chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Neuralgic amyotrophy, Winged scapula
Clinical narrative: Developed severe pain in left shoulder and periscapular area on 8/12/19 with limited shoulder ROM and scapula winging that was not improving with NSAIDS, ice/heat, and rest. Diagnosed with Parsonage Turner Syndrome on 8/21/19 by sports medicine provider and given prescription for gabapentin for pain control.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: urticarial lesions started to appear about 5-6hrs after vaccines given. benedryl providing some relief. Has only been 24hrs so symptoms have not resolved yet.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Dry mouth, Eye pruritus, Headache, Hyperhidrosis, Nausea
Clinical narrative: Patient described having itchy eyes, achy head, dry mouth, nausea, fever, sweating, and swollen tongue.  She reported taking a Zyrtec which helped. Says tongue is still feeling slightly thick today and has whiteness on tongue she couldn't get off with a toothbrush.  She said symptoms started a few hours after the shot and lasted a day.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Swollen tongue, Tongue discolouration, Tongue disorder
Clinical narrative: Patient described having itchy eyes, achy head, dry mouth, nausea, fever, sweating, and swollen tongue.  She reported taking a Zyrtec which helped. Says tongue is still feeling slightly thick today and has whiteness on tongue she couldn't get off with a toothbrush.  She said symptoms started a few hours after the shot and lasted a day.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Daughter called to state arm was still red, swollen and itchy from first dose of shingrix. I recommended they follow-up with PCP to take a look at it.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pain
Clinical narrative: The employee said she had localized, swelling and redness at the injection site after the vaccination.  She also stated she had body aches that lasted 3-4 days after the injection.  She also stated that she had a lump at the injection site for >28 days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: bruised, red swollen upper arm which was very hot and also hurt.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Nausea, Pain, Pyrexia
Clinical narrative: Patient presented to ER 3 days after administration of vaccine with pain, erythema, nausea, fevers. Diagnosed with cellulitis to right arm, given Keflex 500mg 1 tablet every 6 hours for 10 days
Age: 27.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Sepsis, Skin warm
Clinical narrative: Cellulitis on right arm, went to ER and then admitted, had become Septic.  Right arm was red and warm to touch.  was in hospital for 4 days and sent home on Clindamycin 300mg one every 8 hours for 10 days.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Received immunization discharged. next morning mom noted arm was red and warm to touch. Child complained of Left arm hurting. No fever or drainage and non tender on exam
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Erythema, Pain in extremity
Clinical narrative: chills, red sore arm, weakness; the latter 2 symptoms are ongoing
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Mom called stating that when they arrived at cross country running practice Patient began profusely vomiting. Mom denies that Patient had been running yet and has otherwise been healthy. Patient complaining of severe abdominal pain with the vomiting. Denied, resp distress, hives or rash or other signs of possible allergic reaction. Due to severity of sx advised that Patient be seen in ER. Mom took her to ER where they gave Zofran and IVF.  Dx of possible gastroenteritis and discharged 4 hours later.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Rash erythematous, Vaccination site induration, Vaccination site pain, Vaccination site reaction
Clinical narrative: erythematous rash, hot, indurated at site of vaccine, some itching painful to touch, was instructed to apply ice, Motrin and plan to start clindamycin for cellulitis if no improvement was given lst dose of varicella vaccine on 9/12/2018, develop similar reaction was placed on clindamycin for concerns for cellulitis a that time
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination site warmth
Clinical narrative: erythematous rash, hot, indurated at site of vaccine, some itching painful to touch, was instructed to apply ice, Motrin and plan to start clindamycin for cellulitis if no improvement was given lst dose of varicella vaccine on 9/12/2018, develop similar reaction was placed on clindamycin for concerns for cellulitis a that time
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: PATIENT CALLED THE FOLLOWING DAY AFTER INJECTION AND COMPLAINED  OF TOTAL ARM  PAIN AND LIMITED RANGE OF MOTION. PATIENT FELT INJECTION WAS "TOO HIGH". SHE WAS ADVISED TO USE IBUPROFEN  OR TYLENOL. FOLLOW UP CALL PLACED TO PATIENT 3RD DAY AFTER INJECTION BUT WAS  UNABLE TO REACH PATIENT FOR OUTCOME
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: the incorrect diluent was used . no adverse reactions or symptoms following the administration of the vaccine with the incorrect diluent.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immunisation, No adverse event, Product preparation error
Clinical narrative: the incorrect diluent was used . no adverse reactions or symptoms following the administration of the vaccine with the incorrect diluent.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site pain, Malaise, Pyrexia
Clinical narrative: Patients wife came to pharmacy to let us know the husband had the following symptoms after the first shingrix dose: facial swelling, injection site pain, fever, headache, dizziness, malaise. Of which the facial swelling was most concerning.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Patients wife came to pharmacy to let us know the husband had the following symptoms after the first shingrix dose: facial swelling, injection site pain, fever, headache, dizziness, malaise. Of which the facial swelling was most concerning.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Mobility decreased, Nausea
Clinical narrative: Pain in injection site, difficulty using arm, headache, fever, nausea, tiredness
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain in injection site, difficulty using arm, headache, fever, nausea, tiredness
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: incorrect diluent used for the shingrix vaccine. no adverse events or symptoms following the administration of this diluent with the shingrix
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immunisation, No adverse event, Product preparation error
Clinical narrative: incorrect diluent used for the shingrix vaccine. no adverse events or symptoms following the administration of this diluent with the shingrix
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient contacted clinic complaining of redness, swelling, soreness from the left elbow to the left shoulder. Denies fever, shortness of breath, difficulty swallowing or itchiness to the injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Syncope, Tremor, Urinary incontinence
Clinical narrative: prolonged syncope,  urinary incontinence, nausea, vomiting, shaking, chills. Patient took ibuprofen and began to fill better.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: prolonged syncope,  urinary incontinence, nausea, vomiting, shaking, chills. Patient took ibuprofen and began to fill better.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Erythema, Feeling abnormal, Feeling cold
Clinical narrative: TODAY IS DAY ONE OF THE SIDE EFFECTS.  FLU LIKE SYMPTOMS.  HEADACHE, OVERALL BODY MUSCLE SORENESS, SKIN SENSITIVITY, COLD WITH SHIVERS, LARGE RED CIRCLE ON LEFT ARM WERE VACCINE WAS ADMINISTERED. WEAKNESS AND FOGGINESS. ONE RED "DOT" HAS APPEARED ON MY LEFT LEG 2 INCHES ABOVE THE KNEE.  IT DOES NOT ITCH OR HURT.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Sensitive skin
Clinical narrative: TODAY IS DAY ONE OF THE SIDE EFFECTS.  FLU LIKE SYMPTOMS.  HEADACHE, OVERALL BODY MUSCLE SORENESS, SKIN SENSITIVITY, COLD WITH SHIVERS, LARGE RED CIRCLE ON LEFT ARM WERE VACCINE WAS ADMINISTERED. WEAKNESS AND FOGGINESS. ONE RED "DOT" HAS APPEARED ON MY LEFT LEG 2 INCHES ABOVE THE KNEE.  IT DOES NOT ITCH OR HURT.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Dyspnoea, Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Patient stated he "could not breath" so had to call paramedics for assistance. Also has no feeling in his left arm all the way down to his hand.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Pain, Pain in extremity
Clinical narrative: INJECTION ARM AND SHOULDER ARE SORE TO THE TOUCH AND CAUSE PAIN TO MOVE.  INJECTION SITE IS WARM TO THE TOUCH.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Skin exfoliation
Clinical narrative: left arm swollen, red, pain, pictures were taken by parents and relayed to office for assessment. The red area was the size of a baseball in diameter, swelling was hard to assess based on the picture. Pt was seen in Urgent Care 8/16/19, was advised to use ice pack and give Tylenol or ibuprofen. Father called on 8/20/19 concerned about appearance. Another picture was received from parents. Dr assessed stating it appeared it was healing, redness was gone but peeling appearance around the edge of the initial redness noted the first day. Advised to moisturize by applying aquaphor or petroleum jelly
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness, Swelling
Clinical narrative: THE PATIENT CALLED AND CLAIMED HIS SHOULDER IS STILL STIFF , SWOLLEN AND DIFFICULT TO MOVE. hE WILL GO TO DOCTOR ON aUGUST 23 ,2019 TO GET CHECKED.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Swelling
Clinical narrative: delayed swelling and erythema; increased calor in the past 24hrs - concern for infectious cellulitis
Age: 1.25
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Site redness, 3? in diameter
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Patient presented with a colorless swollen lump on the inside of her elbow on the left arm.  The lump was about the size of a golf ball and firm to the touch. She claimed the spot was not painful or obstructing her movements. There were no signs of swelling or redness at actual injection site, but the lump she presented with was on the same arm that she received the vaccine in. The patient claimed this was not present prior to vaccine administration. The patient was instructed to self medicate with oral diphenhydramine along with applying ice to the swollen area to reduce swelling.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site urticaria, Tonsillar hypertrophy, Urticaria
Clinical narrative: Hives on legs, gone after 2 days of benadryl. Swollen tonsils. Perscribed prednisoLONE 15mg/5ml. Tonsils are still swollen as of 10:29pm 08/22/2019
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness, Erythema, Muscle spasms, Nausea
Clinical narrative: Patient's face turned red within 2 minutes of administration of Fluad.  This was followed by dizziness, nausea and finally back spasms.  All of these symptoms lasted about 5-10 minutes.  After patient rested for 10 minutes, she felt asymptomatic again.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The next day after vaccine was given the arm at vaccine at site of vaccine given was swollen, red and hot to the touch, Pt mom did not notify us till 3 days later she show us a picture of vaccine site and still was like 8 cm red but the swoelling was gone pt did not complain of aby symtoms . But its gone complete by now.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: & facial droop
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Inflammation, Tenderness
Clinical narrative: Inflammation 3 x 3cm, tenderness x 2 days - improving on own
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: dizziness, nausea & vomiting 2 mins after vaccine administration. 2 episodes of vomiting vitals obtained - WNL, patient reports "feeling better" but was referred to ER for further eval.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient called on 8/21/2019 to claim she is experiencing painful rashes on the back of her right leg. She also complained of rash on back/right side of her head. She claims the rash rash has gotten worse since. She claims that the rash gets painful when she gets out in the heat.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Hypersensitivity, Injection site swelling, Pyrexia
Clinical narrative: Shingrix shot#1- allergic reaction beginning on the day after the shot. Chills, fever, swollen injection area, upset stomach, throat closing. Continued to get worse for two days. Went to doctor. I was told I was having reaction to immunization. For two days I kept trying to clear my throat, thinking I had something caught in my throat. Dr said it was my throat closing off.
Sex: F
Vaccine: VARZOS
Symptoms: Sensation of foreign body, Throat tightness, Vaccination complication
Clinical narrative: Shingrix shot#1- allergic reaction beginning on the day after the shot. Chills, fever, swollen injection area, upset stomach, throat closing. Continued to get worse for two days. Went to doctor. I was told I was having reaction to immunization. For two days I kept trying to clear my throat, thinking I had something caught in my throat. Dr said it was my throat closing off.
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: morphine and Tdap ordered post injury. both in prefilled syringes. RN accidentally gave part of Tdap IV because she had both in her hands. Both were scanned at bedside, but because they were being given at the same time, they were mixed up
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Pt developed a red rash. Denied taking any medication for it. Rash resolved on its own in 1 week.
Age: 71.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Blood test, Chest X-ray, Erythema, Induration, Local reaction
Clinical narrative: Patient begain running fever the day after vaccine given. Fever got up to 102°. Went to his primary doctor & had bloodwork & xray (chest). These were clear Feeling better by 7/18/19. Had a localized reaction on R arm - red, swollen, hardened area.
Age: 71.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Patient begain running fever the day after vaccine given. Fever got up to 102°. Went to his primary doctor & had bloodwork & xray (chest). These were clear Feeling better by 7/18/19. Had a localized reaction on R arm - red, swollen, hardened area.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Night sweats, Pain
Clinical narrative: chills Sweats night sweats (drenching) aches, pains Scratching, itching all over body  Severe diarrhea fever
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Pruritus generalised, Pyrexia
Clinical narrative: chills Sweats night sweats (drenching) aches, pains Scratching, itching all over body  Severe diarrhea fever
Age: 77.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient complained of excruciating pain in the right arm. She cannot move or raise her right arm.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Echocardiogram normal, Facial paralysis, Nuclear magnetic resonance imaging brain normal, Ultrasound Doppler
Clinical narrative: Patient developed severe Bell's Palsy about one hour after receiving the first dose of Shingrix vaccine.  He still has severe residual right 7th cranial nerve palsy about 10 months later.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Ultrasound Doppler normal
Clinical narrative: Patient developed severe Bell's Palsy about one hour after receiving the first dose of Shingrix vaccine.  He still has severe residual right 7th cranial nerve palsy about 10 months later.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Injection site pain
Clinical narrative: next day, upper joint on thumb on left hand could not move. After patient took naprosyn the next day, symptoms subsided.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint range of motion decreased
Clinical narrative: next day, upper joint on thumb on left hand could not move. After patient took naprosyn the next day, symptoms subsided.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Injection site Redness; Heat at injection site; Injection site soreness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2019) for prophylaxis.   On 6th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid and developed 2 by 4 area with redness, heat, soreness but no swelling localized to injection site. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site Redness; Heat at injection site; Injection site soreness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2019) for prophylaxis.   On 6th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid and developed 2 by 4 area with redness, heat, soreness but no swelling localized to injection site. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Dysgeusia, Feeling cold
Clinical narrative: sores in mouth; feeling hot inside; feeling cold; upset stomach; copper taste in mouth; diarrhea; This case was reported by a pharmacist via call center representative and described the occurrence of feeling hot in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 377MK, expiry date 25th September 2021) for prophylaxis.   On 1st August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd August 2019, 1 days after receiving Shingrix, the patient experienced feeling hot, feeling cold, upset stomach, taste metallic and diarrhea. On 9th August 2019, the patient experienced sores mouth. On an unknown date, the outcome of the feeling hot, feeling cold, upset stomach, taste metallic, diarrhea and sores mouth were not recovered/not resolved.   It was unknown if the reporter considered the feeling hot, feeling cold, upset stomach, taste metallic, diarrhea and sores mouth to be related to Shingrix.  Additional information received were as follows: The caller was a pharmacist calling on behalf of a patient. The patient received Shingrix on left deltoid. The patient developed upset stomach, diarrhea and a copper taste in her mouth.  The patient also sometimes felt hot inside like her insides were burning and sometimes she felt cold. 8 days after receiving Shingrix, the patient experienced sores in her mouth. The caller stated that she also submitted a VAERS report.  The caller did not provide any additional details.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Hunger
Clinical narrative: sores in mouth; feeling hot inside; feeling cold; upset stomach; copper taste in mouth; diarrhea; This case was reported by a pharmacist via call center representative and described the occurrence of feeling hot in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 377MK, expiry date 25th September 2021) for prophylaxis.   On 1st August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd August 2019, 1 days after receiving Shingrix, the patient experienced feeling hot, feeling cold, upset stomach, taste metallic and diarrhea. On 9th August 2019, the patient experienced sores mouth. On an unknown date, the outcome of the feeling hot, feeling cold, upset stomach, taste metallic, diarrhea and sores mouth were not recovered/not resolved.   It was unknown if the reporter considered the feeling hot, feeling cold, upset stomach, taste metallic, diarrhea and sores mouth to be related to Shingrix.  Additional information received were as follows: The caller was a pharmacist calling on behalf of a patient. The patient received Shingrix on left deltoid. The patient developed upset stomach, diarrhea and a copper taste in her mouth.  The patient also sometimes felt hot inside like her insides were burning and sometimes she felt cold. 8 days after receiving Shingrix, the patient experienced sores in her mouth. The caller stated that she also submitted a VAERS report.  The caller did not provide any additional details.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Dysgeusia, Feeling cold, Feeling hot
Clinical narrative: sores in mouth; feeling hot inside; feeling cold; upset stomach; copper taste in mouth; diarrhea; This case was reported by a pharmacist via call center representative and described the occurrence of feeling hot in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 377MK, expiry date 25th September 2021) for prophylaxis.   On 1st August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd August 2019, 1 days after receiving Shingrix, the patient experienced feeling hot, feeling cold, upset stomach, taste metallic and diarrhea. On 9th August 2019, the patient experienced sores mouth. On an unknown date, the outcome of the feeling hot, feeling cold, upset stomach, taste metallic, diarrhea and sores mouth were not recovered/not resolved.   It was unknown if the reporter considered the feeling hot, feeling cold, upset stomach, taste metallic, diarrhea and sores mouth to be related to Shingrix.  Additional information received were as follows: The caller was a pharmacist calling on behalf of a patient. The patient received Shingrix on left deltoid. The patient developed upset stomach, diarrhea and a copper taste in her mouth.  The patient also sometimes felt hot inside like her insides were burning and sometimes she felt cold. 8 days after receiving Shingrix, the patient experienced sores in her mouth. The caller stated that she also submitted a VAERS report.  The caller did not provide any additional details.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Stomatitis
Clinical narrative: sores in mouth; feeling hot inside; feeling cold; upset stomach; copper taste in mouth; diarrhea; This case was reported by a pharmacist via call center representative and described the occurrence of feeling hot in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 377MK, expiry date 25th September 2021) for prophylaxis.   On 1st August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd August 2019, 1 days after receiving Shingrix, the patient experienced feeling hot, feeling cold, upset stomach, taste metallic and diarrhea. On 9th August 2019, the patient experienced sores mouth. On an unknown date, the outcome of the feeling hot, feeling cold, upset stomach, taste metallic, diarrhea and sores mouth were not recovered/not resolved.   It was unknown if the reporter considered the feeling hot, feeling cold, upset stomach, taste metallic, diarrhea and sores mouth to be related to Shingrix.  Additional information received were as follows: The caller was a pharmacist calling on behalf of a patient. The patient received Shingrix on left deltoid. The patient developed upset stomach, diarrhea and a copper taste in her mouth.  The patient also sometimes felt hot inside like her insides were burning and sometimes she felt cold. 8 days after receiving Shingrix, the patient experienced sores in her mouth. The caller stated that she also submitted a VAERS report.  The caller did not provide any additional details.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Bright Red rash; This case was reported by a consumer and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Shingrix. On 13th August 2019, 1 days after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was not recovered/not resolved.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced bright red rash under arm puts, elbows and arrow neck. The patient was not sure whether this was normal as still had it on the 14th August 2019, the patient was not sure to get the second dose in two months. The patient was not sure and asked advice whether could donate blood on 23rd Aug 2019.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash papular
Clinical narrative: red bumps; allergic reaction; beginning of chicken pox; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix 50 µg. On 12th August 2019, 5 days after receiving Shingrix, the patient experienced red rash, allergic reaction and chickenpox. On an unknown date, the outcome of the red rash, allergic reaction and chickenpox were recovering/resolving.   It was unknown if the reporter considered the red rash, allergic reaction and chickenpox to be related to Shingrix.  Additional details were provided as follows: The patient started having red bump in his inner thighs, they went to his lower back and upper buttock. It started moving down further on legs. The patient went to an urgent care and the physician's assistant thought that it would be either an allergic reaction or the beginning of chicken pox, however, he was not sure what it was. The reporter did not give consent to follow up. The patient clarified that urgent care was not considered emergency room.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Rash, Rash erythematous, Varicella
Clinical narrative: red bumps; allergic reaction; beginning of chicken pox; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix 50 µg. On 12th August 2019, 5 days after receiving Shingrix, the patient experienced red rash, allergic reaction and chickenpox. On an unknown date, the outcome of the red rash, allergic reaction and chickenpox were recovering/resolving.   It was unknown if the reporter considered the red rash, allergic reaction and chickenpox to be related to Shingrix.  Additional details were provided as follows: The patient started having red bump in his inner thighs, they went to his lower back and upper buttock. It started moving down further on legs. The patient went to an urgent care and the physician's assistant thought that it would be either an allergic reaction or the beginning of chicken pox, however, he was not sure what it was. The reporter did not give consent to follow up. The patient clarified that urgent care was not considered emergency room.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: patient complianing about sour arm and swelling, painful to touch and site a little warm.  Advise patient to take tylenol and see her PCP
Age: 46.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: C-reactive protein, Full blood count, Injection site pain, Injection site rash, Oedema peripheral
Clinical narrative: 1.SWELLING IN THE RIGHT ARMPIT, LOW GRADE FEVER. SWELLING IN RIGHT AXILLA(3 CM) NO DEFINED BORDERS,NO HEAT, NO COLOR CHANGES. DELTOID MINOR CHANGES TENDERNESS AT INJECTION SITE, NO LYMHADENOPATHY IN AXILLA OR TROCLEAR AREA 2.BUMPS ON INJECTION SITE
Age: 46.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Pyrexia
Clinical narrative: 1.SWELLING IN THE RIGHT ARMPIT, LOW GRADE FEVER. SWELLING IN RIGHT AXILLA(3 CM) NO DEFINED BORDERS,NO HEAT, NO COLOR CHANGES. DELTOID MINOR CHANGES TENDERNESS AT INJECTION SITE, NO LYMHADENOPATHY IN AXILLA OR TROCLEAR AREA 2.BUMPS ON INJECTION SITE
Age: 22.0
Sex: F
Vaccine: FLUN4
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Antinuclear antibody positive, Arthralgia, Joint stiffness, Lethargy
Clinical narrative: Lethargy following vaccination. A week after vaccination, sudden onset of severe joint pain and stiffness. Began to affect soft tissues and nerves. Eventually got diagnosed with Lupus, then undifferentiated connective tissue disease, then finally Rheumatoid Arthritis. Treatment has consisted of steroids, disease-modifying anti rheumatic drugs, anti inflammatory drugs, biologic drugs, and alteration of diet. I have not gone into remission and my Rheumatoid arthritis is considered severe and active, despite my young age and no family history of rheumatoid arthritis.
Age: 22.0
Sex: F
Vaccine: FLUN4
Symptoms: Nerve injury, Nuclear magnetic resonance imaging, Rheumatoid arthritis, Soft tissue disorder, Systemic lupus erythematosus
Clinical narrative: Lethargy following vaccination. A week after vaccination, sudden onset of severe joint pain and stiffness. Began to affect soft tissues and nerves. Eventually got diagnosed with Lupus, then undifferentiated connective tissue disease, then finally Rheumatoid Arthritis. Treatment has consisted of steroids, disease-modifying anti rheumatic drugs, anti inflammatory drugs, biologic drugs, and alteration of diet. I have not gone into remission and my Rheumatoid arthritis is considered severe and active, despite my young age and no family history of rheumatoid arthritis.
Age: 22.0
Sex: F
Vaccine: FLUN4
Symptoms: Undifferentiated connective tissue disease, X-ray
Clinical narrative: Lethargy following vaccination. A week after vaccination, sudden onset of severe joint pain and stiffness. Began to affect soft tissues and nerves. Eventually got diagnosed with Lupus, then undifferentiated connective tissue disease, then finally Rheumatoid Arthritis. Treatment has consisted of steroids, disease-modifying anti rheumatic drugs, anti inflammatory drugs, biologic drugs, and alteration of diet. I have not gone into remission and my Rheumatoid arthritis is considered severe and active, despite my young age and no family history of rheumatoid arthritis.
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Gave the patient a second dose of Hepatitis B vaccine on accident.  Vaccine had already been given the day before.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Abnormal faeces, Chills, Defaecation urgency, Dyspepsia
Clinical narrative: Next day woke up with flu-like conditions--chills, sweats, and tiredness--, which lasted through evening.   Patient did not take any medicine or did any treatment other than resting and did not call doctor.   On 8/15 patient felt fine On 8/16 chronic stomach issues started: burning sensation and stool not normal.  Contacted GI doctor in the afternoon and requested to submit another stool sample; dropped it off on 8/17.    Patient submitting another sample because lab missed some tests.    Symptoms are on and off, achy stomach, and having sensation to have to go.   Has follow-up appointment with PCP on Monday.  Patient did not have problems after the first vaccine dose
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hyperhidrosis, Influenza like illness
Clinical narrative: Next day woke up with flu-like conditions--chills, sweats, and tiredness--, which lasted through evening.   Patient did not take any medicine or did any treatment other than resting and did not call doctor.   On 8/15 patient felt fine On 8/16 chronic stomach issues started: burning sensation and stool not normal.  Contacted GI doctor in the afternoon and requested to submit another stool sample; dropped it off on 8/17.    Patient submitting another sample because lab missed some tests.    Symptoms are on and off, achy stomach, and having sensation to have to go.   Has follow-up appointment with PCP on Monday.  Patient did not have problems after the first vaccine dose
Sex: F
Vaccine: HPV9
Symptoms: Maternal exposure before pregnancy, Pregnancy test negative
Clinical narrative: pregnant after administration; This spontaneous report was received from a nurse referring to a currently 33 years old female patient.    The patient's medical history, concurrent conditions, and drug reactions/allergies were not provided. The concomitant therapy included tizanidine hydrochloride.  On 26-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602284, expiration date not reported but upon internal validation established as 26-SEP-2021) (dose, unit not reported), intramuscular for prophylaxis. Pregnancy test was negative upon administration of vaccine.  The patient became pregnant after administration. The last menstrual period (LMP) was reported as 24-JUN-2019 and estimated date of delivery (EDD) was 30-MAR-2020. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was at 4 weeks. The patient sought medical attention. The pregnancy outcome was pending. The outcome of the event was unknown.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: patient had injection site rash 8 hours after was administered PNEUMOVAX23; This spontaneous report has been received from a pharmacist referring to a 69-year-old female patient. The patient's concurrent conditions, medical history and drug or allergy reactions were not reported. Concomitant therapies included atorvastatin, alendronate sodium, losartan and pantoprazole.       On 17-JUL-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose and route were not reported; lot # S002582, expiration reported as 10-AUG-2020) for prophylaxis.      On that date (after 8 ours was vaccinated the vaccine), the patient experienced injection site rash. The rash lasted 3 days. On 20-JUL-2019, the event resolved. There was no treatment given to the subject. No additional information provided. The reporter is requesting an investigation for the lot number the patient received. The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 61.0
Sex: M
Vaccine: VARCEL
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: Today his is showing flu-like symptoms; the patient received his first dose of VARIVAX on 08/14/2019 and subsequently experienced injection site pain that evening; the patient used VARIVAX for prevention of shingles; Information has been received from a physician who wished to remain anonymous, referring to a 61 years old male patient. The patient's concurrent condition was not reported; pertinent medical history and drug reactions/allergies were unknown and his concomitant medication included atorvastatin calcium (LIPITOR).  On 14-AUG-2019, the patient was vaccinated with the first dose ofvaricella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and frequency were not provided; route of administration, lot number and expiration date were unknown by the reporter) for prevention of shingles (product use in unapproved indication).    On 14-AUG-2019 in the evening, the patient experienced injection site pain. On 15-AUG-2019 (reported as today), the patient is showing flu-like symptoms. It was confirmed with the reporter that no rash was present. It was unknown if treatment was given or if lab diagnostics/labs were done for the events. The patient did not seek medical attention. No product quality issue was present. At the reporting time, the outcome of injection site pain and flu-like symptoms was not resolved.   The causality between atorvastatin calcium (LIPITOR) and the events was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: left-sided facial droop/ Bell's palsy; This spontaneous report was received from a lawyer and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 28-AUG-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiry date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date in 2017 (reported as shortly after vaccination), the patient suffered a sudden left-sided facial droop and was diagnosed with Bell's palsy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using vaccine. The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered sudden left-sided facial droop, Bell's palsy to be related to zoster vaccine live (ZOSTAVAX).  The event of sudden left-sided facial droop, Bell's palsy was considered to be disabling. Upon internal review, the event was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Balance disorder, Dyskinesia, Impaired work ability, Tremor
Clinical narrative: involuntary movement disorder; tremors; balance problems; memory loss; This spontaneous report was received from a lawyer and concers a case in litigation and refers to a female patient (pt) of unknown age. There was no information about pt's concurrent conditions, concomitant therapies or medical history provided. On 24-JUL-2017, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Approximately ten days after receiving zoster vaccine live (ZOSTAVAX), pt suffered debilitating neurological injuries including severe involuntary movement disorders, tremors, balance problems and memory loss which have continued until today. These injuries have resulted in substantial medical treatment and have prevented pt from working. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) and caused by zoster vaccine live (ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), pt suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment oflife, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of severe involuntary movement disorders, tremors, balance problems and memory loss were considered disabling.
Sex: M
Vaccine: MMR
Symptoms: Seizure
Clinical narrative: the patient experienced seizures 8 days after receiving the MMR II vaccine; This spontaneous report was received from a consumer referring to her son (a child) with asthma. The patient's medical history included urticaria. Concomitant therapy included albuterol. He had reactions/allergies to oxytocin (PITOCIN).  On an unknown date in 2012, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), one shot in arm for prophylaxis (reported as prevention of mumps, measles and rubella) (strength, dose and frequency were not reported; lot# and expiration date were unknown by the reporter).  On an unknown date in 2012, 8 days after receiving the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine, the patient experienced seizures, which lasted for about 30 to 60 seconds. In the end of the day in 2012, the patient recovered from seizures. The patient did not seek medical attention and no lab diagnostics/studies were performed.   The reporter did not provide the causality between the event seizures and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Upon internal review, the event of seizures was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored dose of VARIVAX; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, past drugs and allergies were not reported. Concomitant therapies included sterile diluent.  On 12-AUG-2019, the patient was vaccinated with one improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number R027995 has been verified to be a valid lot number and expiration date was 01-OCT-2020; strength, dose, frequency and route were unknown) for prophylaxis. No adverse effects were reported. The sterile diluent that was used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. The temperature excursion was seen at temperature of 6-degree Fahrenheit to 14-degree Fahrenheit (7.5 F) for 30 minutes. Previous temperature excursion was noted at temperature of 6-degree Fahrenheit to 14-degree Fahrenheit (10 F) for 28 minutes. This call was because of digital data logger.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: was administered an expired dose ofVARIV AX; no adverse effect; This spontaneous report was received from a medical assistant and refers to a 6 year old patient of unknown gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On 19-AUG-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis, lot # N021719 and expiration date 10-AUG-2019 (dose, strength, route of administration and frequency were not reported).  The patient experienced no adverse effects.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: right-chest wall shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 20-AUG-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiry date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date in 2012 (reported as shortly after vaccination), the patient suffered a bad case of right-chest wall shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using vaccine. The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The reporter considered bad case of right-chest wall shingles to be related to zoster vaccine live (ZOSTAVAX). The event of sudden bad case of right-chest wall shingles was considered to be disabling.
Age: 46.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: GARDASIL 9 was administered to an unspecified 46 year old patient; No adverse effects reported; This spontaneous report was received from a pharmacist and refers to an unspecified 46-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis at the age of 46. No adverse event was reported.