chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as M040141, expiration date: 27-MAR-2018 , lot # M038860, expiration date: 13-MAR-2018, lot # reported as M029931, expiration date: 09-NOV-2017, lot # M018636, expiration date: 11-OCT-2017, lot # M007964, expiration date: 15-AUG-2017 or lot # M006104, expiration date: 07-JUN-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion between 6 and 14 Fahrenheit degrees for 2 days. There were no previous temperature excursions reported. Data logger was involved. No adverse reactions were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1703USA009938: US-009507513-1703USA006914:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.    On unspecified dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # M036056, as prophylaxis (Strength, dose, route and expiration date were not reported), which experienced a temperature excursion between 32 and 35 Fahrenheit degrees for 24 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009947: US-009507513-1703USA007530:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.    On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA lot # M033611, as prophylaxis (Strength, dose, route and expiration date were not reported), which experienced a temperature excursion between 32 and 35 Fahrenheit degrees for 24 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009946: US-009507513-1703USA007530:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling at injection site and redness around area.
Age: 51.0
Sex: M
Vaccine: HEPAB, MMR, TDAP, VARCEL
Symptoms: Blister, Malaise, Pruritus, Pyrexia
Clinical narrative: Pt. Reports fever and malaise which began approximately one week following vaccines. Pt. States she developed pruritus and vesicle/lesions on her trunk, back, arms, and face. Lesions persisted for a month before resolving.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report was received from a physician via a company representative, concerning a 70 year-old female patient. The patient's concurrent conditions included diabetes and hypertension. Her medical history and concomitant medications were not reported. She did not have drug reactions or allergies. On an unspecified date in January 2017 (reported as "about 1 month ago"), the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml one time; route, lot # and expiration date were not reported) to prevent shingles. On the same vaccination day, the patient developed "pain, a burning sensation and tingling sensation" in the arm she received the vaccination in (pain in extremity) (paresthesia) (burning sensation); no rash was reported and no laboratories were performed. The patient sought medical attention by speaking to her doctor. On an unknown date in 2017, the patient recovered from the mentioned adverse events. No product quality complaint was involved (PQC). The causality between the mentioned adverse events and ZOSTAVAX was unknown. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from the patient's wife referring to her husband, a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 03-MAR-2017, the patient was vaccinated with PNEUMOVAX23 (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date in 2017, after receiving PNEUMOVAX23, the patient had unspecified adverse effects (adverse event). The outcome of the adverse events was unknown. The causality between the adverse events and PNEUMOVAX23 was not provided. Additional information is not expected because no consent for follow up was provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates from January 2017 to 08-MAR-2017, the patients were vaccinated with improperly stored doses of GARDASIL lot # M014929, expiration date 27-MAY-2017 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of >46 but < 77 degrees Fahrenheit for 4 hours. Data logger was involved. Previous temperature excursion of  >46 but < 77 degrees Fahrenheit for 2 hours was reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 13-MAR-2017 from a Licensed Practical Nurse who was reporting on a patient of unknown age and gender. No medical history or concomitant medications were reported. On 10-MAR-2017, the patient received their first dose of M-M-R II (lot L00721, expired 03-MAR-2017) (site, dose and route not reported) for prophylaxis, that was past it's expiration date. The vaccine was administered by a registered nurse. No adverse effects reported. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 13-MAR-2017 from a pharmacist who was reporting on an unspecified patient of unknown age and gender. No medical history or concomitant medications were reported. The pharmacist reported that the  unspecified patient received an expired dose of PNEUMOVAX23 (lot, expiration, dose and site were not reported) on an unspecified date. No adverse effects reported. No other information is available. Additional information is not expected. No consent to contact the reporter.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This is a spontaneous report received on 13-MAR-2017 from a pharmacist regarding a patient of unknown age and gender who received a dose of PNEUMOVAX 23 injection on an unknown date for prophylaxis. The pharmacist reported that an expired dose of PNEUMOVAX 23 lot #L012215, exp 13-JAN-2017 was administered to the patient on 13-MAR-2017. The patient has not experienced an adverse effect. No additional information was reported. No further information is expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an emergency medical technician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concurrent conditions was provided. The reporter stated that on an unknown date, the patient might have been vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection, lot number M027884, expiration date: 19-APR-2019 or lot number M032147, expiration date: 14-APR-2019, (dose, dose number, route of administration and injection site were not provided) for prophylaxis. There were no concomitant medications reported. It was reported that the vaccine underwent a temperature excursion in the range of 9 degrees Celsius to 25 degrees Celsius for 47 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter (linked with # 1703USA009932 and 1703USA009933). Additional information has been requested.; Sender's Comments: US-009507513-1703USA009932: US-009507513-1703USA009933:
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Emotional distress, Herpes zoster, Injury, Neuralgia
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age who on 03-APR-2013, was vaccinated with ZOSTAVAX (lot number, dosage, and route of administration not provided) for the prevention of shingles. Prior to receiving the ZOSTAVAX, the patient had never suffered from or been diagnosed with herpes zoster, or any other ailment collectively referred to as "shingles." No other information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-NOV-2015, the patient was treated at an urgent care facility for symptoms of constant pain, worsening in severity in his lower extremities. The patient was then diagnosed with herpes zoster, also known as a shingles outbreak. On or about 12-NOV-2015, the patient was prescribed acyclovir for the treatment of shingles and shingles-related nerve pain. As a direct result of ZOSTAVAX, the patient suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. He suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, a diminished quality of life, physical impairment and injury. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Physical disability, Quality of life decreased
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age who on 03-APR-2013, was vaccinated with ZOSTAVAX (lot number, dosage, and route of administration not provided) for the prevention of shingles. Prior to receiving the ZOSTAVAX, the patient had never suffered from or been diagnosed with herpes zoster, or any other ailment collectively referred to as "shingles." No other information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-NOV-2015, the patient was treated at an urgent care facility for symptoms of constant pain, worsening in severity in his lower extremities. The patient was then diagnosed with herpes zoster, also known as a shingles outbreak. On or about 12-NOV-2015, the patient was prescribed acyclovir for the treatment of shingles and shingles-related nerve pain. As a direct result of ZOSTAVAX, the patient suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. He suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, a diminished quality of life, physical impairment and injury. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an emergency medical technician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concurrent conditions was provided. The reporter stated that on an unknown date, the patient might have been vaccinated with improperly stored doses of PNEUMOVAX23, lot number M029681, expiration date: 22-JAN-2018 or lot number M029680, expiration date: 17-JAN-2018, (dose, dose number, route of administration and injection site were not provided) for prophylaxis. There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion in the range of 9 degrees Celsius to 25 degrees Celsius for 47 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter (linked with MARRS# 1703USA008698 and 1703USA009933). Additional information has been requested.; Sender's Comments: US-009507513-1703USA009933  US-009507513-1703USA008698:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an emergency medical technician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concurrent conditions was provided. The reporter stated that on an unknown date, the patient might have been vaccinated with improperly stored doses of ROTATEQ, orally, lot number reported as M026316, expiration date: 08-FEB-2018, lot number M016238, expiration date: 07-DEC-2017, lot number M006111, expiration date: 18-NOV-2017 or lot number M017514, expiration date: 07-NOV-2017, (dose and dose number were not provided) for prophylaxis. There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion in the range of 9 degrees Celsius to 25 degrees Celsius for 47 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter (linked with MARRS# 1703USA008698 and 1703USA009932).  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA008698: US-009507513-1703USA009932:
Sex: F
Vaccine: FLUX, MENB
Symptoms: Bronchitis, Cough, Eyelid margin crusting, Influenza, Insomnia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales Representative. A female patient of an unspecified age and race/ethnicity received the 2nd single dose of TRUMENBA via an unspecified route of administration, on an unspecified date, for immunisation. Concomitant medication included influenza vaccine on the same unspecified date, for immunisation. The patient medical history was not reported. Since an unspecified date the patient was achy and experienced bronchitis (5 days later), flu nasal congestion, cough, no known fever, difficulty sleeping and crusty eyes. Events outcome was unknown.
Sex: F
Vaccine: FLUX, MENB
Symptoms: Nasal congestion, Pain
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales Representative. A female patient of an unspecified age and race/ethnicity received the 2nd single dose of TRUMENBA via an unspecified route of administration, on an unspecified date, for immunisation. Concomitant medication included influenza vaccine on the same unspecified date, for immunisation. The patient medical history was not reported. Since an unspecified date the patient was achy and experienced bronchitis (5 days later), flu nasal congestion, cough, no known fever, difficulty sleeping and crusty eyes. Events outcome was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Aphasia, Social avoidant behaviour
Clinical narrative: This is a spontaneous report from a contactable Nurse communicated to a Pfizer sales representative. A Nurse Practitioner administered PREVNAR 13 to his child daughter, via an unspecified route of administration, on an unspecified date (approximately two years ago) at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  After vaccination the patient was kind of got very withdrawn and she stopped speaking for about a week.  The patient recovered from the events on an unspecified date.  She resumed to her normal activity.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Adult dose of PF Flu vaccine (0.5ml) was given instead of 0.25ml.  No adverse event followed.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: BOOSTRIX vaccine administered incorrectly. It was give subcutaneously, rather than IM. Estimate about 75% of dose was given before I recognized the error. Followed with a new complete dose IM in the same arm. (Pt also received ZOSTAVAX in other arm).
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Periarthritis
Clinical narrative: Left shoulder pain (same arm as flu shot) began within 2-3 hours of injection, and continued to get increasingly worse. Limited motion resulted. Physician consulted 2/21/2017 and diagnosed with frozen shoulder (adhesive capsulitis). Left shoulder steroid injection received 3/3/2017 and physical therapy begun 3/13/2017.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Hypersensitivity, Injection site induration, Injection site mass, Pain
Clinical narrative: Hard lump at injection site, then break out in chicken pox type lesions, widespread on body, still present 4 months later.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised, Rash vesicular
Clinical narrative: Hard lump at injection site, then break out in chicken pox type lesions, widespread on body, still present 4 months later.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Localized erythema, pain, and swelling in arm injection was given.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient passed out and fell off the exam table about one minute after receiving vaccine.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: I noticed hives on her thighs where she had the two injections around 7pm on 3/10/17. the next morning she had hives all over her body that came and went for about 5 days.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Bed sharing, Death, General physical condition abnormal, Resuscitation, Unresponsive to stimuli
Clinical narrative: Mother reported patient was abnormal looking and unresponsive.  911 called and CPR administered by EMTs.  Patient arrived to ER, CPR still in progress, 4 doses epinephrine administered with no change.  Patient declared dead at 6:28 AM (20 hours post vaccine administration).
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Child began a fever on Saturday the 18th that peaked at 101.4 and continued at varying grades throughout Monday the 20th. On Tuesday the 21st at 7:00 AM , he developed a measles like looking rash predominantly  on his torso as well as the rest of his body, hands and face included.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: PATIENT HAS REDNESS AT INJECTION SITE. POSSIBLE ALLERGIC REACTION.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness
Clinical narrative: "Arm takes a while to get moving in the morning"  Sometimes she has to take ibuprofen.  Seems to be fine later in the day after she has been up for a while.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Large Lump at injection site. Redness, swelling, impaired movement of limb. Nauseous, diarrhea.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Large Lump at injection site. Redness, swelling, impaired movement of limb. Nauseous, diarrhea.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Pt has a rash with "bumps" in it over the left leg that the chicken pox vaccination was given. Vaccne given on 3/13/2017. Rash appeared on 3/21/2017, rash appears larger today than yesterday. RN instructed grandmother to go seek medical attention from PCP. She states they don't have one yet but she will take him to ED if it gets worse. Instructed her to put a line around it and watch the size of the area and she may use OTC Benadryl but to seek advise from pharmacist for dosage. Grandmother verbalized understanding of instructions.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Oropharyngeal pain, Rash, Rash maculo-papular, Streptococcus test negative
Clinical narrative: Pt developed maculopapular rash originally b/l neck and hips and then spread to her trunk and arms. At same time developed sore throat and cough. Strep test negative.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Allergy test, Anxiety, Cough, Crying, Ear pain
Clinical narrative: My daughter had a peanut butter sandwich at 1145. She has never had a reaction to peanuts before. She had her four year old well check at 130, and they administered the MMRV and the DTaP vaccines at 145. At 2PM, we left the clinic. She started sneezing uncontrollably and her nose was running clear. She began complaining anxiously about her ears hurting. On the drive home, she started a dry repetitive cough. When we got home (220), she complained of something hurting on her foot. She had a hive. I took off her clothes and saw two more hives. She was crying a lot and then she started itching her eyes and ears like crazy, while more hives began appearing. I drove her to the ER. On the way to the ER, her ear and lip began swelling and she was trying to fall asleep (losing consciousness). I was shouting at her and she was responding when I yelled. When we got to the ER, they said her throat was swelling. They administered an epipen, benadryl, and 1-2 other antihistamines. She began resolving quickly with the administration of medicine. She had no other subsequent issues. Since then, we have tested her for peanuts, and she has 15.5 kU/L. We are going to do further testing for vaccine ingredients and a food challenge to see if she reacts to peanuts now.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Ear swelling, Eye pruritus, Lip swelling, Pain in extremity, Pharyngeal oedema
Clinical narrative: My daughter had a peanut butter sandwich at 1145. She has never had a reaction to peanuts before. She had her four year old well check at 130, and they administered the MMRV and the DTaP vaccines at 145. At 2PM, we left the clinic. She started sneezing uncontrollably and her nose was running clear. She began complaining anxiously about her ears hurting. On the drive home, she started a dry repetitive cough. When we got home (220), she complained of something hurting on her foot. She had a hive. I took off her clothes and saw two more hives. She was crying a lot and then she started itching her eyes and ears like crazy, while more hives began appearing. I drove her to the ER. On the way to the ER, her ear and lip began swelling and she was trying to fall asleep (losing consciousness). I was shouting at her and she was responding when I yelled. When we got to the ER, they said her throat was swelling. They administered an epipen, benadryl, and 1-2 other antihistamines. She began resolving quickly with the administration of medicine. She had no other subsequent issues. Since then, we have tested her for peanuts, and she has 15.5 kU/L. We are going to do further testing for vaccine ingredients and a food challenge to see if she reacts to peanuts now.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Rhinorrhoea, Sneezing, Somnolence, Urticaria
Clinical narrative: My daughter had a peanut butter sandwich at 1145. She has never had a reaction to peanuts before. She had her four year old well check at 130, and they administered the MMRV and the DTaP vaccines at 145. At 2PM, we left the clinic. She started sneezing uncontrollably and her nose was running clear. She began complaining anxiously about her ears hurting. On the drive home, she started a dry repetitive cough. When we got home (220), she complained of something hurting on her foot. She had a hive. I took off her clothes and saw two more hives. She was crying a lot and then she started itching her eyes and ears like crazy, while more hives began appearing. I drove her to the ER. On the way to the ER, her ear and lip began swelling and she was trying to fall asleep (losing consciousness). I was shouting at her and she was responding when I yelled. When we got to the ER, they said her throat was swelling. They administered an epipen, benadryl, and 1-2 other antihistamines. She began resolving quickly with the administration of medicine. She had no other subsequent issues. Since then, we have tested her for peanuts, and she has 15.5 kU/L. We are going to do further testing for vaccine ingredients and a food challenge to see if she reacts to peanuts now.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Rash, Skin induration
Clinical narrative: Patient was fine leaving the pharmacy. After 1 to 3 hours after receiving ZOSTAVAX vaccine, patient described skin on arm to be itchy, with developing rash on face, arm and stomach, plus having headaches, and muscular pains in back. Patient visited doctor on 3/16/17 and received RX for prednisone. Followed up with patient on 3/21/17, and rash is slowly fading.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Paralysis
Clinical narrative: Paralyzed from the waist down.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Blood bicarbonate normal, Blood chloride normal, Blood creatinine decreased, Blood glucose normal, Blood potassium normal
Clinical narrative: 2 hours after vaccine administration, he developed respiratory depression (respiratory rate 6/min), hypothermia (33.2 degrees C) and rhythmic head movements consistent with seizure activity requiring intravenous ATIVAN. After supportive treatment with oxygen therapy and patient warming, he returned to baseline neurologic function after about 15 hours from the time of vaccine administration.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Blood sodium normal, Blood urea normal, Dyskinesia, Electroencephalogram abnormal, Haemoglobin normal
Clinical narrative: 2 hours after vaccine administration, he developed respiratory depression (respiratory rate 6/min), hypothermia (33.2 degrees C) and rhythmic head movements consistent with seizure activity requiring intravenous ATIVAN. After supportive treatment with oxygen therapy and patient warming, he returned to baseline neurologic function after about 15 hours from the time of vaccine administration.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Hypothermia, Platelet count normal, Respiratory depression, Seizure, White blood cell count increased
Clinical narrative: 2 hours after vaccine administration, he developed respiratory depression (respiratory rate 6/min), hypothermia (33.2 degrees C) and rhythmic head movements consistent with seizure activity requiring intravenous ATIVAN. After supportive treatment with oxygen therapy and patient warming, he returned to baseline neurologic function after about 15 hours from the time of vaccine administration.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of anaphylaxis in a 4-year-old male patient who received KINRIX. Co-suspect products included PROQUAD. On an unknown date, the patient received KINRIX at an unknown dose and PROQUAD at an unknown dose. On an unknown date, less than an hour after receiving KINRIX, the patient experienced anaphylaxis (serious criteria GSK medically significant). The patient was treated with EPIPEN. On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to KINRIX. Additional details were provided as follows: The patient required emergency care including EPIPEN administration within minutes of administration of the vaccines. The patient was referred to an allergist, who would like to do further testing, but a dose of KINRIX was needed. The nurse inquired about the allergy clinic for a dose of KINRIX. It was unknown if the reporter considered the anaphylaxis to be related to PROQUAD.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Injection site induration
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site induration in a 18-year-old male patient who received BEXSERO (batch number 1568018, expiry date 31st August 2017). On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site induration and headache. On an unknown date, the outcome of the injection site induration was recovered/resolved and the outcome of the headache was unknown. It was unknown if the reporter considered the injection site induration and headache to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in an unknown arm. The sales representative was aware about the adverse event during a speaker program. The physician described the injection site mark (induration) as a marble size mark in the arm. The injection site mark went away after about 4 days. The sales representative could call back for follow up.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Nodule, Pain in extremity, Rash
Clinical narrative: Client received vaccine on 3/16/17 around noon and on morning of 3/17/17 on arm that shot was administered on became red and had rash on it. Client also reported arm being very sore and having hard knot on it. Client went to doctor on 3/17/17. Client contacted Health Department 3/21/17.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Myalgia, Pain in extremity, Pallor, Pyrexia
Clinical narrative: Papular blanching rash, fever 103.6, 102.9 within 48 h of med, arm pain, myalgias and weakness.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Rash papular
Clinical narrative: Papular blanching rash, fever 103.6, 102.9 within 48 h of med, arm pain, myalgias and weakness.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Bursa disorder, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain (L) shoulder immediately. Lasted several weeks, loss of mobility. Sought treatment with PCP 1/23/17 about. MD considered it a administration issue, felt bursa was affected. Currently in physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Injection site swelling, Pain in extremity, Skin discolouration
Clinical narrative: Red (L) forearm, (L) fingers painful and purple, (L) upper arm and shoulder swollen. 12-23-16 swelling almost gone; fingers pink and no longer painful; feels fine; almost resolved.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Cough, Pyrexia, Rhinorrhoea
Clinical narrative: Yellow/clear runny nose little cough fever for 1 week on an off.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RVX
Symptoms: Hypotonia, Infantile spitting up, Somnolence, Tonic clonic movements
Clinical narrative: The patient is a 20 mo old male whose parents reports a historical adverse reaction to 4 and 6 months vaccines. Parents report he did fine with 2 month vaccines although may have had increased crying. One day after receipt of 4 month vaccines. MOP describes episodic tonic/clonic movements, less than 1 minute duration. She feels they were about 3 per day and continued for several days, then resolved. FOP states he witnessed some as well. These typically occurred while breast feeding; he would unlatch, go limp and sleep for an hour or more. Sometimes he spit up. There were no associated episodes of bowel and she cannot differentiate if increased voiding. She didn't try to wake him. She didn't bring to ER because they resolved so quickly there was nothing for them to see. At 6 month visit she discussed with the pediatrician but states she only received reassurance. He received his 6 month vaccines and episodes recurred 1 day post vaccine receipt following similar characteristics and pattern, although duration was prolonged to nearly a week. She did not have further evaluation because she had been given reassurance. He did not have significant fever (at most less than 100). He had no other illness signs. There is no family history of adverse reaction to vaccine. He has received no further vaccines. He has had no recurrence episodes.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Grip strength decreased, Impaired driving ability, Joint range of motion decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Unbearable pain to right arm. Pain level greater than 10. Patient had limited ROM. Decreased grasp in right hand. Patient has not been able to pick up child or drive due to decreased movement.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Unbearable pain to right arm. Pain level greater than 10. Patient had limited ROM. Decreased grasp in right hand. Patient has not been able to pick up child or drive due to decreased movement.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Mom called and states (R) leg still red and knotted up. Had to get Imm. on 3-9-17. Informed to see PCP.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Pt woke up on 3/8/17 with area where injection was given red, hard and warm to touch. Area itchy as well. Ice applied and hct.cream as well. Mom said area of redness measured approx. 6in x 4in. Area totally resolved by Saturday 3/11/17.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Crying
Clinical narrative: Excessive crying. Patient has been inconsolable since immunizations given. TYLENOL given by mom at 1:00pm. MOTRIN given in doctor's office at 4:13pm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Contusion, Fall, Head injury, Pyrexia, Skin abrasion
Clinical narrative: Fever and brief syncope without loss of consciousness. Slept a little. Normal exam with physician except abrasion and bruise due to minor head injury with fall.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Syncope
Clinical narrative: Fever and brief syncope without loss of consciousness. Slept a little. Normal exam with physician except abrasion and bruise due to minor head injury with fall.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Clumsiness, Inappropriate affect, Toxicologic test normal
Clinical narrative: Within 5 minutes of receiving the vaccine patient had trouble controlling emotions - would laugh or cry inappropriately. Talking like a toddler, seemed clumsy. This lasted several hours - she was seen in the ER and had a normal exam and negative labs - returned to baseline.
Age: 25.0
Sex: M
Vaccine: YF
Symptoms: Anaphylactic reaction, Lip swelling, Rash, Swelling face
Clinical narrative: Received YF (yellow fever) vaccine and approx 50 min later returned to office C/O rash, lip swelling, facial swelling C/W anaphylaxis epinephrine 0.3 mg IM; BENADRUL 50mg IM stat.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Crying, Decreased appetite, Irritability
Clinical narrative: Fussy and crying for 4 days after vaccines. Decreased appetite. Seen by pediatrician 3/20/17.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Patient observed a large bump, 1-inch in diameter on the injection site. It was also itchy and hard. She observed this reaction on 3-16-17. She was put on doxycycline and states that she is better.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Dizziness, Hyporesponsive to stimuli
Clinical narrative: 3/22/17 Approximately at 10:37 AM patient ambulated approximately 7 minutes after GARDASIL vaccine when became dizzy light headed and had to be assisted to chair. Minimally responsive for 5 seconds, started to cry and awakened.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Drooling, Erythema, Swollen tongue, Tongue biting, Urticaria
Clinical narrative: Approx 20 seconds after receiving vaccines, mom noticed child had bitten his tongue. About 5 seconds later his entire face was red with hive like lesions. He was drooling and tongue began to swell. Mom was driving home so she turned into ER for TX. Was given steroid, EPIPEN and BENADRYL. Total time to treat approximate 40 seconds.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Patient requests to get GARDASIL vaccine, signed immunization consent for GARDASIL-9, stating she is not pregnant. Patient was found to be pregnant after vaccine was administered.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Fever and localized reaction/pain (edema, redness, warmth) started at injection site today at school. Parents and school nurse were concerned with size of reaction (size of grapefruit). Will follow-up tomorrow.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pyrexia
Clinical narrative: Fever and localized reaction/pain (edema, redness, warmth) started at injection site today at school. Parents and school nurse were concerned with size of reaction (size of grapefruit). Will follow-up tomorrow.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Pruritus, Rash, Rash macular
Clinical narrative: BEXSERO given 3/9/17 -  had sore arm x 1 week other side effects. 3/21 patches macular fine pink, rash forearms waist and lower extremities. Slightly itchy - resolving on 3/22/17. No other symptoms.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Lt arm extremely swollen, red and hot to touch. Ibuprofen Tab., 600mg. 1 Tab Every 8 h. Clindamycin cap. 300mg, 1cap. PO every 8h, x 10 days. Diphenhydramine cap. 25mg, 1cap, PO TID, x7days. Mupirocin 3xaday.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Injection site induration, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Lt arm extremely swollen, red and hot to touch. Ibuprofen Tab., 600mg. 1 Tab Every 8 h. Clindamycin cap. 300mg, 1cap. PO every 8h, x 10 days. Diphenhydramine cap. 25mg, 1cap, PO TID, x7days. Mupirocin 3xaday.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder, Tenderness
Clinical narrative: Sore arm for approximately 1 month following immunization, couldn't sleep on that side or apply pressure, also couldn't raise arm.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 12 hrs later noticed redness, swelling and pain at injection site. 24 hrs later whole upper arm swollen.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Blood culture, Blood test, Influenza, Renal failure, Sepsis
Clinical narrative: Flu symptoms. Progressed to sepsis and septic shock, renal failure.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Septic shock
Clinical narrative: Flu symptoms. Progressed to sepsis and septic shock, renal failure.
Age: 22.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Catheterisation cardiac, Chest discomfort, Chest pain, Fibrin D dimer, Middle insomnia
Clinical narrative: This unsolicited case was received on 13-Mar-2017 via a third party query tool search on the VAERS database, under reference number 671090. This case involves a 22-year-old male patient who was vaccinated with ACAM2000 via intradermal route (Lot number: VV03-019-C, expiry date, dose, dose in series and site of administration were unknown) and with IXIARO (manufacturer: INTERCELL) (Lot number: JEV15K04E; expiry date, dose, route and site of administration were not reported) and BIOTHRAX (manufacturer: EMERGENT) via intramuscular route (Lot number: FAV482A; expiry date, dose were not reported) in right arm on 28-Nov-2016. Patient previously vaccinated with Anthrax (no brand name reported) vaccine. It was also reported that patient had no known drug allergies (NKDA), no pre-existing conditions, no family history, no birth defects, no allergies. Patient did not had prescription or nonprescription medications at all. On 07-Dec-2016, nine days following the vaccination, the patient woken from sleep (Sleep disorder) with crushing, burning chest pain rated a 7/10 on pain scale, blood pressure was 155/90. Wife brought him to local emergency room (ER), experienced increase in troponin as initial troponin level was 2.13 (unit unspecified) and when rechecked 1.5 hours later, 3.11 (unit unspecified). Then transferred to larger city hospital, underwent several tests including serial troponins taken 3 hours apart were: 2.21, 1.50, and 0.94 (unit unspecified) and had fibrin d dimer as initial D-Dimer level test 1.35 (unit unspecified), finally concluding with a cardiac catheterization; also patient had myocarditis, which was later cardiologist team diagnosed as myopericarditis. The patient required emergency visit after events. The patient's other laboratory investigation and corrective treatment were not reported. Outcome of the events were unknown. Case was considered serious for life threatening events. List of documents held by sender: none. Sender's Comments: A 22-year-old male patient presented with Myocarditis, 9 days after smallpox vaccination. The symptoms and evolution is consistent with the reported diagnosis of myopericarditis. Patient also received IXIARO and BIOTHRAX. Time to onset is compatible with the role of vaccine. Myopericarditis is a listed adverse event in the company's reference document for smallpox vaccine. Patient previously vaccinated with Anthrax (no brand name reported). It was also reported that patient had no known drug allergies (NKDA), no pre-existing conditions, Patient denied any pre-existing conditions, allergies, family history or birth defects. Further information on risk factors, Investigation results to rule out alternative etiology would be needed for complete assessment. Moreover, as multiple vaccines were administered concomitantly, the role of each component cannot be assessed. Based on available information, the role of vaccine cannot be ruled out.
Age: 22.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Myocarditis, Troponin increased
Clinical narrative: This unsolicited case was received on 13-Mar-2017 via a third party query tool search on the VAERS database, under reference number 671090. This case involves a 22-year-old male patient who was vaccinated with ACAM2000 via intradermal route (Lot number: VV03-019-C, expiry date, dose, dose in series and site of administration were unknown) and with IXIARO (manufacturer: INTERCELL) (Lot number: JEV15K04E; expiry date, dose, route and site of administration were not reported) and BIOTHRAX (manufacturer: EMERGENT) via intramuscular route (Lot number: FAV482A; expiry date, dose were not reported) in right arm on 28-Nov-2016. Patient previously vaccinated with Anthrax (no brand name reported) vaccine. It was also reported that patient had no known drug allergies (NKDA), no pre-existing conditions, no family history, no birth defects, no allergies. Patient did not had prescription or nonprescription medications at all. On 07-Dec-2016, nine days following the vaccination, the patient woken from sleep (Sleep disorder) with crushing, burning chest pain rated a 7/10 on pain scale, blood pressure was 155/90. Wife brought him to local emergency room (ER), experienced increase in troponin as initial troponin level was 2.13 (unit unspecified) and when rechecked 1.5 hours later, 3.11 (unit unspecified). Then transferred to larger city hospital, underwent several tests including serial troponins taken 3 hours apart were: 2.21, 1.50, and 0.94 (unit unspecified) and had fibrin d dimer as initial D-Dimer level test 1.35 (unit unspecified), finally concluding with a cardiac catheterization; also patient had myocarditis, which was later cardiologist team diagnosed as myopericarditis. The patient required emergency visit after events. The patient's other laboratory investigation and corrective treatment were not reported. Outcome of the events were unknown. Case was considered serious for life threatening events. List of documents held by sender: none. Sender's Comments: A 22-year-old male patient presented with Myocarditis, 9 days after smallpox vaccination. The symptoms and evolution is consistent with the reported diagnosis of myopericarditis. Patient also received IXIARO and BIOTHRAX. Time to onset is compatible with the role of vaccine. Myopericarditis is a listed adverse event in the company's reference document for smallpox vaccine. Patient previously vaccinated with Anthrax (no brand name reported). It was also reported that patient had no known drug allergies (NKDA), no pre-existing conditions, Patient denied any pre-existing conditions, allergies, family history or birth defects. Further information on risk factors, Investigation results to rule out alternative etiology would be needed for complete assessment. Moreover, as multiple vaccines were administered concomitantly, the role of each component cannot be assessed. Based on available information, the role of vaccine cannot be ruled out.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Erythema, Malaise, Swelling face, Throat tightness, Urticaria
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 4-year-old male patient with allergies/reactions to dairy products. The patient had no medical history, or concomitant therapies. On 22-FEB-2017, the patient was vaccinated with PROQUAD subcutaneously (lot #, expiration date, and dose were not reported) for immunization. On the same date, shortly after the patient was vaccinated, he experienced an anaphylactic reaction. The patient was treated with EPIPEN intramuscularly (dose unknown by the reporter) and was sent to an emergency room where he fully recovered. There were no laboratory tests performed. No other information was available. No product quality complaint (PQC) was involved. The causality assessment between anaphylactic reaction and PROQUAD was not reported. The reporter considered that the anaphylactic reaction was a life threatening event. Upon internal review, the anaphylactic reaction was considered as a medically significant event. Additional information has been requested.