chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Incorrect route of product administration, Injection site cellulitis, Injection site swelling, Pain
Clinical narrative: Multipara, 31 weeks gestation AMA, Rh negative s/p Rhogam 8/2019, obesity  Developed significant swelling and pain after 24 hours - was given Claritin and Tylenol through an Urgent Care. 4 days post injection, went to ED and diagnosed with cellulitis. Prescribed Keflex with improvement so far. Based on site of swelling and cellulitis, injection not given intramuscularly, but appeared to be given subcutaneously inferior to the deltoid
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Redness and swelling over anterior RT and LT thigh. 0.5 cm wheal appeared near injection sight on RT thigh along with a 2cm sized welt under skin. Doctor was notified and assessed the patient. Ice packs applied to both thighs and patient monitored. Swelling and redness decreased and wheal resolved. Welt still palpable but had decreased in size. Patient given Motrin for inflammation and instructed on follow-up care. Attempted to contact parent next morning to check on patient status. Left message to call office back for update
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Patient was given HPV on 8/12/19, Mom stated 5 minutes after bandaid was placed on arm the the area  around where injection was given was red and itchy. Dr aware and spoke with Mom ice pack applied to site. Mom called when she got home stating arm still itching, she will continue with ice and update the next day. Mom called on 8/13/19 and states that the itching resolved. Mom called back on 8/28/19 stating that patient is complaining that the are where injection was given is sore and there is a mosquito size "lump". Mom advised Dr said that it should resolve and patient should not ever receive another HPV.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Client presented with hive like rash to left upper extremity, area was warm to the touch and slightly swollen.  Client reported that area itched and that she applied topical hydrocortisone cream to area.  Client also reports that she has had flew shots before but this is the first time she has had a reaction.  Client denied any difficulty breathing.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: LT deltoid redness, swelling, and painful
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: MOM STATES THAT THE NEXT MORNING AFTER PATIENT RECEIVED HIS FIRST DOSE OF VARIVAX HE BROKE OUT IN A RASH AND WAS DIAGNOSED WITH CHICKEN POX AT HIS LOCAL PEDIATRICIAN'S OFFICE.
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT STATED SHE HAD SOME SWELLING AROUND THE INJECTION SITE.  THE SWOLLEN AREA WAS RED AND IN AN OVAL SHAPE COVERING ABOUT 4IN X 2.5IN, WITH THE INJECTION ENTRY AT THE CENTER.  PATIENT WAS TREATING WITH ICE AND TAKING OTC MOTRIN WHICH SHE STATED HAS BEEN HELPING.  THE SWELLING STARTED A FEW HOURS AFTER RECEIVING VACCINE AND HAS ONLY GOTTEN BETTER SINCE AND THE REDNESS HAS NOT SPREAD BEYOND CURRENT MARGINS.  PATIENT HAS FULL ROTATION/MOVEMENT OF ARM AND ONLY SORE TO THE TOUCH.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Swollen, hard, redness, stiffness, aching.  Warmth at injection site.  Has not improved since symptoms began, taking naproxen for pain relief.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Swollen, hard, redness, stiffness, aching.  Warmth at injection site.  Has not improved since symptoms began, taking naproxen for pain relief.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Decreased appetite, Injection site swelling, Nausea
Clinical narrative: Patient developed temp of 100.7-102,  chills, loss of appetite, abdominal pain and nausea, bodyaches, and slight swelling at injection site but no redness or warmth
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient developed temp of 100.7-102,  chills, loss of appetite, abdominal pain and nausea, bodyaches, and slight swelling at injection site but no redness or warmth
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Cough, Hyperhidrosis, Pain in extremity
Clinical narrative: Chills, Fever, weakness, cough,  (fever range 99.5 - 102.7), sweat.     First night  symptoms were worst, woke up with . 100.7 fever, weak with sore arm
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, Fever, weakness, cough,  (fever range 99.5 - 102.7), sweat.     First night  symptoms were worst, woke up with . 100.7 fever, weak with sore arm
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Decreased appetite, Feeling hot, Flushing
Clinical narrative: About 6-7 hours after injection began not feeling well.  Generalized aching, swelling at the injection site.  Muscle and joint pain increased over night.  9/12 had flushing, felt hot, acute soreness of muscles and joints.  Slept all day.  Wheezing present.  Did not seek medical help.  Treated with Tylenol q6 hours - two 500 mg each time.  No appetite, genderalized weakness.    Flushing/ fever broke during the night.   9/13 - Generalized weakness continues.  Symptoms lessened. Injection site swollen, sore and hot. Felt like he had had flu/ flu like symptoms.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: About 6-7 hours after injection began not feeling well.  Generalized aching, swelling at the injection site.  Muscle and joint pain increased over night.  9/12 had flushing, felt hot, acute soreness of muscles and joints.  Slept all day.  Wheezing present.  Did not seek medical help.  Treated with Tylenol q6 hours - two 500 mg each time.  No appetite, genderalized weakness.    Flushing/ fever broke during the night.   9/13 - Generalized weakness continues.  Symptoms lessened. Injection site swollen, sore and hot. Felt like he had had flu/ flu like symptoms.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pain, Pyrexia, Wheezing
Clinical narrative: About 6-7 hours after injection began not feeling well.  Generalized aching, swelling at the injection site.  Muscle and joint pain increased over night.  9/12 had flushing, felt hot, acute soreness of muscles and joints.  Slept all day.  Wheezing present.  Did not seek medical help.  Treated with Tylenol q6 hours - two 500 mg each time.  No appetite, genderalized weakness.    Flushing/ fever broke during the night.   9/13 - Generalized weakness continues.  Symptoms lessened. Injection site swollen, sore and hot. Felt like he had had flu/ flu like symptoms.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 9/9/19 - pAiN iN lEft ARm, Achy joiNts 9/10/19 - HEADAchE @ 7pm, REDNEss At iNjEction site 9/11/19 sx iMpRovED some, hot not REsolvED 9/12/19 site RED swollen & wARm to thE touch
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: 9/9/19 - pAiN iN lEft ARm, Achy joiNts 9/10/19 - HEADAchE @ 7pm, REDNEss At iNjEction site 9/11/19 sx iMpRovED some, hot not REsolvED 9/12/19 site RED swollen & wARm to thE touch
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Limb discomfort
Clinical narrative: Vaccine was received Wednesday afternoon which resulted in mild arm discomfort which began to get better through Friday. On Saturday Morning, I woke up and there was a bright red mark at the sight of injection and then extended below it by about 3 inches, and was about 4 inches wide. It was painful and hot to the touch. I consulted a Nurse at my PCP by phone who advised me to go to medical Care since all the regular clinics were closed. I went to medical Care and the Dr diagnosed me with Cellulitis, likely staph infection from the Tetanus shot. I started Cephalexin antibiotic treatment on Saturday. So far, the infection has reacted well to the treatment and the mark has mostly disappeared. I still have two more days of antibiotics to take.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Staphylococcal infection, Vaccination complication
Clinical narrative: Vaccine was received Wednesday afternoon which resulted in mild arm discomfort which began to get better through Friday. On Saturday Morning, I woke up and there was a bright red mark at the sight of injection and then extended below it by about 3 inches, and was about 4 inches wide. It was painful and hot to the touch. I consulted a Nurse at my PCP by phone who advised me to go to medical Care since all the regular clinics were closed. I went to medical Care and the Dr diagnosed me with Cellulitis, likely staph infection from the Tetanus shot. I started Cephalexin antibiotic treatment on Saturday. So far, the infection has reacted well to the treatment and the mark has mostly disappeared. I still have two more days of antibiotics to take.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: JOINT PAIN.  Joint pain began in hands on Day 4 (Aug 12).  Pain spread to feet approximately one week later, and then quickly spread to other joints, including knees, hips, shoulders, elbows, and wrists.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: 103 degree fever for 15 hours before diminishing to 100 degrees for another 12 hours.
Age: 47.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Haematoma, Pain, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: woke up at 2 am with severe right arm pain, on examination by provider large hematoma noted with swelling, tenderness, pain with range of motion
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Night chills and low fever, aches and fatigue
Age: 77.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Periarthritis
Clinical narrative: patient has painful shoulder, cant raise left arm above shoulder level,  believes it is adhesive capsulitis
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV, VARZOS
Symptoms: Pain, Pyrexia, Rash, Rash erythematous, Vaccination site induration
Clinical narrative: PATIENT STATES RED, PAINFUL AND SLIGHTLY WARM RASH FOR 72 HOURS. RASH IS 6 INCH BY 3 INCH SIZE, ABOUT 3 INCHES LOWER THEN VACCINE AREA (RASH DOES NOT INCORPORATE EITHER OF THE VACCINE LOCATIONS). AREA IS NOT ITCHY BUT IT HAS BEEN HARD TO THE TOUCH FOR 24-48 HOURS.  COMPLAINS OF FEVERISH SYMPTOMS AND FULL BODY ACHES THAT CAME ON 12 HOURS AFTER THE VACCINE AND LASTED FOR LESS THEN 24 HOURS.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV, VARZOS
Symptoms: Vaccination site reaction, Vaccination site warmth
Clinical narrative: PATIENT STATES RED, PAINFUL AND SLIGHTLY WARM RASH FOR 72 HOURS. RASH IS 6 INCH BY 3 INCH SIZE, ABOUT 3 INCHES LOWER THEN VACCINE AREA (RASH DOES NOT INCORPORATE EITHER OF THE VACCINE LOCATIONS). AREA IS NOT ITCHY BUT IT HAS BEEN HARD TO THE TOUCH FOR 24-48 HOURS.  COMPLAINS OF FEVERISH SYMPTOMS AND FULL BODY ACHES THAT CAME ON 12 HOURS AFTER THE VACCINE AND LASTED FOR LESS THEN 24 HOURS.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: states chronic pain in right shoulder "like bursitis" and can't lift over heard or vacuum and such. some days hurt worse than others but pain is there all the time.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain at injection site; Swelling at injection site; Joint pain; Body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site swelling, joint pain and general body pain. On an unknown date, the outcome of the injection site pain, injection site swelling, joint pain and general body pain were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, joint pain and general body pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's husband. The age at vaccination was not reported but it could be 64 or 65 years. The patient experienced pain at injection site, swelling at injection site, joint pain, body aches. The reporter asked to remain anonymous and did not provide demographics. This case has been linked with US2019161263, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: Pain at injection site; Not feeling well; This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain and feeling unwell. On an unknown date, the outcome of the injection site pain and feeling unwell were unknown.   It was unknown if the reporter considered the injection site pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix from her general patient population and had pain at injection site and not feeling well. It was a general observation but provided a small point of clarity stating that she has seen a greater of reaction from healthier patients as opposed to those whose immune system has declined.  No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: myalgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced myalgia. The patient was treated with paracetamol (Acetaminophen). On an unknown date, the outcome of the myalgia was recovered/resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The shingrix batch number was unknown. The physician reported that, after vaccination with dose of Shingrix, the patient experienced myalgia, which was relieved by acetaminophen and resolved in approximately two days. The reporter consent to follow up. No further details were provided. For tolerance to 2nd dose, refer case US2019162043.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Back pain, Cardiac disorder, Chest pain, Herpes zoster
Clinical narrative: Heart problem; Stabbing chest pain that went through to her back; Stabbing chest pain that went through to her back; Rash on breast; Pain under arm; Shingles; Arm swelled up really bad; Arm was very sore; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number XC972, expiry date 29th August 2021) and (batch number H2HM2, expiry date 29th August 2021) for prophylaxis.   On 23rd August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 23rd August 2019, less than a day after receiving Shingrix, the patient experienced swelling arm. On 4th September 2019, the patient experienced pain in arm, chest pain, back pain, rash, axillary pain and shingles. On an unknown date, the patient experienced heart disorder. On an unknown date, the outcome of the swelling arm, chest pain, back pain, rash, axillary pain, shingles and heart disorder were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the swelling arm, pain in arm, chest pain, back pain, rash, axillary pain, shingles and heart disorder to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient said her arm was swelled up really bad and was very sore for 3 or 4 days.  On 1st September 2019, the patient went to the emergency room with stabbing chest pain that went through to her back. The patient was checked for heart problems and released.  On 3rd September 2019, patient went to her family doctor with the same pain and a rash on her breast.  The pain also under her arm. The patient was diagnosed with Shingles. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Heart problem; Stabbing chest pain that went through to her back; Stabbing chest pain that went through to her back; Rash on breast; Pain under arm; Shingles; Arm swelled up really bad; Arm was very sore; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number XC972, expiry date 29th August 2021) and (batch number H2HM2, expiry date 29th August 2021) for prophylaxis.   On 23rd August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 23rd August 2019, less than a day after receiving Shingrix, the patient experienced swelling arm. On 4th September 2019, the patient experienced pain in arm, chest pain, back pain, rash, axillary pain and shingles. On an unknown date, the patient experienced heart disorder. On an unknown date, the outcome of the swelling arm, chest pain, back pain, rash, axillary pain, shingles and heart disorder were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the swelling arm, pain in arm, chest pain, back pain, rash, axillary pain, shingles and heart disorder to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient said her arm was swelled up really bad and was very sore for 3 or 4 days.  On 1st September 2019, the patient went to the emergency room with stabbing chest pain that went through to her back. The patient was checked for heart problems and released.  On 3rd September 2019, patient went to her family doctor with the same pain and a rash on her breast.  The pain also under her arm. The patient was diagnosed with Shingles. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: swelling at injection site; redness at injection site; hot to touch at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 30th November 2020) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st July 2019, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and skin warm. On 4th July 2019, the outcome of the extensive swelling of vaccinated limb, erythema of extremities and skin warm were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingix in left arm. The pharmacist reported that the injection site reactions the patient experienced spread throughout her left arm.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: swelling at injection site; redness at injection site; hot to touch at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 30th November 2020) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st July 2019, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and skin warm. On 4th July 2019, the outcome of the extensive swelling of vaccinated limb, erythema of extremities and skin warm were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingix in left arm. The pharmacist reported that the injection site reactions the patient experienced spread throughout her left arm.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Pruritus
Clinical narrative: 15 minutes after the injection and application of bandaid at injection site patient complained of itching. On evaluation of the site noted  redness 5-6cm around the injection site. Bandaid was removed. Continued to monitor site. within 45 minutes she no longer complained of itching and redness was almost gone.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: patient states she had a fever and chills and then an abdominal rash. she called md
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Pain, Pyrexia, Skin lesion
Clinical narrative: On same day mother reports patient had an elevated indurated large circular erythematous lesion that was painful and firm.  Slight tactile fever.  Pain slightly improved with Tylenol.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: On same day mother reports patient had an elevated indurated large circular erythematous lesion that was painful and firm.  Slight tactile fever.  Pain slightly improved with Tylenol.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Agitation, Dizziness, Dysphonia, Dyspnoea, Headache
Clinical narrative: Breathing problems started around 9pm-ish last night. I used a rescue inhaler various times throughout the middle of the night as well as this morning though it didn't help much; I'm still experiencing hoarseness and wheezing.  My heart was racing last night and I was agitated and dizzy. Within a couple hours, I felt a low-grade fever, body aches, a headache, and extreme sinus drainage/post nasal drip which hasn't let up yet and I'm still experiencing these symptoms.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Palpitations, Paranasal sinus hypersecretion, Pyrexia, Upper-airway cough syndrome
Clinical narrative: Breathing problems started around 9pm-ish last night. I used a rescue inhaler various times throughout the middle of the night as well as this morning though it didn't help much; I'm still experiencing hoarseness and wheezing.  My heart was racing last night and I was agitated and dizzy. Within a couple hours, I felt a low-grade fever, body aches, a headache, and extreme sinus drainage/post nasal drip which hasn't let up yet and I'm still experiencing these symptoms.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Wheezing
Clinical narrative: Breathing problems started around 9pm-ish last night. I used a rescue inhaler various times throughout the middle of the night as well as this morning though it didn't help much; I'm still experiencing hoarseness and wheezing.  My heart was racing last night and I was agitated and dizzy. Within a couple hours, I felt a low-grade fever, body aches, a headache, and extreme sinus drainage/post nasal drip which hasn't let up yet and I'm still experiencing these symptoms.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash macular
Clinical narrative: "red marks like blotches on my chest area and shoulders"
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: RED, MILD HOT/ INDURATED 4 X 5 CM AREA ON ANTERIOR LT. THIGH AT INJECTION SITE. TACTILE FEVER ON 09/13/2019 A.M RX- ORAL MOTRIN.;  SEEN TODAY AND RX 9/13/2019- TMP/SMX 7 ML P.O. BID X 7 DAYS ; DIPHENHYDRAMINE 2.5 ML Q6H PRN
Age: 98.0
Sex: F
Vaccine: PNC13
Symptoms: Palpitations
Clinical narrative: Res had palpitations that started in the evening of 8/3/19.  Physician notified.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Vaccination site cellulitis, Vaccination site induration
Clinical narrative: Developed cellulitis in the area the vaccine was administered.  Started ~7 days after vaccine was administered.  Developed fever, redness, induration at that site.  Started on oral antibiotics to treat it.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no known adverse effects; patient received a dose of M-M-R II via the intramuscular route in error; patient received a dose of M-M-R II via the intramuscular route in error; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 23-AUG-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, injection site, lot # and expiration date were not reported) for prophylaxis via intramuscular route in error. There was no known adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; improperly stored vaccine administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 23-AUG-2019, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # R035227, expiration date 01-JAN-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 50 degrees Fahrenheit for 49 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There was no adverse effects reported.
Age: 27.0
Sex: U
Vaccine: MMRV
Symptoms: Medication error, No adverse event
Clinical narrative: No adverse effects; the patient inadvertently received proquad due to medication error; This spontaneous report as received from a nurse refers to a 27-year-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 20-JUN-2019, the patient was inadvertently vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot number, expiration date and route of administration were not reported) dose of 0.5 ml, diluted in sterile diluent. The patient received the vaccine due to medication error. It was unknown if the intended vaccine was measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) or varicella virus vaccine live (Oka/Merck) (VARIVAX). Confirmed that was not product confusion. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 49 or 50 years. It was reported that the patient had 2 to 3 days of a sore arm and went away on its own. The reporter did not agree to follow up.
Sex: F
Vaccine: MENB
Symptoms: Chest pain, Chills, Dyspnoea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Fever; Chills; Soreness; Chest Pain; Difficulty breathing; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of pyrexia (received 1st dose on an unknown date and experienced chills, difficulty in breathing, refer case US2019161286).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fever, chills, pain, chest pain and difficulty breathing. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the fever, chills, pain, chest pain and difficulty breathing were unknown.   It was unknown if the reporter considered the fever, chills, pain, chest pain and difficulty breathing to be related to Bexsero.  Additional details were provided as follows: This case was reported by patient's mother. The age at vaccination was not provided. The reporter stated that, after vaccination, the patient experienced fever of 103.4 degree C. The patient's physician recommended for emergency room visit. No further details were provided. The reporter did not want to provide any demographic or address information.      Lab Comments: on a unknown date, patient had fever
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Have pain in my arm; This case was reported by a consumer and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: The patient experienced pain in arm. The patient waanted to know whether how long should this pain exist and should she get her second shot while her arm was still hurting at the time of reporting.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Feeling hot, Headache, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: My arm stated hurting; I got a headache; Felt feverish; Feel like I have the flu; This case was reported by a consumer and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 4th September 2019, the patient received the 1st dose of Shingrix and Flu vaccine. On 4th September 2019, 4 hrs after receiving Shingrix and Flu vaccine, the patient experienced pain in arm. In September 2019, the patient experienced headache, feeling hot and influenza like illness. On an unknown date, the outcome of the pain in arm, headache, feeling hot and influenza like illness were unknown.   It was unknown if the reporter considered the pain in arm, headache, feeling hot and influenza like illness to be related to Shingrix and Flu vaccine.  Additional case details were reported as follows: The patient got the first Shingrix vaccine the day before reporting. The patient received vaccine in unknown arm. The patient's husband did as well. They asked their local pharmacist about side effects, and he didnt seem to think there were any unusual ones. The patient arm stated hurting about 4 hours later, got a headache and felt feverish overnight and still do. The patient felt almost like that she had the flu. It has been about 30 hrs. since the injection. The patient reported that we did also get the flu shot at the same time, but we had got it many times with no side effects.  Our pharmacist said it should not cause a problem. The reporter requesting consent to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: lymphoma side effects of itchy feet and odd feeling to her left ear had resolved; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic drug effect in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included lymphoma, pruritus (Itchy feet) and night sweat.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced unexpected therapeutic drug effect. On an unknown date, the outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic drug effect to be related to Shingrix.  Additional details were provided as follows: The patient stated that shortly after vaccination she noticed that her lymphoma side effects of itchy feet and odd feeling to her left ear had resolved, and her night sweats, also a side effect of her lymphoma, was not as bad. The patient went to her oncologist. The patient was due for her second Shingrix vaccination at the end of September. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abnormal behaviour, Arthralgia, Asthenia, Bedridden
Clinical narrative: severe arthralgia; pleuritic pain; confusion; making stupid mistakes; myalgia; upset stomach; fever of approximately 100 degrees; chills; shakes; feeling weak; unable to get out of bed; This case was reported by a physician via call center representative and described the occurrence of myalgia in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (after receiving 1st dose, see case US2019AMR166034).   On 3rd September 2019, the patient received the 2nd dose of Shingrix. On 3rd September 2019, less than a day after receiving Shingrix, the patient experienced myalgia, upset stomach, fever, chills, tremor and feelings of weakness. On an unknown date, the patient experienced arthralgia, pleuritic pain, bedridden, confusion and behavior abnormal. On an unknown date, the outcome of the myalgia, upset stomach, fever, chills, tremor, arthralgia, pleuritic pain, bedridden, confusion and behavior abnormal were recovered/resolved and the outcome of the feelings of weakness was not recovered/not resolved.   It was unknown if the reporter considered the myalgia, upset stomach, fever, chills, tremor, feelings of weakness, arthralgia, pleuritic pain, bedridden, confusion and behavior abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number of Shingrix vaccine was not reported. The physician reported that, approximately 10 am on 3rd Septrember 2019, the patient received 2nd dose of Shingrix. After vaccination, the patient developed severe arthralgia, pleuritic pain, which described as pain on inhalation. The reporter reported that, the patient could not get out of bed for almost 2 days and also mentioned that, during those two days post vaccination experienced confusion, and making stupid mistakes on the computer. The confusion described as telling her son the same things more than once. The patient had fever of approximately 100 degrees. The patient stated that, at the time of reporting, the symptoms were recovered, but stii had feeling weak. The reporter consented to follow up. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Confusional state, Myalgia, Pleuritic pain, Pyrexia
Clinical narrative: severe arthralgia; pleuritic pain; confusion; making stupid mistakes; myalgia; upset stomach; fever of approximately 100 degrees; chills; shakes; feeling weak; unable to get out of bed; This case was reported by a physician via call center representative and described the occurrence of myalgia in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (after receiving 1st dose, see case US2019AMR166034).   On 3rd September 2019, the patient received the 2nd dose of Shingrix. On 3rd September 2019, less than a day after receiving Shingrix, the patient experienced myalgia, upset stomach, fever, chills, tremor and feelings of weakness. On an unknown date, the patient experienced arthralgia, pleuritic pain, bedridden, confusion and behavior abnormal. On an unknown date, the outcome of the myalgia, upset stomach, fever, chills, tremor, arthralgia, pleuritic pain, bedridden, confusion and behavior abnormal were recovered/resolved and the outcome of the feelings of weakness was not recovered/not resolved.   It was unknown if the reporter considered the myalgia, upset stomach, fever, chills, tremor, feelings of weakness, arthralgia, pleuritic pain, bedridden, confusion and behavior abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number of Shingrix vaccine was not reported. The physician reported that, approximately 10 am on 3rd Septrember 2019, the patient received 2nd dose of Shingrix. After vaccination, the patient developed severe arthralgia, pleuritic pain, which described as pain on inhalation. The reporter reported that, the patient could not get out of bed for almost 2 days and also mentioned that, during those two days post vaccination experienced confusion, and making stupid mistakes on the computer. The confusion described as telling her son the same things more than once. The patient had fever of approximately 100 degrees. The patient stated that, at the time of reporting, the symptoms were recovered, but stii had feeling weak. The reporter consented to follow up. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: severe arthralgia; pleuritic pain; confusion; making stupid mistakes; myalgia; upset stomach; fever of approximately 100 degrees; chills; shakes; feeling weak; unable to get out of bed; This case was reported by a physician via call center representative and described the occurrence of myalgia in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (after receiving 1st dose, see case US2019AMR166034).   On 3rd September 2019, the patient received the 2nd dose of Shingrix. On 3rd September 2019, less than a day after receiving Shingrix, the patient experienced myalgia, upset stomach, fever, chills, tremor and feelings of weakness. On an unknown date, the patient experienced arthralgia, pleuritic pain, bedridden, confusion and behavior abnormal. On an unknown date, the outcome of the myalgia, upset stomach, fever, chills, tremor, arthralgia, pleuritic pain, bedridden, confusion and behavior abnormal were recovered/resolved and the outcome of the feelings of weakness was not recovered/not resolved.   It was unknown if the reporter considered the myalgia, upset stomach, fever, chills, tremor, feelings of weakness, arthralgia, pleuritic pain, bedridden, confusion and behavior abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number of Shingrix vaccine was not reported. The physician reported that, approximately 10 am on 3rd Septrember 2019, the patient received 2nd dose of Shingrix. After vaccination, the patient developed severe arthralgia, pleuritic pain, which described as pain on inhalation. The reporter reported that, the patient could not get out of bed for almost 2 days and also mentioned that, during those two days post vaccination experienced confusion, and making stupid mistakes on the computer. The confusion described as telling her son the same things more than once. The patient had fever of approximately 100 degrees. The patient stated that, at the time of reporting, the symptoms were recovered, but stii had feeling weak. The reporter consented to follow up. No further details were provided.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Bursitis, Hypoaesthesia, Injected limb mobility decreased, Injection site bruising, Injection site pain
Clinical narrative: sack of fluid on elbow; numbness feeling on left arm; soreness at injection site; bruise at injection site; difficulty lifting arm; rash on chest; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site bruising, injected limb mobility decreased and rash. On 9th July 2019, the patient experienced elbow bursitis and numbness of upper extremities. On 13th July 2019, the outcome of the injection site bruising, injected limb mobility decreased and rash were recovered/resolved. On 9th August 2019, the outcome of the elbow bursitis and numbness of upper extremities were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site bruising, injected limb mobility decreased, rash, elbow bursitis and numbness of upper extremities to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient experienced difficulty lifting arm, rash on chest, sack of fluid on elbow and numbness feeling on left arm. The patient planned to follow up with his pharmacist on an unknown date. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: sack of fluid on elbow; numbness feeling on left arm; soreness at injection site; bruise at injection site; difficulty lifting arm; rash on chest; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site bruising, injected limb mobility decreased and rash. On 9th July 2019, the patient experienced elbow bursitis and numbness of upper extremities. On 13th July 2019, the outcome of the injection site bruising, injected limb mobility decreased and rash were recovered/resolved. On 9th August 2019, the outcome of the elbow bursitis and numbness of upper extremities were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site bruising, injected limb mobility decreased, rash, elbow bursitis and numbness of upper extremities to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient experienced difficulty lifting arm, rash on chest, sack of fluid on elbow and numbness feeling on left arm. The patient planned to follow up with his pharmacist on an unknown date. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included allergic reaction.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Flu vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced hives with the flu vaccine. The pharmacist inquired if a patient who was allergic to the flu shot (unknown if it was a GSK brand or non-GSK), would be okay to get the Shingrix vaccine. The healthcare professional declined to leave any patient demographics. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Patient reports onset 1 day ago with redness at injection site, feverish, started the morning after injection. Today redness still at injection site, are is warm to touch, pain at site, area is "hard". Patient states she has been taking tylenol for the pain and fever. Ice to injection site
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site reaction, Rash macular
Clinical narrative: -pt arrived on 9/7/19 at pharmacy presented with  a non raised Red Blotchy Rash on medial left arm -referred pt to pcp -follow up with pt. pt has not responded to calls  pt has not responded to follow up requests
Age: 71.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient returned to pharmacy and stated he received 3 doses of Shingrix. Confirmed patient was vaccinated on 8/8/2018, 12/27/2018, 9/10/2019.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB, PPV, VARCEL
Symptoms: Abnormal behaviour, Acoustic stimulation tests normal, Autism spectrum disorder, Chromosome analysis normal, Decreased eye contact
Clinical narrative: Patient fell asleep on the way home from her vaccinations. She woke up within an hour or so. Around 3:00pm she spiked a fever of 104.4 so I gave her Tylenol. 4-6 hours later I gave her Motrin and a luke warm bath. Her fever remained high for 3 consecutive days and eventually breaking by day 4. I continued alternating the motrin/tylenol during this time as medical professionals in my family suggested. During that time, she began banging her head like she was in pain, screaming a very loud pitch sound I had never heard before and just wasn't "herself" The fever broke, but her behaviors continued. Within 4-6 weeks she lost all words, eye contact, and socialization. Her behaviors remained the same and I then took her into her Pediatrician. Her doctor referred us to a Ped Neurologist where they then began tests. She began to have chronic ear infection and tubes were placed in July 2018 by Dr at the Medical Clinic.