chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Mobility decreased, Pyrexia
Clinical narrative: Patient is 70 Years Old Female LUE erythematous rash, swelling, pain and warmth after PCV13 administration 8/28/2017 to Left upper arm. Pain worse the night of getting shot, unable to move arm, had fever as well that night. On 9/1/2017 visit, pain improved but rash spread downward toward elbow, rash very pink and warm, no skin peeling, and patient no longer febrile. Skin Comment: erythematous flat rash L upper arm following humeral distribution down to L elbow, very warm to touch, nontender, negative Nikolsky's sign. Assessed Skin rash, allergic as comment only - PCV vaccine, PO and topical Benadryl.
Age: 70.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Rash erythematous
Clinical narrative: Patient is 70 Years Old Female LUE erythematous rash, swelling, pain and warmth after PCV13 administration 8/28/2017 to Left upper arm. Pain worse the night of getting shot, unable to move arm, had fever as well that night. On 9/1/2017 visit, pain improved but rash spread downward toward elbow, rash very pink and warm, no skin peeling, and patient no longer febrile. Skin Comment: erythematous flat rash L upper arm following humeral distribution down to L elbow, very warm to touch, nontender, negative Nikolsky's sign. Assessed Skin rash, allergic as comment only - PCV vaccine, PO and topical Benadryl.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site pain, Injection site pruritus, Pain
Clinical narrative: Immediate pain and muscle soreness at site of injection. Five days later the injection site itches, is bruised, and remains tender to touch.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient had some arm pain the day after vaccines on 8/16/17, but was told that that was a normal reaction. On 9/5/17, patient came into pharmacy complaining of pain continuing in arm/shoulder area at a scale of 5-8 out of 10 for 90-95% of the time. She also complained of muscle/arm weakness, sometimes so bad that it is difficult to dress herself and has to physically pick up the arm with her other hand.
Age: 0.42
Sex: F
Vaccine: IPV, PNC13
Symptoms: Contusion, Erythema, Local reaction, Skin warm
Clinical narrative: Local Reaction with bruising, Area red warm to touch.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at injection site.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced inflammation and redness in the injection site on an unspecified date with outcome of unknown.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received from a physician's assistant regarding a 4-week-old infant of unknown gender who on 21-AUG-2017 inadvertently received a first dose of ROTATEQ, vial 2 ml orally (lot and expiration unknown) for prophylaxis. Medical history and concomitant medication were not reported . No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 21-AUG-2017, the patient was vaccinated with one dose (1 DF) of improperly stored dose of VARIVAX lot # M048200 expiry date 07-DEC-2018 (route, anatomical location unknown) for prophylaxis (incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) (lot # and expiry date were unknown) used for reconstitution did not undergo a temperature excursion. The vaccine was exposed to a temperature of -14 degree Centigrade to -10 degree Centigrade for a time frame of 7 hours. There was no previous temperature excursion The call was due to a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown demographics. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (Strength, dose, frequency, route and anatomical location were not reported) of lot # M038859 with an expiry date of 14-SEP-2018, for prophylaxis. Co-suspect therapy included sterile diluent (Strength, dose, frequency and route were not reported) of lot # N006324 with an expiry date of 19-JUL-2024. There were no concomitant therapies reported. The vaccines were exposed to - 2.4 degree Celsius (C) for 1 hour and 7 minutes. There was previous temperature excursion which involved exposure to - 6 degree Celsius (C) for 2 hours. Digital data logger was involved. There were no adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Lot number N006324 has been verified to be a valid lot number for sterile diluent. Sender's Comments: US-009507513-1709USA000772.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 01-SEP-2017 from a lawyer regarding a case in litigation concerning a male patient who was inoculated with a dose of ZOSTAVAX vaccine on or about 01-OCT-2011, administered by a physician at a physician's office, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-NOV-2011, the patient was treated by a physician at a care center, for the onset of a severe vesicular rash accompanied by a weakened immune system, which was diagnosed as severe herpes zoster, or shingles. On or about 01-OCT-2015, the patient was treated by a physician at a hospital urgent care for recurrent zoster outbreaks that were resistant to antiviral therapies. The patient has been prescribed VALTREX, prednisone (manufacturer unknown), ZOSTRIX HP and VICODIN for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 01-SEP-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age who was inoculated with a dose of ZOSTAVAX vaccine on or about 25-APR-2014 at a Medical Center, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During May of 2016, the patient was treated at the Medical Center for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 05-OCT-2015 (dosage, lot number, and route of administration unknown) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-JUL-2016, the patient was treated by a physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as chronic herpes zoster, or shingles. The patient was prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 31-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route and lot # were not reported) on or about 17-JUL-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-JUL-2016, the patient was treated by a LPN and a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information was received on 31-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 11-OCT-2006 at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-AUG-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 16-NOV-2016 the patient was treated again by a physician for ongoing and worsening symptoms of shingles outbreaks. On or about 18-DEC-2016 the patient sought treatment for ongoing shingles and management of significant and uncontrolled pain. On or about 28-DEC-2016 the patient was treated by a physician for intense residual pain, which was diagnosed as post-herpetic neuralgia, a condition of chronic nerve pain and damage secondary to shingles infections. The patient was prescribed valacyclovir (VALTREX), domeboro soaks, acyclovir, gabapentin and lidocaine patches for pain management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown demographics. The patients medical history was not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of PROQUAD recombinant human albumin (rHA) (Strength, dose, frequency, route and anatomical location were not reported) of lot # N001488 with an expiry date of 12-JUL-2018, for prophylaxis. Co-suspect therapy included sterile diluent (Strength, dose, frequency and route were not reported) of lot # N006324 with an expiry date of 19-JUL-2024. There were no concomitant therapies reported. The vaccines were exposed to - 2.4 degree Celsius (C) for 1 hour and 7 minutes. There was previous temperature excursion which involved exposure to - 6 degree Celsius (C) for 2 hours. Digital data logger was involved. There were no adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. The therapy type is recombinant human albumin (rHA) for PROQUAD.; Sender's Comments: US-009507513-1708USA013663:
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Mobility decreased, Paraesthesia, Paralysis, Spinal pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72-year-old male patient. The patient received unspecified concomitant medications. No information regarding the patient's medical history and concurrent conditions was provided. The patient had no drug reactions or allergies. On 31-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N004564, expiration date: 22-OCT-2018, 1 dose, intramuscularly to prevent pneumonia. On 01-SEP-2017, the patient experienced adverse effects of pain in the back and spine, causing the feeling of paralysis. The patient also felt tingling in the face and could not move. The patient was given an unspecified treatment for the events but did not have any laboratory test performed. The patient sought medical attention at the pharmacy, however the pharmacist told him to go to a hospital. It was unknown if the patient went to the hospital or which hospital the patient went to. The reporter requested a time sensitive lot check for PNEUMOVAX 23. The outcome of the events was reported as not recovered. The casual relationship between the events and PNEUMOVAX 23 was not reported. Upon internal review, the event of feeling of paralysis was considered to be medically significant. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA000941.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 29-AUG-2017, the patient was vaccinated with ZOSTAVAX, 19400 plaque forming units injection, via subcutaneous route for shingles prevention (dose, lot # and expiration date were not reported), reconstituted with sterile diluent (manufacturer unknown) (dose, lot # and expiration date were not reported). On an unknown date in 2017 (on or after 29-SEP-2017), the patient's arm was very red near the injection site. The size was smaller than a baseball but larger than a golf ball. It did not hurt or itch. The patient did not receive treatment for the adverse event. The outcome of the event was reported as not recovered/not resolved. The relatedness between the adverse event and ZOSTAVAX and sterile diluent (manufacturer unknown) was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. {Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 31-AUG-2017, the patient was vaccinated with PROQUAD and VARIVAX for prophylaxis. Other suspect therapies included sterile diluent(STERILE DILUENT). On 31-AUG-2017, the patient experienced overdose. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. In August 2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M040423 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA001288: US-009507513-1709USA001289: US-009507513-1709USA001230: US-009507513-1709USA001045:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. In August 2017, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M045545 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA001287: US-009507513-1709USA001289: US-009507513-1709USA001290: US-009507513-1709USA001045:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. In August 2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M035140 for prophylaxis reconstituted with sterile diluent (STERILE DILUENT). No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA001290: US-009507513-1709USA001288: US-009507513-1709USA001297: US-009507513-1709USA001045:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to four patients of unknown demographics. On an unknown date in August 2017, the patients were vaccinated with improperly stored doses of PROQUAD injection, lot # M043308 with expiration date on 24-APR-2018; lot # N010247 with expiration date on 25-SEP-2018, reconstituted with properly stored sterile diluent (manufacturer unknown). Additional information has been requested.; Sender's Comments:  US-009507513-1709USA000870:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. Additional information has been requested.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Antibody test positive, Thrombocytopenia
Clinical narrative: This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer. A 15-year-old patient of unspecified race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation and PNEUMOVAX, via an unspecified route of administration, on an unspecified date, at unspecified dose, for immunisation. Relevant medical history included immunodeficiency. Concomitant medications were not reported. The antibody titer increased after vaccinations. It was reported that the patient experienced thrombocytopenia and PREVNAR 13 and PNEUMOVAX was administered at the same time to a 15 years old with immune deficiency all on unspecified date with outcome of unknown.
Sex: U
Vaccine: PNC13
Symptoms: Cerebrovascular accident
Clinical narrative: This is a spontaneous report from a contactable nurse. An elderly patient of unspecified age (over 65 years old), gender and race/ethnicity received PREVNAR 13 on an unspecified date, at single dose, for immunization. Medical history and concomitant medications were not reported. On an unspecified date, 24 hours after vaccination, the patient had a stroke. Event outcome was unknown. No follow-up attempts possible. No further information expected.; Sender's Comments: There is no plausible mechanism to implicate the suspect vaccine to the occurrence of the serious event .  Considering the patient's old age (over 65 years), the event more likely related to the underlying clinical conditions of the patient and unrelated to the vaccination with PREVENAR 13. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: PNC13
Symptoms: Asthenia, Dizziness
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. This Physician reported similar events for 3 patients. This is first of three reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lightheadedness/dizziness on an unspecified date with outcome of recovered, weakness on an unspecified date with outcome of recovered. Event was described as lightheadedness, dizziness and weakness lasting 2-3 minutes after injection, resolved by lying down, given fluids and glucose tablet. occurred in 3 patients of Pakistani Indian descent.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017379977 different patient, same product, same event; US-PFIZER INC-2017379978 different patient, same product, same event.
Sex: M
Vaccine: PNC13
Symptoms: Diet refusal, Insomnia, Irritability, Pyrexia, Rash generalised
Clinical narrative: This is a spontaneous report from a non-contactable consumer (mother) reported for her baby. A 5-month-old male patient of an unspecified ethnicity received the 1st dose of PREVNAR 13 (Lot # S35324) at single dose on 29Aug2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient previously took PREVNAR 13 for immunisation and experienced no adverse event. The patient received the 1st dose of PREVENAR 13 in June (year not clarified) for immunization and he didn't have any sort of reaction. On 29Aug2017 night the patient experienced high fever, rash all over his body, very irritable, unable to sleep, doesn't want to eat. The outcome of the events was unknown. Course of the events: The patient had his first vaccine of this (PREVNAR 13) back in June (Year not clarified) and he didn't have any sort of reaction, Then he had the vaccine on 30Aug2017 and the reaction was extreme, high fever, rash all over his body, very irritable, unable to sleep, doesn't want to eat. The reporter wanted to know, what's the difference between the two LOT numbers if they made any change to the formula, because he  had no reaction in June and now he had the bad reaction. No follow-up attempts are possible. No further information expected.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable nurse. A 4-month-old female patient of an unspecified ethnicity received PREVNAR 13 (lot number S31255 and expiration date 01Jul2018) intramuscular (left thigh), at 16:14, at 0.5 ml, single; PEDIARIX (manufacturer GSK; lot number 7275T and expiration date 16Sep2019)  via an unspecified route of administration; PEDVAXHIB (manufacturer Merck; lot number N007752 and expiration date 01Dec2019) via an unspecified route of administration; and ROTARIX (manufacturer GSK; lot number LL773 and expiration date 19Feb2019)  via an unspecified route of administration, all given on 17Aug2017 for routine immunization for a 4-month well visit. The patient had no medical history. Concomitant medications were not reported. On 18Aug2017, the patient developed hives. Therapeutic measures included administration of diphenhydramine (BENADRYL) for a couple of days and has not needed this. Outcome of the event was recovered on an unknown date. The physician thinks that it was unlikely that it was related to the vaccine.
Sex: F
Vaccine: PNC13, UNK
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her mother, communicated to a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single  dose in one arm for immunisation and influenza vaccine (FLU), via an unspecified route of administration on an unspecified date at an unspecified dose in the same arm for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient received both vaccines, pneumococcal 13-val conjugate vaccine (dipht crm197 protein) and influenza vaccine, in the same arm. The patient experienced  a lot of redness, swelling, and pain on an unspecified date. The outcome of the events pain, redness and swelling was recovered on an unspecified date.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Dysphonia, Erythema, Rash, Throat irritation
Clinical narrative: Rash began close to site of injection 5 minutes post injection (09:35 am). Redness began to spread over arm. BENADRYL given PO 12.5 mg at 09:35. Another 37.5 mg PO BENADRYL given at 10:08. Patient being monitored post-BENADRYL. Vital signs stable. Patient given albuterol treatment 5mg for asthma exacerbation. Oxygen saturation 99%, heart rate 95 bpm, 24 respirations per minute. Post treatment: Oxygen saturation 100%, respirations 24, heart rate 71 bpm. Patient complaining of "itchy" throat and voice change noted by MD at 10:35 am. Epinephrine 1:1000 given - 0.5mL IM given at 10:40 am. Patient escorted to ER for continued monitoring and treatment. Oxygen saturation 100%, BP 137/81, 87 heart rate, 98.0 temp before epi given. After epi given, oxygen saturations monitored en route to ER. Oxygen saturation remained 100% and heart rate remained consistent between 70-80 bpm.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Pyrexia, Rash generalised, Rash morbilliform, Vaccination complication
Clinical narrative: Shot given at 11:45 am and by 10pm he had a fever. At 6:00 am the next morning he was violently throwing up to the point he couldn't stop and severe diarrhea. The nurse on call told me to take him to the emergency room. Took him to the emergency room where they stated this was reaction to the vaccine. They gave him ZOFRAN to stop the vomiting and after an hour or so gave him a popsicle and sent him home. 2 days later he broke out in a measles like rash over his entire body. He had the rash for almost 10 days. By the 4th day I took him to the doctor's office on August 20th where the doctor on call tried to state it wasn't from the vaccine but I know it was. After 10 days the rash finally cleared but then showed up again September 3rd and still has it now.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Shot given at 11:45 am and by 10pm he had a fever. At 6:00 am the next morning he was violently throwing up to the point he couldn't stop and severe diarrhea. The nurse on call told me to take him to the emergency room. Took him to the emergency room where they stated this was reaction to the vaccine. They gave him ZOFRAN to stop the vomiting and after an hour or so gave him a popsicle and sent him home. 2 days later he broke out in a measles like rash over his entire body. He had the rash for almost 10 days. By the 4th day I took him to the doctor's office on August 20th where the doctor on call tried to state it wasn't from the vaccine but I know it was. After 10 days the rash finally cleared but then showed up again September 3rd and still has it now.
Age: 77.0
Sex: M
Vaccine: TTOX
Symptoms: Lipoma
Clinical narrative: Note: Pt does not want his name, DOB, or contact information on the VAERS report. He also doesn't want VAERS to contact the treating physician or vaccine administrator, so that information was purposely omitted. The only purpose of submitting this report is to share the adverse event. Pt developed lipoma after tetanus vaccine.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray normal, Culture urine negative, Fatigue, Injection site swelling, Polymerase chain reaction
Clinical narrative: Patient received vaccine that afternoon and went to be that evening without issue. The next morning woke up with localized swelling and had decreased weight bearing on left leg. Was fatigued and napping alot throughout the day. Taken to the ER for low grade fever, given Tylenol and Benadryl and discharged home. Represented to ER later for temp of 103, stabilized with motrin and discharged home. The following morning was admitted to hospital for vomiting, fever of 10, and rash over the neck and chest. ID work-up with viral PCR, urine culture, chest xray was negative. Patient discharged from hospital after 72 hrs stay.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Rash, Somnolence, Viral test negative, Vomiting
Clinical narrative: Patient received vaccine that afternoon and went to be that evening without issue. The next morning woke up with localized swelling and had decreased weight bearing on left leg. Was fatigued and napping alot throughout the day. Taken to the ER for low grade fever, given Tylenol and Benadryl and discharged home. Represented to ER later for temp of 103, stabilized with motrin and discharged home. The following morning was admitted to hospital for vomiting, fever of 10, and rash over the neck and chest. ID work-up with viral PCR, urine culture, chest xray was negative. Patient discharged from hospital after 72 hrs stay.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Weight bearing difficulty
Clinical narrative: Patient received vaccine that afternoon and went to be that evening without issue. The next morning woke up with localized swelling and had decreased weight bearing on left leg. Was fatigued and napping alot throughout the day. Taken to the ER for low grade fever, given Tylenol and Benadryl and discharged home. Represented to ER later for temp of 103, stabilized with motrin and discharged home. The following morning was admitted to hospital for vomiting, fever of 10, and rash over the neck and chest. ID work-up with viral PCR, urine culture, chest xray was negative. Patient discharged from hospital after 72 hrs stay.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Tic
Clinical narrative: Patient developed vocal tic within 1 week of vaccine administration.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: ARM SWOLLEN, VERY RED, HOT AND TENDER.
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Patient called this morning with redness from shoulder to elbow, left arm.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via skin contact, No adverse event
Clinical narrative: Information was received on 10-AUG-2017 from a nurse who reported that on 10-AUG-2017, the nurse (unknown age, gender, medical history or concomitant medication) who was administering the GARDASIL 9 vaccine (lot M042853, expires 17-JUL-2019) to a patient and inadvertently splashed the vaccine onto her own skin and eyes. No adverse effects were reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU, intradermally (dose, anatomical location, lot# and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (MRK) intradermally (dose, route of administration, anatomical location, lot# and expiration date were not reported). On an unknown date (reported as afterwards the vaccination), the patient did have a bit of redness at the injection site, but it looked to be getting better (at the time of the report). The relatedness between the event and therapy with ZOSTAVAX and sterile diluent (MRK) was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. On 28-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M035693, subcutaneous for prophylaxis.  Concomitant therapies included sterile diluent (STERILE DILUENT). On 30-AUG-2017, 3 days after onset of therapy the patient experienced injection site pruritus, skin warm, erythema, pruritus and injection site erythema. The outcome of pruritus, injection site erythema, injection site pruritus and erythema was reported as recovering/resolving. The outcome of skin warm was reported as not recovered/not resolved.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 31-AUG-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 09-JUN-2009, the patient was inoculated with ZOSTAVAX, administered by the physician at a health care facility as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot #, were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-NOV-2012, he was treated by the physician (same physician who administered the vaccine on or about 09-JUN-2009) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 10-APR-2013, the male patient received subsequent treatment from the same physician for ongoing and worsening symptoms of active problematic herpes zoster. The male patient has been prescribed valacyclovir (VALTREX) for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 31-AUG-2017 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 22-APR-2015, at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-OCT-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 31-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route and lot # were not reported) on or about 12-NOV-2008 at an Internal Medicine Group, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-DEC-2011, the patient was treated by a physician at an Internal Medicine Group for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. Beginning on or about 09-APR-2012, the patient was treated for a ongoing and worsening outbreak of shingles, which actively manifested continuously until  27-APR-2015.The patient  has suffered exception complications of shingles, including persistent outbreaks for a period of more than three years. The patient has been prescribed valacyclovir (VALTREX), diclofenac sodium) (VOLTAREN), Tramadol, Lidocaine, and Lipoderm for management of her symptoms and pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. In August 2017, the patients were vaccinated with improperly stored doses of VAQTA lot # N005274 and N008823 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA001288: US-009507513-1709USA001289: US-009507513-1709USA001290: US-009507513-1709USA001287:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. In August 2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M043310) for prophylaxis reconstituted with sterile diluent. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA001045: US-009507513-1709USA001289: US-009507513-1709USA001288: US-009507513-1709USA001287.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Said he had a fever and right arm was swollen.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Angiotensin converting enzyme decreased, Antinuclear antibody negative, Bartonella test negative, Blindness, Borrelia test negative
Clinical narrative: I am a nurse practitioner and have received flu vaccines for many years. 2 weeks after receiving the flu vaccine in 2016, I developed a uveitis of the right eye and lost vision. I was referred to an uveitis specialist and PhD in immunology at Hospital by a local ophthalmologist. A paracentesis revealed Varicella Zoster Virus Retinitis. I was given antiviral injections in the eye on multiple occasions as well as oral antivirals and steroids. November 16, 2016 I had surgery that was initially planned to prevent retinal detachment, but the retina detached the night prior so the surgery was to correct that. I haven't been able to have a second surgery yet to remove the silicone oil to see if I have any vision left because of the inflammation behind the retina. I continue to be on eye drops (DUREZOL 8 times a day and Dorzolamide 3 times a day), Prednisone (since this started), and VALTREX (since this started).  This condition is high risk for developing in the other eye, therefore, I have been advised not to ever get another flu shot since we are not sure how my immune system will react. I will be on antivirals for the rest of my life, and I may never have vision in my right eye.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: HLA-B*27 assay, Paracentesis eye abnormal, Retinal detachment, Retinitis viral, Retinopexy
Clinical narrative: I am a nurse practitioner and have received flu vaccines for many years. 2 weeks after receiving the flu vaccine in 2016, I developed a uveitis of the right eye and lost vision. I was referred to an uveitis specialist and PhD in immunology at Hospital by a local ophthalmologist. A paracentesis revealed Varicella Zoster Virus Retinitis. I was given antiviral injections in the eye on multiple occasions as well as oral antivirals and steroids. November 16, 2016 I had surgery that was initially planned to prevent retinal detachment, but the retina detached the night prior so the surgery was to correct that. I haven't been able to have a second surgery yet to remove the silicone oil to see if I have any vision left because of the inflammation behind the retina. I continue to be on eye drops (DUREZOL 8 times a day and Dorzolamide 3 times a day), Prednisone (since this started), and VALTREX (since this started).  This condition is high risk for developing in the other eye, therefore, I have been advised not to ever get another flu shot since we are not sure how my immune system will react. I will be on antivirals for the rest of my life, and I may never have vision in my right eye.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Treponema test negative, Uveitis, Varicella virus test positive, Varicella zoster virus infection
Clinical narrative: I am a nurse practitioner and have received flu vaccines for many years. 2 weeks after receiving the flu vaccine in 2016, I developed a uveitis of the right eye and lost vision. I was referred to an uveitis specialist and PhD in immunology at Hospital by a local ophthalmologist. A paracentesis revealed Varicella Zoster Virus Retinitis. I was given antiviral injections in the eye on multiple occasions as well as oral antivirals and steroids. November 16, 2016 I had surgery that was initially planned to prevent retinal detachment, but the retina detached the night prior so the surgery was to correct that. I haven't been able to have a second surgery yet to remove the silicone oil to see if I have any vision left because of the inflammation behind the retina. I continue to be on eye drops (DUREZOL 8 times a day and Dorzolamide 3 times a day), Prednisone (since this started), and VALTREX (since this started).  This condition is high risk for developing in the other eye, therefore, I have been advised not to ever get another flu shot since we are not sure how my immune system will react. I will be on antivirals for the rest of my life, and I may never have vision in my right eye.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Blood test normal, Diarrhoea, Nausea, Pyrexia
Clinical narrative: By night nausea started, had the runs, had high fever went on until 11am the next day. Had no energy/ strained her. Went to see the doctor, gave medicine for nausea and diarrhea. Symptoms went away and then restarted after 2 days. This pattern has continued since January. Has been ok for 8 days stomach wise but low grade fever persist.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Peripheral swelling, Pruritus, Rash, Skin warm
Clinical narrative: The patient reports swelling from her elbow to her shoulder. Also hives, rash and itching. She also reports the arm is warm to the touch. The patient has felt ill since she received the injection.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: The patient reports swelling from her elbow to her shoulder. Also hives, rash and itching. She also reports the arm is warm to the touch. The patient has felt ill since she received the injection.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Fatigue, Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: -Red, hot, swollen skin on left leg, pt feeling fatigued: called in for med eval on 8/30 and advised to use cold compress and ibuprofen and go to the ER if symptoms get worse. -Patient seen for evaluation on 8/31 and prescribed hydrocortisone cream. -Per 9/5 phone call patient was seen at the ER and prescribed antibiotics for cellulitis on both legs.
Age: 46.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Patient went to the doctor because of large redness around the area and felt hot. Doctor prescribed CIPRO and asked patient to return for lab CBC next day. Doctor told patient it was cellulitis.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Throat tightness
Clinical narrative: About 2 hours after vaccine, patient describes her throat feeling like it was closing, difficulty swallowing.