chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Flatulence, Muscle contractions involuntary, Muscle spasticity, Muscular weakness, Myoclonus
Clinical narrative: This spontaneous report was received from a company representative and refers to a 25 year old male patient. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown. On 02-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9; on 02-MAY-2018, the patient was vaccinated with the second dose of GARDASIL 9. Both doses were administered for prophylaxis (strength, route of administration, frequency, lot# and expiration date were unknown). On April 2018, the patient experienced gradual onset of generalized extremity and facial weakness (muscular weakness)(facial paresis) with muscle fasciculations (muscle contractions involuntary), hypnic jerks (myoclonus), hypersalivation (salivary hypersecretion), startle reflex (exaggerated startle response), spasticity (muscle spasticity), gas (flatulence), trouble swallowing (dysphagia), and difficulty breathing (dyspnoea) ongoing over last few months. On an unknown date, the patient had lab test results of ANA 1:640 and an MRI of brain and spine that were reported as normal. The patient has been evaluated by a primary health physician, a neurologist and a rheumatologist with inconclusive results. Causality between GARDASIL 9 and the mentioned events was unknown.
Sex: M
Vaccine: HPV9
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Salivary hypersecretion
Clinical narrative: This spontaneous report was received from a company representative and refers to a 25 year old male patient. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown. On 02-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9; on 02-MAY-2018, the patient was vaccinated with the second dose of GARDASIL 9. Both doses were administered for prophylaxis (strength, route of administration, frequency, lot# and expiration date were unknown). On April 2018, the patient experienced gradual onset of generalized extremity and facial weakness (muscular weakness)(facial paresis) with muscle fasciculations (muscle contractions involuntary), hypnic jerks (myoclonus), hypersalivation (salivary hypersecretion), startle reflex (exaggerated startle response), spasticity (muscle spasticity), gas (flatulence), trouble swallowing (dysphagia), and difficulty breathing (dyspnoea) ongoing over last few months. On an unknown date, the patient had lab test results of ANA 1:640 and an MRI of brain and spine that were reported as normal. The patient has been evaluated by a primary health physician, a neurologist and a rheumatologist with inconclusive results. Causality between GARDASIL 9 and the mentioned events was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Chemotherapy, Leukaemia
Clinical narrative: Information has been received from a physician via a company representative concerning to an 18 year old female patient. The patient had not medical history, drug reactions nor concomitant medications. On an unknown date, the patient completed the 3 dose GARDASIL (lot numbers and expiration date not reported), intramuscular vaccination series for prophylaxis. On an unknown date, after completion of GARDASIL, the patient was diagnosed with leukemia. In 2013, the patient completed an unspecified chemotherapy regimen and recovered from leukemia. No lab diagnostic test were performed. The reporter considered leukemia to be life threatening. Upon internal review, leukemia was considered medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This non valid spontaneous report was received from a pharmacist referring to five unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. Between 13-JUL-2018 and 02-AUG-2018, the patients were vaccinated with an expired dose of VARIVAX (dose, anatomical location and route of administration were not reported) lot # M033214, expiration date: 13-JUL-2018, indicated for prophylaxis.  The reporter did not know the lot# and expiration date of the sterile diluent used to reconstitute the vaccine as the doses were administered at another clinic. There was no previous temperature excursions reported. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB), lot number M031574 with expiration date on 11-NOV-2018 (strength, Thimerosal status, anatomical location, dose number and route of administration were not provided), for prophylaxis. The RECOMBIVAX HB was stored at a temperature range of 47 degrees Fahrenheit (°F) to 77 °F (55°F), for a time frame of 30 hours and 43 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1808USA002487: US-009507513-1808USA002488: US-009507513-1808USA002489: US-009507513-1808USA002490: US-009507513-1808USA002491:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot number N022015 with expiration date on 10-MAR-2019 (strength and dose number were not provided), for prophylaxis. The ROTATEQ was stored at a temperature range of 47 degrees Fahrenheit (°F) to 77 °F (55°F), for a time frame of 30 hours and 43 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1808USA002488: US-009507513-1808USA002489: US-009507513-1808USA002490: US-009507513-1808USA002491: US-009507513-1808USA002453:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot number N022015 with expiration date on 10-MAR-2019 (strength and dose number were not provided), for prophylaxis. The ROTATEQ was stored at a temperature range of 47 degrees Fahrenheit (°F) to 77 °F (55°F), for a time frame of 30 hours and 43 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1808USA002487: US-009507513-1808USA002489: US-009507513-1808USA002490: US-009507513-1808USA002491: US-009507513-1808USA002453.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot number N022015 with expiration date on 10-MAR-2019 (strength and dose number were not provided), for prophylaxis. The ROTATEQ was stored at a temperature range of 47 degrees Fahrenheit (°F) to 77 °F (55°F), for a time frame of 30 hours and 43 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1808USA002487: US-009507513-1808USA002488: US-009507513-1808USA002490: US-009507513-1808USA002491: US-009507513-1808USA002453.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot number N022015 with expiration date on 10-MAR-2019 (strength and dose number were not provided), for prophylaxis. The ROTATEQ was stored at a temperature range of 47 degrees Fahrenheit (°F) to 77 °F (55°F), for a time frame of 30 hours and 43 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1808USA002487: US-009507513-1808USA002488: US-009507513-1808USA002489: US-009507513-1808USA002491: US-009507513-1808USA002453.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot number N022015 with expiration date on 10-MAR-2019 (strength and dose number were not provided), for prophylaxis. The ROTATEQ was stored at a temperature range of 47 degrees Fahrenheit (°F) to 77 °F (55°F), for a time frame of 30 hours and 43 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1808USA002487: US-009507513-1808USA002488: US-009507513-1808USA002489: US-009507513-1808USA002490: US-009507513-1808USA002453.
Sex: F
Vaccine: HPV4
Symptoms: Mood altered, Personality change
Clinical narrative: This spontaneous report was received from a nurse via a company representative, on behalf of the patient's mother, concerning a currently 24 year old female patient. The patient's historical condition, concurrent condition and concomitant therapy were unknown. On an unknown date (also reported as "years ago"), the patient received the 1 dose of GARDASIL (strength, dose detail, route,  lot# and expiration date were not reported) for prophylaxis. As it reported, the patient received all 3 doses of GARDASIL at unspecified age, with unknown dose detail, route,  lot# or expiration date. The patient's mother reported that her daughter experienced personality change which she described as "moody" on unknown date. At the time of reporting, the outcome of personality change and moody was unknown. The causality assessment between GARDASIL and the aforementioned events was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA001902.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Injection site pain, Lethargy, Myalgia, Pyrexia
Clinical narrative: Aching in muscles, lethargic, soreness around injection site, hot and cold feeling, minor fever. Symptoms were gone after 48 hours.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: After injection felt achiness through entire back, around 5p had chills, had tingling in fingertips in the evening, had headache, fever of 102.8. Took TYLENOL and Ibuprofen which decreased fever to 100.1. States next day still had fever and redness with soreness at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: After injection felt achiness through entire back, around 5p had chills, had tingling in fingertips in the evening, had headache, fever of 102.8. Took TYLENOL and Ibuprofen which decreased fever to 100.1. States next day still had fever and redness with soreness at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Approximately 3 minutes after receiving the above immunizations to left thigh patient developed a single urticarial wheal, approximately 4 cm, to left face adjacent to mouth and then a second approximately 1cm above right aspect of lip. She has received PROQUAD in past; this was first exposure to QUADRACEL. Previous DTaP/IPV immunizations were with PENTACEL.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large red area 50mm x 60mm to Lt Deltoid muscle. Area warm to touch and tender. Pain starts at injection site to Lt Deltoid and radiates to axillary region.
Age: 16.0
Sex: M
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt. tolerated well.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA209339, 2018SA209359 and 2018SA209360 (same reporter). This case involves a four years old female patient who received a 0.5 mL third dose of vaccine IPOL (lot N1G41, expiry date: 28-Jul-2019, route of administration was not reported) in the right deltoid on 30-Jul-2018, which was supposed to be discarded related to an excursion and incorrectly stored. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL for Immunisation; MMR for Immunisation and Varicella Vaccine for Immunisation. It was a case of actual medication error due to incorrect product storage and deteriorated drug administered. It was reported that patient had a Polio vaccine from the same vial that was supposed to be discarded related to an excursion. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received regarding an unsolicited valid non-serious case received from a nurse on 01-Aug-2018. This case involves a 61 years old male patient who accidentally received an 0.5 ml expired dose of TENIVAC (Lot number: U5411AA, expiry date: 30-Jun-2018) via intramuscular route in the deltoid on 12-Jul-2018. It was case of an actual medication error due to expired vaccine used. No AE has been observed. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
Age: 28.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dysphagia, Malaise, Pharyngeal oedema, Pyrexia, Vomiting
Clinical narrative: Started vomiting, low grade fever, throat swelling and difficulty swallowing started around 8:00pm on 8/6/2018. No vomiting morning of 8/7/2018, continues with complaints of throat swelling/difficulty swallowing. Has taken sips of water. General malaise. Seen by provider at Employee Health Services at 10:00am on 8/7/2018. Monitor s/s, sent home from work today, report to the ED for increase in s/s, shortness of breath.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Tired and slight headache.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Balance disorder, Chills, Headache, Nasopharyngitis
Clinical narrative: Chills, disbalance, pounding headache, cold symptoms.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Induration, Peripheral swelling, Rash
Clinical narrative: Rash on upper arm and bottom of neck, swelling and hardening of upper arm, stomach upset. I took BENADRYL at 9PM that Aug. 3 night but did not seem to help rash. I then took ZYRTEC at 2 AM the next Aug 4 morning and again at 7PM. The rash went away with using ZYRTEC as well as the stomach upset. I followed up and called the Doctor's office on Monday Aug. 6 to tell them I had a rash but it went away following consistent use of ZYRTEC.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Red, swollen, painful arm 24 hours after injection.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Laboratory test normal, Seizure
Clinical narrative: Mom states patient had seizure in the parking lot (siting in car), following the administration of immunizations. Mom called 911 and the patient was taken to a local ER for treatment, CT, scan, EKG, and lab work. Mom reports all work up so far has been negative. Patient had a doctors appointment this morning and is scheduled for a EEG later today, 8/7/2018. Patient does not have a history of seizures.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Blood in stool.
Age: 17.0
Sex: F
Vaccine: MEN, MENB, MENB, MNQ
Symptoms: Chills, Dysphagia, Injected limb mobility decreased, Injection site pain, Lymphadenopathy
Clinical narrative: The patient got terrible chills and a fever of 100.4 F the night of receiving the shots. The next day she  could not lift her arms and still had a fever. Her lymph nodes under her right arm were swollen and they still are, 8 days after receiving the vaccine. Her arms still hurt at the location the shots were given. Her neck has been sore for 4 days and she has been having trouble swallowing. We had asked the doctor if there would be any pain or sickness resulting from the vaccines and she said no. On the paper they gave us after the patient received the shots it said 50% of people have these symptoms for two of the vaccines, which were received together. I called a couple days after the patient received the shots and they said they were very busy and just hung up, after telling me that my daughter is "special".
Age: 17.0
Sex: F
Vaccine: MEN, MENB, MENB, MNQ
Symptoms: Mobility decreased, Neck pain, Pyrexia
Clinical narrative: The patient got terrible chills and a fever of 100.4 F the night of receiving the shots. The next day she  could not lift her arms and still had a fever. Her lymph nodes under her right arm were swollen and they still are, 8 days after receiving the vaccine. Her arms still hurt at the location the shots were given. Her neck has been sore for 4 days and she has been having trouble swallowing. We had asked the doctor if there would be any pain or sickness resulting from the vaccines and she said no. On the paper they gave us after the patient received the shots it said 50% of people have these symptoms for two of the vaccines, which were received together. I called a couple days after the patient received the shots and they said they were very busy and just hung up, after telling me that my daughter is "special".
Age: 55.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site pain
Clinical narrative: Pt IS COMPLAINING OF RIGHT SHOULDER PAIN SINCE VACCINATION - JUST NOTIFIED ON 8.6.18.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain/swelling at inj. site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Colour blindness, Dizziness, Fatigue, Nightmare, Pain in extremity
Clinical narrative: After the vaccine administration, the patient complained of (R) arm pain. She developed rhinorrhea which improved with BENADRYL (or other anti-histamine). She woke up that night with a nightmare, was lightheaded, went color blind and lost peripheral vision. The following day, she had prolonged tiredness.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Rhinorrhoea, Visual field defect
Clinical narrative: After the vaccine administration, the patient complained of (R) arm pain. She developed rhinorrhea which improved with BENADRYL (or other anti-histamine). She woke up that night with a nightmare, was lightheaded, went color blind and lost peripheral vision. The following day, she had prolonged tiredness.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Headache, fever, diffuse aches.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: Constant headache for a week since vaccine administration.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pruritus
Clinical narrative: Shingles appeared across the top of my right foot. About 15 blisters, extremely itchy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: KINRIX given for DTap #4 and IPV #4.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 9 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 05-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # N028258, expiration date on 30-MAY-2019, oral for prophylaxis (dosage schedule was not reported) and with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccines experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-JUL-2018, the patient was inadvertently vaccinated with an expired dose of PROQUAD, 0.5 ml once, subcutaneously, lot # M049122 and expiration date on 13-JUN-2018, for prophylaxis. Also on 25-JUL-2018, the patient inadvertently received a concomitant unspecified dose of VARIVAX, lot # N002204 and expiration date on 19-JAN-2019, for prophylaxis. Both vaccines were reconstituted with sterile diluent (MERCK), lot # R002715 and expiration date on 20-FEB-2020. No adverse events were reported and no product quality complaint was involved.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 6 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 09-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # N028258, expiration date on 30-MAY-2019, oral for prophylaxis (dosage schedule was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012292: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513- 1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012293.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 4 year old male patient. The patient previously received one dose of M-M-R, one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 09-JUL-2018, the patient was vaccinated with PROQUAD from lot R003292 dose 1, intramuscular in the right deltoid for prophylaxis. On the same day, the patient was also vaccinated with KINRIX from lot 53NB2 dose 1, subcutaneous in the right arm for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used. The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1807USA007589.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 4 year old male patient. The patient previously received one dose of measles virus vaccine live (Enders-Edmonston) mumps virus vaccine live (Jeryl Lynn) rubella virus vaccine live (Wistar RA 27/3) (M-M-R), one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 11-JUL-2018, the patient was vaccinated with PROQUAD from lot R003292 dose 1, subcutaneous in the right deltoid for prophylaxis. On the same day, the patient was also vaccinated with KINRIX from lot 95FR9 dose 1, intramuscular in the left deltoid for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used.  The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1807USA007589: US-009507513-1808USA000454: US-009507513-1808USA000455: US-009507513-1808USA000456: US-009507513-1808USA000457: US-009507513-1808USA000458: US-009507513-1808USA000459: US-009507513-1808USA000460: US-009507513-1808USA000461: US-009507513-1808USA000462: US-009507513-1808USA000463: US-009507513-1808USA000464: US-009507513-1808USA000465: US-009507513-1807USA007589:
Sex: F
Vaccine: HEP, HEPA, MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a physician and refers to about 10% of 60 female patients of unknown age. The patients' pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown dates (reported as when the patients were children), the patients were vaccinated with M-M-R II, RECOMBIVAX HB and with VAQTA for prophylaxis (frequency, route of administration, lot# and expiration date were not reported for any of the vaccines). On unknown dates between January 2017 and June 2018, vaccine titers were performed as part of prenatal testing on 60 patients, who were substance abusers (it was unknown what substance was being abused) since unknown date (linked with case #1808USA002950). About 10% of that population had negative titers for one or all of those vaccines. The outcome of the events was unknown. The relatedness between the events of substance abuse and negative titers and vaccination with M-M-R II, RECOMBIVAX HB and VAQTA was not reported. Upon internal review, the event of substance abuse was determined to be medically significant. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1808USA002950:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 27-JUL-2018, the patient was inadvertently vaccinated with an expired VAQTA intramuscularly for prophylaxis, lot #N005796 and expiration date 26-MAY-2018 (strength, dose and frequency were not reported). No adverse effects were reported.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse and refers to a 14 year old male patient. The patient's concurrent conditions and medical history were not reported. On 15-MAY-2014 (also reported as "4 years ago"), the patient was vaccinated with a first dose of GARDASIL (dose, route, frequency, lot # and expiration date were not reported) for prophylaxis. The reporter stated that the patient wished to receive GARDASIL 9 at the reporting time (reported as "now"). The patient had not received the second vaccinations yet. No adverse symptoms were reported.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a 40-year-old male patient, who was reporting on himself. The patient did not receive any concomitant therapies and did not have any pertinent medical history. His concurrent condition included allergy to sulfa. On 01-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, once, to prevent pneumonia (reported as phemonia) (route of administration reported as injection; lot# and expiration date were not provided). On the same day, also reported as "the day he got the vaccination", the patient started experiencing pain at the injection site, which got worse at an unspecified point in time. The patient did not receive any treatment for the event. There was no laboratory test performed. The outcome of the event was reported as not recovered. Causality assessment was not provided.
Sex: F
Vaccine: HEP, HEPA, MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a physician and refers to about 90% of 60 female patients of unknown age. The patients' pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown dates (reported as when the patients were children), the patients were vaccinated with M-M-R II, RECOMBIVAX HB and with VAQTA for prophylaxis (frequency, route of administration, lot# and expiration date were not reported for any of the vaccines). On unknown dates between January 2017 and June 2018, vaccine titers were performed as part of prenatal testing on 60 patients, who were also substance abusers (it was unknown what substance was being abused) since unknown date. About 10% of that population had negative titers for one or all of those vaccines (captured in case # 1808USA001708). The outcome of the event was unknown. The relatedness between the event of substance abuse and vaccination with M-M-R II, RECOMBIVAX HB and VAQTA was not reported. Upon internal review, the event of substance abuse was determined to be medically significant. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1808USA001708:
Sex: M
Vaccine: MENB
Symptoms: Influenza
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's parent). This consumer reported similar events for 2 patients. This is the first of 2 reports. A 21-year-old male patient received the first dose TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, reported as Monday, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu symptoms on an unspecified date. The action taken in response to the event for meningococcal group b rlp2086 was not applicable. Outcome of the event of flu symptoms was unknown. The information on the lot/batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018313229 Same reporter and suspect drug, similar events in different patients.
Sex: M
Vaccine: MENB
Symptoms: Influenza
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients (consumer's sons). This is 2nd of 2 reports. An 18-year-old male patient started to receive the first dose of TRUMENBA, via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical and concomitant medications were not reported. The patient experienced flu symptoms on an unspecified date. The action taken in response to the event for meningococcal group B rlp2086 was not applicable. Outcome of the event of flu symptoms was unknown. Information regarding the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018311045 same reporter/different patient, same product, same event.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain upper, Arthralgia, Gait inability, Muscle spasms, Muscular weakness
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A 17-year-old male patient received the first dose of TRUMENBA, via an unspecified route of administration on 02Apr2018 in the physician's office at a single dose for immunisation. There were no medical history and concomitant medications. On 02Apr2018, in the evening after the first dose was administered, the patient experienced stomach pain and pain in knee, cramps in arms and unable to walk probably. Symptoms persisted, the patient returned to doctor office and was sent to emergency room. The patient was treated with ibuprofen 600mg and was sent home. He continued to have leg weakness for 1 more day then began to improve. The patient fully recovered from the events on an unspecified date. Information on the batch number has been requested.
Age: 16.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Ear infection, Sinusitis, Wrong drug administered
Clinical narrative: This is a spontaneous report from a contactable healthcare professional (Physician's assistant) received via a Pfizer sales representative. A 16-year-old male patient received TRUMENBA (lot number and expiration date unknown) at a single dose and BEXSERO at an unspecified dose and frequency; both via an unspecified route of administration on Jul2018 for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jul2018, the patient had a wrong vaccine administered. The reporter explained that in Jul2018, a meningococcal group b rlp2086 and a meningococcal vaccine b rfhbp/nada/nhba omv were both given at the same time, same visit, to the reporter's 16 year old son (the patient). He was supposed to get MENACTRA but was given meningococcal group b rlp2086 instead because they pulled the wrong one. A couple of days after these events, the patient developed a sinus infection and a double ear infection on an unspecified date in 2018. The reporter stated that nothing happened except that the patient did have the sinus infection and a double ear infection a couple of days later. The causality of the events was reported as unknown. The reporter asked when should the patient get the second dose of meningococcal vaccine b rfhbp/nada/nhba omv, and should he wait until he gets his meningococcal (Groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Epistaxis
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A patient of unspecified age and gender started to receive TRUMENBA, via an unspecified route of administration from an unspecified date to an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced a nosebleed on an unspecified date. The doctor stated the nosebleed was not related to receiving meningococcal group b rlp2086. Outcome of the event was unknown. Information about the lot number has been requested. Sender's Comments: The Company acknowledges that the reporter has come to the conclusion that meningococcal group b rlp2086 was not responsible for the event nosebleed.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: PT presents 5 days after administration with pain and moderate limitation of Range of Motion to L arm. Administration site was given too high.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling abnormal, Induration, Peripheral swelling
Clinical narrative: The morning after the shot the patient felt fatigued, faint, and a little unstable. Primary physician was called and by noon the patient was feeling better so they decided that there wasn't anything to be done. Five days after the shot (Monday 8/6/18), the patient felt the arm the shot was administered in, and it was largely swollen and hard to the touch, and the patient reported feeling some swollenness in her legs. Patient came to pharmacy today to report (8/7/18) and she was asked to be evaluated by primary physician asap, and have the swollen arm attended to.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt was vaccinated and then left our clinic. Mom returns with son after going into parking lot and reports pt fainted in vehicle. Mom reports he regained consciousness very quickly and she walked him back into clinic. Pt is placed into wheel chair and is brought back to exam room. Pt reports when asked that he did not have any lunch. Pt is given some birthday cake as that is what was available.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Eyelid rash, Headache, Pyrexia
Clinical narrative: Fever, headache, joint pain and rash around eye... no medical treatment sought and condition has improved.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt began to have swelling, which parents described as approximately 3.5in, tactile warmth & mild pain when touched to his left thigh. Injections were given on 8/1/18, parent called office on 8/3. Nurse advised pt's mother to apply cold compress as needed & have him seen if it worsens or if she becomes concerned. Nurse called to check on pt but got no answer. Voicemail was left.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Crying, Discomfort, Moaning, Mobility decreased
Clinical narrative: Patient couldn't move her arm up, down or sideways. It hurt from around 5:00pm after getting the shot and got worse for 24 hours +. She was in agony and couldn't put her seat belt on in the car and cried through the first night. For the next 24 hours, she was on ADVIL and ice packs. This is Tuesday and she is now just lifting her arm, but not comfortably. The Vaccine was from Glaxo-Smith Kline: Dosage 0.5ml.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: I was the CMA who drew up the vaccines while another CMA administered the vaccines into the patient. I noticed the wrong vaccine was given when I went into the patients chart to document. Patient was given a Tdap when the patient was suppose to get a Dtap. I went and let my supervisor know and she informed the parent/guardian what had happened. Outcome for myself was to re-due medication administration training exam, fill out paper work and do online immunization quizzes and to follow up with my supervisor.
Age: 16.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes in right underarm, lymph nodes sore/painful to the touch -- lasted 4-5 days.
Age: 15.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given a 5th dose of IPV and a dose of Tdap that she wasn't due for (last received 01/14/15).
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Radiculopathy
Clinical narrative: Irritation (severe)-neurologically both sides and back, trunk until noon the next day. Pt has experienced irritation like this before, but this was 4 times as bad as ever before. Pt felt that it was like shingles. Previous possible shingles. Dr. unable to diagnose previous symptoms like these.
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Rash, Rash macular
Clinical narrative: Nine days after receiving MMR and Varicella, she developed a macular rash at the Varicella injection site, then on her neck and torso.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Pain, Syncope
Clinical narrative: Body aches, HA, chills, faint, light headedness.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: Right thigh-red area 2x3cm with raised lesion.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Aspartate aminotransferase increased, Blood creatinine decreased, Blood glucose increased, Blood lactic acid, Blood potassium normal
Clinical narrative: 0300 7/27/2018 Temp of 104.2, then episode of glazed eyes and not moving extremities, making funny noises and was stiff. Was taken to ER. Treated with TYLENOL/MOTRIN, unable to start IV therapy - labs done - PO intake encouraged - per mom fever started after immunization but had been continuing.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Blood sodium decreased, Blood urea normal, C-reactive protein increased, Glassy eyes, Haematocrit normal
Clinical narrative: 0300 7/27/2018 Temp of 104.2, then episode of glazed eyes and not moving extremities, making funny noises and was stiff. Was taken to ER. Treated with TYLENOL/MOTRIN, unable to start IV therapy - labs done - PO intake encouraged - per mom fever started after immunization but had been continuing.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Haemoglobin normal, Moaning, Mobility decreased, Musculoskeletal stiffness, Pyrexia
Clinical narrative: 0300 7/27/2018 Temp of 104.2, then episode of glazed eyes and not moving extremities, making funny noises and was stiff. Was taken to ER. Treated with TYLENOL/MOTRIN, unable to start IV therapy - labs done - PO intake encouraged - per mom fever started after immunization but had been continuing.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: White blood cell count normal
Clinical narrative: 0300 7/27/2018 Temp of 104.2, then episode of glazed eyes and not moving extremities, making funny noises and was stiff. Was taken to ER. Treated with TYLENOL/MOTRIN, unable to start IV therapy - labs done - PO intake encouraged - per mom fever started after immunization but had been continuing.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This was the second booster shot. After I took the shot, in a few hours, my arm started getting sore. I woke up at 4 am with 101 fever. I have been very achy all over. I have been managing the fever and the aches with Advil. This is day 4, and my arm is still swollen and red, although it is finally getting better. I am still achy and feel tired.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This was the second booster shot. After I took the shot, in a few hours, my arm started getting sore. I woke up at 4 am with 101 fever. I have been very achy all over. I have been managing the fever and the aches with Advil. This is day 4, and my arm is still swollen and red, although it is finally getting better. I am still achy and feel tired.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Pt c/o lightheadedness and remained seated for approximately 15 minutes. Pt then left without incident.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Symptoms started with mild aches then had fever which reached 100. This lasted until the next day. My arm was sore and swollen. My arm was sore for a few days and eventually had a nasty bruise. Experienced similar symptoms with the booster which I received on Aug. 6th, 2018.