chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Injection site pain, Middle insomnia
Clinical narrative: This spontaneous case initially received on 05-Dec-2016, was reported by a health professional and concerns a(n) female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) from 30-AUG-2016 to 30-AUG-2016. Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. Non-company suspect drugs: ZOSTAVAX, Dose regimen: 0.65 ml once, Route of administration: Subcutaneous. Batch number: M018453. The patient received a dose of ZOSTAVAX in an unspecified arm and a dose of flu vaccine in the opposite arm. Adverse reactions/events and outcomes: On an unknown date, the patient experienced pain at the ZOSTAVAX injection site (outcome: Not recovered / Not resolved), [Pain at the ZOSTAVAX injection site which] wakes her up at night (outcome: Not recovered / Not resolved).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Insomnia, Myalgia
Clinical narrative: This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Past medical history includes asthma. Concomitant medication: not reported. Drug reactions/allergies: unknown. Administration of company suspect drug(s): On an unknown date a week prior to ZOSTAVAX administration, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. Non-company suspect drugs: In Oct-2016, the patient received ZOSTAVAX. Indication: Prevention of shingles. Dose regimen: 0.65 ml / one injection, Route of administration: Subcutaneous. Batch number: L027321. Adverse reactions/events and outcomes: On the first day after receiving the vaccine, the patient developed a swollen elongated wheel-type rash and it was raised. On the second day, the patient's arm had a softball size welt that was warm to the touch and on the third day post vaccination with ZOSTAVAX, her rash was improving and became lighter but the patient felt super tired but couldn't sleep. She was experiencing severe muscle aches and severe rigors as well. By the fourth day, the patient had developed a bad fever of 104 degrees, a headache and she still had the muscle aches but the aches were more mild and the rash was still present although the rash continued to lessen and become lighter. By the fifth day, the patient was starting to recover from her adverse reaction as described and as of the present time, the patient has made a full recovery. Outcome of all events: recovered/resolved. The patient was treated with ADVIL and TYLENOL.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Skin warm, Swelling, Urticaria
Clinical narrative: This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Past medical history includes asthma. Concomitant medication: not reported. Drug reactions/allergies: unknown. Administration of company suspect drug(s): On an unknown date a week prior to ZOSTAVAX administration, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. Non-company suspect drugs: In Oct-2016, the patient received ZOSTAVAX. Indication: Prevention of shingles. Dose regimen: 0.65 ml / one injection, Route of administration: Subcutaneous. Batch number: L027321. Adverse reactions/events and outcomes: On the first day after receiving the vaccine, the patient developed a swollen elongated wheel-type rash and it was raised. On the second day, the patient's arm had a softball size welt that was warm to the touch and on the third day post vaccination with ZOSTAVAX, her rash was improving and became lighter but the patient felt super tired but couldn't sleep. She was experiencing severe muscle aches and severe rigors as well. By the fourth day, the patient had developed a bad fever of 104 degrees, a headache and she still had the muscle aches but the aches were more mild and the rash was still present although the rash continued to lessen and become lighter. By the fifth day, the patient was starting to recover from her adverse reaction as described and as of the present time, the patient has made a full recovery. Outcome of all events: recovered/resolved. The patient was treated with ADVIL and TYLENOL.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This initial spontaneous report was received via the FDA in a Freedom of Information line listing (VAERS # 675840) referring to a 12 year old male. The patient had no current illnesses and was taking no concomitant medications. On 23-DEC-2016, the patient received GARDASIL 9 intramuscularly in the left leg (lot # M024262), BOOSTRIX intramuscularly in the right arm (lot # EC9A9) and MENACTRA intramuscularly in the left arm (lot # U5425AA). On 28-DEC-2016, the patient experienced bilateral upper extremity redness and warmth at injection site. Patient reported tenderness to palpation almost a 2 inch diameter. He was treated with AUGMENTIN 875 mg, one by mouth twice daily for 10 days. The outcome of the events was unknown. Causality was not specified. On 24-MAY-2017, it was determined that lot # M024262 in not valid for GARDASIL 9. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ, FLU4, HPV9, MENB, MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act referring to a 17 year old female patient with dairy digestive allergy, gluten meal gluten intolerance. The patient's medical history included H. pylori infection. On 05-JAN-2017 the patient was vaccinated with a dose of GARDASIL 9 (lot # M034780), intramuscularly in the left arm for prophylaxis. On the same day, the patient also was vaccinated with a dose of FLUZONE (lot # U5691AB) in right arm, a dose of TRUMENBA (lot # R56655) in right arm and a dose of MENACTRA (lot# U5539AB) in left arm, all intramuscularly for prophylaxis. On 06-JAN-2017, 2 days after onset of therapy the patient experienced fever of 102 F and a headache at 03:00. The outcome of the events was unknown. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 679146). This spontaneous report refers to a 14 year old male patient.   The patient had the current illnesses of back pain and headaches. No medical history and no concomitant medications were reported. On 23-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9, dose reported as "0.0", intramuscular, in left arm, (Lot number M028323; expiration date not reported) (strength and dose number were not provided). On the same day, the male patient was vaccinated with FLUARIX Quadrivalent (Lot number 23L7C), intramuscular, right arm and MENVEO (Lot number M16014) intramuscular, left arm. On 23-JAN-2017, the same date of vaccination, the patient experienced syncope.  He rested 30 minutes. At the time of the report, the outcome of syncope was reported as recovered. The agency did not assess the relatedness between syncope and GARDASIL 9. 24-MAY-2017: Lot number M028323 is valid for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast). Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, PNC, DTAPHEPBIP, PNC13
Symptoms: Diet refusal, Eczema, Fatigue, Irritability, Rash generalised
Clinical narrative: Patient developed rash. Mom feared related to a milk allergy. Seen in urgent care and diagnosed with atopic dermatitis.
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, PNC, DTAPHEPBIP, PNC13
Symptoms: Dermatitis atopic, Rash
Clinical narrative: Patient developed rash. Mom feared related to a milk allergy. Seen in urgent care and diagnosed with atopic dermatitis.
Age: 0.75
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Decreased appetite, Lethargy, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 9-month-old female patient of an unspecified race/ethnicity received the third single dose of PREVNAR 13 (lot R70446, expiry date 30Apr2018) on 19May2017 at 11:30 for routine vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. By 2 P.M. on 19May2017 the patient experienced fever of 102 and ran a fever throughout the weekend. She was also not eating, was lethargic, and had a rash all over her body, since an unspecified date in May2017. The patient recovered from fever in May2017. Rash had not yet resolved. The other events outcome was unknown. The reporting nurse considered fever, not eating and rash all over her body as related to the suspect vaccine.
Age: 0.75
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Diet refusal, Lethargy, Pyrexia, Rash generalised
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 9-month-old female patient of an unspecified race/ethnicity received the third single dose of PREVNAR 13 (lot R70446, expiry date 30Apr2018) on 19May2017 at 11:30 for routine vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. By 2 P.M. on 19May2017 the patient experienced fever of 102 and ran a fever throughout the weekend. She was also not eating, was lethargic, and had a rash all over her body, since an unspecified date in May2017. The patient recovered from fever in May2017. Rash had not yet resolved. The other events outcome was unknown. The reporting nurse considered fever, not eating and rash all over her body as related to the suspect vaccine.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain
Clinical narrative: Extremely painful starting about an hour after the vaccination; very difficult to move arm.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Stomatitis
Clinical narrative: Patient started to develop sores and inflammation in his mouth about a week after receiving the MMR vaccine. He self treated, he took OTC Advil and use salt water gargles to treat his symptoms. Symptoms resolved about one month later.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Crying, Emotional disorder, Lethargy, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Few red bumps on arms, muscle pain, lethargic and was sent home from school. Crying and emotional. Lasted less than two weeks  after getting the HPV.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Rash, Rash erythematous
Clinical narrative: Few red bumps on arms, muscle pain, lethargic and was sent home from school. Crying and emotional. Lasted less than two weeks  after getting the HPV.
Age: 0.67
Sex: M
Vaccine: DTAP, HEP, IPV, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction reported. Pt administered Hepatitis A in error-too early. Lot number for Hepatitis A given-M033611.
Sex: U
Vaccine: PPV
Symptoms: Peripheral swelling, Rash, Tenderness
Clinical narrative: This spontaneous report has been received from a pharmacist and referred to a patient of an unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On 07-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 (strength, dose, frequency, route of administration, and lot number were not reported, the expiration date of the vaccine was June 2018) for prophylaxis. Then, on an unknown date in May 2107, the patient experienced a rash. Subsequently, the patient experienced arm swelling and tenderness and was seen at an emergency room. At the time of this report, the outcome of the rash, arm swelling, and tenderness was unknown.  The causality assessment between rash, arm swelling and tenderness with PNEUMOVAX23 was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 08-MAY-2017 from a licensed practical nurse and refers to a 10 week old infant, gender unknown.  There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided. On 14-SEP-2016, the 10 week old infant received vaccination 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 vaccine experienced the 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.  The licensed practical nurse stated they did not know why the temperature excursions occurred but there were no further excursions. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA004973: US-009507513-1705USA004965: US-009507513-1705USA004952: US-009507513-1705USA004967: US-009507513-1608USA012794: Original case US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004974: US-009507513-1705USA004975: 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-009507513-1705USA004946: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004950: US-009507513-1705USA004949: 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-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1705USA004966: US-009507513-1705USA004968: US-009507513-1705USA004969: US-009507513-1705USA005004: US-009507513-1705USA005005: US-009507513-1705USA005006: US-009507513-1705USA005007: 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: US-009507513-1705USA004943:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 08-MAY-2017 from a licensed practical nurse and refers to a 6 month old infant, gender unknown.  There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided.  On 22-AUG-2016, the 6 month old infant received vaccination 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 vaccine experienced the 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. The licensed practical nurse stated they did not know why the temperature excursions occurred but there were no further excursions. Reference MARRS number 1705USA004893 for report on RECOMIVAX HB. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012794: US-009507513-1705USA004973: US-009507513-1705USA004965: US-009507513-1705USA004967: US-009507513-1705USA004952: US-009507513-1705USA004960: 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-009507513-1705USA004946: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: 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-009507513-1705USA004976: 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-009507513-1705USA005004: US-009507513-1705USA005005: US-009507513-1705USA005006: US-009507513-1705USA005007: US-009507513-1608USA012916: US-009507513-1608USA012908: US-009507513-1705USA004887: US-009507513-1705USA004888: US-009507513-1705USA004889: US-009507513-1705USA004890: US-009507513-1705USA004891: US-009507513-1705USA004892: US-009507513-1705USA004893: 1705USA004893 (This is same patient, RECOMBIVAX HB case.) US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004896: US-009507513-1705USA004897: US-009507513-1705USA004898: US-009507513-1705USA004899: US-009507513-1705USA004943:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 08-MAY-2017 from a licensed practical nurse and refers to a 6 month old infant, gender unknown.  There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided.  On 16-SEP-2016, the 6 month old infant received vaccination 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 vaccine experienced the 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.  The licensed practical nurse stated they did not know why the temperature excursions occurred but there were no further excursions.   This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA004961: US-009507513-1705USA004973: US-009507513-1705USA004965: US-009507513-1705USA004967: US-009507513-1705USA004960: US-009507513-1705USA004952: US-009507513-1608USA012794: US-009507513-1705USA004942: US-009507513-1705USA004943: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004946: 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-009507513-1705USA004963: 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-009507513-1705USA004976: 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-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA005004: US-009507513-1705USA005005: US-009507513-1705USA005006: US-009507513-1705USA005007: 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: U
Vaccine: PPV
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: This spontaneous report has been received from a pharmacist and referred to a patient of an unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On 07-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 (strength, dose, frequency, route of administration, and lot number were not reported, the expiration date of the vaccine was June 2018) for prophylaxis. Then, on an unknown date in May 2107, the patient experienced arm swelling and tenderness. The patient called the pharmacy for information regarding these events, however, did not seek medical attention.  At the time of this report, the outcome of the arm swelling and tenderness was unknown. The causality assessment between arm swelling and tenderness with PNEUMOVAX23 was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and referred to 3 patients of unknown ages and genders. The patients' relevant medical history, concurrent conditions, and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with the doses one of expired M-M-R II (strength, dose, and route of administration were not reported; lot number M032153 with an expiration date 22-APR-2017) for prophylaxis that were reconstituted with sterile diluent (MRK) (lot number and expiration date were not reported). There were no adverse effects reported. Additional information is not expected as there was no contact consent provided.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 70 year old male patient. The patient's medical history included an occasional infection (unspecified) once or twice every year and his historical drug included unspecified antibiotics on an unspecified date in October 2016. His concurrent conditions were not reported. Approximately on 18-MAY-2017 (reported as "2 days ago,") the patient was vaccinated with a dose of ZOSTAVAX lot # M037015, expiry date 22-NOV-2017 (dose and route were not reported) for prophylaxis, along with a sterile diluent, lot #M024782, expiry date 29-FEB-2019 (dose, route and indication were not reported.) Concomitant therapies included uspecified "statins." Approximately in May 2017, the patient experienced an unspecified adverse event, that required a prescription for methylprednisolone (MEDROL DOSEPACK) (dose, route and frequency were not reported.) On 20-MAY-2017, the pharmacist reported that the patient presented himself to the pharmacy with the prescription for methylprednisolone (MEDROL DOSEPACK). However, the reason of the prescription was not reported. Information regarding laboratory tests was not provided. At the reporting time, the outcome of the unspecified adverse event was unknown. The reporter did not provide a causality assessment between the event and the ZOSTAVAX or the sterile diluent. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (formulation, strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The vaccine doses were exposed to an unspecified temperature excursion for an unspecified time; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA012266: US-009507513-1705USA012267: US-009507513-1705USA012268: US-009507513-1705USA012269.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 17-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported.    This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 01-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 17-JAN-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 18-JAN-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 14-MAR-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M002418, expiration date 12-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported.    This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-FEB-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M002418, expiration date 12-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported.    This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 13-MAR-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M002418, expiration date 12-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported.    This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 15-MAR-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M002418, expiration date 12-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported.    This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 57 year old female patient. The patient's pertinent medical history and concomitant medications were reported as none. The patient's concurrent conditions included allergy to food (unspecified). On 19-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M035693, expiration date 07-NOV-2017, in the left arm, for prophylaxis (dose and route of administration were not provided). On 20-MAY-2017, the patient reported to the pharmacist "very red, swollen and itchy at the injection site". On 21-MAY-2017, the patient visited the pharmacy and the pharmacist reported the patient had a "2x2 inch blister at the injection site. It was stated that no treatment was given for the adverse event. At the time of reporting the outcome of the events was reported as not recovered. A product quality complaint was not involved. The causality assessment between the adverse events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-MAY-2017, the patient was vaccinated with an expired dose of PROQUAD lot # L045675 and expiration date on 09-MAY-2017 (strength, dose, anatomical location and administration route was not provided) for prophylaxis. No adverse symptoms were reported. The reporting nurse stated that the PROQUAD vaccine did not have any temperature excursions before the administration. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (formulation, strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The vaccine doses were exposed to an unspecified temperature excursion for an unspecified time; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1705USA012266: US-009507513-1705USA012267: US-009507513-1705USA012269: US-009507513-1705USA010555:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (formulation, strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The vaccine doses were exposed to an unspecified temperature excursion for an unspecified time; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1705USA010555: US-009507513-1705USA012266: US-009507513-1705USA012267: US-009507513-1705USA012268:
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Ageusia, Facial paralysis, Fatigue, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: 11-27-16 tingling fingers. 11-28-16 sore neck, fatigue, muscle cramping. 12-1-16 hands and feet going numb. 12-3-16 lost control of left side of face. 12-3-16 start 5 days of IVIG. 12-4-16 lost control of entire face and sense of taste.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle spasms, Neck pain, Paraesthesia, Sensory loss
Clinical narrative: 11-27-16 tingling fingers. 11-28-16 sore neck, fatigue, muscle cramping. 12-1-16 hands and feet going numb. 12-3-16 lost control of left side of face. 12-3-16 start 5 days of IVIG. 12-4-16 lost control of entire face and sense of taste.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient became dizzy, lightheaded, and nauseous. He had a small to moderate amount of clear liquid emesis. He was told to stay seated, given water and a cold pack, and instructed in deep breathing. His symptoms subsided approximately 15 minutes later.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a clinic manager refers to an unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (dose, route of administration and lot numbers were not reported). The reporter was not aware of an adverse experience. There was no previous temperature excursion. The call was made because of data logger. Administered vaccine experienced the temperature excursion of 32 to 35 degrees Fahrenheit for 15 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.  ; Sender's Comments: US-009507513-1705USA012739: US-009507513-1705USA012738: US-009507513-1705USA012737:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 02-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, therapy type: recombinant human albumin (RHA), lot # M021731 with expiration date 29-OCT-2017 (site, dose and route of administration were not reported). The dose was exposed to the temperature of -14.4 degrees Celsius for 54 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a clinic manager refers to an unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, route of administration and lot numbers were not reported). The reporter was not aware of an adverse experience. There was no previous temperature excursion. The call was made because of data logger. Administered vaccine experienced the temperature excursion of 32 to 35 degrees Fahrenheit for 15 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA012739: US-009507513-1705USA012738: US-009507513-1705USA005716.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a clinic manager refers to an unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration and lot numbers were not reported). The reporter was not aware of an adverse experience. There was no previous temperature excursion. The call was made because of data logger. Administered vaccine experienced the temperature excursion of 32 to 35 degrees Fahrenheit for 15 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.  ; Sender's Comments: US-009507513-1705USA012739: US-009507513-1705USA012737: US-009507513-1705USA005716:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a clinic manager refers to an unspecified patients of unknown age and gender. On an unknown date, the patients were orally vaccinated with improperly stored doses of ROTATEQ  (dose and lot numbers were not reported). The reporter was not aware of an adverse experience. There was no previous temperature excursion. The call was made because of data logger. Administered vaccine experienced the temperature excursion of 32 to 35 degrees Fahrenheit for 15 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. ; Sender's Comments:  US-009507513-1705USA012737: US-009507513-1705USA012738: US-009507513-1705USA005716:
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Limb mass, Pain, Pain in extremity
Clinical narrative: Lump in arm since flu shot and very painful. Right arm aches, hurts to lay on and throbbing. Shooting pains if she lifts something. Using ice and ibuprofen which is helpful. Topical diclofenac cream- not helpful. Physical Therapy not helpful
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Lymph node pain, Lymphadenopathy, Rash, Swelling
Clinical narrative: Tenderness, redness, swelling, small eruptions on left side of forehead and left eyebrow. Swelling and tenderness in lymph nodes on left side of face and neck.  Using nutritional supplements to boost immune response.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Tenderness, redness, swelling, small eruptions on left side of forehead and left eyebrow. Swelling and tenderness in lymph nodes on left side of face and neck.  Using nutritional supplements to boost immune response.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reaction or allergies was not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L034370 with an expiration date 08-SEP-2017 and M002064 with an expiration date 12-JAN-2018) for prophylaxis (dose and route of administration were not reported). Concomitant therapies included sterile diluent (manufacturer unknown). Improperly stored vaccines underwent following temperature excursions: 25.6 F for 13 hours and 5.5 F for 1 hour. No symptoms were reported. There was no previous temperature excursion. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information had been received on 10-MAY-2017 from a physician who reported that an unspecified patient (age and gender not reported) was inadvertently administered a "single dose" of M-M-R II (lot# M004899, expiration 27-JAN-2018) on an unspecified date, that had been improperly stored. Temperature was 59F for a time frame of 20 hours (unsupported). There was no previous temperature excursion. Call was because of a data logger. The physician could not provide the lot# and the expiration date for the properly stored sterile water diluent used to reconstitute the dose of M-M-R II. No adverse effects reported. No further information provided. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist (a daughter of the patient) via a company representative refers to a 81-year-old female patient. The patient's medical history included unspecified dementia. The patient' concurrent conditions and concomitant therapies were not reported. It was reported that, the patient did not think that she had any allergies. On an unknown date in February 2015, the patient received unspecified form of PREVNAR (dose, route of administration, lot number and expiry date were not reported) with unspecified results. On an unknown date in March 2016, during the morning hours, the patient was vaccinated with a dose of PNEUMOVAX 23 in the left arm (lot number, expiry date and route of administration were not reported). On an unknown date in March 2016, reported as on the same day in the afternoon or evening, the patient developed a sunburn-like rash and edema in the whole lower part of her left arm. The pharmacist's mother sought medical attention at an unspecified urgent care clinic on that same day, and the recommended treatment was wrapping of the arm to protect it. The representative states that the pharmacist didn't specify whether or not her mother had ever received PNEUMOVAX 23 before the dose that was administered on an unspecified date in March 2016. The outcome of the adverse events was reported as recovered (unknown date). Relatedness between the events and the vaccination with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 15-MAY-2017, the patient was vaccinated with an expired dose of ROTATEQ (Lot # reported as L035508; expiration date 12-MAY-2017) dose was unknown, orally for prophylaxis. No known adverse effects were reported. No further information was provided. No product quality complaint (PQC) was involved. Lot number L035508 is an invalid lot number for ROTATEQ. Additional information has been requested.