chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 72-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) for prophylaxis. On 20th June 2018, the patient received the 1st dose of SHINGRIX. On 21st June 2018, 1 days after receiving SHINGRIX, the patient experienced headache. On 22nd June 2018, 2 days after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the pain in arm, erythema of extremities and swelling arm were not recovered/not resolved. It was unknown if the reporter considered the headache, pain in arm, erythema of extremities and swelling arm to be related to SHINGRIX. Additional information was reported as follows: On the next day of the vaccination the patient experienced severe headache. The patient's arm was very sore, even to a very light touch. The patient's arm was also red and swollen. Till the day of reporting, the events seemed to be resolved. However, the patient reported that her arm was again swollen and sensitive to touch. No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, fever, nausea and injection site swelling. On an unknown date, the outcome of the injection site erythema, fever, nausea and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema, fever, nausea and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had fever, nausea and redness and swelling at the injection site that lasted for 1 week. No further information was provided. Sales representative did not have any additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Candida infection, Injection site discolouration, Injection site pain, Injection site reaction, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, hives, thrush, injection site discoloration and vaccine administered at inappropriate site. The patient was treated with Steroids. On an unknown date, the outcome of the injection site pain, hives, thrush and injection site discoloration were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site pain, hives, thrush and injection site discoloration to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's spouse. The age at vaccination was not reported. The patient received a dose of SHINGRIX shot a couple of days ago from the date of reporting. The reporter was concerned because, the pharmacist gave the SHINGRIX vaccine way up in the shoulder instead of giving it lower. He felt it was way up high near the top of the shoulder and there's not a whole lot of muscle in there, which led to vaccine administered at inappropriate site. The patient complained about pain right away and hives. About 36 hours later, the patient started to have thrush at the site of the injection and skin discoloration at the injection site. She was been to a clinic twice since then to check on her symptoms. One of the physicians gave her steroids. However, she had not been hospitalized for the symptoms. The patient still had all the symptoms. The reporter would have his wife call with the reference number to provide further information. The reporter did not want to stay on the call for further questions.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, hives, thrush, injection site discoloration and vaccine administered at inappropriate site. The patient was treated with Steroids. On an unknown date, the outcome of the injection site pain, hives, thrush and injection site discoloration were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site pain, hives, thrush and injection site discoloration to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's spouse. The age at vaccination was not reported. The patient received a dose of SHINGRIX shot a couple of days ago from the date of reporting. The reporter was concerned because, the pharmacist gave the SHINGRIX vaccine way up in the shoulder instead of giving it lower. He felt it was way up high near the top of the shoulder and there's not a whole lot of muscle in there, which led to vaccine administered at inappropriate site. The patient complained about pain right away and hives. About 36 hours later, the patient started to have thrush at the site of the injection and skin discoloration at the injection site. She was been to a clinic twice since then to check on her symptoms. One of the physicians gave her steroids. However, she had not been hospitalized for the symptoms. The patient still had all the symptoms. The reporter would have his wife call with the reference number to provide further information. The reporter did not want to stay on the call for further questions.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of general body pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 16th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported via web form email. The age at vaccination was not reported. The HCP (healthcare professional) reported the patient had body pain for 3 hours after a dose of SHINGRIX. The caller did not speak with the HCP. This case has been linked to the US2018115893, reported by the same reporter for the same patient.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 61 days after receiving SHINGRIX, the patient experienced shingles, rash, tingling sensation and hives. On an unknown date, the outcome of the shingles was unknown and the outcome of the rash and hives were recovered/resolved and the outcome of the tingling sensation was not recovered/not resolved. It was unknown if the reporter considered the shingles, rash, tingling sensation and hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was previously reported to a physician. The patient received the SHINGRIX on the left arm. The patient reported that, after two months after receiving the SHINGRIX, the patient experienced rash across ribs which looked like hives or welts. The patient reported that, the rash lasted for approximately 1 week and then subsided. The patient reported after the rash subsided, the patient noticed a tingling sensation that which was in the same area where the rash was located. The patient stated that she noticed the tingling every day. The patient states that she went to visit visit her dermatologist and he was concerned that, she had an outbreak of Shingles and wanted to prescribe medication, however, the patient did not want to take medication. The patient had limited contact information for her healthcare professional (HCP) at the time of the call.
Age: 44.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 44-year-old female patient who received TWINRIX (batch number 53AT5, expiry date 28th November 2020) for prophylaxis. Concurrent medical conditions included nickel sensitivity. On 23rd May 2018, the patient received the 1st dose of TWINRIX. On an unknown date, less than a year after receiving TWINRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown. The reporter considered the injection site rash to be possibly related to TWINRIX. Additional details were provided as follows: The patient received TWINRIX on an unknown arm. The healthcare professional reported that, the patient broke out in a rash at the injection site. The healthcare professional called to verify if TWINRIX has Nickel in it. No additional information was provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 65-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 30th April 2020) for prophylaxis. On 25th June 2018, the patient received the 1st dose of SHINGRIX(intramuscular). On 26th June 2018, 1 days after receiving SHINGRIX, the patient experienced hives, skin warm, pruritus and erythema. On an unknown date, the outcome of the hives, skin warm, pruritus and erythema were recovered/resolved. It was unknown if the reporter considered the hives, skin warm, pruritus and erythema to be related to SHINGRIX. Additional details were provided as follows: At 15:00, the patient received SHINGRIX in the right deltoid. The healthcare professional reported that, the patient developed hives, redness, warm feeling and itching around the waistline for about 3 hours the day after receiving the SHINGRIX.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional (medical assistant). This case is linked to cases 2018SA182241, 2018SA182252, 2018SA182253, 2018SA182254 and 2018SA182255 (same reporter). This case involves an Infant patient (age and gender not reported) who received 0.5 ml dose of IPOL lot N1K931M via Intramuscular route on an unknown date, which reached 52.8 F, for 43 minutes, product reached 48.2 F for greater than 30 minutes. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to product storage error. Laboratory test was not reported. It was not reported if the patient received a corrective treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Document held by sender: None.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed a rash on 3/4 of her body, and gradually disappeared over 3 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Pain, Pain in extremity
Clinical narrative: EXTREMELY SORE ARM, SEVERE BODY ACHES AND 102 TEMPERATURE FOR 2.5 DAYS.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Depressed level of consciousness, Dizziness
Clinical narrative: PATIENT STARTED FEELING DIZZY AND SHE ALMOST FAINTED.MOM WAS HOLDING PATIENT.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Autoscopy, Blood creatine phosphokinase increased, Blood glucose decreased, Blood pressure increased, Body temperature increased
Clinical narrative: I started feeling sleepy around 8P on 6/12/18 and complained that right arm was sore. Woke up around 5A and asked wife should I place so alcohol on site because of soreness. Around 5P on 6/13/18, my daughter reported I was acting like I was having an out of body experience (talking but not coherently, in a daze, but knew my name, location, but not date or time). Daughter called wife and she stated check blood sugar, I did not know how to use the machine which I use daily, strange gestures with my fingers and stretching neck like a giraffe. Told to get 3 tablespoons of ice cream, wife was 20 minutes away. Upon her arrival, she called 911, paramedics came and assessed situation, thinking it was dehydration, not a stroke and blood sugar was 148, EMS did not take to hospital, but suggested forcing fluids and if symptoms worsen call them back. Less than 40 minutes, same symptoms surface, EMS called Blood sugar had dropped to 48, unable to stand up and get out of chair- taken to Hospital for evaluation.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Computerised tomogram head normal, Disorientation, Dysstasia, Feeling abnormal, Heart rate increased
Clinical narrative: I started feeling sleepy around 8P on 6/12/18 and complained that right arm was sore. Woke up around 5A and asked wife should I place so alcohol on site because of soreness. Around 5P on 6/13/18, my daughter reported I was acting like I was having an out of body experience (talking but not coherently, in a daze, but knew my name, location, but not date or time). Daughter called wife and she stated check blood sugar, I did not know how to use the machine which I use daily, strange gestures with my fingers and stretching neck like a giraffe. Told to get 3 tablespoons of ice cream, wife was 20 minutes away. Upon her arrival, she called 911, paramedics came and assessed situation, thinking it was dehydration, not a stroke and blood sugar was 148, EMS did not take to hospital, but suggested forcing fluids and if symptoms worsen call them back. Less than 40 minutes, same symptoms surface, EMS called Blood sugar had dropped to 48, unable to stand up and get out of chair- taken to Hospital for evaluation.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Incoherent, Injection site swelling, Injection site warmth, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: I started feeling sleepy around 8P on 6/12/18 and complained that right arm was sore. Woke up around 5A and asked wife should I place so alcohol on site because of soreness. Around 5P on 6/13/18, my daughter reported I was acting like I was having an out of body experience (talking but not coherently, in a daze, but knew my name, location, but not date or time). Daughter called wife and she stated check blood sugar, I did not know how to use the machine which I use daily, strange gestures with my fingers and stretching neck like a giraffe. Told to get 3 tablespoons of ice cream, wife was 20 minutes away. Upon her arrival, she called 911, paramedics came and assessed situation, thinking it was dehydration, not a stroke and blood sugar was 148, EMS did not take to hospital, but suggested forcing fluids and if symptoms worsen call them back. Less than 40 minutes, same symptoms surface, EMS called Blood sugar had dropped to 48, unable to stand up and get out of chair- taken to Hospital for evaluation.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Sepsis, Somnolence
Clinical narrative: I started feeling sleepy around 8P on 6/12/18 and complained that right arm was sore. Woke up around 5A and asked wife should I place so alcohol on site because of soreness. Around 5P on 6/13/18, my daughter reported I was acting like I was having an out of body experience (talking but not coherently, in a daze, but knew my name, location, but not date or time). Daughter called wife and she stated check blood sugar, I did not know how to use the machine which I use daily, strange gestures with my fingers and stretching neck like a giraffe. Told to get 3 tablespoons of ice cream, wife was 20 minutes away. Upon her arrival, she called 911, paramedics came and assessed situation, thinking it was dehydration, not a stroke and blood sugar was 148, EMS did not take to hospital, but suggested forcing fluids and if symptoms worsen call them back. Less than 40 minutes, same symptoms surface, EMS called Blood sugar had dropped to 48, unable to stand up and get out of chair- taken to Hospital for evaluation.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Pyrexia, Rash, Rash papular
Clinical narrative: Initial low grade fever and chills in first 48 hours followed after about 5 days with gradually worsening rash. Burning itchy papular rash on back, arms, legs and trunk.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Initial low grade fever and chills in first 48 hours followed after about 5 days with gradually worsening rash. Burning itchy papular rash on back, arms, legs and trunk.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dizziness, Fatigue, Nausea, Visual impairment
Clinical narrative: Client c/o of joint pain, increased tiredness, dizziness and nausea off and on the day after Tdap vaccination lasting 6 days. She also reported that she is "seeing 3 lines". Advised client to seek immediate medical attention.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Feeling abnormal, Influenza like illness
Clinical narrative: Patient complains felt bad right away, but did not complain. Main complaint now is claims to have arthritis pain in knees, hips and shoulders since shot and has not got any better. Doctor told her to monitor symptoms and follow up with him. Does not want to get second shot for fear symptoms with worsen. Also said felt like had flu like symptoms for couple of days but they went away after a couple days.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia
Clinical narrative: Patient complains felt bad right away, but did not complain. Main complaint now is claims to have arthritis pain in knees, hips and shoulders since shot and has not got any better. Doctor told her to monitor symptoms and follow up with him. Does not want to get second shot for fear symptoms with worsen. Also said felt like had flu like symptoms for couple of days but they went away after a couple days.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphasia, Computerised tomogram, Confusional state, Electrocardiogram, Nuclear magnetic resonance imaging
Clinical narrative: I had a TIA (minor stroke) beginning symptoms on May 11, 2018. EMS responded to residence on May 12. Was admitted to Hospital via emergency room on May 12, 2018. Was tested with various tests (ekg, electrocariogram, MRI, CAT, etc..scans). Could find no other reasons or cause of TIA.  Symptoms were limited to speech aphasia, and confusion. These symptoms cleared up in 3-days time. All test results are on file with  Hospital in.  Neurologist was Dr. on Cone Hospital staff. Only diagnosis for cause was possibly XARELTO too low in system.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Scan, Transient ischaemic attack
Clinical narrative: I had a TIA (minor stroke) beginning symptoms on May 11, 2018. EMS responded to residence on May 12. Was admitted to Hospital via emergency room on May 12, 2018. Was tested with various tests (ekg, electrocariogram, MRI, CAT, etc..scans). Could find no other reasons or cause of TIA.  Symptoms were limited to speech aphasia, and confusion. These symptoms cleared up in 3-days time. All test results are on file with  Hospital in.  Neurologist was Dr. on Cone Hospital staff. Only diagnosis for cause was possibly XARELTO too low in system.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Nausea, Pain
Clinical narrative: Patient describes aches all over her body (from her head all the way to her toes), nausea, diarrhea, on and off sweats and chills. Reporting day after vaccination, patient still feeling side effects at this time. I will follow-up with patient in 2 days. She did indicated she is feeling better than before but still experiencing the effects. I informed her to call us back if anything changes or gets worse.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: STARTING THE DAY AFTER VACCINATION, PATIENT EXPERIENCED RED, SWOLLEN BLOTCHES NEAR THE INJECTION SITE. THE BLOTCHES COVERED AN 8 INCH BY 4 INCH AREA.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient experienced nausea, vomiting, chills, fever, and feeling faint 8 hours after receiving the SHINGRIX vaccine. Those effects lasted 8 to 9 hours, then went away and have not returned since.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: Patient states the evening of her shot she developed a fever and chills. The next morning a rash had developed about 2 inches in diameter and lasted for approximately 1 week.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction with red, swelling, tenderness, and warmth inferior to injection for 16 cm. Per patient, occurred "shortly" after receiving injection. Patient advised to keep elevated, ice, and diphenhydramine; monitor for any worsening symptoms.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Pt likely had intussusception.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness
Clinical narrative: Flu-like symptoms. Shivering and feeling really run-down.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth, Pruritus
Clinical narrative: Swollen hot red welt 5.5 cm across injection site. Itching. Lasted for 2 days.
Age: 33.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Urticaria
Clinical narrative: Patient called on 7/3 reporting that he had redness/soreness and some hives on his right arm around the Hep A injection site. Pt was counseled to take BENADRYL and keep and eye on it and call us back if symptoms continued. Pt called back 7/5/18 reporting that hives had spread to his back and BENADRYL was not helping. Patient was counceled about any over the counter products (soap, heat rash, food changes, etc.) that could contribute to hives. Pt was also instructed to see his physician since hives were spreading and asked to call back the pharmacy with an update.
Age: 57.0
Sex: F
Vaccine: HEPA, TDAP, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient came to pharmacy 7.3.18 and had 3 imz. HAVRIX and ADACEL in left arm (HAVRIX upper, ADACEL lower) and SHINGRIX in right arm. Daughter called 7.4.18 around 3:30 stating patient's right arm is swollen, red, warm, and raised. Pharmacist asked whether she was taking anything for this--she said no. He also asked if there was swelling of lips/mouth or difficulty breathing--she said no. Pharmacist suggested she take tylenol and benadryl to help symptoms. and that symptoms should resolve in a couple of days--if it gets worse or if swelling of lips, mouth or difficult breathing occurs see PCP.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Rash, Screaming
Clinical narrative: Excessive crying, "screaming" throughout the day on 7/3. Worsening of rash present that was present prior to vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Ataxia, Balance disorder, Gait disturbance, Partial seizures, Pyrexia
Clinical narrative: The vaccine was given on 6/20. She had fever that evening and none thereafter. On the evening of 6/24, parents noted that the patient seemed to be falling more often than normal and was having some difficulty with her balance. This worsened over the course of the next few days. On the morning of 6/28, she had a brief focal seizure and slept for several hours afterwards. She was seen in our office that afternoon and was acting well apart from some mild gait abnormalities/ataxia. Of note, this patient does have a known seizure d/o and it had been recommended by neurology that she be on anti-epileptic medications; however, the parents have been hesitant to start these. I am doubtful that the seizure was related to her vaccines (and suspect that she would have had one again soon without the recommended antiepileptic drugs), but am unclear as to the possibility that her mild ataxia/gait changes may be. Now, about a week later, dad states that the patient is back to her normal self without any ongoing problems. And, they have started her on KEPPRA per her neurologist.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Altered state of consciousness, Blindness transient, Deafness
Clinical narrative: Patient semi passed out approximately 5 -7 min after vaccination, blindness and loss of hearing occurred but returned once patient sat for a few minutes.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Peripheral swelling
Clinical narrative: Swollen feet and headache.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Urticaria
Clinical narrative: PATIENT STATES THAT 2 DAYS LATER SHE BROKE OUT IN HIVES ON HER NECK, BREAST, AND CHEST. ALSO STATES HAD A SORE(FEVER BLISTER) ON HER LIP. CALLED PHARMACY 7/5/18 TO LET US KNOW AND THAT HER MD ADVISED HER TO NOT REPEAT SECOND DOSE.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: About 20 minutes after giving injection, patient came back dizzy, then fainted. I called 911, then gave her an Epi Pen shot in thigh, which revived her, then the ambulance came.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chest pain, Dyspnoea, Pyrexia
Clinical narrative: Pt had fever of 103, increased blood pressure, chest pain and shortness of breath, resolved by itself within a day.
Age: 74.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient states she has pain and limited mobility in her right arm after the vaccine. She states pain radiates from her shoulder to her neck and down her forearm. She said she hoped it would get better as time went on and finally gave up and went to her primary care doctor. She did not contact the doctor or pharmacy until now.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Crying, Eye swelling, Lethargy, Rash, Rash macular
Clinical narrative: Red splotchy face and upper body, progressed from small to covering whole upper body/face/ears/arms within 8hours of shot. Swollen face included eyes. Non stop crying and lethargy after 8hours.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Swelling face
Clinical narrative: Red splotchy face and upper body, progressed from small to covering whole upper body/face/ears/arms within 8hours of shot. Swollen face included eyes. Non stop crying and lethargy after 8hours.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Chills, Erythema, Full blood count normal, Headache
Clinical narrative: Fever greater than 103, Rigors, chills, myalgias, headache, local swelling, redness, abd discomfort.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Liver function test increased, Myalgia, Pyrexia, Swelling
Clinical narrative: Fever greater than 103, Rigors, chills, myalgias, headache, local swelling, redness, abd discomfort.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Pruritus, Rash, Skin warm
Clinical narrative: Left arm red, swollen, warm to touch, itchy, bumps, bruised.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received above vaccines on 7/2/18. Parent noted redness and swelling 7/4/18 on (R) upper arm. Seen in office. ? vaccine reaction vs cellulitis started on cephalexin.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation
Clinical narrative: Local inflammation at injection site. Tx with ice and ibuprofen.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Right leg swelling for INR, Diphendryl 12.5 mg/5 ml, 4 ml, PO, TID, 3 days.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash, Tenderness
Clinical narrative: Right arm redness, rash spreading, arm tender. Warm compresses, ibuprofen as needed area marked with permanent marker. Educated Pt regarding signs/symptoms to report.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Computerised tomogram normal, Mobility decreased, Nausea
Clinical narrative: Pt. reported that 10  hours after vaccination he developed fever and teeth chattering, felt weak and nauseated. He could not move or get up. Paramedic arrived to his home to assist him. Vitals were normal. Pt. received Cat Scan which was also normal. Pt. has been fine since then.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt. reported that 10  hours after vaccination he developed fever and teeth chattering, felt weak and nauseated. He could not move or get up. Paramedic arrived to his home to assist him. Vitals were normal. Pt. received Cat Scan which was also normal. Pt. has been fine since then.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Patient reported a week later with myalgia in the left arm, has been back twice to report condition is not improving and progressing. Wakes up with pain in left arm, limiting rotation. Has seen PCP about this.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Cough, Rash, Wheezing
Clinical narrative: Pt. came in on 7/4 concerned that the rash on her Lt. arm might be Assc. with the recent SHINGRIX vac. The rash appeared patchy and raised - no itchiness or pain - she also complained about asthmatic Sx (wheezing/coughing) 7/2. No treatment at this time.
Age: 27.0
Sex: M
Vaccine: ANTH, FLU4, SMALL, TYP
Symptoms: Chest X-ray abnormal, Chest X-ray normal, Chest discomfort, Chest pain, Echocardiogram abnormal
Clinical narrative: He reported to the ED on 08 Oct with a 2 day hx of chest pain described as tightness in center chest rated number 8 on scale of 1-10. No N/V/diaphoresis. Pain inc with deep breaths, movements and lying flat. No relief with ibuprofen. He had EKG changes and positive cardiac enzymes and was to hospital where he was admitted from 08-11 Oct. and discharged with a diagnosis of myocarditis. Symptoms: Chest pain, unspecified.
Age: 27.0
Sex: M
Vaccine: ANTH, FLU4, SMALL, TYP
Symptoms: Ejection fraction normal, Electrocardiogram PR interval, Electrocardiogram QRS complex normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: He reported to the ED on 08 Oct with a 2 day hx of chest pain described as tightness in center chest rated number 8 on scale of 1-10. No N/V/diaphoresis. Pain inc with deep breaths, movements and lying flat. No relief with ibuprofen. He had EKG changes and positive cardiac enzymes and was to hospital where he was admitted from 08-11 Oct. and discharged with a diagnosis of myocarditis. Symptoms: Chest pain, unspecified.
Age: 27.0
Sex: M
Vaccine: ANTH, FLU4, SMALL, TYP
Symptoms: Myocardial necrosis marker increased, Myocarditis, Pain, Painful respiration, Troponin I increased
Clinical narrative: He reported to the ED on 08 Oct with a 2 day hx of chest pain described as tightness in center chest rated number 8 on scale of 1-10. No N/V/diaphoresis. Pain inc with deep breaths, movements and lying flat. No relief with ibuprofen. He had EKG changes and positive cardiac enzymes and was to hospital where he was admitted from 08-11 Oct. and discharged with a diagnosis of myocarditis. Symptoms: Chest pain, unspecified.
Age: 27.0
Sex: M
Vaccine: ANTH, FLU4, SMALL, TYP
Symptoms: Ultrasound scan abnormal
Clinical narrative: He reported to the ED on 08 Oct with a 2 day hx of chest pain described as tightness in center chest rated number 8 on scale of 1-10. No N/V/diaphoresis. Pain inc with deep breaths, movements and lying flat. No relief with ibuprofen. He had EKG changes and positive cardiac enzymes and was to hospital where he was admitted from 08-11 Oct. and discharged with a diagnosis of myocarditis. Symptoms: Chest pain, unspecified.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Rash, Swelling
Clinical narrative: Swelling, redness and pain in neck & shoulders. Pain in spine. Treated with two prescriptions of cephalexin and 1 prescription of prednisone. Contacted Merck, no help.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Cellulitis, Full blood count, Neck pain, Swelling
Clinical narrative: Swelling, redness and pain in neck & shoulders. Pain in spine. Treated with two prescriptions of cephalexin and 1 prescription of prednisone. Contacted Merck, no help.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Antinuclear antibody, Borrelia test, C-reactive protein, Differential white blood cell count, Erythema
Clinical narrative: Swelling, redness and pain in neck & shoulders. Pain in spine. Treated with two prescriptions of cephalexin and 1 prescription of prednisone. Contacted Merck, no help.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Full blood count, Metabolic function test, Musculoskeletal pain, Neck pain, Red blood cell sedimentation rate
Clinical narrative: Swelling, redness and pain in neck & shoulders. Pain in spine. Treated with two prescriptions of cephalexin and 1 prescription of prednisone. Contacted Merck, no help.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Spinal pain, Swelling
Clinical narrative: Swelling, redness and pain in neck & shoulders. Pain in spine. Treated with two prescriptions of cephalexin and 1 prescription of prednisone. Contacted Merck, no help.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 60-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date June 2019) for prophylaxis. The patient's past medical history included methicillin-resistant staphylococcus aureus infection. Concomitant products included FLONASE, NORVASC, Propranolol, metronidazole, pantoprazole, spironolactone, TEMOVATE and TRICOR. On 22nd June 2018 20:00, the patient received the 1st dose of SHINGRIX 1 ml. On 22nd June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site induration, injection site burning, injection site erythema, injection site swelling and intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site warmth and overdose. The patient was treated with amoxicillin sodium, AUGMENTIN and doxycycline. On an unknown date, the outcome of the injection site induration, injection site burning, injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the injection site warmth, intramuscular formulation administered by other route and overdose were unknown. The reporter considered the injection site induration, injection site burning, injection site erythema and injection site swelling to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on right arm. The patient received the injection subcutaneously, which led to incorrect route of drug administration. The redness, burning, hotness and swelling appeared immediately following the injection. The redness spread to 3 inches around the site by the next morning the area felt hotter and harder. At 8 am on the 24th June she went to urgent care and was given AUGMENTIN. On Monday the 25th June, the redness spread further and she visited her physician. The physician measured the red area to be 4 into 6.5 inches around and drew a marking around it to monitor the size. She was given Doxycycline. On the day of reporting, the redness was all the way down to her elbow measuring 5 into 8 inches. The injection site hardness was currently measuring 2 into 3 inches and feels like a golf ball. The patient had MRSA in the past and said that this felt just like it. The patient had reported this to the CDC.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cellulitis, Incorrect route of drug administration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 60-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date June 2019) for prophylaxis. The patient's past medical history included methicillin-resistant staphylococcus aureus infection. Concomitant products included FLONASE, NORVASC, Propranolol, metronidazole, pantoprazole, spironolactone, TEMOVATE and TRICOR. On 22nd June 2018 20:00, the patient received the 1st dose of SHINGRIX 1 ml. On 22nd June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site induration, injection site burning, injection site erythema, injection site swelling and intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site warmth and overdose. The patient was treated with amoxicillin sodium, AUGMENTIN and doxycycline. On an unknown date, the outcome of the injection site induration, injection site burning, injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the injection site warmth, intramuscular formulation administered by other route and overdose were unknown. The reporter considered the injection site induration, injection site burning, injection site erythema and injection site swelling to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on right arm. The patient received the injection subcutaneously, which led to incorrect route of drug administration. The redness, burning, hotness and swelling appeared immediately following the injection. The redness spread to 3 inches around the site by the next morning the area felt hotter and harder. At 8 am on the 24th June she went to urgent care and was given AUGMENTIN. On Monday the 25th June, the redness spread further and she visited her physician. The physician measured the red area to be 4 into 6.5 inches around and drew a marking around it to monitor the size. She was given Doxycycline. On the day of reporting, the redness was all the way down to her elbow measuring 5 into 8 inches. The injection site hardness was currently measuring 2 into 3 inches and feels like a golf ball. The patient had MRSA in the past and said that this felt just like it. The patient had reported this to the CDC.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 60-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date June 2019) for prophylaxis. The patient's past medical history included methicillin-resistant staphylococcus aureus infection. Concomitant products included FLONASE, NORVASC, Propranolol, metronidazole, pantoprazole, spironolactone, TEMOVATE and TRICOR. On 22nd June 2018 20:00, the patient received the 1st dose of SHINGRIX 1 ml. On 22nd June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site induration, injection site burning, injection site erythema, injection site swelling and intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site warmth and overdose. The patient was treated with amoxicillin sodium, AUGMENTIN and doxycycline. On an unknown date, the outcome of the injection site induration, injection site burning, injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the injection site warmth, intramuscular formulation administered by other route and overdose were unknown. The reporter considered the injection site induration, injection site burning, injection site erythema and injection site swelling to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on right arm. The patient received the injection subcutaneously, which led to incorrect route of drug administration. The redness, burning, hotness and swelling appeared immediately following the injection. The redness spread to 3 inches around the site by the next morning the area felt hotter and harder. At 8 am on the 24th June she went to urgent care and was given AUGMENTIN. On Monday the 25th June, the redness spread further and she visited her physician. The physician measured the red area to be 4 into 6.5 inches around and drew a marking around it to monitor the size. She was given Doxycycline. On the day of reporting, the redness was all the way down to her elbow measuring 5 into 8 inches. The injection site hardness was currently measuring 2 into 3 inches and feels like a golf ball. The patient had MRSA in the past and said that this felt just like it. The patient had reported this to the CDC.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Overdose
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 60-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date June 2019) for prophylaxis. The patient's past medical history included methicillin-resistant staphylococcus aureus infection. Concomitant products included FLONASE, NORVASC, Propranolol, metronidazole, pantoprazole, spironolactone, TEMOVATE and TRICOR. On 22nd June 2018 20:00, the patient received the 1st dose of SHINGRIX 1 ml. On 22nd June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site induration, injection site burning, injection site erythema, injection site swelling and intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site warmth and overdose. The patient was treated with amoxicillin sodium, AUGMENTIN and doxycycline. On an unknown date, the outcome of the injection site induration, injection site burning, injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the injection site warmth, intramuscular formulation administered by other route and overdose were unknown. The reporter considered the injection site induration, injection site burning, injection site erythema and injection site swelling to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on right arm. The patient received the injection subcutaneously, which led to incorrect route of drug administration. The redness, burning, hotness and swelling appeared immediately following the injection. The redness spread to 3 inches around the site by the next morning the area felt hotter and harder. At 8 am on the 24th June she went to urgent care and was given AUGMENTIN. On Monday the 25th June, the redness spread further and she visited her physician. The physician measured the red area to be 4 into 6.5 inches around and drew a marking around it to monitor the size. She was given Doxycycline. On the day of reporting, the redness was all the way down to her elbow measuring 5 into 8 inches. The injection site hardness was currently measuring 2 into 3 inches and feels like a golf ball. The patient had MRSA in the past and said that this felt just like it. The patient had reported this to the CDC.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Erythema, Pain, Skin irritation, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of swelling in a 70-year-old male patient who received SHINGRIX (batch number 9YD45 ?, expiry date 2nd February 2021) for prophylaxis. Concurrent medical conditions included diabetes mellitus. Concomitant products included Metformin ER and Simvastatin. On 25th June 2018 11:00, the patient received SHINGRIX (intramuscular) .5 ml. On 25th June 2018, several hours after receiving SHINGRIX, the patient experienced swelling, fever, shivers, erythema and fatigue. On an unknown date, the outcome of the swelling, fever, shivers, erythema and fatigue were not recovered/not resolved. The reporter considered the swelling, fever, shivers, erythema and fatigue to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The reported batch number 9YD45, does not exist in sales data. The HCP (healthcare professional) reported that after receipt of SHINGRIX the patient developed swelling, redness, fatigue, shivers and fever later that night.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Fatigue, Pyrexia, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of swelling in a 70-year-old male patient who received SHINGRIX (batch number 9YD45 ?, expiry date 2nd February 2021) for prophylaxis. Concurrent medical conditions included diabetes mellitus. Concomitant products included Metformin ER and Simvastatin. On 25th June 2018 11:00, the patient received SHINGRIX (intramuscular) .5 ml. On 25th June 2018, several hours after receiving SHINGRIX, the patient experienced swelling, fever, shivers, erythema and fatigue. On an unknown date, the outcome of the swelling, fever, shivers, erythema and fatigue were not recovered/not resolved. The reporter considered the swelling, fever, shivers, erythema and fatigue to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The reported batch number 9YD45, does not exist in sales data. The HCP (healthcare professional) reported that after receipt of SHINGRIX the patient developed swelling, redness, fatigue, shivers and fever later that night.