chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients received an improperly stored dose of PROQUAD (lot # M033908 expiration date: 16-JAN-2018) (dose and route of administration were not reported) for prophylaxis. No adverse effects reported. Temperature excursion details: Temperature: Between 5 °F and 14 °F; highest temperature: 5.46 °F Time frame: 55 hours Previous temperature excursion? Yes, 13.12 °F for 42 hours and 55 minutes. A data logger was used. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA001822.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients received an improperly stored dose of VARIVAX (lot # M025867 expiration date: 24-MAY-2018; lot # M032494 expiration date: 06-JUL-2018) (dose and route of administration were not reported) for prophylaxis. No adverse effects reported. Temperature excursion details: Temperature: Between 5 °F and 14 °F; highest temperature: 5.46 °F Time frame: 55 hours Previous temperature excursion? Yes, 13.12 °F for 42 hours and 55 minutes.  A data logger was used. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA001818:
Age: 2.0
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 2 year old patient of an unknown gender. There was not information regarding the patient's pertinent medical history, drug reaction, allergies or concomitant therapies. On 11-JAN-2017,  the patient was vaccinated with an improperly stored  dose of VARIVAX (strength, dose, route of administration, and frequency were not provided), lot # M034584 and expiration date 27-JUL-2018, for prophylaxis. The vaccine doses were exposed to a temperature excursion of  -7 Celsius (C) degrees for a time frame of 1 hour and 20 minutes, also she stated that there was not previous temperature excursion; this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA011002: US-009507513-1701USA011003: US-009507513-1701USA011004:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a physician via a company representative referring to a 80 year old female patient. Information regarding medical history, drug reactions, allergies and concomitant therapies was unknown by the reporter. In August-2016, the patient was vaccinated with one dose of ZOSTAVAX (route of administration, strength, lot#, and expiration date were not reported)  for prevent shingles. On an unknown date in 2016, and after the vaccination, the patient developed a mild case of shingles. It was unknown by the reporter if the patient received treatment for the adverse event or if laboratory diagnostics studies were performed. Product quality complaint was not involved. On an unknown date, the patient went to saw the physician. At the time of reporting, the outcome of the a mild case of shingles was unknown.   Additional information is not expected no reporter details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a unspecified patients of unknown gender who were less than 50 years. The patients medical history, concurrent conditions and concomitant therapies were not reported. The pharmacist reported that "he has heard" from unspecified physicians, that on unspecified dates, unspecified patients had received ZOSTAVAX (strength, dose, route and lot number were not reported) for prophylaxis. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 16-JAN-2017, the patient was vaccinated with an improperly stored dose of (incorrect product storage) M-M-R II (lot # M008588 with an expiration date in 16-FEB-2018) for prophylaxis (dose, dose number and frequency were not provided). The dose was stored at a temperature > 46 degrees Fahrenheit but < 77 degrees Fahrenheit with a time frame of 7 hours. No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 4 year old patient of an unknown gender. There was not information regarding the patient's pertinent medical history, drug reaction, allergies or concomitant therapies. On 11-JAN-2017,  the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, and frequency were not provided), lot # M034584 and expiration date 27-JUL-2018, for prophylaxis. The vaccine doses were exposed to a temperature excursion of-7 Celsius (C) degrees for a time frame of 1 hour and 20 minutes, also she stated that there was not previous temperature excursion; this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005479: US-009507513-1701USA011004: US-009507513-1701USA011003:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 4 year old patient of an unknown gender. There was not information regarding the patient's pertinent medical history, drug reaction, allergies or concomitant therapies. On 11-JAN-2017,  the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, and frequency were not provided), lot # M034584 and expiration date 27-JUL-2018, for prophylaxis. The vaccine doses were exposed to a temperature excursion of -7 Celsius (C) degrees for a time frame of 1 hour and 20 minutes, also she stated that there was not previous temperature excursion; this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA011002: US-009507513-1701USA011004: US-009507513-1701USA005479:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 4 year old patient of an unknown gender. There was not information regarding the patient's pertinent medical history, drug reaction, allergies or concomitant therapies. On 11-JAN-2017,  the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, and frequency were not provided), lot # M034584 and expiration date 27-JUL-2018, for prophylaxis. The vaccine doses were exposed to a temperature excursion of-7Celsius (C) degrees for a time frame of 1 hour and 20 minutes, also she stated that there was not previous temperature excursion; this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA011002: US-009507513-1701USA005479: US-009507513-1701USA011003:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.   On an unknown dates,  the patients were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB for prophylaxis (doses, route of administration, anatomical location, lot# and expiration dates were not reported). Administered doses of LIQUID PEDVAXHIB experienced an unknown temperature (out of range temperatures) for an unknown time, on an unknown date. There were multiple previous temperature excursions (dates, time and of the excursions were not reported). It was unknown if the digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012038: US-009507513-1701USA012037: US-009507513-1701USA009285: US-009507513-1701USA012036:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.   On an unknown date, the patients were vaccinated with an improperly stored doses of PNEUMOVAX23 for prophylaxis (dose, route of administration, anatomical location, lot# and expiration date were not reported). Administered doses of PNEUMOVAX23 experienced an unknown temperature (out of range temperatures) for an unknown time, on an unknown date. There were multiple previous temperature excursions (dates, time and of the excursions were not reported). It was unknown if the digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012038: US-009507513-1701USA009285: US-009507513-1701USA012035: US-009507513-1701USA012036:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ZOSTAVAX lot# reported as M041510, expiry date 27-JUL-2017 (dose, route of administration and anatomical location were not reported). It was stored in the temperature in the range of 5 Fahrenheit degrees to 14 Fahrenheit degrees for 15 minutes and in the range of 14 Fahrenheit degrees to 46 Fahrenheit degrees for 1 hour and 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported. Additional information is not expected as no consent for follow up was given.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 24-JAN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX subcutaneously, in the posterior left arm, lot# reported as M035146, expiry date 26-JUL-2017 (dose was not reported). ZOSTAVAX was stored in the temperature higher than 5 Fahrenheit degrees but less than 14 Fahrenheit degrees for 4 hours and 20 minutes. Digital data logger was involved. No previous temperature excursion was performed. No adverse events were reported. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Impaired driving ability, Impaired work ability, Injection site bruising
Clinical narrative: Pain immediate but just usual kind I got with a flu shot.  Later in day noticed red, raised (almost purple) bruising at injection site, but remembered this from daughter's vaccines when she was small so thought it was ordinary.  Diminished over a week.  Weakness, tingling in arm - nothing dramatic, just mild irritation that I was able to ignore.  Noticed a possible slight tremor in left arm after a few weeks.  (Spoke with Dr office today; they have the vaccine as received in right arm.  It was received in the left shoulder.  I asked them to note that I say that is incorrect on the chart.) Very slow, pretty imperceptible over time, increase in pain, ache, weakness and tremor in the left shoulder, arm and hand.  2015 - Dr diagnosed tremor in left arm and for about six months, I was unable to work at desk for more than an hour.  I couldn't drive long distances with left arm, no heavy lifting with left arm but since I didn't do much of that anyway . . . I did not make the connection to the vaccine until about much later when someone told me about their own shoulder injury after a shot.  By 2016, trouble was routine - range of motion limitations impacted abiity to shower, change clothing, general housekeeping, etc.  Advised to see shoulder specialist in 2016 - orthopedist dx frozen shoulder.  Sought deep tissue massage with PT as remedy to increasingly reduced range of motion and constant ache.  PT helped quite a bit, reduced pain and increase range of motion a bit.  PTs thought it was not frozen shoulder but possibly a tissue/muscle/nerve injury and the vaccine as the root cause became more apparent. Right now am pursuing more PT as budget allows.  I have loads more details but not sure those are necessary.  I'm hoping this isn't a permanent disabiity but for now it appears that way.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Joint range of motion decreased, Joint range of motion measurement, Muscular weakness
Clinical narrative: Pain immediate but just usual kind I got with a flu shot.  Later in day noticed red, raised (almost purple) bruising at injection site, but remembered this from daughter's vaccines when she was small so thought it was ordinary.  Diminished over a week.  Weakness, tingling in arm - nothing dramatic, just mild irritation that I was able to ignore.  Noticed a possible slight tremor in left arm after a few weeks.  (Spoke with Dr office today; they have the vaccine as received in right arm.  It was received in the left shoulder.  I asked them to note that I say that is incorrect on the chart.) Very slow, pretty imperceptible over time, increase in pain, ache, weakness and tremor in the left shoulder, arm and hand.  2015 - Dr diagnosed tremor in left arm and for about six months, I was unable to work at desk for more than an hour.  I couldn't drive long distances with left arm, no heavy lifting with left arm but since I didn't do much of that anyway . . . I did not make the connection to the vaccine until about much later when someone told me about their own shoulder injury after a shot.  By 2016, trouble was routine - range of motion limitations impacted abiity to shower, change clothing, general housekeeping, etc.  Advised to see shoulder specialist in 2016 - orthopedist dx frozen shoulder.  Sought deep tissue massage with PT as remedy to increasingly reduced range of motion and constant ache.  PT helped quite a bit, reduced pain and increase range of motion a bit.  PTs thought it was not frozen shoulder but possibly a tissue/muscle/nerve injury and the vaccine as the root cause became more apparent. Right now am pursuing more PT as budget allows.  I have loads more details but not sure those are necessary.  I'm hoping this isn't a permanent disabiity but for now it appears that way.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Paraesthesia, Periarthritis, Tremor, X-ray
Clinical narrative: Pain immediate but just usual kind I got with a flu shot.  Later in day noticed red, raised (almost purple) bruising at injection site, but remembered this from daughter's vaccines when she was small so thought it was ordinary.  Diminished over a week.  Weakness, tingling in arm - nothing dramatic, just mild irritation that I was able to ignore.  Noticed a possible slight tremor in left arm after a few weeks.  (Spoke with Dr office today; they have the vaccine as received in right arm.  It was received in the left shoulder.  I asked them to note that I say that is incorrect on the chart.) Very slow, pretty imperceptible over time, increase in pain, ache, weakness and tremor in the left shoulder, arm and hand.  2015 - Dr diagnosed tremor in left arm and for about six months, I was unable to work at desk for more than an hour.  I couldn't drive long distances with left arm, no heavy lifting with left arm but since I didn't do much of that anyway . . . I did not make the connection to the vaccine until about much later when someone told me about their own shoulder injury after a shot.  By 2016, trouble was routine - range of motion limitations impacted abiity to shower, change clothing, general housekeeping, etc.  Advised to see shoulder specialist in 2016 - orthopedist dx frozen shoulder.  Sought deep tissue massage with PT as remedy to increasingly reduced range of motion and constant ache.  PT helped quite a bit, reduced pain and increase range of motion a bit.  PTs thought it was not frozen shoulder but possibly a tissue/muscle/nerve injury and the vaccine as the root cause became more apparent. Right now am pursuing more PT as budget allows.  I have loads more details but not sure those are necessary.  I'm hoping this isn't a permanent disabiity but for now it appears that way.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Employee developed severe right shoulder & upper arm pain after receiving an influenza vaccination, FLUARIX QUADRIVALENT.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Bowel movement irregularity, Headache, Injection site pain, Mass
Clinical narrative: Woke up with soreness to the injection site, with bad headache, nausea, joint pain (both wrists and knees), rash on forehead and fever; took acetaminophen for relief; noticed decrease in bowel movement for 2 days; noticed painful 1cm lump on R midclavicular area and fullness to soft tissue above R clavicle.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pain, Pyrexia, Rash, Swelling
Clinical narrative: Woke up with soreness to the injection site, with bad headache, nausea, joint pain (both wrists and knees), rash on forehead and fever; took acetaminophen for relief; noticed decrease in bowel movement for 2 days; noticed painful 1cm lump on R midclavicular area and fullness to soft tissue above R clavicle.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Blood pressure decreased, Fall, Foaming at mouth, Loss of consciousness, Posture abnormal
Clinical narrative: Patient lost consciousness, slumped forward and fell out of his chair onto the ground, convulsing and spitting/foaming somewhat at the mouth. He regained consciousness shortly thereafter. His blood pressure was deemed "low" by the attending nurse (but I don't know the exact measurement).
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Seizure
Clinical narrative: Patient lost consciousness, slumped forward and fell out of his chair onto the ground, convulsing and spitting/foaming somewhat at the mouth. He regained consciousness shortly thereafter. His blood pressure was deemed "low" by the attending nurse (but I don't know the exact measurement).
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient describes ongoing Left shoulder pain swelling and soreness since the date of vaccination on 10/12/2016. Patient noticed "a little bump which went away but the soreness continued."
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain, Rash, Swelling, Vomiting
Clinical narrative: Pain, swelling and rash. Occurred one day after. Better with ice and bendadryl. No similar prescription. No fever, chills. No night sweats. No shortness of breath. No wheeze. No tongue or lip swelling. No nausea, vomiting.
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: No adverse event
Clinical narrative: Case number PHEH2015US027167, is a combine initial spontaneous report received from a pharmacist on 23 Dec 2015 and 24 Dec 2015. This report refers to a 16 years old female patient. Past medical history and concomitant medication was not reported. This 16 years old female patient vaccinated with FLUCELVAX (batch number and expiry date: not reported) on an unknown date. No adverse event was reported following this administration error.
Sex: U
Vaccine: HEP, HEPA, PPV
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. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of eighter VAQTA 25/0.5 ml injection (lot # L042838, expiration date 26-MAY-2017; dose, and route of administration were not provided), or RECOMBIVAX HB injection (lot# M013639, expiration date 15-SEP-2017; L036466, expiration date 25-JUN-2017; L030609, expiration date: 26-JUN-2017; dose and route of administration were not provided), or PNEUMOVAX23 injection (lot# M022947, expiration date: 12-NOV-2017; dose and route of administration were not provided). Nurse reported that at least one dose was definitely administered to the patient, but she could not determine which of the three products might have been administered at the time of the report. There was no adverse effect reported. The vaccines experienced the temperature excursion of >46 degrees Fahrenheit but <77 degrees Fahrenheit for 72 hours. There was no previous temperature excursions. Digital data logger was not involved. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of approximately 58 year old at the vaccination time. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. In July 2015 (reported as one and half years ago), the patient was vaccinated with ZOSTAVAX intramuscularly (dose, lot # and expiration date were not reported). On an unknown date, after administration, the patient experienced the injection site swelled into a large knot, that lasted for several days. The symptoms resolved after several days (unspecified date). No product quality complaint was involved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On multiple unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M023169, expiration date: 13-JUN-2018), intramuscularly. No adverse effects were reported. Product quality complaint (PQC) was not involved. Administered doses of vaccines experienced the temperature excursion of >8 degrees Celsius but <25 degrees Celsius for 8 hours and 54 minutes. Data logger was involved. The previous excursions were between 0 to 2 degrees Celsius for 5 hours and 26 minutes and below 0 degrees Celsius for 3 hours and 5 minutes. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: PATIENT REPORTED REDNESS ON 1/24 AT INJECTION SITE MEASURING 4" IN DIAMETER.  ON 1/25, SHE REPORTED 5" OF REDNESS AND HEAT FROM SITE.  ON 1/26, SHE REPORTED COOLER TEMPERATURE, REDNESS RECEDING BUT CENTER STILL VERY RED.  PATIENT STATED SHE WAS ALLERGIC TO BENADRYL AND AFRAID TO TAKE ANY ANTIHISTAMINES SO SHE APPLIED HYDROCORTISONE CREAM INSTEAD WHICH SEEMED TO HELP.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cough, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Pt developed fever, rash, running nose, and cough during the nigh after receiving the 4 month series.
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: No adverse event
Clinical narrative: Case number PHEH2015US027169, is a combined initial and follow up spontaneous report received from a pharmacist on 23 Dec 2015 and 24 Dec 2015. This report refers to a 13 years old female patient. Past medical history and concomitant medications were not reported. This 13 year old female patient was vaccinated with FLUCELVAX (batch number and expiry: not reported) on unknown date. No adverse event was reported following this administration error.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Malaise, Mobility decreased, Nausea, Pyrexia
Clinical narrative: Information had been received on 11-JAN-2017 from a 67 year old female patient who on 10-JAN-2017 was vaccinated with one dose of PNEUMOVAX23 (lot# M029681, expiration date 22-JAN-2018) for unspecified indication. The patient reported that she experienced fever, nausea, "feeling sick", the inability to move her right arm, and pain at the injection site after receiving PNEUMOVAX23. She stated that she started feeling the side effects a few hours after receiving the vaccine. Patient's present status was recovering. Patient talked with physician and received unspecified treatment for her adverse events. No further adverse event information was provided. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a male patient over 65 years old. The patient's concurrent conditions and medical history were not reported. Approximately in January 2017 (reported as "this past week"), the patient was vaccinated with a dose of PNEUMOVAX23 (concentration, dose, route, anatomical place of vaccination, lot # and expiration date were not provided), for pneumonia prevention.  Information regarding concomitant therapies was not reported. Approximately in January 2017 (reported as "the day after he received the vaccine"), the patient experienced achiness, soreness (pain), chills and fever (pyrexia). Therefore, the patient seek for medical attention by contacting the physician and subsequently a treatment was prescribed for the adverse events. At the time of reporting, the patient was recovering from pain, chills and pyrexia.    The reporter did not provide a causality assessment between PNEUMOVAX23, pain, chills and pyrexia. Additional information is not expected, as the reporter did not provide consent for further contact.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema multiforme, Rash, Skin lesion
Clinical narrative: This is a spontaneous report from a contactable nurse (Internal medicine). A 64-year-old female patient received the 1st dose of PREVNAR 13, (Lot # R28322, Expiry Date 01Mar2018) IM at 0.5ml, single in deltoid on 09Jan2017 14:30 for immunization, in the physician office. Medical history included ongoing depression, ongoing osteopenia, ongoing vitamin D deficiency, ongoing hyperthyroidism, ongoing type 2 diabetes mellitus, ongoing gastrooesophageal reflux disease (GERD), ongoing blood cholesterol increased, hypertension, drug hypersensitivity to Codeine, Penicillin and Sulfa Anti-biotic. Concomitant medication included BABY ASPIRIN 81 mg, 1x/day, BENAZEPRIL 1 DF, 1x/day for hypertension, BUPROPION 150 mg, 1x/day for depression, CALCIUM W/VITAMIN D NOS 400 IU, 2x/day for osteopenia and vitamin D deficiency, LEVOTHYROXINE 50 ug, 1x/day for hyperthyroidism, LEXAPRO 20 mg, 1x/day for depression, METFORMIN 500 mg, 1x/day at bed time for Type 2 diabetes mellitus for Diabetes Type 2, NEXIUM 20 mg, 1x/day for GERD, SIMVASTATIN 40 mg, 1x/day for high cholesterol, VENTOLIN for shortness of breath, RELAFEN 500 mg, 1x/day, ONDANSETRON for nausea. The patient previously took codeine experiencing drug hypersensitivity. Last vaccine that she received was her Flu vaccine but that was in October (year not mentioned). No other vaccine was given on the same day of the suspect. On 12Jan2017 (as believed by the reporter who did not know the specific date) the patient experienced rash on her chest, her upper extremities and in her thighs; multiple two to three centimetre area lesions and the doctor made the diagnosis of Erythema Multiforme. The outcome of the event was not recovered. Erythema multiforme was reported as worsened. The reporter stated the doctor considered there was not a reasonable possibility that the event was related to the suspect vaccine. Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported event cannot be excluded based on the known adverse event profile and on the temporal relationship. The Company however considers the administration of concomitant medications an important confounder in the independent assessment of the causal relationship.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer who reported for his wife. A female patient of an unspecified age and race received PREVNAR 13, via an unspecified route of administration at single dose in the arm in Jan2017 for immunisation. The patient medical history and concomitant medications were not reported. In Jan2017, the patient experienced swollen at the site of injection, red and quite painful at the site of injection. The outcome of the events was unknown. The events were described as follows: She has on her arm on the injection site, it's kind of swollen you know somewhat visible, she definitely feels very sensitive and then it is red and quite painful. No follow-up attempts possible. No further information expected.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. A 79 years old male consumer received pneumococcal 13-val conj vac (dipht crm197 protein) (unknown manufacturer) on an unspecified date in 2016 (2 months before the report) in left upper arm at single dose for immunization. Relevant medical history was none. Concomitant medication included influenza vaccine in Oct2016 in right arm for immunization. Since an unspecified date in 2016, about a week after getting the vaccine, the consumer experienced whole body aches (could barely get out of bed) and pain mostly in his left arm at the injection site. Pain was worse when he woke up in the morning. He went to the doctor about 4-5 weeks before this report due to body aches and took an unspecified steroid for 2-3 days and the symptoms went completely away but about 2 days before the report the pain was coming back; he started feeling the pain mostly in his left arm again and some other areas in the body. Relevant tests were none. The final events outcome was unknown. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Age: 39.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Infection, Swelling
Clinical narrative: Swollen shoulder C/W infection.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, PNC13
Symptoms: Blood culture negative, Chest X-ray normal, Full blood count normal, Mental status changes, Pyrexia
Clinical narrative: 1/20 developed fever to 104.5 with period of altered mental status seen in ED for brief resolved unexplained event. Hospitalized x36 hrs for observation and evaluation for fever without a source. Blood culture negative fever resolved after 48 hrs. Rash 2 days later suggestive of Roseola as source rather than vaccine.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, PNC13
Symptoms: Rash, Roseola
Clinical narrative: 1/20 developed fever to 104.5 with period of altered mental status seen in ED for brief resolved unexplained event. Hospitalized x36 hrs for observation and evaluation for fever without a source. Blood culture negative fever resolved after 48 hrs. Rash 2 days later suggestive of Roseola as source rather than vaccine.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during breast feeding, No adverse event
Clinical narrative: Case number PHEH2016US029108, is an initial spontaneous report received from a nurse on 03 Nov 2016. This report refers to a 31 years old female patient. Past medical history and concomitant medications were not reported. This 31 year old breast feeding patient was vaccinated with FLUCELVAX (batch number 187276) at a dose of 0.5 ml intramuscularly on 08 Oct 2016. No adverse event was reported following vaccine exposure via breast milk. The case was lost to follow up at initial.
Age: 73.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Burning sensation, Feeding disorder, Impaired driving ability, Influenza
Clinical narrative: Burning sensation when the shot was administered. Went from my upper arm to my wrist. My right arm became painful and I lost the ability to lift it or stretch it. In a few days I became sick with flu symptoms. I was very sick. Couldn't eat and felt nauseous. Shaky all over. Couldn't think clearly. Couldn't drive. I am currently getting PT for my right shoulder because of pain and lack of range and strength.
Age: 73.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Joint range of motion decreased, Malaise, Mobility decreased, Musculoskeletal pain, Nausea
Clinical narrative: Burning sensation when the shot was administered. Went from my upper arm to my wrist. My right arm became painful and I lost the ability to lift it or stretch it. In a few days I became sick with flu symptoms. I was very sick. Couldn't eat and felt nauseous. Shaky all over. Couldn't think clearly. Couldn't drive. I am currently getting PT for my right shoulder because of pain and lack of range and strength.
Age: 73.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pain in extremity, Thinking abnormal, Tremor
Clinical narrative: Burning sensation when the shot was administered. Went from my upper arm to my wrist. My right arm became painful and I lost the ability to lift it or stretch it. In a few days I became sick with flu symptoms. I was very sick. Couldn't eat and felt nauseous. Shaky all over. Couldn't think clearly. Couldn't drive. I am currently getting PT for my right shoulder because of pain and lack of range and strength.
Age: 73.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Burning sensation, Feeding disorder, Immediate post-injection reaction, Impaired driving ability
Clinical narrative: Burning sensation when the shot was administered. Went from my upper arm to my wrist. My right arm became painful and I lost the ability to lift it or stretch it. In a few days I became sick with flu symptoms. I was very sick. Couldn't eat and felt nauseous. Shaky all over. Couldn't think clearly. Couldn't drive. I am currently getting PT for my right shoulder because of pain and lack of range and strength.
Age: 73.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Influenza, Joint range of motion decreased, Malaise, Mental impairment, Mobility decreased
Clinical narrative: Burning sensation when the shot was administered. Went from my upper arm to my wrist. My right arm became painful and I lost the ability to lift it or stretch it. In a few days I became sick with flu symptoms. I was very sick. Couldn't eat and felt nauseous. Shaky all over. Couldn't think clearly. Couldn't drive. I am currently getting PT for my right shoulder because of pain and lack of range and strength.
Age: 73.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Musculoskeletal pain, Nausea, Pain in extremity, Tremor
Clinical narrative: Burning sensation when the shot was administered. Went from my upper arm to my wrist. My right arm became painful and I lost the ability to lift it or stretch it. In a few days I became sick with flu symptoms. I was very sick. Couldn't eat and felt nauseous. Shaky all over. Couldn't think clearly. Couldn't drive. I am currently getting PT for my right shoulder because of pain and lack of range and strength.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Last night, the injection site on her left arm became red, hard, warm, swollen, and itchy. She called this morning about 9:30 AM to report this to us.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Rash and redness-- it is now all better but the patient wanted it reported.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site papule, Injection site rash
Clinical narrative: Rash: Red papules on B/L thighs in a circular area around where vaccines were administered. No fevers, no other rash.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event...Expired vaccine was inadvertently administered to patient. Manufacturer (Merck) confirmed that the Lot is still effective.
Age: 39.0
Sex: F
Vaccine: FLUR3
Symptoms: Flushing, Hyperaesthesia, Pruritus
Clinical narrative: Skin sensitivity, itchy face in cheeks and mandible folds, flushing in face. Patient took diphenhydramine 25 mg liquid at 10:50 and one more capsule 20 minutes later.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant therapies. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot number M031650 with expiration date of 16-MAR-2018 orally (strenght, dosage schedule and anatomical location were not provided) for prophylaxis.The administered doses were exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes (digital data logger) without any previous temperature excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009504: US-009507513-1701USA008111:
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 15-DEC-2016, the patient was inadvertently vaccinated with a dose of ROTATEQ orally, which had a lot # L008053 and an expiration date of 30-NOV-2016 (concentration and dose were not provided), for prophylaxis. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Drug administered at inappropriate site, Erythema, Local reaction, Mass, Pain
Clinical narrative: RN administered MMR vaccine in non preferred injection site.  RN administered vaccine SQ abdomen.  Preferred immunization site for MMR is upper outer arm SQ. Patient called with local reaction-  rash "size of grapefruit", hard lump under skin "size of half dollar", itching, pain, redness, and swelling.
Age: 49.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: RN administered MMR vaccine in non preferred injection site.  RN administered vaccine SQ abdomen.  Preferred immunization site for MMR is upper outer arm SQ. Patient called with local reaction-  rash "size of grapefruit", hard lump under skin "size of half dollar", itching, pain, redness, and swelling.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Dizziness, Fatigue, Heart rate increased, Hypoaesthesia
Clinical narrative: 1/25/17: felt weak, fatigued, dizzy at work all day. Went to sleep early and awoke from sleep at 10:30pm with racing heart rate, heart palpitations, dizziness, numbness of limbs, unable to move body. Symptoms lasted a few minutes. Went back to sleep. Woke up at 1am with the same symptoms. Rapid heart rate, numbness of limbs, dizziness. Went back to sleep. Woke up 1/26/17 at 7:30 with red welt at injection site and localized rash on neck.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site urticaria, Mobility decreased, Palpitations, Rash
Clinical narrative: 1/25/17: felt weak, fatigued, dizzy at work all day. Went to sleep early and awoke from sleep at 10:30pm with racing heart rate, heart palpitations, dizziness, numbness of limbs, unable to move body. Symptoms lasted a few minutes. Went back to sleep. Woke up at 1am with the same symptoms. Rapid heart rate, numbness of limbs, dizziness. Went back to sleep. Woke up 1/26/17 at 7:30 with red welt at injection site and localized rash on neck.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Nodule, Pain in extremity
Clinical narrative: Arm hurts and has a knot. Has gotten worse ever since vaccination. Has not seen a doctor for this condition yet.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Allergy test positive, Food allergy, Rash erythematous, Urticaria, Vomiting
Clinical narrative: First symptom was vomiting. Vomiting lasted 6 days - 2 to 3 times a day. No treatment given. Second symptoms was red rash/ hives over torso, neck, arms, legs. Rash started 01/06/17 and lasted 5 days. Doctor recommended Benadryl.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abnormal behaviour, Hyperventilation, Respiratory rate increased
Clinical narrative: Vitals Signs temp: 99.1,B/P 124/82,Immunizations administered, Student reported little breakfast. Student given juice/Candy to elevate blood glucose level. Student was breathing deeply and rapidly. School Nurse stated unusual behavior for student. Feet were elevated. Student ambulated to School nurse office, Parents notified. Ambulanced called Rapid breathing persist. When Ambulance arrived. EPI Pen administered.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Insomnia, Mobility decreased
Clinical narrative: Could not lift arm, site extremely heated, upper arm extremely sore to touch. Could not sleep,all night almost 2 nights.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness
Clinical narrative: Right arm weakness.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Injection site discolouration
Clinical narrative: LT arm inject site @ deltoid shows 3/4 size discoloration( deep brown with clearly defined oval edge). Denies numbness, tingling, itching, soreness, fever, or drainage. Has not changed shape or color since 1/5/17.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: Headache, Arthralgia and fever.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Pyrexia
Clinical narrative: Turned really red and feverish about 1 week after injection.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site infection
Clinical narrative: Turned really red and feverish about 1 week after injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Peripheral swelling, Skin warm
Clinical narrative: PATIENT ARM HAD SWELL UP WITH A HEATED KNOT IN HER ARM AND DIDN'T GO DOWN UNTIL ABOUT TWO WEEKS LATER.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pruritus, Pruritus
Clinical narrative: Patient complained of itchiness at the injection site the day after administration. Then since has itchiness and numbness in the arm.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Eye movement disorder, Posture abnormal
Clinical narrative: After administration, client slumped back in chair and eyes rolled back. Had client lean forward with head between knees and her mother and my supervisor assisted her up while I got ice pack. Had client lay on exam table with legs elevated. BP 120/90 P 64.  She lay there for about 5-10 minutes.  Took BP again 110/80 P 62.  She sat up and drank some water and ate a few crackers.  Sat up with legs dangling for a few minutes before standing after she said she was no longer feeling dizzy. Walked out with her and her mother and brother to make sure she got to car ok and suggested she rest and take it easy for the rest of the evening and to drink plenty of fluids and to eat well. Her mother said she had not had a former reaction to the vaccine (this was the third and final dose).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Raised, swollen, red, hot area about 2 inches by 1 inch at site of injection.  **NO** "blisters".
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMRV, DTAP, FLUX, IPV, MMRV
Symptoms: Cough, Crying, Decreased appetite, Emotional distress, Erythema
Clinical narrative: TIRED, HEADACHE, SLEEPY, COLD, FEVER, EXHAUSTED. DOESN'T WANT TO EAT OR DRINK ANYTHING. COLD AND HOT (KEPT GOING ON AND OFF) AND JUST WANT TO SLEEP. COUGHING, RUNNING NOSES AND REDNESS AROUND THE EYES. HE FELT TENDER AT THE INJECTION SITE RIGHT AFTER THE SHOTS. MMRV, FLU, POLIO, DTAP. VERY EMOTIONAL. JUST TEARS ROLLING DOWN HIS CHEEKS AND DOESN'T WANT TO DO ANYTHING AT ALL.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMRV, DTAP, FLUX, IPV, MMRV
Symptoms: Fatigue, Feeling of body temperature change, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: TIRED, HEADACHE, SLEEPY, COLD, FEVER, EXHAUSTED. DOESN'T WANT TO EAT OR DRINK ANYTHING. COLD AND HOT (KEPT GOING ON AND OFF) AND JUST WANT TO SLEEP. COUGHING, RUNNING NOSES AND REDNESS AROUND THE EYES. HE FELT TENDER AT THE INJECTION SITE RIGHT AFTER THE SHOTS. MMRV, FLU, POLIO, DTAP. VERY EMOTIONAL. JUST TEARS ROLLING DOWN HIS CHEEKS AND DOESN'T WANT TO DO ANYTHING AT ALL.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMRV, DTAP, FLUX, IPV, MMRV
Symptoms: Lethargy, Nasopharyngitis, Pyrexia, Rhinorrhoea, Somnolence
Clinical narrative: TIRED, HEADACHE, SLEEPY, COLD, FEVER, EXHAUSTED. DOESN'T WANT TO EAT OR DRINK ANYTHING. COLD AND HOT (KEPT GOING ON AND OFF) AND JUST WANT TO SLEEP. COUGHING, RUNNING NOSES AND REDNESS AROUND THE EYES. HE FELT TENDER AT THE INJECTION SITE RIGHT AFTER THE SHOTS. MMRV, FLU, POLIO, DTAP. VERY EMOTIONAL. JUST TEARS ROLLING DOWN HIS CHEEKS AND DOESN'T WANT TO DO ANYTHING AT ALL.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMRV, DTAP, FLUX, IPV, MMRV
Symptoms: Cough, Crying, Diet refusal, Emotional distress, Erythema of eyelid
Clinical narrative: TIRED, HEADACHE, SLEEPY, COLD, FEVER, EXHAUSTED. DOESN'T WANT TO EAT OR DRINK ANYTHING. COLD AND HOT (KEPT GOING ON AND OFF) AND JUST WANT TO SLEEP. COUGHING, RUNNING NOSES AND REDNESS AROUND THE EYES. HE FELT TENDER AT THE INJECTION SITE RIGHT AFTER THE SHOTS. MMRV, FLU, POLIO, DTAP. VERY EMOTIONAL. JUST TEARS ROLLING DOWN HIS CHEEKS AND DOESN'T WANT TO DO ANYTHING AT ALL.