chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, C-reactive protein increased, Pyrexia, Rash
Clinical narrative: NDC # 58160-828-03; exp date 5/13/22; Dilutant lot number ZS3FY Vaccine given at medical Clinic  Rash starting within 24 hours which subsequently generalized, fever , arthralgias.  Required hospitalization 10/6/ 22 - 10/8/22
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain
Clinical narrative: Headache, extreme pain in joints and injection site. Pain lessened by day 2 with the use of ibuprofen.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Fall
Clinical narrative: Patients Mother stated that he lost balance and may have experienced a fainting spell approximately 5 minutes after receiving vaccination. During the episode the patient fell forward into a rack scratching his neck on a fixture. Patient was conscious and alert as Pharmacist approached, but Patient was placed in Recovery Position with feet up for a few minutes until patient was ready to leave.
Age: 85.0
Sex: M
Vaccine: FLUA4
Symptoms: Adverse reaction
Clinical narrative: Daughter reported to pharmacy on 11.4.20 that her dad had a reaction to the flu vaccine 48 hours after administration. The shot was given on 10.03.20. Daughter could not give any specific information on what type of reaction it was, just that it required hospitalization and that patient  is still being treated.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: Patient called pharmacy stating she experienced low grade fever and flu-like symptoms. Had a fever of 100.7, took Tylenol and woke up drenched.
Age: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Asthenia, Eye infection, Flushing, Guillain-Barre syndrome
Clinical narrative: After vaccine, had flushing and headaches, had GBS, lost all strength in both arms for 3 days, which has not recovered in left arm. Eyes were blurry and  infected, redness and swollen shut, felt like pinkeye which lasted for 4 days. Can feel residual pain in forearm and wrist. Can move left arm now. but still no strength.
Age: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Headache, Ocular hyperaemia, Pain, Pain in extremity, Swelling of eyelid
Clinical narrative: After vaccine, had flushing and headaches, had GBS, lost all strength in both arms for 3 days, which has not recovered in left arm. Eyes were blurry and  infected, redness and swollen shut, felt like pinkeye which lasted for 4 days. Can feel residual pain in forearm and wrist. Can move left arm now. but still no strength.
Age: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Vision blurred
Clinical narrative: After vaccine, had flushing and headaches, had GBS, lost all strength in both arms for 3 days, which has not recovered in left arm. Eyes were blurry and  infected, redness and swollen shut, felt like pinkeye which lasted for 4 days. Can feel residual pain in forearm and wrist. Can move left arm now. but still no strength.
Age: 60.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became red puffy and hot to touch, injection site became size of an egg and she went to the walk in clinic. Body temp was normal, injection site was 108
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: PATIENT CALLED 11/07/202 AND INDICATED HE IS STILL FEELING PAIN FROM FLU VACCINATION RECEIVED 10/28/2020. PATIENT HAS BEEN TAKING ADVIL OVER THE COUNTER AND DOES NOT FEEL IT HELPS WITH THE PAIN. RPH ON DUTY 11/07/20 HAD ADVISED FOR PATIENT TO SEEK MEDICAL CARE FROM DOCTOR. PATIENT INDICATED REFUSAL TO DO SO.  FOLLOW UP PHONE CALL WAS MADE 11/09/2020 AND PATIENT HAS SPECIFIED PAIN WITH MOBILITY AT CERTAIN ANGLES . AGAIN ADVISED PATIENT TO GO SEE DOCTOR TO MAKE SURE EVERYTHING IS OK .  AGAIN PATIENT EXPRESSED REFUSAL TO GO.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site paraesthesia, Paraesthesia
Clinical narrative: Patient states that one week out she is feeling a "tingling sensation" mostly on the left side of the body (@ injection site and left foot, a little tingling on the right side) but is not describing any loss of sensation or pain.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Ear congestion, Eye swelling, Headache
Clinical narrative: On Saturday, November 7 I awoke with an itchy, red rash around my neck, under my arms and on the bend of my elbows. I consulted a Dr. and started Benadryl.  On Sunday November 8 I had the same symtoms and by afternoon my ears were plugging and my eyes were slightly swollen. I went to a walk-in clinic and was diagnosed with an allergic reaction and put on Prednisone  20mg for 5 days. (Prior to all of this-Friday Nov.6- Chills, 100 degree temp, sore arm, headache, achey body-things I was expecting)
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pain, Pain in extremity, Rash, Rash erythematous
Clinical narrative: On Saturday, November 7 I awoke with an itchy, red rash around my neck, under my arms and on the bend of my elbows. I consulted a Dr. and started Benadryl.  On Sunday November 8 I had the same symtoms and by afternoon my ears were plugging and my eyes were slightly swollen. I went to a walk-in clinic and was diagnosed with an allergic reaction and put on Prednisone  20mg for 5 days. (Prior to all of this-Friday Nov.6- Chills, 100 degree temp, sore arm, headache, achey body-things I was expecting)
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: On Saturday, November 7 I awoke with an itchy, red rash around my neck, under my arms and on the bend of my elbows. I consulted a Dr. and started Benadryl.  On Sunday November 8 I had the same symtoms and by afternoon my ears were plugging and my eyes were slightly swollen. I went to a walk-in clinic and was diagnosed with an allergic reaction and put on Prednisone  20mg for 5 days. (Prior to all of this-Friday Nov.6- Chills, 100 degree temp, sore arm, headache, achey body-things I was expecting)
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: CSF protein increased, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Bilateral progressive lower extremity weakness, spinal fluid testing showing an elevated protein possibly consistent with Guillain-Barre syndrome. Receiving IVIG currently
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypersensitivity, Injection site reaction, Lethargy
Clinical narrative: SEVERE ALLERGIC REACTION / TIRDNESS / LETHERGY / AND SITE REACTION
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: patient developed Bell's Palsy within 24 hours of  flu vaccine being adminsitered. pt went to ER and they determined it was likely caused by her flu shot. Patient called the pharmacy, where the shot was administered, the following week just to inform us of incident. pt was given prednisone, valacyclovir and gabapentin at ER. pt was slowly recovering at time of conversation.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Headache, Pyrexia, Urticaria
Clinical narrative: PATIENT REPORTED LOW GRADE FEVER (100.1F), HEADACHE, CHEST TIGHTNESS, AND HIVES. PATIENT REPORTED THAT THE SYMPTOMS APPEARED AROUND 9PM THE EVENING OF THE VACCINATION. SHE DID NOT REPORT THE ADVERSE EVENT UNTIL 11/9/2020 AT 4:00PM. SHE REPORTED THE SYMPTOMS RESOLVED ON THEIR OWN BY THE TIME OF REPORTING. SHE WAS ADVISED TO STILL MAKE AN APPOINTMENT WITH HER PCP FOR A FOLLOW-UP.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Fatigue, Immobile, Nausea, Pain, Pain in extremity
Clinical narrative: PATIENT HAD A SORE ARM AND BODY ACHE. SHE DID NOT NEED ANY MEDICAL HELP. HER ENTIRE ARM WAS IN AGONY AND SHE FELT FATIGUED FOR 24 HOURS. SHE WAS ALSO NAUSEAUS. SHE WAS IMMOBILE FOR A LITTLE OVER 24 HOURS. SHE IS OKAY NOW
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Blood test normal, Computerised tomogram normal, Dizziness, Ear infection viral
Clinical narrative: 8 days after getting the 2nd immunization for Shingrix, I woke up in the morning with dizziness. Dizziness appeared without warning and was more like light-headedness and off-balance issues, not spinning or room spinning type dizziness. No nausea with it. Was active and felt totally fine the day/week before. Tried to work through the dizziness with normal activities, but couldn't. Was on vacation, out of state at the time. On days 8-10 after the vaccination, had two ER visits to understand cause of dizziness, with blood tests, CT, and MRI done to rule out heart attack and stroke. Determined I had labyrinthitis or viral inner ear infection. Gave me steroids for 10 days to reduce inflammation.  It took approximately 18 days following vaccination before I started feeling better and could begin resuming normal activities. 26 days later, I still have some mild dizziness, especially when I roll over in bed at night. I believe that is still from the inner ear issues.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Labyrinthitis, Loss of personal independence in daily activities, Magnetic resonance imaging normal
Clinical narrative: 8 days after getting the 2nd immunization for Shingrix, I woke up in the morning with dizziness. Dizziness appeared without warning and was more like light-headedness and off-balance issues, not spinning or room spinning type dizziness. No nausea with it. Was active and felt totally fine the day/week before. Tried to work through the dizziness with normal activities, but couldn't. Was on vacation, out of state at the time. On days 8-10 after the vaccination, had two ER visits to understand cause of dizziness, with blood tests, CT, and MRI done to rule out heart attack and stroke. Determined I had labyrinthitis or viral inner ear infection. Gave me steroids for 10 days to reduce inflammation.  It took approximately 18 days following vaccination before I started feeling better and could begin resuming normal activities. 26 days later, I still have some mild dizziness, especially when I roll over in bed at night. I believe that is still from the inner ear issues.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: The patient's husband called me and stated that patient's arm is in severe pain which started about 2 hours after her vaccine today. She is also shivering and has a low grade fever of 99.2 degrees. She said she can barely move her arm without it hurting. She then started icing it a little and took some acetaminophen. I advised her that these could be common side effects of the vaccine, especially since this was her second dose and that she can take some Ibuprofen. I let her know that she may call her Doctor tonight if she needs  a second opinion. Also to keep an eye on it and to call her Doctor in the morning to see what he wants her to do. Her husband stated that he did not want us, the pharmacy to call her doctor and that they will in the morning. I asked them where the syringe was put in the arm and they said it was about 4 inches from the top of the arm, so I do not suspect any wrong administration technique.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: When patient received his Boostrix shot, patient's face went blank and he was not responsive to his name. It looked like he could have been having an absent seizure. It took patient 5 minutes to fully regain consciousness. We called the paramedics to further evaluate the patient.
Age: 74.0
Sex: M
Vaccine: FLUA4, PNC13
Symptoms: Malaise, Muscle spasms, Pulmonary congestion, Skin mass
Clinical narrative: The patient is at the ER today 11/09/2020 4:00 PM. Patient claims on November 1, 2020 the third day after getting the immunizations he started feeling sick. He's at the ER today having severe muscle spasms at the stomach and back. There is a knot on the stomach that moves and it is causing him so much pain. They are doing test on him but couldn't find any and he has not taken any new medicine, On November 1st he also got chest congestion, his doctor prescribed him Zpack but didn't get better. No fever.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient reported tingling pain from left deltoid down to finger started after getting  a flu vaccine on 11/6/2020. Patient called pharmacy on 11/9/2020 to report adverse event of shooting, tingling pain in left arm after getting a flu vaccine. The pain comes and goes several times throughout the day and the pain lasts about a few seconds. Patient stated injection site area has no redness, no swelling, and is not tender to touch. Patient did not report any shoulder/neck pain nor any joint pain, just the tingling and shooting pain down her left arm. Patient reported no muscle weakness nor any diminished strength in left arm. The patient was worried that pain started Friday night and still lasts until day reported on 11/9/2020. Pharmacist on duty recommended patient to seek medical care if pain doesn't get any better by next day. Pharmacist will follow up with patient on status of symptom and if patient seeks medical help.
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Injection site reaction, Pain in extremity, Peripheral swelling, Somnolence
Clinical narrative: Patient received a Shingrix shot and Fluzone HD shot this past Saturday. She insisted she have them in the same arm. She woke up Sunday morning feeling very fatigued and stayed in bed most of the day. She felt better on Monday (same day she reported the adverse event). She stated her arm was a little swollen and hurt. I explained to her this was most like an injection site reaction and to apply ice to the painful arm for 20 minutes and then remove for 20 minutes and to also take Motrin or Tylenol for the pain. Instructed her to call me back if she experienced any new or worsening symptoms and I told her I would call her tomorrow to check on her.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt states arm is still very sore especially when lifting arm straight out and up.  This has been going on since the day after injection on 10/25/20.
Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Crying, Diarrhoea, Injection site swelling, Pyrexia, Screaming
Clinical narrative: Fever, screaming/crying for hours at a time, swelling on thigh, diarrhea. Adverse reactions lasted 3 days. We were told to give Tylenol and Ibuprofen, and had 2 follow up appointments in the office.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained of knot in arm at site of injection and swelling in the upper arm extending down towards the hand. Patient states it is sore and warm to the touch throughout arm.
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Developed a rash around the area, recommended to take an antihistamine, use a compress, and seek doctor visit.
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Metabolic function test, Ultrasound abdomen
Clinical narrative: small bowel-small bowel intussusception
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Limb discomfort
Clinical narrative: On Friday, 11/6/20, the patient called to report she was still having intermittent pain from her flu shot. She stated that it's a mild pain and she can still move her arm but it does cause her discomfort. I suggested that she contact her physician which she said she would do once the office opened again on Monday. No follow up has been reported at this time from the patient or the physician.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Nodule, Pain
Clinical narrative: patient says they have a knot and pain.  was given in the lower deltoid
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site rash
Clinical narrative: Patient states rash from elbow to shoulder on arm she received vaccine.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Localised infection
Clinical narrative: Patient developed infection in arm and was prescribed keflex to treat.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Headache, Malaise, Migraine, Nausea
Clinical narrative: My son started to feel ill several days after the first injection -- malaise, headache, fatigue.  About 2 weeks after the first injection, he had a full blown migraine that lasted 6 weeks without relief.  He lay in bed much of the time, frontal lobe area hurt, was nauseated.  It took him about 3 months to recover.  When he had the 2nd HPV injection the reaction was similar starting about 2 weeks later, but not nearly as severe and didn't last as long (maybe 2-3 weeks).
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Pain
Clinical narrative: Patient came to the pharmacy and said it's time for her second dose of Shingrix, but she had pretty bad side effects from the first dose and wondered if she should get the second dose.  She said at first she thought she was having a heart attack.  She had intense pain in her left upper chest area that radiated across her chest over the following 6 days and then faded away.  She took Tylenol the first few days to help with the pain.  She did not contact a doctor or the pharmacy and was not seen or evaluated by a healthcare professional.  She said she feels fine now..
Age: 66.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Diarrhoea, Dizziness, Headache, Influenza
Clinical narrative: Headache, muscle aches (all over), dizziness,  flu symptoms, diarrhea, weakness,
Age: 66.0
Sex: M
Vaccine: FLUC4
Symptoms: Myalgia
Clinical narrative: Headache, muscle aches (all over), dizziness,  flu symptoms, diarrhea, weakness,
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Injected limb mobility decreased, Limb discomfort
Clinical narrative: 3 hours after vaccination arm felt heavy and patient felt fatigued. The next day arm was extremely painful could not lift it and felt tired. In the afternoon she called the pharmacy stating that she was weak nauseous and had chills and a severe headache. I instructed her to go to urgent care.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: 3 hours after vaccination arm felt heavy and patient felt fatigued. The next day arm was extremely painful could not lift it and felt tired. In the afternoon she called the pharmacy stating that she was weak nauseous and had chills and a severe headache. I instructed her to go to urgent care.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: RASH FORMED FROM KNEES TO HIP. MAYBE A LITTLE ON CHEST/BREAST. RED AND WELTY. HIVE-LIKE. BUT DID NOT ITCH.
Age: 68.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: I was woken up by an extreme headache, this was followed by chills, I could not get warm. After moving downstairs, then back up to get back in bed, I began sweating.  The series of effects lasted approximately  2 hours.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Oropharyngeal pain, Pruritus, Skin discolouration, Throat irritation
Clinical narrative: Injection: 16:45 in Right Deltoid Reaction: 20:45 ?both armpits are yellow/brown (I?m fair skin toned) and extremely itchy, my throat is very scratchy and sore and I feel very fatigued.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Extensive Limb Swelling (erythema, warmth, induration), no associated symptoms, 5cm x 7cm
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Haematochezia, Irritability
Clinical narrative: Baby was fussy, developed loose stools and had 1 diaper w/small amount if blood seen in it.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Complained of left deltoid swelling and warm to touch.  Keflex 500mg PO BID X's 7 days prescribed.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Whelps very large redness & swelling
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Pt. developed cellulitis to Left upper arm 6 days after Shingrix injection. Pt. given antibiotic injection in clinic and an oral antibiotic prescription for 10 days. Pt. has a follow up appt. scheduled.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Nausea
Clinical narrative: PATIENT REPORTED DIZZINESS, LIGHTHEADEDNESS, NAUSEA W/O VOMITING, COLD SWEATS. LEGS WERE ELEVATED, CHECKED VITAL SIGNES (ALL NORAL RANGE), WATER GIVEN TO DRINK. PATIENT WAS SUPERVISED TO 15 MIN AFTER VACCINE ADMINISTRATION. PATIENT RECOVERED AND WENT HOME AFTER.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: pain is high up in arm. pain comes + goes. Iced area + put heat on area + took Advil
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Paraesthesia, Peripheral swelling
Clinical narrative: Patient states arm very swollen and red day after receiving. Got increasingly worse - and tingling up to 1 month after. I reached out to MD, they were going to call patient to schedule appointment to evaluate.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: Pt's arm (upper) and shoulder swollen and painful. Pain is keeping her up at night. Pt contacted PCP, and is waiting to hear back. Treating pain w/Ibuprofen currently, but pain is still severe.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram, Demyelination, Magnetic resonance imaging, Multiple sclerosis, Optic neuritis
Clinical narrative: patient had blurred vision of (R) eye -went to ED and reffered to ophthalmology where he was found to (B) papilledema. He was admitted to the hospital to be treated for optic neuritis. Has evidence of a demyelinating process unclear. He mets criteria for MS at this time. He is followed by neurolgy, symptoms  developed in close proximity to his HPV series  but nurology has low suspicion for vaccine causation
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Papilloedema, Vision blurred
Clinical narrative: patient had blurred vision of (R) eye -went to ED and reffered to ophthalmology where he was found to (B) papilledema. He was admitted to the hospital to be treated for optic neuritis. Has evidence of a demyelinating process unclear. He mets criteria for MS at this time. He is followed by neurolgy, symptoms  developed in close proximity to his HPV series  but nurology has low suspicion for vaccine causation
Age: 37.0
Sex: F
Vaccine: FLUR4
Symptoms: Dyspnoea, Injection site swelling, Urticaria
Clinical narrative: Difficulty breathing, hives, bump at injection site.
Age: 85.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Balance disorder, Decreased appetite, Dizziness, Headache
Clinical narrative: IT STARTED WITH A LiTE HEAD ACHE (I DO NOT GET HEAD ACHES) FOR A FEW DAYS, THEN PAIN IN MY SHOULDERS AND NECK, DiZZY, LOSS OF BALANCE AND APPiTiTE, COULDN'T SLEEP BECAUSE OF PAIN, PAIN IN MY WHOLE UPPER BODY. IT LAST OVER 2 WEEKS. MY SON TOOK ME TO THE HOSPITAL EMG. 9-30-20 10:56 AM. (HE LOST 2 DAYS OFF WORK.) IT WAS PAINFUL TO JUST MOVE ANY PART OF MY BODY. IT'S STILL PAINFUL TO BEND MY HEAD BACK. 10-27-20 "IF" I GET A FLU SHOT NEXT YEAR, IT WON'T BE THIS ONE!
Age: 85.0
Sex: F
Vaccine: FLUA4
Symptoms: Neck pain, Pain, Sleep disorder, Torticollis
Clinical narrative: IT STARTED WITH A LiTE HEAD ACHE (I DO NOT GET HEAD ACHES) FOR A FEW DAYS, THEN PAIN IN MY SHOULDERS AND NECK, DiZZY, LOSS OF BALANCE AND APPiTiTE, COULDN'T SLEEP BECAUSE OF PAIN, PAIN IN MY WHOLE UPPER BODY. IT LAST OVER 2 WEEKS. MY SON TOOK ME TO THE HOSPITAL EMG. 9-30-20 10:56 AM. (HE LOST 2 DAYS OFF WORK.) IT WAS PAINFUL TO JUST MOVE ANY PART OF MY BODY. IT'S STILL PAINFUL TO BEND MY HEAD BACK. 10-27-20 "IF" I GET A FLU SHOT NEXT YEAR, IT WON'T BE THIS ONE!
Age: 78.0
Sex: F
Vaccine: FLUC4
Symptoms: Dermatitis acneiform, Rash erythematous, Rash pruritic
Clinical narrative: There was a nickel-size rEd rash, pimply in tExturE and itchy hivE-likE bumps below that.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall
Clinical narrative: PATIENT & MOTHER RECEIVED ANNUAL FLU VACCINE AT 8PM ON EVENING OF 11/09/2020. PATIENT RECEIVED HERS 1ST IN THE RIGHT DELTOID MUSCLE. NO SIGNS/SYMPTOMS NOTED AT THIS TIME. AS SHE WAITED APPROXIMATELY 3 MINUTES STANDING BEHIND SHE BECAME DIZZY/LIGHT HEADED AND FELL TO THE FLOOR. SHE WAS MOVED TO BENCH WHERE SYMPTOMS RETURNED 5 MINUTES LATER. SHE WAS OBSERVED FOR 15 MINUTES, GIVEN GATORADE AND CHIPS, AND LEFT WITH MOTHER ON HER OWN ACCORD.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site scab, Pallor, Papule
Clinical narrative: Generalized diffuse blanching maculopapular rash on face, trunk, extremities and Papule. Nodule, mildly erythematous on posterior left thigh with scab formation overlying nodule. Advised to continue use of warm compress to nodule 15-20 min BID-TID. No fever. Immunizations given 10/8/20, rash started 10/18/20, rash started 10/18/20, visit to Dr. office 10/20/20.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Generalized diffuse blanching maculopapular rash on face, trunk, extremities and Papule. Nodule, mildly erythematous on posterior left thigh with scab formation overlying nodule. Advised to continue use of warm compress to nodule 15-20 min BID-TID. No fever. Immunizations given 10/8/20, rash started 10/18/20, rash started 10/18/20, visit to Dr. office 10/20/20.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was administered an expired Fluzone High Dose with no AE; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case is linked to case 2020SA275909 (75 years old patient, same reporter).  This case involves a 81 years old female patient who received 0.5 ml first dose of an expired INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: UJ306AA, expiry date: 24-JUN-2020) via un unknown route on Deltoid of unknown arm on 30-Sep-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No concomitant therapy given.  It was an actual medication error due to the expired vaccine used (latency same day).  No symptoms occurred to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Blood follicle stimulating hormone abnormal, Fatigue, Headache, Hot flush
Clinical narrative: Night sweats, insomnia / I would spot before my period/ I started having hot flushes and my period never came back / the doctor diagnosed me with premature menopause / premature ovarian failure; fatigue; headaches; This spontaneous report was received from a 24-year-old female patient, reporting about herself. Her medical history, concurrent conditions, allergies and concomitant therapies were not provided.  On 01-APR-2016, at 10:48, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (also referred by the patient as "Gardasil" or "Gardasil vaccine") dose 3 in the right arm as prophylaxis, lot number reported as 040459 (invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)) (strength, exact dose, frequency, and route of administration were not reported).  On 02-APR-2016, the patient started having night-sweats, insomnia, fatigue, and headaches. On 2016 (reported as the same year) she had started unspecified birth control, everything was normal but after the vaccine she realized she would spot before her period. She went to the doctor a couple times, they would always check her thyroid but that was normal. Until June 2019, she stopped her birth control, she started having hot flushes and her period never came back. Before the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) she would get her periods religiously every month. On an unknown date, she went to the doctor, they checked her follicle-stimulating hormone (FSH) levels and diagnosed her with premature menopause.  At the reporting time, the patient had not recovered from the events. Moreover, the casuality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  As of 05-NOV-2020, a telephone call was received from a nurse who would follow up if she has more information.   The events were considered by the reporter as disabling or causing permanent damage.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Insomnia, Metrorrhagia, Night sweats, Premature menopause, Thyroid function test normal
Clinical narrative: Night sweats, insomnia / I would spot before my period/ I started having hot flushes and my period never came back / the doctor diagnosed me with premature menopause / premature ovarian failure; fatigue; headaches; This spontaneous report was received from a 24-year-old female patient, reporting about herself. Her medical history, concurrent conditions, allergies and concomitant therapies were not provided.  On 01-APR-2016, at 10:48, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (also referred by the patient as "Gardasil" or "Gardasil vaccine") dose 3 in the right arm as prophylaxis, lot number reported as 040459 (invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)) (strength, exact dose, frequency, and route of administration were not reported).  On 02-APR-2016, the patient started having night-sweats, insomnia, fatigue, and headaches. On 2016 (reported as the same year) she had started unspecified birth control, everything was normal but after the vaccine she realized she would spot before her period. She went to the doctor a couple times, they would always check her thyroid but that was normal. Until June 2019, she stopped her birth control, she started having hot flushes and her period never came back. Before the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) she would get her periods religiously every month. On an unknown date, she went to the doctor, they checked her follicle-stimulating hormone (FSH) levels and diagnosed her with premature menopause.  At the reporting time, the patient had not recovered from the events. Moreover, the casuality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  As of 05-NOV-2020, a telephone call was received from a nurse who would follow up if she has more information.   The events were considered by the reporter as disabling or causing permanent damage.
Age: 54.0
Sex: M
Vaccine: FLUC4, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pain in left abdomen noted around 31 Oct.  radiated around left side.  Urgent care on 2 Nov for acute left side abdomen pain.   Developed rash on left side on 3 Nov, diagnosed with shingles on 3 Nov.  never had shingles before I got vaccine.
Age: 54.0
Sex: M
Vaccine: FLUC4, VARZOS, VARZOS
Symptoms: Abdominal pain, Blood test normal, Computerised tomogram normal, Herpes zoster, Rash
Clinical narrative: Pain in left abdomen noted around 31 Oct.  radiated around left side.  Urgent care on 2 Nov for acute left side abdomen pain.   Developed rash on left side on 3 Nov, diagnosed with shingles on 3 Nov.  never had shingles before I got vaccine.
Age: 54.0
Sex: M
Vaccine: FLUC4, VARZOS, VARZOS
Symptoms: Urine analysis normal
Clinical narrative: Pain in left abdomen noted around 31 Oct.  radiated around left side.  Urgent care on 2 Nov for acute left side abdomen pain.   Developed rash on left side on 3 Nov, diagnosed with shingles on 3 Nov.  never had shingles before I got vaccine.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Nausea, Urticaria
Clinical narrative: I got vacation for shingles I got allergy  headache  stomach upset. Tired skin rash itching all body . .
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Hypersensitivity, Pruritus
Clinical narrative: I got vacation for shingles I got allergy  headache  stomach upset. Tired skin rash itching all body . .
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: I got vacation for shingles I got allergy  headache  stomach upset. Tired skin rash itching all body . .
Age: 74.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Administration site discolouration, Administration site swelling, Injection site erythema
Clinical narrative: Experienced pain in left arm. Redness, sore, swelling the size of a baseball on 11/08/2020. On Sunday was fatigue and lost appetite. Experienced nausea and jittery. On Monday 11/09/2020, still experiencing nausea, diarrhea, no appetite. Midday yesterday 11/09/2020, fatigue.
Age: 74.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Decreased appetite, Diarrhoea, Erythema, Fatigue, Feeling jittery
Clinical narrative: Experienced pain in left arm. Redness, sore, swelling the size of a baseball on 11/08/2020. On Sunday was fatigue and lost appetite. Experienced nausea and jittery. On Monday 11/09/2020, still experiencing nausea, diarrhea, no appetite. Midday yesterday 11/09/2020, fatigue.
Age: 74.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Experienced pain in left arm. Redness, sore, swelling the size of a baseball on 11/08/2020. On Sunday was fatigue and lost appetite. Experienced nausea and jittery. On Monday 11/09/2020, still experiencing nausea, diarrhea, no appetite. Midday yesterday 11/09/2020, fatigue.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Immediate post-injection reaction, Injection site urticaria, Swelling
Clinical narrative: Immediate reaction at injection site (hive like bump) Within hours started spreading across arms and chest Called nurse hotline for Dr and recommended Benadryl..  within hours she had her face swollen whole body swollen
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness swelling at injection site
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Headache, Injection site discolouration, Injection site irritation
Clinical narrative: I developed daily headaches for 1.5 weeks followed by intermittent headaches for another 1.5 weeks. I had skin discoloration   and moderate irritation at the injection site for 5 weeks.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: no other AE associated with administration; an expired dose of ROTATEQ was administered; This spontaneous report was received from a nurse referring to a 2-month-old male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 26-OCT-2020, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # 1660937, expiration date 25-OCT-2020, at a dose of 2 milliliter, orally for prophylaxis (formulation, strength, dose, frequency, route of administration, indication,  were not reported). The reporter said there were no other adverse events associated with administration.  Lot No.1660937 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ).
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This spontaneous report as received from a lawyer refers to a female patient (pt) of unknown age. Medical history, concurrent conditions, and concomitant medication were not reproted. In or around 03-NOV-2017, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (Dose, lot number, and expiration date  were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving pt's zoster vaccine live(ZOSTAVAX) vaccine, she suffered a sudden onset of left-sided facial paralysis and was diagnosed with Bell's Palsy.  As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). She experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), she sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX)wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review Bell's Palsy was considered as medically significant and disabling event.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Nurse called to report temperature excursion for VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 02-NOV-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number S035125, expiration date 04-NOV-2021 (route of administration) for prophylaxis and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 dosage form (Route of administration, lot number and expiration date were not provided) for prophylaxis.  The vaccines were exposed to the following temperature excursions: -13.9 degrees Celsius (°C) to 14.7°C; -14 to -10°, with an average of -13.9°C for 30 minutes. -14°C to -10°C, with an average of -14.2°C for 15 minutes; -14°C to -10°C, with an average of -14.7°C for 20 minutes and -14°C to -10°C, with an average of -14.6°C for 5 minutes. There were no previous temperature excursions. The call was due to digital data logger.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: given vaccines during improperly stored/temperature excursion; This spontaneous report as received from a licensed practical nurse referring to a 6-year-old patient of unknown age and gender. The patient's pertinent medical history, current condition, previous drug reaction or allergy, and concomitant medication were not reported.  02-NOV-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T006345, expiration date reported and validated as 20-FEB-2022) for prophylaxis (Improper storage of product in use). The vaccine was exposed to the following temperature excursions: -13.9 degrees Celsius to 14.7 degrees Celsius; -14 degrees Celsius to -10 degrees Celsius, with an average of -13.9 degrees Celsius for 30 minutes. -14 degrees Celsius to -10 degrees Celsius, with an average of -14.2 degrees Celsius for 15 minutes; -14 degrees Celsius to -10 degrees Celsius, with an average of -14.7 degrees Celsius for 20 minutes and -14 degrees Celsius to -10 degrees Celsius, with an average of -14.6 degrees Celsius for 5 minutes as recorded by a data logger. There was no previous temperature excursion.; Sender's Comments:  US-009507513-2011USA001488:
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: When she tried to get up that same night she collapsed; She states that the first night she had fever, chills, dizziness, and body was soaking wet.; chills; dizziness; body was soaking wet; She also reports her arm was red from her shoulder to her elbow, and states that it was bright red; her arm is sore; This spontaneous report was received from a female consumer reporting on herself. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On 30-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) second dose, 1 dosage form (route of administration, lot number and expiration date were not provided) to prevent pneumonia.         On an unknown date in 2020, the patient's arm was red from her shoulder to her elbow, and it was bright red and sore (erythema and injection site pain). The patient stated that on 30-OCT-2020 she had fever, chills, dizziness, and her body was soaking wet (pyrexia, syncope, hyperhidrosis, dizziness and chills) that lasted for 5 days.      The outcome of syncope, injection site pain, erythema, hyperhidrosis, dizziness, chills and pyrexia was reported as recovering. The causal relationship between pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) and injection site pain was reported as related. The causal relationship between pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) and the rest of the events was not provided.  Upon internal review, syncope was considered as medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Syncope
Clinical narrative: When she tried to get up that same night she collapsed; She states that the first night she had fever, chills, dizziness, and body was soaking wet.; chills; dizziness; body was soaking wet; She also reports her arm was red from her shoulder to her elbow, and states that it was bright red; her arm is sore; This spontaneous report was received from a female consumer reporting on herself. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On 30-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) second dose, 1 dosage form (route of administration, lot number and expiration date were not provided) to prevent pneumonia.         On an unknown date in 2020, the patient's arm was red from her shoulder to her elbow, and it was bright red and sore (erythema and injection site pain). The patient stated that on 30-OCT-2020 she had fever, chills, dizziness, and her body was soaking wet (pyrexia, syncope, hyperhidrosis, dizziness and chills) that lasted for 5 days.      The outcome of syncope, injection site pain, erythema, hyperhidrosis, dizziness, chills and pyrexia was reported as recovering. The causal relationship between pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) and injection site pain was reported as related. The causal relationship between pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) and the rest of the events was not provided.  Upon internal review, syncope was considered as medically significant.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: fainted; This spontaneous report was received from a pharmacist via a company represent referring to the pharmacist's son of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.  On an unknown date, the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose detail, route, lot # and expiration date were unknown) in the doctor's office for prophylaxis.         On the same date, after receiving the vaccine, the patient fainted. It was unknown if the patient had sought medical attention, laboratory diagnostic studies were performed or if the patient received any treatment. The outcome of the event was unknown. The causality assessment between the patient fainted and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.  Upon internal review, the patient fainted was determined to be medically significant.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE; patient received first dose of VAQTA at age 6 months, and second dose at age 6 years.; patient received first dose of VAQTA at age 6 months, and second dose at age 6 years.; This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On an unspecified date in July 2003, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated(VAQTA) (strength, dose, route, lot number, and expiration date were not reported) for prophylaxis. It was reported that the patient received the second dose of hepatitis a vaccine, inactivated(VAQTA) (strength, dose, route, lot number, and expiration date were not reported) for prophylaxis in approximately 2009 (reported as "at age 6 years"). No additional adverse events were reported.
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis, Malaise
Clinical narrative: THIS CAUSED ME TO BE SICKER THAN THE FLU; NOSEBLEEDS; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     On an unknown date, the patient experienced nosebleeds (preferred term: Epistaxis). On an unknown date, the patient experienced this caused me to be sicker than the flu (preferred term: Malaise).     The outcome of the event(s) of this caused me to be sicker than the flu and nosebleeds was unknown.     The events were considered non-serious.     The reporter considered the following event(s) related to treatment with FluMist: this caused me to be sicker than the flu.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Malaise, Nausea, Vomiting
Clinical narrative: headache; n/v; n/v; malaise; This case was reported by a physician and described the occurrence of headache 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 headache, nausea, vomiting and malaise. On an unknown date, the outcome of the headache, nausea, vomiting and malaise were unknown.   It was unknown if the reporter considered the headache, nausea, vomiting and malaise 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 adult as per the vaccine indication. The patient received Shingrix and had vomiting, nausea, headache and malaise.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020204699:SAME REPORTER
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel crappy; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal 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 adult as per the vaccine indication. The reporter asked if it was normal to feel crappy 24 hours after vaccination.