chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site scab
Clinical narrative: Has a scabbed area where shot was given. Not sure when this started. Patient first came back to tell us of this 12 days after the shot. No redness surrounding the area.
Age: 43.0
Sex: M
Vaccine: FLUX, HEPAB
Symptoms: Incorrect route of product administration
Clinical narrative: I was giving a pt a flu shot and a TWINRIX shot. Someone had mixed in a 5/8 inch needle into the 1 inch needle box. So I gave the TWINRIX shot 1st and then noticed that it was shorter than the 1 inch needle on the second flu shot. I did give both at a 90 degree angle. This is what facts and comparison said "Although subcutaneous administration is not recommended in labeling (antibody response may be suboptimal), the product labeling suggests that subcutaneous administration may be used in patients at risk for hemorrhage (including those with thrombocytopenia)." I called the CDC they said. That if Hepatitis B is given SQ it should be repeated but the Hepatitis A does not need to be repeated. I asked again about the 5/8 inch needle part pt's weighing more than 152 need 1 inch to 1.5 inch needle. Reach out to Dr office (pt's PCP) they said okay to revaccinate with Hepatitis B.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Back pain, Insomnia, Moaning, Neck pain
Clinical narrative: Patient stated the following effects that occurred on 9/10/18 approx. 9 pm: lower back pain (bilateral), body aches, neck ache, anxiety, sleeplessness (the feeling of not being fully asleep throughout the night), moaning during sleep, nightmarish-like state during sleep, some symptoms similar after 1st dose of SHINGRIX, worse with this 2nd dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Poor quality sleep
Clinical narrative: Patient stated the following effects that occurred on 9/10/18 approx. 9 pm: lower back pain (bilateral), body aches, neck ache, anxiety, sleeplessness (the feeling of not being fully asleep throughout the night), moaning during sleep, nightmarish-like state during sleep, some symptoms similar after 1st dose of SHINGRIX, worse with this 2nd dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed Herpes Zoster 9-10-2018; diagnosed in clinic visit 9-11-2018.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: PATIENT PRESENTED TO THE PHARMACY 9/11/18 (3 DAYS AFTER RECEIVING VACCINE) WITH A RED, INDURATED AREA AROUND THE INJECTION SITE MEASURING APPROXIMATELY 2.5" ACROSS. PATIENT SAID THEY ALSO HAD NAUSEA, FEVER, CHILLS, AND FATIGUE THE DAY AFTER RECEIVING THE VACCINE (9/9/18). PATIENT COMPLAINED THAT THE INDURATED AREA WAS SORE AND ITCHED AS WELL. ACCORDING TO THE PATIENT, THE REDNESS AND INDURATED AREA SHE PRESENTED ON 9/11/18 WAS APPROXIMATELY 1/2 THE SIZE OF WHAT IT WHAT ON 9/9/18.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Nausea, Pyrexia
Clinical narrative: PATIENT PRESENTED TO THE PHARMACY 9/11/18 (3 DAYS AFTER RECEIVING VACCINE) WITH A RED, INDURATED AREA AROUND THE INJECTION SITE MEASURING APPROXIMATELY 2.5" ACROSS. PATIENT SAID THEY ALSO HAD NAUSEA, FEVER, CHILLS, AND FATIGUE THE DAY AFTER RECEIVING THE VACCINE (9/9/18). PATIENT COMPLAINED THAT THE INDURATED AREA WAS SORE AND ITCHED AS WELL. ACCORDING TO THE PATIENT, THE REDNESS AND INDURATED AREA SHE PRESENTED ON 9/11/18 WAS APPROXIMATELY 1/2 THE SIZE OF WHAT IT WHAT ON 9/9/18.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Loss of personal independence in daily activities, Paraesthesia
Clinical narrative: Very sore injection site. Fatigue, Flu Like Symptoms, "Pins ands Needles" feeling. Needed to leave work to rest on day following injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: PATIENT HAD PAIN, REDNESS AT SITE OF INJECTION. STATES THAT COULD NOT LIFT UP A GLASS OF WATER TO DRINK. I ASKED PATIENT IF THE PAIN HAS GOTTEN BETTER, WORSE, OR THE SAME AND SHE SAID SAID THAT IT HAD GOTTEN WORSE SINCE SATURDAY. I RECOMMEDEDED THAT SHE GO AND SEE HER PRIMARY CARE DOCTOR AND GET CHECKED OUT. SHE SAID THAT SHE WOULD IF THE PAIN HAD NOT GOTTEN ANY BETTER IN THE NEXT COUPLE DAYS.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphagia, Dysphonia, Pharyngeal oedema
Clinical narrative: Pt received vaccine on 9/6/18, 11:05am. Next morning 9/7/18, woke up with swollen throat, hoarse voice, and difficulty swallowing. He reported that during the day the swelling went down. He said that that night he took two BENADRYL capsules OTC. He said that on 9/8/18, he woke up fine, throat swelling was gone, and no symptoms remained. Pt reported his reaction to the pharmacy 9/11/18, and confirmed that he was not experiencing any problem at the moment. Rph added adverse reaction to pt's file and also contacted pt's new md Dr., to reported reaction to nurse and asked her to follow up with pt.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Blood urine present, Chills, Cough, Diarrhoea
Clinical narrative: PATIENT REPORTED FLU LIKE SYMPTOMS FOR ABOUT 6 DAYS AFTER ADMINISTRATION OF INFLUENZA VACCINE, INCLUDING: CHILLS, FEVER, COUGH, AND DIARRHEA. ON 09/06/2018, PATIENT REPORTED LOWER BACK PAIN AND BLOODY URINE REQUIRING MEDICAL EVALUATION.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza like illness, Pyrexia, Urethral haemorrhage
Clinical narrative: PATIENT REPORTED FLU LIKE SYMPTOMS FOR ABOUT 6 DAYS AFTER ADMINISTRATION OF INFLUENZA VACCINE, INCLUDING: CHILLS, FEVER, COUGH, AND DIARRHEA. ON 09/06/2018, PATIENT REPORTED LOWER BACK PAIN AND BLOODY URINE REQUIRING MEDICAL EVALUATION.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia, Vomiting
Clinical narrative: Vomiting, fatigue, muscle pain, fever, and soreness at the site of injection, Took TYLENOL, iced area, and drink fluids.
Age: 78.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The patient received both vaccines in the same arm and began experiencing a red band around 3/4 of arm, swollen, painful and warm to the touch. I spoke with her today (9/11/18) and she said the side effects have significantly lessened.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test abnormal, Chest X-ray, Ear pain, Fatigue
Clinical narrative: Felt arm soreness the evening of 08/22/18. Then next morning headache ensued and ears felt shooting pain. Since then stated symptoms have not resolved as of 09/11/18 and have increased in intensity. Went to family doctor on 08/30/18. Indomethacin 50 mg was prescribed BID. Then on 09/07/18 went back to the family doctor due to weakness, fatigue, and nausea. Head x-ray and chest x-ray performed. Amoxicillin 875-125 was prescribed BID along with Methylprednisolone 4 mg 6 day progressive dose. X-ray were stated to show lungs have inflammation and blood showed inflammation.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inflammation, Nausea, Pain in extremity, Skull X-ray
Clinical narrative: Felt arm soreness the evening of 08/22/18. Then next morning headache ensued and ears felt shooting pain. Since then stated symptoms have not resolved as of 09/11/18 and have increased in intensity. Went to family doctor on 08/30/18. Indomethacin 50 mg was prescribed BID. Then on 09/07/18 went back to the family doctor due to weakness, fatigue, and nausea. Head x-ray and chest x-ray performed. Amoxicillin 875-125 was prescribed BID along with Methylprednisolone 4 mg 6 day progressive dose. X-ray were stated to show lungs have inflammation and blood showed inflammation.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Rash pruritic, Swelling
Clinical narrative: Swelling, itchy rash, lump -- pt basically waited for it to resolve itself (about 4 days).
Age: 0.58
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RV1
Symptoms: Vomiting
Clinical narrative: Vomiting, 3 times between 13:50 pm and 19:30 pm.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Neuralgia
Clinical narrative: Pt came into pharmacy today, 09/11/2018 reporting that he had been diagnosed with Chronic inflammatory demyelinating polyneuritis (ICD-10 of G61.81) a few months post vaccination. Vaccine ADR could not be ruled out and based of prescription history, it showed a few days after vaccination the patient started receiving Gabapentin for nerve based pain. This then led to hospitalization and PT services over the past several months. Patient just reported all this information to pharmacist over 6 months later, but has been undergoing medical care from the issue that could be vaccine related.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU4, VARZOS
Symptoms: Eyelid oedema
Clinical narrative: Woke up with  very swollen right eye lid.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU4, VARZOS
Symptoms: Urticaria
Clinical narrative: Woke up with  very swollen right eye lid.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Flank pain, Injection site swelling, Joint swelling, Peripheral swelling
Clinical narrative: SWELLING IN AREA OF INJECT AND THEN IT MOVED DOWN THE ARM. A COUPLE DAYS LATER STARTED EXPERIENCING PAIN ON THE RIGHT SIDE AND RIGHT KNEE. RIGHT KNEE STARTED TO SWELL. DID NOT SEEK TREATMENT. SWELLING AND PAIN IS 99 PERCENT GONE 6 DAYS POST IMMUNIZATION.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Cold sweat, Erythema, Inflammation, Influenza like illness
Clinical narrative: -Red and imflammed starting 1 day after continuing x 1 week, warm to touch; -Flu like symptoms 1 day after x 2 days (cold sweats, aching, fever, stomach cramps) -Extremely sore x 1 week -No MD visit, spoke with md on phone.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Skin warm
Clinical narrative: -Red and imflammed starting 1 day after continuing x 1 week, warm to touch; -Flu like symptoms 1 day after x 2 days (cold sweats, aching, fever, stomach cramps) -Extremely sore x 1 week -No MD visit, spoke with md on phone.
Age: 9.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Redness, itching, induration in an approximatly 3in induration presenting 6 days post injection. Pt was seen at day +12.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster
Clinical narrative: Herpes zoster rash on left posterior neck, vesicles in various eruptive stages, with erythema.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Hyperacusis, Pyrexia
Clinical narrative: Fever, pounding headache, sensitivity to noise, upset stomach. Fever 101.4 morning after vaccine.  Normal temperature by evening. At the time of this report (one day after the injection) she is still suffering from severe headache. The first shot was a miserable experience for her as well.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Patient received vaccination on 9/4 and had no reaction. However on 9/10, patient stated they began to experience reactions from shot. Upon analyzing, the patient's arm was visibly red and the patient stated the area was warm to the touch.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Within hours of vaccination, left deltoid area became inflamed, swollen and painful. Area was about 3 inches x 4 inches. Pt used ice and took 2 ADVIL in order to sleep. She presented morning of 9/11/18 and are was still pink and very warm to the touch. Some edema was noted. Injection site was within the boundaries of the deltoid vaccination area. Pt will continue to monitor, use ice and take ADVIL if necessary. Symptoms are improving.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Within hours of vaccination, left deltoid area became inflamed, swollen and painful. Area was about 3 inches x 4 inches. Pt used ice and took 2 ADVIL in order to sleep. She presented morning of 9/11/18 and are was still pink and very warm to the touch. Some edema was noted. Injection site was within the boundaries of the deltoid vaccination area. Pt will continue to monitor, use ice and take ADVIL if necessary. Symptoms are improving.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Patient came into pharmacy two days after immunization with redness on same arm as immunization. The redness was not at the injection site.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Diarrhoea, Hyperhidrosis, Injection site bruising, Injection site swelling, Injection site vesicles
Clinical narrative: Pt reported 102.5 F fever with Nausea/Vomiting/Diarrhea, syncope, sweating. Area around PNEUMOVAX injection site was reported blistered, swollen, and hot to the touch. The area around the flu shot had mild bruising.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site warmth, Nausea, Pyrexia, Syncope, Vomiting
Clinical narrative: Pt reported 102.5 F fever with Nausea/Vomiting/Diarrhea, syncope, sweating. Area around PNEUMOVAX injection site was reported blistered, swollen, and hot to the touch. The area around the flu shot had mild bruising.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Chills, Dehydration, Diarrhoea, Fatigue, Headache
Clinical narrative: Pt reported 102.5 F fever with Nausea/Vomiting/Diarrhea, syncope, sweating. Area around PNEUMOVAX injection site was reported blistered, swollen, and hot to the touch. The area around the flu shot had mild bruising.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Hyperhidrosis, Injection site swelling, Injection site vesicles, Injection site warmth, Pain
Clinical narrative: Pt reported 102.5 F fever with Nausea/Vomiting/Diarrhea, syncope, sweating. Area around PNEUMOVAX injection site was reported blistered, swollen, and hot to the touch. The area around the flu shot had mild bruising.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Pyrexia, Syncope, Vomiting
Clinical narrative: Pt reported 102.5 F fever with Nausea/Vomiting/Diarrhea, syncope, sweating. Area around PNEUMOVAX injection site was reported blistered, swollen, and hot to the touch. The area around the flu shot had mild bruising.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Patient recieved both vaccines in left deltoid. Patient stated arm started to hurt and swell. Patient went to urgentcare 9/10, said arm felt better and swelling had went down. Patients arm had yellow bruising on lower part of left arm toward elbow, not by injection site. Patient had slight elbow swelling without coloration. Doctor gave patient prescription for Keflex 500mg 1 bid x10 days and Prednisone 20mg 1 twice daily for 5 days.
Age: 70.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Diabetic complication, Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: Patient developed red rash (not hives) sporadically located and below injection site. He states that the onset of rash occurred hours after the 2 vaccines. He felt like he had a fever but it did not appear to be cellulitis. I still referred him to be seen by a doctor just to be sure. Doctor believed that diabetes complicated the vaccine administration and caused him to react the way he did. Doctor prescribed cephalexin the following night after immunization. Patients arm cleared up.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient could not move arm and had swelling and warm the next day. After 2 days she could move the arm but was still swollen and painful. She went to er and was given Keflex for cellulitis.
Age: 26.0
Sex: M
Vaccine: TYP, YF
Symptoms: Abdominal discomfort, Blood electrolytes normal, Chills, Dysstasia, Electrocardiogram normal
Clinical narrative: I received both shots well, with the Yellow Fever vaccine hurting slightly more. Upon completion of dosage, I walked approximately 6 blocks back to my office building to get lunch (I had previously had breakfast, but no lunch). After 20 or so minutes I began to experience tunnel vision, headaches, and an upset stomach. I realized I needed to sit down so I made my way to the elevator bank and had difficulty standing. I placed my arm on the wall prior to passing out briefly (<5 min) before being woken by colleagues. I was able to sit up and drank a glass of water prior to a paramedic examined me for immediate issues. I began to sweat profusely and eventually developed chills. I was then taken to the ER where a number of tests were administered prior to discharge. Results were relatively normal (elevated wbc count, which is unusual for me). The doctors presumed it was the result of a syncope.
Age: 26.0
Sex: M
Vaccine: TYP, YF
Symptoms: Headache, Hyperhidrosis, Injection site pain, Syncope, Tunnel vision
Clinical narrative: I received both shots well, with the Yellow Fever vaccine hurting slightly more. Upon completion of dosage, I walked approximately 6 blocks back to my office building to get lunch (I had previously had breakfast, but no lunch). After 20 or so minutes I began to experience tunnel vision, headaches, and an upset stomach. I realized I needed to sit down so I made my way to the elevator bank and had difficulty standing. I placed my arm on the wall prior to passing out briefly (<5 min) before being woken by colleagues. I was able to sit up and drank a glass of water prior to a paramedic examined me for immediate issues. I began to sweat profusely and eventually developed chills. I was then taken to the ER where a number of tests were administered prior to discharge. Results were relatively normal (elevated wbc count, which is unusual for me). The doctors presumed it was the result of a syncope.
Age: 26.0
Sex: M
Vaccine: TYP, YF
Symptoms: White blood cell count increased
Clinical narrative: I received both shots well, with the Yellow Fever vaccine hurting slightly more. Upon completion of dosage, I walked approximately 6 blocks back to my office building to get lunch (I had previously had breakfast, but no lunch). After 20 or so minutes I began to experience tunnel vision, headaches, and an upset stomach. I realized I needed to sit down so I made my way to the elevator bank and had difficulty standing. I placed my arm on the wall prior to passing out briefly (<5 min) before being woken by colleagues. I was able to sit up and drank a glass of water prior to a paramedic examined me for immediate issues. I began to sweat profusely and eventually developed chills. I was then taken to the ER where a number of tests were administered prior to discharge. Results were relatively normal (elevated wbc count, which is unusual for me). The doctors presumed it was the result of a syncope.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bacterial infection, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient came in complaining that her arm looked red and swollen to her, she also stated that it felt warm to touch. She stated that she had received 2 vaccines on 9/10/2018. The FLUZONE HD and PNEUMOVAX 23 into Left arm. Advised patient to go see a provider at urgent care. Patient later on the day advised me she had went, and was provided KEFLEX 500 mg 1 TID with 21 caps. Patient will follow up with primary care provider.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Rash macular
Clinical narrative: SHINGRIX vaccine - red area about size of dollar bill at injection site in upper deltoid, irregular shape, described by patient as a "scald mark" or "blotch" and is "firm" to the touch, not painful or itchy, no fever.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Feeling cold
Clinical narrative: I received the second injection of SHINGRIX on Thursday August 20 at noon. I had no bad reaction from the first injection a couple of months age, but this time it was different. Around 8:00 pm, I started shivering as if it was very cold, and I had very loose diarrhea. I felt very tired so I went to bed. The shivering got worse and I couldn't warm up and I started to have muscle and joint pain from head to toe, and I had a fever of 100, and could not get any sleep.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Pyrexia
Clinical narrative: I received the second injection of SHINGRIX on Thursday August 20 at noon. I had no bad reaction from the first injection a couple of months age, but this time it was different. Around 8:00 pm, I started shivering as if it was very cold, and I had very loose diarrhea. I felt very tired so I went to bed. The shivering got worse and I couldn't warm up and I started to have muscle and joint pain from head to toe, and I had a fever of 100, and could not get any sleep.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Dizziness, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: I received PNEUMOVAX in my left deltoid and my seasonal flu vaccine in my right arm on the above day. The next morning my left arm was extremely sore, the right less so. The next morning I performed an aerobic and light weight lifting workout over an hour and a half. About 15 minutes prior to the conclusion of the workout I had an onset of dizziness which was quickly followed by severe myalgias and generalized joint pain. The left deltoid was swollen, acutely painful and firm. The joint symptoms rapidly progressed in severity and persisted for 2 full days, and a circular area of erythema approximately 4 inches wide developed on the left deltoid PNEUMOVAX injection site. The joint pains subsided by day 4, but the injection site on the left arm is still painful to touch and red on day 5. There was no fever.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Myalgia, Pain in extremity
Clinical narrative: I received PNEUMOVAX in my left deltoid and my seasonal flu vaccine in my right arm on the above day. The next morning my left arm was extremely sore, the right less so. The next morning I performed an aerobic and light weight lifting workout over an hour and a half. About 15 minutes prior to the conclusion of the workout I had an onset of dizziness which was quickly followed by severe myalgias and generalized joint pain. The left deltoid was swollen, acutely painful and firm. The joint symptoms rapidly progressed in severity and persisted for 2 full days, and a circular area of erythema approximately 4 inches wide developed on the left deltoid PNEUMOVAX injection site. The joint pains subsided by day 4, but the injection site on the left arm is still painful to touch and red on day 5. There was no fever.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia, Peripheral swelling, Skin warm
Clinical narrative: Within 4 hours of injection, upper arm muscle hurt to extent difficult to raise my arm. Spread down and around muscle and tissue in upper arm to elbow. Extreme swelling of upper arm. Very sore muscles. Pink skin. Extreme heat in upper arm. Took a full 7 days for all symptoms to disappear; swelling took longest to disappear.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose normal, Blood test normal, Computerised tomogram normal, Dizziness, Nuclear magnetic resonance imaging
Clinical narrative: About two weeks after receiving SHINGRIX I stood up and while getting out of bed I experienced excessive dizziness which reoccurred with less severity during the day. At 2 AM in the morning I went to the ER, and was diagnosed with vertigo. I mentioned receiving the shingles vaccine approximately two weeks prior to this event, and that account seemed to be discounted by the medical staff.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection, Vertigo
Clinical narrative: About two weeks after receiving SHINGRIX I stood up and while getting out of bed I experienced excessive dizziness which reoccurred with less severity during the day. At 2 AM in the morning I went to the ER, and was diagnosed with vertigo. I mentioned receiving the shingles vaccine approximately two weeks prior to this event, and that account seemed to be discounted by the medical staff.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Obtained the SHINGRIX vaccine and had severe reaction necessitating Urgent Care center visit for cortisone, anti nausea, fever and chills, and severe pain from head to base of spine...needed multiple injections. Was sick for 4 days after.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal pain
Clinical narrative: Obtained the SHINGRIX vaccine and had severe reaction necessitating Urgent Care center visit for cortisone, anti nausea, fever and chills, and severe pain from head to base of spine...needed multiple injections. Was sick for 4 days after.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Throat irritation
Clinical narrative: I had the flu shot and was not ill at all. The day afterward I began a cough which is unproductive, and is a tickling cough that is not able to be controlled. It's as if I was exposed to an airborne irritant. I may have had this reaction to the vaccine before in previous years; I do not remember. At this time I am not concerned but since the paperwork said this situation could happen I thought I would report it.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Seizure
Clinical narrative: Seizure less than 24 hours after GARDASIL shot. Happened in the shower. Fell to the floor.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy skin, Pruritus, Rash erythematous, Rash pruritic, Rash pustular
Clinical narrative: My daughter received the AFLURIA QUADRIVALENT, conservative free, one dose flu vaccine made by Seqirus in the morning of August 19 at a pharmacy. Early that same evening, she developed itchy red skin rash and began to develop itchy pustules on her skin. She went back to college last weekend and has been seen by a nurse practitioner in the student health center referred her to a dermatologist who did a biopsy of a pustule. The biopsy was currently undergoing DNA analyses. The skin problem is still ongoing and new pustules appear each day. Patient has had a flu vaccine every year since she was 2 years old and has never experience an adverse effect. My husband and I, each received a flu vaccine from the same pharmacy as patient this year, but we received the double dose FLUZONE vaccine from Sanofi because we are older than 65. We have not experienced an adverse effect.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Incorrect route of product administration, Peripheral swelling
Clinical narrative: Patient called pharmacy to inquire about adverse effects of 1st dose. She experienced severe swelling and redness of the right arm as well as fatigue for 2 weeks. It was discovered that her 1st dose was administered incorrectly. Pharmacist apologized to patient and called GSK to verify 1st dose would still be effective. GSK said per DCD guidelines, 1st dose still effective. GSK said IM is the only approved method of administration because it results in less adverse effects than SC. Pharmacist reported incident per company policies and is reporting to VAERS.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Redness and warmth of the upper arm where the vaccine was given, measuring 2 inches by 2.25 inches.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient reports rash, swelling, pain and itching at and around the injection site. The patient was given the PREVNAR 13 on 10-12-17 and should have been given the PNEUMOVAX on or after 10-12-18. There should have been a year between the 2 vaccines.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Asthenia, Injection site pain, Malaise, Pelvic pain, Red blood cell sedimentation rate increased
Clinical narrative: Pt had extremely sore shoulder (R) within 12 hours of injection on 8/1/18 at 8:30 AM. Gradually both shoulders became very achy with general malaise. Her pain has since traveled also to pelvic girdle, often extreme. Pt very debilitated.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site hypersensitivity
Clinical narrative: (R) upper arm cellulitis vs. allergic reaction. Pt took 50 mg BENADRYL 9/10/18 at 7pm and 9/11/18 at 11am. Rx BACTRIM to start 9/12/18 if symptoms worsen 800mg-160mg BID. Erythema line marked.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (R) upper arm cellulitis vs. allergic reaction. Pt took 50 mg BENADRYL 9/10/18 at 7pm and 9/11/18 at 11am. Rx BACTRIM to start 9/12/18 if symptoms worsen 800mg-160mg BID. Erythema line marked.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient received 1st SHINGRIX dose on 4/13/18. He said his arm was sore but otherwise minimal reaction. After receiving the 2nd dose of SHINGRIX on 7/29/18 the patient said his arm was very sore around the injection site and painful. He said he also had flu-like symptoms with aches and feverish feeling for about 3 days following the injection. He said he knew it wasn't the flu and was still able to go to work.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Vision blurred
Clinical narrative: Minutes after vaccination felt dizzy, vision got cloudy, and passed out into mom's arms. Awoke on the floor.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, HEP, IPV, MMR, TDAP
Symptoms: Crying, Fear, Feeling abnormal, Injection site pain, Loss of consciousness
Clinical narrative: After vaccinating she went into a state of rigid tonic with her eyes open then eventually lost consciousness. She was unable to attain full cognitive ability. Was told to take her to ER for evaluation or clinic would call 911. After admitted into ER bed, was given IV fluids, had low BP and was administered BENADRYL for Hives.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, HEP, IPV, MMR, TDAP
Symptoms: Muscle rigidity, Nausea, Pallor, Staring, Unresponsive to stimuli
Clinical narrative: After vaccinating she went into a state of rigid tonic with her eyes open then eventually lost consciousness. She was unable to attain full cognitive ability. Was told to take her to ER for evaluation or clinic would call 911. After admitted into ER bed, was given IV fluids, had low BP and was administered BENADRYL for Hives.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, HEP, IPV, MMR, TDAP
Symptoms: Cognitive disorder, Full blood count, Human chorionic gonadotropin, Hypertonia, Hypotension
Clinical narrative: After vaccinating she went into a state of rigid tonic with her eyes open then eventually lost consciousness. She was unable to attain full cognitive ability. Was told to take her to ER for evaluation or clinic would call 911. After admitted into ER bed, was given IV fluids, had low BP and was administered BENADRYL for Hives.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, HEP, IPV, MMR, TDAP
Symptoms: Liver function test, Loss of consciousness, Metabolic function test, Muscle rigidity, Urticaria
Clinical narrative: After vaccinating she went into a state of rigid tonic with her eyes open then eventually lost consciousness. She was unable to attain full cognitive ability. Was told to take her to ER for evaluation or clinic would call 911. After admitted into ER bed, was given IV fluids, had low BP and was administered BENADRYL for Hives.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Papilloedema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of optic nerve edema in a 72-year-old female patient who received SHINGRIX (batch number J4D5J, expiry date 16th August 2019) for prophylaxis. On 18th August 2018, the patient received SHINGRIX. On 4th September 2018, 17 days after receiving SHINGRIX, the patient experienced optic nerve edema (serious criteria GSK medically significant). On an unknown date, the outcome of the optic nerve edema was unknown. It was unknown if the reporter considered the optic nerve edema to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that after receiving SHINGRIX, the patient experienced swelling of the optic nerve diagnosed by her optometrist. The symptoms were started approximately 2 weeks after vaccination. The healthcare professional's system did not record expiration year if it was more than 1 year out.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS, FLU4, VARZOS
Symptoms: Gait disturbance, Polyuria, Pyrexia, Urinary incontinence
Clinical narrative: The day after vaccination, had what she states was a "neurological event" - could not walk forward without taking 2 steps backwards first, for most of the day. On the day after vaccination, also had urinary incontinence X 1 for the first time ever, fever of 101F, vomiting X 1 and nausea. Much better the next day. All symptoms resolved as of now, except that she is still having some nausea. Taking ZOFRAN PRN. Did not see her doctor, Is a retired ER nurse.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS, FLU4, VARZOS
Symptoms: Nausea, Nervous system disorder, Pyrexia, Urinary incontinence, Vomiting
Clinical narrative: The day after vaccination, had what she states was a "neurological event" - could not walk forward without taking 2 steps backwards first, for most of the day. On the day after vaccination, also had urinary incontinence X 1 for the first time ever, fever of 101F, vomiting X 1 and nausea. Much better the next day. All symptoms resolved as of now, except that she is still having some nausea. Taking ZOFRAN PRN. Did not see her doctor, Is a retired ER nurse.
Age: 52.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Erythema, Musculoskeletal disorder, Peripheral swelling, Skin warm
Clinical narrative: This is day 5 after vaccination and patient is, again, reporting redness near the injection site that is "hot to the touch" and pain in her arm. She said it is "painful to lift [her] arm", but said this is the exact same reaction she had to the first dose. She said the reaction started the evening of and has continued to this day. She said this reaction lasted for two weeks with the first dose. (This was already reported to VAERS.) She informed her prescriber, again, who said this is typical.
Age: 52.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Skin warm
Clinical narrative: This is day 5 after vaccination and patient is, again, reporting redness near the injection site that is "hot to the touch" and pain in her arm. She said it is "painful to lift [her] arm", but said this is the exact same reaction she had to the first dose. She said the reaction started the evening of and has continued to this day. She said this reaction lasted for two weeks with the first dose. (This was already reported to VAERS.) She informed her prescriber, again, who said this is typical.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Cough, Headache, Injection site rash, Pyrexia
Clinical narrative: Headache, coughing, fever, chills, rash at injection site.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Pain, Pain in extremity
Clinical narrative: Stomach ache, body ache, headache, sore arm.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Injection site swelling, Lacrimation increased, Sneezing
Clinical narrative: This spontaneous report was received from a nurse practitioner via field employee refers to a 4 year old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. The patient had no drug reactions/allergies. On an unknown date, the patient was vaccinated with first dose of M-M-R II (strength, dose, route of administration, lot # and expiry date were not reported) for routine vaccination. The patient had no apparent side effect with the prior dose. On approximately 02-AUG-2018 (reported as 'three weeks ago'), the patient was vaccinated with second dose (reported as 'possible 2nd injection in the series') of M-M-R II (strength, dose, route of administration, lot # and expiry date were not reported). On approximately 02-AUG-2018 (immediately as the dose was being administered), the patient experienced "sneezing repeatedly, his eyes started watering, and a large swelling appeared around the injection site". The clinician gave the patient BENADRYL and sent him to the hospital emergency room. The patient walked to the emergency room to sought medical attention. In the emergency room (ER), the patient received unspecified DECADRON. It was unknown if any lab diagnostics/studies were performed. The patient was not given any intervention to prevent serious criteria. When the clinician called the patient's home later that evening to check his condition, the patient's mother said the patient was "doing fine" and had fully recovered. On approximately 02-AUG-2018 (also reported as 'later that evening'), the outcome of sneezing, injection site swelling and lacrimation increased was recovered. Causality assessment was not reported. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent, historical conditions were not provided.Concomitant therapies included sterile diluent. On 27-JUL-2018 the patient was vaccinated a dose of Oka/Merck VARIVAX 0.5 mg once via intramuscular (incorrect route of drug administration) (lot number N035937, expiration date 18-DEC-2019). No adverse effects were reported. No further information was provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse (office manager) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-AUG-2018, the patient was vaccinated with improperly stored Oka-Merck PROQUAD (lot # R011803, Expiry date: 21-OCT-2019) 1 DF for prophylaxis. Concomitant therapies included MERCK STERILE DILUENT. It was reported that the vaccine experienced a temperature excursion of 6 degrees Fahrenheit up to 14 degrees Fahrenheit (5.5 degrees Fahrenheit) for 13 minutes and 30 seconds (incorrect product storage). There was previous temperature excursion of 6 degrees Fahrenheit up to 14 degrees Fahrenheit (8.6 degrees Fahrenheit) for 24 minutes. There were no adverse effects reported. There was no product quality complaint involved. It was reported that this call was reported due to a digital data logger.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 28-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot# reported as N032958 and expiration date 13-JUL-2020 or lot# N022583 and expiration date 20-JUN-2020 (strength, dose, dose number, site and route of administration were not reported). Administered doses of vaccine were exposed to the temperature excursion below 32 degrees Fahrenheit (29.1 degrees Fahrenheit) for 16 days and the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit (57.9 degrees Fahrenheit) for 15 hours. Data logger was involved. There was no previous temperature excursions. There was no adverse effects reported. This is one of two reports received from the same reporter. Lot number N032958 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).; Sender's Comments:  US-009507513-1809USA000336:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner and the patient's mother referring to a 13 years old female with none medical history, concomitant therapies and drug or allergy reactions. On 19-JAN-2018, the patient recieved the first dose of GARDASIL 9 (strength, dose, frequency, lot # and expiration date were not reported) intramuscularly for prophylaxis. On 22-AUG-2018, the patient recieved another dose of GARDASIL 9 (strength, dose, frequency were not reported) (lot number N032956, expiration date 13-JUL-2020) intramuscularly for prophylaxis. On 22-AUG-2018, an unspecified time after receiving the dose of GARDASIL 9, the patient developed "arm pain that radiated to the shoulder" and still persisted at the time of reported. There was no lab diagnostics, studies performed or treatment given. It was reported the therapy was not discontinued. Causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On 10-SEP-2018 the patient was vaccinated with Oka/Merck VARIVAX lot # N034556 for prophylaxis. Concomitant therapies included sterile diluent. On 10-SEP-2018, 1 day after onset of therapy the patient experienced product storage error. On an unknown date the patient experienced no adverse event.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 27-JUL-2018, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004440: US-009507513-1809USA004441: US-009507513-1809USA004442: US-009507513-1809USA004443: US-009507513-1809USA004444: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004448: US-009507513-1809USA004449.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 07-AUG-2018, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004441: US-009507513-1809USA004442: US-009507513-1809USA004443: US-009507513-1809USA004444: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004448: US-009507513-1809USA004449: US-009507513-1809USA004439.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 09-AUG-2018, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004439: US-009507513-1809USA004440: US-009507513-1809USA004442: US-009507513-1809USA004443: US-009507513-1809USA004444: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004448: US-009507513-1809USA004449.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 13-AUG-2018, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004439: US-009507513-1809USA004440: US-009507513-1809USA004441: US-009507513-1809USA004443: US-009507513-1809USA004444: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004448: US-009507513-1809USA004449.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 13-AUG-2018, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004439: US-009507513-1809USA004440: US-009507513-1809USA004441: US-009507513-1809USA004442: US-009507513-1809USA004444: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004448: US-009507513-1809USA004449.