chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Rash, Secretion discharge
Clinical narrative: A rash started on the front of my neck the next morning July 31st  after the injection. I had stinging pain, burning sensation and the bumps began draining that day causing the rash to spread on my neck .I returned back to state and I went to see my primary care provider today August 2, 2019. I received the medication Valacyclovir 1 GM and have started it tonight 08/02/2019.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Hypersensitivity, Urticaria
Clinical narrative: when I called patient to let them know they were due for their second dose, he said he had an allergic reaction from the first dose. He said about 24 hours after receiving the vaccine, he got a headache, broke out in hives and his joints become tender and sore. he said his symptoms last for 3-4 days
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site inflammation, Injection site pruritus
Clinical narrative: Patients left upper arm became inflamed and itchy on 7/31/19. Applied ice with good relief.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest discomfort, Chest pain, Dyspnoea, Nausea
Clinical narrative: Patient experience shortness of breath,  nausea, weakness, chest pain & pressure so patient went to emergency room
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Approximately 2-3 hours after vaccine experience, chest pains (previous MI), fever/chills, sweats, body aches
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm red & swollen from injection site to elbow noted on 8/1/19. Advil & Benadryl given @ 9:00pm 8/1/19. Redness & swelling gradually improving as of 2:30pm 8/2/19. using ice & Advil q6hrs.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, HIBV, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Body temperature increased, Crying, Mood altered, Rash
Clinical narrative: Temp for 4 days above 101.6, rash all over body starting at day 10 post shots, inconsolible crying, slapping at head, mood changes
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Tremor
Clinical narrative: Headache, weakness, lightheadedness, shaking chills
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood folate normal, Blood thyroid stimulating hormone normal, Electrophoresis normal, Hypoaesthesia, Nerve conduction studies abnormal
Clinical narrative: Shortly after second Shingrix dose I began to develop numbness in toes and feet, fingers and hands.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Vitamin B1, Vitamin B12 normal, Vitamin B6 normal
Clinical narrative: Shortly after second Shingrix dose I began to develop numbness in toes and feet, fingers and hands.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose normal, Chest X-ray normal, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: Initially and days after the injection, I had notable pain at the injection site (which I understand is typical of this vaccine).   About 12 hours after receiving the injection, I also experienced notable feelings of fever, nausea and restlessness.  The next two days I experienced significant fatigue with dizziness.  On 8/3/2019  I went to Urgent Care and was recommended to go to ER that same day.  At the ER I was given IV fluid and Meclazine.   No definitive diagnosis related to the Shingles injection was documented but there were no other circumstances  related to these symptoms.  I am convinced this was a reaction to this injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Injection site pain, Laboratory test normal, Nausea, Pyrexia
Clinical narrative: Initially and days after the injection, I had notable pain at the injection site (which I understand is typical of this vaccine).   About 12 hours after receiving the injection, I also experienced notable feelings of fever, nausea and restlessness.  The next two days I experienced significant fatigue with dizziness.  On 8/3/2019  I went to Urgent Care and was recommended to go to ER that same day.  At the ER I was given IV fluid and Meclazine.   No definitive diagnosis related to the Shingles injection was documented but there were no other circumstances  related to these symptoms.  I am convinced this was a reaction to this injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness, Urine analysis normal
Clinical narrative: Initially and days after the injection, I had notable pain at the injection site (which I understand is typical of this vaccine).   About 12 hours after receiving the injection, I also experienced notable feelings of fever, nausea and restlessness.  The next two days I experienced significant fatigue with dizziness.  On 8/3/2019  I went to Urgent Care and was recommended to go to ER that same day.  At the ER I was given IV fluid and Meclazine.   No definitive diagnosis related to the Shingles injection was documented but there were no other circumstances  related to these symptoms.  I am convinced this was a reaction to this injection.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: PATIENT EXPERIENCED A RASH
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Cold sweat, Feeling abnormal, Lethargy, Nausea
Clinical narrative: 8/2/2019 First time HPV vaccine was adminustered today, concurrent with TDAP (not a first time vaccine). Patient reported no reactions after administration. Was advised to stay in the store area for 15 minutes to be monitored. Patient was checked out at 9:44 AM.   Patient started walking towards the pharmacy with mother and other sibling. Then after about 2-3 minutes ( about 5 minutes after patient left the clinic, approximately 0949 AM), pharmacy called me and said that the patient was having a bad reaction to the vaccine.   Provider immediately went to assess patient, who was currently sitting down in front of the pharmacy. Pharmacist asked to call for EMS. Parent states patient complained she was not feeling good, suddenly felt queasy in the stomach, clammy and sat down. Patient alert oriented, but lethargic. No signs of respiratory distress, rash. Patient denied scratchy itchy throat, chest pain, shortness of breath, throat swelling.   @0949 Vital signs obtained:  Temp=98.7 F HR = 74 BP = 90/60 02 saturation 96%   @0954 EMS en route Patient maintained alertness, but still weak. States she is feeling better, assisted to go back to the clinic. Steady gait, denies any dizziness, and patient  continued to deny: scratchy itchy throat, chest pain, shortness of breath, throat swelling. Color is now normal. Assisted to the chair. Vital signs obtained: Temp= 97.1 F HR=71 BP=90/60 O2 saturation 98 %   @0958 EMS arrived Handed over care to EMS dispatch team Patient assessed Vital signs by EMS team: HR=88 O2 saturation 100% BP= 90/50   EMS team leader discussed options with mother. Mother refused patient to be transported to ER. Patient states she is feeling better now. Parent signed refusal to be transported.   EMS left. Patient assisted to vehicle. Mother states patient has not had anything to eat yet for breakfast and may have contributed to the reaction. Parent advised to seek emergency care as soon as possible if patient reports not feeling good again. Parent verbalized understanding of instructions.   @1255 PM Called up parent to follow up on patient. Parent reports that patient's arm is sore, but ate some food and drank fluids. Color is back to normal, not clammy anymore and denies any stomach pain/N/V/D after eating. Parent sates patient is feeling "okay".   Parent advised to seek emergency care as soon as possible if patient reports not feeling good again. Parent verbalized understanding of instructions.   8/3/2019 @0909 Courtesy follow up call. Unable to reach parent. Advised to seek higher level of care if any of patient's symptoms recur. Advised to call Patient support for any questions or concerns.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: 8/2/2019 First time HPV vaccine was adminustered today, concurrent with TDAP (not a first time vaccine). Patient reported no reactions after administration. Was advised to stay in the store area for 15 minutes to be monitored. Patient was checked out at 9:44 AM.   Patient started walking towards the pharmacy with mother and other sibling. Then after about 2-3 minutes ( about 5 minutes after patient left the clinic, approximately 0949 AM), pharmacy called me and said that the patient was having a bad reaction to the vaccine.   Provider immediately went to assess patient, who was currently sitting down in front of the pharmacy. Pharmacist asked to call for EMS. Parent states patient complained she was not feeling good, suddenly felt queasy in the stomach, clammy and sat down. Patient alert oriented, but lethargic. No signs of respiratory distress, rash. Patient denied scratchy itchy throat, chest pain, shortness of breath, throat swelling.   @0949 Vital signs obtained:  Temp=98.7 F HR = 74 BP = 90/60 02 saturation 96%   @0954 EMS en route Patient maintained alertness, but still weak. States she is feeling better, assisted to go back to the clinic. Steady gait, denies any dizziness, and patient  continued to deny: scratchy itchy throat, chest pain, shortness of breath, throat swelling. Color is now normal. Assisted to the chair. Vital signs obtained: Temp= 97.1 F HR=71 BP=90/60 O2 saturation 98 %   @0958 EMS arrived Handed over care to EMS dispatch team Patient assessed Vital signs by EMS team: HR=88 O2 saturation 100% BP= 90/50   EMS team leader discussed options with mother. Mother refused patient to be transported to ER. Patient states she is feeling better now. Parent signed refusal to be transported.   EMS left. Patient assisted to vehicle. Mother states patient has not had anything to eat yet for breakfast and may have contributed to the reaction. Parent advised to seek emergency care as soon as possible if patient reports not feeling good again. Parent verbalized understanding of instructions.   @1255 PM Called up parent to follow up on patient. Parent reports that patient's arm is sore, but ate some food and drank fluids. Color is back to normal, not clammy anymore and denies any stomach pain/N/V/D after eating. Parent sates patient is feeling "okay".   Parent advised to seek emergency care as soon as possible if patient reports not feeling good again. Parent verbalized understanding of instructions.   8/3/2019 @0909 Courtesy follow up call. Unable to reach parent. Advised to seek higher level of care if any of patient's symptoms recur. Advised to call Patient support for any questions or concerns.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nausea, Pain, Pyrexia, Vaccination complication
Clinical narrative: On 8/01/2019 patient came to pharmacy and talked to pharmacist about  redness  - not around  the injection site but on left arm at different area , pharmacist gave her recommendation to take Benadryl and keep eye on it, as it got severe for redness ,nausea and pain she went to see doctor on 08/02/2019, doctor told patient that it might be vaccine related or cellulitis , gave her rx for ranitidine, ibuprofen, zofran odt . She started to get fever and more swelling so she went to doctor again  on 8/3/2019 , doctor told patient that reaction is vaccine related , gave her keflex.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Approximately 8 hours following the 2nd dose of Shingrix Patient experienced chills, shivering and myalgia. These symptoms lasted approximately 8 hours and were relieved with APAP and IBUPROFEN.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Dysgeusia, Eyelid function disorder, Hypoaesthesia, Hypoaesthesia oral, Immediate post-injection reaction
Clinical narrative: Vaccine was given at another clinic - Clinic on 7/31/19  in the right deltoid per patient report and immediately felt a tingle in the right jaw and a metallic taste in her mouth.  Over the last 3 days has had numbness in the right jaw, tongue, and mouth, but today (8/3/19) start having numbness sensation moving up the right side of the face and having difficulty closing the right eyelids tightly.  No obvious facial asymmetry to the patient, but on exam there is right eyelid weakness and right corner of the mouth is asymmetric with smiling.  Treatment started prednisone 60 mg once daily x 7 days with planned follow-up with PCP 8/5/2019.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Paraesthesia
Clinical narrative: Vaccine was given at another clinic - Clinic on 7/31/19  in the right deltoid per patient report and immediately felt a tingle in the right jaw and a metallic taste in her mouth.  Over the last 3 days has had numbness in the right jaw, tongue, and mouth, but today (8/3/19) start having numbness sensation moving up the right side of the face and having difficulty closing the right eyelids tightly.  No obvious facial asymmetry to the patient, but on exam there is right eyelid weakness and right corner of the mouth is asymmetric with smiling.  Treatment started prednisone 60 mg once daily x 7 days with planned follow-up with PCP 8/5/2019.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Starting approximately 18 hours after the injection onset of low-grade fever (99-100s), malaise, dizziness, and generalized intense joint pain. For 72 hours after the injection a localized erythema, swelling, and pain at the injection site.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Starting approximately 18 hours after the injection onset of low-grade fever (99-100s), malaise, dizziness, and generalized intense joint pain. For 72 hours after the injection a localized erythema, swelling, and pain at the injection site.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Headache, Induration, Oropharyngeal pain, Pain
Clinical narrative: Severe swelling at the location of vaccine and surrounding area, redness, itchiness, hot to the touch, hard to the touch, pain, slight fever, drowsiness, slight sore throat and headache.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Skin warm, Somnolence, Vaccination site swelling
Clinical narrative: Severe swelling at the location of vaccine and surrounding area, redness, itchiness, hot to the touch, hard to the touch, pain, slight fever, drowsiness, slight sore throat and headache.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Neurological symptom, Nuclear magnetic resonance imaging abnormal, Vaccination complication
Clinical narrative: Patient states she had an onset of neurological issues exactly 3 weeks after vaccine. Onset of migraines that her MD decided was due to the vaccine. The patient received a MRI which noted neurological changes and was hospitalized.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site pain, Swelling
Clinical narrative: Patient stated she had significant bruising & swelling following vaccination.  She said it lasted about a month.  She did not seek medical attention and informed us of this reaction today when she was receiving her second dose.  She stated the person administering the vaccination seemed to have trouble getting the needle to go through the Inject-Safe Barrier Bandage we use so he removed that, then administered the vaccination.  She said the needle was painful entering her skin so possibly the needle was dulled from drawing up the solution.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: PT STATES THAT SHE HAS EXPERIENCED NAUSEA, FATIGUE, PAIN, SWELLING, AND REDNESS AT THE INJECTION SITE.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: PT STATES THAT SHE HAS EXPERIENCED NAUSEA, FATIGUE, PAIN, SWELLING, AND REDNESS AT THE INJECTION SITE.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypersensitivity, Myalgia, Nausea
Clinical narrative: muscle pain, a headache, shivering,  nausea
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Neck pain, Pain
Clinical narrative: pt called 8/3/19 to say super achy, feels like glands are swollen and neck is sore. Pt doesn't have a fever and is able to move neck side to side and can touch chin to chest.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Product administered at inappropriate site
Clinical narrative: patient's wife came into my store and told me her husband came in to get the shingrix vaccine and it was given too high up on his arm.  He had to go to the emergency room due to extreme shoulder pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, UNK
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin laceration
Clinical narrative: Extensive arm swelling/tightness/redness/heat to right upper arm from shoulder to elbow and extending to underside of arm. Skin tight to the point of splitting in a couple of linear lacerations. Notified her doctor accompanied by a picture and told to give her Benadryl. Was away from home that evening without her medication with me. Applied cool compress to area. Gave her Benadryl the following evening on 8/2/19 and again in the morning of 8/3/19. Swelling began to resolve.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, UNK
Symptoms: Skin tightness
Clinical narrative: Extensive arm swelling/tightness/redness/heat to right upper arm from shoulder to elbow and extending to underside of arm. Skin tight to the point of splitting in a couple of linear lacerations. Notified her doctor accompanied by a picture and told to give her Benadryl. Was away from home that evening without her medication with me. Applied cool compress to area. Gave her Benadryl the following evening on 8/2/19 and again in the morning of 8/3/19. Swelling began to resolve.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Headache, Nausea
Clinical narrative: nausea for two days now; inability to eat  or drink, mild head ache
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysstasia, Feeling abnormal, Hypophagia, Loss of personal independence in daily activities, Nausea
Clinical narrative: nausea for two days now; inability to eat  or drink, mild head ache
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Retching, Weight decreased
Clinical narrative: nausea for two days now; inability to eat  or drink, mild head ache
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphasia, Cognitive disorder, Headache, Reading disorder
Clinical narrative: The patient felt fine until approximately 7 hours after vaccine administration At that time he experience a rapid onset of headhace and lost of cognitive function. He describes his experience by stating he "could not understand what he was reading, he couldn't recall how to read even simple words, and couln't recall what simple objects like a mirror were called."  These syptoms remained for approximately 2 hours, then he took and Advil.  2 hours after the Advil, he states he returned to feeling normal with the exception of a headache.  He did not experience slurred speech or other symptoms of a stroke to the best of the patient's knowledge.  Upon awakening, he felt normal with the exception of the still present headache.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Skin laceration, Syncope
Clinical narrative: SYNCOPAL EPISODE. PATIENT FAINTED AFTER VACCINE AND FELL ON HIS FACE CAUSING LACERATION TO HIS NOSE. PT WAS TRANSFERRED TO ER VIA EMS FOR EVALUATION
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The right arm where my daughter received the unknown 2 of the 3 vaccines started to form a red lump and swell around 6:30pm, 4 hours after the vaccines were applied. After we got home around 5pm she went to lay down in her bed with immense pain on her right shoulder which was swelling and hot. She developed a small fever around 7:00pm and could not move or lightly touch the right arm without feeling immense pain. Around 8:00pm she developed a swelling and bruised feeling in her top right shoulder socket and right clavicle and side of the neck. It has been almost 48 hours and her right arm is still swollen. The fever and swelling clavicle has gone down but she still feels a bruised feeling in her clavicle.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: The right arm where my daughter received the unknown 2 of the 3 vaccines started to form a red lump and swell around 6:30pm, 4 hours after the vaccines were applied. After we got home around 5pm she went to lay down in her bed with immense pain on her right shoulder which was swelling and hot. She developed a small fever around 7:00pm and could not move or lightly touch the right arm without feeling immense pain. Around 8:00pm she developed a swelling and bruised feeling in her top right shoulder socket and right clavicle and side of the neck. It has been almost 48 hours and her right arm is still swollen. The fever and swelling clavicle has gone down but she still feels a bruised feeling in her clavicle.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Eye movement disorder
Clinical narrative: My sons left eye turned in within 1 week after receiving MMRV 2nd dose and hep A dose 2.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Headache, Hyperhidrosis, Influenza like illness, Middle insomnia
Clinical narrative: Woke up in middle of night after vaccination, feeling like she had the flu.  Patient had aches all over body.  Sweating.  Nausea  Pain in arm of vaccination was extreme and deep "like bone pain", pain radiated up to neck and therefore caused headache.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: Woke up in middle of night after vaccination, feeling like she had the flu.  Patient had aches all over body.  Sweating.  Nausea  Pain in arm of vaccination was extreme and deep "like bone pain", pain radiated up to neck and therefore caused headache.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Myalgia, Skin warm
Clinical narrative: redness, hot to touch,  muscle aches/pain
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: The Patient has bruising redness and swelling at the site, states arm is extremely sore and feels feverish. The area around the injection site is red and seems to feel hot to the touch
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: The Patient has bruising redness and swelling at the site, states arm is extremely sore and feels feverish. The area around the injection site is red and seems to feel hot to the touch
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Blister, Erythema, Induration, Local reaction
Clinical narrative: Pt notes s/p PNA vaccination (unsure of type), on Monday 7/29/19, on awakening Tues 7/30/19 local erythema and blister.  Increasing in area since. Nothing other than intermittent Tylenol, presents to UCC for evaluation on 8/3/19 with concern for allergic reaction.  All other systems neg. Left deltoid and upper arm with 11x16 cm area of erythema, induration and 1+ local edema. Central blistered area to 2x3cm area. Marked with skin marker, no streaking, no local lymph. 2+ radial pulses, distal perfusion and sensation intact. Skin otherwise c/d/i, no other areas of concern. good capillary refill in nail beds,no clubbing, cyanosis, or edema. Lung CTA no stridor, no drooling and GI WNL.  Tx allergic reaction: Benadryl, Medrol pk, Pepcid. Delayed Keflex for cellulitis coverage if worsening. To follow up with vaccinating provider Mon. ER care reviewed at length.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Lethargy, Pain
Clinical narrative: Patient reported fever, lethargy, aches, flu like symptoms, and presented to pharmacy with swollen red injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported fever, lethargy, aches, flu like symptoms, and presented to pharmacy with swollen red injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeding disorder, Intensive care, Unresponsive to stimuli
Clinical narrative: husband of patient came in last week saying that patient was okay after receiving vaccine but became unresponsive the next morning when they woke up.  couple days later, he came into pharmacy and told rph what had happened and said that patient was getting better. husband comes in again today and speaks to a different rph and says that wife is in hospital and was moved to icu today and unable to eat and was still unresponsive.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paralysis, Vaccination complication
Clinical narrative: husband of patient came in last week saying that patient was okay after receiving vaccine but became unresponsive the next morning when they woke up.  couple days later, he came into pharmacy and told rph what had happened and said that patient was getting better. husband comes in again today and speaks to a different rph and says that wife is in hospital and was moved to icu today and unable to eat and was still unresponsive.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Pain in extremity, Vomiting
Clinical narrative: Sore arm, headache for two days Vomiting for 4 days Diarrhea one week Second week, occasional diarrhea and tired Third week, occasional diarrhea and tired
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Feeling abnormal, Headache
Clinical narrative: I experienced terrible joint pain in my knees, hips and rib cage.  Felt like I had been beat up.  By 8PM on the 31 was shaking so hard with chills sat in truck with heater running full blast in 82 degree outside temp.  Profuse sweating followed through out the night along with waves of chills and nausea.  Dry heaved a few times.  Had nothing to eat for two days  Also a terrible headache accompanied this.  Daughter was going to call 911 at 1:30 AM on August 1 but didn't.  She found on site a reference to Tylenol and asked my Primary care id I could take it.  The answer came back it was ok to take.  This helped some.  Too until Friday 08/02 AM when reactions seemed to quit.  Nothing since.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Musculoskeletal chest pain, Nausea, Retching, Tremor
Clinical narrative: I experienced terrible joint pain in my knees, hips and rib cage.  Felt like I had been beat up.  By 8PM on the 31 was shaking so hard with chills sat in truck with heater running full blast in 82 degree outside temp.  Profuse sweating followed through out the night along with waves of chills and nausea.  Dry heaved a few times.  Had nothing to eat for two days  Also a terrible headache accompanied this.  Daughter was going to call 911 at 1:30 AM on August 1 but didn't.  She found on site a reference to Tylenol and asked my Primary care id I could take it.  The answer came back it was ok to take.  This helped some.  Too until Friday 08/02 AM when reactions seemed to quit.  Nothing since.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Patient has a reaction 3 inches lower than the injection site. It is a 3 inch diameter circle red welt, painful, and warm to the touch. Recommended patient monitor site and if it gets worse contact a doctor. It looks like a typical site reaction but it is lower than where the vaccine was injected.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Fever of 99.8F and associated flu-like symtoms.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Fear, Gait disturbance, Irritability, Mobility decreased, Myalgia
Clinical narrative: Started with extreme irritability and screaming. Would not move, walk, crawl etc for a day. Scared to be alone or sleep alone. Next few days he was slow to move and limping. Severe muscle pain. Lots of screaming and fussiness. Followed by high fever over 103 for 3 days.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Screaming
Clinical narrative: Started with extreme irritability and screaming. Would not move, walk, crawl etc for a day. Scared to be alone or sleep alone. Next few days he was slow to move and limping. Severe muscle pain. Lots of screaming and fussiness. Followed by high fever over 103 for 3 days.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: joint pain, right side of body
Age: 56.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood lactic acid, Bone pain, Chest X-ray
Clinical narrative: worst headache i have ever experienced, delirious, high fever, skin felt like it was on fire, every bone in my body hurt too much to move, nausea, indeterminate lower gut pain, couldn't walk, ringing in ears  patient received IV benedryl, carbamazine?, and motrin , day after taking on doloneurobien(sp?)  feels much better
Age: 56.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Culture urine, Delirium, Gait inability, Gastrointestinal pain, Headache
Clinical narrative: worst headache i have ever experienced, delirious, high fever, skin felt like it was on fire, every bone in my body hurt too much to move, nausea, indeterminate lower gut pain, couldn't walk, ringing in ears  patient received IV benedryl, carbamazine?, and motrin , day after taking on doloneurobien(sp?)  feels much better
Age: 56.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Lipase, Metabolic function test, Nausea, Pyrexia, Skin burning sensation
Clinical narrative: worst headache i have ever experienced, delirious, high fever, skin felt like it was on fire, every bone in my body hurt too much to move, nausea, indeterminate lower gut pain, couldn't walk, ringing in ears  patient received IV benedryl, carbamazine?, and motrin , day after taking on doloneurobien(sp?)  feels much better
Age: 56.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Tinnitus, Troponin T, Urine analysis
Clinical narrative: worst headache i have ever experienced, delirious, high fever, skin felt like it was on fire, every bone in my body hurt too much to move, nausea, indeterminate lower gut pain, couldn't walk, ringing in ears  patient received IV benedryl, carbamazine?, and motrin , day after taking on doloneurobien(sp?)  feels much better
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Pyrexia
Clinical narrative: First shot resulted in fever for 3 days with a maximum temperature of 103. Second shot on 7/24/2019 caused canker sores to erupt on tongue which resolved in 2 days.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: By 2pm L arm painfully sore to even lift. By 6pm started with joint pain- elbows, fingers, hips, ankles and h/a. During that night h/a and chills most of night. Next 24 hours had alternating chills with sweating, continued joint pain and h/a which resolved by morning of 8/4/19.  Arm pain at injection site continued for 4 days. Treatment was ibuprofen every 4 hours for about 36 hours.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: By 2pm L arm painfully sore to even lift. By 6pm started with joint pain- elbows, fingers, hips, ankles and h/a. During that night h/a and chills most of night. Next 24 hours had alternating chills with sweating, continued joint pain and h/a which resolved by morning of 8/4/19.  Arm pain at injection site continued for 4 days. Treatment was ibuprofen every 4 hours for about 36 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Vomiting
Clinical narrative: Very bad heacache and vomiting
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Disorientation, Dizziness, Fatigue
Clinical narrative: 12 hours after the vaccination my arm was really sore, and I experienced chills, fever, aches, dizziness, loss of balance. I slept for 20 out of 24 hours. Very fatiqued and disoriented
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Pain, Pain in extremity, Pyrexia
Clinical narrative: 12 hours after the vaccination my arm was really sore, and I experienced chills, fever, aches, dizziness, loss of balance. I slept for 20 out of 24 hours. Very fatiqued and disoriented
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: A lot of pain at injection site.  Redness beside injection site.  Swelling and itching underarm same side as shot.  Itching underarm- head - upper body.  Achy in upper body. Stomach pain. Extreme tiredness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pruritus
Clinical narrative: A lot of pain at injection site.  Redness beside injection site.  Swelling and itching underarm same side as shot.  Itching underarm- head - upper body.  Achy in upper body. Stomach pain. Extreme tiredness.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: Fever, shivering, significant fatigue, generalized muscle soreness, headache, GI discomfort -- limited all activity. Took acetaminophen and slept for 12 hours. Resolved about 16 hours after onset. Other than soreness at injection site, these events did not occur after the first immunization of Shingrix on 4/17/19
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, shivering, significant fatigue, generalized muscle soreness, headache, GI discomfort -- limited all activity. Took acetaminophen and slept for 12 hours. Resolved about 16 hours after onset. Other than soreness at injection site, these events did not occur after the first immunization of Shingrix on 4/17/19
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Fever 2 degrees above normal (normal =97.9); achiness, tenderness at injection site;
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Borrelia test, Facial paralysis
Clinical narrative: Felt Bell?s Palsy effects within four hours of vaccine and officially diagnosed within 24 hours of vaccine. Doctor prescribed prednisone and valacyclovir.  I?m in the second day of Bell?s Palsy treatment with no relief, but I?m wishing soon.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Patient called 8/4/19 to complain of redness, swelling, pain at the injection site, and lethargy beginning  8/2/19.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Patient's wife called today 8/4/19 to state that he experienced redness, swelling, pain at the injection site, and lethargy
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache
Clinical narrative: headache, fatigue, loss of appetite
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Patient reported redness and swelling on 8/3/19. Came back to pharmacy 8/4/19 and two more spots had appeared and they were warm to the touch. Recommended patient go to immediate care facility. Patient was diagnosed with cellulitis and prescribed caphalexin 500 mg twice daily for 10 days.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Paraesthesia, Peripheral swelling
Clinical narrative: swelling  and redness on underside of left arm and swelling of left hand also noted was tingling and numbness in the hand.
Age: 77.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Abdominal pain, Balance disorder, Pain in extremity
Clinical narrative: Sore Arm with pain, Patient felt abdominal pain , wobbling and un-steady
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Tired, achy all over within three hours of shot, soreness at injection location, fever of 100.6 within first 24 hours.
Age: 22.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arthralgia, Chills, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: - has had fever, chills,  nausea, headache, joint pain, arm pain, numbness of hands & feet; rash over chest , and some shortness of breath
Age: 22.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Nausea, Pain in extremity, Pyrexia, Rash
Clinical narrative: - has had fever, chills,  nausea, headache, joint pain, arm pain, numbness of hands & feet; rash over chest , and some shortness of breath
Age: 7.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain, Headache, Pyrexia, Rash morbilliform
Clinical narrative: Measles like rash. Fever and headaches and abdominal pain taking its course like 4 weeks after vaccination
Age: 64.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal discomfort, Chills
Clinical narrative: Upset stomach all day, then woke up physically shivering that night
Age: 25.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Pt called on 8/4/2019 and said that her left arm was tender to touch, red, and painful after the injection. She said that she tried NSAIDs and cold compress and her arm is still painful, and cannot move her left arm much. She is advised to talk to her physician on Monday.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Peripheral swelling, Pyrexia
Clinical narrative: patient experienced fever, chills and swollen arm from shoulder to elbow. These symptoms lasted about 1 week
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Hypersensitivity, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: patient experienced fever, chills and swollen arm from shoulder to elbow. These symptoms lasted about 1 week
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: patient experienced fever, chills and swollen arm from shoulder to elbow. These symptoms lasted about 1 week
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Heart rate irregular, Pain in extremity, Pyrexia
Clinical narrative: Irregular heartbeat.  Fever.  Diarrhea  Arm pain
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: had redness and swelling in my left small finger that lasted for 7 days. this occurred 2 days after receiving second shot.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection was painful and initially caused swelling and redness when received.  The following morning, the swelling was much worse, increased redness along with severe itching.  Two days after the injection, the swelling continued to get worse and the itching is severe even though I have been icing the area and taking Benedryl.  The size is the size of a baseball.  I will see Dr. tomorrow (Monday) and ask what additional treatment I need.   I did not have this reaction to the first injection - it was painful but no lasting redness, swelling or itching.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, HEPA, HPV9, MENB, MNQ
Symptoms: Dyspnoea, Swelling face
Clinical narrative: dyspnoea/shortness of breath; swelling face; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 794965) concerning a 16-year-old male patient. Information on the patient's medical history, concurrent illness, other medication and prior vaccinations was not reported. On 04-JAN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) second dose, intramuscularly in right arm (lot number: R024264, expiration date: 29-OCT-2019 00:00) for prophylaxis. On the same day, the patient received the other suspect vaccines included Meningococca L B (BEXSERO) second dose, intramuscularly in left arm (lot number: ABX657AA), Meningococca L Conjugate (MENACTRA) third dose, intramuscularly in right arm (lot number: U6153AA) and HEP A (HAVRIX) second dose, intramuscularly in left arm (lot number:279H2) for prophylaxis. On the same day, 4 hours after receiving the vaccines, the patient's face began to swell and had difficulty in breathing. The patient's parents took him to the emergency room (ER) and the patient was treated with a steroid and diphenhydramine (BENADRYL) and was sent home. The patient continued treatment with diphenhydramine (BENADRYL) for 3 days and according to his parents the swelling has come down and the patient no longer had issues with breathing. The reporter's causality assessment was not provided.  Follow up information has been received on 03-JUL-2019 from a health care professional. The patient was reported to be vaccinated at 16 year of age. The patient had no prescriptions, over the counter medications, any dietary supplements or herbal remedies being taken at the time of vaccination. The patient was not allergic to any medications or food or any other products. The patient did not have any chronic or long-standing health condition or any other illness at the time of vaccination and up to one month prior.  Follow up information has been received on 02-AUG-2019 from a health care professional. The patient details, reporter details and co-suspect details were updated.
Sex: U
Vaccine: MMRV, UNK, MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects reported; the patient received PROQUAD which was administered with expired DILUENT MRK INJ; This spontaneous report as received from a physician refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-JUN-2019, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD), lot # R017800, expiration date 19-DEC-2019, for prophylaxis (dose, frequency and route of administration were not reported). The vaccine was reconstituted with an expired sterile diluent (Merck, Sharp & Dohme) with lot # L028663 and expiration date 29-MAR-2018 (dose, frequency and route of administration were not provided). There were no adverse effects reported. The outcome of the events was unknown.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain, swelling, redness at injection site- still present 52 hours after injection Fever, headache, body aches, feeling tired and weak- Improved after 48 hours
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Pain, swelling, redness at injection site- still present 52 hours after injection Fever, headache, body aches, feeling tired and weak- Improved after 48 hours
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Impaired work ability
Clinical narrative: The night after patient received the Shingrix vaccine, at 2:00a.m. started to experienced increased body temperature( 38.5C), headache and weakness. Patient was taking ibuprofen for headache and fever with no good effect.Not able to sleep. During the day time, patient was feeling very weak and exhausted. Not having appetite at all . Wasn't able to come to work that day.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pyrexia
Clinical narrative: The night after patient received the Shingrix vaccine, at 2:00a.m. started to experienced increased body temperature( 38.5C), headache and weakness. Patient was taking ibuprofen for headache and fever with no good effect.Not able to sleep. During the day time, patient was feeling very weak and exhausted. Not having appetite at all . Wasn't able to come to work that day.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Crying, Insomnia, Pyrexia, Rash, Rash morbilliform
Clinical narrative: Started with a low grade fever (100.4) on 7/30. Fever subsided followed by a measles like rash over my son?s body. He is having trouble sleeping and cries inconsolably for hours which is not like him at all.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: I developed classic shingles eruption  approximately T5 dermatome over left thorax late yesterday PM exactly one week after immunization. (previously immunized w zostrix approx 7 years ago). Developing vesicles at time of report.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: A little achy and tired
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Pyrexia, Tremor
Clinical narrative: Starting 2 days after the vaccination, patient complains of chills, shakes, sweats, and fever lasting for 3.5 days.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Erythema, Headache, Rash erythematous, Tenderness
Clinical narrative: Patient in today for assessment. Noted a small area approximately 1/2 inch by 1/2 inch on posterior left arm. Area is slightly reddened with a small amount of old purple bruising noted. Patient reports area is no longer tender to touch. Also has a 5-6 unraised  red spots the size of a pencil eraser that she has been scratching. and has scratching the skin of the top of them . Patient reported that areas were never fluid filled. Patient reported that she has had some headaches post vaccine that have been relieved with ibuprofen but besides that she has not ran any fever or had any other problems. Advised patient to not scratch the areas anymore and to avoid contact with any immunocompromised individuals or unvaccinated small children
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Headache, fever (100) with chills, body aches, fatigue.  Felt a lot like I had the flu.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Headache, fever (100) with chills, body aches, fatigue.  Felt a lot like I had the flu.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt with reaction to vaccines given at Dr. office on 8/2. Pt was given Proquad in Left Arm and Kinrix in right arm vaccines on 8/2/2019 Mother noted redness to right deltoid yesterday 8/3/2019 with increased redness/swelling today, Warm to the touch. Pt mother stated that on Saturday it half dollar size. Mother used Benadryl and Ice and bu Sunday tripled in size went to urgent care. They gave Pt steroids  and Benadryl and today 8/5/19 spot has vaccine sight has doubled in size. Nurse for Dr. has contacted Pt mother this morning. Pt mother states that urgent care circled the site and it has doubled in size and she is on her way to Medical Center Emergency Room to have Pt seen.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Pyrexia
Clinical narrative: severe chills, fever 100.4, headache, extreme tiredness, arm red and warm about 4 inch patch
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: severe chills, fever 100.4, headache, extreme tiredness, arm red and warm about 4 inch patch
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Pruritus
Clinical narrative: ON DAY 1, PATIENT REPORTED HAVING AN ITCHY CHEST WITH NO RASH PRESENT. ON DAY 2, THE PATIENT REPORTED HAVING DIARRHEA, CHILLS AND SWEATS.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Area of redness  approximately 1 1/2" by 1 1/2" on LVLM with slight swelling, pain and warmth to touch. Advised to use cold compress and give Tylenol. By 8/2/2019 redness, swelling and warmth and pain was going down. As of 8/5/2019 area completely clear.