chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified date, the patient was vaccinated with an improperly stored dose of VARIVAX injection (dose, frequency and route were not reported) lot # M046004 with expiration date of 18-NOV-2018 or lot # M028547 with expiration date of 07-JUN-2018, for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion of the VARIVAX was between -9 °C and 8 °C for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005163: US-009507513-1706USA005174: US-009507513-1706USA005175: US-009507513-1706USA005176: US-009507513-1706USA005177: US-009507513-1706USA005179:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified date, the patient was vaccinated with an improperly stored dose of VARIVAX injection (dose, frequency and route were not reported) lot # M046004 with expiration date of 18-NOV-2018 or lot # M028547 with expiration date of 07-JUN-2018, for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion of the VARIVAX was between -9 °C and 8 °C for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005163: US-009507513-1706USA005174: US-009507513-1706USA005175: US-009507513-1706USA005176: US-009507513-1706USA005177: US-009507513-1706USA005178:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 12-JUN-2017, the patient was vaccinated with a dose of PROQUAD lot number reported as: M000336, expiration date on 03-JUL-2018 (strength, dose number and route were not provided) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). It was reported that the dose of PROQUAD was improperly stored at 43° Fahrenheit degrees for 11 days. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported.  No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates since 05-JUN-2017, the patients were vaccinated with improperly stored doses of M-M-R II "rHA" (dose, frequency and route were not reported) lot # M045394 with expiration date of 14-NOV-2018 and lot # M040624 with expiration date of 03-OCT-2018, that were reconstituted with diluent MRK (injection; lot # and expiration date were not reported), for prophylaxis. The temperature of the M-M-R II was between 9°C and 25°C for a time frame of 2 hours and 2 minutes. No previous temperature excursion occurred and data logger was involved. No adverse effects were reported. This is one of four reports received from the same source.  Additional information has been requested. Sender's Comments: US-009507513-1706USA004409: US-009507513-1706USA006313: US-009507513-1706USA006314.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Balance disorder, Deafness, Syncope
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative and refers to a 16-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unspecified date in approximately 2015 (reported as "approximately 2 years ago"), the patient was vaccinated with GARDASIL injection (dose, route of administration, lot number and expiration date were not reported), for prophylaxis. On an unknown date, after receiving the GARDASIL, the patient collapsed and then experienced lack of sense of balance and some loss of hearing. At the time of this report, the patient did not recover from the adverse events. The causality assessment between the events and GARDASIL was not provided. No product quality complaint was involved. Upon internal review, the event of collapsing was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 14-JUN-2017 from a lawyer and a female patient of unknown age regarding a case in litigation. It is complained and alleged that the patient was inoculated with ZOSTAVAX (dose, route, lot number and expiration date were not reported) on or about 17-SEP-2009 at a pharmacy as recommended for routine adult health maintenance 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-JAN-2014, the patient was treated by a nurse practitioner for a vesicular outbreak that was diagnosed as severe shingles. On or about 02-SEP-2015, the patient was treated by two physicians at a Medical Center for ongoing and worsening outbreaks of herpes zoster. The patient was prescribed gabapentin, hydrocodone and valacyclovir (VALTREX) 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: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 02-JUN-2017, the patient was vaccinated with improperly stored VARIVAX injection, lot # M046004, expiry date: 18-NOV-2018 (dosing details not reported) which was reconstituted with properly stored sterile diluent (MERCK) (lot#, expiry date unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 180 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA008689: US-009507513-1706USA008691: US-009507513-1706USA008688: US-009507513-1706USA008690: US-009507513-1706USA008692: US-009507513-1706USA008694: US-009507513-1706USA008693.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 02-JUN-2017, the patient was vaccinated with improperly stored VARIVAX injection, lot # M046004, expiry date: 18-NOV-2018 (dosing details not reported) which was reconstituted with properly stored sterile diluent (MERCK) (lot#, expiry date unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 180 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA007776.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 05-JUN-2017, the patient was vaccinated with improperly stored VARIVAX injection, lot # M046004, expiry date: 18-NOV-2018 (dosing details not reported) which was reconstituted with properly stored sterile diluent (MERCK) (lot#, expiry date unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 180 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Additional information has been requested Sender's Comments: US-009507513-1706USA007776.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 06-JUN-2017, the patient was vaccinated with improperly stored VARIVAX injection, lot # M046004, expiry date: 18-NOV-2018 (dosing details not reported) which was reconstituted with properly stored sterile diluent (MERCK) (lot#, expiry date unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 180 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA007776.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 09-JUN-2017, the patient was vaccinated with improperly stored VARIVAX injection, lot # M046004, expiry date: 18-NOV-2018 (dosing details not reported) which was reconstituted with properly stored sterile diluent (MERCK) (lot#, expiry date unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 180 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA007776.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 14-JUN-2017, the patient was vaccinated with improperly stored VARIVAX injection, lot # M046004, expiry date: 18-NOV-2018 (dosing details not reported) which was reconstituted with properly stored sterile diluent (MERCK) (lot#, expiry date unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 180 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA007776.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported.  On 14-JUN-2017, the patient was vaccinated with improperly stored VARIVAX injection, lot # M046004, expiry date: 18-NOV-2018  (dosing details not reported) which was reconstituted with properly stored sterile diluent(MERCK STERILE DILUENT) (lot#, expiry date unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 180 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints This is one of several reports received from the same reporter. Additional information has been requested; Sender's Comments:  US-009507513-1706USA007776:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional concerning to an unknown number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of GARDASIL 9. Lots and expiration dates were unknown by the reporter. No adverse effects reported. The call was made due to a data logger. Excursion information was: Temperature and time frame: 0°C to 1°C for 2.5 hours, 9°C to 25°C (9.36C) for 8.75 hours. No previous temperature excursion. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA008768: US-009507513-1706USA008768.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional concerning to an unknown number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of VAQTA. Lots and expiration dates were unknown by the reporter. No adverse effects reported. The call was made due to a data logger. Excursion information was: Temperature and time frame: 0°C to 1°C for 2.5 hours 9°C to 25°C (9.36C) for 8.75 hours No previous temperature excursion. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA003498: US-009507513-1706USA008767:
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Crying, Dysstasia, Gait disturbance, Intensive care
Clinical narrative: On 1/2/2016 she began fussing/crying and not acting herself. She was not walking normal and as the day progressed it became worse. By the end of that night she would not stand or walk much, she was staring into space at times and not responding normally to our interactions with her. By 1/3/16 she had to be taken to ER and was admitted to PICU with potential GBS diagnosis or ADEM per the ER admitting doc.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Irritability, Staring
Clinical narrative: On 1/2/2016 she began fussing/crying and not acting herself. She was not walking normal and as the day progressed it became worse. By the end of that night she would not stand or walk much, she was staring into space at times and not responding normally to our interactions with her. By 1/3/16 she had to be taken to ER and was admitted to PICU with potential GBS diagnosis or ADEM per the ER admitting doc.
Sex: M
Vaccine: FLU4
Symptoms: Seasonal allergy, Wheezing
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of wheezing in a adult male patient who received Influenza vaccine Quadrivalent unspecified season. Previously administered products included Influenza vaccine Quadrivalent unspecified season (Every year from past several years). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced wheezing and pollen allergy. On an unknown date, the outcome of the wheezing and pollen allergy were unknown. It was unknown if the reporter considered the wheezing and pollen allergy to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. Later, as pollen was strong, patient developed some wheezing which the physician associated with allergies. Patient was hard to understand and hard to pin down whether the event was reportable.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Cough, Decreased activity, Decreased appetite, Diarrhoea, Headache
Clinical narrative: Received GARDASIL 9 vaccine on 4-26-17. Within 12hrs after the vaccine-C/O HA, vomited 1X, diarrhea couple days, no appetite, not active. Office visit 5-1-17 with cough, congestion, again 5-3-17 with cough, sore throat.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Oropharyngeal pain, Respiratory tract congestion, Vomiting
Clinical narrative: Received GARDASIL 9 vaccine on 4-26-17. Within 12hrs after the vaccine-C/O HA, vomited 1X, diarrhea couple days, no appetite, not active. Office visit 5-1-17 with cough, congestion, again 5-3-17 with cough, sore throat.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Chills, fever, nausea.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: Large 4x4 inches red swollen area right of injection where vaccine given 24 hrs ago and lethargy.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Blood culture, Febrile convulsion, Full blood count, Metabolic function test, Pyrexia
Clinical narrative: Fever up to 104, Febrile seizure, Treated and released.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Urine analysis
Clinical narrative: Fever up to 104, Febrile seizure, Treated and released.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Erythema, Injection site pruritus
Clinical narrative: States few days after shot on 12th or 13th itchy at site and joint pains in both hands and redness on L forearm. Came and went few times a day 6/17 or 6/18.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of injection - about 4 inches wide and 2 inches across. This is day 3 (6-17-17).
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, IPV, MMRV
Symptoms: Wrong drug administered
Clinical narrative: Patient was administered PENTACEL instead of DTaP.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received on 31-MAY-2017 from a field representative. Physician had reported to field representative that an unknown male patient (age not reported) had developed a case of shingles (on an unspecified date) after receiving the ZOSTAVAX vial 19400 PFU vaccination (on an unspecified date) (dose, lot#/expiration not reported). The physician also noted that the patient had contracted the shingles (on an unspecified date) in the past prior to the ZOSTAVAX vaccination. Outcome of shingles was unknown. No additional adverse event information provided. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 9 year old male patient with type 1 diabetes mellitus. The patient's pertinent medical history was not provided and he had not any drug reaction/allergy before. His concomitant medications included insulin. On 31-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 subcutaneously, in the right deltoid, Lot # N005096 with an expiration date on 22-OCT-2018 (strength and dose were not reported) for prevention of pneumonia. On this same date, the patient had a fever of 102.5 (units not provided) (pyrexia) (also reported as "no laboratory studies were performed") and his right upper arm became swollen and painful from his right shoulder to his right elbow and his Mom had to cut off his shirt. The nurse practitioner reported that the patient went to an unspecified emergency room on this same date, where his injected arm circumference was 23 cm at the thickest part compared to 18 cm on the non-injected arm and the circumference of his elbow on the injected arm was 20 cm compared to 16 cm on the non-injected arm. Nurse reported that patient treatment received in the emergency room was ice packs and an unspecified dose of acetaminophen (TYLENOL). The patient was discharged from the emergency room to home and told to follow up with his primary care physician. At the reporting time, the patient was not recovered and was at home taking unspecified doses of acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The causality assessment between pyrexia, peripheral swelling and pain in extremity, and vaccination with PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous, Scar
Clinical narrative: This spontaneous report was received from a physician referring to a 63 years old female patient. The patient's medical history, concurrent conditions, drug and allergy history were not reported. On 01-NOV-2015, the patient was vaccinated with ZOSTAVAX 19400 plaque forming units (PFU), by subcutaneous route, lot # K014836 (dose and expiration date were not provided) for prevention of herpes zoster. The patient's concomitant therapy was not reported. On 15-APR-2017, the patient developed a mild case of shingles (herpes zoster) after having previously being vaccinated with ZOSTAVAX. The patient sought the physician for medical attention, she was prescribed 1 gram of valacyclovir 3 times a day for 21 days to treat her shingles, however the patient still had "scarring and red dots from the shingles". At the reporting time, the causality assessment between ZOSTAVAX and shingles was unknown. Additional information is not expected, because there was no consent to contact reporter.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route were not reported), lot # N001528, expiration date: 13-JAN-2019  that was reconstituted with sterile water diluent (MERCK) (lot number and expiration date were not provided) or PROQUAD (dose and route were not reported), lot # N000336, expiration date: 03-JUL-2018 that was reconstituted with sterile water diluent (MERCK) (lot number and expiration date were not provided) both for prophylaxis. The vaccines were exposed to temperature between 6 to 14 degrees Fahrenheit for a time frame of 965 hours and 7 minutes. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. 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 expired dose of PROQUAD lot # L040412 with expiration date: 13-APR-2017 (route and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report from a contactable consumer based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASP2017088236), license party for ENBREL. Initial Receipt Date = 08/JUN/2017. This serious spontaneous report (USASP2017088236) was reported to Amgen on 08/JUN/2017 by a consumer and involves a 56 years old female patient who was experiencing joint pain all over her body while receiving ENBREL. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were reported. The patient's co-suspect medications included PREVNAR 13. The patient began ENBREL on an unknown date in 2015, approximately two years prior to this report. On an unknown date, the patient stated that she went to her primary care physician and received the PREVNAR 13 Vaccine. Subsequently, the patient was experiencing joint pain all over her body. On 08/JUN/2017 on the day of  this report, the patient was due for her dose. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as unknown. Action taken with ENBREL was continued for the event rheumatoid arthritis. The causal relationship between the event rheumatoid arthritis and ENBREL was not provided by the consumer. The reporter declined consent for follow up. Amgen comment:This safety report does not necessarily reflect a conclusion by Amgen that etanercept, caused or contributed to the adverse event reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This is a spontaneous report received from a contactable nurse via sales representative. A patient of an unspecified age, gender and ethnicity received TRUMENBA intramuscularly in the thigh area on an unspecified date at 0.5 ml, single for immunisation. Patient medical history and concomitant medications were not reported. After receiving the vaccine on unspecified date, the patient experienced a large red, hot, swollen, tender and painful area on the thigh where the vaccine was administered. Outcome of the events was unknown.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Dyskinesia, Ear pain, Mobility decreased
Clinical narrative: Had shot on 10-21-16 on 10-25-16 I could not open my mouth far my sides of my ears hurt. On the 10-26-16 I had trouble lifting my feet over a very slight raise in our floor. I had got a walker that night, but I could not get out of my chair so the ambulance came on 10-27-16 to the hosp. I went.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Walking aid user
Clinical narrative: Had shot on 10-21-16 on 10-25-16 I could not open my mouth far my sides of my ears hurt. On the 10-26-16 I had trouble lifting my feet over a very slight raise in our floor. I had got a walker that night, but I could not get out of my chair so the ambulance came on 10-27-16 to the hosp. I went.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral mucosal eruption, Rash
Clinical narrative: Pt said - after injection med a month, pt got a rash on her face. She got a little by little rash around on her mouth.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes, Oral mucosal eruption
Clinical narrative: Pt said - after injection med a month, pt got a rash on her face. She got a little by little rash around on her mouth.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Nausea, then low grade fever, followed by headache/dizziness.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swollen and itchy at ZOSTAVAX injection site. Patient said it felt like a "softball" was in her arm.
Age: 30.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Client received varicella vaccination, RN unaware of pregnancy at time of vaccination. No adverse reaction noted at time of vaccination.
Age: 1.58
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Conversion disorder, Hallucination, Hyperaesthesia, Opisthotonus
Clinical narrative: High fever (104.5) not able to be reduced with MOTRIN, hallucinations, extreme stomach pain, screaming, inconsolable hysterics, extreme skin sensitivity all over body (touching resulted in arching of back and more screaming).
Age: 1.58
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Screaming
Clinical narrative: High fever (104.5) not able to be reduced with MOTRIN, hallucinations, extreme stomach pain, screaming, inconsolable hysterics, extreme skin sensitivity all over body (touching resulted in arching of back and more screaming).
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray, Dyspnoea, Implant site discolouration, Implant site swelling, Injection site erythema
Clinical narrative: Itching on the initial day, it was itchy on and off until the day the site was red. 2 days later I had small red bumps but I didn't think anything of it. The next day the bumps spread all over but I thought it was mosquito bites so I didn't do anything. The implantation site started turning purple and then raised. I felt like I couldn't breathe so I went to the ER. I got a neb treatment and BENADRYL. The next night I had trouble breathing so I had to call an ambulance to get me to the hospital. Less than 24 hours later I was back in the hospital having trouble breathing and the area where I got the implantation was worse so they did a CXR.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Itching on the initial day, it was itchy on and off until the day the site was red. 2 days later I had small red bumps but I didn't think anything of it. The next day the bumps spread all over but I thought it was mosquito bites so I didn't do anything. The implantation site started turning purple and then raised. I felt like I couldn't breathe so I went to the ER. I got a neb treatment and BENADRYL. The next night I had trouble breathing so I had to call an ambulance to get me to the hospital. Less than 24 hours later I was back in the hospital having trouble breathing and the area where I got the implantation was worse so they did a CXR.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Patient was given a MENACTRA shot, less than 5 minutes later she collapse, but still conscious. Called paramedics to check on patient.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Exposure during pregnancy, Vomiting
Clinical narrative: Chest tightness, vomiting.
Age: 16.0
Sex: M
Vaccine: HPVX, MENB
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Nausea
Clinical narrative: Soreness at injection site, fatigue, fever, chills, nausea, muscle pain; gave ibuprofen (2 tablets) every 6-8 hours; fever broke 6/17 AM.
Age: 16.0
Sex: M
Vaccine: HPVX, MENB
Symptoms: Pyrexia
Clinical narrative: Soreness at injection site, fatigue, fever, chills, nausea, muscle pain; gave ibuprofen (2 tablets) every 6-8 hours; fever broke 6/17 AM.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Eye movement disorder, Syncope, Vomiting
Clinical narrative: Information has been received from a medical assistant via a company representative concerning to a 12 year old male patient with prophylaxis. No medical history nor drug allergies were reported. In April 2017 (reported as "a couple of months ago"), the patient was vaccinated with dose 1 of GARDASIL 9 (Lot No. M040412, exp. date not reported) for prophylaxis. Concomitant medications included TDAP and MENVEO which were received on the same visit. After receiving the GARDASIL 9 the patient fainted, eyes rolled back and the patient experienced "jerky motions". The patient was laid down with his feet elevated and "vitals were checked". After resting the patient felt fine; however, the patient then experienced "Throwing up". The patient was kept longer, for a total length of office visit being of two hours and on leaving the office, the patient felt fine and left the office with no other events. The patient was prescribed with ZOFRAN. The patient did not die. The relationship between the aforementioned adverse events and therapy with GARDASIL 9 was not reported. Additional information is not expected as no consent to follow up was obtained.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This initial spontaneous report was received from a physician via a company field representative and refers to a female patient "around 60 years old". Medical history, concurrent conditions and concomitant medications were unknown by the reporter. On an unknown date, the patient received ZOSTAVAX (route and lot # not provided). In approximately May 2017 the patient had some sort of breakout/rash on her arm between the elbow and wrist. The physician reported that "it's been about two weeks and it is starting to clear up". Causality assessment was not provided. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test positive, Rubella antibody positive
Clinical narrative: This spontaneous report was received from a registered pharmacist referring to a 25 year old male patient. The patient's concurrent conditions included seasonal, penicillin and sulfa allergies. The patient's medical history was not reported. Concomitant therapies included FLONASE. On an unknown date in 1990 (at one year of age) and on an unknown date in 1994 (at five years of age), the patient was vaccinated with the first and second dose of M-M-R II, subcutaneously (strength, dose, anatomical location, lot number and expiration date were not provided), for prevention of measles, mumps and rubella, respectively. Then, on an unspecified date in 2011 for an unknown reason, the patient was administered a third dose of M-M-R II, at the same dosage regimen of the first dose, also for prophylaxis. Subsequently, on an unspecified date in 2011 (also reported as two months later), the patient received a fourth dose of M-M-R II, at the same dosage regimen of the first dose, also for prophylaxis. On an unknown day in January 2015, the patient had titers drawn, which showed he had positive titers for mumps (mumps antibody test positive) and rubella (rubella antibody positive), but had low titers for measles with a level of 0.2 (units not provided) (measles antibody negative). On an unknown day in March 2017, the patient was vaccinated with a fifth dose of M-M-R II, at the same dosage regimen of the first dose, also for prophylaxis. However, on 01-JUN-2017, the patient had titers drawn again, which showed his titers for measles were still low at 0.4 (units not provided). The patient did not receive any treatment. At the time of reporting, the outcome of mumps antibody test positive and rubella antibody positive was unknown. As of 01-JUN-2017, the patient had not recovered from the measles antibody negative. The causal relationship between all above mentioned events and the M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 14-JUN-2017, the patient was inadvertently vaccinated one expired dose of with GARDASIL lot # L031245, expiration date on 27-MAY-2017( strength, dose number, route and anatomical location were not provided) for prophylaxis. No adverse events were reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Patient had a bright red rash 2 inches by 3 inches in diameter under the injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Fall, Injection site erythema
Clinical narrative: Erythema site reaction. Slipped and fell in the middle of the night and doesn't remember it happening.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient complained of rash, redness and swelling of area near and around injection site.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPA, HPV4, MENB
Symptoms: Anogenital warts, Biopsy skin abnormal, Cryotherapy, Human papilloma virus test positive, Laser therapy
Clinical narrative: My daughter went twice to the operation room because the doctor decided to laser the Condylomas and the genital warts that beginning in the external vaginal area all thru the vaginal canal to the Uterus, after that in January 2017 he freeze another ones that was located in the vaginal area and he took a biopsy that tested positive to HPV16-DNA. On May 23, 2017 she went again to the operation room in order to remove another condylomas. We need to go every two weeks to the doctor.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site bruising
Clinical narrative: Right thigh contusion. Rx: warm compress.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Rash, Skin warm
Clinical narrative: INFLAMMATION/RASH TYPE SKIN REACTION AND WARM TO THE TOUCH.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Influenza like illness, Pain, Pyrexia, Vomiting
Clinical narrative: Flu-like symptoms - fever, chills, body aches, vomiting for 3 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Varicella post vaccine
Clinical narrative: Pt broke out with the chicken pox diagnosed by PCP. Spread rapidly throughout her entire body. Very itchy. PCP called in acyclovir to help but was too late. Rx didn't arrive to the pharmacy until 6/12 when patient's condition was subsiding. She did not pick it up.
Age: 39.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Dizziness, Pruritus, Rash
Clinical narrative: Patient experienced rash on lower face/jaw, itching, and feeling lightheaded and a little dizzy.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. returned to pharmacy on 6/20/17 C/O red swollen bump on arm at inj. site, it was significantly red and warm to touch. Pt. was referred to PCP to rule out infection and for further treatment. Pt. stated was pink at time of inj. but has become more red over time.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Chest pain, Headache, Musculoskeletal discomfort, Myalgia
Clinical narrative: Called 6/19 and states woke up Saturday 6/17 AM w/discomfort (R) side neck, headaches, muscle ache in bicep. On 6/18 couple episodes of sharp stabbing chest pain lasted 10 seconds.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site reaction, Nerve injury, Radiculopathy
Clinical narrative: Not from med. believe injection done too deep. Nerve damage/irritation-arm numbness like asleep when at computer or various angles-4-5 x a day-slowly improving-still active. Injection site still notable if pressed-nerve pain.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, MMRV
Symptoms: Erythema, Macule, Rash generalised, Rash papular
Clinical narrative: Individual pink macules with slightly papular becoming confluent on thighs, over entire body-Rash x 24hrs. began in sm. patches and then spread. BENADRYL and MORTIN given for Tx as needed.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Decreased appetite, Fatigue, Headache, Injected limb mobility decreased, Malaise
Clinical narrative: A few hours after immunizations nausea, Temp 101. Some tingling in hands and feet. Pain Rt. arm and tender to touch. Slight swelling. Fever, tingling resolved by 6/15/17. 6/16/17 still not feeling well, appetite improving. Fever resolved 6/16/17, still fatigued. Couldn't move Rt. arm for days. Warm to touch, not red. Headache resolved 6/19/17.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Nausea, Pain in extremity, Paraesthesia, Pyrexia, Skin warm
Clinical narrative: A few hours after immunizations nausea, Temp 101. Some tingling in hands and feet. Pain Rt. arm and tender to touch. Slight swelling. Fever, tingling resolved by 6/15/17. 6/16/17 still not feeling well, appetite improving. Fever resolved 6/16/17, still fatigued. Couldn't move Rt. arm for days. Warm to touch, not red. Headache resolved 6/19/17.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Swelling, Tenderness
Clinical narrative: A few hours after immunizations nausea, Temp 101. Some tingling in hands and feet. Pain Rt. arm and tender to touch. Slight swelling. Fever, tingling resolved by 6/15/17. 6/16/17 still not feeling well, appetite improving. Fever resolved 6/16/17, still fatigued. Couldn't move Rt. arm for days. Warm to touch, not red. Headache resolved 6/19/17.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Arms bilaterally warm to touch and itchy (upper arms). Evaluated by Dr. 06/19/17, MOTRIN and BENADRYL advised for symptoms.
Age: 26.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Patient reports a rash and welt developing the day after administration of vaccine on the right arm, which has improved but is still slightly red on 06/16/17. Patient took ALLEGRA.
Age: 1.83
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Contusion, Rash papular
Clinical narrative: Bruising and fine flesh colored papular rash which resolved on its own within one week.
Age: 38.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Chills, Cold sweat, Injection site swelling
Clinical narrative: I took the pneumococcal 13 injection. I have fever, chills, extremely weak, cold sweats, bad a injection site swelling, joint pain.
Age: 38.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: I took the pneumococcal 13 injection. I have fever, chills, extremely weak, cold sweats, bad a injection site swelling, joint pain.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Erythema, Fatigue, Gait disturbance
Clinical narrative: Information was received from a 78 year old female consumer on 07-JUN-2017 who was reporting on herself. Concomitant medications included "a very low dose of ZOLOFT" and an allergy to penicillin. No medical history was reported. On 27-OCT-2015, the patient received a dose of ZOSTAVAX (lot, expiration and dose not reported) subcutaneously and on that same day experienced "redness, fever and soreness" at  the injection site. The patient stated that "the symptoms went away after a few days". The patient then declared that "about 8 days later after getting the ZOSTAVAX vaccine, got shingles". After the patient "got shingles" she stated that "the symptoms appeared over a couple of days". The patient said "over those next couple of days" she experienced the following: her "back felt like it was on fire", "the insides of body was hot", "urine was hot", "swollen and painful glands" (unspecified type of gland), "painful joints", "weakness in legs", "had difficulty walking" and was "extremely fatigued".  During the time the patient had the shingles, she met with her primary physician (unspecified name) on the following dates: 04-NOV-21015, 05-NOV-2015, 17-NOV-2015, 25-NOV-2015, 08-DEC-2015, 16-DEC-2015,  "maybe one more time before 01-JAN-2016". When the patient had met with her physician, she was prescribed acyclovir  (manufacturer unknown) and oxycodone (manufacturer unknown) as treatment for the events. Furthermore, the patient stated that "the shingles had cleared up in February 2016." The patient then stated that she "got sick again with shingles at the end of April 2017" and she mentioned that she "had the same kind of symptoms as the first time she had shingles". She reported that she saw her primary physician on 08-MAY-2017 and 18-MAY-2017 and received acyclovir (manufacturer unknown) as treatment for her outbreak of "shingles". The patient reported that she "still has shingles but the symptoms are clearing up". No other information was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Lymph node pain, Lymphadenopathy, Muscular weakness
Clinical narrative: Information was received from a 78 year old female consumer on 07-JUN-2017 who was reporting on herself. Concomitant medications included "a very low dose of ZOLOFT" and an allergy to penicillin. No medical history was reported. On 27-OCT-2015, the patient received a dose of ZOSTAVAX (lot, expiration and dose not reported) subcutaneously and on that same day experienced "redness, fever and soreness" at  the injection site. The patient stated that "the symptoms went away after a few days". The patient then declared that "about 8 days later after getting the ZOSTAVAX vaccine, got shingles". After the patient "got shingles" she stated that "the symptoms appeared over a couple of days". The patient said "over those next couple of days" she experienced the following: her "back felt like it was on fire", "the insides of body was hot", "urine was hot", "swollen and painful glands" (unspecified type of gland), "painful joints", "weakness in legs", "had difficulty walking" and was "extremely fatigued".  During the time the patient had the shingles, she met with her primary physician (unspecified name) on the following dates: 04-NOV-21015, 05-NOV-2015, 17-NOV-2015, 25-NOV-2015, 08-DEC-2015, 16-DEC-2015,  "maybe one more time before 01-JAN-2016". When the patient had met with her physician, she was prescribed acyclovir  (manufacturer unknown) and oxycodone (manufacturer unknown) as treatment for the events. Furthermore, the patient stated that "the shingles had cleared up in February 2016." The patient then stated that she "got sick again with shingles at the end of April 2017" and she mentioned that she "had the same kind of symptoms as the first time she had shingles". She reported that she saw her primary physician on 08-MAY-2017 and 18-MAY-2017 and received acyclovir (manufacturer unknown) as treatment for her outbreak of "shingles". The patient reported that she "still has shingles but the symptoms are clearing up". No other information was reported. Additional information has been requested.