chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPVX, MNQ
Symptoms: Dizziness, Feeling abnormal, Injection site pain, Syncope, Unresponsive to stimuli
Clinical narrative: Patient became unresponsive and fainted for several minutes within a few minutes of receiving meningitis and hpv vaccines. She continued to complain of a spacey/ dizzy feeling for several hours as well as pain at the injection site.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Morbilliform rash.
Age: 0.33
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abdominal pain upper, Crying, Diarrhoea, Lethargy, Pain
Clinical narrative: Advised has contracted rotavirus by urgent care clinic. Stomach pain, lethargy, painful crying, diarreah, and vomiting.
Age: 0.33
Sex: M
Vaccine: DTAP, IPV
Symptoms: Rotavirus infection, Vomiting
Clinical narrative: Advised has contracted rotavirus by urgent care clinic. Stomach pain, lethargy, painful crying, diarreah, and vomiting.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Axillary pain, Chest pain, Headache, Injection site erythema
Clinical narrative: Severe arm pain and redness at injection site, pain extending under the arm and into the chest wall left breast area. Fever 100.5, muscle and joint pain interfering with ADLs. Headache x48 hours.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: Severe arm pain and redness at injection site, pain extending under the arm and into the chest wall left breast area. Fever 100.5, muscle and joint pain interfering with ADLs. Headache x48 hours.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of erythema in a 17-year-old female patient who received MENVEO (batch number M16075, expiry date 31st March 2018). On 16th March 2017, the patient received MENVEO (intramuscular) .5 ml. On 16th March 2017, less than an hour after receiving MENVEO, the patient experienced erythema. The patient was treated with triamcinolone and non-drug therapy (Cold Compress). In March 2017, the outcome of the erythema was recovered/resolved. The reporter considered the erythema to be related to MENVEO. Additional details were reported as follows: The nurse reported that the patient experienced 6 cm red erythema area within 20 minutes of receiving MENVEO. Cold compresses and Triamcinolone cream 0.1 percent was applied 3 times daily for 10 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site redness in a 4-year-old female patient who received KINRIX (batch number 2AG24, expiry date 10th September 2017). On 27th March 2017, the patient received KINRIX (intramuscular) .5 ml. In March 2017, less than a week after receiving KINRIX, the patient experienced injection site redness, injection site swelling, injection site warmth and injection site tenderness. On 27th March 2017, the patient experienced vaccine administered at inappropriate site. The patient was treated with ibuprofen and non-drug therapy (Warm Compress). On an unknown date, the outcome of the injection site redness, injection site swelling, injection site warmth, injection site tenderness and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site redness, injection site swelling, injection site warmth and injection site tenderness to be related to KINRIX. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by a medical assistant. The patient received KINRIX vaccine as a 5th DTAP and 4th IPV dose in right thigh, which led to an inappropriate site of vaccination. Two days after vaccination, the patient's mother contacted the physician office and reported redness, swelling, warmth and tenderness at the injection site. The patient was seen by the physician the day before reporting date also and recommended to take ibuprofen and follow up on the next day. The warm compresses might be recommended if needed, as determined by the symptoms at that time.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood pressure increased, Cold sweat, Dizziness, Feeling cold, Syncope
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of syncope in a 18-year-old female patient who received BEXSERO. Concomitant products included MENACTRA. On 29th March 2017 10:00, the patient received the 1st dose of BEXSERO. On 29th March 2017 12:00, 2 hrs after receiving BEXSERO, the patient experienced syncope, feeling cold, clamminess, dizziness and tremor. On 29th March 2017, the outcome of the syncope was recovering/resolving. On an unknown date, the outcome of the feeling cold, clamminess, dizziness and tremor to be related to BEXSERO. Additional details were reported as follows: The patient received BEXSERO and MENACTRA one in each arm, location of each vaccine was not reported. The patient returned to school at approximately 12 noon reported feeling cold, clammy, dizzy and shaky. The patient was referred to the school nurse and returned to her physician's office. On 29th March 2017, elevated blood pressure was noted at the physician office. The patient was sent home with family and noted to be a little shaky at the time of discharge. No additional treatment was noted. The lot numbers and expiration dates of vaccines were not reported. No addition treatment was reported.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Tremor
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of syncope in a 18-year-old female patient who received BEXSERO. Concomitant products included MENACTRA. On 29th March 2017 10:00, the patient received the 1st dose of BEXSERO. On 29th March 2017 12:00, 2 hrs after receiving BEXSERO, the patient experienced syncope, feeling cold, clamminess, dizziness and tremor. On 29th March 2017, the outcome of the syncope was recovering/resolving. On an unknown date, the outcome of the feeling cold, clamminess, dizziness and tremor to be related to BEXSERO. Additional details were reported as follows: The patient received BEXSERO and MENACTRA one in each arm, location of each vaccine was not reported. The patient returned to school at approximately 12 noon reported feeling cold, clammy, dizzy and shaky. The patient was referred to the school nurse and returned to her physician's office. On 29th March 2017, elevated blood pressure was noted at the physician office. The patient was sent home with family and noted to be a little shaky at the time of discharge. No additional treatment was noted. The lot numbers and expiration dates of vaccines were not reported. No addition treatment was reported.
Age: 36.0
Sex: M
Vaccine: RAB
Symptoms: Acne, Feeling abnormal, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of whiteheads in a 36-year-old male patient who received RABAVERT (batch number 626011A, expiry date 31st March 2020). On 28th February 2017, the patient received RABAVERT. On 28th February 2017, less than a day after receiving RABAVERT, the patient experienced whiteheads, pain and feeling abnormal. On an unknown date, the outcome of the whiteheads, pain and feeling abnormal were unknown. It was unknown if the reporter considered the whiteheads, pain and feeling abnormal to be related to RABAVERT. Additional details were reported as follows: The patient had white pimple like bumps on his left arm, opposite of the injection site. The patient was not feeling great, which was clarified as feeling achy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cough, Expired product administered, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cough in a 4-year-old male patient who received KINRIX (batch number T325H, expiry date 17th February 2017). On 24th February 2017, the patient received KINRIX. On 24th February 2017, unknown after receiving KINRIX, the patient experienced expired vaccine used. On 17th March 2017, the patient experienced cough and fever. On an unknown date, the outcome of the cough, fever and expired vaccine used were unknown. The reporter considered the cough, fever and expired vaccine used to be unrelated to KINRIX. Additional details were provided as follows: This case was previously reported to Doctor. This case was reported by a Certified Medical Assistant. The call was transferred from Vaccines Service Center. The patient received KINRIX on right thigh, which was already expired on 17th February 2017. On 17th March 2017, 3 weeks after the vaccination, the patient experienced fever and cough. This case was linked with US2017044474, reported by the same reporter.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, Injury associated with device, Laboratory test, Therapy non-responder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 38-year-old female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine and Hepatitis B vaccine. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder and drug dose administration interval too long. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too long were unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. In 2005, the patient received 2 doses of Hepatitis B vaccine. In 2009, the patient received the 3rd dose of Hepatitis B vaccine, which led to lengthening of vaccination schedule. On an unknown date, the patient had titers drawn after inadvertent occupational needle stick which were below 10, leading the patient to be a therapy non-responder.
Age: 66.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 66-year-old female patient who received BOOSTRIX (batch number YG7AY, expiry date 23rd March 2019). Co-suspect products included ZOSTAVAX (batch number M035147, expiry date 25th October 2017). Concomitant products included PREVNAR. On 13th December 2016, the patient received BOOSTRIX (intramuscular) 0.5 ml and ZOSTAVAX (subcutaneous). On 13th December 2016, less than a day after receiving BOOSTRIX, the patient experienced muscle pain. On an unknown date, the patient experienced limbs stiffness. The patient was treated with cyclobenzaprine, tramadol and NSAIDS (Non-Steroidal Anti-Inflammatory Agents). On an unknown date, the outcome of the muscle pain and limbs stiffness were not recovered/not resolved. The reporter considered the muscle pain and limbs stiffness to be possibly related to BOOSTRIX. Additional details were provided as follows: The patient received vaccines at pharmacy back. The patient received BOOSTRIX on left deltoid and ZOSTAVAX on left arm. The patient received PREVNAR (batch number: 202071, expiry date: January 2018) as concomitant medication on right deltoid. On an unknown date, less than a year after receiving BOOSTRIX, the patient experienced stiffness in left arm. The left arm was the only side where patient experienced all events. The patient visited physician and tried multiple medications of OTC (over the counter) non-steroidal anti-inflammatory drugs which didn't help. The reporter was transferred to Medical Information System.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Decreased appetite, Dizziness, Injection site erythema, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 5-year-old male patient who received KINRIX (batch number 5S5TJ, expiry date 19th October 2018). The patient's past medical history included milk allergy and gluten intolerance. On 30th March 2017, the patient received KINRIX. In March 2017, less than a week after receiving KINRIX, the patient experienced fever. On 30th March 2017, the patient experienced injection site erythema and dizziness. On 31st March 2017, the patient experienced appetite lost. On an unknown date, the outcome of the injection site erythema was unchanged and the outcome of the dizziness and appetite lost were recovering/resolving and the outcome of the fever was unknown. It was unknown if the reporter considered the injection site erythema, dizziness, appetite lost and fever to be related to KINRIX. Additional details were reported as follows: This case was reported by the patient's mother. On 30th March 2017, the patient began to develop redness around the injection site. The patient then began to feel dizzy in the evening on the same day. Upon awakening on the 31st March 2017, the patient was still dizzy and feverish, with a temp of 103 degrees. The patient's appetite was lost and the patient did not felt like eating. The lot number 2 in report was intentionally left blank. There was only 1 lot number (not further specified).
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Mild swelling and tenderness at sight (left deltoid).
Age: 58.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling at injection site, warm to the touch, pain and itching.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Scratch
Clinical narrative: Mom came into HP with pt today and said he has a reaction to one of his shots. (L) arm where VZV was given was swollen, red, hard and looked like it had been scratched. Mom said it started on the 3-28-17 with just swelling, but it has gotten worse. She said she has given him TYLENOL and put cool packs to it 2x yesterday. Inst mom to give BENADRYL daily and apply cool packs 4-5x daily. Call mom if no better. Also cont. TYLENOL every 4-6 Hrs.
Age: 3.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Respiration abnormal, Seizure, Skin discolouration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure in a 3-year-old female patient who received HAVRIX pediatric (batch number J3K9H, expiry date 30th November 2018). On 17th March 2017 16:15, the patient received the 2nd dose of HAVRIX pediatric .5 ml. On 17th March 2017 21:15, 5 hrs after receiving HAVRIX pediatric, the patient experienced seizure (serious criteria GSK medically significant), abnormal breathing and skin discoloration. On 17th March 2017, the outcome of the seizure was recovered/resolved. On an unknown date, the outcome of the abnormal breathing and skin discoloration were unknown. It was unknown if the reporter considered the seizure, abnormal breathing and skin discoloration to be related to HAVRIX pediatric. Additional details were reported as follows: The patient was vaccinated with HAVRIX on right arm. As per the health care professional, the mother of the patient said that the patient had a seizure that lasted about 1 to 2 minutes, with breathing change and colour change. No other information was provided.
Age: 3.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Bruxism, Computerised tomogram head normal, Crying, Electroencephalogram normal, Fear
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure in a 3-year-old female patient who received HAVRIX pediatric (batch number J3K9H, expiry date 30th November 2018). On 17th March 2017 16:15, the patient received the 2nd dose of HAVRIX pediatric .5 ml. On 17th March 2017 21:15, 5 hrs after receiving HAVRIX pediatric, the patient experienced seizure (serious criteria GSK medically significant), abnormal breathing and skin discoloration. On 17th March 2017, the outcome of the seizure was recovered/resolved. On an unknown date, the outcome of the abnormal breathing and skin discoloration were unknown. It was unknown if the reporter considered the seizure, abnormal breathing and skin discoloration to be related to HAVRIX pediatric. Additional details were reported as follows: The patient was vaccinated with HAVRIX on right arm. As per the health care professional, the mother of the patient said that the patient had a seizure that lasted about 1 to 2 minutes, with breathing change and colour change. No other information was provided.
Age: 3.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Muscle contractions involuntary, Muscle twitching, Nuclear magnetic resonance imaging brain normal, Opisthotonus, Postictal state
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure in a 3-year-old female patient who received HAVRIX pediatric (batch number J3K9H, expiry date 30th November 2018). On 17th March 2017 16:15, the patient received the 2nd dose of HAVRIX pediatric .5 ml. On 17th March 2017 21:15, 5 hrs after receiving HAVRIX pediatric, the patient experienced seizure (serious criteria GSK medically significant), abnormal breathing and skin discoloration. On 17th March 2017, the outcome of the seizure was recovered/resolved. On an unknown date, the outcome of the abnormal breathing and skin discoloration were unknown. It was unknown if the reporter considered the seizure, abnormal breathing and skin discoloration to be related to HAVRIX pediatric. Additional details were reported as follows: The patient was vaccinated with HAVRIX on right arm. As per the health care professional, the mother of the patient said that the patient had a seizure that lasted about 1 to 2 minutes, with breathing change and colour change. No other information was provided.
Age: 3.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Respiration abnormal, Scan with contrast, Screaming, Seizure, Skin discolouration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure in a 3-year-old female patient who received HAVRIX pediatric (batch number J3K9H, expiry date 30th November 2018). On 17th March 2017 16:15, the patient received the 2nd dose of HAVRIX pediatric .5 ml. On 17th March 2017 21:15, 5 hrs after receiving HAVRIX pediatric, the patient experienced seizure (serious criteria GSK medically significant), abnormal breathing and skin discoloration. On 17th March 2017, the outcome of the seizure was recovered/resolved. On an unknown date, the outcome of the abnormal breathing and skin discoloration were unknown. It was unknown if the reporter considered the seizure, abnormal breathing and skin discoloration to be related to HAVRIX pediatric. Additional details were reported as follows: The patient was vaccinated with HAVRIX on right arm. As per the health care professional, the mother of the patient said that the patient had a seizure that lasted about 1 to 2 minutes, with breathing change and colour change. No other information was provided.
Age: 3.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Somnolence, Tonic convulsion
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure in a 3-year-old female patient who received HAVRIX pediatric (batch number J3K9H, expiry date 30th November 2018). On 17th March 2017 16:15, the patient received the 2nd dose of HAVRIX pediatric .5 ml. On 17th March 2017 21:15, 5 hrs after receiving HAVRIX pediatric, the patient experienced seizure (serious criteria GSK medically significant), abnormal breathing and skin discoloration. On 17th March 2017, the outcome of the seizure was recovered/resolved. On an unknown date, the outcome of the abnormal breathing and skin discoloration were unknown. It was unknown if the reporter considered the seizure, abnormal breathing and skin discoloration to be related to HAVRIX pediatric. Additional details were reported as follows: The patient was vaccinated with HAVRIX on right arm. As per the health care professional, the mother of the patient said that the patient had a seizure that lasted about 1 to 2 minutes, with breathing change and colour change. No other information was provided.
Sex: U
Vaccine: FLU4
Symptoms: Limb injury
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injury to shoulder in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injury to shoulder. On an unknown date, the outcome of the injury to shoulder was unknown. It was unknown if the reporter considered the injury to shoulder to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional called to ask if FLUARIX QIV could cause SIRVA (shoulder injury related to vaccine administration). The healthcare professional stated that they were updating their flu vaccine administration sheet for patients and was asking if they can put the side effect of SIRVA from FLUARIX QIV in the sheet. The reporter was asking if the SIRVA a reported side effect in the FLUARIX QIV package insert or not. The healthcare professional stated that they used FLUARIX QIV along with other QIV flu vaccines and TIV flu vaccines and she said some patients had complained of SIRVA (shoulder injury) after receiving the flu vaccine. The healthcare professional stated that she did not have access to any of the patient information records, therefore, she did not know how many patients experienced SIRVA with FLUARIX QIV or what patients experienced SIRVA with FLUARIX QIV. She did not have any more details to provide since she did not have access to any of the patient records. No further information was provided.
Sex: F
Vaccine: MENB
Symptoms: Malaise, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of general malaise in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced general malaise and pain in arm. On an unknown date, the outcome of the general malaise and pain in arm were recovered/resolved. It was unknown if the reporter considered the general malaise and pain in arm to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional called and said that the daughter of one of the practice doctors and a daughter of a patient experienced pain at the injection site, soreness in injected arm and generalized malaise for 1 week following administration of BEXSRO. The healthcare professional did not have patient demographics or product information or any other information available. This case is linked with case US2017GSK043740 (reported by the same reporter).
Sex: U
Vaccine: MEN, MENB
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a patient who received BEXSERO. Co-suspect products included Meningococcal ACWY Vaccine (potential MENVEO). On an unknown date, the patient received BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO). On an unknown date, unknown after receiving BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced injection site pain, fever and fatigue. On an unknown date, the outcome of the injection site pain, fever and fatigue were unknown. It was unknown if the reporter considered the injection site pain, fever and fatigue to be related to BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO). Additional details were reported as follows: The age at vaccination was not reported. The reporter emailed a GlaxoSmithKline Sales representative who then emailed a GlaxoSmithKline Medical Science Liaison on the same day who contacted the GSK response center. It was reported that, the reporter had starting giving BEXSERO along with the meningococcal vaccine (MCV4) to a 12th grade student. The GlaxoSmithKline Medical Science Liaison said that, email from the GlaxoSmithKline Sales representative stated that, the reporter said a 12th grader whose age and gender is now unknown to the GlaxoSmithKline Medical Science Liaison had a sore arm at the injection site as well as fatigue and fever following vaccine administration which occurred on a Monday. The GlaxoSmithKline Medical Science Liaison said that she spoke with the reporter but did not discuss about this patient and had no further related details to provide.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adolescent female patient who received BEXSERO. Co-suspect products included Meningococcal ACWY Vaccine (potential MENVEO)). On an unknown date, the patient received BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO). On an unknown date, less than a month after receiving BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced injection site pain, injection site mass and injection site redness. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the injection site mass and injection site redness were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site mass and injection site redness to be related to BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO). Additional details were reported as follows: The age at the reporting was 16 years old. The age at vaccination was not reported. the reporter emailed a GlaxoSmithKline Sales representative who then emailed a GlaxoSmithKline Medical Science Liaison on the same day who contacted the GSK response center. It was reported that, she had given one of her daughters BEXSERO along with the meningococcal vaccine (MCV4) to a 12th grade student. The GSK Medical Science Liaison said that she spoke with the reporter the reported commented that her daughter's arm became sore at the injection site after receiving the BEXSERO vaccine and the reporter told her that her daughter also had somewhat pink, not bright red, know on her arm at the injections site which lasted 4 to 5 days and then resolved. The reporter commented that she does not plan in the future to give her daughter a 2nd dose of BEXSERO vaccine. The GSK Medical Liaison had no further related details to provide. The GSK Medical Science Liaison said that the reporter gave permission for GCSP to contact her further related details.
Sex: F
Vaccine: MEN, MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received BEXSERO. Co-suspect products included Meningococcal ACWY Vaccine (potential MENVEO). On an unknown date, the patient received BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO) at an unknown dose. On an unknown date, unknown after receiving BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO). Additional details were reported as follows: The age at vaccination was not reported. The reporter emailed a GlaxoSmithKline Sales representative who then emailed a GlaxoSmithKline Medical Science Liaison on the same day who contacted the GSK response center. It was reported that, the reporter had started giving BEXSERO along with the meningococcal vaccine (MCV4). The GlaxoSmithKline Medical Science Liaison said that, email from GlaxoSmithKline Sales representative stated that, the reporter said the reporter said that one of her daughters of unknown age had a sore arm at the injection site following vaccine administration. The GlaxoSmithKline Medical Science Liaison said that she spoke with the reporter but did not discuss about this patient and had no further related details to provide.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Conjunctivitis, Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 11-year-old male patient who received MENVEO (batch number M16093, expiry date 31st March 2019). On 9th March 2017, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 9th March 2017, less than a day after receiving MENVEO, the patient experienced injection site erythema, injection site swelling, injection site tenderness, allergic reaction and erythematous rash. On 10th March 2017, the patient experienced injection site warmth, injection site rash, injection site itching, fever and injection site urticaria. On 18th March 2017, the patient experienced conjunctivitis. The patient was treated with ibuprofen, medication unknown (Ice Pack), Cortisone Cream and Anti-Itch Cream. MENVEO was continued with no change. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, injection site rash, injection site itching, injection site tenderness, fever, injection site urticaria and erythematous rash were recovered/resolved and the outcome of the conjunctivitis and allergic reaction were unknown. The reporter considered the injection site erythema and injection site tenderness to be possibly related to MENVEO. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site rash, injection site itching, conjunctivitis, fever, injection site urticaria, allergic reaction and erythematous rash to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO on Right deltoid. After vaccination, the patient experienced right deltoid tenderness, redness and swelling at the site. The mother denied fever and treated the events with Ibuprofen. On 10th March 2017, 1 day after vaccination the injection site issues were still continued and also included fever (100.4 degree F) and injection site rash which was itchy, red and swollen. The patient's mother applied old packs, used cortisone cream and anti-itch cream with little relief. On 10th March 2017 at 2:13 PM, the patient was seen by the physician and the patient's temperature was 99 degree F by temporal artery and the right upper arm was described by the doctor as pink, warm with a rash but not tender. He suspected possible urticarial in nature, but stated no cellulitis. The physician contacted an allergist to determine if that allergic reaction would contradict the patient from receiving future doses. On 14th March 2017, the physician notified the parents of the patient that the allergist determined no future contraindication. The planned age was 16 to have the patient return and be monitored for 20 minutes after vaccination. On 18th March 2017, 9 days after vaccination, the patient was seen at an urgent care for left eye conjunctivitis, as noted by the nurse caller.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site rash, Injection site swelling, Injection site urticaria, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 11-year-old male patient who received MENVEO (batch number M16093, expiry date 31st March 2019). On 9th March 2017, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 9th March 2017, less than a day after receiving MENVEO, the patient experienced injection site erythema, injection site swelling, injection site tenderness, allergic reaction and erythematous rash. On 10th March 2017, the patient experienced injection site warmth, injection site rash, injection site itching, fever and injection site urticaria. On 18th March 2017, the patient experienced conjunctivitis. The patient was treated with ibuprofen, medication unknown (Ice Pack), Cortisone Cream and Anti-Itch Cream. MENVEO was continued with no change. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, injection site rash, injection site itching, injection site tenderness, fever, injection site urticaria and erythematous rash were recovered/resolved and the outcome of the conjunctivitis and allergic reaction were unknown. The reporter considered the injection site erythema and injection site tenderness to be possibly related to MENVEO. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site rash, injection site itching, conjunctivitis, fever, injection site urticaria, allergic reaction and erythematous rash to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO on Right deltoid. After vaccination, the patient experienced right deltoid tenderness, redness and swelling at the site. The mother denied fever and treated the events with Ibuprofen. On 10th March 2017, 1 day after vaccination the injection site issues were still continued and also included fever (100.4 degree F) and injection site rash which was itchy, red and swollen. The patient's mother applied old packs, used cortisone cream and anti-itch cream with little relief. On 10th March 2017 at 2:13 PM, the patient was seen by the physician and the patient's temperature was 99 degree F by temporal artery and the right upper arm was described by the doctor as pink, warm with a rash but not tender. He suspected possible urticarial in nature, but stated no cellulitis. The physician contacted an allergist to determine if that allergic reaction would contradict the patient from receiving future doses. On 14th March 2017, the physician notified the parents of the patient that the allergist determined no future contraindication. The planned age was 16 to have the patient return and be monitored for 20 minutes after vaccination. On 18th March 2017, 9 days after vaccination, the patient was seen at an urgent care for left eye conjunctivitis, as noted by the nurse caller.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 11-year-old male patient who received MENVEO (batch number M16093, expiry date 31st March 2019). On 9th March 2017, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 9th March 2017, less than a day after receiving MENVEO, the patient experienced injection site erythema, injection site swelling, injection site tenderness, allergic reaction and erythematous rash. On 10th March 2017, the patient experienced injection site warmth, injection site rash, injection site itching, fever and injection site urticaria. On 18th March 2017, the patient experienced conjunctivitis. The patient was treated with ibuprofen, medication unknown (Ice Pack), Cortisone Cream and Anti-Itch Cream. MENVEO was continued with no change. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, injection site rash, injection site itching, injection site tenderness, fever, injection site urticaria and erythematous rash were recovered/resolved and the outcome of the conjunctivitis and allergic reaction were unknown. The reporter considered the injection site erythema and injection site tenderness to be possibly related to MENVEO. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site rash, injection site itching, conjunctivitis, fever, injection site urticaria, allergic reaction and erythematous rash to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO on Right deltoid. After vaccination, the patient experienced right deltoid tenderness, redness and swelling at the site. The mother denied fever and treated the events with Ibuprofen. On 10th March 2017, 1 day after vaccination the injection site issues were still continued and also included fever (100.4 degree F) and injection site rash which was itchy, red and swollen. The patient's mother applied old packs, used cortisone cream and anti-itch cream with little relief. On 10th March 2017 at 2:13 PM, the patient was seen by the physician and the patient's temperature was 99 degree F by temporal artery and the right upper arm was described by the doctor as pink, warm with a rash but not tender. He suspected possible urticarial in nature, but stated no cellulitis. The physician contacted an allergist to determine if that allergic reaction would contradict the patient from receiving future doses. On 14th March 2017, the physician notified the parents of the patient that the allergist determined no future contraindication. The planned age was 16 to have the patient return and be monitored for 20 minutes after vaccination. On 18th March 2017, 9 days after vaccination, the patient was seen at an urgent care for left eye conjunctivitis, as noted by the nurse caller.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO. Co-suspect products included Meningococcal ACWY Vaccine (potential MENVEO)). On an unknown date, the patient received BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO). On an unknown date, unknown after receiving BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced injection site pain, fever and fatigue. On an unknown date, the outcome of the injection site pain, fever and fatigue were unknown. It was unknown if the reporter considered the injection site pain, fever and fatigue to be related to BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO). Additional details were reported as follows: The age at vaccination was not reported. The reporter emailed a GlaxoSmithKline Sales representative who then emailed a GlaxoSmithKline Medical Science Liaison on the same day who contacted the GSK response center. It was reported that, the reporter had started giving BEXSERO along with the meningococcal vaccine (MCV4) to a 12th grade student. The GlaxoSmithKline Medical Science Liaison said that, email form the GlaxoSmithKline Sales representative stated that, the reporter said a 12th grader whose age and gender is now unknown to the GlaxoSmithKline Medical Science Liaison had a sores arm at the injection site as well as fatigue and fever following vaccine administration which occurred on a Monday. The GlaxoSmithKline Medical Science Liaison said that she spoke with the reporter but did not discuss about this patient and had no further related details to provided. This was the first of two patients whose demographics were unknown beyond being 12th graders which the reporter mentioned in her email according to the GSK Medical Science Liaison.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Hypoaesthesia, Mobility decreased, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Sharp pain radiated pain up and down arm numbness. Pain in body and legs stiffness arm should back pain can't lift arm stabbing pain weak muscle. MRI pain med and muscle relaxers. Physical Therapy.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Sharp pain radiated pain up and down arm numbness. Pain in body and legs stiffness arm should back pain can't lift arm stabbing pain weak muscle. MRI pain med and muscle relaxers. Physical Therapy.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Pain in extremity, Pneumonia
Clinical narrative: Patient's wife reported she believes the flu shot he received caused the patient to become very sick resulting in pneumonia and an extended hospital stay. She also reported that his left arm was still hurting. He received vaccination in right arm. Once told this she stated both arms hurt.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Excessive redness developed on arm (left) of injection site. Also, said sore, itchy.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: After vaccinations 10 days (as of 4/10/17) of ongoing fever up to 104-105 degrees.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Headache, Presyncope, Syncope, Vomiting
Clinical narrative: New onset of headaches with vomiting and syncopal/near syncope episodes since time of vaccinations - occurs only with physical exertion in heat.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Confusional state, Eye movement disorder, Fall, Headache
Clinical narrative: 2-5 minutes after receiving GARDASIL, patient mid sentence, fell back, whole body stiffened, bilateral arms abducted and shaking, eyes rolled backwards. Lasted less than 1 minute. When patient came to, she vomited and had a headache. Patient cannot recall what happened. Pt also lost bladder control. Normal neuro exam except for mild confusion. Cannot remember where she was.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Joint hyperextension, Musculoskeletal stiffness, Neurological examination abnormal, Tremor, Urinary incontinence
Clinical narrative: 2-5 minutes after receiving GARDASIL, patient mid sentence, fell back, whole body stiffened, bilateral arms abducted and shaking, eyes rolled backwards. Lasted less than 1 minute. When patient came to, she vomited and had a headache. Patient cannot recall what happened. Pt also lost bladder control. Normal neuro exam except for mild confusion. Cannot remember where she was.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: 2-5 minutes after receiving GARDASIL, patient mid sentence, fell back, whole body stiffened, bilateral arms abducted and shaking, eyes rolled backwards. Lasted less than 1 minute. When patient came to, she vomited and had a headache. Patient cannot recall what happened. Pt also lost bladder control. Normal neuro exam except for mild confusion. Cannot remember where she was.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Aplastic anaemia, Biopsy bone marrow abnormal, Injection site pain, Transfusion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 564197) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 25 year old male patient. The patient's medical history included injection site pain during vaccination with GARDASIL 9 dose number 1 and dose 2 (lot #, dose, frequency and route of administration were not reported) for prophylaxis on 03-JUN-2013 and on 08-AUG-2013 respectively. On 16-DEC-2013, the patient was vaccinated with GARDASIL 9 dose number 3, (lot/batch # 00049616) intramuscularly in the left arm (dose and frequency were not reported) for prophylaxis. Concomitant therapies included TRUVADA (HIV (Human immune deficiency virus) preparation). On 20-OCT-2014, the patient experienced injection site pain, aplastic anaemia and had blood product transfusion dependent since then and also had biopsy bone marrow abnormal. The patient was hospitalized for a short stay on 30-NOV-2014 and 03-JAN-2015. Lab data revealed that patient had to undergo bone marrow transplant and donor match was found. Patient stated that he was doing well on 04-FEB-2015 and will receive bone marrow soon. The outcome of aplastic anaemia, injection site pain, blood product transfusion dependent and biopsy bone marrow abnormal was reported were reported as not recovered. Causality assessment was not reported. The agency considered the case to be serious as the events aplastic anaemia, injection site pain, blood product transfusion dependent and biopsy bone marrow abnormal were considered to be life-threatening and to have led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 564197) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 25 year old male patient. The patient's medical history included injection site pain during vaccination with GARDASIL 9 dose number 1 and dose 2 (lot #, dose, frequency and route of administration were not reported) for prophylaxis on 03-JUN-2013 and on 08-AUG-2013 respectively. On 16-DEC-2013, the patient was vaccinated with GARDASIL 9 dose number 3, (lot/batch # 00049616) intramuscularly in the left arm (dose and frequency were not reported) for prophylaxis. Concomitant therapies included TRUVADA (HIV (Human immune deficiency virus) preparation). On 20-OCT-2014, the patient experienced injection site pain, aplastic anaemia and had blood product transfusion dependent since then and also had biopsy bone marrow abnormal. The patient was hospitalized for a short stay on 30-NOV-2014 and 03-JAN-2015. Lab data revealed that patient had to undergo bone marrow transplant and donor match was found. Patient stated that he was doing well on 04-FEB-2015 and will receive bone marrow soon. The outcome of aplastic anaemia, injection site pain, blood product transfusion dependent and biopsy bone marrow abnormal was reported were reported as not recovered. Causality assessment was not reported. The agency considered the case to be serious as the events aplastic anaemia, injection site pain, blood product transfusion dependent and biopsy bone marrow abnormal were considered to be life-threatening and to have led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.