chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pruritus
Clinical narrative: Patient called complaining of a purple, red bruised area around the injection site that was the size of a grapefruit; entire bicep started Saturday evening after receiving the vaccination with itching at first and on Sunday morning it progressed to get worse.
Age: 0.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Diet refusal, Insomnia, Irritability, Pyrexia
Clinical narrative: Patient had a high fever, about 103 or above, for three days following this vaccine. She was also irritable, fussy, did not eat or sleep during this time. Had two instances of diarrhea in this time.  We considered going to the ER, but her fever was treated with TYLENOL to provide some relief.   TYLENOL only worked minimally, decreasing her temp from 103 to 101. We were very stressed out about this adverse reaction. She has since recovered from this event.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Influenza, Pain in extremity, Pruritus
Clinical narrative: Following vaccine on 8/30, woke up on 8/31 with terrible headache/flu symptoms, very sore arm and red forehead; 9/1-woke up with rash on chest and both sides of face and milder flu symptoms, sore arm; 9/2: rash diminished followed by itching on arms, face, neck and back, sore arm; 9/3: continued itching and sore arm; 9/4: red face returned, itching less and sore arm.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Following vaccine on 8/30, woke up on 8/31 with terrible headache/flu symptoms, very sore arm and red forehead; 9/1-woke up with rash on chest and both sides of face and milder flu symptoms, sore arm; 9/2: rash diminished followed by itching on arms, face, neck and back, sore arm; 9/3: continued itching and sore arm; 9/4: red face returned, itching less and sore arm.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Condition aggravated, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Patient claims arm sore aggravated rotator cuff.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin negative, Human chorionic gonadotropin positive
Clinical narrative: Pt had a negative pregnancy test on 22 May 18. Pt received Anthrax dose #2 on 1 June 2018.  Pt reports she had a positive home pregnancy test at the end of June 2018 (Exact Date unknown).
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain
Clinical narrative: Severe localized lt deltoid pain, denies rash, fevers, or numbness, took ibuprofen 800mg po and her pain subsided.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient came in 48 hrs after PNEUMOVAX 23 and complained of redness/soreness/swelling on injection arm closer to armpit area but not under the arm.
Age: 18.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: This spontaneous report was received from a registered nurse, via company representative and refers to a 18 year old male patient. Concomitant therapies included meningococcal vaccine (manufacturer unknown) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP). No information was provided regarding the patient's concurrent conditions or medical history. On 14-AUG-2018, the patient was vaccinated with GARDASIL 9, intramuscular for prophylaxis (dose, lot number and expiration date were not reported). Within 7 minutes of injection, the patient lost consciousness and was treated with ammonia inhalant, cold water compress and cold water. Then, the patient regained consciousness and vomited. No lab diagnostics or studies were performed. The events loss of consciousness and vomiting resolved within 20 minutes of starting, on 04-AUG-2018. The causal relationship between the aforementioned events and therapy with GARDASIL 9 were not reported. Upon internal review, the event loss of consciousness was considered to be medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 22 year old female patient. Information on the patient's medical history, drug reactions, allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dosing details and batch/lot number and expiration date unknown) for prophylaxis. It was reported that the patient received two doses of GARDASIL (inappropriate schedule of drug administration), which the patient described as the full (human papillomavirus) HPV vaccination. Either on 21-AUG-2018 or 22-AUG-2018, did a first time pap smear on the patient and showed positive for HPV (papilloma viral infection) low grade SIL (cervical dysplasia). The patient did not received any treatments for the events. On an unknown date, the patient sought medical attention to doctor's office. It was reported that the patient was sexually active and asymptomatic. Outcome of the events was unknown. Causality assessment was not provided. No product quality complaint was involved.
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Fatigue, Haemoglobin decreased, Headache, Tachycardia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 25 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications and the patient had not known drug allergies. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, strength, anatomical location, route of administration, lot number and expiration date were not reported). On 20-JUN-2018, the patient was vaccinated with the second dose of GARDASIL 9, lot number N017686 and expiration date on 02-FEB-2020 (dose, strength, anatomical location and route of administration were not reported). On 28-AUG-2018, the patient presented to the emergency department and was admitted to the hospital with headache, fatigue, shortness of breath (dyspnoea), tachycardia, and a hemoglobin of 5 (haemoglobin abnormal). It was unknown if treatment was given for the events or if laboratory diagnostics or studies were performed. At the time of reporting, the patient still in the hospital and the outcome of the events was unknown The reporter did not assess the causal relationship between vaccination with GARDASIL 9 and the events.
Sex: U
Vaccine: HPVX
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a nurse via company representative, and refers to multiple unspecified adolescent patients between 13 and 16 years old. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The nurse stated that on unknown dates, over the past 10 years (approximately since 2008), the patients were vaccinated with an unspecified number of doses of either GARDASIL (strength, dose number, dose, route, anatomical location, lot # and expiration date not reported), or GARDASIL 9 (strength, dose number, dose, route, anatomical location, lot # and expiration date not reported), for prophylaxis. The nurse reported that the patients, on unknown dates, fainted, passed out or became woozy. She further clarified that this happened to the patients between 13 and 16 years old 95 % of the times, if they were vaccinated on an empty stomach. As treatment, she offered them water and crackers and observed them for a little while. The reporting nurse did not provide the outcome of the events and their causal relationship to vaccination with GARDASIL or GARDASIL 9. Upon internal review, loss of consciousness was considered as a medically significant event.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect dose administered, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 62-year-old female patient who received SHINGRIX (batch number 102778 ?, expiry date unknown, GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis. On 25th June 2018, the patient received the 1st dose of SHINGRIX 1 ml. On an unknown date, several days after receiving SHINGRIX, the patient experienced pain, shingles, fever and overdose. On an unknown date, the outcome of the pain, fever and overdose were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the pain, shingles and fever to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient developed aches, low grade fever and shingles on her feet going up towards her head and internally. Also the patient received 1.0 ml dose of SHINGRIX, instead of 0.5 ml, which led to overdose. The lot number reported was double checked. She said that was the number the pharmacy gave her when she called them for it. Her doctor did not prescribe it, she just went to the pharmacy to get it and has not followed up with a doctor to get a physician documented shingles diagnosis. She was unsure if the pharmacist had reported her reactions already but could not find the pharmacist's name that would have reported it. Her husband also had similar adverse events to her so this was report one of two. This case has been linked with case US2018151971 (husband's case), reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of fatigue in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue, shivering, muscle pain, headache and fever. On an unknown date, the outcome of the fatigue, shivering, muscle pain, headache and fever were unknown. It was unknown if the reporter considered the fatigue, shivering, muscle pain, headache and fever to be related to SHINGRIX. Additional details were provided as follows: The call was presented as an Ad hoc Virtual Meeting (AHVM). The age at vaccination was not reported. The patient was called back, but got voice message and was provided a reference number if the patient wished to call back to ask additional questions, such as date of birth, date, onset timing, and lot number.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Heart rate increased, Immediate post-injection reaction, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 16th May 2018, the patient received SHINGRIX. On 16th May 2018, immediately after receiving SHINGRIX, the patient experienced general body pain, heart rate increased, chest pain and chills. On 17th May 2018, the outcome of the general body pain, heart rate increased, chest pain and chills were recovered/resolved. It was unknown if the reporter considered the general body pain, heart rate increased, chest pain and chills to be related to SHINGRIX. Additional details reported as follows: The patient reported that almost immediately after receiving a SHINGRIX injection, she experienced body aches, chills, rapid heart rate and chest pain. The events resolved the next morning of vaccination.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of enlargement of lymph nodes in a 59-year-old male patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 20th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 21st August 2018, 1 days after receiving SHINGRIX, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved. It was unknown if the reporter considered the enlargement of lymph nodes to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in right deltoid. The patient reported to the pharmacist that his left arm lymph node which was opposite side of the injection site was swollen.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Product administered at inappropriate site
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 55-year-old male patient who received SHINGRIX (batch number G933B, expiry date unknown) for prophylaxis. On 22nd August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On 22nd August 2018, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site erythema, injection site pain, intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the posterior aspect of the left deltoid and therefore there is a great possibility that it was administered by subcutaneous route rather than intramuscular route, which led to inappropriate route of vaccine administration and vaccine administered at inappropriate site. The patient complained of injection site pain and redness.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 73-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date unknown) for prophylaxis. On 1st June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The healthcare professional reported that the patient developed shingles after receiving the dose of the SHINGRIX series. The healthcare professional did not have correct expiration date of the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of light headedness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 20 min after receiving SHINGRIX, the patient experienced light headedness, labored respiration and chest tightness. On an unknown date, the outcome of the light headedness, labored respiration and chest tightness were unknown. It was unknown if the reporter considered the light headedness, labored respiration and chest tightness to be related to SHINGRIX. Additional details were reported as follows: This case was reported via chat. The age at vaccination was not reported. The patient experienced heavy breathing. The HCP did not have patient or vaccine information because the patient received SHINGRIX dose at different location.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever, headache, malaise and general body pain. On an unknown date, the outcome of the fever, headache, malaise and general body pain were unknown. It was unknown if the reporter considered the fever, headache, malaise and general body pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported via chat. The health care professional reported this case for herself. The patient experienced fever, body ache, headache, and malaise after receiving SHINGRIX vaccine. The HCP did not have vaccine information.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 67-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) for prophylaxis. On 15th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th April 2018, 1 days after receiving SHINGRIX, the patient experienced swelling arm and swelling of wrists. On an unknown date, the outcome of the swelling arm and swelling of wrists were recovered/resolved. It was unknown if the reporter considered the swelling arm and swelling of wrists to be related to SHINGRIX. Additional details were reported as follows: The patient experienced arm, wrist, and hand swelling which lasted for 3 to 4 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 23rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain (serious criteria other: serious as per reporter), walking difficulty (serious criteria other: serious as per reporter), injection site erythema (serious criteria other: serious as per reporter) and leg pain (serious criteria other: serious as per reporter). The patient was treated with pregabalin (Lyrica). On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the walking difficulty and leg pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, walking difficulty, injection site erythema and leg pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the gluteal. After receiving SHINGRIX, the patient experienced pain at the injection site that resolved and pain down her leg which had not resolved causing her to have difficulty walking. The sales representative reported that the nurse was also the office manager. The contact detail of the physician was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 91 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. The reporter considered the shingles to be unrelated to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter did not attribute receipt of SHINGRIX with the development of shingles. The reporter did not obtain any information other than patient gender and the dose was received sometime in May 2018 and patient was with shingles at the time of reporting (approximately 3 months latency).
Sex: M
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of vertigo in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was unknown. It was unknown if the reporter considered the vertigo to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a retired physician who himself was patient. The age at vaccination was not reported. The healthcare professional did not want to provide address and date of birth.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Eye movement disorder, Eyelid disorder, Rosacea
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of rosacea in a 72-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included rosacea. Concomitant products included ibuprofen (Advil) and vitamins nos (Vitamin). On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 28 days after receiving SHINGRIX, the patient experienced rosacea, eyelid disorder and eye movement disorder. On an unknown date, the outcome of the rosacea was recovering/resolving and the outcome of the eyelid disorder and eye movement disorder were unknown. The reporter considered the rosacea to be possibly related to SHINGRIX. It was unknown if the reporter considered the eyelid disorder and eye movement disorder to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received first dose of SHINGRIX vaccine on right deltoid and developed Rosacea two weeks after administration. The Rosacea lasted for two months. The patient's condition was improved, 95 percentage of Rosacea was cleared at the time of reporting. The event did not cause the patient to be admitted to the hospital overnight or prolong an existing hospitalization. The reporting health care professional did not consider the events to be life threatening and to result in persistent or significant disability or incapacity. The patient did not die. The event did not require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The event did not result in a congenital anomaly or birth defect. The patient received no prescription medications as concomitant medications. The lot number was not available, reporter stated to contact pharmacy. He stated that around the end of May or the beginning of June 2018 he had a rosacea outbreak which was more severe than he had ever had in the past. He said that his rosacea blew up and that he had zits from hell and that his eyelids looked like hamburger meat and that it was not pleasant to move his eyes. He said he did not go to the hospital and he did not take any serious drugs to treat this but his physician did prescribe some creams. It would get better for 3 to 4 days but then it would get worse again and so the physician would try a different cream. This went on for a couple months. Finally in the past 3 to 4 weeks the rosacea was finally getting better and was almost clear. He stated that his physician did not think it was related to SHINGRIX but that she did not know what it was. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on an unspecified date, for tolerance see case US2018GSK159755). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter asked if the chemical composition of the first dose of SHINGRIX identical to the second dose because his wife (patient) had a sore arm for 2 days after 1st shot (for tolerance see case US2018GSK159755), but got really sick after 2nd shot.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza, Nausea, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of flu symptoms in a 54-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. The patient's past medical history included menopause (had last menstrual period in May 2013). On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th June 2018, less than a day after receiving SHINGRIX, the patient experienced flu symptoms, nausea, fever, headache and chills. On 29th June 2018, the outcome of the flu symptoms, nausea, fever, headache and chills were recovered/resolved. It was unknown if the reporter considered the flu symptoms, nausea, fever, headache and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by licensed vocational nurse (LVN). The patient was a retired police detective.
Sex: F
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were provided as follows: This case was reported by licensed practitioner nurse (LPN). The age at vaccination was not reported. The patient experienced pain and sore for two days after receiving BEXSERO. The reporter did not agree to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis.  In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the swelling arm was recovering/resolving. It was unknown if the reporter considered the pain in arm and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient who was also working in administration. The patient received SHINGRIX shot on 25th or 26th June 2018. She had pain and soreness in her right arm for two weeks. The swelling went down after a week. The reporter agreed to be followed up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 10 hrs after receiving SHINGRIX, the patient experienced myalgia, fever, shivering, nausea and feeling bad. The patient was treated with analgesic, nos (Analgesic). On an unknown date, the outcome of the myalgia, fever, shivering, nausea and feeling bad were recovered/resolved. The reporter considered the myalgia, fever, shivering, nausea and feeling bad to be related to SHINGRIX. Additional details were provided as follows: This case was reported by medical assistant (MA), who herself was patient. The patient's date of birth was unknown. The age at vaccination was not reported. The patient received SHINGRIX at 4 pm. The patient woke at 2 am as she was feeling bad and experienced myalgia, fever (103 degree F), shivering, nausea. The patient felt very bad and was taking analgesics. She had to call in sick to work. The reporter felt this all was caused by SHINGRIX. The reporter did not agree to follow up from GlaxoSmithKline. This was all the information the reporter had.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms, muscle pain and chills. On an unknown date, the outcome of the fever, influenza-like symptoms, muscle pain and chills were unknown. It was unknown if the reporter considered the fever, influenza-like symptoms, muscle pain and chills to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms consisting of muscle aches, chills, and fever. The caller was going to ask the pharmacist questions for an adverse drug event (ADE) report.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Vaccination site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of vaccination site swelling in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 22nd August 2018, the patient received SHINGRIX. On 23rd August 2018, 1 days after receiving SHINGRIX, the patient experienced vaccination site swelling. On an unknown date, the outcome of the vaccination site swelling was recovered/resolved. It was unknown if the reporter considered the vaccination site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The patient experienced severe swelling in the arm. Lasting days and was started 24 hours after administration.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter asked if the chemical composition of the first dose of SHINGRIX identical to the second dose because his wife (patient) had a sore arm for 2 days after 1st shot, but got really sick after 2nd shot (for tolerance see case US2018GSK154791).
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Irritability, Sleep disorder, Somnambulism
Clinical narrative: Mother reports child has sensory disorder, MD plans to test for autism spectrum disorder but has not yet. Reports client's symptoms started getting worse the day after MMR vaccine. Client has always loved water and bath time. She has started having meltdowns anytime she comes in contact with water. She has been fussy and upset to the point of crying daily. She has always had sleeping issues, but has gotten worse since vaccine. She is "having sleep walking type episodes where she tries to jump out of bed, but she is not awake. Client ran fever 101 on 8/31/18 and 9/1/18 but resolved without issue. Mom concerned because symptoms are much worse since vaccination and she is not able to console the child. Instructed mom to take child to her pediatrician, Mom will fax notes from visit to PCP. Mom would only allow MMR on 8/24/18, she chooses her own immunization schedule. Child had birth dose Hep B and received PEDIARIX on 3/30/2014 at another provider. These are the only vaccines child has received.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Band neutrophil count, Blood potassium decreased, Decreased appetite, Dehydration, Diarrhoea
Clinical narrative: One week after receiving the vaccine the infant started presenting irritably, sleeping less and less consolable, reducing food intake. Patient continued presenting this behaviour until Aug 8th, when  infant started presenting vomit (3 episodes) and reduced appetite. No fever presented during the entire disease progression. On Thursday (Aug 9th) infant continued vomiting, with reduced appetite, and started presenting diarrhea. On the same day (night) was admitted at the ER with dehydration, spending the night receiving 2 bolus (40ml/kg) - no diuresis for 8h on admission, presented diuresis after 2 bolus (5 am on Friday). Released to continue treatment at home, continued with vomits, reduced appetite, reduced diuresis, and diarrhea changed its presentation, with watery diarrhea (osmotic diarrhea). On Saturday admitted to the ER again, after several attempts on oral rehydration admitted to the hospital. Diarrhea continued to worsen through the first days of admission with very frequent and watery episodes (osmotic diarrhea). Still no fever. Vomits persisted until Friday Aug 16th, as well as watery diarrhea (hydrolysed milk formula - Similac aliment introduced on Tuesday Aug 13th). - Possible adverse event to the rotavirus vaccine on an infant with suspected underlying milk protein allergy?
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Emotional distress, Hypophagia, Insomnia, Irritability, Laboratory test normal
Clinical narrative: One week after receiving the vaccine the infant started presenting irritably, sleeping less and less consolable, reducing food intake. Patient continued presenting this behaviour until Aug 8th, when  infant started presenting vomit (3 episodes) and reduced appetite. No fever presented during the entire disease progression. On Thursday (Aug 9th) infant continued vomiting, with reduced appetite, and started presenting diarrhea. On the same day (night) was admitted at the ER with dehydration, spending the night receiving 2 bolus (40ml/kg) - no diuresis for 8h on admission, presented diuresis after 2 bolus (5 am on Friday). Released to continue treatment at home, continued with vomits, reduced appetite, reduced diuresis, and diarrhea changed its presentation, with watery diarrhea (osmotic diarrhea). On Saturday admitted to the ER again, after several attempts on oral rehydration admitted to the hospital. Diarrhea continued to worsen through the first days of admission with very frequent and watery episodes (osmotic diarrhea). Still no fever. Vomits persisted until Friday Aug 16th, as well as watery diarrhea (hydrolysed milk formula - Similac aliment introduced on Tuesday Aug 13th). - Possible adverse event to the rotavirus vaccine on an infant with suspected underlying milk protein allergy?
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Polymerase chain reaction, Polyuria, Stool analysis normal, Urine analysis normal, Vomiting
Clinical narrative: One week after receiving the vaccine the infant started presenting irritably, sleeping less and less consolable, reducing food intake. Patient continued presenting this behaviour until Aug 8th, when  infant started presenting vomit (3 episodes) and reduced appetite. No fever presented during the entire disease progression. On Thursday (Aug 9th) infant continued vomiting, with reduced appetite, and started presenting diarrhea. On the same day (night) was admitted at the ER with dehydration, spending the night receiving 2 bolus (40ml/kg) - no diuresis for 8h on admission, presented diuresis after 2 bolus (5 am on Friday). Released to continue treatment at home, continued with vomits, reduced appetite, reduced diuresis, and diarrhea changed its presentation, with watery diarrhea (osmotic diarrhea). On Saturday admitted to the ER again, after several attempts on oral rehydration admitted to the hospital. Diarrhea continued to worsen through the first days of admission with very frequent and watery episodes (osmotic diarrhea). Still no fever. Vomits persisted until Friday Aug 16th, as well as watery diarrhea (hydrolysed milk formula - Similac aliment introduced on Tuesday Aug 13th). - Possible adverse event to the rotavirus vaccine on an infant with suspected underlying milk protein allergy?
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: White blood cell count normal
Clinical narrative: One week after receiving the vaccine the infant started presenting irritably, sleeping less and less consolable, reducing food intake. Patient continued presenting this behaviour until Aug 8th, when  infant started presenting vomit (3 episodes) and reduced appetite. No fever presented during the entire disease progression. On Thursday (Aug 9th) infant continued vomiting, with reduced appetite, and started presenting diarrhea. On the same day (night) was admitted at the ER with dehydration, spending the night receiving 2 bolus (40ml/kg) - no diuresis for 8h on admission, presented diuresis after 2 bolus (5 am on Friday). Released to continue treatment at home, continued with vomits, reduced appetite, reduced diuresis, and diarrhea changed its presentation, with watery diarrhea (osmotic diarrhea). On Saturday admitted to the ER again, after several attempts on oral rehydration admitted to the hospital. Diarrhea continued to worsen through the first days of admission with very frequent and watery episodes (osmotic diarrhea). Still no fever. Vomits persisted until Friday Aug 16th, as well as watery diarrhea (hydrolysed milk formula - Similac aliment introduced on Tuesday Aug 13th). - Possible adverse event to the rotavirus vaccine on an infant with suspected underlying milk protein allergy?
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had redness and swelling and pain at the injection site. She has taken Ibuprofen to help with the pain and inflammation. I have suggested to also take BENADRYL allergy tablets at, one tablet every six hours.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Echocardiogram normal, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: The pharmacist gave me the vaccine in my right shoulder and I commented that I thought it was a bit high and he said "no, it's right where it should be". It hurt quite badly and continued to hurt. I came back to talk to him a few days later. He said that was rather normal for that injection. It woke me up in the middle of the night on Tuesday night and hurt quite badly. It affected my shoulder and right arm and continued. I went to my doctor a few days later and he referred me to a doctor for joints etc. I eventually went to my heart doctor thinking it was a heart problem. I had suffered a heart attack in 2004 when the symptoms were in my right arm (not left). Dr. gave me many tests and said that my heart was OK and that the pain was probably due to that shot. I also have limited motion of my right arm at this time and some pain when I try to move it where it was quite normal before the injection. I cannot do the crawl (swimming) like I did before March 31.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: The pharmacist gave me the vaccine in my right shoulder and I commented that I thought it was a bit high and he said "no, it's right where it should be". It hurt quite badly and continued to hurt. I came back to talk to him a few days later. He said that was rather normal for that injection. It woke me up in the middle of the night on Tuesday night and hurt quite badly. It affected my shoulder and right arm and continued. I went to my doctor a few days later and he referred me to a doctor for joints etc. I eventually went to my heart doctor thinking it was a heart problem. I had suffered a heart attack in 2004 when the symptoms were in my right arm (not left). Dr. gave me many tests and said that my heart was OK and that the pain was probably due to that shot. I also have limited motion of my right arm at this time and some pain when I try to move it where it was quite normal before the injection. I cannot do the crawl (swimming) like I did before March 31.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: KINRIX= 5.5x3.0 cm area on left thigh after injection. Varicella and MMR= 2 cm Erythema at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Parent called on 8-23-18, 2 days after vaccine was given and states that patient has swelling redness on left arm that vaccines QUADRACEL and MMRV was given in. Parent states not hot to touch and patient does not complain with pain only itching. The majority of left upper arm was red, inflamed and looked like a moderate size whelp. I reported this reaction to Dr the patient's physician here and she instructed parent to give patient age appropriate OTC BENADRYL LIQUID dose every 4 hours as needed. Parent also instructed to do ice packs to area about 10 mins several times a day until better. Parent instructed to observe and contact PCP office if needed. Signs and symptoms of anaphylactic reaction discussed and parent instructed to take patient to local emergency department if suspected anaphylactic reaction occurs. Parent stated understanding of all instructions for patient care. This was on a Thursday and BC we had not heard from patient before then I contacted patient back on that following Monday to check on patient. Patients Mom states by Sunday the area was completely better and patient had no problems through weekend or since then. I instructed parent to contact us back with any concerns at any time.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Induration, Mass, Pain, Skin warm
Clinical narrative: Red, warm, hard lump, painful.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Per patient report over phone: Redness, warmth, severe pain at the site where the PNEUMOVAX was administered. Experienced some body aches and a mild headache for the three days after the administration of shot. Patient tried using NORCO, Ibuprofen and AMBIEN to help sleep with the pain and tried Ice packs at the local site. As of 9/04/2018 the pain is improving and getting better. Patient reported that there feels like a hardness is present in the area where the shot was administered.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain
Clinical narrative: Per patient report over phone: Redness, warmth, severe pain at the site where the PNEUMOVAX was administered. Experienced some body aches and a mild headache for the three days after the administration of shot. Patient tried using NORCO, Ibuprofen and AMBIEN to help sleep with the pain and tried Ice packs at the local site. As of 9/04/2018 the pain is improving and getting better. Patient reported that there feels like a hardness is present in the area where the shot was administered.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9, MENB, TDAP
Symptoms: Fatigue, Nausea, Syncope
Clinical narrative: Patient received vaccines in consultation room. Upon walking out of the vaccination room the patient fainted to the ground. She came to (became responsive) within a minute or so. Did not stop breathing.  Upon asking her if she was okay she said she was nauseous. Paramedics were called to check the patient out. No other treatment was given from rite aid staff except for something to settle her stomach- water and crackers. Patient was able to leave the store within 15-30 minutes unassisted. No issues as we could tell. Called patient next day to see how she was doing. Mom of the patient said she was doing fine was just tired.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Rash, Urticaria
Clinical narrative: Initial site reaction of redness and swelling that resolved within 1-2 days. She also developed a rash/hives on her right arm and bilateral thighs that has been present for 6 days.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Shoulder injury related to vaccine administration
Clinical narrative: Patient had sore shoulder remaining after 1 week. She went to a doctor and they diagnosed her with SIRVA (shoulder injury related to vaccine administration).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt stated that she had a developed a hard warm patch on her arm the day after the injection. Area is about 2x2" has not worsen over time. Pt stated redness was a couple inches below site of injection.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Gait disturbance, Injection site rash
Clinical narrative: Patient presented with rash on left arm that extended fro injection site to shoulder and elbow. Patient stated she had trouble breathing and walking after she received vaccine. Patient presented to pharmacy two days after vaccination was received to tell pharmacist about her experience. Patient had waited at pharmacy for about 10 minutes after she received vaccination. Patient was advised to contact her physician.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug allergies or reactions were no provided. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX, lot # N031003, expiration date on 03-NOV-2019, for prophylaxis (strength, dosage, route and frequency were no provided). It was stated that the sterile diluent was properly stored. Also it was explained that the VARIVAX, was during 8 hours in a temperature of 8F, and that there were previously excursions: 41F for 62 hours, 6F to 14F for 72 hours. Data logger was positive. No adverse events were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1809USA000594: US-009507513-1809USA000595: US-009507513-1809USA000596: US-009507513-1809USA000592: US-009507513-1809USA000593:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug allergies or reactions were no provided. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX (lot # N031003), expiration date on 03-NOV-2019, for prophylaxis (strength, dosage, route and frequency were no provided). It was stated that the sterile diluent was properly stored. Also it was explained that the VARIVAX, was during 8 hours in a temperature of 8F, and that there were previously excursions: 41F for 62 hours, 6F to 14F for 72 hours. Data logger was positive. No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA000594; US-009507513-1809USA000595; US-009507513-1809USA000596; US-009507513-1809USA000593; US-009507513-1809USA000587.