chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nasal congestion, Nausea, Pyrexia, Swelling of eyelid, Wheezing
Clinical narrative: Approximately 4 hours after receiving the vaccines, I had nasal congestion, swelling of eye lids, wheezing, chest tightness, fever (99.5), hoarseness, headache, nausea, dizziness, and passed out x2 when I stood up.  After about 24 hours after receiving the vaccines, I  was able to get up without being dizzy and gradually felt better over the next day.  I did not go to the emergency room.  I took diphenhydramine 25 mg and used my Albuterol inhaler.  I called my PCP office on 9/30/19 to report this adverse reaction and to obtain information necessary to report this adverse event.   I have never previously. had an adverse event to a vaccine.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Productive cough, Sensation of foreign body
Clinical narrative: It started on 9/28/19, I felt a lump in my throat and I coughed up some phlegm. I thought it was just a cold or maybe I swallowed something, so I started drinking plenty of fluids and sucking on a peppermint. This didn't do the trick, to help me with the problem I was experiencing. I called my PA to ask a question of what to take over the counter that will help, but I have not heard back from his office as of yet.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Photophobia
Clinical narrative: headache, light sensitive
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Feeling cold, Throat tightness, Tremor
Clinical narrative: Severe shaking and cold feeling all over. Uncontrollable movement in both hand especially in left hand. Tightening in throat area. Extreme coldness and could not get warm. Extreme shaking.  Extreme shaking part lasted 20 minutes. Throat tightening lessened after a few minutes.
Age: 89.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: DIZZY AND LIGHTHEADED
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Balance disorder, Dizziness, Headache
Clinical narrative: Out of balance, weakness, not super dizzy, odd severe headache. There adverse reactions started several hours after vaccination.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Infection, Peripheral swelling
Clinical narrative: SWELLING ON THE ARM AND INFECTION
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Pain
Clinical narrative: Began getting body aches, and nausea about 10 pm on same evening, then diarrhea  by early morning.  Lasted until late Sunday 2 days later.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Decreased appetite, Headache, Limb discomfort
Clinical narrative: Sense of heaviness and soreness, within 10 minutes of injection given.   Tiredness and chills started about 3 hrs later, followed by lower back and upper back - across the shoulders pain.   Muscles were sore, specially in the injection arm and the upper legs and back. Five hours later, the chills were not going away and I had a 101.78  (F) fever.   I took a Tylenol and the fever went down to 100 (F) The body aches got  worse, no appetite,  fever between 99 and 102 until the morning of Sep. 23.  Spent most of Sunday in bed with body aches, fever and a headache - the headache did not start until late Saturday.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Sense of heaviness and soreness, within 10 minutes of injection given.   Tiredness and chills started about 3 hrs later, followed by lower back and upper back - across the shoulders pain.   Muscles were sore, specially in the injection arm and the upper legs and back. Five hours later, the chills were not going away and I had a 101.78  (F) fever.   I took a Tylenol and the fever went down to 100 (F) The body aches got  worse, no appetite,  fever between 99 and 102 until the morning of Sep. 23.  Spent most of Sunday in bed with body aches, fever and a headache - the headache did not start until late Saturday.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: patient complained of arm hurting
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Immunisation, Incorrect route of product administration, Irritability, Vomiting
Clinical narrative: Rotarix vaccine was inadvertently administered intramuscularly instead of orally on 9/26/19 by a per diem nurse working in this office.  The nurse filing this report received a call from mom today who wanted to inquire why the rotavirus vaccine was given IM because she researched and found that it is only given orally.  Reviewed chart and found that the nurse did document it as given in the Right thigh on the consent form.   Patient had some irritability and and one episode of vomiting but patient did receive other vaccinations that day as well.  Spoke to Glaxo Smith Kline regarding this and was advised that there are no studies on the safety of IM injection for Rotavirus but was advised to bring patient back in ASAP to administer an oral dose as the IM dose is invalid.  Patient was brought to the office on 9/30/19 and received an oral dose of Rotarix.  Injection sites were assessed at this time and no symptoms noted.  There was no swelling, redness, or bruising of any of the injection sites.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Arm sensitive to touch, painful, swelling. no redness. Primary Care Physician contacted by patient and told to take Tylenol and Ice area
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Caregiver returned to employee health office the next r/t concerns for rash on bilateral thighs and lower back following the flu shot.  Pt had the same reaction following Tdap in 2/2019.  Injection site was WNL and employee state the rash was not raised today as it was the night the shot was given.  I recommend she receive all  future vaccines and flu shots from PCP for extra monitoring.
Age: 68.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Dizziness, Neck pain
Clinical narrative: PATIENT COMPLAINED OF NECK PAIN AND LIGHTHEADEDNESS. ADVISED PATIENT TO SIT DOWN AND CHECK BLOOD PRESSURE. PRESSURE WAS VERY HIGH AT 199/113. CALLED PATIENT'S MD OFFICE AND THEY ADVISED US TO CALL 911. PATIENT WAS TAKEN TO HOSPITAL BY AMBULENCE.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Headache, Influenza like illness, Limb discomfort
Clinical narrative: Shot made my arm feel very heavy and was sore for several days.  Within 24 hours, I experienced flu-like symptoms--Body aches, fever, headache, fatigue. The fever and body aches are mostly at night; I feel better though tired during the day. (Also, coughing at night but that may just be coincidental rather than causal. ) I took Tylenol as needed to reduce aches and fever which helps temporarily but after 2 nights, I'm still not completely well.  I also use Flovent inhaler and saline nasal spray for coughing as needed.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Shot made my arm feel very heavy and was sore for several days.  Within 24 hours, I experienced flu-like symptoms--Body aches, fever, headache, fatigue. The fever and body aches are mostly at night; I feel better though tired during the day. (Also, coughing at night but that may just be coincidental rather than causal. ) I took Tylenol as needed to reduce aches and fever which helps temporarily but after 2 nights, I'm still not completely well.  I also use Flovent inhaler and saline nasal spray for coughing as needed.
Age: 73.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Limb mass, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pain level 8 down to fingers for hours, swelling, redness, fever, itching, unable to lift arm 2 days, third day swelling from elbow up and feeling like there is lump in my arm, some soreness, 4th day, today still swelling and upper arm turning yellow.  The injection site never was a problem,  but from shoulder to elbow was very painful and could not move some of the time.  I have had these shots before, the flu shot every year, always a little sore, but this side effect.  It was the week end, did not go to the doctor.  Advil and ice packs and being still.
Age: 73.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pruritus, Pyrexia, Skin discolouration
Clinical narrative: Pain level 8 down to fingers for hours, swelling, redness, fever, itching, unable to lift arm 2 days, third day swelling from elbow up and feeling like there is lump in my arm, some soreness, 4th day, today still swelling and upper arm turning yellow.  The injection site never was a problem,  but from shoulder to elbow was very painful and could not move some of the time.  I have had these shots before, the flu shot every year, always a little sore, but this side effect.  It was the week end, did not go to the doctor.  Advil and ice packs and being still.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Insomnia, Pain
Clinical narrative: Approximately 8 hours after receiving the Shingrix vaccine, I got very cold and had a headache. I was feverish, aching and shivering uncontrollably. My skin was hot to the touch but I could not stop shaking with the cold. This lasted approximately 12 hours. I took an ibuprofen about 10 p.m Did not sleep most of the night. Symptoms subsided the next morning.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Approximately 8 hours after receiving the Shingrix vaccine, I got very cold and had a headache. I was feverish, aching and shivering uncontrollably. My skin was hot to the touch but I could not stop shaking with the cold. This lasted approximately 12 hours. I took an ibuprofen about 10 p.m Did not sleep most of the night. Symptoms subsided the next morning.
Sex: M
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: My son was given the shot the nurse set the needle down my son began having a sezier
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Immediate post-injection reaction, Urticaria
Clinical narrative: Immediately after receiving injections, pt developed head to toe hives & a cough Tx: Benadryl, prednisone, albuterol, epi Jr.  outcome: Sent to ER
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Headache, Loss of consciousness, Muscle spasms
Clinical narrative: After administration of the gardisil my 12 year old had an intense splitting headache, an intense stomach cramp, and passed out. The doctor had to monitor his blood pressure and make him lie down for a while. Even after we left the doctors office, he was having muscle spasms in his arm that lasted almost 3 hours after we left the doctors office.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: he examined her and noted "swelling above the elbow, with redness". The Pharmacist reported that the patient stated it "feels like the swelling is travelling to the back of my arm".; swelling in the arm and trouble lifting the arm; he examined her and noted "swelling above the elbow, with redness". The Pharmacist reported that the patient stated it "feels like the swelling is travelling to the back of my arm".; he examined her and noted "swelling above the elbow, with redness". The Pharmacist reported that the patient stated it "feels like the swelling is travelling to the back of my arm".; swelling in the arm and trouble lifting the arm; This spontaneous report was received from a pharmacist (R.Ph.) and refers to a non-pregnant female patient of unknown age.  No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.    On 17-SEP-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R016640 with expiration date of 28-JAN-2020, intramuscularly, for prophylaxis. It was reported that the patient called later in the day (17-SEP-2019) reporting swelling in the arm (peripheral swelling) and trouble lifting the arm (limb discomfort). The pharmacist reported that the patient returned to the Pharmacy, where he examined her and noted swelling above the elbow (joint swelling), with redness (erythema). The Pharmacist reported that the patient stated it "feels like the swelling was travelling to the back of her arm", pharmacist reported the swelling as "transient limb swelling, not directly associated with the injection site" (oedema). It was referred the patient did seek medical attention but not treatment was provided.   The outcome of oedema, peripheral swelling, erythema, joint swelling and limb discomfort was not provided.  The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EFFECT; expired dose of rotatteq inadveretently administered; This spontaneous report was received from a Nurse refers to a 9 week old patient. No information was provided regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies. On 24-SEP-2019, the patient was administered properly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R002805, expiry date: 23-SEP-2019) for prophylaxis. The vaccine was expired one day prior to administration (expired product administered). No adverse effect reported. The nurse confirmed that the product did not have any temperature excursion. No PQC involved. No additional information provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EFFECT; expired dose administered; This spontaneous report was received from a medical assistant regarding a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-SEP-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) lot # N025892, expiration date: 19-SEP-2019 (exact dose, strength, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with a sterile diluent (lot number: N030846, expiration date: 26-APR-2020). No product quality complaints were involved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Small spot of shingles on my lower back; Small spot; This case was reported by a consumer and described the occurrence of shingles 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, 1 day after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient had a small spot of shingles on her lower back broke out the day after receiving Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: mild shingles rash; This case was reported by a physician via sales rep and described the occurrence of shingles 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the physician (MD). The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that, the patient experienced mild shingles rash following first dose of shingrix. The reporter stated that did not recall specifics regarding the patient but wanted to share with GlaxoSmithKline(GSK). The physician did not agree to be followed up. This case has been linked with case US2019AMR172649, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: mild shingles rash; This case was reported by a physician via sales rep and described the occurrence of shingles 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the physician (MD). The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that, the patient experienced mild shingles rash following first dose of shingrix. The reporter stated that did not recall specifics regarding the patient but wanted to share with GlaxoSmithKline(GSK). The physician did not agree to be followed up. This case has been linked with case US2019AMR172644, reported by the same reporter.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure; Came down with the flu; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 71-year-old male patient who received Flu unspecified (Influenza vaccine) for an unknown indication.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 71 or 70 years old at time of vaccination. The reporter stated that they took childhood vaccinations and were ok with those. But knowing what they do now about what our Government had been doing, they could not pay us enough money to get those poisonous things. The patient had received flu shot back a few years ago and came down with the flu of which he did never had.  The reporter stated that she never had a vaccine since she was small and she never will. The reporter never had anything that they were supposed to prevent. This case was considered as suspected vaccination failure as details regarding full vaccination schedule and time to onset for the event was unknown at the time of reporting.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity
Clinical narrative: Joint pain/hip joint; leg pain; neck pain; Pain upon movement; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than a day after receiving Shingrix, the patient experienced joint pain, leg pain, neck pain and pain upon movement. On an unknown date, the outcome of the joint pain, neck pain and pain upon movement were recovering/resolving and the outcome of the leg pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain, leg pain, neck pain and pain upon movement to be related to Shingrix.  Additional details were reported as follows: The patient received her first dose of Shingrix vaccine about 5 weeks ago. The night of vaccination she experienced joint soreness all over the body. The soreness in her neck got better within 4 days, but the soreness in both of her legs was still present and more dominantly on the left legs. The hip joint pain was not gotten better and it was painful upon moving. The reporter consented to follow up. No further details were provided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Pain
Clinical narrative: felt cold; achiness; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd July 2019, less than a day after receiving Shingrix, the patient experienced feeling cold and pain. On 23rd August 2019, the outcome of the feeling cold and pain were recovered/resolved.   It was unknown if the reporter considered the feeling cold and pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the patient's husband. The patient received vaccine in left arm. The reporter consented to follow up. This case had been linked to the case US2019171931, reported by same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Reported to pharmacy on 8/29 to report a potential adverse Rnx to Shigrix. Hives on arm. Advised to see her physician ASAP Patient has been taking Benadryl.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Redness at injection site - between size of a quarter and half dollar; generalized fatigue, stomach cramps, nausea  chills and low grade fever.   These started within 1 - 2 hours after vaccination.   Lasted  1 1/2 days . Injection site painful with extreme soreness when moving arm especially overhead.   Pain is receding and is sore to touch and minial pain on moving. Redness is approximately size of a dime now.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Redness at injection site - between size of a quarter and half dollar; generalized fatigue, stomach cramps, nausea  chills and low grade fever.   These started within 1 - 2 hours after vaccination.   Lasted  1 1/2 days . Injection site painful with extreme soreness when moving arm especially overhead.   Pain is receding and is sore to touch and minial pain on moving. Redness is approximately size of a dime now.
Age: 2.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Administered prior to recommended dose date, due to mix up with sibiling. No adverse reactions to vaccines.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: patient had both shots done on Friday 9/27/2019 at pharmacy. Patient came in with a swollen and itchy arm.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: APPROX 5 MIN AFTER VACCINE PARENTS REPORTED TO PROVIDER LEG RED AND SWOLLEN.  UPON ASSESSMENT PT WITH APPROX 4 IN ROUND, RED, WARM AREA AT INJECTION SITE.  PROVIDER DISCUSSED CARE WITH FAMILY. FAMILY INSTRUCTED TO CALL THE CLINIC TOMORROW WITH UPDATE ON PATIENTS CONDITION.  TO SEEK CARE WITH ANY EMERGENT ISSUES.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Dizziness, Flushing
Clinical narrative: Patient felt like she was going to faint. She felt flushed, and weak
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported a 3 inch rash at the injection site, with swelling, redness and warmth
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA  Shoulder pain, trouble lifting arm
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Grip strength decreased, Impaired driving ability, Mobility decreased, Pain in extremity
Clinical narrative: Patient called to report severe pain in the arm following the administration of the vaccination.  "It hurts really bad, I haven't been able to lift it to hold my cell phone or drive for the last two weeks."
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Asthenopia, Confusional state, Eye pain, Fatigue, Hallucination
Clinical narrative: Severe migraine like headache, light sensitivity, eye pain and strain, hallucinations, mild fever, tremors, confusion, fatique, muscle weakness, exhaustion, trouble speaking.  Began on 9/24 in the morning and progressed throughout the night.  The next 4 days continued with headache, eye pain, and exhaustion.  Symptoms still continue mildly.  I believe it is encephalitis.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Migraine, Muscular weakness, Photophobia, Pyrexia
Clinical narrative: Severe migraine like headache, light sensitivity, eye pain and strain, hallucinations, mild fever, tremors, confusion, fatique, muscle weakness, exhaustion, trouble speaking.  Began on 9/24 in the morning and progressed throughout the night.  The next 4 days continued with headache, eye pain, and exhaustion.  Symptoms still continue mildly.  I believe it is encephalitis.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Speech disorder, Tremor
Clinical narrative: Severe migraine like headache, light sensitivity, eye pain and strain, hallucinations, mild fever, tremors, confusion, fatique, muscle weakness, exhaustion, trouble speaking.  Began on 9/24 in the morning and progressed throughout the night.  The next 4 days continued with headache, eye pain, and exhaustion.  Symptoms still continue mildly.  I believe it is encephalitis.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Nausea, Vomiting
Clinical narrative: I got the Flu shot for this year.I cannot answer the above questions as to exactly what it was. This morning after 1/2 walk came home and after bowel movement vomitted bile. Lower back ache.  An hour later another bowel movement followed by nausea and no vomitting. Still nauseous 1/2 later.  I do not drink, use drugs, have not eaten anything unusual, and am in good health until this am.
Age: 62.0
Sex: F
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Axillary pain, Chills, Decreased appetite, Fatigue, Heart rate increased
Clinical narrative: Later that day I felt extreme fatigue, lack of appetite, thirst and pain and swelling at the injection site spreading to my whole arm and swelling my underarm area. Extremely painful arm due to swelling, especially underarm area. I had chills and felt sick. That night when I tried to sleep my heart rate was really high all night, but seemed to calm down the next day. Had to take pain relieving drugs for 3 days after in order to sleep. (Advil or Tylenol). Still have underarm swelling and pain and it is now 96 hours later.
Age: 62.0
Sex: F
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Injection site pain, Injection site swelling, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Later that day I felt extreme fatigue, lack of appetite, thirst and pain and swelling at the injection site spreading to my whole arm and swelling my underarm area. Extremely painful arm due to swelling, especially underarm area. I had chills and felt sick. That night when I tried to sleep my heart rate was really high all night, but seemed to calm down the next day. Had to take pain relieving drugs for 3 days after in order to sleep. (Advil or Tylenol). Still have underarm swelling and pain and it is now 96 hours later.
Age: 62.0
Sex: F
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Swelling, Thirst
Clinical narrative: Later that day I felt extreme fatigue, lack of appetite, thirst and pain and swelling at the injection site spreading to my whole arm and swelling my underarm area. Extremely painful arm due to swelling, especially underarm area. I had chills and felt sick. That night when I tried to sleep my heart rate was really high all night, but seemed to calm down the next day. Had to take pain relieving drugs for 3 days after in order to sleep. (Advil or Tylenol). Still have underarm swelling and pain and it is now 96 hours later.
Age: 62.0
Sex: F
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: Later that day I felt extreme fatigue, lack of appetite, thirst and pain and swelling at the injection site spreading to my whole arm and swelling my underarm area. Extremely painful arm due to swelling, especially underarm area. I had chills and felt sick. That night when I tried to sleep my heart rate was really high all night, but seemed to calm down the next day. Had to take pain relieving drugs for 3 days after in order to sleep. (Advil or Tylenol). Still have underarm swelling and pain and it is now 96 hours later.
Age: 88.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising
Clinical narrative: Patient stated she had a bruise approximately 3x4 inches in size around the injection site. She did not have any pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: flu like symptoms - fever, chills, headache, body aches and pains. increased redness and soreness at injection sight. Skin is hot to the touch, painful, and about 6" X 4". The redness started on 09/28/2019
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Skin warm
Clinical narrative: flu like symptoms - fever, chills, headache, body aches and pains. increased redness and soreness at injection sight. Skin is hot to the touch, painful, and about 6" X 4". The redness started on 09/28/2019
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: Patient had rash around injection site within 15 minutes of administering vaccine. No breathing issues. Prescribed Benadryl.
Sex: U
Vaccine: HPV4
Symptoms: Death, Human papilloma virus test positive, Papilloma viral infection, Product quality issue
Clinical narrative: died from Hpv vaccine; HPV 16 11 18 (first vial tested and turned out to be positive); PQC present: Yes/sent me at the first vial so i tested and it turned out to be positive altogether 16 vials; This spontaneous report was received from a consumer via social media referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, anatomical location, lot# and expiry date not reported) for prophylaxis. On an unknown date, the patient died from quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). It was reported that, the first vial was sent to the reporter by the local paediatrician. The reporter tested the vial and was turned to be positive with strains HPV 16, 11, 18 (Human papilloma virus test positive and product quality issue). Cause of death was unknown and it was unknown whether autopsy was performed. The outcome of papilloma viral infection and product quality issue was unknown. The reporter considered the event of death as related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). Causality assessment for human papilloma virus test positive and product quality issue was not reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA012460:same reporter US-009507513-0807USA02497:same reporter; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; A patient was given a fourth dose of Gardasil; This spontaneous report as received from a nurse refers to a patient of unknown age and gender.      The patient's pertinent medical history, drug reaction, allergies and concomitant medications were not reported.  On an unknown dates, the patient was vaccinated with the first, second and third doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), for prophylaxis (dose, route of administration, lot# and expiration date were not provided).         On 23-SEP-2019, the patient was given a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot# S008151 with expiration date of 20-NOV-2021, intramuscular injection, for prophylaxis (dose was not provided) (product use issue). No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; one patient was inadvertently administered one dose of expired VARTVAX (lot N021318 exp 8/7/2019) on 24SEP2019; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions or allergies were provided. Concomitant therapies included sterile diluent.  On 24-SEP-2019, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # N021318 with an expiration date on 07-AUG-2019) for prophylaxis (dosage schedule, route and anatomical location were not reported). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Nurse reports one dose of improperly stored pneumovax was administered to patient on 9/23/2019; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. On 23-SEP-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection; lot # R009163, expiration date: 06-JAN-2020 (strength, dose, schedule, anatomical location, and route of administration were not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion below 36-degree Fahrenheit: 34.9 Fahrenheit (reported as "lowest temperature") for a duration of 119 minutes. There was no previous temperature excursion. There was an involvement of data logger. No adverse effects reported. No product quality complaints (PQC) were involved.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Altered dosing schedule; No adverse effect; This spontaneous report was received from a Registered nurse refers to a male patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies. On an unknown date in 2016 (approximately 3 years ago), the patient was administered his first dose of hepatitis a vaccine, inactivated (VAQTA) 1 dosage form for prophylaxis. (strength, dose, frequency, route, lot number, expiry date unspecified). On 26-SEP-2019, the patient was in office to receive booster dose of hepatitis a vaccine, inactivated (VAQTA) (inappropriate schedule of product administration). No adverse effect reported. No PQC involved.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pruritus
Clinical narrative: Pain; Hives; Extreme itching; Redness turned purple and to this day goes its goes completely around my arm; My arm was bright red, hot, swollen at injection site/its goes completely around my arm; My arm was bright red, hot, swollen at injection site; Arm  swollen at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site swelling. In September 2019, the patient experienced pain, hives, pruritus and skin discoloration. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling, pain, hives, pruritus and skin discoloration were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling, pain, hives, pruritus and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the night of vaccination, the patient's arm was bright red, hot, swollen at injection site.  Several days later, the patient got hives and extreme itching along with the pain.  The patient called the doctor who advised to take OTC (over the counter) benedryl.  The patient stated, the redness turned purple and to this day it spread completely around arm, still painful and occasionally itches.  The patient stated, she would not receive 2nd dose of shingles shot and wished to never get the 1st dose.
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Pain; Hives; Extreme itching; Redness turned purple and to this day goes its goes completely around my arm; My arm was bright red, hot, swollen at injection site/its goes completely around my arm; My arm was bright red, hot, swollen at injection site; Arm  swollen at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site swelling. In September 2019, the patient experienced pain, hives, pruritus and skin discoloration. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling, pain, hives, pruritus and skin discoloration were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling, pain, hives, pruritus and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the night of vaccination, the patient's arm was bright red, hot, swollen at injection site.  Several days later, the patient got hives and extreme itching along with the pain.  The patient called the doctor who advised to take OTC (over the counter) benedryl.  The patient stated, the redness turned purple and to this day it spread completely around arm, still painful and occasionally itches.  The patient stated, she would not receive 2nd dose of shingles shot and wished to never get the 1st dose.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient experienced all of the side effects of her second shingles shot. The reporter asked if could she take anything to lessen them.
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site rash, Swelling
Clinical narrative: Infection; Swelling; The site had a "small rash"; This case was reported by a pharmacist via call center representative and described the occurrence of infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, 1 day after receiving Shingrix, the patient experienced infection, swelling and injection site rash. The patient was treated with antibiotics nos, (Antibiotic (Details Unknown)). On an unknown date, the outcome of the infection, swelling and injection site rash were unknown.   It was unknown if the reporter considered the infection, swelling and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that the patient developed swelling. The patient sought treatment at urgent care and was diagnosed with an infection for which she was prescribed antibiotics. The patient also had small rash at the injection site. The reporter consented to follow up.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Oral herpes
Clinical narrative: Injection site swelling; Fever blister; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 91-year-old female patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   On 17th September 2019, the patient received Shingrix (intramuscular). In September 2019, less than a week after receiving Shingrix, the patient experienced injection site swelling and fever blister. On an unknown date, the outcome of the injection site swelling and fever blister were unknown.   It was unknown if the reporter considered the injection site swelling and fever blister to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient experienced injection site swelling and a fever blister of the mouth following a dose of Shingrix. The healthcare professional did not provide exact start date or outcome of events. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased
Clinical narrative: elevated blood pressure, 160/100; This case was reported by a consumer and described the occurrence of increased blood pressure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included medication unknown (Blood Pressure Medication).   On 19th September 2019, the patient received the 1st dose of Shingrix. On 20th September 2019, 1 days after receiving Shingrix, the patient experienced increased blood pressure. On an unknown date, the outcome of the increased blood pressure was not recovered/not resolved.   It was unknown if the reporter considered the increased blood pressure to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient had an elevated blood pressure of 160/100.  The patient also undergoing a blood pressure medication adjustment at this time as well. The reporter does not have vaccine information for this adverse event. The reporter consented to follow up. In the XML document outcome of event was reported as recovering, but in Argus its mentioned as not recovered, so kept as reported in Argus.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: right arm hurts to lift up; unable to lift his right arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient was unable to lift his right arm because it hurts.  The event was ongoing. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Myalgia
Clinical narrative: Upset Stomach; Chills; Headache; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced upset stomach, chills, headache and muscle pain. On an unknown date, the outcome of the upset stomach, chills, headache and muscle pain were unknown.   It was unknown if the reporter considered the upset stomach, chills, headache and muscle pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, however it could be 69 or 70 years. The age group was captured as adult as per Shingrix indication.  The day before reporting, the patient received the second dose of her Shingrix vaccine. The patient experienced upset stomach, chills, headache, and muscle aches. The patient did not want to provide her entire birth date, but she stated her birth year was 1949. The reporter did not consent to follow up.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Haemorrhage subcutaneous, Injection site discolouration, Injection site mass, Petechiae
Clinical narrative: bleeding under the skin; it was green on the top part like a bruise and the darker part of blood is down by the elbow; leaking capillary; Bruising; lump that is movable in front of the deltoid.; This case was reported by a pharmacist via call center representative and described the occurrence of hemorrhage subcutaneous in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   Previously administered products included Shingrix. Concomitant products included warfarin sodium (Coumadin).   On 13th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 20th September 2019, 7 days after receiving Shingrix, the patient experienced hemorrhage subcutaneous (serious criteria GSK medically significant), injection site discoloration, capillary hemorrhage, contusion and skin mass. On an unknown date, the outcome of the hemorrhage subcutaneous and capillary hemorrhage were not recovered/not resolved and the outcome of the injection site discoloration, contusion and skin mass were unknown.   It was unknown if the reporter considered the hemorrhage subcutaneous, injection site discoloration, capillary hemorrhage, contusion and skin mass to be related to Shingrix.  Additional information was provided as follows: The case US2019172828 was found to be duplicate of case US2019172814 . Hence case US2019172828 would be deleted and all the information of this case will be added in case US2019172814 which is the case of record for this patient. The patient received Shingrix on left deltoid. The pharmacist reported that that she might have hit or nicked a capillary while administering Shingrix to a patient taking warfarin. It was leaked/bleed under the skin for some time and now it was down past the elbow. There was no blood at the injection site. It looks like it stopped. It was green on the top part like a bruise and the darker part of blood was down by the elbow. It started the following week after receiving Shingrix. He also reported a lump that is movable in front of the deltoid. The pharmacist was not sure if this was due to the Shingrix injection given its location. The reporter consented to follow up.