chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a male patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with GARDASIL injection (dosing details, strength, lot#, and expiry were not reported) intramuscularly. Fifteen minutes post vaccination, the patient fainted as he was about to leave the physician's office. The patient sought medical attention as he was in the doctor's office. The outcome of syncope was unknown. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. This is two of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug effect decreased, Oral herpes, Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a nurse practitioner, a female patient of unknown age via the company representative reporting on herself. The patient's medical history included cold sores. The patient's concurrent conditions and concomitant medications were not reported. The patient reported that she used to get cold sores regularly but after receiving ZOSTAVAX (dose, route, lot # and expiration date unknown) about seven years ago (in approximately 2009), she stopped getting cold sores completely and the reporter believed that ZOSTAVAX was what kept cold sores away. The reporter mentioned that she believes that ZOSTAVAX efficacy must be lasting about seven years because of an unknown date in 2016 she had experienced cold sore for the first time in seven years after vaccination. The reporter thought that the efficacy of ZOSTAVAX had decreased after seven years and that is why she started to get cold sores again. The outcome of the events was unknown. Causality was not provided by the reporter. Additional information is not expected as the reporter did not provide consent to follow-up.
Age: 33.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 33 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-MAR-2016, the patient was vaccinated with an improperly stored dose of VAQTA lot # L014265, expiration date: 28-APR-2017, 1 ml, intramuscularly, in left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-MAY-2016, the patient was inadvertently vaccinated with expired M-M-R II, lot # K001997, expiry date 10-FEB-2016 (strength, dose, route and site of administration were not reported). 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 was received from a registered nurse refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # L045953, expiry date: 17-NOV-2017; lot # L045954, expiry date: 17-NOV-2017). Nurse reported that the vaccine underwent temperature excursion at 6.5 and 8 degree Fahrenheit (F) for 28 and 30 minutes, respectively. She reported that the vaccine underwent temperature excursion previously also, on unknown dates. The vaccine was exposed to 7F, 7.5F and 6.5F for 22 minutes, 23 minutes and 28 minutes, respectively. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Age: 49.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to himself, a 49 year old male patient. Information regarding relevant medical history and concurrent condition were not reported. On 08-MAR-2016 the patient was vaccinated with GARDASIL 9 (dose 1, lot #, route and dose not reported. Receiving GARDASIL 9 at 49 year old was considered as inappropriate schedule of vaccine administered. No adverse effects reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Seasonal allergy
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 64 year old male patient. The medical history, concurrent condition and drug reactions were none. On 29-APR-2016, the patient was vaccinated with ZOSTAVAX lot # L044529, 09-SEP-2017 subcutaneous. On 09-MAY-2016, the patient was prescribed oral prednisone for use in seasonal allergies. It was unknown if the patient had suffered from seasonal allergies prior to the administration of ZOSTAVAX. The outcome of the event was reported as not recovered/not resolved. Lab tests was none. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 24-MAY-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # L050907, expiration date: 14-JUN-2017, dose was unknown) which was improperly stored (42.3 Fahrenheit (F) for 2 hours 15 minutes). No adverse events were reported. Previous temperature was not excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 24-MAY-2016 the patient was vaccinated with a dose of VARIVAX (lot # L042266, expiration date: 27-OCT-2017, dose was unknown) which was improperly stored (42.3 Fahrenheit (F) for 2 hours 15 minutes). No adverse events were reported. Previous temperature was not excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 13-MAY-2016, the patient was inadvertently vaccinated with an expired dose of PROQUAD (Merck) (dose and route were not reported) lot # K007801, expiration date 29-NOV-2015. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 months old patient of unknown gender. The patient's medical history and current conditions were not provided. On 13-MAY-2016, the patient was inadvertently vaccinated with a dose of VAQTA (lot #, expiration date, dose and route were not reported) instead of RECOMBIVAX HB. No adverse experience has been reported. The healthcare workers reports that there was no product confusion between VAQTQ and RECOMBIVAX HB, the unspecified nurse who administered the vaccines "just grabbed the wrong product". This is one two reports received from the same reporter. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 5 week old patient of unknown gender. The patient's medical history and current conditions were not provided. On 13-MAY-2016, the patient was inadvertently vaccinated with a dose of VAQTA (lot #, expiration date, dose and route were not reported) instead of RECOMBIVAX HB. No adverse experience has been reported. The healthcare worker reports that there was no product confusion between VAQTA and RECOMBIVAX HB, the unspecified nurse who administered the vaccines "just grabbed the wrong product". This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the concurrent condition and medical history was not reported. On 02-MAY-2016 the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L044258 with expiration date of 09-FEB-2017, dose and route unknown. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the concurrent condition and medical history was not reported. On 02-MAY-2016 the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L044528 with expiration date of 09-FEB-2017, dose and route unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the concurrent condition and medical history not reported. On 02-MAY-2016 the patient was vaccinated with an improperly store dose of ZOSTAVAX (lot # L044528 with expiration date of 09-FEB-2017, dose and route unknown). No adverse effect was reported. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse referring to a 33 year old female patient. The patient had no relevant medical history or concomitant medications, and her past drug history was unknown. On 17-MAY-2016 the patient was vaccinated with 1 dose of PROQUAD (Merck) (rHA) (dose unknown, subcutaneous in the left arm, lot# M004895, expiration date 26-JUL-2017) accidentally instead of M-M-R II. The nurse reported the patient did not have any adverse events while she was in the office. It was unknown if there was any relevant laboratory data. At the reporting time it was also unknown if the patient would ever get PROQUAD again. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 62 year old female patient. The concurrent condition and medical history was not reported. On 27-APR-2016 the patient was vaccinated with ZOSTAVAX (dose, route and lot details unavailable). The concomitant medication was not reported. Approximately on 05-MAY-2016 (reported as two days prior to the patient's office visit) patient started developing pain in the vesicles (shingles rash) on the left side "dermatome C3" on the left arm, neck, scalp and face. The patient visited the physician on 07-MAY-2016 and was treated with FAMVIR (50 mg thrice daily for 7 days) and a pain medication (TYLENOL with codeine as needed for pain). No lab tests were performed. The patient has not called the physician's office back yet to inform the physician how she is doing on treatment. The outcome of the events were unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with Dose 2 or Dose 3 GARDASIL (route, lot # and expiration date not reported) late( inappropriate schedule of drug administration). No symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event, Off label use
Clinical narrative: Information has been received from a nurse referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with one dose of GARDASIL 9 (dose, route and lot number not provided) after the completion of the entire three-dose series of GARDASIL (extra dose administered and off label use). This was outside the labeled recommendations in both the GARDASIL 9 and GARDASIL Prescribing Informations. No adverse effect was reported. There was no product quality issue (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 06-MAY-2016 the patient was vaccinated with the first dose of VARIVAX (dose, route, and lot# were unknown), and then received a second dose of VARIVAX (dose, route and lot# were unknown) on 25-MAY-2016; which was outside of the recommendations in the VARIVAX prescribing information. No adverse effect was reported. Additional information has been requested.
Age: 28.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 28 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-MAR-2016, the patient was vaccinated with an improperly stored dose of VAQTA lot # L018498 (expiration date was not provided), 1 ml, intramuscularly, in left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 24 year old of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-MAR-2016, the patient was vaccinated with an improperly stored dose of VAQTA lot # L018498, expiration date: 28-APR-2016, 1 ml, intramuscularly, in left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: Information has been received from a Licensed Practical Nurse via a field representative referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the third and final dose of GARDASIL 9 (dose, route and lot# were not reported). Information regarding concomitant medication was not reported. The date of the first and second doses given was not provided. After taking the third and final dose of GARDASIL 9 the patient developed muscle weakness and a fever. The patient sought medical attention. TYLENOL was given for the adverse events. The outcome of the events and the causality were not reported. Additional information has been requested.
Age: 47.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 47 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2016, the patient vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L042846, expiration date: 15-SEP-2017, 1 ml, intramuscularly, in left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 41.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 41 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L005291, expiration date: 11-FEB-2017, 0.5 ml, intramuscularly, in right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a currently 36 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L004658, expiration date: 11-FEB-2017, 0.5 ml, intramuscularly, in right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Abasia, Arthropathy, Bone disorder, Brain neoplasm, Eczema
Clinical narrative: Information was obtained on a request by the Company from the agency (HA# 376407) via a Public Case Detail concerning a 43 year old female. Patient medical history, concurrent conditions and concomitant medications were not reported. The patient past vaccination history included 1st dose of RECOMBINANT (manufacture unknown) on an unknown date and 2nd dose RECOMBINANT (manufacturer unknown) on an unknown date. On an unknown date in 1993, the patient was vaccinated with third dose of RECOMBINANT (manufacturer unknown) (dosing details not provided) (also reported as it was unclear if 3 doses or a single dose of triple antigen Hepatitis B vaccine administered). Subsequently, since an unknown date, the patient experienced seizures and arching of back for 6 months and had experienced tinea, eczema, gut problems, irreparable neurological damage, a brain tumor, brain inflammation, problems with bones and joints, muscle tension, an inability to heal after injury, spasms in response to electricity and perfume, an inability to walk, an inability to go out in public and eat in public without being sick and multiple organ failure. The doctor advised her to avoid consuming protein and fats. The outcome of the events are reported as unknown. The agency considered the events to be possibly related to vaccination with RECOMBINANT (manufacture unknown). Upon internal review, the events of multiple organ dysfunction syndrome, brain neoplasm, abasia and seizure were determined to be medically significant. Additional information is not expected as no follow up is expected from the agency.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Gastrointestinal disorder, Impaired healing, Malaise, Multiple organ dysfunction syndrome, Muscle spasms
Clinical narrative: Information was obtained on a request by the Company from the agency (HA# 376407) via a Public Case Detail concerning a 43 year old female. Patient medical history, concurrent conditions and concomitant medications were not reported. The patient past vaccination history included 1st dose of RECOMBINANT (manufacture unknown) on an unknown date and 2nd dose RECOMBINANT (manufacturer unknown) on an unknown date. On an unknown date in 1993, the patient was vaccinated with third dose of RECOMBINANT (manufacturer unknown) (dosing details not provided) (also reported as it was unclear if 3 doses or a single dose of triple antigen Hepatitis B vaccine administered). Subsequently, since an unknown date, the patient experienced seizures and arching of back for 6 months and had experienced tinea, eczema, gut problems, irreparable neurological damage, a brain tumor, brain inflammation, problems with bones and joints, muscle tension, an inability to heal after injury, spasms in response to electricity and perfume, an inability to walk, an inability to go out in public and eat in public without being sick and multiple organ failure. The doctor advised her to avoid consuming protein and fats. The outcome of the events are reported as unknown. The agency considered the events to be possibly related to vaccination with RECOMBINANT (manufacture unknown). Upon internal review, the events of multiple organ dysfunction syndrome, brain neoplasm, abasia and seizure were determined to be medically significant. Additional information is not expected as no follow up is expected from the agency.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Muscle tightness, Nervous system disorder, Noninfective encephalitis, Opisthotonus, Seizure
Clinical narrative: Information was obtained on a request by the Company from the agency (HA# 376407) via a Public Case Detail concerning a 43 year old female. Patient medical history, concurrent conditions and concomitant medications were not reported. The patient past vaccination history included 1st dose of RECOMBINANT (manufacture unknown) on an unknown date and 2nd dose RECOMBINANT (manufacturer unknown) on an unknown date. On an unknown date in 1993, the patient was vaccinated with third dose of RECOMBINANT (manufacturer unknown) (dosing details not provided) (also reported as it was unclear if 3 doses or a single dose of triple antigen Hepatitis B vaccine administered). Subsequently, since an unknown date, the patient experienced seizures and arching of back for 6 months and had experienced tinea, eczema, gut problems, irreparable neurological damage, a brain tumor, brain inflammation, problems with bones and joints, muscle tension, an inability to heal after injury, spasms in response to electricity and perfume, an inability to walk, an inability to go out in public and eat in public without being sick and multiple organ failure. The doctor advised her to avoid consuming protein and fats. The outcome of the events are reported as unknown. The agency considered the events to be possibly related to vaccination with RECOMBINANT (manufacture unknown). Upon internal review, the events of multiple organ dysfunction syndrome, brain neoplasm, abasia and seizure were determined to be medically significant. Additional information is not expected as no follow up is expected from the agency.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Tinea infection
Clinical narrative: Information was obtained on a request by the Company from the agency (HA# 376407) via a Public Case Detail concerning a 43 year old female. Patient medical history, concurrent conditions and concomitant medications were not reported. The patient past vaccination history included 1st dose of RECOMBINANT (manufacture unknown) on an unknown date and 2nd dose RECOMBINANT (manufacturer unknown) on an unknown date. On an unknown date in 1993, the patient was vaccinated with third dose of RECOMBINANT (manufacturer unknown) (dosing details not provided) (also reported as it was unclear if 3 doses or a single dose of triple antigen Hepatitis B vaccine administered). Subsequently, since an unknown date, the patient experienced seizures and arching of back for 6 months and had experienced tinea, eczema, gut problems, irreparable neurological damage, a brain tumor, brain inflammation, problems with bones and joints, muscle tension, an inability to heal after injury, spasms in response to electricity and perfume, an inability to walk, an inability to go out in public and eat in public without being sick and multiple organ failure. The doctor advised her to avoid consuming protein and fats. The outcome of the events are reported as unknown. The agency considered the events to be possibly related to vaccination with RECOMBINANT (manufacture unknown). Upon internal review, the events of multiple organ dysfunction syndrome, brain neoplasm, abasia and seizure were determined to be medically significant. Additional information is not expected as no follow up is expected from the agency.
Age: 25.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Altered state of consciousness, Dizziness, Fall, Immediate post-injection reaction
Clinical narrative: Skin around bicep muscle is swollen, excruciating pain down bicep, down brachial artery to side of forearm and wrist. Also radiated down through my arm pit. Cannot put any weight or pressure on left arm. Could not raise arm above waist, rotate it, or put behind me without pain. 3 days later, I still cannot rotate arm without pain, cannot raise my arm above my belly button without pain or put the arm behind me without pain. My injection sites are red and raised, and 1 is turning into a bruise. I have a rash forming of 5 other raised round bumps around injection sites. The pain is now also in my shoulder joint. Got the pneumonia shot on the same day, same arm.
Age: 25.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site rash, Injection site swelling, Loss of consciousness
Clinical narrative: Skin around bicep muscle is swollen, excruciating pain down bicep, down brachial artery to side of forearm and wrist. Also radiated down through my arm pit. Cannot put any weight or pressure on left arm. Could not raise arm above waist, rotate it, or put behind me without pain. 3 days later, I still cannot rotate arm without pain, cannot raise my arm above my belly button without pain or put the arm behind me without pain. My injection sites are red and raised, and 1 is turning into a bruise. I have a rash forming of 5 other raised round bumps around injection sites. The pain is now also in my shoulder joint. Got the pneumonia shot on the same day, same arm.
Age: 25.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Mobility decreased, Pain, Pain in extremity, Swelling
Clinical narrative: Skin around bicep muscle is swollen, excruciating pain down bicep, down brachial artery to side of forearm and wrist. Also radiated down through my arm pit. Cannot put any weight or pressure on left arm. Could not raise arm above waist, rotate it, or put behind me without pain. 3 days later, I still cannot rotate arm without pain, cannot raise my arm above my belly button without pain or put the arm behind me without pain. My injection sites are red and raised, and 1 is turning into a bruise. I have a rash forming of 5 other raised round bumps around injection sites. The pain is now also in my shoulder joint. Got the pneumonia shot on the same day, same arm.
Age: 1.02
Sex: M
Vaccine: HEP, HIBV, VARCEL
Symptoms: Abnormal behaviour, Decreased interest, Eczema, Haemorrhage, Head injury
Clinical narrative: High fever of 101 and above. Contracted chicken pox from the varicella vaccine which lasted one week. Stopped eating solid foods for over two weeks. Extreme thirst. Leg spasems. Abnormal behavior including laying on the floor staring into space or whining refusing to get up or move and being uninterested in playing. Extremely lethargic. He will suddenly start scratching of hitting his head he will scratch until his head and neck bleed. Took to the doctor who stated it was only eczema even though there was no signs of it present but because I (the mother) have it that is all it most likely was. Doctor ignored other symptoms and refused to consider that this could be vaccine related. I have since gotten a second opinion of a pediatric nurse who stated that it was a adverse reaction to the vaccine and to contact VAERS immediately.
Age: 1.02
Sex: M
Vaccine: HEP, HIBV, VARCEL
Symptoms: Hypophagia, Lethargy, Pruritus, Pyrexia, Staring
Clinical narrative: High fever of 101 and above. Contracted chicken pox from the varicella vaccine which lasted one week. Stopped eating solid foods for over two weeks. Extreme thirst. Leg spasems. Abnormal behavior including laying on the floor staring into space or whining refusing to get up or move and being uninterested in playing. Extremely lethargic. He will suddenly start scratching of hitting his head he will scratch until his head and neck bleed. Took to the doctor who stated it was only eczema even though there was no signs of it present but because I (the mother) have it that is all it most likely was. Doctor ignored other symptoms and refused to consider that this could be vaccine related. I have since gotten a second opinion of a pediatric nurse who stated that it was a adverse reaction to the vaccine and to contact VAERS immediately.
Age: 1.02
Sex: M
Vaccine: HEP, HIBV, VARCEL
Symptoms: Thirst, Vaccination complication, Varicella post vaccine
Clinical narrative: High fever of 101 and above. Contracted chicken pox from the varicella vaccine which lasted one week. Stopped eating solid foods for over two weeks. Extreme thirst. Leg spasems. Abnormal behavior including laying on the floor staring into space or whining refusing to get up or move and being uninterested in playing. Extremely lethargic. He will suddenly start scratching of hitting his head he will scratch until his head and neck bleed. Took to the doctor who stated it was only eczema even though there was no signs of it present but because I (the mother) have it that is all it most likely was. Doctor ignored other symptoms and refused to consider that this could be vaccine related. I have since gotten a second opinion of a pediatric nurse who stated that it was a adverse reaction to the vaccine and to contact VAERS immediately.
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Insomnia
Clinical narrative: Patient has been complaining of burning in the shoulder since receiving the shot on 5/11/16; however patient went to ER on 5/16/16 and was given pain meds, muscle relaxer and a shot which he states did not help. He followed up with primary care doctor and is being refereed to a specialist. He states he can not sleep because of it.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: 3 blisters above the vaccination site. Administered diphenhydramine 25 mg and held for additional monitoring.
Age: 0.57
Sex: M
Vaccine: DTAP
Symptoms: Crying, Disorientation, Inability to crawl, Pain, Vomiting
Clinical narrative: Within 1hr of vaccination patient vomited, and started showing signs of pain and disorientation. For a week after symptoms began he was unable to crawl correctly when he was previously close to walking, he cried out continually as if he was in physical pain.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Acoustic stimulation tests abnormal, Deafness, Dizziness, Nausea, Vomiting
Clinical narrative: Hearing loss in left ear progressing by the next am to extreme dizziness nausea and vomiting.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Warm to touch, red circle at injection site 3" in diameter, tolerable, but sore.
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Dizziness, Dyspepsia
Clinical narrative: Feeling faint/weakness, upset stomach (burning), vomiting, mild diarrhea.
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Feeling faint/weakness, upset stomach (burning), vomiting, mild diarrhea.
Sex: M
Vaccine: UNK
Symptoms: Dry skin
Clinical narrative: Rough, dry skin all over head, chest, back, legs, and arms.
Age: 62.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Erythema, Injection site pain, Skin irritation, Swelling
Clinical narrative: Pain at injection site. Swelling, redness (local irritation).
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen around injection site.
Sex: M
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer, referring to a male patient on his 20's with a history of pneumonia and current condition of asthma. No drug reactions were reported. On an unknown date, the patient was vaccinated with PREVNAR 13 administered in left deltoid, intramuscularly, instead of PNEUMOVAX 23 (wrong drug administered). There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer, referring to a female patient on her 30's with a history of pneumonia and current condition of asthma. No drug reactions were reported. On an unknown date, the patient was vaccinated with PREVNAR 13 administered in left deltoid, intramuscularly and was given instead of PNEUMOVAX 23 (wrong drug administered). There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient of unknown age and gender. On 24-NOV-2015 and 20-MAY-2016 the patient was vaccinated with the first and the second doses of VAQTA (dose and route unspecified), lot # L015460 (dose 1) with expiration date 20-JUL-2017 and lot #L023232 (dose 2) with expiration date 25-FEB-2017, respectively. The nurse stated that the 2nd dose was a couple of days shy of the minimum interval of 6 months (inappropriate schedule of drug administration). No adverse effects were reported. Additional information is not expected as the reporter did not wish to be further contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 23-MAY-2016, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (lot # L040442, expiration date 15-JAN-2017; route was not reported; temperature: 13 Fahrenheit; time frame: 10 hours; no previous temperature excursion). No adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse referring to a 16 month old male patient. The patient had no pertinent medical history or drug allergies. On 05-JAN-2016 the patient was vaccinated with VARIVAX (lot # L008273, expiration date 11-MAR-2017) 0.5 ml, subcutaneously. There was no concomitant therapy. On 13-MAY-2016, the patient developed herpes zoster on his right lower thigh as diagnosed by a physician on 16-MAY-2016 when the patient was seen. No treatment was given to the patient. No lab test was done. At the time of this report, the outcome of herpes zoster was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Malaise, Pallor, Vomiting
Clinical narrative: This solicited report was received from a physician regarding a 11 year old female patient as part of a market research program. The patient was a healthy child. There were no concurrent conditions or concomitant medications reported. On an unspecified date in March 2016 the patient was vaccinated first dose of with GARDASIL 9. After the vaccination, on an unspecified date in March 2016, the patient looked pale, was sweating and had to lay down. She went to the bathroom, felt sick and threw up. No tests were done to diagnose the events. The subject recovered with sequelae from the events on the same day. The action taken with the GARDASIL 9 was reported as discontinued due to the events (however it was also reported that second dose was on an unspecified date in May 2016). The reporting physician considered the events (pale, sweating, felt sick and threw up) to be related to GARDASIL 9. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Injection site bruising, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a 58 year old female consumer concerning herself. The patient was allergic to neomycin (reported as "Neomyacin"). The patient's medical history included stomach removal and chickenpox in high school. She had family problems with shingles and her cousin lost eyesight in one eye. On 09-MAY-2016, the patient was vaccinated with ZOSTAVAX (lot# and expiration date unspecified), 1 injection. Concomitant therapies included thyroid medication levothyroxine sodium (manufacturer unknown), unspecified medication for her stomach and "lanadine" nose drops. On approximately 11-MAY-2016 (reported as two days after receiving vaccine), the patient experienced redness, pain, itching, swelling, hard lump, warmth and bruising where the shot was given. On the same day she also developed headache, had a red blot about the size of baseball, skin feels prickly, and had temperature of 100-101 Fahrenheit (F) degrees for a week. Unspecified treatment was given for the events. At the reporting time, the patient did not have recover from the events. The reporter did not provide the causality assessment between the events and ZOSTAVAX. Additional information is not expected as the contact detail was not provided.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Paraesthesia, Rash macular
Clinical narrative: Information has been received from a 58 year old female consumer concerning herself. The patient was allergic to neomycin (reported as "Neomyacin"). The patient's medical history included stomach removal and chickenpox in high school. She had family problems with shingles and her cousin lost eyesight in one eye. On 09-MAY-2016, the patient was vaccinated with ZOSTAVAX (lot# and expiration date unspecified), 1 injection. Concomitant therapies included thyroid medication levothyroxine sodium (manufacturer unknown), unspecified medication for her stomach and "lanadine" nose drops. On approximately 11-MAY-2016 (reported as two days after receiving vaccine), the patient experienced redness, pain, itching, swelling, hard lump, warmth and bruising where the shot was given. On the same day she also developed headache, had a red blot about the size of baseball, skin feels prickly, and had temperature of 100-101 Fahrenheit (F) degrees for a week. Unspecified treatment was given for the events. At the reporting time, the patient did not have recover from the events. The reporter did not provide the causality assessment between the events and ZOSTAVAX. Additional information is not expected as the contact detail was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 21-MAY-2016, the patient was vaccinated with one dose of improperly stored VARIVAX (lot# reported as L043620, expiration date 02-NOV-2017, therapy type: data digital logger; route was not reported; temperature: -12.6 Celsius degree, time frame: 56 minutes). No adverse effects were reported. There was no previous temperature excursion. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Injection site erythema, Injection site pain, Pain
Clinical narrative: Information has been received from a medical assistant via Pfizer (other company# 2016247794) referring to a 62 year old male patient with sleep apnea, arthritis and asthma (asymptomatic at the office).  The patient's medical history included neuroplasty decompression for carpal tunnel syndrome, rhinological surgery and shoulder surgery on unknown dates. There was no known drug allergy. On 22-JUN-2011, the patient was received a dose of PNEUMOVAX 23 (lot# reported as 0130AA, 0.5 ml, intramuscular) in the right arm. Then on 28-APR-2016 at 4:26 pm, the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot # L040178 with expired date 31-AUG-2017, 0.5 ml) intramuscularly in the left deltoid (inappropriate schedule of drug administration). Other suspect therapy included NASONEX (dose, strength and frequency were unknown) for asthma and cough since 26-OCT-2015 (drug use for unapproved indication). There were no other vaccines given on the same date along with the suspect vaccine. Concomitant therapy included diltiazem. On 29-APR-2016, the patient called the office and stated that he experienced weakness and body aches. The reporter was not able to provide a time but stated that the patient did not go to work so the events might start in the early morning. The reporter thought the reported side effects of weakness and body aches were more of a coincidence. The patient was offered to seen in the office on 02-MAY-2016 and he declined because he was feeling better. The office called to follow up with the patient on 02-MAY-2016. The patient was feeling better and went to work that same day. The outcome of the event weakness and body aches was recovered on 02-MAY-2016. The reporter considered the two events to be not related to PNEUMOVAX 23. The causality assessment for NASONEX was not provided. The patient was also placed on therapy with ADVAIR for asthma since 21-DEC-2015 and celecoxib for arthritis since 28-APR-2016. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Inappropriate schedule of drug administration, Pain
Clinical narrative: Information has been received from a medical assistant via Pfizer (other company# 2016247794) referring to a 62 year old male patient with sleep apnea, arthritis and asthma (asymptomatic at the office).  The patient's medical history included neuroplasty decompression for carpal tunnel syndrome, rhinological surgery and shoulder surgery on unknown dates. There was no known drug allergy. On 22-JUN-2011, the patient was received a dose of PNEUMOVAX 23 (lot# reported as 0130AA, 0.5 ml, intramuscular) in the right arm. Then on 28-APR-2016 at 4:26 pm, the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot # L040178 with expired date 31-AUG-2017, 0.5 ml) intramuscularly in the left deltoid (inappropriate schedule of drug administration). Other suspect therapy included NASONEX (dose, strength and frequency were unknown) for asthma and cough since 26-OCT-2015 (drug use for unapproved indication). There were no other vaccines given on the same date along with the suspect vaccine. Concomitant therapy included diltiazem. On 29-APR-2016, the patient called the office and stated that he experienced weakness and body aches. The reporter was not able to provide a time but stated that the patient did not go to work so the events might start in the early morning. The reporter thought the reported side effects of weakness and body aches were more of a coincidence. The patient was offered to seen in the office on 02-MAY-2016 and he declined because he was feeling better. The office called to follow up with the patient on 02-MAY-2016. The patient was feeling better and went to work that same day. The outcome of the event weakness and body aches was recovered on 02-MAY-2016. The reporter considered the two events to be not related to PNEUMOVAX 23. The causality assessment for NASONEX was not provided. The patient was also placed on therapy with ADVAIR for asthma since 21-DEC-2015 and celecoxib for arthritis since 28-APR-2016. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Rash pruritic, Vaccination site reaction
Clinical narrative: Patient described a large saucer shaped swollen, itchy rash on the deltoid of which the vaccine was administered. Patient denied any pain and other symptoms.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and itching started in right arm around injection site and skin was warm to touch. It last for 3 days. Patient was seen by his primary care physician next day. No treatment was prescribed.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Rash erythematous, Rash macular
Clinical narrative: Red rash, splotchy wide marks, some are small red dots. Main areas with rash are upper thighs, and back of upper arms where the vaccinations were given. The rash on legs are more clustered around the back of legs and then spread in smaller areas on upper leg with smaller red dots.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, UNK
Symptoms: Pyrexia, Rash generalised, Vaccination complication
Clinical narrative: Baby experienced fevers for 2 days before waking up on day 3 covered in a full head to toe body rash with little spread out bumps all over body. Ped said it is a reaction to the MMR vaccine she was given 12 days prior.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Local swelling, Peripheral swelling, Pruritus, Swelling face
Clinical narrative: I had an anaphylactic reaction to the injection. I had to go to ER. I was covered in hives and my face, hands, feet, neck, ears were all swollen. I took an Allegra and hydroxyzine prior to going to ER. Once in ER, I was administered Prednisone and Pepcid. After about an hour and a half, I was still progressively getting worse. The doctor finally gave me an Epi injection. It took another hour until I had finally stopped swelling and itching, and the redness subsided.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: I had an anaphylactic reaction to the injection. I had to go to ER. I was covered in hives and my face, hands, feet, neck, ears were all swollen. I took an Allegra and hydroxyzine prior to going to ER. Once in ER, I was administered Prednisone and Pepcid. After about an hour and a half, I was still progressively getting worse. The doctor finally gave me an Epi injection. It took another hour until I had finally stopped swelling and itching, and the redness subsided.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient received both the Adacel and Zostavax injection in her right arm on 5/26/16. On 5/28/16 she came to the pharmacy because the injection site where she received the Zostavax (the back portion of her right arm) had become red. She stated that it did not hurt, nor did it itch or feel hot. It was just red around the area. She stated that if symptoms progressed further she would return and let us know. The patient's physician was notified.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Had injection site reaction (redness swelling) and headache within 1 hour of vaccination. Next morning woke up with itching that started in ear and moved throughout day to different areas of body. Patient stated worsened everyday. Took diphenhydramine on 5/28/2016 pm and it didn't help. Went into urgent care 5/29/2016.