chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick as a dog; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 3 months after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. Last year the patient took the flu shot. Spent November and December and first week of January sick as a dog. This year took the tetanus shot by mistake. So far so good. But  the patient won't do the flu shot again or Covid vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Injection site pain, Malaise
Clinical narrative: feeling of unwellness remained; then irradiated to the back of the patient and down the shoulder; then irradiated to the back of the patient and down the shoulder; pain at the site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th August 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, back pain and shoulder pain. On 30th August 2020, the patient experienced malaise. On 30th August 2020, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the malaise, back pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, malaise, back pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient presented severe pain at the site of injection for Shingrix which then irradiated to the back of the patient and down the shoulder.  The pain left after two days but a general feeling of unwellness remained with the patient.  The reporter consent to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Pain
Clinical narrative: tiredness; achiness; Initial information received on 04-Sep-2020 regarding an unsolicited valid non-serious case received from a non health care professional (patient).  This case involves a female patient (age not reported) who experienced tiredness (fatigue) and achiness (pain), while she received vaccine INFLUENZA VACCINE.  The patient's vaccination(s) included Fluzone High Dose. Medical history, concomitant therapy, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious tiredness (fatigue) and achiness (pain) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Erythema, Nervousness, Peripheral swelling
Clinical narrative: Patient reported that several hours after receiving her flu shot while she was at home in the evening she felt shaky and her BP jumped from about 103/70 to about 170/90. She said she took her as needed bp medication as well as Tylenol and after half an hour to an hour later her bp had lowered to about systolic 150 and she felt well enough to sleep. She also reported redness and swelling on her arm with a diameter of about 4-5 inches.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Syncope less than 5 minutes after injection
Age: 17.0
Sex: F
Vaccine: FLUC4, MENB
Symptoms: Cold sweat, Dizziness, Fatigue, Headache, Loss of consciousness
Clinical narrative: After receiving the two vaccines Influenza and Meningococcal B and the TB PPD test the patient fainted on the examination table. She lost consciousness momentarily for a few seconds. Patient's HR was 49 oxygen 97-98%. When patient awake she felt light headed, cool, clammy, and pale. Initial vital signs were HR 49, BP 99/57, oxygen 97, second vital signs BP 116/76, HR 72, oxygen 98%, third vital signs BP 116/73, HR 76, oxygen 97%. Patient was observed for 30 minutes. Before leaving the clinic she denied dizziness, able to ambulate without difficulty, skin warm and pink. Patient never developed a rash, shortness of breath, hives, or difficulty breathing. Patient was called 2 hours after going home. Denies fainting episode again but did report a mild headache and feeling little tired. Patient denied other new symptoms. Patient instructed to go to ED if new symptoms develop. Patient reports a history of fainting after giving blood in the past.
Age: 17.0
Sex: F
Vaccine: FLUC4, MENB
Symptoms: Pallor, Syncope
Clinical narrative: After receiving the two vaccines Influenza and Meningococcal B and the TB PPD test the patient fainted on the examination table. She lost consciousness momentarily for a few seconds. Patient's HR was 49 oxygen 97-98%. When patient awake she felt light headed, cool, clammy, and pale. Initial vital signs were HR 49, BP 99/57, oxygen 97, second vital signs BP 116/76, HR 72, oxygen 98%, third vital signs BP 116/73, HR 76, oxygen 97%. Patient was observed for 30 minutes. Before leaving the clinic she denied dizziness, able to ambulate without difficulty, skin warm and pink. Patient never developed a rash, shortness of breath, hives, or difficulty breathing. Patient was called 2 hours after going home. Denies fainting episode again but did report a mild headache and feeling little tired. Patient denied other new symptoms. Patient instructed to go to ED if new symptoms develop. Patient reports a history of fainting after giving blood in the past.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Rash
Clinical narrative: RASH
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: cellulitis
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Site of injection became hot, red and swollen by the next day after receiving the vaccine. Tenderness went away in about 2 days, but it took about 4-5 days for the redness to go away. Patient also reported entire body aches and flu-like symptoms for about 2 days. Treated with Tylenol and rest, did not follow up with doctor since it was the weekend and the majority of the symptoms were resolved by Monday morning.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Site of injection became hot, red and swollen by the next day after receiving the vaccine. Tenderness went away in about 2 days, but it took about 4-5 days for the redness to go away. Patient also reported entire body aches and flu-like symptoms for about 2 days. Treated with Tylenol and rest, did not follow up with doctor since it was the weekend and the majority of the symptoms were resolved by Monday morning.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Oxygen saturation decreased, Respiratory rate increased, Sleep disorder, Swelling face, Urticaria
Clinical narrative: Patient woke up in middle of night with facial swelling and hives. Had hives throughout body and neck. He had high respiratory rate and was admitted to the hospital. He was hospitalized for 1 day and presented with low oxygen while hospitalized.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: pain, redness, swelling, itching at sight of injection
Age: 91.0
Sex: F
Vaccine: FLU4
Symptoms: Aphasia, Cerebrovascular accident, Facial paralysis, Magnetic resonance imaging, Transient ischaemic attack
Clinical narrative: Mild stroke/TIA that evening. Loss of speech, but could squeeze her daughters finger.  Slight mouth droop. Refused to go to hospital per daughter.
Age: 91.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound Doppler
Clinical narrative: Mild stroke/TIA that evening. Loss of speech, but could squeeze her daughters finger.  Slight mouth droop. Refused to go to hospital per daughter.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling hot, Loss of consciousness, Posture abnormal, Vomiting
Clinical narrative: PATIENT WAS GIVEN VACCINE PER ALL GUIDLEINES, PATIENT TOLERATED WELL, BUT THEN GOT HOT AND PASSED OUT, FATHER ASSISTED AND CHILD THREW HIS HEAD BACK AGAINST WALL. FATHER AND I FANNED AND OBSERVED CHILD AND HE CAME TO . HE VOMITED AND THEN ASKED FOR A DRINK. AFTER RESTING FOR ABOUT 10 MINUTES CHILD WAS ABLE TO STAND AND DO JUMPING JACKS. I CALLED FATHER AROUNF 7PM AND CHILD HAD RETURNED TO NORMAL ACTIVITIES AND WAS FINE, ADVISED FATHER TO CALL ME IF NEEDED.
Age: 77.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Malaise, Vomiting
Clinical narrative: Pt received vaccines around 2p on august 20th. Pt contacted pharmacy around 730 that night stating that she was vomiting perfusely and felt very ill. She was not willing to go to hospital, hung up on pharmacist. Pharmacist called 911 to send ambulance to pt home. Pt was taken to hospital to be treated.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Discomfort, Fatigue, Feeling abnormal
Clinical narrative: pt reports bad bruising and feeling bad that night.  whole body heaviness and fatigue.  100 % in 2 days
Age: 47.0
Sex: M
Vaccine: FLUR4
Symptoms: Back pain, Influenza like illness, Pain
Clinical narrative: pain in back, achy all over, no fever, started morning after immunization. pt related symptoms to how he felt when he had the flu in February 2019
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: C-reactive protein normal, Full blood count normal, Gait disturbance, Hypoaesthesia, Imaging procedure
Clinical narrative: ABOUT 11 HOURS AFTER receiving the above vaccines developed numbness and weakness of legs with abnormal gait.  went to ED where had labs and imaging done and given IVF bolus.  after receiving IV fluids symptoms improved greatly
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Metabolic function test normal, Muscular weakness, Red blood cell sedimentation rate normal, Spinal X-ray normal, Urine analysis normal
Clinical narrative: ABOUT 11 HOURS AFTER receiving the above vaccines developed numbness and weakness of legs with abnormal gait.  went to ED where had labs and imaging done and given IVF bolus.  after receiving IV fluids symptoms improved greatly
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Injection site pruritus, Pustule, Swelling
Clinical narrative: Patient said he experienced itching but no pain at the injection site later that morning after receiving the vaccination. His arm became inflamed and slightly pustular. He indicates that the itching dissipated but the redness and raised inflamed area has persisted. He indicated he had tried using a prescription corticosteroid as well as OTC betadine with no resolution of inflammation.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Headache, Insomnia, Pain
Clinical narrative: After having the vaccination,  had 104 fever the next day, achy, headache and didn't get out of bed. Next day felt better but not full of energy. Monday, thought felt better. The next day had really bad shoulder pain. Called doctor to let them know what was happening. Ask doctor was it normal, she said no. The PA , printed out information about the vaccine. Able to lift arm but still having some pain and headaches. Having trouble sleeping. It's been about 3 weeks.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: After having the vaccination,  had 104 fever the next day, achy, headache and didn't get out of bed. Next day felt better but not full of energy. Monday, thought felt better. The next day had really bad shoulder pain. Called doctor to let them know what was happening. Ask doctor was it normal, she said no. The PA , printed out information about the vaccine. Able to lift arm but still having some pain and headaches. Having trouble sleeping. It's been about 3 weeks.
Age: 3.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Wrong product administered
Clinical narrative: Ma gave a Tdap to Pt. instead of the correct Dtap. She than gave the correct immunization to Pt. the correct Dtap was given before Pt. left the office.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: No symptoms.
Age: 74.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Fall, Loss of consciousness, Nausea
Clinical narrative: At 3:00 A M the next morning Sep 3, Dizziness, Light Headed, Nausea,  Blacked out and fell on the fioor trying to throw up
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Body aches, excessively swollen, red, warm to touch area about 3 inches by 6 inches that has progressively gotten worse throughout the day
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Pyrexia, Rash papular, Viral infection
Clinical narrative: discomfort at injection site, fever and viral prodrome next day papular rash 5 days later
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site rash, Injection site erythema, Skin warm
Clinical narrative: patient called said she has redness and rash going down from the site of administration, warm to the touch measuring about 3 x 2 in.  provider notified. redness did start to spread.  Information passed on to provider
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Eye pruritus, Lip swelling, Throat irritation
Clinical narrative: pt received immunization around 9:15 am 9/9 got home around 11 am. said eyes started to itch, throat scratchy, and lips swelling. called pharmacy at 2:15 pm. advised pt to take benadryl, call dr or go to dr or er, pt was home with husband. pt wanted took benadryl 50 mg. called back to pharmacy at 3:55 pm and swelling and other symptoms had improved. advised pt to continue benadryl and go to er if worsened. pt states has dr personal number and will call dr if needed. will call pt to check on them in the am 9/10
Age: 91.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever lasting 5 days. Highest emp 100.6 Headache Generalized body aches
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Sleep disorder, Vaccination site bruising
Clinical narrative: patient experienced extreme pain at site of injection. she took tyelnol the same evening. was woken up at 1am and had to take additional tylenol. The pain stopped after the second dose. Later the next day she found her arm bruised below the area the vaccine was injected
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Patient called pharmacy on 09/09/2020 17:15pm.  Spoke with RPH.  Told him about adverse events.  Left store on 09/08/2020 at approximately 09:15am after receiving vaccine.  Soon afterwards, arm began to swell to size of orange around injection site, with red appearance.  Patient described throbbing pain at injection site, and bad, throbbing headache.  She also said that she became very lethargic.  Spent most of the afternoon with spouse at doctor's appointment.  Headache had subsided until she got back home.  At 21:00, she said that headache and arm were both throbbing worse than before.  She took some Tylenol Arthritis and used a heating pad.  CD instructed her to take Ibuprofen 400<CONTINUED ON PAGE 2>
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient called pharmacy on 09/09/2020 17:15pm.  Spoke with RPH.  Told him about adverse events.  Left store on 09/08/2020 at approximately 09:15am after receiving vaccine.  Soon afterwards, arm began to swell to size of orange around injection site, with red appearance.  Patient described throbbing pain at injection site, and bad, throbbing headache.  She also said that she became very lethargic.  Spent most of the afternoon with spouse at doctor's appointment.  Headache had subsided until she got back home.  At 21:00, she said that headache and arm were both throbbing worse than before.  She took some Tylenol Arthritis and used a heating pad.  CD instructed her to take Ibuprofen 400<CONTINUED ON PAGE 2>
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Reports on 9/3 felt a good amount of pain to the affected arm with the Shingrix vaccine however did not develop itching till 2 days later and the redness seems to be expanding with more itching and warmth.No fever, chills, tenderness, increased pain, blistering.Denies shortness of breath, dizziness, palpitations, CP, nausea or vomiting, hives, swelling of face/throat.Had been taking Benadryl and applying cool compresses. Clinical suspicion for possible localized reaction with early cellulitis: Advised patient on OTC oral antihistamines advised in taking both Zyrtec 10 mg once to twice daily and Pepcid daily. Advised in Calamine lotion OTC as needed. Cool compresses. Keflex 500 mg po QID as directed.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: patient had redness and itching. It got resolved in 2 days
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain, Vomiting
Clinical narrative: Fatigue, headache, bodyaches, nausea and vomiting
Age: 61.0
Sex: F
Vaccine: FLUR4, PPV, VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Her arms were red and on fire and very sore below the injection site by 4 to 5 inches. She was nauseous and not feeling well. Did not remember anything the day after the injections. Cold chills.  I told her to put cold packs on injection sites and to go home to rest.
Age: 61.0
Sex: F
Vaccine: FLUR4, PPV, VARZOS
Symptoms: Nausea
Clinical narrative: Her arms were red and on fire and very sore below the injection site by 4 to 5 inches. She was nauseous and not feeling well. Did not remember anything the day after the injections. Cold chills.  I told her to put cold packs on injection sites and to go home to rest.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Injected limb mobility decreased, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Patient's husband reported the patient's shoulder was swollen and stated she "Can't move her arm" after her influenza vaccine was administered.  He reported the injection was about 1/4 inch below her shoulder, "right on the bone."   He also stated she was experiencing chills, shakes, stiffness in neck, and headache.  It was recommended the patient see a trusted PCP for a full assessment and to test range of motion.    Ice and ibuprofen were suggested to reduce pain, swelling, inflammation.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site, Tremor
Clinical narrative: Patient's husband reported the patient's shoulder was swollen and stated she "Can't move her arm" after her influenza vaccine was administered.  He reported the injection was about 1/4 inch below her shoulder, "right on the bone."   He also stated she was experiencing chills, shakes, stiffness in neck, and headache.  It was recommended the patient see a trusted PCP for a full assessment and to test range of motion.    Ice and ibuprofen were suggested to reduce pain, swelling, inflammation.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pruritus, Swelling
Clinical narrative: Patient described redness/rash near injection site of upper arm.  Additionally, the area in his chest where he previously had a port removed became swollen and itchy.  Injection site in arm became red and itchy as well.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Rash over mid back, started this morning, covering 50% of back, itchy, no oral swelling/difficulty breathing
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: FEVER AND VOMITING THE NIGHT PT. GOT THE VACCINE.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Eye swelling, Rash macular
Clinical narrative: PATIENT REPORTED ON THE SECOND SHINGRIX DOSE THAT HER EYES BECAME SWOLLEN & HER SKIN WAS RED AND SPLOTCHY. THE DOCTOR HAD TO GIVE HER A STEROID INJECTION AND SUBSEQUENTLY A 5 DAY SUPPLY OF ORAL PREDNISONE. A NURSE PRACTIONER TOLD THE PT TO REPORT HER REACTION TO US. SHE DID NOT HAVE A REACTION ON THE FIRSTSHINGRIX DOSE OR ANY FLU VACCINE IN THE PAST.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Dyspnoea, Heart rate increased
Clinical narrative: Difficulty breathing Weakness Fast heart beat
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Ongoing blurred, diminished vision
Age: 66.0
Sex: F
Vaccine: FLUA4, PPV, VARZOS
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Patient said she was having a really bad headache and arm pain.  She said her pain meds and extra strength tylenol was not relieving any pain. She said she was also having some nausea
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Syringe issue
Clinical narrative: vaccine attempt unsuccessful. liquid leaked out of syringe or arm during attempt.  will advise to revaccinate as per cdc guidelines.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Swollen arm. Pink in color. Warm to touch. Cannot lift arm due to pain.
Age: 80.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: muscle/body aches and site injection soreness
Age: 66.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Altered state of consciousness, Heart rate increased, Hyperhidrosis, Speech disorder
Clinical narrative: Patient states she had increased heart rate, sweaty palms,trouble talking and felt like she may pass out for about an hour.  After that hour passed she states she felt perfectly fine.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Joint range of motion decreased
Clinical narrative: Patient was diagnosed with cellulitis as well as loss of range of motion in the left shoulder.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: patient's daughter came to pharmacy to pick up medrol dosepack on same day as flu vaccine was given and told pharmacist her mother had trouble breathing around lunch time approximately 2.5 hours after vaccine and went to urgent care clinic. She had trouble breathing and heavy chest per daughter.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Patient was given a pneumovax shot on Monday. On Tuesday, patient came in with redness/swelling. Patient was then instructed to monitor. Patient came back on wednesday with the swelling/redness spreading down to elbow. Patient was instructed to go the ER where she was given a 5 day course of antibiotics (Cephalexin).
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Contraindication to vaccination
Clinical narrative: Live vaccine (Rotavirus) given to a complex medical needs child with multiple medical problems including DiGeorge Syndrome (hypocalcemia, immunodeficiency and at risk for developing SCID). Risk for adverse events.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Arm felt like beaten, intense pain, headache, hurt almost all the way to shoulder but mainly lower down, swelled up, turned red progressively. Patient received the Fluzone HD in the same arm.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: patient sates upper shoulder pain for the past 2 months and has difficult time with arm mobility. went to doctor today and was prescribed prednisone and physical therapy
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Syncope
Clinical narrative: Patient was administered the vaccine and within a couple of minutes (1-2 minutes) reported feeling nauseated and collapsed into mother's arms while sitting down. Patient remained seated at all times and did not lose consciousness.  Within a couple of minutes patient was fully alert and emergency doctors and nurses came to scene to help patient elevate his feet. Juice was provided to patient to help him feel better. Within 10 minutes after vaccine administration patient reported feeling fine and left the scene. A follow-up call was made to patient and 9/9/2020 and patient reported no other adverse events after the syncope incident. Doctor was also contacted on 9/9/2020 and given description of events.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: The MMR vaccine was given intramuscularly instead of subcutaneously. There were no adverse event or symptoms reported
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Dizziness, Pain
Clinical narrative: About 5 minutes after receiving the flu vaccine, pt reported pulsating pain that started at her upper back then travelled down her back to just below hip.  It was intermittent pain, that came and went, which was observable with patient's physical reactions and verbal complaints.  No issues with airway reported and no obvious skin reactions.  Blood pressure at time was 170/90.  Pain came and went for duration of less than 10 minutes and pt was not experiencing pain by the time EMS arrived.  EMS did not administer treatment. Pt still reported lightheadedness & dizziness when stood up.  She was escorted out of store by EMS, daughter and husband.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Disorientation, Eye movement disorder, Fall, Fatigue
Clinical narrative: Requested Pharmacy to provide flu shot at 5:30pm.  Later, At 9:30pm, nightly medications given, as she was going to bed  At 9:40pm, she was sitting On toilet and yawned twice, then her head rotated slowly to the left but far enough for her chin to reach her left shoulder, her eyes rolled back and she began shaking, then cramped her mussels tightly in face, arms, legs and abdomen and the went limp and fell over; episode lasted about 2 to 3 minutes.  BP 107/70; heart rate 95; temp 98.3; weight 116.  Completely disoriented for 15 minutes Afterwards and laid on side staring at the wall.  Eyes blood shot.  Seems very exhausted and has been transferred to her bed, occasionally with shivers.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Hypotonia, Muscle spasms, Ocular hyperaemia, Posture abnormal, Staring
Clinical narrative: Requested Pharmacy to provide flu shot at 5:30pm.  Later, At 9:30pm, nightly medications given, as she was going to bed  At 9:40pm, she was sitting On toilet and yawned twice, then her head rotated slowly to the left but far enough for her chin to reach her left shoulder, her eyes rolled back and she began shaking, then cramped her mussels tightly in face, arms, legs and abdomen and the went limp and fell over; episode lasted about 2 to 3 minutes.  BP 107/70; heart rate 95; temp 98.3; weight 116.  Completely disoriented for 15 minutes Afterwards and laid on side staring at the wall.  Eyes blood shot.  Seems very exhausted and has been transferred to her bed, occasionally with shivers.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: Requested Pharmacy to provide flu shot at 5:30pm.  Later, At 9:30pm, nightly medications given, as she was going to bed  At 9:40pm, she was sitting On toilet and yawned twice, then her head rotated slowly to the left but far enough for her chin to reach her left shoulder, her eyes rolled back and she began shaking, then cramped her mussels tightly in face, arms, legs and abdomen and the went limp and fell over; episode lasted about 2 to 3 minutes.  BP 107/70; heart rate 95; temp 98.3; weight 116.  Completely disoriented for 15 minutes Afterwards and laid on side staring at the wall.  Eyes blood shot.  Seems very exhausted and has been transferred to her bed, occasionally with shivers.
Age: 49.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, Swollen Left Deltoid.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blindness transient, Immediate post-injection reaction, Loss of consciousness, Seizure like phenomena
Clinical narrative: HPV vaccine administered in Right arm. Then meningitis administered in left arm. As soon as second vaccine given patient stated she could not see. Patient then started to pass out and I laid her down on table. Patient had seizure-like tremor one time. Doctor evaluated patient and within five minutes she felt better. After approx. 30 more minutes patient left the office feeling better.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site cellulitis, Rash vesicular
Clinical narrative: Cellulitis @ the site of injection. Full body chicken pox-like rash
Age: 71.0
Sex: M
Vaccine: FLUA4, PNC13
Symptoms: Asthenia, Chills, Decreased appetite, Lethargy, Pyrexia
Clinical narrative: he reported fever, vertigo, weakness, chills, lethargic, no appetite that started less than 24 hrs after shot and Lasted about a week.
Age: 71.0
Sex: M
Vaccine: FLUA4, PNC13
Symptoms: Vertigo
Clinical narrative: he reported fever, vertigo, weakness, chills, lethargic, no appetite that started less than 24 hrs after shot and Lasted about a week.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: The vaccine was given subcutaneously instead of intramuscularly in error. The patient did not report any adverse effects, but this was noticed at pharmacy level.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: PT. Had large Red swollen area- Hot Hard & painful to touch.
Age: 61.0
Sex: U
Vaccine: UNK
Symptoms: Swollen tongue
Clinical narrative: Reports "tongue swelling" in Evening.  R/O Food. - Resolved w/ Benadryl.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Blood prolactin, Breast discharge, Full blood count, Nausea, Oestradiol
Clinical narrative: Sick to my stomach. Arm hurt for a week. Tingleling and Itching in my chest area secretions from both nipples. My shirt was stuck (This occured 4 days post vaccine
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Paraesthesia, Pruritus, Red blood cell sedimentation rate
Clinical narrative: Sick to my stomach. Arm hurt for a week. Tingleling and Itching in my chest area secretions from both nipples. My shirt was stuck (This occured 4 days post vaccine
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Vomiting
Clinical narrative: passed out on ground; contusion noted back of head and left elbow; concussion symptoms multiple times; was hungry; felt sick on stomach; head hurt; emesis; Information has been received on 18-AUG-2020. This spontaneous report as received from a healthcare professional refers to an 18-year-old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On 31-JUL-2019 at 15:00, the patient was intramuscularly vaccinated in his right arm with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose was not reported, lot # R017251, expiration date was not reported but upon internal validation, it was established as 04-MAY-2021) and with a second dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA), intramuscularly in his left arm, lot# U6365AA (exact dose and expiration date were not reported), both for prophylaxis. On the same day at 15:05, after getting shots, the patient walked outside and passed out on a ground. His girlfriend found him lying in parking space unconscious, easily aroused and got health department staff. A nurse went out and assessed the patient. His blood pressure (BP) was 142/88 (units not provided), pulse (P) was 88 (units not provided), neuro checks were completed and all were within normal limits, the patient was alert and oriented to person, place and time. The nurse noted contusion of the patient's back of head and left elbow. The patient was assisted to sit in truck in air conditioning and he received water and candy. He reported felt sick on stomach and head hurt but just thought he was hungry due to not eating since early morning (am). The registered nurse advised the patient to go to emergency room (ER) for further evaluation due to hitting his head and concussion symptoms multiple times, however the patient refused. His girlfriend called back later to advice the patient letting her take him to the ER/department or urgent care for evaluation due to extreme headache and emesis. On an unknown date in 2019, the patient recovered from the events. The relatedness between the events and the suspect vaccines was not reported. The agency considered the report to be non-serious.  Follow-up information was received from the healthcare professional on 04-SEP-2020.  The reporter was not able to locate any additional information because they sought "a lot of eighteen-year-old males". No additional patient demographics were available to assist with follow-up. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename:; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R017251; expirationdate: 04-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 75.0
Sex: M
Vaccine: TDAP, VARZOS, FLU4, PPV, TDAP, VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Night after receiving vaccines, patient reports unbearable joint pain in their right shoulder. Adamant it's from the shingles vaccine in particular. Went to PCP and hospital for pain medicine to treat the pain.
Age: 75.0
Sex: M
Vaccine: TDAP, VARZOS, FLU4, PPV, TDAP, VARZOS
Symptoms: Arthralgia
Clinical narrative: Night after receiving vaccines, patient reports unbearable joint pain in their right shoulder. Adamant it's from the shingles vaccine in particular. Went to PCP and hospital for pain medicine to treat the pain.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Uncontrollable shivering for 20 minutes, covered up and took Tylenol, put pen in mouth.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Rash erythematous
Clinical narrative: Patient had a rash on her arm several inches below the injection site. The rash was red and hard to the touch. Patient says she started experiencing the symptoms the evening (Monday, 9/7) of the shot, and it has been improving. Patient said no other changes in her life that could've caused the rash. Patient already reached out to her PCP on Wednesday (9/9) morning, and is waiting to hear back.
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: expired dose of PROQUAD that was inadvertently administered to a patient; This spontaneous report as received from a nurse regarding a 6 years old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not provided.  On 10-AUG-2020, an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) (lot S003862 and expiration date: 08-AUG-2020; strength, dose, frequency, route, anatomical location were not reported) for prophylaxis was inadvertently administered to the patient (expired product administered). It was unable to determine if vaccine had a previous temperature excursion or not. The outcome of the event was not provided.
Sex: U
Vaccine: MMR
Symptoms: Product use in unapproved indication
Clinical narrative: Because of what pediatrician believes about a potential connection between MMR and COVID, he, his wife, and his personal physician all recently vaccinated themselves with MMR II for protection; This spontaneous report was received from a retired pediatrician, referring to his personal physician, a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  Because of what the reporting pediatrician believed was a potential connection between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and coronavirus (COVID-19), he, his wife (captured in cases 2008USA008655 and 2008USA006838 respectively) and his physician all vaccinated themselves with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for protection against COVID-19 on an unspecified date in 2020 (reported as "recently")  This is one of three reports received from the same reporter.  This case has been considered non-valid due to the lack of patient identifiers.; Sender's Comments:  US-009507513-2008USA006838: US-009507513-2008USA008655:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Patient administered vaccine outside of recommended range; This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.      On 28-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot # T006792 (lot # T006792 was verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date not provided but upon internal validation established as 24-AUG-2021) (dose and route of administration were not reported) for prophylaxis.         The vaccine was exposure to a temperature excursion of -9°C to 8°C (-8.5°C) during a time frame of 1 hour and 19 minutes called by a data logger. The vaccine was also exposure to previous excursion of -14°C to-10°C (-11.9°C) for 55 minutes.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administration of improperly stored vaccines; This spontaneous report was received from a certified medical assistant and refers to a 5-year-old patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha) (PROQUAD) (dosage regimen and route of administration were not provided), lot number S021324, expiration date 05-JAN-2021, as prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT).  The improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha) (PROQUAD) experienced a temperature excursion of 6 degree Fahrenheit (F) to 14 F (average temperature was 10.56 F) for a period of 50 minutes. It was reported that the vaccine had a previous temperature excursion of 6 degree Fahrenheit (F) to 14 F (average temperature was 8.47 F) for a period of 30 minutes. The excursion was called by a digital data logger. No additional adverse event (AE) reported.; Sender's Comments:  US-009507513-2009USA000747: US-009507513-2009USA000777: US-009507513-2009USA000710: US-009507513-2009USA000736: US-009507513-2009USA000749: US-009507513-2009USA000757: US-009507513-2009USA000762: US-009507513-2009USA001006: US-009507513-2009USA001099: US-009507513-2009USA001114: US-009507513-2009USA001123: US-009507513-2009USA001135:
Sex: U
Vaccine: PNC13, PPV
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: No adverse event; Interchange of vaccine products; This Non-valid spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported.     On 02-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration and lot # were not reported) for prophylaxis.  Approximately on 16-SEP-2019 (reported as 2 weeks later), the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dose, route of administration, lot # and indication were not reported) due to charting mistake (interchange of vaccine products). No adverse effects reported
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Female patient received a dose of MMRII on 8/14/2020 that had been improperly stored; This spontaneous report has been received from a licensed practical nurse regarding a female patient of unknown age. Her concurrent conditions, known allergies/reactions, and medical history were not reported. Concomitant medications included steril diluent.   On 30-JUL-2020, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MRR II) (lot # S032826 with expiration date 16-OCT-2021; rHA albumin status) had a temperature excursion above 47 degree farenheit (F) (average temperature was 59.1F) for 225 minutes; and on 04-AUG-2020, above 47 F (average temperature was 51.36F) for 59 minutes. On 14-AUG-2020, the patient was vaccinated with the improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MRR II) (dose regimen and route of administration were not reported) for prophylaxis (product storage error), which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date were not provided). The call was due to a digital data logger. No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Nurse initially calling in for a temperature excursion evaluation. VARIVAX administered post temperature excursion.; This spontaneous report was received from a licensed practice nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, drug reactions/allergies, medical history and historical drugs was not provided.  On 31-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live VARIVAX , 0.5 milliliter lot # S032355 and expiration date 14-OCT-2021 (route of administration not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT).  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -9 to -8 degree Celsius (°C) (-2.8°C) for 5 hours and 2 minutes on unknown date; no previous temperature excursion were reported.  The call was made due to a digital data logger.; Sender's Comments:  US-009507513-2009USA001227: US-009507513-2009USA001249:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Three children received a dose of the VARIVAX that was stored out of recommended temperature range.; Information has been received from the office manager and refers to a child patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On an unknown date, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R035226 and expiration date of 04-DEC-2020 (route of administration and anatomical location were not reported), for prophylaxis, which were stored in the range of 57.9 Fahrenheit degrees for 49 hours. No previous temperature excursion was reported. Unable to retreive the vial as it was disposed of after administration of vaccine.  Digital data logger was involved.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2009USA001660: US-009507513-2009USA002056: US-009507513-2009USA002057:
Age: 0.33
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: VAQTA was given to a 4 month old patient; This spontaneous report was received from a nurse referring to a 4 month old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 01-SEP-2020, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) 0.5 ml, lot # T014835, expiration date on 17-JUL-2021, for prophylaxis (route  and freuqencywas not provided) (Inappropriate age at vaccine administration). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014835; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician, refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 11-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, subcutaneously (lot number S032355, expiration date 14-OCT-2021) (exact dose and anatomical location were not reported), as routine vaccination. The vaccine was reconstituted with properly stored sterile diluent (lot number S032591, expiration date 16-AUG-2022). The vaccine experienced temperature excursions from 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (13.6 F) for 12 hours (multiple excursions) and from 15 degrees Fahrenheit to 46 degrees Fahrenheit (16.0 F) for 30 minutes. Digital data logger was involved. There was no previous temperature excursion. The outcome of the event was unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA001256: US-009507513-2009USA001739: US-009507513-2009USA001283:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: children received a dose of the VARlVAX that was stored out of recommended temperature range; This spontaneous report was received from an other healthcare professional, refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (VARIVAX) injection, 0.5 milliliter (lot # R035226 which has been verified to be valid, expiration date 04-DEC-2020) (route of administration and anatomical location were not reported) for prophylaxis. The vaccine was exposed to temperature of 57.9 degrees Fahrenheit (F) for 49 hours. Digital data logger was involved. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA001660: US-009507513-2009USA001387: