chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ oral liquid (orally, lot # M019690, expiration date 02-NOV-2017 and lot # M019708, expiration date 25-OCT-2017) for prophylaxis (strength and dose were unknown).  On unknown dates, the following temperature excursions were registered : between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 20 minutes and between 46°F and 77°F for 10 minutes. There were no previous temperature excursions. Digital Data Logger was involved. No adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008578: US-009507513-1701USA008577: US-009507513-1701USA002579: US-009507513-1701USA008575: US-009507513-1701USA008579:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with improperly stored VAQTA injection (lot # M002268, expiration date 20-SEP-2017) for prophylaxis (strength, dose and route were unknown).  On unknown dates, the following temperature excursions were registered : between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 20 minutes and between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 10 minutes. There was no previous temperature excursions. Digital Data Logger was involved. No adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008578: US-009507513-1701USA002579: US-009507513-1701USA008576: US-009507513-1701USA008575: US-009507513-1701USA008579:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with improperly stored M-M-R II injection (lot # M008588, expiration date 16-FEB-2018, lot # L040960, expiration date 16-OCT-2017 and lot # reported as L027432, expiration date 22-JUL-2017) for prophylaxis (strength, dose and route were unknown). On unknown dates, the following temperature excursions were registered: between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 20 minutes and between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 10 minutes. There were no previous temperature excursions. Digital Data Logger was involved. No adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002579: US-009507513-1701USA008577: US-009507513-1701USA008576: US-009507513-1701USA008575: US-009507513-1701USA008579.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant, referring to patient of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On an unknown date,  the patient was vaccinated with a dose of an improperly stored VARIVAX (route of administration, dose and frequency were not provided) for prophylaxis  lot # reported as L015460, expiration date 20-JUL-2017. The reporter stated that the current temperature range of the vaccine excursion was15 Fahrenheit (F) and the time frame was 8 hours. On 06-OCT-2016, the previous temperature excursion was 31 Fahrenheit (F) during 3 hours, this information was registered in a data logger. No adverse effect was reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA000942:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with doses of VARIVAX (lot number and expiration dates not reported) for prophylaxis, which were improperly stored at >5°F but < 14°F for 12 hours and 46 minutes and >14°F but < 46°F for 16 minutes. No adverse effects were reported.  There were no previous temperature excursions and call was done because of a data logger. No further information was provided. This is one of 5 reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009572: US-009507513-1701USA009570: US-009507513-1701USA009569: US-009507513-1701USA009571:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 23-DEC-2016, the patient was vaccinated with a expired dose of VAQTA, lot number L034381, expiration date 21-DEC-2016, (dose number, route and anatomical location were not reported), for prophylaxis. No adverse effects were reported. No product quality complain was involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information is not expected because consent for follow up was not given. Sender's Comments: US-009507513-1701USA009559: US-009507513-1701USA001773.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 30-DEC-2016, the patient was vaccinated with a expired dose of VAQTA, lot number L034381, expiration date 21-DEC-2016, (dose number, route and anatomical location were not reported), for prophylaxis. No adverse effects were reported. No product quality complain was involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information is not expected because consent for follow up was not given.; Sender's Comments: US-009507513-1701USA009558: US-009507513-1701USA001773:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with doses of ROTATEQ (lot number and expiration dates not reported) for prophylaxis, which were improperly stored at >46°F but < 77°F for 15 minutes. No adverse effects were reported. There were no previous temperature excursions and call was done because of a data logger. No further information was provided. This is one of 5 reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA009556: US-009507513-1701USA009570: US-009507513-1701USA009571: US-009507513-1701USA009572.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA (lot number and expiration dates not reported) for prophylaxis, which were improperly stored at >46°F but < 77°F for 15 minutes. No adverse effects were reported. There were no previous temperature excursions and call was done because of a data logger. No further information was provided. This is one of 5 reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA009556: US-009507513-1701USA009569: US-009507513-1701USA009571: US-009507513-1701USA009572.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with doses of RECOMBIVAX (lot number and expiration dates not reported) for prophylaxis, which were improperly stored at >46°F but < 77°F for 15 minutes. No adverse effects were reported. There were no previous temperature excursions and call was done because of a data logger. No further information was provided. This is one of 5 reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA009556: US-009507513-1701USA009569: US-009507513-1701USA009570: US-009507513-1701USA009572.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with doses of PNEUMOVAX (lot number and expiration dates not reported) for prophylaxis, which were improperly stored at >46°F but < 77°F for 15 minutes. No adverse effects were reported. There were no previous temperature excursions and call was done because of a data logger. No further information was provided. This is one of 5 reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA009556: US-009507513-1701USA009569: US-009507513-1701USA009570: US-009507513-1701USA009571.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (dosing details, lot# and expiry date were not reported) for prophylaxis. On an unknown date post vaccination, the patients developed shingles. The outcome of shingles was unknown. The reporter did not provide the causality between shingles and ZOSTAVAX. There were no product quality complaints (PQC) involved. Additional information is not expected as the reporter did not wish further contact.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: MOTHER CALLED CLINIC THAT PATIENT HAS RIGHT ARM WHERE VACCINE WAS ADMINISTERED (TDAP) SWOLLEN, RED, AND HOT, AND HAS PAIN FROM SITE TO ELBOW, AND REFERS HE CANNOT MOVE ARM MUCH. SHE TOOK HIM TO THE EMERGENCY ROOM, WHERE THE DOCTOR REFERRED THAT IT WAS AN ADVERSE EFFECT, THEY ADMINISTERED ANTIBIOTICS AND ANTIINFLAMMATORY MEDICATION IV FOR TWO DAYS. ON 1/23/2017 I CALLED TO FOLLOW UP ON PATIENT AND MOTHER REFERS TO SEE HIM MUCH BETTER, WITH MOVEMENT, AND NO PAIN, STILL ON MEDICATION PRESCRIBED BY DOCTOR. SHE REFERS THAT SHE WILL NO LONGER BE VACCINATING CHILD SINCE HE STATES THAT HE NO LONGERS WANTS TO RECEIVE VACCINES. I ORIENTATED MOTHER AND EXPLAINED THE IMPORTANCE TO VACCINATE PATIENT.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: MOTHER CALLED CLINIC THAT PATIENT HAS RIGHT ARM WHERE VACCINE WAS ADMINISTERED (TDAP) SWOLLEN, RED, AND HOT, AND HAS PAIN FROM SITE TO ELBOW, AND REFERS HE CANNOT MOVE ARM MUCH. SHE TOOK HIM TO THE EMERGENCY ROOM, WHERE THE DOCTOR REFERRED THAT IT WAS AN ADVERSE EFFECT, THEY ADMINISTERED ANTIBIOTICS AND ANTIINFLAMMATORY MEDICATION IV FOR TWO DAYS. ON 1/23/2017 I CALLED TO FOLLOW UP ON PATIENT AND MOTHER REFERS TO SEE HIM MUCH BETTER, WITH MOVEMENT, AND NO PAIN, STILL ON MEDICATION PRESCRIBED BY DOCTOR. SHE REFERS THAT SHE WILL NO LONGER BE VACCINATING CHILD SINCE HE STATES THAT HE NO LONGERS WANTS TO RECEIVE VACCINES. I ORIENTATED MOTHER AND EXPLAINED THE IMPORTANCE TO VACCINATE PATIENT.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Pyrexia
Clinical narrative: Started shivering, then developed a fever that eventually rose to 105.5 about midnight. Continued to have fever off and on at least 3 days (today). Not sure how long this will continue.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness, White blood cell count increased
Clinical narrative: Redness, tenderness, warmth, swelling from deltoid to elbow treated with two days of IV ceftriaxone followed by oral cephalexin.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients, concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M024261 (expiry date: 30-JUL-2018), M017983 (expiry date: 30-MAY-2018), M011840 (expiry date 01-FEB-2018) (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines underwent the temperature excursion of 0-2 degrees Celsius for 3 hours, which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA001650.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding medical history, drug allergies, concurrent conditions and concomitant therapies were not provided. On an unknown date, (reported as previously) the patient was vaccinated with GARDASIL, (strength, dose, frequency, route of administration, lot# and expiration date were unknown by the reporter) for prophylaxis. Subsequently, on an unspecified date, the reporter stated that the patient was in the office to continue the series with GARDASIL 9 (strength, dose, frequency, route of administration, lot# and expiration date were unknown by the reporter) for prophylaxis (interchange of vaccine products). No adverse effect reported. A product quality complaint was not involved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient did not have any relevant medical history or drug reactions/ allergies. The patient was not taking any concomitant medication at the time of this report. On 01-DEC-2016, the patient was vaccinated with ZOSTAVAX lot # M032638, expiration date: 30-JUN-2017, subcutaneous for prophylaxis (dose was not provided). On approximately 05-JAN-2017 reported as "about 5 weeks after vaccination",  the patient developed "itchy raised bumps at the nape of her neck", a "raised line" at the nape of her neck and "itchy bumps beneath her breast". It was reported that the patient used hydrocortisone cream (unspecified strength) on unknown dates. The patient changed her shampoo once during that time. It was also noted that the rash was "not symmetrical". At the time of this report, the outcome the events was reported as recovering. The reporter did not assess the relationship between ZOSTAVAX and the events. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2008, the patient was vaccinated with a first dose of GARDASIL (dose, route of administration, lot# and expiration date were not reported) in the vaccination series. On an unspecified date in January 2016, the patient was vaccinated with a second dose of GARDASIL 9 lot# M024261, expiration date 30-JUL-2018 (dose and route of administration were not reported) and then he/she received a third dose of GARDASIL 9 on 09-JAN-2017. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Seroconversion test negative
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a currently 21 year old female patient. The patient's medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of M-M-R II, (dose, frequency, route of administration, lot#, and indication were unknown by the reporter) for prophylaxis. On an unspecified date, after the vaccination, the patient had MMR titers drawn which showed no seroconversion after vaccination. It was unknown by the reporter if the patient received treatment, sought medical attention or required hospitalization. A product quality complaint was not involved. At the time of reporting, the outcome of events were unknown. The relatedness between adverse events and M-M-R II, was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection, subcutaneously, lot # M022401, expiry date 01-NOV-2017 (dose and anatomical location were not specified) for prophylaxis. The administered doses of PROQUAD underwent a temperature excursion between -15 Celsius degrees and -10 Celsius degrees for 747 minutes. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Blood test, Bronchitis, Dizziness, Dyspnoea, Muscle twitching
Clinical narrative: This spontaneous report was received from a female patient of unknown age, reporting on herself. The patient's concurrent condition included scoliosis. The patient had no concomitant medications nor drug reactions or allergies. On an unknown date in February 2014, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly (dose, anatomical location, lot# and expiry date were not reported) as pneumonia vaccine. On an unknown date in March 2014, (also reported as "a couple weeks after the vaccination"), the patient experienced extreme dizziness, trouble breathing, nerve pain, bronchitis, and "muscle twisting". Unspecified treatment was given for the events. The patient had many tests done (magnetic resonance imaging (MRI), X-ray, blood work - results unspecified) and the physician still could not diagnose it and treat it permanently. The patient visited a rheumatologist. At the time of the report, the patient was undergoing unspecified treatment to find why she was having sharp nerve pains, especially in her shoulders. The patient did not recover from the events. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Neuralgia, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: This spontaneous report was received from a female patient of unknown age, reporting on herself. The patient's concurrent condition included scoliosis. The patient had no concomitant medications nor drug reactions or allergies. On an unknown date in February 2014, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly (dose, anatomical location, lot# and expiry date were not reported) as pneumonia vaccine. On an unknown date in March 2014, (also reported as "a couple weeks after the vaccination"), the patient experienced extreme dizziness, trouble breathing, nerve pain, bronchitis, and "muscle twisting". Unspecified treatment was given for the events. The patient had many tests done (magnetic resonance imaging (MRI), X-ray, blood work - results unspecified) and the physician still could not diagnose it and treat it permanently. The patient visited a rheumatologist. At the time of the report, the patient was undergoing unspecified treatment to find why she was having sharp nerve pains, especially in her shoulders. The patient did not recover from the events. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning several unspecified number of patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant therapies reported. Between 16-DEC-2016 and 12-JAN-2017, the patients were vaccinated with unspecified improperly stored doses in series of VAQTA lot number: L031196 with expiration date: 05-FEB-2017 (strenght, dosage schedule, anatomical location and route of administration were not provided), for prophylaxis. On 16-DEC-2016, the administered doses were exposed to a lowest temperature of 29.5°F for 1.5 hours (digital data logger) without any previous temperature excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA006679:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning unspecified number of patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant therapies reported. Between 16-DEC-2016 and 12-JAN-2017, the patients were vaccinated with unspecified improperly stored doses of PNEUMOVAX 23 lot number: M035104 with expiration date: 06-MAY-2018 and lot number: M038359 with expiration date: 13-MAY-2018 (strength, dosage schedule, anatomical location and route of administration were not provided), for prophylaxis. On 16-DEC-2016, the administered doses were exposed to a lowest temperature of 29.5°F for 1.5 hours (digital data logger) without any previous temperature excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA006101.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: This spontaneous report as received from a consumer, a patient's mother, refers to a 11 year old female patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies. No information about concurrent conditions was reported. On 18-JAN-2017, the patient was vaccinated by a nurse with a dose of GARDASIL 9, injection, 0.5 ml (route of administration, lot number and expiration date were not reported). On 18-JAN-2017, (immediately after the patient received the vaccine), the patient experienced a seizure. The patient sought for medical attention (was visited by a physician) and was given orange juice as a treatment. No laboratory test diagnostic was performed. The outcome of seizure was reported as recovered/resolved on 18-JAN-2017. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of seizure was considered as medically significant. Additional information is not expected, as there was no consent to contact the physician.
Age: 0.92
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a 11 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 12-AUG-2016, the patient was vaccinated with a dose of M-M-R II (unspecified strength, dose and frequency) administered subcutaneously in the left lower thigh (lot number: L024267; expiration date: 07-JAN-2017) at age "11 months and 24 days" (drug administered to patient of inappropriate age) for prophylaxis. The patient had not experienced an adverse effect at the time of reporting. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Rash, Rash macular
Clinical narrative: Broke out in red blotchy areas over face and forehead.  Legs also had some redness.  Red areas were not raised.  No respiratory symptoms.   Redness was gone by 11:30 AM.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Death
Clinical narrative: My son was put down for a nap about 12 or a bit after and he never woke up.
Age: 7.0
Sex: M
Vaccine: DTAP, FLU4, HEP, IPV, MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Cough, Infantile spitting up, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Excessive redness at injection site, large lump at injection site size of Brussel sprout, hot to touch, threw up once, spitting up, stuffy nose, dry cough. Used detoxing mud mask on injection site for following week.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Nasal congestion, Vomiting
Clinical narrative: Excessive redness at injection site, large lump at injection site size of Brussel sprout, hot to touch, threw up once, spitting up, stuffy nose, dry cough. Used detoxing mud mask on injection site for following week.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored GARDASIL 9 (dose and route of administration were not provided) for prophylaxis. No adverse event was reported. Temperature/Time frame: 32F and 36F for 30 minutes, 32F and 36F for 30 minutes, 32F and 36F for 30 minutes (3 identical excursions only identified). A data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 19-JAN-2017,  the patient was vaccinated with an improperly stored dose of VARIVAX with lot number M025866 and expiration date of 24-MAY-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at more than 5 Fahrenheit degrees but less than 14 Fahrenheit degrees for 51 hours and 15 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This male consumer patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient received a second dose of PREVNAR 13 by mistake, 18 months after his initial dose. The patient noted that his arm was sore after the second injection. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Respiratory symptom
Clinical narrative: This is a spontaneous report from a contactable physician. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included myasthenia gravis, chronic obstructive pulmonary and asthma, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced upper respiratory symptoms on an unspecified date after the vaccination. The patient was given antibiotics that did not improve his symptoms, so he was treated with steroids and his symptoms improved. The outcome of the event was recovering.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer received via a sales representative. A female patient of an unspecified age and race received PREVNAR 13 on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient said nurse was in a hurry and she rushed when she gave the injection. Since an unknown date after vaccination her arm was red and swollen. Events outcome was unknown. No follow-up attempts possible. No further information expected.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Dizziness, Fatigue, Heart rate increased, Tremor
Clinical narrative: Sudden heart rate increase Aprox. 2 hrs. after a FLU VACCINE SINGLE DOSE INJECTION-3YR+(FLUARIX, FLULAVAL, FLUZONE). My Normal rate is in low 60's -- heart rate more than doubled - very suddenly - lasted for Aprox. 1-1/2 - 2 hours. Shakiness, lightheaded, felt like passing out. Heart rate decreased after an hour slightly, then elevated again, then went down and stayed down. I consulted with daughter who is an RN. I put pressure on my Carotid Artery on one side to see if rate would decrease. No change. I proceeded to just sit and relax until it dissipated and if it was not going to, was prepared to seek further medical treatment. The remainder of the day I was extremely tired.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Shoulder pain at site of injection. Limited range of motion. Prescribed pain medication did not control pain.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Dyskinesia, Eye movement disorder, Muscle contractions involuntary, Tic
Clinical narrative: Sometime end of August, He started rolling his eyes, but we thought it was just something he was doing. Later he started shaking his head involuntarily. During the month of November, when he started shaking his head so many times and clenching, it concerned us. When we read online, it sounded like Tics. Thinking back, it all looks like it started after vaccination.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Rash, Rash vesicular
Clinical narrative: Vesicular Rash to trunk, neck and head, headache.
Age: 66.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Patient fainted and fell on the floor and hit his head. He lost consciousness for 1-2 minutes and regained consciousness.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a 68 year old female patient, referring to herself. No pertinent medical history, concurrent conditions and concomitant therapies were reported. On an unspecified date in June 2008, the patient was vaccinated with a dose of ZOSTAVAX refrigerated vial 19400 PFU, administered subcutaneously (lot number and expiration date were not reported) for prophylaxis (reported as prevention of shingles). On 13-OCT-2014, the patient developed a pimple-like bump on her forehead near her eyebrow, which began to spread to her scalp. The patient visit her dermatologist, who confirmed that she had shingles. Consequently, the patient was treated with azithromycin (Z-PAK) and other unspecified medications (at the reporting time, it was uncertain of medicines received, including the azithromycin (Z-PAK)). No lab diagnostics studies were performed. The patient reported, that about 3 weeks later (on approximately 03-NOV-2014) the shingles rash began to clear up, and eventually went away (on an unspecified date in 2014). The Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Upper respiratory tract infection
Clinical narrative: Information has been received from a pharmacist referring to a currently 56 year old male patient. His medical history, concomitant therapies and concurrent conditions were not provided. On 09-JAN-2017, the patient was vaccinated with ZOSTAVAX (lot # M035149, expiration date 31-OCT-2017) (dose was not provided) as reported, it was administered subcutaneously in the left arm, for prescription from prophylaxis. On an unknown date, the patient experienced upper respiratory infection and on 11-JAN-2017, 2 days after receiving ZOSTAVAX, a patient's healthcare provider (unspecified) prescribed MEDROL for the patient. Another unspecified healthcare provider prescribed a bronchodilator, PROAIR and unspecified antibiotic. The pharmacist stated that he assumed that the prescriptions were for upper respiratory infection. The outcome of upper respiratory infection was unknown. The reporter considered upper respiratory infection to be not related to ZOSTAVAX. Upon internal review the event of upper respiratory infection was considered medically significant. Additional information has been requested. Company Causality Assessment:  Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the investigational therapy and the reported event cannot be established. Lack of medical substantiation precludes a proper causality assessment. Company Comment- No changes to the investigational product safety information are warranted at this time. Merck and Co., Inc., known as MSD outside of the country, continues to monitor the safety profile of the investigational product.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Information regarding their pertinent medical history, concurrent conditions and drug reactions/ allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (which had the possible lot numbers and expiration dates: M027342 and 01-JUN-2018; M024683 and 18-MAY-2018; M006722 and 18-FEB-2018; M027885 and 03-JUN-2018; M024678 and 18-MAY-2018; or M027886 and 03-JUN-2018; however, the dose, dosage number, and anatomical location were unknown), subcutaneously, for prophylaxis. No concomitant therapies were reported. The stated vaccine experienced a temperature excursion of -13 °C for a time frame of 9 minutes. No previous temperature excursions had occurred and this call had not been made because of a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Injection site pain, Muscle injury, Myalgia, Nerve injury
Clinical narrative: PREVNAR 13 joint, muscle pain (ongoing) right arm. FLUZONE High Dose: Joint, muscle, nerve pain. Shoulder to wrist (left arm). Last few weeks (injection site) pain also.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Neuralgia
Clinical narrative: PREVNAR 13 joint, muscle pain (ongoing) right arm. FLUZONE High Dose: Joint, muscle, nerve pain. Shoulder to wrist (left arm). Last few weeks (injection site) pain also.
Sex: F
Vaccine: FLU3
Symptoms: Impaired work ability, Injection site pain
Clinical narrative: Case number PHHY2016US027453, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 609755) website on 29 Feb 2016. This report refers to a 35-years-old female patient. Past medical history and current conditions were not reported. She was vaccinated with FLUVIRIN (batch number: 157901) intramuscularly in left arm on 01 Oct 2015. On 02 Oct 2015, she experienced pain around the rotating left shoulder. She also reported that she missed work for the first two days and used adhesive tape to wrap around the upper arm to give support. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash
Clinical narrative: Patient started to develop tingling in the face and eventually turned into a shingles rash on face and scalp.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Syncope
Clinical narrative: Syncope. Rested for 30 min.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Altered state of consciousness, Back pain, Chest pain, Cough, Erythema
Clinical narrative: Pain in arm, chest, jaw, back.  Fever.  Wheezy, cough, arm swelled up and red. extreme sweating, almost passed out.  Nausea.  Red swollen arm lasted 5 days but better.  Went to Dr. Pharmacy said this happens sometimes and to put cold pack on arm.  Still not feeling well.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hyperhidrosis, Malaise, Nausea, Pain in extremity, Pain in jaw
Clinical narrative: Pain in arm, chest, jaw, back.  Fever.  Wheezy, cough, arm swelled up and red. extreme sweating, almost passed out.  Nausea.  Red swollen arm lasted 5 days but better.  Went to Dr. Pharmacy said this happens sometimes and to put cold pack on arm.  Still not feeling well.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Pyrexia, Wheezing
Clinical narrative: Pain in arm, chest, jaw, back.  Fever.  Wheezy, cough, arm swelled up and red. extreme sweating, almost passed out.  Nausea.  Red swollen arm lasted 5 days but better.  Went to Dr. Pharmacy said this happens sometimes and to put cold pack on arm.  Still not feeling well.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chest pain, Injection site erythema, Injection site swelling, Pain in jaw, Pyrexia
Clinical narrative: Pain in arm, chest, jaw, back.  Fever.  Wheezy, cough, arm swelled up and red. extreme sweating, almost passed out.  Nausea.  Red swollen arm lasted 5 days but better.  Went to Dr. Pharmacy said this happens sometimes and to put cold pack on arm.  Still not feeling well.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pneumonia
Clinical narrative: Patient complained of severe shoulder pain and significant rash and redness at injection site. She stated she was admitted to hospital with pneumonia a little over one month after receiving vaccination.
Age: 1.58
Sex: F
Vaccine: MMR
Symptoms: Cough, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Parents report patient with fever 102.4F runny nose and cough, irritability night of vaccine administration.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring a 15 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 13-FEB-2015, the patient was vaccinated with a dose of GARDASIL for prophylaxis (dose, route, lot # and expiration date were not reported) and on 04-DEC-2015 was vaccinated with a dose of GARDASIL 9 for prophylaxis (dose, route, lot # and expiration date were not reported). No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Administration site induration, Chills, Erythema, Pain, Pyrexia
Clinical narrative: Chills, Low-Grade fever initially, then 100.7 Fever the following day on 1/21/2017. Large induration at administration site, redness, pain, body aches.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Bursa injury, Bursitis, Injection site pain, Nuclear magnetic resonance imaging abnormal, Periarthritis
Clinical narrative: Extreme pain in shoulder of vaccinated arm, followed by frozen shoulder and continuing pain. Treatment included resting arm, hot and cold compresses and massage, followed by three sessions of physical therapy beginning on 02/25/2016 and ending 06/04/2016.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Tendon disorder, Tendon injury, X-ray limb abnormal
Clinical narrative: Extreme pain in shoulder of vaccinated arm, followed by frozen shoulder and continuing pain. Treatment included resting arm, hot and cold compresses and massage, followed by three sessions of physical therapy beginning on 02/25/2016 and ending 06/04/2016.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site inflammation, Injection site pain
Clinical narrative: Immediately after influenza vaccination, the patient developed R shoulder pain near the injection site that has continued until today (23 Jan 2017). On exam, she suffers from decreased range of motion so there seems to be some inflammation/involvement of the shoulder joint where she received the vaccine.
Age: 41.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Pain
Clinical narrative: PT REPORTED LARGE AMOUNT OF SWELLING AT SITE MAKING THE MUSCLE AREA VERY LARGE AND PAIN THE NEXT MORNING UPON AWAKENING, FELT FINE PHYSICALLY. AFTER FOLLOW UP ON DAY 3 PT REPORTED NO PAIN AND SWELLING HAD GONE AWAY.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: LEFT ARM SWELLING, REDNESS, TENDER TO TOUCH AND LOW GRADE FEVER.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccine administered on 1/11/17-noticed swelling at site of TDAP-redness (L) arm where MENACTRA and HPV given-got worse 1/17/17 brought in today-area of redness.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Disorientation, Dizziness, Heart rate increased, Heart rate irregular
Clinical narrative: 24 hours after administration of vaccine, child began having dizziness, weakness, disorientation, and a fast, irregular heartbeat.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Vaccines were given Thursday pm, wok up Friday feeling nauseated and her (L) arm started swelling, itching and was red where she had the vaccine. Redness and swelling spread to 5" x 3" by Saturday along with occipital headache, dizziness, and fatigue. Pt called provider on Saturday evening and then was seen in office 1/23/17. With normal PE, besides 3x5" fading erythema of (L) upper arm.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Injection site swelling, Nausea
Clinical narrative: Vaccines were given Thursday pm, wok up Friday feeling nauseated and her (L) arm started swelling, itching and was red where she had the vaccine. Redness and swelling spread to 5" x 3" by Saturday along with occipital headache, dizziness, and fatigue. Pt called provider on Saturday evening and then was seen in office 1/23/17. With normal PE, besides 3x5" fading erythema of (L) upper arm.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Vaccine both received 1-19-17. Received FLUVIRIN and PNEUMVOAX 23. Left upper arm red, swollen, hot, went down arm. Went to ER 1-22-17. Received BACTRIM, BENADRYL, prednisone Rx.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Vaccine both received 1-19-17. Received FLUVIRIN and PNEUMVOAX 23. Left upper arm red, swollen, hot, went down arm. Went to ER 1-22-17. Received BACTRIM, BENADRYL, prednisone Rx.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Throat irritation
Clinical narrative: Patient complained of scratchy throat. Swelling and redness at injection site. Low grade fever.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Pain in extremity, X-ray abnormal
Clinical narrative: Reported soreness in the arm from Immunization. Had x-rays done where it showed some inflammation.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Swelling and redness at vaccination sites of both arms. Left arm reaction 10 cm x 12 cm, right arm reaction 8 cm x 5 1/2 cm.
Age: 41.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Injected limb mobility decreased, Injection site erythema, Vaccination site pain
Clinical narrative: Sore arm where vaccine was given. A bright red spot and hard to move for few days. Headache.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen (R) deltoid, redness, warm to the touch 1/19/2017.
Age: 62.0
Sex: U
Vaccine: TDAP
Symptoms: Arthralgia, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Left shoulder joint pain very extreme went to ER three (3) times and saw personal doctor within three weeks, pain meds, 2 injections, still no relief of numb finger and bicep arm weak.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Flu shot adm in left deltoid. PNEUMOVAX 23 adm in right deltoid } on 1/12/17 on 1/18/17 pt alerted via phone that right arm had red spot, 2 horizontal lines, and was painful.
Age: 60.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Patient developed (L) shoulder pain 2 days following vaccine administration worsening 2 weeks following administration with reduced range of motion.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated that she had an injection site reaction. (Red, swollen, hot, headache, dizziness).