chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Bedridden, Influenza like illness, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Patient reported high fever and flu like symptoms for 3 days in bed. Three months later experienced 60-70% hair loss. Saw dermatologist and PCP who concluded that hair loss was from vaccine. Received second dose of SHINGRIX on 7/20/18 as well.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Influenza like illness, Pyrexia
Clinical narrative: Patient reported high fever and flu like symptoms for 3 days in bed. Three months later experienced 60-70% hair loss. Saw dermatologist and PCP who concluded that hair loss was from vaccine. Received second dose of SHINGRIX on 7/20/18 as well.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Bedridden, Blood test normal, Influenza like illness, Malaise
Clinical narrative: Patient reported high fever and flu like symptoms for 3 days in bed. Three months later experienced 60-70% hair loss. Saw dermatologist and PCP who concluded that hair loss was from vaccine. Received second dose of SHINGRIX on 7/20/18 as well.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: Patient reported high fever and flu like symptoms for 3 days in bed. Three months later experienced 60-70% hair loss. Saw dermatologist and PCP who concluded that hair loss was from vaccine. Received second dose of SHINGRIX on 7/20/18 as well.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Coma scale abnormal, Posturing, Unresponsive to stimuli
Clinical narrative: Vaccine was administered to right deltoid, less than 5 minutes after she started looking pale, white in color, then started twitching, we sat her down, provider was already in room because of sibling dropping to the floor after vaccine, patient's O2 stats were in the upper 90s and pulse in the 80s...EMS was called, they arrived, was put on a stetcher and in the ambulance to the ER.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Muscle twitching, Pallor
Clinical narrative: Vaccine was administered to right deltoid, less than 5 minutes after she started looking pale, white in color, then started twitching, we sat her down, provider was already in room because of sibling dropping to the floor after vaccine, patient's O2 stats were in the upper 90s and pulse in the 80s...EMS was called, they arrived, was put on a stetcher and in the ambulance to the ER.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Chest X-ray, Computerised tomogram head, Dyspnoea, Electrocardiogram, Endotracheal intubation
Clinical narrative: Vaccine was administered to right deltoid, less than 5 minutes after she started looking pale, white in color, then started twitching, we sat her down, provider was already in room because of sibling dropping to the floor after vaccine, patient's O2 stats were in the upper 90s and pulse in the 80s...EMS was called, they arrived, was put on a stetcher and in the ambulance to the ER.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Full blood count, Immediate post-injection reaction, Pregnancy test negative, Syncope
Clinical narrative: Vaccine was administered to right deltoid, less than 5 minutes after she started looking pale, white in color, then started twitching, we sat her down, provider was already in room because of sibling dropping to the floor after vaccine, patient's O2 stats were in the upper 90s and pulse in the 80s...EMS was called, they arrived, was put on a stetcher and in the ambulance to the ER.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Pain in extremity, Paraesthesia, Skin warm
Clinical narrative: Both arms radiating pain and tingling, flu-like symptoms, redness and warm to touch.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Contusion, Injection site pain, Nausea, Pain in extremity
Clinical narrative: Pain at time of injection, rash on arm, swelling of arm causing whole arm to hurt including down to fingers, bruising, nausea, fever (100), joint aches.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: Pain at time of injection, rash on arm, swelling of arm causing whole arm to hurt including down to fingers, bruising, nausea, fever (100), joint aches.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Ultrasound scan
Clinical narrative: This spontaneous prospective pregnancy report was received from a 25 year old female patient referring to herself. No information was provided regarding the patient's medical history, concurrent conditions or concomitant therapies. On 25-JAN-2018 the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot # and expiration date unknown) for HPV prevention. On 29-MAY-2018, she received the second dose (dose, lot# and expiration date unknown) by intramuscular route. On 29-JUN-2018 she found out she was pregnant. The last menstrual period (LMP) was 11-MAY-2018 and estimated date of delivery (EDD) was 15-FEB-2019. The patient said immediately after finding out she was pregnant she tried initially scheduling an appointment with her gynecology clinic, however, the clinic did not have an appointment opening available until November but the patient did not want to wait until November to see a Gynecologist. So the patient's primary care physician instructed her instead to go to the nearest Emergency Room (ER) which she did on 29-JUN-2018 where at the ER visit she had two sonograms performed. One sonogram was vaginal and the second one was for the surface (results not provided). It was confirmed with the patient that she was not admitted to the ER because after she had the two sonograms done and "some other analysis" (unspecified) was performed she was then released from the ER the same day. The pregnancy gestation was 7 weeks and 3 days at the reporting time and the outcome was pending.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a nurse, concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. From 30-JAN-2018 to the time of this report, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, route of administration, and anatomical location were not reported), both administered for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. The report was due to a digital data logger. Regarding GARDASIL 9 temperature excursions: The lot # N021571 with expiration date 29-APR-2020 had a storage temperature of 35.80 Fahrenheit (degree F) for a total time frame of 0.45 hours. The lot # N021733 with expiration date 01-FEB-2020 had a storage temperature of 35.90 Fahrenheit (degree F) for a total time frame of 0.45 hours.
Age: 44.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a 44 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On 16-JUL-2018, the patient was inadvertently vaccinated with PROQUAD with lot # R001541 and expiration date on 15-JUL-2019, at a dose of 0.5 ml administered once subcutaneously, for prophylaxis; instead of M-M-R II.
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 36 year old female patient. The patient's concomitant medications included SYEDA. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 06-NOV-2017, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly, 0.5 mL, lot # N014470, with expiration date 17-JUN-2019, for HPV prevention (frequency was not provided). On an unspecified date, the patient experienced arm soreness, which resolved on an unknown date. The patient neither sought medical attention nor received treatment for the event. On 23-JUL-2018, the patient was vaccinated with second dose of GARDASIL 9, 0.5 ml for prophylaxis (frequency, route, lot # and expiration date were not provided). No adverse effects were reported following the second dose. The reporter did not assess the relatedness between GARDASIL 9 and the pain in extremity.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Dysphagia, Gastrostomy
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an Infant female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies included ranitidine, TOPAMAX and phenobarbital. On 28-MAR-2018, the patient was vaccinated with first dose of ROTATEQ (strength, dose, lot # and expiry date were not reported) orally for routine vaccination. On 02-MAY-2018, the patient was vaccinated with second dose of ROTATEQ. After receiving the second dose, on an unknown date in 2018, the patient could not swallow and had to use Gastrostomy tube. It was unknown, if treatment was given for the event or if lab diagnostics or studies were performed. The patient sought medical attention and saw physicians. The outcome of dysphagia was unknown. The causality assessment between the event dysphagia and ROTATEQ was not reported. There was no product quality complaint (PQC) reported. The reporting nurse considered the event dysphagia to be serious due to significant disability or incapacity.
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a consumer and refers to a 15 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). It was reported that the patient experienced fever for two days. The outcome of the event pyrexia was resolved and the causal relationship between the event and vaccination with M-M-R II were not reported.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Pallor
Clinical narrative: This spontaneous report was received from a physician via company representative, regarding a 3 month female patient. The patient's drug reactions/allergies included milk protein allergy. No other pertinent medical history or concomitant medication was provided. On an unknown date, the patient was vaccinated with the first dose of ROTATEQ oral, for prophylaxis (dose, strength, frequency, lot# and expiration date were not reported). On an unknown date  (reported as one and a half days after receiving the first ROTATEQ), the patient developed pale skin with bloody stools, but on the next day the patient returned to normal. Despite the patient had not received any more doses of ROTATEQ, on an unknown date, the patient experienced a second episode of pale skin with bloody stools on an unspecified date. The patient sought for medical attention. The outcome of the last events of pale skin with bloody stools was not reported. The causal relationship between ROTATEQ and the events was not reported. Upon internal review, bloody stools was determined to be medically significant.
Age: 19.0
Sex: F
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 27 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. In approximately 2010, when the patient was 19 years old, she received 2 doses of GARDASIL 9 or GARDASIL (strength, lot #, expiration date, dose, route of administration or anatomical location were not provided) for prophylaxis. On 25-JUL-2018, the patient presented to the medical assistant office and stated that she missed her third dose of GARDASIL 9 or GARDASIL; and would like to received GARDASIL 9 (inappropriate schedule of drug administration); but the dose was not administered yet (incomplete course of vaccination). No adverse effects were reported.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning an 18 year old male patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. In November 2012, the patient received the first dose of GARDASIL 9 (lot #, expiration date, strength, dose, route of administration or anatomical location were not provided), for prophylaxis. In January 2014, the patient received the second dose of GARDASIL 9 (lot #, expiration date, strength, dose, route of administration or anatomical location were not provided), for prophylaxis; which was considered an inappropriate schedule of drug administration. No adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Syringe issue, Underdose, Vomiting
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an 11 year old male patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On 26-JUL-2018, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, strength, dose, route of administration or anatomical location were not provided), for prophylaxis (vaccination), but might have possibly not received the full dose. It was described that when the syringe was being withdrawn from the patient, there was visible liquid leaking out of the syringe (underdose). It was also reported that the patient vomited for unspecified reason (vomiting) but did recovered a few minutes later that day and was fine to go home; so there was no need to seek medical attention. It was unknown if any treatment was given for the event or if any laboratory diagnostics studies were performed. The causal relationship between vomiting and GARDASIL 9 was not provided.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Anaemia, Blood test, Syncope, Transfusion
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to a 15 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by the reporter. On 19-JUL-2018, the patient was vaccinated with GARDASIL 9 first dose (dose, routes of administration, lot number and expiration date were not reported) protect against HPV. On the same vaccination date, the patient had a blood drawn, after the vaccine was administered, the patient fainted in the office. The patient was sent to an unspecified emergency room and she was found to be anemic. Then, on an unspecified date in July 2018, the patient was admitted to an unspecified hospital, for one night and the patient received 3 bags of blood. At the reporting time, patient was recovered from the aforementioned adverse events on an unknown date in July 2018. The causality between the events and the therapy with GARDASIL 9 was not reported. Upon internal review, anaemia was considered to be medically significant due to blood transfusion.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 30-MAY-018, the patient was vaccinated with a improperly stored GARDASIL 9 (which had a lot # of N022952 and an expiration date of 14-JUN-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions on an unknown date: 47 degrees F to 77 degrees F for 24 hours. Reportedly, there had been no previous temperature excursions and the aforementioned one were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507512-1807USA013144.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 30-MAY-2018, the patient was vaccinated with a improperly stored ROTATEQ (which had a lot # of N032567 and an expiration date of 10-MAY-2019, per oral; however, dosage number were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions on an unknown date: 47°F to 77°F for 24 hours. Reportedly, there had been no previous temperature excursions and the aforementioned one were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507512-1807USA013076.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site bruising in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was unknown. It was unknown if the reporter considered the injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional additionally reported that the patient experienced bruising below the injection site after intramuscular administration of the vaccine. The patient and product details were unavailable.
Sex: M
Vaccine: VARZOS
Symptoms: Delirium
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of delirium in a 90-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced delirium (serious criteria GSK medically significant). On an unknown date, the outcome of the delirium was recovered/resolved. It was unknown if the reporter considered the delirium to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician spoke with GlaxoSmithKline Medical Science Liaison (GSK MSL) employee that one of his patients experienced delirium 2 to 3 days after a dose of SHINGRIX. The symptoms were resolved however, the physician asked MSL whether the symptoms were associated with the vaccine. The MSL was asked if the sales representative called GSK to report adverse event. The MSL said that she did not think so because she spoke with the physician directly. The MSL did not have contact information for this physician. The MSL was not sure how the last name was spelled either. The MSL would get all those details in a couple of days. The MSL provided reference number and requested a callback so GSK could send follow up to this case.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Feeling abnormal, Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a male patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX. On 16th July 2018, less than an hour after receiving SHINGRIX, the patient experienced feeling abnormal, headache, joint pain, injection site pain, decreased appetite and shoulder pain. On 19th July 2018, the outcome of the feeling abnormal, headache and decreased appetite were recovered/resolved and the outcome of the joint pain was unknown and the outcome of the injection site pain was not recovered/not resolved. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved. It was unknown if the reporter considered the feeling abnormal, headache, joint pain, injection site pain, decreased appetite and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that he was not a healthcare professional but patient as this was the only way to mail GlaxoSmithKline. The reporter was the patient who was told by his doctor's office that GlaxoSmithKline would want to hear about and side effects from his recent SHINGRIX vaccination. The patient had received the SHINGRIX shot in his left shoulder muscle on and within an hour, he started to feel odd, a headache, joint pain, shot location pain and loss of desire to eat. These symptoms lasted through until Thursday evening. The patient did not feel any other symptoms such as fever, vomiting or diarrhea. The patient would receive the 2nd shot of SHINGRIX in early November 2018. The patient had agreed for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a male patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX. On 16th July 2018, less than an hour after receiving SHINGRIX, the patient experienced feeling abnormal, headache, joint pain, injection site pain, decreased appetite and shoulder pain. On 19th July 2018, the outcome of the feeling abnormal, headache and decreased appetite were recovered/resolved and the outcome of the joint pain was unknown and the outcome of the injection site pain was not recovered/not resolved. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved. It was unknown if the reporter considered the feeling abnormal, headache, joint pain, injection site pain, decreased appetite and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that he was not a healthcare professional but patient as this was the only way to mail GlaxoSmithKline. The reporter was the patient who was told by his doctor's office that GlaxoSmithKline would want to hear about and side effects from his recent SHINGRIX vaccination. The patient had received the SHINGRIX shot in his left shoulder muscle on and within an hour, he started to feel odd, a headache, joint pain, shot location pain and loss of desire to eat. These symptoms lasted through until Thursday evening. The patient did not feel any other symptoms such as fever, vomiting or diarrhea. The patient would receive the 2nd shot of SHINGRIX in early November 2018. The patient had agreed for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 45 min after receiving SHINGRIX, the patient experienced injection site pain, fever, general body pain, headache and nausea. On an unknown date, the outcome of the injection site pain, fever, general body pain, headache and nausea were recovering/resolving. It was unknown if the reporter considered the injection site pain, fever, general body pain, headache and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was completely healthy and felt well prior to the injection. The patient did not have any reactions to previous vaccinations. The patient developed a reaction to SHINGRIX which started 45 minutes after receiving the vaccine. The patient had extreme soreness at the injection site. She had fever (body temperature: 100.5 degree F) and terrible body aches all over and also headache and slight nausea. At the time of this report, the symptoms were subsiding but not completely resolved. There was no cough and no shortness of breath (SOB) were observed. The patient's body temperature was 99.5 degree F on the reporting date. On 20th July 2018, the patient made it through work, but had been in bed most of the day on the reporting. The patient did not take any TYLENOL or ibuprofen for symptoms and was advised to push fluids in the evening on the reporting date. The patient would like to get the 2nd dose of SHINGRIX in 2 to 6 months. It was unknown if the nurse gave consent to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was received via an e-mail during non business hours. The age at vaccination was not reported. About 2 months ago from the reporting date, the patient received the SHINGRIX vaccine and experienced the redness and soreness at the injection site. This case has been linked to case US2018GSK136649, reported by same reporter.
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vomiting in a 16-year-old female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to BEXSERO. Additional information reported as follows: The age at vaccination was not reported. The 2 female patients received BEXSERO vaccine and experienced the vomiting. This case has been linked with US2018GSK133107, reported by same reporter.
Sex: U
Vaccine: MENB
Symptoms: Adverse reaction, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a patient who received BEXSERO (batch number 16D501, expiry date unknown) for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced adverse reaction, injection site pain, injection site erythema, fever and injection site swelling. On an unknown date, the outcome of the adverse reaction, injection site pain, injection site erythema, fever and injection site swelling were unknown. It was unknown if the reporter considered the adverse reaction, injection site pain, injection site erythema, fever and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced injection site pain, redness, swelling, and fever were beyond typical reactions the reporter had seen in the past and with other products. The reporter stated that, they noticed that it stems from Lot 16D501 from the Vaccines for Children (VFC) program. At the time of this report the reporter was choosing to not use BEXSERO until they receive further information from VFC program and manufacturer medical team. The reporter agreed to be followed up. This is 1 of the 8 cases (8 out of 20 patients reported adverse reactions) reported by same reporter for same event.
Sex: U
Vaccine: MENB
Symptoms: Adverse reaction, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a patient who received BEXSERO (batch number 16D501, expiry date unknown) for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced adverse reaction, injection site pain, injection site erythema, fever and injection site swelling. On an unknown date, the outcome of the adverse reaction, injection site pain, injection site erythema, fever and injection site swelling were unknown. It was unknown if the reporter considered the adverse reaction, injection site pain, injection site erythema, fever and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced injection site pain, redness, swelling, and fever were beyond typical reactions the reporter had seen in the past and with other products. The reporter stated that, they noticed that it stems from Lot 16D501 from the Vaccines program. At the time of this report the reporter was choosing to not use BEXSERO until they receive further information from Vaccines program and manufacturer medical team. The reporter agreed to be followed up. This is 1 of the 8 cases (8 out of 20 patients reported adverse reactions) reported by same reporter for same event.
Sex: U
Vaccine: MENB
Symptoms: Adverse reaction, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a patient who received BEXSERO (batch number 16D501, expiry date unknown) for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced adverse reaction, injection site pain, injection site erythema, fever and injection site swelling. On an unknown date, the outcome of the adverse reaction, injection site pain, injection site erythema, fever and injection site swelling were unknown.  It was unknown if the reporter considered the adverse reaction, injection site pain, injection site erythema, fever and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced injection site pain, redness, swelling, and fever were beyond typical reactions the reporter had seen in the past and with other products. The reporter stated that, they noticed that it stems from Lot 16D501 from the Vaccines for Children (VFC) program. At the time of this report the reporter was choosing to not use BEXSERO until they receive further information from VFC program and manufacturer medical team. The reporter agreed to be followed up. This is 1 of the 8 cases (8 out of 20 patients reported adverse reactions) reported by same reporter for same event.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a patient who received BEXSERO (batch number 16D501, expiry date unknown) for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced adverse reaction, injection site pain, injection site erythema, fever and injection site swelling. On an unknown date, the outcome of the adverse reaction, injection site pain, injection site erythema, fever and injection site swelling were unknown.  It was unknown if the reporter considered the adverse reaction, injection site pain, injection site erythema, fever and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced injection site pain, redness, swelling, and fever were beyond typical reactions the reporter had seen in the past and with other products. The reporter stated that, they noticed that it stems from Lot 16D501 from the Vaccines for Children (VFC) program. At the time of this report the reporter was choosing to not use BEXSERO until they receive further information from VFC program and manufacturer medical team. The reporter agreed to be followed up. This is 1 of the 8 cases (8 out of 20 patients reported adverse reactions) reported by same reporter for same event.
Age: 38.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient is a 38 yo male that was given a SHINGRIX vaccination on protocol and he does not meet the age requirement for SHINGRIX to be administered. Patient has been notified and has not experienced any adverse events.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Arm pain from shot. Fever, chills muscle aches, exhausted and headache.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Arm pain from shot. Fever, chills muscle aches, exhausted and headache.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth, Local reaction, Pruritus, Rash
Clinical narrative: Client called stating that on day 2 she developed a local reaction at injection site. (red, hot to touch). She also stated that she has three "bumps" on her left side. She stated that on day 3 she developed "2-3" more small raised bumps in a cluster on her leg and back. She denies any blister like appearance. She stated they itch a little. She stated she took benedryl and that helped the itching. She stated they have not gotten worse but have not gotten better. Client was instructed on "breakthrough" chickenpox post vaccination. Client was instructed to contact her PCP for any testing or diagnosis. client verbalized understanding.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Erythema, Headache, Injection site erythema, Pain, Papule
Clinical narrative: Patient mentions that it gave him a headache, vaccination site on left arm is red and swollen. Patient presents a lesion on the left side of the back that appears to be like a papule that is painful to the touch and there is redness.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Vaccination site swelling
Clinical narrative: Patient mentions that it gave him a headache, vaccination site on left arm is red and swollen. Patient presents a lesion on the left side of the back that appears to be like a papule that is painful to the touch and there is redness.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Migraine, Pain
Clinical narrative: Within first 2 hrs extreme fatigue, chills, migraine and a lot of body pain. Slight stomach ache, Lasted over 24hrs.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Balance disorder, Chills, Dizziness, Erythema
Clinical narrative: Within first 2 hrs extreme fatigue, chills, migraine and a lot of body pain. Slight stomach ache, Lasted over 24hrs.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Loss of personal independence in daily activities, Middle insomnia
Clinical narrative: Within first 2 hrs extreme fatigue, chills, migraine and a lot of body pain. Slight stomach ache, Lasted over 24hrs.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Within first 2 hrs extreme fatigue, chills, migraine and a lot of body pain. Slight stomach ache, Lasted over 24hrs.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Antinuclear antibody positive, C-reactive protein, Full blood count, Joint swelling, Metabolic function test
Clinical narrative: On July 5, 2018, 7 days after the MMR vaccine she broke out in a rash all over her face. Then on 7/26/18, she was complaining about hand pain. On Saturday, 7/28/18 it started to swell and be warm around her wrist. She was taken to ER hospital and labs were drawn and x-rays were taken. It was determined she had a positive ANA and other labs indicating possible rheumatological condition after no hx of any immune problems. Undoubtly it was the MMR.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Rash, Red blood cell sedimentation rate, Skin warm, X-ray
Clinical narrative: On July 5, 2018, 7 days after the MMR vaccine she broke out in a rash all over her face. Then on 7/26/18, she was complaining about hand pain. On Saturday, 7/28/18 it started to swell and be warm around her wrist. She was taken to ER hospital and labs were drawn and x-rays were taken. It was determined she had a positive ANA and other labs indicating possible rheumatological condition after no hx of any immune problems. Undoubtly it was the MMR.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen left upper arm with persistent pain and weekness. The lenth of time is about 3 months which resulted in Doctor visits that accured bills.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient did not report adverse event to the pharmacy at the time of the occurrence. She advised when called to return for second SHINGRIX dose. Stated reaction occurred the next day with a red rash from the injection site to the elbow with heat. Rash lasted several days. Patient applied ice at the direction of her niece an RN.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope, Syncope
Clinical narrative: After vaccination patient had an episode of vasovagal response with syncope. Patient was laid down on the exam bed, vital signs taken, cold pack placed at back of neck. No O2 was required as Patient's SpO2 was 100% on room air. Initial BP @ 0938 was 104/59  P- 65 R- 42. Patient aroused within approximately 1 minute after episode of syncope. Vitals repeated @ 0940 BP- 118/70 P-85 R- 24. Mom reported patient had not eaten. Patient fully recovered.
Age: 54.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Chills, Headache, Tremor
Clinical narrative: Had the shingles 2nd vaccine and whooping cough/tetanus. At 12:30 am, woke up with headache and severe chills and shaking. After taking Motrin, the shaking and chills mostly subsided and i was able to go back to sleep. I have a mild headache still and continue to have chills in the office today, but nothing  like last night - it was scary.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Immunisation
Clinical narrative: Expired on 07/31/2018 dose of MEMNVEO given om 08/0182018. Dose was repeated on the same day.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Please note that my symptoms were similar, but somewhat worse, than my first round of SHINGRIX vaccination (this was related to round two as I did not report round one).
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms.
Age: 61.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Pt presented to office 7/25/18, with raised rash on Right forearm and states the rash developed Monday night after getting SHINGRIX vaccine and TD vaccine on Monday 7/23/18. Pt states rash was itchy the first night but the itching has subsided. The rash is on the same arm that SHINGRIX was given so pt concerned it was a reaction. Denies pain, SOB, dizziness, drainage, fever or chills. Vitals taken in office were WNL BP- 118/70, HR- 74, 02 sat- 97% and Temp- 97.7 PO. He said he takes Benadryl at night regularly so he did take this but denies taking anything else. Spoke to PCP who advised pt continue with Benadryl and try otc hydrocortisone cream and if no improvement by the beginning of next week pt should be seen. Pt also aware that if his symptoms worsen he should call sooner to be seen.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site inflammation, Injection site reaction, Pyrexia
Clinical narrative: BLOTCHY RED PATCHES SIZE OF A DIME APPEARED ON RIGHT ARM AROUND INJECTION SITE WITHIN HOURS OF INJECTION. PATCHES FILLED OUT INTO AN INFLAMED AREA SIZE OF A PIECE OF BREAD ABOUT 24 HOURS LATER. HAD SLIGHT FEVER, AND FLU-LIKE SYMPTOMS FOR 24 HOURS AFTER INJECTION. SITE STILL INFLAMED, BUT IMPROVING TODAY (DAY 4). NO MEDICAL TREATMENT SOUGHT OR NEEDED.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: BLOTCHY RED PATCHES SIZE OF A DIME APPEARED ON RIGHT ARM AROUND INJECTION SITE WITHIN HOURS OF INJECTION. PATCHES FILLED OUT INTO AN INFLAMED AREA SIZE OF A PIECE OF BREAD ABOUT 24 HOURS LATER. HAD SLIGHT FEVER, AND FLU-LIKE SYMPTOMS FOR 24 HOURS AFTER INJECTION. SITE STILL INFLAMED, BUT IMPROVING TODAY (DAY 4). NO MEDICAL TREATMENT SOUGHT OR NEEDED.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood glucose increased, Blood pressure decreased, Bradycardia, Cyanosis, Dyskinesia
Clinical narrative: Approximately 15-20 minutes after receiving immunizations patient was noted to have generalized jerking of his body & a small vomitus w/LOC for a few seconds. Patient was shaken awake & returned to baseline but appeared pale & c/o nausea. EMS was called & upon their arrival they noted that patient was pale but able to ambulate. While in the ambulance patient lost consciousness again & appeared pale. Patient's heart rate dropped into the low 30s & BP dropped to 85/42. Patient was given atropine 0.5mg @ 3:05 PM which increased his heart rate to 89 & BP to 120/58. Upon arrival @ the ED patient was alert & oriented but pale w/cyanosis of his distal extremeties. He c/o his legs trembling. Patient was given IM epi & a NS bolus @ 3:37 PM & then SOLU-MEDROL was administered. Patient was admitted to the PICU with a diagnosis of bradycardia & syncope.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Full blood count, Globulins decreased, Heart rate decreased, Intensive care, Loss of consciousness
Clinical narrative: Approximately 15-20 minutes after receiving immunizations patient was noted to have generalized jerking of his body & a small vomitus w/LOC for a few seconds. Patient was shaken awake & returned to baseline but appeared pale & c/o nausea. EMS was called & upon their arrival they noted that patient was pale but able to ambulate. While in the ambulance patient lost consciousness again & appeared pale. Patient's heart rate dropped into the low 30s & BP dropped to 85/42. Patient was given atropine 0.5mg @ 3:05 PM which increased his heart rate to 89 & BP to 120/58. Upon arrival @ the ED patient was alert & oriented but pale w/cyanosis of his distal extremeties. He c/o his legs trembling. Patient was given IM epi & a NS bolus @ 3:37 PM & then SOLU-MEDROL was administered. Patient was admitted to the PICU with a diagnosis of bradycardia & syncope.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Metabolic function test, Nausea, Pallor, Red blood cell count normal, Syncope
Clinical narrative: Approximately 15-20 minutes after receiving immunizations patient was noted to have generalized jerking of his body & a small vomitus w/LOC for a few seconds. Patient was shaken awake & returned to baseline but appeared pale & c/o nausea. EMS was called & upon their arrival they noted that patient was pale but able to ambulate. While in the ambulance patient lost consciousness again & appeared pale. Patient's heart rate dropped into the low 30s & BP dropped to 85/42. Patient was given atropine 0.5mg @ 3:05 PM which increased his heart rate to 89 & BP to 120/58. Upon arrival @ the ED patient was alert & oriented but pale w/cyanosis of his distal extremeties. He c/o his legs trembling. Patient was given IM epi & a NS bolus @ 3:37 PM & then SOLU-MEDROL was administered. Patient was admitted to the PICU with a diagnosis of bradycardia & syncope.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Tremor, Vomiting
Clinical narrative: Approximately 15-20 minutes after receiving immunizations patient was noted to have generalized jerking of his body & a small vomitus w/LOC for a few seconds. Patient was shaken awake & returned to baseline but appeared pale & c/o nausea. EMS was called & upon their arrival they noted that patient was pale but able to ambulate. While in the ambulance patient lost consciousness again & appeared pale. Patient's heart rate dropped into the low 30s & BP dropped to 85/42. Patient was given atropine 0.5mg @ 3:05 PM which increased his heart rate to 89 & BP to 120/58. Upon arrival @ the ED patient was alert & oriented but pale w/cyanosis of his distal extremeties. He c/o his legs trembling. Patient was given IM epi & a NS bolus @ 3:37 PM & then SOLU-MEDROL was administered. Patient was admitted to the PICU with a diagnosis of bradycardia & syncope.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Exposure during pregnancy, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Notes reaction after Tdap vaccine, received in office 7/16/18. Reports her arm is itchy and hurts, warm to touch in the area of injection. Also notes swelling at site of injection and body aches.  Reports having a low grade temp. States she took off work yesterday. Today at work. Reviewed above with Physician. Can apply ice to site of injection. Patient is Gravida 2, para1001.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pain
Clinical narrative: Notes reaction after Tdap vaccine, received in office 7/16/18. Reports her arm is itchy and hurts, warm to touch in the area of injection. Also notes swelling at site of injection and body aches.  Reports having a low grade temp. States she took off work yesterday. Today at work. Reviewed above with Physician. Can apply ice to site of injection. Patient is Gravida 2, para1001.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 101.5 reported by patient about 12 hours after the dose. Fever lasted until about 12pm noon the following day, 07/31/18.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: RECORDS RECEIVED FROM ER 05/10/18 IMMUNIZATION REACTION- INITIAL ENCOUNTER -SIGNIFICANT ERYTHEMA INDURATION AND INCREASE TEMPERATURE OF HIS ENTIRE RIGHT UPPER ARM LATERALLY. SMALL AREA OF INDUCATION AND ERYTHEMA ON HIS LEFY ARM- POSTERIORLY BOTH ARMS HE RECEIVED IMMUNIZATIONS YESTERDAY. PT RECEIVED DECADROM 12.68 MG AND HAD BENADRYL PRIOR. TOLERATED WELL. CONFIRMED BOTH DTAP AND IPV GIVEN IN R ARM.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Right arm is sore after 2nd GARDASIL injection, 2nd shot given in her right deltoid on 6/25/18. Has had tenderness since that day. Denies lump, redness, fever, chills. Tried warm compresses for a few days, Taking ADVIL. Saw Ortho and they rx'd her an anti-inflammatory, Does play sports but none in the last 3 weeks. Plays tennis. Reported by provider during visit.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Dysgeusia, Hypoaesthesia oral
Clinical narrative: Vaccine at 0935 Immediate Metal taste noted by employee (did not report to EH) 10 Minutes later then noted tongue and teeth numb with continued metal taste 1015 took 25 mg Benadryl - sx continue.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue, fever-like symptoms, achiness next morning after second SHINGRIX.