chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: This case was reported by a other health professional and described the occurrence of intramuscular formulation administered by other route in a 6-year-old female patient who received FLUARIX (batch number 5979Z, expiry date 30th June 2015). On 24th November 2014, the patient received FLUARIX (see text) .5 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional information received: This is an asymptomatic report that consumer received 0.5 ml through the nose today.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site erythema in a adult female patient who received Flu QIV. On an unknown date, the patient received Flu QIV (unknown). On an unknown date, an unknown time after receiving Flu QIV, the patient experienced injection site erythema. The patient was treated with ZYRTEC. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to Flu QIV. Additional information received on 14 November 2014: The patient experienced redness at the injection site, described as wider spread than expected. It was unknown if the patient received FLUARIX QIV or FLULAVAL QIV. Follow-up information received on 25 November 2014: The reporter information was updated. This is one of the 2 cases reported by the same reporter for the same vaccine.
Age: 0.33
Sex: F
Vaccine: HIBV, PNC13, RV1
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No reaction, wrong immunization given.
Age: 45.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: REDNESS AND SWELLING MEASURING 170MM X 160MM WITH TENDERNESS AND WARMTH.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Grip strength decreased, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Initially: Pain at site, limited ROM (couldn't lift my arm up), pain w any ROM, decreased strength in right hand, numbness in rt hand.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Itching and swelling of mouth, throat, and injection site. Runny most. Tightness in chest. Heat, swelling, itching, redness (large wheal) at injection site, about 4-5 inches in diameter that persisted about 10 days.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site warmth, Mouth swelling, Oral pruritus, Pharyngeal oedema
Clinical narrative: Itching and swelling of mouth, throat, and injection site. Runny most. Tightness in chest. Heat, swelling, itching, redness (large wheal) at injection site, about 4-5 inches in diameter that persisted about 10 days.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Client states woke up the next morning with welps, itching, soreness and swollen upper left arm.
Age: 1.8
Sex: F
Vaccine: FLU4
Symptoms: Accidental overdose
Clinical narrative: This case was reported by a other health professional and described the occurrence of accidental overdose in a 21-month-old female patient who received FLULAVAL QUADRIVALENT (batch number 2G3J4, expiry date 30th June 2015). On 24th November 2014, the patient received FLULAVAL QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. Additional information: A 21 month old pediatric patient was accidentally given an adult dose of flu vaccine.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Blood test, Fatigue, Headache, Hypoaesthesia, Malaise
Clinical narrative: Aches and Pains in the muscles, hurt to move, Numbness and tingling of legs, unusual tiredness, headache, drowsiness, general feeling of illness.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Myalgia, Nuclear magnetic resonance imaging, Pain, Paraesthesia, Somnolence
Clinical narrative: Aches and Pains in the muscles, hurt to move, Numbness and tingling of legs, unusual tiredness, headache, drowsiness, general feeling of illness.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Ultrasound scan
Clinical narrative: Aches and Pains in the muscles, hurt to move, Numbness and tingling of legs, unusual tiredness, headache, drowsiness, general feeling of illness.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and Redness around injection site about the size of a golf ball, Injection site was for the MMR + Varicella.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Balance disorder, Chest X-ray normal, Lethargy, Pyrexia
Clinical narrative: 9:00 AM 5/30: Severe vomiting, high fever, gray color, non-responsive. Went back to the clinic. They gave him juice and sent us home. He vomited again on the way home, so we took him to the walk-in clinic. He vomited again in the parking lot. That doctor told us to take him to the Emergency Room immediately, as patient was lethargic and his fever was rising. He vomited once more on the way to the E.R. The doctor there tested him for strep throat, did a chest x-ray to check for pneumonia, and checked his urine for a UTI. All came back negative. He informed us that patient had probably just been upset about receiving the vaccination, or had caught another bug and it was just coincidence that he started vomiting after the vaccine. He sent us home. Patient continue to vomit irregularly for two days, until finally we saw a naturopathic doctor who gave us some remedies to help reduce his nausea. Those helped, but patient continued to vomit once every couple day for two and a half weeks. He also had extremely low energy and lost his sense of balance for about a week following the vaccination. Prior to receiving the vaccine, he loved to swing as high and fast on the swing as possible. After receiving the vaccine, he only wanted to swing very slowly. That continued for about 6 months after the vaccination.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Skin discolouration, Streptococcus test negative, Unresponsive to stimuli, Urine analysis normal, Vomiting
Clinical narrative: 9:00 AM 5/30: Severe vomiting, high fever, gray color, non-responsive. Went back to the clinic. They gave him juice and sent us home. He vomited again on the way home, so we took him to the walk-in clinic. He vomited again in the parking lot. That doctor told us to take him to the Emergency Room immediately, as patient was lethargic and his fever was rising. He vomited once more on the way to the E.R. The doctor there tested him for strep throat, did a chest x-ray to check for pneumonia, and checked his urine for a UTI. All came back negative. He informed us that patient had probably just been upset about receiving the vaccination, or had caught another bug and it was just coincidence that he started vomiting after the vaccine. He sent us home. Patient continue to vomit irregularly for two days, until finally we saw a naturopathic doctor who gave us some remedies to help reduce his nausea. Those helped, but patient continued to vomit once every couple day for two and a half weeks. He also had extremely low energy and lost his sense of balance for about a week following the vaccination. Prior to receiving the vaccine, he loved to swing as high and fast on the swing as possible. After receiving the vaccine, he only wanted to swing very slowly. That continued for about 6 months after the vaccination.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Diffuse maculopapular rash.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: Muscle aches, 102.4 deg fever, vomiting starting 1/29/2015 7:00 AM; administered ibuprofen 1/28/2015 9:00 PM and again 1/29/2015 10:00 AM. Fever reduced to 100.8 deg, muscle ache reduced by 1/29/2015 2:00 PM.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Pt got red rash that started at injection site and spread over next 12 hours to shoulder and down arm to elbow.  Pt said rash began to resolve the next day, Sunday.  Rash was almost gone by Monday when pt came in to pharmacy to report incident.  Pt said she was fine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 6 inches of swelling, erythema, warmth induration at RUE.
Age: 41.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Activities of daily living impaired, Asthenia, Chills, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Woke up with fevers, chills, weakness, swollen lymph node in armpit - very painful. Required help to dress and undress, as it was too painful to move the left arm. On the following day, the area of the injection looked reddish and became tender. Throughout the day the fevers (39.1C) and chills continued, the read area became larger and more tender. On the next day the area was swollen, red and hot and measured around 3 inches.
Age: 41.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Lymph node pain, Lymphadenopathy
Clinical narrative: Woke up with fevers, chills, weakness, swollen lymph node in armpit - very painful. Required help to dress and undress, as it was too painful to move the left arm. On the following day, the area of the injection looked reddish and became tender. Throughout the day the fevers (39.1C) and chills continued, the read area became larger and more tender. On the next day the area was swollen, red and hot and measured around 3 inches.
Age: 41.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Woke up with fevers, chills, weakness, swollen lymph node in armpit - very painful. Required help to dress and undress, as it was too painful to move the left arm. On the following day, the area of the injection looked reddish and became tender. Throughout the day the fevers (39.1C) and chills continued, the read area became larger and more tender. On the next day the area was swollen, red and hot and measured around 3 inches.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Skin around injection site began to get red and swell.  Swelling and area of skin/tissue involved has increased over the last few days since injection was administered.  Pain, itching, hot to the touch, and beginning to look bruised in addition to the redness.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Skin around injection site began to get red and swell.  Swelling and area of skin/tissue involved has increased over the last few days since injection was administered.  Pain, itching, hot to the touch, and beginning to look bruised in addition to the redness.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site pallor, Injection site swelling
Clinical narrative: WHITE ROUND AREA AROUND THE INJECTION SITE ALONG WITH SWELLING AND PAIN.
Age: 12.0
Sex: M
Vaccine: DTAP, HPV4, MEN
Symptoms: Abdominal pain upper, Burning sensation, Dyskinesia, Immediate post-injection reaction, Lethargy
Clinical narrative: Burning sensation immediately after shot, feeling of being electrocuted, Severe twitching and jerking of left arm beginning at 5pm...went to ER...identified as a severe motor tic...next 24 hours had vomiting. Nausea, migraines, stomach pain, lethargic, no appetite-48 hours after and as of the time I am filling this out still twitching and having migraines.
Age: 12.0
Sex: M
Vaccine: DTAP, HPV4, MEN
Symptoms: Migraine, Muscle twitching, Paraesthesia, Tic, Vomiting
Clinical narrative: Burning sensation immediately after shot, feeling of being electrocuted, Severe twitching and jerking of left arm beginning at 5pm...went to ER...identified as a severe motor tic...next 24 hours had vomiting. Nausea, migraines, stomach pain, lethargic, no appetite-48 hours after and as of the time I am filling this out still twitching and having migraines.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since an unspecified date in November 2014, doses of ROTATEQ, which were improperly stored (incorrect product stored), were administered orally to unspecified number of patients (dose, dose number, lot number and expiration date were unspecified). No adverse effects were noted. No concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information is not expected, because the reporter not consent further follows up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. A nurse reported that an unspecified number of unknown patients have been administered doses of ROTATEQ, oral, lot # I009745, expiration date 17-FEB-2016, orally that was stored at both 47.1 Fahrenheit degrees for 96 hours and -5 Celsius degrees for 48 hours. ROTATEQ lot # K009745 was given on 14-NOV-2014, 24-NOV-2014 and 20-JAN-2015. No adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a physician refers to a 17 weeks old patient. Medical history and current condition of the patient were not reported. On 22-JAN-2015 (approximately 17 weeks post birth), the patient was vaccinated with the first dose of ROTATEQ, oral, 2 ml, orally (lot#, expiry date unspecified), which was outside of the 6-12 week time frame indicated for 1st dosing in physician's prescribing information. No adverse effects reported. No product quality complaint (PQC) involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: This is a retrospective pregnancy case. This 26-year-old female subject was enrolled in a study. The subject received Flu TIV .5 ml on an unknown date. The subject's estimated date of delivery was 13 January 2015. The subject received Flu TIV at week 28 of the pregnancy and during the second trimester of pregnancy. On an unknown date, an unknown time after receiving Flu TIV the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. Additional information: The reporter has 4 patients that she recently vaccinated. This is report 4 of 4.
Sex: M
Vaccine: FLUX
Symptoms: Pharyngeal oedema
Clinical narrative: This case was reported by a other health professional and described the occurrence of throat swelling in a male patient who received flu vaccine. On an unknown date, the patient received flu vaccine at an unknown dose. On an unknown date, an unknown time after receiving flu vaccine, the patient experienced throat swelling. On an unknown date, the outcome of the throat swelling was unknown. It was unknown if the reporter considered the throat swelling to be related to flu vaccine. Additional information received: Pharmacy school student reporting a case she was assigned involved a male patient who received a flu vaccine and experienced his throat swelling up. She has no other details, other than what she provided during conversation.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site induration, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site induration in a 59-year-old male patient who received FLUARIX (batch number L5E9G, expiry date 30th June 2015). The patient's past medical history included no adverse event. Previously experienced adverse reactions included no adverse event. (The patient had no adverse event following previous vaccinations). On 21st October 2014 14:30, the patient received FLUARIX .5 ml. In 2014, an unknown time after receiving FLUARIX, the patient experienced injection site induration and injection site pain. On an unknown date, the outcome of the injection site induration and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the injection site induration and injection site pain to be related to FLUARIX. Additional information received on 14 November 2014: The patient didn't take any concomitant medications, and previously, he had not received any flu shots. The patient, an employee working at the pharmacist, still had soreness in the muscle at the injection site and had a knot in the muscle like the medicine was still in there.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 30-year-old female subject who was vaccinated with Flu TIV .5 ml on an unknown date. The estimated date of delivery was on 01 November 2014. The subject was exposed to the vaccine during the 3rd trimester. At the time of reporting, the pregnancy was ongoing.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 36-year-old female subject who was vaccinated with Flu TIV .5 ml on an unknown date. The subject's estimated date of delivery was 1st November 2014. The subject received Flu TIV at week 35 of the pregnancy and during the third trimester of pregnancy. At the time of reporting, the pregnancy was ongoing.
Age: 67.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Pt received TdaP and Typhoid tabs on 1/23/15. Hives, swelling, redness developed 1/28/15 only around injection site on (L) deltoid. Pt taking CLARITIN 24 hr. antihistamine.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on abdomen, face, neck and back.
Age: 1.39
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Rash vesicular
Clinical narrative: 18 to twenty days after VARIVAX #1, pt developed 5-6 lesions which look varicelliform. No other symptoms.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt stated she can't lift arm and is very painful. Patient states she first noticed symptoms approximately 2 weeks after receiving the vaccine. She states she has not sought treatment.
Age: 0.47
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: Patient received immunizations on 1-21-15. On 1/24/15 patient was taken to clinic due to rash on both legs moving up trunk of body, swelling to bilateral legs, and low grade fever.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Screaming
Clinical narrative: Mother called at 5:45 pm stating pt. crying since 3 pm (Non-stop)-consoles long enough to "catch her breath" then screamed again. Mother stated patient cried in "cycles" until 8 am the next day.
Age: 0.5
Sex: F
Vaccine: DTAP, FLU3, HIBV, IPV, PNC13
Symptoms: Expired product administered
Clinical narrative: Given expired HIB vaccine (exp 12/7/14). MOC informed. Doctor informed.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 6 x 7 cm swelling with redness, warmth, pain to (L) deltoid.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site erythema in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent (unknown). On an unknown date, an unknown time after receiving Influenza vaccine Quadrivalent, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to Influenza vaccine Quadrivalent. Additional information received on 14 November 2014: The patient experienced redness at the injection site, described as wider spread than expected. It was unknown if the patient received FLUARIX QIV or FLULAVAL QIV. Follow-up information received on 25 November 2014: The reporter information was updated. This is one of the 2 cases reported by the same reporter for the same vaccine.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Contusion, Feeling cold, Hyperhidrosis, Influenza
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of thrombocytopenia in a 42-year-old female patient who received FLUARIX. The patient's past medical history included alcoholism. Concurrent medical conditions included hepatitis C and lumbar disc degeneration (lumbar disc herniation, lumbar radiculopathy; many lumbar problems). Concomitant products included KLOR-CON, Mag oxide, PRILOSEC, buspirone, folic acid, gabapentin, ibuprofen, metoprolol and Multivitamin. On 18th November 2014 09:30, the patient received FLUARIX (intramuscular). In November 2014, an unknown time after receiving FLUARIX, the patient experienced thrombocytopenia and contusion. On 20th November 2014, the patient experienced upset stomach, respiratory tract congestion, sneezing, swollen glands, feeling cold, sweating and lethargy. On an unknown date, the patient experienced chapped skin and influenza. On an unknown date, the outcome of the thrombocytopenia, upset stomach, respiratory tract congestion, sneezing, swollen glands, chapped skin, feeling cold, sweating and contusion were not recovered/not resolved and the outcome of the influenza was recovered/resolved and the outcome of the lethargy was not recovered/not resolved. It was unknown if the reporter considered the thrombocytopenia, upset stomach, respiratory tract congestion, sneezing, swollen glands, chapped skin, influenza, feeling cold, sweating, lethargy and contusion to be related to FLUARIX. Additional information: Caller reports that she got a flu vaccine on 11/18/2014. She does not know what brand flu she received. Starting on Thursday she has been feeling sick with upset stomach, sweating and freezing, bad chest congestion, sneezing, lethargy and one gland is swollen and tender. The end of her nose has become chapped. She says it is still getting worse, especially the congestion and sneezing. She has been receiving the flu vaccine for 5 years now. She got the flu the second year she received the vaccine. She was recently diagnosed with thrombocytopenia, but it is not clear if the diagnosis was before or after this year's flu vaccine. She has a lot of bruising as a result of the thrombocytopenia. She is currently 42 years old.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Lymphadenopathy, Malaise, Respiratory tract congestion, Skin fissures
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of thrombocytopenia in a 42-year-old female patient who received FLUARIX. The patient's past medical history included alcoholism. Concurrent medical conditions included hepatitis C and lumbar disc degeneration (lumbar disc herniation, lumbar radiculopathy; many lumbar problems). Concomitant products included KLOR-CON, Mag oxide, PRILOSEC, buspirone, folic acid, gabapentin, ibuprofen, metoprolol and Multivitamin. On 18th November 2014 09:30, the patient received FLUARIX (intramuscular). In November 2014, an unknown time after receiving FLUARIX, the patient experienced thrombocytopenia and contusion. On 20th November 2014, the patient experienced upset stomach, respiratory tract congestion, sneezing, swollen glands, feeling cold, sweating and lethargy. On an unknown date, the patient experienced chapped skin and influenza. On an unknown date, the outcome of the thrombocytopenia, upset stomach, respiratory tract congestion, sneezing, swollen glands, chapped skin, feeling cold, sweating and contusion were not recovered/not resolved and the outcome of the influenza was recovered/resolved and the outcome of the lethargy was not recovered/not resolved. It was unknown if the reporter considered the thrombocytopenia, upset stomach, respiratory tract congestion, sneezing, swollen glands, chapped skin, influenza, feeling cold, sweating, lethargy and contusion to be related to FLUARIX. Additional information: Caller reports that she got a flu vaccine on 11/18/2014. She does not know what brand flu she received. Starting on Thursday she has been feeling sick with upset stomach, sweating and freezing, bad chest congestion, sneezing, lethargy and one gland is swollen and tender. The end of her nose has become chapped. She says it is still getting worse, especially the congestion and sneezing. She has been receiving the flu vaccine for 5 years now. She got the flu the second year she received the vaccine. She was recently diagnosed with thrombocytopenia, but it is not clear if the diagnosis was before or after this year's flu vaccine. She has a lot of bruising as a result of the thrombocytopenia. She is currently 42 years old.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing, Thrombocytopenia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of thrombocytopenia in a 42-year-old female patient who received FLUARIX. The patient's past medical history included alcoholism. Concurrent medical conditions included hepatitis C and lumbar disc degeneration (lumbar disc herniation, lumbar radiculopathy; many lumbar problems). Concomitant products included KLOR-CON, Mag oxide, PRILOSEC, buspirone, folic acid, gabapentin, ibuprofen, metoprolol and Multivitamin. On 18th November 2014 09:30, the patient received FLUARIX (intramuscular). In November 2014, an unknown time after receiving FLUARIX, the patient experienced thrombocytopenia and contusion. On 20th November 2014, the patient experienced upset stomach, respiratory tract congestion, sneezing, swollen glands, feeling cold, sweating and lethargy. On an unknown date, the patient experienced chapped skin and influenza. On an unknown date, the outcome of the thrombocytopenia, upset stomach, respiratory tract congestion, sneezing, swollen glands, chapped skin, feeling cold, sweating and contusion were not recovered/not resolved and the outcome of the influenza was recovered/resolved and the outcome of the lethargy was not recovered/not resolved. It was unknown if the reporter considered the thrombocytopenia, upset stomach, respiratory tract congestion, sneezing, swollen glands, chapped skin, influenza, feeling cold, sweating, lethargy and contusion to be related to FLUARIX. Additional information: Caller reports that she got a flu vaccine on 11/18/2014. She does not know what brand flu she received. Starting on Thursday she has been feeling sick with upset stomach, sweating and freezing, bad chest congestion, sneezing, lethargy and one gland is swollen and tender. The end of her nose has become chapped. She says it is still getting worse, especially the congestion and sneezing. She has been receiving the flu vaccine for 5 years now. She got the flu the second year she received the vaccine. She was recently diagnosed with thrombocytopenia, but it is not clear if the diagnosis was before or after this year's flu vaccine. She has a lot of bruising as a result of the thrombocytopenia. She is currently 42 years old.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site pain in a 48-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 9X3L3, expiry date 30th June 2015). Previously administered products included flu vaccine with an associated reaction of no reaction to previous exposure to drug. On 15th October 2014, the patient received FLULAVAL QUADRIVALENT. On 15th October 2014, 0 min after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to FLULAVAL QUADRIVALENT. Additional information received: Nurse reported that a patient complained about pain in her arm and where she received the vaccine.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of overdose in a 3-year-old male patient who received FLULAVAL QUADRIVALENT (batch number 579G3, expiry date 20th April 2015). On an unknown date, the patient received FLULAVAL QUADRIVALENT .25 ml. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Antinuclear antibody increased, C-reactive protein increased, Headache
Clinical narrative: This case was reported by a other health professional and described the occurrence of headache in a 55-year-old female patient who received FLUARIX (batch number GA22N, expiry date 30th June 2015). Previously administered products included FLUARIX with an associated reaction of inflammation (with headache, wheezing, muscle aches, elevated CRP and ANA). Concurrent medical conditions included hypothyroidism. On 21st November 2014, the patient received FLUARIX .5 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to FLUARIX. Additional information received: Last year received FLUARIX and had Inflammatory response with headache, wheezing, muscle aches, elevated C-Reactive Protein and ANA. She visited her doctor for this and was told it might be Lupus but no official diagnosis has been made. Due to her history it was recommended that she get latex free and thimerosal free flu vaccine, which she did last year, but still had the same reaction. Caller feels that she might get the same reaction after today's vaccination.
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 5-year-old female patient who received BOOSTRIX (batch number P39AZ, expiry date 15th February 2015). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
Sex: U
Vaccine: RV1
Symptoms: Wrong technique in drug usage process
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a patient who received ROTARIX (batch number A41CB446A, expiry date unknown). On 18th November 2014, the patient received ROTARIX. On an unknown date, an unknown time after receiving ROTARIX, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. Additional information received: Nurse only given the diluent to patient. No other information was provided.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US022307, is an initial spontaneous report received from the pharmacist on 22 Oct 2013. This report refers to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with expired seasonal influenza vaccine (unknown manufacturer, batch number: not reported, expiry date: Jun 2013) intramuscularly on an unspecified date. The physician was not sure of the identity of the flu vaccine and the size of the multi dose vial (1 ml vial or 10 ml vial). No adverse event reported following this maladministration (expired vaccine used).
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Case number PHEH2012US023870 is an initial spontaneous report received from a pharmacy student on 28 Nov 2012: This report refers to a female patient of unknown age group. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown)on an undetermined date five years ago. After vaccination she experienced swelling, warmth and pain in her upper arm. No further information was available.
Sex: U
Vaccine: FLUX
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US020738 is an initial spontaneous report received from a pharmacist on 02 Oct 2013 and a follow up report from the pharmacist received on 06 Nov 2013: This report refers to multiple patients of unknown age and gender. They were vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly on 02 Oct 2013. The pharmacist reported that these patients received flu vaccinations from opened and unopened multi dose vials of flu vaccine that was stored improperly with ice packs during a flu clinic intensive. The ice packs melted during the day and the duration of exposure to room temperature of the MDVs was estimated at 8 hours. At the time of this report, pharmacist was unsure of the identity of the MDVs was FLUVIRIN or another flu vaccine, but they insisted that FLUVIRIN was one of many flu vaccines that were provided at their facility. The reporter did not have any patient information to provide nor any additional information related to number of people who may have been vaccinated inadvertently. No further information about outcome, seriousness and causality was provided. The pharmacist confirmed that there was no adverse event. Follow up report from the pharmacist received on 06 Nov 2013: The pharmacist confirmation regarding the adverse event was updated.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Case number PHEH2013US020246 is an initial spontaneous report received from a consumer on 26 Sep 2013. This report refers to a male patient whose age was not reported. His medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that on an unknown date after vaccination, he had mild symptoms of flu. The outcome of the event was not reported. No further information was provided.
Sex: U
Vaccine: FLUX
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US018759 is an initial spontaneous report received from a pharmacist on 04 Sep 2013. This report refers to multiple patients whose identifiers were not reported. The patients' medical history and concomitant medications were not reported. These patients were vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on unknown dates (the vaccine was of 2013/2014 season). It was reported that these patients were administered the vaccine which was pre-drawn in syringes from multi dose vials. No adverse event was reported following the inadvertent administration.
Sex: U
Vaccine: FLUX
Symptoms: Skin induration
Clinical narrative: Case number PHEH2013US002510 is an initial spontaneous report received from a pharmacist on 24 Jan 2013. This report refers to multiple patients whose identifiers were not reported. These patients were vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on unknown dates. On unknown date, these patients experienced hard under the skin. The outcome of the event was not reported. No further information was provided.
Sex: U
Vaccine: FLUX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US021603 is an initial spontaneous report received from a pharmacist on 15 OCT 2013. This report refers to a patient of unknown age and gender. This patient was vaccinated with an expired dose of a seasonal influenza vaccine (manufacturer and batch number unknown, expiry date: 20 JUN 2013) on 15 OCT 2013. No adverse event was reported following the maladministration.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Case number PHEH2013US021574 is an initial spontaneous report received from a pharmacist on 15 Oct 2013 with a follow up information received from a pharmacist on 07 Nov 2013. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza shot (manufacturer and batch number: not reported) subcutaneously on an unknown date. The pharmacist stated that the shot was not administered at his pharmacy, but at a clinic at a local school and he could not confirm if the vaccine was FLUVIRIN. No adverse event was reported following the maladministration. In the follow up information received on 07 Nov 2013, it was reported that the patient was administered ZOSTAVAX (other manufacturer, batch number: not reported) and reported an adverse event related to ZOSTAVAX and not FLUVIRIN and hence the case would be deactivated. No further information was provided. Follow up information received from a pharmacist on 07 Nov 2013: Patient reported an adverse event related to ZOSTAVAX and not FLUVIRIN and hence the case was deactivated.
Age: 1.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Case number PHEH2013US021911 is an initial spontaneous report from the nurse received on 18 Oct 2013. This report refers to a 01-year-old female patient. She received a flu shot (manufacturer and batch number: not reported, so conservatively coded as seasonal influenza vaccine INN) on an unknown date. On an unknown date, after vaccination she experienced a severe reaction to the vaccine. The outcome of the event was not reported. No other information was available.
Sex: U
Vaccine: FLUX
Symptoms: Expired product administered
Clinical narrative: Case number PHEH2013US022552 is an initial spontaneous report received from a pharmacist on 15 Oct 2013. This report refers to a patient of an unknown age and gender. The patient was vaccinated with seasonal flu vaccine (manufacturer and batch number unknown) on an unspecified date. It was reported that the patient received Flu vaccine that was expired on 20 Jun 2013. It was unknown whether the vaccine was FLUVIRIN or some other vaccine. Reporter enquired whether the patient could revaccinate with FLUVIRIN. No other information was provided.
Age: 99.0
Sex: F
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: Arm started to swell.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2013US023975 is an initial spontaneous report from the pharmacist received on 13 Nov 2013. This report refers to a 62-year-old female patient. She was vaccinated with Flu shot (manufacturer and batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN on an unknown date. On 13 Nov 2013, one week after the Flu shot the patient accidentally received FLUVIRIN, (batch number: 1308701). No adverse event reported following this medication error.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Case number PHHY2013US117484 is an initial report received from Vaccine Adverse Event Reporting System (VAERS reference number: 482627) on 15 Oct 2013. This report refers to a 64-year-old female patient. Historical drugs of this patient include atenolol, dyazide, hydrochlorothiazide, flu vaccine, lisinopril, nifedipine and simvastatin. Current condition of this patient includes hypertension, pre diabetes, obesity, hypercholesterolemia and cardiomegaly. Concomitant medications include acetaminophen, omeprazole, irbesartan and metoprolol. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. She developed allergic reaction to that vaccination on an unspecified date. Outcome of the event, seriousness and causality were not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Swelling
Clinical narrative: Case number PHHY2013US117547 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 490666) website on 15 Oct 2013. This case refers to a 41-year-old female patient. Her medical history included allergy to shellfish, peanuts and almonds, lupus, fibromyalgia, chronic pain and fatigue syndrome. Her concomitant medications were not reported. She was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as seasonal influenza vaccine INN) on an unknown date. On an unknown date after vaccination the patient developed swelling and erythema. The outcome, seriousness and causality assessment of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age, Urticaria
Clinical narrative: Case number PHHY2013US117745 is an initial report received from Vaccine Adverse Event Reporting System (VAERS reference number: 491207). This report refers to a female neonate patient. Current condition of this patient include gelatin allergy and allergic to varicella, DTaP and flu vaccines. She was vaccinated with her first seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date and she experienced hives and on an unknown date. Outcome of the event, seriousness and causality were not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 28-JAN-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J008433 and expiry date: 11-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 05-Nov-2014 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # K003597, expiration date: 12-MAR-2015), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This case was reported by a nurse and described the occurrence of extra dose administered in a patient who received HAVRIX. Previously admininstered products included HAVRIX (dose 1) and HAVRIX (dose 2). On 11th May 2014, the patient received the 3rd dose of HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information received: Nurse reported unspecified patient inadvertently received a 3rd dose of HAVRIX on 11 May 2014. No adverse event were reported. No further information was provided.
Age: 0.4
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received KINRIX (batch number 95ZT, expiry date 22nd October 2015). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of drug administration .On unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule pf drug administration were unknown. Additional information: The nurse reported that a 5 month old received a dose of KINRIX instead of the intended dose of INFANRIX.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 58 years old male patient with none pertinent medical history or drug reactions/allergies. In August 2013 the patient was vaccinated with the dose of ZOSTAVAX (lot# reported as K0112784, expiration date as 28-NOV-2015) in the left arm. Concomitant therapies included simvastatin (manufacturer unknown). On an unknown date the patient experienced pain "starting from the shoulder and down the arm". The patient did not seek medical attention, nor treatment was given. The outcome of was reported as not recovered/not resolved. Relatedness between vaccination and event was not reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Scab
Clinical narrative: This spontaneous report as received from medical assistant refers to a 80 year old female patient. Patient's concurrent conditions and relevant medical history was not reported. Drug reactions/allergies were reported as none. On an unknown date in May 2014 the patient was vaccinated with ZOSTAVAX (lot number, dose, route and frequency unspecified). Concomitant medications were not reported. Approximately on an unknown date in January 2015 (reported as 10 days ago) the patient developed as rash on right side of her chest, which progressively became painful. The patient sought medical attention by visiting the physician on 26-JAN-2015. The physician diagnosed the patient with shingles. The reporter stated that rash had begun to crust over as of patient's appointment on 26-JAN-2015. The patient was treated with TYLENOL for pain and BORAX application to rash. The outcome of shingles was unknown. The causality of the event with ZOSTAVAX was not reported. VZVIP packet was accepted and sent. Additional information has been requested.