chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Heart rate decreased, Hyperhidrosis, Hypotension, Nausea, Peripheral swelling
Clinical narrative: This initial spontaneous report was received from the daughter (who is also a company employee) of a 66 year old female patient. The patient had no pertinent medical history and was taking no concomitant medications. Allergies included intravenous VALIUM. On 13-JUL-2017, the patient received a dose of PNEUMOVAX 23 for the indication of "recommended vaccination" (route and lot # not provided). On 14-JUL-2017, the patient developed nausea, sweating, hypotension, low heart rate, and her arm was swollen and hot to the touch. When asked if the patient sought medical attention, the reported stated "yes, phone call to physician". No treatment was given. The patient was recovering from the events. Causality assessment was not provided. Additional information was not expected as the reporter did not provide consent to follow up.
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: This initial spontaneous report was received from the daughter (who is also a company employee) of a 66 year old female patient. The patient had no pertinent medical history and was taking no concomitant medications. Allergies included intravenous VALIUM. On 13-JUL-2017, the patient received a dose of PNEUMOVAX 23 for the indication of "recommended vaccination" (route and lot # not provided). On 14-JUL-2017, the patient developed nausea, sweating, hypotension, low heart rate, and her arm was swollen and hot to the touch. When asked if the patient sought medical attention, the reported stated "yes, phone call to physician". No treatment was given. The patient was recovering from the events. Causality assessment was not provided. Additional information was not expected as the reporter did not provide consent to follow up.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information was received 11-JUL-2017 via a phone call from a medical services manager who reported that a female employee of unspecified age, who is also a Medical Assistant, was administered MMR II on 30-JUN-2017 (Lot number M045395, expiration date 14-NOV-2018) and she did not know that she was approximately 3 weeks pregnant at the time. Concomitant product was MERCK STERILE DILUENT (Lot number not provided).  No adverse effects were reported. No further information was provided. Additional information was requested.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received 11-JUL-2017 via a phone call from a medical assistant who reported that on 02-MAY-2017, a male patient of unspecified age, was inadvertently administered an expired dose of MMR II (Lot # L007577, expiration date 05-MAR-2017). Concomitant product included MERCK (Lot# not provided). No adverse effect was reported. No additional information was provided. Additional information was requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 10-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M034780, expiration 15-APR-2019 (dose and route of administration were not reported) for prophylaxis. No adverse effect. Temperature:  -1 degrees Celsius (C) or colder (-1.1 C). Time Frame: 4 days 45 minutes. No previous temperature excursion. Digital Data logger report was involved. No further information was provided. This is one of two cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA for prophylaxis. On an unknown date the patient experienced drug administered to patient of inappropriate age and no adverse event.  The outcome of drug administered to patient of inappropriate age and no adverse event is unknown.   The reporter considered drug administered to patient of inappropriate age and no adverse event to be not related to VAQTA.
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a health professional refers to a female patient of unknown age. On an unknown date the patient was exposed to VARIVAX lot # M046924. The patient was pregnant. The LMP and EDD is not known. The pregnancy outcome was outcome pending. On an unknown date the patient experienced accidental exposure to product, no adverse event and exposure during pregnancy. The outcome of accidental exposure to product, no adverse event and exposure during pregnancy is unknown. The reporter considered accidental exposure to product, no adverse event and exposure during pregnancy to be not related to VARIVAX.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 05-JUL-2017 the patient was vaccinated with GARDASIL 9 lot # N004799 dose 4 for prophylaxis. On 05-JUL-2017, 1 year 1 month 27 days after onset of therapy the patient experienced extra dose administered. On an unknown date the patient experienced no adverse event. The outcome of extra dose administered and no adverse event is unknown. The reporter considered extra dose administered and no adverse event to be not related to GARDASIL 9.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea
Clinical narrative: This spontaneous report was received from a 64 year old male patient (who was a company representative). On 25-JUL-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent. On 26-JUL-2017, the patient experienced influenza like illness and nausea. The outcome of influenza like illness and nausea was reported as not recovered/not resolved.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 24-JUL-2017, the patient was vaccinated with a dose of VARIVAX as prophylaxis and a dose of PROQUAD as prophylaxis (Strength, dose, route, lot numbers and expiration dates were not reported). The patient's concomitant medications included sterile diluent (manufacturer unknown). No adverse symptoms were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients' of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection (exact dose, route of administration, lot number and expiry date were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 32 degrees Fahrenheit to 35 degrees Fahrenheit (35 degrees Fahrenheit) on an unspecified date, for a time frame of 6 hours. A digital data logger was not involved. There were no previous temperature excursions. No adverse experiences were reported. There was no product quality complaint involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 10-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M034780, expiration 15-APR-2019 (dose and route of administration were not reported) for prophylaxis. No adverse effect. Temperature:  -1 degrees Celsius (C)  or colder (-1.1 C). Time Frame: 4 days 45 minutes. No previous temperature excursion. Digital Data logger report was involved. No further information was provided. This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005845.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Cardiac function test, Dyspnoea, Pulmonary function test, Weight decreased
Clinical narrative: 1-2 weeks after receiving vaccine--pt developed significant dyspnea, that persists, and remains unexplained after extensive cardiac & pulmonary testing along with weight loss.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain up neck radiating down arm to fingers. Fingers tingle. Area red, warm, swollen. Entire body aches.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Skin warm, Swelling
Clinical narrative: Pain up neck radiating down arm to fingers. Fingers tingle. Area red, warm, swollen. Entire body aches.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Aortic aneurysm, Chest discomfort, Diarrhoea, Discomfort, Eructation
Clinical narrative: "Here today for concern of possible reaction to vaccine. States that she is feeling warm and uncomfortable/tingling in her skin. No rashes, no spots. Got the shingles vaccine. Traveled to another city on Friday after she was here. Did not feel well once she got there. States that she was having some discomfort in the area just under the left side of her nose. Then she was having pain that was under the eyes. That facial discomfort persisted. Her face became swollen. Denied any increased work of breathing or swallowing issues. Developed abdominal pain, nausea, vomiting, diarrhea. Last night she had a lot of pressure in her chest - had a lot of gas and when she belched she would feel better. Denies any fevers. Still feels heat in her face." Provider's Notes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Feeling hot, Flatulence, Malaise, Nausea
Clinical narrative: "Here today for concern of possible reaction to vaccine. States that she is feeling warm and uncomfortable/tingling in her skin. No rashes, no spots. Got the shingles vaccine. Traveled to another city on Friday after she was here. Did not feel well once she got there. States that she was having some discomfort in the area just under the left side of her nose. Then she was having pain that was under the eyes. That facial discomfort persisted. Her face became swollen. Denied any increased work of breathing or swallowing issues. Developed abdominal pain, nausea, vomiting, diarrhea. Last night she had a lot of pressure in her chest - had a lot of gas and when she belched she would feel better. Denies any fevers. Still feels heat in her face." Provider's Notes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Swelling face, Vomiting
Clinical narrative: "Here today for concern of possible reaction to vaccine. States that she is feeling warm and uncomfortable/tingling in her skin. No rashes, no spots. Got the shingles vaccine. Traveled to another city on Friday after she was here. Did not feel well once she got there. States that she was having some discomfort in the area just under the left side of her nose. Then she was having pain that was under the eyes. That facial discomfort persisted. Her face became swollen. Denied any increased work of breathing or swallowing issues. Developed abdominal pain, nausea, vomiting, diarrhea. Last night she had a lot of pressure in her chest - had a lot of gas and when she belched she would feel better. Denies any fevers. Still feels heat in her face." Provider's Notes.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: Patient was given ROTARIX via IM route.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain lower, Asthenia, Flushing, Headache, Hypoaesthesia
Clinical narrative: Patient is a 18 y.o. female who presents for evaluation of multiple complaints. The first being headache that began around 1230 today. Headache is located in the occipital region and radiates frontally. It is constant. She cannot identify aggravating or alleviating factors. She has not taken anything for the pain today. She has a history of migraines. She has a also experiencing perioral and upper extremity numbness and tingling and generalized weakness. She is tachycardic at 143 and states she does not normally have an elevated heart rate. She feels flushed but is afebrile. Denies neck pain or stiffness.  She complains of lower abdominal pain and nausea. Denies vomiting or diarrhea. Denies dysuria, polyuria or hematuria. Denies vaginal discharge or pregnancy concerns. She does take oral contraceptive pills. Last menstrual period was this past Friday. Denies lower extremity swelling, tobacco use, recent trauma, surgery, travel or prolonged periods of immobilization. Mom tells me that she received the meningococcal B vaccine yesterday.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia oral, Nausea, Paraesthesia, Paraesthesia oral, Tachycardia
Clinical narrative: Patient is a 18 y.o. female who presents for evaluation of multiple complaints. The first being headache that began around 1230 today. Headache is located in the occipital region and radiates frontally. It is constant. She cannot identify aggravating or alleviating factors. She has not taken anything for the pain today. She has a history of migraines. She has a also experiencing perioral and upper extremity numbness and tingling and generalized weakness. She is tachycardic at 143 and states she does not normally have an elevated heart rate. She feels flushed but is afebrile. Denies neck pain or stiffness.  She complains of lower abdominal pain and nausea. Denies vomiting or diarrhea. Denies dysuria, polyuria or hematuria. Denies vaginal discharge or pregnancy concerns. She does take oral contraceptive pills. Last menstrual period was this past Friday. Denies lower extremity swelling, tobacco use, recent trauma, surgery, travel or prolonged periods of immobilization. Mom tells me that she received the meningococcal B vaccine yesterday.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: White blood cell count increased
Clinical narrative: Patient is a 18 y.o. female who presents for evaluation of multiple complaints. The first being headache that began around 1230 today. Headache is located in the occipital region and radiates frontally. It is constant. She cannot identify aggravating or alleviating factors. She has not taken anything for the pain today. She has a history of migraines. She has a also experiencing perioral and upper extremity numbness and tingling and generalized weakness. She is tachycardic at 143 and states she does not normally have an elevated heart rate. She feels flushed but is afebrile. Denies neck pain or stiffness.  She complains of lower abdominal pain and nausea. Denies vomiting or diarrhea. Denies dysuria, polyuria or hematuria. Denies vaginal discharge or pregnancy concerns. She does take oral contraceptive pills. Last menstrual period was this past Friday. Denies lower extremity swelling, tobacco use, recent trauma, surgery, travel or prolonged periods of immobilization. Mom tells me that she received the meningococcal B vaccine yesterday.
Age: 31.0
Sex: M
Vaccine: MNQ
Symptoms: Back pain, Chills, Headache, Malaise, Pyrexia
Clinical narrative: Headaches, subjective fever, back pain, chills, general malaise. Back pain, fevers, chills all resolved on day 3. Back pain resolved on day 1. Headaches continue.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: PATIENT FAINTED AFTER BEING GIVEN BOTH IMMUNIZATIONS.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a pharmacist via a company representative concerning a male patient "in his 70s." It was reported that on an unspecified date in 2013, the patient received a dose of ZOSTAVAX 19400 PFU (lot number, dosage, and route of administration not provided), which was reconstituted with sterile diluent (MSD) as a routine vaccination. No information was provided regarding the patient's past medical history, concurrent conditions, or other concomitant medication. In approximately June 2017 (reported as "sometime last month"), the patient developed a shingles rash on his torso. The patient saw his primary care provider who prescribed him an unspecified antiviral treatment. The patient was not considered to be immunocompromised. The outcome of the shingles rash on his torso was reported as recovering. No additional information was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information was received on 07-JUL-2017 from a medical assistant who reported that a 21 year old nursing student (demographics not provided) was administered the 3 dose series of RECOMBIVAX (lot numbers and expiration dates unknown) "at birth, at 2 months and at 6 months" (specific dates were not provided). The primary reporter reported that the patient had "titers drawn" and the result was the patient "had no immunity". The primary reporter reported that the patient has now been administered "the first dose in the second series of RECOMBIVAX (lot number and expiration date unknown) administered on an unknown date in March of 2017". The primary reporter did not want to provide any further information in regard to this patient. The primary reporter also reported that a different patient (see MARRS# 1707USA013254) (demographics not provided) received only 2 doses of RECOMBIVAX (lot number and expiration dates unknown) on unknown dates, also had titers drawn and was considered "immune". The primary reporter did not clarify if this patient was an adolescent when they received the 2 doses of RECOMBIVAX, which is why this is being reported. No additional information was available. This is one of two cases from the same reporter. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a health professional refers to a 85 year old female patient. On 14-JUL-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M047519, lot # N011491 or lot# N001007 for immunisation. On 14-JUL-2017, the patient experienced erythema, musculoskeletal pain, peripheral swelling and pain in extremity. The outcome of erythema, peripheral swelling, musculoskeletal pain and pain in extremity was reported as recovered. This is one of several reports from the same reporter who mentioned that multiple lot numbers resulted in a adverse event, but was unsure which patient received which vaccine. Sender's Comments: US-009507513-1707USA008579: US-009507513-1707USA008989: US-009507513-1707USA007889.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On 28-JUL-2017 the patient was vaccinated with GARDASIL lot # M014929 for prophylaxis. On 28-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event was unknown. The reporter considered expired product administered and no adverse event to be not related to GARDASIL.
Sex: U
Vaccine: HEP
Symptoms: Antibody test positive
Clinical narrative: Information was received on 07-JUL-2017 from a medical assistant who reported that a patient (demographics not provided) received only 2 doses of RECOMBIVAX (lot number and expiration dates unknown) on unknown dates, had titers drawn and was considered "immune". The primary reporter did not clarify if this patient was an adolescent when they received the 2 doses of RECOMBIVAX, which is why this is being reported. No additional information was available. This is one of two cases from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Joint range of motion decreased, Pain
Clinical narrative: This is a spontaneous report from a contactable office manager from a family medical office calling on behalf of the healthcare. A 66-year-old female patient received PREVNAR 13 (lot R94917, Expiration date 31May2018, NDC# 00005197105), via an unspecified route of administration in left deltoid on 24Jul2017 10:33 at 0.5 ml, single for immunisation. Medical history included foot fracture on 07Mar2017 (It was the 4th toe and it was a healing fracture), ongoing insomnia, ongoing gout, ongoing hyperlipidaemia. Concomitant medication included zolpidem for sleep, phentermine hydrochloride for weight loss, ibuprofen for pain. The patient had problems with her range of motion, she was sore, she experienced red, raised, swollen reaction at the site of injection. All the events occurred on an unspecified date and the outcome was not recovered.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dehydration, Fatigue, Headache, Laboratory test, Musculoskeletal stiffness
Clinical narrative: Patient experienced fever, tachycardia and dehydration in the evening following vaccination at 9:52 am. She was seen at ED and treated with IVF, had labs drawn and an xray performed. Seen in office 7/31/17 with symptoms of fatigue, stiff neck and headache. Treated with rest, stretching/massage and ibuprofen prn.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Tachycardia, X-ray
Clinical narrative: Patient experienced fever, tachycardia and dehydration in the evening following vaccination at 9:52 am. She was seen at ED and treated with IVF, had labs drawn and an xray performed. Seen in office 7/31/17 with symptoms of fatigue, stiff neck and headache. Treated with rest, stretching/massage and ibuprofen prn.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Fatigue, Headache, Petechiae
Clinical narrative: Joint pain and inflammation, fatigue, swelling, petchial rash on lower legs. No fevers. Plus headaches.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Swelling
Clinical narrative: Joint pain and inflammation, fatigue, swelling, petchial rash on lower legs. No fevers. Plus headaches.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's arm became really sore, and then started to turn red and swell. Patient states there was no itching but burning of the arm. Patient stated that the medical doctor that examined her said it could be injection site reaction or cellulitis starting.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Peripheral swelling, Skin exfoliation
Clinical narrative: Patient came in the pharmacy on 7/26/17 stating she got a PREVNAR shot in March 2017 (4 months ago) and stated she has been having pain ever since. She stated her arm was swollen and her skin was peeling. Patient said she has not taken any pain meds or gone to the dr. Patient said she is going to see her doctor to do a MRI to see if it's caused by the vaccine. Patient has not reported any issues since getting the vaccine. Patient said it only affects her when she lie down at night, otherwise walking about and touching the area has no pain.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Patient has swelling in his arm/elbow and forearm. He also states that he has pain in those 3 spots as well.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash, per mom taken to ER on 7/28.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Confusional state, Crying, Dysarthria, Musculoskeletal stiffness, Mydriasis
Clinical narrative: 8 days after getting 4y vaccines, pt started looking "sluggish" and had a syncopal episode. Dad caught pt and put him down and pt began to arch back, became very stiff (no jerking) that lasted for 1 minute (pupils dilated with him staring straight forward, but non-responsive). Pt's body then relaxed, but he remained unresponsive with eyes open for an additional 30 s. Pt then acted confused and started crying for "a minute or two". Pt was back to normal self (baseline) 30 minutes later. No lip smacking, drooling, excess salivation. 1 day later (9 days after vaccines) pt had just woken up from a nap and trying to talk to mom. When mom went into his bedroom, mom states he was slurring his speech for approximately 2 minutes. Mom gave PEDIALYTE (she was concerned that maybe he had low sugar) and this seemed to help. Each of these 2 episodes, the patient had just woke up from taking a nap and pt was hungry.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Opisthotonus, Sluggishness, Staring, Syncope, Unresponsive to stimuli
Clinical narrative: 8 days after getting 4y vaccines, pt started looking "sluggish" and had a syncopal episode. Dad caught pt and put him down and pt began to arch back, became very stiff (no jerking) that lasted for 1 minute (pupils dilated with him staring straight forward, but non-responsive). Pt's body then relaxed, but he remained unresponsive with eyes open for an additional 30 s. Pt then acted confused and started crying for "a minute or two". Pt was back to normal self (baseline) 30 minutes later. No lip smacking, drooling, excess salivation. 1 day later (9 days after vaccines) pt had just woken up from a nap and trying to talk to mom. When mom went into his bedroom, mom states he was slurring his speech for approximately 2 minutes. Mom gave PEDIALYTE (she was concerned that maybe he had low sugar) and this seemed to help. Each of these 2 episodes, the patient had just woke up from taking a nap and pt was hungry.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: Pt was given Vaccines at 11:44am was left in the room with mother for 15 minutes to see if pt had any adverse reaction, Pt had fainted and vitals were taken and were normal pt was diagnosed with Vasovagal syncope was monitored and ok to go once provider seen her.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Loss of consciousness, Paraesthesia
Clinical narrative: Prior administration of the vaccine; patient had mentioned that he was afraid of needle injection. 5 minutes after administration of vaccine, patient went to sit down at the waiting bench for observation. He stated he felt light headed; tingling sensation on the injected left arm; he dropped his cell phone on the floor, and then passed out flat on his tummy on the floor for about 5 second.  Nearby stander fire fighter responded right away. Pharmacist activated emergency respond with patient's stepmom approval. Patient was well alerted, oriented, and ventilating well after the event. Patient stated that he may have bitten his lips. However, no injuries noted at the time of the incident. Patient father cancelled the emergency respond. Patient's father (who is an endodontist)  stated that his son would be okay, and he would not want to seek for Emergency Medical help. Pharmacist asked to observe patient for additional 30 minutes; however, stepmom said they were okay and left the pharmacy area at 2:25PM.
Age: 19.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: 07/31/17 1200 Patient's mother calls and reports to the clinic that patient's left arm on Friday the day after Men B vaccine was given that redness/swelling and pain did occur. She was reporting because of the size of diameter of the swelling/redness pt's mother said it was diameter size of baseball. Each day it did improve as weekend progressed and it is currently still sore and slightly red but all s/s are much improved and mom just wanted to make sure it was reported. RN attempted to contact pt directly but unable to get him on the phone. Instruction given to mother that if symptoms are not gone within the next 2 days to have pt come back to clinic to have provider look at arm. As of today the redness and swelling are down to what the normal reaction would be from vaccine.
Age: 1.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: KINRIX was given for 4th polio and 4th Dtap.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling drunk
Clinical narrative: VERY tipsy and woosy. It started to subside after about two hours.
Age: 60.0
Sex: F
Vaccine: HEP, TDAP, VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: PT STATED EXPERIENCED RASH, AND BUMP AT INJECTION SITE (SIZE OF A LIME). NOT PAINFUL, SHE JUST NOTICED IT WHEN SHE TOUCHED HER ARM. ADVISED PT TO ICE THE AREA, AND CONTACT MD FOR FOLLOW UP.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pruritus, Injection site rash, Injection site swelling, Rash pruritic
Clinical narrative: AS PER PATIENT INJECTION SITE WAS SWOLLEN AND ITHCY. SHE HAD HEADACHE FOR 3 DAYS WHICH WAS RESOLVED. ON 07/30/17 SHE WOKE UP WITH RASH ON HER UPPER RIGHT ARM AND RIGHT SIDE OF HER CHEST. IT IS ITCHY AND SHE APPLIED APPLE CIDER VINEGAR AND ITCH WAS RESOLVED WITH THAT.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Drug hypersensitivity, Erythema, Pain, Pruritus
Clinical narrative: Redness, soreness and itching.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: Later in the day of injection, patient experienced light pain and soreness at injection site. Eventually developed a small rash.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient complains of  painful, swollen  left arm from a  shot  given December 9,2016. The arm still hurts when it moves. The patient saw the doctor in April , 2017 the arm was examined and  she was told to take Tylenol.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Vomiting
Clinical narrative: Patient experienced HA and vomiting Thursday evening - onset?
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainting after giving the vaccine.
Age: 45.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Back pain, Impaired work ability, Sciatica
Clinical narrative: Severe lower back pain then severe sciatic nerve pain left side from my butt down the back of my leg. Brutal been of work for 13 weeks.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Right arm 9.5 cm x 10 cm area of erythema and warmth. Injection site - no drainage.
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received second dose of ZOSTAVAX on 7/30/17. First dose given 9/14/16. Patient had no reaction to either as of 7/30/17.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Reoccurring pain in shoulder that vaccine was administered. Pain included difficulty raising left arm, lifting anything, and laying on left side. Pain has been present from 01/11/17 until present.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Post rabies # 1 - some red dots late that pm. Within 24-48 of second dose she developed hives that do not come and go. The red dots would continue to appear and coalesce into the hive. With the third dose she developed more red dots and the hives got bigger. Other than itching she has no other complaints. She has tried BENADRYL but had no relief. Rash and oth nonspec skin eruption.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient briefly fainted 2 minutes after injection HPV 9.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Extremity contracture, Eye movement disorder, Injection site pain, Limb deformity
Clinical narrative: Pt received a blood draw, and then about 2-3min later, 2nd HPV given in the RA. I completed discharge directly after and asked adults in room if there were any questions. As I finished, pt began to slump forward and eyes rolled in the back of her head. Arms and legs stiffened and mouth slightly contorted. Lasted no more than about 5sec. Pt sat up and asked what happened. Vital signs taken and within normal limits. Pt had eaten 4hours prior. After pt calmed down, she commented, "I felt the pain of the shot and I got really really scared. Then I got really dizzy. I don't remember what I did."
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness
Clinical narrative: Pt received a blood draw, and then about 2-3min later, 2nd HPV given in the RA. I completed discharge directly after and asked adults in room if there were any questions. As I finished, pt began to slump forward and eyes rolled in the back of her head. Arms and legs stiffened and mouth slightly contorted. Lasted no more than about 5sec. Pt sat up and asked what happened. Vital signs taken and within normal limits. Pt had eaten 4hours prior. After pt calmed down, she commented, "I felt the pain of the shot and I got really really scared. Then I got really dizzy. I don't remember what I did."
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain, Peripheral swelling
Clinical narrative: Arm swelling with body aches and localized tenderness at sight x 2 days. Took ALEVE, ice to arm.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Erythema, Urticaria
Clinical narrative: PROQUAD administered 7/14/17. 7/15/17 8PM 4 cm welt at site to ER. Was advised to start Clindamycin if area grew. 7/16/17 area was 5 cm by 9AM so clindamycin was started 7/17/17 9-10 cm erythema, but a lot less red. Never with wheezing, fever nausea or vomiting acted well throughout.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Rash
Clinical narrative: Patient developed a rash upper torso a week after receiving ZOSTAVAX. MD has not determined if rash is result of vaccine. Pending biopsy.
Age: 12.0
Sex: F
Vaccine: HEPA, IPV, MMRV, TDAP, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Client was due for last dose of MMR and first dose of VZV, nurse dispensed and administered VZV and MMRV instead of MMR.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Limb mass, Peripheral swelling
Clinical narrative: Patient called evening of 7/24, arm had red, hard lump. 7/25 redness and swelling had spread down to elbow. Patient went to ER and was told it was cellulitis and was given a prescription for KEFLEX.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Redness and swelling at site of injection. Also blister like area in center of elevated area. Approx 2-3 inches in diameter.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Febrile convulsion
Clinical narrative: Had 2 Febrile seizures. 1 seizure at home and 1 seizure in E.R. T 101.4.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Eye swelling, Lacrimation increased, Oropharyngeal pain
Clinical narrative: He developed periorbital swelling, excessive lacrimation and sore throat with an hour of receiving vaccines. No rashes or wheezing noted. Epinephrine was administered and he was transported to hospital.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) tricep area (vaccine injection site) warm painful tender to touch and swollen.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pink, warm area surrounding injection site. Area spread to approx. 10 cm radius c/o pain to area also.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Starting itching then became painful and swollen-pt went to ER got prednisone-swelling has gone down now 7/22/17.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Her left arm swells and is very painful. It hurts when she moves her arm since the night she received the shot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Joint swelling, Skin warm
Clinical narrative: Large red circle around injection site. Arm pain/tenderness at injection site. Ankle very hot and swollen on injection side all last 3 days then resolved.
Age: 1.0
Sex: F
Vaccine: HEP, HIBV, MMRV, PNC13
Symptoms: Decreased appetite, Injection site reaction, Varicella post vaccine, Viral infection
Clinical narrative: Received vaccine on 7/18/17 on 7/20/17 noticed a chicken pox to leg vaccine given in. Fever started on 7/25/17 and noted large red area to left leg, decreased appetite, seen in urgent care DX with viral illness.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: On patient (R) deltoid, was given Tdap and MENVEO. Woke the next day with red, swollen, hot to the touch upper arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination site reaction
Clinical narrative: Patient received vaccine and got a reaction of shingles on her arm where the vaccine was administered.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Site of injection was swollen and red 3 days post exposure, site was size of 50 cent piece. Pt says had hard baseball size. She had aches and fever for 3 days. She treated with ice packs and acetaminophen.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis BL upper arms. RX cephalexin given.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: (R) thigh lump/erythema
Age: 70.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Right arm swelling at injection sight. Spot was hard and swollen for 24 hrs and then decreased.
Age: 16.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Blood pressure decreased, Diarrhoea, Dizziness, Loss of consciousness, Nausea
Clinical narrative: Patient became lightheaded, blacked out for a few seconds, became sick to stomach and had diarrhea. Patient was given cold rag on head/back of neck kept patient laying down. Provided pt with ice water and orange juice. BP at time of reaction 80/52, BP after feeling better 118/74.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Extra dose administered
Clinical narrative: Given Rotavirus (oral) beyond guidelines. I looked at the Drs order and thought a Dx was the order for the rotavirus.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Erythema, Peripheral swelling
Clinical narrative: Within 24 hours unilateral swelling and redness of lower posterior arm and chest with slight pain. Lasted apx 48-72 hours then resolved. (We used BENADRYL x 48 hrs).
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO (batch number 166201, expiry date 30th October 2018). Co-suspect products included MENACTRA. On 14th July 2017, the patient received BEXSERO and MENACTRA. On 14th July 2017, 45 min after receiving BEXSERO, the patient experienced injection site erythema, injection site blisters, injection site pain, injection site swelling, labeled drug-drug interaction medication error and drug administered at inappropriate site. On an unknown date, the outcome of the injection site erythema, injection site blisters and injection site pain were recovering/resolving and the outcome of the injection site swelling, labeled drug-drug interaction medication error and drug administered at inappropriate site were unknown. The reporter considered the injection site erythema, injection site blisters, injection site pain and injection site swelling to be probably related to BEXSERO. Additional details were provided as follows: The health care professional reported that the patient received both BEXSERO and MENACTRA in the right deltoid at the same time, which led to labeled drug-drug interaction medication error and drug administered at inappropriate site. The patient came back to the doctor's office on 20th July 2017 and the site was still sore an red. The patient visited emergency room.
Age: 42.0
Sex: M
Vaccine: VARCEL
Symptoms: Death
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial (lot and expiry date not reported) reconstituted with sterile diluent (manufacturer unknown) injection (lot and expiry date unknown) for prophylaxis. Pharmacist reported that a patient died following administration of ZOSTAVAX on an unspecified date, within the last year. Causality assessment was not provided. Upon internal review, death was considered to be medically significant. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 59 year old female patient referring to herself who was allergic to clindamycin and cephalosporin. There was no concomitant medication and no pertinent medical history. On 21-JUL-2017 the patient was vaccinated with ZOSTAVAX (lot# N012615 with expiration date of 06-JAN-2018, 0.65 ml once, injection) for prophylaxis which was given 2 inches above her elbow. About 2 hours after the shot, she experienced redness, swelling and itching at the injection site and had a headache. The next day she had severe diarrhea. At the time of the report, she still had  redness but she had recovered from the rest of the adverse event symptoms. The causality was not provided.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a 59 year old female patient referring to herself who was allergic to clindamycin and cephalosporin. There was no concomitant medication and no pertinent medical history. On 21-JUL-2017 the patient was vaccinated with ZOSTAVAX (lot# N012615 with expiration date of 06-JAN-2018, 0.65 ml once, injection) for prophylaxis which was given 2 inches above her elbow. About 2 hours after the shot, she experienced redness, swelling and itching at the injection site and had a headache. The next day she had severe diarrhea. At the time of the report, she still had  redness but she had recovered from the rest of the adverse event symptoms. The causality was not provided.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a 59 year old female patient referring to herself who was allergic to clindamycin and cephalosporin. There was no concomitant medication and no pertinent medical history. On 21-JUL-2017 the patient was vaccinated with ZOSTAVAX (lot# N012615 with expiration date of 06-JAN-2018, 0.65 ml once, injection) for prophylaxis which was given 2 inches above her elbow. About 2 hours after the shot, she experienced redness, swelling and itching at the injection site and had a headache. The next day she had severe diarrhea. At the time of the report, she still had  redness but she had recovered from the rest of the adverse event symptoms. The causality was not provided.
Age: 29.0
Sex: M
Vaccine: ANTH, MMR
Symptoms: Arthralgia, Eye pain, Headache, Influenza like illness, Injection site swelling
Clinical narrative: I BEGAN HAVING FLU LIKE SYMPTOMS INCLUDING FEVER, HEADACHES, BODY ACHES, JOINT PAIN, VOMITING, EYE PAIN. I ALSO HAD A "BB" SIZED BUMP IN MY RIGHT ARM (SITE OF ANTHRAX SHOT). THE BUMP IN MY ARM HAS GONE AWAY BUT I AM CURRENTLY STILL FEELING ILL (08/01/2017).
Age: 29.0
Sex: M
Vaccine: ANTH, MMR
Symptoms: Malaise, Pain, Pyrexia, Vomiting
Clinical narrative: I BEGAN HAVING FLU LIKE SYMPTOMS INCLUDING FEVER, HEADACHES, BODY ACHES, JOINT PAIN, VOMITING, EYE PAIN. I ALSO HAD A "BB" SIZED BUMP IN MY RIGHT ARM (SITE OF ANTHRAX SHOT). THE BUMP IN MY ARM HAS GONE AWAY BUT I AM CURRENTLY STILL FEELING ILL (08/01/2017).
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Rash.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous report was received from a Medical Assistant/office manager and refers to an unspecified amount of patients. Medical history, concurrent conditions and concomitant medications were not provided. On 12-JUL-2017, an unspecified number of patients were administered doses of VARIVAX (lot numbers M038226; expiration 07-SEP-2018 and M041081; expiration 06-OCT-2018) and PROQUAD (lot numbers N000678; expiration 05-JUL-2018 and N004629; expiration 07-AUG-2018) that were improperly stored. The Medical Assistant did not have the lot numbers for the sterile diluent used to reconstitute the vaccines. Temperature/time: -14 degrees C to -10 degrees C (-13.5 degrees C) for one hour and nine minutes. Previous temperature excursion: No. Call was because of a data logger. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 07-JUL-2017 the patient was vaccinated with an improperly stored dose of PROQUAD (lot # reported as N002336, expiration date 19-JUL-2018) for prophylaxis, which was reconstituted with properly stored sterile diluent. The vaccine was exposed from 15 Fahrenheit degrees (°F) to 46 Fahrenheit degrees (°F) for 15 hours. There was no previous temperature excursion. The call was made because there was a "data logger".
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 13 year old patient.    On 08-JUL-2015 the patient was vaccinated with GARDASIL lot # K016966 dose 3, 1 DF for prophylaxis. On 08-JUL-2015, 4 months after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age.     On 05-JUL-2017 the patient was vaccinated with and improperly stored dose of LIQUID PEDVAXHIB lot # L051123, expiration date 13-OCT-2018, for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 45 minutes. There was no previous temperature excursion. The call was made because there was a "data logger"
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 year old female patient. On 26-MAY-2017 the patient was inadvertently vaccinated with an expired dose of GARDASIL lot # L035105, expiration date 14-MAY-2017 for prophylaxis. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006828.