chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: FLU3, HEP, TDAP
Symptoms: Computerised tomogram head normal, Computerised tomogram normal, Computerised tomogram pelvis, Culture stool negative, Culture urine negative
Clinical narrative: Patient reported receipt of routine vaccinations while in training with no adverse reactions on 9/10/2014, 10/10/2014 and 11/10/2014. On 3/25/2015 during 9-10am, he received Tdap (BOOSTRIX Lot#5SR2L), injectable influenza (FLUARIX-SK lot #2B472) and Hepatitis B #3 (ENGERIX-B-SK lot #M7JZ4). (Tdap was given as electronic immunization medical records documenting Td being administered 9/2014). Patient recalls onset of right parietal throbbing headache 4-7/10 and then a stabbing like pain to right upper quadrant midline under rib cage <10-15 min after the 3 vaccines that worsened over the next 1-2 hours. He recalls advising immunization staff and was sent to medical. He arrived in medical 3/25/2015 at 11:10 am (1-2 hour after vaccination) where he was diagnosed and treated for headache with NSAIDs and ZOFRAN with some relief (pain at 3-4/10). He described his headache starting as a dull then sharp throbbing pain with nausea. His RUQ pain was sharp (3-6/10) but nondescript with no know aggravating factors (breathing, moving, eating). He denied any visual changes, weakness, facial - neck pain, trauma, recent travel, recent illness/injuries, use of alcohol/drugs, does not smoke, or use of eye glasses or any recent dental care. On 3/27/2015 he returned to medical with persistent headache now lightheaded with nausea and vomiting (x1). He was treated with 1000cc NS, IV ZOFRAN and IM TORADOL and released with prescriptions. He advised while his headache and abdominal pain did decrease. Over the next 3 weeks, he reported neither pain went away. His advised he tolerates both taking medication only when severe while attending school and performing ADL. On 4/20/2015 he returned to medical after "passing out" with worsening headache and expansion of his abdominal pain from RUQ to RLQ. He was transferred to ER for possible appendicitis. An ultrasound and CT of his abdomen/pelvis were normal with no signs of cholecystitis, or appendicitis. He was released with his pain easing with NORCO and ZOFRAN to 3/10. Over the next week he continued to experience both headache (right sided only) and RUQ abdominal pain being able to attend school, eat and exercise. He reported passing out x 2 when head and abdominal pain became severe together. He stated he would stand to leave area which resulted in him "passing out". Witness to these events reported what looked like seizure like activity. His seizures were described as him staring, blacking out, muscles tensing for few seconds and when muscles relaxed he awoke fully aware of where he was. He stated he felt like he just woke up from sleep. There was no report of incontinence during this event or fatigue post event. He did report falling x 1 on 4/27/2015 hitting the right side of head and was again sent to nearby ER for further evaluation and transferred to another hospital for admission.
Age: 19.0
Sex: M
Vaccine: FLU3, HEP, TDAP
Symptoms: Dizziness, Ejection fraction normal, Electrocardiogram normal, Fall, Full blood count normal
Clinical narrative: Patient reported receipt of routine vaccinations while in training with no adverse reactions on 9/10/2014, 10/10/2014 and 11/10/2014. On 3/25/2015 during 9-10am, he received Tdap (BOOSTRIX Lot#5SR2L), injectable influenza (FLUARIX-SK lot #2B472) and Hepatitis B #3 (ENGERIX-B-SK lot #M7JZ4). (Tdap was given as electronic immunization medical records documenting Td being administered 9/2014). Patient recalls onset of right parietal throbbing headache 4-7/10 and then a stabbing like pain to right upper quadrant midline under rib cage <10-15 min after the 3 vaccines that worsened over the next 1-2 hours. He recalls advising immunization staff and was sent to medical. He arrived in medical 3/25/2015 at 11:10 am (1-2 hour after vaccination) where he was diagnosed and treated for headache with NSAIDs and ZOFRAN with some relief (pain at 3-4/10). He described his headache starting as a dull then sharp throbbing pain with nausea. His RUQ pain was sharp (3-6/10) but nondescript with no know aggravating factors (breathing, moving, eating). He denied any visual changes, weakness, facial - neck pain, trauma, recent travel, recent illness/injuries, use of alcohol/drugs, does not smoke, or use of eye glasses or any recent dental care. On 3/27/2015 he returned to medical with persistent headache now lightheaded with nausea and vomiting (x1). He was treated with 1000cc NS, IV ZOFRAN and IM TORADOL and released with prescriptions. He advised while his headache and abdominal pain did decrease. Over the next 3 weeks, he reported neither pain went away. His advised he tolerates both taking medication only when severe while attending school and performing ADL. On 4/20/2015 he returned to medical after "passing out" with worsening headache and expansion of his abdominal pain from RUQ to RLQ. He was transferred to ER for possible appendicitis. An ultrasound and CT of his abdomen/pelvis were normal with no signs of cholecystitis, or appendicitis. He was released with his pain easing with NORCO and ZOFRAN to 3/10. Over the next week he continued to experience both headache (right sided only) and RUQ abdominal pain being able to attend school, eat and exercise. He reported passing out x 2 when head and abdominal pain became severe together. He stated he would stand to leave area which resulted in him "passing out". Witness to these events reported what looked like seizure like activity. His seizures were described as him staring, blacking out, muscles tensing for few seconds and when muscles relaxed he awoke fully aware of where he was. He stated he felt like he just woke up from sleep. There was no report of incontinence during this event or fatigue post event. He did report falling x 1 on 4/27/2015 hitting the right side of head and was again sent to nearby ER for further evaluation and transferred to another hospital for admission.
Age: 19.0
Sex: M
Vaccine: FLU3, HEP, TDAP
Symptoms: Head injury, Headache, Hepatitis A virus test, Hepatitis B test negative, Hepatitis C virus test
Clinical narrative: Patient reported receipt of routine vaccinations while in training with no adverse reactions on 9/10/2014, 10/10/2014 and 11/10/2014. On 3/25/2015 during 9-10am, he received Tdap (BOOSTRIX Lot#5SR2L), injectable influenza (FLUARIX-SK lot #2B472) and Hepatitis B #3 (ENGERIX-B-SK lot #M7JZ4). (Tdap was given as electronic immunization medical records documenting Td being administered 9/2014). Patient recalls onset of right parietal throbbing headache 4-7/10 and then a stabbing like pain to right upper quadrant midline under rib cage <10-15 min after the 3 vaccines that worsened over the next 1-2 hours. He recalls advising immunization staff and was sent to medical. He arrived in medical 3/25/2015 at 11:10 am (1-2 hour after vaccination) where he was diagnosed and treated for headache with NSAIDs and ZOFRAN with some relief (pain at 3-4/10). He described his headache starting as a dull then sharp throbbing pain with nausea. His RUQ pain was sharp (3-6/10) but nondescript with no know aggravating factors (breathing, moving, eating). He denied any visual changes, weakness, facial - neck pain, trauma, recent travel, recent illness/injuries, use of alcohol/drugs, does not smoke, or use of eye glasses or any recent dental care. On 3/27/2015 he returned to medical with persistent headache now lightheaded with nausea and vomiting (x1). He was treated with 1000cc NS, IV ZOFRAN and IM TORADOL and released with prescriptions. He advised while his headache and abdominal pain did decrease. Over the next 3 weeks, he reported neither pain went away. His advised he tolerates both taking medication only when severe while attending school and performing ADL. On 4/20/2015 he returned to medical after "passing out" with worsening headache and expansion of his abdominal pain from RUQ to RLQ. He was transferred to ER for possible appendicitis. An ultrasound and CT of his abdomen/pelvis were normal with no signs of cholecystitis, or appendicitis. He was released with his pain easing with NORCO and ZOFRAN to 3/10. Over the next week he continued to experience both headache (right sided only) and RUQ abdominal pain being able to attend school, eat and exercise. He reported passing out x 2 when head and abdominal pain became severe together. He stated he would stand to leave area which resulted in him "passing out". Witness to these events reported what looked like seizure like activity. His seizures were described as him staring, blacking out, muscles tensing for few seconds and when muscles relaxed he awoke fully aware of where he was. He stated he felt like he just woke up from sleep. There was no report of incontinence during this event or fatigue post event. He did report falling x 1 on 4/27/2015 hitting the right side of head and was again sent to nearby ER for further evaluation and transferred to another hospital for admission.
Age: 19.0
Sex: M
Vaccine: FLU3, HEP, TDAP
Symptoms: Hepatitis viral test negative, Lipase normal, Liver function test normal, Loss of consciousness, Metabolic function test normal
Clinical narrative: Patient reported receipt of routine vaccinations while in training with no adverse reactions on 9/10/2014, 10/10/2014 and 11/10/2014. On 3/25/2015 during 9-10am, he received Tdap (BOOSTRIX Lot#5SR2L), injectable influenza (FLUARIX-SK lot #2B472) and Hepatitis B #3 (ENGERIX-B-SK lot #M7JZ4). (Tdap was given as electronic immunization medical records documenting Td being administered 9/2014). Patient recalls onset of right parietal throbbing headache 4-7/10 and then a stabbing like pain to right upper quadrant midline under rib cage <10-15 min after the 3 vaccines that worsened over the next 1-2 hours. He recalls advising immunization staff and was sent to medical. He arrived in medical 3/25/2015 at 11:10 am (1-2 hour after vaccination) where he was diagnosed and treated for headache with NSAIDs and ZOFRAN with some relief (pain at 3-4/10). He described his headache starting as a dull then sharp throbbing pain with nausea. His RUQ pain was sharp (3-6/10) but nondescript with no know aggravating factors (breathing, moving, eating). He denied any visual changes, weakness, facial - neck pain, trauma, recent travel, recent illness/injuries, use of alcohol/drugs, does not smoke, or use of eye glasses or any recent dental care. On 3/27/2015 he returned to medical with persistent headache now lightheaded with nausea and vomiting (x1). He was treated with 1000cc NS, IV ZOFRAN and IM TORADOL and released with prescriptions. He advised while his headache and abdominal pain did decrease. Over the next 3 weeks, he reported neither pain went away. His advised he tolerates both taking medication only when severe while attending school and performing ADL. On 4/20/2015 he returned to medical after "passing out" with worsening headache and expansion of his abdominal pain from RUQ to RLQ. He was transferred to ER for possible appendicitis. An ultrasound and CT of his abdomen/pelvis were normal with no signs of cholecystitis, or appendicitis. He was released with his pain easing with NORCO and ZOFRAN to 3/10. Over the next week he continued to experience both headache (right sided only) and RUQ abdominal pain being able to attend school, eat and exercise. He reported passing out x 2 when head and abdominal pain became severe together. He stated he would stand to leave area which resulted in him "passing out". Witness to these events reported what looked like seizure like activity. His seizures were described as him staring, blacking out, muscles tensing for few seconds and when muscles relaxed he awoke fully aware of where he was. He stated he felt like he just woke up from sleep. There was no report of incontinence during this event or fatigue post event. He did report falling x 1 on 4/27/2015 hitting the right side of head and was again sent to nearby ER for further evaluation and transferred to another hospital for admission.
Age: 19.0
Sex: M
Vaccine: FLU3, HEP, TDAP
Symptoms: Muscle tightness, Nausea, Seizure like phenomena, Spinal X-ray, Spinal X-ray normal
Clinical narrative: Patient reported receipt of routine vaccinations while in training with no adverse reactions on 9/10/2014, 10/10/2014 and 11/10/2014. On 3/25/2015 during 9-10am, he received Tdap (BOOSTRIX Lot#5SR2L), injectable influenza (FLUARIX-SK lot #2B472) and Hepatitis B #3 (ENGERIX-B-SK lot #M7JZ4). (Tdap was given as electronic immunization medical records documenting Td being administered 9/2014). Patient recalls onset of right parietal throbbing headache 4-7/10 and then a stabbing like pain to right upper quadrant midline under rib cage <10-15 min after the 3 vaccines that worsened over the next 1-2 hours. He recalls advising immunization staff and was sent to medical. He arrived in medical 3/25/2015 at 11:10 am (1-2 hour after vaccination) where he was diagnosed and treated for headache with NSAIDs and ZOFRAN with some relief (pain at 3-4/10). He described his headache starting as a dull then sharp throbbing pain with nausea. His RUQ pain was sharp (3-6/10) but nondescript with no know aggravating factors (breathing, moving, eating). He denied any visual changes, weakness, facial - neck pain, trauma, recent travel, recent illness/injuries, use of alcohol/drugs, does not smoke, or use of eye glasses or any recent dental care. On 3/27/2015 he returned to medical with persistent headache now lightheaded with nausea and vomiting (x1). He was treated with 1000cc NS, IV ZOFRAN and IM TORADOL and released with prescriptions. He advised while his headache and abdominal pain did decrease. Over the next 3 weeks, he reported neither pain went away. His advised he tolerates both taking medication only when severe while attending school and performing ADL. On 4/20/2015 he returned to medical after "passing out" with worsening headache and expansion of his abdominal pain from RUQ to RLQ. He was transferred to ER for possible appendicitis. An ultrasound and CT of his abdomen/pelvis were normal with no signs of cholecystitis, or appendicitis. He was released with his pain easing with NORCO and ZOFRAN to 3/10. Over the next week he continued to experience both headache (right sided only) and RUQ abdominal pain being able to attend school, eat and exercise. He reported passing out x 2 when head and abdominal pain became severe together. He stated he would stand to leave area which resulted in him "passing out". Witness to these events reported what looked like seizure like activity. His seizures were described as him staring, blacking out, muscles tensing for few seconds and when muscles relaxed he awoke fully aware of where he was. He stated he felt like he just woke up from sleep. There was no report of incontinence during this event or fatigue post event. He did report falling x 1 on 4/27/2015 hitting the right side of head and was again sent to nearby ER for further evaluation and transferred to another hospital for admission.
Age: 19.0
Sex: M
Vaccine: FLU3, HEP, TDAP
Symptoms: Staring, Treponema test negative, Ultrasound abdomen normal, Ultrasound pelvis normal, Urine analysis normal
Clinical narrative: Patient reported receipt of routine vaccinations while in training with no adverse reactions on 9/10/2014, 10/10/2014 and 11/10/2014. On 3/25/2015 during 9-10am, he received Tdap (BOOSTRIX Lot#5SR2L), injectable influenza (FLUARIX-SK lot #2B472) and Hepatitis B #3 (ENGERIX-B-SK lot #M7JZ4). (Tdap was given as electronic immunization medical records documenting Td being administered 9/2014). Patient recalls onset of right parietal throbbing headache 4-7/10 and then a stabbing like pain to right upper quadrant midline under rib cage <10-15 min after the 3 vaccines that worsened over the next 1-2 hours. He recalls advising immunization staff and was sent to medical. He arrived in medical 3/25/2015 at 11:10 am (1-2 hour after vaccination) where he was diagnosed and treated for headache with NSAIDs and ZOFRAN with some relief (pain at 3-4/10). He described his headache starting as a dull then sharp throbbing pain with nausea. His RUQ pain was sharp (3-6/10) but nondescript with no know aggravating factors (breathing, moving, eating). He denied any visual changes, weakness, facial - neck pain, trauma, recent travel, recent illness/injuries, use of alcohol/drugs, does not smoke, or use of eye glasses or any recent dental care. On 3/27/2015 he returned to medical with persistent headache now lightheaded with nausea and vomiting (x1). He was treated with 1000cc NS, IV ZOFRAN and IM TORADOL and released with prescriptions. He advised while his headache and abdominal pain did decrease. Over the next 3 weeks, he reported neither pain went away. His advised he tolerates both taking medication only when severe while attending school and performing ADL. On 4/20/2015 he returned to medical after "passing out" with worsening headache and expansion of his abdominal pain from RUQ to RLQ. He was transferred to ER for possible appendicitis. An ultrasound and CT of his abdomen/pelvis were normal with no signs of cholecystitis, or appendicitis. He was released with his pain easing with NORCO and ZOFRAN to 3/10. Over the next week he continued to experience both headache (right sided only) and RUQ abdominal pain being able to attend school, eat and exercise. He reported passing out x 2 when head and abdominal pain became severe together. He stated he would stand to leave area which resulted in him "passing out". Witness to these events reported what looked like seizure like activity. His seizures were described as him staring, blacking out, muscles tensing for few seconds and when muscles relaxed he awoke fully aware of where he was. He stated he felt like he just woke up from sleep. There was no report of incontinence during this event or fatigue post event. He did report falling x 1 on 4/27/2015 hitting the right side of head and was again sent to nearby ER for further evaluation and transferred to another hospital for admission.
Age: 19.0
Sex: M
Vaccine: FLU3, HEP, TDAP
Symptoms: Vomiting
Clinical narrative: Patient reported receipt of routine vaccinations while in training with no adverse reactions on 9/10/2014, 10/10/2014 and 11/10/2014. On 3/25/2015 during 9-10am, he received Tdap (BOOSTRIX Lot#5SR2L), injectable influenza (FLUARIX-SK lot #2B472) and Hepatitis B #3 (ENGERIX-B-SK lot #M7JZ4). (Tdap was given as electronic immunization medical records documenting Td being administered 9/2014). Patient recalls onset of right parietal throbbing headache 4-7/10 and then a stabbing like pain to right upper quadrant midline under rib cage <10-15 min after the 3 vaccines that worsened over the next 1-2 hours. He recalls advising immunization staff and was sent to medical. He arrived in medical 3/25/2015 at 11:10 am (1-2 hour after vaccination) where he was diagnosed and treated for headache with NSAIDs and ZOFRAN with some relief (pain at 3-4/10). He described his headache starting as a dull then sharp throbbing pain with nausea. His RUQ pain was sharp (3-6/10) but nondescript with no know aggravating factors (breathing, moving, eating). He denied any visual changes, weakness, facial - neck pain, trauma, recent travel, recent illness/injuries, use of alcohol/drugs, does not smoke, or use of eye glasses or any recent dental care. On 3/27/2015 he returned to medical with persistent headache now lightheaded with nausea and vomiting (x1). He was treated with 1000cc NS, IV ZOFRAN and IM TORADOL and released with prescriptions. He advised while his headache and abdominal pain did decrease. Over the next 3 weeks, he reported neither pain went away. His advised he tolerates both taking medication only when severe while attending school and performing ADL. On 4/20/2015 he returned to medical after "passing out" with worsening headache and expansion of his abdominal pain from RUQ to RLQ. He was transferred to ER for possible appendicitis. An ultrasound and CT of his abdomen/pelvis were normal with no signs of cholecystitis, or appendicitis. He was released with his pain easing with NORCO and ZOFRAN to 3/10. Over the next week he continued to experience both headache (right sided only) and RUQ abdominal pain being able to attend school, eat and exercise. He reported passing out x 2 when head and abdominal pain became severe together. He stated he would stand to leave area which resulted in him "passing out". Witness to these events reported what looked like seizure like activity. His seizures were described as him staring, blacking out, muscles tensing for few seconds and when muscles relaxed he awoke fully aware of where he was. He stated he felt like he just woke up from sleep. There was no report of incontinence during this event or fatigue post event. He did report falling x 1 on 4/27/2015 hitting the right side of head and was again sent to nearby ER for further evaluation and transferred to another hospital for admission.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a male patient of unknown age refers to himself. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, route of administration, lot# and expiry date unspecified). No concomitant medications were updated. On an unknown date, after receiving ZOSTAVAX, the patient experienced a painful red spot at the injection site. The outcome of the events was unknown. The relatedness between the events and the ZOSTAVAX was not reported. Additional information is not expected as there is no patient and physician's contact information and we could not do follow up with them.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 7 year old patient of an unknown gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. ON an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number were not provided). Concomitant medication was not provided. On an unknown date, the patient was diagnosed with shingles after received VARIVAX (Merck). At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Arthralgia, Chest wall mass, Nuclear magnetic resonance imaging thoracic
Clinical narrative: Chest wall mass. Joint aches.
Age: 45.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Hepatitis vaccine 2nd dose was given early as schedule.
Age: 1.03
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Rash
Clinical narrative: Rash behind ears, neck, trunk rash started 5-3-15 approx 10 days after immunizations administered.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug hypersensitivity, Injection site reaction, Rash vesicular
Clinical narrative: Information has been received from a pharmacist and a nurse referring to a 68 year old female patient. No concurrent or historical conditions were provided. On 14-APR-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml once subcutaneous (lot # K016318, expiration date 24-DEC-2015). Concomitant therapy included levothyroxine sodium. On 15-APR-2015, the patient developed a varicella-like rash at the injection site after ZOSTAVAX was administered. The nurse also reported that patient experienced an unspecified reaction to an unspecified formulation of DARVON, SULFA (manufacturer unspecified).The patient sought medical attention at the pharmacy without any treatment and lab tests. The outcome of varicella-like rash at the injection site was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
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. On 29-APR-2015 the patient was vaccinated with a dose of ROTATEQ (oral, strength, lot#, dose were unspecified) that was stored improperly. No adverse effects reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 1-year-old female patient who received ENGERIX B (batch number 7FN99, expiry date 4th April 2016). Co-suspect products included PEDIARIX (batch number NK947, expiry date 5th September 2016). On an unknown date, the patient received ENGERIX B (intramuscular) .5 ml and PEDIARIX (intramuscular) .5 ml. On an unknown date, an unknown time after receiving ENGERIX B and PEDIARIX, the patient experienced inappropriate schedule of vaccine administered, accidental overdose and wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered, accidental overdose and wrong vaccine administered were unknown. Additional information: Nurse reported giving PEDIARIX with ENGERIX-B instead of PENTACEL which led to maladministrations inappropriate schedule of vaccine administered, accidental overdose and wrong vaccine administered. No adverse event reported.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: After 5 minutes of receiving shots (MCV4 and HPV), patient started to feel dizzy, pt was taken to an exam room and there patient fainted. Kept ger in the room for another five minutes, pt stated she was feeling better and was ready to leave, informed patient to wait in the waiting room for an additional ten minutes. After 10 minutes pt stated feeling nauseous, took her back to an exam room, pt started vomiting, and feeling dizzy again, had pt lay down for another few minutes, check B/P, and vitals patient was stable. Patient waited for another 20 minutes, started feeling better and was sent home.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Induration, Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: On 4-30-15 this patient received KINRIX on right deltoid area. Within 24 hours of the administration of the vaccine, patient developed a 3" x 3" area of redness, local warmth and swelling of 2/3 of right upper arm. She also had local tenderness with mild induration. Moderate fever. Treatment with warm compresses and Acetaminophen every 4 hours. Patient was evaluated at the ED on 5-3-15. On 5-4-15 I saw the patient, the swelling, redness and induration had resolved 50% as compared with picture taken by parent on 5-3-15.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a healthcare worker and a vendor referring to a patient of unknown age and gender. On unknown dates, the patient was vaccinated with his/her first, second and third dose of RECOMBIVAX HB (strength, route, lot#, expiration date and dose were unknown). On an unspecified date, the patient had negative Hepatitis B titers after receiving a full series of RECOMBIVAX HB. The outcome of the adverse event was unknown. The relationship of the adverse event and RECOMBIVAX HB was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy test positive, Anaphylactic reaction, Dyspnoea, Erythema, Eye swelling
Clinical narrative: Referral received for evaluation of anaphylactic reaction after Tdap. Seen by allergist at facility who referred to Allergy Department. This  23 year old female advised she received required BOOSTRIX for school on 3/21/2015 at a pharmacy. She denied any recent  or current health issues. Approximately 2 hours later approximately 1 mile or 15 minutes into her jog, she noticed her palms were itching and her hands felt puffy. This sensation continued spreading to both arms, ankles, face (eyes, lips, ears, oral mucosa), with itchy puffy throat and she felt short of breath. She stopped jogging and was unable to restart and quickly walked home where her mother drove her immediately to nearby Acute Care Clinic. Providers advised her she was bright red (skin flushed from head-toe), and was treated with epinephrine, steroids and BENADRYL (weather was 50-60 degree's cloudy). She was monitored for one hour and released home where symptoms ("swelling-hives) fully resolved 2-3 days later. She advised over next few weeks, if she stopped using her antihistamine ( CLARITIN or BENADRYL) then the "hives" would return. Her "hives" fully resolved approximately 4/15/2015. She advised on 4/29/2015 she began to work out again and she felt her eyes begin to swell (like above incident). She denied any extremity swelling; however she stopped exercising and took a BENADRYL with resolution of symptoms. She has followed up with an allergist at facility and has been identified to have various environmental and food allergies (Bermuda, grass, Johnson grass, Kentucky Blue grass, cat dander, ragweed, Pistachio). Medical record review: 6/16/2015 c/o hives allover body x 10 hours after a workout (in high school). Her exam documented multiple small macular erythematous lesions on torso and she was diagnosed with urticaria.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Food allergy, Hypersensitivity, Peripheral swelling, Pharyngeal oedema
Clinical narrative: Referral received for evaluation of anaphylactic reaction after Tdap. Seen by allergist at facility who referred to Allergy Department. This  23 year old female advised she received required BOOSTRIX for school on 3/21/2015 at a pharmacy. She denied any recent  or current health issues. Approximately 2 hours later approximately 1 mile or 15 minutes into her jog, she noticed her palms were itching and her hands felt puffy. This sensation continued spreading to both arms, ankles, face (eyes, lips, ears, oral mucosa), with itchy puffy throat and she felt short of breath. She stopped jogging and was unable to restart and quickly walked home where her mother drove her immediately to nearby Acute Care Clinic. Providers advised her she was bright red (skin flushed from head-toe), and was treated with epinephrine, steroids and BENADRYL (weather was 50-60 degree's cloudy). She was monitored for one hour and released home where symptoms ("swelling-hives) fully resolved 2-3 days later. She advised over next few weeks, if she stopped using her antihistamine ( CLARITIN or BENADRYL) then the "hives" would return. Her "hives" fully resolved approximately 4/15/2015. She advised on 4/29/2015 she began to work out again and she felt her eyes begin to swell (like above incident). She denied any extremity swelling; however she stopped exercising and took a BENADRYL with resolution of symptoms. She has followed up with an allergist at facility and has been identified to have various environmental and food allergies (Bermuda, grass, Johnson grass, Kentucky Blue grass, cat dander, ragweed, Pistachio). Medical record review: 6/16/2015 c/o hives allover body x 10 hours after a workout (in high school). Her exam documented multiple small macular erythematous lesions on torso and she was diagnosed with urticaria.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash macular, Throat irritation, Tryptase, Urticaria
Clinical narrative: Referral received for evaluation of anaphylactic reaction after Tdap. Seen by allergist at facility who referred to Allergy Department. This  23 year old female advised she received required BOOSTRIX for school on 3/21/2015 at a pharmacy. She denied any recent  or current health issues. Approximately 2 hours later approximately 1 mile or 15 minutes into her jog, she noticed her palms were itching and her hands felt puffy. This sensation continued spreading to both arms, ankles, face (eyes, lips, ears, oral mucosa), with itchy puffy throat and she felt short of breath. She stopped jogging and was unable to restart and quickly walked home where her mother drove her immediately to nearby Acute Care Clinic. Providers advised her she was bright red (skin flushed from head-toe), and was treated with epinephrine, steroids and BENADRYL (weather was 50-60 degree's cloudy). She was monitored for one hour and released home where symptoms ("swelling-hives) fully resolved 2-3 days later. She advised over next few weeks, if she stopped using her antihistamine ( CLARITIN or BENADRYL) then the "hives" would return. Her "hives" fully resolved approximately 4/15/2015. She advised on 4/29/2015 she began to work out again and she felt her eyes begin to swell (like above incident). She denied any extremity swelling; however she stopped exercising and took a BENADRYL with resolution of symptoms. She has followed up with an allergist at facility and has been identified to have various environmental and food allergies (Bermuda, grass, Johnson grass, Kentucky Blue grass, cat dander, ragweed, Pistachio). Medical record review: 6/16/2015 c/o hives allover body x 10 hours after a workout (in high school). Her exam documented multiple small macular erythematous lesions on torso and she was diagnosed with urticaria.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker via company representative refers to an approximately 65 year old patient of unknown gender. No medical history was reported. On 13-MAR-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # J015868, exp. date 25-FEB-2015) (0.5 ml, intramuscular). No concomitant therapy was reported. It was reported that pneumococcal vaccine was administered post expiry. No adverse effects were reported. The outcome of the events was unknown. The events were considered to be not related to PNEUMOVAX 23. No product quality issue was involved. Additional information has been requested.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Case number PHHY2015US031389, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554111) website on 16 Mar 2015 and with follow up information received from the quality assurance department (reference number: 358290) on 18 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 358290) on 08 Apr 2015. This report refers to a male patient of unspecified age. Concurrent condition included diabetes. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 14554P), along with PNEUMOVAX (other manufacturer, batch number: K0070662) into the left arm on 15 Nov 2014. On 17 Nov 2014, the patient developed cellulitis. The outcome of the event was unknown. The event was assessed as non-serious. The causality assessment of the event was not reported. Seriousness assessment of the event cellulitis was upgraded based on NVS-IME list. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 14554P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 358290) on 18 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 358290) on 08 Apr 2015: Updated FLUVIRIN batch review report.
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Purulent discharge
Clinical narrative: Case number PHHY2015US033464, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555635) website on 16 Mar 2015 and with follow up information received from the quality assurance department (reference number: 359342) on 23 Mar 2015, with the follow-up information received from Quality Assurance Department  (reference number: 359342) on 02 Apr 2015. This report refers to a 49-year-old female patient. Concurrent conditions included diabetes and hypertension. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 1421401) intramuscularly into the left arm on 17 Nov 2014. On the same day after vaccination, the patient had swollen arm and it was producing pus. The patient went to a doctor's office and the patient was now on treatment with antibiotics with arm in sling. The outcome of the events was complete recovery. The events were assessed as non-serious. The causality assessment of the events was not reported. Seriousness assessment of event "swollen arm, producing pus" was upgraded based on information available in source document. QA department stated that, as no batch number is reported, this batch review was performed based on a general review of the quality requirements for FLUVIRIN 2014/2015 and the Annual Product Review for the FLUVIRIN 2013, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Non-significant follow up information received from the quality assurance department (reference number: 359342) on 23 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 359342) on 02 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Systemic inflammatory response syndrome, Tachycardia
Clinical narrative: Case number PHHY2015US0318867, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 555842) website on 16 Mar 2015 and with follow up information received from the quality assurance department (reference number: 359205) on 23 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 359205) on 02 Apr 2015. This report refers to a 55-years-old male patient. The patient's medical history included pneumothorax in 1987 and current condition included polysubstance detoxification. Concomitant medications included methadone and clonazepam. The patient was vaccinated with FLUVIRIN (batch number: unknown) into the left arm intramuscularly, along with PNEUMOVAX (other manufacturer, batch number: 6680) into the left arm intramuscularly on 24 Nov 2014. On 25 Nov 2014, the patient developed swelling and pain at injection site. Later, the patient experienced tachycardia and fever which lead to the diagnosis of SIRS (systemic inflammatory response syndrome). The patient was hospitalized on an unspecified date. The outcome and causality of the events were not reported. QA department stated that, as the reported batch number is incorrect (1462), this batch review was performed based on a general review of the quality requirements for FLUVIRIN 2014/2015 and the Annual Product Review for the FLUVIRIN 2013, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes of FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Non-significant follow up information received from the quality assurance department (reference number: 359205) on 23 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 359205) on 02 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Infection, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Case number PHHY2015US033202, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 557427) website on 16 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 359542) on 20 Apr 2015. This report refers to a 51-year-old female patient. Medical history and concomitant medications were not reported. On 04 Dec 2014, she was vaccinated with FLUVIRIN (batch number: 1414001) and PNEUMOVAX (other manufacturer, batch number KG10455), both into left arm. On 05 Dec 2014, the patient's left arm was swollen, red, hot and tender. Due to this patient went to ER. The physician prescribed AUGMENTIN for a suspected infection. Outcome of the events was condition unchanged. The events were assessed as non-serious. Causality of the events was not reported. Seriousness assessment of suspected infection was upgraded based on the available information in the source document. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1414001) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up information received from the Quality Assurance Department (reference number: 359542) on 20 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV2, MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2015US033317, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 557812) website on 16 Mar 2015 and with follow up information received from the quality assurance department (QA reference number: 360045) on 25 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 360045) on 21 Apr 2015. This report refers to a 11-year-old female patient. Her historical conditions and concomitant medication were none. She was vaccinated with MENVEO (batch number: M14040 and expiry date: Jul 2015) on left arm along with FLUARIX (other manufacturer and batch number: F45P5) on left arm and CERVARIX (other manufacturer and batch number: PH43F) on right arm on 08 Dec 2014. On 09 Dec 2014, the patient experienced cellulitis at injection site (left arm). She was treated with Cephalexin 500 mg orally thrice daily. Final outcome of the event reported as recovered. Seriousness of the event reported as non-serious. Causality of the event was not reported. Seriousness of the event vaccination site cellulitis was upgraded based on NVS-IME list. Based on the investigation performed, the QA department stated that, MENVEO (batch number: M14040) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 360045) on 25 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 360045) on 21 Apr 2015: Updated MENVEO batch review report.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Periarthritis
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 63 year old female patient. The patient had medical history of HLD (hyperlipidemia) and hypothyroidism. Her concomitant medications included 'ARMOUR thyroid' and atorvastatin. On 09-Oct-2014, the patient received intramuscular AFLURIA injection (batch number not reported). On 10-Oct-2014, the patient experienced frozen shoulder in the receptive arm and range of motion limited above and below shoulder beginning a few days after vaccination. Patient was receiving PT (Physical Therapy). Outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 50 year old male patient. On the 02-Nov-2014, the patient received AFLURIA injection (batch number T52308) via the intramuscular route at an unknown site. On the 03-Nov-2014, after 24 hours of vaccination, the patient's right side of his face, eye and right hand were swollen badly. The swelling slowly went down and vanished after two days. The patient did not go to see the doctor during this period. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Eye swelling, Peripheral swelling, Swelling face
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 50 year old male patient. On the 02-Nov-2014, the patient received AFLURIA injection (batch number T52308) via the intramuscular route at an unknown site. On the 03-Nov-2014, after 24 hours of vaccination, the patient's right side of his face, eye and right hand were swollen badly. The swelling slowly went down and vanished after two days. The patient did not go to see the doctor during this period. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Dyskinesia, Hypoaesthesia, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 22 year old female patient who had no current illness. On the 13-Jan-2015, the patient received AFLURIA injection (batch number 'T53609A') via an unknown route in the left arm. On the 14-Jan-2015 in the AM (morning), the patient complained of numbness/tingling in the hands but this quickly resolved. The patient participated in a swim practice on the 14-Jan-2015 and left arm flapping occurred. She stated that this did not stop unless she squeezed a stress ball. It did not occur during sleep. On the 15-Jan-2015, the patient lifted weights and participated in a swim practice. On the 16-Jan-2015, the patient attended an ER (Emergency Room) and was told it was stress related. The patient underwent an MRI (Magnetic Resonance Imaging), UA (Urine Analysis) and blood work. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported the symptoms of 'blood test', 'Nuclear Magnetic Resonance Imaging' and urine 'analysis'.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Stress, Urine analysis
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 22 year old female patient who had no current illness. On the 13-Jan-2015, the patient received AFLURIA injection (batch number 'T53609A') via an unknown route in the left arm. On the 14-Jan-2015 in the AM (morning), the patient complained of numbness/tingling in the hands but this quickly resolved. The patient participated in a swim practice on the 14-Jan-2015 and left arm flapping occurred. She stated that this did not stop unless she squeezed a stress ball. It did not occur during sleep. On the 15-Jan-2015, the patient lifted weights and participated in a swim practice. On the 16-Jan-2015, the patient attended an ER (Emergency Room) and was told it was stress related. The patient underwent an MRI (Magnetic Resonance Imaging), UA (Urine Analysis) and blood work. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported the symptoms of 'blood test', 'Nuclear Magnetic Resonance Imaging' and urine 'analysis'.