chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Mom reports received routine vaccines for her 12 month old daughter on 4/14/2016. Varicella (MSD lot L013067) to right thigh SQ and MMR (MSD lot L002873) SC left thigh and Hep A (SKB lot X22P4 and influenza quad pres free (SKB lot U5320AA) IM to left thigh. Approximately 4/23/15 (day 9 after vaccination) she developed a spot to right thigh varicella immunization site. Over next 24 hours it progressed to a large hard knot that was red and TTP. She had a fever of 101.5F. Mom denied any other symptoms (loss appetite, irritability, SOB, anaphylactic like symptoms, etc). on 4/25 she developed a generalized red macular rash all over body and was seen by HCP on 4/26/16. HCP noted rash first on abdomen then chest and face described as one firm nodule to right thigh not TTP or warm; multiple erythematosus papules to abdomen, back, chest legs and cheeks that blanch to touch, with T 97.6 F rectally. No other symptoms/exam nl. Diagnosed with mild pruritic rash and nodule to right thigh s/p immunization - rash unknown etiology and referred to clinic. Px ZYRTEC and topical hydrocortisone cream. 4/28/16 child doing well and playing happily with siblings w/o fever and rash is resolving - less red per mom.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to two patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with inappropriately stored doses of VARIVAX (Merck) lot # K016132 (expiration date 29-SEP-2016) (route, dose, dose number and frequency were not provided). Concomitant medications were not reported. The reporter stated that these doses of VARIVAX (Merck) were stored at 15 degrees Fahrenheit for 15 hours. No adverse events were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored dosed of GARDASIL 9 (lot # L043213 exp date 28-AUG-2017 (dose and route not reported). The nurse reported that the vaccine was stored at a temperature excursion of 34F for 28 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L030869 exp date 08-JUN-2018) (dose and route not reported). The nurse reported that the vaccine was stored at a temperature excursion of 34F for 28 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: Mom contacted office to request VAERS (Vaccine Adverse Event Reporting System). She advised child received KINRIX (SKB lot TZ434) to left thigh IM and MMRV (PROQUAD - MSD lot K025765) SQ to right thigh 4/22/2016. That evening he was okay and she didn't notice any issues on Saturday. Sunday 4/24/2016 church caretakers reported child had a large red raised area to right thigh. Child had no trauma, injury, exposure to new detergents, soaps, clothing, foods, toys, etc. Child seen by medical and told was allergic reaction to vaccines and prescribed oral Prednisone and ZYRTEC which was helping. Child had no fever or rash elsewhere on body.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning unspecified patients of unknown age. Concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with 4 additional doses of improperly stored dose of ZOSTAVAX lot # L033311 (expiration date 01-DEC-2016) (dose and route not reported). Concomitant therapies were not provided. No adverse effects were reported. There was no product quality complaint (PQC) involved. Names of vaccines: ZOSTAVAX (L033311, exp 12/01/2016); Temperature: 39F; Time frame: 18 hours 19 minutes; Was it administered (AE)? Yes; Was previous temperature excursion? Yes, 22F for 5 hours and 23F for 35 hours; Was call because of a "data logger"? (Y/N): No. This is one of several reports received from the same source. Additional information has been requested. Event and narrative were updated.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a 66 patients of unknown ages and genders. The medical history of the patients or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (20 patients with doses of lot number: L042631, expiration date: 16-DEC-2016, 26 patients with doses of lot number: L034381, expiration date: 22-DEC-2016, 20 patients with doses of lot number: L030442, expiration date: 19-DEC-2016) (doses, anatomical sites and routes were not reported). Concomitant medication of the patients were not provided. Additionally, no adverse effects were reported and there was not product quality complain involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 27-APR-2016, the patient was inadvertently administered a dose of expired ZOSTAVAX (lot number# L002424, expiration date 23-APR-2016, dose and route not provided) (expired drug administered). Concomitant therapies were not provided. No adverse effects were reported. There was no product quality (PQC) involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Stomatitis, Tenderness
Clinical narrative: Reported 4/24/16. 3 days after vaccine on one side under tongue unusual sores occurred. Sores are resolving after 2 weeks but do not behave like cold sores, they spread on one side, very tender (not canker sores) and slowly resolving.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Severe shoulder pain with any motion.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chest pain, Dizziness, Hypoaesthesia, Limb discomfort, Mobility decreased
Clinical narrative: Case number PHHY2011US115013 is an initial spontaneous report derived from vaccine adverse event reporting system website (VAERS reference number: 428340) on 30 Sep 2011. This case refers to a 12-year-old female patient. She was vaccinated with MENVEO, (batch number: M10051) in her left arm on 27 Jul 2011. On the same day, she was also vaccinated with HPV4 vaccine, (other manufacturer, batch number: 1569Z) in her right arm and BOOSTRIX vaccine, (batch number: AC52B066AA) in her left arm. She complained of throat and chest pain within five minutes after vaccination. A small amount of water was given, and then emesis occurred. She was pallor and experienced dizziness and near-syncope. She was escorted to an examination room. She stated that her arms felt heavy, numb and difficult to move but she was able to sit up with assistance. Even after thirty minutes, she was not improving and paramedics were called. She was transported to a hospital by the paramedics. The outcome was reported as condition unchanged. Upon internal review performed, according sales data, Tdap vaccine was changed to BOOSTRIX.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Oropharyngeal pain, Pallor, Presyncope, Vomiting
Clinical narrative: Case number PHHY2011US115013 is an initial spontaneous report derived from vaccine adverse event reporting system website (VAERS reference number: 428340) on 30 Sep 2011. This case refers to a 12-year-old female patient. She was vaccinated with MENVEO, (batch number: M10051) in her left arm on 27 Jul 2011. On the same day, she was also vaccinated with HPV4 vaccine, (other manufacturer, batch number: 1569Z) in her right arm and BOOSTRIX vaccine, (batch number: AC52B066AA) in her left arm. She complained of throat and chest pain within five minutes after vaccination. A small amount of water was given, and then emesis occurred. She was pallor and experienced dizziness and near-syncope. She was escorted to an examination room. She stated that her arms felt heavy, numb and difficult to move but she was able to sit up with assistance. Even after thirty minutes, she was not improving and paramedics were called. She was transported to a hospital by the paramedics. The outcome was reported as condition unchanged. Upon internal review performed, according sales data, Tdap vaccine was changed to BOOSTRIX.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Petit mal epilepsy
Clinical narrative: Case number PHHY2011US115054 is an initial spontaneous report derived from Vaccine Adverse Event Reporting System website (VAERS reference number: 429223) on 30 Sep 2011. This case refers to an 11-year-old female patient. She was vaccinated with MENVEO (batch number: M10059) in her right arm on 08 Aug 2011. On the same day she was also vaccinated with BOOSTRIX vaccine (other manufacturer, batch number: AC52B073AA) in her left arm, Varcel vaccine (other manufacturer, batch number: 0030AA) subcutaneously in her right arm and HEPA vaccine (other manufacturer, batch number: 0124AA) in her left arm. On 08 Aug 2011, she experienced petit seizures. It was reported that she had recovered completely without any treatment and there was no postictal period. Upon internal review performed, according sales data, Tdap vaccine was changed to BOOSTRIX (dTPa vaccine).
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Electroencephalogram, Seizure, Tonic clonic movements
Clinical narrative: Case number PHHY2011US114304 is an initial spontaneous report derived from Vaccine Adverse Event Reporting System website (VAERS reference number: 439665) on 30 Dec 2011. This case refers to an 11-year-old female patient. She was vaccinated with MENVEO (batch number: A10051) intramuscularly into her right arm on 22 Aug 2011. On the same day, she was also vaccinated with Tdap vaccine (other manufacturer, batch number: AC52B057DA) intramuscularly into her left arm and HPV4 vaccine (other manufacturer, batch number: 0626AA) intramuscularly into her right arm. On 25 Aug 2011, she had seizure and increased seizure activity. It was reported that at first she had tonic/clonic movements. She was hospitalized for three days due to these events. Electroencephalography was performed but the result was not reported. The outcome was reported as condition unchanged. Upon internal review performed, according sales data, Tdap vaccine was changed to BOOSTRIX.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Serum sickness
Clinical narrative: This case was reported by a physician and described the occurrence of anaphylactic reaction in a 25-year-old female patient who received seasonal Influenza vaccine. Co-suspect products included AFLURIA. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose and AFLURIA at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and serum sickness. On an unknown date, the outcome of the anaphylactic reaction and serum sickness were unknown. it was unknown if the reporter considered the anaphylactic reaction and serum sickness to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The original symptoms (see pharma case US2016026490 for further details) emerged last fall when the patient had an anaphylactic reaction to a Flu shot. The patient had experienced many allergic phenomena, which included anaphylaxis and serum sickness.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Abasia, Blood glucose normal, Head injury, Hypopnoea, Lethargy
Clinical narrative: 12:25PM S/P vaccinations patient collapsed going out to waiting area, mother stated he "just dropped" and hit head. Patient escorted to exam room, MD notified, SPO2=99%, pulse=62-64, glucocheck=91. Patient lethargic, slow to communicate, mother stated patient is fasting, with nothing to eat or drink. Patient given water approx 10oz, and then glucola approx 10 oz, patient refused more, requested to "lay down". Mother instructed to encourage sips of glucola every 2 minutes. Respirations shallow, loud.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Mobility decreased, Respiration abnormal, Syncope, Unresponsive to stimuli
Clinical narrative: 12:25PM S/P vaccinations patient collapsed going out to waiting area, mother stated he "just dropped" and hit head. Patient escorted to exam room, MD notified, SPO2=99%, pulse=62-64, glucocheck=91. Patient lethargic, slow to communicate, mother stated patient is fasting, with nothing to eat or drink. Patient given water approx 10oz, and then glucola approx 10 oz, patient refused more, requested to "lay down". Mother instructed to encourage sips of glucola every 2 minutes. Respirations shallow, loud.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Breath sounds abnormal, Communication disorder, Head injury, Hypopnoea
Clinical narrative: 12:25PM S/P vaccinations patient collapsed going out to waiting area, mother stated he "just dropped" and hit head. Patient escorted to exam room, MD notified, SPO2=99%, pulse=62-64, glucocheck=91. Patient lethargic, slow to communicate, mother stated patient is fasting, with nothing to eat or drink. Patient given water approx 10oz, and then glucola approx 10 oz, patient refused more, requested to "lay down". Mother instructed to encourage sips of glucola every 2 minutes. Respirations shallow, loud.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Lethargy, Syncope
Clinical narrative: 12:25PM S/P vaccinations patient collapsed going out to waiting area, mother stated he "just dropped" and hit head. Patient escorted to exam room, MD notified, SPO2=99%, pulse=62-64, glucocheck=91. Patient lethargic, slow to communicate, mother stated patient is fasting, with nothing to eat or drink. Patient given water approx 10oz, and then glucola approx 10 oz, patient refused more, requested to "lay down". Mother instructed to encourage sips of glucola every 2 minutes. Respirations shallow, loud.
Age: 83.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Incisional drainage, Pain in extremity
Clinical narrative: The PREVNAR 13 booster shot was given to me on Jan 28 2016 at the outpatient clinic prior to a primary doctor visit at 1:30 pm in my left shoulder. That night at 5 PM I became ill. Left arm and shoulder pain and weakness, fever, chills, fast heartbeat etc. I returned to the clinic on Jan 29. Dr called an ambulance which took me to hospital. Dr. removed 2 units of a yellow substance from my left shoulder which he smelled and disposed of it. He sent me home with a KEFLEX prescription. I became extremely ill over the weekend and too weak to remove my clothing. I called the clinic on Mon 1 Feb 2016 and was advised to return to the same hospital. My cousin drove me there. They removed more fluid from my left shoulder which was sent to the lab. Later that day I had emergency surgery on my left shoulder which lasted an hour. On 4 Feb I was moved. They had inserted a PIC on my arm and administered 2 1/2 hours of vancomycin and 1/2 hour of ROCEPHIN every day. I also had daily occupational and physical therapy to regain some strength in my left shoulder. I was released on Mar 4 to my home with nursing care and occupational therapy through 7 April. I've followed up with the orthopedic surgeon and infectious disease doctor. I have not regained my left shoulder strength. Very little improvement. The doctor describe my condition as septic arthritis of shoulder, left (HCC).
Age: 83.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Activities of daily living impaired, Arthritis bacterial, Aspiration joint, Asthenia, Central venous catheterisation
Clinical narrative: The PREVNAR 13 booster shot was given to me on Jan 28 2016 at the outpatient clinic prior to a primary doctor visit at 1:30 pm in my left shoulder. That night at 5 PM I became ill. Left arm and shoulder pain and weakness, fever, chills, fast heartbeat etc. I returned to the clinic on Jan 29. Dr called an ambulance which took me to hospital. Dr. removed 2 units of a yellow substance from my left shoulder which he smelled and disposed of it. He sent me home with a KEFLEX prescription. I became extremely ill over the weekend and too weak to remove my clothing. I called the clinic on Mon 1 Feb 2016 and was advised to return to the same hospital. My cousin drove me there. They removed more fluid from my left shoulder which was sent to the lab. Later that day I had emergency surgery on my left shoulder which lasted an hour. On 4 Feb I was moved. They had inserted a PIC on my arm and administered 2 1/2 hours of vancomycin and 1/2 hour of ROCEPHIN every day. I also had daily occupational and physical therapy to regain some strength in my left shoulder. I was released on Mar 4 to my home with nursing care and occupational therapy through 7 April. I've followed up with the orthopedic surgeon and infectious disease doctor. I have not regained my left shoulder strength. Very little improvement. The doctor describe my condition as septic arthritis of shoulder, left (HCC).
Age: 83.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Chills, Heart rate increased, Injection site pain, Malaise, Muscular weakness
Clinical narrative: The PREVNAR 13 booster shot was given to me on Jan 28 2016 at the outpatient clinic prior to a primary doctor visit at 1:30 pm in my left shoulder. That night at 5 PM I became ill. Left arm and shoulder pain and weakness, fever, chills, fast heartbeat etc. I returned to the clinic on Jan 29. Dr called an ambulance which took me to hospital. Dr. removed 2 units of a yellow substance from my left shoulder which he smelled and disposed of it. He sent me home with a KEFLEX prescription. I became extremely ill over the weekend and too weak to remove my clothing. I called the clinic on Mon 1 Feb 2016 and was advised to return to the same hospital. My cousin drove me there. They removed more fluid from my left shoulder which was sent to the lab. Later that day I had emergency surgery on my left shoulder which lasted an hour. On 4 Feb I was moved. They had inserted a PIC on my arm and administered 2 1/2 hours of vancomycin and 1/2 hour of ROCEPHIN every day. I also had daily occupational and physical therapy to regain some strength in my left shoulder. I was released on Mar 4 to my home with nursing care and occupational therapy through 7 April. I've followed up with the orthopedic surgeon and infectious disease doctor. I have not regained my left shoulder strength. Very little improvement. The doctor describe my condition as septic arthritis of shoulder, left (HCC).
Age: 83.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Pain in extremity, Pyrexia, Shoulder operation
Clinical narrative: The PREVNAR 13 booster shot was given to me on Jan 28 2016 at the outpatient clinic prior to a primary doctor visit at 1:30 pm in my left shoulder. That night at 5 PM I became ill. Left arm and shoulder pain and weakness, fever, chills, fast heartbeat etc. I returned to the clinic on Jan 29. Dr called an ambulance which took me to hospital. Dr. removed 2 units of a yellow substance from my left shoulder which he smelled and disposed of it. He sent me home with a KEFLEX prescription. I became extremely ill over the weekend and too weak to remove my clothing. I called the clinic on Mon 1 Feb 2016 and was advised to return to the same hospital. My cousin drove me there. They removed more fluid from my left shoulder which was sent to the lab. Later that day I had emergency surgery on my left shoulder which lasted an hour. On 4 Feb I was moved. They had inserted a PIC on my arm and administered 2 1/2 hours of vancomycin and 1/2 hour of ROCEPHIN every day. I also had daily occupational and physical therapy to regain some strength in my left shoulder. I was released on Mar 4 to my home with nursing care and occupational therapy through 7 April. I've followed up with the orthopedic surgeon and infectious disease doctor. I have not regained my left shoulder strength. Very little improvement. The doctor describe my condition as septic arthritis of shoulder, left (HCC).
Age: 22.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Lethargy, Nausea, Seizure, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of convulsion in a 22-year-old female patient who received RABAVERT. On 25th April 2016, the patient received the 1st dose of RABAVERT (intravenous) 1 ml. On 25th April 2016, less than a minute after receiving RABAVERT, the patient experienced convulsion (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), vomiting, nausea, intramuscular formulation administered by other route and vaccine administered at inappropriate site. On 26th April 2016, the patient experienced lethargy. On 25th April 2016, the outcome of the convulsion and passed out were recovered/resolved. On an unknown date, the outcome of the vomiting, intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown and the outcome of the nausea and lethargy were recovering/resolving. The reporter considered the convulsion, passed out, vomiting, nausea and lethargy to be related to RABAVERT. Additional details were received as follows: The patient was receiving the RABAVERT for pre exposure since she worked with bats. The patient did not receive any other vaccines at time and did not take any medications on a regular basis. On 25th April 2016 at 1:40, the patient stated that, instead of receiving RABAVERT intramuscularly, she received it intravenously, which led to incorrect route of vaccination. The patient felt that, it was given in a vein because she saw blood from the site. About 1ccu of blood was drawn back when the patient was being given the vaccine. Inappropriate site of vaccine administered, was also reported as an event. However, no details were provided. The patient stated that, her primary physician, who was not from the office that administered the vaccine, believed that the product was probably given intravenously based on the symptom response and the rapid onset of symptoms. Within one to two minutes after receiving RABAVERT, the patient started to have convulsions. The patient was sitting down at the time the vaccination. The nurse in the health department described to the patient that, when the patient was having the convulsions, she passed out. The patient stated that, all she remembered was feeling like her brain was running fast forward. The patient saw snippets of past memories and heard music playing in the background. The nurse observed that, the patient did tense up and was leaning to one side. The patient did not fall and the nurse said that the episode only lasted about ten seconds. When the patient regained consciousness, the nurse explained to her what happened. Two to three minutes later, the patient had another convulsion that lasted about twenty seconds. When the patient regained consciousness, she vomited. Even after vomiting for one time, the patient felt nauseous for the next two to three hours. On the day of the day of reporting, the patient was feeling very lethargic and did not feel 100 percent that morning.
Age: 22.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Nausea, Seizure, Tension, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of convulsion in a 22-year-old female patient who received RABAVERT. On 25th April 2016, the patient received the 1st dose of RABAVERT (intravenous) 1 ml. On 25th April 2016, less than a minute after receiving RABAVERT, the patient experienced convulsion (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), vomiting, nausea, intramuscular formulation administered by other route and vaccine administered at inappropriate site. On 26th April 2016, the patient experienced lethargy. On 25th April 2016, the outcome of the convulsion and passed out were recovered/resolved. On an unknown date, the outcome of the vomiting, intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown and the outcome of the nausea and lethargy were recovering/resolving. The reporter considered the convulsion, passed out, vomiting, nausea and lethargy to be related to RABAVERT. Additional details were received as follows: The patient was receiving the RABAVERT for pre exposure since she worked with bats. The patient did not receive any other vaccines at time and did not take any medications on a regular basis. On 25th April 2016 at 1:40, the patient stated that, instead of receiving RABAVERT intramuscularly, she received it intravenously, which led to incorrect route of vaccination. The patient felt that, it was given in a vein because she saw blood from the site. About 1ccu of blood was drawn back when the patient was being given the vaccine. Inappropriate site of vaccine administered, was also reported as an event. However, no details were provided. The patient stated that, her primary physician, who was not from the office that administered the vaccine, believed that the product was probably given intravenously based on the symptom response and the rapid onset of symptoms. Within one to two minutes after receiving RABAVERT, the patient started to have convulsions. The patient was sitting down at the time the vaccination. The nurse in the health department described to the patient that, when the patient was having the convulsions, she passed out. The patient stated that, all she remembered was feeling like her brain was running fast forward. The patient saw snippets of past memories and heard music playing in the background. The nurse observed that, the patient did tense up and was leaning to one side. The patient did not fall and the nurse said that the episode only lasted about ten seconds. When the patient regained consciousness, the nurse explained to her what happened. Two to three minutes later, the patient had another convulsion that lasted about twenty seconds. When the patient regained consciousness, she vomited. Even after vomiting for one time, the patient felt nauseous for the next two to three hours. On the day of the day of reporting, the patient was feeling very lethargic and did not feel 100 percent that morning.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Very sore arm at injection site. Still sore months later.
Age: 72.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Heart rate increased
Clinical narrative: During my cardiac rehab exercise program, my heart rate jumped up to 150+ much higher than allowable. Exercise was slowed and finally stopped. Rapid heart rate returned to normal around 6-7 PM that evening.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Back pain, Dizziness, Dyspnoea, Heart rate increased, Nausea
Clinical narrative: 15 minutes after injection lips started tingling, short of breath, dizzy, nauseous, and rapid heart rate. Took Albuterol INH 2 puffs, BENADRYL 25 mg by mouth x 2. Symptoms relieved after 3.5 hours.  Had back pain when able to void at the end of 3.5 hours. Had shortness of breath again 3 hours later and took 10 mg CLARITIN and BENADRYL 25 mg x 1.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Paraesthesia oral
Clinical narrative: 15 minutes after injection lips started tingling, short of breath, dizzy, nauseous, and rapid heart rate. Took Albuterol INH 2 puffs, BENADRYL 25 mg by mouth x 2. Symptoms relieved after 3.5 hours.  Had back pain when able to void at the end of 3.5 hours. Had shortness of breath again 3 hours later and took 10 mg CLARITIN and BENADRYL 25 mg x 1.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Erythema, Swelling
Clinical narrative: Mildly erythematous and mildly swollen. Seen by MD on day of reaction and was prescribed KEFLEX.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Extra dose administered
Clinical narrative: No reported events have been reported but 2 additional vaccines were given to the client.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Hypoaesthesia, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Almost immediately pin radiating from L shoulder to lower L arm and hand. Pain continues with weakness, numbness, tingling, loss of range of motion to this day.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Paraesthesia
Clinical narrative: Almost immediately pin radiating from L shoulder to lower L arm and hand. Pain continues with weakness, numbness, tingling, loss of range of motion to this day.
Age: 21.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 21 year old male patient. No relevant medical history or concurrent conditions were reported. On 29-APR-2016, the patient was vaccinated with PROQUAD (Merck) (dose, dose number, route, lot# and expiration date were not reported) (inappropriate schedule of drug administration). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker who reported that multiple unspecified patients received doses of improperly stored PNEUMOVAX 23 (lot# K020215, expired date 15-MAY-2016, dose and route was not reported) on unspecified dates (Incorrect product storage). These vaccines were stored at 52.3 Fahrenheit (F) for 4 hours. The previous temperature excursion was 64 F for 45 minutes. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a other health professional referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 20-APR-2016 the patient was vaccinated with the first dose of  (Merck) VARIVAX (lot# L026405, expiration date 15-JUL-2017, dose and route unknown). The vaccine was improperly stored under 11 F for 4.5 hours without previous excursion. No adverse effects reported. The call was because of a data logger. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 24-APR-2016 the patient received improperly stored dose of ZOSTAVAX (lot# L031272, expiration date 19-NOV-2016, 0.65 ml, subcutaneously) (Incorrect product storage). No adverse effects were reported. Product quality complaint (PQC) was not involved. Name of vaccines involved (including lot/exp): ZOSTAVAX L031272/exp. 11/19/2016. Temperature: 38 F. Time frame: 24 hours. Previous temperature excursion: 43 F for 36 hours. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Information has been received from a medical assistant (MA) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 08-APR-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot  #K023624, expiration date 09-FEB-2016 (dose and route unspecified). The reporter stated that she/he could not say if the patient had an adverse experience or did not have an adverse experience. Additional information is not expected as the reporter did not wish to further contact.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician, as part of a marketing research program, refers to 11 to 18 year old male patients. There were no concurrent condition and medical history. On an unknown dates, the patients were vaccinated with GARDASIL (lot number, dose and route were not reported). There was no concomitant therapy. The physician reported regarding patients who between 2006 to 2012, fainted when they received vaccination with GARDASIL. The physician reported that the incidence of fainting occurred 1 in 100 boys. The pediatrician would then have the patients leg elevated, recover and watch the patient for 15-20 minutes before letting them go. This event did not prevent the administration of second and third doses. The outcome of event was reported to be recovering/resolving. The physician stated that now her practice reminds patients to eat before vaccine and had them sit in office for 15. The physician did not see this adverse event with GARDASIL 9. The physician considered fainting to be non-serious and related to GARDASIL. This case is one of the two reports from same reporter. Additional information is not expected since the physician does not wish to be further contacted.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pain
Clinical narrative: Rt. zygoma; 2nd degree - 0.5 cm. Redness, pain (10/10 per pt.); mild swelling at injection site x 48 hours (per emergency room report included with this form).
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, painful to touch rx BENADRYL 50 mg PO, kenalog 40 mg IM.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Pyrexia
Clinical narrative: Moderate fever (38 C) and headache lasting 3 days.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Borrelia test, Foaming at mouth, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test
Clinical narrative: Patient started feeling tingling and numbness in the feet and it progressed over the next several weeks and months to numbness in the legs and groin area. Patient saw chiropractors, acupuncturists, and neurologists as symptoms progressed and was diagnosed by a neurologist as Guillan Barre Syndrome (GBS). Patient at one point developed foamy jucous in the mouth.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient started feeling tingling and numbness in the feet and it progressed over the next several weeks and months to numbness in the legs and groin area. Patient saw chiropractors, acupuncturists, and neurologists as symptoms progressed and was diagnosed by a neurologist as Guillan Barre Syndrome (GBS). Patient at one point developed foamy jucous in the mouth.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Mom alternating Tylenol with Motrin since 4/27 then redness with peripheral urticaria on L buttocks, Left upper, Left thigh, right calf and right lower arm appeared. Contacted and seen by primary MD on 4/29.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injection site discolouration, Musculoskeletal pain, Pain in extremity
Clinical narrative: large yellow circle at injection site.continuous low level pain extending from wrist to shoulder.
Age: 0.26
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception, Ultrasound scan
Clinical narrative: Hospitalized at hospital 4/24/16. Dx: intussusception.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Computerised tomogram head normal, Full blood count normal, Syncope
Clinical narrative: Several syncopal episodes this morning (day after vaccine administration with possible seizure activity.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Numbness of arm where vaccine was given and pain of arm and down leg- the side of vaccine. Today, numbness has dissipated, but still has pain, but less which she feels especially on mvmt- walking.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Numbness of arm where vaccine was given and pain of arm and down leg- the side of vaccine. Today, numbness has dissipated, but still has pain, but less which she feels especially on mvmt- walking.
Age: 1.65
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid swelling 7 mm diameter red and warm yesterday but improved without any meds/antibiotics.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Irritability, Pityriasis rosea, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Bumps on her stomach the first day of the shot then several day later on her back, face, legs, pubic area. They look like hives. Bumps red and itchy. child was very irritable. Just a note they gave me paperwork for the HPV shot also. But I decline for my 15 year old daughter.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Scarlet fever, Urticaria
Clinical narrative: Bumps on her stomach the first day of the shot then several day later on her back, face, legs, pubic area. They look like hives. Bumps red and itchy. child was very irritable. Just a note they gave me paperwork for the HPV shot also. But I decline for my 15 year old daughter.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Injection site pain, Neck pain, Nodule
Clinical narrative: Soreness at site of injection - started 1 hour after injection progressed to firm nodule that was tender and warm. Resolved after 10 days. Headache on day 1 only. Soreness to neck on side of injection - resolved in two days. Fatigue - resolved in 2 days.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Skin warm, Tenderness
Clinical narrative: Soreness at site of injection - started 1 hour after injection progressed to firm nodule that was tender and warm. Resolved after 10 days. Headache on day 1 only. Soreness to neck on side of injection - resolved in two days. Fatigue - resolved in 2 days.
Age: 0.47
Sex: M
Vaccine: PNC13
Symptoms: Apnoea, Cyanosis, Lethargy, Pyrexia, Seizure
Clinical narrative: At 2:17 pm on 4-12-16, the above named child received PREVNAR 2. At 1:38 AM on 4-13-16, patient presented to ER due to vomiting, seizing with apneic episode. Fever as high at 104 axillary, at home. Was cyanotic and lethargic for 5 minutes.
Age: 0.47
Sex: M
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: At 2:17 pm on 4-12-16, the above named child received PREVNAR 2. At 1:38 AM on 4-13-16, patient presented to ER due to vomiting, seizing with apneic episode. Fever as high at 104 axillary, at home. Was cyanotic and lethargic for 5 minutes.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fatigue, Pallor
Clinical narrative: Seconds after GARDASIL patient looked pale and tired. Base BP 92/68, BP 88/65 x 2. Check q 5 min lying down and improved. P BP ck in 20 min, 30 min, 45 min nl. Mom states he often feels faint with shots. After he left he was WNL. Checked 4/27 - nl pulse.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: 6 x 3 red oval area over DTaP shot given.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Facial hives.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Altered state of consciousness, Feeling abnormal, Gait disturbance, Pain
Clinical narrative: 4:38 pm - Generalized "achiness" - "not feeling good" - laid on table, cool towel to face, sipping Sprite, BP 93/55, HR 81. 4:46 pm - "not feeling better - like I'm gong to pass out" B/P 106/57, HR 86, laying down sipping Sprite. 4:48 pm - CPNP examining pt - "has not eaten since AM" "Get food, monitor, to ER for distress". 4:49 pm - pt brought to car per wheelchair, myself, mom - assisted with walking, looks a littler perkier - no distress.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Patient's wife called me about 12:15 PM stating patient's lips were swollen. I advised her to seek emergency help. I spoke to patient on 4/24/16 he was recovering and had been treated by Dr.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Red area to (R) upper arm 2" (L) x 1" (W) no pain, no itching, no edema no treatment.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Pt. went to school after receiving vaccine at office, two hours later began to have hives on various parts of body.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Mild case of shingles being monitored by Dr.
Age: 19.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MNQ, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: (Wrong) pediatric dose Hep A given to 19 yo. Revaccinated same day with appropriate dosage. Adult Hep A.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash, Swelling face
Clinical narrative: Facial swelling, rash.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 2.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site to (R) thigh; recommended ice packs, ibuprofen for discomfort.
Age: 38.0
Sex: F
Vaccine: HEPA, MNQ, TYP
Symptoms: Chills, Dizziness, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling, warmth of injection site (R) arm - unmeasured fever, shivering - now with headaches (frontal) and feeling dizzy. No respiratory symptoms - no hives.
Age: 38.0
Sex: F
Vaccine: HEPA, MNQ, TYP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Redness, swelling, warmth of injection site (R) arm - unmeasured fever, shivering - now with headaches (frontal) and feeling dizzy. No respiratory symptoms - no hives.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Nodule, Pain, Swelling
Clinical narrative: Swelling, a knot, painful to touch, bruised.
Age: 1.92
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was given an expired immunization - has had no adverse reactions - Pt was given a varicella - Lot # K003412 Exp 3-6-16 Merck - Pt's mother was notified and pt is having no reaction. Will repeat vaccine in 30 days.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, sore 7-10 days after no treatment at site of injection.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Erythema, Injection site erythema, Injection site macule, Irritability, Macule
Clinical narrative: Mother presents with infant who is happy, smiling and blowing bubbles to discuss onset of rash to anterior thigh 24 hours after receipt of 4/15/2016 PEDIARIX. Child also received oral rotavirus on 4/15/2016. Mom advised child was fussy x 24 hours but back to normal self by 4/17/2016. She saw HCP on 4/21 for routine f/u for 4/8 and 4/11/2016 visits where treated for URI/wheezing. He was cleared on 4/21 and received 2 of the 4 recommended vaccines for a 4 month old (mom prefers to split). Mom advised the rash was persisting but not getting worse. Providers document red papules and prescribed topical 1% hydrocortisone. Mom doesn't see much difference but has only applied it once. Child also has several small red raised macules to left thigh surrounding yesterdays Hib and PCV13 vaccinations. Mom denies any new foods (breast feeding only), no new detergents, soaps, lotions, creams, no dogs/cats, does have carpet but doesn't shampoo, etc. Mom advised the had been at the park prior to onset of rash and unsure if bitten by anything...was not placed on grass.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Papule, Rash
Clinical narrative: Mother presents with infant who is happy, smiling and blowing bubbles to discuss onset of rash to anterior thigh 24 hours after receipt of 4/15/2016 PEDIARIX. Child also received oral rotavirus on 4/15/2016. Mom advised child was fussy x 24 hours but back to normal self by 4/17/2016. She saw HCP on 4/21 for routine f/u for 4/8 and 4/11/2016 visits where treated for URI/wheezing. He was cleared on 4/21 and received 2 of the 4 recommended vaccines for a 4 month old (mom prefers to split). Mom advised the rash was persisting but not getting worse. Providers document red papules and prescribed topical 1% hydrocortisone. Mom doesn't see much difference but has only applied it once. Child also has several small red raised macules to left thigh surrounding yesterdays Hib and PCV13 vaccinations. Mom denies any new foods (breast feeding only), no new detergents, soaps, lotions, creams, no dogs/cats, does have carpet but doesn't shampoo, etc. Mom advised the had been at the park prior to onset of rash and unsure if bitten by anything...was not placed on grass.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: Hives 2 days after vaccine given covers whole body.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Two days after pt had Zoster vaccine administered at office her injection site started with redness. Pt is having pain in (Lt) arm w/difficulty raising arm due to pain. Pt is unable to sleep due to pain. Pt given script for baclofen and TYLENOL with codeine.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Tenderness
Clinical narrative: Patient received TRUMENBA on his Rt upper arm. The next day he told mom his arm was slightly tender and red. He states the next day this resolved after using ice and rest.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given an unneeded dose of MENACTRA, pt already had received MENACTRA on 4/24/15, no adverse events noted.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 10 x 7 cm area of redness, warmth and swelling at vaccine site on right upper arm (Deltoid). Tx: oral BENADRYL.
Age: 71.0
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: I was given a flu shot in my left shoulder at pharmacy in Oct. 2015. From that moment until now I've been having shoulder pain.
Age: 63.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Red, hard, itchy patch developed at injection site approximately 1.25" x 2.5".
Age: 38.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Bronchitis, Cough, Feeling hot, Flushing, Nervousness
Clinical narrative: Felt flushed and hot about 20 min after injections. Next A.M. went to urgent care for cough, feeling hot and shaky. Next day went back to urgent care and given Rx Z-Pak Dx bronchitis.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site mass, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Initially did well after HPV9 vaccine was given. Approx. 3 1/2 wks later - redness and visible "lump" to area arm pain and stiffness. Denies bruising. Has improved over past 4 days.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 24 hours after administration patient broke out in hives. Hives worsened. Family sought follow up 5-3-16 when hives were diagnosed.