chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash, Skin burning sensation
Clinical narrative: I have had 2 shingles outbreaks previous to receiving Shingrix. My outbreaks weren't exactly typical as the rashes were small and in unusual places - I had one outbreak on the sole of my foot. The pain would be intense but manageable before the outbreak, easing off once the blisters surfaced. All told an outbreak would last a week to 10 days.   I had Shingrix about 6 months ago. Several weeks ago I pulled a muscle in my back. My back was seizing up, and the pain was migrating around the front of my torso and into my stomach. My whole left side of my torso was in excruciating pain. I first went to an urgent care clinic and was prescribed muscle relaxers. They did nothing. That night the pain was so bad I went to the emergency room. I was given an IV anti-inflammatory drug - nothing. I was then given an IV opioid, which took the edge off.   I was prescribed opioids, and they helped if I took enough. Then the skin on my stomach started to get that burning/itching feeling and I recognized it as shingles. I had a rash on my left buttocks. I went to my provider and she confirmed my condition. I was prescribed neurontin.   Instead of my normal 7 - 10 day manageable outbreak, this one has lasted 18 days and counting. Not only that, but the pain was at a level I never experienced. I've done a full course of Valtrex, but the shingles remains. The rash has now cleared up, but the skin and stomach pain remain.  In my experience, Shingrix not only didn't prevent an outbreak it actually intensified the symptoms X3.   I have HSV2, if that has any bearing on anything.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Dry eye, Eyelid function disorder, Facial paralysis, Musculoskeletal stiffness, Neck pain
Clinical narrative: Right sided Lip tingling with facial drooping. C/o neck pain and stiffness on right side. States eye will not close completely and is drying out.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia oral
Clinical narrative: Right sided Lip tingling with facial drooping. C/o neck pain and stiffness on right side. States eye will not close completely and is drying out.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm. Hurts when I move it over my head.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Pt was administered proquad by intramuscular injection instead of subcutaneous. no adverse effects noted.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Dizziness
Clinical narrative: Donor had adverse event reported on return to center, donor reported lightheadedness x1 day and aching in joints x 4 days which is still unresolved at time of DAE.
Age: 19.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Blood glucose increased, Presyncope
Clinical narrative: vasovagal response
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Emotional distress, Headache, Injection site pain, Injection site rash, Irritability
Clinical narrative: Fever on the day of injections 102.9 (4hours later) Rashes on forehead, arms, cheeks, trunk.  Headache, fussiness, emotional, and left/right arm pain. All started about 4/6 hours after injections and are still ongoing
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Fever on the day of injections 102.9 (4hours later) Rashes on forehead, arms, cheeks, trunk.  Headache, fussiness, emotional, and left/right arm pain. All started about 4/6 hours after injections and are still ongoing
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site inflammation, Lymphadenopathy, Musculoskeletal chest pain
Clinical narrative: 2/27/19 swollen right axillary nodes, mild inflammation and mild erythema at injection site(right deltoid), pain right arm and right lateral chest wall, unable to lift arm
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in extremity
Clinical narrative: 2/27/19 swollen right axillary nodes, mild inflammation and mild erythema at injection site(right deltoid), pain right arm and right lateral chest wall, unable to lift arm
Age: 8.0
Sex: M
Vaccine: UNK
Symptoms: Dyspnoea, Syncope
Clinical narrative: There were 5 Vaccines administered at one time as ordered by Department of Education for my child to attend School. I did NOT consent to this action but my wife, and parent of the patient, did.  My Child is NOT fully Immunized.  During the Administration of the Second round of Immunization as Pt received 3 separate Immunizations in his arm separated by a 15 minute break and then the remaining Immunizations were administered into the opposite arm.  While pt was heavily Restrained by Staff and his Mother was called on to assist in restraining my child, pt cried out "I can't Breath, I can't Breath".  This was followed by dead silence.  The Nurse administering the Immunizations asked my wife, "Did he pass out? "  and again she asked, "Is he OUT!"  Syncope resulted and after a few moments, my child regained breathing after the blood flow was restored to his brain.   My wife is under Order of the Department of Education, Complaint 21,199 that says pt Must be fully Immunized with the first dose of EVERY Immunization "SERIES" by August 12th or he will be unable to attend School On Sept 4,2019 because govt official signed into law Banning Religious Exemptions from Immunizations in School which I pay Taxes to.  I called and asked for information on the Vaccines and received none.  I Notified the Dr's Office that I will be filing a report based on the information my WIFE told me at this visit.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling hot, Hyperhidrosis, Loss of consciousness, Seizure
Clinical narrative: Donor had seizure/ convulsion in parking lot of facility 52 minutes after immunization was given. Donor other symptoms include warmth, sweating, loss of consciousness for 5 minutes, convulsions lasting 30-45 seconds after medical staff arrived. EMS was called and donor was transported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: received improperly stored doses of VARIVAX; No adverse effects reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R030612, expiration date 21-OCT-2020 ) (strength, exact dose and route of administration were not reported) for prophylaxis. It was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # and expiration date not reported). No adverse effects were reported. Administered dose of vaccines experienced the temperature excursion between 15 and 46 Fahrenheit degrees (also reported as between -9 and 8.Celsius degrees; also reported as 17.6 Fahrenheit degrees) for 2 hours. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA013180:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: received improperly stored doses of VARIVAX; No adverse effects reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R030612, expiration date 21-OCT-2020 ) (strength, exact dose and route of administration were not reported) for prophylaxis. It was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # and expiration date not reported). No adverse effects were reported. Administered dose of vaccines experienced the temperature excursion between 15 and 46 Fahrenheit degrees (also reported as between -9 and 8.Celsius degrees; also reported as 17.6 Fahrenheit degrees) for 2 hours. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001755:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; received unspecified dose of Varivax series that was improperly stored; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 25-JUN-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # S003448, expiration date 04-FEB-2021) for prophylaxis (exact dose, frequency, route of administration was not reported). The patient's concomitant therapies included properly stored sterile diluent. The dose of vaccine experienced a temperature excursion of 12.4 degrees Fahrenheit for 16 minutes. No previous temperature excursion was reported. Data logger was involved in recording the excursion details. No adverse event was reported.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Peripheral sensory neuropathy
Clinical narrative: sensitivity in nerves; pain in nerves/ sensitivity in nerves; This case was reported by a consumer via call center representative and described the occurrence of sensory neuropathy in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure. Concomitant products included medication unknown (Blood Pressure Medication).   On 15th January 2019, the patient received the 1st dose of Shingrix 50 ug. On 18th January 2019, 3 days after receiving Shingrix, the patient experienced sensory neuropathy and nerve pain. On 19th January 2019, the outcome of the sensory neuropathy and nerve pain were recovered/resolved.   It was unknown if the reporter considered the sensory neuropathy and nerve pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced all nerves were very sensitive lighted like a large tree. The pain in all nerves. This was lasted for 1 day. Three months after getting the shot the patient had contacted her healthcare professional regarding her experience. The case has been linked with the case US2019AMR083024, reported for the dose 2 of the same patient.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Injection site rash, Rash
Clinical narrative: Shot given to me in left arm at the pharmacy where the rx had been sent by my doctor.  I had head ache right away and a little dizzy then 2 days after shot broke out in hives on neck/face and a rash on arm right below injection and on the right side of my abdomen
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Shot given to me in left arm at the pharmacy where the rx had been sent by my doctor.  I had head ache right away and a little dizzy then 2 days after shot broke out in hives on neck/face and a rash on arm right below injection and on the right side of my abdomen
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Tenderness, Urticaria
Clinical narrative: itchy, erythema, whelp (3.5"x4"), tender to touch
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product preparation issue
Clinical narrative: Hib component of vaccine omitted.  Diluent of Dtap and IPV given.  Called parent of patient to return for administration of Hib. CDC    recommended VAERS report made.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, firmness, and swelling to the L arm at the site of injection.  Patient complaining of itching at the site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: received Shingrix at 10:00am; developed high fever of 103 degrees Fahrenheit at 9:00pm with shaking from 9:00pm-12:00am; took Tylenol and did not go to hospital or call doctor.  at 7:00am on 7/30 temperature was low grade at ~100 degrees Fahrenheit and patient was feeling better.  Pharmacy was called at 10:00am on 7/30 with report from patient and she was encouraged to call her doctor with the report as well
Age: 1.33
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Papule, Skin lesion
Clinical narrative: 7cm x 6cm area of redness with mild induration with slightly raised football shaped lesion in the center and 4 papular lesions.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe pain, swelling, and redness on entire upper right arm and shoulder
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Electrocardiogram normal, Loss of consciousness, Muscle rigidity, Nausea, Seizure like phenomena
Clinical narrative: ADMINISTERD HPV IN R ARM. STEPPED  TO PATIENT'S LEFT SIDE TO ADMINISTER MENINGOCOCCAL VACICNE INTO  L ARM., BUT I NEVER GAVE MENINGOCOCCAL VACCINE.  PATIENT ASKED "AM I SUPPOSE TO FEEL NAUSATED?" THEN, PATIENT BECAME UNCONCIOUS WITH  RIGID  SEIZURE LIKE ACTIVITY NOTED. PATIENT REGAINED COUNSCIOUSNESS IN LESS THAN 30 SECONDS, BUT STILL C/O OF NAUSEA.  COOL TOWEL TO FOREHEAD.  B/P 87/60. PULSE 69. 911 CALLED.  TRANSPORTED TO LOCAL HOSPITAL.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Influenza like illness, Injection site pain, Injection site pruritus, Local reaction
Clinical narrative: Received dose #1 of Heplisav-B on 7/19/19.  At first, it seemed she was having a localized reaction with pain and swelling within a couple of hours.  The site was also itchy.  She self-treated with ice only, no topical anti-itch cream. Her symptoms have continued with achy, flu-like symptoms. This past weekend she has also been feverish. On 7/29/19 the redness has subsided, but it is now purplish in color.  The site is throbbing and she is still achy and flu-like.  She is probably going home sick today. Sent for evaluation, but declined at this time.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pyrexia, Skin discolouration, Swelling
Clinical narrative: Received dose #1 of Heplisav-B on 7/19/19.  At first, it seemed she was having a localized reaction with pain and swelling within a couple of hours.  The site was also itchy.  She self-treated with ice only, no topical anti-itch cream. Her symptoms have continued with achy, flu-like symptoms. This past weekend she has also been feverish. On 7/29/19 the redness has subsided, but it is now purplish in color.  The site is throbbing and she is still achy and flu-like.  She is probably going home sick today. Sent for evaluation, but declined at this time.
Age: 19.0
Sex: F
Vaccine: HPV9, MMR, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Pt was only to have have varicella and HPV vaccines.  Given MMR unecessarilynone
Age: 53.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Dry skin, Erythema, Injection site reaction, Urticaria
Clinical narrative: Patient complains of reaction to the lower shot (Boostrix). Developed a hive for 2 weeks. When the redness disappeared, a patch of dry skin appeared. Dry skin patch has persisted for 1 month and there is a visible mark from injection site. Patient sought medical advice. treated with hydrocortisone cream with no relief.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Eye pain
Clinical narrative: 7/24/19: Pain at injection site.    7/25/19 Chills, body aches, head ache, nausea, vomiting, low grade fever (100), pain at injection site. 7/26/19 Head ache, body aches (especially backache), weakness, dizziness, nausea, pain at injection site. 7/27/10 Weakness, intermittent dizziness and nausea, eye pain, difficulty talking due to weakness, intermittent fever-like symptoms (chills, aches) 7/28/19 Weakness, tiredness, dizziness. Diarrhea Eye pain 7/29/19  Weakness, eye  pain, diarrhea, dizziness 7/30/19 Weakness, tired, eye pain, diarrhea,  dizziness
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pain
Clinical narrative: 7/24/19: Pain at injection site.    7/25/19 Chills, body aches, head ache, nausea, vomiting, low grade fever (100), pain at injection site. 7/26/19 Head ache, body aches (especially backache), weakness, dizziness, nausea, pain at injection site. 7/27/10 Weakness, intermittent dizziness and nausea, eye pain, difficulty talking due to weakness, intermittent fever-like symptoms (chills, aches) 7/28/19 Weakness, tiredness, dizziness. Diarrhea Eye pain 7/29/19  Weakness, eye  pain, diarrhea, dizziness 7/30/19 Weakness, tired, eye pain, diarrhea,  dizziness
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Speech disorder, Vomiting
Clinical narrative: 7/24/19: Pain at injection site.    7/25/19 Chills, body aches, head ache, nausea, vomiting, low grade fever (100), pain at injection site. 7/26/19 Head ache, body aches (especially backache), weakness, dizziness, nausea, pain at injection site. 7/27/10 Weakness, intermittent dizziness and nausea, eye pain, difficulty talking due to weakness, intermittent fever-like symptoms (chills, aches) 7/28/19 Weakness, tiredness, dizziness. Diarrhea Eye pain 7/29/19  Weakness, eye  pain, diarrhea, dizziness 7/30/19 Weakness, tired, eye pain, diarrhea,  dizziness
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported.; one dose of expired ROTATEQ (lot N030176 exp 6/17/2019) was inadvertently administered on 7/12/2019 to the patient; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.    On 12-JUL-2019, one dose of expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot N030176, expiration date 17-JUN-2019) was inadvertently administered to the patient. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects; The patient, who is an adult, was inadvertently administered one dose of the pediatric VAQTA; This spontaneous report was received from a medical assistant concerning an adult patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 26-JUL-2019, the patient was inadvertently administered one dose of the pediatric hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R034339, expiration date 23-NOV-2019 for prophylaxis (frequency and route of administration were not reported) (product administered to patient of inappropriate age).     No adverse effects were reported.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Facial paralysis
Clinical narrative: bell's palsey; This case was reported by a physician via call center representative and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Flu vaccine. On an unknown date, unknown after receiving Shingrix and Flu vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix and Flu vaccine.  Additional details were provided as follows. The age at vaccination was not reported. The retired neurologist reported that his colleague retired gerontologist received first dose of Shingrix on an unknown date and experienced bell's palsey. The patient also received a flu shot on the same day as Shingrix, in the opposite arm. No further details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Inappropriate schedule of product administration, Malaise, Myalgia
Clinical narrative: Vaccination failure; shingles; became ill; headache; myalgia; inappropriate schedule of vaccine; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received the Zostavax vaccine about seven years ago).   In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling unwell, headache, myalgia and drug dose administration interval too short. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles, feeling unwell, headache, myalgia and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the feeling unwell, headache and myalgia to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. Last summer before the date of reporting, the patient received Shingrix and 2nd dose 7 weeks later, earlier than recommended interval, led to the shortening of vaccination schedule between 1st and 2nd dose. A few hours later after the 2nd dose the patient became ill with headache, myalgia and other symptoms. The next day the patient felt better. Three days before the date of reporting the patient came up with shingles on my right side. Within six hours the patient started Valacyclovir.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Vaccination failure; shingles; became ill; headache; myalgia; inappropriate schedule of vaccine; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received the Zostavax vaccine about seven years ago).   In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling unwell, headache, myalgia and drug dose administration interval too short. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles, feeling unwell, headache, myalgia and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the feeling unwell, headache and myalgia to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. Last summer before the date of reporting, the patient received Shingrix and 2nd dose 7 weeks later, earlier than recommended interval, led to the shortening of vaccination schedule between 1st and 2nd dose. A few hours later after the 2nd dose the patient became ill with headache, myalgia and other symptoms. The next day the patient felt better. Three days before the date of reporting the patient came up with shingles on my right side. Within six hours the patient started Valacyclovir.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 9LG54, expiry date 25th September 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 7th June 2019, the patient received the 2nd dose of Shingrix. On 21st July 2019, less than a year after receiving Shingrix and 44 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that patient developed Shingles on 21st July 2019, after receiving 2nd dose of Shingrix on 7th June 2019. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of herpes zoster were unknown at the time of reporting. The reporter was consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Musculoskeletal pain, Peripheral swelling
Clinical narrative: SWOLLEN; RED; SHOULDER PAIN; could not move arm; This case was reported by a nurse via call center representative and described the occurrence of swelling arm in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 3LL4P, expiry date unknown) for prophylaxis.   The patient's past medical history included surgery (2 for removal of tumor) and neoplasm.   On 17th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, shoulder pain and injected limb mobility decreased. On an unknown date, the outcome of the swelling arm, erythema of extremities, shoulder pain and injected limb mobility decreased were recovering/resolving.   It was unknown if the reporter considered the swelling arm, erythema of extremities, shoulder pain and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine on left arm and by 20th July 2019 arm was improving. He had to use the other arm to move the injured arm. Previously the patient had 2 surgeries for removal of a tumor, 32 radiation zaps in the Left arm. The reporter gave consented to follow up.
Age: 26.0
Sex: M
Vaccine: MENB, MNQ, TDAP
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever/chills, nausea, and headache started about 1.5 hours after vaccine administration. Pt presented back to clinic 2.5 hours after vaccine administration. Highest temperature in clinic was 103.1 F. 400 mg of ibuprofen given, water and patient observed for 1 hour. Temperature decreased to 101.9 prior to pt leaving clinic. Pt reports continued fever and chills 24 hours after vaccine administration but is responding to Tylenol and ibuprofen.
Age: 10.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Fall, Pallor
Clinical narrative: Dr. order Tdap, VZV, PPD, IPV PPD was first, Tdap, second, VZV, IPV, last mmr after Tdap was give pt look pale, but did not faint until mmr was given, I forgot bandaid went to get a bandaid after I came back pt was in the floor grab her and called or and put her in the Table (no eye rolling back) pt stayed in the room for 20 min
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Fatigue, Nausea
Clinical narrative: 2 hours after being given the vaccine he experienced fatigue,  nausea, and diarrhea.  He came back to the clinic for evaluation.  He did not have a fever, swelling , difficulty breathing, rash or any other symptoms.  Information given to Dr who agreed to close follow up.  Patient agreed with this plan.  RN call back to follow up7/30/19 and he is feeling back to base line, no diarrhea or nausea noted.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia, Nausea, Pollakiuria
Clinical narrative: Severe headache, fever, chills, nausea, frequent urination, and could not sleep.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe headache, fever, chills, nausea, frequent urination, and could not sleep.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Muscle pain, fever of 101.5 degrees, chills
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site induration, Rash macular, Type IV hypersensitivity reaction, Vaccination site nodule
Clinical narrative: Subjective   HPI Cc: f/u reaction to vaccination of R thigh.    Had been seen at Urgent care 7/19 on amoxicillin for OM. 1.5 cm raised redness, with large knot underneath per Mom.     No limp. + tenderness to touch.  No fever.  No drainage.    Reviewed and updated this visit by provider: Meds | Problems | Med Hx | Surg Hx | Fam Hx |      Review of Systems    The following systems are negative for significant symptoms except as documented in the assessment/HPI: General, ENT, CV, Resp, GI, GU, MS, Derm, and Neuro g     Objective    Pulse 144  | Temp 36.6 °C (97.9 °F) (Temporal)  | Resp 32  | Wt 12.9 kg (28 lb 7 oz)  | BMI 18.64 kg/m²    Physical Exam    Playing and active in exam room as I entered. No limp.    R thigh. 1.5 cm area of blotchy redness. Deep to this there is a silver dollar sized area of induration. No fluctuance to this. The entire area is tender to the child.     Assessment    1. Adverse effect of vaccine, initial encounter        PedvaxHib given R thigh, 7/25/2019 Probably delayed type sensitivity to a vaccine component, possibly aluminum.    VAERS report done.      Plan     Observation for the next 48 hours. Call for any drainage, worsening redness. Fever. Brief review of literature on these types of reactions. Consultation with Dr. as well.  Today, I personally spent 25 minutes in direct face to face time with the patient, of which greater than 50% of the time was spent in patient education, counseling, and coordination of care as described above.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Subjective   HPI Cc: f/u reaction to vaccination of R thigh.    Had been seen at Urgent care 7/19 on amoxicillin for OM. 1.5 cm raised redness, with large knot underneath per Mom.     No limp. + tenderness to touch.  No fever.  No drainage.    Reviewed and updated this visit by provider: Meds | Problems | Med Hx | Surg Hx | Fam Hx |      Review of Systems    The following systems are negative for significant symptoms except as documented in the assessment/HPI: General, ENT, CV, Resp, GI, GU, MS, Derm, and Neuro g     Objective    Pulse 144  | Temp 36.6 °C (97.9 °F) (Temporal)  | Resp 32  | Wt 12.9 kg (28 lb 7 oz)  | BMI 18.64 kg/m²    Physical Exam    Playing and active in exam room as I entered. No limp.    R thigh. 1.5 cm area of blotchy redness. Deep to this there is a silver dollar sized area of induration. No fluctuance to this. The entire area is tender to the child.     Assessment    1. Adverse effect of vaccine, initial encounter        PedvaxHib given R thigh, 7/25/2019 Probably delayed type sensitivity to a vaccine component, possibly aluminum.    VAERS report done.      Plan     Observation for the next 48 hours. Call for any drainage, worsening redness. Fever. Brief review of literature on these types of reactions. Consultation with Dr. as well.  Today, I personally spent 25 minutes in direct face to face time with the patient, of which greater than 50% of the time was spent in patient education, counseling, and coordination of care as described above.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Computerised tomogram head, Deafness unilateral, Echocardiogram, Nuclear magnetic resonance imaging
Clinical narrative: Pt has completely lost the hearing in her left ear, this happened approximately 4 weeks after receiving her first Shingrix immunization..
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Axillary mass, Erythema, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Tender to touch at injection site 5 hours after shot was given, At 24 hours front of upper arm hot, hard and painful. used Ice for 3 day along with ibuprofen 800mg every 4 to 5 hours for 3 days. Redness to back of arm on day 4, still painful and swollen. Day 5 painful to touch injection site. Redness and lump about 3 Inches long and went to the armpit. Patient has pictures.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Tender to touch at injection site 5 hours after shot was given, At 24 hours front of upper arm hot, hard and painful. used Ice for 3 day along with ibuprofen 800mg every 4 to 5 hours for 3 days. Redness to back of arm on day 4, still painful and swollen. Day 5 painful to touch injection site. Redness and lump about 3 Inches long and went to the armpit. Patient has pictures.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Nausea
Clinical narrative: Headache, exhaustion, shivering, feverish, nausea, sweating
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Headache, exhaustion, shivering, feverish, nausea, sweating
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse affects reported; a second dose ofVAQTA was given on 3/29/2019 after the first dose was given on 1/3/2019.; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 03-JAN-2019, the patient was vaccinated with their firs dose of hepatitis a vaccine, inactivated(VAQTA) lot # R034339, expiration date 23-NOV-2019, (dose, frequency, route, vaccination site were not reported), for prophylaxis  On 29-MAR-2019, the patient was vaccinated with their second dose of hepatitis a vaccine, inactivated(VAQTA) lot # R034339, expiration date 23-NOV-2019, (dose, frequency, route, vaccination site were not reported), for prophylaxis.  No adverse affects reported.
Sex: M
Vaccine: HPV9
Symptoms: Syncope, Vomiting
Clinical narrative: the patient fainted; vomited; This spontaneous report was received from a medical assistant via a company representative and refers to a male patient of unknown age. 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) injection (dose, route and site of administration, lot# and expiration date were not reported) for prevention of human papillomavirus (HPV) related diseases. On the same day, the patient was vaccinated with other unspecified vaccines (manufacturer unknown). The patient fainted and vomited after the administrations, while he was still at the office.  The outcome of syncope and vomiting was reported as recovered, on an unknown date. The causality assessment between the events and suspect therapy was not provided.  Upon internal review, the event of syncope was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 28th June 2019, the patient received the 2nd dose of Shingrix. On 28th June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced circumstance or information capable of leading to medication error. On an unknown date, the outcome of the drug dose administration interval too short and circumstance or information capable of leading to medication error were unknown.  Additional details were provided as follows: The age at vaccination was not reported at time of reporting. The age group was not reported but it was selected as adult as per the vaccine indication.  The patient had 1st Shingrix shot on 29th April 2019. The patient reported that when the pharmacy gave the paperwork it said 2nd Shingrix shot was due on 28th June 2019. The patient wanted to know would it be okay if had second shot one day before the exact 2 month mark and if administered might lead to, circumstance or information capable of leading to medication error and shortening of vaccination schedule. The patient asked am still protected.   Follow up information received from the consumer on 22nd July 2019: The patient's demographic details were updated. The patient stated that she did not experienced any side effect apart from arm pain from Shingrix vaccine. Less than a year after vaccination, the patient expereinced arm pain. Previously, captured medication error events (drug dose administration interval too short  and circumstance or information capable of leading to medication error) were deleted since deviation was allowed for Shingrix.  No new details were available. The patient denied permission to contact her physician.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Fainting; This case was reported by a physician via sales rep and described the occurrence of fainting in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   In July 2019, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. In July 2019, less than an hour after receiving Bexsero, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero sometime in the last week from the reporting date. The patient fainted after vaccination of Bexsero. The reporter stated that, a protocol was made in place to make patients wait at least 15 minutes following vaccination due to this event. This case has been linked to US2019133846, reported by the same reporter.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Heart rate increased, Tachycardia
Clinical narrative: About 40 minutes after the vaccination, my patient developed tachycardia with routine movement and ambulation along with lightheadedness. Heart Rate would go from 78-118.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Epistaxis, Full blood count, Immune thrombocytopenic purpura, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: Bloody nose for 2 1/2 hours, on 6-21-19. Pt was seen in the emergency room, a nasal clamp was placed, without results. Pt was found to have a platelet count of 6000, was transferred to Medical Center. He was treated with Prednisolone & Tranexamic Acid and diagnosed with Acute Idiopathic thrombocytopenic purpura.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient received Shingrix  vaccine on  7/25/19. The site became itchy and red the next day. Redness spread down arm . Site is not tender; however, it is red with heat to it. Pt states the site itches from time to time.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Lymphadenopathy, Pyrexia
Clinical narrative: Fever, left facial pain, left preauricular lymphadenopathy
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Rash all over body, on trunk, palms, legs; denies breathing difficulty or throat/tongue swelling Treatment: Depo-Medrol : 1.5 mL (Dose No:1) (Route: Intramuscular) given on left buttock
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood magnesium, Chills, Dizziness, Fatigue
Clinical narrative: Patient came into the office on 7/26/2019 with sudden onset of severe weakness, fatigue, intermittent muscle cramps, headache, chills and dizziness 12 hours after Shingrix vaccine.   Magnesium, CBC and CMP labs were done at visit.  Patient was advised to take Meloxicam and Tylenol for the pain/body aches, stay hydrated and maintain a light diet.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count, Headache, Metabolic function test, Muscle spasms
Clinical narrative: Patient came into the office on 7/26/2019 with sudden onset of severe weakness, fatigue, intermittent muscle cramps, headache, chills and dizziness 12 hours after Shingrix vaccine.   Magnesium, CBC and CMP labs were done at visit.  Patient was advised to take Meloxicam and Tylenol for the pain/body aches, stay hydrated and maintain a light diet.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: I am 29 weeks pregnant and was ordered by my obgyn Dr to take the TDAP vaccine now for my baby to have coverage at birth since I am in my 3rd trimester.   I recieved the tdap vaccine 7/29/19.  Today 7/30/19 I woke up with a red swollen area on my left deltoid measuring 2inches by 2 inches approximately.  I've had the TDAP vaccine before and this has never happened.  I've also given this vaccine before to many children and never seen it happen so I feel it is necessary to report it.  My arm is extremely sore at this time.  I know I should have some soreness but this swelling and extreme pain is very concerning.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Axillary pain, Dizziness, Headache, Injection site pain
Clinical narrative: Fever, severe headache, pain starting from injection site (left arm) traveling up arm, up back of neck then to right shoulder and down right arm to elbow, dizziness, nausea, weakness. 24 hours after injection, node under left armpit swelled to egg size with soreness and pain.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Lymphadenopathy, Musculoskeletal pain, Nausea, Neck pain, Pain in extremity
Clinical narrative: Fever, severe headache, pain starting from injection site (left arm) traveling up arm, up back of neck then to right shoulder and down right arm to elbow, dizziness, nausea, weakness. 24 hours after injection, node under left armpit swelled to egg size with soreness and pain.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Fever, severe headache, pain starting from injection site (left arm) traveling up arm, up back of neck then to right shoulder and down right arm to elbow, dizziness, nausea, weakness. 24 hours after injection, node under left armpit swelled to egg size with soreness and pain.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Patient began having problems with hives about 2 1/2 days following vaccination. They began traveling up the body towards the face. Benadryl wasn't really keeping them under control. On day 4 following vaccination they made a visit to their healthcare provider. At that time, the provider had patient start taking Zyrtec daily. About 1 1/2 weeks after vaccination he was still having trouble with hives on and off with not much relief. After a call to the healthcare provider, they added Claritin daily to his medicine regimen along with continuing Benadryl as needed. At almost two weeks following vaccination, patient encounters the hives about once at day, around two in the morning. They haven't gone away.  Mother reports no other issues at this time. Patient has not had issues with vaccination in the past.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Musculoskeletal disorder, Pain in extremity, Peripheral swelling
Clinical narrative: Extreme arm aching, pain, and upper arm swelling - no relief with NSAIDS or heat or muscle rub. Unable to sleep or use arm normally.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Balance disorder, CSF protein increased, Guillain-Barre syndrome, Nuclear magnetic resonance imaging
Clinical narrative: Guillain-Barre syndrome following vaccination per neurology Difficulty keeping his balance, marked weakness in dorsiflexion of his feet bilaterally, and elevated protein in his cerebrospinal fluid occurred approximately 3 weeks post vaccination.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Rash appeared within half an hour of being vaccinated. 7-29-19 patient developed varicella rash.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Patient claims that her arm was swollen after the shot, but 24 hours later the symptoms were red, swollen, painful, puffy, and tender. Her first shot back in April 2019, she only experienced a swollen arm but not to the level of these symptoms.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt fainted in car with parent in parking lot
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Head injury, Loss of consciousness, Malaise
Clinical narrative: Per history by mother  -- After teen was roomed by the CMA, vaccines were given;  CMA left the room afterwards and teen told mother that she did not feel well, and spontaneously "passed out", hit her head on the wall and fell on the floor.    Per clinic team:  Teen's mother was screaming in the room and available team members responded.  Teen was found sitting on the floor, awake - started to speak "what happened?".  Team member asked if she was alright - teen reported " I am okay".
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Crying, Face oedema, Rash macular, Rash pruritic
Clinical narrative: Mother reported pt had been scratching the rash it was diffused, pink and red splotches. facial edema present.. pt cried when mother tried to put Benadryl cream to sooth her.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Myalgia, Nausea, Pain in extremity
Clinical narrative: SWELLING AND PAIN IN RIGHT ARM FROM INJECTION SITE TO WRIST, PROGRESSED WITH FEVER, NAUSEA, VOMITING, MUSCLE ACHES, ITCHING.  TREATED WITH BENADRYL AND IBUPROFEN.  SYMPTOMS PERSISTED UNTIL MONDAY, JULY 29, 2019, WHEN PATIENT WAS SEEN BY AN URGENT CARE MD, WHO TOLD HER SYMPTOMS WERE NORMAL.  SOME TENDERNESS REMAINS AT INJECTION SITE.  NO OTHER SYMPTOMS PERSIST.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Vomiting
Clinical narrative: SWELLING AND PAIN IN RIGHT ARM FROM INJECTION SITE TO WRIST, PROGRESSED WITH FEVER, NAUSEA, VOMITING, MUSCLE ACHES, ITCHING.  TREATED WITH BENADRYL AND IBUPROFEN.  SYMPTOMS PERSISTED UNTIL MONDAY, JULY 29, 2019, WHEN PATIENT WAS SEEN BY AN URGENT CARE MD, WHO TOLD HER SYMPTOMS WERE NORMAL.  SOME TENDERNESS REMAINS AT INJECTION SITE.  NO OTHER SYMPTOMS PERSIST.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Dizziness, Nausea
Clinical narrative: 10:15 AM After vaccination completed pt presented dizziness and nauseas. No loss of consciousness.O2 by nasal canula at 2 lts / min and legs were elevated. Also pineapple juice and cookies given after mom told us no breakfast taken at home. After that, patient completely recovered, vital signs taken  blood preasure 121/68, Pulse 60  and oxygen saturation 99% . Patient referred no nausea or dizziness. Patient active, oriented and stable. After she completed  a whole breakfast given by mother, she was taken for a pediatrician evaluation with Dr. He evaluated pt with normal findings.