chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: An 18 year old male patient who was administered the first dose of GARDASIL 9 on 25-MAR-2019, the second dose on 27-AUG-2019 and the third dose on 22-OCT-2019.; This spontaneous report was received from a Registered Nurse via company representative referring to a 18 year old male patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  The Registered Nurse reported that about an 18 year old male patient was administered the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown)  on 25-MAR-2019, the second dose on 27-AUG-2019 and the third dose on 22-OCT-2019 for phrophylaxis.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Approximately 30  minutes after receiving the vaccine he develop urticaria on his right elbow. He was evaluated on 12/17/2019 and continued to have an intermittent urticarial rash that would appear on different areas of his arms
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Nausea, Pain in extremity, Vomiting
Clinical narrative: Left arm was red, painful starting PM after receiving IM Influenza vaccine. Pt. also experienced nausea and vomiting.
Age: 1.33
Sex: M
Vaccine: FLU4, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Rash papular
Clinical narrative: Red, painful lump at injection site. Mild erythematous popular rash - diffuse.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous, Swelling
Clinical narrative: Patient developed a red rash with swelling and pain associated that covers her entire body.  Patient also experiencing diffuse body aches
Age: 1.25
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain at the injection site -
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis noted at injection site, 12 cm & 5 cm per provider. Placed on keflex, 5 ml TID for 10 days
Age: 81.0
Sex: F
Vaccine: FLUA3
Symptoms: Rash, Rash pruritic
Clinical narrative: ITCHY RASH ON LEGS AND FEET
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Severe headache on the night of the shot. Woke up at 5:30am with a headache and fatigue after sleeping all night. Fever, body aches and chills started at around noon on 12/19/2019. Took ibuprofen at noon and slept during part of the afternoon. Feeling somewhat better by late afternoon.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Severe headache on the night of the shot. Woke up at 5:30am with a headache and fatigue after sleeping all night. Fever, body aches and chills started at around noon on 12/19/2019. Took ibuprofen at noon and slept during part of the afternoon. Feeling somewhat better by late afternoon.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: rash that looked like shingles on abdomen 3 days following injection
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Blood test, Computerised tomogram, Influenza, Influenza virus test positive
Clinical narrative: Experienced Mild flu symptoms on 11./11/19 AM. Mild fever that night with rhonorrhea and back ache. Fainted Tuesday AM (11/12/19), tachycardia, went to ER and tested positive for Flu
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rhinorrhoea, Scan with contrast, Spinal X-ray, Syncope
Clinical narrative: Experienced Mild flu symptoms on 11./11/19 AM. Mild fever that night with rhonorrhea and back ache. Fainted Tuesday AM (11/12/19), tachycardia, went to ER and tested positive for Flu
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Tachycardia
Clinical narrative: Experienced Mild flu symptoms on 11./11/19 AM. Mild fever that night with rhonorrhea and back ache. Fainted Tuesday AM (11/12/19), tachycardia, went to ER and tested positive for Flu
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient was given flu shot and ppd skin test on 12/17/19 for her CNA program. Patient came in 12/19/19 to have her ppd skin test read and c/o of injection site of the flu was hurting. This writer looked at the injection site and noted it to be red, swollen, raised and hard. This writer then put pt. on the schedule to be further examined by provider.
Age: 55.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Facial paralysis
Clinical narrative: According to the patient she experienced  left facial droop a day after getting her Shingrix 2nd dose and Hepatitis B 3rd dose and  went to the Emergency department. She was treated with  oral steroids , antivirals ,eye drops , physical therapy and is followed up with the neurologist.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, UNK, VARCEL
Symptoms: Mass, Rash
Clinical narrative: Mom noticed new bumps, 1 behind each ear starting 12/13. Mom noted more lumps on the back of his head just today and is here to have those checked. No overlying skin changes, don't seem to bother him.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, UNK, UNK
Symptoms: Irritability, Vomiting projectile
Clinical narrative: Mother brought child to the ED with complaints that son has had 2 episodes of projectile vomiting this morning after each feeding. Also states that baby is more fussy than normal. No fever noted by mom or in ED. This started today prior to coming into the ED. Upon assessment baby was awake and alert, mom denies any difficulty breathing or sleeping. Thighs show no signs of redness. No rash noted on body.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Consciousness fluctuating, Syncope
Clinical narrative: PT RECEIVED ALL 4 VACCINES.  AFTER LAST VACCINE - MENACTRA- WAS ADMINISTERED PT.  FAINTED.  PT WAS SITTING IN A CHAIR AND SLIDE DOWN TO BOTTOM OF CHAIR.  PT DID NOT FALL ON FLOOR-  NO INJURY OCCURRED.   VITAL SIGNS IMMEDIATELY FOLLOWING AT 3:41- BP 80/47- HR 55- RR 16- PT IN AND OUT OF CONSCIOUSNESS .  EMS CALLED- PT STABLE
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pustule, Scab, Secretion discharge
Clinical narrative: About 2 weeks after Shingles shot, I contracted chicken pox-like marks.  Mild.  Only about 5 pox.  I know what they look like.  It wasn't anything else.  They all weeped for a time and then crusted over.  My Dr. and the Pharmacist seemed uninterested even though I couldn't find anything on the internet similar to my symptoms.  My wife's reaction was much more serious.  She was very sick for more than three weeks with aches, chills, fever and severe respiratory distress which all started within a few hours of receiving the shot. No pick marks.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: Severe nausea and head for 2 days following
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Injection site erythema, Injection site oedema, Nausea
Clinical narrative: Patient complained of headache and nausea within a few hours of receiving the vaccine.  The following day she experienced dizziness, near-syncope, significant injection side edema and erythema, and fever 102.3F.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope, Pyrexia
Clinical narrative: Patient complained of headache and nausea within a few hours of receiving the vaccine.  The following day she experienced dizziness, near-syncope, significant injection side edema and erythema, and fever 102.3F.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Cough, Dyspnoea, Injected limb mobility decreased, Injection site joint pain
Clinical narrative: On 10/16 I received the flu shot from  a coworker. I am an RN and getting the flu shot is mandatory for all of us. When she injected the vaccine I looked over at my shoulder because it was more painful than usual and I was also surprised at how high up on my arm it was.  Within 30 minutes of receiving the injection I was experiencing abnormal sensations in my 4th and fifth fingers on my L hand and the sensation that my wrist watch was cutting off my circulation although I could (in actuality) slip a finger between the band and my skin. My shoulder had a deep ache within it and I had deep pain at the injection site. I reported this to my supervisor and was seen by, PA, the Associate Medical Director. She agreed the symptoms were concerning and asked me to update her. That night the abnormal sensations resolved but the joint pain worsened and by the morning I could barely move it above my head. I texted PA and she recommended I see my PCP. I made an appointment with my PCP for next available (Monday  10/20) but I cancelled it because it felt like I had the pain under control and didn't want to miss work. Over the next few days I took Motrin in high amounts, used hot packs and ice packs. This continued through the next week. This same week I began having a spastic cough, severe pain in my ribs and abdominals as well as difficulty catching my breath or taking a deep breath. I ended up in urgent care due to this issue on  10/25.   I stopped taking Motrin and the pain  in my shoulder came back, but even worse during the evening on 10/27. The pain woke me from my sleep . I made an appointment with my PCP and went to see Dr. for both my shoulder pain and the respiratory issue on 10/29.  Dr. put me on a burst of oral steroids from  10/30 - 11/3 for the shortness of breath/coughing. During this time, I also experienced complete respite from the shoulder pain and enjoyed my full range of motion and strength for the first time since the vaccine was given. She also sent a referral for me to see an orthopedist.   I saw Dr., (an orthopedist) on  11/15. At the time of our appointment I was not in pain because I was actually back on steroids (11/12-11/16) for continued respiratory symptoms.  He opted to not give me a cortisone injection because of the oral steroids I was receiving. He prescribed physical therapy to me and told me to come back when I was off the oral steroids if PT did not resolve the issue.  My PCP diagnosed me with SIRVA. (Shoulder Injury Related to Vaccine Administration).  I have been in PT since 11/18. I am still symptomatic except for when I am on oral steroids.  I have an MRI scheduled for 12/29 and a corticosteroid injection  scheduled for 1/2/20.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Middle insomnia, Musculoskeletal chest pain, Poor peripheral circulation, Product administered at inappropriate site
Clinical narrative: On 10/16 I received the flu shot from  a coworker. I am an RN and getting the flu shot is mandatory for all of us. When she injected the vaccine I looked over at my shoulder because it was more painful than usual and I was also surprised at how high up on my arm it was.  Within 30 minutes of receiving the injection I was experiencing abnormal sensations in my 4th and fifth fingers on my L hand and the sensation that my wrist watch was cutting off my circulation although I could (in actuality) slip a finger between the band and my skin. My shoulder had a deep ache within it and I had deep pain at the injection site. I reported this to my supervisor and was seen by, PA, the Associate Medical Director. She agreed the symptoms were concerning and asked me to update her. That night the abnormal sensations resolved but the joint pain worsened and by the morning I could barely move it above my head. I texted PA and she recommended I see my PCP. I made an appointment with my PCP for next available (Monday  10/20) but I cancelled it because it felt like I had the pain under control and didn't want to miss work. Over the next few days I took Motrin in high amounts, used hot packs and ice packs. This continued through the next week. This same week I began having a spastic cough, severe pain in my ribs and abdominals as well as difficulty catching my breath or taking a deep breath. I ended up in urgent care due to this issue on  10/25.   I stopped taking Motrin and the pain  in my shoulder came back, but even worse during the evening on 10/27. The pain woke me from my sleep . I made an appointment with my PCP and went to see Dr. for both my shoulder pain and the respiratory issue on 10/29.  Dr. put me on a burst of oral steroids from  10/30 - 11/3 for the shortness of breath/coughing. During this time, I also experienced complete respite from the shoulder pain and enjoyed my full range of motion and strength for the first time since the vaccine was given. She also sent a referral for me to see an orthopedist.   I saw Dr., (an orthopedist) on  11/15. At the time of our appointment I was not in pain because I was actually back on steroids (11/12-11/16) for continued respiratory symptoms.  He opted to not give me a cortisone injection because of the oral steroids I was receiving. He prescribed physical therapy to me and told me to come back when I was off the oral steroids if PT did not resolve the issue.  My PCP diagnosed me with SIRVA. (Shoulder Injury Related to Vaccine Administration).  I have been in PT since 11/18. I am still symptomatic except for when I am on oral steroids.  I have an MRI scheduled for 12/29 and a corticosteroid injection  scheduled for 1/2/20.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Sensory disturbance, Shoulder injury related to vaccine administration, X-ray limb
Clinical narrative: On 10/16 I received the flu shot from  a coworker. I am an RN and getting the flu shot is mandatory for all of us. When she injected the vaccine I looked over at my shoulder because it was more painful than usual and I was also surprised at how high up on my arm it was.  Within 30 minutes of receiving the injection I was experiencing abnormal sensations in my 4th and fifth fingers on my L hand and the sensation that my wrist watch was cutting off my circulation although I could (in actuality) slip a finger between the band and my skin. My shoulder had a deep ache within it and I had deep pain at the injection site. I reported this to my supervisor and was seen by, PA, the Associate Medical Director. She agreed the symptoms were concerning and asked me to update her. That night the abnormal sensations resolved but the joint pain worsened and by the morning I could barely move it above my head. I texted PA and she recommended I see my PCP. I made an appointment with my PCP for next available (Monday  10/20) but I cancelled it because it felt like I had the pain under control and didn't want to miss work. Over the next few days I took Motrin in high amounts, used hot packs and ice packs. This continued through the next week. This same week I began having a spastic cough, severe pain in my ribs and abdominals as well as difficulty catching my breath or taking a deep breath. I ended up in urgent care due to this issue on  10/25.   I stopped taking Motrin and the pain  in my shoulder came back, but even worse during the evening on 10/27. The pain woke me from my sleep . I made an appointment with my PCP and went to see Dr. for both my shoulder pain and the respiratory issue on 10/29.  Dr. put me on a burst of oral steroids from  10/30 - 11/3 for the shortness of breath/coughing. During this time, I also experienced complete respite from the shoulder pain and enjoyed my full range of motion and strength for the first time since the vaccine was given. She also sent a referral for me to see an orthopedist.   I saw Dr., (an orthopedist) on  11/15. At the time of our appointment I was not in pain because I was actually back on steroids (11/12-11/16) for continued respiratory symptoms.  He opted to not give me a cortisone injection because of the oral steroids I was receiving. He prescribed physical therapy to me and told me to come back when I was off the oral steroids if PT did not resolve the issue.  My PCP diagnosed me with SIRVA. (Shoulder Injury Related to Vaccine Administration).  I have been in PT since 11/18. I am still symptomatic except for when I am on oral steroids.  I have an MRI scheduled for 12/29 and a corticosteroid injection  scheduled for 1/2/20.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: bloody streaks in mucousy stool
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: THERE WERE NO ADVERSE EFFECTS BUT THE PATIENT WAS ON ENBREL AT THE TIME OF ADMINISTRATION. WANT TO CONTRIBUTE TO POST MARKETING SURVEILLANCE INFORMATION  REGARDING IMMUNOCOMPROMISED PATIENTS THAT MAY BE VALUABLE TO THE CDC.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Ear pain, Headache, Impaired work ability, Insomnia
Clinical narrative: Extreme pain and stiffness migrating from the left shoulder to the back and radiating to the neck and into my head around my left ear. Neck and head pain has cause prolonged episodes of vertigo. Normal functions like sleeping and driving have been difficult since the neck stiffness does not allow me to turn my head. Dr. is sending me to physical therapy. I have not started that yet.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain, Vertigo
Clinical narrative: Extreme pain and stiffness migrating from the left shoulder to the back and radiating to the neck and into my head around my left ear. Neck and head pain has cause prolonged episodes of vertigo. Normal functions like sleeping and driving have been difficult since the neck stiffness does not allow me to turn my head. Dr. is sending me to physical therapy. I have not started that yet.
Age: 1.08
Sex: M
Vaccine: FLU4
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: patient had two witnessed tonic clonic seizures lasting about a minute with the first being on 12/18/2019 and another witnessed one 12/19/2019.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling cold, Hyperhidrosis, Night sweats
Clinical narrative: I went to my physician's office to receive the Shingrix vaccination.  I received the immunization  at approximately 2:00 pm.  By 8:00 pm the same day, I had chills and went to bed.  During the night, I woke up with a 103.6 temperature.  I took over the counter medication to reduce my fever.  The second day, I would have chills and run a temperature at around 101.  Again, I took over the counter medication.  The second night, I had a night sweat that was so fierce, my entire bed including sheets, blankets and comforter were completely soaked.  Today is day 3 and no fever, but now I feel cold and weak.  I sincerely regret taking this vaccination and will recommend to family and friends to refrain from taking it.  I don't think I had a "mild" reaction is a fever of 103.6.  If it went any higher, I would have gone to the emergency room.  I had shingles in my early 20's.  I'd take that again any day over this vaccination.  I hope I am going to feel better soon.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I went to my physician's office to receive the Shingrix vaccination.  I received the immunization  at approximately 2:00 pm.  By 8:00 pm the same day, I had chills and went to bed.  During the night, I woke up with a 103.6 temperature.  I took over the counter medication to reduce my fever.  The second day, I would have chills and run a temperature at around 101.  Again, I took over the counter medication.  The second night, I had a night sweat that was so fierce, my entire bed including sheets, blankets and comforter were completely soaked.  Today is day 3 and no fever, but now I feel cold and weak.  I sincerely regret taking this vaccination and will recommend to family and friends to refrain from taking it.  I don't think I had a "mild" reaction is a fever of 103.6.  If it went any higher, I would have gone to the emergency room.  I had shingles in my early 20's.  I'd take that again any day over this vaccination.  I hope I am going to feel better soon.
Age: 52.0
Sex: M
Vaccine: JEV1
Symptoms: Arthralgia, C-reactive protein, Dizziness, Fatigue, Full blood count
Clinical narrative: Dizziness, fatigue, scalp sensitivity, "half-body" numbness, arthralgias, fever blister (left lower lip)
Age: 52.0
Sex: M
Vaccine: JEV1
Symptoms: Hyperaesthesia, Hypoaesthesia, Laboratory test, Oral herpes, Red blood cell sedimentation rate
Clinical narrative: Dizziness, fatigue, scalp sensitivity, "half-body" numbness, arthralgias, fever blister (left lower lip)
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Furuncle, Nodule, Rash
Clinical narrative: BOIL AND RASH ON LEFT ARM BOIL ON BUTTOCKS KNOT ON LEFT ELBOW AREA FACIAL RASH
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: the patient developed a rash on right arm that went from injection site to elbow, unsure if area was warm. rash resolved by day 3
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Insomnia, Joint range of motion measurement, Pain, X-ray
Clinical narrative: PAIN UPON INJECTION ON 12/7/19.  AS OF 12/19/19, IT STILL HURTS TO PUT ON COAT, PANTS, ETC.  PAINFUL AT BEDTIME (COULD NOT SLEEP) ON 12/18/19.  HURTS TO MOVE IT.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: patient has extreme swelling and bruising surrounding injection site
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: patient complain muscle pain,call md
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: PATIENT REPORTED THAT SHE HAS BEEN GOING TO THERAPY DUE TO SHE STILL HAS A LOT OF PAIN IN HER ARM.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: For both injections, within 9 hours I developed a fever.   After the first shot, my fever peaked at 101.4 and I had a fever during most of the following day around 99 degrees..  For the second shot it went up to 102.5, lasting throughout the night.  After the second shot and during the fever period I was extremely dizzy as well with a bad headache that was not relived with aspirin..   The fever broke somewhere around 9 a.m. the following day and I felt very tired and had a bad headache for most of the day.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Muscle tightness, Seizure like phenomena
Clinical narrative: Patient reported teeth chattering and seizure like activity where muscles temporarily locked in legs by 12 am that morning. about 9-10 hours after vaccine.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site nodule
Clinical narrative: Pt arm created LARGE knot at injection site
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Limb immobilisation, Mobility decreased, Musculoskeletal pain
Clinical narrative: The day after receiving the vaccine, the patient was reaching for something and felt a pain in her shoulder. She called me on 12/19/19 to report that she was unable to move her arm and was wearing it in a sling. I advised her to contact her doctor.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site inflammation, Pyrexia
Clinical narrative: 12/14/2019; Patient received two shots, Fluzone High Dose and PneumoVax 23, on his right upper arm.  Fluzone HD was on the upper part, and PneumoVax 23 was on the lower part.   12/19/2019; Patient showed up at the pharmacy and stated that he had developed a severe reaction to the shots.  He described, "The upper arm was severely inflamed along with a fever for the next 24 hours."  (Patient received the Fluzone HD in 2018 and did not have any complaints of)
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Influenza like illness, Pyrexia, Rash
Clinical narrative: Pt developed fever, chills, and flu-like symptoms on 12/12/2019 (day after receiving the shot). On 12/15/19, the pt started developing a rash on his right arm. The rash was diagnosed as shingles, and the pt is now receiving antivirals to treat the infection.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Immediate post-injection reaction, Mass, Pain
Clinical narrative: Patient had pain immediately on injection and developed redness and a baseball size lump by the following day.  Redness and pain started the day of the shot and spread for a day or so afterward.  Lump and redness slowly decreased in size over about a week. Patient also had allover joint pain on both first and second dose of shingrix.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Warm to touch, itching, swelling
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: M.D. OFFICE ADMINISTERED PNEUMOVAX TO PATIENT IN NOVEMBER, 2019. PATIENT CAME IN TO PHARMACY ON 12/11/19 ASKING FOR PNEUMONIA SHOT. ON 12/17/19 PATIENT CALLED INTO PHARMACY AFTER REMEMBERING HE HAD ALREDY RECIEVED THE VACCINATION BY PHYSICIAN OFFICE TO FIND OUT IF HE WOULD BE OK BECAUSE HE RECEIVED SAME SHOT WITHING ONE MONTH PERIOD. I DISCUSSED WITH PATIENT. I ALSO CALLED PHARMACY CLINICAL TO DICUSS. LAST, I CALLED DR.'S OFFICE TO LET THEM KNOW. ALL AGREE NO ADVERSE REACTION.
Age: 11.0
Sex: U
Vaccine: HPV4, MENB, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Skin Rash 3 hours after vaccines given Seen in emergency room was given Benadryl Per ED Note No Rash was actually noted. Due to moms description of hives patient received Mom describes Rash as facial hives. No documentation Per ED NOTE
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: Mother reports patient developed itchy rash to chest & neck one wk. after immunization.
Age: 2.92
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness on Lt thigh 80 mm x 80 mm
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Injection site rash, Pruritus
Clinical narrative: Pt complained of a rash that formed on his arm at the injection site. He also complained of itching & being uncomfortable.
Age: 46.0
Sex: F
Vaccine: HEP, HEPA, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Shot on Monday. Noticed Tuesday morning when got dressed. Injection site @ back of arm raised. Size of a silver dollar. States warm not hot. Denies fever. Did not use cold compressors
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Injection site reaction, Injection site urticaria, Rash erythematous, Urticaria
Clinical narrative: Hep B was given on 12/5/19. On 12/6/19 patient started with red dots on Left thigh, on 12/7/19-hives spread to both legs and arms. Went to Urgent Care and told probably a vaccine reaction. Benadryl given. Rash is gone.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Muscle spasms
Clinical narrative: Patient informed us on 12/16/2019 that she developed left ankle spasms/pain on November 3rd. Patient stated spasms started at left ankle and traveled to the ball of her left foot. Patient described pain similar to a "charley horse" Patient stated spasms would last 30 to 40 seconds. Patient stated these symptoms lasted from November 3 to November 6th. Symptoms reappeared again Thanksgiving weekend, but were not as severe.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Cognitive disorder, Communication disorder, Decreased eye contact, Dysgraphia, Regressive behaviour
Clinical narrative: regress in cognitive abilities; Information has been received from FDA (Agency number 806510) under the Act referring to a male patient of unknown age (age at vaccination: 12 years old). The patient had no known allergies, chronic conditions or concomitant medications.  On 05-FEB-2016 at 16:00, the patient was vaccinated with the third dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.    On 01-JAN-2017 at 16:00, the patient experienced regress in cognitive abilities that he once had, such as writing, drawing, eye contact and communication. He had a doctor or other healthcare professional office/clinic visit. The patient had not recovered from the events.  The causality between the event and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.  The event was considered to be disabling (induced disability or permanent damage).  On 19-DEC-2019, a phone call was placed to a physician. The phone call was answered by  reception. The phone call was transferred to pediatric office. The phone call was answered by  Unit clerk. The clerk was unable to assist since there were no patient identifiers.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site oedema, Oropharyngeal pain, Pain in extremity, Pruritus
Clinical narrative: fever; headache; malaise; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced fever, headache, malaise and diarrhea. On an unknown date, the outcome of the fever, headache, malaise and diarrhea were recovered/resolved.   It was unknown if the reporter considered the fever, headache, malaise and diarrhea to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination with 1st dose experienced  fever, headache, malaise that all lasted for about one week and diarrhea that lasted for about 2 weeks and then all had resolved. The patient consented to follow up. This case has been linked with cases US2019AMR231140, US2019230531 and US2019AMR231309 reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; headache; malaise; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced fever, headache, malaise and diarrhea. On an unknown date, the outcome of the fever, headache, malaise and diarrhea were recovered/resolved.   It was unknown if the reporter considered the fever, headache, malaise and diarrhea to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination with 1st dose experienced  fever, headache, malaise that all lasted for about one week and diarrhea that lasted for about 2 weeks and then all had resolved. The patient consented to follow up. This case has been linked with cases US2019AMR231140, US2019230531 and US2019AMR231309 reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Malaise, Pyrexia
Clinical narrative: fever; headache; malaise; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced fever, headache, malaise and diarrhea. On an unknown date, the outcome of the fever, headache, malaise and diarrhea were recovered/resolved.   It was unknown if the reporter considered the fever, headache, malaise and diarrhea to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination with 1st dose experienced  fever, headache, malaise that all lasted for about one week and diarrhea that lasted for about 2 weeks and then all had resolved. The patient consented to follow up. This case has been linked with cases US2019AMR231140, US2019230531 and US2019AMR231309 reported by the same reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills and nausea for 36 hours. Severe headache for 24 hours followed by mild headache for another 24 hours.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever, chills and nausea for 36 hours. Severe headache for 24 hours followed by mild headache for another 24 hours.
Age: 57.0
Sex: M
Vaccine: UNK, FLUR4
Symptoms: Anxiety, Chest pain, Computerised tomogram, Dyspnoea, Hypoaesthesia
Clinical narrative: Patient stated that on 10/19/19 he felt a bit sick and tingling of left arm and fingers. On 10/21 which spread to right arm on 10/22. He then Felt very sick on 10/23/2019 with shortness at breath and paralysis which led him to go to ER.
Age: 57.0
Sex: M
Vaccine: UNK, FLUR4
Symptoms: Lumbar puncture, Magnetic resonance imaging, Mechanical ventilation, Muscular weakness, Pain in extremity
Clinical narrative: Patient stated that on 10/19/19 he felt a bit sick and tingling of left arm and fingers. On 10/21 which spread to right arm on 10/22. He then Felt very sick on 10/23/2019 with shortness at breath and paralysis which led him to go to ER.
Age: 57.0
Sex: M
Vaccine: UNK, FLUR4
Symptoms: Paraesthesia, Presyncope
Clinical narrative: Patient stated that on 10/19/19 he felt a bit sick and tingling of left arm and fingers. On 10/21 which spread to right arm on 10/22. He then Felt very sick on 10/23/2019 with shortness at breath and paralysis which led him to go to ER.
Age: 57.0
Sex: M
Vaccine: UNK, FLUR4
Symptoms: Dyspnoea, Malaise, Paraesthesia, Paralysis
Clinical narrative: Patient stated that on 10/19/19 he felt a bit sick and tingling of left arm and fingers. On 10/21 which spread to right arm on 10/22. He then Felt very sick on 10/23/2019 with shortness at breath and paralysis which led him to go to ER.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Hyperhidrosis, Nausea, Tremor
Clinical narrative: Pt reported that the day after he got the vaccine he experienced " sick in the stomach, tremors, weakness, sweating" for 1-2 hours then on days two when he called the pharmacy he said he was fully recovered.  Rph recommended him to call doctor if those were symptoms of other issues besides the vaccine.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy, Blood test, Discomfort, Dyspnoea, Pruritus
Clinical narrative: On the evening of having the vaccine I was getting ready to take a shower and noticed raised reddish/ pink splotches on my neck and chest. The next morning my body was becoming itchy and gives were appearing on my arms, stomach, back, legs, etc. Over the course of a few days my entire body was covered in hives and I was having difficulties breathing. By the time I saw my primary care doctor I was extremely uncomfortable, persistent itchiness. I was given various meds however, they were not very effective. Eventually I was Sent to a dermatologist where an exam and biopsy was done on one of the largest hives. The results as I was told was due to a drug allergy and since all my medications have been long term with no adverse affects. The dermatologist said that the flu vaccine was the cause. The affects lasted over 8 months.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular, Urticaria
Clinical narrative: On the evening of having the vaccine I was getting ready to take a shower and noticed raised reddish/ pink splotches on my neck and chest. The next morning my body was becoming itchy and gives were appearing on my arms, stomach, back, legs, etc. Over the course of a few days my entire body was covered in hives and I was having difficulties breathing. By the time I saw my primary care doctor I was extremely uncomfortable, persistent itchiness. I was given various meds however, they were not very effective. Eventually I was Sent to a dermatologist where an exam and biopsy was done on one of the largest hives. The results as I was told was due to a drug allergy and since all my medications have been long term with no adverse affects. The dermatologist said that the flu vaccine was the cause. The affects lasted over 8 months.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Pruritus
Clinical narrative: Entire injection arm (left side) was pruritic for 48 hours post injection. There was a hard, red, lump at the injection site.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash erythematous, Swelling
Clinical narrative: Began with mild itching all over, and increased in severity on both arms, hands, and face, with swelling and red-raised bumps.  Eventually included torso.  Severe itching of palms.  Patient took Benadryl 50mg over the counter on 12/06/19  at 8:00 p.m., with no relief of symptoms.  Severe itching of palms decreased over a 2 day period.  Itching, bumps, and swelling continued, but did not worsen, and patient was seen by, PA-C, on 12/09/19, and was treated with ranitidine 150mg 2 times daily for 10 days, and prednisone 20mg 1 tab daily for 5 days.  Patient was also prescribed triamcinolone topical 0.1% cream, to apply to affected area two times daily.  Patient was seen again in clinic on 12/11/19, with improvement of symptoms.  Spoke with patient via telephone on 12/19/20, and patient states she has fully recovered - raised bumps, itching and swelling completely gone.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: pharmacist administered an expired dose ofGARDASIL 9 to a patient; This spontaneous report was received from a pharmacist refers to a patient of unknown gender and age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-NOV-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter dose, lot # N017832, expiration date: 16-NOV-2019 (number of dose and route of administration were not reported) for prophylaxis.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effect reported; The second and third dose are also outside the administration schedule; This spontaneous report was received from a clinical coordinator refers to a 12 years old male patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 28-OCT-2018, the patient received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R008164, expiration date not reported, but upon internal validation established as 12-NOV-2020)(strength and anatomical location were not reported) intramuscularly for prophylaxis. On 06-JUN-2019, the patient received his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R011630, expiration date not reported, but upon internal validation established as 12-DEC-2020) (strength and anatomical location were not reported) intramuscularly for prophylaxis. On 22-OCT-2019, the patient inadvertently received a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R029512, expiration date not reported, but upon internal validation established as 08-JUL-2021)(strength and anatomical location were not reported) intramuscularly for prophylaxis(inappropriate schedule of product administration). The patient was eligible for a two dose series which was administered on 28-OC-2018 and 06-JUN-2019 which was within the 2 dose schedule listed in the prescribing information. It is unknown if there were any temperature excursions for the three lot numbers. No additional adverse effect reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; Reported improperly stored PROQUAD was administered to patient on 10/24/2019; Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 24-OCT-2019, the patient was vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)(PROQUAD) injection as prophylaxis (lot number: S003176 with expiration date in 30-JUL-2020) (dose, route of administration, strength and anatomical location were not reported) (incorrect product storage).  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8 °C (3.4C) for the time frame of 98 hours and 45 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects reported.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: symptoms of Bell´s Palsy; This case was reported by a other health professional via sales rep and described the occurrence of bell's palsy in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th January 2019, the patient received the 1st dose of Shingrix. On 22nd January 2019, 4 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix at pharmacy. The patient had symptoms of Bell's Palsy. On 24th January 2019, the patient had a visit. The provider did not have a record of the vaccine's lot number and the patient has not visited or communicated with the office since the last visit.  No more information was known about the adverse events duration or outcome. The reporter did not give consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives in hands and back; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, after vaccination with Engerix B, the patient had  hives in hands and back. The batch number and expiry date were not available since the first dose was not administered in the same facility where the reporter called. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction 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, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, after vaccination, the patient had allergic reactions. No further details were provided. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site nodule
Clinical narrative: Swelling knot in the injection arm, close to injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number FE272, expiry date 18th February 2022) for prophylaxis.   On 14th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th December 2019, 1 days after receiving Shingrix, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site lump to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The pharmacist reported that, next day after vaccination, the patient went to pharmacy to report experiencing swelling knot in the injection site arm, closer to injection site but in bicep area.
Sex: M
Vaccine: FLUX
Symptoms: Drug ineffective, Influenza, Vaccination failure
Clinical narrative: contracted the flu; had received the flu vaccine and still contracted the flu, Lack of efficacy; Based on additional information received on 06-DEC-2019, this case initially considered as non-case was upgraded to serious: patient received the flu vaccine and still contracted the flu.   Initial information was received on 04-Dec-2019 regarding an unsolicited valid serious case from a consumer.  This case involves male patient of an unknown age who experienced flu (influenza), while he received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination 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 not reported via unknown route at an unknown administration site.  On an unknown date, the patient developed a serious flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported as a case of vaccination failure. Patient had received the flu vaccine and still contracted the flu. Lack of efficacy.  (Other relevant tests included no laboratory data.)  Final diagnosis was influenza and vaccination failure.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown.  Information on the batch number was requested.  Follow-up information was received on 06-DEC-2019 from a consumer.  This case initially considered as non-case was upgraded to serious: patient received the flu vaccine and still contracted the flu.; Sender's Comments: This case concerns male patient of an unknown demographics who experienced  influenza after and despite vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. More ever, there is no information regarding patient's condition at time of vaccination, immune status and congenital predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: slight redness & warmth on upper arm, hardness to touch. Area is 60mmx60mm, child's temp is 98.9.   Examined in clinic- explained to mother she should take to physician for evaluation especially if worsening.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: loss of range of motion, pain when sleeping on that side
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 3 inch x 2 inch oval shape area of redness, moderate swelling, firmness, and warmth to touch in location of flu vaccine. Advised monitor for increase in size, swelling and pain. Area outlined. Apply ice for comfort, if site itchy can apply otc hydrocortisone cream locally. If not improving  in next 24 hours, or worsening come back in to be evaluated again.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Facial paresis, Muscular weakness, Sensory loss
Clinical narrative: weakness and decreased sensation in your arms and legs that progressed to face