chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Extensive swelling of vaccinated limb, Hypersensitivity, Injection site swelling, Skin test negative
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a 58-year-old female patient who received FLUARIX. The patient's past medical history included rheumatoid arthritis. Previously administered products included FLUARIX with an associated reaction of hypersensitivity (local swelling and induration to 2-3 inches at the site of injection). Concurrent medical conditions included ankylosing spondylitis, allergic reaction to antibiotics and allergy. On an unknown date, the patient received the 2nd dose of FLUARIX (intramuscular) .5 ml. On an unknown date, unknown after receiving FLUARIX, the patient experienced allergic reaction, condition aggravated, extensive swelling of vaccinated limb and injection site swelling. FLUARIX was discontinued. On an unknown date, the outcome of the allergic reaction and condition aggravated were recovered/resolved and the outcome of the extensive swelling of vaccinated limb and injection site swelling were unknown. It was unknown if the reporter considered the allergic reaction, condition aggravated, extensive swelling of vaccinated limb and injection site swelling to be related to FLUARIX. Additional information received: The reporter called to ask if RN in office (the patient) can receive BOOSTRIX and if it has anything in common with FLUARIX TIV. To the best of their knowledge, FLUARIX TIV caused the patient to have an allergic reaction of local swelling and induration to 2-3 inches at site of injection on first dose 2-3 years ago when she was 56-57 yo (see case US2015GSK022607). A repeat dose of FLUARIX TIV the next year resulted in her whole arm swelling, which required doctor's office attention. No details about treatment or lot numbers or exactly where she received all of these injections. After the second reaction she was given skin tests that reacted negative for egg yolk, egg white and gelatin, but immediate reaction of hives at testing site when FLUARIX injection was placed on skin. She was then advised not to ever get an influenza vaccine again, but doctor who performed tests did not pursue further ingredient allergenicity testing. She has three antibiotic allergies according to the reporter this event, but unknown which ones, as well other unknown possible allergies.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Local injection site soft tissue swelling, heat and pain. Treated with ice, NSAIDS.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Local redness.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient with no drug reactions or allergies. On 18-MAR-2015, the patient was vaccinated with ZOSTAVAX 0.65 ml, lot # K026365, expiry date: 15-MAR-2016, subcutaneous in the right arm. Concomitant therapies included hydrochlorothiazide, MAXZIDE, BACTRIM DS and triamcinolone cream. On 24-MAR-2015, the patient woke up with rash/bumps on her left forearm and later in the day, rash became red and started to blister. Patient also reported itching around rash. Patient described rash to pharmacist as "looking like fiery ants bites". The patient sought medical attention - spoke to pharmacist. Pharmacist reported that patient put BENADRYL cream on rash and BENADRYL helped with itching. Pharmacist reported that patient received ZOSTAVAX in her right arm and rash appeared on left forearm. No lab diagnostic studies had been performed. The outcome of the events was reported as not recovered/ not resolved. Relatedness between the events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient was vaccinated with hepatitis b vaccine (manufacturer unknown) strength reported as: 2.5 mcg/0.5ml (dose, route and lot # not provided) on 07-JUN-2011, 08-AUG-2011 and on 10-OCT-2011. No adverse effects were reported. This is one of several reports received from the same patient. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age. On 24-MAR-2015 the patient was subcutaneously vaccinated with 0.5 ml of (Oka-Merck) PROQUAD (lot # reported as K023364, expiration date 20-MAY-2016), which was exposed to -11.5 Centigrade 2 hours and 10 minutes. No adverse effects were reported. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: TTOX
Symptoms: Rash
Clinical narrative: Rash
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site atrophy, Injection site cellulitis
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 32 year old, non-pregnant female patient. The patient's concurrent conditions included cancer (not specified). On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, dose, lot# and expiration date were not reported. On an unknown date, the patient was diagnosed as developing cellulitis at the site of injection for an unspecified amount of time. The patient sought medical attention. The patient was prescribed antibiotics (unspecified) for an unspecified amount of time. It was reported, that on an unknown date, the cellulitis did go away after an unspecified amount of time. The patient was left with a small indentation at the site of injection. The relatedness between the event and PNEUMOVAX 23 was not provided. Additional information is not expected, because there was no consent to contact the reporter.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 62 year old male patient referring to himself. The patient's concurrent condition and medical history were not reported. On 21-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route were unknown). Concomitant therapies were not reported. On 22-MAR-2015, the patient developed a white bump and pain near the injection site of his ZOSTAVAX injection. The patient said the pain bothered him when he lied on his arm. No treatment was given for the adverse events. The patient sought for medical attention by physician visit. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a female patient of unknown age referring herself. The patient concurrent conditions and medical history was not reported. On an unknown date in September 2014, the patient was vaccinated with ZOSTAVAX (dose and route were not reported). Concomitant medications were unknown. On an unknown date, the patient experienced a rash that comes and goes. The outcome of rash that comes and goes was reported as not recovered/not resolved. The relatedness of the rash with ZOSTAVAX was not reported. Additional information is not expected as the reporter details were not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (route, strength, dose, lot # and frequency were unknown). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date unspecified patients received improperly stored VARIVAX (Merck) (route, dose, frequency and lot # not reported). No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning unspecified number of patients of unknown age and gender. Nurse reported that since 30-JUL-2014, improperly stored M-M-R II (therapy type, lot#, dose, route and duration were unspecified) were administered to unspecified patients. No adverse effects were noted. Follow up information has been received during a telephone call from the nurse on 13-MAR-2015. The reporter stated that unspecified number of patient received M-M-R II, lot# J007929, Expiry date: 28-JUN-2015. The reporter did not have patient identification information readily available at the time of the call. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date an unspecified patients received improperly stored M-M-R II (route, dose, frequency and lot # not reported). No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain
Clinical narrative: Shingles like rash on head/face/eye. Pain. Family doctor prescribed valacyclovir 1gm tid and Hydrocodone/ACAP. Patient referred to ophthalmologist.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and drug reactions/allergies were not reported. On 12-MAR-2015 the patient was vaccinated with an expired dose of M-M-R II, lot # J002505, expiration date 28-FEB-2015 (dose and route were not reported). Information regarding concomitant medications was not reported. No adverse experience had been observed or reported. Additional information has been requested.
Age: 57.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: On 11/21/14 patient noticed heat and pain and redness at the site. Redness measured 81/2 cm by 1 3/2cm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm was red and swollen (influenza vaccination).
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin reaction
Clinical narrative: Local skin reaction. Red and swollen and hot to the touch. Area is 7 1/2 cm x 5 cm in length (influenza vaccination).
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Acupuncture, Erythema, Feeling hot, Injection site joint pain, Local reaction
Clinical narrative: Information has been received from a 64 year old female patient nurse referring to herself with lyme disease and no allergy. On 01-DEC-2014 the patient was vaccinated with ZOSTAVAX (strength, lot number, dosage and route unspecified) for prevention of zoster virus. There were no concomitant therapies. On 02-DEC-2014, the patient experienced a large, red, swollen, warm, itchy, painful area at the site of injection. Patient reported that the redness and swelling resolved over an unspecified period of time but still experienced persistent pain which had "now" spread from the site of injection to her elbow and tendons. The patient used "Pain-A-Trate" (unknown manufacturer) at the injection site when she began to experience the symptoms. The patient did not seek medical attention and no lab diagnostics studies were performed. The outcome of other events was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a 64 year old female patient nurse referring to herself with lyme disease and no allergy. On 01-DEC-2014 the patient was vaccinated with ZOSTAVAX (strength, lot number, dosage and route unspecified) for prevention of zoster virus. There were no concomitant therapies. On 02-DEC-2014, the patient experienced a large, red, swollen, warm, itchy, painful area at the site of injection. Patient reported that the redness and swelling resolved over an unspecified period of time but still experienced persistent pain which had "now" spread from the site of injection to her elbow and tendons. The patient used "Pain-A-Trate" (unknown manufacturer) at the injection site when she began to experience the symptoms. The patient did not seek medical attention and no lab diagnostics studies were performed. The outcome of other events was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Pain, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a 64 year old female patient nurse referring to herself with lyme disease and no allergy. On 01-DEC-2014 the patient was vaccinated with ZOSTAVAX (strength, lot number, dosage and route unspecified) for prevention of zoster virus. There were no concomitant therapies. On 02-DEC-2014, the patient experienced a large, red, swollen, warm, itchy, painful area at the site of injection. Patient reported that the redness and swelling resolved over an unspecified period of time but still experienced persistent pain which had "now" spread from the site of injection to her elbow and tendons. The patient used "Pain-A-Trate" (unknown manufacturer) at the injection site when she began to experience the symptoms. The patient did not seek medical attention and no lab diagnostics studies were performed. The outcome of other events was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Tendon pain
Clinical narrative: Information has been received from a 64 year old female patient nurse referring to herself with lyme disease and no allergy. On 01-DEC-2014 the patient was vaccinated with ZOSTAVAX (strength, lot number, dosage and route unspecified) for prevention of zoster virus. There were no concomitant therapies. On 02-DEC-2014, the patient experienced a large, red, swollen, warm, itchy, painful area at the site of injection. Patient reported that the redness and swelling resolved over an unspecified period of time but still experienced persistent pain which had "now" spread from the site of injection to her elbow and tendons. The patient used "Pain-A-Trate" (unknown manufacturer) at the injection site when she began to experience the symptoms. The patient did not seek medical attention and no lab diagnostics studies were performed. The outcome of other events was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 64 year old female patient nurse referring to herself with lyme disease and no allergy. On 01-DEC-2014 the patient was vaccinated with ZOSTAVAX (strength, lot number, dosage and route unspecified) for prevention of zoster virus. There were no concomitant therapies. On 02-DEC-2014, the patient experienced a large, red, swollen, warm, itchy, painful area at the site of injection. Patient reported that the redness and swelling resolved over an unspecified period of time but still experienced persistent pain which had "now" spread from the site of injection to her elbow and tendons. The patient used "Pain-A-Trate" (unknown manufacturer) at the injection site when she began to experience the symptoms. The patient did not seek medical attention and no lab diagnostics studies were performed. The outcome of other events was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Paraesthesia
Clinical narrative: Reported redness, pain > 7 days on 3-10-15 and patient called back to report still had rash and arm pain 4 weeks later on 4-2-15. Left arm.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Rash
Clinical narrative: Reported redness, pain > 7 days on 3-10-15 and patient called back to report still had rash and arm pain 4 weeks later on 4-2-15. Left arm.
Age: 0.88
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood glucose, C-reactive protein, Culture urine, Cyanosis, Differential white blood cell count
Clinical narrative: 11:00AM  Injection of PCV13 Vaccine. After injection she was happy, playing, and socializing. I did not give her any Tylenol; because she did not show any signs or symptoms of being in pain or having a fever. 1:00PM  Decreased appetite. She drank 3.5 oz. of formula. She normally drinks 5 oz. of formula. She started getting sleepy; I laid her down in her Pack-N-Play for a nap. 2:10PM  I checked on her in her Pack-N-Play. She was having difficulty breathing, grunting (as if trying to clear her throat), and making an unusual whine-like noise. Her face had a greyish tint, her hands/arms were blue/purple and somewhat swollen, her body felt extremely hot, and she was shivering/shaking (from fever? The room wasn't too hot or too cold), and her entire body was limp. 2:20PM  Drove her to the ER, 5 minutes away, we did not have time to wait 10-20 minutes for an ambulance. She started vomiting while in her car seat as soon as I put the car in park and as we were walking into the ER. (Cleaned her car seat a couple days later and found a couple spots that looked like dried blood/stomach bile). ER took her immediately. Her entire body was blue/purple. They gave her oxygen. 103.1 fever. X-Rayed her lungs to make sure there was no vomit in her lungs. Pricked her 5-7 times trying to get an IV, IV access was attempted but was unsuccessful.  A NSS bolus was given by IO. After an hour? She was Life-Flighted to another ER 20 miles away. On Life Flight it was noticed that she had stridor. At the ER she received a breathing treatment, steroids, and Tylenol. She dry heaved and vomited a little after the breathing treatment/steroids. She was given Dexamethasone and racemic epinephrine. All tests that they performed on her came back normal, confirmed allergic reaction to the PCV13 vaccine. They observed her and discharged her at 9:00PM. At home, she had a fever of 100-102 for 2 days, acted sluggish, and slept a lot. Weeks after the vaccine, she seems to have sleep issues that weren't present before the vaccine. Doesn't self-soothe, cries when placed in crib, wants to be held while sleeping, and wakes up crying several times throughout the night (she never used to wake up at night).
Age: 0.88
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Full blood count, Metabolic function test, Pyrexia, Stridor, Tachycardia
Clinical narrative: 11:00AM  Injection of PCV13 Vaccine. After injection she was happy, playing, and socializing. I did not give her any Tylenol; because she did not show any signs or symptoms of being in pain or having a fever. 1:00PM  Decreased appetite. She drank 3.5 oz. of formula. She normally drinks 5 oz. of formula. She started getting sleepy; I laid her down in her Pack-N-Play for a nap. 2:10PM  I checked on her in her Pack-N-Play. She was having difficulty breathing, grunting (as if trying to clear her throat), and making an unusual whine-like noise. Her face had a greyish tint, her hands/arms were blue/purple and somewhat swollen, her body felt extremely hot, and she was shivering/shaking (from fever? The room wasn't too hot or too cold), and her entire body was limp. 2:20PM  Drove her to the ER, 5 minutes away, we did not have time to wait 10-20 minutes for an ambulance. She started vomiting while in her car seat as soon as I put the car in park and as we were walking into the ER. (Cleaned her car seat a couple days later and found a couple spots that looked like dried blood/stomach bile). ER took her immediately. Her entire body was blue/purple. They gave her oxygen. 103.1 fever. X-Rayed her lungs to make sure there was no vomit in her lungs. Pricked her 5-7 times trying to get an IV, IV access was attempted but was unsuccessful.  A NSS bolus was given by IO. After an hour? She was Life-Flighted to another ER 20 miles away. On Life Flight it was noticed that she had stridor. At the ER she received a breathing treatment, steroids, and Tylenol. She dry heaved and vomited a little after the breathing treatment/steroids. She was given Dexamethasone and racemic epinephrine. All tests that they performed on her came back normal, confirmed allergic reaction to the PCV13 vaccine. They observed her and discharged her at 9:00PM. At home, she had a fever of 100-102 for 2 days, acted sluggish, and slept a lot. Weeks after the vaccine, she seems to have sleep issues that weren't present before the vaccine. Doesn't self-soothe, cries when placed in crib, wants to be held while sleeping, and wakes up crying several times throughout the night (she never used to wake up at night).
Age: 0.88
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Urine analysis, Vomiting
Clinical narrative: 11:00AM  Injection of PCV13 Vaccine. After injection she was happy, playing, and socializing. I did not give her any Tylenol; because she did not show any signs or symptoms of being in pain or having a fever. 1:00PM  Decreased appetite. She drank 3.5 oz. of formula. She normally drinks 5 oz. of formula. She started getting sleepy; I laid her down in her Pack-N-Play for a nap. 2:10PM  I checked on her in her Pack-N-Play. She was having difficulty breathing, grunting (as if trying to clear her throat), and making an unusual whine-like noise. Her face had a greyish tint, her hands/arms were blue/purple and somewhat swollen, her body felt extremely hot, and she was shivering/shaking (from fever? The room wasn't too hot or too cold), and her entire body was limp. 2:20PM  Drove her to the ER, 5 minutes away, we did not have time to wait 10-20 minutes for an ambulance. She started vomiting while in her car seat as soon as I put the car in park and as we were walking into the ER. (Cleaned her car seat a couple days later and found a couple spots that looked like dried blood/stomach bile). ER took her immediately. Her entire body was blue/purple. They gave her oxygen. 103.1 fever. X-Rayed her lungs to make sure there was no vomit in her lungs. Pricked her 5-7 times trying to get an IV, IV access was attempted but was unsuccessful.  A NSS bolus was given by IO. After an hour? She was Life-Flighted to another ER 20 miles away. On Life Flight it was noticed that she had stridor. At the ER she received a breathing treatment, steroids, and Tylenol. She dry heaved and vomited a little after the breathing treatment/steroids. She was given Dexamethasone and racemic epinephrine. All tests that they performed on her came back normal, confirmed allergic reaction to the PCV13 vaccine. They observed her and discharged her at 9:00PM. At home, she had a fever of 100-102 for 2 days, acted sluggish, and slept a lot. Weeks after the vaccine, she seems to have sleep issues that weren't present before the vaccine. Doesn't self-soothe, cries when placed in crib, wants to be held while sleeping, and wakes up crying several times throughout the night (she never used to wake up at night).
Age: 0.88
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chest X-ray normal, Chills, Crying, Cyanosis, Decreased appetite
Clinical narrative: 11:00AM  Injection of PCV13 Vaccine. After injection she was happy, playing, and socializing. I did not give her any Tylenol; because she did not show any signs or symptoms of being in pain or having a fever. 1:00PM  Decreased appetite. She drank 3.5 oz. of formula. She normally drinks 5 oz. of formula. She started getting sleepy; I laid her down in her Pack-N-Play for a nap. 2:10PM  I checked on her in her Pack-N-Play. She was having difficulty breathing, grunting (as if trying to clear her throat), and making an unusual whine-like noise. Her face had a greyish tint, her hands/arms were blue/purple and somewhat swollen, her body felt extremely hot, and she was shivering/shaking (from fever? The room wasn't too hot or too cold), and her entire body was limp. 2:20PM  Drove her to the ER, 5 minutes away, we did not have time to wait 10-20 minutes for an ambulance. She started vomiting while in her car seat as soon as I put the car in park and as we were walking into the ER. (Cleaned her car seat a couple days later and found a couple spots that looked like dried blood/stomach bile). ER took her immediately. Her entire body was blue/purple. They gave her oxygen. 103.1 fever. X-Rayed her lungs to make sure there was no vomit in her lungs. Pricked her 5-7 times trying to get an IV, IV access was attempted but was unsuccessful.  A NSS bolus was given by IO. After an hour? She was Life-Flighted to another ER 20 miles away. On Life Flight it was noticed that she had stridor. At the ER she received a breathing treatment, steroids, and Tylenol. She dry heaved and vomited a little after the breathing treatment/steroids. She was given Dexamethasone and racemic epinephrine. All tests that they performed on her came back normal, confirmed allergic reaction to the PCV13 vaccine. They observed her and discharged her at 9:00PM. At home, she had a fever of 100-102 for 2 days, acted sluggish, and slept a lot. Weeks after the vaccine, she seems to have sleep issues that weren't present before the vaccine. Doesn't self-soothe, cries when placed in crib, wants to be held while sleeping, and wakes up crying several times throughout the night (she never used to wake up at night).
Age: 0.88
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dyspnoea, Grunting, Hypersensitivity, Hypotonia, Laboratory test normal
Clinical narrative: 11:00AM  Injection of PCV13 Vaccine. After injection she was happy, playing, and socializing. I did not give her any Tylenol; because she did not show any signs or symptoms of being in pain or having a fever. 1:00PM  Decreased appetite. She drank 3.5 oz. of formula. She normally drinks 5 oz. of formula. She started getting sleepy; I laid her down in her Pack-N-Play for a nap. 2:10PM  I checked on her in her Pack-N-Play. She was having difficulty breathing, grunting (as if trying to clear her throat), and making an unusual whine-like noise. Her face had a greyish tint, her hands/arms were blue/purple and somewhat swollen, her body felt extremely hot, and she was shivering/shaking (from fever? The room wasn't too hot or too cold), and her entire body was limp. 2:20PM  Drove her to the ER, 5 minutes away, we did not have time to wait 10-20 minutes for an ambulance. She started vomiting while in her car seat as soon as I put the car in park and as we were walking into the ER. (Cleaned her car seat a couple days later and found a couple spots that looked like dried blood/stomach bile). ER took her immediately. Her entire body was blue/purple. They gave her oxygen. 103.1 fever. X-Rayed her lungs to make sure there was no vomit in her lungs. Pricked her 5-7 times trying to get an IV, IV access was attempted but was unsuccessful.  A NSS bolus was given by IO. After an hour? She was Life-Flighted to another ER 20 miles away. On Life Flight it was noticed that she had stridor. At the ER she received a breathing treatment, steroids, and Tylenol. She dry heaved and vomited a little after the breathing treatment/steroids. She was given Dexamethasone and racemic epinephrine. All tests that they performed on her came back normal, confirmed allergic reaction to the PCV13 vaccine. They observed her and discharged her at 9:00PM. At home, she had a fever of 100-102 for 2 days, acted sluggish, and slept a lot. Weeks after the vaccine, she seems to have sleep issues that weren't present before the vaccine. Doesn't self-soothe, cries when placed in crib, wants to be held while sleeping, and wakes up crying several times throughout the night (she never used to wake up at night).
Age: 0.88
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Middle insomnia, Peripheral swelling, Pyrexia, Retching, Skin discolouration
Clinical narrative: 11:00AM  Injection of PCV13 Vaccine. After injection she was happy, playing, and socializing. I did not give her any Tylenol; because she did not show any signs or symptoms of being in pain or having a fever. 1:00PM  Decreased appetite. She drank 3.5 oz. of formula. She normally drinks 5 oz. of formula. She started getting sleepy; I laid her down in her Pack-N-Play for a nap. 2:10PM  I checked on her in her Pack-N-Play. She was having difficulty breathing, grunting (as if trying to clear her throat), and making an unusual whine-like noise. Her face had a greyish tint, her hands/arms were blue/purple and somewhat swollen, her body felt extremely hot, and she was shivering/shaking (from fever? The room wasn't too hot or too cold), and her entire body was limp. 2:20PM  Drove her to the ER, 5 minutes away, we did not have time to wait 10-20 minutes for an ambulance. She started vomiting while in her car seat as soon as I put the car in park and as we were walking into the ER. (Cleaned her car seat a couple days later and found a couple spots that looked like dried blood/stomach bile). ER took her immediately. Her entire body was blue/purple. They gave her oxygen. 103.1 fever. X-Rayed her lungs to make sure there was no vomit in her lungs. Pricked her 5-7 times trying to get an IV, IV access was attempted but was unsuccessful.  A NSS bolus was given by IO. After an hour? She was Life-Flighted to another ER 20 miles away. On Life Flight it was noticed that she had stridor. At the ER she received a breathing treatment, steroids, and Tylenol. She dry heaved and vomited a little after the breathing treatment/steroids. She was given Dexamethasone and racemic epinephrine. All tests that they performed on her came back normal, confirmed allergic reaction to the PCV13 vaccine. They observed her and discharged her at 9:00PM. At home, she had a fever of 100-102 for 2 days, acted sluggish, and slept a lot. Weeks after the vaccine, she seems to have sleep issues that weren't present before the vaccine. Doesn't self-soothe, cries when placed in crib, wants to be held while sleeping, and wakes up crying several times throughout the night (she never used to wake up at night).
Age: 0.88
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Skin warm, Sleep disorder, Sluggishness, Somnolence, Stridor
Clinical narrative: 11:00AM  Injection of PCV13 Vaccine. After injection she was happy, playing, and socializing. I did not give her any Tylenol; because she did not show any signs or symptoms of being in pain or having a fever. 1:00PM  Decreased appetite. She drank 3.5 oz. of formula. She normally drinks 5 oz. of formula. She started getting sleepy; I laid her down in her Pack-N-Play for a nap. 2:10PM  I checked on her in her Pack-N-Play. She was having difficulty breathing, grunting (as if trying to clear her throat), and making an unusual whine-like noise. Her face had a greyish tint, her hands/arms were blue/purple and somewhat swollen, her body felt extremely hot, and she was shivering/shaking (from fever? The room wasn't too hot or too cold), and her entire body was limp. 2:20PM  Drove her to the ER, 5 minutes away, we did not have time to wait 10-20 minutes for an ambulance. She started vomiting while in her car seat as soon as I put the car in park and as we were walking into the ER. (Cleaned her car seat a couple days later and found a couple spots that looked like dried blood/stomach bile). ER took her immediately. Her entire body was blue/purple. They gave her oxygen. 103.1 fever. X-Rayed her lungs to make sure there was no vomit in her lungs. Pricked her 5-7 times trying to get an IV, IV access was attempted but was unsuccessful.  A NSS bolus was given by IO. After an hour? She was Life-Flighted to another ER 20 miles away. On Life Flight it was noticed that she had stridor. At the ER she received a breathing treatment, steroids, and Tylenol. She dry heaved and vomited a little after the breathing treatment/steroids. She was given Dexamethasone and racemic epinephrine. All tests that they performed on her came back normal, confirmed allergic reaction to the PCV13 vaccine. They observed her and discharged her at 9:00PM. At home, she had a fever of 100-102 for 2 days, acted sluggish, and slept a lot. Weeks after the vaccine, she seems to have sleep issues that weren't present before the vaccine. Doesn't self-soothe, cries when placed in crib, wants to be held while sleeping, and wakes up crying several times throughout the night (she never used to wake up at night).
Age: 0.88
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Tremor, Vomiting
Clinical narrative: 11:00AM  Injection of PCV13 Vaccine. After injection she was happy, playing, and socializing. I did not give her any Tylenol; because she did not show any signs or symptoms of being in pain or having a fever. 1:00PM  Decreased appetite. She drank 3.5 oz. of formula. She normally drinks 5 oz. of formula. She started getting sleepy; I laid her down in her Pack-N-Play for a nap. 2:10PM  I checked on her in her Pack-N-Play. She was having difficulty breathing, grunting (as if trying to clear her throat), and making an unusual whine-like noise. Her face had a greyish tint, her hands/arms were blue/purple and somewhat swollen, her body felt extremely hot, and she was shivering/shaking (from fever? The room wasn't too hot or too cold), and her entire body was limp. 2:20PM  Drove her to the ER, 5 minutes away, we did not have time to wait 10-20 minutes for an ambulance. She started vomiting while in her car seat as soon as I put the car in park and as we were walking into the ER. (Cleaned her car seat a couple days later and found a couple spots that looked like dried blood/stomach bile). ER took her immediately. Her entire body was blue/purple. They gave her oxygen. 103.1 fever. X-Rayed her lungs to make sure there was no vomit in her lungs. Pricked her 5-7 times trying to get an IV, IV access was attempted but was unsuccessful.  A NSS bolus was given by IO. After an hour? She was Life-Flighted to another ER 20 miles away. On Life Flight it was noticed that she had stridor. At the ER she received a breathing treatment, steroids, and Tylenol. She dry heaved and vomited a little after the breathing treatment/steroids. She was given Dexamethasone and racemic epinephrine. All tests that they performed on her came back normal, confirmed allergic reaction to the PCV13 vaccine. They observed her and discharged her at 9:00PM. At home, she had a fever of 100-102 for 2 days, acted sluggish, and slept a lot. Weeks after the vaccine, she seems to have sleep issues that weren't present before the vaccine. Doesn't self-soothe, cries when placed in crib, wants to be held while sleeping, and wakes up crying several times throughout the night (she never used to wake up at night).
Age: 4.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: On 25-FEB-2015 the patient was vaccinated with the first dose of PROQUAD (Merck) (dose and lot# not reported, route reported as injection). On 12-MAR-2015 the patient received his second PROQUAD (Merck) dose too soon after the first dose, which was a misuse adverse event (inappropriate schedule of drug administration). No side effects were reported. It was unknown if the patient sought medical attention or not. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: This consumer spontaneous report (25-Mar-2015) concerns a 59 year old male patient who had a medical history of a small non-malignant tumour which was removed in Dec-2014. About one year ago, he was prescribed sulfamethoxazole/trimethoprim for a suspected bladder/prostate infection and after taking it for 6-7 days, he felt fatigued and the sulfamethoxazole/trimethoprim was ceased and went to the Emergency Room where they could not find the source of the fatigue. It was discovered that he had a kidney stone and not a bladder/prostate infection. The fatigue lasted 9-10 months and had almost gone. His neurologist explained that the sulfamethoxazole/trimethoprim was most likely the cause of the fatigue. The patient was not on any concomitant medications. On the 10-Oct-2014, the patient received AFLURIA (batch number not reported). In late Dec-2014 or early Jan-2-15, the patient started to feel shoulder pain. He had not been self treating the pain because it did not bother him most of the time, only when he reached for something behind him. He sought medical advice from his neurologist who stated that the patient may have had a delayed response to the vaccine given his past medical history and was advised to take naproxen or ibuprofen. The pain had lasted for a couple of months and was subsiding. Outcome was reported as not yet recovered. Reporter comments: The consumer stated that the shoulder pain was probably not related to vaccination.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Head discomfort, Muscle twitching, Musculoskeletal pain
Clinical narrative: Dizziness, fatigue, nerve twitching; 'heavy head, extreme pain and swelling of the arm. One arm is hotter than the other. Nerve twitching suggestive of nerve damage. Extreme soreness of the shoulder.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Nerve injury, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Dizziness, fatigue, nerve twitching; 'heavy head, extreme pain and swelling of the arm. One arm is hotter than the other. Nerve twitching suggestive of nerve damage. Extreme soreness of the shoulder.
Age: 11.0
Sex: F
Vaccine: HPVX, MEN, TDAP, HPVX, MNQ, TDAP
Symptoms: Pruritus, Rash erythematous, Tenderness
Clinical narrative: Itching to under arm, then bumps on top of left arm and down the left side, painful to touch. Bumps red with little white heads.
Age: 11.0
Sex: F
Vaccine: HPVX, MEN, TDAP, HPVX, MNQ, TDAP
Symptoms: Pain, Pain in extremity, Pruritus, Rash, Rash erythematous
Clinical narrative: Itching to under arm, then bumps on top of left arm and down the left side, painful to touch. Bumps red with little white heads.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to unknown number of patients of unknown age and gender. Information about current conditions or medical history was not reported. The healthcare worker reported that on unspecified dates the patients received doses of GARDASIL (lot#, dose, route not reported) stored improperly. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site discomfort, Injection site pain, Insomnia
Clinical narrative: Initial event was unusual sudden release of pressure during injection. Felt discomfort at inj site in evening, could not sleep on left side due to shoulder pain. Could not abduct Left arm more than 6 inch away from body for 3 days.  Interfered with household tasks and ball toss when serving at tennis. Was no swelling, fever or other reaction (as with a flu shot), only pain. Dr advised using heating pad but was no help. Movement improved slowly over the following 6 months.  Still have some movement restriction and occasional pain, now 7 months after event. (I have been exercising to improve surrounding muscles to help situation). Nurse was standing while I was sitting - have read this may be a factor in the injury.  Hesitate to check Permanent Disability box below not knowing how long the issue will last.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: None.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Diarrhoea, Fatigue, Hyperhidrosis, Malaise
Clinical narrative: Fatigue, fever, sweats, sever diarrhea, weakness.  General malaise for two and 1/2 days.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fatigue, fever, sweats, sever diarrhea, weakness.  General malaise for two and 1/2 days.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to unknown number of patients of unknown age and gender. Information about current conditions or medical history was not reported. The healthcare worker reported on unspecified dates the patients received doses of PNEUMOVAX 23 (lot#, dose, route not reported) stored improperly. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 30-MAR-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # K008871, exp. date:19-DEC-2015 (dose, dose number, route and application site were not reported). Concomitant therapy was not reported. The temperature excursion for the PROAQUAD (Merck) was found to be supported with in-house stability data. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients. On unspecified dates the patients were vaccinated with doses of improperly stored ROTATEQ orally (dose, frequency and lot# were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients. On unspecified dates the patients were vaccinated with doses of improperly stored VAQTA (dose, frequency, route and lot# were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.35
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 month old male patient. Patient's historical conditions, current conditions and concomitant medications were unknown. On 30-MAR-2015 the patient was vaccinated with expired (Oka/Merck) VARIVAX lot # J003532, expiry: 25-MAR-2015. No adverse event was reported. Product quality complaint was not reported. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to unknown number of patients of unknown age and gender. Information about current conditions or medical history was not reported. The healthcare worker reported that on unspecified dates the patients received doses of PEDVAXHIB (lot#, dose, route not reported) stored improperly. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, Immediate post-injection reaction, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Concurrent conditions, medical history and concomitant medications were not reported. On 26-MAR-2015, the patient was vaccinated with ZOSTAVAX, (lot #, expiration, dose, frequency, route of administration and indication were not provided). Patient did not receive an expired dose of ZOSTAVAX. On 26-MAR-2015, experienced itching at injection site immediately following the injection. On an unknown date in 2015, the outcome of itching at injection site was resolved without any treatment. Causality was not provided. No additional information was reported. This is one of two reports that received from the same reporter (linked with MARRS# 1504USA000724). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unknown age and gender. On unknown dates the patients were vaccinated with ROTATEQ, orally, that had been improperly stored (dose, lot # not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On 21-NOV-2014, the patient was vaccinated with ZOSTAVAX dose 0.65 ml (strength, product lot# and expiry date not reported) intramuscularly. No adverse experience was reported. There was no product quality complaint involved. The outcome of the events was unknown. Follow up information has been received from the pharmacist regarding a 65 years old male patient. On 21-NOV-2014, the patient was vaccinated with the first dose of ZOSTAVAX lot # reported as K10620. There was no illnesses at the time of vaccination. On 23-NOV-2014, the patient experienced redness, itching and some swelling which lasted 3 days. On  26-NOV-2014, the patient recovered from the events. Relatedness between the events and vaccination with ZOSTAVAX was not reported. Lot # K10620 is not valid for ZOSTAVAX. Additional information is not reported.