chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Hyperacusis, Neck pain, Pain in extremity, Photophobia
Clinical narrative: 8pm on july 22 patient began with severe headache dizziness lightheadedness and neck and back pain she also had severe pain in her left arm. Around 10pm she started running a fever of 103.5 we gave motrin and this did bring the fever down to 101.8 for about an hour then back up again. She was shaking, had chills very bad and had gotten to the point that we had to carry her back and forth to use the bathroom because she was unable to walk on her own from the dizziness, shaking and headache. The following morning symptoms continued and she remained in bed curled up in a ball all day as light and sound became unbearable as well.,she couldn't bare to even be out in the living room around either. She was unable to eat and continued with symptoms until around 2am on 7/25/2019 when her fever finally broke and she has since remained fever free. She continued over the next few days from the 25th with mild dizziness, headache and neck and back pain.  All symptoms I talked to the Doctors about but they fall under the Normal reactions as i saw on the sheet that came home after vaccines and on the cdc sight. But my daughter was unable to live any life during this time and that is not normal to me
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Tremor
Clinical narrative: 8pm on july 22 patient began with severe headache dizziness lightheadedness and neck and back pain she also had severe pain in her left arm. Around 10pm she started running a fever of 103.5 we gave motrin and this did bring the fever down to 101.8 for about an hour then back up again. She was shaking, had chills very bad and had gotten to the point that we had to carry her back and forth to use the bathroom because she was unable to walk on her own from the dizziness, shaking and headache. The following morning symptoms continued and she remained in bed curled up in a ball all day as light and sound became unbearable as well.,she couldn't bare to even be out in the living room around either. She was unable to eat and continued with symptoms until around 2am on 7/25/2019 when her fever finally broke and she has since remained fever free. She continued over the next few days from the 25th with mild dizziness, headache and neck and back pain.  All symptoms I talked to the Doctors about but they fall under the Normal reactions as i saw on the sheet that came home after vaccines and on the cdc sight. But my daughter was unable to live any life during this time and that is not normal to me
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash erythematous, Vaccination site pain, Vaccination site reaction
Clinical narrative: Low grade fever (99) small red rash in 2 different spots slightly below where vaccine was administered. Red/rash is painful to the touch
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: adolescent patient was administered adult formulation of Vaqta, need to know what to do next; adolescent patient was administered adult formulation of Vaqta, need to know what to do next; This spontaneous report was received from a office manager and refers to an adolescent patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. The patient was administered adult formulation of hepatitis a vaccine, inactivated (VAQTA) (inappropriate formulation of drug administered), (inappropriate dose of drug administered).
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: chills; fever; aches; This case was reported by a consumer via call center representative and described the occurrence of chills in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever and pain. On an unknown date, the outcome of the chills, fever and pain were unknown.   It was unknown if the reporter considered the chills, fever and pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however the patient's age group could be elderly. The patient received Shingrix and experienced chills, fever and aches.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling hot, Injection site pain, Myalgia
Clinical narrative: sore arm; fatigue; mild muscle aches; Felt faint/ dizzy; hot; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue and muscle pain. On 24th July 2019, the patient experienced felt faint and feeling hot. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the fatigue, muscle pain, felt faint and feeling hot were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fatigue, muscle pain, felt faint and feeling hot to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced soreness at the injection site. Next day, she felt faint, dizzy and hot, She had to sit down in a chair under a fan and the symptoms resolved after 10 minutes. The reporter consented for follow up. This case has been linked with the case US2019134725, reported for patient's wife.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot, Injection site pain
Clinical narrative: sore arm; felt faint/dizzy; Feeling hot; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 24th July 2019, the patient experienced felt faint and feeling hot. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the felt faint and feeling hot were recovered/resolved.   It was unknown if the reporter considered the injection site pain, felt faint and feeling hot to be related to Shingrix.  Additional details were provided as follows: The reporter is husband of the patient. The patient received Shingrix and experienced soreness at the injection site. Next day, she felt faint, dizzy and hot, She had to sit down in a chair under a fan and the symptoms resolved after 10 minutes. The reporter consented for follow up. This case has been linked with US2019134723, for same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: THE PATIENT IS COMPLAINING THAT HER ARM IS STILL HURTING
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Erythema, Fatigue, Feeling abnormal, Headache
Clinical narrative: very sore arm (redness, swelling, heat, pain--couldn't sleep on L side).  Fatigue.  Soreness in neck/shoulder on L side.  Achiness.  Headache.  Balance affected adversely.  "Stupid" feeling.  Completely resolved in 72 hours.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Neck pain, Pain, Pain in extremity
Clinical narrative: very sore arm (redness, swelling, heat, pain--couldn't sleep on L side).  Fatigue.  Soreness in neck/shoulder on L side.  Achiness.  Headache.  Balance affected adversely.  "Stupid" feeling.  Completely resolved in 72 hours.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: very sore arm (redness, swelling, heat, pain--couldn't sleep on L side).  Fatigue.  Soreness in neck/shoulder on L side.  Achiness.  Headache.  Balance affected adversely.  "Stupid" feeling.  Completely resolved in 72 hours.
Age: 19.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Seizure
Clinical narrative: Seizure, patient was laid on exam table, fan placed in room, provider notified, parent was called. Provider stayed with patient, symptoms lasted 30-45 seconds. patient was observed for 15 minutes.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted after 5 minutes of HPV given.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: In March 2019 I developed shingles on my left face, ear, throat, gums, and tongue (possible Ramsay Hunt Syndrome). Treated with valacylovar, prednisone, gabapentin, lidocaine. Rash disappeared within two weeks or so. I still suffer from PHN.
Age: 18.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Erythema, Injection site reaction, Papule, Polymerase chain reaction positive, Post vaccination autoinoculation
Clinical narrative: 18 yo healthy male who received SPV #1 (lot# VV03019C) on 26 JUN 2019 in addition to Typhoid #1. Our office was contacted by provider due to concern for autoinoculation with lesions at his axilla, nares (L), bridge of nose, Left ear and left thigh. He developed an initial lesion at initial R deltoid vaccine site (normal): 01 JUL 2019. He states this was above the inoculation site and he thought it was a normal acne pustule so he "popped" it.  He noted a  2nd site (R Axilla) on 04 JUL, 3rd Site  at the bridge of his nose, which he also popped on 04 JUL 2019. This site became large and ulcerated by 06 JUL 19. A 4th site  to his L nare  appeared also 06 JUL 19. A 5th site of an erythematous tender papule appeared 07 JUL 17  and a 6th site to his L medial thigh appeared 07 JUL.
Age: 18.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Skin lesion, Skin ulcer, Tenderness
Clinical narrative: 18 yo healthy male who received SPV #1 (lot# VV03019C) on 26 JUN 2019 in addition to Typhoid #1. Our office was contacted by provider due to concern for autoinoculation with lesions at his axilla, nares (L), bridge of nose, Left ear and left thigh. He developed an initial lesion at initial R deltoid vaccine site (normal): 01 JUL 2019. He states this was above the inoculation site and he thought it was a normal acne pustule so he "popped" it.  He noted a  2nd site (R Axilla) on 04 JUL, 3rd Site  at the bridge of his nose, which he also popped on 04 JUL 2019. This site became large and ulcerated by 06 JUL 19. A 4th site  to his L nare  appeared also 06 JUL 19. A 5th site of an erythematous tender papule appeared 07 JUL 17  and a 6th site to his L medial thigh appeared 07 JUL.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema
Clinical narrative: Local erythema 7.5 cm vertically 4.5 cm horizontally. No fluctuance, no color Recommended ibuprofen and ice
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: 1sT Shingrix vaccination 2/5/19. Terrible reaction. every part of my Body HuRT. CONFINeD to BED. Lasted 24 houRS. Arm soreness too.   2nd Shingrix vaccination 5/14/19. WOrse reaction Than after 1st oNe. 4" Band of Bright reD around injection site, all around ARM. ExTreme aches, extreme FATigue For weeks.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Headache, Pyrexia, Rash
Clinical narrative: We noticed a rash on his face, neck, chest and back 9 days after vaccination. He had a low grade fever, headache and was tired. The next day the rash spread to upper arms then upper legs. Day 12 after vacc. symptoms began to fade.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Pain
Clinical narrative: wife reports that patient experienced chills, pain (body aches), sweats, & fatigue for 3-4 days
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, Shoulder injury related to vaccine administration, X-ray limb
Clinical narrative: SIRVA: severe Left shoulder pain experienced <24 hours after injection that has not resolved to present day. Completed Ortho evaluation x 2 visits, cortisone injection x 2 - refractory to treatment. MRI completed. FU with Dr. diagnosed me with SIRVA from influenza vaccination.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Chills, Dry mouth, Headache
Clinical narrative: I got my shot at about 1000 hrs 7/30/19 and went to bed at 2130 hrs. About 45 minutes later, my joint started aching, I started shivering and my head started splitting. I got up to empty my bladder every 45 to 60 minutes. I also have a dry mouth and sinuses. Got no sleep at all.  At 0400 hrs this morning may temperature was 102.2. At 1234 hrs, my temperature is 101.8, I still have the aches, headache and emptying my bladder every hour.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Paranasal sinus hyposecretion, Pollakiuria
Clinical narrative: I got my shot at about 1000 hrs 7/30/19 and went to bed at 2130 hrs. About 45 minutes later, my joint started aching, I started shivering and my head started splitting. I got up to empty my bladder every 45 to 60 minutes. I also have a dry mouth and sinuses. Got no sleep at all.  At 0400 hrs this morning may temperature was 102.2. At 1234 hrs, my temperature is 101.8, I still have the aches, headache and emptying my bladder every hour.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Fatigue, Pyrexia, Rash, Seizure like phenomena, Sudden onset of sleep
Clinical narrative: Fever of 102 for 6 days straight had to give motrin/ tylonol every 6 hours and only brought it down 1 degree. Very weary during that time. When her fever was 102 she would tense up and start almost convulsing like, as well as just unexpectedly fall asleep in my arms. It's now been almost two days without fever and she has a bad rash on stomach and back.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Tension
Clinical narrative: Fever of 102 for 6 days straight had to give motrin/ tylonol every 6 hours and only brought it down 1 degree. Very weary during that time. When her fever was 102 she would tense up and start almost convulsing like, as well as just unexpectedly fall asleep in my arms. It's now been almost two days without fever and she has a bad rash on stomach and back.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Red small raised dots with rash on neck, chest, lower back, and inside of elbow. Forehead is bright red and itchy. Injection site is warm to the touch, red, swollen, and feels like a bump is present. Symptoms began on 7/31/19 upon awakening
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Red small raised dots with rash on neck, chest, lower back, and inside of elbow. Forehead is bright red and itchy. Injection site is warm to the touch, red, swollen, and feels like a bump is present. Symptoms began on 7/31/19 upon awakening
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: PATIENT CALLED PHARMACY ON 7/31/19 AROUND 1:20 PM, STATED THAT HE STILL HAD SOME SORENESS AT THE SITE OF INJECTION.  HE ALSO STATED THAT HE NOTICED  (2) SMALL DIME SIZED RASH ON STOMACH AND BACK THAT HAD SMALL DOTS, PT DID NOT MENTION ANY PAIN WITH THE RASH, DID NOT SEEM TO BOTHER HIM, HE WAS CONCERNED THAT THEY SHOWED AFTER THE VACCINATION. AND WAS CONCERNED ABOUT SECOND DOSE.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Contusion
Clinical narrative: pt reports extensive bruising still evident on 7/31/19, but states it appears to be getting better. no swelling, pain, redness, or other adverse effects reported.
Sex: U
Vaccine: MMRV, UNK, MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported.; administered with expired DILUENT MRK JNJ; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. 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 (dose and route of administration were not reported) which was administered with expired sterile diluent (Merck Sharp & Dohme) lot# L028663, expiration date: 29-MAR-2018 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: redness; Itch; This case was reported by a consumer and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix 6 days ago and still had redness 2 inch by 4 inches. No pain but it did itch.  The pharmacist asked if it was common and the side effect information did list as side effect but did not say how long it should last. The reporter asked should they be concerned. The reporter asked could the patient use over the counter Benadryl or Cortizone for itching.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: not adverse effects; improperly stored VARIVAX; This spontaneous report was received from a registered nurse prescriber concerning patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions/allergies or concomitant medications.  On 13-JUL-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 1 dose, lot number R029517 with expiration date on 14-OCT-2020 (exact dose, and route of administration were not reported) for prophylaxis (Incorrect product storage).  Administered doses of vaccine experienced temperature excursion between 15 degrees Fahrenheit (F) up to 46 F (32 F) for 3.5 hours and between 6 F up to 14 F (14 F) for 1.5 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adver se effects were reported; The patient inadvertently administered a dose of VARIVAX and a dose of PROQUAD at the same time.; This spontaneous report was received from a pharmacy student regarding a 12 month patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.   On 29-JUL-2019, the patient was vaccinated inadvertently (overdose) with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R030604, expiration date 23-OCT-2020, and a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number S002498, expiration date 23-JUL-2020  both vaccines for prophylaxis (strength, dosage, frequency and route of administration were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: felt fatigue; aches; This case was reported by a nurse via sales rep and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue and pain. On an unknown date, the outcome of the fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the fatigue and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was unable to recall the details other than female patient who felt fatigue, aches for two days. The reporter agreed to follow up from GlaxoSmithKline (GSK).
Sex: M
Vaccine: DTAPIPV
Symptoms: Anaphylactic reaction, Rubber sensitivity
Clinical narrative: anaphylactic reaction; Latex allergy; This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a child male patient who received DTPa-IPV (Kinrix) (batch number AC20B204AA, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, unknown after receiving Kinrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and latex allergy. On an unknown date, the outcome of the anaphylactic reaction and latex allergy were unknown.   It was unknown if the reporter considered the anaphylactic reaction and latex allergy to be related to Kinrix.  Additional information was provided as follows: The age at vaccination was not reported, however the patient's age could be 4 or 5 years old. The patient received Kinrix in 2013 and experienced anaphylactic shock. The patient had since been diagnosed with latex allergy. The reporter did not have expiration date of Kinrix. The reporter consented for follow up.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age
Clinical narrative: shingles outbreak; inappropriate age at vaccine administration; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 47-year-old male patient who received Herpes zoster (Shingrix) (batch number 7M2KB, expiry date 30th March 2020) for prophylaxis.   The patient's past medical history included shingles (had a prior history of shingles before dose 1 was administered).   On 14th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th May 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. The patient received dose of Shingrix at the age of 47 years, which led to inappropriate age at vaccine administration. Couple of days after vaccination, the patient experienced shingles outbreak, and at the time of this report it was persisting. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Fever (~101F)/chills, drowsy, "in a fog." Upon inspection by pharmacist, redness, swelling, warmth, slightly larger in size than a baseball and about 4 inches below injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Somnolence
Clinical narrative: Fever (~101F)/chills, drowsy, "in a fog." Upon inspection by pharmacist, redness, swelling, warmth, slightly larger in size than a baseball and about 4 inches below injection site.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt states that he is still having arm pain since the injection.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Brief syncope immediately after receiving vaccine; less than 1 min
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Asthenia, Blood pressure increased, Chills, Dizziness, Headache
Clinical narrative: SUDDEN ONSET LOW GRADE FEVER (99.3), MALAISE, WEAKNESS, MUSCLE ACHES, DIZZINESS, THROBBING SENSATION IN RIGHT SIDE, HEADACHE, INCREASED BLOOD PRESSURE, PULSE AND RESPIRATION, CHILLS
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Heart rate increased, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: SUDDEN ONSET LOW GRADE FEVER (99.3), MALAISE, WEAKNESS, MUSCLE ACHES, DIZZINESS, THROBBING SENSATION IN RIGHT SIDE, HEADACHE, INCREASED BLOOD PRESSURE, PULSE AND RESPIRATION, CHILLS
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Respiratory rate increased
Clinical narrative: SUDDEN ONSET LOW GRADE FEVER (99.3), MALAISE, WEAKNESS, MUSCLE ACHES, DIZZINESS, THROBBING SENSATION IN RIGHT SIDE, HEADACHE, INCREASED BLOOD PRESSURE, PULSE AND RESPIRATION, CHILLS
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema
Clinical narrative: Less than 5 minutes after receiving IZ, pt noticed a redness on his left arm at injection site.  Erythema was a round are of 2 cm,  No swelling.  25 mg of diphenhydramine given and ice applied.  Moc advised to continue with ice and Benadryl OTC as directed on label.  RTC here or to ER if symptoms become more concerning or worsen
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Dizziness, Headache, Pyrexia, Tachycardia
Clinical narrative: LOW GRADE FEVER (99.1), TACHYCARDIA, DIZZINESS, HEADACHE, CHILLS, SHAKY, TENSE FEELING
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Tension, Tremor
Clinical narrative: LOW GRADE FEVER (99.1), TACHYCARDIA, DIZZINESS, HEADACHE, CHILLS, SHAKY, TENSE FEELING
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Balance disorder, Crying, Drug screen negative, Headache, Muscular weakness
Clinical narrative: My daughter woke up with temperature of 102.6, crying in pain from severe headache, said legs felt very weak and felt they couldn't support her body. She was inconsolable from the headache pain and crying non-stop. Complained of nausea and her throat felt a little sore. I administered two ibuprofen and drove her to walk-in clinic. She was able to walk but felt unsteady. Her temperature came down to 100.8 from the ibuprofen. The NP administered Strep and Urine screen, both returned negative. She reviewed CDC info. regarding vaccine reactions, as well as called the administering pharmacy. She noted concern for possible Guillain-Barré syndrome. Released her and directed to follow up with Primary Care Physician.  Fever continued through day, she remained in bed, I gave her Tylenol for discomfort and fever. Woke up next morning fever-free and feeling much better.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, Streptococcus test negative, Urine analysis normal
Clinical narrative: My daughter woke up with temperature of 102.6, crying in pain from severe headache, said legs felt very weak and felt they couldn't support her body. She was inconsolable from the headache pain and crying non-stop. Complained of nausea and her throat felt a little sore. I administered two ibuprofen and drove her to walk-in clinic. She was able to walk but felt unsteady. Her temperature came down to 100.8 from the ibuprofen. The NP administered Strep and Urine screen, both returned negative. She reviewed CDC info. regarding vaccine reactions, as well as called the administering pharmacy. She noted concern for possible Guillain-Barré syndrome. Released her and directed to follow up with Primary Care Physician.  Fever continued through day, she remained in bed, I gave her Tylenol for discomfort and fever. Woke up next morning fever-free and feeling much better.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Upon arriving home the day of injection, patient noticed pain, redness, swelling and hot to the touch. She applied a cold pack to area.  The next day, swelling and redness had spread. Patient went to minute clinic on Wed. July 31. Area measured 15x9cm. Area very red and swollen and still hot to the touch. Patient advised to take Raniditine 300mg and Benadryl 25mg by MD.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness immediately; fever (100.3 F), headache
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash
Clinical narrative: Day after shot: Patient had flu-like symptoms Day 2: Rash on the left side of body (same side of administration site). No reports of pain, no difficulty breathing, no swelling, no fever. After 1 week: rash spread. Called us on 7/30/2019: Advised patient to take Benadryl and monitor.  At follow up with patient, no signs of improvement after 2 doses of Benadryl at night and no improvement of symptoms in the morning.  Then, advised patient to see his primary care physician for evaluation.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash
Clinical narrative: FATIGUE AND RASH AT INJECTION SITE. VACCINE RECIVED ON 071919. FOLLOWED BY THE ADVERSE EVENTS WHICH OCCURRED FROM 072019-072319. SAME SYMPTOMS REAPPEARED ON 073019.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; that were improperly stored./ excursion occurred; This spontaneous report was received from a vaccine coordinator regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 21-JUL-2019, the patients were vaccinated with improperly doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error) for prophylaxis, lot number N022727, expiration date 12-JUN-2020 (strength, dosage, frequency, and route of administration was not reported). No adverse effects reported.   The administered dose of vaccine experienced the temperature excursion on 25-AUG-2018 with 30 Celsius for 3 hours. Data logger was involved. There were no previous excursions reported.  This is one of four reports, received from the same reporter.; Sender's Comments:  US-009507513-1907USA016724: US-009507513-1907USA016723: US-009507513-1907USA016725:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; that were improperly stored./ excursion ocurred; This spontaneous non-valid report was received from a vaccine coordinator regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On unknown date, the patient was vaccinated with improperly doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error) for prophylaxis, lot number N022727, expiration date 12-JUN-2020 (strength, dosage, frequency, and route of administration was not reported). No adverse effects reported.   The administered dose of vaccine experienced the temperature excursion on an unknown date with 30 Celsius for 3 hours. Data logger was involved. There were no previous excursions reported.  Follow up information has been received from the reporter, on 29-JUL-2019.   There was an identifiable patient who on 30-MAR-2019 and on 09-JUN-2019, the patient was vaccinated with improperly doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error). On 25-AUG-2018, the administered vaccine experienced the temperature excursion.    This is one of four reports, received from the same reporter.; Sender's Comments:  US-009507513-1907USA015535: US-009507513-1907USA016724: US-009507513-1907USA016725:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; that were improperly stored./ excursion occurred; This spontaneous non-valid report was received from a vaccine coordinator regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On an unknown date, the patients were vaccinated with improperly doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error) for prophylaxis, lot number N022727, expiration date 12-JUN-2020 (strength, dosage, frequency, and route of administration was not reported). No adverse effects reported.   The administered dose of vaccine experienced the temperature excursion on 25-AUG-2018 with 30 Celsius for 3 hours. Data logger was involved. There were no previous excursions reported.  Follow up information has been received from the reporter, on 29-JUL-2019.   There was an identifiable patient who on 21-JUL-2019, was vaccinated with improperly dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error). On 25-AUG-2018, the administered vaccine experienced the temperature excursion.    This is one of four reports, received from the same reporter.; Sender's Comments:  US-009507513-1907USA015535: US-009507513-1907USA016723: US-009507513-1907USA016725:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; that were improperly stored./ excursion occurred; This spontaneous report was received from a vaccine coordinator regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 21-JUL-2019, the patients were vaccinated with improperly doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error) for prophylaxis, lot number N022727, expiration date 12-JUN-2020 (strength, dosage, frequency, and route of administration was not reported). However, no adverse effects reported.   The administered dose of vaccine experienced the temperature excursion on 25-AUG-2018 with 30 Celsius for 3 hours. Data logger was involved. There were no previous excursions reported.  This is one of four reports, received from the same reporter.; Sender's Comments:  US-009507513-1907USA015535: US-009507513-1907USA016724: US-009507513-1907USA016723:
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Flu-like symptoms; Redness; Swelling; Tired; body ache; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2019, the patient received Shingrix. On 19th May 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, injection site erythema, injection site swelling, fatigue and generalized aching. On an unknown date, the outcome of the influenza-like symptoms, injection site erythema, injection site swelling, fatigue and generalized aching were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site erythema, injection site swelling, fatigue and generalized aching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced flu like symptoms, redness and swelling in the injection site, fatigue and body ache. No further information was received. This case has been linked with case US2019093477, reported by the same reporter. There was a discrepancy with respect to the patient's initials. In initial source document it was given as one set of initials however in follow up source document it was given as different initials.  As no information available of which is the correct one, worst approch we have retain both cases.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pentacel was given at the same time as Hib.  Pt. did not have any reactions.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Blood test normal, Body temperature increased, Computerised tomogram normal
Clinical narrative: Had the normal reaction that most people have following the vaccine and those lasted 24 hours. (nausea, 101 temperature, muscle pain, headache, fatigue)     A couple days later I developed the following symptoms and they have continued for the past 60 days.  Shingle type pain on right side along waist line (no rash), internal pain on right side in stomach area and waist area, slightly increased pancreatic enzymes, nausea without vomiting, upset stomach, no appetite, headache, fatigue.  I'm slowly getting better but I am not back to normal yet.  Still have external and internal pain on right side.  Sometimes have upset stomach.  Still not much of an appetite.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Hepatic enzyme increased, Myalgia
Clinical narrative: Had the normal reaction that most people have following the vaccine and those lasted 24 hours. (nausea, 101 temperature, muscle pain, headache, fatigue)     A couple days later I developed the following symptoms and they have continued for the past 60 days.  Shingle type pain on right side along waist line (no rash), internal pain on right side in stomach area and waist area, slightly increased pancreatic enzymes, nausea without vomiting, upset stomach, no appetite, headache, fatigue.  I'm slowly getting better but I am not back to normal yet.  Still have external and internal pain on right side.  Sometimes have upset stomach.  Still not much of an appetite.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neuralgia, Pancreatic enzymes increased, Ultrasound scan normal, Urine analysis normal
Clinical narrative: Had the normal reaction that most people have following the vaccine and those lasted 24 hours. (nausea, 101 temperature, muscle pain, headache, fatigue)     A couple days later I developed the following symptoms and they have continued for the past 60 days.  Shingle type pain on right side along waist line (no rash), internal pain on right side in stomach area and waist area, slightly increased pancreatic enzymes, nausea without vomiting, upset stomach, no appetite, headache, fatigue.  I'm slowly getting better but I am not back to normal yet.  Still have external and internal pain on right side.  Sometimes have upset stomach.  Still not much of an appetite.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Iron deficiency
Clinical narrative: Patient reported to pharmacy that she was recently hospitalized due to an iron deficiency.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Seizure
Clinical narrative: Patient had no complications at time of injection on 7/26. He was ok the rest of the night. Next morning on 7/27, patient did not feel well and ended up having a seizure that morning. Patient was hospitalized until noon 7/28. No problems with first dose.
Age: 77.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Blood test, Bronchitis, Cardiac stress test, Dyspnoea, Electrocardiogram
Clinical narrative: ?After 1 dose of SHINGRIX in 3 days pt experienced rapid heartbeat, bronchitis, excess mucus, extreme fatigue, extreme trouble breathing, blood work issues. MD was most concerned about HR and bloodwork. Pt felt like she could have died.  Had to be put on a nebulizer as a result.
Age: 77.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Fatigue, Fear of death, Heart rate increased, Positron emission tomogram, Secretion discharge
Clinical narrative: ?After 1 dose of SHINGRIX in 3 days pt experienced rapid heartbeat, bronchitis, excess mucus, extreme fatigue, extreme trouble breathing, blood work issues. MD was most concerned about HR and bloodwork. Pt felt like she could have died.  Had to be put on a nebulizer as a result.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: NO ADVERSE EVENTS REPORTED, adult dose of Hep A and Hep B was administered to 16 year old female.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pain at injection site morning after vaccine. Pain progressed to severe pain at injection site and pain radiating down left leg.  Severe flu like symptoms lasting approximately one week.  Lingering pain in arm and leg for 2 weeks. Patient dealt with symptoms at home.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Defaecation urgency, Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: Sore arm, extreme shivering, body felt like I had been hit by a truck, felt like I was going to throw up and poop my pants
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Lip swelling, Swelling, Swelling face
Clinical narrative: Patient experienced extremely swollen upper lip, general swelling around the face and body, and a red discoloration of her skin.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: chills/fever/ nausea/ headache symptoms started around 9:30pm and were gone by morning
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Fever of 102.0
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Headache, Musculoskeletal stiffness, Nausea, Paraesthesia
Clinical narrative: Headaches, dizziness, nausea, neck stiffness, tingling in hands
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Rash
Clinical narrative: Has a rash on her face arm and leg
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: WARMTH, REDNESS, AND SWELLING AT INJECTION SITE AND DOWN ENTIRETY OF LEFT ARM BEGINNING 07/30/2019 AND WORSENING. PATIENT ADVISED TO ICE ARM, KEEP ELEVATED, AND TO TAKE BENADRYL.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Migraine
Clinical narrative: Red, swollen area around the injection site, severe migraine headache
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Nausea, Somnolence
Clinical narrative: Patient felt stomach pain, nausea, weakness, and sleepiness after about 5 hours after vaccination
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5, UNK
Symptoms: Allergy test positive, Allergy to animal, Discomfort, Food allergy, Milk allergy
Clinical narrative: Upon 2 month booster shots, patient began to show a red rash on her left cheek.  Over the next few weeks the rash progressed into a larger area, began to darken in redness and began to ooze plasma or weep.  This caused discomfort for her and she would scratch due to itchiness.  Pediatrician was unable to determine a cause for the reaction and many ointments were prescribed with no results.  A blood test was recommended and completed on April 11, 2014 with diary, peanut, egg, dog dander and soybean allergies.  As a nursing mother, I eliminated the allergens completely from my diet and still no change in patient's face.  This continued her entire first year of life.  She has had two additional allergy tests performed and continues to remain allergic to Cows milk, peanut and Egg whites.  She will carry an Epi-pen for the rest of her life.  Her skin becomes itchy and turn into hives if in contact with allergen as well as discomfort in tongue should she ingest allergen.  Due to her reactions, she also has not received any vaccinations since her 2 mth shots administered on 02-10-2014.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5, UNK
Symptoms: Pruritus, Rash, Rash erythematous, Secretion discharge, Tongue discomfort
Clinical narrative: Upon 2 month booster shots, patient began to show a red rash on her left cheek.  Over the next few weeks the rash progressed into a larger area, began to darken in redness and began to ooze plasma or weep.  This caused discomfort for her and she would scratch due to itchiness.  Pediatrician was unable to determine a cause for the reaction and many ointments were prescribed with no results.  A blood test was recommended and completed on April 11, 2014 with diary, peanut, egg, dog dander and soybean allergies.  As a nursing mother, I eliminated the allergens completely from my diet and still no change in patient's face.  This continued her entire first year of life.  She has had two additional allergy tests performed and continues to remain allergic to Cows milk, peanut and Egg whites.  She will carry an Epi-pen for the rest of her life.  Her skin becomes itchy and turn into hives if in contact with allergen as well as discomfort in tongue should she ingest allergen.  Due to her reactions, she also has not received any vaccinations since her 2 mth shots administered on 02-10-2014.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5, UNK
Symptoms: Urticaria
Clinical narrative: Upon 2 month booster shots, patient began to show a red rash on her left cheek.  Over the next few weeks the rash progressed into a larger area, began to darken in redness and began to ooze plasma or weep.  This caused discomfort for her and she would scratch due to itchiness.  Pediatrician was unable to determine a cause for the reaction and many ointments were prescribed with no results.  A blood test was recommended and completed on April 11, 2014 with diary, peanut, egg, dog dander and soybean allergies.  As a nursing mother, I eliminated the allergens completely from my diet and still no change in patient's face.  This continued her entire first year of life.  She has had two additional allergy tests performed and continues to remain allergic to Cows milk, peanut and Egg whites.  She will carry an Epi-pen for the rest of her life.  Her skin becomes itchy and turn into hives if in contact with allergen as well as discomfort in tongue should she ingest allergen.  Due to her reactions, she also has not received any vaccinations since her 2 mth shots administered on 02-10-2014.
Age: 95.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site pain
Clinical narrative: Patient came in on 7/31/2019 to report bruising from her Shingrix shot. She was bruised from the site of her shot on her left upper arm to her elbow.  Her bruise was very dark and patient reports it being tender to the touch.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Immunisation, No adverse event, Product preparation error
Clinical narrative: Upon mixing the Shingrix, I accidentally reconstituted with sterile water and not the adjuvant.  I followed up with the clinical team and was told it needed to be redosed.  Pt received the redosed injection mixed with the adjuvant on 7/31/2019.  Pt did not present with any symptoms on this date.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Emotional disorder, Irritability, Pyrexia
Clinical narrative: High fever, irritability, unconsolable
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injected limb mobility decreased, Pain in extremity, Tenderness, Ultrasound Doppler
Clinical narrative: 32 weeks pregnant woman received a Tdap from a local pharmacy.  Estimated Due date is 9/26/2019. Unknown pregnancy history as she  sees an OB for that care.  She called the Primary Care Clinic due to continued L arm pain 7 days after receiving Tdap shot in L arm. She states that it is so painful she has a hard time lifting her arm or putting clothes on. Also L arm is painful to touch. This RN scheduled patient for visit today (7/31/2019) with PCP.  Patient reports that immunization was given 4cm inferior to acromium and 2cm posterior and final diagnosis to be determined after ultrasound per physician.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Insomnia
Clinical narrative: cold chills, flu like symptoms, trouble sleeping