chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 16-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (lot # R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 06-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R029815 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: a dose of PNEUMOV AX 23 was administered after being improperly stored at an elevated temperature; No adverse effects were reported in the patient; This spontaneous report was received from a medical assistant concerning a patient of unknown age, gender and race. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On unknown date, the patient was vaccinated with one dose of improperly stored Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) intramuscular, lot number S012245 with expiration date on 09-FEB-2021 (frequency was not reported) for prophylaxis.  Administered dose of vaccine experienced elevated temperature. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported in the patient.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: abdominal rash/rash on arm; shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2018).   In September 2018, the patient received the 2nd dose of Shingrix. On 19th June 2019, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  The reporting pharmacist was the patient. The patient developed a rash on her arm that she initially thought was poison oak, but she later developed a rash on her abdomen. She has never had a rash on her abdomen before. The reporter consented to follow up.  Call transferred to MI.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: achy; fatigue; chills; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 27th June 2019, less than a day after receiving Shingrix, the patient experienced joint pain, fatigue and chills. On an unknown date, the outcome of the joint pain, fatigue and chills were not recovered/not resolved.   It was unknown if the reporter considered the joint pain, fatigue and chills to be related to Shingrix.  Additional details were provided as follows: In night of one day before reporting, the patient began feeling achy in her joints, with fatigue and chills. The reporter gave consent to follow up. There is a discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Pain in extremity, Skin warm
Clinical narrative: Wrong Route of Administration; pain left arm; left arm warm to the touch; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. In June 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and skin warm. On 26th June 2019, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the pain in arm and skin warm were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the pain in arm and skin warm to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The registered nurse stated that, she administered a Shingrix dose to the patient subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The patient was experienced pain in the left arm and his left arm was warm to the touch. There is a discrepancy between the outcome reported in the structured field " recovering/resolving" and the outcome reported in the sender's comment " not recovered/not resolved."
Sex: F
Vaccine: VARZOS
Symptoms: Solar dermatitis
Clinical narrative: rash/rash over sun exposed areas; This case was reported by a physician via call center representative and described the occurrence of solar rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced solar rash. On an unknown date, the outcome of the solar rash was unknown.   It was unknown if the reporter considered the solar rash to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient developed a rash over sun exposed areas 1 week after the vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever; tiredness; achey all over; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 3P25J, expiry date 21st September 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date).   On 25th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced fever, tiredness and general body pain. On an unknown date, the outcome of the fever, tiredness and general body pain were unknown.  Additional information received were as follows: The patient experienced sore arm after receiving 1st dose of Shingrix. The patient received 2nd dose of Shingrix on left arm. The patient experienced achey all over and soreness in arm.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine; shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 28th June 2019, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced drug dose administration interval too long. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  At the time of reporting, the patient developed shingles. The shingles was treated with acyclovir. It was also over 6 months since 1st dose and the patient was considering getting the 2nd dose, which led to lengthening of vaccination schedule.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to plants (Aloe vera plant allegy).   On 28th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 28th March 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix vaccine on left deltoid. The patient experienced flu like symptoms after receiving 1st dose of Shingrix. For tolerance of 2nd dose, refer case US2019AMR118900.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Muscle Pain; Pain in arms; Pain in the knees; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced muscle pain, pain in arm and knee pain. The patient was treated with prednisone. On an unknown date, the outcome of the muscle pain was recovering/resolving and the outcome of the pain in arm and knee pain were unknown.   It was unknown if the reporter considered the muscle pain, pain in arm and knee pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine on left arm. The patient experienced muscle pain, pain in arms and knees after receiving Shingrix vaccine. The patient was prescribed prednisolone. Consent to follow up was provided. No further details were provided. This case was linked to case US2019AMR120937, due to same patient.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal faeces, Injection site pain, Mucous stools, Muscular weakness, Pyrexia
Clinical narrative: Fever OF 99.8 degree F; bowel movement slimy; legs are weak; Injection site Pain; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included chlortalidone (Chlorthalidone).   On 27th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On 28th June 2019, the patient experienced fever, abnormal stools and lower extremities weakness of. On 28th June 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the abnormal stools and lower extremities weakness of were unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the fever, abnormal stools, lower extremities weakness of and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine before the date of reporting and had a fever of 99.8 degrees Fahrenheit on same day the fever had resolved.  The patient also described that her first bowel movement of the day was a little slimy like there was mucus.  The patient then had a normal bowel movement. The next bowel movement a little slimy.  The patient said that her legs are little weak at the time of reporting but that could be due to her physical therapy she had this past.  The patient did describe that she had some pain at the injection site that resolved quickly.  The patient did not consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Feeling abnormal, Headache, Pyrexia
Clinical narrative: headaches; fever; diarrhea; felt terrible; shivering; This case was reported by a physician via call center representative and described the occurrence of headache in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a day after receiving Shingrix, the patient experienced headache, fever, shivering, diarrhea and feels awful. On an unknown date, the outcome of the headache, fever, shivering, diarrhea and feels awful were recovered/resolved.   It was unknown if the reporter considered the headache, fever, shivering, diarrhea and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that his wife received Shingrix. After vaccination in the evening she developed headaches, fever, shivering and diarrhea. The shivering was so bad that it was like she had rigors. The shivering resolved within about a day, but she still felt terrible for 3 days before the symptoms resolved. The patient looked so bad that he was close to taking her to the emergency room when it suddenly improved.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a nurse via the patient assistance program and described the occurrence of shingles in a 90-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.    On 27th June 2019, the patient received the 1st dose of Shingrix .5 ml. On 28th June 2019, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The batch number and expiry date of Shingrix was not reported, as the patient received vaccine elsewhere. The nurse reported that, the patient received vaccine at the pharmacy, and on the date of reporting, the patient experienced Shingles.
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood pressure increased, Hypersensitivity, Immunodeficiency, Impaired work ability, Joint swelling
Clinical narrative: Throat swelled; Knees started to swell; Blood pressure increased; Immune system has been compromised; Can not work and she can not do anything; Allergic reaction; This is a spontaneous report from a contactable consumer reporting for herself. This 67-year-old female patient received on 15May2019 pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot X39675) at single dose as she had pneumonia. Medical history included pneumonia, allergy and allergic to cats. Concomitant medications were none. In May2019 the patient experienced throat swelled that recovered in May2019 (serious for hospitalization) and blood pressure increased with outcome of unknown. On 10Jun2019 knees started to swell. This event recovered in Jun2019. Patient was in hospital for knees started to swell from 16Jun2019 to 20Jun2019. On an unknown date in 2019 patient had immune system compromised, allergic reaction and cannot work and she cannot do anything, all with outcome of unknown. Treatment was provided for the events of allergic reaction, blood pressure increased, and throat swelled. Laboratory data included blood pressure increased in May2019. Course of the events were reported as follows: She had pneumococcal 13-val conj vac (dipht crm197 protein) after having pneumonia. The Saturday after she got the shot, her throat swelled up and went to a physician on the following Monday. They thought it was a salivary gland and was told to eat lemons. When she was going to the doctor to have tests read, the ENT told her that it was an allergic reaction and gave her steroids. She cannot work, and she cannot do anything. She has been hospitalized. She had high blood pressure. She was taking medication before but then her dose was increased. Her knees started to swell up. She is supposed to see an immunologist on 25Jun2019 as her immune system has been compromised. The steroids have reduced the swelling.
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Loss of personal independence in daily activities, Pharyngeal swelling
Clinical narrative: Throat swelled; Knees started to swell; Blood pressure increased; Immune system has been compromised; Can not work and she can not do anything; Allergic reaction; This is a spontaneous report from a contactable consumer reporting for herself. This 67-year-old female patient received on 15May2019 pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot X39675) at single dose as she had pneumonia. Medical history included pneumonia, allergy and allergic to cats. Concomitant medications were none. In May2019 the patient experienced throat swelled that recovered in May2019 (serious for hospitalization) and blood pressure increased with outcome of unknown. On 10Jun2019 knees started to swell. This event recovered in Jun2019. Patient was in hospital for knees started to swell from 16Jun2019 to 20Jun2019. On an unknown date in 2019 patient had immune system compromised, allergic reaction and cannot work and she cannot do anything, all with outcome of unknown. Treatment was provided for the events of allergic reaction, blood pressure increased, and throat swelled. Laboratory data included blood pressure increased in May2019. Course of the events were reported as follows: She had pneumococcal 13-val conj vac (dipht crm197 protein) after having pneumonia. The Saturday after she got the shot, her throat swelled up and went to a physician on the following Monday. They thought it was a salivary gland and was told to eat lemons. When she was going to the doctor to have tests read, the ENT told her that it was an allergic reaction and gave her steroids. She cannot work, and she cannot do anything. She has been hospitalized. She had high blood pressure. She was taking medication before but then her dose was increased. Her knees started to swell up. She is supposed to see an immunologist on 25Jun2019 as her immune system has been compromised. The steroids have reduced the swelling.
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hypertension, Joint swelling, Rash, Swelling, Visual impairment
Clinical narrative: Throat swelled; Knees started to swell; Blood pressure increased; Immune system has been compromised; Can not work and she can not do anything; Allergic reaction; This is a spontaneous report from a contactable consumer reporting for herself. This 67-year-old female patient received on 15May2019 pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot X39675) at single dose as she had pneumonia. Medical history included pneumonia, allergy and allergic to cats. Concomitant medications were none. In May2019 the patient experienced throat swelled that recovered in May2019 (serious for hospitalization) and blood pressure increased with outcome of unknown. On 10Jun2019 knees started to swell. This event recovered in Jun2019. Patient was in hospital for knees started to swell from 16Jun2019 to 20Jun2019. On an unknown date in 2019 patient had immune system compromised, allergic reaction and cannot work and she cannot do anything, all with outcome of unknown. Treatment was provided for the events of allergic reaction, blood pressure increased, and throat swelled. Laboratory data included blood pressure increased in May2019. Course of the events were reported as follows: She had pneumococcal 13-val conj vac (dipht crm197 protein) after having pneumonia. The Saturday after she got the shot, her throat swelled up and went to a physician on the following Monday. They thought it was a salivary gland and was told to eat lemons. When she was going to the doctor to have tests read, the ENT told her that it was an allergic reaction and gave her steroids. She cannot work, and she cannot do anything. She has been hospitalized. She had high blood pressure. She was taking medication before but then her dose was increased. Her knees started to swell up. She is supposed to see an immunologist on 25Jun2019 as her immune system has been compromised. The steroids have reduced the swelling.
Sex: F
Vaccine: PNC13
Symptoms: Arthritis, Bronchitis
Clinical narrative: Arthritis; Bronchitis; The patient have PREVENAR 13 almost yearly; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients (mother and herself). This is 1st of 2 reports.   A 69-year-old female patient (reporter) receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date at single dose (once every year) for immunisation.   Medical history included pneumonia in the past. The patient's concomitant medications were not reported.   The patient experienced arthritis (non-serious) on an unspecified date with outcome of unknown, bronchitis (non-serious) on an unspecified date with outcome of unknown.   The patient and her mother have PREVENAR 13 almost yearly. They do it themselves, not through an organization, not recommended by physician.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019282907 Same reporter, product, similar event/ different patient
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given 2nd dose of Shingrix within 4 weeks of receiving the 1st dose.  Per product guidelines, that dose is considered invalid and patient is to receive a valid 2nd dose again in 2 months from this invalid dose.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Back pain, Crying, Erythema, Hyperhidrosis
Clinical narrative: Right after PCV23 was administered, patient started crying and writhing because of abdominal and back pain.,His face was transiently reddened, palms felt sweaty and he would not permit exam of his back and abdomen. Vital signs: O2 sat in RM air 96%, HR 78. BP right arm seated 112/68. After about 5minutes he reverted to baseline. Abdo and back exams were normal, and lower extremities CNS exam was also normal. After 30minutes observation, patient was deemed to be well enough to be discharged home
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Neurological examination normal
Clinical narrative: Right after PCV23 was administered, patient started crying and writhing because of abdominal and back pain.,His face was transiently reddened, palms felt sweaty and he would not permit exam of his back and abdomen. Vital signs: O2 sat in RM air 96%, HR 78. BP right arm seated 112/68. After about 5minutes he reverted to baseline. Abdo and back exams were normal, and lower extremities CNS exam was also normal. After 30minutes observation, patient was deemed to be well enough to be discharged home
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: The patient called about 30-60 min after receiving the 1st dose of shingrix saying her lips were tingling and asked if there was penicillin in the vaccine. The pharmacist told her there was no penicillin and to take benadryl and if it were to get worse to go to the emergency room. The pharmacist tried following up several times on 7/2/19 but the patient did not answer. On 7/3/19 the pharmacist called and the patient said she continued taking benadryl on 7/2/19 and her lips had a slight tingling sensation but not enough to medicate.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Dizziness, Headache
Clinical narrative: Dizziness,weakness,severe headache, fever, nausea,muscle aches,shivering,stomach pain
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Dizziness,weakness,severe headache, fever, nausea,muscle aches,shivering,stomach pain
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Rash in axilla appeared on 7/7/19.  No fever, chills or body aches.  Area is sore and not does not itch
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: expired DTaP vaccine  (later revaccinated)
Age: 23.0
Sex: F
Vaccine: DTAP, HEP, MMR
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: Given wrong dose given DTap instead of Tdap
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: R upper arm with raised, erythematous, warm area. Approx 1inx1in. Larger surrounding area w/mild erythema. Entire right upper arm tender to touch.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Herpes zoster, Rash pruritic
Clinical narrative: shingles; This spontaneous report was received from a company representative who refers to an 81-year-old female patient (her mother). Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 01-JAN-2007, the patient was vaccinated with the first dose of zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not reported). On 30-APR-2007, she was vaccinated with the second dose of zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not reported). Concomitant therapies included sterile diluent.  On 18-JUN-2019 (reported as 6 days ago), an itchy rash appeared. The rash presented unilaterally as small blisters on the patient's left ankle and left lower back and she complained of fatigue. The patient had no fever or headache. A doctor at urgent care confirmed she had shingles.  The outcome of shingles was unknown.  The relatedness between shingles and the vaccine was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 16-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (lot # R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 17-APR-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number reported as R021930 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  Lot number R021930 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000964: US-009507513-1907USA000965:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 22-APR-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number reported as R021930 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  Lot number R021930 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001841: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001842: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 30-APR-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number reported as R021930 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  Lot number R021930 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 01-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number reported as R021930 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  Lot number R021930 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
Sex: U
Vaccine: HPV9
Symptoms: Nasal oedema, Throat irritation
Clinical narrative: swelling of nose; throat itching; This spontaneous report was received from a nurse regarding a 12-year-old patient with unspecified reactions to bug bites and seasonal allergies to pollen, trees, grass. The patient's medical history included a laser removal of lip hemangioma, concomitant therapies were not reported. On 01-JUL-2019 at 11 am the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, frequency were not reported, lot # R022422 and expiration date) via intramuscular route for prophylaxis (also reported as to prevent HPV). On 01-JUL-2019 at 1:30 pm, the patient's mother  called later to report that patient had developed swelling of nose (nasal oedema) and throat itching (throat irritation). The patient had received treatment for the adverse events. It was unknown if lab or diagnostic studies were performed. The patient did not sought medical attention she has called to the office. There was no involvement of product quality complaint (PQC). The patient had recovered from the events, nasal oedema and throat irritation. Causality assessment was not reported.