chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: This case was reported by a consumer and described the occurrence of erythema of extremities in a female patient who received SHINGRIX (batch number ZJ4P2, expiry date unknown) for prophylaxis.  On 15th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, pain in arm and skin warm. On an unknown date, the outcome of the erythema of extremities, pain in arm and skin warm were unknown. It was unknown if the reporter considered the erythema of extremities, pain in arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was curious that a side effect that was normal. On Monday morning, the patient received SHINGRIX on left deltoid. The patient experienced redness, soreness and heat from the injection site to the elbow. The redness, heat and soreness had moved her arm approximately from Tuesday evening to the evening of the reporting date. The reporter will provide pictures if they wish to see them.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a female patient who received FLUARIX QUADRIVALENT for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, 21 days after receiving FLUARIX QUADRIVALENT, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to FLUARIX QUADRIVALENT. Additional information received as follows: The case was reported by the office manager. The patient (worker in this office) took Fluarix QIV and 2 to 3 weeks later got the flu. This case was considered as a suspected vaccination failure case as the lab test confirmation for influenza were unknown. The reporter agreed to follow up from GlaxoSmithKline. This is 1 of the 3 linked cases reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, 21 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information received as follows: The case was reported by the office manager. The patient (worker in this office) took FLUARIX QIV and 2 to 3 weeks later got the flu. This case was considered as a suspected vaccination failure case as the lab test confirmation for influenza were unknown. The reporter agreed to follow up from GlaxoSmithKline. This is 1 of the 3 linked cases reported by the same reporter. The contact details of the physician were provided.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, 21 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information received as follows: The case was reported by the office manager. The patient (worker in this office) took FLUARIX QIV and 2 to 3 weeks later got the flu. This case was considered as a suspected vaccination failure case as the lab test confirmation for influenza were unknown. The reporter agreed to follow up from GlaxoSmithKline. This is 1 of the 3 linked cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site inflammation in a female patient who received Shingrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. The patient's past medical history included shingles (had a bout of shingles in 2005 or 2006). Previously administered products included Shingle vaccine (original vaccine received on an unknown date). In May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site inflammation, injection site warmth, injection site pain, injection site swelling, unwell and product supply issue. On an unknown date, the outcome of the injection site inflammation, injection site warmth, injection site pain, injection site swelling and product supply issue were unknown and the outcome of the unwell was recovered/resolved. It was unknown if the reporter considered the injection site inflammation, injection site warmth, injection site pain, injection site swelling and unwell to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that her doctor prescribed the Shingrix vaccine and she got the first injection in late May 2018, and the day after the a vaccination, the injection site on her upper arm was quite inflamed, hot to the touch, painful and puffy. The patient felt ill for a couple of days. After a couple of months, the patient went back for the second injection knowing the second injection was supposed to be within two to six months of the original dose. The vaccine had not been available. First the pharmacy told the patient that end of September 2018 and at the time of reporting pharmacy had informed the patient not until the end of December 2018. The patient stated that this would exceed the six month limit and asked that how would this impact on her immunity. The patient said that the Shingles the first time was awful and did not want back want to have it again. The patient concerned about she paid $66.92 (portion uncovered by my insurance) and she would have to paid again to start the two dose series again, if the time period exceeds six month limit. She asked for advice.
Sex: F
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site inflammation in a female patient who received Shingrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. The patient's past medical history included shingles (had a bout of shingles in 2005 or 2006). Previously administered products included Shingle vaccine (original vaccine received on an unknown date). In May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site inflammation, injection site warmth, injection site pain, injection site swelling, unwell and product supply issue. On an unknown date, the outcome of the injection site inflammation, injection site warmth, injection site pain, injection site swelling and product supply issue were unknown and the outcome of the unwell was recovered/resolved. It was unknown if the reporter considered the injection site inflammation, injection site warmth, injection site pain, injection site swelling and unwell to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that her doctor prescribed the Shingrix vaccine and she got the first injection in late May 2018, and the day after the a vaccination, the injection site on her upper arm was quite inflamed, hot to the touch, painful and puffy. The patient felt ill for a couple of days. After a couple of months, the patient went back for the second injection knowing the second injection was supposed to be within two to six months of the original dose. The vaccine had not been available. First the pharmacy told the patient that end of September 2018 and at the time of reporting pharmacy had informed the patient not until the end of December 2018. The patient stated that this would exceed the six month limit and asked that how would this impact on her immunity. The patient said that the Shingles the first time was awful and did not want back want to have it again. The patient concerned about she paid $66.92 (portion uncovered by my insurance) and she would have to paid again to start the two dose series again, if the time period exceeds six month limit. She asked for advice.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a 58-year-old female patient who received Shingrix for prophylaxis. On 22nd September 2018, the patient received the 1st dose of Shingrix. On 15th October 2018, 23 days after receiving Shingrix, the patient experienced shingles and erythema. On an unknown date, the patient experienced fever. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles, fever and erythema were recovered/resolved. It was unknown if the reporter considered the shingles, fever and erythema to be related to Shingrix. Additional details were provided as follows: This case was reported by pharmacist for herself. The age at vaccination was not reported but it could be 57 or 58 years. After receiving Shingrix, the patient experienced low grade fever of about 100 degree F for 24 hours. On 15 October 2018, the patient got first red spot which began to spread next day. The patient went to doctor and diagnosed with shingles and received Valacyclovir as treatment. Shingles took 6 days to dry up. The pharmacist agreed to receive follow up and would call medical directly to ask about how long to wait after outbreak of Shingles and Valacyclovir to get her 2nd shot.
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received FLULAVAL TETRA 2018-2019 season for prophylaxis. On an unknown date, the patient received FLULAVAL TETRA 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLULAVAL TETRA 2018-2019 season, the patient experienced influenza-like symptoms and stinging. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the stinging was unknown. It was unknown if the reporter considered the influenza-like symptoms and stinging to be related to FLULAVAL TETRA 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms after receiving FLULAVAL TETRA 2018-2019 season vaccine which was lasting for 2 to 3 days. The patient also experienced stinging at time. The reporter agreed to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a elderly female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose, refer case US2018192695). On 5th October 2018, the patient received the 2nd dose of Shingrix. On 5th October 2018, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On 11th October 2018, the patient experienced erythematous rash and itchy rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, erythematous rash, itchy rash and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, erythematous rash, itchy rash and injection site warmth to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported however; the patient was over the age of 65 years. The patient wanted to remain anonymous. The patient's injection site became red, swollen, and hot to the touch on the same day of vaccination. The area was described as 8 inch by 3 inch. On 11th October 2018, 6 days after receiving Shingrix, the patient developed 2 small red bumps on her upper thigh. The night before the reporting date, 2 more bumps appeared on her right wrist and on the day of reporting morning 2 more under her left knee. The bumps were itchy.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a elderly female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose, refer case US2018192695). On 5th October 2018, the patient received the 2nd dose of Shingrix. On 5th October 2018, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On 11th October 2018, the patient experienced erythematous rash and itchy rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, erythematous rash, itchy rash and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, erythematous rash, itchy rash and injection site warmth to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported however; the patient was over the age of 65 years. The patient wanted to remain anonymous. The patient's injection site became red, swollen, and hot to the touch on the same day of vaccination. The area was described as 8 inch by 3 inch. On 11th October 2018, 6 days after receiving Shingrix, the patient developed 2 small red bumps on her upper thigh. The night before the reporting date, 2 more bumps appeared on her right wrist and on the day of reporting morning 2 more under her left knee. The bumps were itchy.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not applicable. This case was previously reported to the physician. The age group was not provided, but was selected as adult as per the vaccine indication. The reporter stated that, she heard about 3 people while in line at her local pharmacy mention that they all had terrible reaction to the Shingrix vaccine. The patient had denied permission to contact their physician. This case was linked with case US2018192637, reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. This Physician reported that a 16 year old patient received the first dose of TRUMENBA on an unknown date in the arm at single dose for immunization. Patient medical history and concomitant medications were not reported. It was stated that the patient experienced a swollen, sore arm from shoulder down to elbow. The information on the batch number has been requested.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a female patient (age reported as early 40's) who received a dose of FLUZONE QUADRIVALENT (batch number U5958AA, expiry date 30 June 2018, route and site of administration were not reported) on an unspecified date. Patient had no concomitant medication. It was a case of actual medication error as expired vaccine used. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Adult patient who experienced high fever, while he/she received vaccine ADULT TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect ADULT TENIVAC lot number not reported. On an unknown date, patient developed a non-serious high fever (pyrexia) following the administration of ADULT TENIVAC. (Other relevant tests included no lab data.) Final diagnosis was high fever. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for high fever.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Balance disorder, Decreased appetite, Dizziness, Electrocardiogram, Erythema
Clinical narrative: Pain, redness at site of injection. Swelling of face, sore throat, malaise. Redness and swelling extended to inner aspect of arm for about 8 in. Lasted about one week and 12 days following PNEUMOVAX vac. 10/23/18 nausea vomiting - dizziness, unsteady of ft. Room spinning. Loss appetite. 10-23-18 1700 hrs Dr's office closed seen by PAC at urgent care. EKG done. 10/25/18 Feeling much better. PNEUMOVAX was not ordered by Dr. I just went to pharmacy.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Malaise, Nausea, Oropharyngeal pain
Clinical narrative: Pain, redness at site of injection. Swelling of face, sore throat, malaise. Redness and swelling extended to inner aspect of arm for about 8 in. Lasted about one week and 12 days following PNEUMOVAX vac. 10/23/18 nausea vomiting - dizziness, unsteady of ft. Room spinning. Loss appetite. 10-23-18 1700 hrs Dr's office closed seen by PAC at urgent care. EKG done. 10/25/18 Feeling much better. PNEUMOVAX was not ordered by Dr. I just went to pharmacy.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Swelling face, Vertigo, Vomiting
Clinical narrative: Pain, redness at site of injection. Swelling of face, sore throat, malaise. Redness and swelling extended to inner aspect of arm for about 8 in. Lasted about one week and 12 days following PNEUMOVAX vac. 10/23/18 nausea vomiting - dizziness, unsteady of ft. Room spinning. Loss appetite. 10-23-18 1700 hrs Dr's office closed seen by PAC at urgent care. EKG done. 10/25/18 Feeling much better. PNEUMOVAX was not ordered by Dr. I just went to pharmacy.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Product packaging confusion, Wrong product administered
Clinical narrative: Patient was due to receive MMR, Varicella and Hep A vaccines. MMRV was given in error instead of MMR. The boxes are the same color and I got them mixed up and gave the wrong vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Gait disturbance, Injection site pain, Pain, Pyrexia, Weight bearing difficulty
Clinical narrative: Patient presented with fever the evening of 10/29/2108. Fever lasted approximately 24 hours. Patient c/o right leg pain, is limping and cannot walk up stairs. At time of exam, patient holding right leg with knee bent, avoiding weight bearing. Right leg uncomfortable with with palpation around injection site on Right thigh, pain with knee flexion and extension.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Severe allergic reaction with itching, hives erythema. No respiratory symptoms. Given oatmeal cream, Benadryl, Solu-medrol IM and symptoms subsided. Given oral prednisone and instruction when to call and/or go to ER.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Flushing, Lip pruritus, Pruritus, Rash
Clinical narrative: Patient woke on Saturday feeling flushed and itchiness centralized to her face. The redness and itchiness radiates to her neck and she noticed little bumps on her neck. She reported to the clinic on 29Oct2018 and stated the itchiness had not subsided. She was itchy all over her face including her lips. She stated she had not issues at any time with her breathing, swallowing or experiencing any itchiness or swelling inside her mouth. She had not taken any medications to help reduce the itchiness.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Gingival pain, Headache
Clinical narrative: On Monday afternoon I started feeling headache, slight dizziness. That carried into Tuesday. On Wednesday evening my chest tightened, and I've had difficulty breathing since then. I woke up with a sore neck and shoulders and could not move my neck. My teeth/gums also ache.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Toothache
Clinical narrative: On Monday afternoon I started feeling headache, slight dizziness. That carried into Tuesday. On Wednesday evening my chest tightened, and I've had difficulty breathing since then. I woke up with a sore neck and shoulders and could not move my neck. My teeth/gums also ache.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The child arrived to school two days after receiving the flu shot two days prior. Patient c/o pain to his upper left arm. There was a 2cm bruise at the injection site, below the injection site there was a 10x10cm area of redness and swelling which was hot to the touch. There was about a 2cm space between the bruise and the redness. Patient states his mom took him to the doctor yesterday and was given medication to take. Unknown what medication.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Neuropsychiatric syndrome, Psychiatric symptom
Clinical narrative: Potential trigger of new onset automimmune condition, PANS. Debilitating psychiatric symptoms.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, PNC13, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old patient was given QUADRACEL outside of recommended age range.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema
Clinical narrative: Redness, cellulitis. Counseled to use cold compress, antihistamine if not allergic (benadryl allergy on file).
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Feeling abnormal, Loss of consciousness
Clinical narrative: Lightheaded, dizzy, weak to the point of nearly "passing out" within 10 minutes of vaccine and lasting for hours after. Treated with elevated feet, rest, and juice and food to help with low blood sugar feeling.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site pain, Insomnia, Pain, Peripheral swelling
Clinical narrative: Immediately felt pain at site of injection. Felt a pop in shoulder, felt injection had not been given properly. Got worse as day went on by evening around 6:00pm could not raise arm. Kept her awake all night unable to move without pain. Took Tylenol. Hand and arm felt swollen. By the30th able to move arm a little, by Nov 1st able to raise arm, but continues to be sore. Still painful if roll on it at night.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient states that she has been having trouble moving her arm after the flu shot. She is going to be seen by urgent care.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia
Clinical narrative: Soreness of deltoid muscle for 2 weeks after the shot.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt scratching vaccine site after administration. Redness and swelling noted around vaccine site to right thigh the morning of 10/31/18. Redness and swelling have increased. Red area feels warm. Pt had a fever last night.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Patient received the vaccine Monday morning on the 29th. Mom gave pt some Ibuprofen right after vaccination due to the patient saying his arm was sore. Patient's arm itched Tuesday at school. Tuesday night Mom noticed the swelling and redness of arm. She drew a line around the swelled/red area on arm Tuesday night and gave him 10ml of liquid Benadryl at 9pm. Wednesday morning (10-31) Mom gave pt another 10ml of Benadryl liquid and noticed that the swelling had spread past the original marked area. The swelling spread down the arm and along the inside of arm towards the armpit. This was verified by pharmacist and recommended Mom take pt to see provider. Mom took pt to see a doctor and received a prescription for prednisolone 15mg/5ml (10ml by mouth once daily x3 days).
Age: 63.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: Client called clinic to report that she started having leg cramping (5 out of 10 reported severity) for "a number of hours" starting at approximately 11:00 PM. She also reported that she has a continued low-grade fever the morning after. She stated she did not feel the need to seek medical attention, and reported no medications taken for relief.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Patient reported swelling within a few hours of receiving the vaccination. Swelling started at injection site and continued down arm and into hand and fingers. Patient went to the emergency room to see physician. Patient was sent home in an arm sling. Unknown what the emergency room physician instructed patient to do.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a female patient of unknown age, reporting on herself. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date, after receiving the GARDASIL 9 vaccine, the patient discovered that she was pregnant. The patient's last menstrual period, due date and estimated date of conception were not provided.
Age: 1.17
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a medical assistant regarding to an 14 month old patient of unknown gender. There was no information about the patient's concomitant medications, concurrent conditions or pertinent medical history reported. On an unknown date, the patient was inadvertently vaccinated with GARDASIL 9 lot # 1586749 with expiration date 13-FEB-2021 per intramuscular route (dose, strength, frequency and anatomical location were not provided) for prophylaxis instead of an intended dose of HAVRIX. No adverse effect was reported and no product quality complaint (PQC) was involved.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report was received from a 66 year old male patient with hypertension. The patient's medical history included shoulder injury. His concomitant therapy included chlorothiazide. On 14-OCT-2018 the patient was vaccinated with a PNEUMOVAX 23 (dose, route and lot# were not provided) for prophylaxis. On 14-OCT-2018, the patient experienced itching at the injection (injection site pruritus). No treatment was administered for the event. The outcome of injection site pruritus was reported as recovered on an unspecified date in October 2018. The causal relationship between itching at the injection and pneumococcal PNEUMOVAX 23 was not provided.
Age: 6.0
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked with 2018SA297470, 2018SA297469, 2018SA297471, 2018SA297472, 2018SA297473 (same reporter). This case involves a 6 years old patient (unknown gender) who received single 0.25 ml of vaccine FLUZONE QUADRIVALENT (Suspension for injection) (lot UT6259JA and expiration date 30-Jun-2019) instead of the 0.5 ml via unknown route in the right thigh on an unknown date (reported Sep-25 - Oct-12) for Immunization. Patient's medical history was not reported. No concomitant therapies was received by patient. It was a case of actual medication error due to vaccine underdoes. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA296383, 2018SA297471, 2018SA297470, 2018SA297472, and 2018SA297473 (same reporter). This case involves a four-year-old patient (gender not reported) who received 0.25 ml of vaccine FLUZONE QUADRIVALENT (lot UT6259JA and expiration date 30-Jun-2019) (frequency once, Suspension for injection) instead of the 0.5 ml via unknown route in the right thigh on an unknown date (reported as in between Sep-25 to Oct 12). It is an actual medication error case due to vaccine underdose. It was not reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 7.0
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA296383, 2018SA297469, 2018SA297473, 2018SA297471, 2018SA297472 (same reporter). Medical history and concomitant medications were not reported. This case involves a seven years old patient (gender not reported) who received 0.25 ml once of vaccine FLUZONE QUADRIVALENT (lot UT6259JA and expiration date 30-Jun-2019) instead of the 0.5 ml via unknown route in the left thigh on an unknown date (also reported as 25-Sep - 12-Oct). It was a case of actual medication error due to vaccine underdose. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA296383, 2018SA297469, 2018SA297470, 2018SA297472, and 2018SA297473 (same reporter). This case involves a four year old patient (gender not reported) who received 0.25 ml of vaccine FLUZONE QUADRIVALENT (lot UT6259JA and expiration date 30-Jun-2019) (frequency once, Suspension for injection) instead of the 0.5 ml via unknown route in the right thigh on 25-Oct-2012. It is an actual medication error case due to vaccine underdose. It was not reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA296383, 2018SA297469, 2018SA297473, 2018SA297471 and 2018SA297470 (same reporter). This case involves a 5 years old patient who received 0.25 ml of vaccine FLUZONE QUADRIVALENT (lot UT6259JA and expiration date 30-Jun-2019) via unknown route in unknown site of administration (left side) on an unspecified date. It was a case of actual medication error due to Vaccine underdose. It was reported that six children received FLUZONE QUAD 0.25 mL instead of the 0.5 mL. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves eight patients of age between 30-40 year who were vaccinated with dose of (0.5 ml) INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (batch number: UJ009AA, expiration date: 30-Jun-2019, via unknown route in right and left deltoid) on 19-OCT-2018. The patients' medical history and concomitant medications were not reported. No other vaccines for any of these patients. It was an actual medication error due to incorrect product storage. It was unknown whether the patients had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Patient complains of rash. It began 3 days ago. The symptom onset was sudden. Associated symptoms include rash. He denies chills, cough, diarrhea, headache, nausea, sore throat, sweats or vomiting. He did received his 1 year immunizations 1 week prior. Mother states she thinks he had 2 small areas of the rash the day he received the immunization. The rash continued to worsen over the past 24 hours. He has been asymptomatic. No sick contacts. No outdoor exposure. No recent medications.
Sex: F
Vaccine: HPVX
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. No information regarding the patient's concurrent conditions, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date the patient was vaccinated with a human papilloma virus (HPV) vaccine, the type and manufacturer unknown, (Lot number, expiration date and route of administration were not reported). After the vaccination the patient became pregnant. The LMP and EDD is not known. The outcome of pregnancy is unknown.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a pharmacist, concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (thimerosal free) lot # R004185 with expiration date on 06-NOV-2020 (strength, anatomical location or route of administration were not provided) for prophylaxis. The storage temperature of the vaccines was reported as 9 to 25 degrees Celsius (°C) (maximum 8.5 °C) for a time frame of 1 hour; digital data logger involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This case is considered non-valid due to the lack of patients' identifiers.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative and refers to 5 or 6 patients over the age of 65 years of an unknown gender. The patients' pertinent medical history, drug reactions and allergies were not provided. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, lot number, route of administration, anatomical location and expiration date were not provided) for prevention of pneumococcal disease and with an unspecified influenza virus vaccine (dose, lot number, route of administration, anatomical location and expiration date were not provided). It was reported that the patients developed severe injection site reactions when co-administered with an unspecified influenza virus vaccine being administered in the opposite arm. The outcome of the event injection site reaction was unknown and causality assessment was not provided.
Age: 1.5
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from an office manager via a company representative referring to an 18 month old female patient. Information about concurrent condition, concomitant therapy, drug reactions/allergies and medical history was not provided. On an unknown date, the patient inadvertently received a dose of GARDASIL 9 (strength, route, lot # and expiration date were not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions were not reported. Concomitant medication included a sterile diluent. On an unspecified date, VARIVAX (product storage error) (lot: r009821, expiry date: 03-APR-2020) subcutaneously. Sterile diluent used to reconstitute was stored in proper range. The vaccine was exposed to -14C to -10C for 1 hour and 30 minutes. There was a previous temperature excursion -14C to -10C (-11.1C) for 2 hours. The call was because of a data logger. No adverse effects reported.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Mobility decreased, Pyrexia, Urticaria
Clinical narrative: This spontaneous report has received from a medical assistant via a field representative refers to a 38 years old female patient with unspecified heart condition who was also a nurse working in the office. Information about drug reactions/allergies, concomitant medication and medical history was not provided. In approximately 2018 (reported as recent past), the patient received a dose of PNEUMOVAX 23 (Lot# R016638, expiration date 02-JAN-2020; strength, dose, frequency were not reported) intramuscularly in the arm for prophylaxis. On an unknown date of 2018, the patient experienced welts, redness, fever, pain at injection site; all symptoms worsened over time, so the patient saw nurse practitioner in the office. The patient was treated (unspecified) and out of work 2 days with earlier specified symptoms including difficulty lifting arm. The patient was considered recovered at the time of reported. Per medical assistant, there were no reports of PNEUMOVAX 23 undergoing any temperature excursion. The causality assessment was not provided. The events were considered to be significant disability or incapacity by the medical assistant. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1810USA011628.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 3 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-APR-2018, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. On 27-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX of lot # N022981 with an expiry date of 23-AUG-2019 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the time of excursion (Product storage error). The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that the supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
Age: 1.83
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 2 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-APR-2018, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. On 16-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX of lot # N022981 with an expiry date of 23-AUG-2019 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the time of excursion. The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that the supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Cellulitis, Joint swelling, Syncope, White blood cell count increased
Clinical narrative: This spontaneous report was received from an office manager, referring to a 63 year old male patient. The patient did not have concomitant medication, pertinent medical history, drug reactions or allergies. On 23-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R002084, expiration date 26-OCT-2019, intramuscular, for prophylaxis (reported as indication: "Over 60 year old"). On the same date of vaccination, the patient "experienced pain and swelling in patient's elbow." Subsequently, "the patient also experienced syncope on unspecified date, therefore, the patient went back to the office on 24-OCT-2018." The office manager reported that "unspecified physician tapped patient's elbow and determined there was high white blood cell count and the patient was referred to the emergency room." It was also reported that the patient was "diagnosed with cellulitis in the elbow and he was hospitalized on 24-OCT-2018." Additionally, the patient received unspecified intravenous (IV) antibiotics in the hospital. The outcome of cellulitis and syncope was reported as not recovered. The causality assessment between cellulitis and syncope and therapy with PNEUMOVAX 23 was not provided. Upon internal review the event cellulitis was determined to be medically significant.