and routes were not reported) for prophylaxis. Concomitant medication included sterile diluent (STERILE DILUENT). The temperature involved was -14 degrees Celsius to -10 degrees Celsius for 1 minute. The previous temperature excursion was -14 degrees Celsius to -10 degrees Celsius for 9 minutes. A data logger was involved. This is one of three cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA010562: Original Case: 1705USA010469 US-009507513-1705USA010561: Original Case : 1705USA010469.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot number reported as M041508, expiration date 09-APR-2018 (doses and routes were not reported) for prophylaxis. Concomitant medication included sterile diluent (STERILE DILUENT). The temperature involved was -14 degrees Celsius to -10 degrees Celsius for 1 minute. The previous temperature excursion was -14 degrees Celsius to -10 degrees Celsius for 9 minutes. A data logger was involved. This is one of three cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA010562: Original Case : 1705USA010469 US-009507513-1705USA010469: Original Case : 1705USA010469.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot number M019646, expiration date 18-JUL-2017 (doses and routes were not reported) for prophylaxis. Concomitant medication included sterile diluent (STERILE DILUENT). The temperature involved was -14 degrees Celsius to -10 degrees Celsius for 1 minute. The previous temperature excursion was -14 degrees Celsius to -10 degrees Celsius for 9 minutes. A data logger was involved. This is one of three cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA010469: Original Case : 1705USA010469 US-009507513-1705USA010561: Original Case : 1705USA010469.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates since 24-APR-2017, the patients were vaccinated with improperly stored doses of VARIVAX (lot number M040137 with expiration date of 28-SEP-2018, lot number M038858 with expiration date of 14-SEP-2018, lot number M028551 with expiration date of 07JUN-2018 and lot number M027342 with expiration date of 01-JUN-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 15 minutes at a temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit on unspecified dates, and a temperature excursion during 1 hour 54 minutes at a temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit on unspecified dates. No previous temperature excursion was reported. A data logger issue was involved. No adverse experiences were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009207:
Sex: U
Vaccine: PNC13
Symptoms: Cardiac disorder
Clinical narrative: This is a spontaneous report from a contactable pharmacist based on the information received by Pfizer from Merk & Co., Inc. (manufacturer control number: 00449354). A patient received PREVNAR 13 on 30Nov2016 at single dose for immunization. It was reported that patient had a "cardiac condition". The reporter disconnected prior to the event questions were asked. It could not be ruled out that the patient had the "cardiac condition" before pneumococcal 13-val conj vaccine. No follow up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection related reaction
Clinical narrative: REDNESS ALONG ARM , DIFFUSE NON SPECIFIC LOCATION. MD REVIEWED  GAVE ANTIBIOTIC AS A PRECAUTION , FELT MORE LIKELY  A REACTION TO SHOT.
Age: 22.0
Sex: F
Vaccine: FLU4, HEPA, TYP
Symptoms: Confusional state, Cough, Feeding disorder, Feeling abnormal, Headache
Clinical narrative: 05/23/17 CLIENT CALLED STATING SHE HAS BEEN "REALLY SICK" SINCE VACCINATIONS ON 5/3. CLIENT DESCRIBES HER SYMPTOMS STARTED THE EVENING OF THE DAY OF VACCINATION (5/3). STATES SHE FELT "CONFUSED," "WEIRD," AND "LOOPY" AND SHE HAD A HEADACHE. STATES THAT ONE DAY LATER SHE GOT A SORE THROAT AND COUGH AND SHE COULD SEE WHITE SPOTS AT BACK OF HER THROAT. STATES THESE DISAPPEARED BY THE NEXT DAY. FROM THEN, CLIENT STATES SHE HAS HAD NAUSEA THAT DOES NOT GO AWAY; THAT SHE IS "STARVING" BUT CAN'T EAT DUE TO NAUSEA. LAST SYMPTOM TO SHOW WAS WHAT CLIENT CALLS A "RASH" THAT APPEARED ON 5/21/17. THIS RASH IS FOUND UNDER BOTH ARMS, EXTENDING FROM THE ARMPIT TO THE WRIST. WHEN ASKED TO FURTHER DESCRIBE RASH, STATES IT IS NOT RAISED, NOT ITCHY, NOT UNCOMFORTABLE, AND THERE ARE NO "PINPOINTS." STATES THAT IF SHE RUNS HER FINGER THROUGH THE RASH, IT DOES NOT FEEL ANY DIFFERENT THAN THE REST OF HER SKIN. SHE CHARACTERIZED IT AS A "WEIRD PIGMENTATION." CLIENT DENIES A POSSIBILITY OF PREGNANCY. CLIENT WAS MOST CONCERNED ABOUT THE ONGOING NAUSEA AND WHAT TO DO ABOUT IT. STATES SHE HAS NOT TAKEN ANY REMEDIES OR MEDICATIONS TO HELP WITH SYMPTOMS. GAVE CLIENT HOME REMEDIES TO HELP WITH NAUSEA (GINGER, SMALL MEALS AND SNACKS, ETC). AND RECOMMENDED GOING TO SEE PRIMARY CARE PROVIDER OR URGENT CARE FOR AN ASSESSMENT AND FOR POSSIBLY GETTING ZOFRAN FOR NAUSEA.
Age: 22.0
Sex: F
Vaccine: FLU4, HEPA, TYP
Symptoms: Malaise, Nausea, Oropharyngeal pain, Rash
Clinical narrative: 05/23/17 CLIENT CALLED STATING SHE HAS BEEN "REALLY SICK" SINCE VACCINATIONS ON 5/3. CLIENT DESCRIBES HER SYMPTOMS STARTED THE EVENING OF THE DAY OF VACCINATION (5/3). STATES SHE FELT "CONFUSED," "WEIRD," AND "LOOPY" AND SHE HAD A HEADACHE. STATES THAT ONE DAY LATER SHE GOT A SORE THROAT AND COUGH AND SHE COULD SEE WHITE SPOTS AT BACK OF HER THROAT. STATES THESE DISAPPEARED BY THE NEXT DAY. FROM THEN, CLIENT STATES SHE HAS HAD NAUSEA THAT DOES NOT GO AWAY; THAT SHE IS "STARVING" BUT CAN'T EAT DUE TO NAUSEA. LAST SYMPTOM TO SHOW WAS WHAT CLIENT CALLS A "RASH" THAT APPEARED ON 5/21/17. THIS RASH IS FOUND UNDER BOTH ARMS, EXTENDING FROM THE ARMPIT TO THE WRIST. WHEN ASKED TO FURTHER DESCRIBE RASH, STATES IT IS NOT RAISED, NOT ITCHY, NOT UNCOMFORTABLE, AND THERE ARE NO "PINPOINTS." STATES THAT IF SHE RUNS HER FINGER THROUGH THE RASH, IT DOES NOT FEEL ANY DIFFERENT THAN THE REST OF HER SKIN. SHE CHARACTERIZED IT AS A "WEIRD PIGMENTATION." CLIENT DENIES A POSSIBILITY OF PREGNANCY. CLIENT WAS MOST CONCERNED ABOUT THE ONGOING NAUSEA AND WHAT TO DO ABOUT IT. STATES SHE HAS NOT TAKEN ANY REMEDIES OR MEDICATIONS TO HELP WITH SYMPTOMS. GAVE CLIENT HOME REMEDIES TO HELP WITH NAUSEA (GINGER, SMALL MEALS AND SNACKS, ETC). AND RECOMMENDED GOING TO SEE PRIMARY CARE PROVIDER OR URGENT CARE FOR AN ASSESSMENT AND FOR POSSIBLY GETTING ZOFRAN FOR NAUSEA.
Age: 51.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Malaise, fever, chills.
Age: 73.0
Sex: F
Vaccine: PNC
Symptoms: Dizziness, Erythema, Injection site reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Patient presented to pharmacy with complaint of a reaction at site of injection. Her right arm was red and swollen and she complained that it was sore. She stated she was dizzy but that did not begin right away. Patient was advised to follow up with PCP if it doesn't get better and to apply ice on it. She did not have any other symptoms.
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Feeling abnormal, Vertigo
Clinical narrative: This is third consecutive flu vaccination in which I have experienced vertigo, lightheadedness, fatigue and a general "mentally foggy" feeling after receiving the flu shot.  On all occassions, symptoms started about 3 weeks after vaccination.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Lymphadenopathy, Pain, Pyrexia, Skin warm
Clinical narrative: Diffuse redness covering entire upper arm with warmth, axillary gland swelling, localized pain. With fever upon medical examination on 5/22/17 - antibiotics administereed.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Swelling, redness, hot to touch, hard traveled down biscep---no treatment.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, hot to touch, hard traveled down biscep---no treatment.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Local injection site redness, swelling, warmth, itching, and pain.
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Seizure
Clinical narrative: I got the PREVNAR 13 Syringe vaccine at 1200. I had 2 seizures at 1900 while sleeping and had to be taken by ambulance to the ER.
Sex: F
Vaccine: MMR
Symptoms: Brain oedema, Computerised tomogram, Condition aggravated, Electroencephalogram, Epilepsy
Clinical narrative: After receiving the MMR my daughter had brain swelling, which left her with lifetime deficits and has epilepsy as a result.
Sex: F
Vaccine: MMR
Symptoms: Sleep study
Clinical narrative: After receiving the MMR my daughter had brain swelling, which left her with lifetime deficits and has epilepsy as a result.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Cellulitis, Erythema nodosum
Clinical narrative: Cellulitis or Erythema Nodosum. See attached office visit note.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Condition aggravated, Dizziness, Headache, Hypopnoea, Nausea
Clinical narrative: Patient reported dizziness, shallow breathing, fever 101 degree F, headache, nausea, severe left arm pain starting 3 hours after vaccine administration seen in ER 5/19/17 and treated for sickle cell crisis.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Sickle cell anaemia with crisis
Clinical narrative: Patient reported dizziness, shallow breathing, fever 101 degree F, headache, nausea, severe left arm pain starting 3 hours after vaccine administration seen in ER 5/19/17 and treated for sickle cell crisis.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Blood glucose normal, Body temperature increased, Chills, Injection site discomfort, Injection site pain
Clinical narrative: At 1000am 5/17/17, patient received PPSV23 left deltoid. By early evening patient was having 9/10 pain left deltoid and was having chills. Spouse stated "he also said a few things which did not make sense". Patient was checked by EMS temp was 99F and other VS and CBG were all normal. Left deltoid area not red or swollen per spouse. Patient has discomfort left deltoid area am of 5/18/17 but is feeling much better per spouse.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Eyelid oedema
Clinical narrative: Patient received TDAP and MCV in office at about 10:45 am. At about 1:00 pm, patient's mom called stating patient's eyes were swollen shut. Mom was instructed to return patient back to clinic for evaluation.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash started 9 days after vaccine was administered.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Feeling hot, Headache, Nausea, Peripheral swelling
Clinical narrative: Patient received TDAP on 5/16/17. After injection she felt hot and right arm was warm and swollen. The next day she had a fever of 101.9, slight nausea, headache, and fatigue. Denies hives, difficulty breathing, SOB.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Patient received TDAP on 5/16/17. After injection she felt hot and right arm was warm and swollen. The next day she had a fever of 101.9, slight nausea, headache, and fatigue. Denies hives, difficulty breathing, SOB.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Induration, Pain in extremity
Clinical narrative: Patient received vaccine (HPV) on 4/19/17. On 5/9/17 presented to urgent care for Left arm pain. She returned to our clinic on 5/10/17, for pain developing 2 days prior. There was 1.5cm round firm area.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Pallor, Presyncope
Clinical narrative: My then 13-yr old son was given the GARDASIL 9 vaccination. He sat in the examination room for 10-15 minutes after the shot. We then proceeded to walk to the office lobby to leave when my son became white as a sheet, dizzy and nearly fainted. I was just able to get him in a chair before he passed out. For 20 minutes we sat in the chair while he felt light headed and he vomited a few times. The doctor brought out a cart to monitor his pulse and blood pressure, which was elevated initially, but then returned to normal. After 30 minutes the episode was over - but it was scary.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: My then 13-yr old son was given the GARDASIL 9 vaccination. He sat in the examination room for 10-15 minutes after the shot. We then proceeded to walk to the office lobby to leave when my son became white as a sheet, dizzy and nearly fainted. I was just able to get him in a chair before he passed out. For 20 minutes we sat in the chair while he felt light headed and he vomited a few times. The doctor brought out a cart to monitor his pulse and blood pressure, which was elevated initially, but then returned to normal. After 30 minutes the episode was over - but it was scary.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Pt pale, sweaty, weak/lightheaded after HPV vaccine #2 of 2.
Age: 24.0
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Nausea
Clinical narrative: Pt received Pneumo23 at 0830. Report feeling nausea and tightness in chest. No warmth, no redness at site. Lungs clear. Provided ALEVE. Pt to agency.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, X-ray
Clinical narrative: Pain in shoulder, inability to move arm, X-rays, MRI Oct 25 - Dec 20, 2016 Prednisone, Ibuprofen, Cortisone shot. Limited mobility Oct 2016 - present.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dizziness, Injection site erythema, Malaise
Clinical narrative: (L) upper arm erythema, malaise, dizziness, chills x 1week after vaccine. Afebrile.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness postural, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: Mom called patient started with arm soreness, nausea, dizziness when sanding and leg weakness today at school.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Somnolence, Urticaria
Clinical narrative: Pt's father reported "pea sized welts on her stomach". Also reported "one welt by eye" and "slight drowsiness". Dr. recommended BENADRYL liquid-2.5mL PO Every 6 hours PRN. Instructed to go to ER if worsening rash or difficulty breathing, swelling of tongue and lips.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Mom called at five stating patient screaming non stop. Shots given at 10:00. TYLENOL given by mom with cold compress. Calmed down in doctors office.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Pt given 2nd dose of HPV9 vaccine at 3:00. Pt left clinic with parent. On the way home pt noticed Hives on legs and arms. Pt returned to clinic. RN gave 25 mg of BENADRYL orally at 3:30. No difficulty breathing or other symptoms.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Computerised tomogram head, Dizziness, Head injury, Hypoaesthesia, Loss of consciousness
Clinical narrative: On the way out of the office, pt was checking out and stated she felt dizzy and passed out. Patient hit her head on the floor and was unconscious for about 30 seconds. She was monitored in the office and then sent for stat head CT, pt complained of LA pain and numbness with swelling. Pt was referred to neurology.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain in extremity, Swelling
Clinical narrative: On the way out of the office, pt was checking out and stated she felt dizzy and passed out. Patient hit her head on the floor and was unconscious for about 30 seconds. She was monitored in the office and then sent for stat head CT, pt complained of LA pain and numbness with swelling. Pt was referred to neurology.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Computerised tomogram head, Dizziness, Head injury, Headache, Hypoaesthesia
Clinical narrative: On the way out of the office, pt was checking out and stated she felt dizzy and passed out. Patient hit her head on the floor and was unconscious for about 30 seconds. She was monitored in the office and then sent for stat head CT, pt complained of LA pain and numbness with swelling. Pt was referred to neurology.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Pain in extremity, Peripheral swelling
Clinical narrative: On the way out of the office, pt was checking out and stated she felt dizzy and passed out. Patient hit her head on the floor and was unconscious for about 30 seconds. She was monitored in the office and then sent for stat head CT, pt complained of LA pain and numbness with swelling. Pt was referred to neurology.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Dizziness, Dyspepsia, Feeling abnormal, Loss of personal independence in daily activities
Clinical narrative: Daughter had the GARDASIL vaccination on Monday. That night she felt nauseous, dizzy and thought she was going to throw up. She went to school on Tuesday and felt terrible. The symptoms really kicked in on Wednesday and she stayed home from school. She didn't eat anything and just was in so much pain. Thursday she tried to go to school and made it a half day before coming home. Called the GI doc, she recommended ZANTAC. We tried that, no relief. Burning stomach pain, nausea, dizziness still happened. She is trying to go to school today but she really feels awful. This was her final dose. She had a milder form of this with her first two, but nothing like this.