chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (previously had a ZOSTAVAX vaccination) and Infusion. On 23rd February 2019, the patient received SHINGRIX. On 24th February 2019, 1 days after receiving SHINGRIX, the patient experienced arm discomfort, headache, shivering and mobility decreased. On 5th March 2019, the patient experienced injection site pain, injection site warmth, injection site induration, injection site erythema and injection site rash. On an unknown date, the patient experienced pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site induration, injection site erythema, injection site rash, arm discomfort, headache, shivering and pain were recovered/resolved and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site induration, injection site erythema, injection site rash, arm discomfort, headache, shivering, pain and mobility decreased to be related to SHINGRIX. Additional information was provided as follows: The patient had an Magnetic resonances imaging and infusion the next day after the vaccination. The patient experienced discomfort in her left arm after receiving SHINGRIX. Ten days later she had redness and a rash at the injection site. The area was hot to the touch and felt hard. She was having recurring trouble raising her arm and it has lasted 4 to 5 days. While exercising her arm the patient felt better, but later in the day, the pain returned. She was applying a cold compress to the area and took TYLENOL yesterday and the pain resolved. Lab Comments: The patient had an MRI and IV the next day after the vaccination
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 26th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced blood pressure high. On an unknown date, the outcome of the blood pressure high was not recovered/not resolved. It was unknown if the reporter considered the blood pressure high to be related to SHINGRIX. Additional information was provided as follows: The patient received SHINGRIX in right arm. The reporter indicated that the patient experienced high blood pressure since receiving SHINGRIX vaccine on the morning. The same day she received the vaccine, she had her yearly physical and her blood pressure was 122 per74. This morning her blood pressure was 150 per 95. The reporter said that her blood pressure was 160 per 103 last week. He has a new blood pressure monitor and did not feel that there was any wrong with it. The reporter consented to follow up. The reporter unable to obtain additional information. This case linked with US2019057148, reported by same reporter. Lab Comments: lab test performed on unknown date.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female elderly exposed to SHINGRIX in utero. The parent received the product for prophylaxis. On 22nd March 2019, the mother received SHINGRIX. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The elderly was diagnosed with pain in arm. The elderly was treated with TYLENOL and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was provided as follows: The patient received SHINGRIX a week ago, she was still experiencing arm soreness at the time of reporting. She was applying ice and heat and took TYLENOL.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site warmth, Neck pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 51-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (Received 1st dose in October 2018, for tolerance refer case US2019GSK062395). Concomitant products included simvastatin. On 26th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 26th March 2019, 9 hrs after receiving SHINGRIX, the patient experienced injection site warmth, injection site erythema, pain in arm, general body pain, tremor, headache, neck pain and fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site warmth, injection site erythema, pain in arm, general body pain, tremor and fever were recovering/resolving and the outcome of the headache and neck pain were not recovered/not resolved. It was unknown if the reporter considered the injection site warmth, injection site erythema, pain in arm, general body pain, tremor, headache, neck pain and fever to be related to SHINGRIX. Additional details were reported as follows: The reporter consented to follow up. This case has been linked to case US2019GSK062395, reported by the same reporter for the same patient.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 51-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (Received 1st dose in October 2018, for tolerance refer case US2019GSK062395). Concomitant products included simvastatin. On 26th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 26th March 2019, 9 hrs after receiving SHINGRIX, the patient experienced injection site warmth, injection site erythema, pain in arm, general body pain, tremor, headache, neck pain and fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site warmth, injection site erythema, pain in arm, general body pain, tremor and fever were recovering/resolving and the outcome of the headache and neck pain were not recovered/not resolved. It was unknown if the reporter considered the injection site warmth, injection site erythema, pain in arm, general body pain, tremor, headache, neck pain and fever to be related to SHINGRIX. Additional details were reported as follows: The reporter consented to follow up. This case has been linked to case US2019GSK062395, reported by the same reporter for the same patient.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received SHINGRIX for prophylaxis. On 27th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX. Additional case details were provided as follows: This case was reported by the patient's daughter. The patient received first a dose of SHINGRIX vaccine, within 24 hours, the patient experienced redness and warmth about 2 inches in circumference at the site of injection. No further details were provided.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: chronic Right deltoid pain
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: severe pain from shoulder to Fingers, swelling of arm to Fingers Low grade fever loss of movement of arm & fingers pain in neck & shoulder *arm receiving therapy to regain full motion of arm
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: severe pain from shoulder to Fingers, swelling of arm to Fingers Low grade fever loss of movement of arm & fingers pain in neck & shoulder *arm receiving therapy to regain full motion of arm
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Cellulitis
Clinical narrative: Cellulitis of Right deltoid. KEFLEX ordered.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Nausea/malaise, extreme fatigue. Pain, swelling, fever at inj site. Fever/chills. All symptoms lasting 3 days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: Nausea/malaise, extreme fatigue. Pain, swelling, fever at inj site. Fever/chills. All symptoms lasting 3 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Polymerase chain reaction positive, Pyrexia, Rash, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Child developed chicken pox rash & fever that lasted 1 week.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Pediarix was administered orally instead of the correct way (intramuscular) patient observed for 1 hour and no adverse reactions were noted
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Rash
Clinical narrative: Patient didn't report any pain during vaccination. The next day, the patient had to have Gabapentin, Valacyclovir and a MEDROL DOSEPAK filled. The wife reported that the patient said he didn't feel very good yesterday evening. They didn't go to the doctor until the next day, when they said they saw a rash developing. The only thing different he said he did was get the SHINGRIX shot. The wife, having received the same vaccination on the same day didn't report any side effects.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: After receiving the vaccine, pt reported fever of 101 degrees Fahrenheit and major chills within hours of receiving the vaccine. The next morning, patient noticed a "rash" around the injection site. The "rash" consisted of redness that spread a little bit down the arm, but went away by the next day. All symptoms resolved within 48 hours of receiving vaccine.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal faeces, Autism spectrum disorder, Diarrhoea
Clinical narrative: Patient developed diarrhea 4 days after vaccine administration date.  Mom wanted this reported because he had the same reaction after his first MMR, then developed a regression in milestones. He has since been diagnosed with autism.   Stool is described as liquid and grainy.  He will have liquid stools every few weeks now for a while.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pyrexia, Urticaria
Clinical narrative: Extreme lethargy, 101 fever, hives all over torso and neck.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site eczema, Vaccination site dryness
Clinical narrative: Mother reports Hx. of eczema that generally is only on trunk. Mother reports 5 days after Hep A vaccine 2 dry patches adjacent to the vaccination site appeared. Subsequently the client has a 6inx4in area of eczema localized to the area around the Hep A vaccine on left thigh. Client continue to have eczema on trunk but now dealing with flare ups on the left thigh were the vaccine was given, even 4 months after the fact.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed rash around lower right ankle and calf. Rash diagnosed as shingles.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Night sweats, Pain in extremity, Pyrexia
Clinical narrative: next evening following vaccine, on January 27,  fever 101, chills, and nightsweat overnight. I was not sick, these were brief reactions to the Shingrix vaccine. On January 28, diarrhea once. My arm was so sore for 5 nights that I could not lay on it at all.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Date 03/21/2019 - Headache and extreme fatigue. So extreme that I had no strength at all. It was like my muscles had failed to exist. At about noon I slept for approx. an hour and when I woke up it was a lot better but did not totally feel right until around 6 pm on the same day.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Influenza like illness, Pain, Peripheral swelling, Skin warm
Clinical narrative: Pt reported to Clinic with concerns of possible reaction to PCV13 on 4/08/2019. Pt has redness and swelling in LT arm. Pt started to have flu like symptoms day after receiving vaccination. Pt states 4 April 2019 her arm started to get warm to touch, body aches , redness and swelling. Pt was using cortisone cream for sx with no improvement. Pt states her sx have improved but still has redness and swelling with some pain. Marked area of swelling in left arm informed pt if sx get worse return to Clinic or ED. Contacted Dr. to inform him of discussion and post care. Dr. agreed for pt to return in sx get worse.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Fatigue, Feeling abnormal, Gait inability
Clinical narrative: 3 hours after injection extreme fatigue. 15 hours after injection I was awaken by extreme pain in my left armpit (same arm as injection sight), injection sight severe pain, and severe flu like symptoms, chills, aches, headache, stiffness, muscle aches, out of it, could not think straight or process simple things and I probably should not have driven...these symptoms were so severe I had to get Ibuprofen ingested and lay back down before I could even get out of bed to cancel a plane ticket by phone. I could not even think or walk. I felt my left armpit and it was extremely painful and swollen (I have pictures) 4 hours after taking the Ibu and going back to bed I awoke and had same symptoms for the next 3 days but also nausea. Went to urgent care clinic 24 hours after injection and was negative on flu test. Went to my GP on Monday 72 post injection and he ordered an ultrasound of my armpit. Benign reactive lymph nodes. This took almost 3 weeks to resolve. In the days that followed I had tingling, numb feet, the ear ringing (still), and am wiped out by 6 pm almost daily. I am a high energy person in excellent health so this is disturbing issue. From onset to present is a high pitched, tin like ringing in my ears constantly.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Influenza like illness, Influenza virus test negative, Injection site pain
Clinical narrative: 3 hours after injection extreme fatigue. 15 hours after injection I was awaken by extreme pain in my left armpit (same arm as injection sight), injection sight severe pain, and severe flu like symptoms, chills, aches, headache, stiffness, muscle aches, out of it, could not think straight or process simple things and I probably should not have driven...these symptoms were so severe I had to get Ibuprofen ingested and lay back down before I could even get out of bed to cancel a plane ticket by phone. I could not even think or walk. I felt my left armpit and it was extremely painful and swollen (I have pictures) 4 hours after taking the Ibu and going back to bed I awoke and had same symptoms for the next 3 days but also nausea. Went to urgent care clinic 24 hours after injection and was negative on flu test. Went to my GP on Monday 72 post injection and he ordered an ultrasound of my armpit. Benign reactive lymph nodes. This took almost 3 weeks to resolve. In the days that followed I had tingling, numb feet, the ear ringing (still), and am wiped out by 6 pm almost daily. I am a high energy person in excellent health so this is disturbing issue. From onset to present is a high pitched, tin like ringing in my ears constantly.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Mental impairment, Musculoskeletal stiffness, Myalgia, Nausea, Oedema peripheral
Clinical narrative: 3 hours after injection extreme fatigue. 15 hours after injection I was awaken by extreme pain in my left armpit (same arm as injection sight), injection sight severe pain, and severe flu like symptoms, chills, aches, headache, stiffness, muscle aches, out of it, could not think straight or process simple things and I probably should not have driven...these symptoms were so severe I had to get Ibuprofen ingested and lay back down before I could even get out of bed to cancel a plane ticket by phone. I could not even think or walk. I felt my left armpit and it was extremely painful and swollen (I have pictures) 4 hours after taking the Ibu and going back to bed I awoke and had same symptoms for the next 3 days but also nausea. Went to urgent care clinic 24 hours after injection and was negative on flu test. Went to my GP on Monday 72 post injection and he ordered an ultrasound of my armpit. Benign reactive lymph nodes. This took almost 3 weeks to resolve. In the days that followed I had tingling, numb feet, the ear ringing (still), and am wiped out by 6 pm almost daily. I am a high energy person in excellent health so this is disturbing issue. From onset to present is a high pitched, tin like ringing in my ears constantly.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Tinnitus, Ultrasound scan normal
Clinical narrative: 3 hours after injection extreme fatigue. 15 hours after injection I was awaken by extreme pain in my left armpit (same arm as injection sight), injection sight severe pain, and severe flu like symptoms, chills, aches, headache, stiffness, muscle aches, out of it, could not think straight or process simple things and I probably should not have driven...these symptoms were so severe I had to get Ibuprofen ingested and lay back down before I could even get out of bed to cancel a plane ticket by phone. I could not even think or walk. I felt my left armpit and it was extremely painful and swollen (I have pictures) 4 hours after taking the Ibu and going back to bed I awoke and had same symptoms for the next 3 days but also nausea. Went to urgent care clinic 24 hours after injection and was negative on flu test. Went to my GP on Monday 72 post injection and he ordered an ultrasound of my armpit. Benign reactive lymph nodes. This took almost 3 weeks to resolve. In the days that followed I had tingling, numb feet, the ear ringing (still), and am wiped out by 6 pm almost daily. I am a high energy person in excellent health so this is disturbing issue. From onset to present is a high pitched, tin like ringing in my ears constantly.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Aches, chills, redness, itching, and swelling at injection site. Redness went almost all the way around arm. Bigger than softball size. As of today, still looks blue and purple, size of baseball. Still itches
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Aches, chills, redness, itching, and swelling at injection site. Redness went almost all the way around arm. Bigger than softball size. As of today, still looks blue and purple, size of baseball. Still itches
Age: 29.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: redness, warmth, knot at site of injection
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: The patient was given an IM injection of SHINGRIX (NDC: 58160-0823-11, Lot: N72HZ, ED: 06/09/2021). The evening after the immunization the patient reports she started experiencing Atrial Fib. This continued off and on for the following three days. The patient also reported she recognized the Atrial Fib. because she experienced the feeling before.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, sore arm at injection site. Patient went to doctor's office who start to monitor it, but simple injection site reaction.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt. received SHINGRIX on 3/22/19 IMRA; pt developed red rash with itching over weekend-Pt reported reaction to pharmacy on Monday 3/25/1 - pt took BENADRYL over weekend - This was the 2nd dose; there was no reaction like this after 1st dose SHINGRIX photos included.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effect reported; The patient was inadvertently administered VARIVAX and PROQUAD; This spontaneous report has been received from a license practical nurse regarding to a patient of unknown age and gender. Patient's concurrent condition, medical history, concomitant medication and drug allergies or reaction were not provided.   On 28-MAR-2019, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), lot # R013563  and expiration date 13-MAY-2020, and a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) Lot # R024020 and expiration date 19-FEB-2020 (also reported as 19-FEB-2019) (overdose); both vaccines were  reconstituted with a properly stored diluent  and were administered for prophylaxis (dose, route of administration and anatomical location of vaccines were not reported). No adverse effect was reported.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Feeling abnormal, Flushing, Injection site reaction, Insomnia
Clinical narrative: Normal arm soreness about hr. later - worsened at day advanced. Unable to Lift arm - Sl. Temp. 99 but felt flushed, shakey, dizzy as evening progressed. Felt miserable & not able to sleep. Noticed several welts on Left upper arm Anterior and Toward chest. No breathing problems etc. Went to Dr. (clinic) and saw available Doctor. No treatment (Just Reporting).
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Tremor, Urticaria
Clinical narrative: Normal arm soreness about hr. later - worsened at day advanced. Unable to Lift arm - Sl. Temp. 99 but felt flushed, shakey, dizzy as evening progressed. Felt miserable & not able to sleep. Noticed several welts on Left upper arm Anterior and Toward chest. No breathing problems etc. Went to Dr. (clinic) and saw available Doctor. No treatment (Just Reporting).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Pain
Clinical narrative: Approx around 9:00pm on 3/21/19 same day I took vaccine, I started to feel tired, weak, developed a weird headache. I began to get chills, skin got itchy and began to get red bumps on upper part of my body, especially on my arms and hands. Was tired for at least 2-3 days afterwards. Approx 4th day started to feel pain usually feel when I get shingles. Went to Dr.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Approx around 9:00pm on 3/21/19 same day I took vaccine, I started to feel tired, weak, developed a weird headache. I began to get chills, skin got itchy and began to get red bumps on upper part of my body, especially on my arms and hands. Was tired for at least 2-3 days afterwards. Approx 4th day started to feel pain usually feel when I get shingles. Went to Dr.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Severe generalized pruritis alleviated by 900mg Gabapentin & prescriptions of topical corticosteroid preparations.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Chest pain, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Pain severe as when I broke a  bone - hurt from back of shoulder to sternum and could not lift my arm P.S hurt like hell
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: I experienced intense shivering, aching, and headache, and I developed a fever which got as high as 101.3. It was a miserable experience. The symptoms were better by the morning of 04/07/2019, although milder symptoms continued for an additional day. I really feel that people should be on notice as to just how severe the symptoms may be so that they can evaluate (1) whether to have the vaccine, and, if so, (2) when to have it. Also, are there any precautions that could help prevent serious side effects such as consistent dosing with acetaminophen or ibuprofen prior to and following the vaccination? Also, the information about long-term benefit from the vaccine is unclear. The CDC website provides statistics for the 4 year period following vaccination. What is known about longer term benefits?
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: Patient requested IM injection into left buttock since she had a double Mastectomy and prefers injections in other muscle than her upper arm.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hypoaesthesia, Malaise, Nausea, Pain
Clinical narrative: Right arm sore, achy and nausious.  Woke up with pain down right arm, numbness, tingling, headache. Gen feeling of "being sick". Red dot like rash arms, back, trunk, down to groin.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia, Rash, Rash erythematous
Clinical narrative: Right arm sore, achy and nausious.  Woke up with pain down right arm, numbness, tingling, headache. Gen feeling of "being sick". Red dot like rash arms, back, trunk, down to groin.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Injected limb mobility decreased, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Severe sudden pain and swelling in upper left arm starting at injection site. Cannot move left arm due to pain. Now 3 days after injection and still cannot bend arm at elbow more than 30 deg. Seen in ED and evaluated by orthopedic surgeon who said there is nothing wrong with the shoulder  joint. But because of pain, patient cannot use arm for activities of daily living, including combing hair, driving, or lifting arm to do any other things.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate increased, White blood cell count normal, X-ray limb
Clinical narrative: Severe sudden pain and swelling in upper left arm starting at injection site. Cannot move left arm due to pain. Now 3 days after injection and still cannot bend arm at elbow more than 30 deg. Seen in ED and evaluated by orthopedic surgeon who said there is nothing wrong with the shoulder  joint. But because of pain, patient cannot use arm for activities of daily living, including combing hair, driving, or lifting arm to do any other things.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site discolouration, Injection site swelling, Injection site vesicles
Clinical narrative: Per RN: Mother of child reports anterior & posterior swelling in upper left arm from shoulder to elbow that began 04/04/2019. Swelling persisted, along with purple discoloration and blister formation on upper arm of child. Child taken to minor care center 04/06/2019, pm & prescribed antibiotics for symptoms.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site reaction, Neuralgia
Clinical narrative: Patient is complaining about nerve pain in deltoid area of right arm.  States never had reactions to prior flu shots. Paperwork indicate shot was given in left arm.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Malaise, Nausea, Pain
Clinical narrative: About 12 hours after the injection (around 10:30 PM Friday 3/39) I had chills for 3 hours, plus fever, aches, pains, nausea, headache, general malaise until  approximately 6 PM Saturday 3/30.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: About 12 hours after the injection (around 10:30 PM Friday 3/39) I had chills for 3 hours, plus fever, aches, pains, nausea, headache, general malaise until  approximately 6 PM Saturday 3/30.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient DX with shingles from ER. Given VALTREX 1000mg TID. Patient says whole left leg involved. Patient has shingles rash.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gastrointestinal pain, Headache, Lethargy
Clinical narrative: Intestinal cramps, chills, lethargy, headache lasting 24 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Foreign body sensation in eyes
Clinical narrative: Pt states she woke up Saturday, 2 days later, and her right eye hurt and was stinging, felt like something was in her eye. She called her eye doctor monday and he advised her that it was very unlikely due to the vaccination.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Headache
Clinical narrative: Pt reported at 6pm he started to feel shaky, chills, joint aches, tired and a headache which all lasted about 24 hours. Also patient reports a 6" diameter circle of redness which is still present today 4/18 10am.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Pt reported at 6pm he started to feel shaky, chills, joint aches, tired and a headache which all lasted about 24 hours. Also patient reports a 6" diameter circle of redness which is still present today 4/18 10am.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Headache, Heart rate increased
Clinical narrative: Total body muscle and joint aching pain, fever 101.5, nausea, headache and back of neck pain, rapid heart rate, dizziness, weakness. Started about three hours after being administered. The worst of symptoms lasted approximately a day and a half. Was not completely recovered until almost three days later. I did not seek medical help and chose to self monitor.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Neck pain, Pyrexia
Clinical narrative: Total body muscle and joint aching pain, fever 101.5, nausea, headache and back of neck pain, rapid heart rate, dizziness, weakness. Started about three hours after being administered. The worst of symptoms lasted approximately a day and a half. Was not completely recovered until almost three days later. I did not seek medical help and chose to self monitor.
Age: 38.0
Sex: F
Vaccine: SMALL
Symptoms: Alopecia, Extra dose administered
Clinical narrative: PT STATES SHE REMEMBERS HAVING A LITTLE HAIR LOSS WITH HER FIRST SMALLPOX VACCINATION IN NOV 2003, BUT IT RESOLVED PRETTY QUICKLY.  THIS LAST TIME SHE GOT ON 31 MAY 2018 AND STATES SHE HAD A LOT OF HAIR LOSS, WITH NO RESOLUTION.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Persistent left upper arm pain X 2 months.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face, Swelling of eyelid
Clinical narrative: Pt had her BP 150/109, HR 102, her forehead got swollen, baggy water under eyes. She got treated with EPIPEN, BENADRYL, Steroid at ER on Saturday at approx. 8:30PM and sent home. Her condition got worse the next morning Sunday 03/31/2019, she returned to ER again.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Blood test, Eye swelling, Heart rate increased, Swelling
Clinical narrative: Pt had her BP 150/109, HR 102, her forehead got swollen, baggy water under eyes. She got treated with EPIPEN, BENADRYL, Steroid at ER on Saturday at approx. 8:30PM and sent home. Her condition got worse the next morning Sunday 03/31/2019, she returned to ER again.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: Pt had her BP 150/109, HR 102, her forehead got swollen, baggy water under eyes. She got treated with EPIPEN, BENADRYL, Steroid at ER on Saturday at approx. 8:30PM and sent home. Her condition got worse the next morning Sunday 03/31/2019, she returned to ER again.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented to the pharmacy 4/8/2019, stating that shortly after receiving vaccination, has soreness and itching at the injection site. The injection site is also swollen, hard and warm to the touch. Patient denies fever, vomiting, or diarrhea. Does state that experienced fatigue within the first 36 hours post vaccination. Patient has full mobility of affected arm, is able to raise and rotate her arm around without hindrance. The swollen area is getting progressively softer.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient presented to the pharmacy 4/8/2019, stating that shortly after receiving vaccination, has soreness and itching at the injection site. The injection site is also swollen, hard and warm to the touch. Patient denies fever, vomiting, or diarrhea. Does state that experienced fatigue within the first 36 hours post vaccination. Patient has full mobility of affected arm, is able to raise and rotate her arm around without hindrance. The swollen area is getting progressively softer.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Pt received TRUMENBA in right deltoid on 04/03/19. The next morning, patient's mother called the clinic and reported that the previous night pt's shoulder was red, "splotchy", and hot extending slightly onto his shoulder. She gave him BENADRYL, MOTRIN, and used cold pack to area and symptoms lessened. The next morning area had improved greatly. When area assessed in clinic approx. 24 hours after injection, there was a red area that was warm to the touch approximately the size of a golf ball. Pt denied trouble breathing, itchy throat, or throat swelling at any time.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Raised rash on both arms near crease of arm where elbow bends and also on chest. Earlier in day he had a fever.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: Pain at injection site, muscle soreness, and tiredness. Put me down for a day and a half.
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Chills, prolonged exhaustion, sore arm
Age: 3.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Malaise, Pyrexia, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: 10 days after vaccine child developed malaise, fever and a maculopapular red rash that started on head spreading to trunk and extremities
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT DESCRIBES "OUTBREAK OF SHINGLES STARTED 3 TO 4 DAYS AFTER VACCINATION, OUTBREAK OCCURRED ONLY INSIDE MOUTH".
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gingival blister, Gingival erythema, Gingival pain, Noninfective gingivitis, Rash pustular
Clinical narrative: PATIENT DESCRIBES "OUTBREAK OF SHINGLES STARTED 3 TO 4 DAYS AFTER VACCINATION, OUTBREAK OCCURRED ONLY INSIDE MOUTH".
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased, Injection site rash, Pyrexia
Clinical narrative: Fever for three days, 99-100. Large rash on upper left arm. Headache, rapid pulse for one day.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Mobility decreased, Pain, Pyrexia
Clinical narrative: The next day patient got very sick, the area below the shot has terrible pain, fever. Up to this moment it is very hard to lift. 1st shot is fine but 2nd shot is not.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Diarrhoea, Eye swelling, Nausea, Throat irritation
Clinical narrative: 4/6/19-nausea, vomiting (about 15-20 times), diarrhea 4/7/19-swelling in the right eye starting in the am, diarrhea (given Benadryl for swelling before bed). 4/8/19-swelling in both eyes (given Benadryl at 1:15pm), hives that cover entire body, cough, itchy throat starting around 7pm. (Given Benadryl at 7:30pm). Diarrhea.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria, Vomiting
Clinical narrative: 4/6/19-nausea, vomiting (about 15-20 times), diarrhea 4/7/19-swelling in the right eye starting in the am, diarrhea (given Benadryl for swelling before bed). 4/8/19-swelling in both eyes (given Benadryl at 1:15pm), hives that cover entire body, cough, itchy throat starting around 7pm. (Given Benadryl at 7:30pm). Diarrhea.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt developed pain at injection site on day 1. Then developed redness and itching 2 day after injection. The itching became diffuse and pt noted redness at sites of itching (ie -legs). The itching is improving and is mostly at the injection site. On exam right deltoid area has 4-5 inch diameter area of mild, confluent erythema with palpable warmth and minimal tenderness. Recommended that pt take BENADRYL QHS to help with symptoms. Will refer to allergy/immunology given concern for type 4 hypersensitivity reaction and to help identify which vaccine component caused the reaction.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Erythema multiforme, Injection site pain, Pruritus, Urticaria
Clinical narrative: 70 year old M reported skin erythema, worsening and painful around injection site on 01/19/19 after receiving SHINGRIX shot 01/18/19. Patient was advised to go to local ER due to being 100 miles away from facility. Patient went to ER on 1/20/19 in which no interventions were documented upon discharge from ER the same day. Erythema Multiforme, Urticaria Pruritus.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Pt had got SHINGRIX on 3/6/19, after about 10 days, he had few rash on his body, but after a month he was covered all over his body with rash and he called and I told him to go to Dr and she gave him Prednisone for 5 day course.
Age: 1.5
Sex: M
Vaccine: FLU4, HEPA, MMRV, PNC13
Symptoms: Body temperature increased, Feeling hot, Hypotonia, Tremor
Clinical narrative: Pt seen 4-1-19 w/cough/wheeze.  Diagnosed w/BOM Rx Augmentin -Given Immz at 11AM. Aprox 9PM -Hot, fully body shaking/limp. Pt seen ED w/101 temp.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Myalgia
Clinical narrative: Left side of face became numb continuously for 24 hours then off and on for a few days. Muscle aches for several days.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Lymphadenopathy
Clinical narrative: Pt. Reported an enlarged lymph node in axilla of (L) arm. Same side vaccine was given. Lasted approx. 2 days.
Age: 0.83
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Mother reported he had a fever at 2am on 2-12-19 with a seizure that lasted 4-5 min.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red, Itchy patch ~ 4" diameter (R) deltoid where MMRV was given
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tenderness of left lower limb 2 days post admin.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Contusion, Rash, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bruising in a 67-year-old female patient who received SHINGRIX (batch number N72HZ, expiry date 9th June 2021) for prophylaxis. On 28th March 2019, the patient received SHINGRIX (intramuscular). On 30th March 2019, 2 days after receiving SHINGRIX, the patient experienced bruising. On an unknown date, the outcome of the bruising was recovering/resolving. It was unknown if the reporter considered the bruising to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported that the patient got SHINGRIX vaccine and noticed bruising under her arm, that started as dots. The bruising spread into a rope-like appearance underneath her arm and on Monday (1st April 2019), it spread down onto her torso and onto her breast. The bruising was not on the top side of the injection site but it was on the same side. The bruising had not spread any on the day of reporting and looked like it was getting better.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bruising in a 67-year-old female patient who received SHINGRIX (batch number N72HZ, expiry date 9th June 2021) for prophylaxis. On 28th March 2019, the patient received SHINGRIX (intramuscular). On 30th March 2019, 2 days after receiving SHINGRIX, the patient experienced bruising. On an unknown date, the outcome of the bruising was recovering/resolving. It was unknown if the reporter considered the bruising to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported that the patient got SHINGRIX vaccine and noticed bruising under her arm, that started as dots. The bruising spread into a rope-like appearance underneath her arm and on Monday (1st April 2019), it spread down onto her torso and onto her breast. The bruising was not on the top side of the injection site but it was on the same side. The bruising had not spread any on the day of reporting and looked like it was getting better.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypertension
Clinical narrative: Precipitous rise in blood pressure headache.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Blood thyroid stimulating hormone, Brain natriuretic peptide, Headache, Metabolic function test
Clinical narrative: Precipitous rise in blood pressure headache.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Migraine, Neck mass, Neck pain
Clinical narrative: 8/10 pain in her left deltoid area, lump in her neck, neck pain on right, migraine headache after injection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Rash
Clinical narrative: Patient experienced rash on elbow of the same arm of vaccination the day after vaccination & then 2 days after noticed a "pimple"-like bump on her right wrist. The rash went away. The bump is not itchy, blistery or painful. Patient requested for reporting to be completed, but reassured it is not severe.
Age: 0.5
Sex: F
Vaccine: HIBV, IPV, RV5
Symptoms: Choking, Crying, Emotional distress, Screaming
Clinical narrative: My baby girl SCREAMED her lil head off for well over and hour in a half..she was inconsolable..She  also appears to be choking on her saliva .Like she is inhaling it or something. Didn't take a bottle or breast..Alsoher cry sounds completely diffrent.Almost like it's a comoletly diffrent child..I can't sleep because I'm so afraid my lil girl will choke on her saliva and drowned.. Or possibly stop breathing
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Bursa injury, Hypoaesthesia, Immediate post-injection reaction, Impaired work ability
Clinical narrative: Immediately after being give flu shot in upper left arm experienced pain which continually worsened.  The following day I was unable to lift my left arm, contacted my PMC at the hospital who instructed me to give the issue time to resolve treat with ice. Thursday and Friday taken off work. Contacted PMC Monday left message if not better by the end of the week she would schedule an x-ray. X-ray ordered along with PT. X-ray showed no broken bones, PT unable to schedule until mid-Nov. 11/22/17 PT unable to lift arm heat applied no relief. Limited duty work required as I was not able to climb ladders or lift arm. 10/31/18 apt w/PMC, able to lift arm with assistance however still extremely painful -level 5+ debilitating at times. MRI ordered scheduled for 1/16/18. 12/1/18 PT heat applied, moved arm with assistance causing extreme pain. 1/16 MRI completed showing .6cm bursal sided tear. PMC ordered cortisone shot, lab determined inappropriate without continual PT -PCM order topical which provided no relief. 1/17/18 EMI ordered to determine cause of numbness in left hand middle, ring and little fingers persistent before shot. Continued topical w/ice until 02/02/18 seen by Orthopedic given a Cortisone with order of continue PT w/ heat & ice. Relief that evening until 7/6/18 received second Cortisone injection w/ suggesting of PRP injection scheduled for 12/5/18. 9/26/18 tore right bicep tendon received first right arm Cortisone shot. December both shoulders causing extreme pain scheduled surgery for right shoulder along with PRP injection in left arm for 1/25/19. Pain in left arm continues at level 1-2 since PRP however movement of shoulder produces a noticeable clicking and continual use will increase pain. Comments wrt block 21:  I was seen by my PCM 3 times, Orthopedics 4 times, MRI & x-ray.  Urgent care clinic for two injections. Required to take several days off along with continual issues with shoulder.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Joint injection, Joint noise, Musculoskeletal pain
Clinical narrative: Immediately after being give flu shot in upper left arm experienced pain which continually worsened.  The following day I was unable to lift my left arm, contacted my PMC at the hospital who instructed me to give the issue time to resolve treat with ice. Thursday and Friday taken off work. Contacted PMC Monday left message if not better by the end of the week she would schedule an x-ray. X-ray ordered along with PT. X-ray showed no broken bones, PT unable to schedule until mid-Nov. 11/22/17 PT unable to lift arm heat applied no relief. Limited duty work required as I was not able to climb ladders or lift arm. 10/31/18 apt w/PMC, able to lift arm with assistance however still extremely painful -level 5+ debilitating at times. MRI ordered scheduled for 1/16/18. 12/1/18 PT heat applied, moved arm with assistance causing extreme pain. 1/16 MRI completed showing .6cm bursal sided tear. PMC ordered cortisone shot, lab determined inappropriate without continual PT -PCM order topical which provided no relief. 1/17/18 EMI ordered to determine cause of numbness in left hand middle, ring and little fingers persistent before shot. Continued topical w/ice until 02/02/18 seen by Orthopedic given a Cortisone with order of continue PT w/ heat & ice. Relief that evening until 7/6/18 received second Cortisone injection w/ suggesting of PRP injection scheduled for 12/5/18. 9/26/18 tore right bicep tendon received first right arm Cortisone shot. December both shoulders causing extreme pain scheduled surgery for right shoulder along with PRP injection in left arm for 1/25/19. Pain in left arm continues at level 1-2 since PRP however movement of shoulder produces a noticeable clicking and continual use will increase pain. Comments wrt block 21:  I was seen by my PCM 3 times, Orthopedics 4 times, MRI & x-ray.  Urgent care clinic for two injections. Required to take several days off along with continual issues with shoulder.