chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial Report Received: 27-Feb-2019. Non-significant Follow-up Report Received on 06-Mar-2019 included duplicative data that was already received for this report. A nurse reported that patient, a 52-year-old male patient (race not provided) was administered with HEPLISAV-B for hepatitis B immunization that was reported to be stored at the wrong temperature. Relevant medical history and concomitant medications were reported as unknown. Allergies were reported as unknown. On an unknown date, the patient received the first injection of HEPLISAV-B (lot #1036463, expiration date 28-Jul-2019, NDC #43528-002-05) by a physician. On 27-Feb-2019, a nurse reported that she received a call from a customer service representative at the distributor on this day. The nurse was instructed to remove all vaccines that were received because they were stored at the wrong temperature on distributor's end. The nurse was instructed to return it to the distributor and contact Dynavax. The nurse reported that six patients received HEPLISAV-B from the same lot number. The nurse also reported that all six patients were contacted on this day. No adverse events were reported. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial Report Received: 27-Feb-2019. Non-significant Follow-up Report Received on 06-Mar-2019 included duplicative data that was already received for this report. A nurse reported that patient, a 69-year-old female patient (race not provided) was administered with HEPLISAV-B for hepatitis B immunization that was reported to be stored at the wrong temperature. Relevant medical history and concomitant medications were reported as unknown. Allergies were reported as unknown. On an unknown date, the patient received the second injection of HEPLISAV-B (lot #1036463, expiration date 28-Jul-2019, NDC #43528-002-05) by a physician. On 27-Feb-2019, a nurse reported that she received a call from a customer service representative at the distributor, on this day. The nurse was instructed to remove all vaccines that were received because they were stored at the wrong temperature on distributor's end. The nurse was instructed to return it to the distributor and contact Dynavax. The nurse reported that six patients received HEPLISAV-B from the same lot number. The nurse also reported that all six patients were contacted on this day. No adverse events were reported. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial Report Received: 27-Feb-2019. Non-significant Follow-up Report Received on 06-Mar-2019 included duplicative data that was already received for this report. A nurse reported that patient, a female patient (age and race not provided) was administered with HEPLISAV-B for hepatitis B immunization that was reported to be stored at the wrong temperature. Relevant medical history and concomitant medications were reported as unknown. Allergies were reported as unknown. On an unknown date, the patient received the first injection of HEPLISAV-B (lot #1036463, expiration date 28-Jul-2019, NDC #43528-002-05) by a physician. On 27-Feb-2019, a nurse reported that she received a call from a customer service representative at the distributor, on this day. The nurse was instructed to remove all vaccines that were received because they were stored at the wrong temperature on distributor's end. The nurse was instructed to return it to the distributor and contact Dynavax. The nurse reported that six patients received HEPLISAV-B from the same lot number. The nurse also reported that all six patients were contacted on this day. No adverse events were reported. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever. Acetaminophen 325 mg.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain near the injection site (about the size of a hand).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Vaccination site pain
Clinical narrative: Severe headache 36 hours following vaccination. Affected sleep on patient. Extreme soreness in extremity where vaccine was given.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Myalgia, Rash erythematous
Clinical narrative: Immediately after the vaccine the patient experienced muscle/arm soreness but nothing especially bothersome. However about a week later the patient noticed a red bump appear on her arm which later progressed into red patches/ bumps on various parts of her body. She showed me the bends of her arm which had a red rash and mentioned that a similar rash was also on her flank sides and armpit/breast area. She has been using OTC hydrocortisone cream which has provided minimal relief. She was advised to add BENADRYL allergy to her treatment regimen and to consult her primary care physician.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Gave the paitent an MMRV  and Varicella instead of an MMR and Varicella.
Age: 11.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Dizziness, Headache
Clinical narrative: Patient was dizzy, exhibited a headache within minutes of receiving the 3 vaccines.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain
Clinical narrative: Patient stated it was a little painful at time of injection. She went home and took APAP. A few hours later called into the pharmacy to with chief complaint of a large amount of pain at injection site and weakness when lifting arm. She stated she had very little swelling if any and no numbness or tingling in arm. Patient was reportedly only able to lift arm with assistance and with a lot of pain. She stated pain was localized to area of injection. Pharmacy followed up with patient following morning and was told pain was still present but had decreased a little. Arm was still weak and needed assistance with lifting with no weight but was not as painful when doing so.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Patient stated it was a little painful at time of injection. She went home and took APAP. A few hours later called into the pharmacy to with chief complaint of a large amount of pain at injection site and weakness when lifting arm. She stated she had very little swelling if any and no numbness or tingling in arm. Patient was reportedly only able to lift arm with assistance and with a lot of pain. She stated pain was localized to area of injection. Pharmacy followed up with patient following morning and was told pain was still present but had decreased a little. Arm was still weak and needed assistance with lifting with no weight but was not as painful when doing so.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Blood test, Escherichia infection, Escherichia test positive, Lumbar puncture, Pyrexia
Clinical narrative: I am unsure of what brand of Hep B he received. Received hep b at medical center on 8/19 after birth. On approximated 9/24 he spiked a fever and we were sent to ER.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chest discomfort, Pain, Pyrexia, Rash erythematous
Clinical narrative: Patient experience adverse reaction after first dose on new SHINGRIX vaccine. Patient developed body aches, fever ranging from 99 to 100.3, and chest discomfort. Patient was having sharp pains in stomach and a bright red rash (rash eventually turned pink and became itchy). Patient took TYLENOL for a few days post shot and was instructed to see MD/ER is symptoms worsened. Patient came in to pharmacy today 3-11-19 and was feeling better but still not 100%. Patient still had some topical symptoms but other symptoms had improved (suggested some BENADRYL to help with itching as well). Patient is not likely to get second dose.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient experience adverse reaction after first dose on new SHINGRIX vaccine. Patient developed body aches, fever ranging from 99 to 100.3, and chest discomfort. Patient was having sharp pains in stomach and a bright red rash (rash eventually turned pink and became itchy). Patient took TYLENOL for a few days post shot and was instructed to see MD/ER is symptoms worsened. Patient came in to pharmacy today 3-11-19 and was feeling better but still not 100%. Patient still had some topical symptoms but other symptoms had improved (suggested some BENADRYL to help with itching as well). Patient is not likely to get second dose.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Crying, Fatigue, Irritability, Nausea, Pyrexia
Clinical narrative: Fever started quickly after shot, then nausea and vomiting, Irritability, fatigue and random bursts of crying. And now a runny nose. On day 4 and still fatigued with low grade fever.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Rhinorrhoea, Vomiting
Clinical narrative: Fever started quickly after shot, then nausea and vomiting, Irritability, fatigue and random bursts of crying. And now a runny nose. On day 4 and still fatigued with low grade fever.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 05-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, 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 23-APR-2012, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 23-NOV-2013, the patient was treated by a physician at a hospital emergency room for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the Zoster Vaccine Live (ZOSTAVAX), 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, 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 include 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; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
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 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 2016, the patient's healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 30-OCT-2016 and 11-NOV-2016, the patient was treated by healthcare providers for shingles and neuropathic pain. 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 her 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.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Decreased appetite, Pyrexia
Clinical narrative: Patient cried for non-stop for 24 hours after the dose. No fever over 100. The crying stopped almost 24 hours to the hour from the time the vaccination was administered. Patient had decreased appetite during this time.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Myalgia, shivering, fatigue, and headache.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Dizziness, Feeling cold, Influenza
Clinical narrative: I got this shot around 3:00 p.m. on 2/12/19 and that night suffered shivers (woke up to pee, felt like I was freezing over despite a mountain of blankets on me, took a heating pad on my chest to get warm again). Felt like I had opening stages of the flu the next day, took it easy. Better by noon the NEXT day. OK the 14th and all of 2/15/19. Morning of 2/16/19: Awakened for 5:00 a.m. pee and almost fell over, so dizzy, and faint nausea. By 9:15 a.m. on 2/16/19, I was tipsy, nauseous to the point of dry heaving by 10:00 a.m., and just lazed and dazed, sleeping deep from 11:30 to 1:00 p.m., could only keep 8 ounces of water down, afraid to ingest anything more. The 'early stage flu feeling' subsided by 5:00 p.m. that same day, and could have light cereal and coffee until 9:15 p.m., when my appetite finally returned and I had a light (late) dinner). Why did this happen? I never felt that way before, certainly not (no symptoms at all) with my Age 60 (2015) shingles shot. I suspect it's this shot. My CPA told me that two other men (her clients) my age were 'up and down for about a week' after getting this same shot, especially after the second dose. I sent the paperwork on this shot to Dr.'s office and on 3/1/19, his staff informed me that they now have it in their 'patient portal' system.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Retching, Somnolence
Clinical narrative: I got this shot around 3:00 p.m. on 2/12/19 and that night suffered shivers (woke up to pee, felt like I was freezing over despite a mountain of blankets on me, took a heating pad on my chest to get warm again). Felt like I had opening stages of the flu the next day, took it easy. Better by noon the NEXT day. OK the 14th and all of 2/15/19. Morning of 2/16/19: Awakened for 5:00 a.m. pee and almost fell over, so dizzy, and faint nausea. By 9:15 a.m. on 2/16/19, I was tipsy, nauseous to the point of dry heaving by 10:00 a.m., and just lazed and dazed, sleeping deep from 11:30 to 1:00 p.m., could only keep 8 ounces of water down, afraid to ingest anything more. The 'early stage flu feeling' subsided by 5:00 p.m. that same day, and could have light cereal and coffee until 9:15 p.m., when my appetite finally returned and I had a light (late) dinner). Why did this happen? I never felt that way before, certainly not (no symptoms at all) with my Age 60 (2015) shingles shot. I suspect it's this shot. My CPA told me that two other men (her clients) my age were 'up and down for about a week' after getting this same shot, especially after the second dose. I sent the paperwork on this shot to Dr.'s office and on 3/1/19, his staff informed me that they now have it in their 'patient portal' system.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Vaccination complication
Clinical narrative: Patient received her second dose of SHINGRIX on Friday 3/8/19 at approximately 1112 am. Patient stated she felt the heat from the injection before she even left the pharmacy. She stated it became painful, red, and warm to the touch later that evening. She stated that was the worse it was. It slowly has been getting better day by day. It is still red and warm to the touch.
Age: 0.58
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Wrong product administered
Clinical narrative: Pt was given KINRIX instead of PENTACEL.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Pain, Pyrexia, Urticaria
Clinical narrative: Fever = 101.1, pain and inflammation, hives.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Erythema, Injection site pain
Clinical narrative: Patient came into pharmacy on 3/10/19 to report pain at injection site. She said she got the chills and weakness on day 1 after the vaccine was given. She had a large, red spot on her arm. She said it had gotten better over the last day or so.  I explained to help with the swelling she can take APAP or ibuprofen if necessary and to alternate icing/heating the arm.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache, fever, chills, right arm pain.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: Patient broke out into a measles-like rash almost exactly 10 days after receiving the vaccine. When taken to the doctor they confirmed that it was a vaccine rash.
Age: 50.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given by IM route rather than SQ route in error.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: Extreme flu-like symptoms. Chills, headache, muscle aches.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Patients reported symptoms of fever, shivering, and vomiting.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR
Symptoms: Cyanosis, Eye movement disorder, Grunting, Pyrexia, Rash
Clinical narrative: On day 12 patient developed a fever. On day 13 temp up to 103. Parents report shaking of extremities and rolling of eyeballs. Parents report patient unresponsive and making grunting noises for 5 to 10 minutes and lips turned blue. On the way to ER, the baby came out of it and parents returned home. Fever continued through the next day. Rash appeared today day 15.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR
Symptoms: Rash maculo-papular, Tremor, Unresponsive to stimuli
Clinical narrative: On day 12 patient developed a fever. On day 13 temp up to 103. Parents report shaking of extremities and rolling of eyeballs. Parents report patient unresponsive and making grunting noises for 5 to 10 minutes and lips turned blue. On the way to ER, the baby came out of it and parents returned home. Fever continued through the next day. Rash appeared today day 15.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Fatigue, Loss of personal independence in daily activities
Clinical narrative: I had fatigue on day 2 which I anticipated. Day three brought stomach upset with diarrhea and fatigue. Day 4 brought dizziness and inability to carry on normal activiities.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Onset of hives, urticaria and fever on day 10 post vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Feeling abnormal, Feeling cold, Headache
Clinical narrative: I got my vaccination yesterday (Sunday, 03/10/19) at about 4 p.m. Today (3/11/19), I woke up at 5 a.m. freezing. I was not able to get warm all day until after 6:30 p.m. (11 1/2 hours after waking up) despite cranking up the heater, bundling up, and staying under thick comforters all day. As the morning progressed, I got a headache, felt achy all over, got a slight fever, and severe chills. All of these symptoms lasted all day. I also had some diarrhea after breakfast, but it hasn't recurred. By 10 a.m. I couldn't get out of bed I felt so awful. It took until 7:00 p.m. before I started feeling slightly better. The chills seem to have subsided but I still have a slight headache and I'm still achy.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: I got my vaccination yesterday (Sunday, 03/10/19) at about 4 p.m. Today (3/11/19), I woke up at 5 a.m. freezing. I was not able to get warm all day until after 6:30 p.m. (11 1/2 hours after waking up) despite cranking up the heater, bundling up, and staying under thick comforters all day. As the morning progressed, I got a headache, felt achy all over, got a slight fever, and severe chills. All of these symptoms lasted all day. I also had some diarrhea after breakfast, but it hasn't recurred. By 10 a.m. I couldn't get out of bed I felt so awful. It took until 7:00 p.m. before I started feeling slightly better. The chills seem to have subsided but I still have a slight headache and I'm still achy.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Vomiting
Clinical narrative: Shivering for 12 hours. Upset stomach with vomiting the following evening (02/18/2019).
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: Customer called said they believed they had a reaction to the PNEUMOVAX-23 injection they had last Wednesday. She said Thursday, the day after the injection, her arm was swollen and the injection site was light red and sensitive to the touch. She came home from work at about 3 PM and went to bed and slept until 6 AM, waking twice to take some ADVIL. On Friday she said she had redness on the inside of her arm down to her elbow and by Saturday the redness was past the elbow but starting to resolve. Today (Monday) she said it was almost cleared up but that she wanted us to know what happened. She has called her Doctor but had to leave a message and is still waiting to hear from their office.
Age: 1.17
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Crying, Decreased appetite, Glassy eyes, Pain
Clinical narrative: 3 days after his vaccinations his skin color changed to a pale yellow and green tint, he didn't want to drink anything and started crying a lot day 3 night did not sleep well woke up every few hours day 4 woke up with a 101 temperature crying uncontrollably didn't want to eat or drink, gave him TYLENOL did not break his fever gave him MOTRIN did not break his fever would not eat or drink and cried all day for night did not sleep woke up screaming every few hours in pain day 5 woke up still had 101 temperature still trying TYLENOL and MOTRIN alternating nothing with break the fever still crying not wanting to eat or drink day five night woke up screaming every few hours in pain gut-wrenching screams by day 4 and 5 he was walking around glassy-eyed and it days just crying Non-Stop. I called the doctor's office day 4 and 5 both days talk to the nurse she told me to continue giving TYLENOL and MOTRIN she said this was normal day 6 I looked on the CDC website to find that it was not recommended to do MMR with flu shot and saw that it's not recommended to vaccinate when a child has an immune issue like C-diff. I called the doctor on day 6 talk to the practice manager and the doctor told them how frustrated I was scared to death my child did not act normal for 3 to 4 days finally by the end of the fourth day of running a temperature it broke and he began to eat and drink again.
Age: 1.17
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Poor quality sleep, Pyrexia, Screaming, Skin discolouration, Yellow skin
Clinical narrative: 3 days after his vaccinations his skin color changed to a pale yellow and green tint, he didn't want to drink anything and started crying a lot day 3 night did not sleep well woke up every few hours day 4 woke up with a 101 temperature crying uncontrollably didn't want to eat or drink, gave him TYLENOL did not break his fever gave him MOTRIN did not break his fever would not eat or drink and cried all day for night did not sleep woke up screaming every few hours in pain day 5 woke up still had 101 temperature still trying TYLENOL and MOTRIN alternating nothing with break the fever still crying not wanting to eat or drink day five night woke up screaming every few hours in pain gut-wrenching screams by day 4 and 5 he was walking around glassy-eyed and it days just crying Non-Stop. I called the doctor's office day 4 and 5 both days talk to the nurse she told me to continue giving TYLENOL and MOTRIN she said this was normal day 6 I looked on the CDC website to find that it was not recommended to do MMR with flu shot and saw that it's not recommended to vaccinate when a child has an immune issue like C-diff. I called the doctor on day 6 talk to the practice manager and the doctor told them how frustrated I was scared to death my child did not act normal for 3 to 4 days finally by the end of the fourth day of running a temperature it broke and he began to eat and drink again.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Site: right arm red and swollen on vaccine site x1 day. No tenderness felt on area. Per Dr. it was a localized vaccine reaction. No treatment necessary at the moment. On 3/11 called mother and she stated theres no redness at site anymore and site is a little purple now.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dyskinesia, Muscle spasms
Clinical narrative: Patient experienced approximately 15-20 spasm episode over the course of 12 hours after immunizations. Episodes of facial grimace and body "tightening" for 1-2 seconds. No post-lethal phase. Tm-100.2" Episodes did not recur thereafter.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Hypophagia, Occult blood negative, Vomiting
Clinical narrative: Blood flecks in stool 24 hours after 1st dose. Had vomiting twice and no documented fever. Stool guaiac testing negative 5 days after dosing. Decreased eating also noted.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Localized redness and swelling to injection site.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient started having shoulder pain the next day, she tried home remedies, visited her regular doctor who sent her to the orthopedic specialist. Currently patient is on physical therapy and non steroidal anti-inflammatory medications.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Patient states she has burning, achy and shooting pain in her left arm. Pain is centered in shoulder. Onset of pain was noticed when patient stopped taking meloxicam (taken for another injury). Patient went to urgent care and was prescribed muscle relaxers.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Right arm - 35mm x 40mm reddened-raised-hot to touch and itchy. Recommended she talk with her family provider to determine if she needed anything for the itch.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Headache, Heart rate increased, Injection site urticaria, Migraine
Clinical narrative: Patient experienced severe headache and nausea/vomiting for 2 days after vaccination. Patient also had a rapid heart rate and pressure in the chest which prompted an emergency room visit on 3/8/19. Patient now (3/11/19) has developed hives around the injection site and still has migraine headaches from time to time.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Patient experienced severe headache and nausea/vomiting for 2 days after vaccination. Patient also had a rapid heart rate and pressure in the chest which prompted an emergency room visit on 3/8/19. Patient now (3/11/19) has developed hives around the injection site and still has migraine headaches from time to time.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Pruritus, Rash
Clinical narrative: Pt received SHINGRIX on 2/22/18. From 2/24/19 pt started having increasing pain in the arm. It progressed and pt noticed rash on back. Pt was seen in clinic and treated for shingles with VALTREX 1GM one 1d x 7 day. Prednisone 40 mg x 5 days. Calamine lotion 4-5 x daily for itchiness. Ibuprofen for pain.
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: Five days after receiving 2 vaccines in the left upper thigh, developed a red, hot and hardened macular lesion where the vaccines were administered. There is no fluctuance, induration, purulent discharge, or pore visible.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient received the shot on 2/20/19 and he said he had pain in his right shoulder starting that day. He came into the pharmacy a couple weeks after saying he could not lift his arm. He said there was never any bruising or redness, just pain.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Generalised erythema, Seizure, Swelling, Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 63-year-old female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In February 2019, less than an hour after receiving SHINGRIX, the patient experienced seizure (serious criteria hospitalization and GSK medically significant), generalized erythema (serious criteria hospitalization) and swelling (serious criteria hospitalization). The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the seizure, generalized erythema and swelling were recovered/resolved. It was unknown if the reporter considered the seizure, generalized erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received her first dose of SHINGRIX about 1 month before the date of reporting. Within an hour, the patient had 3 seizures, turned bright red, and her head swelled up. The patient was in the hospital for 3 days and treated with a ton of Benedryl. The patient was not going to get the 2nd dose of SHINGRIX. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Generalised erythema, Seizure, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 63-year-old female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In February 2019, less than an hour after receiving SHINGRIX, the patient experienced seizure (serious criteria hospitalization and GSK medically significant), generalized erythema (serious criteria hospitalization) and swelling (serious criteria hospitalization). The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the seizure, generalized erythema and swelling were recovered/resolved. It was unknown if the reporter considered the seizure, generalized erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received her first dose of SHINGRIX about 1 month before the date of reporting. Within an hour, the patient had 3 seizures, turned bright red, and her head swelled up. The patient was in the hospital for 3 days and treated with a ton of Benedryl. The patient was not going to get the 2nd dose of SHINGRIX. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Joint swelling, Lymph node pain, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 72 year old female patient with hypertension, blood cholesterol increased, thyroid disorder, fibromyalgia, anxiety, drug hypersensitivity to penicillin and drug hypersensitivity to sulfonamide. Concomitant therapies included tizanidine hydrochloride, metoprolol, ATIVAN, PRAVACHOL, HEP A, HEP B and levothyroxine sodium. On 24-JAN-2019, the patient was vaccinated with a dose of M-M-R II, 1 shot, subcutaneously, for prophylaxis as the patient required to travel outside country (strength, lot number and expiration date were not provided). On the same date, the patient also received a cortisone shot for tendinitis. On approximately 02-FEB-2019 (reported as "10 days later"), the patient experienced general aching. On an unspecified date in February 2019 (reported as "14 to 16 days after the vaccination"), the patient started to experience a light rash on her neck and chest, and sore glands at the base of the neck. On approximately 09-FEB-2019 (reported as "17 days after the vaccination"), the patient started to get a swollen knee that was painful for a few hours. On an unspecified date in February 2019 (reported as "last week"), the patient had some mild tingling. As a result, the patient sought for medical attention with a nurse practitioner but it was reported that no treatment was given for the reported events and laboratories were performed to the patient as well. At the time of reporting, the outcome of tendonitis, paraesthesia, arthralgia, lymphadenopathy, rash, joint swelling and pain was reported as resolving. Causality assessment was not provided.
Age: 72.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Paraesthesia, Rash, Tendonitis
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 72 year old female patient with hypertension, blood cholesterol increased, thyroid disorder, fibromyalgia, anxiety, drug hypersensitivity to penicillin and drug hypersensitivity to sulfonamide. Concomitant therapies included tizanidine hydrochloride, metoprolol, ATIVAN, PRAVACHOL, HEP A, HEP B and levothyroxine sodium. On 24-JAN-2019, the patient was vaccinated with a dose of M-M-R II, 1 shot, subcutaneously, for prophylaxis as the patient required to travel outside country (strength, lot number and expiration date were not provided). On the same date, the patient also received a cortisone shot for tendinitis. On approximately 02-FEB-2019 (reported as "10 days later"), the patient experienced general aching. On an unspecified date in February 2019 (reported as "14 to 16 days after the vaccination"), the patient started to experience a light rash on her neck and chest, and sore glands at the base of the neck. On approximately 09-FEB-2019 (reported as "17 days after the vaccination"), the patient started to get a swollen knee that was painful for a few hours. On an unspecified date in February 2019 (reported as "last week"), the patient had some mild tingling. As a result, the patient sought for medical attention with a nurse practitioner but it was reported that no treatment was given for the reported events and laboratories were performed to the patient as well. At the time of reporting, the outcome of tendonitis, paraesthesia, arthralgia, lymphadenopathy, rash, joint swelling and pain was reported as resolving. Causality assessment was not provided.
Age: 72.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Joint swelling, Lymph node pain, Pain, Paraesthesia
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 72 year old female patient with hypertension, blood cholesterol increased, thyroid disorder, fibromyalgia, anxiety, drug hypersensitivity to penicillin and drug hypersensitivity to sulfonamide. Concomitant therapies included tizanidine hydrochloride, metoprolol, ATIVAN, PRAVACHOL, HEP A, HEP B and levothyroxine sodium. On 24-JAN-2019, the patient was vaccinated with a dose of M-M-R II, 1 shot, subcutaneously, for prophylaxis as the patient required to travel outside country (strength, lot number and expiration date were not provided). On the same date, the patient also received a cortisone shot for tendinitis. On approximately 02-FEB-2019 (reported as "10 days later"), the patient experienced general aching. On an unspecified date in February 2019 (reported as "14 to 16 days after the vaccination"), the patient started to experience a light rash on her neck and chest, and sore glands at the base of the neck. On approximately 09-FEB-2019 (reported as "17 days after the vaccination"), the patient started to get a swollen knee that was painful for a few hours. On an unspecified date in February 2019 (reported as "last week"), the patient had some mild tingling. As a result, the patient sought for medical attention with a nurse practitioner but it was reported that no treatment was given for the reported events and laboratories were performed to the patient as well. At the time of reporting, the outcome of tendonitis, paraesthesia, arthralgia, lymphadenopathy, rash, joint swelling and pain was reported as resolving. Causality assessment was not provided.
Age: 72.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Rash, Tendonitis
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 72 year old female patient with hypertension, blood cholesterol increased, thyroid disorder, fibromyalgia, anxiety, drug hypersensitivity to penicillin and drug hypersensitivity to sulfonamide. Concomitant therapies included tizanidine hydrochloride, metoprolol, ATIVAN, PRAVACHOL, HEP A, HEP B and levothyroxine sodium. On 24-JAN-2019, the patient was vaccinated with a dose of M-M-R II, 1 shot, subcutaneously, for prophylaxis as the patient required to travel outside country (strength, lot number and expiration date were not provided). On the same date, the patient also received a cortisone shot for tendinitis. On approximately 02-FEB-2019 (reported as "10 days later"), the patient experienced general aching. On an unspecified date in February 2019 (reported as "14 to 16 days after the vaccination"), the patient started to experience a light rash on her neck and chest, and sore glands at the base of the neck. On approximately 09-FEB-2019 (reported as "17 days after the vaccination"), the patient started to get a swollen knee that was painful for a few hours. On an unspecified date in February 2019 (reported as "last week"), the patient had some mild tingling. As a result, the patient sought for medical attention with a nurse practitioner but it was reported that no treatment was given for the reported events and laboratories were performed to the patient as well. At the time of reporting, the outcome of tendonitis, paraesthesia, arthralgia, lymphadenopathy, rash, joint swelling and pain was reported as resolving. Causality assessment was not provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Blood glucose, Blood pressure increased, Cardiac imaging procedure, Dizziness
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovering/resolving. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe adverse vaccine reactions after receiving 1st dose of SHINGRIX vaccine.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Electrocardiogram, Feeling abnormal, Laboratory test, Nausea, Palpitations
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovering/resolving. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe adverse vaccine reactions after receiving 1st dose of SHINGRIX vaccine.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urine analysis, Vision blurred
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovering/resolving. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe adverse vaccine reactions after receiving 1st dose of SHINGRIX vaccine.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovering/resolving. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe adverse vaccine reactions after receiving 1st dose of SHINGRIX vaccine.
Age: 25.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from the office manager in charge of vaccine storage referring to a patient who at the time of vaccination was 25 years old. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions and allergies. On 01-AUG-2018, the patient was vaccinated with the first dose of GARDASIL 9 with lot number N020139 and expiration date on 14-FEB-2020, for prophylaxis (dose, route of administration and anatomical injection site were not reported), the second dose of GARDASIL 9 on 29-AUG-2018 wit lot number N019104 and expiration date on 02-MAR-2020, for prophylaxis (dose, route of administration and anatomical injection site were not reported) and on 05-MAR-2019, the third dose of GARDASIL 9 with lot number R017249 and expiration date on 04-MAY-2021, for prophylaxis (dose, route of administration and anatomical injection site were not reported) (Inappropriate schedule of product administration). No adverse effect was reported.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 77-year-old female patient who received SHINGRIX (batch number EY93J, expiry date unknown) for prophylaxis. Co-suspect products included SHINGRIX (batch number 7X743, expiry date unknown) for prophylaxis. The patient's past medical history included shingles. Previously administered products included ZOSTAVAX vaccine (received at 7 years ago). On 17th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th December 2018, the patient received the 2nd dose of SHINGRIX. On 2nd March 2019, 136 days after receiving SHINGRIX and 78 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The shingles was on her face and she reported that it was very disturbing and a worse case than her previous case of shingles which occurred last May 2018. She claims that she was diagnosed with shingles on this past Saturday 2nd March 2019. The patient claims that her shingles diagnosis has caused her to cancel her engagements this week including a wedding. The reporter consented to follow up. Follow-up with the patient directly.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Loss of personal independence in daily activities, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 77-year-old female patient who received SHINGRIX (batch number EY93J, expiry date unknown) for prophylaxis. Co-suspect products included SHINGRIX (batch number 7X743, expiry date unknown) for prophylaxis. The patient's past medical history included shingles. Previously administered products included ZOSTAVAX vaccine (received at 7 years ago). On 17th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th December 2018, the patient received the 2nd dose of SHINGRIX. On 2nd March 2019, 136 days after receiving SHINGRIX and 78 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The shingles was on her face and she reported that it was very disturbing and a worse case than her previous case of shingles which occurred last May 2018. She claims that she was diagnosed with shingles on this past Saturday 2nd March 2019. The patient claims that her shingles diagnosis has caused her to cancel her engagements this week including a wedding. The reporter consented to follow up. Follow-up with the patient directly.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Eczema, Fatigue, Hypersomnia, Somnolence
Clinical narrative: Fatigue, groggy ness, sleeping for long hous, and eczema weeks later.