chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hypoaesthesia, Pain in extremity
Clinical narrative: Patient had a sore arm for a day or so. She went to pick up an object and her hand "felt like it belonged to someone else". Her hand went numb and stayed that way for 1-2 hours. She said her brain was foggy too. She recovered but she does not want the second dose. Everything cleared up at the same time.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dysphonia, Dyspnoea, Throat irritation
Clinical narrative: Shortness of breath, lightheaded, itching throat, hoarseness.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Urticaria
Clinical narrative: Full body rash - urticarial with erythematous base. Head, neck, trunk, upper and lower extremities. Fever - Started diphenhydramine - continued TYLENOL for fever.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Headache, chills, fever up to 101.8, soreness in arm, body aches.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired driving ability, Injection site pain, Mobility decreased, Muscle tightness, Pain
Clinical narrative: Patient stated during shot that it was painful. Pharmacist told her that her muscle was extremely tight. Patient stated that within 30 minutes after she had trouble driving. She reported that for the next 4-5 days she could only lift her arm a few inches and was in pain. She stated that the symptoms gradually improved and is now fine. She feels that no medical intervention was or is warranted.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: Patient said her arm at the injection site got bruised, and got darker the next day, it now the fifth day, the bruise seems to be disappearing. She does not have any other symptoms other than bruising.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Injection site in Right upper arm - tender to touch, swelling, muscular pain that radiated to shoulder/Axilla area and down to elbow at times. No home Tx done. Instructed to take NSAIDS and ice arm.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Herpes zoster, Musculoskeletal pain, Paraesthesia
Clinical narrative: This initial spontaneous report was received on 14-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-SEP-2016, the patient was inoculated with ZOSTAVAX at a pharmacy for routine health maintenance for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, on or about 16-SEP-2016, the patient presented to a physician with complaints of a painful, itchy rash appearing on her upper back area in conjunction with complaints of mild tingling and burning in her arms. She was evaluated and diagnosed as suffering from shingles. Her complaints of tingling and pain in her upper back and left shoulder did not improve. Accordingly, on or about 27-SEP-2016, the patient returned to the physician and was diagnosed as suffering from post-herpetic neuralgia. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash, Rash pruritic
Clinical narrative: This initial spontaneous report was received on 14-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-SEP-2016, the patient was inoculated with ZOSTAVAX at a pharmacy for routine health maintenance for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, on or about 16-SEP-2016, the patient presented to a physician with complaints of a painful, itchy rash appearing on her upper back area in conjunction with complaints of mild tingling and burning in her arms. She was evaluated and diagnosed as suffering from shingles. Her complaints of tingling and pain in her upper back and left shoulder did not improve. Accordingly, on or about 27-SEP-2016, the patient returned to the physician and was diagnosed as suffering from post-herpetic neuralgia. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dehydration, Haematochezia, Pyrexia, Rotavirus infection, Salmonellosis
Clinical narrative: W/i 24 hours pt developed diarrhea that had streaks of blood and mucous. Pt was advised to take pt to hospital er. Pt transported for ER. Pt dx with salmonella enteritis. Hospitalized x 2 days for treatment of dehydration.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Stool analysis
Clinical narrative: W/i 24 hours pt developed diarrhea that had streaks of blood and mucous. Pt was advised to take pt to hospital er. Pt transported for ER. Pt dx with salmonella enteritis. Hospitalized x 2 days for treatment of dehydration.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dehydration, Diarrhoea, Diarrhoea haemorrhagic, Gastroenteritis salmonella, Salmonella test positive
Clinical narrative: W/i 24 hours pt developed diarrhea that had streaks of blood and mucous. Pt was advised to take pt to hospital er. Pt transported for ER. Pt dx with salmonella enteritis. Hospitalized x 2 days for treatment of dehydration.
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Asthenia, Mobility decreased
Clinical narrative: R arm felt weak, pt had trouble moving arm, pt couldn't raise arm. Pt tried taking acetaminophen to ease pain, but it did not help.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: The description of the vaccine shows 0.5ML IMM/0.25ML Injection/FLUZONE/FLUCELVAX Lot UI975AA Exp:6/30/19. Not sure if it is FLUZONE of FLUCELVAX so I listed both names above with the provided Lot #. I noticed my son's arm was swollen, hard to the touch and red upon picking him up from school. He said it was tender and itchy. Overnight the swelling doubled in size with increased regions of redness and hot to the touch. Later that day upon checking the swelling had increased still with redness extending more than 2 inches outwards from the injection site. This was firm deep swelling, skin hot to the touch. Upon speaking with a nurse I began administering BENADRYL every 4 hours. The first dose  given 8pm 9/18/18. By 6am 9/19/18 there was a noticeable reduction in the redness and swelling. As of 9/19/18 10pm there is still some swelling, redness and bruising, increased warmth but improving
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: The description of the vaccine shows 0.5ML IMM/0.25ML Injection/FLUZONE/FLUCELVAX Lot UI975AA Exp:6/30/19. Not sure if it is FLUZONE of FLUCELVAX so I listed both names above with the provided Lot #. I noticed my son's arm was swollen, hard to the touch and red upon picking him up from school. He said it was tender and itchy. Overnight the swelling doubled in size with increased regions of redness and hot to the touch. Later that day upon checking the swelling had increased still with redness extending more than 2 inches outwards from the injection site. This was firm deep swelling, skin hot to the touch. Upon speaking with a nurse I began administering BENADRYL every 4 hours. The first dose  given 8pm 9/18/18. By 6am 9/19/18 there was a noticeable reduction in the redness and swelling. As of 9/19/18 10pm there is still some swelling, redness and bruising, increased warmth but improving
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chest pain, Confusional state, Diarrhoea, Disturbance in attention, Dizziness
Clinical narrative: 9/18/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up. As of 3:25am 9/20/18 the issue still continues.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Dysgeusia, Dyspnoea, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: 9/18/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up. As of 3:25am 9/20/18 the issue still continues.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pain, Palpitations, Pyrexia, Spinal pain
Clinical narrative: 9/18/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up. As of 3:25am 9/20/18 the issue still continues.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Abdominal discomfort, Chest pain, Confusional state, Diarrhoea, Disturbance in attention
Clinical narrative: 9/18/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up. As of 3:25am 9/20/18 the issue still continues.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Dizziness, Dysgeusia, Dyspnoea, Feeding disorder, Feeling hot
Clinical narrative: 9/18/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up. As of 3:25am 9/20/18 the issue still continues.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Hyperhidrosis, Nausea, Pain, Palpitations, Pyrexia
Clinical narrative: 9/18/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up. As of 3:25am 9/20/18 the issue still continues.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Spinal pain
Clinical narrative: 9/18/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up. As of 3:25am 9/20/18 the issue still continues.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Insomnia
Clinical narrative: It is 5:15 AM on 09/20/2018 and I have been awake for most of the night - unable to sleep - like my brain is wide awake and racing and won't go to sleep. I tried 3 different sleeping areas, sleep hypnosis, relaxation meditation, and I am still wide awake. I am supposed to be to work at 8:00 AM which includes a 45 minute drive - which I am uncomfortable doing since I don't know when the tiredness is going to kick in today. This episode reminds me of a time I took prednisone in the later hours of the day. No one advised me that it would keep me up all night - but it did!
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Malaise, Pruritus, Rash
Clinical narrative: Sick (injection site SHINGRIX site - looks good now/pt had violent shivering after SHINGRIX was given/pt was gardening last Wednesday) and Rash (arms, abdomen/itchy/pt had SHINGRIX last Friday - noticed rash on RUE - that afternoon, became blister on Sunday/other spots appeared on the R side of the abdomen/more spots noticed on LUE on Monday).
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Syncope
Clinical narrative: Fainting and dizziness.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Musculoskeletal disorder, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm swelling and pain, Significant swelling and redness on approx. 4 inches of upper arm.  Patient in significant pain and unable to do anything with arm. Shot occurred 10 AM on Friday morning, side effects started approx. 8 PM on Friday. 48 hours of above symptoms. Still significant swelling and bruising on Monday morning (when patient returned to pharmacy), however, symptoms were starting to improve.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Patient complained it hurt at time of injection, had pain all night, limited arm movement.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient complained it hurt at time of injection, had pain all night, limited arm movement.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Pain at the time of injection, then followed by throbbing 2-3 hours later that increased overnight. Next day unable to lift or move arm from the shoulder without severe pain has continued without improvement.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Pain at the time of injection, then followed by throbbing 2-3 hours later that increased overnight. Next day unable to lift or move arm from the shoulder without severe pain has continued without improvement.
Sex: F
Vaccine: HEPA
Symptoms: Fatigue
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VAQTA (dose, units, frequency, lot and expiry date were not reported). On an unknown date the patient experienced fatigue. The outcome of fatigue was reported as not recovered. The causality assessment of the event was not reported. There was no product quality compliant reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist referring to a patient of unknown age and gender. Information about the patient's medical history, concomitant medications and drug reactions/allergies was not provided. On 06-SEP-2018, the patient was vaccinated with VARIVAX (lot # N035940, expired date 21-DEC-2019) with STERILE DILUENT intramuscularly instead of via the subcutaneous route for prophylaxis(Subcutaneous injection formulation administered by other route). Concomitant therapies included sterile diluent. No adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient (age and gender unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-JUN-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 10-SEP-2016, the patient was treated at a medical facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2016, the patient was treated at a medical facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2016, the patient was treated at a medical facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2016, the patient was treated at a medical facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient (age and gender unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 10-SEP-2016, the patient was treated at a medical facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a license practical nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot number N035957 and expiration date of 10-OCT-2020) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On 06-SEP-2018, the reporter stated that there were 10 vials of GARDASIL 9 in a multi-vial carton and a flip cap was missing (Product quality issue) from one of the vials of GARDASIL 9, the same vial of GARDASIL 9 appeared excessively cloudy when compared to other vials in box, the color was white and was more viscous (Liquid product physical issue). It was also mentioned that the reporter usually see thru the liquid in a GARDASIL 9 vial, nevertheless it looked like thick sugar water with little particulates visible. The appearance of the liquid appears different when compared to the other vials that were in the same shipment of GARDASIL 9. No adverse effects were reported. The outcome of product quality issue and issue and liquid product physical issue was unknown. Additionally, the reporter did not provide causality assessment between the events and vaccination with GARDASIL 9.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and indication not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as a severe herpes zoster or shingles for the long term prevention of shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic 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. On or about 14-MAY-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles or zoster-related injuries as intended. On or about 06-AUG-2015, the patient was treated for herpes zoster. The patient was prescribed gabapentin for management of her painful symptoms and chronic pain. On or about 16-JUL-2015, the patient was treated and was diagnosed with postherpetic neuralgia. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD lot # R002934, expiration date 29-JUL-2019 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with a properly stored of sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit  for 35 hours 18 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 39 hours 57 minutes.
Age: 6.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 6 years old male patient who was vaccinated FLUBLOK QIV in error. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, (reported as today) the patient received a dose of suspect FLUBLOK QIV lot QFAA1801 via unknown route in the left deltoid. It was case of actual medication error due to inappropriate age at vaccine administration. It was unknown any adverse reaction occurred 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial unsolicited report received from nurse on 11-Sep-2018. This case involves a [24 months old] male patient who was vaccinated with once 0.5 ml dose of PENTACEL Batch number, expiration date, route and site of administration was not reported) on an unknown date without ACT HIB. The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate reconstitution technique (PENTACEL diluent portion given without ACT HIB). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Cough
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 81 years old female patient who had started coughing monday night and has been coughing since the vaccine was administered, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Sep-2018, the patient received a dose of suspect FLUZONE HIGH DOSE (lot number not reported) via intramuscular route in the left arm. On unknown date, the patient developed a non-serious started coughing Monday night and has been coughing since following the administration of FLUZONE HIGH DOSE. Relevant tests were not reported. Final diagnosis was started coughing Monday night and has been coughing since. The patient was treated with DELSYM. The outcome for the event was not reported. List of documents held by sender: none.
Age: 0.58
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven- months old patient who was vaccinated with only ACTHIB portion of PENTACEL (Single administration) (lot C5426AA for Dtap-IPV, expiry date: 04-Oct-2019, lot C5529AA (vial) lot C5529AA(carton)) (dose in series, route and site of administration was not reported) on 15-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included PREVNAR 13 for Immunisation; and ROTAVIRUS VACCINE for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique and product use issue since only the ACTHIB portion was administered but that was reconstituted with sterile water, did not receive all the components. 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 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 sender: none.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Patient fainted during flu vaccine administration.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Hypertension
Clinical narrative: The patient received the flu vaccine at 10 AM. Patient reported no previous reactions to flu shot other than localized redness/swelling. Patient advised to check in 20 minutes post vaccine. Patient had shortness of breath and hypertension about 10 minutes following the vaccine. Patient has an underlying disease state of Lupus, has had anaphylaxis due to antibiotics in the past. Patient self-administered EPI-PEN that is carried at 10:22 AM, 911 was called. Nurses monitor vitals and remained with the patient as pressure improved. Vitals at 10:25 AM - BP 160/90 and Pulse 72; 10:28 AM - BP 122/80 and Pulse 88; 10:30 AM - BP not taken, Pulse 82. At 10:28 paramedics arrived and was transported to hospital.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Chest X-ray normal, Electrocardiogram normal, Heart rate increased, Hypoaesthesia, Laboratory test normal
Clinical narrative: Reported from father: Developed rapid heart rate on 9/9/18 after only doing mild workout that remained and caused hands to feel numb. Called EMS. Went to ER on 9/10/18 with same symptoms. Racing heart woke from sleep on 9/11 am. 9/12 went to Dr., everything was ok, no Holter monitor worn, has follow-up appointment in 6 weeks. Father reports that EKG, CXR, and labs all ok. Student returned to school 9/17/18. Student takes GHOST pre-workout supplement before workouts and has been taking for about 2 years.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Palpitations
Clinical narrative: Reported from father: Developed rapid heart rate on 9/9/18 after only doing mild workout that remained and caused hands to feel numb. Called EMS. Went to ER on 9/10/18 with same symptoms. Racing heart woke from sleep on 9/11 am. 9/12 went to Dr., everything was ok, no Holter monitor worn, has follow-up appointment in 6 weeks. Father reports that EKG, CXR, and labs all ok. Student returned to school 9/17/18. Student takes GHOST pre-workout supplement before workouts and has been taking for about 2 years.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Anxiety, Headache, Respiratory tract congestion
Clinical narrative: Patient reported to the ER with stomach ache/cramp, anxiety, congestion, and headache. No local arm irritation.
Age: 57.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Arthropod bite, Foreign travel, Pruritus, Pyrexia
Clinical narrative: 9/19/18 @ 425PM, PATIENT CALLED WITH CONCERNS ABOUT POTENTIAL SIDE EFFECTS FROM TRAVEL VACCINES RECEIVED 7/12/18 FOR TRIP, RETURNED 8/10/18. PT STATES X 3 WEEKS, HAS HAD INTERMITTENT NIGHT FEVERS TMAX 101, IMPROVED WITH MOTRIN, AND CONSISTENT ITCHY HANDS AND FEET X 3 WEEKS, TEMPORARY RELIEF WITH BENADRYL. DENIES NVD, SORE THROAT, BLISTERS/RASHES. PATIENT DENIES ANY NEW MEDICATIONS/FOODS/CREAMS/HYGIENE PRODUCTS. PATIENT REPORTS CONSISTENT EXPOSURE TO "BLACK BUGS" AND DID HAVE SEVERAL BUG BITES DURING HER TRIP-- DENIES MOSQUITO EXPOSURE. PATIENT DID NOT TAKE ANY ANTIMALARIAL PROPHYLAXIS. ADVISED PATIENT TO FOLLOW UP WITH PCP FOR FURTHER EVALUATION ASAP OR REPORT TO ER/URGENT CARE IF S/S WORSEN, FAIL TO IMPROVE. CONCERNS FOR POTENTIAL VACCINE REACTION ADDRESSED-- WILL SEND VAERS REPORT (ATTACHED TO 7/12/18 ENCOUNTER). CONCERNS FOR POTENTIAL VECTOR-BORNE RELATED ILLNESS ADDRESSED AS WELL. PATIENT VOICED UNDERSTANDING AND AGREED WITH PLAN OF CARE/RN
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dehydration, Diarrhoea, Gastroenteritis salmonella, Haematochezia, Laboratory test
Clinical narrative: Pt presented as a new pt for 4 month well visit. Pt was given all 4 month vaccines on 9/12 including dtap, ipv, hep B, hib, pcv and ROTATEQ. Pt presented with sx of severe watery, mucousy diarrhea that started on 9/17. Pt had vomited x1. Mom had noted some blood in the stool. Pt visibly dehydrated. Consulted Pediatrician who suggested sending through ER. Pt chose hospital. Spoke with mom who reports pt was getting IV fluids around 4:00pm and was expected to stay. Noted today dx of Salmonella enteritis. Unable to reach mom by cell phone today to check on pt. Contacted Health dept. Was forced to leave message at state office. Message left with name, situation and return numbers. Notified local staff and admin of problem. Vaccine being held. No further given until this is confirmed and action given.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Pt presented as a new pt for 4 month well visit. Pt was given all 4 month vaccines on 9/12 including dtap, ipv, hep B, hib, pcv and ROTATEQ. Pt presented with sx of severe watery, mucousy diarrhea that started on 9/17. Pt had vomited x1. Mom had noted some blood in the stool. Pt visibly dehydrated. Consulted Pediatrician who suggested sending through ER. Pt chose hospital. Spoke with mom who reports pt was getting IV fluids around 4:00pm and was expected to stay. Noted today dx of Salmonella enteritis. Unable to reach mom by cell phone today to check on pt. Contacted Health dept. Was forced to leave message at state office. Message left with name, situation and return numbers. Notified local staff and admin of problem. Vaccine being held. No further given until this is confirmed and action given.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Bundle branch block right, Electrocardiogram T wave inversion, Hypoaesthesia oral, Lip erythema, Lip pruritus
Clinical narrative: Upper lip itching, swelling, numbness and redness. At 1312 complained of a cramping sensation to the Left chest area, no shortness of breath or pain.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Muscle spasms
Clinical narrative: Upper lip itching, swelling, numbness and redness. At 1312 complained of a cramping sensation to the Left chest area, no shortness of breath or pain.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Was contacted by parent of client regarding a reaction to an immunization on September 18th, 2018. Parent reported redness, induration and tenderness of the right post arm of child. Parent stated that child did not have a fever. Parent requested to have child seen at Public Health. Parent and child presented on September 19th, 2018 at 16:00. Child stated that arm did not hurt. When area of redness was touched, child retracted arm. Right post arm was red, cool to the touch and measured 20 cm in diameter. In comparison, the left post arm measured 19 cm. Child was active and responsive during visit. Advised parent to continue to monitor site and if symptoms were to worsen, child should be taken to a care provider.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Condition aggravated, Seizure
Clinical narrative: Step mother reports child had a seizure while attending the Parade. He bent over to get candy that was thrown and had a seizure which the entire event lasted about 3 minutes. She has contacted his specialist and his medication has been increased.
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Bed rest, Fatigue, Influenza like illness
Clinical narrative: Extreme fatigue--flu like, in bed 36 hrs, no temp. or fluids etc.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain in extremity
Clinical narrative: Arm pain that restricted movement starting immediately after injection progressing to severe pain and complete immobilization approximately 9 hours later. Treated with NSAID and Benadryl. Pain decreased over the next 48 hours and was gone by 9/17/18.
Age: 0.92
Sex: M
Vaccine: MMRV
Symptoms: Aphasia, Developmental regression
Clinical narrative: Lost all speech he had gained days after having MMR, regressed developmentally to 6 months.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Muscular weakness, Myalgia, Pyrexia, Walking aid user
Clinical narrative: Local reaction at site of injection, fever, myalgia, weakness in legs to the point where she had to use a walker for 2 weeks.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Rash erythematous
Clinical narrative: Red rash on arm, nausea.
Age: 65.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Chills, Injection site pain, Pollakiuria, Pyrexia
Clinical narrative: PATIENT COMPLAINING OF ARM SORENESS IN THE RIGHT ARM WHERE SHINGRIX VACCINE WAS INJECTED. WOKE OVERNIGHT WITH SHIVERS, FEVER OF 100 DEGREES, AND URINARY FREQUENCY.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: No adverse event
Clinical narrative: There has been no adverse events nor symptoms at this time.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Rash erythematous, Rash generalised
Clinical narrative: Mother stated that after the vaccines the left leg at injection site was red and swollen. Reassured mother that was a normal reaction. Mother also stated infant broke out in a fine pinpoint red rash over his body, no fever or problems breathing. Mother called Dr. regarding rash and was instructed to give BENADRYL q6 hours for 24 hours and if started having problems breathing go to ER. Mom states the next day the rash was starting to fade and no other problems. The infant still has a few pinpoint size red dots on abdomen and left leg. The patient had previously received only a PEDIARIX at 2 months of age at PCP. Mother states they were out of other vaccines.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Death
Clinical narrative: Client passed away 9/3/2018 at home.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted post flu vaccination. Vitals taken, offered water, repositioned patient to the floor.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood test, Nausea, Syncope
Clinical narrative: Patient presented nausea and reported feeling weak, she fainted after about two hours after the shot. We called 911 and they took the patient to the hospital.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mildly swollen, is warm to the touch to below the elbow and there is redness present around the injection site and slightly below (2 inches) with area of induration. Patient has been complaining that his arm hurts, has been guarding arm since the injection and feels his arm hurts most with extension or movement. Patient is not reporting pain now. Patient denies SOB, or other systematic complaints.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Mildly swollen, is warm to the touch to below the elbow and there is redness present around the injection site and slightly below (2 inches) with area of induration. Patient has been complaining that his arm hurts, has been guarding arm since the injection and feels his arm hurts most with extension or movement. Patient is not reporting pain now. Patient denies SOB, or other systematic complaints.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 11-SEP-2018, the patient received a partial dose of Oka-Merck PROQUAD (rHa) lot # R012413 with expiration date of 28-OCT-2019, for prophylaxis; it was reconstituted with MERCK STERILE DILUENT (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported). No adverse effect was reported. No additional information was provided.