chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: PNC13, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old infant, female patient. The patient's medical history, concurrent conditions, concomitant medications, and drug reactions/allergies were unknown. On 05-DEC-2018, the patient was vaccinated with ROTATEQ (Strength, dose and frequency were not reported) of lot # R002517 with an expiry date of September 2019, orally for vaccination. On the same day, the patient developed a temperature of 102.9 fahrenheit (F) (39.3 degree Celsius) with vomiting. The patient sought medical attention and was taken to an unspecified emergency department. The patient was treated with an unspecified TYLENOL and an unspecified ondansetron. The medical assistant reported that the patient was not admitted to the hospital. There were no lab diagnostics/studies performed. No product quality complaint was associated with this report. The outcome of the events of pyrexia and vomiting was reported to be recovered on 07-DEC-2018. The causality assessment was not provided.
Age: 1.83
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Ear, nose and throat examination, Eczema, Eczema weeping, Full blood count, Measles antibody
Clinical narrative: My son developed a severe rash resembling measles within 3 days after receiving the vaccine that started on his face. By day 5, His body was completely covered from head to toe with what looked like the chicken pox or measles. He has had severe pain and itching with this rash. The rash and itching is still present. Four days after the rash started he was presenting with fevers over 103° F. We brought him to urgent care, they ruled out hand foot and mouth and gave him an antibiotic due to his rash looking like an infection was starting. They told us to follow up with our regular doctor.  We weren't able to see our normal doctor so we saw the next available one 2 days after urgent care visit. This doctor did no tests, and said it was scabies. We then went to a holistic nutritionist to get a second opinion and they said it was absolutely not scabies and did cold laser treatment on his body. They thought it was fully related to the vaccines. My son has been in daycare and around his siblings with no one getting any of the signs and symptoms he presented with. After that we got in to our regular doctor (at the beginning of October), at this point the rash was so severe my son was itching chunks of skin off his body. Up to this point, we tried, coconut oil, antibiotics, creams, lotions, anti-itch, BENADRYL. At this appointment he was prescribed another antibiotic. 3 days later his head was seeping pus, and we were sent to the hospital. He was tested for many things and given IV antibiotics and topical steroids but still did not have any answers to what it was and did not get better. After 5 days we were discharged home still with rash present. We continued with BACTRIM at home for 10 days. The hospital used ATARAX to help itching, this did not help relieve the symptoms. We followed up with his primary after that and he said there wasn't much he could do for him we just had to wait it out. On December 12th, 2018 we went to a holistic doctor. He said it was eczema most likely caused by vaccinations.
Age: 1.83
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Pyrexia, Rash, Rash generalised, Rash morbilliform, Rash pruritic
Clinical narrative: My son developed a severe rash resembling measles within 3 days after receiving the vaccine that started on his face. By day 5, His body was completely covered from head to toe with what looked like the chicken pox or measles. He has had severe pain and itching with this rash. The rash and itching is still present. Four days after the rash started he was presenting with fevers over 103° F. We brought him to urgent care, they ruled out hand foot and mouth and gave him an antibiotic due to his rash looking like an infection was starting. They told us to follow up with our regular doctor.  We weren't able to see our normal doctor so we saw the next available one 2 days after urgent care visit. This doctor did no tests, and said it was scabies. We then went to a holistic nutritionist to get a second opinion and they said it was absolutely not scabies and did cold laser treatment on his body. They thought it was fully related to the vaccines. My son has been in daycare and around his siblings with no one getting any of the signs and symptoms he presented with. After that we got in to our regular doctor (at the beginning of October), at this point the rash was so severe my son was itching chunks of skin off his body. Up to this point, we tried, coconut oil, antibiotics, creams, lotions, anti-itch, BENADRYL. At this appointment he was prescribed another antibiotic. 3 days later his head was seeping pus, and we were sent to the hospital. He was tested for many things and given IV antibiotics and topical steroids but still did not have any answers to what it was and did not get better. After 5 days we were discharged home still with rash present. We continued with BACTRIM at home for 10 days. The hospital used ATARAX to help itching, this did not help relieve the symptoms. We followed up with his primary after that and he said there wasn't much he could do for him we just had to wait it out. On December 12th, 2018 we went to a holistic doctor. He said it was eczema most likely caused by vaccinations.
Age: 1.83
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Rash vesicular, Skin abrasion, Staphylococcus test positive, Vaccination complication, Varicella virus test
Clinical narrative: My son developed a severe rash resembling measles within 3 days after receiving the vaccine that started on his face. By day 5, His body was completely covered from head to toe with what looked like the chicken pox or measles. He has had severe pain and itching with this rash. The rash and itching is still present. Four days after the rash started he was presenting with fevers over 103° F. We brought him to urgent care, they ruled out hand foot and mouth and gave him an antibiotic due to his rash looking like an infection was starting. They told us to follow up with our regular doctor.  We weren't able to see our normal doctor so we saw the next available one 2 days after urgent care visit. This doctor did no tests, and said it was scabies. We then went to a holistic nutritionist to get a second opinion and they said it was absolutely not scabies and did cold laser treatment on his body. They thought it was fully related to the vaccines. My son has been in daycare and around his siblings with no one getting any of the signs and symptoms he presented with. After that we got in to our regular doctor (at the beginning of October), at this point the rash was so severe my son was itching chunks of skin off his body. Up to this point, we tried, coconut oil, antibiotics, creams, lotions, anti-itch, BENADRYL. At this appointment he was prescribed another antibiotic. 3 days later his head was seeping pus, and we were sent to the hospital. He was tested for many things and given IV antibiotics and topical steroids but still did not have any answers to what it was and did not get better. After 5 days we were discharged home still with rash present. We continued with BACTRIM at home for 10 days. The hospital used ATARAX to help itching, this did not help relieve the symptoms. We followed up with his primary after that and he said there wasn't much he could do for him we just had to wait it out. On December 12th, 2018 we went to a holistic doctor. He said it was eczema most likely caused by vaccinations.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with expired PNEUMOVAX 23 lot # N000463 for prophylaxis. The physician also stated that PNEUMOVAX 23 did not have prior excursions prior to vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On 13th December 2018, the patient received the 2nd dose of SHINGRIX. On 14th December 2018, 1 days after receiving SHINGRIX, the patient experienced weakness generalized, feels awful, tiredness and general body pain. In December 2018, the patient experienced fever, chills and muscle pain. On an unknown date, the outcome of the fever, chills, muscle pain, weakness generalized, feels awful, tiredness and general body pain were unknown. It was unknown if the reporter considered the fever, chills, muscle pain, weakness generalized, feels awful, tiredness and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had fever, chills and muscle aches all night. On the day of reporting, the patient had sore all over and was extremely tired. The patient asked how long they could expect to feel this way.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On 13th December 2018, the patient received the 2nd dose of SHINGRIX. On 14th December 2018, 1 days after receiving SHINGRIX, the patient experienced weakness generalized, feels awful, tiredness and general body pain. In December 2018, the patient experienced fever, chills and muscle pain. On an unknown date, the outcome of the fever, chills, muscle pain, weakness generalized, feels awful, tiredness and general body pain were unknown. It was unknown if the reporter considered the fever, chills, muscle pain, weakness generalized, feels awful, tiredness and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had fever, chills and muscle aches all night. On the day of reporting, the patient had sore all over and was extremely tired. The patient asked how long they could expect to feel this way.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: Information has been received from a physician referring to a 4 years old female patient. The patient's concomitant medication included FLOVENT and multivitamin. The patient's pertinent concurrent conditions included Thalassaemia minor and asthma. The patient was allergic to dogs, cats, pollen, trees and dust. On 10-JUN-2014, the patient received first dose of M-M-R II (lot number and expiration date unspecified) with sterile diluent (lot number and expiration date unspecified) subcutaneously for prevention of measles, mumps, rubella. On 26-JUN-2017, the patient received second dose of M-M-R II (lot number and expiration date unspecified) with sterile diluent (lot number and expiration date unspecified) subcutaneously for prevention of measles, mumps, rubella. The patient had negative measles titer on 01-MAR-2018. On 17-MAY-2018, the patient received a third dose M-M-R II (lot number N014485, expiration date 10-MAY-2019) with sterile diluent (lot number and expiration date unspecified) subcutaneously for prevention of measles, mumps, rubella (extra dose administrated). The patient had negative measles titer on 02-NOV-2018. Treatment was given for the events and the patient saw physician for seeking medical attention. The outcome of the events was reported as not recovered. The causality assessment between the events and suspect therapies was not provided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 75 year old female patient. The patient's concomitant therapies included metformin, lisinopril and glipizide. The patient's pertinent medical history included diabetes. The patient had none drug reactions/allergies. In 2003 (reported as 15 years ago) the patient was vaccinated with ZOSTAVAX (1 injection, route was reported as injection, strength, frequency, lot# and expiration date were unknown) for prophylaxis (reported as shingles prevention). In 2015 (reported as 3 years ago) the patient was diagnosed with shingles. Treatment was given for the event. No lab diagnostics or studies were performed for the event. The patient had sought medical attention. The outcome of the event was recovered. The causality assessment was not provided by the reporter.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a female nurse via Pfizer regarding herself. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient received PNEUMOVAX 23 for prophylaxis (dosing schedule was not reported). On an unknown date, the patient had allergic reaction to PNEUMOVAX 23 (allergy to vaccine). Outcome of the event was not reported. Causality was assessed to be related to PNEUMOVAX 23.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 26-NOV-2018, the patient was administered with improperly stored ROTATEQ (lot# R003149, expiry date: 19-FEB-2019) for prophylaxis. Dosing details were unknown for the vaccine. No adverse effect reported. The temperature excursion occurred between 0 degree Celsius to 1 degree Celsius (0.5 degree Celsius multiple) for a time frame of 13 hours and 18 minutes. There were no previous temperature excursions occurred. Data logger was involved. No product quality complaint was involved. This is one of the two reports received from the same reporter (cross linked case reference: 1812USA002036). Sender's Comments: US-009507513-1812USA002036.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse by phone. This case involves a 18 months old male patient who was vaccinated with a fourth dose of ACTHIB (batch number: UI905AA and expiry date: 18-Nov-2019) via intramuscular route in the left thigh on 11-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13, ROTATEQ and DTAP on same visit. It was a case of actual medication error due to inappropriate reconstitution technique because the diluent portion of the ACTHIB was given without mixing in the powder. It was unknown if any adverse event occurred or not following the vaccination. 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 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. Documents held by the sender: none.
Age: 28.0
Sex: F
Vaccine: RAB, TTOX
Symptoms: Incomplete course of vaccination
Clinical narrative: Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 28 years old female patient who received vaccine IMOVAX RABIES.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Immunoglobulins Nos and Tetanus Vaccine for Immunisation along with three other unspecified shots. On 03 Dec 2018, the patient was bitten by monkey on her left forearm. Patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported via intramuscular route along with Immunoglobulin and Tetanus toxoid by IM route. Patient was asked to received dose on 3rd day, 7th day and 14th day however she missed those because she was traveling. It has been 15 days since her last rabies shot. She has missed the rest of her Rabies shots. It was a case of actual medication error due to incomplete course of vaccination. It was unknown whether any adverse event occurred. 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.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Had a fever of 102, a rash on his face, and vomiting. Tylenol was given, fever went away and vomiting stopped. Rash started to disappear on Monday.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring a 1 year old patient of an unknown gender. No information was provided regarding the patient's historical medication, concurrent conditions or concomitant medications. On 28-NOV-2018, the patient inadvertently administered one dose of with PROQUAD with lot number R013575 and expiration date on 10-NOV-2019 (dose, dose number, route of administration and anatomical injection site were not reported), for prophylaxis, and one dose of VARIVAX (dose, dose number, route of administration, anatomical injection site, lot number and expiration date were not reported), for prophylaxis, at the same visit (Accidental overdose). No adverse effects were reported.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Erythema, Inflammation, Peripheral swelling
Clinical narrative: Swollen red inflamed skin on left leg after vaccines no fever.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Skin irritation, Urticaria
Clinical narrative: Fever developed on 12/19/18 and 12/20/18 on and off, fever reached its highest temperature at 101.4F. On 12/21/18 in the evening around 5:30pm it was noticed that the face had  irritation around the nose and cheeks area. Around 7:30pm the irritation on the face looked more like hives and hives started forming on chest and upper back. On 12/22/18 around 8:00am the hives had continued to spread down her chest, onto her belly and lower back. I called the doctor, scheduled an emergency appointment for 11:30am that day. Around 11:45am I noticed the hives were spreading onto her legs, feet, arms and hands. Around 12:05pm she was seen by Dr. whom said something along the lines that this reaction was extremely rare but typical with the vaccine. She would get worse before she got better; expect it to last 7-10 days; give Benadryl every 6 hours.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Abscess, Pain, Ultrasound scan
Clinical narrative: Patient had right arm injection 10/3. She finished antibiotics approximately 1 month ago. She has 1/10 pain. She denies fever or chills.
Age: 40.0
Sex: F
Vaccine: FLUA3
Symptoms: Loss of personal independence in daily activities, Pain, Vaccination complication
Clinical narrative: I'm not sure what the specific flu vaccine was but I received it and within about 24 hours I was in extraordinary pain. I wasn't able to even pick up my infant daughter. This went on for about 3 to 4 months. It was excruciating and I would've much rather had the flu then the reaction that I had from that flu shot. I contacted the pharmacy, and they just told me to go to my doctor. I didn't see the point since my doctor wouldn't have any kind of solution for me. I just had to wait it out. When I went online, I discovered that other people had the exact same reaction. And it took anywhere from 4 to 12 months to get over. For me, it was probably a good six months before everything was out of my system.
Age: 60.0
Sex: F
Vaccine: FLUX, HEPA, PPV
Symptoms: Culture, Debridement, Fungal test, Injection site pain, Mycobacterium test
Clinical narrative: Patient had influenza and pneumonia vaccination on 10/3/18 in right upper extremity. At injection site, which was the proximal right upper extremity on skin overlying the deltoid muscle, she noticed increased tenderness. States that the pain in her right upper extremity near the injection site is 6-7/10 at its worse. States that the pain today is 2/10. States that the pain is worse when palpated. Patient states that the pain radiates through to her right shoulder and feels like "hot needles". Denies any drainage, fever, chills, sweats, nausea, vomiting, erythema. Patient states she also received hepatitis A injection in the left arm, but denies any problems with that arm currently. Ultrasound. Incision and debridement, cultures obtained, irrigated and packed with gauze.
Age: 60.0
Sex: F
Vaccine: FLUX, HEPA, PPV
Symptoms: Ultrasound scan, Wound treatment
Clinical narrative: Patient had influenza and pneumonia vaccination on 10/3/18 in right upper extremity. At injection site, which was the proximal right upper extremity on skin overlying the deltoid muscle, she noticed increased tenderness. States that the pain in her right upper extremity near the injection site is 6-7/10 at its worse. States that the pain today is 2/10. States that the pain is worse when palpated. Patient states that the pain radiates through to her right shoulder and feels like "hot needles". Denies any drainage, fever, chills, sweats, nausea, vomiting, erythema. Patient states she also received hepatitis A injection in the left arm, but denies any problems with that arm currently. Ultrasound. Incision and debridement, cultures obtained, irrigated and packed with gauze.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 19-APR-2014, a healthcare provider, at a healthcare facility/office administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-DEC-2015, the patient was treated by a healthcare provider at a healthcare facility/office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Cough, Fatigue, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program. A male patient of an unspecified age received PREVNAR 13, in 2015 and 2017, both via an unspecified route of administration at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient got the pneumococcal 13-val conj vac (dipht crm197 protein) shot three years ago, and then got the booster shot one year ago. Two weeks ago (2018) he got pneumonia. The doctor put patient on antibiotics, and he still had a cough and got tired a lot, all in 2018.The outcome of all events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (01035471). A contactable healthcare professional on behalf of a pharmacist reported similar events for 3 patients. This is 1st of three reports. A patient of unspecified age and gender started to receive PREVNAR 13, via an unspecified route of administration on Sep2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient developed severe injection site redness, rash, and soreness in 2018. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Linked Report(s): US-PFIZER INC-2018525857 same reporter, drug, event, and different patient; US-PFIZER INC-2018525856 same reporter, drug, event, and different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (01035471). A contactable healthcare professional on behalf of a pharmacist reported similar events for 3 patients. This is 2nd of three reports. A patient of unspecified age and gender started to receive PREVNAR 13, via an unspecified route of administration on Sep2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient developed severe injection site redness, rash, and soreness in 2018. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Linked Report(s): US-PFIZER INC-2018525839 same reporter, drug, event, and different patient; US-PFIZER INC-2018525857 same reporter, drug, event, and different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (01035471). A contactable healthcare professional on behalf of a pharmacist reported similar events for 3 patients. This is 3rd of three reports. A patient of unspecified age and gender started to receive PREVNAR 13, via an unspecified route of administration in Sep2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient developed severe injection site redness, rash, and soreness in 2018. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Linked Report(s): US-PFIZER INC-2018525839 same reporter, drug, event, and different patient; US-PFIZER INC-2018525856 same reporter, drug, event, and different patient.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable other healthcare professional reported that an 80-year-old female patient started to receive PREVNAR 13, (Solution for injection in pre-filled syringe), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported, the patient is allergic to PREVNAR on an unspecified date. The action taken in response to the event for pneumococcal 13-val conj vac (dipht crm197 protein) was unknown. Outcome of the event was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A female patient of an unspecified age received for immunization, a single dose of PREVNAR 13 on an unknown date in 2017 and a single dose of PNEUMOVAX 23 on 23Sep2018. The patient medical history and concomitant medications were not reported. The patient experienced signs of pneumonia on an unspecified date. She took antibiotics but was not 100% well yet. Planning to go to the hospital to see a doctor. Final outcome of the event was recovering. Information on the batch number has been requested. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded towards the onset of pneumonia.
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Feeling hot, Malaise, Pain, Pain of skin
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 42 years old female patient who experienced Pain of skin, Burning sensation, vaccination site pain, Skin exfoliation, Feeling hot, Malaise and pain while she received vaccine FLUZONE QUADRIVALENT (Suspension for injection). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was received. On 11-Oct-2018, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6260BA (expiry date: 30-Jun-2019) in right arm. On unknown date, the patient started to feel sick, was achy, wasn't feeling good, skin felt like I was on fire, face was peeling, skin hurts if anything touched, it was reported that there was soreness at the injection site and that the burning was in her face and neck post vaccination with FLUZONE QUADRIVALENT. No lab test was reported. Final diagnosis was Pain of skin, Burning sensation, vaccination site pain, Skin exfoliation, Feeling hot, Malaise and pain. As corrective treatment, patient received Prednisone which she took for three days. Outcome of the events was recovering (reported that there was relief in her symptoms). Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Skin exfoliation, Vaccination site pain
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 42 years old female patient who experienced Pain of skin, Burning sensation, vaccination site pain, Skin exfoliation, Feeling hot, Malaise and pain while she received vaccine FLUZONE QUADRIVALENT (Suspension for injection). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was received. On 11-Oct-2018, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6260BA (expiry date: 30-Jun-2019) in right arm. On unknown date, the patient started to feel sick, was achy, wasn't feeling good, skin felt like I was on fire, face was peeling, skin hurts if anything touched, it was reported that there was soreness at the injection site and that the burning was in her face and neck post vaccination with FLUZONE QUADRIVALENT. No lab test was reported. Final diagnosis was Pain of skin, Burning sensation, vaccination site pain, Skin exfoliation, Feeling hot, Malaise and pain. As corrective treatment, patient received Prednisone which she took for three days. Outcome of the events was recovering (reported that there was relief in her symptoms). Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Dry skin, Rash, Skin exfoliation
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 30 years old female patient who experienced rash on her face (only her face), the day after that the skin got dry while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6260BA via unknown route in the left deltoid. On an unknown date, the patient developed a non-serious she got a rash on her face (only her face) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious the day after that the skin got dry and was peeling following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious the day after that the skin got dry and was peeling following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data). Final diagnosis was the day after that the skin got dry and was peeling, the day after that the skin got dry and was peeling and she got a rash on her face (only her face). No corrective treatment was received. The patient outcome is reported as Recovered/Resolved on an unknown date for she got a rash on her face (only her face), as Recovered/Resolved on an unknown date for the day after that the skin got dry and was peeling and as Recovered/Resolved on an unknown date for the day after that the skin got dry and was peeling. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves two adult patients (age and gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number, expiry date was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage and deteriorated drug administered. It was not reported whether the patient experienced any adverse events. 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: F
Vaccine: FLU4
Symptoms: Burning sensation, Feeling abnormal, Feeling hot, Malaise, Pain
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a female patient of unknown age who experienced Pain of skin, Burning sensation, vaccination site pain, Skin exfoliation, Feeling hot, Malaise and pain while she received vaccine FLUZONE QUADRIVALENT (Suspension for injection). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6260BA (expiry date: 30-Jun-2019) via unknown route and unknown site. On an unknown date, the patient started to feel sick, was achy, wasn't feeling good, skin felt like I was on fire, face was peeling, skin hurts if anything touched, it was reported that there was soreness at the injection site and that the burning was in her face and neck post vaccination with FLUZONE QUADRIVALENT. No lab test was reported. Final diagnosis was Pain of skin, Burning sensation, vaccination site pain, Skin exfoliation, Feeling hot, Malaise and pain. It was not reported if the patient received a corrective treatment. Outcome of the events was unknown for all the events. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Pain of skin, Skin exfoliation, Vaccination site pain
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a female patient of unknown age who experienced Pain of skin, Burning sensation, vaccination site pain, Skin exfoliation, Feeling hot, Malaise and pain while she received vaccine FLUZONE QUADRIVALENT (Suspension for injection). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6260BA (expiry date: 30-Jun-2019) via unknown route and unknown site. On an unknown date, the patient started to feel sick, was achy, wasn't feeling good, skin felt like I was on fire, face was peeling, skin hurts if anything touched, it was reported that there was soreness at the injection site and that the burning was in her face and neck post vaccination with FLUZONE QUADRIVALENT. No lab test was reported. Final diagnosis was Pain of skin, Burning sensation, vaccination site pain, Skin exfoliation, Feeling hot, Malaise and pain. It was not reported if the patient received a corrective treatment. Outcome of the events was unknown for all the events. Documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial unsolicited report received from Health Care Professional on 18 Dec 2018. This case involves five-year-old patient who was vaccinated with 0.5 ml fourth dose of PENTACEL (Batch number: C5553AA, expiration date: 10-Oct-2019, dose, route was not reported) in left deltoid (frequency once) on 18-Dec-2018. The patient's medical history and concomitant medications were not reported. No other vaccines. It was an actual medication error due to inappropriate age at vaccine administration. Caller reported that a 5 year old received their fourth dose of PENTACEL today and wants to know how to proceed. It was unknown if patient had 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: F
Vaccine: RAB
Symptoms: Product storage error
Clinical narrative: Based on information received on 19-Dec-2018, the report previously considered as non-valid became valid as identifiable female patient was present in the Follow up. Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a female patient of unknown age who received vaccine IMOVAX RABIES (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 04-Dec-2018, 07-Dec-2018 and 11-Dec-2018 (schedule as day 0, 3 and 7) which was also involved in cold chain break as vaccines had reached 50 F, for over 72 hours. Patient's medical history and concomitant medication were not reported. It was a case of actual medication error due to product storage error. It was not reported that if the patient experienced any adverse reaction or not. 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. Follow up information received on 19-Dec-2018 from a pharmacist. Case become valid from invalid as identifiable patient was present. List of documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Flatulence, Foetal disorder, Prenatal screening test abnormal
Clinical narrative: This is a serious observational study case initially received on 26-Nov-2018, concerning a 34-year-old adult, female, pregnant subject of body weight 120 lbs, height 64 inches and body mass index (BMI) 20.6, enrolled in V130_11OB, a prospective observational safety study. The subject's obstetrical history included one full term live birth and one preterm live birth. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal/paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The pregnancy status of the subject was collected, and no pregnancy complications were noted. The subject's last menstrual period date was 03-Sep-2018. The gestational age of the subject was 05 weeks. The concomitant medications included CITRANAL ASSURE (300mg, daily [qd], orally) for healthy pregnancy and MAKENA, dose: 275 mg, once a week as needed via subcutaneous route to reduce the risk of preterm birth. On 11-Oct-2018, the pregnant subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: 252232, dose, route of administration, expiry date and anatomical location: not reported) for an unknown indication (explicitly considered as exposure during pregnancy). On 10-Nov-2018, the subject started treatment at gestational age 9.7 weeks with simethicone (80 mg, as needed, orally) for gas. On 27-Nov-2018, after administration of study vaccine, the subject underwent first trimester screening and risk of Down syndrome was identified. On an unknown date, the subject experienced gas. The subject's estimated date of delivery was reported as 10-Jun-2019. Significant follow-up received from other health professional on 13-Dec-2018: Concomitant medication (MAKENA) was added in the product tab. The event (Down's syndrome) was added in the event tab. The case was upgraded from non-serious to serious. The narrative was amended accordingly. Reporter's Comments: A 34-year-old female pregnant subject was administered Flu Vaccine Cell Subunit QIV NVD at 05 weeks of gestational age (explicitly coded as vaccine exposure during pregnancy) and experienced gas. The company assessed the causality of the event vaccine exposure during pregnancy as not related to suspect vaccine, considering the special case scenario. The causality of the event gas was assessed as unassessable due to lack of information regarding onset latency. The event Down syndrome risk identified on first trimester screen was assessed as not related to suspect vaccine, as there are no known biological mechanism due to vaccination and progressive age of the mother appears to be plausible cause of the event. The company assessed the case as serious (medically significant).
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Injected limb mobility decreased, Injection site pain, Rotator cuff syndrome, X-ray normal
Clinical narrative: When Vacine was administered, I remember thinking it was given too high in the arm, and the administrator stated it was VERY hard to push in. About 17 hours after receiving shot I awoke to significant pain in the left shoulder, where I received the shot. Over the next day or so the pain continued but also seemed to worsen whenever I tried to use that arm-as in reaching across, over my head or behind me. After about a week and a half I went to the doctors- he told me just to watch it and take Aleve instead of ibuprofen. After another several days I called back as pain is not lessening-he recommended I go to muscle- skeletal doctor-as well as have x-ray and blood work done (both showed nothing). I was seen at ortho about 3 weeks to a month after administration of shot. That doctor said it was a probable rotator-cuff injury and to even double or triple my aleve intake as well as start PT.  (First appointment with PT tomorrow 12/27/18.) In the mean time I followed up with my PCP. (The first doctor I saw was at my PCP's office but not her.) My regular PCP- prescribed an oral steroid as my pain had not improved or lessened taking aleve or Ibuprofen. My understanding is PT and steroids and if the pain continues then we will do an MRI of the soft tissue. I have been unable to effectively use my left arm related to pain for over one month currently.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Alanine aminotransferase, Angiogram, Anion gap, Aspartate aminotransferase, Basophil count
Clinical narrative: 10 days after receiving vaccine, I developed chest pains and shortness of breath. All the symptoms of a heart attack. Felt like a 200 pound of pressure on my chest. After 10 days I felt fine with no lingering pressure or pain.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood chloride
Clinical narrative: 10 days after receiving vaccine, I developed chest pains and shortness of breath. All the symptoms of a heart attack. Felt like a 200 pound of pressure on my chest. After 10 days I felt fine with no lingering pressure or pain.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Blood cholesterol, Blood creatinine, Blood glucose, Blood potassium, Blood sodium
Clinical narrative: 10 days after receiving vaccine, I developed chest pains and shortness of breath. All the symptoms of a heart attack. Felt like a 200 pound of pressure on my chest. After 10 days I felt fine with no lingering pressure or pain.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Blood triglycerides, Blood urea, Carbon dioxide, Cardiac stress test, Chest X-ray
Clinical narrative: 10 days after receiving vaccine, I developed chest pains and shortness of breath. All the symptoms of a heart attack. Felt like a 200 pound of pressure on my chest. After 10 days I felt fine with no lingering pressure or pain.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Computerised tomogram thorax, Dyspnoea, Eosinophil count
Clinical narrative: 10 days after receiving vaccine, I developed chest pains and shortness of breath. All the symptoms of a heart attack. Felt like a 200 pound of pressure on my chest. After 10 days I felt fine with no lingering pressure or pain.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Exercise electrocardiogram, Fibrin D dimer, Glomerular filtration rate, Granulocyte count, Haematocrit
Clinical narrative: 10 days after receiving vaccine, I developed chest pains and shortness of breath. All the symptoms of a heart attack. Felt like a 200 pound of pressure on my chest. After 10 days I felt fine with no lingering pressure or pain.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Haemoglobin, High density lipoprotein, International normalised ratio, Lipase, Low density lipoprotein
Clinical narrative: 10 days after receiving vaccine, I developed chest pains and shortness of breath. All the symptoms of a heart attack. Felt like a 200 pound of pressure on my chest. After 10 days I felt fine with no lingering pressure or pain.